Industry Literature

Industry Literature

Preservation for heart transplantation is actively evolving. Stay abreast of news with this helpful resource for informative publications. The following industry specific literature citations are selected for the content of donor heart preservation and perfusion.  The purpose of this curated information is to provide a trusted guide to emerging high-value information from a dedicated and sustained critical search of thousands of news sources.

Differences in Metabolic Profiles of Human Hearts after 6 Hour Preservation with a Novel Hypothermic Machine Perfusion Preservation Device Compared to Cold Storage April 1, 2020

While cardiac transplantation remains the most effective therapy for end-stage heart failure, it continues to be plagued by a severe donor shortage. Many potentially suitable organs are not transplanted due to concerns of inadequate preservation with hypothermic static storage. Experimental and clinical studies suggest that machine perfusion preservation improves myocardial preservation. The purpose of this study is to test the hypothesis that a novel hypothermic machine perfusion preservation device maintains allograft oxidative metabolism, limits lactate accumulation, and more effectively preserves high energy phosphate stores compared to cold storage in a human model.

Minimizing Cardiac Oedema during Ex Vivo Perfusion in a Juvenile Porcine Model – How Much Does Coronary Flow Matter? April 1, 2020

Transmedic Organ Care System (OCS) allows preservation of the donor heart by perfusing the organ at 34°C in a beating state and providing additional assessment options. The perfusion protocols as established by the manufacturer is valid for adult human hearts, using coronary flows in the 8-900ml/min range guided by lactate measurements. Higher flow can facilitate higher degrees of cardiac oedema which can be associated with diastolic dysfunction, and generel impairment of contractility of the heart.

Ex Vivo Organ Perfusion for Heart Procurement in High-Risk Transplantations: A Multicenter Study April 1, 2020

Ex vivo heart perfusion is an innovative preservation technique, that permits graft assessment and extended out-of-body intervals. In times of high-risk recipients and donors with extended criteria, we hypothesized that its properties for prolonged heart preservation might be especially beneficial.

Eight-Hour Ex Situ Perfusion with Functional Assessment of an Adult Heart after 12 Hours Hypothermic Preservation: A Case Study April 1, 2020

Ex situ heart perfusion (ESHP) allows resuscitation and functional assessment of marginal donor hearts to expand the donor pool. The current clinically available ESHP platform does not enable contractile assessment. We sought to determine if a marginal donor heart could be resuscitated and assessed on our custom ESHP system following an extended period of cold storage.

COVID-19’s impact on organ donation and transplantation discussed at multi-society webinar March 23, 2020

Organ donation and transplant professionals from around the world convened on March 23 in a town hall webinar aimed at helping health care professionals navigate the ever-evolving COVID-19 health crisis. “Our goal was to share our experiences to date and respond to questions about the impact of COVID-19 on organ donation and transplantation,” said Shandie Covington, Chief Executive Officer of the American Society of Transplantation (AST) who worked with colleagues from nearly a dozen organizations to produce the free live webinar for 1,000 organ donation and transplant professionals across the country.

A recording of “COVID-19: Organ Donation and Transplant Town Hall” is now available online.

Welcome and Introduction – Emily Blumberg (AST)

COVID-19: Presentation, Diagnosis, Testing, Treatment, and Prevention – Moderator: Deepali Kumar (AST)

  • Background/Disease Presentation – Erika Lease (ISHLT)
  • U.S. Cases – Ajit Limaye
  • Immunosuppression management in COVID+  – Attilio Iacovoni (ESOT)
  • Antivirals and Immunomodulators – Paolo Grossi (ESOT)
  • Prevention (infection control) – Marian Michaels (AST)
  • Pediatrics – impact on this population  –  Lara Danziger-Isakov (ISHLT)

Getting to Transplant: Donor Issues and Candidate Concerns – Moderator: Lloyd Ratner (ASTS)

  • Getting to transplant
    • Donor issues/screening and testing platforms – Mike Ison (TTS)
    • Procurement strategies – special safeguards needed for HCW, OPO and surgeon – Ajit Limaye, Kevin O’Connor (AOPO), Kelly Ranum
  • Candidate concerns – managing the organ offer – Luciano Potena (ESOT)

Operational Issues (In-House and Managing Patient Concerns) – Moderator: Maryl Johnson (UNOS)

  • Operational Issues
    • Working with the institution to function during a pandemic – scaling back services, patient cohorting, logistics, determining resource sharing – Atul Humar (CST), Luciano Potena (ESOT)
    • Managing patient and family concerns, 90-day medication supply – Stacee Lerret (NATCO)
    • Practical approaches to visits off-site (telemedicine, etc.) – Lewis Tepermann (ASTS)

Next steps: Data Collection and Sharing – Moderator: Stuart Sweet (ISHLT)

  • Next steps
    • Data collection – the need to collect data and better understand what we are seeing – Tim Pruett (ASTS)
    • Clearing peer review to get information into journals efficiently – Allan Kirk (AJT)

 Closing and Resources: Emily Blumberg (AST)

  • Available Resources
  • Refreshing resources as new information is established
  • Closing Thoughts

The town hall webinar was a collaborative effort between:

For more information about COVID-19, including advice from the Centers for Disease Control and Prevention, the Organ Procurement and Transplantation Network, and other sources, please visit UNOS’ COVID-19 resources page. The page will be refreshed regularly with the most currently available information.

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Portable Normothermic Cardiac Perfusion System in Donation After Cardiocirculatory Death: A Health Technology Assessment. March 20, 2020

Ont Health Technol Assess Ser. 2020;20(3):1-90

Authors: Ontario Health (Quality)

Abstract
Background: Heart transplantation is the most effective treatment for people experiencing end-stage heart failure whose quality of life and life expectancy are unacceptable. However, there is a chronic shortage of donor hearts to meet the demand, so it is essential to expand the donor pool and increase supply. Heart donation mainly occurs after brain death (neurological determination of death [NDD]), but it may also be feasible after cardiocirculatory death (when the heart has stopped beating and there is no longer blood flow or a pulse), provided specialized preservation techniques are used. An investigational device, a portable normothermic cardiac perfusion system, could make it possible to procure, preserve, and transport hearts donated after cardiocirculatory death (DCD). We conducted a health technology assessment of a portable normothermic cardiac perfusion system for the preservation and transportation of DCD hearts for adult transplantation. This included an evaluation of the effectiveness, safety, value for money, and budget impact of publicly funding this system, as well as an evaluation of patient preferences and values.
Methods: We performed a systematic review of the clinical literature published since 1998 that examined the clinical safety and effectiveness of a portable normothermic cardiac perfusion system for DCD heart transplantation. We assessed the risk of bias of each included study and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We also reviewed the economic evidence published during the same time period for the cost-effectiveness of a portable normothermic cardiac perfusion system for DCD hearts compared with cold storage for NDD hearts. We further estimated the 5-year net budget impact of publicly funding a normothermic cardiac perfusion system for DCD heart transplantation for adults on Ontario’s waitlist. To contextualize the potential value of a portable normothermic cardiac perfusion system, we spoke with people waiting for a heart transplant, people who had received a heart transplant, and family members of organ donors.
Results: We screened 2,386 clinical citations. One study and two case reports met the inclusion criteria. The survival of recipients of DCD hearts procured with a portable normothermic cardiac perfusion system did not differ significantly from the survival of recipients of hearts donated after NDD at 30 days or 90 days, nor was there a significant difference in cumulative survival at 1 year post-transplant (GRADE: Very Low). The occurrence of rejection and graft failure also did not significantly differ between the groups (GRADE: Very Low). Cardiac function in the early post-operative period was better in DCD hearts than NDD hearts (GRADE: Very Low). There were no differences in outcomes between DCD procurement techniques.The economic literature search yielded 62 citations. One report met the inclusion criteria but was not directly applicable to the Ontario context. Given the lack of clinical and economic evidence on long-term outcomes, we did not conduct a primary economic evaluation. In the budget impact analysis, based on the number of DCD donors under 40 years of age in the last 5 years, we estimated that the increased availability of donor hearts made possible by the technology would result in an additional seven transplants in year 1, increasing to 12 in year 5. The annual net budget impact of publicly funding a normothermic cardiac perfusion system for the transplantation of DCD hearts in Ontario over the next 5 years is about $2.0 million in the first year and about $0.9 million in each of years 2 through 5, yielding a total net budget impact of about $5.6 million. This number increases to about $10.3 million if the transplant volume increases to 18 hearts in year 1 (meaning a subsequent increase of up to 21 hearts in year 5). If transplantation were limited to people who do not qualify for a ventricular assistive device or who qualify but do not wish to receive one, the total 5-year net budget impact would be about $7.9 million.People waiting for a heart transplant or who had received a heart transplant and family members of organ donors expressed no substantial concerns about the potential use of a portable normothermic cardiac perfusion system. They hope that it may increase the number of donor hearts available for transplant. For family members of organ donors, a perfusion system may provide comfort and value if it can increase the successful procurement of donor hearts.
Conclusions: Based on very low quality of evidence, the outcomes for recipients of DCD hearts preserved using a portable normothermic cardiac perfusion system appear to be similar to outcomes for recipients of NDD hearts. Owing to a lack of evidence relevant to the Ontario context, we were unable to determine whether a portable normothermic perfusion system may be cost-effective. We estimate that publicly funding a portable normothermic cardiac perfusion system for DCD heart transplantation over the next 5 years will cost about $5.6 million. The people we spoke with believe that the system may increase the number of hearts available for transplant and therefore increase the number of heart transplants that can be done.

PMID: 32190164 [PubMed – in process]

Call for nominations for OPTN Heart Committee and Lung Committee March 13, 2020

The Organ Procurement and Transplantation Network Board of Directors has approved replacing the OPTN Thoracic Organ Transplantation Committee with two separate committees – a Heart Transplantation Committee and a Lung Transplantation Commiteee.

The new committees will begin their work on July 1, 2020 and will allow the OPTN to be more representative and responsive to the community’s needs, which will in turn help patients.

There is an immediate need to fill a number of positions on the Heart and Lung Committees. Committee members are volunteers, representing a variety of professional disciplines, personal experience and expertise in organ transplantation.

United Network for Organ Sharing as the OPTN values diversity and strives for a Board and Committee system that represents the community we serve. Therefore, members may be donation or transplant professionals, transplant candidates or recipients, living donors, donor families, and/or members of the general public.    

  •  If you wish to be considered for a Heart Transplantation Committee or Lung Transplantation Committee volunteer position beginning July 1, 2020, complete the online Biography Form no later than March 25, 2020.
  • Please note: in the Biography Form under “area(s) of interest” you must select “Thoracic Committee” in order to be considered.  Applications received after this date are not guaranteed review for the coming cycle.
  • To update a previously submitted Biography Form, follow these instructions.
  • To learn about volunteer responsibilities and the selection process, visit the Get Involved page.
  • If you have questions about your application, please contact volunteer@unos.org.

Find information about serving on committees, and details about current openings on the Heart Transplantation Committee and the Lung Transplantation Committee on the OPTN website.

Please contact Sara Rose Wells, Transplant Community Administrator, at sararose.wells@unos.org with any questions.

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Combating Donor Organ Shortage: Organ Care System Prolonging Organ Storage Time and Improving the Outcome of Heart Transplantations. March 3, 2020
Icon for Wiley Icon for PubMed Central Related Articles

Cardiovasc Ther. 2019;2019:9482797

Authors: Sunjaya AF, Sunjaya AP

Abstract
Introduction: Cardiovascular diseases are the number one cause of death globally contributing to 37% of all global deaths. A common complication of cardiovascular disease is heart failure, where, in such cases, the only solution would be to conduct a heart transplant. Every 10 minutes a new patient is added to the transplant waiting list. However, a shortage of human donors and the short window of time available to find a correct match and transplant the donors’ heart to the recipient means that numerous challenges are faced by the patient even before the operation could be done, reducing their chances of living even further.
Methods: This review aims to evaluate the application of the Organ Care System (OCSTM) in improving the efficiency of heart storage based on journal articles obtained from PubMed, Elsevier Clinical Key, and Science Direct.
Results: Studies have shown that OCS is capable of extending the ischemic time 120 minutes longer than conventional methods without any detrimental effect on the recipient nor donor’s safety. Based on the PROTECT I and PROCEED II study, 93% of transplantation recipients using the OCS system passed through the 30-day mortality period.
Discussion: OCS is able to prolong the ischemic time of donors’ hearts by perfusing the organ at 34°C in a beating state, potentially reducing the detrimental effect of cold storage and providing additional assessment options. Another clear advantage is the implanting surgeon can assess the quality of the donor heart before surgery as well as providing a time safety buffer in unanticipated circumstances that will reduce the mortality risk of transplant recipients.

PMID: 31772620 [PubMed – indexed for MEDLINE]

Using data to save lives: Neelam Singh on UNOS business intelligence February 17, 2020

Business intelligence, or BI, is the process of transforming data into meaningful information. Some organizations use these insights to make decisions to improve performance and reduce operational costs, but in transplantation — when data literally has the power to save lives — its value is beyond measure.

The BI and data products team I lead at United Network for Organ Sharing works with the organ donation and transplantation community to build effective, efficient and user-friendly data tools that help members better navigate transplant’s many challenges. To do this, we need to have an in-depth understanding of not only data but also complex policy specific to different organs. We want to empower users to make optimal use of the information available to them.

BI and data products team (left to right) Adam Bacigalupo, Neelam Singh, Tim Baker and Read Urban.

The data tools we build provide performance indicators, operational metrics and comparison analyses that can assist transplant programs in identifying problem areas. This helps them make better decisions. A number of our efforts right now are focused toward helping transplant programs find anomalies in their data. If we help them make corrections at the right time, the data can increase a patient’s chance of finding the right organ.

We also partner with other UNOS departments like Member Quality. Connecting with and training site surveyors offers us an opportunity to cultivate other data tool learning opportunities for members, which is invaluable.

We are making improvements to existing visual analytics tools such as the kidney waiting list management tool and the living liver donor follow-up report. My team is always thinking about usability and clarifying the objectives of these tools. Even a seemingly subtle change like adding a separate documentation tab can be a significant enhancement for users.

Everyone in the donation and transplant community will tell you that managing data through information technology is at the heart of the work. It’s how people save lives every day. So it’s exciting to get the community involved in these changes — that collaboration is what helps us do our job, which is ultimately to save lives by increasing transplants.

The business intelligence team is eager to work directly with members while developing products and revamping the existing catalog. To submit feedback on any of the data portal tools, or to submit ideas for new tools, please email dataportalfeedback@unos.org. 

Neelam Singh joined the UNOS Research Department in 2019 as manager of the BI and data products team. While earning her MBA in finance from Goa University in India, she had the opportunity to study abroad for a semester at Technische Hochschule, an applied sciences university in Ingolstadt, Germany. This blend of technical ability and business insight has uniquely prepared her for a career in business intelligence. She brings to UNOS more than 10 years of health care data management experience, including building and implementing quality data marts, developing business intelligence capabilities, providing data solutions, designing data process roadmaps and leading standardized reporting projects.

 

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“An Expedia for organ transplantation” February 12, 2020

New project aims to better predict organ travel time.

Airplanes making heart path

In the past ten years, more than 45,000 organs recovered for transplantation were not used to save lives, according to data from the Organ Procurement and Transplantation Network.

Part of the organ discard rate can be attributed to prolonged cold ischemic time, which is the time that an organ spends outside the body between procurement and transplantation. “Cold ischemic time not only limits how far an organ can travel, it is also linked with higher rates of organs being declined by transplant hospitals,” said United Network for Organ Sharing data science manager Andrew Placona. Each organ possesses its own cold ischemic time limit. While kidneys can typically survive outside the body for 24 to 36 hours, livers, intestines and pancreata only last on average for about 12 to 18 hours. Hearts and lungs have even shorter cold ischemic time limits, typically lasting outside the body for four to six hours on average.

“Speedier transportation will result in more organs transplanted, more lives saved and more improved long-term outcomes for transplant recipients,” explained Placona, who is serving as principal investigator on research that aims to help organ procurement organization, or OPO, professionals make more informed decisions about optimal travel routes for procured organs.

A joint effort

Partnering with seven OPOs across the country—along with the travel companies they enlist to help transport organs—Placona’s team is conducting real-time data analysis to refine a feasibility algorithm aimed at predicting the optimal route for organ transplantation.

Describing the algorithm as an Expedia-like application that OPO and transplant hospital professionals can use to choose the best route for an organ, Placona said he envisions people using the application to make informed decisions about optimal travel methods for organs and then tracking the organs in real time as they make their way from the donor hospital to the transplant hospital.

“This project addresses a complex problem in organ transplantation, mainly coordinating logistics for organ transport and understanding the components of cold ischemic time,” said Jeffrey Orlowski, president and CEO of LifeShare Transplant Donor Services of Oklahoma, which is the organ recovery organization for the state of Oklahoma.

Beginning December 2019, the UNOS information technology team began assessing the feasibility of building application programming interfaces that will act as bridges between the OPOs’ transportation vendor databases and UNOS’ systems to enable the flow of data between the applications. The feasibility study will continue through August 2020.

The other portion of the project involves analysis to determine if the collected data can contribute to the existing feasibility algorithm, which combines major airline and limited charter availability with current drive times to potentially determine the most efficient travel options at any given moment. The research is being conducted through UNOS LabsSM, which is an experimental incubator that unites data, technology and industry expertise to test transformational ideas and hypotheses for improving the transplant system.

“With a better understanding of how transit time impacts cold ischemic time, we could potentially assign an estimated cold ischemic time upon arrival into UNet,” explained Placona. UNetSM is UNOS’ electronic network that allows transplant professionals to register transplant candidates on the national organ waiting list, match the candidates with donated organs and enter vital medical data on candidates, donors and transplant recipients. “This would allow for more informed organ offer considerations.”

Using big data to solve complex problems

In the future, the research team plans to expand the algorithm to incorporate additional data inputs, such as weather, flight cargo limits and expanded charter flight availability. They also plan to validate the model using previously planned organ travel information, collaborating with courier services and OPOs. After validating the model, UNOS will create a user-friendly application that will enable piloting of the algorithm with more OPOs.

“In our line of work, time is critical and lives depend on timely response,” Orlowski said. “This project explores solutions to organ transportation and will help optimize travel and troubleshoot for weather, traffic and flight changes in real time.”

Placona expects the project to eventually result in reduced prolonged cold ischemic time and enable better transplant outcomes, including reducing organ discards and rejections. “Ultimately, our goal is to increase organ utilization and improve outcomes for patients,” he said. “If we can use data science to figure out where the inefficiencies are in the organ procurement process, then we can start finding solutions.”

“This project explores solutions to organ transportation and will help optimize travel and troubleshoot for weather, traffic and flight changes in real time.”

Interested in increased efficiency?

UNOS technology specialists develop APIs that connect OPOs, transplant hospitals and histocompatibility centers so their applications can seamlessly exchange data with UNetSM applications. Learn about available APIs.

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Hydrogen gas inhalation during ex vivo lung perfusion of donor lungs recovered after cardiac death. January 28, 2020
Icon for Elsevier Science Related Articles

J Heart Lung Transplant. 2018 10;37(10):1271-1278

Authors: Haam S, Lee JG, Paik HC, Park MS, Lim BJ

Abstract
BACKGROUND: Ex vivo lung perfusion (EVLP) is a system that circulates normothermic perfusate into procured lungs, allowing for improved lung function and lung assessment. We investigated whether ventilation with hydrogen gas during EVLP improves the donation after cardiac death lung function and whether this effect persists after actual transplantation.
METHODS: Ten pigs were randomly divided into a control group (n = 5) and a hydrogen group (n = 5). No treatment was administered to induce warm ischemic injury for 1 hour after cardiac arrest, and EVLP was applied in procured lungs for 4 hours. During EVLP, the control group was given room air for respiration, and the hydrogen group was given 2% hydrogen gas. After EVLP, the left lung graft was orthotopically transplanted into the recipient and reperfused for 3 hours. During EVLP and reperfusion, the functional parameters and arterial blood gas analysis (ABGA) were measured every hour. Superoxide dismutase, heme oxygenase, interleukin (IL)-6, IL-10, tumor necrosis factor-α, and nucleotide-binding oligomerization domain-like receptor protein 3 were evaluated in lung tissue after reperfusion. Pathologic evaluations were performed, and the degree of apoptosis was evaluated. The wet/dry ratio was measured.
RESULTS: During EVLP and reperfusion, functional parameters and ABGA results were better in the hydrogen group. The expressions of superoxide dismutase (p = 0.022) and heme oxygenase-1 (p = 0.047) were significantly higher in the hydrogen group. The expressions of IL-6 (p = 0.024) and nucleotide-binding oligomerization domain-like receptor protein 3 (p = 0.042) were higher in the control group, but IL-10 (p = 0.037) was higher in the hydrogen group. The lung injury severity score and the number of apoptotic cells were higher and the degree of pulmonary edema was more severe in the control group than in the hydrogen group.
CONCLUSIONS: Hydrogen gas inhalation during EVLP improved donation after cardiac death lung function via reduction of inflammation and apoptosis, and this effect persisted after LTx.

PMID: 30100327 [PubMed – indexed for MEDLINE]

Public comment open from Jan. 22 through March 24 2020 January 22, 2020

The Organ Procurement and Transplantation Network is offering 11 proposals for public comment beginning on Wed., Jan. 22.

Comments and replies will be published on https://optn.transplant.hrsa.gov/governance/public-comment/, to promote transparency and trust in the national transplant system. Visitors can also share comments on social media, if they wish.

We encourage patients, transplant candidates and recipients, living donors, donor families and transplant professionals to learn more about the proposals and provide valuable feedback to help shape U.S. organ transplant policy.

These are the proposals available for public comment:

  • HLA equivalency tables update 2020
  • Distribution of kidneys and pancreata from Alaska
  • Addressing medically urgent candidates in new kidney allocation policy
  • Enhancements to the National Liver Review Board
  • Data collection to assess socioeconomic status and access to transplant
  • Modify blood type determination and reporting policies
  • Guidance on blood type determination
  • Modifications to released kidney and pancreas allocation
  • National Heart Review Board for pediatrics
  • Update to VCA transplant outcomes data collection
  • Measuring transplant outcomes by collecting data on children born to uterus recipients

There are educational webinars available that provide everyone an opportunity to learn more about the proposals.

See webinar dates and register.

Public comment closes on March 24. All comments received about a proposed change are reviewed before the OPTN Board of Directors votes.

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Novel Organ Perfusion and Preservation Strategies in Transplantation – where are we going in the UK? January 13, 2020

Transplantation. 2020 Jan 13;:

Authors: O’Neill S, Srinivasa S, Callaghan CJ, Watson CJ, Dark JH, Fisher AJ, Wilson CH, Friend PJ, Johnson R, Forsythe JL, Ploeg RJ, Mirza DF, Wigmore SJ, Oniscu GC

Abstract
This review article focuses on current clinical outcomes with novel perfusion strategies in organ transplantation. Broadly, these approaches can be divided into in-situ regional perfusion in the donor and ex-situ machine perfusion of individual organs. In both settings hypothermic and normothermic techniques are in clinical use. Evidence from full text articles, abstracts and data presented at scientific meetings has been considered. Animal studies have been excluded. The review focuses on kidney, liver, pancreas, heart and lungs. The level of evidence ranges from quasi-experimental work in human pancreas to multiple meta-analyses of Randomised Controlled Trials for hypothermic machine perfusion of kidneys. The data in this review was presented to experts in organ perfusion and preservation at the National Health Service Blood and Transplant Preservation and Perfusion Future Strategy Summit in London in October 2018. The outcomes of the meeting are discussed in the review after due consideration of the available evidence base.

PMID: 31972706 [PubMed – as supplied by publisher]

Ethical and Logistical Concerns for Establishing NRP-cDCD Heart Transplantation in the United States. January 8, 2020
Icon for Wiley Related Articles

Am J Transplant. 2020 Jan 08;:

Authors: Parent B, Moazami N, Wall S, Carillo J, Kon Z, Smith D, Walsh BC, Caplan A

Abstract
Controlled heart donation after circulatory determination of death (cDCD) is well-established internationally with good outcomes and could be adopted in the United States to increase heart supply if ethical and logistical challenges are comprehensively addressed. The most effective and resource-efficient method for mitigating warm ischemia after circulatory arrest is normothermic regional perfusion (NRP) in situ. This strategy requires restarting circulation after declaration of death according to circulatory criteria, which appears to challenge the legal circulatory death definition requiring irreversible cessation. Permanent cessation for life-saving efforts must be achieved to assuage this concern and ligating principal vessels maintains no blood flow to the brain, which ensures natural progression to cessation of brain function. This practice – standard in some countries – raises unique concerns about prioritizing life-saving efforts, informed authorization from decision-makers, and the clinician’s role in the patient’s death. To preserve public trust, medical integrity, and respect for the donor, the donation conversation must not take place until after an un-coerced decision to withdraw life-sustaining treatment made in accordance with the patient’s treatment goals. The decision maker(s) must understand cDCD procedure well enough to provide genuine authorization and the preservation/procurement teams must be kept separate from the clinical care team.

PMID: 31913567 [PubMed – as supplied by publisher]

DSA to be removed from thoracic allocation system Jan. 9, 2020 January 6, 2020

Overview of Changes

On Thursday, Jan. 9, 2020, several OPTN policy updates will be implemented to eliminate the use of donation service areas, or DSAs, from heart transplantation and replace them with a 250 nautical mile circle.  Additionally, the term “zone” will be removed from thoracic (heart and lung) allocation policies and replaced with the actual distances in nautical miles between donor hospital and transplant hospitals where candidates are listed.   (Previous policy action in 2017 removed DSA from lung allocation).  An additional changes will remove current policy language regarding prioritization of sensitized candidates within a DSA.

All of the policy updates are included in this policy notice, reflecting actions the OPTN Board of Directors approved at its June, 2019 meeting.

System Implementation Information

To implement these changes, the UNOS Secure EnterpriseSM system, which includes UNetSM and other transplant applications such as WaitlistSM, DonorNet®, TIEDI® and KPDSM, will be unavailable on Thursday, Jan. 9, from 7:00 a.m. until approximately 7:30 a.m. EST.

The policy changes do not affect definitions of “local” thoracic candidates used in:

  • donor acceptance criteria within Waitlist
  • contact management within DonorNet
  • notification limits for organ offers

Review processes described in the OPTN Member Evaluation Plan are not affected by any of these updates.

Resource information

  • A resource document, “Thoracic Allocation Using Nautical Miles,” is available in UNOS Connect from the Heart category of the course catalog, offering HRT105-Dhttps://unosconnect.unos.org/
  • Online help documentation covering UNetSM functionality will be available when the system updates go into effect. Access Secure Enterprise and then choose Waitlist. On the Help menu, click Waitlist Help. You may search for a specific help topic or use the table of contents to assist with your search.

Questions?
If you have questions about the implemented updates, contact UNOS Customer Service at 800-978-4334.  For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

 

 

 

 

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The hypothermic option January 6, 2020

 

Pictured above: The LifePort Transporters were developed after CEO David Kravitz’s father needed a heart transplant. Photos courtesy of Organ Recovery Systems

INSIGHTS

While static cold storage remains the organ preservation standard, an alternative technology is seeking to combine its benefits with the promise of machine perfusion.

Organ Recovery Systems founder and CEO David Kravitz has more than a professional interest in transplantation. In the 1990s while the entrepreneur was running a company under contract with the U.S. military to improve battlefield trauma care, his own father ended up needing a heart transplant.

At the time Kravitz had no experience with organ transplantation, so he was astonished to learn that the heart that would save his father’s life could only come from within a few hours’ distance and would “show up in a beer cooler,” he said. “I just couldn’t quite believe it, and the doctors were telling me that was the state-of-the-art.”

Kravitz was sure there had to be a better way to protect and preserve an organ in transit. For years his efforts had been focused on trying to use interventional hypothermia — deliberately lowering a patient’s body temperature — to protect the brain from neurological complications following battlefield trauma. Drawing on this work, he conceived an interventional hypothermia-inspired design for a mechanized organ transporter. “The original vision was to enhance portability and preservation, keeping the organ alive and sustained so it could travel longer and be healthier,” he said.

Organ Recovery Systems CEO David Kravitz developed the idea for an interventional hypothermia-inspired design for a mechanized organ transporter after his father needed a heart transplant. Photo courtesy of Organ Recovery Systems.

From idea to action

A company focused on organ preservation products and services, Organ Recovery Systems was formed to develop the interventional hypothermia-inspired organ transporter concept. In the early 2000s the company’s LifePort Kidney Transporter, a transportable device for hypothermic machine perfusion, or HMP, gained Food and Drug Administration approval. Unlike normothermic preservation, which preserves organs at normal physiological temperatures, or static cold storage, which chills organs in a preservation solution in an ice box, hypothermic machine perfusion pumps a preservation solution continuously through the organ at temperatures between 1 and 10 degrees Celsius.

Today LifePort Kidney Transporter is routinely used in more than 300 transplant programs in 39 countries, with a performance record of more than 112,000 kidney transplant procedures. In France, LifePort Kidney Transporter has been specified as the HMP standard of care nationwide, from donor to recipient bedside, and is used in the majority of deceased donor kidney transplantation surgeries performed in that country.

Compounding success

Building upon the success of LifePort Kidney Transporter, Organ Recovery Systems researchers began developing a second LifePort system for livers, completing the first commercial-built prototype in 2016. As part of the FDA registration process, LifePort Liver Transporter is now in a phase three pivotal non-inferiority clinical trial comparing HMP to static cold storage. Phase three clinical trials compare two or more competing therapies. While most phase three trials aim to demonstrate the superiority of a new treatment in comparison with a control treatment, non-inferiority phase three trials assess if a more convenient, less toxic, or more affordable intervention is at least as efficacious as an existing standard of care.

“Our primary endpoint for the trial is early allograft dysfunction, based on how the liver functions in the first seven days after transplant,” said James Guarrera, M.D., who directs the liver transplantation program at University Hospital in Newark, New Jersey, and serves as co-lead investigator for the LifePort Liver Transporter clinical trial. “We are following patients out to a year, because a one-year graft survival time point is such an important metric in the U.S.,” he said. With those results, Guarrera says that transplant professionals will be able to “really take a critical look at the technology and then decide if they want to utilize it.”

Guarrera has been researching the potential of HMP for liver transplantation for nearly two decades. As a faculty member at Columbia University in 2010, he was lead author on the first published human prospective trial of liver HMP. The pilot study conducted at Columbia University used a prototyped perfusion system developed by the Columbia research team to reduce early allograft dysfunction in the HMP livers compared to static cold storage livers. Though these were small and non-randomized studies, the researchers demonstrated “a reduction in ischemia reperfusion injury, a reduction in early allograft dysfunction, less biliary complications and a shorter length of stay in the hospital,” Guarrera said. That research helped form the clinical basis for Organ Recovery Systems’ LifePort Liver Transporter.

Continuous improvement

Beyond ease of use, the LifePort Liver Transporter offers a benefit to transplant teams in its portability. Weighing about 100 pounds when fully loaded, it can be handled by two people. Already in the current clinical trial, livers have flown at least five times without issues.

“Functionality, in parallel with making sure that it was as transportable as possible, was really important,” Kravitz said.

 United Network for Organ Sharing chief medical officer David Klassen, M.D., expects research to eventually reveal that any form of machine perfusion — normothermic or hypothermic — is superior to the current standard of static cold storage, but no research as of yet has conclusively compared normothermic to hypothermic or established a standard-of-care perfusion protocol. There is a growing body of evidence, however, that machine perfusion can safely extend preservation time. With allocation policies evolving to promote broader geographic sharing, organs are likely to continue traveling longer over greater distances. Particularly for the most time-sensitive organs, such as livers, “this technology has big implications for allocation policy,” Klassen said.

It is in the longer distances and travel times made possible by HMP that Guarrera believes LifePort Liver Transporter offers a potential benefit. Additionally, in the event of technical failure, LifePort Liver Transporter is designed to fail safely, and still function as an effective static cold storage device. “You have the safety of that gold standard backup of cold storage,” Guarrera said. “As we are potentially sending livers over longer distances or don’t have experienced teams going with the organ, that is going to be a huge plus.”

For Kravitz, the experience of his own father’s transplant continues to inspire Organ Recovery Systems’ mission, which is focused on improving outcomes, lowering the cost of transplantation and honoring the gift of life. “It’s a passion for us, not a job,” he said.

Disclaimer: Any reference obtained from this article/publishing to a specific product, process, or service does not constitute or imply an endorsement by UNOS of the product, process, or service, or its producer or provider. The views and opinions expressed in any referenced do not necessarily state or reflect those of UNOS.

Organ Recovery Systems

LifePort Kidney Transporter
LifePort Liver Transporter
Company headquarters: Chicago, Illinois
Organ: Kidney, liver
FDA status: 510(k) for LifePort Kidney Transporter, IDE for LifePort Liver Transporter
Current clinical trial: U.S.: Study to Evaluate Performance of LifePort® Liver Transporter System, a Machine Perfusion System, for Liver

The post appeared first on UNOS.

Pre-implementation notice: Removing DSA from thoracic allocation system December 9, 2019

Audience:

Heart transplant program directors, surgeons, physicians, administrators, clinical coordinators and data coordinators; compliance and quality managers; clinical support staff; OPO executive directors and procurement directors/managers

Implementation date:

January 9, 2020

 Overview of Changes

On Thursday, Jan. 9, several OPTN policy updates will be implemented to eliminate the use of donation service areas (DSAs) from heart transplantation and replace them with a 250 nautical mile circle.  Additionally, the term “zone” will be removed from thoracic (heart and lung) allocation policies and replaced with the actual distances in nautical miles between donor hospital and transplant hospitals where candidates are listed.   (Previous policy action in 2017 removed DSA from lung allocation).  An additional changes will remove current policy language regarding prioritization of sensitized candidates within a DSA.

All of the policy updates are included in this policy notice, reflecting actions the OPTN Board of Directors approved at its June, 2019 meeting. 

System Implementation Information

To implement these changes, the UNOS Secure EnterpriseSM system, which includes UNetSM and other transplant applications such as WaitlistSM, DonorNet®, TIEDI® and KPDSM, will be unavailable on Thursday, Jan. 9, from 7:00 a.m. until approximately 7:30 a.m. EST.

The policy changes do not affect definitions of “local” thoracic candidates used in:

  • donor acceptance criteria within Waitlist
  • contact management within DonorNet
  • notification limits for organ offers

Review processes described in the OPTN Member Evaluation Plan are not affected by any of these updates.

Resource information

  • A resource document, “Thoracic Allocation Using Nautical Miles,” is available in UNOS Connect from the Heart category of the course catalog, offering HRT105-D
  • Online help documentation covering UNetSM functionality will be available when the system updates go into effect. Access Secure Enterprise and then choose Waitlist. On the Help menu, click Waitlist Help. You may search for a specific help topic or use the table of contents to assist with your search.

 

Questions?
If you have questions about the implemented updates, contact UNOS Customer Service at 800-978-4334.  For policy-related questions, send an e-mail to member.questions@unos.org or call 844-395-4428.

 

 

 

The post appeared first on UNOS.

Human heart transplantation from donation after circulatory-determined death donors using normothermic regional perfusion and cold storage. November 27, 2019
Icon for Elsevier Science Related Articles

J Heart Lung Transplant. 2018 07;37(7):865-869

Authors: Messer S, Page A, Colah S, Axell R, Parizkova B, Tsui S, Large S

Abstract
Heart transplantation from donation after circulatory-determined-death (DCD) donors is emerging as an additional avenue to increase heart transplant activity. Previous methods of DCD heart retrieval include direct procurement and cold storage, direct procurement, and machine perfusion and normothermic regional perfusion, followed by machine perfusion during transportation. Herein we report a further technique resulting in successful DCD heart transplantation utilizing normothermic regional perfusion and permitting functional assessment followed by cold storage.

PMID: 29731238 [PubMed – indexed for MEDLINE]

The Implementation of Physiological Afterload during Ex Situ Heart Perfusion Augments Prediction of Post-Transplant Function. November 27, 2019

Am J Physiol Heart Circ Physiol. 2019 Nov 27;:

Authors: Gellner B, Xin L, Ribeiro RV, Bissoondath V, Adamson MB, Yu F, Lu P, Paradiso E, Mbadjeu A, Simmons CA, Badiwala MV

Abstract
Ex Situ heart perfusion (ESHP) is an emerging technique that aims to increase the number of organs available for transplantation by augmenting both donor heart preservation and evaluation. Traditionally, ESHP has been performed in an unloaded Langendorff Mode (LM), though more recently groups have begun to use Pump Supported Working Mode (PSWM) and Passive Afterload Working Mode (PAWM) to enable contractile evaluation during ESHP. To this point, however, neither the predictive effectiveness of the two working modes, nor the predictive power of individual contractile parameters have been analyzed. In this paper, we utilize our previously described system, to analyze the predictive relevance of a multitude of contractile parameters measured in each working mode. Ten porcine hearts were excised and perfused ex situ in LM for four hours, evaluated using pressure-volume catheterization in both PSWM and PAWM and transplanted into size matched recipient pigs. After three hours, hearts were weaned from cardiopulmonary bypass and evaluated. Correlating post-transplant measurements to their ex situ counterparts, we report that parameters measured in both modes show sufficient power (Spearman Rank Coefficient > 0.7) in predicting global post-transplant function, characterized by cardiac index and preload recruitable stroke work. For the prediction of specific post-transplant systolic and diastolic function however, a large discrepancy between the two working modes was observed. With nine of ten measured post-transplant parameters showing stronger correlation with counterparts measured in PAWM it is concluded that PAWM allows for a more detailed and nuanced prediction of post-transplant function than can be made in PSWM.

PMID: 31774696 [PubMed – as supplied by publisher]

Ex-vivo lung perfusion. November 4, 2019
Related Articles

Curr Opin Anaesthesiol. 2019 Nov 04;:

Authors: Moreno Garijo J, Roscoe A

Abstract
PURPOSE OF REVIEW: Ex-vivo lung perfusion (EVLP) has been developed to expand the donor pool for lung transplantation recipients. The role of EVLP in organ preservation, evaluation and potential reconditioning is reviewed.
RECENT FINDINGS: EVLP has been shown to significantly increase the utilization of donor lungs for transplantation. Evidence suggests that patient outcomes from EVLP lungs are comparable to standard procurement technique. Novel strategies are being developed to treat and recondition injured donor lungs. EVLP may also prove to be a tool for translational research of lung diseases.
SUMMARY: EVLP has been shown to be an effective system to expand donor pool for lung transplantation without detriment to recipients. Future potential ex-vivo developments may further improve patient outcomes as well as increasing availability of donor organs.

PMID: 31688085 [PubMed – as supplied by publisher]

Inside the Organ Center: Partnering with the community August 30, 2019

Meet the OC team and learn how they work hand in hand with OPOs and transplant centers to place organs every day, around the clock.

The Organ Center at UNOS is open 365 days a year

The Organ Center at UNOS has been open for 35 years, around the clock, helping organ placement and transplant centers to deliver the gift of life.

Video channel

“We measure just about everything we do. How much we do. How fast we do it. How accurate that work is and is that work meeting the needs of the community?”

Roger Brown, Director, Organ Center

In this series of videos, you’ll hear from Organ Center Director Roger Brown as he talks about how his staff works with the donation and transplant community to meet the daily challenge of matching organs and saving lives. Plus, how OC staff are trained, what motivates them, and the story of a 1-in-1,000 chance connection that gave a struggling firefighter a long-awaited chance for a longer life.

About the F.M. Kirby Foundation Organ Center

In continuous operation for more than 35 years, the F.M. Kirby Foundation Organ Center has been described as the “heart” of UNOS. Like a beating heart, it’s at work continuously—days, nights, weekends, holidays and during inclement weather and even national disasters—saving lives by matching donors with candidates on the transplant waiting list.

What does the Organ Center do?

  • Assist in placing donated organs for transplantation
  • Assist in gathering donor information and running the donor/recipient computer matching process
  • Assist with transportation of organs and tissues for the purposes of transplantation
  • Act as a resource to the transplant community regarding organ-sharing policies

Read more about the Organ Center’s mission and history.

Direct Heart Procurement After Donation After Circulatory Death With Ex Situ Reperfusion. August 23, 2019
Icon for Elsevier Science Related Articles

 

Ann Thorac Surg. 2018 10;106(4):e211-e214

Authors: Smail H, Garcia-Saez D, Stock U, Ahmed-Hassan H, Bowles C, Zych B, Mohite PN, Maunz O, Simon AR

Abstract
The most extended technique of heart procurement from donors after circulatory death involves direct procurement and reperfusion in an ex situ normothermic platform using the Organ Care System (TransMedics, Inc, Andover, MA). This report describes a modified technique (at the Harefield Hospital, London, United Kingdom) with rapid donor blood drainage using a cell-saving device and synchronized perfusion on the Organ Care System.

PMID: 29752920 [PubMed – indexed for MEDLINE]

Ex Vivo Heart Perfusion for 72 Hours Using Plasma Cross Circulation. August 22, 2019
Related Articles

ASAIO J. 2019 Aug 22;:

Authors: McLeod JS, Poling C, Church JT, Jung J, Sarosi E, Langley M, Hayes M, Phillips JP, Hirschl J, Weir W, Hoenerhoff M, Rojas-Pena A, Bartlett RH, Owens GE

Abstract
Preservation of a donor heart for transplantation is limited to 6-8 hours. Based on our demonstration of 12 hour perfusion with plasma cross circulation, this study aimed to evaluate ex vivo heart perfusion (EVHP) for up to 72 hours using cross plasma circulation (XC-plasma) from a live, awake paracorporeal sheep (PCS). Six ovine hearts were perfused for 72 hours using plasma cross circulation at a rate of 1 L/min with a live, awake PCS. Controls were seven perfused hearts without cross circulation. Experiments were electively ended at 72 hours, and epinephrine (0.1 mg) was delivered to demonstrate hormonal responsiveness. All controls failed at 6-10 hours. All six hearts perfused for 72 hours maintained normal heart function, metabolism, and responsiveness to epinephrine. Blood gases, electrolytes, and lactate levels were normal and stable throughout the study. All hearts appeared suitable for transplantation. We have demonstrated successful normothermic EVHP for 72 hours.

PMID: 31453833 [PubMed – as supplied by publisher]

View distance from donor hospital to transplant hospital on heart and lung matches July 24, 2019

Audience

All DonorNet® match users

On July 24, 2019, we added a new report feature to the DonorNet match page that shows the distance in nautical miles from the donor hospital to each transplant hospital that appears on the match run. To access this feature, users can simply click on the organ link titled “Show distance to transplant center(s)” which appears at the top of the match run page.

This feature is currently visible for heart, lung and heart/lung matches because only those organ allocation policies classify candidates based on distance in nautical miles.  We will expand the availability of this feature when we implement OPTN policy changes for other organs that use distance to classify candidates.

Contact us

If you have questions, please contact UNOS customer service at unethelpdesk@unos.org or (800) 978-4334.

The post appeared first on UNOS.

Comparison of Custodiol vs warm blood cardioplegia and conditioning of donor hearts during transportation with the organ care system. July 23, 2019
Related Articles

J Card Surg. 2019 Jul 23;:

Authors: Kaliyev R, Lesbekov T, Bekbossynov S, Bekbossynova M, Nurmykhametova Z, Novikova S, Smagulov N, Medressova A, Faizov L, Ashyrov Z, la Fleur P, Samalavicius R, Pya Y

Abstract
OBJECTIVES: Cold crystalloid cardioplegia for donor heart harvesting and cold ischemic storage conditions during the transportation is the standard of care during heart transplantation procedure. Organ care system (OCS) was introduced for more prolonged and reliable ex vivo organ management. This study evaluated the two different techniques used for myocardial preservation during the procurement and transportation of the heart using the OCS.
METHODS: We performed prospective analysis of 43 patients with heart failure undergoing heart transplantation and using the OCS for donor organ transport. Donor hearts were arrested using blood cardioplegia and conditioning (n = 30) or standard Custodiol (SC) solution ( n = 13). Perfusion and cardiac function parameters were continuously monitored while the donor hearts were perfused in the OCS. Impact of preservation techniques on biochemical parameters and clinical outcomes were evaluated.
RESULTS: All donor hearts had stable perfusion and lactate characteristics in the OCS, with similar measures between the two groups at the beginning of the ex vivo perfusion. Ex vivo heart perfusion mean ending concentration of Interleukin (IL)-6 and IL-8 was significantly lower in the blood cardioplegia group compared to the standard care group. Clinical outcomes were comparable between the two groups of patients.
CONCLUSIONS: The use of blood cardioplegia and conditioning could be a safe method for myocardial protection in distant procurement and preservation of donor hearts in the OCS.

PMID: 31332833 [PubMed – as supplied by publisher]

OPTN Board approves updated heart, VCA allocation June 10, 2019

Richmond, Va. – The OPTN Board of Directors, at its meeting June 10, approved new geographic areas to match heart and vascularized composite allograft (VCA) transplant candidates with available organs from deceased donors. Both systems will now be based on distance from the donor hospital to the transplant hospital, replacing fixed and irregular donation service area (DSA) and regional boundaries.

“We continue to refine the organ distribution process to create the most equitable access for all people in need of a transplant,” said Sue Dunn, president of the OPTN Board. “The new distribution systems will help us do so, and they have been well supported by clinicians and the public. They also are in keeping with federal regulatory guidance to minimize differences in transplant access based on where candidates live or which transplant hospital they choose.”

Under the revised policy for heart and lung allocation, the most local level of heart distribution will be for transplant candidates listed at hospitals located within 250 nautical miles of the donor hospital. This replaces all references to the hospitals within the DSA where the heart is recovered. Lung distribution policy was updated in November 2017 to replace local DSA boundaries with the same distribution area (transplant candidates listed at programs within 250 nautical miles of the donor hospital).

VCA distribution will now begin with compatible candidates listed at transplant hospitals within a 500 nautical mile distance from the donor hospital. The great majority of VCA transplants performed up until now have come from donors within this distance.

Other key actions
In other action, the OPTN Board approved an amendment to the OPTN’s variance for the HIV Organ Policy Equity (HOPE) Act. Programs meeting HOPE Act research and experience requirements will now be able to recover additional organ types from donors identified as HIV-positive and transplant them into candidates who are also HIV-positive. This measure broadens organs transplantable from liver and kidney to also include heart, lung, pancreas, kidney-pancreas and intestinal organs.

The Board amended a proposed voluntary national protocol encouraging the greater use of split liver transplants (dividing a liver from a deceased donor into two segments that may be transplanted into two different candidates). After discussion, the Board approved the protocol for use in OPTN Region 8, which had requested it on a regional basis prior to the proposed national variance. Other regions may apply later for a similar protocol if they choose.

The Board also endorsed two guidance documents: one outlining ethical implications of multi-organ transplants and one describing effective practices in broader organ distribution.

About the OPTN Board of Directors
The Organ Procurement and Transplantation Network (OPTN) Board of Directors establishes and updates OPTN policies and bylaws, consistent with statutory and regulatory requirements. The Board consists of 42 volunteer experts from around the country in organ procurement and transplantation as well as organ recipients, living donors, and donor families. The Board is supported by the efforts and recommendations of 21 OPTN committees, also comprised of volunteers representing the diversity of people, perspectives and expertise involved in the nation’s organ transplant network.

United Network for Organ Sharing (UNOS) serves as the OPTN under federal contract.

The post appeared first on UNOS.

Successful clinical transplantation of hearts donated after circulatory death using normothermic regional perfusion. June 1, 2019
Related Articles

 

J Heart Lung Transplant. 2019 Jun;38(6):593-598

Authors: Tchana-Sato V, Ledoux D, Detry O, Hans G, Ancion A, D’Orio V, Massion PB, Amabili P, Bruls S, Lavigne JP, Monard J, Delbouille MH, Sakalihasan N, Defraigne JO

Abstract
BACKGROUND: Heart transplantation (HT) from donation after circulatory death (DCD) has yet to achieve wide clinical application despite the encouraging resultsreported recently. In this study we describe 2 cases of successful adult DCD HT performed at our institution using an original protocol.
METHODS: Our local abdominal DCD protocol was updated to allow DCD heart procurement, and was accepted by the institutional ethics committee. The main features of the protocol include: pre-mortem insertion of peripheral venoarterial extracorporeal membrane oxygenation cannulas; thoracoabdominal normothermic regional perfusion (NRP) by clamping the 3 aortic arch vessels to exclude cerebral circulation; and in-situ heart resuscitation. The retrieved hearts were directly transplanted into recipients located in an adjoining operating room.
RESULTS: The procurement warm ischemic time was 25 minutes for the first donor, and 26 minutes for the second donor. The cold ischemic time was 16 minutes for the first recipient and 17 minutes for the second recipient. The suture time was 30 minutes for the first recipient, and 53 minutes for the second recipient. Both recipients were easily weaned off cardiopulmonary bypass in sinus rhythm and inotropic support. Post-operative evaluation of cardiac function was excellent and the patients were subsequently discharged home.
CONCLUSIONS: Transplantation of hearts from DCD donors is now a clinical reality.NRP is a useful tool for resuscitation, reperfusion, and preservation of transplanted hearts. It also offers the opportunity to assess the function and viability of organs before transplantation. However,due to ethical issues, some may object to ante-mortem intervention.

PMID: 31128600 [PubMed – in process]

Next steps for the first national donor image sharing hub May 31, 2019

Learnings from the pilot will help inform a national rollout

The first phase of the UNOS imaging study pilot concluded in April. During the pilot, the six participating OPOs uploaded 1,153 image studies from 385 donors. These studies were viewed 4,101 times by 763 individual users. UNOS is using the pilot to solidify plans to rollout a large-scale, national donor image sharing platform in DonorNet®. What did they learn?

  • Pilot usage data indicates that most OPOs will upload images for all (100 percent of) heart donors and 85 percent of non-heart donors with other organs recovered.
  • Based on historical data, a national system would need to support around 5,000 donor image uploads a month.

Clinical and administrative staff from six OPOs and many transplant hospitals contributed to the pilot. They provided useful feedback through conversations, surveys and a UNOS innovation event with surgeons. Among their suggestions for improvement:

  • Better mobile access
  • A way to securely and easily share imaging studies with non-UNetSM users
  • Allow OPOs to forward studies to image interpretation services
  • Allow donor hospital to send image studies directly to DonorNet

With continued help from donation and transplant professionals, the UNOS team will build system enhancements into the national plan. We will provide additional information as plans progress.

The post appeared first on UNOS.

New CARE tool visualizes organ acceptance and refusal May 9, 2019

Using the new Center Acceptance and Refusal Evaluation (CARE) tool, transplant centers can see all of the outcomes for organ offers they accept as well as all of those they refuse.

This interactive tool allows transplant centers to review their own organ acceptance rates for specific types of donors, along with transplant specific and aggregate outcomes information on the organs they refused that were transplanted elsewhere.

“The CARE tool offers instantaneous visualization of transplant centers’ organ utilization,” says Scott LeHew, Business Development Manager, UNOS Solutions, “and a better understanding of the decisions they’re making regarding organ refusal and acceptance.”

Updated monthly, the tool includes information on all organs (other than VCA) offered to the center during the most recent two-year period available. The data are divided into two separate reports by organ type—thoracic, which includes data on offers to heart, lung, and heart-lung patients, and abdominal, which includes data on offers to kidney, pancreas, kidney-pancreas, liver, and intestine patients.

The report features at least three separate visualizations for each organ type: Accept, Offers, and Survival.

For kidney and kidney-pancreas offers, a fourth visualization is provided to review the rate of delayed graft function of organs accepted by the center as compared to those refused and transplanted elsewhere.

ACCEPT

The Accept visualization allows the user to view the number and percentage of organs (donors for kidneys, lungs, and split livers) offered and accepted by the center during the two-year period. Only those offers where the center had the opportunity to accept the organ (i.e. the center had at least one “primary” offer and their first candidate was above the last acceptor on the match run) are included in the calculation of these rates.

These data can be filtered by a variety of different match, donor, and organ characteristics, including Recovery OPO and Distance to Donor Hospital.

OFFERS

The Offers visualization provides the user with a detailed listing of all the offers that were displayed in aggregate on the Accept page.

These data can be filtered by a variety of different match, donor, and organ characteristics similar to Accept reports with some additional filters, including Primary Refusal Code if users only want to review refusals for Donor Age/Quality, or Patient ID/Unavailable.

SURVIVAL

The Survival visualization provides aggregate Kaplan-Meier graft and patient survival rates at six months and one year post-transplant. It compares organs the center transplanted with those the center was able to accept for at least one candidate and were ultimately transplanted at another U.S. transplant center.

Filters for this visualization are specific to the applicable donor characteristics of the organ type analyzed. For all organ types, filters include Declined for Donor Related Reasons and Survival Types, which allow the user to toggle between patient and graft survival rates.

DGF

This visualization is only available for kidney and kidney-pancreas transplant. Similar to the Survival visualization, this piece of the tool allows the user to compare the Delayed Graft Function Rate (defined as need for dialysis within first week post transplant, collected on Transplant Recipient Registration form) for those organs they transplanted with the organs they refused for at least one candidate at their center and were ultimately transplanted at another U.S. center. The filters available are similar to those in the Accept and Offer visualizations for the same organ types.

Learn more about custom data solutions offered by UNOS.

In focus


Center Acceptance and Refusal Evaluation (CARE) Report allows transplant centers to see all of the offers they accept as well as all those they refuse.

The post appeared first on UNOS.

Game changers: At the forefront of organ perfusion technology April 15, 2019

INSIGHTS

Game changers

Companies at the forefront of organ perfusion technology

“We work on the lungs like a team works on a patient.”

Martine Rothblatt, PhD, Chairman & CEO, United Therapeutics

Lung Bioengineering

Toronto EVLP System (IDE for clinical trial lungs)
XVIVO XPS (HDE for non-trial lungs)

Company headquarters: Silver Spring, Maryland

Organ: Lung

Current clinical trials: FDA approval received for Phase 3 trial for 16 centers and 93, or fewer, EVLP transplants.

Company website

One significant challenge to widespread implementation of NMP is having the technology and skilled clinical specialists available when needed. Lung Bioengineering, a United Therapeutics subsidiary, seeks to address this challenge with freestanding, centralized perfusion facilities staffed around the clock, to serve multiple transplant centers. Initially unacceptable/marginal lungs are transported to the facility and perfused.

Real-time HD monitoring allows the transplant team to examine the lung remotely during perfusion; if deemed acceptable, the lung is returned to the transplant center. “We work on the lungs like a team works on a patient,” notes United Therapeutics’ Chairman and CEO Martine Rothblatt, PhD. She says during the Phase 2 clinical trial, about two-thirds of the initially unacceptable lungs received by the center were recovered, accepted and successfully transplanted, with perfusion performed on the Toronto EVLP System technology developed at University Health Network in Toronto, Canada. (Lung perfusion services are also available for transplant centers not participating in the trial, with the XVIVO XPS device under the FDA’s HDE approval.)

“Ultimately our goal is to ramp up the availability of lungs for transplant,” says Rothblatt; the company hopes to establish four perfusion centers nationwide with the goal of doubling the number of lung transplants performed annually in the US.

An EVLP Suite

Lung Bioengineering’s headquarters in Silver Spring, Maryland

“Ideally speaking, every organ that is salvageable that has the potential to be transplanted should be assessed and should be allowed time on perfusion technology without impact of ischemia and cold static preservation.”

Tamer Khayal, M.D., Chief Commercial Officer, TransMedics

TransMedics Inc.

Organ Care System (OCS™) Transportable NMP

Company headquarters: Andover, Massachusetts

Organ: Lung, heart, liver

FDA status: PMA for OCS lung, IDE – EA for OCS heart, IDE for OCS liver

Current clinical trials:

  • U.S. OCS Heart EXPAND
  • U.S. The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry – OCS™ Lung TOP PAS Registry
  • International OCS Lung EXPAND
  • International OCS Liver PROTECT

Company website

The OCS Lung is currently “the only PMA approved medical technology for ex-vivo perfusion and assessment for routine donor/standard criteria lung transplants in the US,” says TransMedics Chief Commercial Officer Tamer Khayal, M.D. The OCS—which the company has developed for lung, liver, and heart transplantations—is a portable device for NMP that makes it possible to perform perfusion continuously from donor recovery to recipient.

OCS devices were designed to minimize ischemic injury, in comparison to static cold storage preservation. The OCS also allows for diagnostic monitoring of organ viability or function and therapeutic or optimization capabilities during perfusion.

The TransMedics vision is that “ideally speaking, every organ that is salvageable that has the potential to be transplanted should be assessed and should be allowed time on perfusion technology without impact of ischemia and cold static preservation,” says Khayal.

To date, OCS devices have been used in nearly 1,200 transplants worldwide.

“Risk and urgency are the two areas we are tackling head-on with this technology.”

Craig Marshall, CEO, OrganOx

OrganOx

metra®

Company headquarters: Oxford, England

Organ: Liver

FDA status: Clinical trial IDE

Current clinical trials: U.S. OrganOx metra®

Company website

“Risk and urgency are the two areas we are tackling head-on with this technology,” says OrganOx CEO Craig Marshall.

The metra® (pronounced meetra, from the Greek for womb) is a transportable normothermic machine perfusion (NMP) device that is now in a multi-center Investigational device exemption (IDE) clinical trial in the U.S. comparing the safety and efficacy of preservation and transport on the device to conventional static cold storage (SCS).

“By making it possible to assess the liver ex vivo, we are attempting to reduce the risk associated with lack of information about an organ,” says Marshall. And with clinical data from Europe indicating that livers can be perfused safely for up to 24 hours on the metra®, the device, Marshall says, benefits transplant surgery teams and recipients alike by reducing the urgency of the critical time limits imposed by SCS.

Surgeons David Nasralla and Annemarie Weissenbacher inspecting a liver perfusing on the OrganOx metra® device

“We can offer an additional tool in the clinician’s toolbox to assess lungs that might previously have not been utilized.”

Dan Martinelli, Head of Sales America, XVIVO Perfusion

XVIVO Perfusion

XPS

Company headquarters: Gothenburg, Sweden

Organ: Lung

FDA status: HDE “for flushing and temporary continuous normothermic perfusion of initially unacceptable excised donor lungs.”

Current clinical trials: None

Company website

Directed by the company’s vision “that nobody should have to die waiting for an organ,” XVIVO focuses on expanding the use of ex vivo lung perfusion to increase the number of transplantable lungs, says XVIVO Head of Sales Dan Martinelli.

In the completed NOVEL clinical trial, initially unacceptable extended criteria/marginal donor lungs were assessed for transplant via NMP on the XPS device.

Before perfusion, “the majority of those lungs were turned down by the majority of the transplant centers” enrolled in the trial, says Martinelli. Those found acceptable following perfusion and active evaluation, however, were successfully transplanted and demonstrated outcomes—including three-year survival rates—comparable to standard criteria lungs.

“It is the first trial in the U.S. that specifically looked at marginal lungs” and resulted in the FDA’s HDE approval for the XPS, notes XVIVO clinical research program manager Jaya Tiwari. Now, says Martinelli, the XPS can offer “an additional tool in the clinician’s toolbox” to assess lungs that might previously have not been utilized.

Photos courtesy of XVIVO Perfusion

Learn more

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.

FDA Terms

The post appeared first on UNOS.

James Pittman on the art of transplant administration April 12, 2019

Chair of the OPTN Transplant Administrators Committee previews opening session at TMF

“The transplant administrator, at the end of the day, is really the heart and the mind of the transplant program. They keep it running. They make sure their center is appropriately staffed, that they recruit the right team, and that they have a positive work environment. It’s a demanding job because it requires a kind of maestro to orchestrate all of that and keep everyone in sync. It’s non-stop, 24/7.”

James Pittman, RN, MSN

It’s a job James Pittman, RN, MSN, knows well. The current chair of the OPTN Transplant Administrators Committee began his work in transplant administration at the former Methodist Hospital in Houston (now Houston Methodist at Texas Medical Center). Today, he serves as Assistant Vice President of Transplant Services for Nashville-based HCA Healthcare, which comprises 185 hospitals in the U.S., including 13 transplant centers across the country.

“But I’ve always been in transplant, since the beginning when I was at the bedside.” After graduating from nursing school at the University of Texas at Austin, he started out in the ICU, where he cared for heart and lung transplant recipients.

Pittman says among the many issues transplant administrators must navigate, are new allocation policies: “It’s a big topic right now, and we have to be accountable to all of that. And we have to be the ones who have the vision and foresight to mitigate any sort of risk we might encounter and do it proactively and find solutions.”

When he gives remarks at the TMF opening welcome session this year, Pittman will be speaking to a broad community of thought leaders in the field at what he describes as the preeminent education event for transplant administration.

“When physician leaders and hospital executives and up-and-coming future administrators attend TMF, it’s of great benefit to the entire community. To really focus on the art and practice of administering and leading a transplant program, we as administrators need partners in all of our aspects.”

Connect with James Pittman and other transplant administration leaders at the 27th Annual UNOS Transplant Management Forum in Orlando, May 13-16, 2019.

Register for TMF

More about the OPTN Transplant Administrators Committee (TAC)

TAC considers issues related to the administration of transplant programs and provides input to the other Committees and the Board with regard to the potential impact of developing policies and other OPTN requirements on transplant program operations. Through Non-OPTN resources provided by UNOS as available, the committee develops initiatives and tools that foster effective transplant program administration such as the annual UNOS Transplant Management Forum, the transplant program staffing survey, and the standardized payer Request for Information (RFI) tool. Find out more about the committee here.

The post appeared first on UNOS.

EVLP: Ready for Prime Time? April 10, 2019
Icon for Elsevier Science Icon for W.B. Saunders Related Articles

Semin Thorac Cardiovasc Surg. 2019;31(1):1-6

Authors: Loor G

Abstract
Ex vivo lung perfusion implies perfusion and ventilation of a donor lung outside of the human body. The 2 most clinically relevant and commercially available devices currently in clinical trials are XVIVO Perfusion System (XPS Perfusion, Goteborg, Sweden) and Organ Care System (Transmedics, Andover, MA). Our review focuses on the needs met by ex vivo lung perfusion, and the clinical literature on both devices.

PMID: 29935227 [PubMed – indexed for MEDLINE]

Will organ perfusion transform transplantation? April 8, 2019

Insights: FEATURE

A look at the rapidly evolving technology that could make more organs available than ever before.

Across five decades of advances in transplant medicine, static cold storage (SCS) has remained a largely unchanged but vital link in the chain between donor and recipient. Yet static cold storage has well-recognized limitations. SCS slows, but doesn’t prevent, ischemic injury, which in turn increases the risk of graft non-function, ischemia reperfusion injury, primary graft dysfunction, and other post-transplant complications in the recipient. In addition, only a limited assessment of the organ is possible during SCS, making it difficult to accurately predict how well an organ may function following transplant.

Now, however, the rapidly advancing technology of ex vivo normothermic machine perfusion (NMP) holds promise for improved preservation, better assessment and even reconditioning of organs before transplant. And while many questions remain to be resolved regarding the implementation of this still-young technology, already NMP has had an important impact on transplant medicine in the U.S. (and globally), expanding the donor pool by allowing surgeons to assess and successfully transplant organs that once would have gone unutilized.

In comparing NMP with SCS, a primary benefit the technology appears to offer is the luxury of time …

Preserving time

The basic principle of NMP technologies is to approximate “near physiologic” conditions of temperature, nutrients and oxygen outside the body and to enable the organ to function much as it would within the body. Videos of ex vivo NMP vividly illustrate the concept—a heart beats, lungs expand.

In comparing NMP with SCS, a primary benefit the technology appears to offer is the luxury of time; although a safe time limit has not yet been established for NMP, clinical evidence suggests that organs are substantially protected from ischemic injury while being perfused—in essence, NMP “stops the clock” on ischemic injury. “Extending preservation time is a clear benefit, and that is solid and well-established,” says UNOS Chief Medical Officer David Klassen, M.D., former director of the kidney and pancreas transplant programs at University of Maryland Medical Center.

NMP may make it possible, then, for organs to be transported over greater distances, for recipients to travel further to a transplant center, and for surgeons to have more flexibility to schedule optimal surgical times and increase surgical time for complex recipient cases.

“The day will come when the idea of cold storage will be a historical footmark that people will chuckle about as the way we used to do transplant.”

Matthew Hartwig, M.D.

Associate Professor of Surgery in the Division of Cardiovascular and Thoracic Surgery at Duke University Medical School

In essence, normothermic machine perfusion (NMP) “stops the clock” on ischemic injury.

Developing the technology

Three companies are currently leading the development of ex vivo NMP in the U.S., with devices in current and/or recently completed clinical trials.

Massachusetts-based TransMedics offers the transportable Organ Care System (OCS) devices for heart, lung, and liver; OrganOx, based in the UK, has developed the metra® transportable perfusion device for liver; and Swedish-headquartered XVIVO Perfusion offers the non-transportable XPS lung perfusion system.

A fourth company, Lung Bioengineering, based in Maryland, has focused on making perfusion technology more widely accessible by developing a centralized, free-standing perfusion facility to serve multiple transplant centers. The facility employs both the XPS and the Toronto EVLP System developed at University Health Network in Toronto, Canada.

Assessing function and expanding the donor pool

Perhaps most important among its many potential benefits, NMP makes it possible for organs to be functionally evaluated. When surgeons have had to make educated judgements about the condition of donor organs, potentially usable organs—particularly those considered “marginal” or “extended criteria”—have inevitably gone unutilized. This problem is a particularly critical factor in the low utilization rate for donor lungs; only about 20-25 percent of  lungs are transplanted from all deceased donors, according to UNOS research scientist Rebecca Lehman, PhD, and more than half are never even recovered for the purpose of transplant.

But with NMP, says Duke University lung transplant surgeon Dr. Matthew Hartwig, “The devices allow us in a very safe and reproducible fashion to assess the lung outside of the complex environment of the donor and to evaluate the function of the lung in isolation.” Using NMP through clinical trials at Duke, says Hartwig, has made it possible to more objectively determine which organs are most likely to be successfully transplanted. As a result, “We have been able to utilize some lungs that otherwise would not have been used for transplant but that could have been and should have been,” he says.

One such trial was Lung Bioengineering’s multicenter Phase 2 clinical trial, which ended in August of 2018. Initially unacceptable lungs were transported to the company’s Silver Spring perfusion center to be assessed; all lungs that were deemed acceptable after being evaluated via NMP were successfully transplanted.

“If they do well in ex vivo, they do well in transplant,” confirms transplant surgeon Dr. Pablo Sanchez, director of the ex vivo lung perfusion program at the University of Pittsburgh, another of the Lung Bioengineering clinical trial locations.

OrganOX metra®, a transportable liver NMP device now in clinical trials in the U.S.

Comparable benefits have been seen for other organs. In a UK trial of the OrganOX metra®, a transportable liver NMP device now in clinical trials in the U.S., 31 livers initially declined by all seven UK liver transplant centers were assessed on the device, and 22 were successfully transplanted, according to Craig Marshall, CEO of OrganOX.

As Marshall notes, there is “risk associated with lack of information about an organ”—being able to “assess an organ ex vivo and make an informed decision” increases information and decreases that risk. Clinical data thus far seem to indicate comparable outcomes for initially unacceptable or extended-criteria organs transplanted following assessment via NMP—offering the promise that many more organs, such as those from DCD donors, will prove safe for transplant to help address critical shortages.

Video courtesy of XVIVO Perfusion

Lung Bioengineering’s EVLP Suite

Up close

Leading the Way

Meet the companies developing ex vivo NMP in the U.S.

TransMedics, Andover, Massachusetts, Transportable Organ Care System (OCS™) devices for heart, lung, and liver

OrganOX, Oxford, England, metra® transportable perfusion device for liver

XVIVO Perfusion, Gothenburg, Sweden, Non-transportable XPS lung perfusion system

Lung Bioengineering, Silver Spring, Maryland, Centralized, free-standing perfusion facility serving multiple transplant centers

Future potential, future questions

Beyond the immediate benefits already being demonstrated, NMP technology is widely believed to have the potential to powerfully transform the future of transplant medicine.

Although clinical trials have focused on demonstrating the safety of using ex vivo NMP before transplant, researchers and transplant professionals believe that the same technology will likely soon make it possible to improve the condition of recovered organs or even treat them therapeutically for problems such as bacterial or fungal infections, with the goals of further expanding the donor pool and also improving post-transplant outcomes for recipients.

And in the long term, biotechnology experts hope organs could be modified through ex vivo perfusion to prevent or reduce the need for anti-rejection medications, a development that could support advances in xenotransplantation—the modification of nonhuman organs to use in human transplant.

For now, however, basic questions still need to be addressed in the implementation of this technology:

  • What criteria should determine whether an organ is perfused, or should NMP become standard protocol for all donor organs?
  • Where, when, and for how long should NMP be applied?
  • Will the possible benefits of NMP outweigh the costs (including equipment, training, and personnel) of implementing this technology, and how will those costs be distributed across the OPTN?

“We still have a lot of work to do as a community to determine what is going to be the best way to perfuse, evaluate, rehabilitate and eventually improve the organ in an ex vivo setting,” says transplant surgeon Matthew Hartwig. Nevertheless, he believes the day will come, he says, when “the idea of cold storage will be a historical footmark that people will chuckle about as the way we used to do transplant.”

“We still have a lot of work to do as a community to determine what is going to be the best way to perfuse, evaluate, rehabilitate and eventually improve the organ in an ex vivo setting.”

The post appeared first on UNOS.

Heart Allocation in France Since the Introduction of the New Allocation System April 1, 2019

The new French allocation system based on the candidate risk score (CRS) considered donor-recipient matching and implemented nationwide donor heart sharing. In candidates for whom the CRS did not predict accurately waitlist mortality score exceptions can be requested. This study aimed to describe the heart allocation modalities and donor-recipient matching since implementation of the new system on January 2, 2018.

Human Hearts Declined for Transplant Were Resuscitated on the Visible Heart® Apparatus April 1, 2019

Improved utilization of donor hearts would benefit chronic heart failure patients awaiting transplant. Limitations to cardiac allograft preservation include ischemic time, donor organ quality, and accurate graft assessment. We hypothesized that human hearts declined for transplant may be resuscitated after varied ischemic times. The unique studies performed within the Visible Heart® Laboratory for over two decades have provided unique insights relative to optimizing large mammalian functions post-cardioplegia.

Metabolic Alterations in Myocardial Metabolism during Ex Situ Heart Perfusion April 1, 2019

Ex situ heart perfusion (ESHP) is a novel method for preservation of the donated heart in a semi-physiologic state and provides the opportunity to evaluate pre-transplant function. Because of the well-described extraordinary metabolic requirements of the heart, efficient metabolic support is critical for optimal preservation of function and viability. Our aim was to determine changes in energy metabolism/energy substrates during extended ex situ perfusion of hearts in two different perfusion modes, working mode (WM) and non-working mode (NWM).

Successful Utilization of Extended Criteria Donor (ECD) Hearts for Transplantation – Results of the OCS™ Heart EXPAND Trial to Evaluate the Effectiveness and Safety of the OCS Heart System to Preserve and Assess ECD Hearts for Transplantation April 1, 2019

The OCS Heart EXPAND Trial is a prospective, multi-center trial to evaluate the effectiveness of the OCS™ to resuscitate, preserve and assess donor hearts that may not meet current standard donor heart criteria for transplantation to potentially improve donor heart utilization for transplantation.

HLA Epitope Mismatching is Associated with Rejection and Worsened Graft Survival in Heart Transplant Recipients April 1, 2019

At present the assessment of the heart transplant (HTx) recipient’s personal alloimmune risk is still not precise enough. The aim of this study was to evaluate the impact of molecular-level human leukocyte antigen (HLA) matching on post-transplant graft survival, rejection and cardiac allograft vasculopathy (CAV).

Coronary Angiography and Intravascular Ultrasound in an Ex-Vivo Perfused Heart Using the Organ Care System (OCS) April 1, 2019

To describe technical aspects of angiography and intravascular ultrasound (IVUS) in ex-vivo perfused hearts using the Organ Care System (OCS, TransMedics, Andover, MA USA).

Impact of the New Heart Allocation System in France on Candidates’ Profile and Waitlist Outcomes April 1, 2019

The new French allocation system (NFAS) based on the candidate risk score has been launched on January 2, 2018. This study aimed to evaluate the effect of implementation of NFAS on newly registered candidates’ profile and their waitlist outcomes.

Short-Term Outcome after Heart Transplantation is Comparable When Using Extended-Criteria Donors April 1, 2019

The lack of donor organs limits the availability of heart transplantation as an optimal treatment option for advanced heart failure patients. In an effort to expand a pool of acceptable donor organs we explored a correlation between donor age and 1-year outcome in patients undergoing heart transplantation.

Myocardial Flow Reserve Using 13N Ammonia PET for Detection of Cardiac Allograft Vasculopathy April 1, 2019

Risk stratification and early detection of cardiac allograft vasculopathy (CAV) are essential in heart transplantation patients. CAV presents a diffuse vascular involvement, and has been difficult to noninvasively diagnose by the lack of a sensitive method to detect developing vascular pathology in the allograft. The present study investigates the ability of 13N-ammonia PET for detection of CAV in heart transplant patients.

Cardiac Biomarkers for Early Identification of Primary Graft Dysfunction April 1, 2019

Primary graft dysfunction (PGD) is a leading cause of mortality and morbidity following heart transplantation. Our study aimed to determine the feasibility of measuring cardiac biomarkers in the donor heart directly after preservation and use as predictors for PGD.

Interactive Maps for UNOS Data Visualization April 1, 2019

In the United States, heart allocation is administered by the United Network for Organ Sharing (UNOS). UNOS collects demographics and clinical data for all transplant candidates, donors, and recipients listed since 1995. While the data is available to the public upon requests; it has been used predominately for research rather than clinical decision making, transplant patient use and policy makers. The aim of this project is to build a web application to visualizes UNOS data and promote easy access to summary statistics for diverse members of the transplant community.

Novel Intravascular Ultrasound Measurements to Assess for Coronary Allograft Vasculopathy in Patients after Orthotopic Heart Transplant April 1, 2019

Among patients who undergo orthotopic heart transplant (OHT), intravascular ultrasound (IVUS) detection of coronary allograft vasculopathy (CAV), defined as ≥ 0.5 mm increase in maximal intimal thickness (Δ MIT), is associated with worse outcomes at 5 years. Other IVUS-derived measurements of arterial plaque, while validated in studies of coronary atherosclerosis, have not been well studied in CAV.

Effect of Heart Rate on Early Progression of Cardiac Allograft Vasculopathy: A Prospective Study Using Highly Automated 3-D Optical Coherence Tomography Analysis April 1, 2019

Despite the controversial effect of elevated heart rate on progression of cardiac allograft vasculopathy (CAV), heart-rate-slowing agents are frequently prescribed with the assumption that higher heart rate predicts worse outcomes in cardiovascular disease.

Psychosocial Contraindications to Heart Transplant Listing in an Urban Academic Medical Center April 1, 2019

Psychosocial assessment is a key component of heart transplantation (HT) evaluation. Criteria such as patient compliance to medical therapy, level of social support, and history of substance abuse are important considerations when assessing appropriateness for listing. The aim of this study was to characterize the patients who do not satisfy listing criteria due to psychosocial criteria and assess the reasons for which they are rejected.

Importance of a Partnered Heart Failure Network to Increase Access to Advanced Heart Failure Therapies April 1, 2019

Our hypothesis is that by improving access to advanced heart failure specialists (AHFS) through partnered outreach clinics, we can increase the number of patients benefitted by advanced heart failure (AHF) therapies delivered at our center. This partnered network approach can potentially overcome distance barriers, optimize referral timing, and expedite access to AHFS from the regional center of excellence.

Does Donor-Recipient Age Difference Matter in the Outcome of Heart Transplantation? April 1, 2019

With the growing shortage of organ donors, marginal donor organs are increasingly accepted, which may partially explain the continued increase in donor age. The potential interactions between donor-recipient (D/R) age difference and outcomes after heart transplantation (HT) are not well known, and organ allocation systems do not routinely consider D/R age matching. We thus aimed to study the impact of D/R age difference on HT outcomes.

Hearts Donated After Circulatory Death and Reconditioned Using Normothermic Regional Perfusion Can Be Successfully Transplanted Following an Extended Period of Static Storage. April 1, 2019

Circ Heart Fail. 2019 Apr;12(4):e005364

Authors: Ribeiro RVP, Alvarez JS, Yu F, Paradiso E, Adamson MB, Maria Ruggeri G, Fukunaga N, Bissoondath V, Serrick C, Meineri M, Ross H, Rao V, Badiwala MV

Abstract
BACKGROUND: There has been an increased interest in donation after circulatory death (DCD) to expand donor pool for cardiac transplantation. Normothermic regional perfusion (NRP) allows in situ assessment of DCD hearts, allowing only acceptable organs to be procured. We sought to determine if extended cold storage was possible for DCD hearts following NRP and to compare hearts stored using standard cold storage with a novel cardioprotective solution designed for room temperature storage.
METHODS AND RESULTS: Donor pigs underwent hypoxic cardiac arrest (DCD) followed by 15 minutes of warm ischemia and resuscitation on NRP. They were then randomly assigned to static storage with histidine-tryptophan-ketoglutarate (HTK) at 4°C (HTK group, n=5) or SOM-TRN-001 at 21°C (SOM group, n=5). Conventional beating-heart donations were used as controls (n=4). Fourteen transplants were successfully performed. HTK hearts showed initial dysfunction following reperfusion; however, they demonstrated significant recovery up to 3 hours post-transplant. No significant differences were seen between HTK and control hearts post-transplantation (cardiac index: control 49.5±6% and HTK 48.5±5% of baseline). SOM improved myocardial preservation; hearts showed stable contractility after transplantation (cardiac index: 113.0±43% of NRP function) and improved diastolic function compared with HTK. Preservation in SOM also significantly reduced proinflammatory cytokine production and release following transplantation and partially prevented endothelial dysfunction.
CONCLUSIONS: DCD hearts stored using a standard preservation solution demonstrated comparable post-transplantation myocardial function to standard controls. Thus, short periods of cold storage following successful NRP and documented adequate function is an acceptable strategy for DCD hearts. Preservation in SOM at room temperature is feasible and can improve cardiac recovery by minimizing endothelial dysfunction and tissue injury.

PMID: 30998401 [PubMed – in process]

The donor heart and organ perfusion technology. April 1, 2019
Related Articles

J Thorac Dis. 2019 Apr;11(Suppl 6):S938-S945

Authors: Chew HC, Macdonald PS, Dhital KK

Abstract
Recent advancement in organ perfusion technology has led to increase clinical transplantation of marginal donor organs and allow for distant procurement of cardiac allograft beyond the time limitation of cold static storage. Ex-situ heart perfusion also provides essential nutrients to maintain cell integrity, thereby reducing the risk of ischaemic injury for functional preservation and provides a platform to assess organ viability and feasibility, with the potential for pharmacotherapy to recover these hearts. Notably, the use of NMP has led to the first distant procurement cardiac transplantation from a donation after circulatory death (DCD) in 2014, which resulted in the adoption of DCD heart transplantation in 4 centres between the United Kingdom and Australia. To date, over 100 DCD heart transplants have been performed utilising cardiac perfusion system with an estimated 10-15% increase in transplant activity in the individual units. This review aims to provide an overview of current experience and outcomes using cardiac perfusion technology, including future technologies and recent advancement within the field.

PMID: 31183173 [PubMed]

Bioengineering approaches to organ preservation ex vivo. March 19, 2019
Related Articles

Exp Biol Med (Maywood). 2019 Mar 19;:1535370219834498

Authors: Pinezich M, Vunjak-Novakovic G

Abstract
IMPACT STATEMENT: Over the past several decades, ex vivo perfusion has emerged as a promising technology for the assessment, preservation, and recovery of donor organs. Many exciting pre-clinical findings have now been translated to clinical use, and successful transplantation following ex vivo perfusion has been achieved for heart, lung, and liver. While machine perfusion provides distinct advantages over traditional cold preservation, many challenges remain, including that of long-term (multi-day) ex vivo support. Here, we provide an overview of the current status of ex vivo machine perfusion in the pre-clinical and clinical setting and share our perspective on the future direction of the field.

PMID: 30889963 [PubMed – as supplied by publisher]

Myocardial functional decline during prolonged ex situ heart perfusion. March 11, 2019
Related Articles

Ann Thorac Surg. 2019 Mar 11;:

Authors: Hatami S, White CW, Shan S, Haromy A, Qi X, Ondrus M, Kinnear A, Himmat S, Michelakis E, Nagendran J, Freed DH

Abstract
BACKGROUND: Myocardial function declines in a time dependent fashion during ex situ heart perfusion. Cell death and metabolic alterations may contribute to this phenomenon, limiting the safe perfusion period and the potential of ex situ heart perfusion to expand the donor pool. Our aim is to investigate the etiology of myocardial functional decline in ex situ perfused hearts.
METHODS: Cardiac function, apoptosis, effectors and markers of cell death, and metabolic function were assessed in healthy pig hearts, perfused for 12 hours. These hearts were perfused either in non-working mode (NWM), or working mode (WM).
RESULTS: Cardiac function declined during ex situ heart perfusion regardless of perfusion mode but was significantly better preserved in the hearts perfused in WM (11-hour cardiac index / 1-hour cardiac index: WM=33 vs. NWM=10%, p=0.025). The rate of apoptosis was higher in the ex situ perfused hearts compared to in vivo samples (% apoptotic cells: in vivo=0.13, WM=0.54, NWM=0.88%, p<0.001) but the absolute values were low and out of proportion to the decline in function in either group. Myocardial dysfunction at the end of the perfusion interval was partially rescued by delivery of a pyruvate bolus.
CONCLUSIONS: Hearts preserved ex situ experience a significant decline in myocardial function over time that is out of proportion to the magnitude of myocyte cell death present in dysfunctional hearts. Alterations in myocardial substrate utilization during prolonged ex situ heart perfusion may contribute to this phenomenon, and represent an avenue to improve donor heart preservation.

PMID: 30872100 [PubMed – as supplied by publisher]

Primary Graft Dysfunction: Worry Less about Organ Quality and Do More to Improve Candidate Condition March 10, 2019

In this issue of the Journal, Profita and colleagues report findings from a well-controlled analysis matching outcomes from the Organ Procurement and Transplantation Network (OPTN) and the Extracorporeal Life Support Organization (ELSO) datasets to identify incidences of and risk factors for severe primary graft dysfunction (PGD) in pediatric heart transplant recipients within the United States.1 The authors find no change in the incidence of severe PGD across two decades of pediatric heart transplant.

Sixteen-Hour Ex Vivo Donor Heart Perfusion During Long-Distance Transportation for Heart Transplantation. March 1, 2019
Icon for Wiley Icon for PubMed Central Related Articles

Artif Organs. 2019 Mar;43(3):319-320

Authors: Kaliyev R, Bekbossynov S, Nurmykhametova Z

PMID: 30585343 [PubMed – indexed for MEDLINE]

An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms February 5, 2019

We previously reported a microarray-based diagnostic system for heart transplant endomyocardial biopsies (EMBs), using either 3-archetype (3AA) or 4-archetype (4AA) unsupervised algorithms to estimate rejection. The present study aimed to examine the stability of machine-learning algorithms in new biopsies, compare 3AA vs. 4AA algorithms, assess supervised binary classifiers trained on histologic or molecular diagnoses, create a report combining many scores into an ensemble of estimates, and examine possible automated sign-outs.

Creating the first national donor image sharing hub February 5, 2019

Pilot project tests new system that could offer quick access to high-quality medical images and facilitate more transplants

By Judy Ivey

Rob McTier, United Network for Organ Sharing

UNOS business architect Rob Mctier (standing) working with the technology development team.

A medical image sharing pilot project underway now at UNOS may soon give organ procurement organizations, and donor and transplant hospitals universal access to high-quality medical imaging studies during the organ offer process. Creating a consistent, reliable and secure national image sharing system has the potential to decrease the number of organs that are not used and increase the number of transplants overall.

How image sharing often happens now

When the procurement team at Baltimore-based Living Legacy Foundation of Maryland needs images of a donor’s organs, they often take them with their iPhones. The OPO has more than 150 donors each year.

The images are emailed or sent via text to Living Legacy’s communications center and then shared with surgeons who request them explains Debbi McRann, Chief Clinical Officer. “But the quality isn’t good and we can’t upload it to DonorNet® because the file is too big. We’re only giving surgeons a partial scan because of the limitations.”

DonorNet® currently accommodates certain images as attachments, but file sizes are limited and the process of acquiring and attaching images is inefficient, preventing routine use.
When surgeons can’t clearly see the organ being offered, given the risk of travel to recover and the possibility that the organ won’t meet their patient’s needs when they see it in person, it stands to reason that they would hesitate to accept some offers. This results in unused organs that could otherwise help save patients’ lives.

“Another one of the challenges we’ve been having when we receive offers from outside centers is that they will have multiple donors listed, so the risk is it’s not linked to the actual donor record so you could potentially download the wrong CT and send it to the surgeon,” explains McRann.

The pilot includes functionality that addresses this risk. When an OPO uploads an imaging study, DonorNet® compares the patient name, gender, and date of birth on the imaging study with the donor name, gender, and date of birth in DonorNet®. If there are differences, DonorNet® warns the OPO user and allows the OPO user to resolve the conflicting data before displaying the imaging study to transplant hospital users.

While some OPOs use image sharing systems, the existing process can be costly, involving multiple vendors and external applications that don’t necessarily talk with each other.

The pilot project currently underway could make a high quality universal donor image system a reality.
UNOS is partnering with New York City-based image sharing provider Ambra Health and six OPOs around the country to test a solution that would make available large file-size medical images, radiographs, videos of echocardiograms, catheterizations, pulmonary bronchoscopies, and other images to OPOs, and transplant and donor hospitals.

“If we can have a consistent way for everyone to transfer information, that’s going to decrease errors,” says McRann. “Right now, there are many different ways of showing these images. If there were only one, there’d be more standardization and fewer errors” and surgeons could decide to transplant organs they may not have considered otherwise.

Target solution

“This pilot is just the first step,” says UNOS business architect Rob McTier who helms the seven-member team that has spent the last several years developing the system. “We want to be able to provide an infrastructure that will enable the sharing of this information.”

“Donor imaging helps other programs learn from each other,” says Jared Sierkierka, Clinical Operations Manager for Donor Network West, based in San Ramon, California, which adopted an image sharing system in 2011. “Transplant hospitals can look at the causes of hesitation when an organ is declined. Other organizations will look at why others accepted an organ they declined and learn.”

How it works

During the pilot, OPOs receive high-quality imaging studies on CDs or thumb-drives. They login to DonorNet® with their existing username and password to upload the imaging study similar to the way they upload smaller attachments. DonorNet® links the imaging studies to a specific donor’s record in DonorNet®. Transplant hospitals login to DonorNet® with their existing username and password to view the imaging study using a DICOM viewing tool.

If the pilot is successful, the national system could work like this:

  • The OPO requests an imaging study for a donor from a donor hospital.
  • The donor hospital sends the imaging study to UNOS’s imaging hub.
  • DonorNet® will automatically connect the imaging study to the appropriate donor record.
  • Both the OPO and transplant hospital will log in to DonorNet® and be able to view the imaging study using a DICOM viewing tool.

“I was amazed when I saw the images,” says Dr. Daniel Jacoby, Director of the Comprehensive Heart Failure Program at Yale School of Medicine and founder and director of Yale’s cardiomyopathy program who tested the system. “They look like you’re looking directly at an echo screen. This is a step forward for our patients.”

Says McRann, “I think, because they’re connected right to the donor record, more surgeons and coordinators will be able to look at the images faster and make their decisions faster. This can speed up allocation.”

What’s next

If the pilot is successful, McTier says UNOS plans to make the system available nationwide. Over the next few months, look for updates on UNOS.org about the pilot, including a Q&A with the development team.

Read more about the pilot and for information about available education resources for participating OPOs.

OPOs participating in the pilot

  • Center for Organ Recovery and Education, Pittsburgh, PA
  • Donor Network West, San Ramon, CA
  • Lifesharing: A Donate Life Organization, San Diego, CA
  • LifeQuest Organ Recovery Services, Gainesville, FL
  • Nevada Donor Network, Las Vegas, NV
  • One Legacy, Los Angeles, CA

The post appeared first on UNOS.

Incidence, predictors, and outcomes after severe primary graft dysfunction in pediatric heart transplant recipients January 23, 2019

Previous reports of primary graft dysfunction (PGD) in pediatric heart transplant (HT) recipients are limited to descriptive series of children who required extracorporeal membrane oxygenation (ECMO) support shortly after HT. In this study we sought to determine the incidence, risk factors, and survival after severe PGD in pediatric HT recipients.

Data definition process in place to bring clarity and consistency to transplant forms January 15, 2019

Audience

All UNetSM users who complete OPTN data collection forms

Implementation

January 15, 2019; quarterly updates

At-a-glance

A cross-functional team of UNOS staff and OPTN members is working on a data governance initiative to improve the consistency and quality of OPTN data collection. The first set of data definitions using a new format are published in UNet online Help as of January 15, 2019.

We will provide a list of revised definitions each quarter, to answer member questions about existing data fields and to clarify new requirements.

More details

This effort aims to provide clear, concise data definitions, improve quality of data, and provide transparency into changes. Clarifications are intended to provide guidance for future data entry; you are not required to amend data submitted before the collection date. The process to create revised data definitions includes reviews by multidisciplinary UNOS staff and the Data Advisory Committee.

Summary of definition changes

Data Element System Form Description
Gender TIEDI®
DonorNet®
KPDSM
DDR and LDR
DNR
Add/Edit Donor
Intent is to collect biologic and physiologic traits (sex) at birth.
Total Cold Ischemic Time TIEDI® Liver TRR Cold ischemic time starts when the organ is cross-clamped and ends when it is first perfused with warm recipient blood (i.e. first clamp removed in situ). Previous to this change, the hepatic artery and portal vein clamps both had to be removed before ischemic time ended.
Prior Cardiac Surgery (non-transplant) TIEDI® Heart, Lung and Heart-Lung TCR VAD should be included in the report of previous cardiac surgeries.
Time of implant/initiation WaitlistSM Adult Heart Status Justification Form New data collection element released, initial definition established with implementation of heart allocation policy on 10/18/2018.
Patient Using Either Oral Medication or Diet for Blood Sugar Control TIEDI® Pancreas and Kidney-Pancreas TRR and TRF Any anti-hyperglycemic medications should be listed in this field, including oral and non-insulin injectables.

Where to find the info in Help Documentation

Access Secure Enterprise and then choose TIEDI. On the menu, choose Help and click Online Help. Details can be found under Manage Data – Data Definitions and History of Definition Changes. Record Field Descriptions have also been updated to include each data element.

Background

The OPTN’s secure transplant information database contains all national data on the candidate waiting list, organ donation and matching, and transplantation. Organ transplant institutions use the system to match waiting candidates with donated organs. Institutions also rely on the database to manage time-sensitive, life-critical data, before and after their patients’ transplants.

Contact

If you have questions, please contact UNOS Customer Service at (800) 978-4334 or unethelpdesk@unos.org.

Organ transplants in United States set sixth consecutive record in 2018 January 15, 2019
Organ transplants in United States set sixth consecutive record in 2018

The 36,527 organ transplants performed in the United States in 2018 set an annual record for the sixth straight year, according to preliminary data from United Network for Organ Sharing (UNOS), which serves as the national Organ Procurement and Transplantation Network (OPTN) under federal contract. In 2018, the total number of organ transplants exceeded 750,000 performed since 1988, the first full year national transplant data were collected.

The number of transplants, using organs from both deceased and living donors, increased five percent over 2017. Approximately 81 percent (29,680) of the transplants performed in 2018 involved organs from deceased donors. Living donor transplants accounted for the remaining 19 percent (6,849). The number of living donor transplants represented the highest total since 2005 and increased nearly 11 percent over 2017.

“We are incredibly proud and grateful to have facilitated a record number of lifesaving organ transplants in 2018,” said Sue Dunn, president of the OPTN/UNOS Board of Directors. “We never forget that our work is made possible by the selfless donors and their courageous families who make the powerful decision to give the gift of life. We will continue to work tirelessly to maximize that gift on behalf of the nearly 114,000 who await a transplant.

“In 2018, 10,721 people provided one or more organs for transplantation as deceased organ donors. This was a four percent increase over the 2017 total, and it continues an eight-year trend of record-setting donation.

While the number of potential deceased organ donors varies among different areas of the country due to differences in population size and medical characteristics, increases were noted in many areas. Of the 58 organ procurement organizations (OPOs) coordinating deceased organ donation nationwide, 41 (70 percent) experienced an increase in donors from 2017 to 2018, including at least one OPO in each of UNOS’ 11 regions.

“A key to continuing the success of the field is to support efficient decision-making and improve communications among OPOs and transplant centers,” said Brian Shepard, Chief Executive Officer of UNOS. “We are working on a number of innovation projects to increase the efficiency of these key processes.”

As in several previous years, some of the increase in deceased donation is due to increased usage of donors with a broader set of medical criteria than was considered in the past. Nearly 20 percent of donors in 2018 donated after circulatory death as opposed to brain death. Nine percent of deceased donor kidney transplants involved organs with a kidney donor profile index (KDPI) score of 86 or higher, which may function less time compared to low KDPI kidney offers but may also shorten the waiting time for transplant candidates. Other donor characteristics setting all-time records in 2018 included an age of 50 or older and/or being identified as having increased risk for blood-borne disease.

Normothermic Ex Situ Heart Perfusion in Working Mode: Assessment of Cardiac Function and Metabolism. January 12, 2019

J Vis Exp. 2019 Jan 12;(143):

Authors: Hatami S, White CW, Ondrus M, Qi X, Buchko M, Himmat S, Lin L, Cameron K, Nobes D, Chung HJ, Nagendran J, Freed DH

Abstract
The current standard method for organ preservation (cold storage, CS), exposes the heart to a period of cold ischemia that limits the safe preservation time and increases the risk of adverse post-transplantation outcomes. Moreover, the static nature of CS does not allow for organ evaluation or intervention during the preservation interval. Normothermic ex situ heart perfusion (ESHP) is a novel method for preservation of the donated heart that minimizes cold ischemia by providing oxygenated, nutrient-rich perfusate to the heart. ESHP has been shown to be non-inferior to CS in the preservation of standard-criteria donor hearts and has also facilitated the clinical transplantation of the hearts donated after the circulatory determination of death. Currently, the only available clinical ESHP device perfuses the heart in an unloaded, non-working state, limiting assessments of myocardial performance. Conversely, ESHP in working mode provides the opportunity for comprehensive evaluation of cardiac performance by assessment of functional and metabolic parameters under physiologic conditions. Moreover, earlier experimental studies have suggested that ESHP in working mode may result in improved functional preservation. Here, we describe the protocol for ex situ perfusion of the heart in a large mammal (porcine) model, which is reproducible for different animal models and heart sizes. The software program in this ESHP apparatus allows for real-time and automated control of the pump speed to maintain desired aortic and left atrial pressure and evaluates a variety of functional and electrophysiological parameters with minimal need for supervision/manipulation.

PMID: 30688296 [PubMed – in process]

Cardiac Allograft Vasculopathy and Graft Failure in Pediatric Heart Transplant Recipients After Rejection with Severe Hemodynamic Compromise December 19, 2018

Rejection with severe hemodynamic compromise (RSHC) carries a mortality risk approaching 50%. We aimed to identify current risk factors for RSHC and predictors of graft failure after RSHC.

Exosomal profiling in cardiac allograft rejection: Best basic science article in 2018. December 19, 2018

Identifying patients who are at risk for complications after thoracic transplantation assists in better defining outcomes and promoting discovery of new mechanisms that can be targeted to mitigate these complications. The gold-standard for diagnosing rejection, a major cause of morbidity and mortality after transplantation, is biopsy, which (1) is not risk-free, (2) may not be practical in critically ill patients and (3) may result in false-negative findings.1 Exosomes had been described as far back as in 1981 as membrane fragments from reticulocytes detected in body fluids.

Sizing it Up in Heart Transplantation: Time to Change the Guidelines? December 13, 2018

It’s not the size of a man, but the size of his heart that matters.Evander Holyfield, American professional boxer (1962-)

Utilization of organs to pediatric heart transplant recipients December 13, 2018

While survival after pediatric heart transplantation (pHT) has improved in the past few decades and mechanical circulatory support is increasingly used to bridge children to transplantation, waiting list deaths remain a stark reality. To increase the donor pool, strategies such as ABO-incompatible transplantation or donation after cardiac death (DCD) have been attempted.1,2 The real question we have to ask is whether the current donor pool offers are appropriately being used. The article by Davies and colleagues in this issue of the journal looked at the rate of declines in donor offers for pediatric recipients and their consequences.

Hypothermic perfusion of donor heart with a preservation solution supplemented by mesenchymal stem cells December 6, 2018

Heart transplantation is the definitive treatment for end-stage heart failure. A shortage of donor hearts forced transplant programs to accept older donors and longer ischemic times. Previous studies have suggested that administration of mesenchymal stem cells (MSCs) or their conditioned medium (CM) protects the heart against ischemia/reperfusion injury (IRI). We hypothesized that the preservation of donor hearts with a CM would protect the graft from IRI after prolonged storage in 15-month-old rats and investigated mRNA changes attributable to CM.

Consistent success in life-supporting porcine cardiac xenotransplantation. December 5, 2018
Related Articles

Nature. 2018 Dec 05;:

Authors: Längin M, Mayr T, Reichart B, Michel S, Buchholz S, Guethoff S, Dashkevich A, Baehr A, Egerer S, Bauer A, Mihalj M, Panelli A, Issl L, Ying J, Fresch AK, Buttgereit I, Mokelke M, Radan J, Werner F, Lutzmann I, Steen S, Sjöberg T, Paskevicius A, Qiuming L, Sfriso R, Rieben R, Dahlhoff M, Kessler B, Kemter E, Klett K, Hinkel R, Kupatt C, Falkenau A, Reu S, Ellgass R, Herzog R, Binder U, Wich G, Skerra A, Ayares D, Kind A, Schönmann U, Kaup FJ, Hagl C, Wolf E, Klymiuk N, Brenner P, Abicht JM

Abstract
Heart transplantation is the only cure for patients with terminal cardiac failure, but the supply of allogeneic donor organs falls far short of the clinical need1-3. Xenotransplantation of genetically modified pig hearts has been discussed as a potential alternative4. Genetically multi-modified pig hearts that lack galactose-α1,3-galactose epitopes (α1,3-galactosyltransferase knockout) and express a human membrane cofactor protein (CD46) and human thrombomodulin have survived for up to 945 days after heterotopic abdominal transplantation in baboons5. This model demonstrated long-term acceptance of discordant xenografts with safe immunosuppression but did not predict their life-supporting function. Despite 25 years of extensive research, the maximum survival of a baboon after heart replacement with a porcine xenograft was only 57 days and this was achieved, to our knowledge, only once6. Here we show that α1,3-galactosyltransferase-knockout pig hearts that express human CD46 and thrombomodulin require non-ischaemic preservation with continuous perfusion and control of post-transplantation growth to ensure long-term orthotopic function of the xenograft in baboons, the most stringent preclinical xenotransplantation model. Consistent life-supporting function of xenografted hearts for up to 195 days is a milestone on the way to clinical cardiac xenotransplantation7.

PMID: 30518863 [PubMed – as supplied by publisher]

Utilization of the organ care system – a game-changer in combating donor organ shortage. November 18, 2018
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Utilization of the organ care system – a game-changer in combating donor organ shortage.

Med Sci Monit Basic Res. 2015 Mar 12;21:29-32

Authors: Popov AF, García Sáez D, Sabashnikov A, Patil NP, Zeriouh M, Mohite PN, Zych B, Schmack B, Ruhparwar A, Kallenbach K, Dohmen PM, Karck M, Simon AR, Weymann A

Abstract
For patients with end-stage heart failure, cardiac transplantation persists to be the gold standard. Nevertheless, the availability of organs remains a main constraint to the treatment. Through mounting usage of ex vivo heart perfusion an increase in organ availability was achieved by reconditioning of organs formerly not regarded as appropriate for transplantation. We propose the future standard application of this state-of-the-art technology to improve the pool of donor organs by evaluating hearts outside standard acceptability criteria.

PMID: 25761708 [PubMed – indexed for MEDLINE]

Successful transplantation in canines after long-term coronary sinus machine perfusion preservation of donor hearts. November 18, 2018
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Successful transplantation in canines after long-term coronary sinus machine perfusion preservation of donor hearts.

J Heart Lung Transplant. 2016 08;35(8):1031-6

Authors: Brant S, Holmes C, Cobert M, Powell L, Shelton J, Jessen M, Peltz M

Abstract
BACKGROUND: Machine perfusion is a promising strategy for donor heart preservation, but delivery of perfusate through the aorta may be limited by aortic valve incompetence. We hypothesized that retrograde machine perfusion preservation through the coronary sinus avoided this issue and allowed for recovery of donor hearts after long-term storage.
METHODS: Canine hearts were procured after arrest with 1 liter University of Wisconsin Machine Perfusion Solution (UWMPS) and preserved for 14 hours by static hypothermic storage (Static group, n = 5) or retrograde machine perfusion through the coronary sinus (RP group, n = 5). Myocardial oxygen consumption (MVo2) and lactate were monitored in perfused hearts. Hearts were implanted and reperfused for 6 hours. The pre-load recruitable stroke work was determined as a measure of myocardial function. Cardiac enzyme release was quantified. Cell death was evaluated by TUNEL (terminal deoxynucleotidyltransferase-mediated deoxy uridine triphosphate nick-end label).
RESULTS: MVo2 decreased initially then stabilized. Lactate accumulation was low in RP hearts. All RP hearts separated from cardiopulmonary bypass. All Static hearts required a return to bypass (p < .05). Pre-load recruitable stroke work in RP hearts was increased (55 ± 7 mm Hg) compared with Static (20 ± 11 mm Hg, p < .05) and did not differ from baseline values. Creatine kinase release was greater in Static group hearts (102 ± 16 IU/liter/g) than in RP hearts (51 ± 8 IU/liter/g, p < .05). The fraction of TUNEL-positive cells was higher in the Static group, but this difference was not significant.
CONCLUSIONS: Retrograde machine perfusion can preserve donor hearts for long intervals. Cardiac function after implantation suggested excellent myocardial protection. Retrograde machine perfusion appears promising for extending the donor ischemic interval and improving results of heart transplantation.

PMID: 27160493 [PubMed – indexed for MEDLINE]

Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial. November 18, 2018
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Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial.

Lancet. 2015 Jun 27;385(9987):2577-84

Authors: Ardehali A, Esmailian F, Deng M, Soltesz E, Hsich E, Naka Y, Mancini D, Camacho M, Zucker M, Leprince P, Padera R, Kobashigawa J, PROCEED II trial investigators

Abstract
BACKGROUND: The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation.
METHODS: We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712.
FINDINGS: Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events.
INTERPRETATION: Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study.
FUNDING: TransMedics.

PMID: 25888086 [PubMed – indexed for MEDLINE]

Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: a case series. November 18, 2018
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Adult heart transplantation with distant procurement and ex-vivo preservation of donor hearts after circulatory death: a case series.

Lancet. 2015 Jun 27;385(9987):2585-91

Authors: Dhital KK, Iyer A, Connellan M, Chew HC, Gao L, Doyle A, Hicks M, Kumarasinghe G, Soto C, Dinale A, Cartwright B, Nair P, Granger E, Jansz P, Jabbour A, Kotlyar E, Keogh A, Hayward C, Graham R, Spratt P, Macdonald P

Abstract
BACKGROUND: Orthotopic heart transplantation is the gold-standard long-term treatment for medically refractive end-stage heart failure. However, suitable cardiac donors are scarce. Although donation after circulatory death has been used for kidney, liver, and lung transplantation, it is not used for heart transplantation. We report a case series of heart transplantations from donors after circulatory death.
METHODS: The recipients were patients at St Vincent’s Hospital, Sydney, Australia. They received Maastricht category III controlled hearts donated after circulatory death from people younger than 40 years and with a maximum warm ischaemic time of 30 min. We retrieved four hearts through initial myocardial protection with supplemented cardioplegia and transferred to an Organ Care System (Transmedics) for preservation, resuscitation, and transportation to the recipient hospital.
FINDINGS: Three recipients (two men, one woman; mean age 52 years) with low transpulmonary gradients (<8 mm Hg) and without previous cardiac surgery received the transplants. Donor heart warm ischaemic times were 28 min, 25 min, and 22 min, with ex-vivo Organ Care System perfusion times of 257 min, 260 min, and 245 min. Arteriovenous lactate values at the start of perfusion were 8·3-8·1 mmol/L for patient 1, 6·79-6·48 mmol/L for patient 2, and 7·6-7·4 mmol/L for patient 3. End of perfusion lactate values were 3·6-3·6 mmol/L, 2·8-2·3 mmol/L, and 2·69-2·54 mmol/L, respectively, showing favourable lactate uptake. Two patients needed temporary mechanical support. All three recipients had normal cardiac function within a week of transplantation and are making a good recovery at 176, 91, and 77 days after transplantation.
INTERPRETATION: Strict limitations on donor eligibility, optimised myocardial protection, and use of a portable ex-vivo organ perfusion platform can enable successful, distantly procured orthotopic transplantation of hearts donated after circulatory death.
FUNDING: NHMRC, John T Reid Charitable Trust, EVOS Trust Fund, Harry Windsor Trust Fund.

PMID: 25888085 [PubMed – indexed for MEDLINE]

Moderate hypothermia during ex vivo machine perfusion promotes recovery of hearts donated after cardiocirculatory death†. November 18, 2018
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Moderate hypothermia during ex vivo machine perfusion promotes recovery of hearts donated after cardiocirculatory death†.

Eur J Cardiothorac Surg. 2016 Jan;49(1):25-31

Authors: Tolboom H, Olejníčková V, Reser D, Rosser B, Wilhelm MJ, Gassmann M, Bogdanova A, Falk V

Abstract
OBJECTIVES: To establish the optimal machine perfusion temperature for recovery of hearts in a rodent model of donation after declaration of cardiocirculatory death (DCD).
METHODS: Hearts from male Lewis rats (n = 14/group) were subjected to 25 min of in situ warm (37°C) ischaemia to simulate DCD. They were then explanted and reperfused with diluted autologous blood for 60 min at 20, 25, 30, 33 or 37°C, after which they were stored at 0-4°C in Custodiol preservation solution for 240 min. Fresh-excised and cold-stored ischaemic hearts were used as controls. The viability of the different groups was assessed by comparing heart rate and left ventricular contractility in a Langendorff circuit, as well as perfusate levels of troponin-t and creatine kinase (CK), and myocardial levels of adenosine triphosphate (ATP) and reduced glutathione.
RESULTS: During ex vivo reperfusion, hearts in all groups resumed beating within minutes. The mean heart rate was highest in the 37°C group at 154.72 ± 33.01 beats × min(-1) (bpm), and declined in proportion to temperature to 39.72 ± 5.53 bpm at 20°C. Troponin-t levels were highest in the 37°C group (79.49 ± 20.79 µg/l), the values were significantly lower in all other reconditioned groups with a minimum of 12.472 ± 7.08 µg/l in the 20°C group (P < 0.0001). Tissue ATP levels ranged from 4.32 ± 1.71 µmol/g at 33°C to 4.59 ± 1.41 µmol/g at 30°C, all significantly higher than the mean ATP level of 1.41 ± 0.93 µmol/g in untreated ischaemic hearts (P < 0.0001). During Langendorff assessment, the mean heart rate and contractility of all groups were higher than those of cold-stored ischaemic hearts (P < 0.0001), yet not significantly different from those of fresh controls. The perfusate levels of troponin-t and CK, and myocardial levels of reduced-glutathione and ATP were not significantly different between groups.
CONCLUSION: Our results suggest that mild hypothermia during ex vivo reperfusion improves recovery of ischaemic hearts in a rodent DCD model.

PMID: 25740820 [PubMed – indexed for MEDLINE]

Evaluation of the organ care system in heart transplantation with an adverse donor/recipient profile. November 18, 2018
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Evaluation of the organ care system in heart transplantation with an adverse donor/recipient profile.

Ann Thorac Surg. 2014 Dec;98(6):2099-105; discussion 2105-6

Authors: García Sáez D, Zych B, Sabashnikov A, Bowles CT, De Robertis F, Mohite PN, Popov AF, Maunz O, Patil NP, Weymann A, Pitt T, McBrearty L, Pates B, Hards R, Amrani M, Bahrami T, Banner NR, Simon AR

Abstract
BACKGROUND: A severe shortage of available donor organs has created an impetus to use extended criteria organs for heart transplantation. Although such attempts increase donor organ availability, they may result in an adverse donor-recipient risk profile. The TransMedics Organ Care System (OCS) (TransMedics, Inc, Boston) allows preservation of the donor heart by perfusing the organ at 34°C in a beating state, potentially reducing the detrimental effect of cold storage and providing additional assessment options. We describe a single-center experience with the OCS in high-risk heart transplant procedures.
METHODS: Thirty hearts were preserved using the OCS between February 2013 and January 2014, 26 of which (86.7%) were transplanted. Procedures were classified as high risk based on (1) donor factors, ie, transport time more than 2.5 hours with estimated ischemic time longer than 4 hours, left ventricular ejection fraction (LVEF) less than 50%, left ventricular hypertrophy (LVH), donor cardiac arrest, alcohol/drug abuse, coronary artery disease or (2) recipient factors, ie, mechanical circulatory support or elevated pulmonary vascular resistance (PVR), or both.
RESULTS: Donor and recipient age was 37 ± 12 years and 43 ± 13 years, respectively. Allograft cold ischemia time was 85 ± 17 minutes and OCS perfusion time was 284 ± 90 minutes. The median intensive care unit stay was 6 days. One death (3.8%) was observed over the follow-up: 257 ± 116 (109-445 days). There was preserved allograft function in 92% of patients, with a mean LVEF of 64% ± 5%.
CONCLUSIONS: Use of the OCS is associated with markedly improved short-term outcomes and transplant activity by allowing use of organs previously not considered suitable for transplantation or selection of higher risk recipients, or both.

PMID: 25443013 [PubMed – indexed for MEDLINE]

Characterizing cardiac donation after circulatory death: implications for perfusion preservation. November 18, 2018
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Characterizing cardiac donation after circulatory death: implications for perfusion preservation.

Ann Thorac Surg. 2014 Dec;98(6):2107-13; discussion 2113-4

Authors: Brant SM, Cobert ML, West LM, Shelton JM, Jessen ME, Peltz M

Abstract
BACKGROUND: Donation after circulatory determination of death (DCDD) involves variable definitions of death among hospitals, and DCDD hearts are not generally considered for transplantation. The definition can affect ischemic times, and machine perfusion preservation appears promising for recovery of DCDD hearts. The purpose of the current study was to investigate the agonal phase of DCDD donors and evaluate retrograde perfusion preservation of DCDD donor hearts in a large animal model of cardiac transplantation.
METHODS: Ten canines were anesthetized and then disconnected from mechanical ventilation. Time to loss of pulse (systolic blood pressure <50 mm Hg), loss of pressure, and asystole or fibrillation were recorded. Five minutes after asystole, hearts were exposed and arrested with 1 L of University of Wisconsin Machine Perfusion Solution. Eight hearts were cold preserved for 4 hours by retrograde machine perfusion or static storage (n = 4/group), then reimplanted and reperfused for 6 hours. The preload recruitable stroke work was used to measure myocardial function.
RESULTS: The agonal phase was similar between groups. Loss of pulse and pressure were consistent between animals (7.9 ± 0.5 minutes [range, 5 to 11 minutes], 10.2 ± 0.4 minutes [range, 9 to 13 minutes], respectively). Electrical silence was variable at 26.9 ± 3.8 minutes (range, 11 to 43 minutes). All perfused hearts separated and remained off cardiopulmonary bypass. Three of four static hearts initially separated from cardiopulmonary bypass, but two returned by the end of the reperfusion period. The preload recruitable stroke work was significantly higher in perfused hearts.
CONCLUSIONS: Protocols for DCDD have implications on ischemic times of donor hearts. Machine perfusion preservation can recover DCDD hearts more consistently than static storage.

PMID: 25443014 [PubMed – indexed for MEDLINE]

A whole blood-based perfusate provides superior preservation of myocardial function during ex vivo heart perfusion. November 18, 2018
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A whole blood-based perfusate provides superior preservation of myocardial function during ex vivo heart perfusion.

J Heart Lung Transplant. 2015 Jan;34(1):113-21

Authors: White CW, Hasanally D, Mundt P, Li Y, Xiang B, Klein J, Müller A, Ambrose E, Ravandi A, Arora RC, Lee TW, Hryshko LV, Large S, Tian G, Freed DH

Abstract
BACKGROUND: Ex vivo heart perfusion (EVHP) provides the opportunity to resuscitate unused donor organs and facilitates assessments of myocardial function that are required to demonstrate organ viability before transplantation. We sought to evaluate the effect of different oxygen carriers on the preservation of myocardial function during EVHP.
METHODS: Twenty-seven pig hearts were perfused ex vivo in a normothermic beating state for 6 hours and transitioned into working mode for assessments after 1 (T1), 3 (T3), and 5 (T5) hours. Hearts were allocated to 4 groups according to the perfusate composition. Red blood cell concentrate (RBC, n = 6), whole blood (RBC+Plasma, n = 6), an acellular hemoglobin-based oxygen carrier (HBOC, n = 8), or HBOC plus plasma (HBOC+Plasma, n = 7) were added to STEEN Solution (XVIVO Perfusion, Goteborg, Sweden) to achieve a perfusate hemoglobin concentration of 40 g/liter.
RESULTS: The perfusate composition affected the preservation of systolic (T5 dP/dtmax: RBC+Plasma = 903 ± 99, RBC = 771 ± 77, HBOC+Plasma = 691 ± 82, HBOC = 563 ± 52 mm Hg/sec; p = 0.047) and diastolic (T5 dP/dtmin: RBC+Plasma = -574 ± 48, RBC = -492 ± 63, HBOC+Plasma = -326 ± 32, HBOC = -268 ± 22 mm Hg/sec; p < 0.001) function, and the development of myocardial edema (weight gain: RBC+Plasma = 6.6 ± 0.9, RBC = 6.6 ± 1.2, HBOC+Plasma = 9.8 ± 1.7, HBOC = 16.3 ± 1.9 g/hour; p < 0.001) during EVHP. RBC+Plasma hearts exhibited less histologic evidence of myocyte damage (injury score: RBC+Plasma = 0.0 ± 0.0, RBC = 0.8 ± 0.3, HBOC+Plasma = 2.6 ± 0.2, HBOC = 1.75 ± 0.4; p < 0.001) and less troponin-I release (troponin-I fold-change T1-T5: RBC+Plasma = 7.0 ± 1.7, RBC = 13.1 ± 1.6, HBOC+Plasma = 20.5 ± 1.1, HBOC = 16.7 ± 5.8; p < 0.001). Oxidative stress was minimized by the addition of plasma to RBC and HBOC hearts (oxidized phosphatidylcholine compound fold-change T1-T5: RBC+Plasma = 1.83 ± 0.20 vs RBC = 2.31 ± 0.20, p < 0.001; HBOC+Plasma = 1.23 ± 0.17 vs HBOC = 2.80 ± 0.28, p < 0.001).
CONCLUSIONS: A whole blood-based perfusate (RBC+Plasma) minimizes injury and provides superior preservation of myocardial function during EVHP. The beneficial effect of plasma on the preservation of myocardial function requires further investigation.

PMID: 25447577 [PubMed – indexed for MEDLINE]

Changing paradigms in organ preservation and resuscitation. November 18, 2018
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Changing paradigms in organ preservation and resuscitation.

Curr Opin Organ Transplant. 2015 Apr;20(2):152-8

Authors: Ali F, Dua A, Cronin DC

Abstract
PURPOSE OF REVIEW: Shortage of donor organs has increased consideration for use of historically excluded grafts. Ex-vivo machine perfusion is an emerging technology that holds the potential for organ resuscitation and reconditioning, potentially increasing the quality and number of organs available for transplantation. This article aims to review the recent advances in machine perfusion and organ preservation solutions.
RECENT FINDINGS: Flow and pressure-based machine perfusion has shown improved kidney graft function and survival, especially among expanded criteria donors. Pressure-based machine perfusion is demonstrating promising results in preservation and resuscitation of liver, pancreas, heart, and also lung grafts. August 2014 marked Food and Drug Administration approval of XPS XVIVO Perfusion System (XVIVO Perfusion Inc., Englewood, Colorado, USA), a device for preserving and resuscitating lung allografts initially considered unsuitable for transplantation. Although there is no consensus among physicians about the optimal preservation solution, adding antiapoptotic and cell protective agents to preservation solutions is an interesting research area that offers potential to improve preservation.
SUMMARY: Ex-vivo machine perfusion of solid organs is a promising method that provides the opportunity for resuscitation and reconditioning of suboptimal grafts, expanding the number and quality of donor organs.

PMID: 25719899 [PubMed – indexed for MEDLINE]

Low-flow hypothermic crystalloid perfusion is superior to cold storage during prolonged heart preservation. November 18, 2018
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Low-flow hypothermic crystalloid perfusion is superior to cold storage during prolonged heart preservation.

Transplant Proc. 2014 Dec;46(10):3309-13

Authors: Ou R, Lim YW, Choong JW, Esmore DS, Salamonsen RF, McLean C, Forbes J, Bailey M, Rosenfeldt FL

Abstract
BACKGROUND: Preservation of donor hearts for transplantation has traditionally been performed with the use of static cold storage. We have developed and tested a novel gravity-powered system of cold crystalloid perfusion for prolonged donor heart preservation.
METHODS: Greyhounds were anesthetized; their hearts were arrested with cold cardioplegic solution and excised. Hearts were allocated to 12 hours of perfusion preservation (n = 6) or cold storage in ice (n = 5). Non-preserved hearts (n = 5) served as a normal reference group. Perfusion hearts were perfused (20 mL/min, 8-12°C) with a novel oxygenated nutrient-containing preservation solution. After preservation, the recovery of the hearts was assessed in a blood-perfused working heart rig over 2 hours in terms of function, blood lactate level, myocardial adenosine triphosphate, and histology.
RESULTS: After 2 hours of reperfusion, in comparison with cold storage hearts, perfused heart function curves showed superior recovery of cardiac output (P = .001), power (P = .001), and efficiency (0.046 ± 0.01 vs 0.004 ± 0.003 joules/mL O2, P = .034). Myocardial adenosine triphosphate content (mmol/mg protein) was reduced significantly from the normal level of 26.5 (15.9, 55.8) to 5.08 (0.50, 10.4) (P = .049) in cold storage hearts but not in perfused hearts. Over a period of 2 hours, lactate levels in the blood perfusate were significantly lower in the perfusion group than in the cold storage group (P < .05).
CONCLUSIONS: Continuous hypothermic crystalloid perfusion provides myocardial preservation superior to cold storage for long-term heart preservation, with potential applicability to marginal and donation after circulatory death hearts.

PMID: 25498042 [PubMed – indexed for MEDLINE]

Normothermic ex vivo perfusion provides superior organ preservation and enables viability assessment of hearts from DCD donors. November 18, 2018
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Normothermic ex vivo perfusion provides superior organ preservation and enables viability assessment of hearts from DCD donors.

Am J Transplant. 2015 Feb;15(2):371-80

Authors: Iyer A, Gao L, Doyle A, Rao P, Cropper JR, Soto C, Dinale A, Kumarasinghe G, Jabbour A, Hicks M, Jansz PC, Feneley MP, Harvey RP, Graham RM, Dhital KK, MacDonald PS

Abstract
The shortage of donors in cardiac transplantation may be alleviated by the use of allografts from donation after circulatory death (DCD) donors. We have previously shown that hearts exposed to 30 min warm ischemic time and then flushed with Celsior supplemented with agents that activate ischemic postconditioning pathways, show complete recovery on a blood-perfused ex vivo working heart apparatus. In this study, these findings were assessed in a porcine orthotopic heart transplant model. DCD hearts were preserved with either normothermic ex vivo perfusion (NEVP) using a clinically approved device, or with standard cold storage (CS) for 4 h. Orthotopic transplantation into recipient animals was subsequently undertaken. Five of six hearts preserved with NEVP demonstrated favorable lactate profiles during NEVP and all five could be weaned off cardiopulmonary bypass posttransplant, compared with 0 of 3 hearts preserved with CS (p < 0.05, Fisher’s exact test). In conclusion, DCD hearts flushed with supplemented Celsior solution and preserved with NEVP display viability before and after transplantation. Viability studies of human DCD hearts using NEVP are warranted.

PMID: 25612491 [PubMed – indexed for MEDLINE]

Ex vivo heart perfusion after cardiocirculatory death; a porcine model. November 18, 2018
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Ex vivo heart perfusion after cardiocirculatory death; a porcine model.

J Surg Res. 2015 May 01;195(1):311-4

Authors: García Sáez D, Elbetanony A, Lezberg P, Hassanein A, Bowles CT, Popov AF, Zych B, Sabashnikov A, Mohite P, Simon AR

Abstract
BACKGROUND: Donation after cardiocirculatory death (DCD) has lead to an increase in organ availability. However, because of medical, logistic, and ethical issues, the use of hearts from DCD donors for transplantation is not generally considered to be feasible. In this study, we investigated the feasibility of ex vivo resuscitation and assessment of the porcine heart after circulatory death using the organ care system (OCS).
METHODS: Cardiocirculatory death was induced in five pigs by cessation of mechanical ventilation. No heparin was administered. The agonal time (AT) was calculated as the time between a reduction of blood pressure <50 mm Hg or a fall in saturation beneath 70% and the cessation of electrical activity. After a further 15 min of warm ischemia, hearts were procured and implanted into the OCS, mimicking the actual clinical scenario for other organs. Thus, procured grafts were assessed ex vivo over a period of 4 h.
RESULTS: Four hearts were successfully resuscitated on the system (AT 8, 15, 20, and 34 min) Three grafts had excellent visual contractility and lactate trends and were considered to be transplantable. One graft (AT 34 min) had an increased lactate and abnormal contractility being unsuitable for transplantation. One heart with 48-min AT could not be resuscitated.
CONCLUSIONS: Our data show that hearts from nonheparinized DCD porcine donors can be successfully resuscitated using the OCS in a scenario, which closely simulates clinical conditions.

PMID: 25617972 [PubMed – indexed for MEDLINE]

Extracorporeal heart perfusion before heart transplantation: the heart in a box. November 18, 2018
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Extracorporeal heart perfusion before heart transplantation: the heart in a box.

Curr Opin Organ Transplant. 2016 06;21(3):336-42

Authors: Macdonald PS, Chew HC, Connellan M, Dhital K

Abstract
PURPOSE OF REVIEW: Cold static storage is a time-tested and simple method of preserving hearts retrieved from optimal donors after brain death (DBD). The increasing gap between supply and demand for donor organs together with changing donor and recipient characteristics have led to renewed interest in the use of machine perfusion to increase both the quality and quantity of donor hearts for transplantation.
RECENT FINDINGS: Two major approaches to machine perfusion of donor hearts have been investigated – hypothermic (HMP) and normothermic machine perfusion (NMP). Recent preclinical studies with HMP confirm that it provides superior donor heart preservation to cold static storage. HMP systems have been developed for human heart preservation but have yet to be tested clinically. In contrast, NMP has undergone extensive clinical evaluation in human heart transplantation, including optimal and higher risk DBD donors. In addition, NMP has enabled distant procurement and successful transplantation of hearts retrieved from human donation after circulatory death donors.
SUMMARY: Initial clinical experience suggests that NMP of donor hearts retrieved from higher risk DBD and donation after circulatory death donors enables well tolerated ex-vivo reanimation, preservation, and assessment of these organs. In particular, this technology allows successful utilization of extended-criteria donor hearts that would otherwise be discarded.

PMID: 26967996 [PubMed – indexed for MEDLINE]

Safe orthotopic transplantation of hearts harvested 24 hours after brain death and preserved for 24 hours. November 18, 2018
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Safe orthotopic transplantation of hearts harvested 24 hours after brain death and preserved for 24 hours.

Scand Cardiovasc J. 2016 Jun;50(3):193-200

Authors: Steen S, Paskevicius A, Liao Q, Sjöberg T

Abstract
OBJECTIVES: The aim of this study was to demonstrate safe orthotopic transplantation of porcine donor hearts harvested 24 hours after brain death and preserved for 24 hours before transplantation.
DESIGN: Circulatory normalization of brain dead (decapitated) pigs was obtained using a new pharmacological regimen (n = 10). The donor hearts were perfused at 8 °C in cycles of 15 min perfusion followed by 60 min without perfusion. The perfusate consisted of an albumin-containing hyperoncotic cardioplegic nutrition solution with hormones and erythrocytes. Orthotopic transplantation was done in 10 recipient pigs after 24 hours’ preservation. Transplanted pigs were monitored for 24 hours, then an adrenaline stress test was done.
RESULTS: All transplanted pigs were stable throughout the 24-hour observation period with mean aortic pressure around 80 mmHg and normal urine production. Mean right and left atrial pressures were in the range of 3-6 and 5-10 mmHg, respectively. Blood gases at 24 hours did not differ from baseline values. The adrenaline test showed a dose dependent response, with aortic pressure increasing from 98/70 to 220/150 mmHg and heart rate from 110 to 185 beats/min.
CONCLUSION: Orthotopic transplantation of porcine hearts harvested 24 hours after brain death and preserved for 24 hours can be done safely.

PMID: 26882241 [PubMed – indexed for MEDLINE]

Assessment of donor heart viability during ex vivo heart perfusion. November 18, 2018
Related Articles

Assessment of donor heart viability during ex vivo heart perfusion.

Can J Physiol Pharmacol. 2015 Oct;93(10):893-901

Authors: White CW, Ambrose E, Müller A, Li Y, Le H, Hiebert B, Arora R, Lee TW, Dixon I, Tian G, Nagendran J, Hryshko L, Freed D

Abstract
Ex vivo heart perfusion (EVHP) may facilitate resuscitation of discarded donor hearts and expand the donor pool; however, a reliable means of demonstrating organ viability prior to transplantation is required. Therefore, we sought to identify metabolic and functional parameters that predict myocardial performance during EVHP. To evaluate the parameters over a broad spectrum of organ function, we obtained hearts from 9 normal pigs and 37 donation after circulatory death pigs and perfused them ex vivo. Functional parameters obtained from a left ventricular conductance catheter, oxygen consumption, coronary vascular resistance, and lactate concentration were measured, and linear regression analyses were performed to identify which parameters best correlated with myocardial performance (cardiac index: mL·min(-1)·g(-1)). Functional parameters exhibited excellent correlation with myocardial performance and demonstrated high sensitivity and specificity for identifying hearts at risk of poor post-transplant function (ejection fraction: R(2) = 0.80, sensitivity = 1.00, specificity = 0.85; stroke work: R(2) = 0.76, sensitivity = 1.00, specificity = 0.77; minimum dP/dt: R(2) = 0.74, sensitivity = 1.00, specificity = 0.54; tau: R(2) = 0.51, sensitivity = 1.00, specificity = 0.92), whereas metabolic parameters were limited in their ability to predict myocardial performance (oxygen consumption: R(2) = 0.28; coronary vascular resistance: R(2) = 0.20; lactate concentration: R(2) = 0.02). We concluded that evaluation of functional parameters provides the best assessment of myocardial performance during EVHP, which highlights the need for an EVHP device capable of assessing the donor heart in a physiologic working mode.

PMID: 26317524 [PubMed – indexed for MEDLINE]

Twelve-Hour Hypothermic Machine Perfusion for Donor Heart Preservation Leads to Improved Ultrastructural Characteristics Compared to Conventional Cold Storage. November 18, 2018
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Twelve-Hour Hypothermic Machine Perfusion for Donor Heart Preservation Leads to Improved Ultrastructural Characteristics Compared to Conventional Cold Storage.

Ann Transplant. 2015 Aug 11;20:461-8

Authors: Michel SG, La Muraglia GM, Madariaga ML, Titus JS, Selig MK, Farkash EA, Allan JS, Anderson LM, Madsen JC

Abstract
BACKGROUND Hypothermic machine perfusion of donor hearts has the theoretical advantage of continuous aerobic metabolism and washes out toxic metabolic byproducts. Here, we studied the effect of hypothermic machine perfusion on cardiac myocyte integrity when hearts are preserved for longer ischemic times (12 hours). MATERIAL AND METHODS Pig hearts were harvested and stored in Celsior® solution for 12 hours using either conventional cold storage on ice (12 h CS, n=3) or pulsatile perfusion with the Paragonix Sherpa Perfusion™ Cardiac Transport System at different flow rates (12 h PP, n=3 or 12 h PP low flow, n=2). After cold preservation, hearts were reperfused using an LV isovolumic Langendorff system. Controls (n=3) were reperfused immediately after organ harvest. Biopsies were taken from the apex of the left ventricle before storage, after storage and after reperfusion to measure ATP and endothelin-1 content in the tissue. TUNEL staining for signs of apoptosis and electron microscopy of the donor hearts were performed. RESULTS 12 h PP hearts showed significantly more weight gain than 12 h CS and controls after preservation. Pulsatile perfused hearts showed less ATP depletion, lower endothelin-1 levels and less apoptosis after preservation compared to CS. Electron microscopy showed damaged muscle fibers, endothelial cell rupture, and injury of mitochondria in the 12 h CS group, while machine perfusion could preserve the cell structures. CONCLUSIONS Hypothermic machine perfusion of donor hearts can preserve the cell structures better than conventional cold storage in prolonged ischemic times. Hypothermic pulsatile perfusion may therefore enable longer preservation times of donor hearts. Whether this method is able to avoid primary graft failure after orthotopic heart transplantation remains to be evaluated in further studies.

PMID: 26259549 [PubMed – indexed for MEDLINE]

Cold Crystalloid Perfusion Provides Cardiac Preservation Superior to Cold Storage for Donation After Circulatory Death. November 18, 2018
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Cold Crystalloid Perfusion Provides Cardiac Preservation Superior to Cold Storage for Donation After Circulatory Death.

Transplantation. 2016 Mar;100(3):546-53

Authors: Choong JW, Ou R, Lim YW, Rosenfeldt FL

Abstract
BACKGROUND: We previously showed that donation after circulatory death (DCD) canine hearts can be resuscitated if perfused with warm blood. However, clinical application of this technique is complex and difficult. We have developed a simplified system of cold crystalloid perfusion and compared it with standard cold storage for DCD heart preservation.
METHODS: Anesthetized greyhounds underwent 30 minutes DCD by withdrawal of ventilation followed by assignment to either 4 hours of perfusion (n = 6) or cold storage (n = 7). Nonpreserved hearts (n = 5) served as a normal reference group. Perfusion hearts were reperfused with a protective solution then perfused for 4 hours with a novel oxygenated, nutrient-containing solution at 20 mL/min at 4°C to 10°C. Cold storage hearts were flushed with St Thomas’ cardioplegic solution and stored in ice. After preservation, the recovery of the hearts was assessed on a blood-perfused working heart rig.
RESULTS: During preservation, perfusion hearts consumed oxygen (0.09 ± 0.01 mL/100 g per minute) and showed decreasing lactate production in the perfusate (initial: 0.031 ± 0.004 vs final: 0.007 ± 0.002 mmol/min; P = 0.001). After preservation, compared to cold storage hearts, perfusion hearts had higher cardiac output (P = 0.004), LV dP/dt max (P = 0.003) and myocardial oxygen efficiency (P = 0.01), with lower blood perfusate lactate (P = 0.007). Hemodynamic values of perfused hearts reached 60% or more those in the normal reference group.
CONCLUSIONS: Continuous cold crystalloid perfusion in a canine model of DCD: (1) facilitates aerobic metabolism and resuscitates the DCD heart, (2) provides functional and metabolic recovery superior to cold storage, (3) shows promise for improved clinical preservation of DCD and marginal donor hearts.

PMID: 26569064 [PubMed – indexed for MEDLINE]

Hypothermic continuous machine perfusion enables preservation of energy charge and functional recovery of heart grafts in an ex vivo model of donation following circulatory death. November 18, 2018
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Hypothermic continuous machine perfusion enables preservation of energy charge and functional recovery of heart grafts in an ex vivo model of donation following circulatory death.

Eur J Cardiothorac Surg. 2016 May;49(5):1348-53

Authors: Van Caenegem O, Beauloye C, Bertrand L, Horman S, Lepropre S, Sparavier G, Vercruysse J, Bethuyne N, Poncelet AJ, Gianello P, Demuylder P, Legrand E, Beaurin G, Bontemps F, Jacquet LM, Vanoverschelde JL

Abstract
OBJECTIVES: Cardiac transplantation using hearts from donors after circulatory death (DCD) is critically limited by the unavoidable warm ischaemia and its related unpredictable graft function. Inasmuch as hypothermic machine perfusion (MP) has been shown to improve heart preservation, we hypothesized that MP could enable the use of DCD hearts for transplantation.
METHODS: We recovered 16 pig hearts following anoxia-induced cardiac arrest and cardioplegia. Grafts were randomly assigned to two different groups of 4-h preservation using either static cold storage (CS) or MP (Modified LifePort© System, Organ Recovery Systems©, Itasca, Il). After preservation, the grafts were reperfused ex vivo using the Langendorff method for 60 min. Energetic charge was quantified at baseline, post-preservation and post-reperfusion by measuring lactate and high-energy phosphate levels. Left ventricular contractility parameters were assessed both in vivo prior to ischaemia and ex vivo during reperfusion.
RESULTS: Following preservation, the hearts that were preserved using CS exhibited higher lactate levels (57.1 ± 23.7 vs 21.4 ± 12.2 µmol/g; P < 0.001), increased adenosine monophosphate/adenosine triphosphate ratio (0.53 ± 0.25 vs 0.11 ± 0.11; P < 0.001) and lower phosphocreatine/creatine ratio (9.7 ± 5.3 vs 25.2 ± 11; P < 0.001) in comparison with the MP hearts. Coronary flow was similar in both groups during reperfusion (107 ± 9 vs 125 ± 9 ml/100 g/min heart; P = ns). Contractility decreased in the CS group, yet remained well preserved in the MP group.
CONCLUSION: MP preservation of DCD hearts results in improved preservation of the energy and improved functional recovery of heart grafts compared with CS.

PMID: 26604296 [PubMed – indexed for MEDLINE]

Design and Evolution of the Asporto Heart Preservation Device. November 18, 2018
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Design and Evolution of the Asporto Heart Preservation Device.

J Extra Corpor Technol. 2015 Jun;47(2):119-24

Authors: Rivard AL

Abstract
The Asporto Heart Preservation Device is a system providing perfusion of cardioplegia to the donor heart using a computer-controlled peristaltic pump in a thermoelectrically cooled and insulated container. In 1998, a user interface was developed at the University of Minnesota consisting of a touch screen and battery-backed microcontroller. Power was supplied by a 120 VAC to 12 VDC converter. An upgrade to the insulated cooler and microcontroller occurred in 2002, which was followed by proof of concept experimental pre-clinical transplants and tests demonstrating the efficacy of the device with isolated donor hearts. During the period between 2002 and 2006, a variety of donor organ containers were developed, modified, and tested to provide an optimal sterile environment and fluid path. Parallel development paths encompass formalized design specifications for final prototypes of the touch screen/microcontroller, organ container, and thermoelectric cooler.

PMID: 26405361 [PubMed – indexed for MEDLINE]

Donor Organ Turn-Downs and Outcomes Following Listing for Pediatric Heart Transplant September 28, 2018

Pediatric heart transplant waitlist mortality remains significant but allograft offer refusals are common and allografts continue to be discarded.

PREDICTED HEART MASS IS THE OPTIMAL METRIC FOR SIZE MATCH IN HEART TRANSPLANTATION September 26, 2018

Traditionally, donor-recipient size match is assessed by body weight. We assessed the ability of 5 size match metrics – predicted heart mass (PHM), weight, height, body mass index (BMI) and body surface area (BSA) – to predict 1-year mortality after heart transplant and to assess the effect on size match on donor heart turn-down for size.

Obstacles to Improving Outcomes of Heart Transplantation for Adults with Congenital Heart Disease September 14, 2018

Adults with congenital heart disease (ACHD) represent a growing, albeit still small, proportion of heart transplant (HT) recipients (1, 2). These patients frequently present with complex anatomy and physiology, and atypical manifestations of cardiac failure. Despite being younger than other HT candidates, they have higher risk for adverse outcomes early after HT. This relates to prior thoracic operations, longer allograft ischemic time, a high prevalence of sensitization, less frequent use of pre-transplant mechanical circulatory support (1), and underappreciated end-organ dysfunction.

Clinical Implications of the Total Artificial Heart: Adversity and Progress August 7, 2018

The history of the SynCardia Total Artificial Heart – temporary (TAH-t; SynCardia Systems, LLC, Tuscon, AZ) is a fascinating medical tale of success, failure and perseverance that has highlighted the lives of many physicians, scientists and patients while episodically consuming the attention of the public. Although, perhaps not as dramatic as its first implantation in a human in 1982, a major and significant milestone in the history of this device was the Food and Drug Administration (FDA) approval of the SynCardia TAH-t in October of 2004 for bridge to transplant indication in the United States, culminating decades of scientific investigation and clinical study and making this device available for commercial use.

Worldwide trends in heart and lung transplantation: Guarding the most precious gift ever. July 19, 2018
Related Articles

Worldwide trends in heart and lung transplantation: Guarding the most precious gift ever.

Best Pract Res Clin Anaesthesiol. 2017 Jun;31(2):141-152

Authors: von Dossow V, Costa J, D’Ovidio F, Marczin N

Abstract
Transplantation is sadly a therapy to die for. The survival of a recipient with end-stage heart or lung disease requires the demise of a human being through brain death or cessation of circulation, with the noblest final act of offering one’s organs to another. However, transplantation is constrained by severe hemodynamic, regulatory, inflammatory, and metabolic stresses in the donor, rendering the majority of offered organs unsuitable for transplantation. Coupled with our inability to acquire exact molecular and cellular information and missed opportunities for effectively modulating deteriorations of donors and allografts, anesthesia and critical care contributes to ongoing organ shortages. Progress is made with improving waiting lists by bridging patients for transplantation using mechanical support. However, this represents more complex recipients, higher risk transplant operations, and increased resource utilization. The advent of ex vivo perfusion allows implementing novel diagnostic and therapeutic strategies with real potential of reconditioning less ideal organs. This review advocates a paradigm change in critical care management of the potential donor for improving retrieval practices and for more intellectual involvement of our specialties in organ preservation, ex vivo evaluation and reconditioning, and the need for great advancement in our efficiency in converting unacceptable allografts to suitable donor organs.

PMID: 29110788 [PubMed – indexed for MEDLINE]

Center Volume and Post-Transplant Survival Among Adults with Congenital Heart Disease July 15, 2018

Eighty five percent of congenital heart disease patients currently survive to adulthood due primarily to advancements in surgical treatments1. For these survivors with Adult Congenital Heart Disease (ACHD), heart failure (HF) remains the leading cause of death2. Thus, the number of ACHD patients requiring heart transplantation (HT) continues to grow, and with this growth has come improvements in outcomes. In 2009, Lamour et al. demonstrated a 1-year survival of 83% for non-Fontan congenital HT and 71% for patients with Fontan palliation3.

MICRORNAS SIGNATURES IN CARDIAC BIOPSIES AND DETECTION OF ALLOGRAFT REJECTION July 2, 2018

Identification of heart transplant rejection currently rely on immunohistologic and immunohistochemistry. We aimed to identify specific sets of microRNAs (miRNAs) to characterize acute cellular (ACR), antibody-mediated (pAMR) and mixed (MR) rejections in monitoring formalinfixed paraffin-embedded (FFPE) endomyocardial biopsies (EMBs) in heart transplant (HTx) patients.

Upcoming heart allocation policy change June 21, 2018

If you are a patient on the national waiting list for a heart, your urgency for a transplant is currently based on three statuses:

  • 1A (most urgent)
  • 1B (somewhat urgent)
  • 2 (least urgent)

As we learn more about heart disease and successful treatment of it, the transplant community determined we needed more specific criteria that reflects a heart patient’s current health and care they are getting. To accommodate these needs, we are making changes to heart policy and the first phase of the new heart allocation policy will take effect on September 18.

Heart candidates can find specific information here about how this change will affect you. You can also download a print version from the website.

Temporary circulatory support devices as a bridge to transplant: Boon or bane? June 12, 2018

The allocation of donor hearts evolves in response to the changing landscape of advanced heart failure therapies and expanded understanding of donor/recipient matching. The novel, heart allocation algorithm is a natural response to the success of mechanical circulatory support (MCS) and further aligns severity of illness with urgency. In the novel, 6-status system, candidates supported with veno-arterial, extracorporeal membrane oxygenation devices (ECMO) and biventricular, extracorporeal ventricular assist devices (VAD) receive Status 1 urgency, while Status 2 urgency comprises candidates with univentricular extracorporeal VADs, percutaneous, endovascular mechanical circulatory support (e.g.

Donor heart selection and outcomes: An analysis of over 2,000 cases April 28, 2018

Decision-making when offered a donor heart for transplantation is complex, and supportive data describing outcomes according to acceptance or non-acceptance choices are sparse. Our aim was to analyze donor heart acceptance decisions and associated outcomes at a single center, and after subsequent acceptance elsewhere.

New booklet advises parents of pediatric transplant patients April 24, 2018

A new resource booklet, “What Every Parent Needs to Know,” is available for parents and caregivers of children and adolescents who need or receive an organ transplant. The OPTN/UNOS Patient Affairs Committee spearheaded the booklet’s development in collaboration with a number of transplant professionals and parents of organ transplant recipients*.

The booklet explains the transplant process from a parent’s viewpoint. It addresses issues before and during a transplant such as financial concerns and explaining deceased donation to a child, as well as guidance on helping children manage life after a transplant. It addresses a number of concepts and terms relating to transplantation and provides references to other helpful resources.

* The Patient Affairs Committee also wishes to thank the following organizations for reviewing the booklet:

  • American Liver Foundation
  • American Society of Transplantation
  • Anne & Robert H. Lurie Children’s Hospital of Chicago
  • Children’s Cardiomyopathy Foundation
  • Children’s Organ Transplant Association
  • International Pediatric Transplant Association
  • National Kidney Foundation
  • Pediatric Heart Transplant Study
OPTN/UNOS Board members named March 8, 2018

Richmond, Va. — Members of the national organ donation and transplantation community have elected 25 members to the OPTN/UNOS board of directors, including a new president, vice-president/president-elect, vice president for patient and donor affairs and secretary. United Network for Organ Sharing (UNOS) serves as the Organ Procurement and Transplantation Network (OPTN) under federal contract.

All board members are volunteers and serve terms ranging from one to three years, depending on the office to which they are elected. Their terms of service begin on July 1, 2018.

Sue Dunn, RN, B.S.N., M.B.A., currently the Vice President/President-Elect, will assume the presidency. She is president and chief executive officer of Donor Alliance in Denver.

Maryl Johnson, M.D., will become the Vice President/President-Elect. She is professor of medicine, heart failure and heart transplantation at the University of Wisconsin Hospitals and Clinics.

Deanna Santana, B.S., will become the Vice President for Patient and Donor Affairs. She is senior public education coordinator at Sierra Donor Services in Sacramento, Calif. She is also a donor mother and a living donor.

Theresa Daly, M.S., RN, B.S.N., FNP, will become the Secretary. She is director of transplant clinical operations at New York Presbyterian/Columbia Medical Center.

Other newly elected members are as follows:

Immediate Past President – Yolanda Becker, M.D., University of Chicago Medicine

Region 3 Councillor – Christopher Anderson, M.D., University of Mississippi Medical Center

Region 4 Councillor – Steven Potter, M.D., FACS, East Texas Medical Center

Region 5 Councillor – Kunam Reddy, M.D., Mayo Clinic, Phoenix

Region 6 Councillor – Susan Orloff, M.D., FACS, AASLD, Oregon Health & Science University

Region 9 Councillor – Rob Kochik, Finger Lakes Donor Recovery Network

At Large Abdominal Surgery Representative –, Rene Romero, M.D., Children’s Healthcare of Atlanta

At Large Hepatology Representative – Simon Horslen, M.B., Ch.B., Seattle Children’s Hospital

At Large Nephrology Representatives:
Eileen Brewer, M.D., Texas Children’s Hospital
Jerry McCauley, M.D., M.P.H., FACP, Thomas Jefferson University Hospital

At Large Pulmonology Representative – Marc Schecter, M.D., Children’s Hospital Medical Center, Cincinnati

At Large Transplant Administrator Representative – Timothy Stevens, RN, B.S.N. CCTC, Sacred Heart Medical Center

OPO Representative – Diane Brockmeier, RN, B.S.N., M.H.A., Mid-America Transplant Services

Histocompatibility Representative – Walter Herczyk, MT, CHS, Gift of Life Michigan Histocompatibility Laboratory

Transplant Coordinator Representative – Mary Francois, RN, M.S., CCTC, NATCO

Medical/Scientific Organization Representatives:
Sharon Bartosh, M.D., University of Wisconsin Hospital and Clinics
Charles Miller, M.D., Cleveland Clinic Foundation

Patient and Donor Affairs Representatives:
Randee Bloom, Ph.D., M.B.A., RN
Rosemary Berkery, J.D.
Laura DePiero, RN, B.S.N.
Joseph Hillenburg

Public comment sought January 22, 2018

The Organ Procurement and Transplantation Network (OPTN) offers policy proposals for public comment from January 22 through March 23, 2018.

Comments and replies will be published on the OPTN public comment page, to promote transparency and trust in the national transplant system. Visitors can also share comments on social media, if they wish.

Feedback for selected proposals will be sought via a response form. This is part of a trial to study potential enhancements to the public comment process. For the proposals using the response form, the comments related to the proposal will be displayed on the public comment page in the same manner as the blog-style responses to all other proposals.

One of the proposals is a draft of an updated OPTN/UNOS strategic plan. The plan, to be finalized by the OPTN/UNOS Board of Directors after public input, will serve as a roadmap to help prioritize the OPTN’s work through 2021 and provide metrics to assess progress toward key goals.

We encourage patients, transplant candidates and recipients, living donors, donor families and transplant professionals to learn more about the proposals below and provide valuable feedback to help shape U.S. organ transplant policy:

  • Aligning VCA program membership requirements with other transplant programs
  • Modifications to the distribution of deceased donor lungs
  • Clarifying informed consent policies for transmissible disease risk
  • Concept paper on expedited organ placement
  • Reducing reporting burdens and clarify policies on extra vessels
  • Guidance on optimizing VCA recovery from deceased donors
  • Changes to waiting time criteria for kidney pancreas candidates
  • Modifying the lung Transplant Recipient Form to improve post-transplant lung function data
  • Revising OPTN Bylaws Appendix L
  • White paper on manipulating waitlist priority
  • Guidance for ABO subtyping of Blood Type A and AB organ donors
  • Concept paper on improving the OPTN/UNOS committee structure
  • Guidance on deceased donor requested information
  • OPTN/UNOS strategic plan
  • Review board guidance on heart candidates with exceptions for HCM and RCM
Deceased organ donors in United States exceeded 10,000 for first time in 2017 January 9, 2018

During 2017, the number of deceased organ donors in the United States topped 10,000 for the first time, according to preliminary data from United Network for Organ Sharing (UNOS), which serves as the national Organ Procurement and Transplantation Network (OPTN) under federal contract. For the year, organs were recovered from 10,281 donors, representing a 3.1 percent increase over 2016 and an increase of 27 percent since 2007.

A total of 34,768 organ transplants were performed in 2017 using organs from both deceased and living donors, according to preliminary data. This total is a 3.4 percent increase over 2016 and marks the fifth consecutive record-setting year for transplants in the United States. Record number of donor organs were recovered and transplants occurred for each of the four most common organs transplanted – kidney, liver, heart and lung.

“We are grateful that more lives are being saved, year after year, thanks to the boundless generosity of organ donors,” said Yolanda Becker, M.D., president of the OPTN/UNOS Board of Directors. “We remain committed to increasing the number of transplants still further to help the many thousands of people in need of a transplant to sustain them and vastly improve their quality of life.”

Approximately 82 percent (28,587) of the transplants performed in 2017 involved organs from deceased donors. Living donor transplants accounted for the remaining 18 percent (6,181). In the 30-year span from 1988 (the first full year national transplant data were collected) through 2017, a total of 721,742 transplants have been performed nationwide.

While the number of potential organ donors varies among different areas of the country due to differences in population size and medical characteristics, increases were noted in many areas. Of the 58 organ procurement organizations (OPOs) coordinating deceased organ donation nationwide, 35 (60 percent) experienced an increase in donors from 2016 to 2017, including at least one OPO in each of UNOS’ 11 regions.

“Donation and transplantation continues to increase across the country,” said Brian Shepard, Chief Executive Officer of UNOS. “We are working with donation and transplantation professionals nationwide to help identify additional transplant opportunities and enhance the efficiency of the organ acceptance process.”

Broadening of clinical criteria for potential donors accounts for some of the ongoing increase in deceased organ donation and transplantation. In 2017, as compared to 2016, a higher proportion of donors had medical characteristics such as donation after circulatory death as opposed to brain death, drug intoxication as a mechanism of death, age of 50 or older, and/or being identified as having increased risk for blood-borne disease.

“As we increase our understanding of medical criteria that contribute to successful transplantation, donation and transplantation professionals have been able to use organs from a wider set of potential donors,” said David Klassen, M.D., UNOS Chief Medical Officer. “In doing so, we continue to carefully balance the opportunity for transplantation with a commitment to maintaining patient safety.”

United Network for Organ Sharing (UNOS) serves as the national Organ Procurement and Transplantation Network (OPTN) under contract with the Department of Health and Human Services, Health Resources and Services Administration. The OPTN brings together medical professionals, transplant recipients and donor families to develop national organ transplantation policy.

Board of Directors releases University Hospitals of Cleveland from probation October 3, 2017

At a meeting by teleconference October 3, 2017, the OPTN/UNOS Board of Directors restored full member privileges for University Hospitals of Cleveland, a transplant center in Cleveland, Ohio.

The Board had placed the hospital on probation in June 2016, after peer review of low transplant volume and early-term recipient deaths at its heart transplant program revealed concerns with the program’s quality management protocols. The hospital has since instituted actions that successfully address the previous concerns.

United Network for Organ Sharing (UNOS) serves as the national Organ Procurement and Transplantation Network (OPTN) under contract with the Department of Health and Human Services, Health Resources and Services Administration, Division of Transplantation. The OPTN brings together medical professionals, transplant recipients and donor families to develop national organ transplantation policy.