Industry Literature Archives | Page 7 of 9

HLA Epitope Mismatching is Associated with Rejection and Worsened Graft Survival in Heart Transplant Recipients

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)

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).

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

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.

An integrated molecular diagnostic report for heart transplant biopsies using an ensemble of diagnostic algorithms

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

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.

Armed with better and more accurate information on which to base clinical decisions, surgeons could consider transplanting organs they may rejected otherwise.
High-quality images could be used to routinely supplement clinical data delivered during the organ offer process via DonorNet®.
OPOs could see a decrease in the number of organs considered for transplant yet never recovered, and organs not used upon arrival at the transplant hospital.
A more efficient process could eliminate steps in organ allocation, saving time and costs, streamlining the flow between donor and transplant hospitals and most importantly, saving lives.

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

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

Audience

All UNet^SM 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^® KPD^SM	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	Waitlist^SM	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

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.

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

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.

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.

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