Science and Innovation

FDA Approves the Use of New Technology for Donation After Circulatory Death After Groundbreaking Trial

In April, the U.S. Food and Drug Administration (FDA) granted premarket approval of TransMedic’s OCS™ Heart System (OCS Heart) for use with organs from donors after circulatory death (DCD). AdventHealth was one of 13 transplant centers throughout the country that participated in a multi-center clinical trial to investigate the safety and effectiveness of this new technology, performing Florida’s first DCD transplant in July 2020. The transplant was a team effort in partnership with AdventHealth Translational Research Institute and the organ procurement agency OurLegacy.

The OCS Heart system keeps a heart which was stopped prior to donation viable for hours, keeping it in a near-physiological, beating state with a warmed, donor-based perfusate that is supplemented with nutrients and oxygen. It also allows surgeons to assess the heart’s functional quality and viability for transplant.

DCD heart transplantation gives hope to patients and physicians faced with a growing organ shortage across America. According to the U.S. Department of Health & Human Services Organ Procurement and Transplantation Network, more than 3,000 people are currently on the national heart transplant waiting list.

“DCD provides us with access to many additional hearts,” explains Scott Silvestry, MD, Surgical Director for Thoracic Transplant at the AdventHealth Transplant Institute. “The hearts that will be transplanted as a result of this new technology would have been buried before.”

Professional headshot of Dr. Scott Silvestry

Dr. Silvestry served as a Principal Investigator for AdventHealth Orlando in the national the OCS DCD Heart Trial, with the results presented at the

2022 Annual Meeting of the International Society of Heart and Lung Transplantation in Boston, Massachusetts. The results were recently published in The Journal of Heart and Lung Transplantation. In the trial, patients awaiting heart transplantation were randomized in a three to one manner to a DCD eligible arm or donors before death (DBD) cold stored hearts arm. Endpoints included 6- and 12-month patient survival post-transplantation as well as OCS DCD hearts utilization rate and incidence of Heart Graft-related Serious Adverse Events (HGRSAEs) in the first 30 days post-transplant. A total of 180 patients were randomized and transplanted in the trial, and it demonstrated that the use of the OCS Heart resulted in a high rate of DCD heart utilization for transplantation with excellent patient and graft survival outcomes compared to DBD donor hearts.

“The results support the increased use of DCD hearts,” says Dr. Silvestry. “DCD transplants have been conducted in the U.S. with other organs, including the lungs, liver and kidney, for years. However, until the availability of the OCS system, the use of DCD hearts has been limited. In addition, traditional cold storage techniques did not allow us to evaluate a heart’s function and check for any damage before transplantation. Now, thanks to this new technology, we can significantly expand the donor pool and save even more lives.”

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