First Beating-Heart Transplant in United States Performed by McCurry

Kenneth R. McCurry

Protected by its own nutrients and blood supply, a beating heart supported by an investigational organ-preservation device has been successfully transplanted at the University of Pittsburgh Medical Center (UPMC) into a 47-year-old man with congestive heart failure and pulmonary hypertension.

The surgery was performed April 8 by Kenneth R. McCurry, an assistant professor of surgery in the Pitt School of Medicine’s Division of Cardiothoracic Surgery and director of cardiopulmonary transplantation in UPMC’s Heart, Lung, and Esophageal Surgery Institute. It was the first such transplantation in the United States.

The patient, who is from Portage, Pa., is doing well and was discharged from the hospital April 30. The donated heart, from a 46-year-old man, was maintained in a beating state on the investigational Organ Care System (OCS) for two hours and 45 minutes.

McCurry is principal investigator of the PROCEED Trial at UPMC, which is evaluating the safety and efficacy of the OCS for heart transplants. Manufactured by TransMedics Inc., of Andover, Mass., the OCS is designed to maintain donor hearts in a beating, functioning state during transportation from the donor to the recipient’s hospital.

After removal from the donor, the heart is placed into the OCS, where it is immediately revived to a beating state, perfused with oxygen and nutrient-rich blood, and maintained at the appropriate temperature. Using the OCS, organs are kept in their physiological, beating state for delivery to the recipient and until implantation.

“This study presents an exciting opportunity to apply the latest medical technology to help patients receive lifesaving transplants,” McCurry said. “By maintaining the organ in near perfect physiologic state, the OCS will reduce injury and help extend the life of these organs, which also will improve patient outcomes with less rejection and shorter length of ICU and hospital stay.”

In April, the U.S. Food and Drug Administration approved TransMedics Inc. to begin the pilot phase of a trial of the investigational device exemption at five centers in the United States. In addition to UPMC, the participating centers include Brigham and Women’s Hospital in Boston, the UCLA Medical Center in Los Angeles, the University of Chicago Hospitals Cardiac Center, and the Cleveland Clinic Heart and Vascular Institute. Twenty patients will be enrolled in this phase of the PROCEED trial.

The current standard of preserving a transplanted organ is cold preservation, which involves perfusing the organ with a cold solution and then packing it in sterile ice. With cold preservation, the maximum storage time for a heart is four to six hours; during the time between the donor and recipient surgeries, the organ is without blood or oxygen, which may injure it and, ultimately, lead to rejection.
Using OCS, surgeons will have the opportunity to evaluate the organ immediately prior to transplant and may be able to test it even more extensively for existing diseases. More comprehensive tissue matching also may be possible, which could lead to an optimization of organ allocation and reduced risk of organ rejection.

The number of people requiring life-saving organ transplants continues to rise faster than the number of available donors. Of the 96,000 people in the United States currently waiting for a donor organ, only a third will receive a transplant, while nearly 7,000 will die each year while waiting for an organ. This means approximately 19 transplant candidates die each day while waiting to receive donor organs.

Results of the PROTECT-1 Trial in Europe were reported at the 27th Annual Meeting of the International Society of Heart Lung Transplantation in San Francisco in April. They showed success with the device in 20 heart transplants with 30-day graft and patient survival at 100 percent.

Coinvestigators of the PROCEED Trial at UPMC, all from the Pitt medical school’s Department of Surgery, are Robert Kormos, professor of surgery; Yoshiya Toyoda and Christian Bermudez, assistant professors of surgery; and Diana Zaldonis, research coordinator.