PITTSBURGH, May 17 – Protected by its own nutrients and blood supply, a beating heart supported by an investigational organ preservation device was successfully transplanted into a 47-year-old man with congestive heart failure and pulmonary hypertension on Sunday, April 8. The surgery was performed at UPMC by Kenneth R. McCurry, M.D., assistant professor of surgery, division of cardiothoracic surgery at the University of Pittsburgh School of Medicine and director of cardiopulmonary transplantation at UPMC's Heart, Lung and Esophageal Surgery Institute.
The patient, who is from Portage, Pa., is doing well and was discharged from the hospital on Monday, April 30. The donated heart, from a 46-year-old Caucasian male, was maintained in a beating state on the investigational Organ Care System (OCS) for two hours and 45 minutes.
Dr. 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. 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," said Dr. McCurry.
Last month, 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, other centers participating 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.
This technology has the potential to greatly reduce ischemic injury to the transplanted organ by enabling the organ to continue to be perfused and oxygenated with its own blood supply. The current standard of preserving a transplanted organ is cold preservation. In this approach the organ is initially perfused with a cold solution and then packed in sterile ice.
Ischemic injury occurs during the period between the donor and the recipient surgeries. During this time the organ is without blood or oxygen, which may cause injury to the transplanted organ, which may ultimately lead to rejection.
Results of the European PROTECT -1 Trial using the OCS were reported at the 27th Annual Meeting of the International Society of Heart Lung Transplantation in San Francisco last month. Results from the European study showed success with the device in 20 heart transplants with 30-day graft and patient survival at 100 percent.
Co-investigators at UPMC include Robert Kormos, M.D., professor of surgery; Yoshiya Toyoda, M.D., Ph.D., assistant professor of surgery; Christian Bermudez, M.D., assistant professor of surgery; and Diana Zaldonis, M.P.H., B.S.N., research coordinator, all from the department of surgery, division of cardiothoracic surgery at the University of Pittsburgh School of Medicine.
Patient benefits from new method
Conventional methods store organs waiting to be transplanted in a cold, ischemic state (with no blood circulation), which makes it impossible to maintain them in a functional state. The maintenance of a functioning organ offered by the OCS yields several benefits. Surgeons now 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 in the future, which could lead to an optimization of organ allocation and reduced risk of organ rejection.
Disadvantages of conventional conservation methods
Cold ischemic storage of organs can lead to substantial organ damage in isolated cases. The faster the organ reaches the patient, the better the chance for a successful transplantation. International data shows that the one year survival of heart transplant is directly and significantly related to the length of time an organ is without blood between the donor and the recipient surgeries. If the time window between removal and implantation is too long, the organ will become unusable. The maximum storage time for a heart is presently four to six hours.
The Growing Need for New Transplant Technologies
The number of people requiring a life-saving transplant 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 a donor organ.