A patient with terminal heart disease received a pig heart transplant and is doing well three days later. The patient only had one currently available option. The University of Maryland School of Medicine and the University of Maryland Medical Center collaborated to conduct the historic surgery.
The transplant demonstrated that a genetically-modified animal heart can function like a human heart without being rejected by the body. The patient, David Bennett, a Maryland resident, is being carefully monitored over the next days and weeks to determine whether the transplant provides life-saving benefits. He was ineligible for a conventional heart transplant at UMMC and several other leading transplant centers that reviewed his medical records.
It was either die or do this transplant. I want to live. Mr. Bennett said he knew it was a shot in the dark, but it was his last choice. He had been hospitalized for a while. I will get out of bed after I recover.
Emergency authorization was granted by the FDA for the surgery on New Year's Eve. When an experimental medical product is the only option for a patient with a serious or life-threatening medical condition, it is called an experimental medical product. The authorization to proceed was granted to save the patient's life.
The surgery brought us one step closer to resolving the organ shortage crisis. There is not enough donor human hearts available to meet the long list of potential recipients. The Thomas E. and Alice Marie Hales Endowed Professor in Transplant Surgery is Dr. Griffith. We are cautiously proceeding, but we are optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.
The Cardiac Xenotransplantation Program was established five years ago by Muhammad M. Mohiuddin, MD, Professor of Surgery at UMSOM. The program's Scientific/Program Director is Dr. Mohiuddin, while the Clinical Director is Dr. Griffith.
This is the culmination of years of research to hone this technique in animals with longer survival times. The FDA used our data and data on the experimental pig to authorize the transplant in an end-stage heart disease patient who had no other treatment options. Valuable information was provided to the medical community by the successful procedure.
More than 6,000 patients die each year before getting an organ transplant, according to the federal government's organdonor.gov. There is a chance of triggering a dangerous immune response, which is one of the risks of enotransplantation. These responses can cause an immediate rejection of the organ, which can be fatal.
After the case of Baby Fae at the University of California, it was abandoned the first time that enotransplants were tried. The infant who received a baboon heart transplant died within a month of the procedure due to the immune system's rejection of the foreign heart. For many years pig heart valves have been used to replace valves in humans.
Mr. Bennett was fully aware of the risks and benefits of the transplant before he agreed to receive it. He had been in the hospital for more than six weeks with arrythmia and was connected to a heart-lung bypass machine. He wasn't on the transplant list because of his arrhythmia, and was also ineligible for an artificial heart pump.
The pig was genetically-modified by Revivicor to be used in the UMSOM xenotransplantation laboratory. The pig's heart was removed on the morning of the transplant surgery and placed in the XVIVO Heart Box, a machine that preserves the heart until surgery.
A new drug was used along with conventional anti-rejection drugs to suppress the immune system and prevent the body from rejecting a foreign organ. Kiniksa Pharmaceuticals made the experimental drug.
This historic procedure shows the importance of research which lays the groundwork for patients to benefit in the future. The culmination of our longstanding commitment to discovery and innovation is what it is. Our transplant surgeon-scientists are some of the most talented in the country, and are helping to bring the promise of xenotransplantation to fruition. We hope that one day it will become a standard of care for patients in need of organ transplants. The University of Maryland School of Medicine continues to address the most complex medical and scientific problems.
Bruce Jarrell, MD, President of the University of Maryland, Baltimore, who himself is a transplant surgeon, said that he and Dr. Griffith began as organ transplant surgeons when it was in its infancy. It is gratifying to see that the long-sought goal of achieving xenotransplantation is clearly in view, and it was the dream of every transplant surgeon back then. It is a great achievement.
This is a monumental step forward. The University of Maryland Medical Center has long been at the forefront of research driving progress toward the promise of xenotransplantation as a viable solution to the organ crisis. I am proud to say that the future is now. Our skilled team of UMMC and UMSOM physician-scientists will continue to advance and adapt medical discovery for patient care that could offer a lifeline for more patients in dire need.
The University of Maryland Medical System is committed to working with the University of Maryland School of Medicine to explore, research, and implement the innovations in patient care that make it possible. The courage of this live recipient, who made an extraordinary decision to participate in this procedure to potentially extend his own life, is something we are very proud of.
Organs from genetically modified pigs have been the focus of much of the research in xenotransplantation. The UMSOM received a research grant to evaluate Revivicor pig UHearts.
Three genes that play a role in the rejection of pig organs by humans were knocked out in the pig. The pig heart's immune acceptance genes were inserted into the human genome. There were 10 unique gene edits made in the donor pig that were knocked out to prevent excessive growth of the pig heart tissue.
The University of Maryland School of Medicine has a world-class team of transplant surgeons. This is the first transplant of its kind, and is a step in the investigation of xeno organs for human use.
The research team spent the past five years refining the surgical technique for pig hearts to be used in non-human primates. Dr. Mohiuddin's research experience spans over 30 years, during which time he demonstrated in peer-reviewed research that genetically-modified pig's hearts can function for as long as three years. Success was dependent on the right combination of genetic modifications to the pig and anti-rejection drugs.
This is an amazing moment in the history of our field, as a cardiothoracic surgeon who does lung transplants. This achievement is the result of decades of research at Maryland and elsewhere. Christine Lau is the Dr. Robert W. Buxton Professor and Chair of the Department of Surgery at UMSOM. This is a continuation of the steps that have been taken to make xenotransplantation a reality for patients in need.
"This is a breakthrough for the field of organ transplantation and medicine," said Daniel G Maluf, Professor of Surgery and Medicine at UMSOM. This event is the culmination of years of research and testing by our multidisciplinary team. I am proud of our team.
Peter Rock said that they carefully considered the needs of the patient in preparing him for surgery and the intricacies involved in modifying their anesthetic techniques. Thanks to the hard work of the medical team, the surgery could not have gone better.
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The materials were provided by the University of Maryland. Deborah Kotz wrote the original. Content can be edited for style and length.
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