More than six million Americans have heart failure, and about 100,000 of those individuals have end stage heart failure. Due to a lack of organ donors, many of these people die waiting for a heart transplant — U.S. surgeons performed only about 3,800 heart transplants last year.
NYU Langone is pioneering research to address the organ deficiency that causes so many patients to die while waiting for human hearts to become available for transplant. In the past 30 days, the New York City-based health system successfully transplanted two genetically engineered pig hearts into deceased people who donated their bodies to medical research.
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Cardiac xenotransplantation, which refers to the transplantation of an organ from one species to another, has only been performed in human subjects three times — the two recent experimental procedures at NYU Langone and the case of David Bennett. In January, Bennett became the world’s first recipient of a genetically modified pig heart following a transplant procedure performed by Dr. Bartley Griffith at the University of Maryland Medical Center.
Bennet passed away two months after the procedure. Still, it was a “tremendous feat” that the genetically modified pig heart could keep him alive for two months, according to Dr. Robert Montgomery, director of NYU Langone’s Transplant Institute. He said medical field is still struggling to understand why the heart ended up failing and why Bennett died.
Speaking at a Tuesday media conference, Dr. Montgomery said Bennett’s death shows that the medical field still has a lot to understand and probe when it comes to xenotransplants in humans — and that research will be best performed on deceased patients for the time being.
NYU’s recent experimental procedures were led by Dr. Nader Moazami, the transplant institute’s surgical director of heart transplantation. Both pig hearts used for these xenotransplants had 10 individual gene modifications. Most of the modifications were related to avoiding rejection of another species’ organ, and one was meant to ensure the heart does not grow too much and is adaptable to the human chest cavity.
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The procedures were conducted on two patients who had been pronounced brain-dead and had previously consented to their bodies being kept alive for medical research. The surgeries were performed over several hours, and heart function was monitored for three days following the operation. There were no signs of early rejection for either organ. Both of the transplanted hearts functioned normally with standard post-transplant medications and without mechanical support.
These xenotransplants allowed NYU Langone’s research team to understand the human body’s response to a pig heart — an understanding that cannot be obtained from previous studies involving primates. The team was able to see how the human body was able to maintain its body functions and blood flow, and also discovered the exciting finding that these surgeries could be performed without the help of a perfusion pump.
Perfusion pumps help patient’s blood flow through their body tissue while they are undergoing cardiac surgery. In previous studies involving pig heart xenotransplantation into primates, use of a perfusion pump during the procedure was essential to sustain the heart’s function.
Finding answers to questions like whether or not pumps are needed for heart xenotransplants in humans is why experimental research in deceased humans is so important, Dr. Montgomery said. He pointed out that perfusion pumps are difficult to use and expensive. If pumps are not needed for heart xenotransplants in humans, that greatly increases the number of transplant centers that could participate in these life-saving surgeries.
Though the preliminary data his team is sharing is exciting, Dr. Moazami was careful to point out that the two studies only lasted 72 hours each. Researchers do not know how long the human body can sustain pig hearts over time.
“There are still many questions that need to be answered before a Phase 1 clinical trial, including what sort of patients would be appropriate to participate in this trial,” he said. “So I think we’re looking at these results with cautious optimism.”
NYU Langone is planning to conduct similar studies on deceased humans so that they can gather as much data as possible before embarking on a Phase 1 trial. Generous donors are hard to come by, so the system is waiting on more patients to donate their bodies to science. In terms of when a Phase 1 trial may be on the horizon, Dr. Montgomery said that it’s hard to say, but it could come before 2025.
“It’s a little bit like asking ‘How long is a piece of string?’” he said. It’s really hard to know because there has to be permission granted by the FDA in order to begin these kinds of trials, we still don’t fully know what level of evidence is going to be necessary to begin a Phase 1 trial. Our strategy is to continue to try to learn as much as we can so we go into those trials fully informed.”
While there is still much research to be done, Dr. Montgomery said his team is encouraged by their recent findings and excited to continue studying xenotransplantation in humans. He said medical researchers are now one step closer to creating a “renewable, sustainable source of organs.”
Picture: Natali_Mis, Getty Images
