A 57-year-old with terminal heart disease has received a successful “first of its kind” transplant of a genetically-modified pig heart.
According to medics, this was the “only available” option for the male. After examining his medical records, they deemed him ineligible for a traditional transplant.
University of Maryland School of Medicine (UMSOM) faculty at the University of Maryland Medical Center (UMMC), together known as the University of Maryland Medicine, conducted the historic surgery.
This organ transplant, demonstrated for the first time, that a genetically-modified animal heart can function like a human heart without immediate rejection by the body.
Medics will monitor Bennett over the following days and weeks to determine whether the transplant provides life-saving benefits.
Bennett, a day before he underwent surgery, said:
“It was either die or do this transplant. I want to live. I know it’s a shot in the dark, but it’s my last choice.”
He had been hospitalised and bedridden for the past few months but said, “I look forward to getting out of bed after I recover”.
Genetically-modified pig heart
The U.S. Food and Drug Administration granted emergency authorisation for the surgery on New Year’s Eve through its expanded access (compassionate use) provision.
They use this when an experimental medical product, in this case, the genetically-modified pig’s heart, is the only option available for a patient faced with a serious or life-threatening medical condition.
The U.S. Food and Drug Administration granted authorisation to proceed in the hope of saving his life.
Bartley P. Griffith, MD, who surgically transplanted the pig heart into the patient:
“This was a breakthrough surgery and brings us one step closer to solving the organ shortage crisis. There are simply not enough donor human hearts available to meet the long list of potential recipients.”
Dr. Griffith is the Thomas E. and Alice Marie Hales Distinguished Professor in Transplant Surgery at UMSOM.
“We are proceeding cautiously, but we are also optimistic that this first-in-the-world surgery will provide an important new option for patients in the future.”
Muhammad M. Mohiuddin, MD, Professor of Surgery at UMSOM, joined the UMSOM faculty five years ago and established the Cardiac Xenotransplantation Program with Dr Griffith.
Dr Mohiuddin serves as the program’s Scientific/Program Director and Dr Griffith as its Clinical Director.
“This is the culmination of years of highly complicated research to hone this technique in animals with survival times that have reached beyond nine months,” Dr Mohiuddin said.
“The FDA used our data and data on the experimental pig to authorise the transplant in an end-stage heart disease patient who had no other treatment options.”
“The successful procedure provided valuable information to help the medical community improve this potentially life-saving method in future patients.”
They believe Xenotransplantation could potentially save thousands of lives.
However, it does carry a “unique” set of risks, including the possibility of triggering a dangerous immune response.
These responses can trigger an immediate rejection of the organ with a potentially deadly outcome to the patient.
Before consenting to receive the transplant, Bennett, the team informed him of the procedure’s risks. Medics told him that the procedure was experimental with unknown risks and benefits.
He had been admitted to the hospital more than six weeks earlier with life-threatening arrythmia. He was connected to a heart-lung bypass machine, called extracorporeal membrane oxygenation (ECMO), to remain alive.
In addition to not qualifying to be on the transplant list, he was also deemed ineligible for an artificial heart pump due to his arrhythmia.
Revivicor, a regenerative medicine company, provided the genetically-modified pig to the xenotransplantation laboratory at UMSOM.
On the morning of the transplant surgery, the surgical team, led by Dr Griffith and Dr Mohiuddin, removed the pig’s heart and placed it in the XVIVO Heart Box, perfusion device, a machine that keeps the heart preserved until surgery.
The physician-scientists also used a new drug and conventional anti-rejection drugs. These suppress the immune system and prevent the body from rejecting the foreign organ.
The new drug they used is an experimental compound Kiniksa Pharmaceuticals made.
Albert Reece, MD, PhD, MBA hopes it will one day become a standard of care for patients in need of organ transplants.
Peter Rock, MD, MBA, is the Dr Martin Helrich Chair and Professor in the Department of Anesthesiology at UMSOM.
He said the surgery “could not have gone better” thanks to the team’s “herculean” efforts.