![]() We all knew that the approval itself was historic, but the work had just begun. Fast forward to New Year’s Eve at 5 PM–after two FDA conference calls, four revisions, multiple sleepless nights, and canceled family holiday travel plans-we received the email notifying us of approval. Griffith made the phone call to the FDA as part of the application process for a physician-directed “compassionate use” authorization. Bennett arrived at the UMMC with end-stage heart failure, on VA-ECMO, and with no other options or hope to leave the hospital before almost certain death, we knew this was our opportunity. We were now talking about the first-in-human clinical trials and began approaching the US Food and Drug Administration. ![]() We began getting consistent 6-month survival and soon were up to 9 months. Xenograft survival in primates improved to 2 months, then to 3 months, and then we had our first 6-month survivor. ![]() It did, and things in the lab eventually started improving. Goerlich and Aakash Shah removing the xenograft from the XVIVO perfusion box with cameras and onlookers in the background (Photo Credit: Joseph Rabin) I thought to myself: “There really are no more obstacles that could possibly get in our way, and Murphy’s Law should eventually just give way.” Corbin E. We even had a team meeting where the lab discussed all the obstacles that were experienced over the prior 18 months. But we kept pursuing improved surgical techniques, postoperative care, and cardiac preservation techniques and learning about other’s experiences. There were many trials and tribulations, and at one point I thought that the lab may have to call it quits and I would have to somehow explain to my program director that the once-in-a-lifetime opportunity that I begged to pursue would amount to a premature return back to my general surgery training. We all thought it would be simpler to translate the same rejection-free survival seen in the heterotopic model but get the xenograft to pump in a normal anatomic position.īut it just wasn’t so. Griffith saying that the exact same transplantation in the clinical setting would never look like this. Unanticipated problems included seemingly indescribable and mysterious primary graft dysfunction that would lead to graft failure within the first 48 hours and, furthermore, life-limiting diastolic dysfunction shortly thereafter. When I began working in the lab, the field was still struggling to transition from a proof-of-concept abdominal heterotopic cardiac xenotransplantation model to one of life-supporting orthotopic transplantation that actually replaces the native recipient heart. Goerlich, Ivan Tatarov, Billeta Lewis, Muhammad Mohiuddin, Faith Sentz, Avneesh Singh, Sarah Mudd (Photo Credit: University of Maryland School of Medicine) From left to right: Tianshu Zhang, Aakash Shah, Corbin E. Part of the Xenoheart team on January 7, 2022, prior to donor heart procurement. ![]() That was probably the smoothest part of my entire experience leading up to Mr. She said yes, and I began working there shortly thereafter. I immediately emailed my program director asking if I could work in the cardiac xenotransplantation lab as part of my dedicated research time for the residency program. Mohiuddin’s work while I was in medical school and was elated to hear that his lab was down the street in Bethesda, MD, at the National Institutes of Health it soon moved even closer to UMMC in downtown Baltimore. ![]() I had no idea what my experience in Baltimore would bring, but I had aspirations of becoming an academic surgeon and always had an insatiable desire to pursue my passions, which usually routed me to working in a cutting-edge science lab. A Texas native, I joined the cardiac xenotransplantation lab of Muhammad Mohiuddin, MD, and Bartley Griffith, MD, at the University of Maryland School of Medicine (UMMC), having recently moved from Houston to Baltimore to attend the Johns Hopkins Hospital for general surgery residency. What a wild ride this week has been: being a part of the team that conducted the world’s first transplantation of a genetically modified pig heart into 57-year-old David Bennett.Īs a trainee, I find myself reflecting back on the last 4 years that led us to this point. ![]()
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