Originally published in Volume 36 Issue 8 of Artificial Organs, 06 August 2012
It is an honor for me to be labeled “pioneer.” In my case, this meant taking the risk of doing something new. The risk was failure, but I was so caught up in caring for patients that the risk was just the enemy.
Why could I take such risks? Having the desire and confidence to struggle with the unknown was a gift from family and upbringing. School and training, where I learned medicine and surgery, made me ready. And, having a few “firsts” before the total artificial heart (TAH) bridge to transplantation experience taught me to succeed. I was the benefactor of learning from outstanding mentors, colleagues, residents, nurses, and others. As opportunities presented, it was the sum total of this “force” that seemed to allow me to move forward without a second thought. Some observers may have considered my actions audacious, but to me, they stemmed from the same intensity that I brought to all patient care situations. Taking risk and being intense for the benefit of a patient was normal. The real pioneers were the patients.
The first successful bridge to transplantation with a TAH 1 in August 1985 was planned because of a previous unplanned event, the Phoenix heart. There were a few important firsts that predated this. It started in the transplant laboratory at the Palo Alto Veterans Hospital where William Angell, an attending, helped me, a senior medical student, do a heart transplant. I caught fire with the idea of cardiac transplantation and, under Edward Stinson at the National Heart Institute, was able to have dogs survive transplantation with hearts preserved for 24 h prior to transplantation 2. At Stanford under Randall Griepp, I performed the first successful cardiac retransplant in a human 3. After 2 years as faculty at the University of Arizona, I started a “heart transplant program.” At the time, we were the sixth such program in the world. Then, in 1981, I was with a small group of colleagues, cofounder of the International Society for Heart and Lung Transplantation. That same year, my first Arizona cardiac recipient, with my help, sued Medicare in an administrative court in Tucson for coverage of his procedure. He won. Medicare stopped payment on all heart transplants in the USA to that date and eventually initiated “The National Heart Transplant Study” led by Roger Evans. The judge had ruled that cardiac transplantation was not experimental and was “reasonable and necessary” and therefore should be funded by Medicare throughout the USA. Thanks to this study, cardiac transplantation was eventually supported by governmental and private insurance.
In our Arizona cardiac transplantation program, our first 12 consecutive transplants had survived before we lost two patients “on the table” from “graft failure.” This was in late 1984, and I was depressed. At that point, I vowed to myself that I would never allow such deaths to occur again. In March 1985, when Christian Cabrol and his wife and fellow transplanter Anik Cabrol were visiting Tucson from Paris, I received a “donor call” about a potential donor for a very sick young man in our intensive care unit. There were some irregularities with the donor, and the Cabrols both advised me not to use that heart. I did use that heart for our sick patient and within hours was faced with another graft failure. The recipient was barely alive, and his sepsis correlated with a postharvest blood culture positive for pseudomonas. At this point, before we had any culture results, with global donor heart failure, we needed a TAH to keep our patient alive (of course, he was later treated for pseudomonas sepsis). I had only read about the Jarvik heart and had heard rumors of a Phoenix heart that was being used in calves. I called the headquarters for both devices and they were most receptive to helping. On the way down from Salt Lake City with the Jarvik-7, Don Olsen, one of the most experienced people with the Jarvik, called the media. Cecil Vaughn and Kevin Cheng (the inventor) brought the Phoenix heart by helicopter. Since the Phoenix group arrived first, we implanted the Phoenix heart. It supported the circulation beautifully, and, after a few days, we were able to retransplant our patient 1. Massive media coverage of the event did not escape Food and Drug Administration (FDA) officials who were faced with the “use of an unapproved device.” There was a celebrated FDA visit and great fear of what they might do. I met the FDA representative in the Dean’s Conference room at University Medical Center. Fortunately, he was an old friend and colleague from the National Institutes of Health who was highly intelligent and very sensible. The end result of this fearful meeting was a letter from the FDA stating that in a true emergency, anyone could use an unapproved device one time if they thought it might be life saving.
The importance of the TAH could not have been more dramatically demonstrated than with the Phoenix heart, and the necessity of being ready to use an approved heart was clear. Within a few months, we trained with Don Olsen in Salt Lake City on the Jarvik-7. Our opportunity to use this device came in August 1985. A young grocery clerk with global myocardial dysfunction, four-chamber dilatation, and cardiogenic shock unresponsive to inotropes was transferred from Phoenix. We quickly implanted the Jarvik-7. The fit was perfect as was the function. We were uncertain about antiaggregant and anticoagulant therapy and only later learned from Jacques Szefner at La Pitie Hospital in Paris the importance of aspirin and dipyridamole as antiplatelet therapy and how to dose heparin and coumadin 4. Our patient had a mild stroke characterized only by a mild expressive aphasia that resolved completely. His transplant was 9.5 days after his device implant, much sooner than optimal by current standards. We have since learned to use TAH support until the patient becomes a strong, physically rehabilitated transplant candidate. Our patient, as the Phoenix heart patient, was highly celebrated by the media. His discharge from the hospital was an international event. He lived for over 5.5 years, dying of post-transplantation lymphoproliferative disease involving the small bowel. He, Michael Drummond, was the true pioneer of the TAH, the first in the world to walk out of the hospital after a TAH bridge to transplantation. Since then, a slow and steady growth in the use of this technology has been based upon acceptance in many centers in the USA and Europe. Over 960 of the SynCardia/CardioWest TAHs have been implanted since 1993. Over 25,000 outpatient days on the device have accumulated thanks to portable drivers. For me, a former Michael Drummond Distinguished Professor at the University of Arizona, the most important reward has been seeing others in the heart failure community realize the value of the TAH in critically ill patients.
Biosketch: Dr. Jack G. Copeland is a professor of cardiothoracic surgery at the University of California San Diego who has devoted much of his clinical research time to cardiac support and replacement. His early years at Stanford and the NIH led to a strong interest in cardiac transplantation. His subsequent 33 years at the University of Arizona were spent in pediatric and adult conventional cardiac surgery, transplantation, mechanical circulatory support, and also in recovery of native heart function in infants and children.