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| Vol. 23, No. 19 |
| October 15, 2001 |
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World's Third Artificial Heart Recipient "Doing Well" A patient who last month was dying of end-stage chronic heart disease is doing well after his failing heart was removed and a permanent artificial heart was implanted in its place, doctors reported at a Sept. 28 press conference held at the Texas Heart Institute at St. Luke's Episcopal Hospital. The male patient, who will remain anonymous for at least 30 days following the implantation, received the artificial heart during a Sept. 26 surgery performed at St. Luke's, the clinical partner and home of the world-famous Texas Heart Institute. The mechanical heart, dubbed the "AbioCor Implantable Replacement Heart," was developed by engineers at Massachusetts-based ABIOMED Inc., in conjunction with more than a decade of Texas Heart Institute studies that led to the finalized design of the heart. Dr. O.H. Frazier, who led the research team conducting the studies at Texas Heart Institute, first shared his vision for the future artificial heart in 1985 with the advisory council of the National Heart, Lung and Blood Institute, an arm of the National Institutes of Health. The NIH, together with investor funds raised by ABIOMED Inc., provided funding for the artificial heart's development. "I told them it must allow the patient to leave the hospital and lead a productive, active life. The artificial heart would have to be totally implantable, unobtrusive in the patient's daily activities, and essentially forgettable by the patient and his or her family and friends," said Dr. Frazier, who is director of surgical research and chief of cardiopulmonary transplantation at the Texas Heart Institute, and chief of transplant service at St. Luke's Episcopal Hospital. That goal is becoming more real with the development of the AbioCor Implantable Heart. Unlike previous artificial hearts which were intended only to keep patients alive while they waited for a human heart to become available for transplant, the AbioCor is intended to function as a permanent replacement for the human heart. Older versions of artificial hearts were powered by bulky external machines attached to patients' bodies via electrical wires and tubes. The first artificial hearts of the 1980s were cumbersome and prone to infection. In contrast, the three-pound AbioCor needs no external connections. A small battery pack worn on the patient's belt sends power across the skin to the AbioCor heart. The replacement heart is "intelligent," in that it monitors the patient's activity, and "knows" to increase pumping action when the patient is active, and decrease pumping action when the patient is resting. The built-in monitoring system also continuously checks for problems and issues an alert if anything goes wrong. The Houston patient is only the third person in the world to receive the AbioCor heart. Two previous patients, also male, received AbioCor replacement hearts at Jewish Hospital in Louisville, Ky., in July and September of this year. In a Sept. 25 news release issued by the University of Louisville, the university's surgeons who performed the surgeries reported that each of their patients continues to recover well. The three existing AbioCor patients are participating in a clinical trial that requires the heart to be implanted into five patients nationwide. Other sites approved by the U.S. Food and Drug Administration are Brigham and Women's Hospital and Massachusetts General Hospital, both in Boston; UCLA Medical Center in Los Angeles; and Hahnemann University Hospital in Philadelphia. To qualify for the trial, each of the five patients must be expected to die within 30 days if not offered the surgery, be ineligible for a human heart transplant, and untreatable with existing methods of surgical intervention or drug therapy. If preliminary results for the first five patients are good, the clinical trial will be expanded to include an additional 10 patients. The full round of trials is expected to last at least five years. "The goal of this study will not be decided by the outcome of a single patient, but determined by a positive outcome from the initial study group," said Dr. Frazier. "We hope to be able to extend the potential benefits of this technology to the tens of thousands of patients dying prematurely of heart disease as soon as possible, in keeping with our established goals outlined in cooperation with the FDA." Dr. Frazier said cooperation among the research teams is critical in order to maximize the opportunity of this study. He visited the first AbioCor implant patient in Kentucky shortly after surgery, and returned to Kentucky to be present for the second patient's surgery. In a similar gesture, the Louisville surgical team of Drs. Laman Gray and Robert Dowling traveled to Houston to observe the third artificial heart implantation. Successful completion of the clinical trials will mean that heart patients may no longer have to die while waiting for a human donor heart. Statistics from the American Heart Association indicate that more than 700,000 Americans die each year from heart failure, and only about 2,000 human hearts become available for transplant in any given year. Doctors at the Texas Heart Institute said the AbioCor could potentially replace heart transplants within seven to 10 years. "This is going to be so much more important than transplants," said Dr. Reynolds Delgado, cardiologist for the Houston patient who received the AbioCor heart. The AbioCor has not yet been approved for commercial distribution, and is not available for use or sale outside of the initial clinical trial. At this time, the only way patients can receive the heart is to participate in the clinical trials. Every person who enters these trials, or who is eligible and considers entering them at any of the five nationwide test sites, is assigned an independent patient advocate who assists patients and their families in understanding and weighing the risks and benefits of entering the AbioCor trials. Other research trials have incorporated the use of patient advocates, but typically these are provided by the hospital or corporation. The AbioCor trial is unique in that the patient advocates are entirely independent, and almost all are medical doctors. In addition to Drs. Frazier and Delgado, others speaking at the Sept. 28 press conference included Dr. James Willerson, who is medical director of the Texas Heart Institute, chief of cardiology at St. Luke's Episcopal Hospital, and president of The University of Texas Health Science Center at Houston, and Dr. Denton Cooley, Texas Heart Institute founder, president and surgeon in chief, and chief of cardiovascular surgery at St. Luke's. In 1969, Dr. Cooley performed the world's first implantation of a total artificial heart in a patient waiting for a human heart transplant, proving that a mechanical device could support life.
- With contributions from Kathy Watson, Texas Heart Institute; Paul Harasim, St. Luke's Episcopal Hospital; and Ronda Wendler, Texas Medical Center News
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