July 6, 2001 (LOUISVILLE) – A Jewish Hospital clinical team led by University of Louisville surgeons Laman A. Gray, Jr., M.D., and Robert D. Dowling, M.D., successfully implanted ABIOMED, Inc.'s AbioCor replacement heart in a mid-to-late 50-year-old patient on Monday, July 2. The seven-hour surgery, performed with a team of 14 nurses, perfusionists, physician assistants, anesthesiologists and other support staff, was the first of its kind in the world.
The experimental procedure is the result of 20-plus years of product research and development by Danvers, Mass.-based ABIOMED, INC., and a three-year partnership with the University of Louisville and Jewish Hospital, where pre-clinical in-vivo device research was performed.
The Louisville-based research accomplished two major goals in the completion of the pre-clinical stage of the project. First, three years of successful pre-clinical implants of the AbioCor offered sufficient evidence to the Food and Drug Administration that the device was biocompatible and was capable of sustaining life. Second, the surgical team from Jewish Hospital and the University of Louisville developed its procedural protocols – ranging from pre-surgical patient care to post-surgery recovery and rehabilitation.
“While we are very pleased so far with this first implant and are hopeful for our patient's recovery, it is important to remember that this is the first chapter of many volumes that we have still to learn about the use of these devices in humans,” said Gray, co-principal investigator for the Jewish Hospital and University of Louisville AbioCor research team and professor of surgery at the University of Louisville. “As with any innovative development, we must master walking before we learn to run.”
David M. Lederman, Ph.D., the president and CEO of ABIOMED, Inc., said, “This important and historic event would not have been possible without the vision and support of the National Heart Lung and Blood Institute of the National Institutes of Health and without the Food and Drug Administration's approval of the initial AbioCor clinical trial.”
As more and more people survive heart attacks, but are left with a damaged heart, the incidence of heart failure is increasing. In fact, heart failure is the only major cardiovascular disease that is rising in incidence and prevalence. The number of deaths in the U.S. from this disease has more than doubled since 1979. In comparison, the death rate from coronary heart disease has dramatically dropped statistically over a similar period.
Dowling, co-principal investigator for the Jewish Hospital/University of Louisville AbioCor research team and an associate professor of surgery at UofL said, “Once heart failure patients have reached maximum medical management of heart failure, their only option until now was a heart transplant. Only about 2,000 heart transplants are performed each year. There are a vastly larger number of potential patients who could benefit.” He said there are up to 100,000 potential recipients for a replacement heart when the technology is clinically demonstrated.
The initial patients eligible to receive an AbioCor device are those who are not eligible for heart transplant and who are determined to have less than a 30-day life expectancy. In short, Gray explains, “These patients are the sickest of the sick. They will die in a very short time without some kind of intervention. These patients and their families understand the risks of the surgery, and the risks of no further intervention.”
In fact, the medical team views the first patient as a medical pioneer, and credits the patient's family for their support. While the critically ill patient and family did receive an intense education about the device and the risks of its implantation, “it takes a great deal of courage to agree to take a step that no one else has ever taken,” Gray continued.
Jewish Hospital is among the top ten cardiac centers in the United States and, along with the University of Louisville, is dedicated to excellence, research and education. University of Louisville surgeons at Jewish Hospital have performed many heart care “firsts,” including Kentucky's first heart transplant, the world's first heart transplant following the use of a Thoratec left ventricular assist device, the world's first endoscopic saphenous vein harvest and the first ventricular remodeling in the region.
For more information, please visit http://www.heartpioneers.com
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