IRVINE, Calif., Aug. 8, 2001 -- Patients who have received a pericardial tissue heart valve to replace their malfunctioning aortic valve continue to experience excellent long-term clinical results 17 years after their procedure, it was announced by Dr. Michael K. Banbury of The Cleveland Clinic Foundation during a presentation delivered at the first biennial meeting of the Society for Heart Valve Disease held recently in London.
In his presentation, "Hemodynamic Stability Over 17 Years of the Carpentier-Edwards Aortic Pericardial Bioprosthesis," Dr. Banbury presented results from a multi-institution study of long-term hemodynamic performance, which characterizes the flow of blood through the heart. While it is common for replacement heart valves to be assessed for short-term hemodynamic performance, the Carpentier-Edwards aortic pericardial valve is the first to show excellent hemodynamic performance at 17 years. These results add to previously reported 17-year data demonstrating the Carpentier-Edwards aortic valve's long-term durability.
In this latest study, 267 patients who had received a Carpentier-Edwards aortic replacement heart valve made of bovine pericardium between 1981 and 1983 were evaluated annually after their implant. The first study ever to include measurements of long-term hemodynamic stability evaluated several performance factors, including left ventricular volume, pressure gradients across the valve, velocity (speed of blood flow across the valve), size of the valve's opening, known as the "effective orifice area," and the presence of any aortic regurgitation (whether the valve permitted any inappropriate backflow of blood). Patients also were evaluated for long-term improvements or declines in their classifications in the well-known New York Heart Association (NYHA) measures, which are used to categorize cardiac disease patients based on clinical symptoms and prognosis.
Dr. Banbury reported that patients in the study who received aortic pericardial replacement heart valves experienced low overall complication rates. In addition, even 17 years after implantation, pericardial valves were shown to be performing at levels similar to those with early porcine tissue valve implants, a strong indication of the pericardial valves' excellent performance and durability.
Follow-up assessments also showed that while many patients preoperatively had been categorized as NYHA Class IV, the most severe classification, the majority experienced a sustained improvement of one to two NYHA levels even at the 17-year postoperative mark.
"The Carpentier-Edwards aortic pericardial bioprosthesis demonstrates excellent hemodynamic stability over 17 years, with acceptable long-term transvalvular gradients and mild aortic regurgitation," Dr. Banbury said, adding that "pericardial valves should be considered appropriate for younger patients."
In addition to the Cleveland Clinic, other participating institutions contributing to the study included Good Samaritan Hospital, Portland, Ore., and Montefiore Medical Center/Albert Einstein, New York. The study is part of the long-term clinical trial follow-up requirements of the U.S. Food and Drug Administration (FDA). All of the patients in the study presented had received a Carpentier-Edwards aortic PERIMOUNT pericardial heart valve, made of bovine pericardium, from Edwards Lifesciences Corporation (NYSE: EW).
Tissue Valves Offer Quality-of-Life Benefits for Patients
Cardiovascular disease is the No. 1 cause of death in the world and among the top three diseases in terms of healthcare spending in nearly every country in the world. Each year, an estimated 300,000 people worldwide undergo open- heart surgery to treat their malfunctioning or diseased heart valves. Of these surgeries, nearly two-thirds are aortic valve procedures.
In many cases, surgeons choose to replace an affected valve with either a bioprosthetic valve generally made of animal tissue, or a prosthetic mechanical valve made of metal and carbon. One of the key advantages of tissue valves is that patients typically do not have to take blood-thinning agents on a long-term basis, as they do with mechanical valves. Due to their quality-of-life benefits and improvements over previously available bioprosthetic valves, today's tissue valves are increasingly chosen by clinicians and their patients over mechanical valves, and are the fastest- growing areas of heart valve therapy products in the United States.
About Edwards Lifesciences
Edwards Lifesciences is a leader in advanced cardiovascular disease treatments and the number-one heart valve company in the world. Headquartered in Irvine, Calif., Edwards focuses on four main cardiovascular disease states: heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure. The company's global brands, which are sold in over 80 countries, include Carpentier-Edwards, Cosgrove-Edwards, Swan-Ganz and Fogarty. Additional company information can be found at www.edwards.com.
Edwards Lifesciences and Edwards are trademarks of Edwards Lifesciences Corporation. Carpentier-Edwards, PERIMOUNT, Cosgrove-Edwards, Swan-Ganz and Fogarty are trademarks of Edwards Lifesciences Corporation, registered in the U.S. Patent and Trademark Office.