New Endovascular Procedure May Be An Alternative To Open-Heart Aortic Valve Replacement For Seriously Ill Elderly Patients 1/20/2003
From: Sonja R. Sorrel or Julie Semancik for the International Symposium on Endovascular Therapy, 312-558-1770, or from Jan. 19 - 23, 305-674-4782 MIAMI BEACH, Fla., Jan. 20 -- An experimental procedure that replaces a diseased aortic valve with a prosthetic one - completely without open-heart surgery - offers hope of a treatment alternative for saving and preserving the quality of life of patients who are too elderly or too sick for an operation. The first case report of the endovascular procedure in a profoundly ill patient with a severely malfunctioning aortic valve and no other treatment options was presented today at the 15th Annual International Symposium on Endovascular Therapy. Clinical trials of the procedure are beginning in Europe in the next few months, and trials are expected to begin in the United States on patients with severe aortic stenosis by the third quarter of this year, according to Martin Leon, M.D., director and chief executive officer, Cardiovascular Research Foundation, Lenox Hill Hospital, New York, who presented the case. Aortic stenosis (deterioration of the valve leading from the left ventricle of the heart to the aorta) usually is an age-related phenomenon that causes shortness of breath and heart pain in patients in their 70s and 80s, although it also occurs in younger individuals. "This procedure is early-stage technology, but it has a lot of potential for the future," said Dr. Leon, who is spearheading the development of clinical trials of the procedure in this country. "If in the future we can demonstrate that these valves are durable, that we can do the procedure repeatedly, reliably and safely, it may, in fact, be competitive with surgical valve replacement under many circumstances." The first patient to undergo the procedure was a 57-year-old Frenchman with a severely thickened and calcified aortic valve. He was not a candidate for standard, open-heart valve replacement because his condition was too unstable; he was in shock and had substantial fluid accumulation in the lungs. Surgeons attempted to stretch open the valve to improve blood flow to the body's organs by inserting a balloon into a blood vessel in the leg, threading it to the aortic valve and inflating it. Within a week, however, the man's condition progressively deteriorated, his blood pressure fell precipitously and he faced imminent death. Under these desperate circumstances, physicians at the Hopital Charles Nicolle, Rouen, France, and the patient's family agreed to the use of percutaneous heart valve implantation. The patient improved dramatically after the procedure, according to Dr. Leon. Signs of congestive heart failure improved, and the patient was able to resume some normal activities. He died four months later because of complications that were not related to the procedure or to heart disease. During the procedure, the surgeons inserted a balloon catheter into the femoral vein at the groin and guided it to the diseased aortic valve. The artificial valve was then advanced to the site of the aortic valve and positioned so it would replace the old valve after being deployed by inflating the balloon. The procedure makes use of a new type of heart valve that has been specially designed to work with well-established endovascular techniques and tools, such as balloon catheters and very large stents. The heart valve is made of the same material used in valves that are transplanted surgically; however, the valve is placed within a stent that can be expanded so it can be implanted entirely percutaneously, or through a puncture in the skin rather than open surgery. "The goal of percutaneous valve replacement is to address a population of patients who are too sick for an operation or who have a high risk of mortality. The advantages will be obvious," Dr. Leon said. "Any time you can do less invasive treatment in critically ill patients, you reduce morbidity and you improve results." Considered to be the premier meeting on endovascular therapy, ISET celebrates 15 years of innovation in education. More than 1,100 physicians, researchers and industry professionals from around the world attend the meeting each year. The meeting is well known for its live patient demonstrations that focus on the most recent procedures and devices for treating cardiovascular disease as well as for promoting a multidisciplinary approach to the diagnosis, treatment and prevention of endovascular diseases. ISET is presented by the Miami Cardiac & Vascular Institute and cosponsored by the Society of Interventional Radiology. AT A GLANCE: -- The first case of aortic valve replacement done entirely without open-heart surgery in a gravely ill patient is reported. -- Clinical trials of the procedure are beginning in Europe and the United States. -- The procedure may replace surgery for elderly patients with aortic stenosis. ------ The 2003 ISET news releases are available online at http://www.pcipr.com/newsroom/ISET. |