Apr 4 2011
A major new study presented today at the yearly scientific meeting of the American College of Cardiology (ACC) in New Orleans shows conclusively that replacing defective aortic valves in elderly patients through non-invasive "catheterization" – rather than through much more invasive open-heart surgery – leads to significantly better outcomes.
The new clinical trial study (PARTNER cohort A: Transcatheter valves noninferior to surgery), documents important scientific evidence for the fact that a new "transcatheter" approach to aortic heart valve replacement is safer and less strenuous for older patients than the older open-heart procedure.
The new high-tech method of implanting replacement aortic heart valves relies on delivering them to the heart via plastic catheters threaded through arteries, rather than implanting them after cutting through the chest.
The results of the large, authoritative study, presented at the ACC meeting – and conducted among 699 elderly patients at 26 sites in the U.S., Canada and Germany – confirmed that delivering new synthetic heart valves to elderly patients suffering from "aortic stenosis" (age-related valve-narrowing) via catheter tubes results in fewer deaths and about four times less severe bleeding than when the valves are delivered via traditional "chest-cracking" open-heart surgery.
The study is certain to have a major impact on interventional cardiac care, since it documents the importance of non-surgical approaches to heart valve replacement in elderly patients who are often too weak or impaired by disease conditions to endure the older form of chest surgery.
"The findings that were presented today in New Orleans are very significant for older patients who need aortic valve replacement," said Theodore L. Schreiber, M.D., the president of the CVI and a catheterization pioneer who was the first cardiac physician in the world to design a method for delivering synthetic valves to the heart via the groin artery. "The results of the randomized, multi-center trial show conclusively that implanting new aortic valves through catheter tubes is much easier on patients than subjecting them to the pain, trauma and infection-risk that accompanies open-heart surgery."
Only about a month ago, a multidisciplinary team of DMC physicians, nurses, research teams and technologists made headlines by achieving two aortic valve implants. Using a new "Medtronic CoreValve" device expressly designed for that purpose, Dr. Schreiber and Dr. Ali Kafi, chief of clinical cardio-thoracic surgery at DMC Harper University Hospital, performed the breakthrough procedure with two heart patients in late February.
The two CVI patients who received the new aortic valves are among more than 300,000 people worldwide (100,000 in the U.S.) now struggling with aortic valve stenosis. That often-disabling condition, usually caused by narrowing of the valve and resulting restriction of blood flow from the heart to the body, typically develops by age 50-70 and progresses with advancing age.
Until the recent development of the TAVI system, however, the only therapeutic alternative for patients with stenosis was open-heart surgery.
Dr. Schreiber, who was also a pioneer in developing the stent procedure for relieving blocked carotid arteries, said that the results of the just-released ACC study, organized and administered by a team of interventional cardiologists and cardiac surgeons at Columbia University, provides "powerful scientific evidence that non-invasive catheterization is superior to open-heart surgery among older patients."
SOURCE Detroit Medical Center
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