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A multicenter clinical trial showed that transcatheter aortic valve (TAVR) replacement was more effective than open-heart surgery in low-risk patients with severe aortic stenosis. The study found that one year after the intervention, the death, stroke or rehospitalization rate was significantly lower with the TAVR than during an intervention surgical.
The findings were presented at the latest clinical trials session of the American College of Cardiology Conference in New Orleans and were published simultaneously online in New England Journal of Medicine.
"When TAVR was introduced, it was considered an alternative for patients too sick to undergo open-heart surgery.The current results suggest that TAVR could be superior to surgery, even for patients with low operative risk", said Martin B. Leon. , MD, professor of medicine at the Columbia College of Physicians and Surgeons Vagelos, director of the Center for Interventional Vascular Therapy at New York-Presbyterian / Columbia Medical Center, Columbia University, and principal investigator of the trial.
In the United States, about 5 million adults suffer from aortic stenosis – a build-up of calcium in the aortic valve that can lead to heart failure. Previously, patients had to undergo open-heart surgery to have the valve replaced. But many of those most in need of valve replacement were too sick or too fragile to undergo surgery.
For almost ten years, TAVR has been a less invasive option for these patients. In the TAVR, doctors introduce a catheter into the groin and into the heart through an artery, so that a new aortic valve can be installed inside the diseased valve without opening surgically. the thorax.
Since the beginning of its introduction in the mid-2000s, no less than 400,000 patients worldwide have had a TAVR.
The first PARTNER (Placement of AoRtic TraNscathetER) trial, published in 2010 and led by Leon, found that this procedure significantly reduced the risk of death in inoperable patients – less than 10% of those with severe aortic stenosis – compared to those medically treated; In subsequent PARTNER trials, published in 2011 and 2016, TAVR is also found to be effective for patients at high or intermediate risk of death or serious complications due to surgery.
But the researchers did not know how TAVR would compare to surgery in the vast majority of patients considered good candidates for open surgery. In the new PARTNER 3 study, researchers recruited 1,000 patients from 71 centers with severe aortic stenosis and an operating risk of less than 2% (surgical risk below 4% is considered low). Patients were randomized to TAVR with replacement of SAPIEN 3 expandable balloon valve or surgical aortic valve replacement.
One year after the intervention, 42 patients (8.5%) of the TAVR group had died, had a stroke or had been hospitalized for a heart problem or a surgical complication, compared to 68 patients (15.1% ) of the 46% reduction group.
After 30 days, patients with RVAC had fewer recent strokes and atrial fibrillation cases than patients who had surgery. The average duration of hospitalization was shorter in patients with RVAC (3 days vs 7 days for operated patients).
"The main limitation of the study lies in the fact that the current results reflect results after one year, which is not long enough to badess the long-term durability of the replacement valve," he said. said Leon. "Patients in the study will be followed for at least 10 years so that we can measure their long-term results and inform the medical community."
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About paper
The document entitled "Replacement of aortic valve by catheter with expandable balloon valve in low-risk patients" and was published online in New England Journal of Medicine.
The authors are Michael Mack (Baylor, Scott and White, Plano, Texas), Vinod Thourani (Georgetown University, Washington, DC), Martin Leon (Irving Medical Center of Columbia University and New York-Presbyterian), Raj Makkar (Cedars-Sinai Heart Institute, Los Angeles, CA), Susheel Kodali (CUIMC and New York-Presbyterian), Mark Russo (Rutgers University, New Brunswick, NJ), Samir Kapadia (CUIMC and New York-Presbyterian), S. Chris Malaisrie (Northwestern University, Chicago, IL)), David Cohen (St. Luke Mid-America Heart Institute, Kansas City, Missouri), Phillippe Pibarot (Laval University, Quebec, Canada), Jonathan Leipsic (University of Colombia Columbia, Vancouver, Canada), Rebecca Hahn (CUIMC and NewYork-Presbyterian), Philipp Blanke (University of British Columbia), Matthew Williams (Langone Medical Center, New York University, New York, NY), James McCabe (Washington University, Seattle), David Brown (Baylor, Scott t White), Vasilis Babaliaros (Emory University Hospital, Atlanta, Georgia), Scott G oldman (Lankenau Medical Center, Wynnewood PA), Wilson Szeto (University of Pennsylvania Hospital, Philadelphia, PA), Philippe Genereux ( Morristown Medical Center, Morristown, NJ), Ashish Pershad (Banner University Medical Center, Phoenix, AZ), Stuart Pobad (London School of Hygiene and Tropical Medicine, London, England), Maria Alu (CUIMC and New York-Presbyterian), John Webb (University of British Columbia) and Craig Smith (CUIMC and NewYork-Presbyterian).
The trial was funded by Edwards Lifesciences.
Information about the Columbia University Irving Medical Center authors and New York-Presbyterian writers is available online in the journal.
The Irving Medical Center at Columbia University provides international leadership in the areas of basic, preclinical and clinical research; teaching of medical and health sciences; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists and nurses from the College of Physicians and Surgeons Vagelos, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and related research centers and institutions. The Irving Medical Center at Columbia University is home to the largest medical research enterprise in the city and state of New York and one of the Northeast's largest faculty clinics. For more information, visit cuimc.columbia.edu or columbiadoctors.org.
NewYork-Presbyterian
NewYork-Presbyterian is one of the most comprehensive and integrated academic health care delivery systems in the country. His organizations are dedicated to providing the highest quality and compbadionate care and services to patients in the Greater New York area, nationally and around the world. In collaboration with two renowned medical schools, Weill Cornell Medicine and the College of Physicians and Surgeons Vagelos of Columbia University, New York-Presbyterian is still recognized as a leader in medical education, innovative research and innovative, patient-centered clinical care.
NewYork-Presbyterian has four main divisions:
- The New York-Presbyterian Hospital is ranked No. 1 in the New York metropolitan area by the US News and World Report and is repeatedly featured on the Honor Roll of "Best Hospitals in America".
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