Clinical Trial Concludes Transcatheter Aortic Valve Replacement Can Be Considered for Patients in All Surgical Risk Classes
TAVR, previously studied in higher-risk patients, also shows promise for low-risk surgical patients, according to a clinical trial presented at AATS 99th Annual Meeting
TORONTO – May 6, 2019 – Transcatheter aortic valve replacement (TAVR) has been studied as an alternative to surgical aortic valve replacement in high and intermediate-risk surgical patients for more than five years. A new clinical trial, one of two studies on the topic presented today at the American Association for Thoracic Surgery’s 99thAnnual Meeting, finds the procedure to be equivalent or potentially preferable to surgical aortic valve replacement (SAVR) for low risk patients.
The international, multicenter, clinical trial enrolled over 1400 patients with severe aortic stenosis at low risk for surgical mortality, as determined by local multidisciplinary heart team assessment. Patients were randomized 1:1 to surgery with an aortic valve of the surgeon’s choice or TAVR with a supra-annular self-expanding valve. Endpoints included death from any cause or disabling stroke at 24 months, as well as quality of life and functional recovery at 30 days. Time from procedure to discharge was also measured.
Periprocedural outcomes for both SAVR and TAVR patient categories were equivalently positive, with strong post-procedure benefits for TAVR patients. Of the patients in the study treated with TAVR, only one percent were performed through non-femoral access in the groin. TAVR patients also had fewer re-hospitalizations. Also, TAVR had improved quality of life metrics at 30-days, as did sternal-sparing SAVR, compared to traditional sternotomy SAVR.
According to lead author Dr. Basel Ramlawi, Chairman and Cardiothoracic Surgeon, Heart & Vascular Center at Valley Health, “Anytime you have an equivalent safety and efficacy for a less invasive procedure, the benefits to patients in terms of recovery are superior. For self-expanding TAVR, outcomes were superior to SAVR for many endpoints. With fairly rapid improvements in TAVR technology, we can expect to continue to see improvements in outcomes for patients as the technology matures.”
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Notes for Editors:
Causes of death and periprocedural recovery following transcatheter or surgical aortic valve replacement in patients at low surgical risk for mortality*Basel Ramlawi1, Michael Deeb2, Jeffery J Popma3, Steven J Yakubov4, Michael Reardon5 1Valley Health System, Winchester, VA;2University of Michigan Hospitals, Ann Arbor, MI;3Beth Israel Deaconess Medical Center, Boston, MA;4Riverside Methodist – Ohio Health, Columbus, OH;5Methodist DeBakey Heart and Vascular Center, Houston, TX
Presented by Dr. Basel Ramlawi, Monday, May 6, 2019 at the AATS 99th Annual Meeting.
ABOUT THE AMERICAN ASSOCIATION FOR THORACIC SURGERY (AATS)
The American Association for Thoracic Surgery (AATS) is an international organization that encourages, promotes, and stimulates the scientific investigation of cardiothoracic surgery. Founded in 1917 by a respected group of the earliest pioneers in the field, its original mission was to “foster the evolution of an interest in surgery of the Thorax.” Today, the AATS is the premiere association for cardiothoracic surgeons in the world and works to continually enhance the ability of cardiothoracic surgeons to provide the highest quality of patient care. Its more than 1500 members have a proven record of distinction within the specialty and have made significant contributions to the care and treatment of cardiothoracic disease. Visit www.aats.org to learn more.