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Trial Results Provide Insights into TAVR for Aortic Stenosis

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John Forrest, MD, FACC, FSCAI, associate professor of medicine (cardiovascular medicine), recently shared four-year outcome results from the Evolut Low Risk Trial at the TCT (Transcatheter Cardiovascular Therapeutics) Conference. The study, which was simultaneously published in the Journal of the American College of Cardiology (JACC), compares two approaches to treating severe aortic stenosis: transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). Offering a detailed analysis over a four-year period, the trial sheds light on the effectiveness and safety of these treatments for patients with aortic stenosis.

Aortic stenosis is a common condition where the heart's aortic valve narrows and obstructs blood flow from the heart to the rest of the body. Severe aortic stenosis may require valve replacement. Although SAVR has traditionally been used to treat patients, recent clinical trials have investigated the role of TAVR as an alternative, less invasive approach.

The study, involving 1,414 patients who underwent either procedure, offers a nuanced view of the relative benefits and limitations of each approach over a four-year period. The findings showed a 26% relative reduction in the risk of death or disabling stroke in the TAVR group compared to the SAVR group.

Forrest, the study's lead author, shared insightful perspectives on this research. "This is the first study to demonstrate that newer generation TAVR valves not only appear durable when compared to surgery but may potentially offer slightly better outcomes in specific parameters such as all-cause mortality or disabling stroke," Forrest stated. "However, it's crucial to understand that each patient case is unique, and treatment decisions should be made on an individual basis."

The trial's focus on low-risk patients, who traditionally have been good candidates for surgery, marks a shift in the exploration of treatment options. "Seeing this durable benefit in low-risk patients, a group not previously the primary focus for TAVR, is significant. It opens up discussions on treatment approaches in this demographic," Forrest noted.

In the study, TAVR patients showed sustained improvement in heart function, measured by echocardiography, and had lower aortic valve mean gradients and greater effective orifice area. However, the trial also revealed a higher necessity for pacemaker implantation in the TAVR group.

The Evolut Low Risk trial is a critical contribution to the field of cardiology, especially in the treatment of aortic stenosis. Discussing the broader implications of the study, Forrest pointed out, "The results from this trial are a step forward in our understanding of TAVR, especially in low-risk populations. However, more data and ongoing research are needed before making broader recommendations, particularly for younger patients or those at lower risk."

While the results indicate certain advantages of TAVR over SAVR in specific aspects, the study also highlights the need for individualized patient evaluation and treatment planning. Forrest also highlighted the comprehensive nature of patient care. "Our approach is collaborative, involving not just interventional cardiologists but also cardiac surgeons, imaging specialists, and other professionals. This multidisciplinary team considers patient-specific anatomy and the best approach for each individual."

For more information about the study, read the article “4-Year Outcomes of Patients With Aortic Stenosis in the Evolut Low Risk Trial.”

Forrest JK, Deeb GM, Yakubov SJ, et al. 4-Year Outcomes of Patients With Aortic Stenosis in the Evolut Low Risk Trial [published online ahead of print, 2023 Oct 18]. J Am Coll Cardiol. 2023;S0735-1097(23)07628-3. doi:10.1016/j.jacc.2023.09.813

The Department of Internal Medicine at Yale School of Medicine is among the nation's premier departments, bringing together an elite cadre of clinicians, investigators, educators, and staff in one of the world's top medical schools. To learn more, visit Internal Medicine.

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Schedule17 May 2024