In this episode, Dr. Roxana Mehran and Dr. Martha Gulati engage in a captivating discussion about how the SMART Trial is making a difference for women with aortic stenosis.[†,1] The SMART Trial is the largest, most rigorous clinical trial to date to randomize patients to the two most widely used TAVR devices, and to enroll predominantly women.[1] Featured faculty: Martha Gulati, MD MS FACC FAHA FASPC FESC Director of Preventive Cardiology and Professor of Cardiology, Cedars Sinai Smidt Heart Institute Associate Director, Barbra Streisand Women’s Heart Center Associate Director, Preventive and Cardiac Rehabilitation Center Anita Dann Friedman Endowed Chair in Women’s Cardiovascular Medicine & Research Roxana Mehran, MD, FACC, FESC, FAHA, MSCAI Director, Women's Heart and Vascular Center at Mount Sinai Fuster Heart Hospital Director, The Center for Interventional Cardiovascular Research and Clinical Trials Professor of Medicine (Cardiology) and Population Health Science and Policy, Icahn School of Medicine at Mount Sinai Disclosures: Faculty for this event are consultants for Medtronic and compensated for this event. Dr. Gulati: I serve on advisory boards for Novartis, Esperion, New Amsterdam and Medtronic. I serve on a DSMB for Merck. All except Medtronic unrelated to our discussion Dr. Mehran reports institutional research payments from: Abbott, Alleviant Medical, Beth Israel Deaconess Medical Center, Concept Medical, Cordis, Elixir Medical, Faraday Pharmaceuticals, Idorsia Pharmaceuticals, Janssen, MedAlliance, Mediasphere Medical, Medtronic, Novartis, Protembis GmbH, RM Global Bioaccess Fund Management, Sanofi US Services, Inc. ; Personal fees from: Elixir Medical, IQVIA, Medtronic, Medscape/WebMD Global, NovoNordisk ; Equity 1% in: Elixir Medical, Stel, ControlRad (spouse) ; No Fees from: SCAI (Women in Innovations Committee Member), Faculty Cardiovascular Research Foundation (CRF), Women as One (Founding Director) ; Honorarium: AMA - JAMA Cardiology (Associate Editor), ACC (BOT Member, SC Member CTR Program) TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. †Evolut™ TAVR is indicated to treat patients who have been diagnosed with symptomatic severe aortic stenosis. 1. Tchétché D, Mehran R, Blackman DJ, et al. Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. Published online October 9, 2024. The Medtronic CoreValve™ Evolut™ R, Evolut™ PRO+, and Evolut™ FX Systems are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The Medtronic CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (e.g., STS predicted risk of operative mortality score ≥ 8% or at a ≥ 15% risk of mortality at 30 days).
