Late-Breaking Science Abstracts and Featured Science Abstracts From the American Heart Association's Scientific Sessions 2021 and Late-Breaking Abstracts in Resuscitation Science From the Resuscitation Science Symposium 2021
Marko Banović, Svetozar Putnik, Martin Pěnička, Gheorghe Doros, Marek Deja, Radka Kočková, Martin Kotrč, Sigita Glaveckaitė, Hrvoje Gasp- Arovic, Nikola Pavlović, Lazar Velicki, Stefano Salizzoni, Wojciech Woja- Kowski, Guy Van Camp, Serge Nikolic, Bernard Iung, Jozef Bartúnek, James S. Gammie, Michael Chu, Peter Smith, Jessica Overbey, Michael J. Mack, Pierre Voisine, Markus Krane, A. Marc Gillinov, Michael E. Bowdish, Steven F. Bolling, Marissa A. Miller, Wendy C. Taddei‐Peters, Neal Jeffries, Mariell Jessup, Eric A. Rose, John C. Mullen, Stanley Chukwunonso Raymond, Ellen Moquete, Karen O’Sullivan, Mary E. Marks, Alexander Irib- Arne, Friedhelm Beyersdorf, Michael A. Borger, Arnar Geirsson, Emilia Bagi- Ella, Judy Hung, Alan J. Moskowitz, Annetine C. Gelijns, Patrick T. O’Gara, Gorav Ailawadi, Volkmar Falk, Daniel J. Goldstein, John D. Puskas, Helena Chang, Alexander Iribarne, John H. Alexander, Yuliya Vengrenyuk, Samantha Raymond, Bradley Taylor, François Dagenais, J. Michael DiMaio, Jagat Narula, Judson Williams, Juan A. Crestanello, Vin- Cent Scavo, Michael Acker, Annetine Geli- Jns, Emilia Bagiella, Emilia Bagiella, Dylan Burger 3, Bruno Caramelli 4 ; Roland Van Kimmenade 20, Richard Wainford, Bryan Williams 22, Anthony Rodgers 23
Abstract
Background: There is a class I indication for surgical aortic valve replacement (SAVR) in symptomatic patients with severe aortic stenosis (AS). However, indications for early SAVR in asymptomatic patients with severe AS and normal left ventricular function remain debated. Method: The Avatar trial is an investigator-initiated international prospective randomized controlled event-driven trial that evaluated the safety and efficacy of early SAVR in the treatment of asymptomatic patients with severe AS according to common criteria (valve area 1 cm 2 with aortic jet velocity >4 m/s or a mean transaortic gradient 40 mm Hg) and normal LV function (EF >50%). Negative exercise testing was mandatory for inclusion. The primary hypothesis was that early SAVR will reduce a primary composite endpoint comprising all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure, as compared to conservative strategy following guidelines. The trial was designed as event-driven to reach at least 35 prespecified events. The study has been performed in 9 centers in 7 European countries. Results: Between June 2015 and September 2020, 157 patients (mean age 67 years, 57% men) were randomly allocated to early surgery (n=78) or conservative treatment (n=79). Data collection, including follow-up was completed in May 2021. The overall median follow-up was 32 months: 28 months in early surgery group and 35 months in the conservative treatment group with a total of 39 events. In the early surgery group, 72 patients (92.3%) underwent SAVR. In an intention-to-treat analysis, patients randomized to conservative strategy had significantly higher incidence of primary composite endpoint (26 vs. 13 in early surgery group, HR 0.46, 95% CI 0.23-0.90, p=0.02). Freedom from HF or all-cause death was also significantly lower in conservative treatment group as compared to the early surgery group (HR 0.40, 95% CI 0.19-0.84, p=0.013). Conclusion: In asymptomatic patients with severe AS, early SAVR reduced a primary composite of all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure as compared to conservative treatment. This advocates for early aortic valve replacement once AS becomes severe regardless of symptoms.