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
Authors: Marko Banovic, Svetozar Putnik, Martin Penicka, Gheorghe Doros, Marek Deja, Radka Kockova, Martin Kotrc, Sigita Glaveckaite, Hrvoje Gasp- Arovic, Nikola Pavlovic, Lazar Velicki, Stefano Salizzoni, Wojciech Woja- Kowski, Guy Camp, Serge Nikolic, Bernard Iung, Jozef Bartunek, James Gammie, Michael Chu, Peter Smith, Jessica Overbey, Michael Mack, Pierre Voisine, Markus Krane, A Gillinov, Michael Bowdish, Steven Bolling, Marissa Miller, Wendy Taddei-Peters, Neal Jeffries, Mariell Jessup, Eric Rose, John Mullen, Saman- Tha Raymond, Ellen Moquete, Karen O'sullivan, Mary Marks, Alexander Irib- Arne, Friedhelm Beyersdorf, Michael Borger, Arnar Geirsson, Emilia Bagi- Ella, Judy Hung, Alan Moskowitz, Annetine Gelijns, Patrick Ogara, Gorav Ailawadi, Volkmar Falk, Daniel Goldstein, John Puskas, Helena Chang, Alexander Iribarne, John Alexander, Yuliya Vengrenyuk, Samantha Raymond, Bradley Taylor, Francois Dagenais, J Dimaio, Jagat Narula, Judson Williams, Juan Crestanello, Vin- Cent Scavo, Michael Acker, Annetine Geli- Jns, Emilia Bagiella
Journal: Circulation (2021)

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.