Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial

作者：Gregg W. Stone, JoAnn Lindenfeld, Josep Rodés‐Cabau, Stefan D. Anker, Michael R. Zile, Saibal Kar, Richard Holcomb, Michael Pfeiffer, Antoni Bayés‐Genís, Jeroen J. Bax, Alan J. Bank, Maria Rosa Costanzo, Stefan Verheye, Ariel Roguin, Gerasimos Filippatos, Julio Núñez, Elizabeth C. Lee, Michal Laufer‐Perl, Gil Moravsky, Sheldon E. Litwin, Edgard A. Prihadi, Hemal Gada, Eugene S. Chung, Matthew J. Price, Vinay Thohan, Dimitry Schewel, Sachin Kumar, Stephan Kische, Kevin Shah, Daniel J. Donovan, Yiran Zhang, Neal Eigler, William T. Abraham, John Gorcsan, Marrick Kukin, Kunjan Bhatt, David Shavelle, Liviu Klein, Alicia Del Carmen Becerra Romero, Garrie J. Haas, Vijay Swarup, Elizabeth Volz, F. Collado, Amit Badiye, Luanda Grazette, Michelle Hamilton, Tom McRae, Sumant Lamba, Steven K. Krueger, Timothy Byrne, Leslie A. Miller, Youssef Al-Saghir, Robin Chand, David Shavelle, Saeb F. Khoury, Ira Dauber, Sula Mazimba, Suneet Mittal, Steven Driver, Stanislav Weiner, Samir Kapadia, Priyanka Gosain, Rajeev Singh, Zvonimir Krejcer, Lynn Punnoose, Stuart Russell, Maria Karas, Gautam Kumar, Ajith Nair, Robert Widmer, Ramesh Kundur, Nabil Dib, Ugochukwu Egolum, Miguel Alvarez Villela, John Boehmer, George Petrossian, Jeffrey Teuteberg, Peter Bittenbender, Ignacio J. Amat‐Santos, Ana Maria Garcı́a, María Del Trigo, S. Mirabet, Luis Nombela‐Franco, Domingo A. Pascual‐Figal, Israel Gotsman, Wadi Kinany, Sorel Goland, Dov Freimark, Tal Hasin, Oren Caspi, Eli I. Lev, Hilmi Alnsasra, Burkhard Sievers, Mohammad Sherif, Karl Fengler, Rolf Wachter, Ince Hüseyin, Jörg Hausleiter, Ralf Stephan Von Bardeleben, Ince Hüseyin, Reda Ibrahim, Eric Horlick, Bartosz Krakowiak, Adam Witkowski, Wojciech Wojakowski, Jan Van der Heyden, Nicholas Van Mieghem, Martijn C. Post, Carmine G. De Pasquale, Frank Ruschitzka, Richard W. Troughton · 发表于：Circulation · 年份：2024 · DOI：10.1161/circulationaha.124.070870 · 被引用次数：61 · 研究领域：Cardiovascular and Diving-Related Complications、Mechanical Circulatory Support Devices、Cardiovascular Function and Risk Factors

BACKGROUND: An interatrial shunt may provide an autoregulatory mechanism to decrease left atrial pressure and improve heart failure (HF) symptoms and prognosis. METHODS: Patients with symptomatic HF with any left ventricular ejection fraction (LVEF) were randomized 1:1 to transcatheter shunt implantation versus a placebo procedure, stratified by reduced (≤40%) versus preserved (>40%) LVEF. The primary safety outcome was a composite of device-related or procedure-related major adverse cardiovascular or neurological events at 30 days compared with a prespecified performance goal of 11%. The primary effectiveness outcome was the hierarchical composite ranking of all-cause death, cardiac transplantation or left ventricular assist device implantation, HF hospitalization, outpatient worsening HF events, and change in quality of life from baseline measured by the Kansas City Cardiomyopathy Questionnaire overall summary score through maximum 2-year follow-up, assessed when the last enrolled patient reached 1-year follow-up, expressed as the win ratio. Prespecified hypothesis-generating analyses were performed in patients with reduced and preserved LVEF. RESULTS: Between October 24, 2018, and October 19, 2022, 508 patients were randomized at 94 sites in 11 countries to interatrial shunt treatment (n=250) or a placebo procedure (n=258). Median (25th and 75th percentiles) age was 73.0 years (66.0, 79.0), and 189 patients (37.2%) were women. Median LVEF was reduced (≤40%) in 206 patie...