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2-Year Outcomes of an Atrial Shunt Device in HFpEF/HFmrEF: Results From REDUCE LAP-HF II.
Gustafsson, Finn; Petrie, Mark C; Komtebedde, Jan; Swarup, Vijendra; Winkler, Sebastian; Hasenfuß, Gerd; Borlaug, Barry A; Mohan, Rajeev C; Flaherty, James D; Sverdlov, Aaron L; Fail, Peter S; Chung, Eugene S; Lurz, Philipp; Lilly, Scott; Kaye, David M; Cleland, John G F; Cikes, Maja; Leon, Martin B; Cutlip, Donald E; van Veldhuisen, Dirk J; Solomon, Scott D; Shah, Sanjiv J.
Afiliação
  • Gustafsson F; Rigshospitalet, University of Copenhagen, Denmark. Electronic address: finn.gustafsson@regionh.dk.
  • Petrie MC; British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland, United Kingdom.
  • Komtebedde J; Corvia Medical, Inc, Tewksbury, Massachusetts, USA.
  • Swarup V; Arizona Heart and Rhythm Center, Phoenix, Arizona, USA.
  • Winkler S; B.G. Klinikum Unfallkrankenhaus, Berlin, Germany.
  • Hasenfuß G; Heart Center, University Medical Center, Göttingen, Germany.
  • Borlaug BA; Mayo Clinic, Rochester, Minnesota, USA.
  • Mohan RC; Scripps Health, La Jolla, California, USA.
  • Flaherty JD; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
  • Sverdlov AL; John Hunter Hospital, University of Newcastle, New Lambton Heights, Australia.
  • Fail PS; Cardiovascular Institute of the South, Houma, Louisiana, USA.
  • Chung ES; The Lindner Research Center at The Christ Hospital, Cincinnati, Ohio, USA.
  • Lurz P; Cardiology Center, University Medical Center, Johannes Gutenberg University, Mainz, Germany.
  • Lilly S; Ohio State University, Columbus, Ohio, USA.
  • Kaye DM; Alfred Hospital, Melbourne, Australia.
  • Cleland JGF; British Heart Foundation Centre of Research Excellence, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, Scotland, United Kingdom.
  • Cikes M; University of Zagreb School of Medicine, University Hospital Centre Zagreb, Zagreb, Croatia.
  • Leon MB; Cardiovascular Research Foundation, New York, New York, USA.
  • Cutlip DE; Baim Clinical Research Institute, Boston, Massachusetts, USA.
  • van Veldhuisen DJ; University Medical Center Groningen, Groningen, the Netherlands.
  • Solomon SD; Brigham and Women's Hospital, Boston, Massachusetts, USA.
  • Shah SJ; Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA. Electronic address: sanjiv.shah@northwestern.edu.
JACC Heart Fail ; 12(8): 1425-1438, 2024 Aug.
Article em En | MEDLINE | ID: mdl-38934964
ABSTRACT

BACKGROUND:

The REDUCE LAP-HF II (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II) trial found that, compared with a sham procedure, the Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction. However, after 12-month follow-up, "responders" (peak-exercise pulmonary vascular resistance <1.74 WU and absence of a cardiac rhythm management device) were identified.

OBJECTIVES:

This study sought to determine 1) the overall efficacy and safety of the atrial shunt vs sham control after 2 years of follow-up; and 2) whether the benefits of atrial shunting are sustained in responders during longer-term follow-up or are offset by adverse effects of the shunt.

METHODS:

The study analyzed 2-year outcomes in the overall REDUCE LAP-HF II trial, as well as in responder and nonresponder subgroups. The primary endpoint was a hierarchical composite of cardiovascular death or nonfatal ischemic/embolic stroke, total heart failure events, and change in health status.

RESULTS:

In 621 randomized patients, there was no difference between the shunt (n = 309) and sham (n = 312) groups in the primary endpoint (win ratio 1.01 [95% CI 0.82-1.24]) or its individual components at 2 years. Shunt patency at 24 months was 98% in shunt-treated patients. Cardiovascular mortality and nonfatal ischemic stroke were not different between the groups; however, major adverse cardiac events were more common in those patients assigned to the shunt compared with sham (6.9% vs 2.7%; P = 0.018). More patients randomized to the shunt had an increase in right ventricular volume of ≥30% compared with the sham control (39% vs 28%, respectively; P < 0.001), but right ventricular dysfunction was uncommon and not different between the treatment groups. In responders (n = 313), the shunt was superior to sham (win ratio 1.36 [95% CI 1.02-1.83]; P = 0.037, with 51% fewer HF events [incidence rate ratio 0.49 [95% CI 0.25-0.95]; P = 0.034]). In nonresponders (n = 265), atrial shunting was inferior to sham (win ratio 0.73 [95% CI 0.54-0.98]).

CONCLUSIONS:

At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group. The potential clinical benefit identified in the responder group after 1 and 2 years of follow-up is currently being evaluated in the RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure) trial. (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II [REDUCE LAP-HF II]; NCT03088033).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Volume Sistólico / Átrios do Coração / Insuficiência Cardíaca Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JACC Heart Fail Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Volume Sistólico / Átrios do Coração / Insuficiência Cardíaca Limite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: JACC Heart Fail Ano de publicação: 2024 Tipo de documento: Article