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Left atrial to coronary sinus shunting for treatment of heart failure with mildly reduced or preserved ejection fraction: The ALT FLOW Early Feasibility Study 1-year results.
Urey, Marcus A; Hibbert, Benjamin; Jorde, Ulrich; Eckman, Peter; Simard, Trevor; Labinaz, Marino; Nazer, Babak; Wiley, Mark; Gupta, Bhanu; Sauer, Andrew; Shah, Hirak; Sorajja, Paul; Pineda, Andres M; Missov, Emil; Mahmud, Ehtisham; Kahwash, Rami; Lilly, Scott; Latib, Azeem; Murthy, Sandhya; Fam, Neil; Garcia, Santiago; Chung, Eugene S; Klein, Liviu; Cheng, Richard; Houston, Brian A; Amoroso, Nicholas S; Chang, Lee; Gafoor, Sameer; Chaudhry, Sunit-Preet; Hermiller, James; Schwartz, Jonathan G; Aldaia, Lillian; Koulogiannis, Konstantinos; Gray, William A; Zahr, Firas.
Afiliación
  • Urey MA; Division of Cardiovascular Medicine, University of California San Diego, La Jolla, CA, USA.
  • Hibbert B; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
  • Jorde U; CAPITAL Research, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, ON, Canada.
  • Eckman P; Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY, USA.
  • Simard T; Department of Cardiology, Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN, USA.
  • Labinaz M; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
  • Nazer B; CAPITAL Research, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, ON, Canada.
  • Wiley M; Division of Cardiology, University of Washington Medical Center.
  • Gupta B; Cardiovascular Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
  • Sauer A; Virginia Mason Franciscan Health, Seattle, WA, USA.
  • Shah H; Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
  • Sorajja P; Cardiovascular Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
  • Pineda AM; Department of Cardiology, Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN, USA.
  • Missov E; Division of Cardiology, Duke University Medical Center, Durham, NC, USA.
  • Mahmud E; Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
  • Kahwash R; Division of Cardiovascular Medicine, University of California San Diego, La Jolla, CA, USA.
  • Lilly S; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.
  • Latib A; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.
  • Murthy S; Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY, USA.
  • Fam N; Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY, USA.
  • Garcia S; St. Michael's Hospital Unity Health, Toronto, ON, Canada.
  • Chung ES; The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education, Cincinnati, OH, USA.
  • Klein L; Lindner Research Center at The Christ Hospital, Cincinnati, OH, USA.
  • Cheng R; Advanced Heart Failure Comprehensive Care Center, Division of Cardiology, University of California San Francisco, San Francisco, CA, USA.
  • Houston BA; Division of Cardiovascular Medicine, University of California San Francisco, San Francisco, CA, USA.
  • Amoroso NS; Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.
  • Chang L; Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.
  • Gafoor S; Swedish Heart and Vascular, Seattle, WA, USA.
  • Chaudhry SP; Swedish Heart and Vascular, Seattle, WA, USA.
  • Hermiller J; Cardiovascular Center Frankfurt, Frankfurt, Germany.
  • Schwartz JG; Ascension St. Vincent Heart Center, Indianapolis, Indiana and Ascension St. Vincent Cardiovascular Research Institute, Indianapolis, IN, USA.
  • Aldaia L; Ascension St. Vincent Heart Center, Indianapolis, Indiana and Ascension St. Vincent Cardiovascular Research Institute, Indianapolis, IN, USA.
  • Koulogiannis K; Sanger Heart & Vascular Institute, Atrium Health, Charlotte, NC, USA.
  • Gray WA; Department of Cardiovascular Medicine, Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA.
  • Zahr F; Department of Cardiovascular Medicine, Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA.
Eur J Heart Fail ; 26(4): 1065-1077, 2024 Apr.
Article en En | MEDLINE | ID: mdl-38606485
ABSTRACT

AIMS:

Patients with heart failure and mildly reduced or preserved ejection fraction have limited therapeutic options. The ALT-FLOW Early Feasibility Study evaluated safety, haemodynamics and outcomes for the APTURE transcatheter shunt system, a novel left atrium to coronary sinus shunt in these patients. METHODS AND

RESULTS:

Safety and shunt implantation success was evaluated for all 116 enrolled patients. An analysis population of implanted patients with a left ventricular ejection fraction (LVEF) >40% (n = 95) was chosen to assess efficacy via paired comparison between baseline and follow-up haemodynamic (3 and 6 months), and echocardiographic, clinical and functional outcomes (6 months and 1 year). Health status and quality of life outcomes were assessed using the Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS). The primary safety endpoint, major adverse cardiac, cerebral, and renal events, and reintervention through 30 days, occurred in 3/116 patients (2.6%). All implanted shunts were patent at 1 year. In patients with LVEF >40%, the mean (95% confidence interval) reduction in exercise pulmonary capillary wedge pressure (PCWP) at 20 W was -5.7 (-8.6, -2.9) mmHg at 6 months (p < 0.001). At baseline, 8% had New York Heart Association class I-II status and improved to 68% at 1 year (p < 0.001). KCCQ-OSS at baseline was 39 (35, 43) and improved at 6 months and 1 year by 25 (20-30) and 27 (22-32) points, respectively (both p < 0.0001). No adverse changes in haemodynamic and echocardiographic indices of right heart function were observed at 1 year. Overall, the reduction in PCWP at 20 W and improvement in KCCQ-OSS in multiple subgroups were consistent with those observed for the entire population.

CONCLUSIONS:

In patients with heart failure and LVEF >40%, the APTURE shunt demonstrated an acceptable safety profile with significant sustained improvements in haemodynamic and patient-centred outcomes, underscoring the need for further evaluation of the APTURE shunt in a randomized trial.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Volumen Sistólico / Estudios de Factibilidad / Seno Coronario / Atrios Cardíacos / Insuficiencia Cardíaca Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Heart Fail Asunto de la revista: CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Volumen Sistólico / Estudios de Factibilidad / Seno Coronario / Atrios Cardíacos / Insuficiencia Cardíaca Límite: Aged / Female / Humans / Male / Middle aged Idioma: En Revista: Eur J Heart Fail Asunto de la revista: CARDIOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido