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

Marcus A Urey; Benjamin Hibbert; Ulrich Jorde; Peter Eckman; Trevor Simard; Marino Labinaz; Babak Nazer; Mark Wiley; Bhanu Gupta; Andrew Sauer; Hirak Shah; Paul Sorajja; Andres M Pineda; Emil Missov; Ehtisham Mahmud; Rami Kahwash; Scott Lilly; Azeem Latib; Sandhya Murthy; Neil Fam; Santiago Garcia; Eugene S Chung; Liviu Klein; Richard Cheng; Brian A Houston; Nicholas S Amoroso; Lee Chang; Sameer Gafoor; Sunit-Preet Chaudhry; James Hermiller; Jonathan G Schwartz; Lillian Aldaia; Konstantinos Koulogiannis; William A Gray; Firas Zahr

doi:10.1002/ejhf.3241

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

Eur J Heart Fail. 2024 Apr 12. doi: 10.1002/ejhf.3241. Online ahead of print.

Authors

Marcus A Urey¹, Benjamin Hibbert^{2

3}, Ulrich Jorde⁴, Peter Eckman⁵, Trevor Simard², Marino Labinaz³, Babak Nazer⁶, Mark Wiley⁷, Bhanu Gupta⁸, Andrew Sauer⁹, Hirak Shah⁷, Paul Sorajja⁵, Andres M Pineda¹⁰, Emil Missov¹¹, Ehtisham Mahmud¹, Rami Kahwash¹², Scott Lilly¹², Azeem Latib⁴, Sandhya Murthy⁴, Neil Fam¹³, Santiago Garcia¹⁴, Eugene S Chung¹⁵, Liviu Klein¹⁶, Richard Cheng¹⁷, Brian A Houston¹⁸, Nicholas S Amoroso¹⁸, Lee Chang¹⁹, Sameer Gafoor^{19

20}, Sunit-Preet Chaudhry²¹, James Hermiller²¹, Jonathan G Schwartz²², Lillian Aldaia²³, Konstantinos Koulogiannis²³, William A Gray²⁴, Firas Zahr²⁵

Affiliations

¹ Division of Cardiovascular Medicine, University of California San Diego, La Jolla, CA, USA.
² Department of Cardiovascular Medicine, Mayo Clinic, Rochester, MN, USA.
³ CAPITAL Research, Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, ON, Canada.
⁴ Division of Cardiology, Montefiore Medical Center, Albert Einstein College of Medicine, The Bronx, NY, USA.
⁵ Department of Cardiology, Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, MN, USA.
⁶ Division of Cardiology, University of Washington Medical Center.
⁷ Cardiovascular Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
⁸ Virginia Mason Franciscan Health, Seattle, WA, USA.
⁹ Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
¹⁰ Division of Cardiology, Duke University Medical Center, Durham, NC, USA.
¹¹ Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA.
¹² Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.
¹³ St. Michael's Hospital Unity Health, Toronto, ON, Canada.
¹⁴ The Christ Hospital and The Carl and Edyth Lindner Center for Research and Education, Cincinnati, OH, USA.
¹⁵ Lindner Research Center at The Christ Hospital, Cincinnati, OH, USA.
¹⁶ Advanced Heart Failure Comprehensive Care Center, Division of Cardiology, University of California San Francisco, San Francisco, CA, USA.
¹⁷ Division of Cardiovascular Medicine, University of California San Francisco, San Francisco, CA, USA.
¹⁸ Division of Cardiology, Medical University of South Carolina, Charleston, SC, USA.
¹⁹ Swedish Heart and Vascular, Seattle, WA, USA.
²⁰ Cardiovascular Center Frankfurt, Frankfurt, Germany.
²¹ Ascension St. Vincent Heart Center, Indianapolis, Indiana and Ascension St. Vincent Cardiovascular Research Institute, Indianapolis, IN, USA.
²² Sanger Heart & Vascular Institute, Atrium Health, Charlotte, NC, USA.
²³ Department of Cardiovascular Medicine, Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA.
²⁴ Lankenau Heart Institute, Wynnewood, PA, USA.
²⁵ Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR, USA.

PMID: 38606485
DOI: 10.1002/ejhf.3241

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.

Keywords: Atrial shunt; HFpEF; Heart failure.

Grants and funding

Edwards Lifesciences