Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.

BACKGROUND

Heart failure (HF) is associated with both mortality and a significant decline in health status. Interatrial shunting is increasingly being investigated as a novel therapeutic option.

OBJECTIVES

The ALT FLOW Early Feasibility Study was designed to evaluate the safety of the Edwards left atrial to coronary sinus APTURE Transcatheter Shunt System in patients with symptomatic HF.

METHODS

A total of 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure >15 mm Hg at rest or 25 mm Hg during exercise.

RESULTS

Between May 2018 and September 2022, 87 patients underwent attempted APTURE shunt implantation. Mean age was 71 years, and 53% were male. At baseline, mean left ventricular ejection fraction was 59% with 90% of the patients being in NYHA functional class III. Device success was achieved in 78 patients (90%), with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 patients (2.3%) at 30 days. At 6 months, health status improved: 67% of participants achieved NYHA functional class I to II status, with a 23-point improvement (P < 0.0001; 95% CI: 17-29 points) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-W exercise pulmonary capillary wedge pressure was 7 mm Hg lower (P < 0.0001; 95% CI: -11 to -4 mm Hg) without change in right atrial pressure or other right heart function indices.

CONCLUSIONS

In this single-arm experience, the APTURE Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in pulmonary capillary wedge pressure and clinically meaningful improvements in HF symptoms and quality of life indices.

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This study was funded by Edwards Lifesciences, who also directed the design and conduct of the study, the collection, analysis, and interpretation of the data with input from their lead investigators. Dr Hibbert has received institutional research support from Abbott, NXT, Edwards Lifesciences, Boston Scientific, and Occlutech. Dr Zahr is a consultant to Edwards Lifesciences and Medtronic; and has received research and educational grants from Edwards Lifesciences, Medtronic, and Siemens. Dr Simard is a consultant to Boston Scientific; and has received research support from Edwards Lifesciences. Dr Nazer is a consultant to Boston Scientific and Biosense Webster; and has received investigator-initiated research funding from Siemens and Galaxy Medical. Dr Sorajja has served on advisory boards for 4C Medical, Abbott Vascular Structural, Boston Scientific SHV Strategic Advisory Board, Medtronic Structural Advisory Board, and VDyne; and is a consultant to 4C Medical, Anteris, Abbott Structural, Boston Scientific, Edwards Lifesciences, Evolution Medical, Foldax, GLG, Medtronic, Phillips, Siemens, Shifamed, WL Gore, VDyne, and xDot. Dr Pineda is a consultant to Cardiovascular Systems, Inc. Dr Schwartz has been a consultant for Abbott Vascular Structural, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, WL Gore, Cordis; serves on advisory boards for Medtronic, Boston Scientific, Edwards Lifesciences, and Cordis; and has received research funding from Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, Philips, WL Gore, and Cordis. Dr Wiley is a consultant to Edwards Lifesciences. Dr Sauer has received speaker or consulting honoraria from Edwards Lifesciences, Abbott, Boston Scientific, Biotronik, Medtronic, Bayer, General Prognostics, Impulse Dynamics, and Story Health. Dr Jorde is a consultant to Abbott, Edwards Lifesciences, and AncoraHeart. Dr Latib is a consultant for Edwards Lifesciences, Abbott Vascular, Medtronic, Boston Scientific, and Philips. Dr Kahwash is a consultant and serves on advisory boards for Medtronic, Cardionomic, and Impulsedynamics. Dr Gafoor is a consultant to Edwards Lifesciences, Abbott Lifesciences, and Boston Scientific. Dr Chaudhry has received speaker honoraria from Medtronic; and consultation fees from Edwards Lifesciences. Dr. Hermiller is a consultant to Edwards Lifesciences. Drs Aldaia and Koulogiannis are members of a cardiovascular core lab, for which they receive no direct compensation, that has agreements with Edwards Lifesciences, Abbott, Medtronic, and NXT Biomedical. Dr Koulogiannis is also a consultant to Edwards Lifesciences and Abbott; and serves on an advisory board for Edwards Lifesciences. Dr Gray is a consultant to Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.