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;26(4):1065-1077. doi: 10.1002/ejhf.3241. Epub 2024 Apr 12.

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.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Cardiac Catheterization / methods
  • Coronary Sinus* / physiopathology
  • Echocardiography / methods
  • Feasibility Studies*
  • Female
  • Follow-Up Studies
  • Heart Atria* / diagnostic imaging
  • Heart Atria* / physiopathology
  • Heart Failure* / physiopathology
  • Heart Failure* / surgery
  • Heart Failure* / therapy
  • Hemodynamics / physiology
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Stroke Volume* / physiology
  • Treatment Outcome
  • Ventricular Function, Left / physiology

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