Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure
Benjamin Hibbert, Firas Zahr, Trevor Simard, Marino Labinaz, Babak Nazer, Paul Sorajja, Peter Eckman, Andrés M. Pineda, Emil Missov, Ehtisham Mahmud, Jonathan Schwartz, Bhanu Gupta, Mark Wiley, Andrew J. Sauer, Ulrich P. Jorde, Azeem Latib, Rami Kahwash, Scott Lilly, Lee Chang, Sameer Gafoor, Sunit‐Preet Chaudhry, James Hermiller, Lillian Aldaia, Konstantinos Koulogiannis, William A. Gray
Abstract
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.