Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure.
JACC Cardiovasc Interv
washington; swedish; swedish heart
Background: Heart failure (HF) is associated with both mortality and a significant decline in health status. Inter-atrial 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 APTURETM Transcatheter Shunt System in patients with symptomatic HF.
Methods: 18 centers enrolled patients with symptomatic HF with a pulmonary capillary wedge pressure (PCWP) >15mmHg at rest or 25mmHg during exercise.
Results: Between May 2018 and September 2022, 87 patients underwent attempted APTURETM shunt implantation. Mean age was 71 years, and 53% were male. At baseline mean LVEF was 59% with 90% of the patients being NYHA III. Device success was achieved in 78 (90%) of patients with no device occlusions or associated adverse events identified after implantation. The primary safety outcome occurred in only 2 (2.3%) patients at 30 days. At 6 months health status improved: 68% of participants achieved NYHA I-II status, with a 23-point improvement (p<0.0001, 95% CI [17, 29]) in the Kansas City Cardiomyopathy Questionnaire overall summary score. Also at 6 months, 20-watt exercise pulmonary capillary wedge pressure was -7mmHg lower (p<0.0001, 95% CI [-11, -4]) without change in right atrial pressure or other right heart function indices.
Conclusions: In this single-arm experience, the APTURETM Transcatheter Shunt System in patients with symptomatic HF was observed to be safe and resulted in reduction in PCWP and clinically meaningful improvements in HF symptoms and quality of life indices.
Keywords: HFpEF; HFrEF; atrial shunting; coronary sinus; heart failure; inter-atrial shunting; left atrial.
Hibbert, Benjamin; Zahr, Firas; Simard, Trevor; Labinaz, Marino; Nazer, Babak; Sorajja, Paul; Eckman, Peter; Pineda, Andres M; Missov, Emil; Mahmud, Ehtisham; Schwartz, Jonathan; Gupta, Bhanu; Wiley, Mark; Sauer, Andrew; Jorde, Ulrich; Latib, Azeem; Kahwash, Rami; Lilly, Scott; Chang, Lee; Gafoor, Sameer; Chaudhry, Sunit-Preet; Hermiller, James; Aldaia, Lillian; Koulogiannis, Konstantinos; Gray, William A; and ALTFLOW investigators, "Left Atrial to Coronary Sinus Shunting for Treatment of Symptomatic Heart Failure." (2023). Articles, Abstracts, and Reports. 7279.