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

作者：Marcus A. Urey, Benjamin Hibbert, Ulrich P. Jorde, Peter Eckman, Trevor Simard, Marino Labinaz, Babak Nazer, Mark Wiley, Bhanu Gupta, Andrew J. Sauer, Hirak Shah, Paul Sorajja, Andrés M. Pineda, Emil Missov, Ehtisham Mahmud, Rami Kahwash, Scott Lilly, Azeem Latib, Sandhya Murthy, Neil Fam, Santiago García, Eugene S. Chung, Liviu Klein, Richard K. Cheng, Brian A. Houston, Nicholas Amoroso, Lee Sin Chang, Sameer Gafoor, Sunit‐Preet Chaudhry, James Hermiller, Jonathan Schwartz, Lillian Aldaia, Konstantinos Koulogiannis, William A. Gray, Firas Zahr · 发表于：European Journal of Heart Failure · 年份：2024 · DOI：10.1002/ejhf.3241 · 被引用次数：13 · 研究领域：Cardiovascular Function and Risk Factors、Cardiac pacing and defibrillation studies、Cardiovascular and Diving-Related Complications

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 chan...