Marcus A Urey, Benjamin Hibbert, Ulrich Jorde, Peter Eckman, Trevor Simard, Marino Labinaz, Babak Nazer, Mark Wiley, Bhanu Gupta, Andrew Sauer, Hirak Shah, Paul Sorajja, Andres M Pineda, Emil Missov, Ehtisham Mahmud, Rami Kahwash, Scott Lilly, Azeem Latib, Sandhya Murthy, Neil Fam, Santiago Garcia, Eugene S Chung, Liviu Klein, Richard Cheng, Brian A Houston, Nicholas S Amoroso, Lee Chang, Sameer Gafoor, Sunit-Preet Chaudhry, James Hermiller, Jonathan G Schwartz, Lillian Aldaia, Konstantinos Koulogiannis, William A Gray, Firas Zahr
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)...
April 12, 2024: European Journal of Heart Failure