Results from early clinical evaluation of the Alleviant System to treat heart failure patients with preserved and reduced ejection fraction (HFpEF and HFrEF) was presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions. This multi-center evaluation across three trial programs (ALLEVIATE-HF-1, HF-2 and HFrEF) demonstrated procedural safety and feasibility with a promising efficacy signal through six months.
Impacting more than 26 million people worldwide, heart failure occurs when the heart muscle is unable to pump effectively enough to meet the body’s need for blood and oxygen (NLM). Currently guidelines recommend medical therapy for heart failure patients with HFpEF and HFrEF, however some remain symptomatic despite optimal medical therapy. The Alleviant System is a transcatheter technology intended to reduce pressure within the left atrium through the creation of a therapeutic interatrial shunt without a permanent cardiac implant or open-heart surgery.
Patients aged ≥ 40 years, New York Heart Association (NYHA) class II, III or ambulatory IV with elevated peak exercise PCWP were included in the study. Baseline screening included echocardiography, exercise right heart catheterization, KCCQ and 6MWT. Following a transseptal puncture, the Alleviant device was inserted through the femoral vein (located near the groin), advanced to the heart and supplied with a short pulse of radiofrequency energy in order to remove a segment of the interatrial septum – a thin wall of tissue that separates the right and left atria of the heart. Procedures were performed under fluoroscopic and echocardiographic guidance.