Abstract
Chronic heart failure (HFpEF and HFrEF) remains an important area of unmet need despite current best medical therapies available. Implantable interatrial shunt devices may improve quality of life and functional capacity with favorable safety signals but require permanent implantation to maintain patency. We report the 6-month clinical outcomes of a no-implant approach to interatrial shunting across three studies: ALLEVIATE-HF-1 and ALLEVIATE-HF-2 for HFpEF, and a dedicated HFrEF study.
Patients aged ≥ 40 years, NYHA class II, III or ambulatory IV and elevated left atrial pressure (PCWP) during supine ergometry were included in the studies. Baseline assessments included echocardiography, exercise right heart catheterization, KCCQ and 6MWT. Femoral venous access and standard transseptal catheterization techniques were employed. The device was utilized to excise a segment of the interatrial septum using a pulse of radiofrequency energy to create a shunt under fluoroscopic and echocardiographic guidance.
A total of 28 HFpEF and 5 HFrEF patients were enrolled. Mean left ventricular ejection fraction was 61 ± 8% and 30 ± 8% in HFpEF and HFrEF patients, respectively. Procedures were successful with no device or procedure-related adverse events. Six-month outcomes are reported in the table. Transthoracic echocardiography and computer tomography confirmed all shunts remained patency (n=30). There were no significant changes in right-sided structure or function. No device or procedure-related serious adverse events occurred upon discharge and through 6 months.
This early feasibility clinical experience demonstrates procedural safety and feasibility of the Alleviant no-implant interatrial shunt creation with a promising efficacy signal through 6 months in patients with HFpEF and HFrEF. Enrollment for the randomized sham-controlled pivotal study (ALLAY-HF, FDA IDE approved) is currently underway.