First-In-Human Visone Heart Failure Study: Asymptomatic Diaphragmatic Stimulation For Chronic Heart Failure With Reduced Ejection Fraction: Case Report, Ana Jorbenadze, Nikoloz Shaburishvili, Michael Mirro Md, Facc, Fhrs, Faha, Michel Zuber, Paul Erne, Tamaz Shaburishvili

Parkview Heart Institute

Background

Asymptomatic Diaphragmatic Stimulation (ADS) is a novel device-based HF therapy under investigation. ADS gaited with the cardiac cycle transiently modulates intrathoracic pressure, thereby enhancing pre- and afterload, and stroke volume. It is hypothesized that ADS improves cardiac function and exercise tolerance in HFrEF patients.

Methods

HFrEF patients (15) underwent laparoscopic implantation of the VisONE ADS system (NCT03484780). Post-implant stimulation levels imperceptible to the patient are determined. At discharge, ADS therapy is turned on. Measures of cardiac function, HF status, QoL and adverse events are assessed every 3 months for 12 months.

Results

Results are presented from an initial patient …