Cardiac Autonomic Nerves Stimulation Improves Hemodynamics and Clinical Status in Advanced Heart Failure Patients

Abstract

Despite heart failure therapy advances, symptomatic congestion and low cardiac output in acute heart failure is a leading cause of mortality and morbidity. The purpose of this study was to investigate transvenous cardiac autonomic nerve stimulation (CANS) effects on in-hospital hemodynamics and clinical status. The study was a single-center, open label, clinical investigation of CANS. Twenty two subjects with LVEF <40% and at least two signs and symptoms of congestion were consented and enrolled. A purpose-built electrical stimulation catheter was placed in the left brachiocephalic vein via left subclavian vein access and connected to a purpose-built bedside neurostimulator used to deliver CANS therapy in-hospital for up to 96 hrs. The subjects had a mean baseline NT-proBNP of 10,518 pg/mL, LVEF of 25%, pulmonary capillary wedge pressure (PCWP) of 20 mmHg and presented with symptoms. CANS therapy was provided for a mean duration of 70 hrs. There were no device or study related adverse events reported. During CANS therapy mean cardiac index increased (1.8 to 2.0 L/min./m2), mean systemic vascular resistance decreased (24 to 20 WU), and mean PCWP decreased (20 to 14 mmHg) with stable MAP and HR. At discharge, mean edema pitting score improved 2 points, mean 6 minute hall walk distance (6MHW) increased 92 m and mean KCCQ-12 increased 12 points. At 30 day follow-up, edema pitting score improved 3 points, 6MHW increased 102 m and mean KCCQ-12 improved 38 points from baseline. Hemodynamic and clinical improvements occurred in the presence of stable medical management. Patients received at least 80 mg/day of furosemide, had minimal change to existing heart failure medical management, received no new IV vasoactive therapies, and a majority of the patients (17/22) received no furosemide dose uptitration during CANS Therapy. Alongside concomitant medical therapy, CANS holds promise as a tool to improve in-hospital hemodynamics and relieve congestion.