A First in Human Multi-center, Open Label, Prospective Study to Evaluate Safety, Usability and Performance of the VisONE System for Heart Failure with a Reduced Left Ventricular Ejection Fraction

Abstract

Introduction

Synchronized Diaphragmatic Stimulation (SDS) produces localized diaphragmatic contractions gaited to the cardiac cycle that transiently modulate intra-thoracic pressure, thereby affecting ventricular preload and afterload. This study prospectively evaluated the safety and effectiveness of delivering SDS therapy in HFrEF (NCT03484780).

Hypothesis

Chronic SDS therapy improves symptoms, exercise capacity and hemodynamics in patients with HFrEF.

Methods

Symptomatic patients with an LVEF<= 35% who were in sinus rhythm, but did not have ventricular dyssynchrony, underwent laparoscopic implantation of the VisONE SDS system, comprising an implantable pulse generator and leads affixed to the inferior side of the diaphragm. Other exclusion criteria included severe COPD and contraindications to laparoscopy. Therapy was programmed to deliver SDS at imperceptible outputs. Patients were followed at 1, 3, 6 and 12-months to observed effects on symptoms, quality of life (SF36), exercise capacity (6-minute walk test), cardiac function (echocardiography) and safety.

Results

Nineteen patients were screened and 15 men (60 [56, 67] years, LV EF 27 [23, 33] %, 100% ischemic etiology, NYHA class II [53%] / III [47%], QRSd 117 [100, 125] ms, NT-proBNP 1779 [911, 2072] pg/ml) were enrolled and successfully implanted. For all patients, a threshold SDS stimulus that caused imperceptible localized diaphragmatic contraction could be identified. All patients were discharged without therapy-related complications. No procedure or therapy related AEs occurred through 12 months. Between discharge with SDS off and SDS on at 3, 6 and 12 months, improvements were seen in exercise capacity, SF-36 and LVEF with larger effects when diaphragmatic synchronization was >80% (Figure).

Conclusions

These encouraging effects on symptoms and exercise capacity should now be investigated in adequately powered randomized trials.

Document Type

Article

Publication Date

10-2020

Publication Title

Journal of Cardiac Failure

Comments

SUPPLEMENT S64

Link to Full Text

Share

COinS