Synchronized diaphragmatic stimulation for heart failure using the VisONE system: a first-in-patient study

Area of Science:

• Cardiology
• Medical Devices
• Heart Failure Research

Background:

• Heart failure with reduced left ventricular ejection fraction (HFrEF) affects millions globally.
• Current therapies for HFrEF have limitations, necessitating novel treatment approaches.
• Synchronized diaphragmatic stimulation (SDS) shows potential for improving cardiac function by modulating intrathoracic and intra-abdominal pressures.

Purpose of the Study:

• To assess the feasibility and one-year effects of a novel, minimally invasive SDS device (VisONE-HF) in patients with HFrEF.
• To evaluate the safety and efficacy of SDS in improving clinical outcomes for HFrEF patients.

Main Methods:

• A first-in-patient, observational study involving fifteen men with symptomatic HFrEF and ischemic heart disease.
• Minimally invasive laparoscopic implantation of the SDS system, including a pulse generator and diaphragmatic leads.
• Evaluation of device safety, quality of life (SF-36 QOL), 6-minute hall walk distance (6MHWd), and echocardiographic parameters at 3, 6, and 12 months post-implantation.

Main Results:

• 100% implant success rate with no device- or lead-related adverse events reported.
• Significant improvements observed in 6-minute hall walk distance (P=0.004) and SF-36 Quality of Life scores (physical scale P=0.006; emotional scale P=0.001) by 12 months.
• A trend towards decreased left ventricular end-systolic volume (P=0.05) was noted, alongside a non-significant decrease in LVEF and NT-proBNP levels.

Conclusions:

• Laparoscopic implantation and delivery of the SDS device are feasible and safe for HFrEF patients.
• The study demonstrated encouraging preliminary results regarding quality of life and exercise capacity.
• Further investigation in adequately powered randomized trials is warranted to confirm these findings.