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First-in-man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure

Zhengbin Zhu1,2, Jiwei Yu1, Kai Xu3

  • 1Department of Cardiology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions
|June 25, 2019
PubMed

Insights

The Heartech® left ventricular partitioning device (LVPD) shows promise in treating heart failure (HF) post-myocardial infarction. This first-in-man study found the device safe and effective, improving patient outcomes and cardiac function.

Area of Science:

  • Cardiovascular Medicine
  • Medical Devices
  • Regenerative Medicine

Background:

  • Chronic heart failure (HF) following myocardial infarction (MI) remains a significant clinical challenge, often leading to adverse left ventricular remodeling.
  • Current treatment options for HF post-MI have limitations in addressing the underlying structural changes.
  • Percutaneous ventricular restoration (PVR) offers a novel approach to managing HF by reshaping the left ventricle.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Heartech® left ventricular partitioning device (LVPD) in a first-in-man (FIM) study.
  • To assess the feasibility of the PVR procedure using the Heartech® LVPD in patients with HF post-MI.
  • To determine the impact of LVPD implantation on cardiac function, exercise capacity, and quality of life.

Main Methods:

  • A prospective, single-arm study involving 16 patients with HF post-MI across three cardiac intervention centers.
  • All patients underwent percutaneous implantation of the Heartech® LVPD.
  • Safety was assessed by monitoring major adverse cardiovascular and cerebrovascular events (MACCEs), while efficacy was evaluated through echocardiography, cardiopulmonary exercise testing (CPET), 6-minute walk test (6MWT), and the EQ-5D quality of life scale.

Main Results:

  • The Heartech® LVPD demonstrated a high device success rate of 93.75% with 100% procedural safety.
  • No MACCEs were reported during the short-term follow-up period (36 ± 4.5 days).
  • Significant improvements were observed in left ventricular volumes (LVESVi and LVEDVi), left ventricular ejection fraction (LVEF), 6MWT distance, and EQ-5D scores.

Conclusions:

  • The Heartech® LVPD is a safe and effective device for percutaneous ventricular restoration in patients with HF post-MI.
  • LVPD implantation can lead to significant improvements in cardiac structure and function, as well as enhanced exercise capacity and quality of life.
  • This FIM study provides a strong foundation for further investigation into the long-term benefits of the Heartech® LVPD in HF management.
Abstract

Keywords:
acute myocardial infarctionheart failureleft ventricular partitioning devicepercutaneous ventricular restoration

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