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

Abstract

Objective This first‐in‐man (FIM) study aimed to determine the safety and efficacy of the Heartech® left ventricular partitioning device (LVPD) in patients with chronic heart failure (HF) postmyocardial infarction. Methods Sixteen patients were enrolled from three cardiac intervention centers in China. All patients underwent percutaneous ventricular restoration (PVR) procedures with implantation of the Heartech® LVPD. Safety and immediate success rates were recorded. Major adverse cardiovascular and cerebrovascular events (MACCEs) including all‐cause mortality, myocardial infarction, stroke, emergent or selective surgery or interventional therapy, renal failure requiring hemodialysis, and major bleeding were recorded. Efficacy features included functional status, echocardiographic characteristics, life quality characteristics including peak oxygen consumption of cardiopulmonary exercise testing (CPET), European five‐dimensional health scale (EQ‐5D), 6‐min walk test (6MWT) at baseline and during follow‐up (NCT 02938637). Results The device success rate was 93.75% (15 successes in 16 patients) with 100% safety. During follow‐up of 36 ± 4.5 days, no MACCEs were found. The left ventricular end‐systolic volume index decreased significantly (LVESVi, 72.47 ± 22.77 mL/m2 vs. 50.13 ± 13.36 mL/m2, p < .001) as did left ventricular end diastolic volume index (LVEDVi, 106.27 ± 28.01 mL/m2 vs. 83.20 ± 16.87 mL/m2, p = .001). Left ventricular ejection fraction (LVEF, 32.47 ± 6.98% vs. 40.41 ± 6.15, p < .001), 6MWT (383.13 ± 108.70 vs. 453.47 ± 88.24, p < 0.001) and EQ‐5D (65.93 ± 11.25 vs. 78.67 ± 8.35, p < .001) improved significantly. Conclusions Heartech® LVPD appeared to be safe and effective for treatment of HF postmyocardial infarction.

Heartech® left ventricular partitioning device improves left ventricular systolic function of patients with chronic heart failure post‐myocardial infarction at 1‐year follow‐up

“…Our previous study elucidated the safety and efficacy of this device in patients with HF post-MI at 1-month of follow-up. 13 As we know, LV diastolic function can There are also several limitations in the present study that should be mentioned. First, this study was designed as a single-arm investigation, so there was no control group being treated with standardized medical therapy or other LV partitioning devices against which to compare our LVPD recipients.…”

“…The details of the Heartech ® LVPD, the implantation procedure, and the study design were presented in our previous study. 13 Briefly, the enrolled patients were required to meet the following criteria: aged 18 years or older with a diagnosis of LV anterior wall motion abnormalities due to MI, an LV ejection fraction of at least 15% but not greater than 40%, and a diagnosis of New York Heart Association (NYHA) class II to IV HF receiving standard HF medical therapy. Study exclusion criteria were as follows: Significant valve disease, chronic obstructive pulmonary disease, end-stage renal disease requiring hemodialysis, cerebral vascular accident, or transient ischemic attacks occurring within 6 months of the study, history of acute MI within 2 months, and history of not having undergone complete revascularization post-MI.…”

“…Previously, our first-in-man study of Heartech ® LVPD proved its safety and efficacy in patients with chronic HF following MI at 1 month after implantations. 13 The present study aimed to present the echocardiographic outcomes of the same patients at 1 year of follow-up.…”

Heartech: Another parachute looking for a landing zone in interventions for heart failure

“…In this issue of CCI, Zhenbing and colleagues report the first in human experience with the Heartech LV partitioning device . In 16 patients, they observed a 93.75% device success rate without any reported MACCE at 36 days of follow up.…”