Less invasive ventricular reconstruction for ischaemic heart failure.

Area of Science:

• Cardiology
• Medical Devices
• Minimally Invasive Surgery

Background:

• Chronic heart failure (HF) due to ischemic cardiomyopathy often involves left ventricular (LV) dilatation and dysfunction.
• Surgical ventricular reconstruction is an established therapy, but less invasive options are sought.

Purpose of the Study:

• To evaluate the 12-month efficacy and safety of the BioVentrix Revivent TC System for treating symptomatic ischemic heart failure.
• To assess the system's impact on LV volumes, ejection fraction, and patient quality of life.

Main Methods:

• An international multicenter study enrolled 89 patients with symptomatic HF (NYHA class ≥II) and LV dysfunction post-myocardial infarction.
• The Revivent TC System, using micro-anchor pairs, was used to exclude scarred myocardium in 86 patients.
• Follow-up included assessment of LV volumes, ejection fraction, New York Heart Association (NYHA) class, quality of life, and survival at 12 months.

Main Results:

• Significant improvement in LV ejection fraction (29% to 34%, P<0.005) and reduction in LV volumes (end-systolic and end-diastolic indices, P<0.001).
• 90.6% survival at 12 months, with a significant decrease in patients classified as NYHA class III (59% to 22%).
• Marked improvements in quality of life (Minnesota Living with Heart Failure Questionnaire) and 6-minute walking test distance (P<0.001).

Conclusions:

• The Revivent TC System provides a less invasive alternative for surgical ventricular reconstruction.
• Treatment leads to significant and sustained improvements in LV volumes, cardiac function, and patient-reported outcomes in ischemic heart failure.