Transcatheter Left Ventricular Reconstruction in Heart Failure Patients With Prior Anterior Myocardial Infarction: The Prospective ALIVE Trial.

Abstract

Background: Left ventricular (LV) dilatation and extensive scar portend a poor prognosis in heart failure (HF). The Revivent TC system (BioVentrix Inc) is used either during a hybrid transcatheter-surgical or a surgical-only procedure to exclude transmural scar and reduce LV dimensions.

Objectives: The purpose of this study was to examine the safety and efficacy of the Revivent TC® anchor system in patients with HF.

Methods: We conducted a prospective, multicenter, nonrandomized (2:1 device vs control) trial in patients with NYHA functional class III-IV symptoms, LV ejection fraction ≤45%, LV end-systolic volume index ≥50 mL/m², and transmural anterior LV scar. Patients with inadequate scar or previous sternotomy served as the control group. The primary safety endpoint was the composite of major adverse events in the device arm compared with a performance goal of 40.5%. The primary effectiveness endpoint was the hierarchical composite of cardiovascular mortality, HF hospitalization, change in 6-minute walk test, change in Minnesota Living With Heart Failure questionnaire score, and change in NYHA functional classification assessed at 12 months as the win ratio in the device group compared with the control group.

Results: In total, 126 patients (84 device; 42 control) were enrolled at 28 sites. Mean LV ejection fraction was 29.6% ± 7.2%, and mean LV end-systolic volume index was 93.9 ± 35.5 mm. The primary 30-day safety performance goal endpoint was met (major adverse events 15 of 84 [17.9%]; 1-sided 97.5% upper confidence limit 27.7%; P < 0.0001). There was no significant difference in the primary 12-month hierarchical composite efficacy endpoint (win ratio 1.13; P = 0.32). In post hoc analysis, the surgical only approach (23 treated patients) had more favorable outcomes than the hybrid approach (60 treated patients).

Conclusions: The Revivent TC® system safely reduced LV dimensions in HF patients caused by extensive anterior scar but did not improve clinical effectiveness outcomes at 1 year. A randomized trial is warranted to further define the risks and benefits of the surgical only approach. (BioVentrix Revivent TC™ System Clinical Study; NCT02931240).