Long Term Post Explant Outcomes from RESTAGE-HF: A Prospective Multi-Center Study of Myocardial Recovery Using LVADs

Purpose RESTAGE-HF is a multi-center prospective study performed in 6 US centers which showed a protocol of optimized LVAD unloading, combined with standardized specific pharmacological therapy to induce reverse remodeling and regular testing of myocardial function resulted in a high incidence of LVAD explantation. The purpose of this study was to investigate the long-term outcomes after explantation from the RESTAGE-HF study including durability and long term myocardial structure and function. Methods Forty patients with chronic advanced HF due to non-ischemic cardiomyopathy, requiring LVAD implantation as BTT or DT were enrolled. Prior to implant age was 35.1±10.8 years, 27 (67.5%) were male, HF duration was 20.8±20.6 months, 95% required inotropic and 20% temporary mechanical support, ejection fraction (EF) was 14.5±5.3%, end-diastolic diameter (EDD) 7.33±0.89cm and end-systolic diameter (ESD) was 6.74±0.88cm. LVAD Explant criteria (with LVAD reduced to no net flow) were EF>45%, EDD 2.4 L/min/m2. Results Overall 19 (52.3%) of 36 evaluable patients receiving the protocol reaching the explant criteria were explanted (4 enrolled patients not undergoing the protocol due to complications unrelated to the study were considered non evaluable). Of all the enrolled patients 40% (16/40) achieved the primary endpoint (reaching explant criteria within 18 months and remaining free from transplant/VAD/death at 12 months), p Conclusion In this multicenter prospective study, this strategy resulted in sustained durable recovery from chronic HF in the majority of explanted patients.