Abstract 19838: REmission From Stage D Heart Failure (RESTAGE-HF): Interim Results and Insights From a Prospective Multi-Center Non-Randomized Study of Myocardial Recovery Using LVADs
Introduction: Myocardial recovery from advanced heart failure (HF) can occur following LVAD support. However the rate sufficient to allow device explantation is generally considered low.
Hypothesis: A combination of prolonged optimized LVAD mechanical unloading together with a standardized protocol of specific pharmacological therapy to induce reverse structural remodeling and reduce fibrosis with regular testing of underlying myocardial function can increase that incidence
Methods: A multi-center Prospective Non-randomized study (RESTAGE-HF) consisting of HeartMate II LVAD support, with an aggressive pharmacological regimen (Lisinopril 40mg, spironolactone 25mg, digoxin 125mic and losartan 150mg daily and coreg 25mg bid) with low speed echos (at 6000rpm & with 6mw) to test cardiac function regularly.
Results: Enrolment from 6 centers is now complete of 40 patients (age criteria 18-59), with advanced HF due to non ischaemic cardiomyopathy, requiring HeartMate II LVAD implantation as BTT or DT. Prior to implant age was 34.9±10.5 years, 27 (67.5%) were males, EF was 15±0.05% and 37 were in NYHA IV and 3 in NYHA Class IIIB. The primary objective is the proportion of subjects with sufficient improvement to allow LVAD removal with sustained remission from HF at 12 months. Preliminary data from 40 patients shows 4 patients (3 who died at 14, 63 and 148 days and one who was explanted at 209 days) who did not receive either the therapy or testing are considered non evaluable. Of the remaining 36 patients, 13 (36%) to date have been explanted, 2 transplanted, 1 died at 763 days post implant and 20 are ongoing (2 of which are also scheduled for explant). Of the 13 explants duration of support was 344±182 days, EF pre-explant (measured with the pump at 6000rpm for 15 mins) was 55±4%, EDD was 46±6mm and ESD 34±3.2mm, PCWP was 9.2±6.4mmHg and PA sats 67±14%. Prior to explant there was no difference in Fick cardiac output/index with the pump on (4.97±1.1/2.43±0.4L/min/m2) or at 6000rpm (4.8±0.9/2.36±0.3L/min/m2).
Conclusions: Preliminary results from our study suggest that this protocol can result in higher rates of explantation/remission from heart failure, reproducible in several centers. The final proportion/ durability will need to be reported when follow up is completed.
Author Disclosures: E.J. Birks: Research Grant; Significant; Thoratec to my institution. Ownership Interest; Modest; Husband owns Heartware Stock. E. Rame: None. S.R. Patel: None. C. Selzman: None. C. Cunningham: None. R. Starling: None. J. Um: None. D. Goldstein: None. M. Slaughter: Consultant/Advisory Board; Modest; EvaHeart, Oregon Heart. Research Grant; Significant; Heartware to Institution, Carmat to Institution. P. Alturi: None. D. Spevack: None. D. Farrar: Employment; Significant; St Jude Medical. B.D. Lowes: None. S.G. Drakos: Consultant/Advisory Board; Modest; Heartware, Abiomed, Amgen.
- © 2016 by American Heart Association, Inc.