Author Interviews, Heart Disease, JACC / 20.10.2015
LVADs Improve Survival and Quality of Life In Some Heart Failure Patients
MedicalResearch.com Interview with:
Jerry D. Estep, MD, FACC, FASE
Associate Professor of Clinical Cardiology
Houston Methodist Institute of Academic Medicine
Section Head of Heart Transplant & Mechanical Circulatory Support, Division of Heart Failure
Medical Director, Heart Transplant & LVAD Program
Methodist DeBakey Heart & Vascular Center
Houston Methodist
Medical Research: What is the background for this study? What are the main findings?
Dr. Estep: Data for left ventricular assist devices (LVADs) in non-inotrope-dependent advanced heart failure (HF) patients are limited. The risk-benefit tradeoff of LVADs versus optimal medical management (OMM) in this patient cohort is not well understood. ROADMAP is the first prospective, nonrandomized, observational study comparing LVAD support to OMM in advanced, ambulatory HF patients who are not dependent on intravenous inotropic support, and meet the FDA-approved indications for LVAD destination therapy. The main 5 findings from the ROADMAP Study include the following:
1) LVAD patients were more severely ill, with more INTERMACS profile 4 compared to OMM patients (65% LVAD vs. 34% OMM, p < 0.001);
2) more LVAD patients met the primary endpoint of survival on original therapy with improvement in 6 minute walk distance of at least 75 meters at 12 months (39% LVAD vs. 21% OMM; [OR: 2.4 [95% CI: 1.2 to 4.8]; p = 0.012) with differences in the primary endpoint primarily due to the use of delayed LVADs in the OMM group;
3) on the basis of as-treated (event free) analysis, 12-month survival (freedom from death, urgent transplant, or delayed LVAD) was greater for LVAD versus OMM (80 ± 4% vs. 63 ± 5%, p = 0.022);
4) adverse events (AEs) were higher in LVAD patients, at 1.89 events/patient-year (eppy), primarily driven by bleeding (1.22 eppy), than with OMM, at 0.83 eppy, primarily driven by worsening HF (0.68 eppy); and
5) health-related quality of life and depression improved from baseline more significantly with LVADs than with OMM (Δvisual analog score [VAS]: 29 ± 25 vs. 10 ± 22, p < 0.001 and ΔPHQ9: -5 ± 7 vs. -1 ± 5, p < 0.001).






















