Practice Update: Cardiology

HEART FAILURE & TRANSPLANTATION 19

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients JACC: Heart Failure Take-home message

COMMENT By Clyde W Yancy MD, MSc, MACC, FAHA, MACP, FHFSA F or patients with advanced heart failure, placement of a left ventricular assist device, or LVAD, is no longer a heroic act nor is it worth media attention, and it is, in fact, embedded in the most contemporary clinical practice guidelines. We are approximating 5000 annual implants of LVAD therapies with many lives sustained to heart trans- plantation and many others given extended survival. These are imperfect devices, with ever-present risks of thrombo- sis, stroke, and bleeding, but as the technology evolves so will the morbidity decline. What’s on the horizon? In the ROADMAP study, patients with NYHA class IIIB heart failure (defined as symptomatic heart failure with evidence of persistent congestion) were evaluated in an open label, nonrandomized observational study to evaluate the ther- apeutic efficacy of mechanical circulatory support (MCS) vs optimal medical therapy. The outcomes for LVAD-sup- ported patients out to 2 years were observed to be better. Although not a randomized trial, these data set a new fron- tier – LVAD therapies may be effective for a larger cohort of patients than previously considered; not only the desper- ately ill NYHA class IV patient, but also those functioning slightly better in our offices as outpatients but with easily provoked symptoms. Candidate selection remains the most important consideration, but the indications are expanding. The next frontier is exciting The use of an LVAD to spur recovery of ventricular function is the holy grail. We know this happens in a small cohort of patients with advanced heart failure treated aggres- sively with LVAD support and ideal medical therapy, but in whom and why? When those questions are answered, we can then expand the indication for an LVAD to a “bridge to recovery.” Much more mechanistic insight is needed here, but imagine where this work may lead! A strategy that fun- damentally reverses heart failure would be a breakthrough of considerable importance. Finally, we are this year celebrating 50 years since left ventricular replacement with transplantation or mechanical devices was introduced to clinical medicine. What began as a hopeless attempt to rescue the dying but later evolved to a determined effort through research to solve the com- plexity of support for the failing heart has now led to the everyday use of a technology deployed to more and more patients. Today, many of the patients in our practices might benefit and few may even recover. We know that patients with heart failure who are less ill have much reason for hope with new therapies and new guidelines; but, soon, more hope will be available to those with more disease. 

• This prospective nonrandomized observational study compared outcomes among 97 ambulatory heart failure patients with a left ventricular assist device (LVAD) and 103 patients who received optimal medical management (OMM). At the 2-year follow-up, 30% of patients in the LVAD armmet the primary composite end- point (survival on original therapy with improvement in 6-minute walk distance ≥75 meters) compared with 12% of patients in the OMM arm (P = 0.012). In the LVAD arm, 2-year survival was significantly higher than in the OMM arm (70 ± 5% vs 41 ± 5%; P < 0.001). LVADs were implanted in 22% of patients in the OMM arm during the study period. There was a decline in gastrointestinal bleeding and arrhythmias due to LVADs after the first year. • At the 2-year follow-up, survival and improvement in walk dis- tance were superior for LVAD patients compared with OMM patients; key adverse events in the LVAD group declined after the first year of implantation. Abstract OBJECTIVES The authors sought to provide the pre-specified primary endpoint of the ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Fail- ure Patients) trial at 2 years. BACKGROUND The ROADMAP trial was a prospective nonrandomized obser- vational study of 200 patients (97 with a left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed that survival with improved functional status at 1 year was better with LVADs compared with OMM in a patient population of ambulatory New York Heart Association func- tional class IIIb/IV patients. METHODS The primary composite endpoint was survival on original therapy with improvement in 6-min walk distance ≥75 m. RESULTS Patients receiving LVAD versus OMM had lower baseline health-re- lated quality of life, reduced Seattle Heart Failure Model 1-year survival (78% vs. 84%; p = 0.012) predominantly INTERMACS (Interagency Registry for Mechan- ically Assisted Circulatory Support) profile 4 (65% vs. 34%; p < 0.001) versus profiles 5 to 7. More LVAD patients met the primary endpoint at 2 years: 30% LVAD versus 12% OMM (odds ratio 3.2 [95% confidence interval 1.3 to 7.7]; p = 0.012). Survival as treated on original therapy at 2 years was greater for LVAD versus OMM (70 ± 5% vs. 41 ± 5%; p < 0.001), but there was no difference in intent-to-treat survival (70 ± 5% vs. 63 ± 5%; p = 0.307). In the OMM arm, 23 of 103 (22%) received delayed LVADs (18 within 12 months; 5 from 12 to 24 months). LVAD adverse events declined after year 1 for bleeding (primarily gastrointestinal) and arrhythmias. CONCLUSIONS Survival on original therapy with improvement in 6-min walk distance was superior with LVAD compared with OMM at 2 years. Reduction in key adverse events beyond 1 year was observed in the LVAD group. The ROADMAP trial provides risk-benefit information to guide patient- and phy- sician-shared decision making for elective LVAD therapy as a treatment for heart failure. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients. JACC Heart Fail 2017 Apr 11;[EPub Ahead of Print], RC Starling, JD Estep, DA Horst- manshof, et al.

VOL. 2 • NO. 1 • 2017