ESC Congress 2016 - 14

clINIcAl TRIAl HIgHlIgHTs For the secondary outcomes, there was a 23% nonsignificant reduction in cardiovascular mortality (HR, 0.77; 95% CI, 0.57 to 1.05; P = .10; Figure 2), while sudden cardiac deaths were reduced by 50% (HR, 0.50; 95% CI, 0.31 to 0.82; P = .005; Figure 3). 0.0 Cumulative Event Rate 0.2 0.4 0.6 0.8 1.0 Figure 2. Cardiovascular Mortality HR, 0.77 (95% CI, 0.57 to 1.05) P = .10 Controls ICD 0 1 2 3 560 556 540 540 517 526 438 451 4 Years 344 358 5 6 7 248 272 169 186 88 107 8 12 Controls 17 ICD ICD, implantable cardioverter defibrillator. Reproduced from New England Journal of Medicine, Køber L et al. A Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. 2016;DOI: 10.1056/NEJMoa1608029. Copyright © 2016 Massachusetts Medical Society. Reprinted with permission from the Massachusetts Medical Society. Figure 3. Sudden Cardiac Death 1.0 Cumulative Event Rate 0.2 0.4 0.6 0.8 0.0 MORE CARE: Remote Monitoring of Patients With Biventricular Defibrillators Reduces Health Care Utilization Without Compromising Safety Written by Maria Vinall HR, 0.50 (95% CI, 0.31 to 0.82) P = .005 Controls ICD 0 1 2 3 560 556 540 540 517 526 438 451 4 Years 344 358 5 6 7 248 272 169 186 88 107 8 12 Controls 17 ICD ICD, implantable cardioverter defibrillator. Reproduced from New England Journal of Medicine, Køber L et al. A Defibrillator Implantation in Patients with Nonischemic Systolic Heart Failure. N Engl J Med. 2016;DOI: 10.1056/NEJMoa1608029. Copyright © 2016 Massachusetts Medical Society. Reprinted with permission from the Massachusetts Medical Society. Among the prespecified subgroups, the only treatment interaction was for age (P-interaction = .009), which was due primarily to a significant reduction in all-cause mortality for patients aged < 68 years (HR, 0.64; 95% CI, 0.45 to 0.90; P = .01). There was no difference in the rate of device infection (4.9% in the ICD group vs 3.6% in the control group; P = .29). The rate of serious device infection (ie, those requiring lead extraction or life-long antibiotics) was low and not significantly different between patients in the ICD group and controls (2.7% vs 2.3%, ICD vs control; P = .65). Bleeding requiring intervention occurred in 1 patient in the ICD group. There were 17 cases of 14 pneumothorax: 11 in the ICD group (2%) and 6 in the control group (1.1%). Inappropriate shocks occurred in 33 patients (5.9%). In conclusion, this definitive trial showed no significant survival benefit with primary prophylactic ICD implantation among patients with symptomatic nonischemic cardiomyopathy and moderate-to-high background use of optimal medical therapy and CRT. These findings contrast with current HF guideline recommendations, which were based on previous small to mediumsize trials or subgroups. The results of the DANISH trial will influence HF guidelines and expectedly there will be a slowing of enthusiasm for ICD implantation in such patients, except perhaps in younger individuals. That hypothesis-generating observation will first require duplication in a dedicated trial. October 2016 Giuseppe Boriani, MD, PhD, University of Modena & Reggio Emilia, Cardiology, Modena, Italy, presented results from the MORE-CARE study [Boriani G et al. Eur J Heart Fail. 2016] showing that remote monitoring of patients with systolic heart failure (HF) implanted with a biventricular defibrillator for cardiac resynchronization therapy-implantable cardioverter defibrillator (CRT-D) does not reduce mortality, or the risk of cardiovascular (CV) or device-related hospitalization, but does reduce health care resource utilization. MORE-CARE was an international, prospective, multicenter, randomized controlled trial in patients with advanced systolic HF. The aim of the study was to evaluate the clinical and economic value of remote monitoring compared with standard follow-up strategies. The primary composite endpoint included all-cause death and CV and device-related hospitalization (≥ 48-hour stay), calculated as time to first event over a 2-year follow-up. The secondary study endpoint was the 2-year rate of health care utilization (CV hospitalizations, CV emergency department [ED] admissions, and CV in-office follow-ups). To be eligible, patients must have had an indication for a CRT-D according to the 2009 European Society of Cardiology guidelines (ie, NYHA class III-IV; left ventricular ejection fraction ≤ 35%; QRS ≥ 120 ms, www.escardio.org/ESCcongressinreview http://www.escardio.org/ESCcongressinreview

Table of Contents for the Digital Edition of ESC Congress 2016