AIMS: The decision to implant a cardiac resynchronization therapy (CRT) system with (defibrillator, CRT-D) or without (pacemaker, CRT-P) cardioverter defibrillator should weigh its benefits and risks. This study examined the (i) incidence of loss of capture and infectious complications and (ii) 1-year clinical outcomes of 402 CRT-D and CRT-P recipients enrolled in the MASCOT study. METHODS AND RESULTS: The indications for CRT-D or CRT-P were posed by the implanting physicians. All (i) losses of atrial and right and left ventricular capture, (ii) system-related infections, and (iii) clinical outcomes, including hospitalizations for worsening heart failure (HF) and deaths from all causes, were recorded up to 1 year of follow-up. Cardiac resynchronization therapy-defibrillator was implanted in 228 (57%) and CRT-P in 174 (43%) patients. The incidence of loss of capture was greater in CRT-D with 21 patients (9.2%) than in CRT-P with 6 patient (3.5%) recipients (P = 0.01), while the infection rates were 1.3% (3 patients) and 1.2% (2 patients), respectively (ns). In the CRT-D group, 42 of 228 patients (18.4%) died or were hospitalized for HF, compared with 38 of 174 patients (21.8%) in the CRT-P group (ns). In the CRT-D group, 23 patients (10.1%) were hospitalized for worsening HF and 20 (8.8%) patients died, vs. 22 (12.6%) and 19 (10.9%) patients, respectively, in the CRT-P group (ns for both comparisons). CONCLUSIONS:Cardiac resynchronization therapy-defibrillator was implanted in 57% of candidates for CRT. Within 1 year after device implant, the incidence of loss of capture at any lead was nearly three-fold greater among CRT-D than among CRT-P recipients. System-related infections were infrequent and clinical outcomes were similar in both groups.
RCT Entities:
AIMS: The decision to implant a cardiac resynchronization therapy (CRT) system with (defibrillator, CRT-D) or without (pacemaker, CRT-P) cardioverter defibrillator should weigh its benefits and risks. This study examined the (i) incidence of loss of capture and infectious complications and (ii) 1-year clinical outcomes of 402 CRT-D and CRT-P recipients enrolled in the MASCOT study. METHODS AND RESULTS: The indications for CRT-D or CRT-P were posed by the implanting physicians. All (i) losses of atrial and right and left ventricular capture, (ii) system-related infections, and (iii) clinical outcomes, including hospitalizations for worsening heart failure (HF) and deaths from all causes, were recorded up to 1 year of follow-up. Cardiac resynchronization therapy-defibrillator was implanted in 228 (57%) and CRT-P in 174 (43%) patients. The incidence of loss of capture was greater in CRT-D with 21 patients (9.2%) than in CRT-P with 6 patient (3.5%) recipients (P = 0.01), while the infection rates were 1.3% (3 patients) and 1.2% (2 patients), respectively (ns). In the CRT-D group, 42 of 228 patients (18.4%) died or were hospitalized for HF, compared with 38 of 174 patients (21.8%) in the CRT-P group (ns). In the CRT-D group, 23 patients (10.1%) were hospitalized for worsening HF and 20 (8.8%) patients died, vs. 22 (12.6%) and 19 (10.9%) patients, respectively, in the CRT-P group (ns for both comparisons). CONCLUSIONS: Cardiac resynchronization therapy-defibrillator was implanted in 57% of candidates for CRT. Within 1 year after device implant, the incidence of loss of capture at any lead was nearly three-fold greater among CRT-D than among CRT-P recipients. System-related infections were infrequent and clinical outcomes were similar in both groups.