title: Lead complications, device infections, and clinical outcomes in the first year after implantation of cardiac resynchronization therapy-defibrillator and cardiac resynchronization therapy-pacemaker.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Friedrich-Ebert Hospital, Medical Clinic, Friesenstr. 11, D 24531 Neumünster, Germany. andreas.schuchert@fek.de
authors.forename: Andreas
authors.initials: A
authors.lastname: Schuchert
authors.forename: Carmine
authors.initials: C
authors.lastname: Muto
authors.forename: Themistoklis
authors.initials: T
authors.lastname: Maounis
authors.forename: Robert
authors.initials: R
authors.lastname: Frank
authors.forename: Eric
authors.initials: E
authors.lastname: Boulogne
authors.forename: Alexander
authors.initials: A
authors.lastname: Polauck
authors.forename: Luigi
authors.initials: L
authors.lastname: Padeletti
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy / Q000401:mortality*; D015897:Comorbidity; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004868:Equipment Failure; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000401:mortality*; D006333:Heart Failure / Q000401:mortality* / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D016459:Prosthesis-Related Infections / Q000401:mortality*; D012307:Risk Factors; D016037:Single-Blind Method; D016019:Survival Analysis; D015996:Survival Rate; D016896:Treatment Outcome