title: Long-term complications related to biventricular defibrillator implantation: rate of surgical revisions and impact on survival: insights from the Italian Clinical Service Database.
abstract: BACKGROUND
  Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome.
  
  
  RESULTS
  We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single- and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; P=0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; P=0.682).
  
  
  CONCLUSIONS
  In current clinical practice device-related events are more frequent in CRT-D than in single- or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.
authors.affiliation: Dipartimento di Cardiologia, Fondazione IRCCS Policlinico San Matteo, P.le Golgi 2, 27100, Pavia, Italy. elettrofisiologia@smatteo.pv.it
authors.forename: Maurizio
authors.initials: M
authors.lastname: Landolina
authors.forename: Maurizio
authors.initials: M
authors.lastname: Gasparini
authors.forename: Maurizio
authors.initials: M
authors.lastname: Lunati
authors.forename: Saverio
authors.initials: S
authors.lastname: Iacopino
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Boriani
authors.forename: Carlo
authors.initials: C
authors.lastname: Bonanno
authors.forename: Antonello
authors.initials: A
authors.lastname: Vado
authors.forename: Alessandro
authors.initials: A
authors.lastname: Proclemer
authors.forename: Alessandro
authors.initials: A
authors.lastname: Capucci
authors.forename: Chantal
authors.initials: C
authors.lastname: Zucchiatti
authors.forename: Sergio
authors.initials: S
authors.lastname: Valsecchi
authors.forename: Renato P
authors.initials: RP
authors.lastname: Ricci
authors.forename: Massimo
authors.initials: M
authors.lastname: Santini
mesh_terms: D000368:Aged; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects*; D016208:Databases, Factual; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000628:therapy; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000209:etiology / Q000401:mortality*; D012086:Reoperation / Q000401:mortality* / Q000639:trends*; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome