title: Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices: a systematic review of randomized clinical trials.
abstract: The number of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy (CRT) implantations is increasing drastically worldwide, and hence, the number of implanting centers is also increasing. Despite abundant data on the beneficial effect of these devices, little is known regarding safety and complication rates. Eleven ICD and 7 CRT trials were systematically reviewed to provide data on the frequency of in-hospital mortality and complications related to the implantation. Average in-hospital mortality was 2.7% in trials using both thoracotomy and nonthoracotomy ICDs, 0.2% in trials using nonthoracotomy ICDs, and 0.3% in CRT trials. The pneumothorax rate was similar between the nonthoracotomy ICD and CRT trials (0.9%) Coronary sinus complications occurred in 2.0% of patients undergoing CRT. Lead dislodgement rates were higher in CRT trials (5.7%) than in nonthoracotomy ICD trials (1.8%).
authors.affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, Leiden, the Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Rees
authors.forename: Mihály K
authors.initials: MK
authors.lastname: de Bie
authors.forename: Joep
authors.initials: J
authors.lastname: Thijssen
authors.forename: C Jan Willem
authors.initials: CJ
authors.lastname: Borleffs
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
authors.forename: Lieselot
authors.initials: L
authors.lastname: van Erven
mesh_terms: D058409:Cardiac Resynchronization Therapy Devices; D017147:Defibrillators, Implantable; D006801:Humans; D011183:Postoperative Complications / Q000453:epidemiology; D019919:Prosthesis Implantation / Q000009:adverse effects* / Q000401:mortality; D016032:Randomized Controlled Trials as Topic