Implantation-Related Complications of Implantable Cardioverter-Defibrillators and Cardiac Resynchronization Therapy Devices: A Systematic Review of Randomized Clinical Trials

• Published in: Journal of the American College of Cardiology Vol. 58; no. 10; pp. 995 - 1000
• Main Authors: VAN REES, Johannes B, DE BIE, Mihaly K, THIJSSEN, Joep, BORLEFFS, C. Jan Willem, SCHALIJ, Martin J, ERVEN, Lieselot Van
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 30.08.2011; Elsevier Limited
• Subjects: Biological and medical sciences; Cardiac Resynchronization Therapy Devices; Cardiology; Cardiology. Vascular system; Clinical trials; Defibrillators, Implantable; Dissection; Heart attacks; Hospitals; Humans; Medical sciences; Medicare; Mortality; Ostomy; Postoperative Complications - epidemiology; Prosthesis Implantation - adverse effects; Prosthesis Implantation - mortality; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Randomized Controlled Trials as Topic; Studies; Veins & arteries; Cardiac resynchronization; Intensive cardiocirculatory care; Device; Instrumentation therapy; Cardioversion; Implantation; Review; Instrumental stimulation; Randomization; Implanted; Complication; Clinical trial; Circulatory system; Cardiology; Defibrillation; Bibliographic review; Defibrillator
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2011.06.007

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%).