title: Complications associated with pectoral implantation of cardioverter defibrillators. World-Wide Jewel Investigators.
abstract: Pectoral placement of ICD pulse generators is now routine after downsizing of these devices. However, the safety of this approach is not well documented. The aim of this study was to evaluate complications in a large cohort of patients undergoing initial pectoral ICD implantation. The subjects for this study were 1,000 consecutive patients receiving a Medtronic Jewel ICD at 93 centers worldwide. Cumulative follow-up for all patients was 634 patient-years, with 64.9% of patients followed for 6 months or longer. The complications evaluated were erosion, pocket hematoma, seroma, wound infection, dehiscence, device migration, lead fracture, and dislodgment. In this series, 1.8% of patients experienced a pocket complication with only 3 (0.3%) erosions and 2 (0.2%) infections. Lead complications were observed in 2.1% of subjects, most commonly early dislodgment of the RV lead. We conclude that pectoral implantation of a downsized ICD system can be performed with a low rate of complications. However, careful attention to anchoring techniques and close early monitoring is important given the 1.7% rate of lead dislodgment that occurred primarily during the first month following implantation.
authors.affiliation: Department of Medicine, University of Maryland School of Medicine, Baltimore, USA.
authors.forename: M R
authors.initials: MR
authors.lastname: Gold
authors.forename: R W
authors.initials: RW
authors.lastname: Peters
authors.forename: J W
authors.initials: JW
authors.lastname: Johnson
authors.forename: S R
authors.initials: SR
authors.lastname: Shorofsky
mesh_terms: D015331:Cohort Studies; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D005069:Evaluation Studies as Topic; D005122:Exudates and Transudates; D005260:Female; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000209:etiology; D006406:Hematoma / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009135:Muscular Diseases / Q000209:etiology; D010369:Pectoralis Muscles / Q000473:pathology / Q000601:surgery*; D011183:Postoperative Complications; D013529:Surgical Wound Dehiscence / Q000209:etiology; D013530:Surgical Wound Infection / Q000209:etiology