Lead perforation: incidence in registries.
St. Jude Medical CRMD, Sylmar, California 91342, USA.Pacing and Clinical Electrophysiology (impact factor: 1.35). 02/2008; 31(1):13-5. DOI:10.1111/j.1540-8159.2007.00943.x pp.13-5
Article: Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population[show abstract] [hide abstract]
ABSTRACT: Clinical Performance of the St. Jude Medical Riata Defibrillation Lead in a Large Patient Population. Objective: The purpose of this large multicenter study was to evaluate the long-term reliability of an implantable cardioverter defibrillator (ICD) lead to determine the incidence of adverse events (AEs).Background: A recent concern has been the performance of cardiac defibrillator leads. There have been conflicting reports regarding the rate of lead perforation and other AEs.Methods: Medical records from patients implanted from 6-1-2001 to 11-27-2007 with the St. Jude Medical Riata family of RV leads at 23 US (N = 12,969) and 5 German (N = 2,418) centers were reviewed for chronic lead-related AEs. These included perforation, dislodgment, conductor fracture and insulation damage. The mean follow-up period was 18.0 months. AEs were defined as those that required Riata lead revision, extraction, or replacement.Results: The incidence of lead AEs was <1% for each AE type. Perforation occurred in 0.38%, dislodgement in 0.93%, conductor fracture in 0.18%, and insulation damage in 0.21% of patients studied.Conclusions: During the follow-up of the 15,387 patients with Riata leads, the incidence of AEs which included perforation, dislodgement, conductor fraction and insulation damage was low and within the range of what is considered clinically acceptable. (J Cardiovasc Electrophysiol, Vol. 21, pp. 551-556, May 2010)Journal of Cardiovascular Electrophysiology 04/2010; 21(5):551 - 556. · 3.06 Impact Factor
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ABSTRACT: Lead perforation is a major complication of cardiac rhythm management devices (CRMD), occurring in about 1%. While most lead perforations occur early, numerous instances of delayed lead perforation (occurring >30 days after implantation) have been reported in the last few years. Only about 40 such cases have been published, with the majority occurring <1 year after implantation. Herein, we describe the case of an 84-year-old female who presented with recurrent syncope and was diagnosed to have delayed pacemaker lead perforation 4.8 years after implantation. Through this report, we intend to highlight the increasing use of CRMD in elderly patients, and the lifelong risk of complications with these devices. Presentation can be atypical and a high index of suspicion is necessary for diagnosis.Cardiology research and practice. 01/2010; 2010.
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