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Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry
- Source :
- Circulation. 122(16)
- Publication Year :
- 2010
-
Abstract
- Background— Prospective studies defining the risk associated with pacemaker or implantable cardioverter-defibrillator replacement surgeries do not exist. These procedures are generally considered low risk despite results from recent retrospective series reporting higher rates. Methods and Results— We prospectively assessed predefined procedure-related complication rates associated with elective pacemaker or implantable cardioverter-defibrillator generator replacements over 6 months of follow-up. Two groups were studied: those without (cohort 1) and those with (cohort 2) a planned transvenous lead addition for replacement or upgrade to a device capable of additional therapies. Complications were adjudicated by an independent events committee. Seventy-two US academic and private practice centers participated. Major complications occurred in 4.0% (95% confidence interval, 2.9 to 5.4) of 1031 cohort 1 patients and 15.3% (95% confidence interval, 12.7 to 18.1) of 713 cohort 2 patients. In both cohorts, major complications were higher with implantable cardioverter-defibrillator compared with pacemaker generator replacements. Complications were highest in patients who had an upgrade to or a revised cardiac resynchronization therapy device (18.7%; 95% confidence interval, 15.1 to 22.6). No periprocedural deaths occurred in either cohort, although 8 later procedure-related deaths occurred in cohort 2. The 6-month infection rates were 1.4% (95% confidence interval, 0.7 to 2.3) and 1.1% (95% confidence interval, 0.5 to 2.2) for cohorts 1 and 2, respectively. Conclusions— Pacemaker and implantable cardioverter-defibrillator generator replacements are associated with a notable complication risk, particularly those with lead additions. These data support careful decision making before device replacement, when managing device advisories, and when considering upgrades to more complex systems. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00395447.
- Subjects :
- Male
medicine.medical_specialty
Pacemaker, Artificial
medicine.medical_treatment
Cohort Studies
Postoperative Complications
Risk Factors
Physiology (medical)
Medicine
Humans
Prospective Studies
Registries
Cardiac Surgical Procedures
Prospective cohort study
Device Removal
Aged
Retrospective Studies
Aged, 80 and over
Venous Thrombosis
Hematoma
business.industry
Incidence
Retrospective cohort study
Middle Aged
Implantable cardioverter-defibrillator
Confidence interval
Surgery
Defibrillators, Implantable
Heart Arrest
Private practice
Cohort
Equipment Failure
Female
Cardiology and Cardiovascular Medicine
business
Complication
Cohort study
Follow-Up Studies
Subjects
Details
- ISSN :
- 15244539 and 00395447
- Volume :
- 122
- Issue :
- 16
- Database :
- OpenAIRE
- Journal :
- Circulation
- Accession number :
- edsair.doi.dedup.....a5c7a7a548e634236200116fff253732