Complications of replacing implantable devices in response to advisories: A single center experience

Moore, John W.; Barrington, William; Bazaz, Raveen; Jain, Sandeep; Němec, Jan; Ngwu, Ogundu; Schwartzman, David; Shalaby, Alaa; Saba, Samir

doi:10.1016/j.ijcard.2007.12.070

Cited by 19 publications

(23 citation statements)

References 12 publications

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“…Previously published data suggested that complications associated with generator replacement could occur in 1% to 10% of patients. [15][16][17][18][19] A minimum of 700 patients would permit estimating a 95% confidence interval (CI) width of Ϯ1% around an observed event rate of 1%, whereas an event rate of 10% would have an associated interval width of Ϯ2.5%. Because complication rates were expected to be lower in cohort 1, a minimum of 1000 patients was planned for this cohort to enable detection of infrequent events, with the remainder, or up to 750 patients, in cohort 2.…”

Section: Discussionmentioning

confidence: 99%

“…14 Although retrospective series have examined complications with generator replacements, prospective data are unavailable. [15][16][17][18][19] Furthermore, risks related to generator replacements with lead additions are not well understood, particularly upgrades to cardiac resynchronization therapy (CRT). 20 -23 To answer these questions, we prospectively collected 6-month complication rates in patients undergoing pacemaker or ICD generator replacement, including CRTpacemakers and CRT-ICDs.…”

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confidence: 99%

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Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures

et al. 2010

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for the REPLACE Registry InvestigatorsBackground-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.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures

et al. 2010

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“…As a "prescribed entity" under Ontario health information privacy legislation, the coordinating center (Institute for Clinical Evaluative Sciences), is allowed to collect data on all patients in this registry without informed consent, conditional on adequate privacy protection, and therefore all patients had their data entered into the database without participation bias. 8 Disclosure of events that occurred in Յ5 individuals is not reported for privacy purposes but is included in the analysis and reported in summary data.…”

Section: Patientsmentioning

confidence: 99%

Predictors of Short-Term Complications After Implantable Cardioverter-Defibrillator Replacement

Krahn

Lee

Birnie

et al. 2011

Circ: Arrhythmia and Electrophysiology

147

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Background— Complications after implantable cardioverter-defibrillator (ICD) replacement are often clinically devastating, particularly when infection or reoperation occurs. Identifying factors contributing to complications may permit identification of high-risk individuals that warrant incremental monitoring and therapy to attenuate risk. In addition, replacement may be a discretionary decision in the context of an advisory or borderline device performance and patient, device, and implanter factors that predict adverse outcome may assist in clinical decision-making. Methods and Results— In a prospective, multicenter, population-based registry of all ICD patients at 18 centers in Ontario, Canada, we examined 45-day complication and all-cause mortality rates from February 2007 to August 2009 in patients undergoing ICD generator replacement. Complications were determined longitudinally and were categorized as major or minor. ICD replacement was performed in 1081 of 5176 patients (20.8%) undergoing ICD implantation (age, 64.3±12.7 years; 78.5% men). In patients undergoing ICD replacement, 47 patients (4.3%) had a complication within 45 days, with 47 major complications in 28 patients (2.6%), most commonly infection (n=23), lead revision (n=35), electrical storm (n=14), and pulmonary edema (n=13). Minor complications occurred in 2.3% of patients, most commonly incisional infection (n=10) and pocket hematoma (n=10). On multivariable analysis, risk factors associated with major complications were Canadian Cardiovascular Society angina class (adjusted hazard ratio [HR], 3.70 for class 2 to 4 versus 0 to 1; P =0.027) and multiple previous procedures on the pocket (adjusted HR, 3.35 for >1 versus 1; P =0.058). Risk factors associated with any complication were the use of antiarrhythmic therapy (adjusted HR, 6.29; P =0.001), implanter volume (adjusted HR 10.4 for <60/y versus >120/y, P =0.026), and Canadian Cardiovascular Society angina class (adjusted HR, 3.00 for class 2 to 4 versus 0 to 1; P =0.031). In a Cox model with a time-dependent variable of major complication within 45 days after replacement, major complications after ICD replacement were associated with an increased risk of mortality at 45, 90, and 180 days (adjusted HR, 9.61, 12.69, and 6.41, respectively; P =0.002 to 0.039). Conclusions— Risk factors associated with complications after ICD replacement include the presence of angina, antiarrhythmic therapy, increased number of previous procedures, and low implanter volume. Major complications may be associated with increased risk of subsequent mortality.

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“…[45][46][47] This study examines both the frequency and predictors of complications after ICD device replacement. The authors enrolled patients ≥18 years from 18 centers undergoing ICD generator replacement in the prospective Ontario Implantable Cardioverter Defibrillator registry from 2007-2009 (N=1081, 21% women).…”

Section: Predictors Of Short-term Complications After Implantable Carmentioning

confidence: 99%

Most Important Outcomes Research Papers on Device Therapies for Cardiomyopathies

Gupta¹,

Dharmarajan²,

Dreyer³

et al. 2013

Circ: Cardiovascular Quality and Outcomes

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The following articles are being highlighted as part of the Circulation: Cardiovascular Quality and Outcomes Topic Review series. This series will summarize the most important manuscripts, as selected by the Editor that have published in the Circulation portfolio. The objective of this new series is to provide our readership with a timely, comprehensive selection of important papers that are relevant to the quality and outcomes, and general cardiology audience. The studies included in this article represent the most significant research related to device therapies for cardiomyopathies and its common presentation of heart failure and sudden cardiac death. (Circ Cardiovasc Qual Outcomes. 2013;6:e36-e47.)

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Complications of replacing implantable devices in response to advisories: A single center experience

Cited by 19 publications

References 12 publications

Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures

Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures

Predictors of Short-Term Complications After Implantable Cardioverter-Defibrillator Replacement

Most Important Outcomes Research Papers on Device Therapies for Cardiomyopathies

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