Complications Associated with Generator Replacement in Response to Device Advisories

Costea, Alexandru; Rardon, David P.; Padanilam, Benzy J.; Fogel, Richard I.; Prystowsky, Eric N.

doi:10.1111/j.1540-8167.2007.01047.x

Cited by 47 publications

(40 citation statements)

References 8 publications

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“…Two further single-center studies included pacemakers and ICDs and reported major complication rates of 1.2% in 732 patients at 2 months and 4.1% in 222 patients at 3 months, respectively. 17,18 We report novel data on complication rates in patients who had a generator replacement combined with a plan to add 1 or more transvenous leads. The clinical profile of these patients suggests more advanced cardiovascular disease compared with the patients who had a generator replacement alone.…”

Section: Discussionmentioning

confidence: 99%

“…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%

Section: Discussionmentioning

confidence: 99%

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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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“…Kapa et al [15] reported a 0.62% complication rate for generator replacements undertaken due to advisories. Costea et al [16] reported a 4.1% major complication rate for advisory replacements. It is likely that differences may reflect varying definitions of complications; however, it is clear the device replacement was not without risk.…”

Section: Recalls and Advisoriesmentioning

confidence: 98%

The Effect of Device Advisories on Implantable Cardioverter-defibrillator Therapy

Amin

Ellenbogen

2010

Curr Cardiol Rep

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Implantable cardioverter-defibrillators have been shown to improve survival by terminating life-threatening ventricular tachyarrhythmias. As the devices have become more complex, there has been an increase in the incidence of device and lead malfunction. The device manufacturers issue advisories and recalls to alert physicians of the potential for malfunction. When patients are faced with a recalled device or lead, the initial question is whether or not to replace it. A rational approach to evaluating these patients and the associated advisory can help gauge the competing risks of elective device removal or extraction versus keeping the device in place. It is important to keep in mind that the risks of replacing devices or extracting leads are not insignificant and may outweigh the risks of death from malfunction. Despite the increasing number of advisories and attention to device and lead failure, the overall reliability and efficacy of these devices for appropriate patients remains high. In general, patients should be counseled prior to implant of the potential for device and lead malfunction, and careful consideration must be employed when decisions are made to replace generators or extract leads.

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“…In a survey of generator replacements because of device recalls, major complications have been reported in 4.1 to 5.8% of patients. 18,19 Also lead longevity is a major concern in the long term: Kleemann et al reported that only 60% of leads functioned properly after an eight-year follow-up. 20 Secondly, most patients are not aware of an imminent risk of sudden death when offered ICD therapy, and labelling them as such may profoundly influence the quality of life.…”

Section: Limitations Of Current Guidelinesmentioning

confidence: 99%

Primary prevention with the ICD in clinical practice: not as straightforward as the guidelines suggest?

Bracke

Dekker²,

Voort³

et al. 2009

NHJL

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Complications Associated with Generator Replacement in Response to Device Advisories

Abstract: Even with experienced operators complications can occur when replacing generators for a device recall. Careful risk assessment for each individual patient should be performed and efforts made to minimize generator changes.

Cited by 47 publications

References 8 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

The Effect of Device Advisories on Implantable Cardioverter-defibrillator Therapy

Primary prevention with the ICD in clinical practice: not as straightforward as the guidelines suggest?

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