Clinical Judgment Versus Decision Analysis for Managing Device Advisories

Amin, Mitesh S.; Wood, Mark A.; Shepard, Richard K.; Kalahasty, Gautham; Ellenbogen, Kenneth A.

doi:10.1111/j.1540-8159.2008.01171.x

Cited by 9 publications

(10 citation statements)

References 11 publications

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“…Six of the seven included studies reported data collected retrospectively (9–14), and one reported prospectively collected data (15). Three were multicenter (10,11,13) and four were single center (9,12,14,15).…”

Section: Resultsmentioning

confidence: 99%

“…Three were multicenter (10,11,13) and four were single center (9,12,14,15). All but one reported experience within the US only(10), however in all cases, advisories and recalls were issued by the FDA rather than a local or international regulator of medical devices.…”

Section: Resultsmentioning

confidence: 99%

“…Six of seven studies reported the distribution of CIED type, and in these studies, more than 90% of CIEDs replaced prophylactically were ICDs. (9–11,13–15) Cardiac resynchronization devices with or without an ICD represented only 2% of CIEDs in the six studies reporting device type. Three studies reported a mean patient age – 64, 67, and 68 years, respectively.…”

Section: Resultsmentioning

confidence: 99%

“…Three studies reported a mean patient age – 64, 67, and 68 years, respectively. (10,14,15) Three of the remaining studies reported outcomes in adult patients without specifying an actual mean or median age (9,11,12) whereas Mahajan et al described outcomes in pediatric and patients with congenital heart disease. (13)…”

Section: Resultsmentioning

confidence: 99%

“…(9,10,14,15) In the case of Gould et al and Moore et al, pacemaker dependency was one qualifying condition that led to prophylactic replacement. Three studies reported the number of ICD patients with primary vs secondary prevention devices.…”

Section: Resultsmentioning

confidence: 99%

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Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis

et al. 2015

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Background The number of cardiac implantable electronic device (CIED) recalls and advisories has increased over the past three decades, yet no consensus exists on how to best manage patients with these CIEDs partially because rates of complications from prophylactic replacement are unknown. Objective To establish rates of complications when recalled CIED generators are replaced prophylactically Methods We searched MEDLINE and Cochrane Controlled Trials Register for reports of prophylactic replacement of recalled CIED generators. Studies with < 20 subjects were excluded. We then conducted a meta-analysis of qualifying studies to determine the rates of mortality, reoperation, and combined major complications. Results We identified 7 citations meeting our inclusion criteria and reporting ≥1 endpoint of interest. Four were single center; three were multicenter. Six studies collected data retrospectively (n=1213) and one prospectively (n=222). Using a random effects model to combine data from all included studies, the rate of major complications was 2.5% (95% CI 1.0–4.5%). Combining data from 6 studies reporting mortality and reoperation, the rates were 0.5% (95% CI 0.1–0.9%) and 2.5% (95% CI 0.8–4.5%), respectively. Conclusions Prophylactic replacement of recalled CIED generators is associated with a low mortality rate but non-trivial rates of other major complications similar to those reported when CIED generators are replaced for other reasons. Thus, when considering replacing a recalled CIED generator, known risks of elective generator replacement likely apply and can be weighed against risks associated with device failure.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis

et al. 2015

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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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Guidelines for Managing Pacemaker and Implantable Defibrillator Advisories

Kramer¹,

Maisel²

2011

Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy

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Clinical Judgment Versus Decision Analysis for Managing Device Advisories

Cited by 9 publications

References 11 publications

Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis

Complications from prophylactic replacement of cardiac implantable electronic device generators in response to United States Food and Drug Administration recall: A systematic review and meta-analysis

The Effect of Device Advisories on Implantable Cardioverter-defibrillator Therapy

Guidelines for Managing Pacemaker and Implantable Defibrillator Advisories

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