Management of Recalled Pacemakers and Implantable Cardioverter-Defibrillators

Amin, Mitesh S.; Matchar, David B.; Wood, Mark A.; Ellenbogen, Kenneth A.

doi:10.1001/jama.296.4.412

Cited by 56 publications

(29 citation statements)

References 30 publications

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“…In general, for pacemaker-dependent patients, advisory device failure rates in excess of 0.3% warrant consideration of device replacement; in patients with ICD generators under advisory, an estimated failure rate of 3% favors replacement in the majority of cases, decreasing to 1% when procedural mortality rates are 0.1% or less and/or risk of fatal arrhythmias increases to 20% per year. 526 It is anticipated that the above general recommendations and estimates will vary as a function of the specific nature of the advisory, how the malfunction presents, whether early detection and/or reprogramming may be employed in addressing the potential device failure, and whether the lead (versus the generator) is affected. This has been demonstrated, for example, in the case of a recent lead advisory associated with spurious shocks attributable to lead fracture, oversensing, and high impedance; reprogramming to minimize overdetection of noise, enabling of alert features to detect changes in impedance, and increasing utilization of remote monitoring to follow such leads may have an effect on future rates of invasive lead replacement and/or extraction.…”

Section: Elements Of Implantable Cardioverterdefibrillator Follow-upmentioning

confidence: 99%

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

Epstein¹,

DiMarco²,

Ellenbogen³

et al. 2008

Circulation

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488

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Section: Elements Of Implantable Cardioverterdefibrillator Follow-upmentioning

confidence: 99%

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

Epstein¹,

DiMarco²,

Ellenbogen³

et al. 2008

Circulation

Self Cite

1,243

488

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“…This finding is in concordance with other studies that have reported a higher risk of infection and other complications from device removal/replacement. 18,19 It is surprising that the risk of complications was not higher for ICDs with cardiac resynchronization therapy as implanting these devices is technically more challenging than implanting regular ICDs; however, our study may not have had enough power to address this question.…”

Section: Discussionmentioning

confidence: 88%

Patient and Implanting Physician Factors Associated With Mortality and Complications After Implantable Cardioverter-Defibrillator Implantation, 2002–2005

Al‐Khatib

Greiner

Peterson

et al. 2008

Circ: Arrhythmia and Electrophysiology

103

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Background— Little is known about factors that influence survival and complications after implantable cardioverter-defibrillator (ICD) implantation in routine clinical practice. We examined patient and implanting physician factors associated with outcomes of ICD therapy in Medicare beneficiaries from 2002 through 2005. Methods and Results— We limited this analysis to patients aged ≥65 with Medicare fee-for-service coverage who received an ICD between January 2002 and September 2005. The main outcome measures are time to postprocedural complications within 90 days and 1-year mortality. During the study period, 8581 patients had an ICD implanted by 1959 physicians. The number of procedures increased from 1644 in 2002 to 2374 in the first 3 quarters of 2005. The overall complication rate declined from 18.8% in 2002 to 14.2% in 2005 ( P <0.001). Factors independently associated with an increased hazard of complications include chronic lung disease, dementia, renal disease, implantation by a thoracic surgeon, and implantation with removal/replacement. History of congestive heart failure, outpatient implantation, and more recent years of ICD implantation were associated with a lower risk of complications ( P <0.05 for all factors). From 2002 to 2005, we observed a decline in 1-year mortality ( P <0.001). Conclusions— We observed an appreciable increase in the number of ICD implants, which was associated with a significant decrease in the rate of complications and 1-year mortality. We identified factors associated with an increased risk of mortality and postprocedural complications that may support more nuanced treatment decisions than are currently possible.

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“…3,[12][13][14][15][16] The recent focus on failure rates and related implications for the related leads has focused on patient and system characteristics that influence fracture risk. The Fidelis lead has shown wide variation in survival rate among centers in the manufacturer's CareLink PLUS study (n=21 500 Fidelis leads), implying that there are factors or combinations of factors that are not yet fully understood that result in center to center variation.…”

Section: Discussionmentioning

confidence: 99%

Radiographic Predictors of Lead Conductor Fracture

Krahn

Morissette

Lahm

et al. 2014

Circ: Arrhythmia and Electrophysiology

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All 23 adult Canadian implantable cardioverter defibrillator implantation centers were surveyed to identify centers that routinely capture anteroposterior or posteroanterior (AP) and lateral x-rays within 2 weeks of implant and at least AP x-rays at the time of fracture identification. Eight of those centers collected those x-rays routinely. All eligible centers agreed to participate in the study. Centers were © 2014 American Heart Association, Inc. Original ArticleBackground-Lead fracture is a limiting factor in high voltage lead durability. Fractures noted with the Medtronic Fidelis leads provide an opportunity to examine factors captured on implant chest x-ray that correlate with risk for lead conductor fracture. We evaluated contributory factors in a large population of fractures. Methods and Results-We conducted a retrospective case-control study at 8 Canadian centers that routinely capture anterior posterior and lateral chest x-rays within 2 weeks of implant. Cases were patients that experienced confirmed Medtronic Fidelis 6949 lead fracture based on standard definitions, matched one-to-one to controls for date of implant, sex, and age with normally functioning Fidelis leads from the same center. Select chart data and x-rays were collected for all patients. Radiographic measurements by ≥2 individuals per case/control were blinded to patient status. The data were analyzed using a time to failure multivariable Cox proportional hazards model with stratification for each matched pair. X-ray pairs from 111 fracture patients were compared with 111 controls (age 61.5±12.8 years, 75% male, 221 model 6949 leads). Six parameters included in the statistical analysis were significantly associated with risk of fracture, including slack/ tortuosity measures, pulse generator and superior vena cava coil location, and angle of lead exit from the pocket. Conclusions-Pocket, intravascular and intracardiac lead characteristics on x-ray correlate with risk of lead conductor fracture. These observations may be useful to direct implant technique to optimize lead durability. Validation in larger populations and other lead models may inform the application of these results. (Circ Arrhythm Electrophysiol.

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Management of Recalled Pacemakers and Implantable Cardioverter-Defibrillators

Abstract: The decision to replace a device under advisory is determined primarily by the incidence of device malfunction and the likely effects of device failure. This analysis provides a framework for managing recalled devices in the context of device, patient, and institutional characteristics.

Cited by 56 publications

References 30 publications

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

Patient and Implanting Physician Factors Associated With Mortality and Complications After Implantable Cardioverter-Defibrillator Implantation, 2002–2005

Radiographic Predictors of Lead Conductor Fracture

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