Complication Risk with Pulse Generator Change: Implications When Reacting to a Device Advisory or Recall

Kapa, Suraj; Hyberger, Linda K.; Rea, Robert F.; Hayes, David L.

doi:10.1111/j.1540-8159.2007.00742.x

Cited by 51 publications

(33 citation statements)

References 15 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%

mentioning

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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“…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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“…Gould and Krahn 29 reported that in Canada, the risk of major complications of ICD replacement in response to recalls that required reoperation was 5.8% (31 of 533 patients), which included 2 deaths after extraction for pocket infection. Kapa et al 30 reported a 1.4% complication risk at Mayo Clinic.…”

Section: Risk Factorsmentioning

confidence: 99%

Update on Cardiovascular Implantable Electronic Device Infections and Their Management

Baddour¹,

Epstein²,

Erickson³

et al. 2010

Circulation

950

893

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Abstract-Despite improvements in cardiovascular implantable electronic device (CIED) design, application of timely infection control practices, and administration of antibiotic prophylaxis at the time of device placement, CIED infections continue to occur and can be life-threatening. This has prompted the study of all aspects of CIED infections.Recognizing the recent advances in our understanding of the epidemiology, risk factors, microbiology, management, and prevention of CIED infections, the American Heart Association commissioned this scientific statement to educate clinicians about CIED infections, provide explicit recommendations for the care of patients with suspected or established CIED infections, and highlight areas of needed research. (Circulation. 2010;121:458-477.)

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Complication Risk with Pulse Generator Change: Implications When Reacting to a Device Advisory or Recall

Abstract: Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices.

Cited by 51 publications

References 15 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

Radiographic Predictors of Lead Conductor Fracture

Update on Cardiovascular Implantable Electronic Device Infections and Their Management

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