Formation of a national network for rapid response to device and lead advisories: The Canadian Heart Rhythm Society Device Advisory Committee

Krahn, Andrew D.; Simpson, Christopher S.; Parkash, Ratika; Yee, Raymond; Champagne, Jean; Healey, Jeffrey S.; Cameron, Douglas; Thibault, Bernard; Mangat, Iqwal; Tung, Stanley; Sterns, Laurence D.; Birnie, David H.; Exner, Derek V.; Sivakumaran, Soori; Davies, Ted; Coutu, Benoit; Crystal, Eugene; Wolfe, Kevin; Stephenson, Elizabeth A.; Sanatani, Shubhayan; Gow, Robert M.; Connors, Sean P.; Ayala‐Paredes, F.; Turabian, Mike; Kús, Teresa; Essebag, Vidal; Gardner, Martin

doi:10.1016/s0828-282x(09)70502-1

Cited by 7 publications

(4 citation statements)

References 7 publications

(6 reference statements)

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“…6 -8 This lead-specific observation and its magnitude are consistent with the report by Kleemann et al in 990 patients receiving a variety of ICD leads (none were Fidelis). 13 In that study, the hazard ratio for failure was 1.61 for female sex. It has been suggested that differences in vascular anatomy may be the explanation for sex findings; further research is necessary.…”

Section: Circulation March 13 2012mentioning

confidence: 78%

“…[11][12][13][14] All centers reported their centerspecific failure rates. The centers were then stratified into high and low failure rate centers (above and below median).…”

Section: Clinical Perspective On P 1225mentioning

confidence: 99%

“…20 There are few contemporary data comparing these newer approaches with cephalic vein access. The 3 largest studies of ICD failure, Kleemann et al (990 patients), 13 Hauser et al (1023 patients), 7 and Ecksten et al (1317 patients) 21 did not report data on access vein. Two of the small single-center Fidelis publications did have data on access vein, and both studies did not find that vein was predictive.…”

Section: Circulation March 13 2012mentioning

confidence: 99%

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Clinical Predictors of Fidelis Lead Failure

Birnie

Parkash²,

Exner³

et al. 2012

Circulation

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104

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Background-Approximately 268 000 Fidelis leads were implanted worldwide until distribution was suspended because of a high rate of early failure. Careful analyses of predictors of increased lead failure hazard are required to help direct future lead design and also to inform decision making on lead replacement. We sought to perform a comprehensive analysis of all potential predictors in a multicenter study. Methods and Results-A total of 3169 Sprint Fidelis leads were implanted in 11 centers with a total of 251 failures. Lead failure rates at 3, 4, and 5 years were 5.3%, 10.6%, and 16.8%, respectively. The rate of lead failure continues to accelerate (PϽ0.001). There were 4 independent predictors of failure: center, sex, access vein, and previous lead failure. Women had a higher hazard of failure (hazard ratio 1.51; 95% confidence interval, 1.14 -2.04; Pϭ0.005). Both axillary and subclavian access increased the hazard of failure (Pϭ0.007); hazard ratio for axillary was 1.94, (95% confidence interval, 1.23-3.04) and for subclavian 1.63 (95% confidence interval, 1.08 -2.46). Previous lead failure increased the hazard of a subsequent Fidelis failure with a hazard ratio of 3.12 (95% confidence interval, 1.80 -5.41; PϽ0.001). Conclusions-The rate of Fidelis failure continues to increase over time, with failures approaching 17% at 5 years.Women, patients with leads inserted via the subclavian or axillary vein, and those with a previous lead fracture were at greatest risk of Fidelis failure. Our data suggest that Fidelis replacement should be strongly considered at the time of generator replacement. (Circulation. 2012;125:1217-1225.)

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Section: Circulation March 13 2012mentioning

confidence: 78%

“…[11][12][13][14] All centers reported their centerspecific failure rates. The centers were then stratified into high and low failure rate centers (above and below median).…”

Section: Clinical Perspective On P 1225mentioning

confidence: 99%

Section: Circulation March 13 2012mentioning

confidence: 99%

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Clinical Predictors of Fidelis Lead Failure

Birnie

Parkash²,

Exner³

et al. 2012

Circulation

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104

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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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Managing Advisories of Cardiac Implantable Electronic Devices

Parkash¹,

Bennett²

2017

Clinical Cardiac Pacing, Defibrillation and Resynchronization Therapy

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Formation of a national network for rapid response to device and lead advisories: The Canadian Heart Rhythm Society Device Advisory Committee

Cited by 7 publications

References 7 publications

Clinical Predictors of Fidelis Lead Failure

Clinical Predictors of Fidelis Lead Failure

Radiographic Predictors of Lead Conductor Fracture

Managing Advisories of Cardiac Implantable Electronic Devices

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