Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: A report from the Canadian Heart Rhythm Society Device Advisory Committee

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

doi:10.1016/j.hrthm.2008.01.029

Cited by 76 publications

(52 citation statements)

References 9 publications

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“…1 Fractures of pace-sense conductors in defibrillation leads may cause an oversensing of nonphysiological potentials that results in inappropriate detection of ventricular fibrillation (VF) and shocks. [2][3][4][5][6][7][8] Despite alerts based on high impedance, fractures commonly present with clusters of inappropriate shocks. [2][3][4][5] Fractures have been reported to cause loss of pacing, failure of defibrillation, or fatal proarrhythmia.…”

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confidence: 99%

Downloadable Software Algorithm Reduces Inappropriate Shocks Caused by Implantable Cardioverter-Defibrillator Lead Fractures

et al. 2010

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Background-Downloadable software upgrades are common in consumer electronics but not in implantable medical devices. Fractures of implantable cardioverter-defibrillator (ICD) leads present commonly as inappropriate shocks. A lead-integrity alert (LIA) designed to reduce inappropriate shocks is the first software download approved to enhance nominally functioning, previously implanted ICDs. Methods and Results-We performed a prospective study to determine whether an LIA could reduce inappropriate shocks.Patients were included if they had ICD lead fractures confirmed by analysis of explanted leads. The LIA group included the first 213 patients who met the inclusion criteria after the LIA was approved who had the LIA downloaded. The LIA is triggered either by high impedance or rapid oversensing. It responds by delaying detection of ventricular fibrillation and initiating a patient alert every 4 hours. The control group included the first 213 patients who did not have the LIA downloaded. They were monitored by conventional daily impedance measurements that respond with a daily alert. The LIA group had a 46% relative reduction (95% confidence interval 34% to 55%) in the percentage of patients with Ն1 inappropriate shock (LIA 38% versus control 70%, PϽ0.001) and a 50% relative reduction (95% confidence interval 33% to 61%) in the percentage with Ն5 shocks (25% versus 50%, PϽ0.001). The LIA group also had a higher percentage of patients who either did not receive a shock or had Ն3 days of warning before the shock (72% versus 50%, PϽ0.001). Conclusions-A software download that upgrades previously implanted ICDs without surgical revision reduces inappropriate shocks caused by lead fractures. (Circulation.

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Downloadable Software Algorithm Reduces Inappropriate Shocks Caused by Implantable Cardioverter-Defibrillator Lead Fractures

et al. 2010

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“…It is anticipated that the Committee and its chair will interface with the president of the CHRS to provide input and representation to COPE and the Heart Rhythm Society on matters regarding device and lead advisories. Data from all Canadian ICD centres regarding lead performance were collected within eight weeks and fast-tracked for publication in a leading international heart rhythm journal (6). The recommendations of the Committee regarding this advisory were highly sought after by physicians, patients and hospital administrators, and were immediately and widely recognized as a key body of thought on this issue.…”

Section: Advisory Response Processmentioning

confidence: 99%

“…An initially ad hoc group of Canadian investigators collaborated to collect and report a larger scale 'Canadian' perspective on the outcome of device advisories (3), and has generated several ongoing projects that address outcomes in specific device-related patient groups (4)(5)(6). This group formed the nidus for the more formal assembly of the CHRS Device Advisory Committee to allow for a national collaboration on device advisories.…”

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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

Krahn

Simpson

Parkash

et al. 2009

Canadian Journal of Cardiology

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“…4 There have been a number of registry-based and single-center studies examining predictors of lead failure, but none have examined this in the context of a large-scale, randomized clinical trial in which all patients were systematically followed up regularly with minimal loss to followup. 5,6 Complications related to revision of this lead have been reported to be significant, with a higher number of complications related to lead removal. 7 Others have found that extraction of this lead may be accomplished with few complications.…”

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Sprint Fidelis Lead Fractures in Patients With Cardiac Resynchronization Therapy Devices

et al. 2012

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Background-Using data from the Resynchronization/Defibrillation for Ambulatory Heart Failure (RAFT) study, we examined whether Fidelis lead failure was more common in patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy (ICD-CRT) than in patients with an ICD only. Methods and Results-All cases of patients who had a right ventricular defibrillation lead revision in the RAFT study were adjudicated for the presence of lead fracture. Criteria for fracture were at least 2 of the following: (1) Impedance rise (Ͼ50% or Ͼ500 ⍀ in 1 week), (2) short interval count Ͼ10 times per day or 300 times per month, or (3) inappropriate shock caused by noise, verified by stored electrogram. A total of 1798 patients were enrolled into the RAFT study, with a mean follow-up of 40Ϯ20 months. There were 818 patients (45.5%) who received a Fidelis lead at the original implantation, 405 with an ICD only and 413 with an ICD-CRT. There were 47 confirmed defibrillation lead fractures; 45 were Fidelis leads (5.5% of Fidelis leads). The overall rate of fracture in the ICD group was 3.2% compared with 7.8% in the ICD-CRT group (Pϭ0.006; hazard ratio, 2.42; 95% confidence interval, 1.27-4.61). Significant correlates of lead fracture in this population were undergoing an ICD-CRT implantation and having Ն2 leads. Conclusions-In this analysis of the RAFT study, patients with an ICD-CRT were found to have a significantly higher fracture rate than patients with an ICD. This finding needs to be considered when these patients are assessed for possible lead revision at the time of an elective generator replacement. (Circulation. 2012;126:2928-2934.)

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Outcome of the Fidelis implantable cardioverter-defibrillator lead advisory: A report from the Canadian Heart Rhythm Society Device Advisory Committee

Cited by 76 publications

References 9 publications

Downloadable Software Algorithm Reduces Inappropriate Shocks Caused by Implantable Cardioverter-Defibrillator Lead Fractures

Downloadable Software Algorithm Reduces Inappropriate Shocks Caused by Implantable Cardioverter-Defibrillator Lead Fractures

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

Sprint Fidelis Lead Fractures in Patients With Cardiac Resynchronization Therapy Devices

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