User-reported abrasion-related lead failure is more common with durata compared to other implantable cardiac defibrillator leads

Hirsh, David S.; Langberg, Jonathan J.

doi:10.1016/j.hrthm.2015.07.013

Cited by 17 publications

(8 citation statements)

References 11 publications

(7 reference statements)

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“…However, the Optim layer does not cover the silicone elastomer insulation under the shock coils. Recent reports have described insulation failure of the Durata lead 6, 7, 8, 9. To prevent tissue ingrowth, the cross section of the outer wire of the shock coil is not round but flat and thin.…”

Section: Discussionmentioning

confidence: 99%

Unusual fracture in a Durata lead with shock coil fragmentation and cable externalization

Sato

Soejima

Yoshino

et al. 2017

HeartRhythm Case Reports

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Section: Discussionmentioning

confidence: 99%

Unusual fracture in a Durata lead with shock coil fragmentation and cable externalization

Sato

Soejima

Yoshino

et al. 2017

HeartRhythm Case Reports

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“…Could the Optim insulation itself be the problem? Although failure and abrasions have been reported on the Riata ST Optim and Durata defibrillator leads, prospective data on these leads seems to be reliable . On the other hand, the Optim insulation for the Tendril leads probably is thinner than and not as strong as that for the Durata leads.…”

Section: Discussionmentioning

confidence: 91%

Inappropriate noise detection in Tendril family pacing leads

Zhu

Chu

Zager

et al. 2019

Cardiovasc electrophysiol

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Introduction Noise oversensing encountered in patients with Abbott Tendril leads in our hospital triggered an internal investigation. Methods We retrospectively analyzed patients with a Tendril lead model 1688, 1788, 1888, and 2088. Most leads were connected to Abbott generators. To exclude a primary generator issue as the cause of noise oversensing, we enrolled a cohort of patients in whom Medtronic CapSureFix leads model 4076 and 5076 were prospectively connected to similar Abbott generators. Results A total of 1063 Tendril leads were implanted in 869 patients. Noise was encountered in 66 leads (6.2%) during a follow‐up of 3.9 years. Most affected leads had normal impedance and only a few of these patients were symptomatic. Reprogramming was attempted in 44 of 66 (67%), and reduced oversensing in 34 of 44 (77%) of these patients. Seventeen malfunctioning leads (1.5%) were replaced, including 16 of 66 (24%) of those with noise. Of the four leads with noise extracted and returned to the manufacturer, lead to device abrasion was identified in two and inner insulation breach in one. None of the 145 Medtronic CapSureFix leads connected to Abbott generators had noise during a follow‐up of 3.6 years. Conclusion Noise oversensing was relatively common in Tendril leads, but was not detected in Medtronic leads despite connecting to Abbott generators. Although the majority of the affected leads did not show abnormal impedance, outer or inner insulation breach was identified in three of the four returned leads. As patients with affected leads are generally asymptomatic, most of them can be managed conservatively.

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“…However, previous single case reports show failure of the HV circuitry and failure to defibrillate despite nominal low‐voltage shock impedance measurements 4,10 . Analyzing both internal and external insulation breaches, Shah et al reported that three of four patients with Durata ICD leads (St. Jude Medical, St. Paul, MN) presented with failure of HV shock therapy or death without a history of electrical malfunction 11 . With the goal to assess internal insulation breaches in Durata ICD leads, Hauser et al searched the Food and Drug Administration Manufacturer and User Facility Device Experience database 12 .…”

Section: Discussionmentioning

confidence: 99%

Low‐voltage shock impedance measurements: A false sense of security

Parwani

Lacour

Franke

et al. 2020

Pacing Clinical Electrophis

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Background: Implantable cardioverter defibrillators use low-voltage shock impedance measurements to monitor the lead integrity. However, previous case reports suggest that low-voltage shock impedance measurements may fail to detect insulation breaches that can cause life-threatening electrical short circuits. Methods and results: We report six cases of insulation breaches in transvenous defibrillation leads that were not obvious during standard interrogations and testing of the lead beforehand. In two cases, an electrical short circuit during commanded shock delivery for internal electrical cardioversion resulted in a total damage of the ICD generator. In one of these cases, commanded shock delivery induced ventricular fibrillation, which required external defibrillation. In two cases, a shock due to ventricular tachycardia was aborted as the shock impedance was less than 20 Ω. However, in both cases the tiny residual shock energy terminated the ventricular tachycardia. In contrast, in one case the residual energy of the aborted shock did not end ventricular fibrillation induced at defibrillator threshold testing. In one case, the ICD indicated an error code for a short circuit condition detected during an adequate shock delivery. Conclusions: This case series illustrates that low-voltage shock impedance measurements can fail to detect insulation breaches. These data suggest that in patients without a contraindication, traditional defibrillator threshold testing or high voltage synchronized shock at the time of device replacement should be considered.

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User-reported abrasion-related lead failure is more common with durata compared to other implantable cardiac defibrillator leads

Cited by 17 publications

References 11 publications

Unusual fracture in a Durata lead with shock coil fragmentation and cable externalization

Unusual fracture in a Durata lead with shock coil fragmentation and cable externalization

Inappropriate noise detection in Tendril family pacing leads

Low‐voltage shock impedance measurements: A false sense of security

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