Long-term electrical survival analysis of Riata and Riata ST silicone leads: National Veterans Affairs experience

Sung, Raphael K.; Massie, Barry M.; Varosy, Paul D.; Moore, Hans; Rumsfeld, John S.; Lee, Byron K.; Keung, Edmund C.

doi:10.1016/j.hrthm.2012.08.006

Cited by 64 publications

(48 citation statements)

References 14 publications

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“…For Riata leads, with oversensing, the fraction of LFs that presented with inappropriate shocks was 5%, significantly lower than the ≈50% using conventional diagnostics. 10,16 The low incidence of inappropriate shocks in patients who had Fidelis leads is similar to what we and others have reported and contrasts dramatically with historical controls who have not received the LIA algorithm. [7][8][9] This suggests that LIA warnings resulted in clinical actions that prevented subsequent inappropriate shocks in both Medtronic and St. Jude leads.…”

Section: Lia Performancesupporting

confidence: 83%

Performance of Lead Integrity Alert to Assist in the Clinical Diagnosis of Implantable Cardioverter Defibrillator Lead Failures

Ellenbogen

Gunderson

Stromberg

et al. 2013

Circ: Arrhythmia and Electrophysiology

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Original ArticleBackground-The Lead Integrity Alert (LIA) was developed for Medtronic implantable cardioverter defibrillators to reduce inappropriate shocks for rapid oversensing caused by conductor fractures and reported for Medtronic Fidelis conductor fractures. The goal of this study was to compare the performance of LIA with conventional impedance monitoring for identifying lead system events (LSEs) and lead failures (LFs) in lead families that differ from Fidelis. Methods and Results-We analyzed data from 12 793 LIA enabled implantable cardioverter-defibrillator and lead combinations including 6123 St. Jude Riata or Durata, 5114 Boston Scientific Endotak, and 1556 Fidelis combinations followed in the CareLink remote monitoring network for LSEs and LFs. Each alert was adjudicated based on implantable cardioverterdefibrillator stored electrograms/diagnostics and clinical data as an LSE or non-lead system event by 2 physicians after reviewing the electrograms and clinical data. During 13 562 patient-years of LIA follow-up, there were 179 adjudicated alerts, of which 84 were LSEs (including 65 LFs) and 95 were non-lead system events. LIA identified >66% more LSE and >67% more LF compared with conventional impedance monitoring and did not differ by lead family for LSE (P=0.573) or LF (P=0.332). Isolated spikes on electrogram were associated more often with LF in St. Jude leads (71%) compared with Endotak (9%; P<0.001) and Fidelis leads (11%; P<0.001). The non-lead system event detection rate was different among lead families (P<0.001) ranging from 1 in every 78.5 years (Endotak), 228.9 years (St. Jude leads), and 627.6 years (Fidelis). Conclusions-LIA markedly increased the detection rate of LSE compared with conventional impedance monitoring. 1561, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592, 1940, 7000, 7001, 7002, 7010, 7020, 7021, 7022, 7040, 7041, 7042, 7052, 7070, 7071, 7120, 7121, 7122, 7130) or a Boston Scientific Endotak ICD lead (0061, 0064, 0072, 0074, 0075, 0095, 0115, 0125, 0127, 0128, 0134, 0135, 0137, 0138, 0144, 0145, 0147, 0148, 0149, 0154, 0155, 0157, 0158, 0159, 0171, 0174, 0175, 0180, 0181, 0182, 0184, 0185, 0186, 0187) with a CareLink remote monitoring transmission between August 28, 2008, and October 4, 2011, were included in the analysis. Patients with Fidelis leads (models 6930, 6931, 6948, 6949) from a separate prospectively defined cohort were included as controls. Device diagnostic data associated with LIA triggers or any pace-sense impedances that triggered conventional impedance alerts (>2000 or <200 ohms) were reviewed. Follow-up time was calculated in years from the date the LIA algorithm was programmed on to the date of the last LIA enabled transmission. Lead Integrity AlertThe present LIA requires 2 of 3 of components to be satisfied within 60 days: abrupt pace-sense impedance change, frequent extremely short R-R intervals, and rapid nonsustained ventricular tachycardia episodes. 7,11 The abrupt impedance change requires an increase >75% or decrease to <50% of th...

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Section: Lia Performancesupporting

confidence: 83%

Performance of Lead Integrity Alert to Assist in the Clinical Diagnosis of Implantable Cardioverter Defibrillator Lead Failures

Ellenbogen

Gunderson

Stromberg

et al. 2013

Circ: Arrhythmia and Electrophysiology

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“…Addition of another ICD lead to an existing lead with extruded conductors can possibly interfere with the ICD lead function such as during delivery of HV shock due to possibility of short circuiting thereby leading to failed defibrillation. In a large Veterans Affairs study by Sung et al [22], defibrillation testing demonstrated a 10-J safety margin in 18 patients who had abandoned Riata ® family leads and underwent addition on a new ICD lead. Also no electrical malfunctions due to lead-lead interaction were observed for an average follow-up of 18.2 months in the same study.…”

Section: Discussionmentioning

confidence: 99%

Fluoroscopic investigation of Riata® transvenous defibrillator leads

et al. 2015

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“…9 The most common presentation of either conductor fracture or insulation breach is oversensing of rapid nonphysiological signals. 11,22 Before diagnostic tools that incorporated oversensing, pace-sense fractures presented most commonly as inappropriate shocks, despite daily automated measurements of pacing impedance. 23,24 Oversensing also results in inhibition of pacing.…”

Section: Clinical Presentationsmentioning

confidence: 99%

“…A few fractured cable filaments may generate nonphysiological signals without measurable 26 and 15% of clinically diagnosed Riata failures. 22 Abrupt relative changes in impedance are more specific than absolute measurements, which record out-of-range values for gradual changes at the electrode-myocardial interface, 25 but a single abrupt change can be spurious. Pacing impedance <200 Ω is thought to indicate an insulation breach, but evidence is limited ( Figure 5).…”

Section: Impedance and Impedance Trends Pace-sense Circuitsmentioning

confidence: 99%

“…Reduced pacing impedance has been reported with insulation breaches in older coaxial defibrillation leads 35 and rarely in silicone abrasions of multilumen leads, 22 but most breaches in multilumen leads present with impedance within the nominal range, although some have reduced impedance within that range. Optimal diagnostic criteria are unknown.…”

Section: Abnormal Pacing Impedance With or Without Oversensingmentioning

confidence: 99%

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