Detection and management of animplantable cardioverter defibrillator lead failure (original) (raw)
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Sensing Failure Associated with the Medtronic Sprint Fidelis Defibrillator Lead
Journal of Cardiovascular Electrophysiology, 2008
Introduction: The diameter of implantable cardioverter-defibrillator (ICD) leads has become progressively smaller over time. However, the long-term performance characteristics of these smaller ICD leads are unknown.Methods: We retrospectively evaluated 357 patients who underwent implantation of a Medtronic Sprint Fidelis™ defibrillating lead at two separate centers between September 2004 and October 2006. Lead characteristics were measured at implant, at early follow-up (1–4 days post implant), and every 3–6 months thereafter.Results: During the study period, 357 patients underwent implantation of the Medtronic Sprint Fidelis™ lead. The mean R-wave measured at implant through the device was not different (P = NS) when compared with that measured at first follow-up (10.5 ± 5.0 mV vs 10.7 ± 5.1 mV). Forty-one patients (13%) had an R-wave amplitude ≤ 5 mV measured through the device at implant. Of those patients with an R-wave amplitude ≤ 5 mV at implant measured through the device, 63% (n = 26) remained ≤ 5 mV for the duration of follow-up. The mean time to R-wave amplitude ≤ 5 mV was 96.2 ± 123 days. During follow-up, 65 (18%) patients developed R-wave ≤ 5 mV. Overall 10 lead revisions (2.8%) were performed during the first year of follow-up.Conclusion: Abnormal R-wave sensing is frequently observed during follow-up with the Medtronic Fidelis ICD lead. Lead revision was necessary in 2.8% of the patients, most often (8 of 10) due to abnormal R-wave sensing along with elevated pacing threshold. Whether this issue is limited to this lead or reflects a potential problem with all downsized ICD leads merits further investigation.
An algorithm to predict implantable cardioverter-defibrillator lead failure
Journal of the American College of Cardiology, 2004
The goal of this analysis was to test an algorithm that identifies implantable cardioverterdefibrillator (ICD) lead problems before clinical failure and/or inappropriate therapy. BACKGROUND The ICD lead failures typically present as inappropriate shock therapy. Identifying lead failures before their clinical presentation may prevent patient discomfort, improve device longevity, and avoid device-induced proarrhythmia.
Long-Term Follow-up of Transvenous Defibrillation Leads
Circulation Journal, 2006
he implantable cardioverter-defibrillator (ICD) is an established treatment for the prevention of sudden cardiac death in patients with a history of lifethreatening ventricular tachyarrhythmias, 1 and recent studies have reported their efficacy in the primary prevention of sudden cardiac death in patients with structural heart disease and decreased left ventricular (LV) function. 2-4 Therefore, the number of cases of prophylactic use of ICDs has increased worldwide, and as both the number of patients with an ICD and the follow-up period after implantation have increased, several issues concerning ICD management, including lead fractures, have arisen. 5 ICD lead failures associated with long-term fatigue is a serious complication because it results in oversensing of noise and subsequent inappropriate shocks or failure of the ICD to deliver a shock. In particular, ICD leads with a coaxial polyurethane insulated design have frequently been the cause of lead failures and inappropriate shocks. 6,7 However, the long-term consequences of ICD lead malfunctions in the Japanese patient population have not been analyzed and that was the goal of the present study. Methods Patients The study population comprised 241 patients with 249
Indian Pacing and Electrophysiology Journal, 2019
Aims: Riata ® implantable cardioverter-defibrillator (ICD) leads from St. Jude Medical are prone to malfunction. This study aimed to describe the rate of this lead's malfunction in a very long-term follow-up. Methods: This single-centre observational study included 50 patients who received a Riata 7Fr dual-coil lead between 2003 and 2008. Follow-up was conducted both in person and remotely, and analysed at 8month intervals. We evaluated the rates of cable externalization (CE), electrical failure (EF), and the interaction of these two complications. Structural lead failure was defined as radiographic CE. Oversensing of non-cardiac signal or sudden changes in impedance, sensing, or pacing thresholds constituted EF. Results: During a mean follow-up of 10.2 ± 2.9 years, 16 patients (32%) died. We observed lead malfunction in 13 patients (26%): three (23%) due to CE, six (46%) to EF and four (31%) to both complications. Of the malfunctioning leads, 77% failed after seven years of follow-up. The incidence rate (IR) of overall malfunction per 100 patients per year was 0.9 during the first seven years post-implantation, increased to 7.0 after the 7th year and more than doubled (to 16.7) after 10 years. Beyond seven years postimplantation, IR per 100 patient-years increased in both EF and CE (from 0.6 to 5.6 vs. 0.3 to 4.2, respectively). Presence of CE was associated with a 4-fold increase in the proportion of EF. Conclusion: The incidence of Riata ICD lead malfunction, both for EF and CE, increased dramatically after seven years and then more than doubled after 10 years post-implantation.
Risk of failure of transvenous implantable cardioverter-defibrillator leads
Circulation. Arrhythmia and electrophysiology, 2009
Despite the positive effect on mortality in selected patients, implantable cardioverter-defibrillator therapy is also associated with potential malfunction of the implanted system. The present study provides the long-term lead failure rate in a large single-center cohort. Since 1992, a total of 2068 implantable cardioverter-defibrillator patients with 2161 defibrillation leads were prospectively collected. Data of the implant procedure and all follow-up visits were recorded. All cases of lead removal or capping or placing of an additional pace or sense lead were noted and analyzed. Lead models were grouped by manufacturer and approximate lead diameter in French. During a mean follow-up of 36 months, 82 (3.8%) cases of lead failure were identified. Cumulative incidence of lead failure at 1 year was 0.6%; at 5 years, 6.5%; and at 10 years, 16.4%. The highest risk of lead failure was found in small-diameter leads. Adjusted hazard ratio was 6.4 (95% CI, 3.2 to 12.8) for Medtronic 7F lea...
Comparative study of the failure rates among 3 implantable defibrillator leads
Heart Rhythm, 2016
Background: Following the introduction of the Biotronik Linox S/SD high-voltage lead, several cases of early failure have been observed. Objective: To assess the performance of the Linox S/SD lead in comparison to 2 other contemporary leads. Methods: We used the prospective Erasmus MC ICD registry to identify all implanted Linox S/SD (n=408), Durata (St. Jude Medical, model 7122)(n=340) and Endotak Reliance (Boston Scientific, model 0155, 0138 and 0158)(n=343) leads. Lead failure was defined by low/highvoltage impedance, failure to capture, sense or defibrillate, or the presence of nonphysiological signals not due to external interference. Results: During a median follow-up of 5.1 years, 24 Linox (5.9%), 5 Endotak (1.5%) and 5 Durata (1.5%) leads failed. At 5-years follow-up, the cumulative failure rate of Linox leads (6.4%) was higher compared to Endotak (0.4%; P<0.0001) and Durata leads (2.0%; P=0.003). The incidence rate was higher in Linox leads (1.3 per 100 patient-years) compared to Endotak and Durata leads (0.2 and 0.3 per 100 patient-years, respectively; P<0.001). Log-log analysis of cumulative hazard for Linox leads functioning at 3 years revealed a stable failure rate of 3%/year. The majority of failures consisted of noise (62.5%) and abnormal impedance (33.3%). Conclusions: This study demonstrates a higher failure rate of Linox S/SD high-voltage leads compared to contemporary leads. Although the mechanism of lead failure is unclear, the majority presents with abnormal electrical parameters. Comprehensive monitoring of Linox S/SD high-voltage leads includes remote monitoring to facilitate early detection of lead failure.
Necessity for Surgical Revision of Defibrillator Leads Implanted Long-Term: Causes and Management
Circulation, 2008
Background-Defibrillator lead malfunction is a potential long-term complication in patients with an implantable cardioverter-defibrillator (ICD). The aim of this study was to determine the incidence and causes of lead malfunction necessitating surgical revision and to evaluate 2 approaches to treat lead malfunction. Methods and Results-We included 1317 consecutive patients with an ICD implanted at 3 European centers between 1993 and 2004. The types and causes of lead malfunction were recorded. If the integrity of the high-voltage part of the lead could be ascertained, an additional pace/sense lead was implanted. Otherwise, the patients received a new ICD lead. Of the 1317 patients, 38 experienced lead malfunction requiring surgical revision and 315 died during a median follow-up of 6.4 years. At 5 years, the cumulative incidence was 2.5% (95% confidence interval, 1.5 to 3.6). Lead malfunction resulted in inappropriate ICD therapies in 76% of the cases. Implantation of a pace/sense lead was feasible in 63%. Both lead revision strategies were similar with regard to lead malfunction recurrence (Pϭ0.8). However, the cumulative incidence of recurrence was high (20% at 5 years; 95% confidence interval, 1.7 to 37.7). Conclusions-ICD lead malfunction necessitating surgical revision becomes a clinically relevant problem in 2.5% of ICD recipients within 5 years. In selected cases, simple implantation of an additional pace/sense lead is feasible. Regardless of the chosen approach, the incidence of recurrent ICD lead-related problems after lead revision is 8-fold higher in this population.