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Background: Device patients may require upgrade interventions from simpler to more complex cardiac implantable electronic devices. Prior to upgrading interventions, clinicians need to balance the risks and benefits of transvenous lead extraction (TLE), additional lead implantation or lead abandonment. However, evidence on procedural outcomes of TLE at the time of device upgrade is scarce. Methods: This is a post hoc analysis of the investigator-initiated multicenter Swiss TLE registry. The objectives were to assess patient and procedural factors influencing TLE outcomes at the time of device upgrades. Results: 941 patients were included, whereof 83 (8.8%) had TLE due to a device upgrade. Rotational mechanical sheaths were more often used in upgraded patients (59% vs. 42.7%, p = 0.015) and total median procedure time was longer in these patients (160 min vs. 105 min, p < 0.001). Clinical success rates of upgraded patients compared to those who received TLE due to other reasons were not different (97.6% vs. 93.0%, p = 0.569). Moreover, multivariable analysis showed that upgrade procedures were not associated with a greater risk for complications (HR 0.48, 95% confidence interval 0.14–1.57, p = 0.224; intraprocedural complication rate of upgraded patients 7.2% vs. 5.5%). Intraprocedural complications of upgraded patients were mostly associated with the implantation and not the extraction procedure (67% vs. 33% of complications). Conclusions: TLE during device upgrade is effective and does not attribute a disproportionate risk to the upgrade procedure. [ABSTRACT FROM AUTHOR]

Background: Due to high failure rates, Medtronic withdrew the Sprint Fidelis lead (SFL) from the market. Passive fixation lead models exhibited better survival than active models, but most studies have limited follow‐up. Aim of this study was to give insights into passive lead survival with a follow‐up of 10 years. Methods: In two large Swiss centers, patients with passive SFLs were identified and data from routine implantable cardioverter defibrillator (ICD) follow‐ups were collected. Patients were censored at time of death, last device interrogation (if lost to follow‐up), time of lead revision (in non‐SFL‐related problems), or at database closure (31th December 2017). We defined lead failure as any of the following: lead fracture with inappropriate discharge; sudden increase in low‐voltage impedance to >1500 or high‐voltage impedance to >100 Ω; >300 nonphysiological short VV‐intervals. Results: We identified 145 patients. Age at implant was 60 ± 12 years with a median follow‐up of 10.2 (interquartile range [IQR]: 5.0‐11.2) years. Thirty‐five percent of patients died after 5.4 ± 2.7 years. A total of 19 leads (13%) failed after 6.7 ± 3.2 years (range: 1.2‐12.0). Overt malfunction with shocks existed in four patients (3%). Cumulative lead survival was 93.1% at 6, 88.2% at 8, 83.8% at 10, and 77.6% at 11 years, respectively, with 35% of implanted leads under monitoring at 10 years. Lead survival fits best a Weibull distribution with accelerating failure rates (k = 1.95, 95% CI 1.32‐2.87, P < 0.001). Conclusions: During very long‐term follow‐up, failure rate of the passive SFL shows an increase resulting in an impaired lead survival of 84% at 10 years. [ABSTRACT FROM AUTHOR]

Background The Medtronic Sprint Fidelis lead (SFL; Medtronic Inc., Minneapolis, MN, USA) has a significantly impaired long-term survival, and active fixation leads fare worse than passive leads. The goal of this study was to present data of a series of passive SFL only with very long mean follow-up of more than 6 years. Methods Patients in whom a passive SFL was implanted in two large Swiss centers were followed. We excluded eight (5.5%) patients with a follow-up of <6 months. Patients who died or were lost during follow-up were censored at death or last device check, all others on January 31, 2014. We employed two different definitions of failure: strict = fracture with inappropriate discharge; sudden increase in impedance >1,500 or high-voltage impedance >100 Ohm; >300 nonphysiological short interventricular-intervals. Lenient = any of the above plus a linear increase in impedance >1,500 Ohm or a linear decrease in sensing to a level that treating cardiologists considered inappropriate. Results We included 137 patients. Age was 60 ± 12 years. Mean and median follow-up were 6.2 ± 2.1 and 6.8 (interquartile range 4.8-7.8) years. Applying the strict definition, 12 leads (8.8%) were replaced after 4.9 ± 2.4 years (range 1.2-8.1). Applying the lenient definition, 14 leads (10.2%) failed. Cumulative lead survival was 98.5% at 3, 96.9% at 4, 94.2% at 5, and 93.1% at 6 years. Leads 'at risk' were: n = 122 (89%), 115 (84%), 101 (74%), and 88 (64%). Conclusions In this population with passive SFLs, 5-year lead survival is impaired with 94.2% based on 74% of leads 'at risk' at this time point. [ABSTRACT FROM AUTHOR]