Subcutaneous implantable cardiac defibrillators: indications and limitations.

The implantable cardioverter defibrillator is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However, trans-venous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and during follow-up. Trans-venous endocardial lead is the weak link of implantable cardioverter defibrillator (ICD) technology being the source of most mechanical complications on vessels and heart structures and exposed to infection, malfunction and recalls. A totally subcutaneous defibrillation lead has recently been introduced in clinical practice. With the subcutaneous pulse generator forms a defibrillation system that leaves the vessels and the heart completely "untouched." Subcutaneous ICD has proven to be safe and effective in many clinical trials. Patients without pacing indications and at higher risk of complications from trans-venous lead implantation represent the perfect candidates to S-ICD technology. However, with technical improvement, it is reasonable to expect a further expansion of indications.

Safety and efficacy of internal transjugular approach for transvenous extraction of implantable cardioverter defibrillator leads.

AIMS: We report our 15 years experience of a mechanical single-sheath technique with a multiple venous entry-site approach. We evaluated the effectiveness and safety of this technique in implantable defibrillator (ICD) lead extraction and investigated the potential association between clinical and lead-related factors and procedural complexity. METHODS AND RESULTS: The proposed technique consists of an initial attempt at manual traction, followed by mechanical dilatation performed through the venous entry-site and, if necessary, by crossover to the internal transjugular approach. The study cohort comprised 545 consecutive patients referred to our institution for transvenous lead extraction from January 1997 to December 2012. Initial manual traction resulted in the effective removal of 6% of leads. Mechanical dilatation increased the success rate to 89% when performed through the venous entry-site, and to 99% when subsequently attempted via the internal jugular vein. No major complications were associated with lead extraction. Dwell-time, a passive fixation mechanism and dual-coil lead design were independently associated with the need for mechanical dilatation. However, dwell-time was the only variable associated with crossover to the internal transjugular approach. Specifically, a dwell-time of 20 months best predicted the need for venous entry-site mechanical dilatation, while a value of 55 months predicted crossover to the internal transjugular approach. CONCLUSION: Mechanical transvenous extraction of ICD leads is a complex but safe and effective procedure. A longer lead dwell-time is associated with the need for mechanical dilatation and for crossover to the internal transjugular approach; this should be considered when planning the removal procedure. Moreover, passive lead fixation and dual-coil lead design predict a more challenging extraction procedure.

Transvenous extraction profile of Riata leads: procedural outcomes and technical complexity of mechanical removal.

BACKGROUND: Riata (RT) and Sprint Fidelis (SF) leads were recalled by the United States Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications. OBJECTIVE: The purpose of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF leads. METHODS: From January 1997 to April 2014, all consecutive RT and SF leads extracted transvenously were analyzed. Among 661 consecutive patients with 705 ventricular implantable cardioverter-defibrillator (ICD) leads extracted, 194 patients with 134 RT leads (RT group) and 61 SF leads (SF group) were identified. Removal indications often were infective (64%), and extracted leads had a prevalence of dual-coil design (89%). Baseline patients and lead characteristics were comparable between groups. RESULTS: Success rate was high in both groups (97.8% RT vs 100% SF) without major complications. Mechanical dilation was comparable between groups, but RT leads often required larger sheaths (11.7 ± 1.4 vs 11.3 ± 1.4), a more frequent crossover to the internal transjugular approach (14% vs 3%), and a longer procedural time (23 ± 33 minutes vs 12 ± 16 minutes). Implantation time (odds ratio 4.84, 95% confidence interval 1.05-22.2, P = .042) and RT leads (odds ratio 1.04, 95% confidence interval 1.02-1.06, P <.001) were independent predictors of the internal transjugular approach. CONCLUSION: Extraction of RT leads is feasible and effective. However, extraction of RT leads is more complex than that of SF leads. Lack of coil backfilling and cable externalization in RT group may account for these differences.