Stefano Viani

Major predictors of fibrous adherences in transvenous implantable cardioverter-defibrillator lead extraction

BACKGROUND Percutaneous removal of implantable cardioverter-defibrillator (ICD) leads is a difficult procedure because of the consequence of massive fibrous tissue growth along the lead. OBJECTIVE The purpose of this study was to describe the occurrence and location of fibrous adherences in ICD lead extraction and to identify potential predictors among patient and lead characteristics. METHODS We studied 637 consecutive patients who underwent transvenous extraction of 678 ICD leads from 1997 to 2013. RESULTS Procedural success rate was 99%, without major complications. Areas of adherence were found in the subclavian vein (78%), innominate vein (65%), superior vena cava (66%), and heart (73%). Dwell-time, passive fixation, and dual-coil lead design were independently associated with adherences. Dual-coil lead design was associated with adherences in the innominate vein and superior vena cava, whereas coil treatment (eg, expandable polytetrafluoroethylene-coated or medical adhesive back-filled strategies) prevented adherences. Passive fixation mechanism was associated with adherences in the heart. CONCLUSION ICD leads, after long dwell-time, are affected by fibrous adherences uniformly distributed along the lead course. Lead features represent major predictors of the phenomenon. Careful lead selection is recommended at the time of implantation to prevent adherences. In addition, lead-related risk stratification is mandatory before a transvenous extraction procedure.

Large, Single-Center Experience in Transvenous Coronary Sinus Lead Extraction: Procedural Outcomes and Predictors for Mechanical Dilatation

Background: The aim of this study was to evaluate procedural outcomes of coronary sinus (CS) lead extraction, focusing on predictors and need for mechanical dilatation (MD) in the event that manual traction (MT) is ineffective.

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.

Effectiveness of subcutaneous implantable cardioverter-defibrillator testing in patients with hypertrophic cardiomyopathy

BACKGROUND Subcutaneous ICD (S-ICD) is a promising option for Hypertrophic Cardiomyopathy (HCM) patients at risk of Sudden Cardiac Death (SCD). However, its effectiveness in terminating ventricular arrhythmias in HCM is yet unresolved. METHODS Consecutive HCM patients referred for S-ICD implantation were prospectively enrolled. Patients underwent one or two attempts of VF induction by the programmer. Successful conversion was defined as any 65J shock that terminated VF (not requiring rescue shocks). Clinical and instrumental parameters were analyzed to study predictors of conversion failure. RESULTS Fifty HCM patients (34 males, 40±16years) with a mean BMI of 25.2±4.4kg/m2 were evaluated. Mean ESC SCD risk of was 6.5±3.9% and maximal LV wall thickness (LVMWT) was 26±6mm. In 2/50 patients no arrhythmias were inducible, while in 7 (14%) only sustained ventricular tachycardia was induced and cardioverted. In the remaining 41 (82%) patients, 73 VF episodes were induced (1 episode in 14 and >1 in 27 patients). Of these, 4 (6%) spontaneously converted. In 68/69 (98%) the S-ICD successfully cardioverted, but failed in 1 (2%) patient, who needed rescue defibrillation. This patient was severely obese (BMI 36) and LVMWT of 25mm. VF was re-induced and successfully converted by the 80J reversed polarity S-ICD. CONCLUSIONS Acute DT at 65J at the implant showed the effectiveness of S-ICD in the recognition and termination of VT/VF in all HCM patients except one. Extreme LVH did not affect the performance of the device, whereas severe obesity was likely responsible for the single 65J failure.

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.

Short-term extraction profile of cardiac pacing leads with hybrid silicone–polyurethane insulator: A pilot study

[8]. There are no other studies which were designed to compare vernakalant versus EC. Our study is the first clinical investigation which compared these two protocols and showed that the conversion rate and hospital stay length were similar in both groups without statistical differences with the same safety. With these results with a protocol for EC which needs sedation and fasting for a minimum of 3 to 6 h depending on the different recommendations, we think that vernakalant is a safe and effective drug for conversion recent-onset atrial fibrillation instead of EC in this population, althoughwe believe thatwe need clinical randomized trials withmore patients to be able to reach the certainty that these results are able to extrapolate to the daily practice. Study limitations: Not to be a randomized trial is the most important limitation of this study. The sample size may underestimate the differences between the groups. A larger sample size could produce statistically significant differences in conversion rate and hospital stay length between both groups. Conclusions: The conversion rate of recent-onset AF and hospital stay length was similar in vernakalant and EC group without statistical differences. No adverse events were reported in both groups. References

Cardiac resynchronization therapy after coronary sinus lead extraction: feasibility and mid-term outcome of transvenous reimplantation in a tertiary referral centre

AIMS Few data are available on cardiac resynchronization therapy (CRT) after coronary sinus (CS) lead extraction. We aimed to evaluate the feasibility and mid-term outcome of transvenous CS lead reimplantation in a tertiary referral centre. METHODS AND RESULTS We enrolled all patients who were referred to our hospital for CS lead removal from December 2000 through to May 2009 and were transvenously reimplanted with a CRT system before June 2009. One-year follow-up was performed to evaluate the incidence of infections, malfunctions, and mortality. We studied 113 consecutive patients undergoing successful CS lead extraction; 90 patients (75 male, mean age 69.2, range 35-84) underwent CS lead reimplantation (success rate: 95.6%; right-sided approach: 64.4%). In these patients, cardiac device infection was the usual indication for extraction (74.4%) and the subsequent reimplantation was performed after a median time of 3 days. The coronary sinus lead was usually positioned in the left ventricular (LV) postero-lateral region (62.2%); two procedures were required in two cases (2.2%). Balloon angioplasty was necessary for two patients (failure in one), whereas for the others we used a conventional implant technique. During follow-up, we observed four cases (4.4%) of local infection and six cases (6.7%) of system malfunction, requiring reintervention (two cases during the same hospitalization). One-year mortality was 5.5%. CONCLUSION Left ventricular lead reimplantation is in our experience an effective and safe procedure, also in the case of right-sided approach. During follow-up, 1-year mortality was particularly low, whereas overall infection rate was higher than first implant procedures.

Where is the future of cardiac lead extraction heading

ABSTRACT Introduction: Transvenous lead extraction (TLE) is the gold standard for lead removal. The increasing rate of cardiac implantable electronic device (CIED) implantations and of CIED related complications highlight the importance of transvenous lead extraction . Areas covered: The TLE scenario is constantly changing. Optimizing lead related technology and improving TLE practice across the world are the cornerstones to improving safety and efficacy. We review the state of the art in TLE, focusing on potential future implications and improvements in terms of skills and technologies. Expert commentary: The increased number of extractions will increase the necessity of safe and effective TLE. New technologies, techniques and appropriate training is warranted across the world.

Subcutaneous implantable cardioverter defibrillator eligibility according to a novel automated screening tool and agreement with the standard manual electrocardiographic morphology tool

PurposeSince subcutaneous implantable cardioverter defibrillator (S-ICD) introduction, the pre-implant screening based on a dedicated manual ECG tool (MST) was required to assure adequate sensing by the S-ICD. A novel automated screening tool (AST) has been recently developed. We assessed and compared the pass rate with AST and MST, and we measured the agreement between screening tools.MethodsThree electrodes were positioned at locations mimicking the placement of the S-ICD, and ECG recordings were collected in the supine and standing postures at rest. The three sensing vectors were analyzed with the MST and the AST. Eligibility was defined by the presence of at least one or two appropriate vectors in both postures.ResultsA total of 235 patients with an indication to ICD and no need for permanent pacing were enrolled. At least one suitable vector was identified in 214 (91%) patients with MST and 221 (94%) patients with AST (p = 0.219). At least two vectors were appropriate in 162 (69%) patients with MST and 187 (80%) patients with AST (p = 0.008). Overall, out of 1587 ECG analyzed, 1035 (65%) qualifying leads were identified with MST and 1111 (70%) with AST (p = 0.004). The agreement between the results of MST and AST ECG analysis was moderate (Kappa = 0.570; standard error = 0.022; CI = 0.526–0.613). The results were consistent regardless of the underlying cardiomyopathy. The most frequent reason for screening failure with MST was a high-amplitude T-wave (31% of failures). With AST, 23% of recordings that failed with MST for high-amplitude T-wave were classified as acceptable.ConclusionThe AST is associated with higher pass rate than the standard MST. It seems more tolerant of high-amplitude T-waves. Consequently, the agreement between MST and AST findings was only moderate.