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Hybrid minimally invasive technique with the bidirectional rotational Evolution^® mechanical sheath for transvenous lead extraction: A collaboration between electrophysiologists and cardiac surgeons.

ABSTRACT: We report a case of a 63-year-old man referred for lead extraction with the bidirectional rotational Evolution ^® RL mechanical sheath because of systemic infection. As it was judged a "high-risk" procedure, we opted for a "hybrid," minimally invasive approach consisting in a minithoracotomic access. This technique is a feasible approach, and it might be a potential safer alternative in the most challenging transvenous lead extraction procedures.

SUBMITTER: Migliore F

PROVIDER: S-EPMC6009986 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Hybrid minimally invasive technique with the bidirectional rotational Evolution® mechanical sheath for transvenous lead extraction: A collaboration between electrophysiologists and cardiac surgeons.

Migliore Federico F Cavalli Giacomo G Bottio Tomaso T Testolina Martina M De Lazzari Manuel M Bertaglia Emanuele E Iliceto Sabino S Gerosa Gino G

Journal of arrhythmia 20180430 3

We report a case of a 63-year-old man referred for lead extraction with the bidirectional rotational Evolution ® RL mechanical sheath because of systemic infection. As it was judged a "high-risk" procedure, we opted for a "hybrid," minimally invasive approach consisting in a minithoracotomic access. This technique is a feasible approach, and it might be a potential safer alternative in the most challenging transvenous lead extraction procedures. ...[more]

PMID: 29951157

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Associated factors and outcomes of crossover from a laser sheath to a bidirectional rotational mechanical sheath during transvenous lead extraction.

Project description:BackgroundDuring transvenous lead extraction (TLE), a GlideLight laser sheath (Philips) cannot always be advanced over the lead, and crossover to the Evolution system (i.e., an Evolution RL sheath or Evolution Shortie RL sheath [Cook Medical]) is required. We aimed to determine the associated factors and outcomes of such device crossover.MethodsThis observational study included 112 patients who underwent TLE. The patients were divided into crossover and non-crossover groups. Outcomes and associated factors of crossover were evaluated.ResultsOverall, 57 (50.9%) patients required crossover to the Evolution system (crossover group), whereas 55 (49.1%) patients did not require crossover (non-crossover group). Clinical success rate was similar between the two groups (98.3% vs. 100%; p = 1.00). No major intraprocedural complications related to powered sheaths occurred. Multivariate logistic regression analysis results showed that dwell time of the oldest extracted lead (per year) (odds ratio [OR]: 1.18, 95% confidence interval [CI]: 1.02-1.36; p = .026), number of leads extracted per procedure (OR: 7.23, 95% CI: 1.74-29.99; p = .007), and use of a femoral approach (OR: 21.09, 95% CI: 2.33-190.67; p = .007) were associated factors of crossover. The cutoff for crossover was 7.7 years from the implant (sensitivity 90.5%, specificity 64.9%, area under the curve 0.80).ConclusionsBoth groups showed a high rate of clinical success. Switching to the Evolution system may facilitate a safe and effective TLE when a laser sheath does not advance despite laser activation.

| S-EPMC10692839 | biostudies-literature

Evaluation of tricuspid valve regurgitation following transvenous rotational mechanical lead extraction.

Project description:AimsTransvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes.Methods and resultsIn 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035).ConclusionSignificant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.

| S-EPMC11282457 | biostudies-literature

Transvenous lead extraction using the TightRail mechanical rotating dilator sheath for Asian patients.

Project description:The need for transvenous lead extraction (TLE) is increasing worldwide including in Asia-Pacific regions. However, supporting evidence for TightRail, a relatively new rotating mechanical dilator sheath, is still lacking in Asian patients. The efficacy and safety of TLE using TightRail performed between March 2018 and June 2021 were evaluated in 86 consecutive patients with 131 leads. The mean lead age was 11.7 ± 7.3 (range, 1.0-41.4) years. Clinical and complete procedural success using TightRail were achieved in 93.0% and 89.5% of 86 patients, respectively, with 6 min of median fluoroscopic time and 9.3% of major complication rate: death (1.2%), cardiac tamponade (3.5%), severe tricuspid regurgitation (3.5%), and stroke (1.2%). However, in 46 patients with longest lead age ≤ 10 years, clinical/complete success and major cardiac complication rates turned out better as 97.8%, 95.7%, and 2.2%, respectively. Additionally, when patients were divided into 3 groups: the first 28, second 29, and the last 29 patients, there was a clear trend toward better efficacy and safety outcomes with more experience with TightRail (Ptrend < 0.05). Longest lead age > 10 years was closely associated with TLE-related major cardiac complication (P = 0.046) with 85.7% sensitivity, 57.0% specificity, 15.0% positive predictive value, and 97.8% negative predictive values. In conclusion, TLE using TightRail may be effectively and safely performed by experienced operators for Asian patients with the longest lead age ≤ 10 years. However, as TightRail is a potentially aggressive tool, special attention should be paid to patients with longer lead dwelling times (e.g., > 10 years).

| S-EPMC8764071 | biostudies-literature

Angioscopic observation of venous endothelium after transvenous lead extraction with excimer laser sheath: Initial experience

Project description: Not available

| S-EPMC9810997 | biostudies-literature

Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, international clinical study.

Project description:BackgroundTransvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices. Mechanical TLE tools, including rotational sheaths, are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools.ObjectiveTo prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage.MethodsPatients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified and complications were adjudicated by an independent clinical events committee (CEC).ResultsBetween October 2018 and January 2020, mechanical TLE tools, including rotational sheaths, were used to extract 460 leads with a median indwell time of 7.4 years from 230 patients (mean age 64.3 ± 14.4 years). Noninfectious indications for TLE were more common than infectious indications (61.5% vs 38.5%, respectively). The extracted leads included 305 pacemaker leads (66.3%) and 155 implantable cardioverter-defibrillator leads (33.7%), including 85 leads with passive fixation (18.5%). A bidirectional rotational sheath was needed for 368 leads (88.0%). Clinical success was obtained in 98.7% of procedures; complete procedural success was achieved for 96.3% of leads. CEC-adjudicated device-related major complications occurred in 6 of 230 (2.6%) procedures. No isolated superior vena cava injury or procedural death occurred.ConclusionThis prospective clinical study demonstrates that use of mechanical TLE tools, especially bidirectional rotational sheaths, are effective and safe.

| S-EPMC8183877 | biostudies-literature

Predictors of lead break during transvenous lead extraction.

Project description:BackgroundThe incidence, predictors, and clinical impact of lead break during transvenous lead extraction (TLE) were previously unknown.MethodsWe included consecutive patients who underwent TLE between September 2013 and July 2019 at our institute. Lead break during removal was defined as lead stretching and becoming misshapen, as assessed by fluoroscopy.ResultsA total of 246 patients underwent TLE for 501 leads. At a patient level, complete success was achieved in 226 patients (91.9%). At a lead level, 481 leads (96.0%) were completely removed and 101 leads (20.1%) were broken during the procedure. Of 392 identified pacemaker leads, 71 (18.3%) were broken during the TLE procedure. A multivariable analysis confirmed high lead age (odds ratio [OR] 1.12, 95% confidence interval (CI) 1.07-1.17; P < .001), passive leads (OR 2.29 95% CI 1.09-4.80; P = .028), coradial leads (OR 3.45 95% CI 1.72-6.92; P < .001), and insulators made of nonpolyurethane (OR 2.38 95% CI 1.03-5.26; P = .04) as predictors of lead break. Broken leads needed longer procedure times and were associated with a higher rate of cardiac tamponade.ConclusionsLead age, coradial bipolar leads, passive leads, and leads without polyurethane insulation were predictors of lead break and could increase the difficulty of lead extraction.

| S-EPMC8207345 | biostudies-literature

Transvenous lead extraction: The jugular snare technique.

Project description: Not available

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A 'ghost' after transvenous intracardiac lead extraction.

Project description: Not available

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Rotational Thromboelastometry (ROTEM®) in Relation to Inflammatory Biomarkers and Clinical Outcome in COVID-19 Patients.

Project description:Background: The pathogenesis of hypercoagulability in COVID-19 patients is complex and not fully understood. Rotational thromboelastometry (ROTEM®) is a viscoelastic method that allows the definition of a patient's hemostatic profile. This study aimed to assess the relationship between ROTEM® parameters, the profile of inflammatory cytokines, and clinical outcomes in COVID-19 patients. Methods: A total of 63 participants (n = 29 symptomatic non-ICU COVID-19 patients, and n = 34 healthy controls) were prospectively included in the study. We assessed the relationship between the parameters of three ROTEM® tests (NATEM®, EXTEM®, and FIBTEM®) and levels of CRP, interleukin-8, interleukin-1β, interleukin-6, interleukin-10, tumor necrosis factor, interleukin 12p70, and clinical outcomes. Results: ROTEM® indicated hypercoagulability in COVID-19 patients in all the tests performed. The levels of all inflammatory cytokines were significantly higher in COVID-19 patients. NATEM more frequently detected hypercoagulability in COVID-19 patients compared to EXTEM. The strongest correlations with inflammatory biomarkers and CT severity score were with FIBTEM parameters. The elevated maximum clot elasticity (MCE) in FIBTEM was the strongest predictor of poor outcomes. Conclusions: Increased FIBTEM MCE may be associated with greater severity of COVID-19. Non-activated ROTEM (NATEM test) seems to be more valuable for detecting hypercoagulability in COVID-19 patients compared to the tissue factor activated test (EXTEM).

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Rexin-G®, a tumor-targeted retrovector for malignant peripheral nerve sheath tumor: A case report.

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| S-EPMC5451875 | biostudies-literature