ArticleLiterature Review

Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction With the Excimer Sheath (PLEXES) Trial

May 1999
Journal of the American College of Cardiology 33(6):1671-1676

May 1999
33(6):1671-1676

DOI:10.1016/S0735-1097(99)00074-1

Authors:

Bruce Wilkoff

Cleveland Clinic

Charles J Love

The Ohio State University

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OBJECTIVESThe purpose of this study was to evaluate the safety and effectiveness of pacemaker lead extraction with the excimer sheath in comparison to nonlaser lead extraction.BACKGROUNDFibrotic attachments that develop between chronically implanted pacemaker leads and to the venous, valvular and cardiac structures are the major obstacles to safe and consistent lead extraction. Locking stylets and telescoping sheaths produce a technically demanding but effective technique of mechanically disrupting the fibrosis. However, ultraviolet excimer laser light dissolves instead of tearing the tissue attachments.METHODSA randomized trial of lead extraction was conducted in 301 patients with 465 chronically implanted pacemaker leads. The laser group patients had the leads removed with identical tools as the nonlaser group with the exception that the inner telescoping sheath was replaced with the 12-F excimer laser sheath. Success for both groups was defined as complete lead removal with the randomized therapy without complications.RESULTSComplete lead removal rate was 94% in the laser group and 64% in the nonlaser group (p = 0.001). Failed nonlaser extraction was completed with the laser tools 88% of the time. The mean time to achieve a successful lead extraction was significantly reduced for patients randomized to the laser tools, 10.1 ± 11.5 min compared with 12.9 ± 19.2 min for patients randomized to nonlaser techniques (p < 0.04). Potentially life-threatening complications occurred in none of the nonlaser and three of the laser patients, including one death (p = NS).CONCLUSIONSLaser-assisted pacemaker lead extraction has significant clinical advantages over extraction without laser tools and is associated with significant risks.

Transvenous Lead Extraction: Work in Progress

Article

Full-text available

Jun 2023

Cardiac implantable electronic devices are the cornerstone of cardiac rhythm management, with a significant number of implantations annually. A rising prevalence of cardiac implantable electronic devices coupled with widening indications for device removal has fuelled a demand for transvenous lead extraction (TLE). With advancement of tools and techniques, the safety and efficacy profile of TLE has significantly improved since its inception. Despite these advances, TLE continues to carry risk of significant complications, including a superior vena cava injury and mortality. However, innovative approaches to lead extraction, including the use of the jugular and femoral accesses, offers potential for further gains in safety and efficacy. In this review, the indications and risks of TLE are discussed while examining the evolution of this procedure from simple traction to advanced methodologies, which have contributed to a significant improvement in safety and efficacy.

Atrial Fibrillation and Transvenous Lead Extraction—A Comprehensive Subgroup Analysis of the GermAn Laser Lead Extraction RegistrY (GALLERY)

Article

Full-text available

Nov 2022

Background: Atrial fibrillation is the most common arrhythmia and has been described as driver of cardiovascular morbidity and risk factor for cardiac device-related complications, as well as in transvenous lead extraction (TLE). Objectives: Aim of this study was to characterize the procedural outcome and risk-factors of patients with atrial fibrillation (AF) undergoing TLE. Methods: We performed a subgroup analysis of all AF patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) database. Predictors for all-cause mortality were assessed. Results: A total number of 510 patients with AF were identified with a mean age of 74.0 ± 10.3 years. Systemic infection (38.4%) was the leading cause for TLE, followed by local infection (37.5%) and lead dysfunction (20.4%). Most of the patients (45.9%) presented with pacemaker systems to be extracted. The total number of leads was 1181 with a 2.3 ± 0.96 leads/patient. Clinical procedural success was achieved in 97.1%. Occurrence of major complications was 1.8% with a procedure-related mortality of 1.0%. All-cause mortality was high with 5.9% and septic shock being the most common cause. Systemic device infection (OR: 49.73; 95% CI: 6.56–377.09, p < 0.001), chronic kidney disease (CKD; OR: 2.67; 95% CI: 1.01–7.03, p = 0.048) and a body mass index < 21 kg/m2 (OR: 6.6; 95% CI: 1.68–25.87, p = 0.007) were identified as independent predictors for all-cause mortality. Conclusions: TLE in AF patients is effective and safe, but in patients with systemic infection the mortality due to septic shock is high. Systemic infection, CKD and body mass index <21 kg/m2 are risk factors for death in patient with AF undergoing TLE.

Our Nuts and Bolts in The Permanent Pacemakers’ Explanation Techniques

Article

Full-text available

Sep 2022

Objective: Our goal is to share our two decades of experience with implantable electrical device explanation at our electrophysiology centre at Hayat Abad Medical Complex in Peshawar. Methodology: After baseline patient were brought nil by mouth to catheterization laboratory (Cath: lab). A temporary pacemaker (TPM) implanted for backup. In case of box change, a new device is attached after checking the integrity of the lead and device placed in the same pocket. But if of lead extraction was also needed, then stylet was put inside the lead and with twisting movement and mild traction the lead removed and new lead implanted with Seldinger,s technique, battery attached and wound closed in layers. Results: Out of 1670, there were 1535 (91.9%) new implantations and 135 (8.08%) repeat procedures. The pulse generator was replaced without lead replacement in 59 (3.5%) patients. In 36 (2.15%) patients, the ventricular lead or atrial lead was successfully reposition. A total of 32 (1.9%) successful explanations were performed in the study period. Conclusion: The explanation of devices like implantation needs special gadgets and training for the safe and successful procedure.

Safety and Effectiveness of Transvenous Lead Extraction in Patients with Infected Cardiac Resynchronization Therapy Devices; Is It More Risky than Extraction of Other Systems?

Article

Full-text available

May 2022
Int J Environ Res Publ Health

Background: Transvenous lead extraction (TLE) in patients with implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices is considered as more risky. The aim of this study was to assess the safety and effectiveness of TLE in patients with infected CRT systems. Methods: Data of 3468 patients undergoing TLE in a single high-volume center in years 2006-2021 were analyzed. The clinical and procedural parameters as well as the efficacy and safety of TLE were compared between patients with infected CRT and pacemakers (PM) and ICD systems. Results: Infectious indications for TLE occurred in 1138 patients, including 150 infected CRT (112 CRT-D and 38 CRT-P). The general health condition of CRT patients was worse with higher Charlson's comorbidity index. The number of extracted leads was higher in the CRT group, but implant duration was significantly longer in the PM than in the ICD and CRT groups (98.93 vs. 55.26 vs. 55.43 months p < 0.01). The procedure was longer in duration, more difficult, and more complex in patients with pacemakers than in those in the CRT group. The occurrence of major complications and clinical and procedural success as well as procedure-related death did not show any relationship to the type of CIED device. Mortality at more than one-year follow-up after TLE was significantly higher among patients with CRT devices (22.7% vs. 8.7%) than among those in the PM group. Conclusion: Despite the greater burden of lead and comorbidities, the complexity and efficiency of removing infected CRT systems is no more dangerous than removing other infected systems. The duration of the implant seems to play a dominant role.

Transvenous Lead Extraction without Procedure-Related Deaths in 1000 Consecutive Patients: A Single-Center Experience

Article

Full-text available

Aug 2021
Vasc Health Risk Manag

Background: Transvenous lead extraction (TLE) is now a first-line technique for the treatment of complications related to cardiac implantable electronic devices. The aim of the study was to demonstrate that it is possible to safely perform difficult TLE procedures with a maximum reduction of peri-procedural major complications. Methods: A total of 1000 consecutive patients undergoing TLE in a single high-volume center from 2016 to 2019 were studied. All procedures were performed in a hybrid room or operating room by a specialized TLE team. TLE was performed under general anesthesia and monitored by transesophageal echocardiography, and the operating room was suitably equipped for immediate surgical intervention. The effectiveness and safety of the procedures were assessed, with particular emphasis on major complications. Results: In all, 1952 leads with the mean implant duration of 111.7 ± 77.6 months had been extracted. Complete procedural success of patients was achieved in 95.9% and clinical success in 99.1%. Major complications, predominantly cardiac tamponade (63.3%), occurred in 22 patients (2.2%). Rapid diagnosis and immediate intervention were the key to a 100% survival in patients with this complication. Conclusion: Performing procedures in a hybrid operating room under general anesthesia in the presence of a cardiac surgeon and with the use of transesophageal echocardiography significantly improves the safety of transvenous lead extraction.

Lead Extraction of Very Old Leads—A GALLERY Subgroup Analysis

Conference Paper

Feb 2024
THORAC CARDIOV SURG

Safety and Efficacy of Excimer Laser Powered Lead Extractions in Obese Patients: A GALLERY Subgroup Analysis

Article

Full-text available

Jun 2023

Background: The incidence of cardiac implantable electronic device (CIED)-related complications, as well as the prevalence of obesity, is rising worldwide. Transvenous laser lead extraction (LLE) has grown into a crucial therapeutic option for patients with CIED-related complications but the impact of obesity on LLE is not well understood. Methods and results: All patients (n = 2524) from the GermAn Laser Lead Extraction RegistrY (GALLERY) were stratified into five groups according to their body mass index (BMI, <18.5; 18.5-24.9; 25-29.9; 30-34.9; ≥35 kg/m2). Patients with a BMI ≥ 35.0 kg/m2 had the highest prevalence of arterial hypertension (84.2%, p < 0.001), chronic kidney disease (36.8%, p = 0.020) and diabetes mellitus (51.1%, p < 0.001). The rates for procedural minor (p = 0.684) and major complications (p = 0.498), as well as procedural success (p = 0.437), procedure-related (p = 0.533) and all-cause mortality (p = 0.333) were not different between groups. In obese patients (BMI ≥ 30 kg/m2), lead age ≥10 years was identified as a predictor of procedural failure (OR: 2.99; 95% CI: 1.06-8.45; p = 0.038). Lead age ≥10 years (OR: 3.25; 95% CI: 1,31-8.10; p = 0.011) and abandoned leads (OR: 3.08; 95% CI: 1.03-9.22; p = 0.044) were predictors of procedural complications, while patient age ≥75 years seemed protective (OR: 0.27; 95% CI: 0.08-0.93; p = 0.039). Systemic infection was the only predictor for all-cause mortality (OR: 17.68; 95% CI: 4.03-77.49; p < 0.001). Conclusions: LLE in obese patients is as safe and effective as in other weight classes, if performed in experienced high-volume centers. Systemic infection remains the main cause of in-hospital mortality in obese patients.

The GermAn Laser Lead Extraction RegistrY: GALLERY

Article

Jun 2022
EUROPACE

Aims The GermAn Laser Lead Extraction GallerY (GALLERY) is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany. Methods and results Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. About 5499 leads with a median lead dwell time of 96 (62–141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease. Conclusion In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

Comparison between laser sheaths, femoral approach and rotating mechanical sheaths for lead extraction

Article

Full-text available

Dec 2021

Introduction Efficiency and safety are important features in the selection of lead extraction tools. We report our experience with different endovascular techniques to extract individual pacing and defibrillator leads. Methods This is a single-centre study of consecutive lead extraction procedures from 1997 until 2019. A total of 1725 leads were extracted in 775 patients. Direct traction sufficed for 588 leads, and 22 leads were primarily removed by surgery. The endovascular techniques used in the remainder were a laser sheath (190 leads), the femoral approach (717 leads) and rotating mechanical sheaths (208 leads). Results The three approaches were comparably effective in completely removing the leads ( p = 0.088). However, there were more major complications with the laser sheath than with the femoral approach or rotating mechanical sheaths (8.4%, 0.5% and 1.2%, respectively). Therefore, the procedural result—extraction without major complications—was significantly better with both the femoral approach and rotating mechanical sheaths than with the laser sheath ( p < 0.001). This result was confirmed after propensity score matching to compensate for differences between lead cohorts ( p = 0.007). Cross-over to another endovascular tool was necessary in 7.9%, 7.1% and 8.2% of laser, femoral and rotating mechanical attempts, respectively. Conclusion All three endovascular lead extraction techniques showed comparable efficacy. However, there were significantly more major complications using the laser sheath compared to the femoral approach or rotating mechanical sheaths, leading us to abandon the laser technique. Importantly, no single endovascular technique sufficed to successfully extract all leads.

Efficacy and mortality of rotating sheaths versus laser sheaths for transvenous lead extraction: a meta-analysis

Article

Full-text available

Nov 2021
J INTERV CARD ELECTR

Background Rotating and laser sheaths are both routinely used in transvenous lead extraction (TLE) which can lead to catastrophic complications including death. The efficacy and risk of each approach are uncertain. To perform a meta-analysis to compare success and mortality rates associated with rotating and laser sheaths. Methods We searched electronic academic databases for case series of consecutive patients and randomized controlled trials published 1998–2017 describing the use of rotating and laser sheaths for TLE. Among 48 studies identified, rotating sheaths included 1,094 patients with 1,955 leads in 14 studies, and laser sheaths included 7,775 patients with 12,339 leads in 34 studies. Patients receiving rotating sheaths were older (63 versus 60 years old) and were more often male (74% versus 72%); CRT-P/Ds were more commonly extracted using rotating sheaths (12% versus 7%), whereas ICDs were less common (37% versus 42%), p > 0.05 for all. Infection as an indication for lead extraction was higher in the rotating sheath group (59.8% versus 52.9%, p = 0.002). The mean time from initial lead implantation was 7.2 years for rotating sheaths and 6.3 years for laser sheaths ( p > 0.05). Results Success rates for complete removal of transvenous leads were 95.1% in rotating sheaths and 93.4% in laser sheaths ( p < 0.05). There was one death among 1,094 patients (0.09%) in rotating sheaths and 66 deaths among 7,775 patients (0.85%) in laser sheaths, translating to a 9.3-fold higher risk of death with laser sheaths (95% CI 1.3 to 66.9, p = 0.01). Conclusions Laser sheaths were associated with lower complete lead removal rate and a 9.3-fold higher risk of death.

Comparison of non-laser and laser transvenous lead extraction: a systematic review and meta-analysis

Article

Full-text available

Oct 2023
EUROPACE

Background: Transvenous lead extraction (TLE) is performed using non-laser and laser techniques with overall high efficacy and safety. Variation in outcomes between the two approaches does exist with limited comparative evidence in the literature. Aim: We sought to compare non-laser and laser TLE in a meta-analysis. Methods: We searched Medline, Embase, Scopus, ClinicalTrials.gov and CENTRAL databases for TLE studies published between 1991-2021. From the included 68 studies, safety and efficacy data was carefully evaluated and extracted. Aggregated cases of outcomes were used to calculate odds ratio (OR) and pooled rates were synthesised from eligible studies, to compare non-laser and laser techniques. Subgroup comparison of rotational tool and laser extraction was also performed. Results: Non-laser in comparison to laser had lower procedural mortality (pooled rate 0% vs 0.1%, p < 0.01), major complications (pooled rate 0.7% vs 1.7%, p < 0.01) and superior vena cava (SVC) injury (pooled rate 0% vs 0.5%, p < 0.001), with higher complete success (pooled rate 96.5% vs 93.8%, p < 0.01). Non-laser comparatively to laser was more likely to achieve clinical (OR 2.16 [1.77-2.63], p < 0.01) and complete (OR 1.87 [1.69-2.08], p < 0.01) success, with a lower procedural mortality risk (OR 1.6 [1.02-2.5], p < 0.05). In the subgroup analysis, rotational tool compared to laser achieved greater complete success (pooled rate 97.4% vs 95%, p < 0.01) with lower SVC injury (pooled rate 0% vs 0.7%, p < 0.01). Conclusion: Non-laser TLE is associated with a better safety and efficacy profile when compared to laser methods. There is a greater risk of SVC injury associated with laser sheath extraction.

Transvenous Lead Extraction in a European Low-Volume Center without On-Site Surgical Support

Article

Full-text available

Sep 2023

Indications for cardiac implantable electronic devices (CIEDs) are increasing. Almost one-third of device-related infections are endocarditis. Transvenous lead extraction (TLE) has emerged as an effective and safe approach for treating device-related infections and complications. Multiple types of extraction tools are being used worldwide. Our goal is to evaluate the safety and effectiveness of TLE using non-powered extraction tools. The study included patients between October 2018 and July 2022 requiring TLE according to EHRA expert consensus recommendations on lead extraction. A total of 88 consecutive patients were included. Indications for TLE included device-related infections in 74% of the patients. Of those, 32% had device-related endocarditis with or without sepsis. Staphylococcus Aureus was the most frequent pathogen in patients with endocarditis and positive bacteremia, and 57% had negative bloodstream cultures. A total of 150 cardiac pacing and defibrillator leads were targeted for extraction. The mean dwell time for leads was 6.92 ± 4.4 years; 52.8% were older than 5 years, 15.8% were older than ten years, and the longest lead dwell time was 26 years. Patients’ age varied between 18 and 98, with a mean age of 66 ± 16 years. Sixty-seven percent of patients were males. Using only non-powered extraction tools, we report 93.3% complete lead removal and 99% clinical success with partial extraction. We report no procedure-related death nor major complications. Minor complication incidence was 6.8%, and all complications resolved spontaneously. The 30-day mortality rate was 3.4%. TLE using non-powered extraction tools is safe and effective even without surgical backup on site.

Antegrade approach for peripheral intravascular lithotripsy pretreatment to facilitate laser lead extraction

Article

Full-text available

Aug 2023
J INTERV CARD ELECTR

Use of peripheral intravascular lithotripsy (Shockwave balloon) pretreatment to facilitate laser lead extraction

Safety and Efficacy of a Single Procedure of Extraction and Reimplantation of Infected Cardiovascular Implantable Electronic Device (CIED) in Comparison with Deferral Timing: An Observational Retrospective Multicentric Study

Article

Full-text available

Jun 2023

(1) Background: Infections are among the most frequent and life-threatening complications of cardiovascular implantable electronic device (CIED) implantation. The aim of this study is to compare the outcome and safety of a single-procedure device extraction and contralateral implantation versus the standard-of-care (SoC) two-stage replacement for infected CIEDs. (2) Methods: We retrospectively included 66 patients with CIED infections who were treated at two Italian hospitals. Of the 66 patients enrolled in the study, 27 underwent a single procedure, whereas 39 received SoC treatment. All patients were followed up for 12 months after the procedure. (3) Results: Considering those lost to follow-up, there were no differences in the mortality rates between the two cohorts, with survival rates of 81.5% in the single-procedure group and 84.6% in the SoC group (p = 0.075). (4) Conclusions: Single-procedure reimplantation associated with an active antibiofilm therapy may be a feasible and effective therapeutic option in CIED-dependent and frail patients. Further studies are warranted to define the best treatment regimen and strategies to select patients suitable for the single-procedure reimplantation.

Same-day discharge after transvenous lead extraction: feasibility and outcomes

Article

Full-text available

Dec 2022
EUROPACE

Aims: Same-day discharge (SDD) is safe for patients undergoing electrophysiology procedures. There is no existing data regarding SDD for patients undergoing transvenous lead extraction (TLE). We report our experience with SDD for patients undergoing TLE. Methods and results: The study group included patients undergoing TLE between February 2020 and July 2021 without an infectious indication. A modified SDD protocol for device implants/ablations was applied to TLE patients. Patient characteristics, extraction details, outcomes, and complications were reviewed. Of 239 patients undergoing TLE, 210 were excluded (94 infections and 116 did not meet SDD criteria). Of the remaining 29 patients, seven stayed due to patient preference and 22 were discharged home the same day. The SDD group had an average age of 65.9 ± 12 (47-84), 41% female, and LVEF of 52.2 ± 18% (10-80). The indication for TLE was malfunction (20), upgrade (4), advisory lead (2), and magnetic resonance imaging compatibility (1). Extractions included four implantable cardioverter-defibrillators (ICDs), 17 pacemakers (PPM), and one cardiac resynchronization therapy (CRT)-P system. The leads were 9.6 years (1.5-21.7) old, and 1.8 leads were removed per patient (1-3); the lead extraction difficulty (LED) score was 11.6 ± 7. Twenty underwent cardiovascular implantable electronic device (CIED) re-implantation (2 ICD, 3 CRT-D, 13 PPM, and 2 CRT-P). For CIED re-implants, patients sent a remote transmission the next day, and all patients received a next-day call. There were no procedure or device-related issues, morbidities, or mortalities in the 30 days after discharge. Conclusion: Same-day discharge after TLE for non-infectious aetiologies is safe and feasible in a select group of patients with early procedure completion who meet strict SDD criteria.

Sex differences in outcomes of transvenous lead extraction: insights from National Readmission Database

Article

Full-text available

Nov 2022
J INTERV CARD ELECTR

Background With the growing use of implantable cardiac devices, the need for transvenous lead extraction has increased, which translates to increased procedural volumes. Sex differences in lead extraction outcomes are not well studied.Objective The present study aims at evaluating the impact of sex on outcomes of lead extraction.Methods We identified 71,754 patients who presented between 2016 and 2019 and underwent transvenous lead extraction. Their clinical data were retrospectively accrued from the National Readmission Database (NRD) using the corresponding diagnosis codes. We compared clinical outcomes between male and female patients. Odds ratios (ORs) for the primary and secondary outcomes were calculated, and multivariable regression analysis was utilized to adjust for confounding variables.ResultsCompared to male patients, female patients had higher in-hospital complications including pneumothorax (OR 1.26, 95% CI (1.07–1.4), P < 0.01), hemopericardium (OR 1.39, 95% CI (1.02–1.88), P = 0.036), injury to superior vena cava and innominate vein requiring repair (OR 1.88, 95% CI (1.14–3.1), P = 0.014; OR 3.4, 95% CI (1.8–6.5), P < 0.01), need for blood transfusion (OR 1.28, 95% CI (1.18–1.38), P < 0.01), and pericardiocentesis (OR 1.6, 95% CI (1.3–2), P < 0.01). Thirty-day readmission was also significantly higher in female patients (OR 1.09, 95% CI (1.02–1.17), P < 0.01). There was no significant difference regarding in-hospital mortality (OR 0.99, 95% CI (0.87–1.14), P = 0.95).Conclusion In female patients, lead extraction is associated with worse clinical outcomes and higher 30-day readmission rate.

Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction

Article

Oct 2022
CIRC-ARRHYTHMIA ELEC

Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes. Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group. Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P<0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study. Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths. Registration: URL: https://www. Clinicaltrials: gov; Unique identifier: NCT03772704.

Is cardiopulmonary bypass standby still required for laser lead extractions?

Article

Full-text available

Sep 2022
J CARDIOTHORAC SURG

Objective Over the last two decades there has been an increase in the number of cardiac implantable electronic devices and consequently, there has also been an increased need for lead extractions. Fibrotic attachments develop between the lead and the venous and cardiac structures that may require the use of a laser to mobilize the lead. Cardiothoracic surgeons (CTS) have traditionally provided backup for surgical emergencies for these extractions. This study evaluates the surgical outcomes of patients undergoing transvenous laser lead extractions (TLE) and determines if CTS are still needed for backup. Methods A retrospective review of consecutive patients undergoing laser lead extractions at a single academic center. Lead extractions using only laser sheaths were analyzed. The clinical characteristics, complications, and mortality of the patients were evaluated. Results One hundred and twenty-one patients underwent TLEs from January 1st, 2014 to December 31st, 2018. The majority were male (N = 80, 66.1%), and the average age was 66.48 ± 14 years. The indication for removal was either laser lead malfunction or infection. A total of 30 patients (24.8%) had complications postoperatively including wound hematomas, superficial infections, and arrhythmias. The average length of stay was 9 ± 12 for all the patients in the study. 2 patients (1.6%) had injuries that required emergency surgical repair with injuries to the posterior superior vena cava and right ventricle. Both patients survived the initial injury with one patient was discharged home on day 4 and the other succumbing to his injuries on postoperative day 20. Conclusion Although the incidence of surgical emergencies is rare the morbidity and mortality for TLE require that surgical backup be available.

Predictors of Perforation During Lead Extraction; Results of the Canadian Lead ExtrAction Risk (CLEAR) Study

Article

Full-text available

Oct 2021

Background: Transvenous lead extraction can have serious adverse events such as cardiac or vascular perforation. Risk factors have not been well characterized. Objective: To identify factors associated with perforation and death, and characterize lead extraction in a large contemporary population. Methods: We performed a retrospective multi-center study examining patients undergoing lead extraction at 8 Canadian institutions from 1996 through 2016. Demographic and clinical data were used to identify variables associated with perforation and mortality using logistic regression modelling. Results: 2,325 consecutive patients (61.9 ±16.5 years) underwent extraction of 4,527 leads. Perforation rate was 2.7% (63/2,325) and 30-day mortality was 1.6% with mortality of 0.4% due to perforation (38/2,325; 10/2325). Variables associated with perforation included no previous cardiac surgery (Odds ratio [OR] 3.33, 95% confidence interval [CI] 1.54-7.19, p=0.002), female sex (OR 3.27, 95% CI 1.91-5.60, p<0.001), left ventricular ejection fraction > 40% (OR 2.81, 95% CI 1.28-6.14, p=0.010), lead age >8 years (OR 2.64, 95% CI 1.52-4.60, p<0.001), ≥ 2 leads extracted (OR 2.49, 95% CI 1.23-5.04, p=0.011), and diabetes (OR 2.12, 95% CI 1.16-3.86, p=0.014). Variables associated with death included infection as indication for extraction (OR 3.85, 95% CI 1.38-10.73, p=0.010), anemia (OR 3.14, 95% CI 1.38-6.61, p=0.003) and patient age (OR 1.04, 95% CI 1.01-1.07, p=0.012). Conclusion: Risk factors associated with perforation in lead extraction include no history of cardiac surgery, female sex, preserved left ventricular ejection fraction, lead age > 8 years, ≥ 2 leads extracted, and diabetes.

Magnetic resonance conditionality of abandoned leads from active implantable medical devices at 1.5 T

Article

Full-text available

Aug 2021
MAGN RESON MED

Purpose During MR scans, abandoned leads from active implantable medical devices (AIMDs) can experience excessive heating at the lead tip, depending on the type of termination applied to the proximal contacts (proximal end treatment). The influence of different proximal end treatments (ie, [1] freely exposed in the tissue, [2] terminated with metal in contact with the tissue, or [3] capped with plastic, and thereby fully insulated, on the RF‐induced lead‐tip heating) are studied. A technique to ensure that MR Conditional AIMD leads remain MR Conditional even when abandoned is recommended. Methods Abandoned leads from three MR Conditional AIMDs ([1] a sacral neuromodulation system, [2] a cardiac rhythm management pacemaker system, and [3] a deep brain stimulator system) were investigated in this study. The computational lead models (ie, the transfer functions) for different proximal end treatments were measured and used to assess the in vivo lead‐tip heating for four virtual human models (FATS, Duke, Ella, and Billie) and compared with the lead‐tip heating of the complete MR Conditional AIMD system. Result The average and maximum lead‐tip heating for abandoned leads proximally capped with metal is always lower than that from the complete AIMD system. Abandoned leads proximally insulated could lead to an average in vivo temperature rise up to 3.5 times higher than that from the complete AIMD system. Conclusion For the three investigated AIMDs under 1.5T MR scanning, our results indicate that RF‐induced lead‐tip heating of abandoned leads strongly depends on the proximal lead termination. A metallic cap applied to the proximal termination of the tested leads could significantly reduce the RF‐induced lead‐tip heating.

Implementation of laser equipment in a center experienced in lead extraction: safety and efficacy at 1-year follow-up

Article

Apr 2021

Predictors of lead break during transvenous lead extraction

Article

Full-text available

Mar 2021

Background The incidence, predictors, and clinical impact of lead break during transvenous lead extraction (TLE) were previously unknown. Methods We 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. Results A 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. Conclusions Lead age, coradial bipolar leads, passive leads, and leads without polyurethane insulation were predictors of lead break and could increase the difficulty of lead extraction.

Cardiac Pacemaker and Defibrillator

Chapter

Apr 2024

Yida Tang

With the understanding of cardiovascular diseases and development of technology, the original concept of pacing as a treatment for heart block has expanded dramatically. A large number of well-designed, randomized clinical trials have supported the applications of novel implantable devices, which revealed a booming era in the therapy of bradyarrhythmias, tachyarrhythmias, as well as heart failure. In this chapter, we will give a general overview of the principle and advances of cardiac pacemaker and defibrillator.

A “Hands On” Approach to Femoral Lead Extraction: Indications, Tools and Techniques

Article

Nov 2023
HEART RHYTHM

Laser lead extraction in octo- and nonagenarians. A subgroup analysis from the GALLERY registry

Article

Jul 2023
J CARDIOVASC ELECTR

Introduction: In an aging population with cardiac implantable electronic devices, an increasing number of octo- and even nonagenarians present for lead extraction procedures. Those patients are considered at increased risk for surgical procedures including lead extraction. Here, we investigated safety and efficacy of transvenous lead extraction in a large patient cohort of octo- and nonagenarians. Methods and results: A subgroup analysis of all patients aged ≥80 years (n = 499) in the German Laser Lead Extraction Registry (GALLERY) was performed. Outcomes were compared to the nonoctogenarians from the registry. Primary extraction method was Laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. An analysis of patient- and device characteristics, as well as an assessment of predictors for adverse events via multivariate analyses was conducted. Mean patients age was 84.3 ± 3.7 years in the octogenarians group and 64.1 ± 12.4 years in the nonoctogenarians group. The median lead dwell time was 118.0 months (78; 167) and 92.0 months [60; 133], p < .001 in the octogenarians and nonoctogenarians group, respectively. Clinical procedural success rate was achieved in 97.6% of the cases in octogenarians and 97.9% in nonoctogenarians (p = .70). Overall complication rate was 4.4% in octogenarians and 4.3% in nonoctogenarians (0.91). In octogenarians procedure-related mortality was 0.8% and all-cause in-hospital mortality was 5.4%, while in nonoctogenarians, procedure related and all-cause in-hospital mortality were 0.5% and 3.1%, respectively. A body mass index (BMI) <20 kg/m2 , was the only statistically significant predictor for procedure-related complications in octogenarians, while systemic infection, BMI ≤20 kg/m2 , procedural complications and chronic kidney disease were predictors for in-hospital mortality. Conclusions: Laser lead extraction in octo- and nonagenarians is safe and effective. BMI ≤20 kg/m2 was the only statistically significant predictor for procedural complications. According to our data, advanced age should not be considered as contraindication for laser lead extraction.

Técnica de extracción de electrodos de dispositivos electrónicos implantables cardíacos asistida con láser excimer

Article

Jun 2023

Resumen: El implante de dispositivos electrónicos implantables cardíacos ha aumentado significativamente en respuesta al incremento de sus indicaciones basadas en la evidencia y, paralelamente, ha asociado también un ascenso en el número de dispositivos electrónicos implantables cardíacos a extraer por diferentes causas. Los electrodos de dispositivos electrónicos implantables cardíacos crónicamente implantados desarrollan frecuentemente tejido fibroso a nivel de la interfase entre electrodos adyacentes, endotelio venoso y endocardio, lo que implica una extracción de electrodos transvenosa facilitada por herramientas especializadas para liberar dichas adherencias.La extracción de electrodos transvenosa con láser excimer proporciona excelentes tasas de éxito completo del procedimiento y de éxito clínico, permitiendo tratar algunos pacientes que difícilmente podrían ser abordados con las otras técnicas existentes.El abordaje multidisciplinar «Heart Team» en un entorno apropiado para el procedimiento, con adecuado entrenamiento del personal, es fundamental para la detección precoz y el manejo exitoso de las complicaciones cardiovasculares de la extracción de electrodos transvenosa facilitada con láser. Abstract: The increase in the implantation rate of cardiac implantable electronic devices in the last decade has given rise to the need for transvenous lead extraction techniques, frequently in high-risk patients. Chronically implanted cardiac leads tend to develop a fibrous scar tissue surrounding them and among the venous endothelium and cardiac endocardium. This phenomenon makes necessary to resort to powered sheaths for TLE procedures.Laser-facilitated transvenous lead extraction of cardiac implantable electronic devices is a safe and highly effective procedure even in high-risk patients.A multidisciplinary “Heart Team” approach and an appropriate surgical work-up are mandatory for early identification and treatment of major cardiovascular complications.

Efficacy and Safety of Adjunctive and Primary Use of the TightRail Mechanical Cutting Sheath for Lead Extraction

Article

Jun 2023
CIRC-ARRHYTHMIA ELEC

Background: Rotational cutting tools are increasingly used in transvenous lead extraction. There are limited data on their safety and efficacy, particularly when used adjunctively for stalled progression. The aim of this study was to evaluate the utilization, safety, and effectiveness of mechanical rotational cutting tools for transvenous lead extraction. Methods: Patients undergoing transvenous lead extraction at a single tertiary center (April 2015 to January 2021, n=586) were included in this retrospective analysis. The study characterized the 251 patients (42.8%) whose cases involved the TightRail mechanical cutting tool. Results: Among 251 patients, 526 leads were extracted and TightRail was used for 70.5%. The TightRail was used adjunctively with the laser for 65.2% of leads, 97.8% of the time as the second tool after stalled progression. Using a multivariable logistic regression model, we found that active-fixation leads (odds ratio, 2.78 [95% CI, 1.62-4.78]; P=0.0002), dual-coil leads (odds ratio, 3.39 [95% CI, 1.87-6.16]; P<0.0001), and lead dwell time (odds ratio, 1.16 [95% CI for 1-year increase, 1.11-1.21]; P<0.0001) were factors independently associated with adjunctive TightRail use. Stalled progression requiring TightRail occurred most often in the innominate vein and superior vena cava (59.3%). The clinical success rate was 96.8%, and the rate of major adverse events was 2.8%. Only 1 major adverse event was observed during TightRail use. Conclusions: Rotational cutting with TightRail was used in 42.8% of transvenous lead extractions, predominantly in an adjunctive manner after stalled laser progression in the innominate vein and superior vena cava, and more frequently for dual-coil and leads with longer dwell times. Adjunctive TightRail use carries a low risk of major complications.

Think outside the box: A case report of utilisation of an excimer laser sheath as an intracardiac bioptome

Article

Full-text available

Feb 2023

Background Malignant cardiac tumours are rare entities that cause severe morbidity and mortality. Possible treatment options vary between surgical removement, (immuno-) chemotherapy and palliative care, while diagnostic workup comprises of imaging and histopathology analysis. Excimer laser sheaths are a new possibility to extract significant tissue samples to offer adequate treatment. Case summary A 67-year-old Caucasian female presented with progressive shortness of breath, new onset of fevers, weight loss and recurrent night sweats. She showed signs of upper venous stasis. Cardiac imaging revealed an obstructive, hypoperfused right atrial mass superior to the tricuspid valve and a sessile structure at the mitral valve. Guideline directed therapy for endocarditis was started subsequently. A conventional intracardiac biopsy of the tumour was unsuccessful, but an off-label approach using an excimer laser sheath as bioptome lead to the diagnosis of a diffuse large B-cell lymphoma. Immuno-chemotherapy was commenced, leading to reduction in tumour size and rapid improvement in quality of life. Discussion Intracardiac biopsies are an important piece of the puzzle in the diagnostic workup of cardiac neoplasms. This case report is the first description of the utilisation of a laser lead extraction tool as a bioptome for intracardiac tumours. Two imaging modalities (echocardiogram, fluoroscopy), as well as the precise technique of the excimer laser ensured safety for the patient. Clinical studies are paramount to further evaluate the laser sheath as a possible new instrument in the toolbox of an interventional cardiologist.

Electrodos no funcionantes ¿Extracción o abandono?

Article

Feb 2023

Resumen: Actualmente existe controversia con respecto a la necesidad de extracción de electrodos abandonados o no funcionantes, sin infección y que no están suponiendo un riesgo evidente para el paciente.Esta situación puede presentarse en pacientes en los que, bien por disfunción de algún electrodo o por la necesidad de actualizar un dispositivo anterior, es necesario implantar nuevos electrodos. En estos casos ¿qué es lo más indicado, extracción o abandono de los electrodos previos? También en pacientes mayores, frágiles o con poca expectativa de esperanza de vida es frecuente replantearse la necesidad de someter al paciente al potencial riesgo de un procedimiento de extracción de electrodos abandonados.Aunque son varios los argumentos que suelen aludirse a la hora de inclinarnos hacia una postura más o menos conservadora en estas situaciones, cuando analizamos la evidencia publicada, es frecuente encontrar estudios con resultados contrapuestos en torno a estos argumentos. No obstante, el progresivo aumento de los procedimientos de extracción durante los últimos años, los avances técnicos producidos en este terreno y los buenos resultados conseguidos deberían favorecer una tendencia cada vez más favorable hacia la indicación de extracción en estos casos. Abstract: There is currently controversy regarding the need to remove abandoned or non-functioning electrodes, without infection and that are not posing an obvious risk to the patient.This situation can occur in patients in whom, either due to dysfunction of an electrode or the need to update a previous device, it is necessary to implant new electrodes. What is the most indicated, extraction or abandonment of the previous electrodes? Similarly, in elderly, frail patients or those with short life expectancy, it is common to rethink the need to subject the patient to the potential risks of the extraction procedure.There are several arguments that can be used when leaning towards a more or less conservative position in these situations. However, when we analyze the published evidence, it is common to find studies with conflicting results regarding these arguments. However, the progressive increase in extraction procedures, the technical advances produced in this field and the good results achieved should favor an increasingly favorable trend towards the indication of extraction in these cases.

Transvenous Lead Extraction

Article

Dec 2022

Chronic kidney disease is associated with increased all‐cause mortality in transvenous lead extraction: A systematic review and meta‐analysis

Article

Nov 2022

Background: The impact of chronic kidney disease (CKD) or end-stage renal disease (ESRD) on patients receiving transvenous lead extraction (TLE) is not well-established. Objective: We performed a systematic review and meta-analysis to explore the association between CKD and all-cause mortality in TLE. Methods: We searched the databases of PUBMED and EMBASE from inception to April 2022. Included studies were published TLE studies that compared the risk of mortality in CKD patients compared to control patients. Data from each study were combined using the random-effects model. Results: Eight studies (5013 patients) were included. Compared with controls, CKD patients had a significantly higher risk of overall all-cause mortality (hazard ratio [HR] = 2.14, 95% confidence interval [CI]: 1.65 - 2.77, I2 = 51.1%, p<0.001). The risk of overall all-cause mortality increased with the severity of CKD for nonspecific CKD (HR = 2.01, 95% CI: 1.49 - 2.69, I2 = 53.4, p<0.001) and ESRD (HR = 2.79, 95% CI: 1.85 - 4.23, I2 = 0%, p<0.001). The risk of all-cause mortality in CKD is double at follow-up ≤1 year (HR = 1.99, 95% CI: 1.29 - 3.09, I2 = 50.9%, p = 0.002) and higher at follow-up >1 year (HR = 2.36, 95% CI: 1.63 - 3.42, I2 = 59.7%, p<0.001). Conclusions: Our meta-analysis demonstrates a significantly increased risk of overall all-cause mortality in patients with CKD who underwent TLE compared to controls. This article is protected by copyright. All rights reserved.

A head-to-head comparison of laser vs. powered mechanical sheaths as first choice and second line extraction tools

Article

Full-text available

Nov 2022

Aims During transvenous lead extraction (TLE) longer dwelling time often requires the use of powered sheaths. This study aimed to compare outcomes with the laser and powered mechanical tools. Methods and results Single-centre data from consecutive patients undergoing TLE between 2012 and 2021 were retrospectively analysed. Efficacy and safety of the primary extraction tool were compared. Procedures requiring crossover between powered sheaths were also analysed. Moreover, we examined the efficacy of each level of the stepwise approach. Out of 166 patients, 142 (age 65.4 ± 13.7 years) underwent TLE requiring advanced techniques with 245 leads (dwelling time 9.4 ± 6.3 years). Laser sheaths were used in 64.9%, powered mechanical sheaths in 35.1% of the procedures as primary extraction tools. Procedural success rate was 85.5% with laser and 82.5% with mechanical sheaths (P = 0.552). Minor and major complications were observed in similar rate. Procedural mortality occurred only in the laser group in the case of three patients. Crossover was needed in 19.5% after laser and in 12.8% after mechanical extractions (P = 0.187). Among crossover procedures, only clinical success favoured the secondary mechanical arm (87.1 vs. 54.5%, aOR: 0.09, 95% CI: 0.01–0.79, P = 0.030). After step-by-step efficacy analysis, procedural success was 64.9% with the first-line extraction tool, 75.1% after crossover, 84.5% with bailout femoral snare, and 91.8% by non-emergency surgery. Conclusion The efficacy and safety of laser and mechanical sheaths were similar, however in the subgroup of crossover procedures mechanical tools had better performance regarding clinical success. Device diversity seems to help improving outcomes, especially in the most complicated cases.

A Unique Case of Central Line Fracture Due to Laser Lead Extraction

Article

Full-text available

Nov 2022

Transvenous laser-assisted lead extraction is successful, with a low procedural complication rate for a wide range of indications. Here, we report a case of right internal jugular triple-lumen central venous catheter fracture and subsequent embolism to the right pulmonary artery during laser lead extraction that was successfully retrieved with a gooseneck snare. (Level of Difficulty: Advanced.)

Preprocedure Cardiac Computed Tomography: Insights into Complex Lead Extractions

Article

Nov 2022
CIRC-ARRHYTHMIA ELEC

Jonathan Chrispin

Transvenous Lead Extraction Procedure-Indications, Methods, and Complications

Article

Full-text available

Nov 2022

Transvenous lead extraction (TLE) is a complex and technically challenging procedure useful in the management strategy for many complications related to the presence of cardiac im-plantable electronic devices (CIEDs). The decision to perform lead extraction should take into consideration the clinical indication for the procedure, risks versus benefits, extractor and team experience , and also patient preference for the procedure. A variety of techniques can be used when performing TLE procedures, such as simple traction, traction devices, and various types of sheaths or snares. TLE is a procedure with a potentially high risk of complications that can be divided into major complications, which require rapid intervention, and minor complications, which are more frequent but are not life-threatening. The present review aims to highlight the indications, contra-indications, methods, and complications of transvenous lead extraction procedures.

Pacemaker Insertion, Revision, and Extraction

Chapter

Jan 2012

Mark H. Schoenfeld

Usefulness of the controlled-rotation dilator sheath "Evolution RL" for extraction of old leads in two Japanese centers - An experience in use

Article

Jun 2022

Background: Transvenous lead extraction (TLE) is an established procedure for the management of cardiovascular implantable electronic devices. However, some difficulties and risks of complications still exist, especially in old and adhered leads. Evolution RL (Cook Medical, Bloomington, IN, USA) is a newly introduced device for TLE; however, no clinical results have been reported in Japan, and the results with older leads are unknown. We investigated the efficacy and safety of Evolution RL and its usefulness for old leads at two TLE centers in Japan. Methods: A total of 27 consecutive patients who underwent lead extraction using Evolution RL at Shinshu University Hospital and Tokyo Women's Medical University Hospital from September 2017 to December 2019 were retrospectively enrolled. We examined the backgrounds of the patients and leads and investigated the efficacy and safety of the procedures. We divided the leads into two groups according to the number of years of implantation (10 years) and compared the results. Results: Among the 27 patients, 20 (74.1%) were men, and the median age was 62 (14-91) years. The total number of leads was 58, and the median implantation duration was 136 months (8-448). We achieved clinical success in all patients and complete procedural success in 24 patients (88.9%). In three patients, the broken tip of the lead remained in the heart. No major complications were noted. Of the 58 leads, there were 34 leads with more than 10 years of implantation, with significantly more Evolution RLs used (94.1% vs. 54.2%, p = 0.001) and significantly higher percentages of Evolution 11Fr, 13Fr, and steady sheaths used (79.4% vs. 33.3%, p = 0.001, 52.9% vs. 16.7%, p = 0.006, and 64.7% vs. 20.8%, p = 0.001, respectively). Conclusions: In two TLE centers in Japan, Evolution RL was shown to be safe and effective, even in leads older than 10 years.

Innovative Approaches and Technology Platforms for Pacemaker Lead Extraction

Chapter

Jan 2022

This chapter reviews the challenges and techniques involved in transvenous extraction of pacemaker and defibrillator leads. Risk factors associated with increased procedural complications and short- and long-term mortality are discussed, as are current tools for risk assessment. Current techniques and tools for lead extraction are then reviewed followed by recent advances and their impact on the field. Finally, areas for future advancement are discussed.

Evaluation and Management of Tricuspid Regurgitation in Patients with Cardiac Implantable Electronic Devices

Chapter

Jan 2022

Approximately 200,000 permanent pacemakers (PPMs) and 120,000 implantable cardioverter-defibrillators (ICDs) are implanted annually in the United States. Cardiac implantable electronic devices (CIEDs) have increased the quality and duration of life for millions of patients by providing support of heart rate, atrioventricular/interventricular/intraventricular synchrony, and prevention of sudden cardiac death. Tricuspid valve dysfunction after CIED implantation can occur. We review in this chapter, the various mechanisms of tricuspid valve dysfunction associated with CIED placement, the imaging modalities used for its diagnosis, and various treatment options.KeywordsTricuspid valve dysfunctionCardiac implantable electronic devicesPermanent pacemakersImplantable cardioverter-defibrillatorsLead-induced tricuspid regurgitationTricuspid lead extractionRight ventricular dysfunction

Article

Full-text available

Apr 2022

Background: With an increasing number of cardiac implantable electronic devices, there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce. Objective: We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units. Method: Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005-2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality. Results: Cardiac surgeons performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs 62 [31-102 IQR] months, CS vs cardiologists, p < 0.001) and with pre-dominantly non-infectious indications (57.4% vs 50.2%, CS vs cardiologists, p < 0.001). Cardiac surgeons achieved a higher complete success per lead than the cardiologists (98.1% vs 95.7%, respectively, p < 0.01), with a higher number of minor complications (5.51% vs 2.1%, p < 0.01) and similar number of major complications (0.47% vs 1.3%, p = 0.12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76% vs 0.94%,p = 0.21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p < 0.01), procedure duration (OR 1.01 [1.01-1.02], p < 0.01) and CS operator (OR 2.67, [1.12-6.37], p = 0.027) were associated with 30-day mortality. Conclusion: Transvenous lead extraction by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centres. This article is protected by copyright. All rights reserved.

Successful Avoidance of Superior Vena Cava Injury During Transvenous Lead Extraction Utilizing Tandem Femoral-Superior Approach

Article

Mar 2022
HEART RHYTHM

Background Transvenous pacemaker and defibrillator lead extraction is a higher risk procedure with variation in preferred technique. A frequently fatal complication of this procedure is perforation of the superior vena cava. We have developed a tandem femoral-superior technique which incorporates snaring of targeted leads from a femoral approach combined with use of a rotational cutting sheath advanced over the lead from the subclavian vein. Objective We sought to evaluate the safety and efficacy of a tandem femoral-superior approach to lead extraction. Methods Consecutive patients undergoing transvenous extraction of at least 1 pacemaker or defibrillator lead with implant duration >1 year in which a tandem femoral-superior technique was used as the initial extraction strategy were included. The registry spanned 2010-2018 and consisted of procedures performed by a single primary operator. Results A total of 131 patients were included. A total of 267 leads with mean implant duration of 9.8 years, including 90 (33.7%) defibrillator leads, were targeted for extraction. No superior vena cava perforation or other vascular damage occurred. Clinical procedural success was achieved in 96.2 % of cases. There were 5 major complications (3.8% of patients) with 3 being pericardial effusion requiring intervention. There were no deaths. Conclusion A tandem femoral-superior approach to lead extraction effectively eliminated superior vena cava injury. This is a safe and effective technique for transvenous lead extraction.

Efficacy and safety of the new TightRail™ mechanical sheath for transvenous lead extraction: Results of a French multicenter study

Article

Feb 2022

Introduction: The aim of this study was to assess the safety and efficacy of the TightRail™ sheath for pacemaker/defibrillator transvenous lead extraction (TLE). Methods: Multicenter observational study including patients who underwent a TLE with the TightRail™ sheath in five French university hospitals from September 2014 to January 2020. Results: 225 patients (76% male, 71±12 years) underwent a TLE procedure with the TightRail™. A total of 438 leads were extracted using the TightRail™, and the mean age of the extracted leads was 128±85 months; of these, 344 (79%) were pacing leads and 94 (21%) were ICD leads. The overall clinical success of the extraction procedures was 93%. Overall, 410 of the 438 leads (95%) were extracted (complete or incomplete removal). After multilevel mixed-effects logistic regression model, we found that lead age ((OR, 95%CI for a 1 year increase) 1.11 (1.07-1.15), p<0.001) and number of leads extracted (OR, 95%CI 2.09 (1.50-2.96), p<0.001) were the two independent factors associated with complete lead removal failure. Finally, there were 7 (3%) cases of major complications but no per-procedural death. Conclusion: This is the first large-scale survey assessing the efficacy and safety profile of the Tightrail™ mechanical sheath. The clinical success rate was 93 %, and the lead removal failure was dependent on the age and number of leads. We show a satisfactory safety profile in this cohort of patients from primarily low-volume centers with older leads. This article is protected by copyright. All rights reserved.

Outcomes of Lead Extraction Using the TIghtRail(TM) Sheath: An Opportunity for Increasing Access While Preserving Outcomes?

Article

Feb 2022
J CARDIOVASC ELECTR

Transvenous lead extraction (TLE) has evolved significantly since initial techniques were described more than 30 years ago. In the present study, Artus et al describe outcomes with a commonly used extraction tool - the TightRailTM sheath - at five low-moderate volume extraction centers in France following their establishment by recently trained operators. This retrospective observational analysis offers an important contribution to the limited literature on outcomes using the TightRailTM sheath. Following training at high volume centers, operators returned to five regional medical centers to launch TLE programs. Over 6 years, 225 patients underwent TLE targeting 438 leads (22% ICD leads) with a mean lead dwell time of 10 years. Overall, clinical success was achieved in 93% of procedures with a 3% rate of major complications. This series, one of the largest using TightRailTM and the largest using it exclusively, demonstrates favorable outcomes and safety data even in centers early in their clinical experience with relatively low annual volumes, averaging 10 TLE procedures per year. This study, in addition to supporting use of the TightRailTM sheath for TLE, also indicate that with appropriate training and support it can be safely and effectively offered outside of high-volume centers using this tool without necessarily requiring availability of a more capital-intensive excimer laser sheath. Further investigation on appropriate patient selection, definition of the "learning curve," and optimal tool selection is needed to help deliver the best outcomes for patients in need of this complex procedure. This article is protected by copyright. All rights reserved.

Left common carotid artery to left innominate vein arteriovenous fistula after transvenous laser lead extraction

Article

Jan 2022

Transvenous lead extraction is used for lead infection, lead debulking, venous recanalization and device upgrades. Lead extraction is performed using specialized tools including locking stylets, mechanical or rotating sheaths, femoral snares or laser sheaths. The most feared complications associated with lead extraction are bleeding, vascular tear, cardiac avulsion and tamponade. Despite technological progress, the incidence of major procedural complications including death remains slightly above 1%. This case depicts an asymptomatic left common carotid artery to left innominate vein arteriovenous fistula after laser-assisted transvenous lead extraction successfully treated with an endovascular covered stent. This article is protected by copyright. All rights reserved

Data Driven Observations in Superior Vena Cava Injuries: A Call to Action

Article

Dec 2021
ANN THORAC SURG

Canadian Heart Rhythm Society Task Force Report on Physician Training and Maintenance of Competency For Cardiovascular Implantable Electronic Device Therapies: Educating Future Generations Of Canadian Physicians

Article

Sep 2021

Physicians engaged in cardiovascular implantable electronic device (CIED)-related practice come from diverse training backgrounds with variable degrees of CIED implant training. The objective of the Canadian Heart Rhythm Society Task Force on CIED Implant Training was to establish a common structure and content for training programs in CIED implantation, related activities and maintenance of competency. This executive summary presents the essence of the report with key recommendations included, with the complete version made available in a linked supplement. The goals are to ensure that future generations of CIED implanters are better prepared for continuously evolving CIED practice and quality care for all Canadians.

Powered sheaths for lead extraction

Article

Sep 2021

Transvenous lead extraction (TLE) has seen a rapid expansion in the past 20 years. Procedure has changed from early techniques involving simple manual traction that frequently proved themselves ineffective for chronically implanted leads, and carried a significant periprocedural risks including death, to availability of a wide range of more efficacious techniques and tools, providing the skilled extractor with a well-equipped armamentarium. The reduction in morbidity and mortality associated with these new extraction techniques have widened indications to TLE from prevalent use in life-threatening situations, such as infection and sepsis, to a more widespread use even in non infectious situations like malfunctioning leads. Powered sheaths have been a remarkable step forward in this improvement in TLE procedures and recent registries at high-volume centers report high success rates with exceedingly low complication rates. This review is aimed at describing technical features of powered sheaths as well as reported performance during TLE procedures. This article is protected by copyright. All rights reserved

Outcomes of Transvenous Lead Extraction Using the TightRailTM Mechanical Rotating Dilator Sheath and Excimer Laser Sheath

Article

May 2021

Background Transvenous lead extraction (TLE) is an important part of comprehensive lead management. The selection of tools available has expanded in recent years but data on their efficacy is limited. Objective To evaluate outcomes using the TightRailTM mechanical rotating mechanical dilator sheath in comparison to excimer laser sheaths and describe factors predictive of successful extraction. Methods Patients undergoing TLE at a single tertiary center (2013-2019) were included in a prospective registry. Leads targeted for extraction with either an SLS II/GlidelightTM or TightRailTM sheath were included. Outcomes were analyzed on a per-lead basis. Generalized estimating equation (GEE) models were used to assess differences in lead extraction success by extraction tool used while adjusting for non-independence of multiple leads extracted from the same patient. Covariates included patient comorbidities, lead characteristics, and sheath size. Results A total of 575 leads extracted from 372 patients were included. Overall success rate was 97%. TightRailTM was the first tool used in 180 (31.3%) leads with success rate of 61.7%; laser sheaths were the first tool in 395 leads (68.7%) with success rate of 67.8%. Predictors of successful extraction included lead age, lead type, and sheath sizing. Extraction success did not differ based on whether a laser or TightRailTM sheath was used (AOR=0.94; 95%CI=0.59–1.50). Conclusion The TightRailTM sheath is an effective tool for TLE. Lead age, lead type, and sheath sizing were predictive of successful extraction, but choice of sheath type was not. These findings are hypothesis generating and warrant further investigation in a prospective, randomized study. This article is protected by copyright. All rights reserved.

Implanting and Extracting Cardiac Devices

Chapter

May 2021

The physician implanting a cardiac rhythm device must have a thorough working knowledge of cardiac pacing, defibrillation, and resynchronization, as well as a complete understanding of sterile technique and the specific surgical skills necessary for pulse generator implantation. This chapter includes a discussion of lead extraction as an implant‐related procedure. Lead extraction is usually performed under general anesthesia. When the left ventricular lead is advanced, gentle pressure should cause mild buckling in the coronary sinus and proximal ventricular vein so that the lead conforms to the curvature of the venous system. Advances in cardiac implantable electronic devices technology over the last few years have resulted in leadless pacemakers and totally subcutaneous implantable cardioverter‐defibrillators. The chapter discusses techniques relevant to implantation and removal of newer devices. After implantation, the incision is covered with sterile gauze and tape or a “coverlet.” This is removed the next morning, and if the incision is dry it is left uncovered.

The use of laser lead extraction sheath in the presence of supra-cardiac occlusion of the central veins for cardiac implantable electronic device lead upgrade or revision

Article

Full-text available

May 2021
PLOS ONE

Background The implantation of cardiac implantable electronic devices (CIED) has increased in the last decades with improvement in the quality of life of patients with cardiac rhythm disorders. The presence of bilateral subclavian, innominate or superior vena cava obstruction is a major limitation to device revision and/or upgrade. Methods and material This is retrospective study of patients who underwent laser-assisted lead extraction (LLE) (GlideLight laser sheath, Spectranetics Corporation, Colorado Springs, USA) with lead revision or upgrade using the laser sheath as a guide rail. Patients with known occlusion, severe stenosis or functional obstruction of the venous access vessels with indwelling leads were included in this study. Results 106 patients underwent percutaneous LLE with lead revision and/or upgrade. Preoperative known complete occlusion or severe stenosis of access veins was present in 23 patients (21.5%). More patients with implantable cardioverter-defibrillator (ICD) underwent LLE (64.1%) than patients with CRT-Ds (24.5%) and pacemaker patients (11.3%). In total 172 leads were extracted: 79 (45.9%) single-coil defibrillator leads, 35 (20.3%) dual-coil defibrillator leads, 31 (18.0%) right atrial leads, 24 (13.9%) right ventricular leads and three (1.7%) malfunctional coronary sinus left ventricular pacing leads. The mean age of leads was 99.2±65.6 months. The implantation of new leads after crossing the venous stenosis/obstruction was successful in 98 (92.4%) cases. Postoperative complications were pocket hematoma in two cases and wound infection in one case. No peri-operative and no immediate postoperative death was recorded. One intraoperative superior vena cava tear was treated by immediate thoracotomy and surgical repair. Conclusion In a single-center study on LLE in the presence of supra-cardiac occlusion of the central veins for CIED lead upgrade and revision we could demonstrate a low procedural complication rate with no procedural deaths. Most of the leads could be completely extracted to revise or upgrade the system. Our study showed a low complication rate, with acceptable mortality rates.

Applied Logistic Regression

Article

Full-text available

Mar 2012

Andrew Cucchiara

Introduction to the Logistic Regression Model Multiple Logistic Regression Interpretation of the Fitted Logistic Regression Model Model-Building Strategies and Methods for Logistic Regression Assessing the Fit of the Model Application of Logistic Regression with Different Sampling Models Logistic Regression for Matched Case-Control Studies Special Topics References Index.

Chronic pacemaker lead extraction

Article

Jan 1995
Prim Cardiol

Chronically implanted pacemaker leads are fixed to the myocardium by fibrous tissue and often surrounded by a fibrous sheath. At times, removal of these leads is desirable, but attempted explantation by simple manual traction is often ineffective because of the fibrosis. Newer techniques for lead removal have been developed and have a high success rate.

Applied Logistic Regression

Article

Jan 1994

Stepwise logistic regression. Applied logistic regression

Article

Jan 2000

Applied Logistic Regressio

Book

Oct 2004

From the reviews of the First Edition."An interesting, useful, and well-written book on logistic regression models . . . Hosmer and Lemeshow have used very little mathematics, have presented difficult concepts heuristically and through illustrative examples, and have included references."—Choice"Well written, clearly organized, and comprehensive . . . the authors carefully walk the reader through the estimation of interpretation of coefficients from a wide variety of logistic regression models . . . their careful explication of the quantitative re-expression of coefficients from these various models is excellent."—Contemporary Sociology"An extremely well-written book that will certainly prove an invaluable acquisition to the practicing statistician who finds other literature on analysis of discrete data hard to follow or heavily theoretical."—The StatisticianIn this revised and updated edition of their popular book, David Hosmer and Stanley Lemeshow continue to provide an amazingly accessible introduction to the logistic regression model while incorporating advances of the last decade, including a variety of software packages for the analysis of data sets. Hosmer and Lemeshow extend the discussion from biostatistics and epidemiology to cutting-edge applications in data mining and machine learning, guiding readers step-by-step through the use of modeling techniques for dichotomous data in diverse fields. Ample new topics and expanded discussions of existing material are accompanied by a wealth of real-world examples-with extensive data sets available over the Internet.

Excimer laser catheter for pacing lead removal

Article

May 1997
Proceedings of SPIE

A novel laser catheter design has been utilized to assist in the removal of chronically implanted pacing leads. The catheter, or 'laser sheath,' uses fiber optics to convey pulsed 308 nm light from a CVX-300 XeCl excimer laser to the distal tip of the catheter. As the catheter is threaded over an implanted pacing lead, into the patient's vasculature, lasing action can be used to cut through fibrotic adhesions that typically overgrow the lead, making lead removal difficult. In a randomized clinical trial, greater than 300 patients have been treated with the laser sheath, with no complications secondary to the use of the laser. Leads were totally removed in nearly all laser cases. Design features of the laser sheath that contribute to its clinical success are discussed.

Five‐Years Experience with Intravascular Lead Extraction

Article

Jun 2006
PACE

From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1.299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4–7 years, and 31 % of leads 8–24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%. including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke). With experienced operators, appropriate precautions, and appropriate patient selection, modern techniques allow the successful extraction of up to nearly 98% of intravascular leads with a relatively low incidence of complications.

The encapsulation of polyurethan-insulated transvenous cardiac pacemaker leads

Article

Jul 1995
CARDIOVASC PATHOL

When cardiac pacemakers are implanted, the tranvenous route is typically preferred. For dual chamber pacemakers, an atrial and a ventricular lead are required. Based on postmortem examination of 101 canines with polyurethane insulated leads implanted from 10 days through 13 years, encapsulation of these leads is initiated by thrombus secondary to endothelial damage and/or blood flow perturbations. Organization of thrombus results in a vascularized collagenous capsule. With continued blood flow perturbation, more thrombi can form and reorganize to cause the collagenous capsules to grow with implant time. Under certain conditions, the encapsulating sheath can differentiate into cartilage, mineralized tissue, and even bone. The least commonly encapsulated area is in or just superior to the annulus of the valve. The most common locations for capsule formation are within the upper right atrium (where two leads are often bound together by the tissue) and the right ventricle. The ventricular sheaths are often adhered firmly to tricuspid valve structures. The presence of relatively large, friable, partially organized thrombi on chronic leads is not unusual, even after more than 10 years' implantation. It is recommended that chronic leads be imaged prior to attempts to remove them to detect the presence and location of embolizable structures.

Clinical results with excimer laser coronary angioplasty

Article

Jun 1996
Semin Intervent Cardiol

John Andrew Bittl

This comprehensive review of randomized trials and registry reports makes several assertions about the clinical usefulness of excimer laser angioplasty. First, refinements in patient selection and excimer laser technique have resulted in improved procedural outcome. Second, the overall rates of clinical success for excimer laser angioplasty are approximately 90%, major and minor complications 6%, and vessel perforation 1%. Third, superior success rates are achieved for saphenous vein graft lesions, ostial stenoses and total occlusions, but decreased success rates are obtained for bifurcation, calcified and thrombus-containing lesions. The routine use of saline infusion during excimer laser angioplasty and careful evaluation of this therapy for new indications such as in-stent restenosis will increase the usefulness of excimer laser angioplasty in interventional cardiovascular medicine.

Fundamental laser-tissue interactions

Article

Jun 1996
Semin Intervent Cardiol

Pulsed xenon chloride excimer and holmium laser-tissue interaction is primarily based on tissue water vaporization. Consequently, each ablative laser pulse produces a rapidly expanding and imploding vapour bubble in blood or the target tissue. In experimental studies, explosive water vaporization is the major mechanical cause of observed tissue dissections. By reduction of the induced bubble volume, a reduction in experimentally and clinically observed dissections after coronary excimer laser angioplasty is to be expected. This reduction of mechanical damage, however, in combination with efficient and substantial plaque debulking is the major challenge in the development of laser angioplasty.

Lead extraction. Indications and techniques

Article

Dec 1992
CARDIOL CLIN

Each of the extraction techniques and their ancillary tools was reported as used successfully; however, until now, no technique has been successful when used in more than a few isolated instances. The technique for intravascular countertraction and the associated tools described in this paper were devised and selected in an attempt to develop one technique to be used on all patients, with all types of leads, and with a very low complication rate. Its versatility permitted single or multiple lead extractions combined with the precision of selecting and extracting a specific lead. In our experience, as well as the experience of others, the techniques described in this paper have proved to be superior by minimizing the inherent risk and morbidity, allowing us to expand the indications for lead removal beyond septicemia and free-floating leads, to include infection, abandonment of pockets, and replacement of malfunctioning or fractured leads. Intravascular countertraction was a consistently safe and efficacious method of removing transvenous pacemaker leads regardless of the duration of the implant, thus permitting extractions in patients not considered candidates for a more extensive surgical procedure. Intravascular countertraction encompasses surgical and fluoroscopic techniques possessed by most physicians experienced in pacemaker and automatic implantable cardioverter defibrillator implants. However, there is a learning curve, predicating caution for the inexperienced physician. In addition, advanced surgical skills may be needed in handling associated conditions such as debridement and primary closure of chronically inflamed tissues, especially in submuscular pockets and sinus tracts in the neck. Although the potential for a cardiovascular complication is small, it does exist, and cardiovascular surgical backup is a recommended precaution.

XeCl laser ablation of atherosclerotic aorta: Optical properties and energy pathways

Article

Jan 1992

The energetics of 308-nm excimer laser irradiation of human aorta were studied. The heat generation that occurred during laser irradiation of atherosclerotic aorta equaled the absorbed laser energy minus the fraction of energy for escaping fluorescence (0.8-1.6%) and photochemical decomposition (2%). The absorbed laser energy is equal to the total delivered light energy minus the energy lost as specular reflectance (2.4%, air/tissue) and diffuse reflectance (11.5-15.5%). Overall, about 79-83.5% of the delivered light energy was converted to heat. We conclude that the mechanism of XeCl laser ablation of soft tissue involves thermal overheating of the irradiated volume with subsequent explosive vaporization. The optical properties of normal wall of human aorta and fibrous plaque, both native and denatured were determined. The light scattering was significant and sufficient to cause a subsurface fluence (J/cm2) in native aorta that equaled 1.8 times the broad-beam radiant exposure, phi o (2.7 phi o for denatured aorta). An optical fiber must have a diameter of at least 800 microns to achieve a maximum light penetration (approximately 200 microns for phi o/e) in the aorta along the central axis of the beam.

Effect of force on ablation depth for a XeCl excimer laser beam delivered by an optical fiber in contact with arterial tissue under saline

Article

Jan 1992

The effect of force applied to a 430 micron single fiber, delivering 60 pulses of 308 nm XeCl laser radiation at 20 Hz, on the ablation depth in porcine aortic tissue under saline has been investigated. Energy densities of 8, 15, 25, 28, 31, 37, and 45 mJ/mm2 were used. Force was applied by adding weights from 0 to 10 grams to the fiber. The fiber penetration was monitored by means of a position transducer. At 0 grams, the ablation depth increased linearly with incident energy density, but the fiber did not penetrate the tissue; with any weight added, the fiber penetrated the tissue at energy densities above 15 mJ/mm2. The fiber did not penetrate during the first several pulses, possibly due to gas trapped under the fiber. After these first pulses, a smooth linear advancement of the fiber began, which lasted until the pulse train stopped. The ablation depth increased with increasing energy densities and weights. This effect was largest above 25 mJ/mm2 where the ablation efficiencies (unit mm3/J), with weights added to the fiber, were substantially larger than values found in 308 nm ablation experiments described in the literature, which were conducted with either a focused laser beam or a fiber without additional force. The results imply that in 308 nm excimer laser angioplasty, force must be applied to the beam delivery catheter for efficient recanalization, and that experiments performed with a focused beam or without actual penetration of the fiber do not represent the situation encountered in excimer laser angioplasty.

Extraction of implanted transvenous pacing leads: A review of a persistent clinical problem

Article

Apr 1991
AM HEART J

Within a few months of implantation, permanent pacemaker leads become ensheathed in fibrocollagenous tissue. This tissue may anchor the lead so that it is difficult, dangerous, or impossible to remove it. Leads with bulbous or finned tips are particularly resistant to extraction. The risks of applying traction to an entrapped lead include induction of bradycardia or ventricular tachycardia and fibrillation, invagination of the right ventricle, avulsion of the right ventricular myocardium or tricuspid valve, hemopericardium, and cardiac tamponade. Forceful traction may result in uncoiling of the conductor, disruption of the insulation, or complete fracture, leaving an intravascular remnant that may embolize or be a source for thrombosis. Although fixation and abandonment of an inactive chronically implanted lead is frequently appropriate and is known to pose little long-term risk, the retained inactive lead may interact adversely with a new active lead and then increase the risk of venous thrombosis, serve as a potential nidus for infection, or produce spurious electrical sensing signals that may be sensed by the pulse generator. Absolute indications for lead removal are those in which there would be a life-threatening situation if the lead were to remain in situ. In the absence of an absolute indication, the decision to proceed with extraction must be made by weighing the potential for serious morbidity or mortality against risks of the extraction technique. Techniques for lead removal include traction and open cardiotomy operations. When a portion of the lead is intravascular, forceps, snares, baskets, countertraction, or lead-transection devices may be used to retrieve the fragment.

The Fate of Permanent Intracardiac Electrodes

Article

Aug 1966

Five-years experience with intravascular lead extraction. U.S. Lead Extraction Database

Article

Dec 1994

From December 1988 to April 1994, the extraction of 2,195 intravascular pacing leads from 1,299 patients was attempted at 193 centers. Indications were: infection (54%, including 10% septicemia), pacemaker reoperation with removal of nonfunctional or incompatible leads (40%), and other causes (6%). Extraction was attempted via the implant vein using locking stylets and dilator sheaths, via the femoral vein using snares, retrieval baskets, and sheaths, or via both approaches. Leads had been implanted for 0.2 months to 24 years (mean 56 months). At the conclusion of the intravascular procedure, 86.8% of the leads were completely removed, 7.5% were partially removed, and 5.7% were not removed. For physicians performing their first case, 12% of leads were not removed; for physicians who had performed more than 10 cases, only 2% of leads were not removed. Of the 189 leads where extraction attempts had previously failed, 75.1% were completely removed, 14.8% were partially removed, and 10.1% were not removed. Scar tissue increased in severity with implant duration, was a complicating factor, and was the main cause of failure to remove leads. Use of the femoral approach increased with implant duration (5% of leads implanted 12 months or less, 11% of leads 13 months to 3 years, 20% of leads 4-7 years, and 31% of leads 8-24 years), primarily because of increasingly abundant scarring and prior lead damage. Fatal and near fatal complications occurred in 2.5%, including 8 (0.6%) deaths (3 hemopericardium/tamponade, 1 hemothorax, 3 pulmonary embolus, 1 stroke).(ABSTRACT TRUNCATED AT 250 WORDS)

Extraction of the Telectronics Accufix 330–801 Atrial Lead: The Mayo Clinic Experience

Article

Apr 1996

To document a cumulative experience with removal of the Telectronics 330-801 Accufix atrial lead after it was withdrawn from the market. We reviewed our results with 96 attempted lead extraction procedures through Dec. 1, 1995. All patients underwent preoperative assessment, including fluoroscopic screening of the lead. Patients had blood typing and screening done before the extraction procedure, and extractions were performed with cardiac surgical intervention available. Pacing dependence was assessed to determine the need for temporary pacing. The mean patient age was 65.7 +/- 1.6 years and the mean duration of lead implantation was 31.0 +/- 1.4 months. Of the 96 lead extractions attempted, 94 were successful. Of the 96 cases, the retention wires were normal in 29, fractured without protrusion in 34, and fractured with protrusion in 33. Fifty-three leads were removed with use of simple traction only, and seven leads were removed by using a locking stylet and telescoping sheaths. The Cook workstation was used in the removal of 32 leads through the femoral vein; in 1 of these 32 patients, the retention wire was removed before lead extraction. The retention wire was removed but the lead was left intact in one patient. One lead was removed during an opertive maze procedure. Associated complications were minimal. Although lead extraction is a potentially fatal procedure, the Telectronics 330-801 Accufix atrial lead can be extracted safely with minimal morbidity when performed by experienced personnel.

Excimer laser induced bubble: Dimensions, theory, and implications for laser angioplasty

Article

Jan 1996

Previous studies have demonstrated that during Xenon-Chloride excimer laser ablation of tissue, rapidly expanding and imploding bubbles (diameter < 3 mm), predominantly containing water vapor, are formed. These short lived bubbles (life time < 300 microseconds) induce mechanical damage in adjacent tissue. In the present study, a theoretical analysis of the volume of vaporized water is correlated with measured bubble volumes formed in hemoglobin solution. The dimensions of the rapidly expanding and imploding vapor bubble induced by the XeCl excimer laser pulses (308 nm, 115 ns), delivered via a 300, 550, or 950 microns diameter monofiber in 16% w/v hemoglobin solution (at 37 degrees C), were measured. Theoretical analysis and the experimental data correlated well (correlation coefficient r = 0.97). The diameter of excimer laser induced bubbles increased with increasing pulse energy. For a given radiant exposure, the bubble size was decreased by either decreasing the fiber tip area or by decreasing the absorption coefficient of the hemoglobin solution. We conclude that, for a wide range of conditions, theory agrees well with experimental data. Thus, during delivery of excimer laser pulses in blood, bubble dimensions can be reduced by flushing with saline or by reduction of the area radiated with each laser pulse, for example, by pulse multiplexing or using a smaller multifiber catheter.

Large laser sheaths for pacing and defibrillator lead removal

Article

Feb 1998

In a recent clinical trial, the 12-F laser sheath showed 95% success in completely explanting chronically implanted pacing leads smaller than 7.5-F diameter. For larger leads, two new sizes of laser sheath have been implemented, the 14-F and 16-F (outer diameter) devices, which accommodate leads up to 9.5- and 11.5-F, respectively. The object of this study was to determine the cutting ability of the larger devices compared to the 12-F design. The rate of device advancement through fresh porcine aorta was measured for three sizes of laser sheath as pulsed ultraviolet light from a 308-nm XeCl excimer laser was applied. Dependent variables were fluence (mJ/mm2), laser pulse repetition rate, and pressure applied between the device and the tissue. At 60 mJ/mm2, 40 Hz repetition rate and 1.4 kg/cm2 pressure, all devices produced cutting rates in the range of 9-13 microns/pulse. Improvement in advancement per laser shot can be attained by increasing any independent variable studied. Physicians must apply only slightly greater force to the larger laser sheaths, and maximum available repetition rate and fluence implies maximum cutting speed.

Predictors of life threatening and major intravascular extraction complications with an Accufix atrial J lead (abstr)

Jan 1996
577

Love

Love CJ, Brinker J, Rozkovec A, et al. Predictors of life threatening and major intravascular extraction complications with an Accufix atrial J lead (abstr). PACE Pacing Clin Electrophysiol 1996;19:577.

Pacemaker lead extraction: mono-center comparison of lead removal via the implantation vein or via the femoral vein (abstr)

Jan 1997
1110

M Jarwe
D Klug
P Lefranc
D Lacrois
C Kouakam
S Kacet

Jarwe M, Klug D, LeFranc P, Lacrois D, Kouakam C, Kacet S. Pacemaker lead extraction: mono-center comparison of lead removal via the implantation vein or via the femoral vein (abstr). PACE Pacing Clin Electrophysiol 1997;20:1110.

Extracting chronically implanted pacemaker leads using the spectranetics excimer laser: initial clinical experience (abstr)

Jan 1996
567

C L Byrd

Byrd CL. Extracting chronically implanted pacemaker leads using the spectranetics excimer laser: initial clinical experience (abstr). PACE Pacing Clin Electrophysiol 1996;19:567.

Extraction of the Telectronics Accufix 330-801 atrial lead: the Mayo Clinic experience

Jan 1996
230-234

M A Lloyd
D L Hayes
D R Holmes
Jr

Lloyd MA, Hayes DL, Holmes DR Jr, et al. Extraction of the Telectronics Accufix 330-801 atrial lead: the Mayo Clinic experience. Mayo Clinic Proc 1996;71:230 -4.

May 1999
1671-1676

Wilkoff

Wilkoff et al. JACC Vol. 33, No. 6, 1999 PLEXES Results May 1999:1671-6

Extracting chronically implanted pacemaker leads using the spectranetics excimer laser

Jan 1996
567

Byrd

Large laser sheaths for pacing and defibrillator lead removal

Jan 1998
42

Reiser

Extraction of implanted transvenous pacing leads

Jan 1991
881

Myers

XeCl laser ablation of atherosclerotic aorta

Jan 1992
585

Oraevsky

Extraction of the Telectronics Accufix 330-801 atrial lead

Jan 1996
230

Lloyd

Pacemaker lead extraction with the laser sheath: Results of the Pacing Lead Extraction With the Excimer Sheath (PLEXES) Trial

Abstract

No full-text available

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