Transvenous Lead Extraction Procedures Research Articles

PREDICTIVE MACHINE LEARNING MODEL FOR MECHANICAL DILATATION IN TRANSVENOUS LEAD EXTRACTION PROCEDURES

Abstract Background Transvenous lead extraction (TLE) remains a procedure that requires a high level of expertise, with a doubled risk of death and clinical failure when performed in low–volume centers compared to high–volume ones. PURPOSE The aim of this study was to create a machine learning (ML)–based risk stratification system for predicting the need for mechanical dilatation in patients undergoing TLE due to infection. Methods We designed a ML–based risk stratification system trained with data from our registry to predict the need for mechanical dilatation in patients undergoing TLE for infection. An extensive evaluation of 5 different ML models (k–nearest neighbors, support vector machine, decision tree, and decision tree ensembles, such as random forest and gradient boosting machine) was conducted to identify a classifier with the highest potential to correctly predict previously unseen patients. Results Data to train the model was extracted from our 25–year registry of patients undergoing TLE (June 1998 – March 2023), for a total of 491 patients (77.8% male; age 69.7 ± 12.8 years) and 938 leads (ICD 21.2%; pacing 78.8%; indwelling time 61 ± 60 months) removed with success in 100% of cases. Each patient was represented by a set of 21 attributes (14 clinical, 7 device–related). Manual traction (MT) was used in 27.5% of cases, and mechanical dilatation (MD) was employed in the remaining 72.5% of cases. 5–fold nested cross validation was used to estimate performances: in turn, 393 patients were used for training and model selection, and 98 patients were used for independent testing. According to the evaluation, Gradient Boosting Machine performed best, achieving test accuracy of 89% (+/– 2% std. dev.), test sensitivity of 95% (+/– 3% std. dev.), test specificity of 73% (+/– 8% std. dev.), test AUROC of 92% (+/– 1% std. dev.). A further interpretability analysis on the best performing decision tree was conducted, showing remarkable adherence between the internal decisions taken by the model to make predictions and the current clinical practice for TLE. Conclusion ML models have enhanced the prediction of MD requirements in TLE procedures. This data may support the referral of patients to specialized and high–volume centers, thereby improving preoperative risk assessment.

Analysis of 1051 ICD Leads Extractions in Search of Factors Affecting Procedure Difficulty and Complications: Number of Coils, Tip Fixation and Position-Does It Matter?

Background: Implantable cardioverter-defibrillator (ICD) leads are considered a risk factor for major complications (MC) during transvenous lead extraction (TLE). Methods: We analyzed 3878 TLE procedures (including 1051 ICD lead extractions). Results: In patients with ICD lead removal, implant duration was almost half as long (69.69 vs. 114.0 months; p < 0.001), procedure complexity (duration of dilatation of all extracted leads, use of more advanced tools or additional venous access) (15.13% vs. 20.78%; p < 0.001) and MC (0.67% vs. 2.62%; p < 0.001) were significantly lower as compared to patients with pacing lead extraction. The procedural success rate was higher in these patients (98.29% vs. 94.04%; p < 0.001). Extraction of two or more ICD leads or additional superior vena cava (SVC) coil significantly prolonged procedure time, increased procedure complexity and use of auxiliary or advanced tools but did not influence the rate of MC. The type of ICD lead fixation and tip position did not affect TLE complexity, complications and clinical success although passive fixation reduces the likelihood of procedural success (OR = 0.297; p = 0.011). Multivariable regression analysis showed that ICD lead implant duration ≥120 months (OR = 2.956; p < 0.001) and the number of coils in targeted ICD lead(s) (OR = 2.123; p = 0.003) but not passive-fixation ICD leads (1.361; p = 0.149) or single coil ICD leads (OR = 1.540; p = 0.177) were predictors of higher procedure complexity, but had no influence on MC or clinical and procedural success. ICD lead implant duration was of crucial importance, similar to the number of leads. Lead dwell time >10 years is associated with a high level of procedure difficulty and complexity but not with MC and procedure-related deaths. Conclusions: The main factors affecting the transvenous removal of ICD leads are implant duration and the number of targeted ICD leads. Dual coil and passive fixation ICD leads are a bit more difficult to extract whereas fixation mechanism and tip position play a much less dominant role.

LECOM (Lead Extraction COMplexity): A New Scoring System for Predicting a Difficult Procedure.

(1) Background: Transvenous lead extraction (TLE) can become far more complex when unanticipated difficulties arise. The aim was to develop a simple scoring system that allows for the prediction of the difficulty and complexity of this significant procedure. (2) Methods: Based on analysis of 3741 TLE procedures with and without complicating factors (extended fluoroscopy time, need for second-line instruments, and advanced techniques and instruments), a five-point Complex Indicator of Difficulty of (TLE) Procedure (CID-TLEP) scale was developed. Two or more points on the CID-TLEP scale indicate a higher level of procedure complexity. (3) Results: Patient age below 51 years at first CIED implantation, number of abandoned leads, number of previous procedures, passive fixation and multiple leads to be extracted, and a ratio of dwell time of oldest lead to patient age during TLE of >0.13 are significant predictors of higher levels of lead extraction complexity. The ROC analysis demonstrates that a point total (being the sum of the odds ratios of the above variables) of >9.697 indicates a 21.83% higher probability of complex TLE (sensitivity 74.08%, specificity 74.46%). Finally, a logistic function was calculated, and we constructed a simple equation for lead extraction complexity that can predict the probability of a difficult procedure. The risk of complex extraction (as a percentage) is calculated as [1/(1 + 55.34 · 0.754X)] · 100 (p < 0.001). (4) Conclusion: The LECOM score can effectively predict the risk of a difficult transvenous lead extraction procedure, and predicting the probability of a more complex procedure may help clinicians in planning lead removal and improving patient management.

Novel Hematological Parameters in the Assessment of the Extent of Cardiac Implantable Electronic Device-Related Infections

Background: Patients with infectious complications related to the presence of cardiac implantable electronic devices (CIED) constitute a heterogeneous group, ranging from local pocket infection (PI) to lead-related infectious endocarditis (LRIE) infection spreading along the leads to the endocardium. The detection of isolated LRIE and the assessment of the spread of infection in a patient with PI is often difficult and requires complex imaging and microbiological tests. The aim of the current study is to evaluate the usefulness of new simple hematological parameters in detecting infectious complications in patients with CIED, differentiating vegetation and vegetation-like masses, and assessing the extent of infections in patients with PI. Methods: A retrospective analysis of clinical data of 2909 patients (36.37% with CIED-related infections), undergoing transvenous lead extraction (TLE) procedures in three high-volume centres in the years 2006–2020, was conducted. Receiver operating characteristic (ROC) curve analysis was used to assess the sensitivity and specificity of neutrophil-to-lymphocyte ratio (NLR), neutrophil-to-platelet ratio (NPR), and lymphocyte-to-platelet ratio (LPR) in the diagnosis of CIED infections, evaluate the spread of the infectious process in patients with PI and differentiate additional structures related to the presence of lead. Results: The values of NLR and NPR were significantly higher in infectious patients than non-infectious controls (3.07 vs. 2.59; p &lt; 0.001, and 0.02 vs. 0.01; p = 0.008) and the area under the ROC curve (AUC) was 0.59; p &lt; 0.001 and 0.56; p &lt; 0.001, respectively. The high specificity of the new markers in detecting the infectious process was demonstrated: 72.82% for NLR (optimal cut-off value: 3.06) and 79.47% for NPR (optimal cut off value: 0.02). The values of NLR and NPR were significantly higher in patients with vegetations than in non-infectious patients with the presence of additional lead-related masses (3.37 vs. 2.61; p &lt; 0.001 and 0.03 vs. 0.02; p = 0.008). The AUC of NLR and NPR for the prediction of vegetations was 0.65; p &lt; 0.001 and 0.60; p &lt; 0.001 with the highest specificity of NPR (82.78%) and an optimal cut-off value of 0.03. NLR and NPR were higher in patients with LRIE compared to isolated PI (4.11 vs. 2.56; p &lt; 0.001 and 0.03 vs. 0.02; p &lt; 0.001) and the ROC curve analysis for coexistence LRIE with PI showed the AUC for NLR: 0.57; p &lt; 0.001 and AUC for NPR: 0.55; p = 0.001. High specificity in the detection of coexistence between PI and LRIE was demonstrated for NLR (87.33%), with an optimal cut-off value of 3.13. Conclusions: Novel hematological markers (NLR and NPR) are characterized by high specificity in the initial diagnosis of CIED infections, with optimal cut-off values of 3.06 and 0.02. NLR is also useful in the assessment of the spread of infection in patients with PI, with a calculated optimal cut-off value of 3.13. NPR may be helpful in the differentiation of vegetation and vegetation-like masses with an optimal cut-off value of 0.03.

Impact of fixation mechanism and helix retraction status on right ventricular lead extraction

BackgroundThe impact of lead fixation mechanism on extractability is poorly characterized. ObjectiveWe aimed to compare the technical difficulty of transvenous lead extraction (TLE) of active vs passive fixation right ventricular (RV) leads. MethodsA total of 408 patients who underwent RV TLE by a single expert electrophysiologist at Oregon Health & Science University between October 2011 and June 2022 were identified and retrospectively analyzed; 331 (81%) had active fixation RV leads and 77 (19%) had passive fixation RV leads. The active fixation cohort was further stratified into those with successfully retracted helices (n = 181) and failed helix retraction (n = 109). A numerical system (0–9) devised using 6 procedural criteria quantified a technical extraction score (TES) for each RV TLE. The TES was compared between groups. ResultsHelix retraction was successful in ≥55% of active fixation TLEs. The mean TES for active-helix retracted, active-helix non-retracted, and passive fixation groups was 1.8, 3.5, and 3.7, respectively. The TES of the active-helix retracted group was significantly lower than those of the active-helix non-retracted group (adjusted P < .01) and the passive fixation group (adjusted P < .01). There was no significant difference in TES between the passive fixation and active-helix non-retracted groups in multivariate analysis (P = .18). The TLE success rate of the entire cohort was >97%, with a major complication rate of 0.5%. ConclusionTLE of active fixation leads where helical retraction is achieved presents fewer technical challenges than does passive fixation RV lead extraction; however, if the helix cannot be retracted, active and passive TLE procedures present similar technical challenges.

Abstract 18561: Trends Among Patients Undergoing Transvenous Lead Extraction: A Single Center Experience

Background: In recent years there has been an increase in cardiac device-related infections and the need for transvenous lead extraction (TLE). Limited data exist on secular trends in baseline characteristics and outcome measures among patients undergoing this high-risk procedure. Objective: To examine secular trends in baseline characteristics and outcomes for patients undergoing lead extraction procedure at our institution. Methods: We conducted a retrospective chart review of patients undergoing TLE from 2010 to 2021, at a tertiary academic institution. Patients were divided into three epochs (2010-2013, 2014-2017 and 2018-2021). Baseline characteristics in hospital length of stay (LOS) and survival were compared between groups. Results: A total of 794 patients, with a mean age of 64±16 years, were analyzed. 481 (60%) patients had infection as the indication for TLE. On average, 2 ± 1 leads were extracted per patient. The longest lead dwell time was 6.5 ± 4.8 years. Significant progressive increase in baseline comorbidity over time is noted (Table 1). A concomitant increase in infection indication versus lead management was also noted. There was a significant increase in the median hospital LOS across epochs; 3.88 IQR (1.26-10.06) for epoch 1 vs 7.34 IQR (2.25-13.35) for epoch 2, vs 9.06 IQR (5.78-14.05) for epoch 3 (P &lt; 0.0001). While there was no difference in long term survival curves (log rank p =0.4), between group analysis showed higher risk for 30 day [RR 2.24(1.08-4.66) p=0.0306] and 1 year mortality [RR 1.44 (1.004-2.05) p=0.0478] between epoch 3 vs epoch 1. Conclusion: Across epochs, the number of TLE procedures performed decreased while patient morbidity increased with a notable increase in infection indication for the procedure. This corresponded to a progressive increase in hospital LOS and an emergent signal toward increased near-term mortality.

Safety and success of transvenous lead extraction using excimer laser sheaths: a meta-analysis of over 1700 patients.

While numerous studies have demonstrated favourable safety and efficacy of the excimer laser sheath for transvenous lead extraction (TLE) in smaller cohorts, comprehensive large-scale investigations with contemporary data remain scarce. This study aims to evaluate the safety and performance of laser-assisted TLE through a meta-analysis of contemporary data. A systematic literature search was conducted to identify articles that assessed the safety and performance of the spectranetics laser sheath (SLS) II and GlideLight Excimer laser sheaths in TLE procedures between 1 April 2016 and 31 March 2021. Safety outcomes included procedure-related death and major/minor complications. Performance outcomes included procedural and clinical success rates. A random-effects, inverse-variance-weighting meta-analysis was performed to obtain the weighted average of the evaluated outcomes. In total, 17 articles were identified and evaluated, including 1729 patients with 2887 leads. Each patient, on average, had 2.3 ± 0.3 leads with a dwell time of 7.9 ± 3.0 years. The TLE procedural successes rate was 96.8% [1440/1505; 95% CI: (94.9-98.2%)] per patient and 96.3% [1447/1501; 95% CI: (94.8-97.4%)] per lead, and the clinical success rate per patient was 98.3% [989/1010, 95% CI: (97.4-99.0%)]. The procedure-related death rate was 0.08% [7/1729, 95% CI: (0.00%, 0.34%)], with major and minor complication rates of 1.9% [41/1729; 95% CI: (1.2-2.8%)] and 1.9% [58/1729; 95% CI: (0.8-3.6%)], respectively. This meta-analysis demonstrated that excimer laser sheath-assisted TLE has high success and low procedural mortality rates. It provides clinicians with a reliable and valuable resource for extracting indwelling cardiac leads which require advanced extraction techniques.

Transvenous Lead Extraction: Outcomes From a Single Centre Providing a National Service for New Zealand.

With increasing demand for cardiac implantable electronic devices there is a parallel increase in the need for transvenous lead extraction (TLE). Due to its small population, all TLE procedures in New Zealand are currently performed in a single centre, Auckland City Hospital. We analysed the clinical characteristics and outcomes of those undergoing TLE since this service was established. We performed a retrospective, single-centre cohort study of all TLE procedures between October 2015 and December 2021. Definitions from the European Lead Extraction Controlled study, Heart Rhythm Society, European Heart Rhythm Association consensus documents were used. A total of 247 patients had 480 leads extracted, averaging 40 TLE procedures annually. Patients had a median lead dwell time of 6 (interquartile range [IQR] 3-11) years, 60 (13%) of leads had been in-situ >15 years, median age 61 (IQR 48-70) years, 73 (30%) female, 28 (11%) Māori, 23 (9%) Pasifika. Lead dysfunction (115 patients, 47%) and infection (90 patients, 37%) were the most common indications for TLE. Complete clinical and radiological success was achieved for 96% and 95%, respectively. Procedure-related complications occurred in 16 (7%) patients. Major intra-procedure complications occurred in 5 patients (2%), including 2 (1%) deaths. Death within one year of TLE occurred in 13 (26%) with systemic infection, 5 (3%) with local infection, and 5 (3%) with non-infection indications for TLE, p <0.01. TLE is associated with high radiographic and clinical success, low complication, and low mortality rate. At our single centre providing a national service, TLE outcomes are comparable with those achieved internationally.

Cardiologist-Directed Sedation Management in Patients Undergoing Transvenous Lead Extraction: A Single-Centre Retrospective Analysis.

The demand for transvenous lead extraction (TLE) has increased. In line with this, the safety of such procedures has also increased. Traditionally, TLE is performed under resource-intensive general anaesthesia. This study aims to evaluate the safety and outcomes of Cardiologist-lead deep sedation for TLE. We retrospectively analysed 328 TLE procedures performed under deep sedation from 2016 to 2019. TLE procedures were performed by experienced electrophysiologists. Sedation was administered by a specifically trained cardiologist (bolus midazolam/fentanyl and propofol infusion). Procedural sedation data including blood pressure, medication administration and sedation time were collected. Complications related to sedation and the operative component of the procedure were analysed retrospectively. The sedation-associated complication rate during TLE was 22.0%. The most common complication (75% of complications) was hypotension requiring noradrenaline, followed by bradycardia requiring atropine (13% of complications). Additionally, the unplanned presence of an anaesthesiologist was needed in one case (0.3%). Deep sedation was achieved with midazolam (mean dose 42.9 ± 26.5 µg/kg), fentanyl (mean dose 0.4 ± 0.6 µg/kg) and propofol (mean dose 3.5 ± 1.2 mg/kg/h). There was no difference in medication dosage between those with a sedation-associated complication and those without. Sedation-associated complications appeared significantly more in patients with reduced LVEF (p = 0.01), renal impairment (p = 0.01) and a higher American Society of Anaesthesiologists (ASA) class (p = 0.01). Deep sedation for TLE can be safely performed by a specifically trained cardiologist, with a transition to general anaesthesia required in only 0.3% of cases. We continue to recommend the on-call availability of an anaesthesiologist and cardiac surgeon in case of major complications.

Long-Term Outcomes of Transvenous Lead Extraction: A Comparison in Patients with or without Infection from the Italian Region with the Oldest Population.

The gold standard for the treatment of cardiac implantable electronic devices (CIEDs)-related infection and lead malfunction is transvenous lead extraction (TLE). To date, the risk of mortality directly related to TLE procedures is relatively low, but data on post-procedural and long-term mortality are limited, even more in the aging population. Consecutive patients with CIEDs who underwent TLE were retrospectively studied. The primary outcome was the endpoint of death, considering independent predictors of long-term clinical outcomes in the TLE aging population comparing patients with and without infection. One hundred nineteen patients (male 77%; median age 76 years) were included in the analysis. Eighty-two patients (69%) documented infection, and thirty-seven (31%) were extracted for a different reason. Infected patients were older (80 vs. 68 years, p-value > 0.001) with more implanted catheters (p-value < 0.001). At the last follow-up (FU) available (median FU 4.1 years), mortality reached 37% of the patient population, showing a statistically significant difference between infected versus non-infected groups. At univariable analysis, age at TLE, atrial fibrillation, and anemia remained significant correlates of mortality; at multivariable analysis, only patients with anemia and atrial fibrillation have a 2.3-fold (HR 2.34; CI 1.16-4.75) and a 2.5-fold (HR 2.46; CI 1.33-4.54) increased rate of death, respectively. Our long-term data showed that aging patients who underwent TLE for CIED-related infection exhibit a high mortality risk during a long-term follow-up, potentially leading to a rapid and effective procedural approach in this patient population.

Transvenous lead extraction, factors affecting procedural difficulty

Background A complex transvenous lead extraction (TLE) procedure could be associated with lower success and higher complication rates in inexperienced hands. In this study, we aim to assess the factors that determine procedural difficulty in TLE. Methods We retrospectively studied 200 consecutive patients undergoing TLE in a single referral centre from June 2020 to December 2021. Lead extraction difficulty was assessed by the success of simple manual traction with or without a locking stylet, the need for advanced extraction tools and the number of tools required to extract the lead. Logistic and linear regression analyses were used to determine the factors independently affecting these 3 parameters. Results 363 leads were extracted from 200 patients (79% males, mean age 66.85 years). The indication for TLE was device-related infection in 51.5%. Multivariate analysis revealed the lead indwelling time to be the only factor affecting the 3 parameters of difficulty. Passive fixation leads and dual coil leads increased procedural difficulty by affecting 2 parameters each. Factors that affected one parameter included infected leads, coronary sinus leads, older age of the patient and a history of valvular heart disease, all associated with a simpler procedure. Right ventricular leads were associated with a more complex one. Conclusion The most important factor that increased TLE procedural difficulty was a longer lead indwelling time, followed by passive fixation and dual-coil leads. Other contributing factors were the presence of infection, coronary sinus leads, older patients, a history of valvular heart disease and right ventricular leads.

Heart failure is associated with increased risk of all-cause mortality after transvenous lead extraction: A systematic review and meta-analysis.

Transvenous lead extraction (TLE) is increasingly considered in cardiac implantable electronic device management. Heart failure (HF) might be associated with mortality risks after the TLE procedure. This study aims to assess mortality risk in HF patients undergoing TLE. We searched MEDLINE and Embase databases from inception to June 2022 to identify articles that included patients with and without HF who underwent TLE, which reported mortality in both groups. The pooled effect size was calculated with a random-effects model and 95% CI to compare post-TLE mortality between the two groups. Eleven studies were included in the analysis. Each left ventricular ejection fraction (LVEF) increased by 1% was associated with reduced mortality by 2% (HR = 0.98, 95% CI: 0.97-0.99, I 2 = 74.9%, p < .01). The presence of HF compared to those without HF was associated with higher mortality rates (OR: 3.04, 95% CI: 2.56-3.61, I 2 = 0.0%, p < .531). There was a significant increase in the mortality rates in patients with New York Heart Association (NYHA) function class III (OR: 2.29, 95% CI: 1.29-4.06, I 2 = 0.0%, p = .498) and NYHA IV (OR: 8.5, 95% CI: 2.98-24.3, I 2 = 0.0%, p = .997). Our study found that post-TLE mortality decreases by 2% as LVEF increases by 1%, also mortality is higher in patients with NYHA III and IV.

High success and safety of transvenous lead extraction using excimer laser sheaths in more than 1700 patients: a meta-analysis

Abstract Funding Acknowledgements Type of funding sources: Private company. Main funding source(s): Philips Background The excimer laser sheath is a commonly used advanced transvenous lead extraction (TLE) tool to aid the successful extraction of indwelling cardiac leads by ablating the tissues adhering to the leads. Many studies have reported favorable safety and efficacy results with leaser sheath assisted TLE in small patient groups. However, to date, there are no comprehensive large-scale studies using contemporary data to analyze the outcomes of excimer laser sheaths assisted TLE. Purpose To assess the performance and safety of excimer laser sheath assisted TLE using meta-analysis of contemporary data. Methods A systematic literature search was performed to identify articles relevant for the evaluation of the safety and performance of the SLS II and GlideLight excimer laser sheaths in TLE procedures from April 1, 2016 to March 31, 2021. Safety outcomes included procedure-related deaths and major and minor complications. Performance outcomes included procedural success and clinical success rates achieved in TLE procedures as defined by 2017 HRS and 2018 EHRA consensus guidelines. A random-effects, inverse-variance-weighting meta-analysis using arsine square root transformation was performed to obtain the weighted average of evaluated outcomes. Results A total of 17 articles were identified and included for evaluation and data extraction, among which 6 were prospective studies and 11 were retrospective studies. The evaluated studies included 1,729 patients with 2,887 leads, among which 311 leads were extracted with the SLS II device, 1,688 were extracted using GlideLight, and the rest (n=888) involved both devices. Overall, 38.5% of leads were extracted due to infection. The most common lead type targeted for extraction were ICDs (47.9%). On average, each patient had 2.3 ± 0.3 leads and the lead dwell time was 7.9 ± 3.0 years. The TLE procedure successes rate per patient was 96.8% (1,440/1,505; 95% CI: [94.9%-98.2%]) and per lead 96.6% (1,447/1,501; 95% CI: [95.1%-97.7%]). The clinical success rate per patient was 98.3% (989/1,010, 95% CI: [97.4%-99.0%]). The weighted average of the procedure-related death rate was 0.08% (7/1,729, 95% CI: [0.00%, 0.34%]), comparable to the mortality rate reported in other studies on lead extraction safety. The most common complications were pericardial effusion or tamponade (n=21), hematoma (n=20) and cardiovascular injuries (n=18). Conclusion TLE utilizing the excimer laser sheath has high success and low mortality rates and provides physicians with a valuable tool for safe and effective extraction of indwelling cardiac leads that require advanced extraction techniques.

Single center experience with a novel short rotating dilator sheath in transvenous lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. Background Transvenous lead extraction has become a frequent procedure in the context of device lead management and various tools are available. The aim of this study was to investigate the efficacy and safety of the novel short rotating dilator sheath TightRailTM Sub-C (Sub-C) designed to facilitate vessel entry in the beginning of a transvenous lead extraction procedure necessitating active mechanical extraction tools. Methods For this retrospective single center analysis, we included consecutive patients undergoing transvenous lead extraction using the Sub-C from January 2018 until February 2020 at a university heart center. Results A total of 87 leads were extracted within 45 patients using the Sub-C extraction sheath. The mean dwell time of the leads was 112 ± 9.1 months. Complete procedural success was achieved in 95.6% (43/45) and clinical procedural success in 97.8% (44/45). Two major complications (4.4%, 2/45, 1 device pocket bleeding, 1 hemothorax) occurred, but neither were directly related to the Sub-C. Conclusion The TightRailTM Sub-C appears to be a safe and efficient short rotating dilator sheath for achieving vessel entry in the beginning of a transvenous lead extraction procedure.

Shockwave Intravascular Lithotripsy Facilitated Transvenous Lead Extraction

BackgroundDense calcifications encasing pacing leads with long dwell times are common and increase the difficulty of and risks associated with transvenous lead extraction procedures (TLE). Shockwave intravascular lithotripsy (IVL) focuses sound waves to fracture calcified tissue within a narrow radius to the catheter. ObjectivesThis study sought to assess the impact of Shockwave IVL pretreatment during extraction of long dwell time pacemaker and defibrillator leads. MethodsData were compiled retrospectively from patients undergoing TLE at Essentia Health in Duluth, Minnesota, from October 2019 to April 2023. IVL pretreatment was performed using currently available 7- and 8-mm balloons with ≤300 pulses delivered in close proximity to the leads via a retrograde approach, after which the procedure was completed as usual. ResultsOf the 120 patients undergoing TLE procedures, 55 were excluded from the study because the leads were freely mobile. Among the remaining 65 patients, 14 received IVL pretreatment. The median patient ages were similar at 67 (IQR: 63-76) years, with a lead dwell time of 10.7 (IQR: 6.9-14.9) years. The frequencies of diabetes, stroke, prior sternotomy, and lead types were not significantly different between the IVL and conventional groups. IVL pretreatment resulted in an average of 25 (IQR: 9-42) fewer minutes actively extracting leads (P = 0.007). ConclusionsThese data represent the first known cases using Shockwave IVL as an adjunctive measure during extraction of high-risk and high-complexity leads, with a resulting significant reduction in the amount of time spent engaging in the highest-risk phase of the procedure.

Unexpected Procedure Difficulties Increasing the Complexity of Transvenous Lead Extraction: The Single Centre Experience with 3721 Procedures.

Transvenous lead extraction (TLE) should be completed, even when facing difficulties which have yet to be described. The aim was to explore unexpected TLE obstacles (the circumstances of the occurrence and influence on TLE outcome). The retrospective analysis of a single centre database containing 3721 TLEs. Unexpected procedure difficulties (UPDs) occurred in 18.43% of cases (singles in 12.20% of cases and multiples in 6.26% of cases). These included blockages in the lead venous approach in3.28% of cases, functional lead dislodgement in 0.91% of cases, and loss of broken lead fragment in 0.60% of cases. All of them, including implant vein-in 7.98% of cases, lead fracture during extraction-in 3.84% of cases, and lead-to-lead adherence-in 6.59% of cases, Byrd dilator collapse-in 3.41% of cases, including the use of an alternative prolonged the procedure but had no influence on long-term mortality. Most of the occurrences were associated with lead dwell time, younger patient age, lead burden, and poorer procedure effectiveness and complications (common cause). However, some of the problems seemed to be related to cardiac implantable electronic devices (CIED) implantation and the subsequent lead management strategy. A more complete list of all tips and tricks is still required. (1) The complexity of the lead extraction procedure combines both prolonged procedure duration and the occurrence of lesser-known UPDs. (2) UPDs are present in nearly one fifth of the TLE procedures, and can occur simultaneously. (3) UPDs, which usually force the extractor to expand the range of techniques and tools, should become part of the training in transvenous lead extraction.

Transvenous lead extractions in a single high-volume center over a 24-year period: High success rate and low complication rate

Transvenous lead extraction (TLE) procedures can be complicated and are associated with a small but significant risk of cardiovascular complications. However, methods and tools vary among centers. The purpose of this study was to the present the methods and results of pacemaker and implantable cardioverter-defibrillator TLE procedures in our center over a 24-year period. From April 1997 through 2020, we attempted to extract 2964 leads in 1780 procedures and 1642 patients. We mainly utilized single sheath technique using snaring or mechanical rotational sheaths and steel sheaths when necessary. Difficult procedures were performed by an experienced cardiologist, and close supervision was emphasized. Most of the extractions were performed using local anesthesia with sedation. Median age of patients was 65.0 [interquartile range 20.00] years, and median dwelling time of leads was 5.0 [7.0] years. Clinical success was achieved in 1739 procedures (97.7%) and complete technical success in 2841 leads (95.8%). Clinical success (leaving <4 cm of the lead in the body and achieving the clinical goal for the patient) was achieved for 79 leads (2.7%). TLE failed in 44 leads (1.1%) and 41 procedures (2.3%) among 36 patients (2.2%). There were 23 cases (1.3%) of major complications, with only 1 death directly related to the procedure (<0.1%). In addition, 2 patients with sepsis died within the first 24 hours after the procedure. No caval tears occurred. Single sheath lead extractions utilizing snaring or mechanical rotational sheaths were effective and safe in our high-volume center as performed by experienced operators.

To grade or not to grade safety requirements for transvenous lead extraction: Experience with 2216 procedures.

Transvenous lead extraction (TLE) procedures are now increasingly safe, but there is still a risk of major complications (MC). We aimed to assess the impact of TLE organization on the safety of procedures. We analyzed 2216 TLE procedures performed in two centers in the years 2006-2021 and compared three organizational procedural models: (1) TLE in an electrophysiology laboratory (EP-LAB) with intravenous analgesia/sedation; (2) TLE with grading of safety requirements (high-risk patients in the cardiac surgery operating theatre, others in EP-LAB); (3) TLE in the hybrid room in all patients under general anesthesia with transesophageal echocardiographic (TEE) monitoring. The safety of procedures and mortality after TLE in three-year follow-up were assessed. The rate of MC in the EP-LAB group was 1.55%, and the rate of procedure-related deaths (PRD) was 0.33%. While using the graded approach to safety requirements, the percentage of MC was 2.61% and PRD 0.29%. When performing TLE procedures in the hybrid room, the MC percentage was 1.33% and PRD 0.00%. Long-term survival after TLE was comparable in all study groups. A key factor in preventing TLE-related deaths is procedure organization that enables emergency cardiac surgery. TLE performed in a hybrid room with a collaborating cardiac surgeon and vital signs monitoring appears to be the safest possible option for the patient. A graded safety approach is associated with the risk of unexpected MC and PRD. Any newly established TLE center can achieve satisfactory results if the optimal organizational model of the procedure is used.

Mechanical extraction of implantable cardioverter-defibrillator leads with a dwell time of more than 10 years: insights from a single high-volume centre.

To analyze and compare the effectiveness and safety of transvenous lead extraction (TLE) of implantable cardioverter-defibrillator (ICD) leads with a dwell time of >10 years (Group A) vs. younger leads (Group B) using mechanical extraction systems. Between October 2011 and July 2022, we performed TLE in 318 patients. Forty-six (14.4%) extracted ICD leads in 46 (14.5%) patients that had been implanted for >10 years. The median dwell time of all extracted ICD leads was 5.9 years. Cardiovascular implantable electronic device-related infection was an indication for TLE in 31.8% of patients. Complete ICD leads removal and complete procedural success in both groups were similar (95.7% in Group A vs. 99.6% in Group B, P = 0.056% and 95.6% in Group A vs. 99.6% in Group B, P = 0.056, respectively). We did not find a significant difference between major and minor complication rates in both groups (6.5% in Group A vs. 1.5% in Group B and 2.2% in Group A vs. 1.8% in Group B, P = 0.082, respectively). One death associated with the TLE procedure was recorded in Group B. The TLE procedures involving the extraction of old ICD leads were effective and safe. The outcomes of ICD lead removal with a dwell time of >10 years did not differ significantly compared with younger ICD leads. However, extraction of older ICD leads required more frequent necessity for utilizing multiple extraction tools, more experience and versatility of the operator, and increased surgery costs.

Cardiac surgery simulation: Advances in transvenous lead extraction

The clinical importance of procedures for transvenous lead extraction has increased greatly because the volume of cardiac implantable electronic devices has increased. Consequently, the number of device-related complications requiring lead extraction has also been increasing. Great improvements in lead extraction techniques have occurred in recent years with the development of transvenous lead extraction tools and techniques. Experienced centres can achieve high success rates with infrequent complications. However, even in experienced hands, life-threatening complications can occur, and any physician performing these procedures must be prepared and trained for such eventualities. Moreover, because the occurrence of these stressful situations cannot be accurately predicted, training obtained in simulated environments can be decisive. We have developed a training module that simulates all the ordered steps of a transvenous lead extraction procedure and thus is able to help surgeons refine their surgical techniques and improve their performance.