Andrzej Kutarski

Background: Patients with defects of the atrial septum (DAS) undergoing transvenous lead extraction (TLE) may be at increased risk of systemic embolism due to transient right‐to‐left shunting. However, data on the prevalence and clinical relevance of DAS in patients undergoing TLE remain limited. Methods: This retrospective study included 3637 patients undergoing TLE between 2006 and 2024 with complete preprocedural assessment of the atrial septum and at least 3 years of follow‐up. We evaluated the prevalence of DAS and its association with procedural complexity, major complications, and survival. Results: DAS was identified in 3.71% of patients. Patent foramen ovale was present in 2.45%, secundum atrial septal defect in 1.15%, and both defects in 0.08%. Most defects were small, with predominant left‐to‐right shunting. Patients with DAS more frequently had lead‐related infective endocarditis and vegetations on transesophageal echocardiography ( p < 0.001). TLE procedures in patients with DAS were more complex, with longer extraction times and more frequent use of advanced extraction tools. Despite higher predicted procedural risk, the incidence of major complications, including stroke, was low. DAS was not associated with increased in‐hospital, 30‐day, 1‐year, or 3‐year mortality. Conclusions: In this large TLE cohort, DAS was uncommon and associated with greater procedural complexity, but not with a higher incidence of major complications or worse long‐term survival. Clinically apparent systemic embolic events were rare.

Long-term mortality after transvenous lead extraction (TLE) remains substantial despite high procedural success. However, simple tools for estimating long-term prognosis after successful TLE are lacking. This retrospective multicenter study included 3368 consecutive patients undergoing TLE between 2006 and 2020 with complete 5-year follow-up. Patients were assigned in a 1:1 ratio to derivation and validation cohorts (n = 1684 each). Independent predictors of mortality were identified using multivariable Cox proportional hazards analysis and incorporated into a point-based risk score, the List of Independent Factors for Estimated 5-Year Survival (LIFE-5S). During follow-up, cumulative 5-year mortality was 32.2%. Independent predictors included male sex, older age, permanent atrial fibrillation, advanced heart failure (NYHA class III/IV), type 2 diabetes, renal dysfunction, reduced left ventricular ejection fraction, pocket infection, lead-related infective endocarditis, and the presence of cardiac resynchronization therapy. Each 1-point increase in the LIFE-5S score was associated with higher mortality risk (HR 1.36, 95% CI 1.33-1.39; p < 0.001). The model demonstrated good discrimination (AUC 0.786 in the derivation cohort and 0.785 in the validation cohort) and good calibration across score strata. To facilitate clinical application, an online calculator based on the LIFE-5S model is available (https://usuwanieelektrod.pl/life5scalculator). The LIFE-5S score provides a simple bedside tool for long-term prognostic stratification after TLE. This model may support clinical decision-making, patient counseling, and planning of individualized follow-up strategies after TLE.

Background: Multimorbidity significantly affects prognosis in patients after transvenous lead extraction (TLE). The CHA₂DS₂-VASc and CHA₂DS₂-VA scores, widely used for stroke risk stratification in atrial fibrillation, include clinical factors that are also associated with long-term mortality. Purpose: To evaluate the usefulness of the CHA₂DS₂-VASc and CHA₂DS₂-VA scores in predicting short- and long-term mortality in patients following non-laser TLE. Methods: This retrospective study included 3822 patients who underwent non-laser TLE between March 2006 and April 2023 at high-volume centres. The median follow-up was 1848 days (Q1-Q3: 815– 3146 days). Patients were stratified into two groups according to CHA₂DS₂-VASc score (< 3 vs. ≥ 3). 30-day, 1-year, and 3-year, and overall follow-up mortality were assessed. Cox proportional hazards models were used to identify independent predictors of death during short and long follow-up. Results: Patients with CHA₂DS₂-VASc ≥ 3 had significantly higher mortality at 30 days 1 year, 3 years, and during overall follow-up compared with those scoring < 3. A cut-off ≥ 3 showed 80.6% sensitivity and 62.3% specificity for predicting 3-year mortality. Mortality increased progressively with higher CHA₂DS₂-VASc scores (Spearman’s r = 0.983, p< 0.001). The multivariate Cox regression demonstrated that number of points on CHA₂DS₂-VASc and CHA₂DS₂-VA scores were independent predictors long-term mortality, alongside Charlson comorbidity index, atrial fibrillation, infective TLE indications, and renal dysfunction. Each 1-point increase in the CHA₂DS₂VA score was associated with an 11.7% increase in the risk of death. In sex-specific analysis, the risk increased by 33.0% per point in females (HR 1.330; p< 0.001) and by 20.6% in males (HR 1.206; p< 0.001). Conclusion: CHA₂DS_2-VASc and CHA₂DS_2-VA score may be a useful tool for predicting the risk of death during long-term observation of patients after TLE. Incorporation of this score into clinical decision-making may improve risk stratification and support individualized management of patients undergoing TLE.

Background: Transvenous removal of implantable cardioverter‐defibrillator (ICD) leads is considered to be more difficult and risky. The goal was to explore the impact of ICD lead design on transvenous lead extraction (TLE) safety and effectiveness. Methods: Analysis of 3929 TLE procedures (including 1068 with ICD lead extraction) were analyzed retrospectively. Results: The extracted ICD leads were about three years younger than pacemaker (PM) leads (medians: 61.00 vs. 97.00 months). The rate of major TLE complications (MC) was significantly higher in the PM lead extraction group (2.25% vs. 0.75%; p = 0.002) and complete procedural success was achieved significantly less often (by 4.11%; p < 0.001 in entire group of patients and by 3.74%; p < 0.001 in patients matched according to age of extracted lead). However, no significant differences were found in the scores of TLE complexity and major complications during extraction of ICD leads produced by different manufacturers. Lower rates of complete procedural success, compared to Medtronic ICD leads, were found in patients with Abbott and Biotronik ICD leads (99.45% vs. 97.32%; p = 0.009 and 96.65%; p = 0.003). Conclusions: 1. ICD lead implant duration was 3.17 years shorter and perhaps for this reason ICD lead extraction was often less difficult, the procedure less complex and MC significantly rare (0.75%) in comparison with PM lead extraction (2.55%). There were no differences between groups matched according to age of extracted lead. Achieving of complete procedural success was lower in PM lead extraction both in entire as in matched group of patients. 2. There were no significant differences in the complexity of TLE procedures or the incidence of major complications depending on ICD lead manufacturer, despite the fact that Biotronik leads were 16–19 months older. 3. The extraction of Abbot and Biotronik leads was associated with a lower rate of complete procedural success (by 2.13% and 2.80%).

Background and Objectives: There is limited knowledge on ICD lead lifespan, the reasons for lead failure, and the influence of lead models. Our aim in this study was to compare the lifetime of individual lead models and the reasons for their extraction. Materials and Methods: We analyzed 3929 transvenous lead extractions (TLEs) (including 1068 ICD lead extractions). Results: The median age of an ICD lead removed (for all causes) was 61 months, three years shorter than that of PM leads. Old models with thick leads survived almost twice as long as thin and modern leads. ICD leads were removed due to infection (35.6%), mechanical damage (33.6%), and dysfunction (including perforation) (20.8%). Riata leads presented higher resistance to mechanical damage compared to Sprint Fidelis and Linox (dwell time medians; 124.0, 47.0 and 70.0 months). However, Durata leads presented higher resistance to mechanical damage compared to Sprint Fidelis and Linox (dwell time medians; 81.0, 68.0 and 70.0 months). Riata leads lasted almost twice as long as Sprint Fidelis. Linox leads lasted as long as theoretically fail-safe Sprint Quatro leads. Conclusions: 1. The median of ICD lead survival was three years shorter than that of PM leads. 2. ICD leads were most commonly removed due to infection, mechanical lead damage, and undamaged lead dysfunction (including perforation). 3. Old models of thick leads (Sprint, Ventritex, and Kainox) survived almost twice as long as thin leads from the transition period (Riata and Sprint Fidelis) and modern leads. Despite advances in the design of ICD leads, their lifetime has not changed significantly.

Aims: The clinical spectrum of cardiac implantable electronic device (CIED) infections includes isolated pocket infection (IPI), pocket infection complicated by infective endocarditis (PIRIE), and lead-related infective endocarditis (LRIE). The aim of this study was to assess the risk factors, clinical course, and outcomes in patients with CIED infections and to demonstrate differences between PIRIE and LRIE. Methods and results: The retrospective analysis of data from 3847 patients undergoing transvenous lead extraction for non-infectious (2640; 68.62%) and infectious (1207; 31.38%) indications, including 361 (29.91%) IPI, 472 (39.11%) PIRIE, and 374 (30.99%) LRIE, showed some differences in risk factors, clinical course, and outcomes between the subgroups. Unlike PIRIE, diabetes [hazard ratio (HR) = 1.488; 95% confidence interval (CI; 1.178–1.879), P < 0.001] and lead abrasion [HR = 2.117; 95% CI (1.665–2.691), P < 0.001] increased the risk of LRIE. The risk of pocket infection spread was greater with Staphylococcus aureus infection [HR = 1.596; 95% CI (1.202–2.120), P < 0.001]. Compared with LRIE, patients with PIRIE had lower levels of inflammatory markers and lower prevalence of vegetations. Mortality in PIRIE compared with LRIE patients was lower (53.18 vs. 62.30%; P < 0.001) and comparable to IPI (50.69%; P = 0.162) at long-term [median 1828 (815–3139) days] follow-up. Conclusion: Cardiac implantable electronic device infections share common risk factors; however, diabetes and intra-cardiac lead abrasion predispose to LRIE, whereas multiple leads and S. aureus in pocket culture are risk factors for pocket infection spread. Compared with LRIE, the clinical course of PIRIE was milder, and short- and long-term mortalities were lower, but comparable with IPI after >1 year. This may be an argument in favour of categorization into primary LRIE and secondary endocarditis, i.e. PIRIE.

Background: Removal of spontaneously fractured leads with their proximal ends migrated into the vascular space has not been analysed in detail thus far. The study aimed to compare the effectiveness of different approaches and auxiliary tools for removing fractured leads with migrated proximal ends. Methods: Retrospective analysis of 72 cases from a database containing 3847 TLEs (transvenous lead extraction). Results: Most of the leads were passive, especially unipolar. Procedure complexity in such cases was high but with satisfying effectiveness (procedural success rate 93.06%) and independent of the position of the proximal end. The rate of major complications was 2.78%, which may be attributed to long implant duration (152.2 months). Extraction of such leads did not influence long-term survival. The femoral approach was most often used (62.50%). In 79.16% of leads, mechanical dissection was required. In 66.7%, proximal ends were strongly attached to the wall, and a loop had to be applied. In 15.28% of procedures, the lead was wrapped around a pig-tail catheter (“spaghetti twisting technique”). Conclusions: (1) Spontaneous lead fracture with the proximal ends migrated into the vascular space is a rare finding (1.87% of the TLE). (2) Removal of such leads requires the use of different approaches as well as dedicated and non-dedicated tools. (3) Despite a high level of procedure complexity, its effectiveness is high, with an acceptable rate of major complications.

Background: Transesophageal echocardiography (TEE) is mandatory before transvenous lead extraction (TLE), but its usefulness remains underestimated. This study aims to describe the broad range of TEE findings in TLE candidates, as well as their influence on procedure complexity, major complications (MCs) and long-term survival. Methods: Preoperative TEE was performed in 1191 patients undergoing TLE. Results: Lead thickening (OR = 1.536; p = 0.007), lead adhesion to heart structures (OR = 2.531; p < 0.001) and abnormally long lead loops (OR = 1.632; p = 0.006) increased the complexity of TLE. Vegetation-like masses on the lead (OR = 4.080; p = 0.44), lead thickening (OR = 2.389; p = 0.049) and lead adhesion to heart structures (OR = 6.341; p < 0.001) increased the rate of MCs. The presence of vegetations (HR = 7.254; p < 0.001) was the strongest predictor of death during a 1-year follow-up period. Conclusions: TEE before TLE provides a lot of important information for the operator. Apart from the visualization of possible vegetations, it can also detect various forms of lead-related scar tissue. Build-up of scar tissue and the presence of long lead loops are associated with increased complexity of the procedure and risk of MCs. Preoperative TEE performed outside the operating room may have an impact on the clinical decision-making process, such as transferring potentially more difficult patients to a more experienced center or having the procedure performed by the most experienced operator. Moreover, the presence of masses or vegetations on the leads significantly increases 1-year and all-cause mortality.

Background: CHA2DS2VASc scale is commonly used to risk stratification of stroke in atrial fibrillation patients. With the exception of female gender, the remaining components of the scale are also risk factors for long-term prognosis. Aim: Assessment of the usefulness of the CHA2DS2VASc scale for predicting the short and long term risk of death in the population of transvenous lead extraction (TLE) patients. Methods: Retrospective analysis of data of 3822 consecutive patients underwent TLE followed by to 6239 days: median (Q1-Q3) 1846 (852 – 3146). Results: The strong corelation between number of CHA2DS2VASc scale points and mortality was detected both in 30-days, 1-year, 3-year and all time of follow-up (Spearman r for all follow-up = 0.983, p<0.001). In all TLE population multivariable Cox regression shown that number of points of CHA2DS2VASc scale is independent predictor of death [HR=1.181; 95%CI (1.104-1.264), p<0.001], alongside Carlson index, atrial fibrillation, infective TLE indications and renal dysfunction. A scale value higher by 1 point is associated with an increase in the risk of death by 18.1%. In female group the risk increased by 37.5% [HR=1.375; 95%CI(1.193-1.584), p<0.001)] and in male group the risk increased by 22.00% [HR=1.220; 95%CI 1.110-1.342), p<0.001)]. Conclusion: The commonly known stroke risk CHA2DS2VASc scale may be a useful tool for predicting the risk of death both in short and long-term observation in the group of patients after transvenous lead extraction.Table 1

Background: There are no reports describing lead break (LB) during transvenous lead extraction (TLE). Our aim was to compare the effectiveness of different approaches and tools used for LB removal during 127 procedures. Methods: Retrospective analysis of 3825 consecutive TLEs using mechanical sheaths. Results: Fracture of the lead defined as LB with a long lead fragment (LF) occurred in 2.48%, LB with a short LF in 1.20%, LB with the tip of the lead in 1.78% and LB with loss of a free-floating LF in 0.57% of cases. In total, extractions with LB occurred in 6.04%. In cases in which lead remnant was equivalent to a lead fragment (more than the lead tip only) there was a 50.31% chance of removing the LF in its entirety and an 18.41% chance of significantly reducing its length (to less than 4 cm). Risk factors for LB are similar to those for major complications and increased procedure complexity: long lead dwell time [OR=1.018], higher LV ejection fraction, multiple previous CIED-related procedures and extraction of passive fixation leads. A superior approach was the most popular (75.59%), femoral (15.75%) and combined (8.66%) approaches were the least common. Broken lead fragments (BLFs) were removed in their entirety in 63.78% and BLF length was significantly reduced (to less than 4 cm) in 24.41%. The best results were achieved when BLFs were longer (>4 cm) (66.67%), either free-floating or in the pulmonary circulation (68.42%) but not in cases of short BLFs (20.0%). Complete procedural success was achieved in 70.87% of procedures, the lead tip retained in the heart wall and short BLFs were found in 25.98%, whereas BLFs > 4 cm were left in place in 3.15% of procedures only. There was no relationship between approach in lead remnant removal and long-term mortality. All forms of LB were associated with increased procedure complexity and major complications (9.96% and 1.53%). There was no procedure-related death among such patients and LB did not affect survival after TLE. Conclusions: 1. LB during TLE occurs in 6.04% of procedures and it increases procedure complexity and risk of major complications. Thus, the possibility of LB should be taken into account when planning lead extraction strategy and training. 2. Effectiveness of fractured lead removal is satisfactory. 3.Risk factors for lead fracture are implant duration (16.27 years on average), ventricular leads (71.65%), passive fixation leads (97.63%) and pacemaker leads (92.13%), but not ICD leads (only 7.87% of lead fractures). 4. Broken lead removal using a coronary sinus access sheath as a "subclavian workstation" for continuation of dilatation with conventional tools deserves attention.