Outcomes of patients with definite and possible infective endocarditis related to a cardiac implantable electronic device.

INTRODUCTION: Diagnosis of lead related infective endocarditis (LRIE) is often a real challenge. Current diagnostic criteria include LRIE definite and possible. OBJECTIVES: Comparison of the outcomes of patients with definite and possible LRIE undergoing transvenous lead extraction (TLE) procedures. PATIENTS AND METHODS: A retrospective analysis of data from 3782 patients undergoing TLE between 2006 and 2023 was performed. The study included 838 patients with definite and possible LRIE. The analysis of clinical data and short and long-term survival was performed. RESULTS: The comparison of clinical data showed more frequent occurrence of vegetations (81.58% vs 37.21%; P <0.001), positive blood cultures (66.12 % vs 51.64%; P <0.001) and septic pulmonary embolism (40.14% vs 13.78%; P <0.001) in patients with definite LRIE. Long-term mortality of patients with definite and possible LRIE (median follow up 4.61 [1.04-9.40] and 5.06 [2.07-8.75] years respectively) was 61.14% vs 49.29%; P <0.001. Predictors of mortality in patients with marked LRIE include advanced age, low left ventricular ejection fraction (LVEF), comorbidities, septic pulmonary embolism, positive blood culture, and the presence of an abandoned lead. In possible LRIE, only the influence of advanced age, low LVEF and comorbidities was demonstrated. There has been no documented direct impact of delayed diagnosis on the long-term survival of patients after TLE Conclusions: The study documented better survival in patients with possible LRIE, which confirms the need to use extended diagnostic criteria for LRIE. Implementation of appropriate treatment at an early stage of infection allows for improved prognosis.

VDD Lead Extraction-Differences with Other Leads and Practical Tips in Management.

Background: VDD (atrial sensing, ventricular sensing/pacing) leads are relatively rarely implanted; therefore, experience in their extraction is very limited. We aimed to investigate whether VDD lead removal may be a risk factor for the increased complexity of transvenous lead extraction (TLE) or major complications. Methods: We retrospectively analyzed 3808 TLE procedures (including 103 patients with VDD leads). Results: If TLE included VDD lead removal, procedure duration (lead dilation time) was prolonged, complicated extractions were slightly more common, and more advanced tools were required. This is partly due to longer implant duration (in patients with VDD systems-135.2 months; systems without VDD leads-109.3 months; p < 0.001), more frequent presence of abandoned leads (all systems containing VDD leads-22.33% and all systems without VDD leads-10.77%), and partly to the younger age of patients with VDD leads (51.74 vs. 57.72 years; p < 0.001, in the remaining patients) at the time of system implantation. VDD lead extraction does not increase the risk of major complications (1.94 vs. 2.34%; p = 0.905). Conclusions: The extraction of VDD leads may be considered a risk factor for increased procedure complexity, but not for major complications. However, this is not a direct result of VDD lead extraction but specific characteristics of the patients with VDD leads. Operator skill and team experience combined with special custom maneuvers can enable favorable results to be achieved despite the specific design of VDD leads, even with older VDD lead models.

Multilevel Venous Obstruction in Patients with Cardiac Implantable Electronic Devices.

Background and Objectives: The nature of multilevel lead-related venous stenosis/occlusion (MLVSO) and its influence on transvenous lead extraction (TLE) as well as long-term survival remains poorly understood. Materials and Methods: A total of 3002 venograms obtained before a TLE were analyzed to identify the risk factors for MLVSO, as well as the procedure effectiveness and long-term survival. Results: An older patient age at the first system implantation (OR = 1.015; p < 0.001), the number of leads in the heart (OR = 1.556; p < 0.001), the placement of the coronary sinus (CS) lead (OR = 1.270; p = 0.027), leads on both sides of the chest (OR = 7.203; p < 0.001), and a previous device upgrade or downgrade with lead abandonment (OR = 2.298; p < 0.001) were the strongest predictors of MLVSO. Conclusions: The presence of MLVSO predisposes patients with cardiac implantable electronic devices (CIED) to the development of infectious complications. Patients with multiple narrowed veins are likely to undergo longer and more complex procedures with complications, and the rates of clinical and procedural success are lower in this group. Long-term survival after a TLE is similar in patients with MLVSO and those without venous obstruction. MLVSO probably better depicts the severity of global venous obstruction than the degree of vein narrowing at only one point.

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 < 0.001, and 0.02 vs. 0.01; p = 0.008) and the area under the ROC curve (AUC) was 0.59; p < 0.001 and 0.56; p < 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 < 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 < 0.001 and 0.60; p < 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 < 0.001 and 0.03 vs. 0.02; p < 0.001) and the ROC curve analysis for coexistence LRIE with PI showed the AUC for NLR: 0.57; p < 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.

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.

Discontinuation of cardiac implantable electronic device therapy after transvenous lead extraction.

BACKGROUND: Patients with cardiac implantable electronic devices (CIEDs) may no longer be eligible for continued therapy. AIMS: The study aimed to assess the circumstances under which CIED reimplantation may not be necessary after transvenous lead extraction (TLE). METHODS: A retrospective analysis of 3646 TLE procedures was performed with assessment of indications for device reimplantation. RESULTS: Reimplantation was not performed immediately after TLE in 169 (4.6%) and, in long-term follow-up, in 146 (4.0%) of patients. No further need for CIED reimplantation was mostly associated with establishment of stable sinus rhythm (2.4%), conversion of sinus node dysfunction to chronic atrial fibrillation (AF; 1.4%), or improvement in left ventricular ejection fraction (LVEF) (0.9%). Independent prognostic factors were in the pacing groups: LVEF (odds ratio [OR], 1.03; 95% confidence interval [CI], 1.01-1.05; P <0.001), AF (OR, 3.8; 95% CI, 2.4-15.7; P <0.001), patients' age during first CIED implantation (OR, 0.97; 95% C, 0.96-0.98; P <0.001), and New York Heart Association (NYHA) class (OR, 0.616; 95% CI, 0.43-0.86; P <0.01); in the cardioverter-defibrillator group: LVEF (OR, 1.06; 95% CI, 1.04-1.09; P <001). Non-reimplanted patients had more complex procedures and more frequent complications, but survival after TLE was better in this group of patients. CONCLUSIONS: Reassessment of the need for continuation of CIED therapy should be considered in all patients following lead extraction and also before planned device replacement as TLE delay increases implant duration, complexity, and procedural risk. The predictors of non-reimplantation are a younger age during the first CIED implantation, lower NYHA class, presence of AF, and higher LVEF in pacemaker carriers, and, in the defibrillator group, only higher LVEF. A decision not to reimplant does not negatively affect the long-term prognosis.

Lead Extraction in Children and Young Adults: When is the Best Time for Lead/System Replacement?

The best strategy for lead management in children is a matter of debate, and our experiences are limited. This is a retrospective single-center study comparing difficulties and outcomes of transvenous lead extraction (TLE) implanted ich childhood and at age < 19 years (childhood-implanted-childhood-extracted, CICE) and at age < 19 (childhood-implanted-adulthood-extracted, CIAE). CICE patients-71 children (mean age 15.1 years) as compared to CIAE patients (114 adults (mean age 28.61 years) were more likely to have VVI than DDD pacemakers. Differences in implant duration (7.96 vs 14.08 years) appeared to be most important, but procedure complexity and outcomes also differed between the groups. Young adults with cardiac implantable electronic device implanted in childhood had more risk factors for major complications and underwent more complex procedures compared to children. Implant duration was significantly longer in CIAE patients than in children, being the most important factor that had an impact on patient safety and procedure complexity. CIAE patients were more likely to have prolonged operative duration and more complex procedures due to technical problems, and they were 2-3 times more likely to require second-line or advanced tools compared to children, but the rates of clinical and procedural success were comparable in both groups. The difference between the incidence of major complications between CICE and CIAE patients is very clear (MC 2.9 vs 7.0%, hemopericardium 1.4 vs 5.3% etc.), although statistically insignificant. Delay of lead extraction to adulthood seems to be a riskier option than planned TLE in children before growing up.

Shared Decision Making and Cardioneuroablation Allow Discontinuation of Permanent Pacing in Patients with Vagally Mediated Bradycardia.

BACKGROUND: Safe discontinuation of pacemaker therapy for vagally mediated bradycardia is a dilemma. The aim of the study was to present the outcomes of a proposed diagnostic and therapeutic process aimed at discontinuing or not restoring pacemaker therapy (PPM) in patients with vagally mediated bradycardia. METHODS: The study group consisted of two subgroups of patients with suspected vagally mediated bradycardia who were considered to have PPM discontinued or not to restore their PPM if cardioneuroablation (CNA) would successfully treat their bradycardia. A group of 3 patients had just their pacemaker explanted but reimplantation was suggested, and 17 patients had preexisting pacemakers implanted. An invasive electrophysiology study was performed. If EPS was negative, extracardiac vagal nerve stimulation (ECVS) was performed. Then, patients with positive ECVS received CNA. Patients with an implanted pacemaker had it programmed to pace at the lowest possible rate. After the observational period and control EPS including ECVS, redo-CNA was performed if pauses were induced. The decision to explant the pacemaker was obtained based on shared decision making (SDM). RESULTS: After initial clinical and electrophysiological evaluation, 17 patients were deemed eligible for CNA (which was then performed). During the observational period after the initial CNA, all 17 patients were clinically asymptomatic. The subsequent invasive evaluation with ECVS resulted in pause induction in seven (41%) patients, and these patients underwent redo-CNA. Then, SDM resulted in the discontinuation of pacemaker therapy or a decision to not perform pacemaker reimplantation in all the patients after CAN. The pacemaker was explanted in 12 patients post-CNA, while in 2 patients explantation was postponed. During a median follow-up of 18 (IQR: 8-22) months, recurrent syncope did not occur in the CNA recipients. CONCLUSIONS: Pacemaker therapy in patients with vagally mediated bradycardia could be discontinued safely after CNA.

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

BACKGROUND: 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). METHODS: The retrospective analysis of a single centre database containing 3721 TLEs. RESULTS: 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. CONCLUSIONS: (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.

Incomplete Lead Removal During the Extraction Procedure: Predisposing Factors and Impact on Long-Term Survival in Infectious and Non-Infectious Cases: Analysis of 3741 Procedures.

BACKGROUND: The long-term significance of lead remnants (LR) following transvenous lead extraction (TLE) remains disputable, especially in infectious patients. METHODS: Retrospective analysis of 3741 TLEs focused on the relationship between LR and procedure complexity, complications and long-term survival. RESULTS: The study group consisted of 156 individuals with LR (4.17%), and the control group consisted of 3585 patients with completely removed lead(s). In a multivariable model, a younger patient age at CIED implantation, more CIED procedures and procedure complexity were independent risk factors for retention of non-removable LR. Although patients with LR showed better survival outcomes following TLE (log rank p = 0.041 for non-infectious group and p = 0.017 for infectious group), multivariable Cox regression analysis did not confirm the prognostic significance of LR either in non-infectious [HR = 0.777; p = 0.262], infectious [HR = 0.983; p = 0.934] or the entire group of patients [HR = 0.858; p = 0.321]. CONCLUSIONS: 1. Non-removable LRs are encountered in 4.17% of patients. 2. CIED infection has no influence on retention of LRs, but younger patient age, multiple CIED-related procedures and higher levels of procedure complexity are independent risk factors for the presence of LR. 3. Better survival outcomes following TLE in patients with LRs are not the effects of their presence but younger patient and better health status.

How does a CIED presence influence chances and safety of haemodialysis access? Conclusions from over 3000 thoracic venografies.

Patients requiring temporal or permanent catheter or arterio-venous fistula (AVF) for haemodialysis may be in challenging situation, if they are cardiovascular implantable electronic devices (CIED) carriers. MATERIALS AND METHODS: The authors analysed preoperative venogrphies of 3100 patients referred for transvenous lead extraction for a possible chance of safe haemodialysis catheter (HC) implantation or proper AVF function. RESULTS: A chance of safe catheter implantation parallel to existing leads reaches 68.8% ipsilaterally to CIED. Contraindications for implantation have been found in less than 2% of cases contralaterally. Ipsilaterally proper AVF function chance has been found in 50.3% of the cases and almost 98% contralaterally. A bilateral chest electrodes location require the special attention. Abandoned lead, lead burden, bilateral leads, additional lead implantation or abandonment, and implant duration may have a significant influence on HC insertion or proper function of arteriovenous fistula. CONCLUSION: (1) Obstruction of prominent thoracic veins is a frequent finding in CIED carriers and may impede or disable implantation haemodialysis accesses. (2) Implantation of temporary or permanent HC may be questionable ipsilaterally to the CIED in 31.2% and contralaterally in 2.0% of patients. Proper function of AVF is uncertain in 49.7% ipsilaterally and 2.1% contralaterally to CIED. (3) Pacing history and leads dwell time influence chances of success haemodialysis access even on the free-from CIED chest side. (4) Proper venous flow evaluation seems to be valuable in CIED carriers before an attempt of haemodialysis access formation, even contralaterally.

Transvenous Lead Extraction in Pediatric Patients　- Is It the Same Procedure in Children as in Adults?

BACKGROUND: Cardiac implantable electronic devices (CIED) are very rare in the pediatric population. In children with CIED, transvenous lead extraction (TLE) is often necessary. The course and effects of TLE in children are different than in adults. Thus, this study determined the differences and specific characteristics of TLE in children vs. adults.Methods and Results: A post hoc analysis of TLE data in 63 children (age ≤18 years) and 2,659 adults (age ≥40 years) was performed. The 2 groups were compared with respect to risk factors, procedure complexity, and effectiveness. In children, the predominant pacing mode was a single chamber ventricular system and lead dysfunction was the main indication for lead extraction. The mean implant duration before TLE was longer in children (P=0.03), but the dwell time of the oldest extracted lead did not differ significantly between adults and children. The duration (P=0.006) and mean extraction time per lead (P<0.001) were longer in children, with more technical difficulties during TLE in the pediatric group (P<0.001). Major complications were more common, albeit not significantly, in children. Complete radiographic and procedural success were significantly lower in children (P<0.001). CONCLUSIONS: TLE in children is frequently more complex, time consuming, and arduous, and procedural success is more often lower. This is related to the formation of strong fibrous tissue surrounding the leads in pediatric patients.

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

BACKGROUND: Transvenous lead extraction (TLE) procedures are now increasingly safe, but there is still a risk of major complications (MC). AIMS: We aimed to assess the impact of TLE organization on the safety of procedures. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).

AIMS: Standardized data definitions are essential for monitoring and assessment of care and outcomes in observational studies and randomized controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology aimed to develop contemporary data standards for atrial fibrillation/flutter (AF/AFL) and catheter ablation. METHODS AND RESULTS: We used the EuroHeart methodology for the development of data standards and formed a Working Group comprising 23 experts in AF/AFL and catheter ablation registries, as well as representatives from the European Heart Rhythm Association and EuroHeart. We conducted a systematic literature review of AF/AFL and catheter ablation registries and data standard documents to generate candidate variables. We used a modified Delphi method to reach a consensus on a final variable set. For each variable, the Working Group developed permissible values and definitions, and agreed as to whether the variable was mandatory (Level 1) or additional (Level 2). In total, 70 Level 1 and 92 Level 2 variables were selected and reviewed by a wider Reference Group of 42 experts from 24 countries. The Level 1 variables were implemented into the EuroHeart IT platform as the basis for continuous registration of individual patient data. CONCLUSION: By means of a structured process and working with international stakeholders, harmonized data standards for AF/AFL and catheter ablation for AF/AFL were developed. In the context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based RCTs, and post-marketing surveillance of devices and pharmacotherapies.

Pacemaker leads as a potential source of problems in patients who might need a central venous access port.

Background: Lead-dependent venous occlusion may impede the insertion of a central venous access device (CVAD). The aim of this retrospective, cohort study was to assess the chance of implantation of CVAD in patients with cardiac implantable electronic devices (CIEDs). Methods: We reviewed and analyzed 3,075 venograms of patients with CIEDs undergoing transvenous lead extraction (TLE) between June 2008 and July 2021. Relationship between venous patency and the chance of CVAD placement was estimated. Results: In 2,318 (75.38%) patients, venography showed no potential obstacles to venous port implantation on the ipsilateral side. In patients with leads on the left side, significant narrowing more often affected the subclavian vein than the brachiocephalic vein [1,595 (55.29%) vs. 830 (28.63%), respectively] or the superior vena cava (SVC) [21 (0.73%) cases]. Furthermore, the subclavian and brachiocephalic veins on the opposite side were also narrowed [35 (2.35%) and 27 (1.24%), respectively]. The chances of port insertion were assessed as easy on CIED side or opposite side in 2,318 (75.38%) and 2,291 (97.91%) patients, respectively), as difficult insertion/questionable performance in 246 (8.00%) and 22 (0.94% patients) and doubtful or impossible insertion/questionable performance in 511 (16.62%)/27 (1.15%) patients with CIED. Conclusions: (I) Varying degrees of lead-dependent venous obstruction (LDVO) is a frequent finding in patients with CIEDs; (II) the major thoracic veins on the opposite side of the chest may also be significantly narrowed; (III) venography should be considered before attempted CVAD insertion in patients with long lead dwell times or in patients after CIED removal, including planned contralateral port placement.

Repeat Transvenous Lead Extraction-Predictors, Effectiveness, Complications and Long-Term Prognostic Significance.

BACKGROUND: Data regarding repeat transvenous lead extraction (TLE) are scarce. The aim of study was to explore the frequency of repeat TLE, its safety, predisposing factors, as well as effectiveness of repeat procedures. METHODS: Retrospective analysis of a large single-center database of 3654 TLEs. RESULTS: Repeat TLE was a rare occurrence (193, i.e., 5,28% among 3654 TLEs). Subsequent re-extractions occurred in 12.21% of the patients. Lead failure was the most common cause of re-extraction (51.16%). Cox regression analysis showed that patients who were older at first implantation [HR = 0.987; p = 0.003], had infection-related TLE [HR = 0.392; p < 0.001] and complete procedural success [HR = 0.544; p = 0.034] were less likely to undergo repeat TLE. Functional leads left in place for continuous use [HR = 1.405; p = 0.012] or superfluous leads left in place (abandoned) [HR = 2.370; p = 0.011] were associated with an increased risk of undergoing a repeat procedure. Overall mortality in patients with repeat TLE and subsequent re-extraction in the entire FU period was similar to that in patients without a history of re-extraction [HR = 0.949; p = 0.480]. CONCLUSIONS: Repeat TLE was a rare occurrence (5.28%) among TLEs. Left of both active and nonactive leads during TLE increased the risk of re-extraction. Re-extraction has no effect on the long-term mortality.

Assessment of the impact of organisational model of transvenous lead extraction on the effectiveness and safety of procedure: an observational study.

OBJECTIVES: To estimate the impact of the organisational model of transvenous lead extraction (TLE) on effectiveness and safety of procedures. DESIGN: Post hoc analysis of patient data entered prospectively into a computer database. SETTING: Data of all patients undergoing TLE in three centres in Poland between 2006 and 2021 were analysed. PARTICIPANTS: 3462 patients including: 985 patients undergoing TLE in a hybrid room (HR), with cardiac surgeon (CS) as co-operator, under general anaesthesia (GA), with arterial line (AL) and with transoesophageal echocardiography (TEE) monitoring (group 1), 68 patients-TLE in HR with CS, under GA, without TEE (group 2), 406 patients-TLE in operating theatre (OT) using 'arm-C' X-ray machine with CS under GA and with TEE (group 3), 154 patients-TLE in OT with CS under GA, without TEE (group 4), 113 patients-TLE in OT with anaesthesia team, using the 'arm-C' X-ray machine, without CS (group 5), 122 patients-TLE in electrophysiology lab (EPL), with CS under intravenous analgesia without TEE and AL (group 6), 1614 patients-TLE in EPL, without CS, under intravenous analgesia without TEE and AL (group 7). KEY OUTCOME MEASURE: Effectiveness and safety of TLE depending on organisational model. RESULTS: The rate of major complications (MC) was higher in OT/HR than in EPL (2.66% vs 1.38%), but all MCs were treated successfully and there was no MC-related death. The use of TEE during TLE increased probability of complete procedural succemss achieving about 1.5 times (OR=1.482; p<0.034) and were connected with reduction of minor complications occurrence (OR=0.751; p=0.046). CONCLUSIONS: The most important condition to avoid death due to MC is close co-operation with cardiac surgery team, which permits for urgent rescue cardiac surgery. Continuous TEE monitoring plays predominant role in immediate decision on rescue sternotomy and improves the effectiveness of procedure.