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Background Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. The aim of this study was to evaluate safety and efficacy of mechanical transvenous lead extraction (TLE) in elderly patients. Methods Patients who had undergone TLE in single tertiary referral center were divided in two groups (Group 1: ≥80 years; group 2: Results Our analysis included 1316 patients (group 1: 202, group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities and more pacemakers, whereas the dwelling time of the oldest lead was similar, irrespectively of patient's age. In group 1 the radiological success rate for lead was higher (99.0% vs 95.9%; P Conclusions Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure and no procedural-related deaths. Funding Acknowledgement Type of funding source: None

Background Transvenous lead extraction (TLE) has become the mainstay therapy for device-related infections. Though TLE procedures are associated with low complication and high success rates, risk factors for major procedure-related complications remain not well defined. Purpose To evaluate the safety and efficacy of TLE in a large single centre cohort and to identify risk factors for major complications. Methods All consecutive patients who had undergone TLE in our department between May 2012 and January 2020 were included in a prospective registry. Our protocol for TLE followed a stepwise approach according to lead dwell time and estimated complexity of the procedure: use of simple traction ± locking stylet (LS) ± mechanical and/or powered sheaths ± snare technique. In case of unsuccessful extraction from the venous entry site, femoral or jugular access was approached. Patient characteristics, procedural data and complications were gathered and analysed. Logistic regression analysis was applied to identify risk factors for major procedure-related complications. Results A total of 1717 leads (443 [25.9%] ICD leads) were targeted for TLE in 810 patients (67±15 years; 76% male). The mean lead dwell time was 83±60 months. The leading indication for TLE was cardiac device related infection (CDRI) in 527 patients (65.1%), of whom 273 (51.8%) had systemic and 254 (48.2%) localized infection. Two hundred eighty-three patients (34.9%) underwent TLE for non-CDRI causes. Leads were extracted by simple traction in 28.2%, traction with LS in 4.1%, dilator sheaths with LS in 50.1%, and additional use of powered mechanical sheaths in 13.0%. The snare technique was used in 4.6%. Venous access for TLE was exclusively from the entry site in 94.8%, combined from femoral in 4.0% and jugular in 1.2%. TLE was completely successful in 96.2%, partially successful in 2.1%, and failed in 1.7% of all attempted leads, which translated to a clinical success rate of 96.8%. Eighteen patients (2.2%) experienced minor and 12 patients (1.5%) had major procedure-related complications (cardiac tamponade/perforation) including one intraprocedural death (0.1%) from fulminant pulmonary embolism. Lead-years-per-patient (HR 1.064, 95% CI 1.032–1.096; p Conclusion TLE is feasible, effective and safe in our large single centre experience. Overall complication and failure rates are low. Following our TLE protocol, dwelling time of the extracted leads and low BMI were associated with major procedure-related complications. Funding Acknowledgement Type of funding source: None

Background The PADIT trial identified 5 independent predictors of cardiac implantable electronic device (CIED) infection (prior procedure, age, chronic kidney disease, immunosuppression and type of procedure) and developed a novel infection risk score. Aim To assess whether the PADIT score (PS) could predict CIED reinfection and adverse events in patients (pts) submitted to transvenous lead extraction (LE) using the Pisa Technique (PT) due to CIED infection. Methods We conducted a single-centre prospective study of consecutive procedures (P) of LE using the PT between February 2013 and October 2019. Demographic, clinical, microbiological, device/ procedure related variables, morbidity and mortality data were retrieved during follow-up (FUP). An univariate analysis was performed to evaluate the ability of the PS to predict CIED reinfection (Re), procedural complications (C), all-cause hospital mortality (M), all-cause mortality/ hospitalization during first year of follow-up (MH1) and cardiovascular mortality (CM). Results A total 171 Ps including 159 pts, of which 80.7% (130 pts)were due to CIED infection: 55.1% due to pocket site infection, 18.8% to occult bacteremia with probable CIED infection and 26.1% due to both pocket site and systemic infection, with 44% of pts presenting with valvular/ lead vegetation (mean age - 70.3Y, 77.7% male, mean LVEF of 49.6%). The Rs rate was 93.1% and the clinical success rate was 99.2%. There were no deaths related to the procedure. During a mean FUP of 33 months, 11 pts had to undergo a new P, 5 of them due to pocket reinfection. The mortality rate was 24.2% (37 pts), with 8 pts dying during hospital stay, and 19 pts during the first year post-P. The mean PS was 2.9±2.5 (min- 0, max- 10). A higher PS value was associated with Re (HR - 1,43, CI95% 1.09–1.87, p=0.011), CM (HR - 1,39, CI95% 1.06–1.85, p=0.018) and MH1 (OR - 1,19, CI95% 1.03–1.38, p=0.021). There was no association between the PS and the rate of clinical success of the procedure (2.9% vs 4.5%, p=0.395), procedural complications (2.9% vs 3.3%, p=0.656) and M (4.0% vs 2.8%, p=0.192). Interestingly, a higher PS was not associated with a higher use of an antibacterial envelope during device reimplantation (3.5% vs 2.9%, p=0.371). Conclusion The PADIT score revealed a high predictive power for reinfection, all-cause mortality/ hospitalization during first year of follow-up and cardiovascular mortality in pts submitted to LE using the PT for CIED infection. Funding Acknowledgement Type of funding source: None

A 44-year-old lady, a follow-up case of idiopathic dilated cardiomyopathy and cardiac resynchronization therapy defibrillator device implantation with epicardial left ventricular (LV) lead, underwent a transvenous LV lead revision in view of epicardial lead malfunction. A chest X-ray after this, done for worsening dyspnea, revealed pneumopericardium along with left pneumothorax. The computed tomography (CT) revealed a communication between the left pleural and pericardial cavities, around the old epicardial lead. Drainage of the left pleural cavity resolved both the pneumothorax and pneumopericardium and the patient remained well on follow up.

Background: Clinical factors associated with development of intravascular lead adherence (ILA) are unreliable predictors. Because vascular injury in the superior vena cava-right atrium during transvenous lead extraction is more likely to occur in segments with higher degrees of ILA, reliable and accurate assessment of ILA is warranted. We hypothesized that intravascular ultrasound (IVUS) could accurately visualize and quantify ILA and degree of ILA correlates with transvenous lead extraction difficulty. Methods: Serial imaging of leads occurred before transvenous lead extraction using IVUS. ILA areas were classified as high or low grade. Degree of extraction difficulty was assessed using 2 metrics and correlated with ILA grade. Lead extraction difficulty was calculated for each patient and compared with IVUS findings. Results: One hundred fifty-eight vascular segments in 60 patients were analyzed: 141 (89%) low grade versus 17 (11%) high grade. Median extraction time (low=0 versus high grade=97 seconds, P P Conclusions: IVUS is a feasible imaging modality that may be useful in characterizing ILA in the superior vena cava-right atrium region. An ILA grading system using imaging correlates with extraction difficulty. Most patients with clinical factors associated with higher extraction difficulty may exhibit lower ILA and extraction difficulty based on IVUS imaging. Graphic Abstract: A graphic abstract is available for this article.

OnBehalf GALLERY investigators Background The number of cardiac implantable electronic device (CIED)-associated complications such as infection, lead dysfunction or thrombotic events is continuously rising and thus making transvenous lead extraction (TLE) an ever more needed procedure in clinical practice today. Patients with abandoned leads represent a special cohort with a potentially higher susceptibility to CIED-related infections and vascular complications. Moreover, according to literature abandoned leads seem to be associated with more procedural complications and mortality during TLE. Aim The aim of this study was to provide an insight on safety, procedural outcome and risk prediction on pacemaker patients with abandoned leads undergoing TLE from the largest national laser-sheath registry to date. Methods + Results: We conducted a retrospective analysis of the GALLERY database, which collected 2533 patients undergoing TLE in Germany between 2013 and 2017. Out of 903 pacemaker patients, who underwent TLE, 226 patients (25.0%) with abandoned leads were identified. Those patients had a higher number of leads per patient (3.2 ± 0.8 vs. 1.9 ± 0.3; ns) and longer lead dwell-times (168.0 ± 89.7 vs. 123.0 ± 69.2 months; p < 0.0001) compared to pacemaker patients without abandoned leads. There were no differences in age (71.5 vs. 72.3 years; ns), body mass index (26.5 ± 4.5 vs. 26.78 ± 4.8 kg/m2; ns) or gender distribution (69.0 vs. 66.5% male; ns). Leading indication for TLE was device infection with no difference between groups (79.7 vs 77.8 %; ns). There were no differences in terms of pacemaker dependency, length of hospitalization or comorbidities. Patients with abandoned leads had longer procedure times (112.0 ± 69.0 vs. 86.4 ± 53.0 minutes; p < 0.0001) and a higher incidence of procedural complications (6.6 vs. 3.1%; p = 0.03), but there were no differences in neither procedural and clinical success rates (96.5 vs. 97.3%; ns), nor all-cause mortality (1.33 vs. 2.66%; ns). Multivariate logistic regression revealed abandoned leads (OR 2.1, CI 1.0-4.4, p = 0.04) and female gender (OR 2.4, CI 1.2-4.9, p = 0.02) as independent predictors for procedural complications. Systemic infection (OR 5.4, CI 2.0-14.8, p = 0.001) and chronic kidney disease (OR 4.0, CI 1.5-10.7, p = 0.007) were strong predictors for all-cause mortality in patients with indwelling pacemaker. Patient age > 75 years (OR 3.9, CI 2.7-5.6, p < 0.0001) and a lead dwell-time > 10 years (OR 1.6, CI 1.1-2.2, p = 0.01) were identified as risk factors for an infectious cause for TLE. Conclusion Abandoned leads are frequently encountered in pacemaker patients undergoing TLE and pose an important risk factor for procedural complications. Systemic CIED-related infections are the strongest driver of mortality in this patient cohort and urgently call for further improvements in early diagnosis and prevention.

Background Reduced left ventricle ejection fraction (LVEF) is a common risk factor of complications in patients undergoing different procedures. Aim of study The aim of the study was to assess efficiency and safety of transvenous lead extraction (TLE) procedures in patients with reduced LVEF (< 40%) compared to patients with mid-range reduced and preserved LVEF (≥40%). Study group Data from 3434 of TLE procedures (patient"s age during TLE-65,5 ± 15,5 years, female; 1168 (34,01%), performed in two high volume European Centers (PISA – Italy, Lublin-Zamość – Poland) were analysed. Results In group with reduced LVEF (A) compared to the group of patients with LVEF ≥ 40% (B) the smaller number of female was found (p Conclusion The effectiveness and safety of TLE in patients with reduced left ventricle ejection fraction does not differ from the results of the TLE procedures in patients with mid-range reduced and preserved LVEF. Abstract Table

Introduction: Transvenous lead extraction (TLE) has become a frequently used tool for the management of complications related to pacemakers, implantable cardiac defibrillators and cardiac resynchronization therapy devices. However, it is still a matter of debate whether the lead extraction procedure is a safe treatment choice in the elderly. Methods: We collected the clinical information from 3,810 patients undergoing TLE in 2 high-volume centers (Poland and Italy) between 2006 and 2017. We tested risk factors, effectiveness, safety and long-term survival in 3 groups of patients: those aged 80–89.99 years, ≥90 years and 30–79.99 years. Results: Lower BMI, lower levels of hemoglobin and more comorbidities characterized the patients, whose ages ranged from 80 to 89.99 years. Those aged ≥90 years most often had single-chamber pacemakers. Octogenarians and nonagenarians were more often undergoing TLE due to infectious indications (57.19 and 74.29 vs. 45.35% in younger individuals). Lead age and the number of leads extracted were comparable in the 3 groups. In octogenarians, leads were more often removed using standard extraction techniques: simple traction and mechanical dilatators, whereas in nonagenarians TLE was more complex. The duration of the procedure was shorter in older patients, while clinical and procedural effectiveness was similar to that in younger individuals. The rate of major complications related to TLE did not differ between octogenarians and younger subjects (2.0 vs. 1.38%, p = ns), and the number of procedure-related risk factors was smaller in older people. Nonagenarians did not develop any major complication related to TLE. Long-term mortality after TLE was similar among octogenarians and nonagenarians (39.67 and 40.00%) but higher than in younger patients (24.41; p < 0.001 and 0.05). Conclusions: Lead extraction procedures appear effective and safe in octogenarians and nonagenarians, comparable to younger individuals. Procedure-related risk in the elderly is not associated with most of the typical risk factors encountered in younger subjects, but only with the higher number of pacemaker, implantable cardiac defibrillator and cardiac resynchronization therapy device procedures before TLE. Long-term survival after TLE was found to be similar among octogenarians and nonagenarians being about 60% at over 3 years of follow-up. Age alone should not be considered a risk factor for the occurrence of major complications or procedure-related death, and therefore it should not prevent candidacy for TLE.

Background: Transesophageal echocardiography (TEE) is a valuable tool for monitoring the patient during transvenous lead extraction (TLE), but the direct impact of TEE on the effectiveness and safety of TLE has not yet been documented. Methods: The effectiveness of TLE and short-term survival were compared between two groups of patients: 2106 patients in whom TEE was performed before and after TLE and 1079 individuals in whom continuous TEE monitoring was used. The procedure-related risk of major complications was assessed using a predictive SAFeTY TLE score. Results: The patients monitored by TEE were characterized by older age, more comorbidities and higher SAFeTY TLE scores (6.143 &plusmn, 4.395 vs. 5.593 &plusmn, 4.127, p = 0.004). Complete procedural success was significantly higher in the TEE-guided group (97.683% vs. 95.442%, p &lt, 0.01). The rate of serious complications in the TEE-guided group was lower than the predictive SAFeTY TLE score&mdash, a reduction of 28.75% (p &lt, 0.05). Periprocedural mortality in the TEE-guided and non-TEE-guided groups was zero vs. six deaths (p = 0.186). Short-term survival was comparable between the groups. Conclusions: Transesophageal echocardiography as a monitoring tool during transvenous lead extraction provides valuable results&mdash, higher rates of complete procedural success and a reduced risk of the most severe complications, thus preventing periprocedural deaths.

Background Transvenous lead extractions (TLEs) in Japan have grown to become the standard therapy since the approval of the laser extraction system in 2008. However, little is known about the current indications, methods, success rate, and acute complications in the real‐world setting. Methods The Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by the Japanese Heart Rhythm Society (JHRS) in collaboration with the National Cerebral and Cardiovascular Center. This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system. The acute success rate at discharge and complications associated with TLEs will be collected in all cases. Based on the provided information, the annual incidence and predictive factors for the outcomes will be investigated by the Event Assessment Committee (EAC). This registry started in July 2018 and the number of participating medical institutions will be more than 50 hospitals and the target number of procedures will be 500‐1000 per year. We will also compare the results with other registries in foreign countries. Result The results of this study are currently under investigation. Conclusion The J‐LEX registry will provide real‐world data regarding the results and complications of TLEs for the various types of indications, methods, and performing hospitals in Japan., The Japanese Lead EXtraction (J‐LEX) registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society (JHRS), collaborated with National Cerebral and Cardiovascular Center (NCVC). This study is a nationwide registry ordered by the JHRS and its data are collected prospectively using the Research Electronic Data Capture (REDCap) system.

Background Studies on femoral approach during transvenous lead extraction (TLE) are limited. Methods We retrospectively evaluated 75 patients undergoing TLE from September 2014 through November 2019 via supportive femoral approach (Femoral/Superior group; n = 22) and superior approach alone (Superior group; n = 53). Results No significant between‐group differences were observed regarding patients’ baseline characteristics except for a higher incidence of access vein occlusion in the Femoral/Superior group (59.1% vs. 31.4%; P = .037). The Femoral/Superior group exhibited significantly longer dwell times of the oldest extracted lead (median: 13.4 years; interquartile range [IQR]: 8.8‐21.2 years vs. median, 7.2 years; IQR: 3.7‐10.8 years; P 11.8 years and whose access veins are occluded., Access vein occlusion and lead age were predictors of femoral approach. The cutoff for the need for femoral approach was 11.8 years from the implant placement. Lowering the threshold for introducing the femoral approach would become the cornerstone for successful lead extraction.

INTRODUCTION Due to the prolonged survival of patients with cardiovascular implantable electronic devices, leads often need to be removed in elderly individuals. OBJECTIVES We aimed to analyze indications for transvenous lead extraction (TLE), procedure effectiveness and safety, as well as 30‑day follow‑up in younger patients (≤80 years) and octogenarians (>80 years). PATIENTS AND METHODS This prospective study included 667 patients who underwent TLE: 90 octogenarians (13.5%) at a mean age of 83.8 (range, 80.4-93) years and 577 younger patients (86.5%) at a mean age of 64.2 (range, 18.9-79.9) years. RESULTS Octogenarians had a greater number of comorbidities, fewer implantable cardioverter‑defibrillators implanted, and more frequently had infection as an indication for TLE, as compared with younger patients (33.3% vs 17.1%; P

Background: To ensure the safety and efficacy of the increasing number of transvenous lead extractions (TLEs), it is necessary to adequately assess the procedure-related risk. Methods: We analyzed potential clinical and procedural risk factors associated with 2049 TLE procedures. The TLEs were performed between 2006 and 2016 using only simple tools for lead extraction. Logistic regression analysis was used to develop a risk prediction scoring system for TLEs. Results: Multivariate analysis showed that the sum of lead dwell times, anemia, female gender, the number of procedures preceding TLE, and removal of leads implanted in patients under the age of 30 had a significant influence on the occurrence of major complications during a TLE. This information served as a basis for developing a predictive SAFeTY TLE score, where: S = sum of lead dwell times, A = anemia, Fe = female, T = treatment (previous procedures), Y = young patients, and TLE = transvenous lead extraction. In order to facilitate the use of the SAFeTY TLE Score, a simple calculator was constructed. Conclusion: The SAFeTY TLE score is easy to calculate and predicts the potential occurrence of procedure-related major complications. High-risk patients (scoring more than 10 on the SAFeTY TLE scale) must be treated at high-volume centers with surgical backup.

Background: Cardiac implantable electronic device (CIED) implantation procedures with transvenous lead placement afford an opportunity to observe vascular anatomic variations. The course of CIED implantation depends largely on morphometric and topographic characteristics of the relevant brachiocephalic vein (BCV), which is the left BCV in the case of lead insertion via the left clavipectoral triangle. This study aims to present left BCV anomalies arising from abnormal systemic vein embryogenesis and encountered during CIED implantation. Materials and methods: Venograms obtained during CIED implantation procedures and illustrating left BCV topography/morphometry were analysed retrospectively for two types of anomalies: anomalies of the left BCV itself (data from the period 2014–2018) and a combination of left BCV variations with a persistent left superior vena cava (PLSVC); since the latter instances are rare, the analysed period was longer (2003–2018). Results: Analysis of data from the first, 5-year-long, period included data from a group of 1812 patients and revealed 5 (0.3%) cases of developmental left-BCV anomalies (3 double left BCV and 2 cases of a single subaortic left BCV). The 16-year-long analysed period included 6110 CIED implantation procedures, which showed 12 (0.2%) cases of PLSVC including 4 (33%) cases of left BCV agenesis. Conclusions: The analysed venograms rarely showed isolated left-BCV aberrations (0.3%), with the combination of left-BCV agenesis and PLSVC being much more common (33%). The morphometry and/or topography of aberrant left-BCV may result in difficulties during cardiac lead insertion.

Aims The usefulness of transesophageal echocardiographic (TEE) monitoring for transvenous lead extraction (TLE) procedures is still controversial. The purpose of the current study was to present new TEE values in detecting invisible events in fluoroscopy and preventing the development of dangerous complications. Methods From 2015 to 2019, a total of 1026 procedures were performed in single TLE center. In total, 1108 leads had been extracted with a mean lead dwell time of 115.8 ± 77.6 months. Continuous TEE was used in 936 patients with a mean age of 67.1 ± 14.4 years. Results Preprocedure examination revealed looped leads in 181 (19.3%) patients, dry cardiac perforation in 151 (16.1%), lead-to-lead adhesion in 172 (18.4%), lead adhesion to the myocardium in 317 (33.9%), and vegetations in 119 (12.7%) patients. Intra-procedural TEE demonstrated pulling on the atrial wall, ventricular wall, or tricuspid valve in 380 (40.5%), 235 (25.1%), and 78 (8.3%) patients, respectively. Acute tamponade requiring sternotomy occurred in 11 (1.1%) patients. Migration of vegetation or connective tissue fragments were seen in 69 (7.3%) and 111 (11.8%) patients, respectively. After procedure, TEE was helpful in navigating an implantation, a new lead in 97 (10.3%) patients, and removing the remnants of lead/silicone insulation in 50 (5.3%) patients. Conclusion Real time transesophageal echocardiography for the guidance of transvenous lead extraction informs the operator about the danger of manipulations close to delicate cardiac structures and whether immediate modification to the plan of lead removal is necessary in order to prevent the occurrence of unwanted events.

Aims Transvenous lead extraction (TLE) should ideally be undertaken by experienced operators in a setting that allows urgent surgical intervention. In this analysis of the ELECTRa registry, we sought to determine whether there was a significant difference in procedure complications and mortality depending on centre volume and extraction location. Methods and results Analysis of the ESC EORP European Lead Extraction ConTRolled ELECTRa registry was conducted. Low-volume (LoV) centres were defined as Conclusion Primary operator cardiologists in LoV centres are more likely to have extractions complicated by procedure-related deaths. There was no significant difference in procedure complications between different extraction settings. These findings support the need for TLE to be performed in experienced centres with appropriate personnel present.

Among the complications of cardiac implantable electronic devices (CIED), infections represent one of the nastiest in view of the heavy impact on clinical outcomes and associated costs for healthcare systems. CIED-related infections (CIEDI) can present with several different clinical manifestations increasing the complexity of the diagnostic process. Clinical examination, laboratory exams, blood cultures, and swabs all are mandatory steps for the diagnostic process, similarly to what occurs during diagnosis of endocarditis. However, since signs and symptom may be mild or confusing, imaging has a key role in providing the correct diagnosis. In the present chapter we will discuss the various aspects of echocardiography (transthoracic, transesophageal, and intracardiac) in ruling out CIEDI diagnosis. Later we will discuss the role of computer tomography and magnetic resonance in view of their increasing use in the management of endocarditis, focusing on their pros and cons in the CIEDI setting. Finally, we will focus on nuclear imaging discussing all the various aspects of 18F-FDG PET scan and white blood cell SPET for diagnosis of CIEDI elucidating the advantages among the other imaging techniques but also clarifying how to obtain the maximum from these tools. Notably, the role of imaging techniques is not limited to help defining the diagnosis of CIEDI. For this reason we will dedicate a large part of this chapter to discuss their role in assessment of the extension of the infectious process, detection of complications, supporting transvenous lead extraction (TLE) procedures, planning CIED reimplantation, and helping in predicting post-TLE risk of reinfection or death.

Aims A validated risk stratification schema for transvenous lead extraction (TLE) could improve the management of these procedures. We aimed to derive and validate a scoring system to efficiently predict the need for advanced tools to achieve TLE success. Methods and results Between November 2013 and March 2018, 1960 leads were extracted in 973 consecutive TLE procedures in two national referral sites using a stepwise approach. A procedure was defined as advanced extraction if required the use of powered sheaths and/or snares. The study population was a posteriori 1:1 randomized in derivation and validation cohorts. In the derivation cohort, presence of more than two targeted leads (odds ratio [OR] 1.76, P = 0.049), 3-year-old (OR 3.04, P = 0.001), 5-year-old (OR 3.48, P Conclusion In this study, we developed and tested a simple point-based scoring system able to efficiently identify patients at low and high risk of needing advanced tools during TLE procedures.

Introduction The need for transvenous lead extractions due to cardiac implantable electronic device (CIED)-related infections continues to rise. Current guidelines recommend complete device removal in the setting of an active infection, which can be challenging in pacemaker-dependent patients. Methods We retrospectively reviewed all leadless pacemaker implants between January 2018 and November 2019 and identified a subset of patients who had undergone a concomitant CIED extraction in the setting of an active infection. Baseline characteristics, procedural details, and clinical follow-ups were recorded. Results Seventeen patients received a leadless pacemaker during the same procedure as the CIED extraction. There were no procedural complications. All patients were being treated for an active CIED infection at the time of the procedure. Fourteen patients (82.4%) were completely pacemaker-dependent and four patients (23.5%) had positive blood cultures at the time of the leadless pacemaker implantation. During a median follow-up of 143 days (interquartile range: 57, 181 days), there were no recurrent infections. Conclusion Simultaneous leadless pacemaker implantation and CIED extraction are safe and feasible in the setting of an active infection. This strategy may be particularly useful in patients that are pacemaker-dependent.

Cardiac implantable electrical device infections (CIEDI) are one of the most feared complications for patients implanted with pacemakers (PM) or defibrillators (ICD). The only curative treatment is complete extraction of all pacing/defibrillation system. Several improvements have been made in the results of transvenous lead extraction (TLE), moving from a high-risk procedure to a more safe treatment with major complications in the range of several other electrophysiological procedures. However, management of patients with CIEDI does not end with TLE, since many of them will require re-implantation of a PM/ICD in the challenging setting of a healing local or even systemic infection. In the present chapter we will discuss the various aspects of re-implantation after TLE: reassessment of indications, bridging approaches, alternative options, and timing. New technologies will also be covered for their use in this particular context.

Removal of cardiovascular implantable electronic devices (CIED) is an important and growing field when managing patients presenting with device infections, need for upgrades, and lead failure. The complex skillset of transvenous lead removal is in high demand along with increasing numbers of implanted CIEDs. A systematic and comprehensive approach to this field, including knowledge of all available tools and vascular access techniques is essential for successful outcomes. This article serves as a practical resource presenting tools and techniques of transvenous lead extraction to help refine and master one's skill.

BACKGROUND Transvenous lead extractions have been performed using 40-Hz laser sheaths. Recently, a new 80-Hz laser sheath became available, but only a few reports have compared the effectiveness of the 40- and 80-Hz laser sheaths. Methods and Results: This study included 215 patients. Lead extractions using only laser sheaths were analyzed. The clinical characteristics, extraction parameters, and extraction tools were evaluated. The procedures were performed with 40-Hz sheaths in 150 patients (group 1: 270 leads) and 80-Hz sheaths in 65 (group 2: 99 leads). No statistically significant differences were observed in the clinical parameters except for sex. The mean implant duration was 95.3±86.0 and 78.2±56.8 months in groups 1 and 2, respectively (P=0.07). The respective mean laser time and number of laser pulses were 48.5±52.1 and 48.1±56.1 s (P=0.96) and 2,035.0±2,384.0 and 3,955.1±2,339.3 pulses (P

Cardiac implantable electronic devices have been successfully treating patients with brady- and tachyarrhythmias for decades. However, there are still significant complications related to this therapy modality, many related to the transvenous lead. Paradigm-shifting technologies, such as the subcutaneous implantable cardioverter-defibrillator (S-ICD) and leadless cardiac pacemakers (LCP), have emerged to address these complications. The novel modular cardiac rhythm management (mCRM) system, consisting of a communicating antitachycardia pacing-enabled LCP and S‑ICD, is the first system to integrate wireless intrabody communication between devices to allow for coordination of leadless pacing and defibrillator therapy delivery. In this review, the design and concept of the mCRM system are presented and available evidence is summarized.

Aims: Mechanical force applied during leads removal is the main cause for major complications and cardiovascular injuries. Aim of this study was to retrospectively analyse safety and effectiveness of a stepwise interdisciplinary approach for mechanical transvenous lead extraction.

Background: An increase in the number of cardiac implantable electronic device (CIED) implantations is associated with a higher frequency of electrotherapy complications. Aim: The aim of the study was to determine the risk factors for late electrotherapy complications and to evaluate the effectiveness of transvenous lead extraction (TLE) and survival after TLE. Methods: We analysed the clinical data of 225 patients with electrotherapy complications referred for TLE in a single centre in the years 2006 to 2015. Indications for TLE, risk factors for infectious complications, effectiveness of TLE, and survival after the procedure were assessed. Results: In the study group, non-infectious indications for TLE predominated (78.2%). Analysis of risk for infectious complications demonstrated the important role of chronic renal failure (hazard ratio [HR] 1.842, p = 0.034) and a greater number of CIED-related procedures (HR 4.768, p < 0.001). High effectiveness of TLE and significantly higher long-term mortality of patients with infectious complications compared with the remainder (50% vs. 20%, p < 0.05) were documented. Conclusions: The study demonstrated a high rate of patients with non-infectious complications referred for TLE and very high effectiveness of the procedure. The worse long-term survival of patients with infectious complications, as well as increased risk for such complications due to the greater number of prior procedures, should prompt the consideration of early referral for TLE in the case of lead dysfunctions.

Background: The recent introduction of leadless pacemakers (PMs) was aimed to eliminate transvenous lead- and pocket-related complications. While the initial results with the leadless PMs seem promising, the nonrandomized nature, limited implant experience of operators, and short follow-up period of these studies preclude a simple comparison to transvenous PMs. Objectives: The objective of this study was to provide a balanced comparison of leadless and transvenous single-chamber PM therapies through a propensity score-matched analysis. Methods: Leadless patients from 3 experienced leadless implant centers were propensity score-matched to VVI-R patients from a contemporary prospective multicenter transvenous PM registry. The primary outcome was device-related complications that required invasive intervention during mid-term follow-up. Separate analyses including and excluding PM advisory–related complications were performed. Results: A total of 635 patients were match-eligible (leadless: n = 254; transvenous: n = 381), of whom 440 patients (median age 78 years; interquartile range 70–84 years; 61% men) were successfully matched (leadless: n = 220 vs transvenous: n = 220). The complication rate at 800 days of follow-up was 0.9% (95% confidence interval [CI] 0%–2.2%) in the leadless group vs 4.7% (95% CI 1.8%–7.6%) in the transvenous group when excluding PM advisory–related complications (P =.02). When including these PM advisory–related complications, the complication rate at 800 days increased to 10.9% (95% CI 4.8%–16.5%) in the leadless group vs 4.7% (95% CI 1.8%–7.6%) in the transvenous group (P =.063). Conclusion: This study reveals favorable complication rates for leadless compared to transvenous single-chamber pacing therapy at mid-term follow-up in a propensity score-matched cohort. When including PM advisory–related complications, this advantage is no longer observed.

INTRODUCTION To evaluate the outcomes of video-assisted thoracoscopic surgery (VATS) during transvenous lead extractions (TLEs). METHODS AND RESULTS Ninety-one high-risk patients who underwent TLE in the operating room from January 1, 2015, to March 31, 2017, were included in the study. Of these, 9 patients underwent VATS during TLE. Their clinical characteristics, indications for lead extraction, and complications associated with TLE in the 9 patients who had VATS were compared with those for the 82 patients who did not have VATS. The mean (SD) age of the study patients was 61 (17) years (64.8% were male). The lead dwell time, number of leads extracted, and clinical comorbidities were similar between the 2 groups. Superior vena cava (SVC) tear occurred in 2 of the 9 patients in VATS group and in 1 of the 82 in the non-VATS group (22.2% vs. 1.2%, P = 0.03). Of the 2 patients in the VATS group who had SVC tears, in 1 the tear was visualized immediately and there was no hemodynamic compromise. In the other patient, the SVC tear was within the pericardium; the blood pressure recovered quickly after sternotomy and repair. Both patients had complete lead extraction and survived hospitalization. The patient in the non-VATS group who had an SVC tear had a successful repair but died of postoperative complications. CONCLUSIONS Utilization of VATS to facilitate TLE is beneficial for early recognition of SVC tear and timely surgical repair in select high-risk patients.

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

Background The major complication rate of transvenous lead extraction (TLE) is estimated to be 1%–2%. Laceration of the central veins can be fatal. Objectives To define the incidence and extent of venous injuries on a microscopic level after TLE and compare these data with those of clinically documented events of venous laceration. Methods We studied all patients who underwent TLE at our tertiary center within 30 months via a variety of techniques. Extracted leads and tissue around them were fixed in formalin. Pathologic examination was standardized to examine the leads identifying the areas covered by tissue cuffs along the length of the lead. The cuffs were removed and sectioned transversely to their longitudinal axis. Microscopic examination was performed using hematoxylin and eosin stains and Movat stains to identify the presence of vein tissue. Results In all, 861 leads (585 pacemaker and 272 defibrillator leads) were extracted from 461 patients (median age 63 years, standard deviation 15 years), with an average of 1.9 leads per patient and a median lead age of 2546 days. On microscopic review, 80 leads (9.3%) in 72 of 461 patients (15.6%) showed segments of vein, most of which were transmural (venous tissue including adventitia). Despite this finding, only 5 catastrophic complications (1.1%) occurred that required emergent surgical intervention. Risk factors for venous injury included implantable cardioverter defibrillator lead, age of lead, and the use of laser sheath. Conclusions Microscopic venous injuries during lead extraction are common but often not recognized clinically.

BACKGROUND A proportion of patients who undergo an initial lead extraction procedure will require a second, repeat extraction. Data regarding this clinical entity are scarce and neither the predisposing risk factors for, nor outcomes from, these procedures have been described previously. We sought to determine the incidence, risk factors, and outcomes of repeat lead extraction. METHODS A database of extraction procedures from 2001 to 2015 was analyzed. Repeat extraction procedures were identified and the indication for extraction was dichotomized into infection and lead-related problems. Univariate and multivariate analyses were performed to identify predictors of repeat extraction. RESULTS 807 extraction procedures were identified in 755 patients of whom 6% required a repeat extraction. At multivariate analysis, only suffering a major complication at the initial extraction procedure (odds ratio [OR] 21.5, 95% confidence interval [CI] 2.69-171.92; P

In the past years we have been observing the dynamic development of electrotherapy, as evidenced by the steadily rising number of implanted pacemakers (PM), as well as devices used in the treatment of dangerous arrhythmia and heart failure, such as implantable cardioverter defibrillators (ICD) and cardiac resynchronisation therapy (CRT-P/D). This is a consequence of the ageing of the populations of the majority of developed countries and also the gradually widening indications for the use of such devices. Along with the observed rise in the number of new implantations, the number of complications of electrotherapy is rising as well. In view of the increase in the incidence of complications, it is necessary to systematize the knowledge on this subject, because there is still no official classification of this type of complication and guidelines for dealing with such cases do not appear to cover the scale of the problem. In addition, late complications of electrotherapy play the most important role, in which case the removal of the entire pacing system, transvenous lead extraction (TLE), is a challenge due to the older age of leads strongly attached to the venous walls and endocardium of the heart cavity. The present paper presents a modern classification of electrotherapy complications and discusses the types of complications according to the most recent literature reports. Moreover, the diagnosis and management of particular types of complications with the assessment of indications for TLE are discussed.

A heart transplant recipient presented with right heart failure. He had a history of implantable cardioverter-defibrillator implantation and extraction before undergoing heart transplantation 4 years earlier. A large fistula was found between the left subclavian artery and vein. Following successful percutaneous fistula closure, symptoms and right ventricular function improved. (Level of Difficulty: Advanced.), Graphical abstract, A heart transplant recipient presented with right heart failure, He had a history of implantable cardioverter-defibrillator implantation and…

Permanent His bundle pacing (HBP) has rapidly been adapted into clinical practice in recent years as a physiologic pacing. The 3830 (Medtronic Inc, MN, USA) pacing lead commonly used for HBP is lumenless, and there are limited reports available on extraction of this lead. No data exists on transvenous lead extraction (TLE) of very old HBP lead. Concerns remain about injury to the conduction system during extraction and the lack of lumen for placing a locking stylet for TLE when powered sheaths are required. We reported a unique case of TLE of very old HBP lead (14 years and 3 months) and other two leads, such as passive atrial and passive right ventricular apex backup.

18 F-FDG-PET/CT is promising tool to visualize not only transvenous lead infection but also epicardial lead infection.

A 92-year-old woman underwent an implantation of a leadless pacemaker (Micra; Medtronic, Inc, Minneapolis, MN) for complete atrioventricular block after a transvenous lead extraction due to a pocket infection of a dual chamber pacemaker. Marked scoliosis and a humpback due to an advanced age made it impossible to direct the tip of the pacemaker delivery catheter towards the right ventricular septum or apex and shape the catheter into a gooseneck-shape. Thus, by attaining a halo-catheter shape of the delivery catheter, the catheter tip could be directed toward the infero-basal portion of the right ventricular septum. The pacemaker was successfully deployed at that site without any complications, and good device parameters were achieved. The halo-shape technique may be also an alternative method for delivering a leadless pacemaker in patients with an unsuccessful delivery of a leadless pacemaker to the right ventricular septum using the conventional gooseneck-shape technique.