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.

Cardiac tamponade as an inherent but potentially nonfatal complication of transvenous lead extraction: Experience with 1126 procedures performed using mechanical tools.

INTRODUCTION: Cardiac tamponade (CT) is one of the most common and dangerous complications of transvenous lead extraction (TLE). So far, however, there has been little discussion about the problem. METHODS: We analyzed the occurrence of CT in a group of 1226 patients undergoing TLE at a single reference center between June, 2015 and February, 2021. Using standard mechanical devices as first-line tools, a total of 2092 leads had been extracted. RESULTS: CT occurred in 18 patients (1.47%): due to injury to the wall of the right atrium in 14 patients (1.14%) and other cardiac walls in four patients (0.33%). Younger patient age at first implantation, female gender, high left ventricular ejection fraction (LVEF), lower New York Heart Association class, low Charlson comorbidity index, longer implant duration, and the number of previous procedures related to cardiac implantable electronic devices (CIED) are important patient-related risk factors for CT. Significant procedure-related risk factors include the number of extracted leads, extraction of atrial leads and longer dwell time of extracted leads. Intraoperative transoesophageal echocardiography (TEE) provides a lot of information about pulling on various cardiac structures and is able to detect a very early phase of bleeding to the pericardial sac. As a result of implementing best practices guidance in performing extraction procedures and close collaboration with cardiac surgeons that allowed immediate rescue intervention in our series of 18 CT cases, there were no procedure-related deaths (mortality 0%). CONCLUSIONS: The need for rescue surgery due to CT has no influence on clinical and procedural success. Early diagnosed (TEE monitoring) and properly managed CT does not generate any additional risk in short- and long-term follow-up after TLE.

The role of cardiac surgeon in transvenous lead extraction: Experience from 3462 procedures.

INTRODUCTION: The professional society guidelines recommend that transvenous lead extraction (TLE) operating teams collaborate closely with cardiac surgeons in the management of life-threatening complications. METHODS: We assessed the role of cardiac surgeons participating in 3462 TLE procedures at a high-volume center between 2006 and 2021. The roles for cardiac surgery in TLE can be categorized into five areas: emergency surgical interventions for the management of cardiac laceration and severe bleeding (1.184%), cardiac surgery complementing partially successful TLE or vegetation removal (0.693%), delayed surgical treatment of TLE-related tricuspid valve dysfunction (0.751%), epicardial pacemaker implantation through sternotomy during emergency, complementing or delayed surgical interventions (0.607%), and delayed epicardial lead implantation (0.491%). RESULTS: Isolated damage to the wall of the right atrium was the most common cause of cardiac tamponade (53.66% of emergency surgeries) followed by injury to the right ventricle and vena cava (both 7.317%). CONCLUSIONS: Emergency cardiac surgery for the management of severe hemorrhagic complications is still the most common treatment option. The remaining areas include surgery complementing partially successful TLE: repair of tricuspid valve or epicardial ventricular lead placement to achieve permanent cardiac resynchronization. The experience at a single high-volume TLE center indicates the necessity of close collaboration with the cardiac surgeons whose roles appear broader than the mere surgical standby. Mortality in patients who survived cardiac surgery during TLE does not differ from the survival of other patients after TLE without complications requiring surgical intervention.

A new approach to the continuous monitoring of transvenous lead extraction using transesophageal echocardiography-Analysis of 936 procedures.

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.

The role of cardiac surgery in transvenous lead extraction. A high-volume center experience with 3207 procedures.

Introduction: The guidelines stress the importance of cardiac surgery in the management of life-threatening complications arising from lead removal. Aim: To delineate the roles of the cardiac surgeon during transvenous lead extraction (TLE). Material and methods: 3207 patients (38.7% F), average age 65.7 years, underwent the extraction of PM/ICD leads using standard non-powered mechanical systems within the last 14 years. Results: Procedural success 96.1%, clinical success 97.8%, procedure-related death 0.18%, major complications 1.9% (cardiac tamponade 1.2%, hemothorax 0.2%, tricuspid valve damage 0.3%, stroke and pulmonary embolism < 1%). The roles for cardiac surgery in TLE have been categorized into five areas: 1. Emergency cardiac surgery (1.18% of all patients), 2. Late surgical intervention (TLE-related tricuspid valve dysfunction) (0.44%), 3. Cardiac surgery complementing partially successful TLE (0.68%: removal of lead fragments), 4. Epicardial pacemaker implantation through sternotomy for the above-mentioned reasons (0.65%), 5. Delayed surgical intervention after TLE to place epicardial LV leads (0.53%). Additionally, surgical experience can help in prevention and treatment of wound infection after TLE. Conclusions: Emergency cardiac surgery (mainly due to severe bleeding) is still the most frequent reason for intervention (33.63% (38/113) of all surgical procedures). The other areas of surgical interventions in lead management are: cardiac surgery complementing partially successful TLE, repair or replacement of the malfunctioning tricuspid valve secondary to lead extraction and implantation of permanent epicardial pacing leads after sternotomy or epicardial left ventricle lead to optimize cardiac resynchronization. Experience of a single high-volume lead extraction center confirms the need for close collaboration between the cardiologist and the cardiac surgeon, whose role goes far beyond mere surgical standby.

Disparities in transvenous lead extraction in young adults.

Adults with cardiac implantable electronic devices (CIEDs) implanted at an early age constitute a specific group of patients undergoing transvenous lead extraction (TLE). The aim of this study is to assess safety and effectiveness of TLE in young adults. A comparative analysis of two groups of patients undergoing transvenous lead extraction was performed: 126 adults who were 19-29 years old at their first CIED implantation (early adulthood) and 2659 adults who were > 40 years of age at first CIED implantation and < 80 years of age at the time of TLE (middle-age/older adulthood). CIED-dependent risk factors were more common in young adults, especially longer implant duration (169.7 vs. 94.0 months). Moreover younger age of patients at first implantation, regardless of the dwell lead time, is a factor contributing to the greater development of connective tissue proliferation on the leads (OR 2.587; p < 0.001) and adhesions of the leads with the heart structures (OR 3.322; p < 0.001), which translates into worse TLE results in this group of patients. The complexity of procedures and major complications were more common in younger group (7.1 vs. 2.0%; p < 0.001), including hemopericardium (4.8 vs 1.3; p = 0.006) and TLE-induced tricuspid valve damage (3.2 vs.0.3%; p < 0.001). Among middle-aged/older adults, there were 7 periprocedural deaths: 6 related to the TLE procedure and one associated with indications for lead removal. No fatal complications of TLE were reported in young adults despite the above-mentioned differences (periprocedural mortality rate was comparable in study groups 0.3% vs 0.0%; p = 0.739). Predictors of TLE-associated major complications and procedure complexity were more likely in young adults compared with patients aged > 40 to < 80 years. In younger aged patients prolonged extraction duration and higher procedure complexity were combined with a greater need for second line tools. Both major and minor complications were more frequent in young adults, with hemopericardium and tricuspid valve damage being predominant.

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.

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

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

Analysis of Risk Factors for Major Complications of 1500 Transvenous Lead Extraction Procedures with Especial Attention to Tricuspid Valve Damage.

BACKGROUND: Transvenous lead extraction (TLE) is a relatively safe procedure, but it may cause severe complications such as cardiac/vascular wall tear (CVWT) and tricuspid valve damage (TVD). METHODS: The risk factors for CVWT and TVD were examined based on an analysis of data of 1500 extraction procedures performed in two high-volume centers. RESULTS: The total number of major complications was 33 (2.2%) and included 22 (1.5%) CVWT and 12 (0.8%) TVD (with one case of combined complication). Patients with hemorrhagic complications were younger, more often women, less often presenting low left ventricular ejection fraction (LVEF) and those who received their first cardiac implantable electronic device (CIED) earlier than the control group. A typical patient with CVWT was a pacemaker carrier, having more leads (including abandoned leads and excessive loops) with long implant duration and a history of multiple CIED-related procedures. The risk factors for TVD were similar to those for CVWT, but the patients were older and received their CIED about nine years earlier. Any form of tissue scar and technical problems were much more common in the two groups of patients with major complications. CONCLUSIONS: The risk factors for CVWT and TVD are similar, and the most important ones are related to long lead dwell time and its consequences for the heart (various forms of fibrotic scarring). The occurrence of procedural complications does not affect long-term survival in patients undergoing lead extraction.

A Study of Major and Minor Complications of 1500 Transvenous Lead Extraction Procedures Performed with Optimal Safety at Two High-Volume Referral Centers.

Background: Transvenous lead extraction (TLE) is the preferred management strategy for complications related to cardiac implantable electronic devices. TLE sometimes can cause serious complications. Methods: Outcomes of TLE procedures using non-powered mechanical sheaths were analyzed in 1500 patients (mean age 68.11 years; 39.86% females) admitted to two high-volume centers. Results: Complete procedural success was achieved in 96.13% of patients; clinical success in 98.93%, no periprocedural death occurred. Mean lead dwell time in the study population was 112.1 months. Minor complications developed in 115 (7.65%), major complications in 33 (2.20%) patients. The most frequent minor complications were tricuspid valve damage (TVD) (3.20%) and pericardial effusion that did not necessitate immediate intervention (1.33%). The most common major complication was cardiac laceration/vascular tear (1.40%) followed by an increase in TVD by two or three grades to grade 4 (0.80%). Conclusions: Despite the long implant duration (112.1 months) satisfying results without procedure-related death can be obtained using mechanical tools. Lead remnants or severe tricuspid regurgitation was the principal cause of lack of clinical and procedural success. Worsening TR(Tricuspid regurgitation) (due to its long-term consequences), but not cardiac/vascular wall damage; is still the biggest TLE-related problem; when non-powered mechanical sheaths are used as first-line tools.

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

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

Transesophageal Echocardiography As a Monitoring Tool During Transvenous Lead Extraction-Does It Improve Procedure Effectiveness?

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 ± 4.395 vs. 5.593 ± 4.127; p = 0.004). Complete procedural success was significantly higher in the TEE-guided group (97.683% vs. 95.442%, p < 0.01). The rate of serious complications in the TEE-guided group was lower than the predictive SAFeTY TLE score-a reduction of 28.75% (p < 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-higher rates of complete procedural success and a reduced risk of the most severe complications, thus preventing periprocedural deaths.

Safety and effectiveness of coronary sinus leads extraction - single high-volume centre experience.

INTRODUCTION: Transvenous leads extraction (TLE) of permanently implanted coronary sinus (CS) leads is widely believed to present greater risks than the removal of other leads. AIM: To assess the safety and efficacy of CS leads extraction based on large research material obtained by one operator performing procedures in two TLE centres. MATERIAL AND METHODS: We extracted 408 CS leads from 389 patients, and the results were compared to a control group of 2465 patients who underwent non-CS lead TLE procedures. RESULTS: There were no significant differences in the clinical success rate (97.9% vs. 98.0%) or the major complication rate (2.1% vs. 1.8%) between the CS and control group. CS lead destination (LV/LA pacing) and tip location (CS ostium/mid CS /CS tributaries) influenced the procedural and radiological success rates and procedural complexity but not the complications. CS lead extraction did not affect the necessity for a cardiosurgical intervention or presence of procedure-related death. CONCLUSIONS: TLE of CS leads can be achieved with a high procedural success rate. The major complication rate is not higher than that seen in non-CS lead extraction patients. More than half of CS leads cannot be removed by simple traction and the use of mechanical sheaths may be necessary. The detachment of CS leads from connective tissue scars in the venous and atrial areas up to the CS ostium is generally sufficient for further removal of the lead using simple traction.