Extraction and Reimplantation of a Subcutaneous Implantable Cardioverter Defibrillator: Two Cases and a Review of the Literature.

For several years, implantable cardioverter defibrillators (ICDs) have been the cornerstone for the prevention of sudden cardiac death. However, the weakness of traditional transvenous ICD systems lies in the intravascular lead, which is prone to issues such as conductor fracture, insulation abrasion, risk of dislodgement, and infection. With the new generation of subcutaneous defibrillators, these risks are far less common. To date, the frequency of lead fracture is very low, and infection is much rarer. The management of these complications requires complete lead extraction. Traction is the reference procedure, sometimes necessitating the use of a dilating sheath. These techniques remain straightforward to perform without significant risk of procedural complications. Nevertheless, they must be carried out by an expert in cardiac pacing. We report here two cases with indications for lead extraction: one for lead dysfunction and the other for an infection related to a replacement procedure. The management approaches will be described, followed by a review of the literature.

Indications and outcomes of elective open chest lead extractions.

BACKGROUND: Complications associated with cardiovascular implantable electronic devices may necessitate device and lead removal. An open approach to removal may be electively chosen in cases with high risk of complications or those requiring additional concomitant cardiac surgery. This study aimed to investigate outcomes of patients who underwent elective open lead extractions (OLE) at two large tertiary care centers. METHODS: The records of 29 patients undergoing elective OLE were analyzed through retrospective chart review. RESULTS: 69 total leads were extracted from 29 patients (77% completely, 23% partially). The average age of the oldest leads was 13.3 ± 11.3 years. Infective endocarditis with severe valvular insufficiency requiring valvular intervention (41%)-an infectious etiology, and tricuspid valve intervention to correct RV lead-related severe TR (38%)-a noninfectious etiology, were the most common reasons for OLE. 38% of the patients had additional co-primary or secondary indications for open extraction, such as CABG and pericardiectomies. The rate of major complications and procedural failure was 3% each (1/29). 30-day survival was 100%, and 1-year survival was 92%. The average length of hospital stay was 15 days and higher among those undergoing OLE for infectious indications. CONCLUSION: Open lead extractions offered a similar clinical success rate (97%) to transvenous extractions in this cohort and may be a viable alternative for those necessitating valvular intervention or when the risk of complications from TLE is considered very high.

Case Report: Extraction of a stylet-driven lead for left bundle branch area pacing >2†years after implantation.

Left bundle branch pacing has recently emerged as a significant alternative to right ventricular pacing. The rate of implanted stylet-driven septal leads is expected to increase substantially in the coming years, along with the need to manage long-term complications. Experience in extracting these leads is currently very limited; however, the number of complex extractions is anticipated to increase in the future. We report a complex case involving the extraction of a long-dwelling Solia lead used for left bundle branch pacing in a 21-year-old man. The lead was extracted through the implant vein 27 months after implantation, using a methodology that involved a locking stylet and compression coil. The new lead insertion was challenging due to venous occlusion but after successful venoplasty, the His lead was successfully implanted. The postoperative course was uneventful, demonstrating the feasibility of extraction without complications.

What Important Information Does Transesophageal Echocardiography Provide When Performed before Transvenous Lead Extraction?

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

Incidence and outcomes of cardiovascular implantable electronic device infections in patients with end-stage kidney disease.

BACKGROUND: End-stage kidney disease (ESKD) patients are prone to bloodstream infections that may result in a higher risk of cardiac implantable electronic device (CIED) infections. OBJECTIVE: The objective of this study was to assess the incidence, risk predictors, management strategies, and long-term outcomes of CIED infections in ESKD patients undergoing de novo CIED implantation. METHODS: This is a retrospective study using the United States Renal Data System. ESKD patients with de novo CIED implantation between January 1, 2006, and September 30, 2014, were included. Patients were observed until death, kidney transplantation, end of Medicare coverage, or September 30, 2015, to assess incidence of CIED infection. Management approach was determined from procedure codes for lead extraction within 60 days of CIED infection diagnosis. Patients with CIED infection were observed until December 31, 2019, to assess long-term outcomes. RESULTS: Of 15,515 ESKD patients undergoing de novo CIED implantation, incidence of CIED infection was 4.8% during a median follow-up of 1.3 years. The presence of a defibrillator (adjusted hazard ratio [aHR], 1.48), higher body mass index (aHR, 1.01), and younger age (aHR, 0.96) were independent risk factors for CIED infection. Lead extraction occurred in only 50.71% of patients by 60 days. After propensity score matching, the 3-year mortality was higher in those who did not undergo lead extraction compared with those who did (80.3% vs 72.3%) and time to mortality was shorter (0.3 vs 0.6 year). Only 13.8% of patients underwent reimplantation with a new CIED after lead extraction. CONCLUSION: CIED infections occur frequently in ESKD patients and are associated with a high mortality. Early lead extraction is not performed routinely but is associated with improved survival.

Percutaneous Extraction of Transvenous Permanent Pacemaker/Defibrillator Leads-A Single-Center Experience.

Background and Objectives: The number of cardiac pacemakers being used has increased in recent decades, and this increase has led to a rise in device-related complications, requiring percutaneous device extraction. Our aim was to present our single-center clinical experience in percutaneous lead extractions. Materials and Methods: We analyzed an observational retrospective cohort study of 93 patients for the transvenous removal of a total of 163 endocardial leads. We evaluated the device details, indications, lead characteristics, extraction methods, complications, reimplantation procedure, follow-up data, effectiveness, and safety. Results: Patients' mean age was 68.6 ± 11.6 years. Lead extraction indications were pocket infection in 33 (35.5%), lead dysfunction in 33 (35.5%), and system upgrade in 21 (23%) cases, and lead endocarditis in 6 (6%) cases. The duration from implantation to extraction time was a detected median of 43 (24-87) months. The most common retracted lead type was the RV defibrillator lead (62%), and the lead fixation type was active for one hundred (61%) patients. A new device was inserted in 74 (80%) patients, and the device type was most commonly a CRT-D (61%). Patients were followed up at a median of 17 (8-36) months, and 18 patients (19%) died at follow-up. Complete procedural success was obtained in 78 (84%) patients, and clinical procedural success was obtained in 83 (89%) patients. Procedural failure was detected in 15 (16%) patients. Major and minor complications were detected in 10 (11%) and 6 (6.5%) patients, respectively. The most common minor complication was pocket hematoma. Conclusions: Our experience suggests that transvenous lead extraction has a high success rate with an acceptable risk of procedural complications. The simple manual traction method has a high rate of procedural success, despite a high dwell time of the lead.

When pacing or defibrillator leads become redundant: Extract or abandon?

The 2017 Heart Rhythm Society expert consensus paper on lead management and extraction did not express a preference for either extracting or abandoning pacing or defibrillator leads that are dysfunctional or superfluous after an upgrade (hereafter referred to as redundant leads). However, no randomized or even nonrandomized trials show a better patient outcome with extraction. Many experienced centers currently advise patients to have redundant leads removed to prevent more complicated procedures after years of abandonment. According to the literature, however, not all abandoned leads need to be extracted as >90% will have an uneventful follow-up. As immediate extraction of redundant leads has a small but significant risk, this will generate more adverse events at the population level than when extraction is limited to the patients with future lead complications, even considering a higher extraction risk at that time. Lead extraction is also limited to specialized centers and often necessitates expensive tools, in contrast to abandoning leads, which can be safely performed by any experienced device specialist without additional cost.

Trends and outcomes of inpatient cardiac implantable electronic device transvenous lead extractions: a nationwide analysis.

BACKGROUND: Higher rates of CIED implantations have been associated with an increased rate of lead failures and complications resulting in higher rates of transvenous lead extractions (TLE). OBJECTIVE: To assess the trends TLE admissions and evaluate the patient related predictors of safety outcomes. METHODS: National Readmission Database was queried to identify patients who underwent TLE from January 2016 to December 2019. We conducted a multivariate regression analysis to identify variables associated with in-hospital mortality in patients undergoing TLE. Additionally, we compared trends and outcomes of TLE among patients with prior sternotomy versus those without prior sternotomy and analyzed sex-based differences among patients undergoing TLE. RESULTS: We identified 30,128 hospitalizations for TLE. The index admission in-hospital mortality rate was 3.21% with cardiac tamponade happening in 1.46% of the admissions. Age, infective endocarditis, CKD, congestive heart failure and anemia were associated with higher in-hospital mortality rates. There was a lower rate of in-hospital mortality in patients with history of prior sternotomy versus patients without (OR 0.72, CI: 0.59-0.87, p-value < 0.001). There was no difference in in-hospital mortality rate between males and females. Females had a shorter length and a higher cost of stay when compared to male gender. CONCLUSION: TLE admissions continue to increase. Overall rates of mortality and complications are relatively low. Patients with prior sternotomy had better outcomes and less complications when compared to those without prior sternotomy. Female gender is associated with higher rates of cardiac tamponade, yet shorter length of stay with lower cost.

Outcome of transvenous lead extraction in nonagenarians: A single-center retrospective study.

BACKGROUND: Transvenous lead extraction (TLE) for cardiovascular implantable electronic device (CIED)-related infections has increased. The incidence of TLE in nonagenarians is low, with limited reports outlining the outcomes of this procedure. Therefore, in this study, we aimed to clarify the outcomes of TLE in nonagenarians. METHODS: Patients with TLE treated at our hospital between 2014 and 2023 were retrospectively examined; patient characteristics, device type, indications, procedures, complications, and clinical data of nonagenarians were analyzed. RESULTS: Of 12 patients with 24 leads (active fixation lead, n = 11; passive fixation lead, n = 13) who underwent TLE, the indication for TLE was infection (pocket infection, n = 8; sepsis, n = 4). Methicillin-resistant Staphylococcus epidermidis was the most frequently identified causative agent (n = 4). The median patient age was 91 years; five patients were female. The median lead dwell time was 9 years. Excimer laser sheath (16 leads), mechanical sheath (five leads), Evolution RL (one lead), and manual traction (two leads) were employed in TLE. The procedure was successful in all patients, and only one had a minor complication. Six patients required CIED re-implantation, and leadless pacemakers were selected for five patients. The 30-day mortality after TLE was 0%. CONCLUSION: TLE can be safely performed in nonagenarians. The decision to perform TLE should not be based on old age alone; the suitability of removing infected CIEDs should be determined based on each patient's condition.

Extraction of lumenless pacing leads from the His bundle and left bundle branch area: outcomes of the high-volume centre.

AIMS: The application of conduction system pacing (CSP) in clinical practice is growing, and the need for lead extraction will also increase. The data on outcomes and safety of CSP lead extraction are limited. The aim of this study was to assess procedural outcomes and safety of CSP lead removal. METHODS AND RESULTS: Forty-seven patients from the EXTRACT Registry with the indication for CSP lead removal were enrolled in the study conducted at the Department of Electrocardiology in Katowice, Poland. Extraction technique, outcomes, safety, and complication were evaluated. Forty-three (91.5%) leads were successfully removed, and 41 (87.2%) were removed with traction only. The dwelling time of 28 extracted leads was longer than 1 year, and the oldest extracted lead was implanted for 89 months. Seven (14.9%) leads were removed from the left bundle branch (LBB) area and 36 from the His bundle (HB). Transient complete atrioventricular block occurred during the procedure in two patients. In 27 out of 31 attempts (87.1%), new CSP leads were implanted: nine (33.3%) HB pacing leads and 18 (66.7%) LBB area pacing leads. CONCLUSION: The CSP lead extraction is safe and feasible with a low complication rate and high rate of CSP lead reimplantation.

Evaluation of tricuspid valve regurgitation following transvenous rotational mechanical lead extraction.

AIMS: Transvenous lead extraction (TLE) is potentially complicated by significant tricuspid valve regurgitation increase (TRI). However, there are limited data on the effect of the bidirectional rotational mechanical sheaths on significant TRI. The aim of the present study was to investigate the rate of significant changes in tricuspid regurgitation (TR) severity following mechanical rotational TLE and their outcomes. METHODS AND RESULTS: In 158 patients (mean age 66 ± 16.9 years) undergoing mechanical rotational TLE, acute changes in TR severity were assessed by echocardiography evaluation. A significant acute TRI was defined as an increase of at least one grade with a post-extraction severity at least moderate. A total of 290 leads were extracted (mean implant duration, 93 ± 65 months). Significant TRI was noted in 5.7% of patients, and it was linked to tricuspid valve damage, TLE infection indication, and longer lead implant duration. Univariate predictors of significant TRI included implant duration of all leads [odds ratio (OR) 1.01; 95% confidence interval (CI) 1.003-1.018; P = 0.001] and right ventricular leads (OR 1.01; 95% CI 1.004-1.017; P = 0.002). Severe increase of TR following TLE was an independent predictor of mortality [hazard ratio (HR) 5.20; 95% CI 1.44-18.73; P = 0.012 ] along with severe systolic dysfunction (HR 2.37; 95% CI 1.01-5.20; P = 0.032), and systemic infection (HR 2.28; 95% CI 1.06-4.89; P = 0.035). CONCLUSION: Significant TRI was detected in 5.7% of patients following transvenous rotational mechanical lead extraction. The duration of lead implantation emerged as the sole predictor of significant TRI. Physicians engaged in TLE should exercise greater vigilance for this potential complication.

An unusual cause of inappropriate shocks delivered by an implantable cardioverter defibrillator.

INTRODUCTION: Cardiac implantable electronic device (CIED) complications present significant challenges in clinical practice, especially in elderly patients with multiple comorbidities. Common adverse events include infection, lead malfunction, and device migration. Twiddler's Syndrome, a rare but serious CIED complication characterised by patient manipulation causing lead displacement and device malfunction, is often underreported. The literature consists mainly of case reports and small series, providing limited guidance on prevention and management. As CIEDs are critical for managing cardiac arrhythmias and heart failure, understanding and addressing Twiddler's Syndrome is essential. This case report aims to contribute to the literature by detailing a case of Twiddler's Syndrome, emphasising the importance of a multidisciplinary approach for optimal management. CASE PRESENTATION: A 59-year-old male presented with discomfort around his implantable cardioverter defibrillator (ICD) site and the sternal area over the past two days. He denied pain, dyspnoea, or dizziness. Clinical examination revealed a normal heart rhythm and no peripheral pulse deficit. Ultrasound revealed a reduced left ventricular ejection fraction. The atrial lead was not visible, and the shock coil was misplaced. ICD interrogation showed inappropriate shocks due to sensing artifacts and exit block in both leads, with no arrhythmias detected. An X-ray confirmed lead dislodgement and significant entanglement in the pocket. The patient was diagnosed with Twiddler's Syndrome and scheduled for surgical revision. DISCUSSION/CONCLUSIONS: Dilated cardiomyopathy (DCM), characterised by left ventricular dilatation and dysfunction, accounts for a significant proportion of systolic heart failure cases. Despite advancements in heart failure management, DCM patients remain at high risk for sudden cardiac death (SCD), making ICD implantation crucial. However, CIED placement carries risks of complications, including Twiddler's Syndrome. This condition can lead to lead dislodgement and device malfunction, resulting in inappropriate shocks and potential patient harm. In this case, a single-session extraction and re-implantation were successfully performed using a multidisciplinary approach, emphasising the importance of comprehensive management strategies to address such complications effectively. Regular follow-up showed no adverse events, highlighting the procedure's success and the potential benefits of using advanced antimicrobial adjuncts to prevent infections. This case underscores the need for awareness and standardised protocols for managing Twiddler's Syndrome to improve patient outcomes in the growing population of CIED recipients.

Managing superior vena cava syndrome in patients with cardiac implantable electronic device leads: Strategies and considerations.

BACKGROUND: Data on transvenous (TV) lead-associated superior vena cava (SVC) syndrome are limited. The management of this problem might require a multidisciplinary approach, often involving transvenous lead extraction (TLE) followed by angioplasty and stenting. OBJECTIVE: The purpose of this study was to describe the management and outcome of TV lead-associated SVC syndrome. METHODS: We retrospectively identified patients with a diagnosis of SVC syndrome and TV leads at Emory Healthcare between 2015 and 2023. RESULTS: Fifteen patients with lead-related SVC syndrome were identified. The cohort average age was 50 years. Symptoms included swelling of the face, neck, and upper extremities (67%); shortness of breath (53%); and lightheadedness (40%). Patients had an average of 2 ± 0.7 leads crossing the SVC, with a lead dwell time of 9.8 ± 7.5 years. Thirteen patients were managed with TLE, followed by SVC stenting and angioplasty in 10 and angioplasty alone in 2; 1 patient had no intervention after TLE. One patient was managed with anticoagulation, and another had angioplasty and stenting with lead jailing. One patient experienced SVC perforation and cardiac tamponade during SVC stenting, which was managed successfully with a covered stent and pericardiocentesis. Among the 12 patients with TLE and angioplasty ± stenting, 7 underwent reimplantation of a transvenous lead. Two of those patients had symptoms recurrence, and none of the 5 patients without lead reimplantation had recurrence of symptoms. CONCLUSION: Lead-related SVC syndrome management requires a multidisciplinary approach often including TLE followed by angioplasty and stenting. Avoiding TV lead reimplantation might help reduce symptoms recurrence.

Computed tomography predictors of increased transvenous lead extraction difficulty.

BACKGROUND: The ability of computed tomography (CT) characteristics to predict the difficulty of transvenous lead extraction (TLE) is an evolving subject. OBJECTIVE: To identify CT characteristics associated with increased TLE difficulty. METHODS: All consecutive patients undergoing TLE at the University of California San Diego from January 2018 to February 2022 were analyzed, utilizing the UC San Diego Lead Extraction Registry. Patients underwent cardiac-gated chest CT scans with intravenous contrast; all scans were reviewed by a single radiologist. Lead extraction was performed per standard institutional protocol with the initial use of a laser sheath and crossover to a mechanical sheath as needed. Multivariable linear and logistic regression analyses were performed to identify predictors of individual lead-removal fluoroscopy time and mechanical sheath use, as markers of extraction difficulty. RESULTS: A total of 343 patients were analyzed. The mean age of the study population was 63.8 ± 15.4 years; 71% were male. The mean lead dwell-in duration was 8.6 ± 5.7 years. In multivariable linear regression analysis, venous occlusion detected on CT was independently associated with higher individual lead-removal fluoroscopy time (p = 0.004), when adjusting for clinical characteristics such as lead dwell time. In multivariable logistic regression analysis, calcification and venous occlusion were independently associated with a higher need for mechanical sheath use during TLE (odds ratio:5.08, p < 0.001, 95% CI: 2.54-10.46) and (odds ratio:3.72, p < 0.001, 95% CI: 1.89-7.35), respectively. CONCLUSION: In patients undergoing TLE, venous occlusion identified by chest CT is associated with increased fluoroscopy time. Patients with lead-associated calcification or venous occlusion detected by chest CT are each five and three times more likely to require crossover from laser to a mechanical sheath.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool.

BACKGROUND AND AIMS: The rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. METHODS: This was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. RESULTS: A total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5-7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5-7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. CONCLUSIONS: Systemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Sex differences in long-term outcomes following transvenous lead extraction.

INTRODUCTION: Transvenous lead extraction (TLE) is generally considered a safe procedure, albeit not without risks. While gender-based disparities have been noted in short-term outcomes following TLE, a notable gap exists in understanding the long-term consequences of this procedure. The objective of this analysis was to investigate sex differences in both acute and long-term outcomes among patients who underwent TLE at a tertiary referral center. METHODS: In this retrospective cohort study, consecutive patients who underwent TLE between January 2014 and January 2016 were enrolled. The primary outcome comprised a composite of all-cause mortality and need for repeated TLE procedures. Secondary outcomes included fluoroscopy time, lead extraction techniques, success rates, and major and minor complications. Results were compared between female and male cohorts. RESULTS: The study population comprised 191 patients (median age, 70 years), 29 (15.2%) being women and 162 men (84.8%). Study groups had similar baseline characteristics. Complete procedural success was achieved in 189 out of 191 patients (99.0%), with no significant difference observed between the two groups (p = .17). No major complications were reported in the total cohort. However, there was a significantly higher incidence of minor complications in women compared to men (17.2% vs. 2.5%, p < .01). Following a median follow-up of 6.5 years, the incidence of the primary composite outcome occurred similarly between the study groups (log-rank p = .68). CONCLUSION: Women who underwent TLE exhibited a significantly higher incidence of minor acute intra- and peri-procedural complications than men. However, no differences in long-term outcomes between genders were observed.

Change in Tricuspid Valve Function after Transvenous Lead Extraction, Predisposing Factors and Prognostic Roles.

Background: Changes in tricuspid valve (TV) function following transvenous lead extraction (TLE) and their impact on long-term survival have not yet been investigated. Methods: From 3633 patients undergoing lead extraction between 2006 and 2021, TV function before and after TLE was evaluated in 2693 patients. Results: After TLE, the TV function remained unchanged in 82.36% of patients, worsened in 9.54%, and improved in 8.10%. Abandoned leads (odds ratio, OR = 1.712; p = 0.044), fibrotic adhesions between leads and TV apparatus (OR = 3.596; p < 0.001), or right ventricular wall (OR = 2.478; p < 0.001) were predisposed to TV worsening. Non-infectious indications for TLE (OR = 1.925; p < 0.001), the severity of tricuspid valve regurgitation (TVR) before TLE (OR = 3.125; p < 0.001), and lead encapsulation (OR = 2.159; p < 0.001) were predictors of improvement in TV function. Although either worsening or improving TV function had no impact on long-term survival in all patients, decreased TVR severity in the subgroup of patients with initial regurgitation grades 3-4 was associated with a better prognosis (hazard ratio, HR = 0.622; p = 0.005). Conclusions: 1. Changes in TV function after TLE were observed in 17.64% of patients. 2. Various factors can predispose to lead-related TV changes, although the common denominator in these events is an extensive buildup of scar tissue. 3. Worsening TV function had no impact on survival after TLE. In patients with severe TV dysfunction, reduction in TVR following TLE was associated with a 40% reduction in mortality during a mean follow-up of 1673 days.