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Background Superior vena cava (SVC) tears are rare but potentially lethal complications associated with transvenous lead extraction. When lacerations occur, surgeons need to be prepared for an emergent response. Nonetheless, little is known about the precise whereabouts of these lesions. Understanding the location and injury patterns enables a more anticipated and targeted surgical response. Methods We collected data via physician interviews after an SVC laceration occurred. These physicians were identified through the US Food and Drug Administration's Manufacturer and User Facility Device Experience database and independent physician reports of adverse events. We identified 116 reports of SVC tears between July 1, 2016, and July 31, 2018. For an SVC tear to be included in our registry, a cardiothoracic surgeon had to be physically present to confirm the injury via emergent sternotomy. In each case, the surgeon recorded the SVC injury's exact location after a repair was attempted. Results During the study period, 116 SVC tears were confirmed by sternotomy. Tears occurred in any combination of the following locations: SVC–innominate vein, body of the SVC, and SVC–right atrial junction. The majority of tears (n = 72; 62%) were located in the isolated body of the SVC, followed by the SVC–right atrial junction (n = 23;19.8%) and the SVC–innominate junction (n = 17;14.6%). Combined tears were rare, accounting for only 3.6% (n = 4) of the adverse events recorded. Conclusions Most SVC tears occurred in the isolated body of the SVC. The second most common location was the SVC–right atrial junction. The SVC–innominate junction was the third most common location for these injuries. Combined tears were uncommon.

Background Longer-term outcomes of patients post transvenous lead extraction (TLE) are poorly understood in patients with cardiac resynchronization therapy (CRT) devices. Objectives A propensity score (PS)–matched analysis evaluating outcomes post TLE in CRT and non-CRT populations was performed. Methods Data from consecutive patients undergoing TLE between 2000 and 2019 were prospectively collected. Patients surviving to discharge and reimplanted with the same device were included. The cohort was split depending on presence of CRT device. Associations with all-cause mortality and hospitalization were assessed by Kaplan-Meier estimates. An exploratory endpoint was evaluated whether early (7 days) reimplantation was associated with poorer outcomes. Results Of 1005 patients included, 285 (25%) had a CRT device. Median follow-up was 57.00 [27.00–93.00] months, age at explant was 67.7 ± 12.1 years, 83.3% were male, and 54.4% had an infective indication for TLE. PS was calculated using 43 baseline characteristics. After matching, 192 CRT patients were compared with 192 non-CRT patients. In the matched cohort, no significant difference with respect to mortality (hazard ratio [HR] = 1.01, 95% confidence interval [CI] [0.74–1.39], P = .093) or hospitalization risk (HR = 1.2, 95% CI [0.87–1.66], P = .265) was observed. In the matched CRT group, late reimplantation was associated with increased mortality (HR = 1.64, [1.04–2.57], P = .032) and hospitalization risk (HR = 1.57, 95% CI [1.00–2.46], P = .049]. Conclusion Outcomes of CRT patients post TLE are similarly as poor as those of non-CRT patients in matched populations. Reimplantation within 7 days was associated with better outcomes in a CRT population but was not observed in a non-CRT population, suggesting prolonged periods without biventricular pacing should be avoided.

Background Transvenous lead extraction (TLE) is rising in parallel to cardiac implantable electronic device implantations. Persistent left side superior vena cava (PLSVC) is a relatively common anatomical variant in the healthy population; TLE in patients with a PLSVC is rare. Method Data were collated from 6 European TLE institutes of 10 patients who had undergone lead extraction with a PLSVC. Patient demographics, procedural challenges and outcomes were reported. Results Ten patients aged 73.4 ± 7.8 years (60% male) underwent TLE of 20 leads (3 left ventricle, 10 right ventricle, 7 right atrium) with dwell time of 82.95 ± 39.1 months. Of the 10 cases, 4 had an infection indication and 5 were biventricular system extractions; 25% of the extracted leads were defibrillator leads. The majority of the procedures were completed in the cardiac catheterization suite (80%) under general anaesthesia (60%) by cardiologists (80%) using a rotational powered sheath (65%). The Tandem approach was used successfully in 3 cases. Complete procedural success was obtained in 100% of cases in the absence of complications within 127.4 ± 74.7 min. There was no 30-day mortality. Conclusion TLE in PLSVC is feasible albeit rare. Standard extraction techniques in experienced hands are associated with favorable outcomes; the Tandem procedure may be an additional technique to improve the safety and efficacy of TLE in PLSVC.

Subcutaneous implantable cardioverter/defibrillators (S-ICDs) have been developed to offer ICD treatment to patients without venous access to the heart and to overcome complications associated with transvenous leads, particularly lead fracture/insulation defects and endocarditis. Several studies and registries have demonstrated the feasibility and safety of S‑ICD in different groups of patients. Further developments in S‑ICD technology involve the combination with devices that can provide anti-bradycardia and anti-tachycardia pacing if needed. The extravascular ICD (EV-ICD) is a new system that similarly offers ICD therapy without a transvenous lead but uses a substernal instead of a subcutaneous lead to facilitate detection of ventricular fibrillation and to provide anti-tachycardia and also temporary anti-bradycardia pacing. The first animal but also clinical data on EV-ICDs have been published. This review discusses the current state, potential advantages and limitations, and future research of both S‑ICD and EV-ICD.

INTRODUCTION AND OBJECTIVES Data are scarce on outcomes of transvenous lead removal (TLR) in adult congenital heart disease (CHD). We evaluated the safety of the TLR procedure in adult CHD patients from a 10-year national database. METHODS We used the Healthcare Cost and Utilization Project Nationwide Inpatient Sample to identify TLR procedures in adult patients with and without CHD from 2005 to 2014. Outcomes included in-hospital mortality and complications. RESULTS Of 132 068 adult patients undergoing TLR, 1939 had simple CHD, 657 had complex CHD, and 626 had unclassified CHD. The number of TLR procedures in adult CHD slightly increased from 236 in 2005 to 445 in 2014, with fluctuations over the study period. The overall rate of any complications in the TLR procedure was 16.6% in patients with CHD vs 10.1% in patients without CHD (P

Броят на имплантациите на електронни устройства за кардиостимулация постоянно се повишава в световен мащаб. С това респективно се увеличава и броят на пациентите, които имат абсолютни индикации за екстракция на електроди (пейсмейкърни и ICD). Целта на настоящото проучване е да се представят непосредствените и дългосрочните резултати при пациенти след трансвенозна екстракция на електроди, проведена в Клиниката по кардиология на УМБАЛ „Света Анна“ – София. Материали и методи: Проведено е ретроспективно проучване при пациенти с имплантирано устройство за електрокардиостимулация с давност повече от 1 година, при които е направена екстракция на трансвенозните електроди. Проучени са клиничните и процедурните характеристики, успеваемостта и усложненията с проследяване честотата на реинфекция след процедурата. Резултати: В периода август 2016–май 2021 г. при нас са постъпили 54 пациенти с абсолютна индикация за екстракция на системата за електрокардиостимулация. При проведените 54 процедури са екстрахирани 114 пейсмейкърни и ICD електрода. При 47 процедури (87%) е постигнат пълен технически успех с премахване на всички електроди, а при 53 (98,1%) – клиничен успех на процедурата. Регистрирани са 2 големи перипроцедурни усложнения (3,7%), изискващи спешна кардиохирургична интервенция. При направеното проследяване се установява много ниска честота на повторна инфекция – само при 1 пациент (1.9%). Изводи: Екстракцията на трансвенозни електроди е ефективна и безопасна процедура. Изграждането на специализиран център с организирана програма за екстракция на електроди е от ключово значение за постигането на добри непосредствени и дългосрочни резултати. There has been increased rate of cardiac implantable electronic devices (CIED) implanted worldwide. Respectively the numbers of patients with absolute indications for lead extraction (pacemaker and ICD) grow up exponentially. The aim of our study is to present the initial experience and long-term results of pacemaker and ICD lead extraction in patients treated in Cardiology department of University hospital “Sveta Anna” Sofi a. Material and Methods: Retrospective study was performed of patients with CIED implanted greater than 1 year and indications for lead extraction. Clinical and procedural characteristics, success rate, complications rate, and reinfection rate data were collected and analyzed. Results: In the period August 2016 to May 2021, a total of 54 patients were admitted to our department with an absolute indication for lead extraction. A total of 114 pacemakers and ICD electrodes were extracted during 54 procedures. In 47 patients (87%) was shown complete technical success with removal of all hardware and in 53 patients (98.1%) clinical success of the procedure was found. The incidence of major periprocedural complications requiring urgent cardiac surgery in our series was 2 (3.7%). Follow-up revealed a very low recurrence infection rate – only 1 patient (1.9%). Conclusion: Lead extraction is a safe and effective procedure. The establishment of a specialized center with an organized system for lead extraction is key in achieving excellent short- and long-term results.

Background Transesophageal echocardiography (TEE) is commonly used during cardiothoracic procedures. TEE has also become standard during transvenous lead extraction (TLE) procedures, but its effect and role have not been optimally defined. The goal of this study is to identify how TEE was used during TLE at our institute and review its utility. Methods We retrospectively reviewed high-risk patients undergoing TLE, for whom more complications during extraction procedures, from June 2012 to September 2020. The patients were divided into TEE group and non-TEE group according to real-time TEE monitoring. We compared the rate of procedural success, complications between two groups and concluded the clinical utility of TEE during TLE. Results A total of 195 patients were included (105 in TEE group vs 90 in non-TEE group), the rate of procedure success (97.8% vs 96.5%, p = 0.41) and complications during extraction (8.6% vs 12.2%, p = 0.40, major complication 5.7% vs 12.2%, p = 0.11, minor complication 2.9% vs 0%, p = 0.30) were comparable. In TEE group, 12 patients (11.4%) received following benefits: altering surgical plans, guiding subsequent therapy strategies, and rapidly diagnosing complications, moreover no complications occurred from TEE. Conclusions This study demonstrates that real-time monitoring by TEE cannot change the rate of procedural success and complication during TLE; however, TEE provides valuable information to instruct clinical therapy and improves the safety of TLE.

Long-term outcomes are poorly understood, and data in patients undergoing transvenous lead extraction (TLE) are lacking.The purpose of this study was to evaluate factors influencing survival in patients undergoing TLE depending on extraction indication.Clinical data from consecutive patients undergoing TLE in the reference center between 2000 and 2019 were prospectively collected. The total cohort was divided into groups depending on whether there was an infective or noninfective indication for TLE. We evaluated the association of demographic, clinical, and device-related and procedure-related factors on mortality.A total of 1151 patients were included. Mean follow-up was 66 months, and mortality was 34.2% (n = 392). Of these patients, 632 (54.9%) and 519 (45.1%) were for infective and noninfective indications, respectively. A higher proportion in the infection group died (38.6% vs 28.5%; P.001). In the total cohort, multivariable analysis demonstrated increased mortality risk with age75 years (hazard ratio [HR] 2.98; 95% confidence interval [CI] 2.35-3.78; P.001), estimated glomerular filtration rate60 mL/min/1.73 mLong-term mortality for patients undergoing TLE remains high. Consensus guidelines recommend evaluating risk for major complications when determining whether to proceed with TLE. This study suggests also assessing longer-term outcomes when considering TLE in those with a high risk of medium- and long-term mortality, particularly for noninfective indications.

BACKGROUND Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non-laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. METHODS Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005-December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [

BACKGROUND Transvenous lead extraction (TLE) is standard of care for the management of patients with cardiac implantable electronic device infection or lead-related complications. Currently, objective data on TLE in Latin America is lacking. OBJECTIVE To describe the current practice standards in Latin American centers performing TLE. METHODS An online survey was sent through the mailing list of the Latin American Heart Rhythm Society. Online reminders were sent through the mailing list; duplicate answers were discarded. The survey was available for 1 month, after which no more answers were accepted. RESULTS A total of 48 answers were received, from 44 different institutions (39.6% from Colombia, 27.1% from Brazil), with most respondents (82%) being electrophysiologists. Twenty-nine institutions (66%) performed

Background Transesophageal echocardiography (TEE) is a useful tool in preoperative evaluation of patients undergoing transvenous lead extraction (TLE). Hypothesis Echocardiographic phenomena may determine the difficulty and safety of the procedure. Methods Data from 936 transesophageal examinations (TEE) performed at a high volume center in patients awaiting TLE from 2015 to 2019 were assessed. Results TEE revealed a total of 1156 phenomena associated with the implanted leads in 697 (64.85%) patients, including: asymptomatic masses on endocardial leads (AMEL) (58.65%), vegetations (12,73%), fibrous tissue binding the lead to the vein or heart wall (33.76%), lead‐to‐lead binding sites (18.38%), excess lead loops (19.34%), intramural penetration of the lead tip (16.13%) and lead‐dependent tricuspid dysfunction (LDTD) (6.41%). Risk factors for technical difficulties during TLE in multivariate analysis were: fibrous tissue binding the lead to atrial wall (OR = 1.738; p

Introduction Current guidelines advocate reviewing peri-procedural anticoagulation on individual case basis for transvenous lead extraction (TLE). We investigated the safety of TLE on uninterrupted warfarin with therapeutic INR. Methods Retrospective registry of consecutive patients undergoing TLE on uninterrupted warfarin (Warfarin Group) across two centres. Age and sex matched controls not on anticoagulation (No-Warfarin Group) and undergoing TLE over the same time-period were included. Both groups were compared over one-year. Results 121 TLEs over 18-months. 22 patients on uninterrupted anticoagulation were compared to 22 controls. Groups were well matched for baseline demographics other than INR. Warfarin group had mean INR of 2.2 ± 0.6 (range 2–3.5). Primary end point was procedural safety and efficacy. Amongst cases, 43/45 (96%) leads were removed in their entirety compared to 37/40 (93%) in controls (p = 0.66). In the cases, these included 44% defibrillator, 47% pace-sense and 9% CS leads of average duration 7yrs. There was no reported tamponade, haemothorax or procedural mortality in either group. One patient amongst cases required inotropic support while two patients amongst controls had device-site haematomas. No significant difference reported in Hb drop post-procedure or overall complication rate between the groups (p = 0.11,0.32). Cox regression showed a significant association between procedural success and device infection, number of leads extracted, serum creatinine (p = 0.03, 0.04, 0.02). Over a 1-year follow-up, there was lead displacement in one case and one control had infection of the re-implanted device. Conclusion TLE can be carried out safely in anticoagulated patients with therapeutic INRs. Larger multicentre studies are required to confirm these findings.

Background Managing elderly patients with infection or malfunction deriving from a cardiac implantable electronic device (CIED) may be challenging. We report the safety and effectiveness of transvenous lead extraction in Chinese octogenarian patients. Hypothesis Transvenous lead extraction can be performed safely and successfully in the Chinese octogenarians. Methods We retrospectively identified all patients who underwent TLE at our institution between March 2013 and January 2021. This population was divided into the following two groups based solely on age: octogenarians and non‐octogenarians. These two groups were compared on the basis of several characteristics and clinical outcomes. Results Consecutive 1106 patients were analyzed, including 184 (16.6%) octogenarians and 922(83.4%) non‐octogenarians. The octogenarians presented more comorbidities. A total of 378 leads and 2004 leads were removed from the patients in the octogenarian group and non‐octogenarian group, respectively. The mean lead implant duration was 6.1 ± 5.1 and 5.8 ± 4.6 years for octogenarians and non‐octogenarians (p = 0.296). The majority of the patients in both groups underwent TLE through the femoral approach (67.5% vs 61.6%, p = 0.14). The complete procedure success rate was similar between the octogenarian and non‐octogenarian group (96.7% vs.95.3%, p = 0.39). There were no differences with respect to the proportion of minor, major complications and deaths. Long‐term mortality (median time 3.3 years) after TLE in octogenarians was significantly higher compared with younger individuals. Conclusions At experienced centers, transvenous lead extraction can be performed safely in Chinese octogenarians with procedural success rate and complication rate comparable to younger individuals.

Transvenous lead extraction (TLE) is necessary because of system infection, lead malfunction, or system upgrade. Patients with severe left ventricular dysfunction (SLVD) undergoing TLE may be at a higher risk because hemodynamic parameters may change unfavorably during or after TLE; however, this has not yet been clarified.The purpose of this study was to examine whether patients with SLVD undergoing TLE have higher mortality.All patients who underwent TLE were stratified as follows: patients with ejection fraction ≤ 35% (SLVD group) and those with ejection fraction35% (non-SLVD group).We assessed the data of 200 patients [SLVD group, 36 (18%); non-SLVD group, 164 (82%)]). Brain natriuretic peptide level and cardiac resynchronization therapy rate were higher in the SLVD group than in the non-SLVD group. There were no significant between-group differences in major complications and clinical success rates. Patients with SLVD were more likely to require additional hemodynamic support, such as catecholamine infusion, temporary atrium-ventricle sequential pacing, and temporary cardiac resynchronization therapy pacing (27.8% vs 1.2%; P.001). The survival rate was not significantly different between the groups at 30 days and 1 year after TLE (SLVD vs non-SLVD: 30 days: 97.2% vs 99.4%; P = .215; 1 year: 80.6% vs 91.5%; P = .053). Multivariate Cox regression analysis revealed log brain natriuretic peptide and serum hemoglobin levels as predictors for 1-year mortality.The prognosis after TLE was comparable between patients with and without SLVD. However, additional hemodynamic support was often necessary for patients with SLVD.

Transvenous lead extraction is an invaluable procedure within the contemporary management of cardiac implantable electronic devices. Transvenous lead extraction has traditionally been guided by fluoroscopy. Complementary imaging with intracardiac echocardiography can provide valuable additional information, such as identification of complications, lead-adherent echodensities, and sites of lead-tissue adherence. As such, it can be used to aid in risk stratification before lead removal, help to choose tools or techniques, and provide visual monitoring throughout the procedure. Intracardiac echocardiography can be incorporated into the lead extraction workflow of the contemporary electrophysiologist and provide valuable information supporting safety and efficacy.

Superior vena cava (SVC) syndrome is a rare complication associated with transvenous cardiac implantable electronic devices that may present with a variety of manifestations. Various strategies such as transvenous lead extraction, anticoagulation, venoplasty, and stenting have been used to treat this condition, but the optimal management protocols have yet to be defined. Subcutaneous implantable cardioverter-defibrillator (ICD) (S-ICD) therapy can be an alternative option to a transvenous system for those who require future ICD surveillance. We present a case of lead-associated SVC syndrome where thoracic venous congestion due to SVC obstruction influenced preimplant S-ICD QRS vector screening. Following treatment of venous obstruction, QRS amplitude may change and patients who were not initially S-ICD candidates may later become eligible.

BACKGROUND Powered transvenous lead extraction (TLE) tools are commonly required to remove the leads with long implant duration due to fibrotic adhesions. However, comparative data are lacking among different types of TLE tools. AIM To compare the efficacy and safety of two different rotational mechanical dilator sheaths in retrospectively analyzed patients who underwent TLE. METHODS AND RESULTS A total of 566 lead extractions from 302 patients using TightRail™ (333 lead extractions from 169 patients) and Evolution® (233 lead extractions from 133 patients) mechanical dilator sheaths were performed between July 2009 and June 2018. Acute and long-term outcomes of study groups were compared. There is no statistically significant difference between Evolution® and TightRail™ groups in procedural success (93.9% vs. 94%), clinical success (99.2% vs. 98%), and major complications (3.8% vs. 1.2%), respectively (p > .05). In multivariate regression analysis, lead dwell time, the number of extracted leads, and baseline leukocyte count were found as independent predictors of procedural success (p .05). Chronic renal disease, heart failure, and coagulopathy were shown as independent predictors of all-cause mortality in multivariate regression analysis (p

Background The incidence, predictors, and clinical impact of lead break during transvenous lead extraction (TLE) were previously unknown. Methods We included consecutive patients who underwent TLE between September 2013 and July 2019 at our institute. Lead break during removal was defined as lead stretching and becoming misshapen, as assessed by fluoroscopy. Results A total of 246 patients underwent TLE for 501 leads. At a patient level, complete success was achieved in 226 patients (91.9%). At a lead level, 481 leads (96.0%) were completely removed and 101 leads (20.1%) were broken during the procedure. Of 392 identified pacemaker leads, 71 (18.3%) were broken during the TLE procedure. A multivariable analysis confirmed high lead age (odds ratio [OR] 1.12, 95% confidence interval (CI) 1.07‐1.17; P, The extraction of cardiac implantable electronic device leads due to infections, malfunctions, and recalls is common, and can lead to complications such as lead break resulting in incomplete lead removal and cardiac tamponade. We found that older lead age, co‐radial leads, passive leads, and non‐polyurethane leads were independent predictors of lead break during extraction. These findings will guide clinicians to make appropriate choices of procedure and take greater care when these risk factors are present.

Background In the aging population equipped with cardiac implantable electronic devices, an increasing number of octogenarians require lead extractions. This patient population is often considered as a high-risk group for surgical procedures. We, therefore, investigated the safety and efficacy of transvenous lead extraction in octogenarians using powered extraction sheaths. Methods Between January 2013 and March 2017, 403 patients underwent lead extraction at two high-volume lead extraction centers. A total of 71 octogenarians were treated with laser lead extraction and were included in this analysis. Primary extraction method was laser lead extraction, with additional use of mechanical rotational sheaths or femoral snares, if necessary. Patient-based and procedural data were collected and analyzed retrospectively. Results Mean age was 83.5 ± 3.3 years, 64.7% were males. A total of 152 leads were extracted. The mean lead dwell time of treated leads was 10.2 ± 5.2 years. Complete procedural success rate was 92.9%, while clinical success was achieved in 98.6%. Failure of extraction occurred in one patient (1.4%). In six (7.7%) patients, additional mechanical rotational sheaths or femoral snares were used. Overall complication rate was 4.2%, including one (1.4%) major (RA perforation) and two (2.8%) minor complications. No procedure-related mortality was observed in any of the patients. Conclusion Transvenous lead extraction in octogenarians with old leads is safe and effective when performed in experienced centers. Patient's age should therefore not be considered as contraindication for lead extraction using powered extraction sheaths.

The aim of the investigation was to study the issue of making challenging decisions concerning abandonment or removal of non-infected superfluous leads during lead revisions or cardiac implantable electronic device upgrades. Materials and Methods. From 2010 to 2019, a total of 482 patients who had undergone cardiac implantable electronic device implantation in the past were admitted to hospital for generator replacement or lead revision. In 126 patients, 155 malfunctioning leads were found. Mean age of the patients was 59.2±16.7. Total venous occlusion was found in 10 cases of these patients. All patients were divided into two groups: extracted leads group (n=83) and abandoned leads group (n=43). The main factor which influenced our strategy was the mean age of the lead. In group 1 the mean age of the lead was 6.9±5.6 years. In group 2 it was about 12 years. Results. Lead extraction was performed by manual traction in 69 (61.7%) leads, by lead locking device in 32 (28.5%) leads, and 11 (9.8%) leads were removed using TightRail rotating dilator sheath. In 1 case of total occlusion of the superior vena cava, we performed a video-assisted thoracoscopic lead extraction at the time of vein occlusion recanalisation and electronic device reimplantation. In abandoned leads group 3 patients had lead-related complications. Conclusion. Transvenous lead extraction with the mean age of the lead less than 10 years is an effective and safe strategy. Preventive transvenous lead extraction of non-infected leads allows avoiding lead-related complications in the long-term period.

Background After the reports of recalled leads, several technological improvements have been introduced and the durability of implantable cardioverter defibrillator (ICD) leads has improved. The incidence of lead failures is now less than in the previous studies. However, there are few reports that have shown the long-term durability of ICD leads as compared to pacemaker (PM) leads. This study analyzed the medium to long-term performance of transvenous ICD leads as compared to PM leads. Methods We retrospectively studied 1227 cases from April 2007 to December 2017 who underwent an initial transvenous ICD or PM implantation. The number of lead failures and patient background characteristics were analyzed. Results During a median 3-3.5 years follow up period, 1 (0.3%) ICD lead and 18 (2.4%) PM leads failed. The incidence of lead failures was significantly higher in the PM group than ICD group (p = .019). Males were associated with a higher incidence of lead failures in the PM group. Conclusion Since the era of recalled ICD leads, the durability of ICD leads has remarkably improved and the incidence of lead failures with non-recalled ICD leads has been less than that for PM leads.

Aims The subcutaneous cardioverter-defibrillator (S-ICD) may be a valuable option in patients after successful transvenous lead extraction (TLE) without indication for pacemaker therapy and persistent risk of sudden cardiac death. The aim of this study was to evaluate device performance, postoperative outcome, and safety in patients who received a S-ICD after TLE compared to patients who underwent de-novo S-ICD implantation. Methods A retrospective analysis of all patients included into our institution's S-ICD database between September 2010 and May 2019 was conducted.The patients were divided in two groups, depending on whether they had received their S-ICD after TLE (n = 31) or de-novo (n = 113). Results The TLE group was significantly older with a mean age of 54.3 ± 15.7 versus 46.7 ± 14.4 years; p = .007. Leading S-ICD indication in the TLE group was previous infection (50%), whereas in the de-novo group the S-ICD was primarily chosen due to young patient age (74.6%). Median duration of follow-up was 527.0 versus 472.5 days, respectively; p = .576. Most common complication during follow-up was inappropriate ICD therapy (12.9% vs. 13.3%); p = 1.000. Pocket erosion/infection occurred in 3.2% versus 3.5% with no reported cases of systemic (re-)infection in either group; p = 1.000. All-cause mortality was low (6.2% vs. 2.7%) and entirely unrelated to S-ICD implantation or the device itself; p = .293. Conclusion The S-ICD is a safe and effective alternative for patients after TLE with very similar results regarding device performance and postoperative outcome, when compared to patients who underwent de-novo S-ICD implantation.

Introduction Transvenous lead extraction (TLE) is critical in the long-term management of patients with cardiac implanted electronic devices (CIEDs). The aim of the study is to evaluate the outcomes of TLE and to investigate the impact of infection. Methods and results Data of patients undergoing extraction of permanent pacemaker and defibrillator leads during October 2014-September 2019 were prospectively analyzed. Overall, 242 consecutive patients (aged 71.0 ± 14.0 years, 31.4% female), underwent an equal number of TLE operations for the removal of 516 leads. Infection was the commonest indication (n = 201, 83.1%). Mean implant-to-extraction duration was 7.6 ± 5.4 years. Complete procedural success was recorded in 96.1%, and clinical procedural success was achieved in 97.1% of attempted lead extractions. Major complications occurred in two (0.8%) and minor complications in seven (2.9%) patients. Leads were removed exclusively by using locking stylets in 65.7% of the cases. In the subgroup of noninfective patients, advanced extraction tools were more frequently required compared to patients with CIED infections, to extract leads (success only with locking stylet: 55.8% vs. 67.8%, p = .032). In addition, patients without infection demonstrated lower complete procedural success rates (90.7% vs. 97.2%, p = .004), higher major complication rates (2.4% vs. 0.5%, p = .31) and longer procedural times (136 ± 13 vs. 111 ± 15 min, p = .001). Conclusions Our data demonstrate high procedural efficacy and safety and indicate that in patients with noninfective indications, the procedure is more demanding, thus supporting the hypothesis that leads infection dissolves and/or prohibits the formation of fibrotic adherences.

Transesophageal echocardiography (TEE) is regarded as the gold standard in diagnostic cardiology and has become an essential tool for monitoring the patient undergoing cardiac surgery and transcatheter procedures. Considering the increasing number of complications related to cardiac implantable electronic devices, TEE can also be used to detect these irregularities. Transvenous lead extraction (TLE) is the first--line treatment for cardiac implantable electronic device-related complications. The essence of TLE is the dissection of leads from connective tissue adhesions that attach them to the walls of the heart and vessels. Separation of strongly immobilized leads may cause injury to the veins or heart resulting in life--threatening bleeding. For this reason, the guidelines from the American and European cardiac societies recommend clinicians to use TEE for monitoring the patient undergoing TLE. The advantage of such an approach is immediate detection, localization, and evaluation of TLE complications and sequelae. Additionally, according to our experience, continuous monitoring of the TLE procedure enables the operator to be informed about the expected technical problems.

Although the Needle's Eye Snare (Cook Medical) has been considered useful for lead extraction, serious complications can occur. We presented a case of atrial septal perforation associated with the Needle's Eye Snare. Our case highlights the importance of not persisting with the Needle's Eye Snare to prevent atrial damage.

Theleadless pacemaker (LLPM) therapy has been developed in recent years to overcome the transvenous lead and device pocket-related complications. The LLPMs now available are self-contained right ventricular pacemakers and are limited to single-chamber ventricular pacing modality. This literature review deals with the current status of LLPM technology and current areas of clinical applicability. The safety and efficacy outcomes published from randomized clinical trials and real world registries are analyzed and compared with historical conventional transvenous pacemaker data. Furthermore, new pacing modalities and future perspectives to broaden the clinical use and cover most of pacing indications are discussed. Due to the overall safe and effective profile in the short term and intermediate term, also in fragile patients, the LLPM use is constantly growing in daily clinical practice. Actually, it can be considered a landmark innovation, through which a new era of cardiac pacing has begun.

A leadless intracardiac transcatheter pacing system has been designed to overcome the need for a pacemaker pocket and transvenous lead. Currently, the leadless pacemaker only offers VVI/R pacing and cannot provide atrial pacing. Additional clinical data are required to enable comparison with transvenous devices. In order to prepare a patient for the procedure, nurses need to understand the rationale and treatment options, including risk factors to ensure that patient safety remains central to all care. This article reviews leadless pacemakers as a treatment option, explores the key aspects of nursing care and analyses the complications of these pacemakers.

Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures.The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures.All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined.Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates.Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates.

Tricuspid regurgitation (TR) is a well-known complication after permanent pacemaker implantation. The aim of this study was to compare the degree of TR and the relationship of lead position across the tricuspid valve (TV) between patients with right ventricular apical (RVA) and non-RVA pacing determined by three-dimensional echocardiography.Conventional and three-dimensional echocardiography was performed in 284 patients to determine the change in TR severity following permanent pacemaker implantation. Transvenous lead locations were based on fluoroscopic images. This was a retrospective study, and the selected pacing mode was not randomized.RVA pacing had more frequent severe TR (37.9% vs 25.7%, P = .03) compared with non-RVA pacing. Severe TR occurred in 9.7%, 12.6%, and 58.8% of patients when the lead passed through the middle, between the commissures, and impinging the TV leaflets, respectively. Non-RVA leads were more likely to be positioned in the middle of the TV (30.3% vs 12.1%, P .01) and had the lowest chance of leaflet impingement (33.6% vs 51.5%, P .01) compared with RVA leads. RVA pacing was associated with worsening of grade ≥2 TR severity compared with non-RVA pacing (42.4% vs 27.6%, P .01). A TV lead passage angle of -15° to 15° minimized TR.Pacing-induced TR is more prevalent with RVA than non-RVA pacing. Preferential lead impingement on the TV leaflet, as determined by TV lead passage angle, can explain the development and progression of pacing-induced TR.

Graphical abstract, Highlights • Vacuum-assisted aspiration of large CIED lead vegetations is a promising technology. • TEE guidance is critical for the safe and complete aspiration of vegetations. • Real-time TEE identifies important residual findings following lead extraction.

Six months after subcutaneous implantable cardioverter defibrillator (S-ICD) implantation a 26-year-old Brugada patient presented because of a beeping tone emitted by his device. Chest X-ray displayed two functionless transvenous shock leads and the S-ICD system with a lead fracture. During lead revision procedure, extensive preparation of the lead from unexpectedly firm surrounding fibrous tissue encapsulating the lead was necessary before it could be removed, and a new shock lead could be implanted. This is the first report of an S-ICD lead exchange due to very early lead fracture and unexpectedly severe fibrous tissue hampering surgical lead extraction.

BACKGROUND The constant interaction between intracardiac leads and the heart and veins results in excessive accumulation of fibrous connective tissue around the leads. The extent of this pathological phenomenon, which is visible on transesophageal echocardiography (TEE), and predisposing factors are not well defined. METHODS We examined 936 transesophageal echocardiograms prior to transvenous lead extraction (TLE) performed at a high-volume centre between 2015 and 2019. RESULTS The most important echocardiographic findings were fibrous binding sites between leads and cardiovascular structures, lead-to-lead adhesions, excessive lead loops, lead-dependent tricuspid dysfunction (LDTD), asymptomatic masses on endocardial leads (AMEL) and vegetations. Fibrotic reaction within the walls of the heart and veins correlated with the presence of lead loops (OR = 1.771; p

Purpose During transvenous lead extraction (TLE), the femoral snare has mainly been used as a bail-out procedure. The purpose of the present study is to evaluate the efficacy and safety of a TLE approach with a low threshold to use a combined superior and femoral approach. Methods This is a single-center observational study including all TLE procedures between 2012 till 2019. Results A total of 264 procedures (median age 63 (51–71) years, 67.0% male) were performed in the study period. The main indications for TLE were lead malfunction (67.0%), isolated pocket infection (17.0%) and systemic infection (11.7%). The median dwelling time of the oldest targeted lead was 6.8 (4.0–9.7) years. The techniques used to perform the procedure were the use of a femoral snare only (30%), combined rotational powered sheath and femoral snare (25%), manual traction only (20%), rotational powered sheath only (17%) and locking stylet only (8%). The complete and clinical procedural success rate was 90.2% and 97.7%, respectively, and complete lead removal rate was 94.1% of all targeted leads. The major and minor procedure-related complication rates were 1.1% and 10.2%, respectively. There was one case (0.4%) of emergent sternotomy for management of cardiac avulsion. Furthermore, there were 5 in-hospital non-procedure-related deaths (1.9%), of whom 4 were related to septic shock due to a Staphylococcus aureus endocarditis after an uncomplicated TLE with complete removal of all leads. Conclusion An effective and safe TLE procedure can be achieved by using the synergy between a superior and femoral approach.

Background: Transvenous lead extraction of cardiovascular implantable electronic device (CIED) has been proven safe in the general patient population with the advances in extraction techniques. Octogenarians present a unique challenge given their comorbidities and the perceived increase in morbidity and mortality. Objective: To assess the safety and outcomes of CIED extraction in octogenarians to younger patients. Methods: We performed an extensive literature search and systematic review of studies that compared CIED extraction in octogenarians versus non-octogenarians. We separately assessed the rate of complete procedure success, clinical success, procedural mortality, major and minor complications. Risk ratio (RR) 95% confidence intervals were measured using the Mantel-Haenszel method. The random effects model was used due to heterogeneity across study cohorts. Results: Seven studies with a total of 4,182 patients were included. There was no difference between octogenarians and non-octogenarians in complete procedure success (RR 1.01, 95% CI 1.00 – 1.02, p = 0.19) and clinical success (RR 1.01, 95% CI 1.00 – 1.01, p = 0.13). There was also no difference in procedural mortality (RR 1.43, 95% CI 0.46 – 4.39, p = 0.54), major complication (RR 1.40, 95% CI 0.68 – 2.88, p = 0.36), and minor complication (RR 1.43, 95% CI 0.90 – 2.29, p = 0.13). Conclusion: In this study, there was no evidence to suggest a difference in procedural success and complication rates between octogenarians and younger patients. Transvenous lead extraction can be performed safely and effectively in the elderly population.

Background Transvenous lead extractions (TLEs) have increased in number due to an increased prevalence of cardiac implantable devices. Bleeding complications associated with TLEs can be catastrophic, and many institutions order blood components to be available in the procedure room. There are few studies supporting or refuting this practice. We evaluated transfusion rates for TLEs at a single, high-volume center to assess the need for having blood in the procedure room. Study design and methods Patients undergoing TLEs from April 2010 to February 2019 were identified from our institutional database. The percentage of patients transfused intraoperatively, the number of units transfused, and the reasons for transfusion were determined from the database and by manual chart review. Results A total of 473 patients underwent a TLE during this time frame. Of these, only 17 patients (3.6%) received a red blood cell (RBC) transfusion. Ten of the 17 patients received RBCs secondary to preoperative anemia. Of the remaining seven patients, only four patients received more than 2 RBC units, and only one received more than 10 RBC units. No patient received more than 2 RBC units or any plasma or platelets in the past 4 years. Conclusion Due to improvements in procedural techniques, advent of accessible remote blood allocation systems, and changes in transfusion practice (e.g., electronic crossmatch), routinely having blood components in the procedure room for every TLE may be an outdated practice for high-volume centers.

Small vegetations (2.0 cm) associated with infected cardiac device leads can be managed percutaneously, whereas larger vegetations typically are removed via open heart surgery. Unfortunately, many patients with intracardiac vegetations are not candidates for open removal.The purpose of this study was to report our experience in the outcomes associated with the percutaneous management of large vegetations.Prospective data from January 2010 to August 2018 identified 826 patients with infections undergoing lead extraction. One hundred nineteen cases had vegetations measured in 2 dimensions (length and width) by transesophageal echocardiogram. Thirty-two patients had 3 characteristics: (1) at least 1 vegetation dimension ≥2.0 cm; (2) not a surgical candidate; and (3) had undergone transvenous lead extraction. The cohort was classified into 2 groups according to shape: (1) globular if the difference between dimensions was30% between dimensions; and (2) nonglobular if the difference was30%. The Fisher exact test and Pearson t test were used for analysis. P.05 was considered significant.Retrospective analysis of a single tertiary cardiac surgery center registry showed a significantly lower chance of being alive at discharge in patients with globular vegetations compared to patients with nonglobular vegetations (P = .002).Vegetation size is an important determinant of outcomes in patients who are not surgical candidates undergoing transvenous lead extraction. However, vegetation shape is also a relevant factor, as globular vegetations may predict a worse result compared to nonglobular vegetations.

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

Aim The aim of this study is to assess the safety and efficacy of the new bidirectional rotational mechanical sheath TightRail™ (Spectranetics) for lead extraction. Methods and results This is a bicentric prospective study that included patients who underwent a transvenous lead extraction (TLE) in two Italian centers (San Raffaele Hospital and Humanitas Gavazzeni Hospital). From November 2016 to December 2018, 26 patients underwent a TLE procedure in which the TightRail™ was used. The new TightRail Sub‐C was used in 20 (76%) patients to overcome the fibrosis between the vessel and the first rib. Median age was 69 (IQR 60.7‐79.5) years. The indication for TLE were infection (57.7%) or lead dysfunction (42.3%). A total of 57 leads (range 1‐4), 40 of which using the TightRail (range 1‐4), were extracted. Overall mean implant duration was 98.2.0 ± 66.5 months. Mean age of the lead extracted with the TightRail sheath was 99.1 ± 70.2 months and was higher compared to that of the leads extracted manually (84.4 ± 60.3 months, P = .001). The overall clinical success was 100% and complete procedural success without the use of a snare was achieved in 98.3%. There were no cases of death or major complications and only two minor complications occurred. All patients were event‐free at 6‐month follow‐up. Conclusion This initial experience using the TightRail™ suggests a high safety and efficacy profile for extractions in a wide range of lead age., The bidirectional rotational mechanical sheath TightRail™ (Spectranetics) is a novel tool for transvenous lead extraction (TLE). This is the first multicentric study evaluating the safety and efficacy of this new extraction system. This is the first experience with the new TightRail Sub‐C sheath to overcome the fibrous between the vessel and the first rib.

Background: While major complications associated with CIED lead extractions are uncommon, they carry a significant risk of morbidity and mortality in the absence of surgical intervention. However, there is limited data on the differences in outcomes of these procedures between centers with and without on-site CS support. The present study examined outcomes of transvenous cardiac implantable electronic device (CIED) lead extractions according to admitting hospitals’ cardiac surgery (CS) facilities.\ud \ud Methods: We analyzed the National Inpatient Sample for CIED lead extraction procedures, stratified by hospitals’ CS facilities into two groups; on-site and off-site CS. Logistic regression analyses were performed to estimate the adjusted odds (aOR) of procedure-related complications in off-site CS centers. \ud \ud Results: In 221,606 procedures over an 11-year-period, CIED lead extractions were increasingly undertaken in on-site as opposed to off-site CS centers (Onsite CS 2004 vs. 2014: 78.2% vs. 90.4%, p

ObjectivesTransvenous lead extraction (TLE) poses a significant economic and resource burden on healthcare systems; however, limited data exist on its true cost. We therefore estimate real-world healthcare reimbursement costs of TLE to the UK healthcare system at a single extraction centre.MethodsConsecutive admissions entailing TLE at a high-volume UK centre between April 2013 and March 2018 were prospectively recorded in a computer registry. In the hospital’s National Health Service (NHS) clinical coding/reimbursement database, 447 cases were identified. Mean reimbursement cost (n=445) and length of stay (n=447) were calculated. Ordinary least squares regressions estimated the relationship between cost (bed days) and clinical factors.ResultsMean reimbursement cost per admission was £17 399.09±£13 966.49. Total reimbursement for all TLE admissions was £7 777 393.51. Mean length of stay was 16.3±15.16 days with a total of 7199 bed days. Implantable cardioverter-defibrillator and cardiac resynchronisation therapy defibrillator devices incurred higher reimbursement costs (70.5% and 68.7% higher, respectively, both pConclusionsFinancial costs to the NHS from TLE are substantial. Consideration should therefore be given to cost/resource-sparing potential of leadless/extravascular cardiac devices that negate the need for TLE particularly in patients with prior valve surgery and/or heart failure. Additionally, use of antibiotic envelopes and other interventions that reduce infection risk in patients receiving transvenous leads should be considered.

In the era of coronavirus disease 2019 (COVID-19), the management of cardiac implantable electronic devices infections with concomitant viral infection has not been completely defined yet. In this explorable context, we report the first experience of a Cardiac resynchronization therapy with defibrillator (CRT-D) implantation after transvenous lead extraction for endocarditis in a COVID-19 patient. We describe both the measures and procedures implemented to reduce the cross-infection in the operating room and our clinical practice to improving procedure effectiveness on patient care. This article is protected by copyright. All rights reserved.