Mechanical Lead Extraction Research Articles

Effective and safe mechanical transvenous lead extraction in a low-volume center

Effective and safe mechanical transvenous lead extraction in a low-volume center

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

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. 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). 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.

317 IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR IN ARRHYTMIC MITRAL VALVE PROLAPSE: YOU'LL BE CONSIDER IT FOR PRIMARY PREVENTION OF SUDDEN CARDIAC DEATH?

Abstract A 50-year-old female with a history of bileaflet mitral valve prolapse (MVP) was admitted to our Department for persistent palpitation. Physical examination revealed a mid-systolic click, followed by a mid-to-late apical systolic murmur. The electrocardiogram showed sinus rhythm with negative T-waves in inferior leads and repetitive polymorphic premature ventricular contractions (PVCs) with a right bundle branch block pattern and superior axis morphology suggestive of a possible origin from the posterior papillary muscle. The echocardiography confirmed normal ventricular ejection fraction, bileaflet MVP with moderate regurgitation, systolic curling and mitral annulus disjunction. Exercise stress testing demonstrated an increase of polymorphic PVCs during maximum effort. The cardiac magnetic resonance showed an underlying late gadolinium enhancement at the level of the papillary muscles and in the inferobasal region. After a multidisciplinary evaluation, a transvenous implatable cardioverter defibrillator (ICD) was implanted for primary prevention without clear indications deriving from current guidelines. After eleven years, the patients experienced two appropriate shocks due to polymorfic ventricular tachycardia while she was sleeping. Furthermore, the patient underwent successful mechanical transvenous lead extraction and ICD re-implantation for lead failure. During this hospitalization a subsequent echocardiography detected severe ventricular dilatation with moderate systolic disfunction. Conclusion Our report demonstrated that MVP represents potentially cause of life-threatening ventricular arrhythmias and tachycardia induced cardiomyopathy. Beta-blockers are often inadequate in order to reduce PVCs burden. We need more arrhytmic predictors to assestment of sudden cardiac death risk and evaluate ICD for primary prevention. Obtain left ventricular function recovery is difficult and it requires a multidisciplinary approach. It will be important in the future to better define the role will play cathether ablation and mitral valve repair or replacement to prevent malignant arrhytmias.

Patient related outcomes of mechanical lead extraction techniques (PROMET) study: A comparison of two professions.

With an increasing number of cardiac implantable electronic devices (CIEDs), there has been a paralleled increase in demand for transvenous lead extraction (TLE). Cardiac surgeons (CS) and cardiologists perform TLE; however, data comparing the two groups of operators is scarce. We compared the outcomes of TLE performed by cardiologists and CS from six European lead extraction units. Data was collected retrospectively of 2205 patients who had 3849 leads extracted (PROMET) between 2005 and 2018. Patient demographics and procedural outcomes were compared between the CS and cardiologist groups, using propensity score matching. A multivariate regression analysis was also performed for variables associated with 30-day mortality. CS performed the majority of extractions (59.8%), of leads with longer dwell times (90 [57-129 interquartile range (IQR)] vs. 62 [31-102 IQR] months, CS vs. cardiologists, p<.001) and with pre-dominantly non-infectious indications (57.4%vs. 50.2%, CS vs. cardiologists, p<.001). CS achieved a higher complete success per lead than the cardiologists (98.1%vs. 95.7%, respectively, p<.01), with a higher number of minor complications (5.51%vs. 2.1%, p<.01) and similar number of major complications (0.47%vs. 1.3%, p=.12). Thirty-day mortality was similarly low in the CS and cardiologist groups (1.76%vs. 0.94%, p=.21). Unmatched data multivariate analysis revealed infection indication (OR 6.12 [1.9-20.3], p<.01), procedure duration (OR 1.01 [1.01-1.02], p<.01) and CS operator (OR 2.67, [1.12-6.37], p=.027) were associated with 30-day mortality. TLE by CS was performed with similar safety and higher efficacy compared to cardiologists in high and medium-volume lead extraction centers.

The valuable interaction among cardiac surgeon and electrophysiologist for transvenous rotational mechanical lead extraction.

Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical, USA) is an effective and safe technique for transvenousleadextraction (TLE). We reported our experience with the bidirectional rotational mechanical toolsusing a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. The study population comprised 84 patients (77% male; mean age 65 ± 18 years) undergoing TLE. After a multidisciplinary evaluation, a combined procedure was considered. The main indication for TLE was infection in 54 cases (64%). Overall, 152 leads were extracted with a mean implant duration of 94 ± 63 months (range 12-421). Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6% (77/84), 97.6% (82/84), and 98.6% (150/152), respectively. Eighteen combined procedures were performed in 12 patients (14%), such as "hybrid approach" (n=2) or TLE concomitant to: 1) transcatheter aspiration procedure for large vegetation (n=8); 2) left ventricular assistance device implantation as bridge to cardiac transplantation (n=1); 3) permanent pacing with epicardial leads (n=6); 4) tricuspid valve replacement (n=1). One major complication (1.2%) and 11 (13%) minor complications were encountered. No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21 ± 18 months, 17 patients (20%) died. They were more often diabetics (p=.02), and they underwent TLE more often for infection (p=.004). Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the Evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators.

655 The valuable interaction among cardiac surgeon and electrophysiologist for transvenous rotational mechanical lead extraction

Abstract Aims Recent studies have shown that evolution RL bidirectional rotational mechanical sheath (Cook Medical, USA) is an effective and safe technique for transvenous lead extraction (TLE). We reported our experience with the bidirectional rotational mechanical tools using a multidisciplinary approach highlighting the value of a joint cardiac surgeon and electrophysiologist collaboration. Methods and results The study population comprised 84 patients (77% male; mean age 65 ± 18 years) undergoing TLE. After multidisciplinary evaluation, a combined procedure was considered. The main indication for TLE was infection in 54 cases (64%).Overall, 152 leads were extracted with a mean implant duration of 94 ± 63 months (range: 6–421). Complete procedural success rate, clinical success rate, and lead removal with clinical success rate were 91.6% (77/84), 97.6% (82/84), and 98.6% (150/152), respectively. Eighteen combined procedures were performed in 12 patients (14%), such as ‘hybrid approach’ (n = 2) or TLE concomitant to: (i) transcatheter aspiration procedure for large vegetation (n = 8); (ii) left ventricular assistance device implantation as bridge to cardiac transplantation (n = 1); (iii) permanent pacing with epicardial leads (n = 6); and (iv) tricuspid valve replacement (n = 1).One major complication (1.2%) and 11 (13%) minor complications were encountered. No injury to the superior vena cava occurred and no procedure-related deaths were reported. During a mean time follow-up of 21 ± 18 months, 17 patients (20%) died. They were more often diabetics (P = 0.02), and they underwent TLE more often for infection (P = 0.004). Conclusions Our results support the finding that excellent outcomes can be achieved in performing TLE of chronically implanted leads by using the evolution RL bidirectional rotational mechanical sheath and a multidisciplinary team approach involving both electrophysiologist and cardiac surgeon as first line operators.

Success and complication rate of Tightrail mechanical percutaneous lead extraction: A multicentre French study

Our objective was to assess Philips TightRail rotating dilator sheath efficacy and safety for extraction of endocardial leads. No large-scale multicenter data is available on this mechanical lead extraction device, now commonly used in France. We conducted a retrospective, multicentre (from 4 French university hospitals) study. These centres that only perform mechanical lead extraction using this device were selected on the basis of the annual volume of procedures (> 10 leads/year). All patients from January 2015 to January 2020 who underwent at least one extraction of an endocardial lead with using TightRail were included. All of the extracted leads were > 12 months old and indications for extraction were based on ESC guidelines. Overall, 395 leads were extracted using TightRail in 203 patients (mean age 70 years, 75% male sex). Indications for lead removal included cardiac device infection in 172 (85%) cases, lead malfunction in the 25 (12%) cases, vein thrombosis in 3 (1.5%) cases and 3 for other indications (1.5%). The extracted devices were pacemaker in 134 (66%) cases, implantable cardioverter-defibrillator (ICD) in 69 (44%) cases. The mean time from implantation was 124 months. Complete procedural success with TightRail system alone was achieved in 180 (89.1%) patients (352 leads) and overall clinical success was 93% (367 leads). Fifteen right-sided leads were completely removed with the help of femoral snare. Ten (5%) patients had at least one major perioperative complication: 3 cardiac tamponades, 1 haemothorax, 1 stroke, 5 vascular breaches requiring surgical intervention. No in-hospital death was observed. Our large scale retrospective study in 4 high-volume mechanical lead extraction centres shows that TightRail is highly effective for chronically implanted lead extraction. The safety profile appears similar to the rate recently described with power sheaths.

Mechanical extraction of cardiac implantable electronic devices leads with long dwell time: Efficacy and safety of the step up approach.

The aim of this study was to evaluate the efficacy and safety of the stepwise mechanical transvenous lead extraction approach in a patient population with chronically implanted transvenous leads with a long dwell time. From January 2014 till December 2018, all lead extractions with lead dwell time ≥5 years performed at our tertiary centre were retrospectively analysed. A total of 173 leads, from 78 patients (median age 68 years; 81% male) with a median dwell time of 9 years (interquartile range [IQR] 5) were extracted, with three or more leads in 42% of the patients. Right atrial leads: 41%; right ventricular pacing leads: 16%; implantable cardioverter-defibrillator (ICD) leads: 31% (72% dual coil); coronary sinus leads: 12%. The majority (75%) of the leads had an active fixation. Most frequent indication for extraction was pocket infection/erosion (76%). Overall clinical success was 97%, and complete procedural success was 93%. Venous patency, assessed with venous angiography, was well preserved in 93% of the cases. The overall procedural complication rate was 3.8% (2.6% major and 1.3% minor). Despite the complexity of the population and a very long dwell time (median 9 years), a clinical success rate of 97% was achieved with the stepwise mechanical approach. Analysis of impeding progression of pectoral extraction suggests that dense fibrosis and sharp lead curvature in the transvenous trajectory pose a challenge. Complication rate was low, and acute venous patency was generally well preserved.

Success and complication rate of Tightrail mechanical percutaneous lead extraction: a multicenter French study

Abstract Background Our objective was to assess Philips TightRail™ rotating dilator sheath efficacy and safety for extraction of endocardial leads. No large scale multicenter data is available on this mechanical lead extraction device, now commonly used in France. Methods and results We conducted a retrospective, multicenter (from 4 French university hospitals) study. These centers that only perform mechanical lead extraction using this device were selected on the basis of the annual volume of procedures (&amp;gt;10 leads/year). All patients from January 2015 to January 2020 who underwent at least one extraction of an endocardial lead with using TightRail™ were included. All of the extracted leads were &amp;gt;12 months old and indications for extraction were based on ESC guidelines. Overall, 395 leads were extracted using TightRail™ in 203 patients (mean age 70 years, 75% male sex). Indications for lead removal included cardiac device infection in 172 (85%) cases, lead malfunction in the 25 (12%) cases, vein thrombosis in 3 (1.5%) cases and 3 for other indications (1,5%). The extracted devices were pacemaker in 134 (66%) cases, implantable cardioverter-defibrillator (ICD) in 69 (44%) cases. The mean time from implantation was 124 months. Complete procedural success with TightRail™ system alone was achieved in 180 (89.1%) patients (352 leads) and overall clinical success was 93% (367 leads). Fifteen right sided leads were completely removed with the help of femoral snare. Ten (5%) patients had at least one major perioperative complication: 3 cardiac tamponades, 1 haemothorax, 1 stroke, 5 vascular breaches requiring surgical intervention. No in-hospital death was observed. Conclusion Our large scale retrospective study in 4 high-volume mechanical lead extraction centers shows that TightRail™ is highly effective for chronically implanted lead extraction. The safety profile appears similar to the rate recently described with power sheaths. Funding Acknowledgement Type of funding source: None

Transvenous lead extraction: procedural outcomes and in-hospital mortality in octogenarian patients

Abstract 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:&amp;lt;80 years) and their acute and chronic outcomes were compared. All patients were treated with manual traction or mechanical dilatation. Results Our analysis included 1316 patients (group 1: 202, group 2: 1114 patients), with a total of 2513 leads extracted. Group 1 presented more comorbidities and more pacemakers, whereas the dwelling time of the oldest lead was similar, irrespectively of patient's age. In group 1 the radiological success rate for lead was higher (99.0% vs 95.9%; P&amp;lt;0.001) and the fluoroscopy time lower (13.0 vs 15.0 minutes; P=0.04) than in group 2. Clinical success was reached in 1273 patients (96.7%), without significant differences between groups (group 1: 98.0% vs group 2: 96.4%; P=0.36). Major complications occurred in 10 patients (0.7%) without significative differences between patients with more or less than 80 years (group 1: 1.5% vs group 2: 0.6%; P=0.24). In the elderly group no in-hospital mortality occurred (0.0% vs 0.5%; P=0.42). Conclusions Mechanical TLE in elderly patients is a safe and effective procedure. In the over-80s, a comparable incidence of major complications with younger patients was observed, with at least a similar efficacy of the procedure and no procedural-related deaths. Funding Acknowledgement Type of funding source: None

Corrigendumto: Results of the Patient Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicenter retrospective study on advanced mechanical lead extraction techniques.

Corrigendumto: Results of the Patient Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicenter retrospective study on advanced mechanical lead extraction techniques.

Safety and efficacy of transvenous mechanical lead extraction in patients with abandoned leads

Optimal management of redundant or malfunctioning leads is controversial. We aimed to assess safety and efficacy of mechanical transvenous lead extraction (TLE) in patients with abandoned leads. Consecutive TLE procedures performed in our centre from January 2009 to December 2017 were considered. We evaluated the safety and efficacy of mechanical TLE in patients with abandoned (Group 1) compared to non-abandoned (Group 2) leads. We analysed 1210 consecutive patients that required transvenous removal of 2343 leads. Group 1 accounted for 250 patients (21%) with a total of 617 abandoned leads (26%). Group 2 comprised 960 patients (79%) with 1726 leads (74%). The total number of leads (3.0 vs. 2.0), dwelling time of the oldest lead (108.00 months vs. 60.00 months) and infectious indications for TLE were higher in Group 1. Clinical success was achieved in 1168 patients (96.5%) with a lower rate in Group 1 (90.4% vs. 98.1%; P < 0.001). Major complications occurred in only 9 patients (0.7%), without significant differences among the two groups. The presence of one or more abandoned leads [odds ratio (OR) 3.47; 95% confidence interval (CI) 1.07-11.19; P = 0.037] and dwelling time of the oldest lead (OR 1.01 for a month; 95% CI 1.01-1.02; P < 0.001) were associated with a higher risk of clinical failure. Transvenous mechanical lead extraction is a safe procedure also in high-risk settings, as patients with abandoned leads. Success rate resulted a bit lower, especially in the presence of abandoned leads with long implantation time.

Results of the Patient-Related Outcomes of Mechanical lead Extraction Techniques (PROMET) study: a multicentre retrospective study on advanced mechanical lead extraction techniques.

AimsSeveral large studies have documented the outcome of transvenous lead extraction (TLE), focusing on laser and mechanical methods. To date there has been no large series addressing the results obtained with rotational lead extraction tools. This retrospective multicentre study was designed to investigate the outcomes of mechanical and rotational techniques.Methods and resultsData were collected on a total of 2205 patients (age 66.0 ± 15.7 years) with 3849 leads targeted for extraction in six European lead extraction centres. The commonest indication was infection (46%). The targeted leads included 2879 pacemaker leads (74.8%), 949 implantable cardioverter-defibrillator leads (24.6%), and 21 leads for which details were unknown; 46.6% of leads were passive fixation leads. The median lead dwell time was 74 months [interquartile range (IQR) 41–112]. Clinical success was obtained in 97.0% of procedures, and complete extraction was achieved for 96.5% of leads. Major complications occurred in 22/2205 procedures (1%), with a peri-operative or procedure-related mortality rate of 4/2205 (0.18%). Minor complications occurred in 3.1% of procedures. A total of 1552 leads (in 992 patients) with a median dwell time of 106 months (IQR 66–145) were extracted using the Evolution rotational TLE tool. In this subgroup, complete success was obtained for 95.2% of leads with a procedural mortality rate of 0.4%.ConclusionPatient outcomes in the PROMET study compare favourably with other large TLE trials, underlining the capability of rotational TLE tools and techniques to match laser methods in efficacy and surpass them in safety.

Interdisciplinary stepwise approach for an effective and safe Mechanical Transvenous Lead Extraction

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

New onset of phrenic nerve palsy after laser-assisted transvenous lead extraction: a single-centre experience.

Phrenic nerve palsy (PNP) after mechanical transvenous lead extraction (TLE) was recently described for the first time. We aimed to analyse our TLE database for the presence of PNP. All consecutive patients referred to our institution were included in this study. Every available post-procedural chest X-ray was compared to the routinely performed pre-procedural radiographs. A newly elevated hemidiaphragm ipsilateral to TLE was considered indicative of PNP. Altogether 255 TLE procedures with extraction of 364 leads were performed. Most common TLE indication was lead malfunction (63%). Complete radiographic success rate was 97.3% with an in-hospital procedure-related major complication rate of 2.4%, including one intra-procedural death (0.4%). We identified five cases with PNP (2%), all occurring after laser-assisted TLE. Clinical presentation varied from subtle and aspecific chest pain/discomfort to severe and acute dyspnoea, with time to diagnosis varying from immediate to several weeks after the procedure. In 80% of cases, the explanted lead was a defibrillator electrode and the median lead dwelling time was 70.2 months (29.3; 1084.9). In four cases, the extraction was performed using high-energy laser (pulse repetition rate 80 Hz). The present study reports the incidence of PNP after laser-assisted TLE. We postulate that the thermal energy generated by laser is not dissipated quickly enough in occluded or heavily calcified lesions, injuring the ipsilateral phrenic nerve. Our findings advise to carefully consider to increase pulse repetition rate at the subclavian level. Larger, possibly prospective studies are needed to evaluate the real incidence through systematic radiological assessment after TLE.

Safety and Efficacy of Transvenous LeadExtraction Utilizing the Evolution Mechanical Lead Extraction System: A Single-Center Experience.

The goal of this study is to assess the safety and efficacy of mechanical lead extraction utilizing the Evolution system. Compared with other techniques commonly used for lead extraction, data regarding the safety and efficacy of mechanical lead extraction using the Evolution system is limited and needs further evaluation. Between June 1, 2009 and September 30, 2016, we retrospectively analyzed 400 consecutive patients who exclusively underwent mechanical lead extraction utilizing the Evolution system. A total of 400 patients underwent mechanical lead extraction of 683 leads. Mean age of extracted leads was 6.77 ± 4.42 years (range 1 to 31 years). The extracted device system was an implantable cardioverter-defibrillator in 274 patients (68.5%) and a pacemaker system in 126 patients (31.5%). Complete lead removal rate was 97% with a clinical success rate of 99.75%. Incomplete lead removal with<4-cm remnant was associated with older leads (lead age >8years). Failure to achieve clinical success was noted in 1 patient (0.25%). Cardiac papillary avulsion, system-related infection, and cardiac tamponade were the major complications noted in 6 patients (1.5%). Minor complications were encountered in 24 patients (6%), of which hematoma requiring evacuation was the most common minor complication. There were no patient deaths. In our single-center study, lead extractions utilizing the Evolution mechanical lead extraction systemwere safe and effective and resulted in high clinical and procedural success, with low complication rates andnofatalities.

Safety and efficacy of the new bidirectional rotational Evolution® mechanical lead extraction sheath: results from a multicentre Italian registry

The aim of this prospective multicentre study is to evaluate safety and efficacy of the new bidirectional rotational mechanical lead extraction (LE) sheath (Evolution RL, Cook Medical, USA) in chronically implanted leads (>1-year-old leads). Between September 2013 and June 2016, a total of 238 leads in 124 consecutive patients were removed by using the new Evolution RL rotational mechanical sheath. Indications for LE were cardiac device infection in 63 (50.8%) cases, lead malfunction in 41 (33.1%), upgrade in 1 (0.8%) case and for other reasons in the remaining 19 cases (15.3%). Ninety-one leads (38.2%) were implantable cardioverter defibrillator leads (81 dual coil vs. 10 single coil), 38 (16%) right ventricular leads, 86 (36.1%) right atrial leads, and 23 (9.7%) coronary sinus leads. The mean implant duration was 92.2 ± 52.9 months (range 12-336). 91.6% of the leads (218/238) were extracted completely with the Evolution RL alone, with the complete success rate rising to 98.7% (235/238 leads) with combined use of a snare. Overall clinical success rate was 100%. No Evolution sheath-related complications were noted. There were no deaths or major complications. Five minor complications (4%) were encountered. In cases of companion leads no wrapping or lead damage were observed. On the basis of our prospective multicentre study, the new hand-powered bidirectional rotational mechanical LE sheath is an effective and safe tool for the extraction of chronically implanted leads without major complications and lead wrapping or lead damage.

Subcutaneous Implantable Cardioverter-Defibrillator and LeftVentricular Assist Device: A Safe and Effective Approach for Refractory Heart Failure.

A 57-year-old man with dilated cardiomyopathy underwent single-chamber implantable cardioverter-defibrillator (ICD) implantation for primary prevention in March 2008. Because of device infection, mechanical lead extraction was performed without complications in April 2011. Subsequently, we decided

Transvenous extraction of pacemaker and implantable cardioverter defibrillator leads using Evolution® mechanical dilator sheath: a single center confirmatory experience.

ObjectiveIn recent years there has been an increase in clinical situations requiring lead extraction procedures of implanted cardiac devices. In our clinic, extraction procedures are performed with Evolution® mechanical lead extraction system. In this manuscript we aimed to evaluate our lead extraction procedures.MethodsWe retrospectively evaluated lead extraction procedures carried out on 41 patients [30 male, 11 female patient; mean age 61.5 ± 18.5 median 67 (23–85)] between 2008 and 2015 using Evolution® system. Procedural success, major and minor complications are determined according to previously published guidelines.ResultsMean duration of the lead implantation was 88.4 ± 62.5 months (6–240). Implanted device was a pacemaker in 27 (65.8 %) and ICD in 14 (34.2 %) of patients. Total 67 leads were extracted from the patients, 22 (32.8 %) were atrial, 30 (44.2 %) were ventricular, 14 (21.5 %) were dual coil defibrillator and 1 (1.5 %) was coronary sinus lead. Indications for lead removal were pacemaker decubitis and infection in 29 (70.8 %), lead dysfunction in 11 (26.8 %) and subclavian vein thrombosis in 1 (2.4 %) patient. Success rate with Evolution® system without using snare was 85.3 %. Clinical success rate was 97.5 % procedural success rate was 95.1 % and failure occured in one patient. Major complications occured in 2 (4.8 %) patients, 1 (2.4 %) was procedure related mortality. Minor complications were seen in 5 (12.2 %) of patients.ConclusionsIn our single center study it is shown that extraction of pacemaker and defibrillator leads of relatively long implantation duration and in an older age patient group may be successfully carried out using the Evolution® system. However due to potentially serious complications it is adviced to be done by experienced operators in centers with cardiovascular surgery backup.

Clinical performance of a new bidirectional rotational mechanical lead extraction sheath.

We investigated the safety and efficacy of a new bidirectional rotational mechanical extraction sheath (Evolution RL, Cook Medical, USA). From April 2013 until September 2014, we performed lead extraction procedures in 71 patients with 112 leads scheduled for extraction. During this time period, we used the new Evolution RL rotational sheath in 40 patients on 52 leads (24 pacemaker leads and 28 implantable cardioverter-defibrillator leads) scheduled for extraction. The mean lead implant duration in these patients was 100.2 (22-271) months. Forty leads were right ventricular leads, 10 right atrial leads, and 2 coronary sinus leads. Clinical success among the leads approached with the Evolution RL device was 98.1%. Operative mortality was zero. Major complications did not occur. Four minor complications were encountered (all pocket haematomas). No device-related complications were noted. In cases with multiple leads in situ, no wrapping of companion leads was seen. The average number of extraction tools used per lead was 2.4 (2-4) in the Evolution RL cohort. Based on the presented results of our initial experience with the new bidirectional rotational mechanical extraction device, its use is safe and efficient with high success rates in long implanted leads.