B-PO04-040 LEAD FIXATION MECHANISM AFFECTS TRANSVENOUS LEAD EXTRACTION DIFFICULTY BUT NOT CLINICAL SUCCESS: DATA FROM THE EUROPEAN LEAD EXTRACTION CONTROLLED REGISTRY (ELECTRA)

Abstract Background The guidelines suggest close co-operation between TLE operating team and cardiac surgery and its key role in the management of life-threatening complications remains unquestionable. But the role of cardiac surgeon seems to be much more extended. Purpose We have analysed the role of cardiac surgery in treatment of patients undergoing TLE procedures. Methods Using standard non-powered mechanical systems we have extracted ingrown PM/ICD leads from 3207 pts (38,7% female, average age 65,7-y) during the last 14 years. Non-infectious TLE indications were in 66,4% of patients. 46% had PM DDD system, 19% PM SSI, 22% ICD, 9% CRT, 4% other systems. In 12% of patients abandoned leads were found. 8% of patients had one lead, 54% - two, 15% - three and 4% - 4–6 leads in the heart. An average dwell time of all leads was 91,5 mth. The lead entry side was left in 96% of patients, right in 3% and both – 4%. Results Procedural success 96,1%, clinical success - 97,8%, procedure-related death 0,2%. Major complications appeared in 1,9% (cardiac tamponade 1,2%, haemothorax 0,2%, tricuspid valve damage 0,3%, stroke, pulmonary embolism <1%). Conclusions Rescue cardiac surgery (for severe haemorrhagic complications) is still the most frequent reason of surgical intervention (1,1%). The second area of co-operation includes supplementary cardiac surgery after (incomplete) TLE (0,8%). The third one is connected with reconstruction or replacement of tricuspid valve, which can be affected by ingrown lead or damaged during TLE procedure (0,5%). Implantation of the complete epicardial system during any surgical intervention (rescue or delayed) should be considered as a supplementation of the operation (0,65%). Some of patients after TLE need implantation of epicardial leads for permanent epicardial pacing (0,6%) and some only left ventricular lead to rebuild permanent cardiac resynchronisation (0,5%). The single experience of large TLE centre indicates the necessity of close co-operation with cardiac surgeon, whose role seems to be more comprehensive than a surgical stand-by itself. Table 1 Funding Acknowledgement Type of funding source: None

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

European Heart Journal ◽

10.1093/ehjci/ehaa946.0829 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

M Giannotti Santoro ◽

L Segreti ◽

G Zucchelli ◽

V Barletta ◽

A Di Cori ◽

...

Keyword(s):

Elderly Patients ◽

Hospital Mortality ◽

Electronic Device ◽

Clinical Success ◽

Similar Efficacy ◽

Lead Extraction ◽

Tertiary Referral Center ◽

Major Complications ◽

Group 2 ◽

Group 1

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:<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<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

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Abstract 11945: Indications and Outcomes Following Transvenous Extraction of ICD versus Pacemaker Leads

Circulation ◽

10.1161/circ.132.suppl_3.11945 ◽

2015 ◽

Vol 132 (suppl_3) ◽

Author(s):

Eric W Black-Maier ◽

Sean D Pokorney ◽

Robert K Lewis ◽

Alexander Christian ◽

Ruth A Greenfield ◽

...

Keyword(s):

Adverse Events ◽

Dwell Time ◽

Clinical Success ◽

Lead Extraction ◽

Index Hospitalization ◽

Lead Failure ◽

Icd Leads ◽

Pacemaker Leads ◽

Pacing Lead ◽

Major Adverse Events

Introduction: Percutaneous transvenous lead extraction of cardiovascular implantable electronic devices (CIEDs) is increasingly common. Although ICD leads are widely considered to be more difficult to extract than pacemaker leads, there are few direct comparisons. Methods/Results: Using a cohort of 368 consecutive patients undergoing lead extraction (dwell time >1 year) between 2005-2012, we compared baseline characteristics/outcomes in extractions involving pacing versus ICD leads. We defined major adverse events (MAE) as any events/complications that required procedural intervention, transfusion, or that resulted in death or serious harm during index hospitalization. Median age was 60.6 yrs and 29.6% were women. There were 136 (37%) pacing lead extractions and 232 (63%) ICD lead extractions. Pacing leads had a longer dwell time (6.14 yrs [IQR 1.2-10.9 ] versus 4.4 yrs [IQR 1.1-6.4], p<0.001) and higher median LVEF (55% [IQR 35-55] vs. 30% [IQR 20-40], p<0.001) compared with ICD lead patients. Indications for pacing and ICD lead extractions included sepsis/endocarditis (21.3% vs. 24.6%, p=0.48), pocket infection (40.4% vs. 34.9%, p=0.29), and lead failure (15.4% vs. 38.8%, p<0.001). There were no significant differences between pacing and ICD lead extractions in median fluoroscopy time (5.5 vs. 8.5 minutes, p=0.86) or femoral bailout rate (4.4% vs. 5.2%, p=0.73). There were similar rates of all-cause MAE during index hospitalization (5.1% vs. 5.6%), death (2.2% vs 3.2%) and clinical success (97.0% vs. 97.0%, p=0.55) in pacemaker and ICD extractions, respectively. Conclusions: ICD leads are more commonly extracted relative to pacemaker leads, and this difference is driven by larger numbers of lead failure within ICD leads. Despite much longer dwell times, major adverse events were similar in pacing lead cases compared with ICD extractions.

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Predictors of success and complications in laser lead extraction

EP Europace ◽

10.1093/europace/euab116.481 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

T Madej ◽

K Matschke ◽

M Knaut

Keyword(s):

Adverse Events ◽

Electronic Device ◽

Clinical Success ◽

Multivariable Analysis ◽

Lead Extraction ◽

Predictors Of Success ◽

Funding Sources ◽

Icd Leads ◽

Short Term Mortality ◽

Major Adverse Events

Abstract Funding Acknowledgements Type of funding sources: None. Background Extraction of cardiac implantable electronic device (CIED) leads using excimer laser is in use since > 20 years, but the predictors of success, all-cause complications and mortality are not yet sufficiently statistically evaluated. Method All consecutive laser extractions performed at our institution between September 2011 and March 2020 with lead age > 12 months were included and retrospectively analysed. Results 792 leads (mean age 75 months) were extracted during 335 procedures. The indication for extraction was pocket infection in 59%, CIED endocarditis in 25%, lead dysfunction or upgrade in 14% and others in 2%. 94.6% of leads were extracted complete, 4.2% partial (< 4 cm rest) and the extraction failed in 1.3% of the leads (retention of ≥ 4 cm rest). Multivariable analysis identified lead age > 7.5 years (odds ratio [OR] 6.5; p = 0.0281), broken leads (OR 28.0; p = 0.0009) and implantable cardioverter-defibrillator (ICD) leads (OR 6.5; p = 0.0010) as independent predictors of failed extraction. CIED-endocarditis was independently associated with complete extraction (OR 3.3; p = 0.0218). Complete procedural success or clinical success was achieved in 330 of 335 procedures (98.6%). The lead extraction failed in five cases (1.5%). Major procedure-associated adverse events (injuries of the great vessels or heart) occurred in four cases (1.2%). Two patients died perioperatively (0.6%). Minor complications occurred in 13 cases (3.9%). Major adverse events (MAE) causally not related to the procedure occurred in 18 (5.4%) of the patients. The most frequent MAE was postoperative aggravation of the sepsis (10 patients; 3.0%). Independent predictors of major adverse events were CIED-endocarditis (OR 6.0; p = 0.0175), preoperative C-reactive-protein (CRP) > 35 mg/l (OR 3.8; p = 0.0412) and body mass index (BMI) ≥ 25 kg/m2 (OR 5.0; p = 0.0489). Ten patients (3%) died during the hospital stay. CIED-endocarditis with preoperative CRP > 35 mg/l was independently associated with hospital mortality in multivariable analysis (OR 10.7; p = 0.0020). The Kaplan-Meyer analysis of 30-day mortality showed a significantly worse survival of patients with endocarditis (Log-Rank p = 0.0102). Conclusion Leads > 7.5 years, broken leads and ICD leads are independent predictors of failed extraction. CIED endocarditis, CRP > 35 and BMI ≥ 25 are associated with MAE. CIED endocarditis is related to higher short-term mortality despite successful lead extraction. Abstract Figure. Predictors of major adverse events

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1260Transvenous lead extraction: efficacy and safety of the procedure in octogenarian patients

EP Europace ◽

10.1093/europace/euaa162.015 ◽

2020 ◽

Vol 22 (Supplement_1) ◽

Author(s):

M Giannotti Santoro ◽

L Segreti ◽

G Zucchelli ◽

V Barletta ◽

F Fiorentini ◽

...

Keyword(s):

Elderly Patients ◽

Electronic Device ◽

Clinical Success ◽

Lead Extraction ◽

Efficacy And Safety ◽

Cardiac Implantable Electronic Device ◽

Major Complications ◽

Group 2 ◽

Manual Traction ◽

Group 1

Abstract Introduction the management of patients with infection or malfunction of a cardiac implantable electronic device (CIED) may be challenging. Purpose The aim of the study is to evaluate the safety and efficacy of transvenous lead extraction (TLE) in elderly patients. Methods a retrospective analysis of patients who underwent to TLE in our center was performed. Patients were divided in two groups: 1) patients 80 years of age or older, 2) patients younger than 80 years. All patients were treated with manual traction or mechanical dilatation. Results our analysis included 1316 patients, with a total of 2513 leads extracted. Group 1 (≥80 years) counted 202 patients and group 2 (<80 years) 1114 patients. The group of elderly patients presented more comorbidities, as hypertension, chronic kidney disease, atrial fibrillation and pulmonary disease. Patients 80 years of age or older had more pacemakers than ICDs, whereas the dwelling time of the oldest lead, the number of leads and the presence of abandoned leads was similar despite patients age. In group 1 the rate of radiological success for lead was higher than in group 2 (99.0% vs 95.9%; P < 0.001). The clinical success was obtained in 1273 patients (96.7%), without significative differences between groups (98.0% vs 96.4%; P = 0.36). Major complications occurred in 10 patients (0.7%), without significative differences (1.5% vs 0.6%; P = 0.24) (figure 1). Conclusion TLE in elderly patients is a safe and effective procedure. In patients older than 80 years there are not more major complications than in younger patients, and the efficacy of the procedure seems to be superior. Abstract Figure 1

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Long-term follow-up of abandoned transvenous defibrillator leads: a nationwide cohort study

EP Europace ◽

10.1093/europace/euaa086 ◽

2020 ◽

Vol 22 (7) ◽

pp. 1097-1102

Author(s):

Anders Fyhn Elgaard ◽

Jens Brock Johansen ◽

Jens Cosedis Nielsen ◽

Christian Gerdes ◽

Sam Riahi ◽

...

Keyword(s):

Clinical Success ◽

Extraction Procedure ◽

Clinical Success Rate ◽

High Volume ◽

Lead Extraction ◽

Related Data ◽

Major Complications ◽

Long Term Follow Up

Abstract Aims Commonly, a dysfunctional defibrillator lead is abandoned and a new lead is implanted. Long-term follow-up data on abandoned leads are sparse. We aimed to investigate the incidence and reasons for extraction of abandoned defibrillator leads in a nationwide cohort and to describe extraction procedure-related complications. Methods and results All abandoned transvenous defibrillator leads were identified in the Danish Pacemaker and ICD Register from 1991 to 2019. The event-free survival of abandoned defibrillator leads was studied, and medical records of patients with interventions on abandoned defibrillator leads were audited for procedure-related data. We identified 740 abandoned defibrillator leads. Meantime from implantation to abandonment was 7.2 ± 3.8 years with mean patient age at abandonment of 66.5 ± 13.7 years. During a mean follow-up after abandonment of 4.4 ± 3.1 years, 65 (8.8%) abandoned defibrillator leads were extracted. Most frequent reason for extraction was infection (pocket and systemic) in 41 (63%) patients. Procedural outcome after lead extraction was clinical success in 63 (97%) patients. Minor complications occurred in 3 (5%) patients, and major complications in 1 (2%) patient. No patient died from complication to the procedure during 30-day follow-up after extraction. Conclusion More than 90% of abandoned defibrillator leads do not need to be extracted during long-term follow-up. The most common indication for extraction is infection. Abandoned defibrillator leads can be extracted with high clinical success rate and low risk of major complications at high-volume centres.

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P3139Transvenous lead extraction: lead age threshold to predict the success of the procedure

European Heart Journal ◽

10.1093/eurheartj/ehz745.0214 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

M Giannotti Santoro ◽

L Segreti ◽

F Fiorentini ◽

G Bernini ◽

V Barletta ◽

...

Keyword(s):

Predictive Value ◽

Dwell Time ◽

Clinical Success ◽

Effective Procedure ◽

Lead Extraction ◽

Youden Index ◽

Operating Characteristics ◽

Roc Curve Analysis ◽

Dwelling Time ◽

Icd Leads

Abstract Introduction Transvenous lead extraction is a safe and effective procedure. The dwell time of the leads, with other factors, is associated with poor outcome of the procedure. However, a precise estimation of the success of the procedure is not available. Purpose The aim of this study is to identify a lead's age threshold able to predict the success of the transvenous lead extraction (TLE) procedure. Methods All patients who underwent TLE in our center from January 2009 to December 2017 were retrospectively analyzed. The primary endpoint was the clinical success of the procedure. The optimal cut-off threshold was determined by the analysis of Receiver-Operating Characteristics (ROC) curves, using the Youden index. Results We analyzed 1210 consecutive patients that required transvenous removal of 2343 leads (686 ICD leads, 1657 pacemaker leads, 322 coronary sinus leads). Clinical success was achieved in 1168 patients (96.5%). Dwelling time median of the oldest lead for a patient was 66 months (interquartile range 27.0–115.0). The oldest lead completely removed was 32 years old. ROC curve analysis showed a dwell time threshold of 107 months – 8,92 years - for clinical success (Positive Predictive Value: 99.5%; Negative Predictive Value: 7.8%) and the area under the curve (AUC) was 0.879. Comparison of ROC for dwelling time and the 0.5 curve was assessed as statistically significative (p<0.0001). Conclusions Transvenous lead extraction is an effective procedure. The best cut-off threshold to predict a very high clinical success is 107 months.

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Transvenous lead extraction procedures in women based on ESC-EHRA EORP European Lead Extraction ConTRolled ELECTRa registry: is female sex a predictor of complications?

EP Europace ◽

10.1093/europace/euz277 ◽

2019 ◽

Author(s):

Anna Polewczyk ◽

Christopher A Rinaldi ◽

Manav Sohal ◽

Pier-Giorgio Golzio ◽

Simon Claridge ◽

...

Keyword(s):

Risk Factors ◽

Clinical Success ◽

Signs And Symptoms ◽

Venous Occlusion ◽

Lead Extraction ◽

Blood Cell Count ◽

Female Sex ◽

Major Complications ◽

Lead Management ◽

Post Hoc

Abstract Aims Female sex is considered an independent risk factor of transvenous leads extraction (TLE) procedure. The aim of the study was to evaluate the effectiveness of TLE in women compared with men. Methods and results A post hoc analysis of risk factors and effectiveness of TLE in women and men included in the ESC-EHRA EORP ELECTRa registry was conducted. The rate of major complications was 1.96% in women vs. 0.71% in men; P = 0.0025. The number of leads was higher in men (mean 1.89 vs. 1.71; P < 0.0001) with higher number of abandoned leads in women (46.04% vs. 34.82%; P < 0.0001). Risk factors of TLE differed between the sexes, of which the major were: signs and symptoms of venous occlusion [odds ratio (OR) 3.730, confidence interval (CI) 1.401–9.934; P = 0.0084], cumulative leads dwell time (OR 1.044, CI 1.024–1.065; P < 0.001), number of generator replacements (OR 1.029, CI 1.005–1.054; P = 0.0184) in females and the number of leads (OR 6.053, CI 2.422–15.129; P = 0.0001), use of powered sheaths (OR 2.742, CI 1.404–5.355; P = 0.0031), and white blood cell count (OR 1.138, CI 1.069–1.212; P < 0.001) in males. Individual radiological and clinical success of TLE was 96.29% and 98.14% in women compared with 98.03% and 99.21% in men (P = 0.0046 and 0.0098). Conclusion The efficacy of TLE was lower in females than males, with a higher rate of periprocedural major complications. The reasons for this difference are probably related to disparities in risk factors in women, including more pronounced leads adherence to the walls of the veins and myocardium. Lead management may be key to the effectiveness of TLE in females.

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PROMET: The effect of operator profession on non-laser transvenous lead extraction

EP Europace ◽

10.1093/europace/euab116.493 ◽

2021 ◽

Vol 23 (Supplement_3) ◽

Author(s):

Z Akhtar ◽

MM Gallagher ◽

A Elbatran ◽

CT Starck ◽

L WM Leung ◽

...

Keyword(s):

Regression Analysis ◽

Multivariate Regression ◽

Dwell Time ◽

Clinical Success ◽

Systemic Infection ◽

High Volume ◽

Multivariate Regression Analysis ◽

High Rate ◽

Lead Extraction ◽

Cardiac Surgeons

Abstract Funding Acknowledgements Type of funding sources: None. OnBehalf PROMET group Background As implantation of cardiac implantable devices (CIED) rises globally, there is a paralleled need for extraction of these devices. Indications for transvenous lead extraction (TLE) is expanding, fuelling demand. This lifesaving procedure is performed by cardiologists and cardiac surgeons (CS). Cardiologists are familiar with transvenous methods whilst cardiac surgeons possess the skillset to address the significant complications associated with this procedure. We compared non-laser TLE outcomes performed by cardiologists and cardiac surgeons from six high-volume extraction centres across Europe. Methods Data was collected retrospectively from six major European TLE centres of 2205 patients and 3849 leads (PROMET). Propensity 1:1 score matching (PSM) was performed to account for confounding variables. PSM model with variables: lead dwell time, infection indication, biventricular system and defibrillator device, was best matched. This dataset was analysed to compare outcomes of TLE performed by the cardiologists and CS. Predictors of 30-day mortality and complications were identified using a multivariate regression analysis. Results Patients treated by CS and cardiologists were similar in age (64.7 vs 66.7 years, p = NS) and equally male (70.3% vs 72.3%, p = 0.39) with a parallel infectious indication (51.7% vs 47.6%, p = 0.1). Surgeons achieved a significantly higher proportion of clinical success than cardiologists (98.9% vs 96.4%, p = 0.001) and complete lead extraction (98% vs 95.9%, p < 0.01) with a higher rate of minor complications (4.1% vs 2.2%, p = 0.024); major complications were similar (0.9% vs 1.2%, respectively, p = 0.46) as was 30-day mortality (3.2% vs 2%, respectively, p = 0.28). Multivariate regression analysis revealed systemic infection (p < 0.001, OR 7.2 [CI 2.3-20.1]) and defibrillator system extraction (p = 0.025, OR 3.4 [CI 1.2-10.2]) increased the odds of 30-day mortality, whilst Evolution™ sheath use reduced the odds (p = 0.025, OR 0.34 [CI 0.13-0.88]); lead dwell time (p = 0.02, OR 1.005 [1-1.009] and Evolution™ sheath use (p = 0.023, OR 2.15[1.1-4.15]) increased the odds of complications. Conclusion Cardiac surgeons and cardiologists achieved a high rate of TLE procedural success and with a similar safety profile, replicating standards seen across Europe.

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P3137Transvenous lead extraction in patients under 30 years of age results from two high volume European centers

European Heart Journal ◽

10.1093/eurheartj/ehz745.0212 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

W Jachec ◽

A Polewczyk ◽

L Segreti ◽

M G Bongiorni ◽

A Kutarski

Keyword(s):

Young People ◽

Clinical Success ◽

Young Patients ◽

High Volume ◽

Young Age ◽

Lead Extraction ◽

Specific Group ◽

Technical Problems ◽

Major Complications ◽

Simple Systems

Abstract Background Young patients are a specific group undergoing transvenous leads extraction (TLE) procedures due to different anatomy, intensive connecting tissue scar and earlier calcification. Aim Evaluation of results of TLE in young patients compared to adults above 30 years old Examined Groups and Methods: 3810 patients (mean age at the time of procedure; 65,21±15,84 years old, 1301 female) who underwent TLE procedures in two high volume experienced European centers (Poland and Italy). We compared clinical and procedural factors in two groups of patients: under the age of 30 (n=172) and between 30 and 80 (n=3054) with exclusion 584 patients above 80 years old. Results Results are presented in Table 1. A: p<0,05, AA; p<0,01, AAA; p<0,001, NS Conclusion Infective indications are less frequent in very young people. In spite of presence of simple systems in this patients the effectiveness of TLE remains lower- with documented lower rate of procedural and clinical success Young age does not influence on the appearance of major complications and procedure related death, however, the frequency of technical problems is increased due to necessity of extraction older, strongly ingrown, calcified leads. TLE in young patients is usually a big challenge and should be performed by the most experienced operators in high volume centers.

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