TY - JOUR
AU - Bongiorni, Maria, Grazia
AB - Abstract Aims 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. Methods and results 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. Conclusion 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. Lead extraction, Abandoned leads, Implantable cardioverter-defibrillator, Pacemaker, Safety What’s new? Transvenous lead extraction (TLE), with the use of mechanical sheaths, is a safe and efficient procedure regardless the presence of abandoned leads. One or more abandoned leads are present in almost a fifth of the patients who require TLE in our series. The presence of abandoned leads does not prejudice the safety of the procedure of TLE, employing the mechanical dilatation with the use of sheaths. The presence of abandoned leads is associated with a lower rate of efficacy of the procedure. The presence of leads with a dwell time lower than 9 years is associated with a very high rate of efficacy. Introduction Transvenous lead extraction (TLE) procedure is considered an effective and safe procedure, with a low rate of major complications.1 Management of redundant or malfunctioning leads remains controversial, with little data available nowadays. An increasing number of TLE procedure is carried out with these indications2 and contrasting results are reported. Although the practice of abandoning leads avoids the risk of an extraction procedure, the presence of multiple leads was associated with an increased risk of infection,3 difficulty for future extractions,4–6 venous thrombosis, interference with pacing function, and tricuspid regurgitation and stenosis.7 A recent ELECTRa sub-analysis showed that TLE in patients with abandoned leads achieved a lower success rate and an increased risk of major complications, especially when powered techniques were applied.8 This study aims to figure out safety and efficacy of mechanical TLE in the management of patients with abandoned leads. Methods All patients who underwent TLE in our centre from January 2009 to December 2017 were included and analysed. Following the Guiding Principles of the Declaration of Helsinki on studies involving humans, all patients gave written informed consent to the procedure and personal data collection. The Institutional Committee on Human Research approved the study at our institution. The patients were divided into two groups based on the presence of one or more abandoned leads (Group 1) or without abandoned leads (Group 2). Electronic and paper records were reviewed to collect data concerning patient demographics, laboratory tests, data for the original device, comorbidities, drugs, procedural characteristics, indications for extraction, and procedural outcomes. All the procedures were performed by an experienced electrophysiologist, and the extraction procedure has been previously described in details.9,10 After device removal, leads were examined visually and by fluoroscopy in all their intravascular segments. The proximal end was then clipped, and a standard stylet inserted into the lead. Lead extraction was firstly attempted by gentle manual traction (MT). If this resulted to be unsuccessful, we switched to mechanical dilatation (MD) with a single-sheath (i.e. non-telescopic) technique, inserting and advancing multi-size dilatators (Cook Intravascular Inc., Leechburg, PA, USA) through the venous entry site as the first choice, or the right internal jugular vein, if required. Procedural success, complications, indications, and lead characteristics were defined according to the ELECTRa study and 2018 European Heart Rhythm Association (EHRA) Expert Consensus statement on lead extraction.1,11 The following definitions were considered: Abandoned lead: lead left in place into the heart and not connected to a cardiac implantable electronic device. It may be functional or non-functional. Clinical success (considered for each patient): complete removal of the leads, or retention of a small portion of a lead that does not negatively impact the outcome goals of the procedure, with an absence of any permanently disabling complication or procedure-related death. Clinical failure (considered for each patient): defined when, as either a procedure-related major complication or a failure to achieve the clinical outcome for which the TLE was scheduled, occurred. Radiological success (considered for each lead): defined when the lead was completely removed. Radiological failure (considered for each lead): defined when more than a 4 cm length of a lead was abandoned after a removal attempt. Partial radiological success (considered for each lead): defined when <4 cm of a lead remained in the patient body. Major complications: any of the outcomes related to the procedure, which is life-threatening or results in death (cardiac or non-cardiac). Minor complications: any undesired event related to the procedure that requires medical intervention or minor procedural intervention to remedy and does not limit persistently or significantly the patient’s function, nor does it threaten the life or cause death. All-cause in-hospital mortality: represented all deaths (cardiac or non-cardiac) that occurred during the hospitalization, irrespective of its classified relation to the procedure. Follow-up data were extracted from electronic medical records and with a phone interview. The primary endpoint was the safety and clinical success of the procedure. Secondary endpoints were: MT effectiveness, procedure and fluoroscopy duration, radiological outcome, and the need for a bailout femoral or jugular extraction approach. Statistical analysis Data analysis was performed using SPSS (IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY, USA: IBM Corp). Continuous variables are summarized as mean with standard deviation in the case of normal distribution and median with interquartile range (IQR) in case of non-Gaussian distribution. Categorical variables are expressed as percentages. Categorical variables were compared using the χ2 statistic or Fisher’s exact test (if any expected cell count was <5 or to compare endpoints). Continuous variables were compared using the Student’s t-test. The Wilcoxon rank-sum test was used for non-normally distributed continuous variables. Logistic regression was performed to identify predictive factors for clinical failure. The optimal cut-off value for the predictive variable was determined by the analysis of receiver-operating characteristics (ROC) curves using the Youden index. A P-value <0.05 was considered significant. Results Patients From January 2009 to December 2017, 1210 consecutive patients required transvenous removal of 2343 leads. Two hundred and fifty patients (20.66%) had one or more abandoned leads (Group 1) with a total of 617 leads (26.33%). The group of patients with non-abandoned leads (Group 2) comprised 960 patients (79.34%) with 1726 leads. Patients with abandoned leads were less likely to have a New York Heart Association (NYHA) Class III or IV (9.60 vs. 21.14% P < 0.001) and chronic obstructive pulmonary disease (8.40% vs. 14.27%; P = 0.023). Patients with abandoned leads tended to have more likely a valvular disease (9.60% vs. 5.43%; P = 0.024), permanent atrial fibrillation (26.40% vs. 14.06%; P = 0.001), vegetations (19.60% vs. 14.37%; P = 0.043), large vegetations (>2.0 cm) (5.60 vs. 3.02%; P = 0.050), previous sternotomy (23.20% vs. 16.67%; P = 0.025), and anticoagulation therapy (37.20% vs. 27.50%, P = 0.004). Patient characteristics are summarized in Table 1. Table 1 Patients’ baseline characteristics Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Age (years), median (IQR) 69.00 (57.00–77.00) 69.00 (58.50–76.50) 68.00 (57.00–77.00) 0.719 Male gender, n/N (%) 932/1210 (77.02%) 202/250 (80.80%) 730/960 (76.04%) 0.129 Body mass index (kg/m2), median (IQR) 25.47 (23.57–27.75) 25.35 (23.51–27.16) 25.62 (23.64–28.01) 0.636 LVEF (%), median (IQR) 47.00 (34.00–58.00) 45.00 (35.00–60.00) 47.00 (33.00–58.00) 0.935 NYHA Class III–IV, n/N (%) 227/1210 (18.76%) 24/250 (9.60%) 203/960 (21.14%) <0.001 Coronary artery disease, n/N (%) 375/1210 (30.99%) 73/250 (29.20%) 302/960 (31.45%) 0.574 Valvular heart disease, n/N (%) 78/1210 (6.44%) 24/250 (9.60%) 54/960 (5.63%) 0.024 Permanent atrial fibrillation, n/N (%) 231/1210 (19.09%) 66/250 (26.40%) 135/960 (14.06%) 0.001 Previous sternotomy, n/N (%) 218/1210 (18.01%) 58/250 (23.20%) 160/960 (16.67%) 0.025 Hypertension, n/N (%) 616/1210 (50.90%) 124/250 (49.60%) 492/960 (51.25%) 0.896 Diabetes mellitus, n/N (%) 253/1210 (20.90%) 48/250 (19.20%) 205/960 (21.35%) 0.601 Chronic heart failure, n/N (%) 511/1210 (42.23%) 110/250 (44.00%) 401/960 (41.77%) 0.511 Chronic kidney disease, n/N (%) 123/1210 (10.16%) 21/250 (8.40%) 102/960 (10.63%) 0.063 Chronic obstructive pulmonary disease, n/N (%) 158/1210 (13.05%) 21/250 (8.40%) 137/960 (14.27%) 0.023 ICD, n/N (%) 719/1210 (59.42%) 140/250 (56.00%) 579/960 (60.31%) 0.209  CRT-D, n/N (%) 339/719 (47.14%) 64/140 (45.71%) 275/579 (47.50%) 0.705 Pacemakers 491/1210 (40.58%) 140/250 (56.00%) 381/960 (39.70%) 0.209  CRT-P, n/N (%) 25/491 (5.01%) 6/140 (4.29%) 19/381 (4.99%) 0.849 Number of total leads, median (IQR) 2.00 (2.00–3.00) 3.00 (3.00–4.00) 2.00 (2.00–3.00) <0.001 Dwell time of the oldest lead (months), median (IQR) 66.00 (27.00–115.00) 108.00 (60.00–168.00) 60.00 (24.00–100.00) <0.001 Vegetations, n/N (%) 187/1210 (15.45%) 49/250 (19.60%) 138/960 (14.37%) 0.043 Large vegetations (>2 cm), n/N (%) 43/1210 (3.56%) 14/250 (5.60%) 29/960 (3.02%) 0.050 Anticoagulation, n/N (%) 357/1210 (29.50%) 93/250 (37.20%) 264/960 (27.50%) 0.004 Infective indications to lead extraction, n/N (%) 816/1210 (67.44%) 192/250 (76.80%) 624/960 (65.00%) <0.001  Systemic infections, n/N (%) 273/816 (33.46%) 64/192 (33.33%) 209/624 (33.49%) 0.197  Local infections, n/N (%) 543/816 (66.54%) 128/192 (66.67%) 415/624 (66.51%) 0.197 Non-infective indications to lead extraction, n/N (%) 394/1210 (32.56%) 58/250 (23.20%) 336/960 (35.00%) <0.001 Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Age (years), median (IQR) 69.00 (57.00–77.00) 69.00 (58.50–76.50) 68.00 (57.00–77.00) 0.719 Male gender, n/N (%) 932/1210 (77.02%) 202/250 (80.80%) 730/960 (76.04%) 0.129 Body mass index (kg/m2), median (IQR) 25.47 (23.57–27.75) 25.35 (23.51–27.16) 25.62 (23.64–28.01) 0.636 LVEF (%), median (IQR) 47.00 (34.00–58.00) 45.00 (35.00–60.00) 47.00 (33.00–58.00) 0.935 NYHA Class III–IV, n/N (%) 227/1210 (18.76%) 24/250 (9.60%) 203/960 (21.14%) <0.001 Coronary artery disease, n/N (%) 375/1210 (30.99%) 73/250 (29.20%) 302/960 (31.45%) 0.574 Valvular heart disease, n/N (%) 78/1210 (6.44%) 24/250 (9.60%) 54/960 (5.63%) 0.024 Permanent atrial fibrillation, n/N (%) 231/1210 (19.09%) 66/250 (26.40%) 135/960 (14.06%) 0.001 Previous sternotomy, n/N (%) 218/1210 (18.01%) 58/250 (23.20%) 160/960 (16.67%) 0.025 Hypertension, n/N (%) 616/1210 (50.90%) 124/250 (49.60%) 492/960 (51.25%) 0.896 Diabetes mellitus, n/N (%) 253/1210 (20.90%) 48/250 (19.20%) 205/960 (21.35%) 0.601 Chronic heart failure, n/N (%) 511/1210 (42.23%) 110/250 (44.00%) 401/960 (41.77%) 0.511 Chronic kidney disease, n/N (%) 123/1210 (10.16%) 21/250 (8.40%) 102/960 (10.63%) 0.063 Chronic obstructive pulmonary disease, n/N (%) 158/1210 (13.05%) 21/250 (8.40%) 137/960 (14.27%) 0.023 ICD, n/N (%) 719/1210 (59.42%) 140/250 (56.00%) 579/960 (60.31%) 0.209  CRT-D, n/N (%) 339/719 (47.14%) 64/140 (45.71%) 275/579 (47.50%) 0.705 Pacemakers 491/1210 (40.58%) 140/250 (56.00%) 381/960 (39.70%) 0.209  CRT-P, n/N (%) 25/491 (5.01%) 6/140 (4.29%) 19/381 (4.99%) 0.849 Number of total leads, median (IQR) 2.00 (2.00–3.00) 3.00 (3.00–4.00) 2.00 (2.00–3.00) <0.001 Dwell time of the oldest lead (months), median (IQR) 66.00 (27.00–115.00) 108.00 (60.00–168.00) 60.00 (24.00–100.00) <0.001 Vegetations, n/N (%) 187/1210 (15.45%) 49/250 (19.60%) 138/960 (14.37%) 0.043 Large vegetations (>2 cm), n/N (%) 43/1210 (3.56%) 14/250 (5.60%) 29/960 (3.02%) 0.050 Anticoagulation, n/N (%) 357/1210 (29.50%) 93/250 (37.20%) 264/960 (27.50%) 0.004 Infective indications to lead extraction, n/N (%) 816/1210 (67.44%) 192/250 (76.80%) 624/960 (65.00%) <0.001  Systemic infections, n/N (%) 273/816 (33.46%) 64/192 (33.33%) 209/624 (33.49%) 0.197  Local infections, n/N (%) 543/816 (66.54%) 128/192 (66.67%) 415/624 (66.51%) 0.197 Non-infective indications to lead extraction, n/N (%) 394/1210 (32.56%) 58/250 (23.20%) 336/960 (35.00%) <0.001 CRT-D, cardiac resynchronization therapy with defibrillator; CRT-P, cardiac resynchronization therapy with pacemaker; ICD, implantable cardioverter-defibrillator; IQR, interquartile range; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association. Open in new tab Table 1 Patients’ baseline characteristics Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Age (years), median (IQR) 69.00 (57.00–77.00) 69.00 (58.50–76.50) 68.00 (57.00–77.00) 0.719 Male gender, n/N (%) 932/1210 (77.02%) 202/250 (80.80%) 730/960 (76.04%) 0.129 Body mass index (kg/m2), median (IQR) 25.47 (23.57–27.75) 25.35 (23.51–27.16) 25.62 (23.64–28.01) 0.636 LVEF (%), median (IQR) 47.00 (34.00–58.00) 45.00 (35.00–60.00) 47.00 (33.00–58.00) 0.935 NYHA Class III–IV, n/N (%) 227/1210 (18.76%) 24/250 (9.60%) 203/960 (21.14%) <0.001 Coronary artery disease, n/N (%) 375/1210 (30.99%) 73/250 (29.20%) 302/960 (31.45%) 0.574 Valvular heart disease, n/N (%) 78/1210 (6.44%) 24/250 (9.60%) 54/960 (5.63%) 0.024 Permanent atrial fibrillation, n/N (%) 231/1210 (19.09%) 66/250 (26.40%) 135/960 (14.06%) 0.001 Previous sternotomy, n/N (%) 218/1210 (18.01%) 58/250 (23.20%) 160/960 (16.67%) 0.025 Hypertension, n/N (%) 616/1210 (50.90%) 124/250 (49.60%) 492/960 (51.25%) 0.896 Diabetes mellitus, n/N (%) 253/1210 (20.90%) 48/250 (19.20%) 205/960 (21.35%) 0.601 Chronic heart failure, n/N (%) 511/1210 (42.23%) 110/250 (44.00%) 401/960 (41.77%) 0.511 Chronic kidney disease, n/N (%) 123/1210 (10.16%) 21/250 (8.40%) 102/960 (10.63%) 0.063 Chronic obstructive pulmonary disease, n/N (%) 158/1210 (13.05%) 21/250 (8.40%) 137/960 (14.27%) 0.023 ICD, n/N (%) 719/1210 (59.42%) 140/250 (56.00%) 579/960 (60.31%) 0.209  CRT-D, n/N (%) 339/719 (47.14%) 64/140 (45.71%) 275/579 (47.50%) 0.705 Pacemakers 491/1210 (40.58%) 140/250 (56.00%) 381/960 (39.70%) 0.209  CRT-P, n/N (%) 25/491 (5.01%) 6/140 (4.29%) 19/381 (4.99%) 0.849 Number of total leads, median (IQR) 2.00 (2.00–3.00) 3.00 (3.00–4.00) 2.00 (2.00–3.00) <0.001 Dwell time of the oldest lead (months), median (IQR) 66.00 (27.00–115.00) 108.00 (60.00–168.00) 60.00 (24.00–100.00) <0.001 Vegetations, n/N (%) 187/1210 (15.45%) 49/250 (19.60%) 138/960 (14.37%) 0.043 Large vegetations (>2 cm), n/N (%) 43/1210 (3.56%) 14/250 (5.60%) 29/960 (3.02%) 0.050 Anticoagulation, n/N (%) 357/1210 (29.50%) 93/250 (37.20%) 264/960 (27.50%) 0.004 Infective indications to lead extraction, n/N (%) 816/1210 (67.44%) 192/250 (76.80%) 624/960 (65.00%) <0.001  Systemic infections, n/N (%) 273/816 (33.46%) 64/192 (33.33%) 209/624 (33.49%) 0.197  Local infections, n/N (%) 543/816 (66.54%) 128/192 (66.67%) 415/624 (66.51%) 0.197 Non-infective indications to lead extraction, n/N (%) 394/1210 (32.56%) 58/250 (23.20%) 336/960 (35.00%) <0.001 Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Age (years), median (IQR) 69.00 (57.00–77.00) 69.00 (58.50–76.50) 68.00 (57.00–77.00) 0.719 Male gender, n/N (%) 932/1210 (77.02%) 202/250 (80.80%) 730/960 (76.04%) 0.129 Body mass index (kg/m2), median (IQR) 25.47 (23.57–27.75) 25.35 (23.51–27.16) 25.62 (23.64–28.01) 0.636 LVEF (%), median (IQR) 47.00 (34.00–58.00) 45.00 (35.00–60.00) 47.00 (33.00–58.00) 0.935 NYHA Class III–IV, n/N (%) 227/1210 (18.76%) 24/250 (9.60%) 203/960 (21.14%) <0.001 Coronary artery disease, n/N (%) 375/1210 (30.99%) 73/250 (29.20%) 302/960 (31.45%) 0.574 Valvular heart disease, n/N (%) 78/1210 (6.44%) 24/250 (9.60%) 54/960 (5.63%) 0.024 Permanent atrial fibrillation, n/N (%) 231/1210 (19.09%) 66/250 (26.40%) 135/960 (14.06%) 0.001 Previous sternotomy, n/N (%) 218/1210 (18.01%) 58/250 (23.20%) 160/960 (16.67%) 0.025 Hypertension, n/N (%) 616/1210 (50.90%) 124/250 (49.60%) 492/960 (51.25%) 0.896 Diabetes mellitus, n/N (%) 253/1210 (20.90%) 48/250 (19.20%) 205/960 (21.35%) 0.601 Chronic heart failure, n/N (%) 511/1210 (42.23%) 110/250 (44.00%) 401/960 (41.77%) 0.511 Chronic kidney disease, n/N (%) 123/1210 (10.16%) 21/250 (8.40%) 102/960 (10.63%) 0.063 Chronic obstructive pulmonary disease, n/N (%) 158/1210 (13.05%) 21/250 (8.40%) 137/960 (14.27%) 0.023 ICD, n/N (%) 719/1210 (59.42%) 140/250 (56.00%) 579/960 (60.31%) 0.209  CRT-D, n/N (%) 339/719 (47.14%) 64/140 (45.71%) 275/579 (47.50%) 0.705 Pacemakers 491/1210 (40.58%) 140/250 (56.00%) 381/960 (39.70%) 0.209  CRT-P, n/N (%) 25/491 (5.01%) 6/140 (4.29%) 19/381 (4.99%) 0.849 Number of total leads, median (IQR) 2.00 (2.00–3.00) 3.00 (3.00–4.00) 2.00 (2.00–3.00) <0.001 Dwell time of the oldest lead (months), median (IQR) 66.00 (27.00–115.00) 108.00 (60.00–168.00) 60.00 (24.00–100.00) <0.001 Vegetations, n/N (%) 187/1210 (15.45%) 49/250 (19.60%) 138/960 (14.37%) 0.043 Large vegetations (>2 cm), n/N (%) 43/1210 (3.56%) 14/250 (5.60%) 29/960 (3.02%) 0.050 Anticoagulation, n/N (%) 357/1210 (29.50%) 93/250 (37.20%) 264/960 (27.50%) 0.004 Infective indications to lead extraction, n/N (%) 816/1210 (67.44%) 192/250 (76.80%) 624/960 (65.00%) <0.001  Systemic infections, n/N (%) 273/816 (33.46%) 64/192 (33.33%) 209/624 (33.49%) 0.197  Local infections, n/N (%) 543/816 (66.54%) 128/192 (66.67%) 415/624 (66.51%) 0.197 Non-infective indications to lead extraction, n/N (%) 394/1210 (32.56%) 58/250 (23.20%) 336/960 (35.00%) <0.001 CRT-D, cardiac resynchronization therapy with defibrillator; CRT-P, cardiac resynchronization therapy with pacemaker; ICD, implantable cardioverter-defibrillator; IQR, interquartile range; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association. Open in new tab Leads The total number of leads was higher in patients with abandoned leads [3.00 (3.00–4.00) vs. 2.00 (2.00–3.00); P < 0.001], and the dwelling time of the oldest lead was significantly longer [108.00 (60.00–168.00) vs. 60.00 (24.00–100.00) months; P < 0.001]. Patients with abandoned leads, compared with the other group, were more likely to have pacing leads (74.07% vs. 69.52%; P = 0.033), an active fixation type (30.96% vs. 23.06%; P = 0.001) and a longer overall dwelling time [80.00 (36.00–142.00) vs. 59.50 (24.00–96.00) months; P < 0.001]. In the group of abandoned leads, there were more infective indications compared to Group 2 (76.80% vs. 65.00%; P < 0.001). Patient baseline characteristics are listed in Table 1 and leads baseline characteristics in Table 2. Table 2 Leads’ baseline characteristics Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Baseline characteristics  Pacing leads, n/N (%) 1657/2343 (70.72%) 457/617 (74.07%) 1200/1726 (69.52%) 0.033  ICD leads, n/N (%) 686/2343 (29.28%) 160/617 (25.93%) 526/1726 (30.48%) 0.033  ICD leads, single coil, n/N (%) 178/686 (25.95%) 52/160 (32.50%) 126/526 (23.45%) 0.022  ICD leads, dual coil, n/N (%) 508/686 (74.05%) 108/160 (67.50%) 400/526 (76.05%) 0.022  Lead tip location, right atrium, n/N (%) 753/2343 (32.14%) 192/617 (31.11%) 561/1726 (32.50%) 0.527  Lead tip location, right ventricle, n/N (%) 1268/2343 (54.12%) 355/617 (57.54%) 913/1726 (52.90%) 0.047  Lead tip location, coronary sinus/branches, n/N (%) 322/2343 (13.74%) 70/617 (11.35%) 252/1726 (14.60%) 0.044  Fixation type, active, n/N (%) 589/2343 (25.14%) 191/617 (30.96%) 398/1726 (23.06%) 0.001  Fixation type, passive, n/N (%) 1794/2343 (76.57%) 426/617 (69.04%) 1328/1726 (76.94%) 0.001  Dwelling time (months), median (IQR) 60.00 (24.00–108.00) 80.00 (36.00–142.00) 59.50 (24.00–96.00) <0.001 Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Baseline characteristics  Pacing leads, n/N (%) 1657/2343 (70.72%) 457/617 (74.07%) 1200/1726 (69.52%) 0.033  ICD leads, n/N (%) 686/2343 (29.28%) 160/617 (25.93%) 526/1726 (30.48%) 0.033  ICD leads, single coil, n/N (%) 178/686 (25.95%) 52/160 (32.50%) 126/526 (23.45%) 0.022  ICD leads, dual coil, n/N (%) 508/686 (74.05%) 108/160 (67.50%) 400/526 (76.05%) 0.022  Lead tip location, right atrium, n/N (%) 753/2343 (32.14%) 192/617 (31.11%) 561/1726 (32.50%) 0.527  Lead tip location, right ventricle, n/N (%) 1268/2343 (54.12%) 355/617 (57.54%) 913/1726 (52.90%) 0.047  Lead tip location, coronary sinus/branches, n/N (%) 322/2343 (13.74%) 70/617 (11.35%) 252/1726 (14.60%) 0.044  Fixation type, active, n/N (%) 589/2343 (25.14%) 191/617 (30.96%) 398/1726 (23.06%) 0.001  Fixation type, passive, n/N (%) 1794/2343 (76.57%) 426/617 (69.04%) 1328/1726 (76.94%) 0.001  Dwelling time (months), median (IQR) 60.00 (24.00–108.00) 80.00 (36.00–142.00) 59.50 (24.00–96.00) <0.001 ICD, implantable cardioverter-defibrillator; IQR, interquartile range. Open in new tab Table 2 Leads’ baseline characteristics Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Baseline characteristics  Pacing leads, n/N (%) 1657/2343 (70.72%) 457/617 (74.07%) 1200/1726 (69.52%) 0.033  ICD leads, n/N (%) 686/2343 (29.28%) 160/617 (25.93%) 526/1726 (30.48%) 0.033  ICD leads, single coil, n/N (%) 178/686 (25.95%) 52/160 (32.50%) 126/526 (23.45%) 0.022  ICD leads, dual coil, n/N (%) 508/686 (74.05%) 108/160 (67.50%) 400/526 (76.05%) 0.022  Lead tip location, right atrium, n/N (%) 753/2343 (32.14%) 192/617 (31.11%) 561/1726 (32.50%) 0.527  Lead tip location, right ventricle, n/N (%) 1268/2343 (54.12%) 355/617 (57.54%) 913/1726 (52.90%) 0.047  Lead tip location, coronary sinus/branches, n/N (%) 322/2343 (13.74%) 70/617 (11.35%) 252/1726 (14.60%) 0.044  Fixation type, active, n/N (%) 589/2343 (25.14%) 191/617 (30.96%) 398/1726 (23.06%) 0.001  Fixation type, passive, n/N (%) 1794/2343 (76.57%) 426/617 (69.04%) 1328/1726 (76.94%) 0.001  Dwelling time (months), median (IQR) 60.00 (24.00–108.00) 80.00 (36.00–142.00) 59.50 (24.00–96.00) <0.001 Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Baseline characteristics  Pacing leads, n/N (%) 1657/2343 (70.72%) 457/617 (74.07%) 1200/1726 (69.52%) 0.033  ICD leads, n/N (%) 686/2343 (29.28%) 160/617 (25.93%) 526/1726 (30.48%) 0.033  ICD leads, single coil, n/N (%) 178/686 (25.95%) 52/160 (32.50%) 126/526 (23.45%) 0.022  ICD leads, dual coil, n/N (%) 508/686 (74.05%) 108/160 (67.50%) 400/526 (76.05%) 0.022  Lead tip location, right atrium, n/N (%) 753/2343 (32.14%) 192/617 (31.11%) 561/1726 (32.50%) 0.527  Lead tip location, right ventricle, n/N (%) 1268/2343 (54.12%) 355/617 (57.54%) 913/1726 (52.90%) 0.047  Lead tip location, coronary sinus/branches, n/N (%) 322/2343 (13.74%) 70/617 (11.35%) 252/1726 (14.60%) 0.044  Fixation type, active, n/N (%) 589/2343 (25.14%) 191/617 (30.96%) 398/1726 (23.06%) 0.001  Fixation type, passive, n/N (%) 1794/2343 (76.57%) 426/617 (69.04%) 1328/1726 (76.94%) 0.001  Dwelling time (months), median (IQR) 60.00 (24.00–108.00) 80.00 (36.00–142.00) 59.50 (24.00–96.00) <0.001 ICD, implantable cardioverter-defibrillator; IQR, interquartile range. Open in new tab Procedural outcomes Clinical success was achieved in 1168 out of 1210 patients (96.53%). Clinical success was lower in patients with abandoned leads [226/250 (90.49%]) than in patients with non-abandoned leads [942/960 (98.13%), P < 0.001]. The only major complication was cardiac tamponade: it occurred in 9 out of 1210 patients (0.70%) (3/250 = 1.20% in Group 1 and 6/960 = 0.63% in Group 2, P = 0.056). Pericardiocentesis was effective in seven cases, whilst cardiac surgery was required in the remaining two cases. In this regard, the two patients who required surgery died, the former during the surgery because of coronary sinus laceration (extraction of inadvertently placed pacing lead in the middle cardiac vein) and the latter after the surgery because of cardiogenic shock [right ventricular lead laceration during Riata 1570 implantable cardioverter-defibrillator (ICD) lead extraction]. There were no significant differences in major complications among groups [3/250 (1.20%) in Group 1 vs. 6/960 (0.63%) in Group 2; P = 0.586]. Rate of minor complications was higher in Group 1 [18/250 (7.20%) vs. 24/960 (2.50%), P < 0.001]. The in-hospital total mortality was 4/1210 (0.33%), without differences between groups: two deaths were procedure-related (as discussed above), and the other two were due to septic shock and not related to the procedure. Patient procedural outcomes are reported in Table 3. The procedure was more complex in the presence of abandoned leads with a lower rate of MT effectiveness (12.97% vs. 17.90%; P = 0.005), longer procedure duration [120.00 (60.00–180.00) vs. 60.00 (60.00–120.00) min; P = 0.003], and a longer fluoroscopy time [15.00 (6.00–30.00) vs. 12.00 (5.00–25.00) min; P < 0.001]. Instead, the need for a bailout femoral or jugular extraction approach involved 199 out of 2343 (8.49%) leads, without significant differences between groups [48/617 (7.78%) in Group 1 vs. 151/1726 (8.75%) in Group 2; P = 0.459]. Leads procedural outcome are reported in Table 4. The failure subgroups sub-analysis showed the need of a crossover to an alternative venous approach in Group 2 failures (27.88%), which was lower in Group 1 failures (8.69%), usually because it was not applicable for a common upper venous system occlusion or the lead was broken by previous extraction attempts (Table 5). As a matter of fact, patients with abandoned leads were more frequently treated with surgical extraction (13/250 = 0.52% vs. 11/960 = 0.11%, P < 0.001) (Table 3). Table 3 Patients' procedural outcome Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Clinical success, n/N (%) 1168/1210 (96.53%) 226/250 (90.40%) 942/960 (98.13%) <0.001 Major complications, n/N (%) 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586  Cardiac tamponade 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586 Minor complications, n/N (%) 42/1210 (3.47%) 18/250 (7.20%) 24/960 (2.50%) <0.001  Pericardial effusiona 9/1210 (0.74%) 4/250 (1.6%) 5/960 (0.52%) 0.10  Haematoma at the surgical site 8/1210 (0.67%) 4/250 (1.6%) 4/960 (0.41%) 0.06  Arrhythmias 6/1210 (0.49%) 1/250 (0.40%) 5/960 (0.52%) 1.00  Otherb 19/1210 (1.57%) 9/250 (0.72%) 10/960 (1.04%) 0.01 Major and minor complications, n/N (%) 51/1210 (4.21%) 21/250 (8.40%) 30/960 (3.12%) <0.001 Surgical approach, n/N (%) 24/1210 (0.19%) 13/250 (0.52%) 11/960 (0.11%) <0.001  Emergency, for complicated TLE 3/1210 (0.02%) 2/250 (0.08%) 1/960 (0.01%) <0.001  Planned, after failed TLE 21/1219 (0.17%) 11/250 (0.44%) 10/960 (0.10%) <0.001 All-cause in-hospital mortality, n/N (%) 4/1210 (0.33%) 2/250 (0.80%) 2/960 (0.21%) 0.191 Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Clinical success, n/N (%) 1168/1210 (96.53%) 226/250 (90.40%) 942/960 (98.13%) <0.001 Major complications, n/N (%) 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586  Cardiac tamponade 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586 Minor complications, n/N (%) 42/1210 (3.47%) 18/250 (7.20%) 24/960 (2.50%) <0.001  Pericardial effusiona 9/1210 (0.74%) 4/250 (1.6%) 5/960 (0.52%) 0.10  Haematoma at the surgical site 8/1210 (0.67%) 4/250 (1.6%) 4/960 (0.41%) 0.06  Arrhythmias 6/1210 (0.49%) 1/250 (0.40%) 5/960 (0.52%) 1.00  Otherb 19/1210 (1.57%) 9/250 (0.72%) 10/960 (1.04%) 0.01 Major and minor complications, n/N (%) 51/1210 (4.21%) 21/250 (8.40%) 30/960 (3.12%) <0.001 Surgical approach, n/N (%) 24/1210 (0.19%) 13/250 (0.52%) 11/960 (0.11%) <0.001  Emergency, for complicated TLE 3/1210 (0.02%) 2/250 (0.08%) 1/960 (0.01%) <0.001  Planned, after failed TLE 21/1219 (0.17%) 11/250 (0.44%) 10/960 (0.10%) <0.001 All-cause in-hospital mortality, n/N (%) 4/1210 (0.33%) 2/250 (0.80%) 2/960 (0.21%) 0.191 TLE, transvenous lead extraction. a Not requiring pericardiocentesis. b Other include pulmonary embolism not requiring surgical intervention (3 patients), tricuspid regurgitation (2 patients), hyperpyrexia (5 patients), blood transfusion related to blood loss during surgery (5 patients), pneumothorax (4 patients). Open in new tab Table 3 Patients' procedural outcome Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Clinical success, n/N (%) 1168/1210 (96.53%) 226/250 (90.40%) 942/960 (98.13%) <0.001 Major complications, n/N (%) 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586  Cardiac tamponade 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586 Minor complications, n/N (%) 42/1210 (3.47%) 18/250 (7.20%) 24/960 (2.50%) <0.001  Pericardial effusiona 9/1210 (0.74%) 4/250 (1.6%) 5/960 (0.52%) 0.10  Haematoma at the surgical site 8/1210 (0.67%) 4/250 (1.6%) 4/960 (0.41%) 0.06  Arrhythmias 6/1210 (0.49%) 1/250 (0.40%) 5/960 (0.52%) 1.00  Otherb 19/1210 (1.57%) 9/250 (0.72%) 10/960 (1.04%) 0.01 Major and minor complications, n/N (%) 51/1210 (4.21%) 21/250 (8.40%) 30/960 (3.12%) <0.001 Surgical approach, n/N (%) 24/1210 (0.19%) 13/250 (0.52%) 11/960 (0.11%) <0.001  Emergency, for complicated TLE 3/1210 (0.02%) 2/250 (0.08%) 1/960 (0.01%) <0.001  Planned, after failed TLE 21/1219 (0.17%) 11/250 (0.44%) 10/960 (0.10%) <0.001 All-cause in-hospital mortality, n/N (%) 4/1210 (0.33%) 2/250 (0.80%) 2/960 (0.21%) 0.191 Variables . Total (N = 1210) . Group 1 (N = 250) . Group 2 (N = 960) . P-value . Clinical success, n/N (%) 1168/1210 (96.53%) 226/250 (90.40%) 942/960 (98.13%) <0.001 Major complications, n/N (%) 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586  Cardiac tamponade 9/1210 (0.70%) 3/250 (1.20%) 6/960 (0.63%) 0.586 Minor complications, n/N (%) 42/1210 (3.47%) 18/250 (7.20%) 24/960 (2.50%) <0.001  Pericardial effusiona 9/1210 (0.74%) 4/250 (1.6%) 5/960 (0.52%) 0.10  Haematoma at the surgical site 8/1210 (0.67%) 4/250 (1.6%) 4/960 (0.41%) 0.06  Arrhythmias 6/1210 (0.49%) 1/250 (0.40%) 5/960 (0.52%) 1.00  Otherb 19/1210 (1.57%) 9/250 (0.72%) 10/960 (1.04%) 0.01 Major and minor complications, n/N (%) 51/1210 (4.21%) 21/250 (8.40%) 30/960 (3.12%) <0.001 Surgical approach, n/N (%) 24/1210 (0.19%) 13/250 (0.52%) 11/960 (0.11%) <0.001  Emergency, for complicated TLE 3/1210 (0.02%) 2/250 (0.08%) 1/960 (0.01%) <0.001  Planned, after failed TLE 21/1219 (0.17%) 11/250 (0.44%) 10/960 (0.10%) <0.001 All-cause in-hospital mortality, n/N (%) 4/1210 (0.33%) 2/250 (0.80%) 2/960 (0.21%) 0.191 TLE, transvenous lead extraction. a Not requiring pericardiocentesis. b Other include pulmonary embolism not requiring surgical intervention (3 patients), tricuspid regurgitation (2 patients), hyperpyrexia (5 patients), blood transfusion related to blood loss during surgery (5 patients), pneumothorax (4 patients). Open in new tab Table 4 Leads’ procedural outcome Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Procedural characteristics  Radiological outcome, complete, n/N (%) 2261/2343 (96.50%) 571/617 (92.54%) 1690/1726 (97.91%) <0.001  Radiological outcome, partial, n/N (%) 24/2343 (1.02%) 10/617 (1.62%) 14/1726 (0.81%) <0.001  Radiological outcome, failure, n/N (%) 58/2343 (2.48%) 36/617 (5.83%) 22/1726 (1.27%) <0.001  Manual traction effectiveness, n/N (%) 389/2343 (16.60%) 80/617 (12.97%) 309/1726 (17.90%) 0.005  Jugular or femoral approach, n/N (%) 199/2343 (8.49%) 48/617 (7.78%) 151/1726 (8.75%) 0.459  Procedure duration (min), median (IQR) 60.00 (60.00–150.00) 120.00 (60.00–180.00) 60.00 (60.00–120.00) 0.003  Fluoroscopy time (min), median (IQR) 12.40 (5.00–26.00) 15.00 (6.00–30.00) 12.00 (5.00–25.00) <0.001 Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Procedural characteristics  Radiological outcome, complete, n/N (%) 2261/2343 (96.50%) 571/617 (92.54%) 1690/1726 (97.91%) <0.001  Radiological outcome, partial, n/N (%) 24/2343 (1.02%) 10/617 (1.62%) 14/1726 (0.81%) <0.001  Radiological outcome, failure, n/N (%) 58/2343 (2.48%) 36/617 (5.83%) 22/1726 (1.27%) <0.001  Manual traction effectiveness, n/N (%) 389/2343 (16.60%) 80/617 (12.97%) 309/1726 (17.90%) 0.005  Jugular or femoral approach, n/N (%) 199/2343 (8.49%) 48/617 (7.78%) 151/1726 (8.75%) 0.459  Procedure duration (min), median (IQR) 60.00 (60.00–150.00) 120.00 (60.00–180.00) 60.00 (60.00–120.00) 0.003  Fluoroscopy time (min), median (IQR) 12.40 (5.00–26.00) 15.00 (6.00–30.00) 12.00 (5.00–25.00) <0.001 IQR, interquartile range. Open in new tab Table 4 Leads’ procedural outcome Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Procedural characteristics  Radiological outcome, complete, n/N (%) 2261/2343 (96.50%) 571/617 (92.54%) 1690/1726 (97.91%) <0.001  Radiological outcome, partial, n/N (%) 24/2343 (1.02%) 10/617 (1.62%) 14/1726 (0.81%) <0.001  Radiological outcome, failure, n/N (%) 58/2343 (2.48%) 36/617 (5.83%) 22/1726 (1.27%) <0.001  Manual traction effectiveness, n/N (%) 389/2343 (16.60%) 80/617 (12.97%) 309/1726 (17.90%) 0.005  Jugular or femoral approach, n/N (%) 199/2343 (8.49%) 48/617 (7.78%) 151/1726 (8.75%) 0.459  Procedure duration (min), median (IQR) 60.00 (60.00–150.00) 120.00 (60.00–180.00) 60.00 (60.00–120.00) 0.003  Fluoroscopy time (min), median (IQR) 12.40 (5.00–26.00) 15.00 (6.00–30.00) 12.00 (5.00–25.00) <0.001 Variables . Total (N = 2343) . Leads in Group 1 (N = 617) . Leads in Group 2 (N = 1726) . P-value . Procedural characteristics  Radiological outcome, complete, n/N (%) 2261/2343 (96.50%) 571/617 (92.54%) 1690/1726 (97.91%) <0.001  Radiological outcome, partial, n/N (%) 24/2343 (1.02%) 10/617 (1.62%) 14/1726 (0.81%) <0.001  Radiological outcome, failure, n/N (%) 58/2343 (2.48%) 36/617 (5.83%) 22/1726 (1.27%) <0.001  Manual traction effectiveness, n/N (%) 389/2343 (16.60%) 80/617 (12.97%) 309/1726 (17.90%) 0.005  Jugular or femoral approach, n/N (%) 199/2343 (8.49%) 48/617 (7.78%) 151/1726 (8.75%) 0.459  Procedure duration (min), median (IQR) 60.00 (60.00–150.00) 120.00 (60.00–180.00) 60.00 (60.00–120.00) 0.003  Fluoroscopy time (min), median (IQR) 12.40 (5.00–26.00) 15.00 (6.00–30.00) 12.00 (5.00–25.00) <0.001 IQR, interquartile range. Open in new tab Table 5 Leads with incomplete TLE radiological outcome (partial and failure) Variables . Total . Leads in Group 1 . Leads in Group 2 . p-value . Leads and procedural characteristics  Leads, total, n/N (%) 82/2343 (3.50%) 46/617 (7.46%) 36/1726 (2.09%) <0.001 Indication for lead extraction  Infections, n/N (%) 53/82 (64.63%) 31/46 (67.39%) 22/36 (61.11%) 0.360   Systemic infections, n/N (%) 22/82 (26.83%) 18/46 (39.13%) 4/36 (11.11%) 0.004   Local infections, n/N (%) 31/82 (37.80%) 13/46 (28.26%) 18/36 (50.00%) 0.037  No infection, n/N (%) 29/82 (35.37%) 15/46 (32.61%) 14/36 (38.89%) 0.360 Baseline characteristics  Dwelling time (months), median (IQR) 177 (106.5–240) 180 (132–256) 144 (85.75–199) 0.015  Previous unsuccessful extraction attempt 17/82 (20.73%) 15/46 (32.60%) 2/36 (5.55%) 0.003 Procedural characteristics  Jugular of femoral approach, n/N (%) 14/82 (17.07%) 4/46 (8.69%) 10/36 (27.77%) 0.024  Technique not applicable, n/N (%) 6/82 (7.32%) 6/46 (13.04%) 0/36 (0%) <0.001 Variables . Total . Leads in Group 1 . Leads in Group 2 . p-value . Leads and procedural characteristics  Leads, total, n/N (%) 82/2343 (3.50%) 46/617 (7.46%) 36/1726 (2.09%) <0.001 Indication for lead extraction  Infections, n/N (%) 53/82 (64.63%) 31/46 (67.39%) 22/36 (61.11%) 0.360   Systemic infections, n/N (%) 22/82 (26.83%) 18/46 (39.13%) 4/36 (11.11%) 0.004   Local infections, n/N (%) 31/82 (37.80%) 13/46 (28.26%) 18/36 (50.00%) 0.037  No infection, n/N (%) 29/82 (35.37%) 15/46 (32.61%) 14/36 (38.89%) 0.360 Baseline characteristics  Dwelling time (months), median (IQR) 177 (106.5–240) 180 (132–256) 144 (85.75–199) 0.015  Previous unsuccessful extraction attempt 17/82 (20.73%) 15/46 (32.60%) 2/36 (5.55%) 0.003 Procedural characteristics  Jugular of femoral approach, n/N (%) 14/82 (17.07%) 4/46 (8.69%) 10/36 (27.77%) 0.024  Technique not applicable, n/N (%) 6/82 (7.32%) 6/46 (13.04%) 0/36 (0%) <0.001 Open in new tab Table 5 Leads with incomplete TLE radiological outcome (partial and failure) Variables . Total . Leads in Group 1 . Leads in Group 2 . p-value . Leads and procedural characteristics  Leads, total, n/N (%) 82/2343 (3.50%) 46/617 (7.46%) 36/1726 (2.09%) <0.001 Indication for lead extraction  Infections, n/N (%) 53/82 (64.63%) 31/46 (67.39%) 22/36 (61.11%) 0.360   Systemic infections, n/N (%) 22/82 (26.83%) 18/46 (39.13%) 4/36 (11.11%) 0.004   Local infections, n/N (%) 31/82 (37.80%) 13/46 (28.26%) 18/36 (50.00%) 0.037  No infection, n/N (%) 29/82 (35.37%) 15/46 (32.61%) 14/36 (38.89%) 0.360 Baseline characteristics  Dwelling time (months), median (IQR) 177 (106.5–240) 180 (132–256) 144 (85.75–199) 0.015  Previous unsuccessful extraction attempt 17/82 (20.73%) 15/46 (32.60%) 2/36 (5.55%) 0.003 Procedural characteristics  Jugular of femoral approach, n/N (%) 14/82 (17.07%) 4/46 (8.69%) 10/36 (27.77%) 0.024  Technique not applicable, n/N (%) 6/82 (7.32%) 6/46 (13.04%) 0/36 (0%) <0.001 Variables . Total . Leads in Group 1 . Leads in Group 2 . p-value . Leads and procedural characteristics  Leads, total, n/N (%) 82/2343 (3.50%) 46/617 (7.46%) 36/1726 (2.09%) <0.001 Indication for lead extraction  Infections, n/N (%) 53/82 (64.63%) 31/46 (67.39%) 22/36 (61.11%) 0.360   Systemic infections, n/N (%) 22/82 (26.83%) 18/46 (39.13%) 4/36 (11.11%) 0.004   Local infections, n/N (%) 31/82 (37.80%) 13/46 (28.26%) 18/36 (50.00%) 0.037  No infection, n/N (%) 29/82 (35.37%) 15/46 (32.61%) 14/36 (38.89%) 0.360 Baseline characteristics  Dwelling time (months), median (IQR) 177 (106.5–240) 180 (132–256) 144 (85.75–199) 0.015  Previous unsuccessful extraction attempt 17/82 (20.73%) 15/46 (32.60%) 2/36 (5.55%) 0.003 Procedural characteristics  Jugular of femoral approach, n/N (%) 14/82 (17.07%) 4/46 (8.69%) 10/36 (27.77%) 0.024  Technique not applicable, n/N (%) 6/82 (7.32%) 6/46 (13.04%) 0/36 (0%) <0.001 Open in new tab Logistic regression analysis demonstrated that 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 the 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. A higher age of the patient (OR 0.97 for a year; 95% CI 0.94–0.99; P = 0.27) and male sex (OR 0.34; 95% CI 0.15–0.75; P = 0.008) were associated with a better outcome. Logistic regression analysis was reported in Table 6. Table 6 Predictors of clinical failure of transvenous lead extraction Variables . Odds ratio . P-value . Sex male 0.33 (0.15–0.75) 0.008 Age (years) 0.97 (0.94–0.99) 0.027 Body mass index (kg/m2) 0.99 (0.93–1.06) 0.866 Pacemaker dependency 0.70 (0.28–1.76) 0.460 Hypertension 1.39 (0.57–3.35) 0.464 Diabetes 2.42 (0.94–6.29) 0.068 Atrial fibrillation 0.40 (0.14–0.18) 0.097 ICD 0.61 (0.19–1.96) 0.409 CRT 0.93 (0.21–4.10) 0.931 One or more abandoned leads 3.47 (1.07–11.18) 0.037 Dwell time of the oldest lead (months) 1.01 (1.01–1.02) <0.001 Number of leads 0.82 (0.42–1.58) 0.549 Variables . Odds ratio . P-value . Sex male 0.33 (0.15–0.75) 0.008 Age (years) 0.97 (0.94–0.99) 0.027 Body mass index (kg/m2) 0.99 (0.93–1.06) 0.866 Pacemaker dependency 0.70 (0.28–1.76) 0.460 Hypertension 1.39 (0.57–3.35) 0.464 Diabetes 2.42 (0.94–6.29) 0.068 Atrial fibrillation 0.40 (0.14–0.18) 0.097 ICD 0.61 (0.19–1.96) 0.409 CRT 0.93 (0.21–4.10) 0.931 One or more abandoned leads 3.47 (1.07–11.18) 0.037 Dwell time of the oldest lead (months) 1.01 (1.01–1.02) <0.001 Number of leads 0.82 (0.42–1.58) 0.549 CRT, cardiac resynchronization therapy; ICD, implantable cardioverter-defibrillator. Open in new tab Table 6 Predictors of clinical failure of transvenous lead extraction Variables . Odds ratio . P-value . Sex male 0.33 (0.15–0.75) 0.008 Age (years) 0.97 (0.94–0.99) 0.027 Body mass index (kg/m2) 0.99 (0.93–1.06) 0.866 Pacemaker dependency 0.70 (0.28–1.76) 0.460 Hypertension 1.39 (0.57–3.35) 0.464 Diabetes 2.42 (0.94–6.29) 0.068 Atrial fibrillation 0.40 (0.14–0.18) 0.097 ICD 0.61 (0.19–1.96) 0.409 CRT 0.93 (0.21–4.10) 0.931 One or more abandoned leads 3.47 (1.07–11.18) 0.037 Dwell time of the oldest lead (months) 1.01 (1.01–1.02) <0.001 Number of leads 0.82 (0.42–1.58) 0.549 Variables . Odds ratio . P-value . Sex male 0.33 (0.15–0.75) 0.008 Age (years) 0.97 (0.94–0.99) 0.027 Body mass index (kg/m2) 0.99 (0.93–1.06) 0.866 Pacemaker dependency 0.70 (0.28–1.76) 0.460 Hypertension 1.39 (0.57–3.35) 0.464 Diabetes 2.42 (0.94–6.29) 0.068 Atrial fibrillation 0.40 (0.14–0.18) 0.097 ICD 0.61 (0.19–1.96) 0.409 CRT 0.93 (0.21–4.10) 0.931 One or more abandoned leads 3.47 (1.07–11.18) 0.037 Dwell time of the oldest lead (months) 1.01 (1.01–1.02) <0.001 Number of leads 0.82 (0.42–1.58) 0.549 CRT, cardiac resynchronization therapy; ICD, implantable cardioverter-defibrillator. Open in new tab Receiver-operating characteristics curve analysis (Figure 1) showed a dwelling time threshold for clinical failure of 107 months (8.92 years), with an area under the curve (AUC) of 0.879. Figure 1 Open in new tabDownload slide ROC curve for clinical failure/dwelling time of the oldest lead. AUC, area under the curve; ROC, receiver-operating characteristics. Figure 1 Open in new tabDownload slide ROC curve for clinical failure/dwelling time of the oldest lead. AUC, area under the curve; ROC, receiver-operating characteristics. A summary of the results is provided in Figure 2. Figure 2 Open in new tabDownload slide Summary of the results. Figure 2 Open in new tabDownload slide Summary of the results. Discussion To the best of our knowledge, this is the most extensive single-centre study on the impact of abandoned leads on the outcome of mechanical lead extraction procedures. The main results of our study can be summarized as follows. First, patients with abandoned leads are more complex, with more leads and comorbidities. In our cohort, patients with abandoned leads tended to have a higher number of leads, a longer dwelling time of the oldest lead, a history of previous unsuccessful extraction, in most cases an infective indication and more vegetations, compared to patients without abandoned leads. These data agree with the available literature where infective indications are higher in patients with abandoned leads (78.8% vs. 49.8% in the ELECTRa, 76.3% vs. 33.0% in the cohort of Merchant).5,8 It is likely that patients with abandoned leads represents a fragile subset, already considered high risk for TLE and therefore only referred for TLE when clinically unavoidable. Second, TLE procedures are often longer and challenging. Manual traction could be ineffective, with the need of sheath dilatation, including alternative venous approaches. This observation is in line with previous experiences, showing that the presence of abandoned leads is associated with a more complex procedure, a lower rate of MT effectiveness, a more extended procedure, longer fluoroscopy time, and a higher percentage of lead breakage.12,13 The evidence for a more aggressive approach to get a satisfactory success rate, arises one more time the question of safety. In terms of safety, the overall complication rate seems to be higher (8.4 vs. 3.1%, P < 0.001), even if no differences were observed for major complications (1.2% vs. 0.63%, P = 0.586), including death, which were all represented by cardiac tamponade, requiring interventions. Minor complications were more frequent (7.2% vs. 2.5%, P < 0.001) and included local haematoma and minimal pericardial effusion (Table 3). There are contrasting data in the literature on the role of the abandoned lead on a safety endpoint. Merchant et al.,5 in their analysis, did not find a significant difference in major complications between the two groups (2.6% vs. 1.2%; P = 0.397). Hussein et al.,6 in patients who underwent extraction for infective disease, found a higher rate of major complication in patients with previously abandoned leads (3.7% vs. 1.4%; P = 0.01), whereas Bracke et al.12 did not find this difference. In a recent analysis of the ELECTRa registry, major complication including deaths (5.5% vs. 2.3%, P = 0.0007) and procedure-related major complications (3.3% vs. 1.4%, P = 0.0123) were higher in patients with abandoned leads, and abandoned leads at the time of TLE was an independent predictor of complications (OR 1.69, CI 1.22–2.35).8 In our analysis, the rate of major complications was lower than observed in the literature. The different techniques and approaches for lead extraction could explain this disparity. Indeed, in previous studies, TLE was performed with mechanical or powered sheaths. In the ELECTRa, 27.1% of the patients were treated with powered sheaths and 19.3% of them with laser sheaths.1 Powered sheaths utilization correlated with procedure-related major complications, including death, and they were used often in patients with one or more abandoned leads.8 In the cohort of Merchant et al.,5 laser sheaths were used in two-thirds of patients without differences regardless the presence of abandoned leads. The rate of major complications was higher than in our experience, without significant differences between groups. In the cohort of Hussein et al.,6 a higher rate of laser sheath was employed in patients with abandoned leads, and the rate of major complications was significantly higher in this group, in comparison to patients with no abandoned leads. Recently, Zucchelli et al.14 found that the use of mechanical sheaths is associated with a lower incidence of vascular avulsion or tear after TLE. Our data, obtained using exclusively mechanical sheaths, confirmed these findings. Further prospective studies are warranted to assess whether outcomes of abandoned lead extraction were technique and approach dependent. Third, regarding efficacy, radiological and clinical success rate were remarkable, even if slightly lower if compared with Group 2 (92.54% vs. 97.91% and 90.40% vs. 98.13%, P < 0.001, respectively) (Tables 3 and4). Recently, Bracke et al.12 found a higher rate of clinical failure in patients with abandoned leads compared with patients without them. However, in their cohort, a different extraction technique was applied, with a femoral approach in 50.4% of patients, and a high rate of use of powered and laser sheaths.12 Another retrospective study5 associated abandoned leads with a higher proportion of femoral bailout extraction, with a lower clinical success, without a significant difference. Nevertheless, in this cohort, the proportion of patients with abandoned leads was lower than in our analysis (5% vs. 21%), and the implant time of the oldest lead was less (91 vs. 108 months).5 A sub-analysis of the ELECTRa registry highlighted a higher clinical failure in patients with previously abandoned leads at the time of TLE (89.8% vs. 96.6%).8 At the failure predictors analysis, efficacy seems to be patients and lead-related, considering that young women with ≥1 abandoned lead and a long dwell time (≥9 years) are at risk of failure (Table 6 and Figure 1). This value is in line with the cut-off threshold of 120 months found in the ELECTRa analysis, where an implant time higher than 120 months quadrupled the risk of clinical failure.1 Results showed that implant time has high sensitivity and specificity (AUC = 0.875) for the prediction of clinical failure and ROC analysis showed a dwelling time cut-off threshold of 107 months (8.92 years). Consistently, Segreti et al.8 found a very similar threshold of 9 years (108 months) for radiological failure and major complications. The use of mechanical sheaths may explain the absence of an excess of major complications in our cohort. Patients with abandoned leads most frequently needed surgical extraction (13/250 = 0.52% vs. 11/960 = 0.11%, P < 0.001) in order to obtain clinical success. The failure subgroups sub-analysis showed the need of a crossover to an alternative venous approach in Group 2 failures (27.88%), which was lower in Group 1 failures (8.69%), usually because it was not applicable for a common upper venous system occlusion or the lead was broken by previous extraction attempts. The higher rate of clinical failure in patients with old leads may be explained with a strong and consistent time-dependent fibrous adherence.15–17 With an increasing lead dwell time, increases in instances of lead adherences and fibrous tissue were observed.4,18–20 The negative effect of broken leads on TLE outcomes, underscores the importance of performing TLE procedures in high-volume centres.1 Notably, the presence of an ICD lead in our cohort was not a predictor of clinical failure. In a subgroup analysis, we observed that patients with an ICD had a lower dwelling time of the oldest lead and less abandoned leads. This result, never reported in the literature up to now, highlights the fact that old and abandoned leads could affect the efficacy of the procedure more than the presence of an ICD lead. These findings contrast with previous results reported in the literature.15 Reports show that patients with ICD lead experience a more complex procedure,16 a higher rate of complications,17 and a higher need for laser extraction. However, in a previous analysis, we reported high efficacy and safety in patients with Riata and Sprint Fidelis leads.18 Moreover, coils covered with expanded polytetrafluoroethylene may be removed more easily and quicker than non-ePTFE (expanded PolyTetraFluoroEthylene) leads, requiring less frequently MD.19 The lower dwelling time of ICD leads (63.3 ± 45.1 months, median 60, IQR 25.5–91) in contrast to pacing leads (81.2 ± 73.0 months, median 60, IQR 24–118) may explain these differences in term of outcome. However, the crossover to the jugular approach was higher in ICD leads than in pacing leads (8.6% vs. 6.5%; P = 0.10); this difference was only numerical and it does not reach statistical significance. Anyway, in our cohort limiting the consideration to patients with previously abandoned leads, the rate of clinical success was higher than 90%, and the rate of major complications was low (0.7%). In summary, patients with abandoned leads seem to be a very fragile subgroup with old leads, requiring challenging and long procedures. If approached with mechanical TLE, they are expected to have a lower, but still acceptable success rate, with only a greater number of minor (but not major) complications. Mechanical TLE could represent the optimal safe approach (single sheath MD and multiple venous approaches)9 in case of high-risk populations, like those patients with abandoned leads. Our data, comparable to those already published, confirm the cut-off of 9 years dwelling time for a safe and effective extraction: this parameter may be used in decision-making for abandoning of non-infected non-functional leads. Limitations The study has the inherent limitations of observational studies, but it includes the data in a prospectively maintained data registry. In case of extraction of more than one lead, it was not possible to identify the specific lead related to the complication. However, most of the patients used to have an infective indication, thus all leads needed to be removed. In the group of patients with abandoned lead a statistically higher rate of infective indications was observed in comparison to the group without abandoned leads. Furthermore, this difference is lower than that found in similar studies. According to these data, we have not enough data to assess the benefit of the extraction procedure in the absence of an infective indication. There is still room for improvement in the abandoned leads group regarding effectiveness, especially for infective indications. In these patients, further techniques may be necessary even in a centre with a great experience in mechanical extraction, in order to improve clinical success. Defining the optimal TLE procedure with the best risk-benefit balance is likely to be dependent on patient selection and centre/operator experience and related factors, which however mandates further analysis and optimally adequately designed randomized trials. Finally, the number of significant complications was low in the examined population; therefore, it was not possible to search for any predicting factor. Conclusions Mechanical TLE is a safe procedure in patients with abandoned leads, being associated with a high success rate and very few major procedural complications. Success rate was lower in the presence of abandoned leads, especially with very long dwelling time (>9 years). We could use the dwelling time of abandoned leads to predict procedural challenge and as a pre-procedural risk stratification marker to avoid useless TLE procedure, especially in case of malfunction. Conflict of interest: none declared. Data availability The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study. The data will be shared on reasonable request to the corresponding author. References 1 Bongiorni MG , Kennergren C , Butter C , Deharo JC , Kutarski A , Rinaldi CA et al. ; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) registry of transvenous lead extraction outcomes . Eur Heart J 2017 ; 38 : 2995 – 3005 . Google Scholar Crossref Search ADS PubMed WorldCat 2 Uslan DZ , Sohail MR , St Sauver JL , Friedman PA , Hayes DL , Stoner SM et al. . Permanent pacemaker and implantable cardioverter defibrillator infection: a population-based study . 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Transvenous extraction profile of Riata leads: procedural outcomes and technical complexity of mechanical removal . Heart Rhythm 2015 ; 12 : 580 – 587 . Google Scholar Crossref Search ADS PubMed WorldCat 19 Di Cori A , Bongiorni MG , Zucchelli G , Segreti L , Viani S , Paperini L et al. . Transvenous extraction performance of expanded polytetrafluoroethylene covered ICD leads in comparison to traditional ICD leads in humans . Pacing Clin Electrophysiol 2010 ; 33 : 1376 – 81 . Google Scholar Crossref Search ADS PubMed WorldCat 20 Di Cori A , Bongiorni MG , Zucchelli G , Segreti L , Viani S , de Lucia R et al. . Large, single center experience in transvenous coronary sinus lead extraction: procedural outcomes and predictors for mechanical dilatation . Pacing Clin Electrophysiol 2012 ; 35 : 215 – 22 . Google Scholar Crossref Search ADS PubMed WorldCat Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. 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TI - Safety and efficacy of transvenous mechanical lead extraction in patients with abandoned leads
JF - Europace
DO - 10.1093/europace/euaa134
DA - 2020-09-01
UR - https://www.deepdyve.com/lp/oxford-university-press/safety-and-efficacy-of-transvenous-mechanical-lead-extraction-in-3JzkSS2zlv
SP - 1401
EP - 1408
VL - 22
IS - 9
DP - DeepDyve
ER -