As cardiac implantable electronic devices (CIED) are increasingly widely used to treat patients with sinus node disease and atrioventricular block, to prevent sudden cardiac death and to manage patients with advanced heart failure, the incidence of pacemaker complications has been rising since the end of the
Since the beginning of the
We analyzed clinical data obtained from 1915 patients undergoing TLE at the Reference Center between 2006 and 2015. TLE was performed by a single operator, most frequently using different polypropylene Byrd dilator sheaths, rarely mechanical sheaths, tools for extraction via the femoral approach, or nonstandard tools for dissecting the proximal lead tips. Laser or electrosurgical dissection sheaths were not used.
TLE was defined according to the 2017 HRS consensus guidelines [
Infectious and noninfectious indications for TLE were classified according to the 2017 HRS consensus guidelines. The efficacy of TLE was assessed also according to the 2017 HRS consensus guidelines as complete procedural success and clinical success including complete and partial radiographic success [
Complication of the procedure was regarded as permanently disabling if patients required emergency sternotomy or thoracotomy, developed significant deterioration of tricuspid valve (at least by 2 grades in echocardiography), and reported any, event mild, constant deterioration in the state of health.
Failure (procedural, clinical, and radiographic) referred to inability to achieve complete procedural or clinical success.
Major (MJC) and minor (MIC) complications were defined according to the 2017 HRS consensus guidelines [
Damage to the outer lead insulation in the intracardiac segment (15-20 cm from the lead tip), frequently exposing the conductor, detected during visual inspection was termed as intracardiac lead abrasion (ILA) [
Factors potentially influencing the efficacy of TLE were analyzed in a group of 1915 patients in whom a total of 3207 leads had been explanted between 2006 and 2015.
Depending on complications occurrence the patients were divided into groups; first included uncomplicated patients (n=1790), second included patients with major complication (n=34) with subgroup of periprocedural death (n=7), and third included patients with minor complication only (n=91). In addition, a group of all patients who died during a 30-day follow-up was separated (n=28). We evaluated the effect of clinical and procedure-related factors such as type of the implanted device and procedures prior to TLE on the development of MJC and MIC as well as periprocedural and 30-day mortality. The data were collected and prepared for multivariate analysis to assess the factors that led someone to developing major (including periprocedural death) and minor complications during TLE.
Mortality at 30 days after TLE was evaluated on the basis of the data obtained from the Ministry of the Interior.
The study was approved by the local Bioethics Committee.
Continuous variables were expressed as mean ± standard deviation and median with interquartile range (IQR). Categorical variables were reported as number and percentage. Due to large differences in the number of compared groups we decided to use nonparametric tests to compare differences between groups. Continuous variables were compared by Mann-Whitney U test, whereas categorical data were compared using the Chi-square test incorporating Yates correction.
Logistic regression analysis was performed to evaluate the relationship between the variables and the development of complications, whereas univariate and multivariate Cox proportional hazards regression model was used for analysis of 30-day survival. Multivariate logistic regression analysis with stepwise algorithm selection was performed to evaluate the relationship between the variables and the development of complications, whereas multivariate Cox proportional hazards regression model with stepwise algorithm selection was used for analysis of 30-day survival, and periprocedural deaths were excluded. The Kaplan-Meier curves of freedom from death were used to evaluate the effect of MJC and MIC on 30-day survival. Differences in survival data were compared with the log-rank test. Analogically to the Cox regression analysis, complete data and cut-off points were included in the log-rank test. Differences between groups were deemed statistically significant if the p value was <0.05 or when the 95% confidence interval did not include 1. Statistical analysis was performed with Statistica 10.0 software, Minneapolis, USA.
Indications for TLE included cardiac device infections (CDI) in 773 (41.3%) patients and noninfectious indications (NI) in 1142 (58.7%) patients. A total of 3207 leads were extracted, including 2882 (89.9%) functional and 325 (10.1%) nonfunctional, abandoned leads. Complete procedural success was achieved in 94.78% of patients, clinical success in 97.86%, and complete and partial radiographic success in 94.78% and 94.83%, respectively. Periprocedural death occurred in 7 (0.4%) patients. There were 34 (1.8%) MJC and 91 (4.8%) MIC. In total, during 30-day follow-up 28 (1.46%) deaths occurred.
A baseline comparative analysis and univariate logistic regression analysis initially showed that the clinical factor significantly increasing the risk of MJC was female gender [OR: 3.345; p<0.001]. Increased risk for developing of MIC (30.2 % by 1 g/dl) was related to lower hemoglobin concentration [OR: 1.302; p<0,001]. The potential clinical factors significantly increasing the risk for developing MIC included female gender [OR: 3.354; p<0.01]; chronic renal failure (CRF) [OR: 2.189; p<0.05); and higher left ventricle ejection fraction (29.4% by 10%) [OR: 1.294; p<0.05]. The increased risk for MIC was additionally found in patients after sternotomy [OR:1.953; p<0.01], implantation of mechanical or bioprosthetic valves [OR: 2.464; p<0.01], and with lead-related infective endocarditis (LRIE) [OR: 1.777; p<0.01], especially isolated LRIE [OR: 2.155; p<0.01], i.e., without signs of pocket infection (PI) (Table
Clinical risk factor analysis of transvenous lead extraction.
Variables | All patients | Uncomplicated procedures | Major complications | Minor complications | Periprocedural death | 30-day mortality |
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all procedures | ||||||
Number of patients (number, %) | 1915 (100%) | 1790 (93.5%) | 34 (1.8%) | 91 (4.8%) | 7 (0.4%) | 28 (1.5%) |
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Patient’s age at TLE (mean, SD median, IQR) | 64.83 | 64.99 | | | | |
±15.95 | ±15.73 | ±17.20 | ±18.91 | ±11.06 | ±10.20 | |
68.00 | 68.00 | 67.00 | 69.00 | 72.00 | 72,00 | |
[58.00-76.00] | [58.00-76.00] | | [56.00-76.00] | [65.00-80.00] | [65.00-80.00] | |
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Female gender (n, %) | 822 (42.90) | 749 (41.20) | | | | |
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BMI (kg/m2) (mean, SD median, IQR) | 27.48 | 27.29 | | | | |
±6.82 | ±4.12 | ±3.59 | ±3.96 | ±1.86 | ±4.68 | |
27.14 | 27.28 | 26.70 | 25.83 | 26.37 | 25.76 | |
[24.03-30.44) | [24.03-30.47] | [24.86-30.19] | [22.49-29.75] | [25.48-27.24] | [21.23-27.76] | |
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NYHA functional class (mean, SD median, IQR) | 1.64 | 1.64 | | | | |
±0.72 | ±0.72 | ±0.71 | ±0.71 | ±0.79 | ±0.89 | |
2 | 2 | 1 | 1 | 1 | 2 | |
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NYHA classes I and II (n, %) | 1675 (87.50) | 1566 (87.50) | | | | |
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NYHA classes III and IV (n, %) | 240 (12.50) | 224 (12.50) | | | | |
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Left ventricular ejection fraction LVEF (mean, SD median, IQR) | 38.91 | 38.74 | | | | |
±13.40 | ±13.40 | ±13.26 | ±13.48 | ±14.64 | ±14.03 | |
41.88 | 41.88 | 45.54 | 44.53 | 42.00 | 34.95 | |
[30.24-46.53] | [29.47-46.53] | [34.01-48.59] | [37.37-47.71] | [29.50-50.00] | [21.28-37.99] | |
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Diabetes types I and II (n, %) | 357 (18.6) | 335 (18.7) | | | | |
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Chronic renal failure (CRF) creatinine level (mean, SD median, IQR) | 1.17 | 1.16 | | | | |
±0.73 | ±0.69 | ±0.67 | ±1.30 | ±0.62 | ±1.61 | |
1.00 | 1.00 | 1.00 | 1.10 | 1.10 | 1.50 | |
[0.84-1.28] | [0.88-1.25] | [0.80-1.25] | [0.80-1.30] | [1.00-1.30] | [1.20-2.10] | |
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CRF creatinine level>2 mg/dl (n, %) | 107 (5,59) | 93 (5.20) | | | | |
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Malignancy (n, %) | 116 (6.06) | 109 (6.09) | | | | |
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Hemoglobin concentration (mean, SD median, IQR) | 13.17 | 13.2 | | | | |
±2.79 | ±1.83 | ±2.23 | ±2.29 | ±2.00 | ±2.59 | |
13.30 | 13.40 | 12.15 | 11.80 | 13.00 | 12.20 | |
[12.00-14.40] | [12.10-14.40] | [10.40-14.00] | [10.70-13.70] | [11.50-14.20] | [8.80-13.60] | |
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Hemoglobin concentration<12 g/dl (n,%) | 463 (24.18) | 396 (22.12) | | | | |
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Valvular cardiac implant (n, %) | 113 (5.90) | 100 (5.59) | | | | |
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Prior sternotomy (n, %) | 291 (15.2) | 256 (14.90) | | | | |
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Permanent AF (n, %) | 429 (22.4) | 406 (22.7) | | 18 | 2 | 10 |
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Chronic anticoagulation (n, %) | 653 (34.1) | 617 (34.5) | 8 | 28 | 2 | 11 |
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Chronic antiplatelet therapy (n, %) | 798 (41.7) | 764 (42.7) | 10 | | 1 | 10 |
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Cardiac device infections (n, %) | 773 (41.3) | 716 (40.0) | 12 | 45 | 5 | |
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Lead-related infective endocarditis (LRIE) ( n%) | 527 (27.5) | 480 (26.8) | 11 | | 4 | |
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Isolated LRIE (n, %) | 217 (11.3) | 191 (10.7) | 7 | | 3 | |
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Pocket infection (PI) (n, %) | 556 (29.0) | 525 (29.3) | 5 | 26 | 2 | 11 |
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Vegetations (n, %) | 383 (20.0) | 347 (19.4) | 7 | 29 | 2 | |
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Large vegetations | 209 (10.9) | 182 (10.2) | 6 | 21 | | |
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Vegetations connected with heart wall (n, %) | 37 (1.93) | 34 (1.90) | 0 | 4 | 0 | 2 |
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Multiple vegetations (n, %) | 191 (9.97) | 173 (9.66) | 3 | 15 | 1 | |
NS: nonsignificant;
From factors that were directly procedure-related, the risk for developing MJC (including periprocedural deaths) and MIC was significantly increased in patients with older leads, measured as dwell time of the oldest one extracted lead in patient: MJC [OR: 1.162; p<0.001] and MIC [OR: 1.069; p<0.001], mean dwell time of leads extracted in patient: MJC [OR: 1.196; p<0.001] and MIC [OR: 1.084; p<0.000], and sum of dwell time of leads extracted in single patient: MJC [OR: 1.073; p<0.001] and MIC [OR: 1.029; p<0.001]. The risk for developing MJC was also higher in patients undergoing atrial lead extraction [OR: 2.830; p<0.05] as well as simultaneous removal of leads from both sides of the chest [OR: 10.27; p<0.001]. Extraction of abandoned leads (and their number) was associated with more frequent occurrence of MJC, respectively: [OR: 2.110; p<0.001] and [OR: 2.427; p<0.001]. Removal of unipolar leads was associated with a significantly higher risk for developing MJC [OR: 3.166; p<0.001] and MIC [OR: 2.027; p<0.01]. A significant increase in the risk of MJC was also observed in patients undergoing extraction of more than four leads [OR: 4.093; p<0.01], via the right-side approach [OR: 5.008; p<0.01] or requiring a more complex approach to lead extraction [OR: 1.860; p<0.001]. Any technical problem during TLE also had a significant influence on the frequency of MJC [OR: 2.476; p<0.001], especially fibrotic adhesions binding the leads together which were associated with MJC occurrence [OR: 4.262; p<0.001] and periprocedural mortality [OR: 7.719; p<0.001) (Table
Procedure-related risk factor analysis of transvenous lead extraction.
Potential risk factors | All patients | Uncomplicated procedures | Major | Minor complications | Periprocedural death | 30-day mortality |
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all procedures | complications | |||||
Number of patients (n, %) | 1915 (100%) | 1790 (93.5%) | 34 (1.8%) | 91 (4.8%) | 7 (0.4%) | 28 (1.5%) |
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Number of active leads in system (mean, SD median, IQR) | 1.90 | 1.81 | 1.76 | 1.76 | 2.00 | 1.71 |
±0.64 | ±0.64 | ±0.61 | ±0.60 | ±0.82 | ±0.71 | |
2 | 2 | 2 | 2 | 2 | 2 | |
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Presence of defibrillation lead -ICD (VVI or DDD) (n, %) | 513 (26.80) | 496 (27.10) | 4 | | 2 | 4 |
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CRT-D system (n, %) | 106 (5.53) | 101 (5.64) | 1 | 4 | 1 | 1 |
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CRT-P system (n, %) | 54 (2.82) | 52 (2.91) | 0 | 2 | 0 | 1 |
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Lead/system implanted under age of 30 (n, %) | 173 (9.03%) | 149 (8.32%) | | | 0 (0.00%) | 1 3.57% |
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Sum of dwell times of all leads in cardiovascular system (CVS) before TLE (years) | 13.75 | 13.08 | | | | 19.24 |
±11.95 | ±11.15 | ±20.52 | ±12.31 | ±20.0 | ±16.57 | |
10.33 | 9.92 | 30.00 | 15.67 | 29.17 | 13.50 | |
[5.17-18.50] | [5.00-18.00] | [20.00-38.17] | [9.42-27.08] | [9.25-41.25] | [7.33-28-00] | |
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Intracardiac lead abrasion (ILA) (n, %) | 423 (22.10) | 473 (20.80) | 12 | 38 | 2 | 0 |
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Number of CIED-related procedures before TLE (mean, SD median, IQR) | 1.92 | 1.89 | 3.29 | 2.27 | 3.57 | 2.54 |
±2.60 | ±2.62 | ±1.78 | ±1.24 | ±2.15 | ±1.60 | |
2 | 2 | 3 | 2 | 2 | 2 | |
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Presence of abandoned lead(s) before TLE (n, %) | 280 (14.6) | 247 (13.80) | 13 | 20 | 3 | 7 |
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Number of abandoned leads per patient (mean, SD median, IQR) | 0.20 | 0.19 | 0.50 | 0.26 | 0.71 | 0.43 |
±0.55 | ±0.52 | ±0.86 | ±0.61 | ±1.25 | ±0.84 | |
0 | 0 | 0 | 0 | 0 | 0 | |
| | | | | | |
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Leads on both sides of the chest (n, %) | 90 (4.70) | 79 (4.41) | 6 | 5 | 1 | 2 |
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Previous upgrade with lead abandonment (n, %) | 121 (6.32) | 105 (5.87) | 5 | 11 | 2 | 6 |
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Lead-related venous occlusion or severe stenosis (n, %) | 632 (33.00) | 586 (32.70) | 16 | 30 | 4 | 9 |
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Previous unsuccessful attempt of lead removal (n, %) | 44 (2.30) | 38 (2.12) | 2 | 4 | 1 | 3 |
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Dwell time of the oldest extracted lead per patient (years) (mean, SD, median, IQR) | 7.61 | 7.31 | 16.35 | 10.38 | 16.35 | 14.73 |
±5.87 | ±5.59 | ±9.00 | ±6.54 | ±9.00 | ±10.85 | |
7.61 | 6.00 | 15.25 | 9.42 | 13.33 | 9.25 | |
[3.25-10.42] | [3.16-10.08] | [10.17-20.42] | [5.50-14.25] | [8.33-19.33] | [4.83-14.58] | |
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Average dwell time of leads extracted per patient (years) (mean, SD median, IQR) | 6.87 | 6.63 | 13.55 | 9.22 | 13.55 | 12.12 |
±4.98 | ±4.81 | ±6.75 | ±5.18 | ±6.75 | ±6.75 | |
5.83 | 5.60 | 13.45 | 8.83 | 10.32 | 8.08 | |
[3.17-9.25] | [3.00-9.08] | [9.04-19.08] | [5.00-13.00] | [8.83-19.33] | [3.67-14,00] | |
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Sum of dwell time of extracted leads in patient (years) (mean, SD median, IQR) | 12.02 | 11.44 | 29.59 | 16.76 | 33.29 | 30.37 |
±11.20 | ±10.55 | ±20.72 | ±12.40 | ±20.52 | ±20.0 | |
8,50 | 8.17 | 27.25 | 13.00 | 27.25 | 13.50 | |
[4.08-16.50] | [4.00-15.83] | [16.42-36.33] | [7.00-24.83] | [9.25-29.17] | 97.33-27.25] | |
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HV/ICD lead extraction (n, %) | 482 (25.2) | 467 (26.1) | 4 | 11 | 2 | 4 |
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Coronary sinus (CS) lead extraction (n, %) | 262 (13.7) | 248 (13.9) | 5 | 9 | 3 | 5 |
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Right atrial (RA) lead extraction (n, %) | 1128 (58.9) | 1048 (58.5) | 27 | 53 | 5 | 18 |
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Right ventricular (RV) lead extraction (n, %) | 1650 (86.2) | 1540 (86.0) | 28 | 82 | 5 | 24 |
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Extraction of leads implanted on both sides of the chest during the same TLE procedure (n, %) | 35 (1.83) | 27 (1.51) | 5 | 3 | 1 | 1 |
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Extraction of abandoned lead (n, %) | 237 (12.4) | 216 (12.1) | 10 | 11 | 0 | 7 |
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0.17 | 0.16 | 0.50 | 0.26 | 0.29 | 0.39 | |
Number of extracted abandoned leads per patient (mean, SD median, IQR) | ±0.50 | ±0.48 | ±0.86 | ±0.61 | ±0.76 | ±0.79 |
0 | 0 | 0 | 0 | 0 | 0 | |
| | | | | | |
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Unipolar (UP) atrial (A) lead extraction (n, %) | 102 | 86 | 7 | 9 | 7 | 0 |
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UP ventricular (V) (PM) lead extraction (n, %) | 184 | 161 | 8 | 15 | 0 | 0 |
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UP A+V (PM) lead extraction (n, %) | 229 | 195 | 15 | 19 | 15 | 0 |
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Extraction of UP leads above median age (n, %) | 137 | 106 | 15 | 16 | 0 | 2 |
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Extraction of 4 and more leads during TLE procedure (n, %) | 81 | 71 | 5 | 5 | 1 | 1 |
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Any technical problems during TLE (n, %) | 294 (15.3) | 256 (14.3) | 13 | 25 | 3 | 6 |
NS: nonsignificant;
Of the other procedure-related factors, the number of preceding procedures had a significant effect on developing both MJC [OR: 1.795; p<0.001] (including higher risk of periprocedural deaths [OR: 1.836; p<0.001]) and MIC [OR: 1.289; p<0.001]. The risk of complications increased significantly in relation with the number of abandoned leads (MIC [OR: 1.694; p<0.05]), (MJC [OR: 3.747; p<0.001]) and TLE of leads implanted on both sides of the chest (MJC [OR: 4.579; p<0.001]) (Table
Potential device-related factors increasing the risk for developing MIC were sum of dwell times of leads in single patient before TLE [OR: 1.028; p<0.001], lead implantation under the age of 30 [OR: 2.234; p<0.005], and presence of intracardiac lead abrasions [OR: 2.680; p<0.001]. TLE of defibrillation leads was connected with decreased risk of MIC by 60% [OR: 0.400; p<0.01)] (Table
A separate analysis demonstrated that the presence of vegetations (especially >2 cm) placed the patient at increased risk of periprocedural death and increased near five times the risk of death in 30-day follow-up [HR: 4.612; p<0.001] (Table
In view of the dominant influence of the system age on TLE complications, a separate analysis of the effect of each of the leads dwell time variants was made. For this purpose, three models of multivariate logistic regression were built based on the dwell time of the oldest one extracted lead in patient, mean dwell time of leads extracted in patient, and sum of dwell time of leads extracted in single patient.
The multivariate logistic regression after stepwise algorithm selection (p<0.2) showed that the strongest values in prediction of MJC are age of the extracted leads (increase in risk by 3.1 to 18.1% per year), female gender (increase in risk from 2.36 to 2.91 times), number of abandonment leads in patients (increase in risk by 65.3 to 75.7%), number of any technical problems during TLE (increase in risk by 36.9%), and number of previous CIED procedures in patient (increase in risk by 27.6%). Lower by 1g/dl of blood hemoglobin concentration was associated with an increase in the risk of MJC occurrence by 22.4% to 27.4% (Table
Risk factors of minor and major complications—multivariate logistic stepwise regression.
| | | |
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Dwell time of the oldest one | 1.138 | 1.090-1.188 | 0.000 |
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Female gender | 2.362 | 1.098-5.078 | 0.028 |
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Hemoglobin concentration | 1.271 | 1.064-1.515 | 0.008 |
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Number of abandoned leads in the patient (by one) | 1.653 | 1.086-2.515 | 0.019 |
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Mean dwell time of leads | 1.181 | 1.118-1.247 | 0.000 |
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Female gender | 2.390 | 1.103-5.180 | 0.027 |
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Hemoglobin concentration | 1.274 | 1.066-1.524 | 0.008 |
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Number of any technical problems during TLE | 1.369 | 1.017-1.841 | 0.038 |
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Number of abandoned leads in the patient (by one) | 1.757 | 1.126-2.742 | 0.013 |
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Sum of dwell time of leads (1 year) | 1.056 | 1.031-1.082 | 0.000 |
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Female gender | 2.709 | 1.266-5.797 | 0.010 |
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Hemoglobin concentration | 1.224 | 1.020-1.468 | 0.029 |
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Number of previous procedures in patient (by one) | 1.276 | 0.980-1.662 | 0.070 |
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Hemoglobin concentration [1g/dl] | 1.332 | 1.198-1.479 | 0.000 |
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Previous sternotomy | 1.756 | 1.062-2.905 | 0.028 |
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Lack of antiplatelet therapy | 1.724 | 1.052-2.825 | 0.031 |
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First implantation of CIED under the age of 30 | 2.170 | 1.195-3.940 | 0.011 |
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Malposition of the lead in the left ventricle | 6.930 | 1.360-35.318 | 0.020 |
Risk of MIC was higher in patients with previous sternotomy (increase in risk by 75.6% [OR: 1.756; p<0.05]), first implantation of CIED under the age of 30 (increase in risk 2.17 times [OR: 2.170; p<0.05]), malposition of the lead in the left ventricle (increase in risk 6.93 times [OR: 6.93; p<0.01]), lack of antiplatelet therapy (increase in risk by 72.4% [OR: 1.724; p<0.05]), and lower blood hemoglobin concentration (increase in risk by 33.2% per 1 g% of hemoglobin [OR: 1.332; p<0.001]) (Table
Multivariate Cox proportional hazards regression showed that the risk factors of death in 30-day follow-up were infective indications (increase risk over nine times [HR: 9.335; p<0.001]), a higher functional class of NYHA [HR: 3.059; p<0.001], chronic renal dysfunction [HR: 5.095; p<0.001], previous unsuccessful TLE [HR: 4.727; p<0.05], and MJC occurrence [HR: 3.147; p<0.05]. Sum of dwell time of leads extracted in single patient also worsened the prognosis but these parameters reached the borderline statistical significance [HR: 1.032; p=0.051] (Figure
Risk factors of death in 30-day follow-up, results of multivariate stepwise Cox regression.
The Kaplan–Meier curves of time free from death depending on clinical success, NYHA class (I,II versus III,IV), infectious indications for TLE, and median of hemoglobin concentration in 30-day follow-up and results of log rang tests were presented in Figure
Kaplan–Meier death-free survival probability in 30-day follow-up depending on (a) failure of clinical success of TLE, (b) indications for TLE (infective versus noninfective), (c) NYHA class before TLE (I,II versus III, IV), and (d) previous unsuccessful attempt to TLE.
The Kaplan-Meier death-free survival probability in 30-day follow-up depending on the indications for TLE (infective versus noninfective), p<0.001
The Kaplan-Meier death-free survival probability in 30-day follow-up depending on chronic renal failure (CRF), p<0.001
The Kaplan-Meier death-free survival probability in 30-day follow-up depending on the NYHA class before TLE (I,II, versus III, IV), p<0.001
The Kaplan-Meier death-free survival probability in 30-day follow-up depending on previous unsuccessful attempt to TLE, p<0.01
Transvenous lead extraction has become a common procedure worldwide. It is estimated that 10-15 thousand leads are removed annually and the need for lead extractions will probably continue to increase [
In the available literature, there is no detailed analysis of procedure-related factors. The world’s largest registry of patients undergoing TLE at the Cleveland Clinic did not confirm the importance of procedure-related factors except the effect of lead implant duration on the development of major cardiovascular injury (MCVI) as well as the relationship between ICD lead removal and 30-day mortality in the univariate analysis. The multivariate analysis did not show the direct effect of the sum of lead dwell times, number, and type of extracted leads on the development of MJC [
The presence of abandoned, superfluous leads was another extremely important predictor of adverse patient outcomes associated with TLE in the present study. There is still much debate about whether we should leave abandoned leads in place or extract them. Although the Cleveland registry did not demonstrate increased risk associated with the presence of abandoned leads, recent reports from the same center evaluating patients undergoing TLE for infectious reasons confirmed apart from more frequent occurrence of vegetations, a higher rate of complications developing during the procedure [
Of the clinical factors in the present study female sex and low hemoglobin levels were the most important predictors of adverse outcomes following TLE. Although in previous investigations women were found to have more complications [
In the present study, apart from evaluating predictors of major complications, we analyzed also minor complications, which appeared to influence significantly 30-day mortality after TLE. Risk factors for MIC were similar to those observed for major ones; however, in the multivariate analysis, a significant effect of the implantation of the system at the young age and the history of sternotomy was demonstrated. A potentially higher procedural risk in patients with implanted devices younger than 30 years is especially worth emphasizing, because there is still a belief in the high risk of TLE in older people. It is however noteworthy that none of the available studies documented the effect of patient older age on the procedure efficacy. Moreover, previous investigators demonstrated the high efficacy of TLE in patients aged 80 and 90 years, comparable to that in younger subjects [
The present study describes mainly procedure-related predictors of adverse outcomes in patients undergoing TLE; however evaluation of survival is very important. As shown in the present study 30-day mortality was affected by entirely different determinants, mainly the clinical ones such as heart failure, renal failure, and device infections. Most of these factors were demonstrated in the Cleveland registry [
Multivariate analysis of such a large number of procedure-related factors is difficult to perform because of mutually exclusive determinants and marked predominance of one parameter over the other. In this situation, trivariate analysis was used to evaluate most reliably the effect of individual factors on the risk associated with TLE.
Procedure-related variables have been found to be the most important predictors of adverse outcomes in patients undergoing transvenous lead extraction. A better understanding of these determinants allows for implementing strategies that minimize procedure-related risk and improve the efficacy and safety of TLE. Female sex and anemia were found to be the only significant clinical, patient-dependent factors. It is noteworthy that other clinical factors, frequently analyzed by other investigators such as heart failure, chronic renal failure, and pacemaker infections did not determine the immediate results of transvenous lead extraction. These factors together with minor complications influenced 30-day mortality after TLE and for this reason should be monitored closely in the periprocedural period.
The data from the TLE database maintained by the main operator used to support the findings of this study are included within the article.
The abstract of the manuscript has been presented as poster in ESC Congress 2017, 26-30 August, Barcelona, Spain.
The authors declare no conflicts of interest.
The study was financed under the grant of Silesian Medical University: KNW-1-106 / K / 7 / K. Publication of an article will be found by Silesian Medical University.