Repeat Transvenous Lead Extraction—Predictors, Effectiveness, Complications and Long-Term Prognostic Significance
Abstract
:1. Introduction
2. Methods
2.1. Study Population
2.2. Lead Extraction Procedure—Definitions
2.3. Procedure Information
2.4. Dataset and Statistical Methods
2.5. Approval of the Bioethics Committee
3. Results
3.1. General Differences between Groups of Patients with One TLE and Patients with re-Extraction
3.2. Patient-Related Risk Factors for Repeat TLE
3.3. TLE Complexity, Efficacy and Outcomes in Patients with Single TLE and Those with Re-Extraction
3.4. Procedure-Related Risk Factors for Repeat TLE
3.5. Predictors of Repeat TLE, Results of Cox Regression Analysis
3.6. Timing of Re-Extraction Procedure and Mortality after TLE
3.7. Indications for Initial and Repeat TLE
3.8. Failure of New (Replaced) and Old Functional Leads Preserved during first TLE
4. Discussion
5. Conclusions
Study Limitations
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Time Intervals [Years] | Number of TLEs N | First Re-Extraction N (%) | Re-Extraction Annually |
---|---|---|---|
2006–2010 | 672 | 13 (1.93%) | 2.60 |
2011–2015 | 1337 | 50 (3.74%) | 10.00 |
2016–2020 | 1394 | 88 (6.31%) | 17.60 |
2021 | 251 | 21 (8.37%) | 21.00 |
2006–2021 | 3654 | 172 (4.71%) | 10.75 |
Subsequent extractions | |||
2006–2021 | First re-extraction | Subsequent re-extraction (second or third) | Subsequent re-extraction annually |
172 | 21 (12.21%) | 1.31 |
All TLE Procedures (Patients) | Patients with a Single TLE | Patients with a First TLE and Re-extraction at a Later Time | Patients with a Second TLE | Patients with a Third and Fourth TLE | |
---|---|---|---|---|---|
N = 3654 Average ± SD n (%) | N = 3304 Average ± SD n (%) | N = 157 Average ± SD n (%) | N = 172 Average ± SD n (%) | N = 21 Average ± SD n (%) | |
Group Ia | Group Ib | Group IIa | Group IIb | ||
Patient characteristics | |||||
Patient age during TLE | 65.98 ± 15.63 | 66.65 ± 15.01 | 57.77 ± 20.32 p < 0.001 | 60.76 ± 19.08 p < 0.001 | 63.43 ± 15.39 p = 0.299 |
Patient age at first implantation | 57.58 ± 17.12 | 58.10 ± 16.56 | 49.92 ± 21.43 p < 0.001 | 54.48 ± 20.50 p = 0.115 | 57.86 ± 19.60 p = 0.744 |
Sex (female) | 1395 (38.18) | 1296 (39.23) | 57 (36.31) p = 0.595 | 41 (23.84) p < 0.001 | 8 (38.09) p = 0.907 |
Etiology—ischemic heart disease | 2033 (55.64) | 1866 (56.48) | 73 (46.50) p = 0.010 | 47 (27.33) p < 0.001 | 10 (47.62) p = 0.565 |
Renal failure (any) | 751 (20.55) | 692 (20.94) | 19 (12.10) p = 0.009 | 38 (22.09) p = 0.367 | 2 (9.52) p = 0.257 |
Diabetes (any) | 728 (19.92) | 680 (20.36) | 22 (14.01) p = 0.035 | 22 (12.79) p = 0.021 | 3 (14.29) p = 0.655 |
NYHA FC III or IV | 548 (15.00) | 502 (15.19) | 49 (31.21) p = 0.010 | 26 (15.12) p = 0.486 | 2 (9.52) p = 0.381 |
LVEF < 40% | 1126 (39.95) | 1007 (30.71) | 50 (31.85) p = 0.997 | 57 (35.63) p = 0.269 | 9 (42.86) p = 0.341 |
Congestive heart failure | 673 (18.42) | 616 (18.64) | 16 (10.19) p = 0.018 | 35 (20.35) p = 0.480 | 6 (28.57) p = 0.352 |
Charlson comorbidity index | 4.71 ± 3.67 | 4.81 ± 3.68 | 3.57 ± 3.45 p < 0.001 | 3.79 (3.41) p < 0.001 | 4.29 ± 3.59 p = 0.490 |
Indications for TLE Pearson’s Chi2 p < 0.001 | |||||
Systemic infection (with or without pocket infection) | 793 (21.70) | 747 (22.61) | 15 (9.55) p < 0.001 | 28 (16.28) p < 0.001 | 3 (14.29) p = 0.490 |
Local (pocket) infection (*—including first TLE performed in other centers) | 363 (9.93) * 366 (10.02) | 335 (10.14) | 7 (4.46) * 10 (6.37) p = 0.009 | 20 (11.63) p = 0.688 | 1 (4.76) p = 0.646 |
Mechanical lead damage (electrical failure) (*—including first TLE performed in other centers) | 984 (26.93) * 996 (27.26) | 876 (26.51) | 65 (41.40) * 77 (49.04) p < 0.001 | 37 (21.51) p = 0.193 | 6 (28.57) p = 0.974 |
Lead dysfunction (exit/entry block, dislodgement, perforation, extracardiac pacing) | 824 (22.55) | 722 (21.85) | 42 (26.75) p = 0.206 | 51 (29.65) p = 0.019 | 9 (42.86) p = 0.040 |
Abandoned lead/prevention of abandonment (upgrading, downgrading AF, multiple leads) | 328 (8.98) | 300 (9.08) | 16 (10.19) p = 0.449 | 10 (5.81) p = 0.481 | 2 (9.52) p = 0.850 |
Threatening/potentially threatening lead (loops, free ends, left heart, LDTVD) | 121 (3.31) | 105 (3.18) | 6 (3.82) p = 0.939 | 10 (5.81) p = 0.101 | 0 (0.00) p = 0.900 |
Other (MRI, cancer, painful pocket, pacing/ICD no longer needed) | 109 (2.98) | 99 (3.00) | 2 (1.27) p = 0.561 | 8 (4.65) p = 0.343 | 0 (0.00) p = 0.842 |
Regained venous access (sympt. occlusion, SVC syndr., lead replacement/upgrading) | 132 (3.61) | 120 (3.63) | 4 (2.55) p = 0.282 | 8 (4.65) p = 0.664 | 0 (0.00) p = 0.870 |
Type of CIED before TLE | |||||
Device type—PM (any) | 2565 (70.20) | 2350 (71.13) | 105 (66.88) p = 0.276 | 99 (57.56) p < 0.001 | 11 (52.38) p = 0.083 |
Device type—ICD | 799 (21.87) | 694 (21.01) | 44 (28.03) p = 0.065 | 53 (30.81) p < 0.001 | 8 (38.10) p = 0.105 |
Device type—CRT-D | 256 (7.01) | 229 (6.91) | 7 (4.46) p = 0.391 | 18 (10.47) p = 0.220 | 2 (9.52) p = 0.975 |
Only abandoned lead (unit removed earlier) | 34 (0.93) | 31 (0.94) | 1 (0.64) p = 0.967 | 2 (1.63) p = 0.915 | 0 (0.00) p = 0.488 |
All TLE Procedures (Patients) | Patients with a Single TLE | Patients with a First TLE and Re-Extraction at a Later Time | Patients with a Second TLE | Patients with a Third and Fourth TLE | |
---|---|---|---|---|---|
Group Ia | Group Ib | Group IIa | Group IIb | ||
N = 3654 Average ± SD n (%) | N = 3304 Average ± SD n (%) | N = 157 Average ± SD n (%) | N = 172 Average ± SD n (%) | N = 21 Average ± SD n (%) | |
Extracted leads | |||||
Dwell time of the oldest extracted lead [months] | 99.69 ± 74.30 | 101.8 ± 74.74 | 93.45 ± 67.97 p = 0.096 | 69.23 ± 62.97 p < 0.001 | 61.24 ± 72.15 p = 0.002 |
Cumulative dwell time of extracted leads [years] | 13.61 ± 12.58 | 14.02 ± 12.77 | 11.50 ± 10.36) p = 0.003 | 8.59 ± 9.30 p < 0.001 | 6.33 ± 6.74 p < 0.001 |
Number of CIED-related procedures before lead extraction | 1.86 ± 1.08 | 1.83 ± 1.06 | 1.84 (1.12) p = 0.581 | 2.37 ± 1.12 p < 0.001 | 3.11 ± 1.84 p = 0.023 |
Extraction of abandoned lead (any) | 378 (10.35) | 348 (10.53) | 19 (12.10) p = 0.497 | 10 (5.81) p = 0.087 | 1 (4.76) p = 0.721 |
Number of extracted leads per patient | 1.65 ± 0.73 | 1.67 ± 0.73 | 1.48 ± 0.68 p < 0.001 | 1.54 ± 0.67 p = 0.030 | 1.33 ± 0.48 p = 0.058 |
Extraction of 3 and more leads | 388 (10.62) | 366 (11.08) | 7 (4.46) p = 0.010 | 15 (8.72) p = 0.432 | 0 (0.00) p = 0.200 |
HV therapy (ICD) lead extraction | 1001 (27.40) | 881 (26.67) | 50 (31.85) p = 0.223 | 64 (37.21) p = 0.002 | 6 (28.57) p = 0.964 |
CS lead extraction | 233 (6.38) | 205 (6.21) | 6 (3.82) p = 0.986 | 21 (12.21) p = 0.060 | 1 (4.76) p = 0.455 |
Lead management strategy | |||||
All leads were extracted (including abandoned leads) | 2785 (76.22) | 2557 (77.39) | 96 (61.15) p < 0.001 | 121 (70.35) p = 0.037 | 11 (52.38) p = 0.015 |
Functional lead was left in place for continued use | 840 (22.99) | 723 (21.88) | 57 (36.31) p < 0.001 | 50 (29.07) p = 0.110 | 10 (47.62) p = 0.032 |
Superfluous lead was left in place (abandoned) | 20 (0.55) | 16 (0.48) | 4 (2.55) p = 0.019 | 0 (0.00) p = 0.480 | 0 (0.00) p = 0.905 |
Non-functional, superfluous lead was extracted | 378 (10.35) | 348 (10.53) | 19 (12.10) p = 0.120 | 10 (5.814) p = 0.117 | 1 (4.76) p = 0.290 |
TLE complexity | |||||
Procedural approach—left or right subclavian | 3518 (96.28) | 3185 (96.40) | 148 (94.27) p = 0.244 | 164 (95.35) p = 0.612 | 21 (100.0) p = 0.767 |
Procedural approach—both sides | 30 (0.82) | 27 (0.82) | 2 (1.27) p = 0.928 | 1 (0.58) p = 0.920 | 0 (0.00) p = 0.443 |
Procedural approach—other, combined | 106 (2.90) | 92 (2.79) | 7 (4.46) p = 0.451 | 7 (4.07) p = 0.452 | 0 (0.00) p = 0.819 |
Technical problems during TLE (%) | 733 (20.06) | 672 (20.34) | 35 (22.29) p = 0.945 | 24 (13.95) p = 0.052 | 2 (9.52) p = 0.170 |
2 or more technical problems (any) | 158 (4.32) | 148 (4.48) | 4 (2.55) p = 0.532 | 6 (3.49) p = 0.866 | 0 (0.00) p = 0.857 |
Procedure duration (sheath-to-sheath time) | 15.01 ± 22.76 | 15.15 ± 23.20 | 15.95 ± 18.66 p = 0.145 | 12.40 ± 18.13 p < 0.001 | 7.62 ± 9.09 p < 0.001 |
Procedure duration (average single lead extraction time) | 8.91 ± 8.91 | 8.90 ± 12.53 | 10.26 ± 9.91 p < 0.001 | 8.10 ± 12.37 p < 0.001 | 6.36 ± 9.14 p < 0.001 |
TLE procedure efficacy and outcomes | |||||
Minor complications (%) | 267 (7.31) | 240 (6.18) | 16 (10.19) p = 0.389 | 11 (6.40) p = 0.950 | 4 (19.05) p = 0.913 |
Major complications (%) | 73 (2.00) | 69 (2.07) | 3 (1.91) p = 0.928 | 1 (0.58) p = 0.272 | 0 (0.00) p = 0.915 |
Cardiac surgical intervention required (%) | 43 (1.78) | 42 (1.27) | 1 (0.64) p = 0.770 | 0 (0.00) p = 0.259 | 0 (0.00) p = 0.645 |
Procedure-related death (intra-, post-procedural) (%) | 6 (0.16) | 6 (0.182) | 0 (0.00) p = 0.687 | 0 (0.00) p = 0.681 | 0 (0.00) p = 0.845 |
Clinical success (%) | 3576 (97.87) | 3234 (97.88) | 153 (97.45) p = 0.971 | 168 (97.67) p = 0.990 | 21 (100.0) p = 0.956 |
Complete procedural success (%) | 3482 (95.29) | 3153 (95.43) | 143 (91.08) p = 0.013 | 166 (96.51) p = 0.747 | 20 (95.24) p = 0.615 |
Partial radiographic success (remained tip or < 4 cm lead fragment) (%) | 144 (3.94) | 128 (3.87) | 10 (6.37) p = 0.010 | 5 (2.91) p = 0.688 | 1 (4.76) p = 0.683 |
Cox Regression Model | Univariable Regression | Multivariable Regression | ||||
---|---|---|---|---|---|---|
HR | 95% CI | p | HR | 95% CI | p | |
Patient age at first implantation [per year] | 0.984 | 0.977–0.992 | <0.001 | 0.987 | 0.978–0.995 | 0.002 |
Patient age during TLE [per year] | 0.981 | 0.973–0.989 | <0.001 | |||
Charlson comorbidity index [per point] | 0.956 | 0.910–1.005 | 0.079 | |||
Etiology—ischemic heart disease | 0.966 | 0.704–1.327 | 0.832 | |||
Cumulative dwell time of extracted leads [per year] | 0.982 | 0.967–0.998 | 0.025 | 0.985 | 0.965–1.006 | 0.153 |
Number of extracted leads per patient | 0.614 | 0.477–0.791 | <0.001 | 1.018 | 0.732–1.416 | 0.916 |
Renal failure (any) | 0.868 | 0.541–1.393 | 0.558 | |||
Diabetes (any) | 0.814 | 0.518–1.278 | 0.371 | |||
Congestive heart failure | 1.079 | 0.646–1.804 | 0.770 | |||
Infectious indications for TLE | 0.281 | 0.179–0.442 | <0.001 | 0.360 | 0.219–0.592 | <0.001 |
Device type—ICD | 1.533 | 1.083–2.171 | 0.016 | 1.405 | 0.962–2.050 | 0.078 |
Functional lead left in place for continued use | 1.677 | 1.337–2.105 | <0.001 | 1.412 | 1.085–1.836 | 0.010 |
Superfluous lead left in place (abandoned) | 2.980 | 1.602–5.506 | <0.001 | 2.358 | 1.195–4.653 | 0.013 |
All leads were extracted | 0.480 | 0.349–0.661 | <0.001 | |||
Mean time of single lead extraction [per minute] | 1.004 | 0.993–1.015 | 0.488 | |||
Complete procedural success | 0.552 | 0.324–0.940 | 0.029 | 0.531 | 0.302–0.933 | 0.028 |
All TLE Procedures (Patients) | Patients with a Single TLE | Patients with a First TLE and Re-Extraction at a Later Time | Patients with a Second TLE | Patients with a Third and Fourth TLE | |
---|---|---|---|---|---|
Group Ia | Group Ib | Group IIa | Group IIb | ||
N = 3654 Average ± SD n (%) | N = 3304 Average ± SD n (%) | N = 157 Average ± SD n (%) | N = 172 Average ± SD n (%) | N = 21 Average ± SD n (%) | |
Timing of re-extraction | |||||
Time since last CIED procedure (implantation, re-implantation, upgrading, downgrading, lead replacement) | 45.44 ± 36.23 | 46.11 ± 47.76 | 47.76 ± 33.87 p = 0.345 | 29.74± 26.75 p < 0.001 | 14.27 ± 12.95 p < 0.001 |
No repeat TLE | 3461 (94.72) | 3304 (100.0) | 157 (100.0) | 0 (0.00) | 0 (0.00) |
Early re-extraction: 0–2 months | 18 (0.49) | 0 (0.00) | 0 (0.00) | 17 (9.88) | 1 (4.76) |
Delayed re-extraction: 3–12 months | 37 (1.01) | 0 (0.00) | 0 (0.00) | 31 (18.03) | 6 (28.57) |
Late re-extraction: 13–60 months | 84 (2.30) | 0 (0.00) | 0 (0.00) | 73 (42.44) | 11 (52.38) |
Very late re-extraction: > 60 months | 54 (1.48) | 0 (0.00) | 0 (0.00) | 51 (29.65) | 3 (14.29) |
All patients | 3654 (100.0) | 3304 (100.0) | 157 (100.0) | 172 (100.0) | 21 (100.0) |
Time since last extraction (months) | 42.56 ± 40.30 | 0.00 | 0.00 | 44.03 ± 41.05) | 30.57 (31.85) |
Short-, mid- and long-term prognosis after TLE | |||||
Follow-up [days] (min. ÷ max.) | 1948 ± 1381 (1÷5874) | 1927 ± 1375 (1 ÷ 5874) | 1507 ± 1109 (9 ÷ 4181) p < 0.001 | 1537 ± 1152 (9 ÷ 4222) p < 0.001 | 1643 ± 1081 (353 ÷ 3962) p = 0.472 |
Alive during follow-up | 2462 (67.38) | 2198 (66.53) | 117 (74.52) | 130 (75.58) | 17 (80.95) |
Died during follow-up | 1192 (32.63) | 1106 (33.48) | 40 (25.48) | 42 (24.42) | 4 (19.05) |
Log-rank p = 0.229 (Ia vs. IIa vs. IIb) | |||||
2-day mortality (first 48 h) | 11 | 11 | 0 | 0 | 0 |
1-month mortality (2–30 days) | 45 | 41 | 0 | 4 | 0 |
1-year mortality (31–365 days) | 237 | 224 | 2 | 10 | 1 |
3-year mortality (366–1095 days) | 300 | 282 | 8 | 9 | 1 |
>3-year mortality (> 1095 days) | 599 | 548 | 30 | 19 | 2 |
TLE Indications | Systemic Infection | Local Pocket Infection | Mechanical Lead Damage | Lead Dysfunction | Other TLE Indications | All TLE n (%) |
---|---|---|---|---|---|---|
Indications for primary TLE | ||||||
Systemic infection | 15 | - | - | - | - | 15 (8.72) |
Local pocket infection | - | 10 | - | - | - | 10 (5.81) |
Mechanical lead damage | - | - | 77 | - | - | 77 (44.77) |
Lead dysfunction | - | - | - | 42 | - | 42 (24.42) |
Other TLE indications | - | - | - | - | 28 | 28 (16.28) |
All | 15 | 10 | 77 | 42 | 28 | 172 (100.0) |
Indications for repeat TLE in patients grouped depending on primary TLE indications | ||||||
Systemic infection | 6 | 6 | 9 | 3 | 4 | 28 (16.28) |
Local pocket infection | 1 | 1 | 9 | 7 | 2 | 20 (11.63) |
Mechanical lead damage | 2 | 1 | 26 | 4 | 4 | 37 (21.51) |
Lead dysfunction | 4 | 1 | 14 | 23 | 9 | 51 (29.65) |
Other TLE indications | 2 | 1 | 19 | 5 | 9 | 36 (20.93) |
All | 15 | 10 | 77 | 42 | 28 | 172 (100.0) |
Indications for repeat (third or fourth) TLE in patients, grouped depending on primary TLE indications | ||||||
Systemic infection | 1 | 1 | 0 | 1 | 0 | 3 (14.29) |
Local pocket infection | 1 | 0 | 0 | 0 | 0 | 1 (4.76) |
Mechanical lead damage | 1 | 0 | 6 | 0 | 1 | 8 (30.10) |
Lead dysfunction | 0 | 0 | 0 | 7 | 0 | 7 (33.33) |
Other TLE indications | 0 | 0 | 0 | 1 | 1 | 2 (9.52) |
All | 3 | 1 | 6 | 9 | 2 | 21 (100.0) |
Lead Failure on Re-Extraction (all) 193 TLE Procedures | ||
---|---|---|
Attached Lead New/Old | Number of Cases | |
Lead dysfunction | new | 50 (48.54%) |
Mechanical lead damage | new | 41 (39.54%) |
Lead dysfunction | old | 9(8.74%) |
Mechanical lead damage | old | 3 (2.91%) |
All | 103 (100%) |
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Kutarski, A.; Jacheć, W.; Nowosielecka, D.; Czajkowski, M.; Tułecki, Ł.; Polewczyk, A. Repeat Transvenous Lead Extraction—Predictors, Effectiveness, Complications and Long-Term Prognostic Significance. Int. J. Environ. Res. Public Health 2022, 19, 15602. https://doi.org/10.3390/ijerph192315602
Kutarski A, Jacheć W, Nowosielecka D, Czajkowski M, Tułecki Ł, Polewczyk A. Repeat Transvenous Lead Extraction—Predictors, Effectiveness, Complications and Long-Term Prognostic Significance. International Journal of Environmental Research and Public Health. 2022; 19(23):15602. https://doi.org/10.3390/ijerph192315602
Chicago/Turabian StyleKutarski, Andrzej, Wojciech Jacheć, Dorota Nowosielecka, Marek Czajkowski, Łukasz Tułecki, and Anna Polewczyk. 2022. "Repeat Transvenous Lead Extraction—Predictors, Effectiveness, Complications and Long-Term Prognostic Significance" International Journal of Environmental Research and Public Health 19, no. 23: 15602. https://doi.org/10.3390/ijerph192315602