The Influence of Lead-Related Venous Obstruction on the Complexity and Outcomes of Transvenous Lead Extraction
Abstract
:1. Background
Goal of the Study
2. Methods
2.1. Study Population
2.2. Venography
2.3. Lead Extraction Procedure
2.4. TEE Monitoring during TLE
2.5. Statistical Analysis
2.6. Approval of the Bioethics Committee
3. Results
Patient Groups
4. Discussion
5. Study Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
AnV | innominate (brachiocephalic) vein |
AxV | axillary vein |
CIED | cardiac implantable electronic device |
CRT | cardiac resynchronization therapy |
EF | ejection fraction |
FU | follow-up |
ICD | implantable cardioverter-defibrillator |
IVC | inferior vena cava |
LR | lead-related |
LRVSO | lead-related venous stenosis/occlusion |
LV | left ventricle |
LVEF | left ventricular ejection fraction |
NYHA | The New York Heart Association (functional class) |
Pts | patients |
PM | pacemaker |
RA | right atrium |
RV | right ventricle |
TEE | transesophageal echocardiography |
TLE | transvenous lead extraction |
ScV | subclavian vein |
SVC | superior vena cava |
TV | tricuspid valve |
VSO | venous stenosis/occlusion |
References
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All Patients (2909) | Mean/Number | SD/% |
---|---|---|
Patient age during TLE [years] | 66.90 | 13.99 |
Patient age at first implantation [years] | 58.51 | 15.67 |
Sex (% of female patients) | 1147 | 39.43% |
Etiology: IHD, MI | 1676 | 57.61% |
Etiology: cardiomyopathy, valvular heart disease | 448 | 15.40% |
Etiology: congenital, channelopathies, neurocardiogenic, post cardiac surgery | 784 | 26.95% |
LVEF [%] | 48.89 | 15.21 |
Renal failure (any) | 607 | 20.87% |
Previous sternotomy | 435 | 14.95% |
Charlson comorbidity index [number of points] | 4.775 | 3.625 |
Systemic infection (with pocket infection or not) | 599 | 20.59% |
Local (pocket) infection | 253 | 8.70% |
Lead failure (replacement) | 1505 | 57.74% |
Change of pacing mode/upgrading, downgrading | 176 | 6.05% |
Other (abandoned lead/prevention of abandonment (AF, superfluous leads), threatening/potentially threatening lead (loops, free ending, left heart, LDTD), other (MRI indications, cancer, painful pocket, loss of indications for pacing/ICD), regaining venous access (symptomatic occlusion, SVC syndrome, lead replacement/upgrading) | 374 | 12.86% |
System: pacemaker (any) | 2013 | 69.20% |
System: ICD-V, ICD-D | 281 | 22.93% |
System: CRT-D | 667 | 7.80% |
Dwell time of the oldest lead per patient before TLE [months] | 101.5 | 75.57 |
Cumulative lead dwell time before TLE [years] | 15.31 | 12.925 |
Major complications: all | 61 | 2.10% |
Major complications (with rescue cardiac surgery) | 35 | 1.20% |
Major complications (without rescue cardiac surgery) | 7 | 1.20% |
Minor complications | 174 | 5.98% |
No Stenosis 1 | Mild Stenosis 2 | Moderate Stenosis 3 | Severe Stenosis 4 | Total Occlusion 5 | ANOVA Kruskal–Wallis Test (1–5) p | Mann–Whitney U/Chi2 Tests (1–2) vs. (4–5) | |
---|---|---|---|---|---|---|---|
Number of Patients | N = 499 (17.15%) | N = 574 (19.73%) | N = 605 (20.80%) | N = 581 (19.97%) | N = 650 (22.34%) | ||
Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | |||
Patient-related risk factors for TLE complexity and complications | |||||||
Patient age during TLE [years] | 64.48 ± 14.85 | 66.74 ± 13.69 | 66.64 ± 13.79 | 68.57 ± 13.04 | 67.68 ± 14.32 | <0.001 | <0.001 |
Male gender | 325 (65.13) | 324 (56.44) | 324 (53.55) | 342 (58.86) | 447 (68.77) | <0.001 | 0.019 |
Etiology: IHD, MI | 278 (55.71) | 329 (57.31) | 353 (58.34) | 361 (62.13) | 355 (54.62) | 0.112 | |
Etiology: non-ischemic | 221 (44.29) | 245 (42.69) | 252 (41.66) | 220 (37.87) | 295 (45.38) | 0.112 | |
NYHA class III and IV (%) | 67 (13.42) | 96 (16.72) | 71 (11.73) | 196 (33.74) | 99 (15.23) | 0.523 | |
LVEF < 40% | 158 (31.66) | 173 (30.14) | 177 (29.26) | 196 (33.74) | 215 (33.08) | 0.847 | |
Renal failure (any) | 88 (17.64) | 119 (20.73) | 122 (20.17) | 121 (20.83) | 156 (24.00) | 0.211 | |
Previous sternotomy | 81 (16.23) | 85 (14.81) | 79 (13.06) | 76 (13.08) | 114 (17.54) | 0.210 | |
Charlson comorbidity index [number of points] | 4.543 ± 3.789 | 4.702 ± 3.380 | 4.688 ± 3.589 | 5.086 ± 3.629 | 4.728 ± 3.550 | 0.038 | 0.016 |
CIED system and history of pacing | |||||||
Device type—pacemaker (any) | 350 (70.14) | 402 (70.04) | 416 (68.76) | 384 (66.09) | 461 (70.92) | 0.193 | |
Device type—ICD-V, ICD-D | 126 (25.25) | 127 (22.13) | 144 (23.80) | 141 (24.27) | 127 (19.54) | 0.142 | |
Device type—CRT-D | 21 (4.208) | 44 (7.666) | 44 (7.237) | 56 (9.639) | 62 (9.54) | 0.006 | 0.002 |
Redundant loop of the lead on X-Rays before TLE | 20 (4.01) | 21 (3.659) | 25 (4.132) | 26 (4.475) | 44 (6.769) | 0.074 | 0.047 |
Lead with proximal end in CVS before TLE | 9 (1.804) | 10 (1.742) | 7 (1.150) | 11 (1.893) | 14 (2.154) | <0.001 | 0.762 |
Number of CIED-related procedures before TLE (SD) | 1.728 ± 0.970 | 1.701 ± 0.881 | 1.777 ± 1.068 | 1.806 ± 0.959 | 2.088 ± 1.300 | <0.001 | <0.001 |
TLE before current TLE | 23 (4.609) | 23 (4.007) | 19 (3.140) | 27 (4.647) | 39 (6.00) | 0.200 | |
Risk factors for major complications and procedure complexity | |||||||
Number of extracted leads per patient [n] | 1.597 ± 0.619 | 1.582 ± 0.681 | 1.623 ± 0.666 | 1.683 ± 0.719 | 1.835 ± 0.880 | <0.001 | <0.001 |
Three or more leads extracted | 30 (6.012) | 46 (8.014) | 55 (9.090) | 73 (12.57) | 113 (17.38) | <0.001 | <0.001 |
Approach: left | 483 (96.79) | 551 (95.99) | 578 (95.54) | 548 (94.32) | 599 (92.15) | 0.002 | <0.001 |
Approach: right | 7 (1.403) | 9 (1.568) | 12 (1.980) | 17 (2.930) | 11 (1.690) | 0.443 | |
Approach: both | 1 (0.200) | 3 (0.523) | 3 (0.496) | 5 (0.860) | 14 (2.154) | 0.003 | 0.009 |
Approach: femoral | 1 (0.200) | 2 (0.348) | 2 (0.331) | 0 (0.00) | 6 (0.923) | 0.225 | |
Approach: subclavian-femoral | 3 (0.601) | 4 (0.697) | 3 (0.496) | 2 (0.344) | 5 (0.970) | 0.581 | |
Approach: other, combined | 4 (0.802) | 3 (0.523) | 5 (0.826) | 9 (1.549) | 14 (2.150) | 0.061 | 0.017 |
Approach: Jugular | 0 (0.00) | 2 (0.348) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0.086 | 0.420 |
Extraction of leads with redundant loop | 14 (2.806) | 14 (2.439) | 20 (3.306) | 21 (3.614) | 37 (5.690) | 0.026 | 0.011 |
Extraction of broken lead with proximal end in CS | 11 (2.204) | 11 (1.916) | 7 (1.157) | 10 (1.721) | 16 (2.460) | 0.756 | |
Extraction of abandoned lead(s) (any) | 35 (7.014) | 45 (7.840) | 39 (6.446) | 60 (10.33) | 102 (15.69) | <0.001 | <0.001 |
Extraction of abandoned lead(s) [n] | 0.074 ± 0.277 | 0.103 ± 0.380 | 0.083 ± 0.340 | 0.138 ± 0.441 | 0.208 ± 0.520 | <0.001 | <0.001 |
Oldest extracted lead (months] | 96.25 ± 73.71 | 102.4 ± 74.46 | 100.3 ± 76.37 | 94.21 ± 70.22 | 104.86 ± 76.70 | 0.078 | |
Average (per patient) extracted lead dwell time [months] | 92.24 ± 67.47 | 97.85 ± 67.97 | 95.38 ± 70.31 | 88.59 ± 62.52 | 96.49 ± 67.68 | 0.163 | |
Cumulative dwell time of extracted leads [years] | 12.30 ± 12.11 | 13.57 ± 12.43 | 13.55 ± 12.47 | 12.98 ± 11.59 | 15.39 ± 14.13 | 0 < 0.001 | 0.008 |
SAFeTY TLE calculator of risk for MC [points] | 5.290 ± 4.117 | 5.828 ± 4.130 | 5.995 ± 4.249 | 5.597 ± 4.090 | 6.333 ± 4.560 | 0.002 | <0.024 |
SAFeTY TLE calculator of risk for MC [%] | 1.470 ± 2.566 | 1.621 ± 2.490 | 1.782 ± 3.430 | 1.608 ± 2.690 | 2.089 ± 3.650 | 0.002 | <0.001 |
No Stenosis 1 | Mild Stenosis 2 | Moderate Stenosis 3 | Severe Stenosis 4 | Total Occlusion 5 | ANOVA Kruskal–Wallis Test (1–5) p | ANOVA Kruskal–Wallis Test (1–2) vs. (4–5) | |
---|---|---|---|---|---|---|---|
Number of Patients | N = 499 | N = 574 | N = 605 | N = 581 | N = 650 | ||
Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | |||
TLE complexity | |||||||
Procedure duration (skin-to-skin) [minutes] | 57.66 ± 22.54 | 59.18 ± 25.99 | 58.23 ± 20.90 | 59.33 ± 24.09 | 64.16 ± 33.85 | 0.018 | 0.075 |
Procedure duration (sheath-to-sheath) [minutes] | 12.36 ± 19.06 | 13.26 ± 21.86 | 12.73 ± 17.14 | 13.56 ± 20.36 | 20.32 ± 32.45 | <0.001 | <0.001 |
Average time of single lead extraction [minutes] | 8.149 ± 11.26 | 8.441 ± 15.05 | 7.755 ± 9.616 | 7.568 ± 8.884 | 10.56 ± 15.30 | <0.001 | 0.126 |
All leads were extracted | 399 (79.96) | 432 (75.26) | 450 (74.38) | 420 (72.29) | 503 (77.38) | 0.040 | 0.181 |
Functional lead was left in place for continuous use | 98 (19.64) | 137 (23.87) | 153 (25.29) | 157 (27.02) | 141 (21.69) | 0.030 | 0.207 |
Non-functional lead was left in place | 1 (0.200) | 3 (0.523) | 1 (0.165) | 1 (0.172) | 6 (0.923) | 0.302 | |
Non-functional superfluous lead was extracted | 35 (7.014) | 45 (7.840) | 39 (6.446) | 60 (10.33) | 102 (15.69) | <0.001 | <0.001 |
Technical problem during TLE (any) | 85 (17.03) | 110 (19.16) | 116 (19.17) | 109 (18.76) | 162 (24.92) | 0.011 | 0.025 |
Block in implant vein (subclavian region) | 34 (6.814) | 39 (6.794) | 48 (7.934) | 43 (7.401) | 65 (10.00) | 0.154 | |
Lead-to-lead binding | 28 (5.611) | 33 (5.749) | 39 (6.446) | 42 (7.229) | 64 (9.846) | 0.030 | 0.009 |
Byrd dilator collapse/torsion/“fracture” | 16 (3.206) | 19 (3.310) | 19 (3.140) | 19 (3.270) | 23 (3.538) | 0.968 | |
Lead fracture during extraction | 22 (4.409) | 22 (3.833) | 31 (5.124) | 29 (4.991) | 51 (7.846) | 0.004 | 0.014 |
Need to change venous approach | 12 (2.405) | 13 (2.265) | 14 (2.314) | 18 (3.098) | 41 (6.308) | <0.001 | <0.002 |
Functional lead dislodgement | 6 (1.202) | 8 (1.394) | 6 (0.992) | 5 (0.861) | 5 (0.769) | 0.824 | |
Loss of lead fragment | 2 (0.401) | 8 (1.394) | 6 (0.992) | 5 (0.861) | 5 (0.769) | 0.800 | |
Reel of ICD lead coil | 2 (0.401) | 4 (0.697) | 5 (0.826) | 1 (0.172) | 2 (0.308) | 0.222 | |
Number of big technical problems | 1.316 ± 0.637 | 1.325 ± 0.718 | 1.313 ± 0.685 | 1.330 ± 0.620 | 1.500 ± 0.784 | 0.002 | 0.053 |
One technical problem only | 57 (11.42) | 65 (11.32) | 76 (12.56) | 64 (11.01) | 81 (12.46) | 0.925 | |
Two technical problems | 16 (3.206) | 12 (2.091) | 12 (1.983) | 21 (3.614) | 33 (5.077) | 0.006 | 0.029 |
Three or more technical problems | 3 (0.601) | 6 (1.045) | 8 (1.322) | 3 (0.515) | 14 (2.154) | <0.001 | 0.302 |
Other smaller technical problems | 25 (5.010) | 23 (4.007) | 26 (4.298) | 22 (3.787) | 49 (7.538) | 0.003 | 0.192 |
Use of additional tools | |||||||
Evolution (old and new) or tight rail | 7 (1.403) | 5 (0.871) | 8 (1.322) | 7 (1.205 | 17 (2.615) | 0.121 | |
Metal sheath | 30 (6.012) | 36 (6.272) | 50 (8.264) | 40 (6.886) | 63 (9.692) | 0.064 | 0.051 |
Lasso catheter/snare | 14 (2.806) | 13 (2.265) | 17 (2.810) | 17 (2.926) | 33 (5.077) | 0.017 | 0.052 |
Basket catheter | 7 (1.403) | 6 (1.045) | 4 (0.661) | 2 (0.344) | 8 (1.231) | 0.284 |
No Stenosis 1 | Mild Stenosis 2 | Moderate Stenosis 3 | Severe Stenosis 4 | Total Occlusion 5 | ANOVA Kruskal–Wallis Test (1–5) p | ANOVA Kruskal–Wallis Test (1–2) vs. (4–5) | |
---|---|---|---|---|---|---|---|
Number of Patients | N = 499 | N = 574 | N = 605 | N = 581 | N = 650 | ||
Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | Mean ± SD n (%) | |||
TLE efficacy and complications | |||||||
Major complications (any) | 8 (1.603) | 10 (1.742) | 11 (1.818) | 16 (2.754) | 16 (2.461) | 0.599 | |
Hemopericardium | 5 (1.002) | 6 (1.045) | 8 (1.322) | 11 (1.893) | 9 (1.385) | 0.707 | |
Hemothorax | 3 (0.601) | 3 (0.523) | 1 (0.165) | 0 (0.00) | 3 (0.462) | 0.288 | |
Tricuspid valve damage during TLE | 2 (0.401) | 4 (0.697) | 2 (0.331) | 5 (0.861) | 3 (0.462) | 0.722 | |
Rescue cardiac surgery | 4 (0.802) | 3(0.523) | 8 (1.322) | 9 (1.549) | 10 (1.538) | 0.286 | |
Minor complications (any) | 31 (6.212) | 35 (6.098) | 46 (7.438) | 44 (7.229) | 60 (8.615) | 0.278 | |
Procedure-related death (intra-, post-procedural) | 1 (0.200) | 1 (0.174) | 1 (0.165) | 2 (0.344) | 1 (0.154) | 0.401 | |
Indication-related death (intra-, post-procedural | 1 (0.200) | 0 (0.00) | 0 (0.00) | 1 (0.172) | 0 (0.00) | 0.485 | |
Partial radiographic success (remained tip or <4 cm lead fragment) | 13 (2.605) | 18 (3.136) | 22 (3.636) | 18 (3.098) | 34 (5.231) | 0.203 | |
Complete clinical success | 492 (98.60) | 563 (98.08) | 592 (97.85) | 570 (98.11) | 634 (97.54) | 0.806 | |
Complete procedural success | 481 (96.39) | 550 (95.82) | 578 (95.54) | 556 (95.70) | 611 (94.00) | 0.322 | |
Organizational model of TLE procedure. TEE monitoring | |||||||
Routine TEE monitoring of lead extraction | 261 (52.31) | 266 (46.34) | 263 (43.37) | 263 (45.27) | 233 (35.85) | <0.001 | <0.001 |
TLE-related TV dysfunction | |||||||
Increase in TR by 1 degree | 22 (4.409) | 26 (4.530) | 29 (4.793) | 38 (6.540) | 39 (6.000) | 0.234 | |
Increase in TR by 2 degrees | 8 (1.603) | 5 (0.871) | 13 (2.149) | 10 (1.721) | 11 (1.692) | 0.632 | |
Increase in TR by 3 degrees | 2 (0.401) | 2 (0.348) | 3 (0.496) | 0 (0.00) | 3 (0.462) | 0.892 | |
Increase in TR by 2 degrees and to Grade IV | 2 (0.401) | 4 (0.697) | 3 (0.496) | 5 (0.861) | 3 (0.462) | 0.839 | |
Damage to chordae tendineae during TLE | 14 (2.806) | 15 (2.613) | 18 (2.975) | 24 (4.131) | 25 (3.846) | 0.531 | |
Short-, mid- and long-term mortality after TLE | |||||||
Survival in 1712 ± 1187 (1–4638) days of follow up | 375 (75.15) | 389 (67.77) | 436 (72.07) | 373 (64.20) | 409 (62.92) | <0.001 | <0.001 |
Death within 48 h | 3/499 (0.601) | 1/574 (0.174) | 1/605 (0.165) | 3/581 (0.516) | 2/650 (0.308) | 0.794 | |
One-month mortality; 2–30 days; n (% of patients with follow-up longer than 2 days) | 4/495 (0.808) | 9/573 (1.571) | 5/604 (0.828) | 4/578 (0.692) | 7/648 (1.080) | 0.464 | |
One-year mortality (31–365 days); n (% of patients with follow-up >30 days) | 31/491 (6.314) | 40/558 (7.168) | 43/597 (7.203) | 38/573 (6.632) | 37/640 (5.781) | 0.889 | |
Three-year mortality (366–1095 days); n (% of patients with follow-up >365 days | 24/433 (5.543) | 51/482 (10.581) | 50/514 (9.728) | 74/499 (14.83) | 59/579 (10.19) | <0.001 | <0.001 |
Death at >3 years (at 1095 days); n (% of patients with follow-up >1095 days) | 62/359 (17.27) | 84/429 (19.58) | 70/447 (18.57) | 89/447 (19.91) | 136/569 (23.90) | <0.001 | <0.001 |
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Czajkowski, M.; Jacheć, W.; Polewczyk, A.; Kosior, J.; Nowosielecka, D.; Tułecki, Ł.; Stefańczyk, P.; Kutarski, A. The Influence of Lead-Related Venous Obstruction on the Complexity and Outcomes of Transvenous Lead Extraction. Int. J. Environ. Res. Public Health 2021, 18, 9634. https://doi.org/10.3390/ijerph18189634
Czajkowski M, Jacheć W, Polewczyk A, Kosior J, Nowosielecka D, Tułecki Ł, Stefańczyk P, Kutarski A. The Influence of Lead-Related Venous Obstruction on the Complexity and Outcomes of Transvenous Lead Extraction. International Journal of Environmental Research and Public Health. 2021; 18(18):9634. https://doi.org/10.3390/ijerph18189634
Chicago/Turabian StyleCzajkowski, Marek, Wojciech Jacheć, Anna Polewczyk, Jarosław Kosior, Dorota Nowosielecka, Łukasz Tułecki, Paweł Stefańczyk, and Andrzej Kutarski. 2021. "The Influence of Lead-Related Venous Obstruction on the Complexity and Outcomes of Transvenous Lead Extraction" International Journal of Environmental Research and Public Health 18, no. 18: 9634. https://doi.org/10.3390/ijerph18189634