Transvenous Lead Extraction in Adult Patient with Leads Implanted in Childhood-Is That the Same Procedure as in Other Adult Patients?
Abstract
:1. Introduction
2. Methods
2.1. Study Population
2.2. Lead Extraction Procedure
2.3. Definitions
2.4. Statistical Analysis
2.5. Approval of the Bioethics Committee
3. Results
4. Discussion
5. Study Limitations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Groups | CIP (A) | AIP (B) | A vs. B | ||
---|---|---|---|---|---|
Number | 98 | 2659 | |||
Mean ± SD n (%) | Mean ± SD n (%) | p | |||
Patient characteristics | |||||
Patient age at TLE [years] | 27.46 | 6.77 | 66.49 | 9.38 | <0.001 |
Patient age at first system implantation [years] | 13.04 | 4.47 | 58.44 | 11.51 | <0.001 |
Sex (female patients) | 48 | 48.98% | 994 | 37.38 | 0.009 |
Etiology: (ischemic heart disease) | 1 | 1.025% | 1507 | 56.68 | <0.001 |
Etiology: cardiomyopathy | 5 | 5.10% | 465 | 17.49 | 0.002 |
Etiology: congenital, channelopathy, neurocardiogenic, or cardiac surgery | 92 | 93.88% | 696 | 26.18 | <0.001 |
NYHA class III and IV | 0 | 0.00% | 401 | 15.08 | <0.001 |
LVEF average [%] | 60.00 | 8.69 | 47.81 | 15.48 | <0.001 |
Tricuspid regurgitation before TLE: significant | 13 | 13.27% | 362 | 13.61% | 0.957 |
Tricuspid regurgitation before TLE: severe | 3 | 3.06% | 89 | 3.35% | 0.895 |
Diabetes (any) | 2 | 2.04% | 561 | 21.10% | <0.001 |
Renal failure (any) | 0 | 0.00% | 543 | 20.42% | <0.001 |
Creatinine level [mg/dL] | 0.83 | 0.17 | 1.24 | 1.84 | <0.001 |
BMI [kg/m2] | 24.34 | 4.40 | 28.31 | 5.40 | <0.001 |
Previous sternotomy | 20 | 21.04% | 400 | 15.04% | 0.191 |
Valve prosthesis | 5 | 5.10% | 216 | 8.12% | 0.372 |
Long-term anticoagulation | 8 | 8.16% | 1076 | 40.47% | <0.001 |
Long-term antiplatelet treatment | 7 | 7.14% | 1229 | 46.22% | <0.001 |
Charlson comorbidity index [points] | 0.20 | 1.01 | 4.73 | 3.52 | <0.001 |
Indications for TLE (main, predominant) | |||||
Systemic infection | 12 | 12.24% | 595 | 22.38% | 0.024 |
Local (pocket) infection | 6 | 6.12% | 263 | 9.89% | 0.289 |
Mechanical lead damage (electrical failure) | 43 | 43.87% | 684 | 25.72% | <0.001 |
Lead dysfunction (exit/entry block, dislodgement, or extracardiac pacing) | 8 | 8.16% | 331 | 12.45% | 0.266 |
Lead dysfunction caused by (usually dry) perforation | 6 | 6.12% | 289 | 10.87% | 0.185 |
Change of pacing mode/upgrading, downgrading | 4 | 4.08% | 163 | 6.13% | 0.536 |
Abandoned lead/prevention of abandonment (AF, superfluous leads) | 2 | 2.04% | 87 | 3.27% | 0.699 |
Threating/potentially threatening lead (loops, free ending, left heart, or LDTVD) | 9 | 9.18% | 80 | 3.01% | 0.002 |
Other (MRI indications, cancer, painful pocket, or pacing/ICD no longer necessary) | 5 | 5.10% | 66 | 2.48% | 0.199 |
Re-establishing venous access (symptomatic occlusion, SVC syndrome, or lead replacement/upgrading) | 3 | 3.06% | 101 | 3.80% | 0.915 |
Groups | CIP (A) | AIP (B) | A vs. B | ||
---|---|---|---|---|---|
Number | 98 | 2659 | |||
Mean ± SD n (%) Median * IQR * | Mean ± SD n (%) Median * IQR * | p | |||
Patient/system/procedure information | |||||
System removal—infection | 17 | 17.35% | 779 | 29.30% | 0.014 |
Upgrading | 18 | 18.36% | 294 | 11.06% | 0.037 |
Downgrading | 0 | 0.00% | 100 | 3.76% | 0.093 |
Lead replacement | 48 | 48.97% | 1289 | 48.48% | 0.943 |
Superfluous lead extraction | 7 | 7.14% | 86 | 3.23% | 0.069 |
Complete device system removal | 4 | 4.08% | 38 | 1.43% | 0.092 |
System removal—reimplantation deferred | 4 | 4.08% | 73 | 2.75% | 0.643 |
System and history of pacing | |||||
PM—AAI | 3 | 3.06% | 192 | 7.22% | 0.169 |
PM—DDD | 62 | 63.27% | 1185 | 44.57% | <0.001 |
PM—VDD | 2 | 2.04% | 53 | 1.99% | 0.738 |
PM—VVI | 22 | 22.45% | 268 | 10.08% | <0.001 |
PM—CRT-P | 0 | 0.00% | 74 | 2.78% | 0.175 |
Abandoned only PM lead (unit removed earlier) before TLE | 1 | 1.02% | 20 | 0.75% | 0.771 |
ICD—VVI | 2 | 2.04% | 347 | 13.05% | 0.002 |
ICD—DDD | 6 | 6.12% | 291 | 10.94% | 0.178 |
ICD—CRT-D | 0 | 0.00% | 220 | 8.27% | 0.006 |
Abandoned only ICD lead (unit removed earlier) before TLE | 0 | 0.00% | 8 | 0.30% | 0.680 |
Leads before TLE | |||||
Number of leads in the system | 1.69 | 0.48 | 1.83 | 0.65 | 0.105 |
Patients with abandoned leads | 19 | 19.39% | 308 | 11.58% | 0.029 |
Number of abandoned leads | 0.26 | 0.60 | 0.16 | 0.49 | 0.328 |
Patients with multiple abandoned leads | 6 | 6.12% | 102 | 3.84% | 0.367 |
Number of leads in the heart | 1.96 | 0.74 | 1.98 | 0.77 | 0.392 |
ICD lead presence | 7 | 7.14% | 839 | 31.55% | <0.001 |
One single-coil ICD lead | 3 | 3.06% | 344 | 12.94% | 0.006 |
Dual-coil ICD lead | 2 | 2.04% | 443 | 16.66% | <0.001 |
CS lead presence | 1 | 1.02% | 481 | 18.09% | <0.001 |
Leads on the left side of the chest | 83 | 84.69% | 2512 | 94.47% | <0.001 |
Leads on the right side of the chest | 5 | 5.10% | 67 | 2.52% | 0.201 |
Leads on both sides of the chest | 10 | 10.20% | 80 | 3.01% | <0.001 |
Previous TLE | 10 | 10.20% | 126 | 4.74% | 0.027 |
Excessive lead slack on X ray | 16 | 16.33% | 137 | 5.15% | <0.001 |
Number of procedures before lead extraction | 2.23 | 1.14 | 1.87 | 1.02 | <0.001 |
Dwell time of oldest lead per patient [months] | 169.0 * | 109.0 * | 75.96 * | 81.96 * | <0.001 |
Mean lead implant duration (per patient) [months] | 156.0 * | 85.68 * | 72.00 * | 73.68 * | <0.001 |
Groups | CIP (A) | AIP (B) | A vs. B | ||
---|---|---|---|---|---|
Number | 98 | 2659 | |||
Mean ± SD n (%) Median * IQR * | Mean ± SD n (%) Median * IQR * | p | |||
Venue of the procedure | |||||
Electrophysiology laboratory | 42 | 42.86% | 1405 | 52.84% | 0.066 |
Cardiac surgery operating room | 18 | 18.37% | 504 | 18.99% | 0.989 |
Hybrid room | 38 | 38.78% | 750 | 28.21% | 0.031 |
The role of cardiac surgeon | |||||
Co-operator | 51 | 52.04% | 1262 | 47.46% | 0.468 |
Standby | 47 | 47,96% | 1397 | 52.54% | 0.468 |
Type of anesthesia | |||||
General anesthesia | 47 | 47.96% | 1162 | 43.70% | 0.465 |
Local anesthesia + general sedation, analgesia | 51 | 52.04% | 1497 | 56.30% | 0.465 |
TEE monitoring as mandatory standard (with rare exceptions) since 2015 y | |||||
Routine TEE in monitoring lead extraction | 38 | 38.78% | 1022 | 38.44% | 0.970 |
Lack of TEE monitoring during TLE procedure as the rule | 60 | 61.22% | 1637 | 61.56% | 0.970 |
Procedure-related risk factors for major complications and increased procedure complexity | |||||
Number of extracted leads in one patient | 1.84 | 0.93 | 1.67 | 0.77 | 0.328 |
One or two leads were extracted | 89 | 90.82% | 2345 | 88.19% | 0.719 |
Three or more leads were extracted | 9 | 9.18% | 312 | 11.73% | 0.562 |
Leads extracted from both sides of the chest during the same TLE | 4 | 4.08% | 33 | 1.24% | 0.051 |
Approach—left (side of the chest) | 79 | 80.61% | 2508 | 94.32% | <0.001 |
Approach—right (side of the chest) | 6 | 6.12% | 48 | 1.81% | 0.008 |
Approach—both (sides of the chest) | 4 | 4.08% | 19 | 0.71% | 0.002 |
Approach—subclavian + femoral | 3 | 3.06% | 21 | 0.79% | 0.002 |
Extraction of lead with endocardial excessive slack | 12 | 12.24% | 94 | 3.54% | <0.001 |
Extraction of broken lead with endocardial excessive slack | 3 | 3.06% | 67 | 2.52% | 0.994 |
Extraction of abandoned lead(s) (any) | 19 | 19.39% | 288 | 10.83% | 0.015 |
Extraction of abandoned lead(s) (per patient) | 2.27 | 0.02 | 0.15 | 0.00 | 0.030 |
ICD lead extracted | 7 | 7.14% | 788 | 29.64% | <0.001 |
CS (LV pacing) lead extracted | 0 | 0.00% | 185 | 6.96% | 0.013 |
Oldest extracted lead dwell time [months] | 169.0 * | 96.00 * | 75.00 * | 81.96 * | <0.001 |
Mean (per patient) extracted lead dwell time [months] | 156.0 * | 89.04 * | 72.96 * | 87.76 * | <0.001 |
Cumulative dwell time of extracted leads (sum of dwell times of extracted leads) [years] | 20.67 * | 15.00 * | 8.83 * | 12.25 * | <0.001 |
SAFeTY score of MC risk [20]—number of points | 10.35 | 4.16 | 5.65 | 4.21 | <0.001 |
Groups | CIP (A) | AIP (B) | A vs. B | ||
---|---|---|---|---|---|
Number | 98 | 2659 | |||
Median * IQR * n (%) | Median * IQR * n (%) | p | |||
Procedure complexity | |||||
Procedure duration (“skin-to-skin”) [minutes] | 63.00 * | 22.00 * | 55.00 * | 20.00 * | <0.001 |
Procedure duration (“sheath-to-sheath”) [minutes] | 21.00 * | 26.00 * | 8.00 * | 8.00 * | <0.001 |
Mean time of single lead extraction (“sheath-to-sheath”/number of extracted leads) [minutes] All leads extracted | 12.50 * | 18.00 * | 4.50 * | 5.00 * | <0.001 |
84 | 88.42% | 2001 | 75.25% | 0.021 | |
Functional leads left in place for continued use | 14 | 14.74% | 636 | 23.92% | <0.001 |
Non-functional leads left in place | 0 | 0.00% | 16 | 0.60% | 0.926 |
Non-functional, superfluous leads extracted | 19 | 20.00% | 288 | 10.83% | 0.013 |
Procedure complexity/unexpected technical problems | |||||
Technical problem during TLE (any) | 48 | 50.53% | 521 | 19.59% | <0.001 |
Blockage in implant vein (subclavian region) | 16 | 16.84% | 188 | 7.07% | <0.001 |
Lead-to-lead adhesion | 14 | 14.74% | 181 | 6.81% | 0.008 |
Byrd dilator collapse/torsion/“fracture” | 15 | 15.79% | 77 | 2.90% | <0.001 |
Extracted lead fracture/rupture during extraction | 22 | 23.16% | 150 | 5.64% | <0.001 |
Need to use alternative approach | 14 | 14.74% | 103 | 3.87% | <0.001 |
Number of technical problems | 1.61 | 1.00 | 1.35 | 0.67 | <0.001 |
One technical problem only | 24 | 25.26% | 304 | 11.43% | <0.001 |
Two technical problems | 13 | 13.68% | 74 | 2.78% | <0.001 |
Three or more technical problems | 4 | 4.21% | 30 | 1.13% | 0.033 |
Other minor technical problems | 14 | 14.74% | 126 | 4.74% | <0.001 |
Use of additional tools | |||||
Evolution (old and RL) or TightRail | 9 | 9.47% | 30 | 1.13% | <0.001 |
Metal sheaths | 17 | 17.89% | 183 | 6.88% | <0.001 |
Lasso catheters/snares/basket catheters | 14 | 14.74% | 86 | 3.23% | <0.001 |
Loop created with a catheter, guidewire, and lasso | 3 | 3.16% | 47 | 1.77% | 0.478 |
Groups | CIP (A) | AIP (B) | A vs. B p | ||
---|---|---|---|---|---|
Number | 98 | 2659 | |||
Partial or lack of radiographic success | |||||
Partial radiographic success (retained tip of lead) | 6 | 6.12% | 51 | 1.92% | 0.012 |
Partial radiographic success (retained <4 cm lead fragment) | 9 | 9.18% | 42 | 1.58% | <0.001 |
Lack of radiographic success (retained lead or long portion of lead) | 0 | 0.00% | 5 | 0.19% | 0.440 |
Major complications | |||||
Major complications (any) | 5 | 5.10% | 54 | 2.03% | 0.088 |
Hemopericardium | 4 | 4.08% | 35 | 1.32% | 0.066 |
Hemothorax | 0 | 0.00% | 5 | 0.19% | 0.667 |
Tricuspid valve injury during TLE (severe) | 2 | 2.04% | 13 | 0.49% | 0.176 |
Rescue cardiac surgery | 4 | 4.08% | 33 | 1.24% | 0.051 |
Minor complications (any) | 12 | 12.24% | 201 | 7.56% | 0.130 |
Procedure-related death (intra-, post-procedural) | 0 | 0.00% | 6 | 0.23% | 0.527 |
Indication-related death (intra-, post-procedural | 0 | 0.00% | 2 | 0.08% | 0.101 |
Clinical success | |||||
Clinical success | 93 | 94.90% | 2545 | 95.71% | 0.891 |
No; planned supplementary TLE or cardiac surgery | 0 | 0.00% | 90 | 3.38% | 0.118 |
No; complication—death | 2 | 2.04% | 17 | 0.64% | 0.305 |
Procedural success | |||||
Complete procedural success | 80 | 81.63% | 2544 | 95.68% | <0.001 |
No; lack of complete radiographic success | 16 | 16.33% | 97 | 3.65% | <0.001 |
No; permanently disabling complication or death | 2 | 2.04% | 18 | 0.68% | 0.339 |
Additional procedure information | |||||
Pacemaker dependence | 35 | 35.71% | 442 | 16.62% | <0.001 |
Condition of extracted leads (intracardiac lead abrasion) | |||||
Probable abrasion (lead significantly damaged) | 12 | 12.24% | 77 | 2.90% | <0.001 |
Certain lead abrasion | 30 | 30.61% | 451 | 16.96% | <0.001 |
TV injury during TLE | |||||
TR increase by 2 degrees | 4 | 4.08% | 40 | 1.50% | 0.112 |
TR increase by 3 degrees | 1 | 1.02% | 9 | 0.34% | 0.805 |
Reference Number | Year, Author, Journal | Number of Pts | Mean Age of Patients | Mean Dwell Time | Major Complications | Procedure-Related Death |
---|---|---|---|---|---|---|
Studies in Adults (Reporting > 1000 TLE Procedures) | ||||||
[20] | 1999, Byrd, C.L., Pacing Clin Electrophysiol | 2338 | 64 | 47 | 1.40% | 0.40% |
[21] | 2008, Bongiorni, M., Eur Heart J. | 1193 | 66 | 69 | 0.70% | 0.30% |
[22] | 2010, Wazny, O., J Am Coll Cardiol. LEXICon Sudy | 1449 | 63 | 82 | 1.40% | 0.30% |
[23] | 2014, Brunner, M.P., Heart Rhythm | 2999 | 67 | 61 | 1.80% | 0.20% |
[24] | 2016, Bashir, J., Circ Arrhythm Electrophysiol | 1082 | 59 | 129 | 3.00% | 0.37% |
[25] | 2017, Hussein, A.A., JACC Clin Electrophysiol | 1836 | 68 | 107.5 | 1.93% | 0.29% |
[26] | 2017, Kutarski, A., Europace | 2049 | 65 | 89 | 1.80% | 0.36% |
[27] | 2017, Bongiorni, M., Eur Heart Journal | 3555 | 65 | 76.8 | 1.70% | 0.50% |
[28] | 2018, Sood, N., Circ Arrhythm Electrophysiol | 11,304 | 65 | 65 | 2.30% | 0.16% |
[29] | 2019, Jacheć, W., Pacing Clin Electrophysiol | 3810 | 65 | 86.4 | 1.44% | 0.17% |
[30] | 2020, Segreti, L., Europace | 1210 | 69 | 72 | 0.70% | 0.16% |
[31] | 2020, Starck, C.T., Europace | 2205 | 66 | 74 | 1.00% | 0.18% |
[32] | 2020, Giannotti Santoro, M., Pacing Clin Electrophysiol | 1316 | 65 | 72 | 0.70% | 0.00% |
All studies in adults, summary | 36,346 | 65.2 | 74.16 | 1.75% | 0.24% | |
Studies in children and juveniles (all available studies) | ||||||
[14] | 1996, Friedman, R.A., 1, PacingClinElectrophysiol | 13 | 13.1 | 54 | 0.00% | 0.00% |
[6] | 2003, Cooper, J.M., J CardiovascElectrophysiol | 14 | 17.9 | 42.4 | 0.00% | 0.00% |
[15] | 2006, Moak, J.P., Pacing Clin Electrophysiol | 25 | 10 | 49.4 | 8.00% | 0.00% |
[16] | 2009, Dilber, E., Med Princ Pract | 30 | 12 | 46 | 2.80% | 0.00% |
[17] | 2010, Cecchin, F., Circ Arrhythm Electrophysiol | 144 | 21.5 | 86.8 | 2.80% | 0.00% |
[18] | 2010, Zartner, P.A., Europace | 22 | 12.9 | 61.2 | 0.00% | 0.00% |
[5] | 2013, Atallah, J., Circulation | 879 | 18.6 | 28.8 | 4.00% | 0.00% |
Studies in children and juveniles, summary | 1127 | 18.42 | 38.22 | 3.73% | 0.00% | |
Our group of patients with leads implanted in childhood | 98 | 27.5 | 171.8 | 5.26% | 0.00% | |
Our control group of adult patients (40–80 years of age) | 2659 | 66.5 | 95.6 | 2.03% | 0.23% |
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Kutarski, A.; Jacheć, W.; Polewczyk, A.; Nowosielecka, D.; Miszczak-Knecht, M.; Brzezinska, M.; Bieganowska, K. Transvenous Lead Extraction in Adult Patient with Leads Implanted in Childhood-Is That the Same Procedure as in Other Adult Patients? Int. J. Environ. Res. Public Health 2022, 19, 14594. https://doi.org/10.3390/ijerph192114594
Kutarski A, Jacheć W, Polewczyk A, Nowosielecka D, Miszczak-Knecht M, Brzezinska M, Bieganowska K. Transvenous Lead Extraction in Adult Patient with Leads Implanted in Childhood-Is That the Same Procedure as in Other Adult Patients? International Journal of Environmental Research and Public Health. 2022; 19(21):14594. https://doi.org/10.3390/ijerph192114594
Chicago/Turabian StyleKutarski, Andrzej, Wojciech Jacheć, Anna Polewczyk, Dorota Nowosielecka, Maria Miszczak-Knecht, Monika Brzezinska, and Katarzyna Bieganowska. 2022. "Transvenous Lead Extraction in Adult Patient with Leads Implanted in Childhood-Is That the Same Procedure as in Other Adult Patients?" International Journal of Environmental Research and Public Health 19, no. 21: 14594. https://doi.org/10.3390/ijerph192114594