Leadless Pacemaker Implantation During Extraction in Patients with Active Infection: A Comprehensive Analysis of Safety, Patient Benefits and Costs
Abstract
1. Introduction
2. Methods
2.1. Extraction Procedure
2.2. LP Implantation Procedure
2.3. SP Implantation Procedure
2.4. Study Endpoints
2.5. Statistical Analysis
2.6. Cost Analysis
3. Results
3.1. Baseline Patient Characteristics
3.2. Extraction Procedure
3.3. Pacemaker Implantation
3.4. Primary and Secondary Endpoints
3.5. Cost Analysis of Both Approaches
4. Discussion
4.1. Study Limitations
4.2. Future Directions
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Entire Cohort (n = 87) | Temporary Transvenous Pacemaker (n = 42) | Leadless Pacemaker (n = 45) | p-Value | |
---|---|---|---|---|
Demographics | ||||
Age, years, mean (SD) | 74 (13) | 72 (14) | 76 (12) | 0.073 |
Female gender, n (%) | 19 (21.8) | 8 (19.0) | 11 (24.4) | 0.543 |
Diabetes mellitus, n (%) | 39 (45.3) | 21 (50) | 18 (40.9) | 0.397 |
Hypertension, n (%) | 59 (68.6) | 29 (69) | 30 (68.2) | 0.931 |
CVA/TIA, n (%) | 23 (26.7) | 12 (28.6) | 11 (25.0) | 0.283 |
Chronic atrial fibrillation, n (%) | 36 (41.4) | 20 (47.6) | 16 (35.6) | 0.254 |
Chronic kidney disease, n (%) | 22 (25.6) | 9 (21.4) | 13 (29.5) | 0.388 |
LVEF, mean (SD) | 49 (12) | 45 (13) | 52 (9) | 0.018 |
Cardiomyopathy, n (%) | 0.015 | |||
Ischemic | 11 (13.8) | 6 (16.7) | 5 (11.4) | |
Dilated | 4 (5.0) | 4 (11.1) | 0 (0.0) | |
Hypertrophic | 3 (3.8) | 3 (8.3) | 0 (0.0) | |
COPD, n (%) | 13 (15.3) | 7 (17.1) | 6 (13.6) | 0.660 |
Severe pulmonary hypertension, n (%) | 15 (19.2) | 7 (20.6) | 8 (18.2) | 0.789 |
Valve replacement, n (%) | 25 (40.3) | 9 (21.4) | 16 (35.6) | 0.396 |
Number of electrodes (Median) | 2.3 (2) | 2.5 (2.5) | 2.1 (2) | 0.011 |
Device type, n (%) | 0.013 | |||
CRTD | 18 (20.9) | 14 (33.3) | 4 (9.1) | |
CRTP | 10 (11.6) | 5 (11.9) | 5 (11.4) | |
Single chamber | 10 (11.6) | 7 (16.7) | 3 (6.8) | |
Dual chamber | 47 (54.7) | 16 (38.1) | 31 (70.4) | |
Pacing indication, n (%) | 0.453 | |||
SSS | 7 (8.04) | 3 (7.14) | 4 (8.9) | |
High degree AV block | 53 (60.91) | 29 (69.04) | 24 (53.3) | |
Atrial fibrillation with AV block | 18 (20.68) | 6 (14.28) | 12 (26.7) | |
Indication for extraction, n (%) | 0.139 | |||
Pocket infection | 33 (37.9) | 19 (45.2) | 14 (31.1) | |
Systemic infection | 23 (26.4) | 8 (19.0) | 15 (33.3) | |
Combined pocket + systemic | 28 (32.2) | 15 (35.7) | 13 (28.9) | |
Type of infection, n (%) | 0.113 | |||
Streptococcus | 4 (5.9) | 2 (5.1) | 2 (4.6) | |
MSSA | 10 (14.7) | 7 (17.9) | 3 (6.8) | |
Staphylococcus (other) | 29 (42.6) | 12 (31.2) | 17 (39.1) | |
Enterococcus | 10 (14.7) | 2 (5.1) | 8 (18.2) |
Temporary Transvenous Pacemaker Patients (n = 42) | Leadless Pacemaker Patients (n = 45) | p-Value | |
---|---|---|---|
Simple Traction (%) | 10 (23.8) | 18 (40) | 0.106 |
Laser (%) | 24 (57.1) | 3 (6.7) | <0.001 |
TightRail (%) | 11 (26.2) | 9 (20) | 0.493 |
Sub C TightRail (%) | 0 (0) | 20 (44.4) | <0.001 |
Femoral Work Station (%) | 3 (7.1) | 1 (2.2) | 0.273 |
Temporary Transvenous Pacemaker Patients (n = 32) | Leadless Pacemaker Patients (n = 42) | p-Value | |
---|---|---|---|
Days in ICU, mean (SD) | 7 (12) | 1 (3) | <0.001 |
Days in hospital, mean (SD) | 17 (17) | 11 (24) | <0.001 |
1-year mortality, n (%) | 9 (23.7) | 10 (22.7) | 0.890 |
Temporary Transvenous Pacemaker Approach (USD) (n = 32) | Leadless Pacemaker Approach (USD) (n = 41) | p-Value | |
---|---|---|---|
ICU, mean (SD) | 7277 (13,457) | 692 (2210) | <0.001 |
Internal Department, mean (SD) | 3217 (2789) | 2286 (3378) | 0.031 |
Device + Temporary Screw in Lead | 1483 | 8743 | |
Procedure | 2732 | 1366 | |
Total, mean | 14,709 | 13,087 | 0.321 |
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Solomon, A.; Tzuberi, M.; Berkovitch, A.; Hoch, E.; Beinart, R.; Nof, E. Leadless Pacemaker Implantation During Extraction in Patients with Active Infection: A Comprehensive Analysis of Safety, Patient Benefits and Costs. J. Clin. Med. 2025, 14, 5450. https://doi.org/10.3390/jcm14155450
Solomon A, Tzuberi M, Berkovitch A, Hoch E, Beinart R, Nof E. Leadless Pacemaker Implantation During Extraction in Patients with Active Infection: A Comprehensive Analysis of Safety, Patient Benefits and Costs. Journal of Clinical Medicine. 2025; 14(15):5450. https://doi.org/10.3390/jcm14155450
Chicago/Turabian StyleSolomon, Aviv, Maor Tzuberi, Anat Berkovitch, Eran Hoch, Roy Beinart, and Eyal Nof. 2025. "Leadless Pacemaker Implantation During Extraction in Patients with Active Infection: A Comprehensive Analysis of Safety, Patient Benefits and Costs" Journal of Clinical Medicine 14, no. 15: 5450. https://doi.org/10.3390/jcm14155450
APA StyleSolomon, A., Tzuberi, M., Berkovitch, A., Hoch, E., Beinart, R., & Nof, E. (2025). Leadless Pacemaker Implantation During Extraction in Patients with Active Infection: A Comprehensive Analysis of Safety, Patient Benefits and Costs. Journal of Clinical Medicine, 14(15), 5450. https://doi.org/10.3390/jcm14155450