Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry
Abstract
:1. Introduction
2. Methods
2.1. Registry Population
2.2. Data Collection, Cohort, and Outcome Definition
- -
- Patients referred from the emergency department (ED) for LPM implantation due to urgent bradyarrhythmias (ED+);
- -
- Patients referred for LPM implantation in a non-urgent scenario, with the procedure performed in an elective setting (ED−).
2.3. Statistical Analysis
3. Results
3.1. Baseline Characteristics of the Study Cohort
3.2. LP Indications and Peri-Procedural Characteristics
4. Discussion
- (1)
- LPM implantation is a feasible procedure for the treatment of severe bradyarrhythmias in an urgent setting, in patients admitted from the ED;
- (2)
- Emergency LPM implantation was not correlated with an increase in the rate of major complications compared to the control group (6.9% for ED+ vs. 4.2% for ED−, p = 0.244);
- (3)
- LPM implantation for severe bradyarrhythmia is associated with longer procedural times (60 (45–80) mins vs. 50 (40–65) mins, p < 0.001), even when controlling for confounders (OR 5.156, CI (4.610–24.872), p = 0.004).
4.1. LPM for Emergency Bradyarrhythmia Treatment: Technical Aspects
4.2. LPM for Emergency Bradyarrhythmia Treatment: Peri-Procedural Outcomes
4.3. Limitations
4.4. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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ED+ Cohort (n = 72) | ED− Cohort (n = 1082) | p | |
---|---|---|---|
Age (years), mean ± st. dev. | 78.9 ± 15.5 | 77.0 ± 12.8 | 0.330 |
Male, n (%) | 24 (33.3) | 389 (35.9) | 0.812 |
BMI, median (IQR) | 24.3 (22.0–27.5) | 25.8 (23.1–28.6) | 0.893 |
Diabetes, n (%) | 18 (25.0) | 239 (22.1) | 0.672 |
Hypertension, n (%) | 39 (54.2) | 582 (53.4) | 0.998 |
CAD, n (%) | 16 (22.2) | 250 (23.1) | 0.996 |
Previous cardiac surgery, n (%) | 13 (18.1) | 153 (14.1) | 0.401 |
CABG, n (%) | 4 (5.5) | 69 (6.4) | 0.995 |
Congenital HD, n (%) | 1 (1.4) | 9 (0.8) | 0.478 |
Valvular HD, n (%) | 28 (38.9) | 257 (23.7) | 0.037 |
CKD needing hemodialysis, n (%) | 4 (5.5) | 44 (4.1) | 0.539 |
HF, n (%) | 15 (20.8) | 106 (9.8) | 0.020 |
LVEF (%), mean ± st. dev. | 55 (47–61) | 56 (52–61) | 0.052 |
OAC, n (%) | 63 (87.5) | 932 (86.1) | 0.929 |
ED+ Cohort (n = 72) | ED− Cohort (n = 1082) | p | |
---|---|---|---|
Micra™-AV | 10 (13.8) | 92 (8.5) | 0.204 |
PM indication, n (%) Slow AF, n (%) AVB, n (%) Sinus node arrest, n (%) Cardioinhibitory syncope, n (%) Ablate and pace, n (%) Other, n (%) | 55 (76.3) 14 (37.5) 3 (4.2) 0 (0) 0 (0) 0 (0) | 538 (49.7) 296 (27.3) 178 (16.4) 32 (2.9) 21 (1.9) 5 (0.46) | 0.025 0.027 0.008 0.255 0.634 1 |
ED+ Cohort (n = 72) | ED− Cohort (n = 1082) | p | |
---|---|---|---|
Right femoral access, n (%) | 69 (95.8) | 1039 (96.0) | 1 |
Femoral vein angiography, n (%) | 16 (22.2) | 358 (33.1) | 0.200 |
Number of delivery attempts, median (IQR) | 1 (1–1) | 1 (1–1) | 1 |
Patients with > 1 delivery attempt, n (%) | 17 (23.6) | 150 (13.8) | 0.068 |
Micra™ repositioning, n (%) | 6 (8.3) | 133 (12.3) | 0.453 |
Use of temporary pacing, n (%) | 68 (94.4) | 313 (28.9) | <0.001 |
Final positioning, n (%) Septum, n (%) RVOT, n (%) Apex, n (%) | 65 (90.3) 0 (0) 7 (9.7) | 718 (66.4) 24 (2.2) 340 (31.4) | 0.086 0.394 0.001 |
Procedure time, mins (IQR) | 60 (45–80) | 50 (40–65) | <0.001 |
Fluoroscopy time, mins (IQR) | 6.5 (5.0–9.7) | 5.1 (3.1–9) | 0.103 |
Overall peri-procedural major complications, n (%) Pericardial effusion, n (%) Pericardial tamponade, n (%) Femoral vascular injury, n (%) Device dislodgement or embolization, n (%) Groin hematoma, n (%) | 5 (6.9) 1 (1.4) 0 (0) 1 (1.4) 0 (0) 2 (4.2) | 45 (4.2) 8 (0.73) 2 (0.18) 6 (0.6) 5 (0.5) 24 (2.2) | 0.244 0.443 1 0.366 1 0.676 |
Sensing, mV | 10 (8–12.8) | 10 (7.5–13.5) | 0.985 |
Impedance, ohm | 695 (570–797) | 690 (580–810) | 0.476 |
Threshold, V | 0.5 (0.38–0.99) | 0.42 (0.28–0.7) | 0.428 |
Length of in-hospital stay (days), median (IQR) | 7 (3–16) | 3 (2–5) | <0.001 |
OR | C.I. | p | aOR | C.I. | p | |
---|---|---|---|---|---|---|
Age | 0.060 | (−0.222–0.016) | 0.091 | 0.084 | (0.251–0.079) | 0.308 |
Male sex | 1.769 | (−4.310–2.633) | 0.636 | |||
Coronary artery disease | 2.01 | (−4.812–3.094) | 0.670 | |||
CABG | 3.86 | (−9.768–5.419) | 0.574 | |||
Valvular HD | 1.950 | (−3.818–3.836) | 0.997 | |||
Hypertension | 1.709 | (−3.299–3.479) | 0.942 | |||
CKD treated with hemodialysis | 4.007 | (−5.792–9.935) | 0.605 | |||
LVEF | 0.097 | (0.372–0.010) | 0.164 | |||
Diabetes | 2.016 | (−6.118–1.796) | 0.284 | |||
Emergency LPM implantation | 3.451 | (6.173–19.717) | 0.000 | 5.156 | (4.610–24.872) | 0.004 |
BMI | 0.263 | (0.041–0.995) | 0.072 | 0.262 | (0.001–1.033) | 0.049 |
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Schiavone, M.; Filtz, A.; Gasperetti, A.; Breitenstein, A.; Palmisano, P.; Mitacchione, G.; Gulletta, S.; Chierchia, G.B.; Montemerlo, E.; Statuto, G.; et al. Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry. Medicina 2023, 59, 67. https://doi.org/10.3390/medicina59010067
Schiavone M, Filtz A, Gasperetti A, Breitenstein A, Palmisano P, Mitacchione G, Gulletta S, Chierchia GB, Montemerlo E, Statuto G, et al. Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry. Medicina. 2023; 59(1):67. https://doi.org/10.3390/medicina59010067
Chicago/Turabian StyleSchiavone, Marco, Annalisa Filtz, Alessio Gasperetti, Alexander Breitenstein, Pietro Palmisano, Gianfranco Mitacchione, Simone Gulletta, Gian Battista Chierchia, Elisabetta Montemerlo, Giovanni Statuto, and et al. 2023. "Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry" Medicina 59, no. 1: 67. https://doi.org/10.3390/medicina59010067
APA StyleSchiavone, M., Filtz, A., Gasperetti, A., Breitenstein, A., Palmisano, P., Mitacchione, G., Gulletta, S., Chierchia, G. B., Montemerlo, E., Statuto, G., Russo, G., Casella, M., Vitali, F., Mazzone, P., Hofer, D., Arabia, G., Tundo, F., Ruggiero, D., Fierro, N., ... Forleo, G. B. (2023). Leadless Pacemaker Implantation in the Emergency Bradyarrhythmia Setting: Results from a Multicenter European Registry. Medicina, 59(1), 67. https://doi.org/10.3390/medicina59010067