Comparative assessment of safety with leadless pacemakers compared to transvenous pacemakers: a systemic review and meta-analysis.
Leadless pacemakers
Meta-analysis
Safety
Transvenous pacemaker
Journal
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing
ISSN: 1572-8595
Titre abrégé: J Interv Card Electrophysiol
Pays: Netherlands
ID NLM: 9708966
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
received:
09
03
2023
accepted:
10
04
2023
medline:
5
12
2023
pubmed:
28
4
2023
entrez:
27
4
2023
Statut:
ppublish
Résumé
Leadless pacemakers (LP) and transvenous pacemakers (TVP) are two stable pacing platforms currently available in clinical practice. Observational data show mixed results with regards to their comparative safety. This meta-analysis was aimed to evaluate the comparative safety of LP over TVP. The study protocol was registered in PROSPERO registry (CRD42022325376). Six databases were searched for published literature from inception to April 12, 2022. RevMan 5.4.1 was used for statistical analysis. Odds ratio (OR) and mean difference were used to estimate the outcome with a 95% confidence interval (CI). A total of 879 studies were imported from the databases. Among these, 41 papers were screened for full text and 17 meet the inclusion criteria. Among them, pooled results showed 42% lower odds of occurrence of complications in the LP group (OR 0.58, CI 0.42-0.80) compared to TVP group. Notably, 70% lower odds of device dislodgment (OR 0.30, CI 0.21-0.43), 46% lower odds of re-intervention (OR 0.54, CI 0.45-0.64), 87% lower odds of pneumothorax (OR 0.13, CI 0.03-0.57), albeit, 2.65 times higher odds of pericardial effusion (OR 2.65, CI 1.49-4.70) were observed in the LP group. This meta-analysis showed LP to be a significantly safer modality compared to TVP, in terms of re-intervention, device dislodgment, pneumothoraxes, and overall complications. However, there were higher rates of pericardial effusion in the LP group. There was a diverse number of patients included, and all studies were observational. Randomized trials are needed to validate our findings.
Sections du résumé
BACKGROUND
BACKGROUND
Leadless pacemakers (LP) and transvenous pacemakers (TVP) are two stable pacing platforms currently available in clinical practice. Observational data show mixed results with regards to their comparative safety. This meta-analysis was aimed to evaluate the comparative safety of LP over TVP.
METHODS
METHODS
The study protocol was registered in PROSPERO registry (CRD42022325376). Six databases were searched for published literature from inception to April 12, 2022. RevMan 5.4.1 was used for statistical analysis. Odds ratio (OR) and mean difference were used to estimate the outcome with a 95% confidence interval (CI).
RESULTS
RESULTS
A total of 879 studies were imported from the databases. Among these, 41 papers were screened for full text and 17 meet the inclusion criteria. Among them, pooled results showed 42% lower odds of occurrence of complications in the LP group (OR 0.58, CI 0.42-0.80) compared to TVP group. Notably, 70% lower odds of device dislodgment (OR 0.30, CI 0.21-0.43), 46% lower odds of re-intervention (OR 0.54, CI 0.45-0.64), 87% lower odds of pneumothorax (OR 0.13, CI 0.03-0.57), albeit, 2.65 times higher odds of pericardial effusion (OR 2.65, CI 1.49-4.70) were observed in the LP group.
CONCLUSIONS
CONCLUSIONS
This meta-analysis showed LP to be a significantly safer modality compared to TVP, in terms of re-intervention, device dislodgment, pneumothoraxes, and overall complications. However, there were higher rates of pericardial effusion in the LP group. There was a diverse number of patients included, and all studies were observational. Randomized trials are needed to validate our findings.
Identifiants
pubmed: 37106267
doi: 10.1007/s10840-023-01550-8
pii: 10.1007/s10840-023-01550-8
doi:
Types de publication
Meta-Analysis
Systematic Review
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
2165-2175Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Zucchelli G, Tolve S, Barletta V, Di Cori A, Parollo M, De Lucia R, et al. Comparison between leadless and transvenous single-chamber pacemaker therapy in a referral centre for lead extraction. J Interv Card Electrophysiol. 2021;61:395–404. https://doi.org/10.1007/S10840-020-00832-9 .
doi: 10.1007/S10840-020-00832-9
pubmed: 32712901
Piccini JP, Stromberg K, Jackson KP, Laager V, Duray GZ, El-Chami M, et al. Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra Transcatheter Pacing System Global Clinical Trial. Hear Rhythm. 2017;14:685–91. https://doi.org/10.1016/J.HRTHM.2017.01.026 .
doi: 10.1016/J.HRTHM.2017.01.026
Reddy VY, Exner DV, Doshi R, Tomassoni G, Bunch TJ, Estes NAM, et al. Primary results on safety and efficacy from the LEADLESS II–phase 2 worldwide clinical trial. Clin Electrophysiol. 2022;8:115–7. https://doi.org/10.1016/J.JACEP.2021.11.002 .
doi: 10.1016/J.JACEP.2021.11.002
Vaidya VR, Dai M, Asirvatham SJ, Rea RF, Thome TM, Srivathsan K, et al. Real-world experience with leadless cardiac pacing. Pacing Clin Electrophysiol. 2019;42:366–73. https://doi.org/10.1111/PACE.13601 .
doi: 10.1111/PACE.13601
pubmed: 30632622
Tachibana M, Banba K, Matsumoto K, Ohara M. The feasibility of leadless pacemaker implantation for superelderly patients. Pacing Clin Electrophysiol. 2020;43:374–81. https://doi.org/10.1111/PACE.13894 .
doi: 10.1111/PACE.13894
pubmed: 32134134
Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, The PRISMA, et al. statement: an updated guideline for reporting systematic reviews. BMJ. 2020;2021:372. https://doi.org/10.1136/BMJ.N71 .
doi: 10.1136/BMJ.N71
Shrestha D, Shtembari J, Awal S, Gyawali P, Raut A. Leadless pacemaker versus conventional transvenous pacemaker: systematic review and meta-analysis. PROSPERO 2022 CRD42022325376. 2022. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=325376 . Accessed 16 Dec 2022.
Covidence systematic review software, Veritas Health Innovation, Melbourne, Australia. n.d. www.covidence.org . Accessed 13 May 2021.
critical-appraisal-tools - Critical Appraisal Tools | Joanna Briggs Institute. n.d. https://jbi.global/critical-appraisal-tools . Accessed 28 Nov 2021.
Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al. Cochrane handbook for systematic reviews of interventions. John Wiley & Sons; 2019.
RevMan for non-Cochrane reviews | Cochrane Training. n.d. https://training.cochrane.org/online-learning/core-software-cochrane-reviews/revman/revman-non-cochrane-reviews . Accessed 26 Jan 2021.
El-Chami MF, Bockstedt L, Longacre C, Higuera L, Stromberg K, Crossley G, et al. Leadless vs. transvenous single-chamber ventricular pacing in the Micra CED study: 2-year follow-up. Eur Heart J. 2022;43:1207–15. https://doi.org/10.1093/EURHEARTJ/EHAB767 .
doi: 10.1093/EURHEARTJ/EHAB767
pubmed: 34788416
Beurskens NEG, Tjong FVY, De Bruin-Bon RHA, Dasselaar KJ, Kuijt WJ, Wilde AAM, et al. Impact of leadless pacemaker therapy on cardiac and atrioventricular valve function through 12 months of follow-up. Circ Arrhythmia Electrophysiol. 2019;12(5):e007124. https://doi.org/10.1161/CIRCEP.118.007124 .
Cabanas-Grandío P, García Campo E, Bisbal F, García-Seara J, Pachón M, Juan-Salvadores P, et al. Quality of life of patients undergoing conventional vs leadless pacemaker implantation: a multicenter observational study. J Cardiovasc Electrophysiol. 2020;31:330–6. https://doi.org/10.1111/JCE.14322 .
doi: 10.1111/JCE.14322
pubmed: 31840881
Cantillon DJ, Dukkipati SR, Ip JH, Exner DV, Niazi IK, Banker RS, et al. Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers. Hear Rhythm. 2018;15:1023–30. https://doi.org/10.1016/j.hrthm.2018.04.022 .
doi: 10.1016/j.hrthm.2018.04.022
Martinez-Sande JL, Garcia-Seara J, Gonzalez-Melchor L, Rodriguez-Mañero M, Baluja A, Fernandez-Lopez XA, et al. Conventional single-chamber pacemakers versus transcatheter pacing systems in a “real world” cohort of patients: a comparative prospective single-center study. Indian Pacing Electrophysiol J. 2021;21:89–94. https://doi.org/10.1016/J.IPEJ.2020.12.004 .
doi: 10.1016/J.IPEJ.2020.12.004
pubmed: 33418071
pmcid: 7952774
Moore SKL, Chau KH, Chaudhary S, Rubin G, Bayne J, Avula UMR, et al. Leadless pacemaker implantation: a feasible and reasonable option in transcatheter heart valve replacement patients. Pacing Clin Electrophysiol. 2019;42:542–7. https://doi.org/10.1111/PACE.13648 .
doi: 10.1111/PACE.13648
pubmed: 30829416
pmcid: 6476663
Okuyama K, Izumo M, Sasaki K, Kuwata S, Kaihara T, Watanabe M, et al. Comparison in clinical outcomes between leadless and conventional transvenous pacemaker following transcatheter aortic valve implantation. J Invasive Cardiol. 2020;32:400–4.
pubmed: 32999094
Pagan E, Gabriels J, Khodak A, Chang D, Beldner S, Epstein LM, et al. Safety of leadless pacemaker implantation in the very elderly. Hear Rhythm. 2020;17:2023–8. https://doi.org/10.1016/j.hrthm.2020.05.022 .
doi: 10.1016/j.hrthm.2020.05.022
Palmisano P, Guido A, Panico V, Chiuri MD, Chiarillo MV, Sergi C, et al. Leadless pacemaker versus transvenous single-chamber pacemaker therapy: peri-procedural aspects, utilization of medical resources and patient acceptance. Expert Rev Med Devices. 2021;18:483–91. https://doi.org/10.1080/17434440.2021.1921573 .
doi: 10.1080/17434440.2021.1921573
pubmed: 33888044
Reynolds D, Duray GZ, Omar R, Soejima K, Neuzil P, Zhang S, et al. A leadless intracardiac transcatheter pacing system. N Engl J Med. 2016;374:533–41. https://doi.org/10.1056/NEJMOA1511643 .
doi: 10.1056/NEJMOA1511643
pubmed: 26551877
Sanchez R, Nadkarni A, Buck B, Daoud G, Koppert T, Okabe T, et al. Incidence of pacing-induced cardiomyopathy in pacemaker-dependent patients is lower with leadless pacemakers compared to transvenous pacemakers. J Cardiovasc Electrophysiol. 2021;32:477–83. https://doi.org/10.1111/JCE.14814 .
doi: 10.1111/JCE.14814
pubmed: 33205561
Sasaki K, Togashi D, Nakajima I, Suchi T, Nakayama Y, Harada T, et al. Clinical outcomes of non-atrial fibrillation bradyarrhythmias treated with a ventricular demand leadless pacemaker compared with an atrioventricular synchronous transvenous pacemaker—a propensity score-matched analysis. Circ J. 2022;86(8):1283–91. https://doi.org/10.1253/CIRCJ.CJ-21-0889 .
Yarlagadda B, Turagam MK, Dar T, Janagam P, Veerapaneni V, Atkins D, et al. Safety and feasibility of leadless pacemaker in patients undergoing atrioventricular node ablation for atrial fibrillation. Hear Rhythm. 2018;15:994–1000. https://doi.org/10.1016/J.HRTHM.2018.02.025 .
doi: 10.1016/J.HRTHM.2018.02.025
Kiehl EL, Makki T, Kumar R, Gumber D, Kwon DH, Rickard JW, et al. Incidence and predictors of right ventricular pacing-induced cardiomyopathy in patients with complete atrioventricular block and preserved left ventricular systolic function. Hear Rhythm. 2016;13:2272–8. https://doi.org/10.1016/j.hrthm.2016.09.027 .
doi: 10.1016/j.hrthm.2016.09.027
Lakkireddy D, Knops R, Atwater B, Neuzil P, Ip J, Gonzalez E, et al. A worldwide experience of the management of battery failures and chronic device retrieval of the Nanostim leadless pacemaker. Hear Rhythm. 2017;14:1756–63. https://doi.org/10.1016/j.hrthm.2017.07.004 .
doi: 10.1016/j.hrthm.2017.07.004
Breeman KTN, Oosterwerff EFJ, Dijkshoorn LA, Salavati A, Beurskens NEG, Wilde AAM, et al. Real-world long-term battery longevity of Micra leadless pacemakers. J Interv Card Electrophysiol. 2022. https://doi.org/10.1007/s10840-022-01447-y .
Li Y, Xing Q, Xiaokereti J, Chen C, Zhang J, Zhou X, et al. Right ventriculography improves the accuracy of leadless pacemaker implantation in right ventricular mid-septum. J Interv Card Electrophysiol. 2022. https://doi.org/10.1007/s10840-022-01399-3 .
Sharma P, Singh Guleria V, Bharadwaj P, Datta R. Assessing safety of leadless pacemaker (MICRA) at various implantation sites and its impact on paced QRS in Indian population. Indian Heart J. 2020;72:376–82. https://doi.org/10.1016/j.ihj.2020.08.001 .
doi: 10.1016/j.ihj.2020.08.001
pubmed: 33189197
pmcid: 7670279