Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta‐Analysis Article Swipe
Linh Ngo
,
Daniel Nour
,
R. Denman
,
Tomos E. Walters
,
Haris M. Haqqani
,
Richard Woodman
,
Isuru Ranasinghe
·
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.1161/jaha.120.019212
YOU?
·
· 2021
· Open Access
·
· DOI: https://doi.org/10.1161/jaha.120.019212
Background Leadless pacemaker is a novel technology, and evidence supporting its use is uncertain. We performed a systematic review and meta‐analysis to examine the safety and efficacy of leadless pacemakers implanted in the right ventricle. Methods and Results We searched PubMed and Embase for studies published before June 6, 2020. The primary safety outcome was major complications, whereas the primary efficacy end point was acceptable pacing capture threshold (≤2 V). Pooled estimates were calculated using the Freedman‐Tukey double arcsine transformation. Of 1281 records screened, we identified 36 observational studies of Nanostim and Micra leadless pacemakers, with most (69.4%) reporting outcomes for the Micra. For Micra, the pooled incidence of complications at 90 days (n=1608) was 0.46% (95% CI, 0.08%–1.05%) and at 1 year (n=3194) was 1.77% (95% CI, 0.76%–3.07%). In 5 studies with up to 1‐year follow‐up, Micra was associated with 51% lower odds of complications compared with transvenous pacemakers (3.30% versus 7.43%; odds ratio [OR], 0.49; 95% CI, 0.34–0.70). At 1 year, 98.96% (95% CI, 97.26%–99.94%) of 1376 patients implanted with Micra had good pacing capture thresholds. For Nanostim, the reported complication incidence ranged from 6.06% to 23.54% at 90 days and 5.33% to 6.67% at 1 year, with 90% to 100% having good pacing capture thresholds at 1 year (pooled result not estimated because of the low number of studies). Conclusions Most studies report outcomes for the Micra, which is associated with a low risk of complications and good electrical performance up to 1‐year after implantation. Further data from randomized controlled trials are needed to support the widespread adoption of these devices in clinical practice.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1161/jaha.120.019212
- https://www.ahajournals.org/doi/pdf/10.1161/JAHA.120.019212
- OA Status
- gold
- Cited By
- 82
- References
- 59
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W3175653285
All OpenAlex metadata
Raw OpenAlex JSON
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https://openalex.org/W3175653285Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1161/jaha.120.019212Digital Object Identifier
- Title
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Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta‐AnalysisWork title
- Type
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reviewOpenAlex work type
- Language
-
enPrimary language
- Publication year
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2021Year of publication
- Publication date
-
2021-06-25Full publication date if available
- Authors
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Linh Ngo, Daniel Nour, R. Denman, Tomos E. Walters, Haris M. Haqqani, Richard Woodman, Isuru RanasingheList of authors in order
- Landing page
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https://doi.org/10.1161/jaha.120.019212Publisher landing page
- PDF URL
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https://www.ahajournals.org/doi/pdf/10.1161/JAHA.120.019212Direct link to full text PDF
- Open access
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YesWhether a free full text is available
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goldOpen access status per OpenAlex
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https://www.ahajournals.org/doi/pdf/10.1161/JAHA.120.019212Direct OA link when available
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Medicine, Meta-analysis, Odds ratio, Incidence (geometry), Internal medicine, Clinical endpoint, Adverse effect, Observational study, Surgery, Randomized controlled trial, Optics, PhysicsTop concepts (fields/topics) attached by OpenAlex
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82Total citation count in OpenAlex
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2025: 20, 2024: 22, 2023: 17, 2022: 21, 2021: 2Per-year citation counts (last 5 years)
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59Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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