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Meta-Analysis
. 2021 Jul 6;10(13):e019212.
doi: 10.1161/JAHA.120.019212. Epub 2021 Jun 25.

Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis

Linh Ngo  1   2   3 , Daniel Nour  2 , Russell A Denman  2 , Tomos E Walters  1   4 , Haris M Haqqani  1   2 , Richard J Woodman  5 , Isuru Ranasinghe  1   2
Affiliations
Meta-Analysis

Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis

Linh Ngo et al. J Am Heart Assoc. .

Abstract

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.

Keywords: efficacy; leadless pacemaker; meta‐analysis; safety; systematic review.

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Conflict of interest statement

Dr Denman has delivered talks for Medtronic on LPs, has run 4 training courses for Medtronic at The Prince Charles Hospital to train other physicians in how to implant the Micra LP. Dr Denman is also a local principal investigator for the St Jude Nanostim study. Dr Haqqani has received speaking and proctoring honoraria from Medtronic and has served on the scientific advisory board of Medtronic. Dr Haqqani has also received speaking honoraria from Abbott. The remaining authors have no disclosures to report.

Figures

Figure 1
Figure 1. Study selection flow diagram.
AV indicates atrioventricular.
Figure 2
Figure 2. Pooled proportion of patients with a successful implant.
Catillon et al (2018) and Roberts et al (2017) both reported the proportion of patients with a successful implant, but they used the same population as the Reddy et al (2015) study (LEADLESS II trial) and El‐Chami et al (2018) study (Micra Post‐Approval Registry), and therefore were not included in this meta‐analysis.
Figure 3
Figure 3. Meta‐analysis of the safety of the leadless pacemaker (LP).
A, Pooled incidence of overall complications at up to 90 days after LP implantation. B, Pooled incidence of overall complications at ≈1 year after LP implantation in studies that reported safety outcomes beyond 90 days. C, Incidence of overall complications in studies that compared the LP with the transvenous pacemaker (TVP) implantation. *Vaidya et al reported complications for both Nanostim (17 patients) and Micra LPs (73 patients) compared with those associated with a TVP (90 patients). OR indicates odds ratio.
Figure 4
Figure 4. Pooled proportion of patients having a pacing capture threshold ≤2 V at 1 year after implantation.
See this image and copyright information in PMC

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