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

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.