Systematic Review and Meta-Analysis of Acute Mortality and Complication Rates Following Leadless Pacemaker Placement...

Area of Science:

• Cardiology
• Medical Devices
• Systematic Reviews & Meta-Analyses

Background:

• Leadless pacemakers offer an innovative approach to managing cardiac arrhythmias, contrasting with traditional transvenous pacemaker systems.
• Assessing the early safety and complication rates of leadless pacemakers is crucial for clinical adoption and patient management.

Purpose of the Study:

• To conduct a meta-analysis comparing acute complication and mortality rates between leadless and transvenous pacemakers using national-level data.
• To calculate pooled odds ratios for acute overall complications, device-related complications, and mortality to evaluate early safety outcomes.

Main Methods:

• Systematic literature search of major databases (PubMed, Scopus, ScienceDirect, Google Scholar) up to October 2024.
• Inclusion of studies providing national-level comparative data on leadless versus transvenous pacemaker recipients.
• Meta-analysis using a random-effects model in RStudio to pool odds ratios for key safety outcomes.

Main Results:

• Five studies met eligibility criteria for the meta-analysis.
• Pooled odds ratios indicated comparable early safety: acute mortality (OR 2.03), overall complications (OR 1.08), and device-related complications (OR 1.02).
• High heterogeneity (I² = 99%) was observed across all outcomes, with statistical significance noted for mortality (p < 0.01).

Conclusions:

• Leadless pacemakers present a promising alternative to transvenous pacemakers, demonstrating a comparable short-term safety profile.
• Technological advancements are expected to further improve the clinical applicability and safety of leadless pacemaker technology.