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Canadian Journal of Cardiology

Real-World Use of Leadless Pacing: Lessons Learned

Published:September 05, 2022DOI:https://doi.org/10.1016/j.cjca.2022.09.002
      Leadless cardiac pacing (LP) consists of a capsule-like device that contains both the electrodes and the battery, implanted via the femoral vein directly into the right ventricle and fixed with tines or a distal screw. This technology was developed to decrease complications with transvenous pacing (TVP) systems, such as pocket issues, lead failure, vascular thrombosis, lead endocarditis, lead-related tricuspid regurgitation, pneumothorax, etc. Transvenous pacemakers have a complication rate at 90 days ranging from 7.8% to 12.4% (half related to the generator or leads) with an annual rate of complications around 1% or 2%.
      • Ngo L.
      • Nour D.
      • Denman R.A.
      • Walters T.E.
      • et al.
      Safety and efficacy of leadless pacemakers: a systematic review and meta-analysis.
      The first LP clinical trials
      • Reddy V.Y.
      • Exner D.V.
      • Cantillon D.J.
      • et al.
      Percutaneous implantation of an entirely intracardiac leadless pacemaker.
      ,
      • Reynolds D.
      • Duray G.Z.
      • Omar R.
      • et al.
      A leadless intracardiac transcatheter pacing system.
      showed the safety profile of this technology and a recent meta-analysis confirmed low complication rates at 90 days (0.46%) and 1 year (1.77%) and lower odds of complications compared with TVP (3.30% vs 7.43%).
      • Ngo L.
      • Nour D.
      • Denman R.A.
      • Walters T.E.
      • et al.
      Safety and efficacy of leadless pacemakers: a systematic review and meta-analysis.
      The use of LP has increased since its Food and Drug Administration (FDA)/Health Canada approval in 2016. In clinical practice, we often observe different outcomes in a real-life population, and little is known about the safety and complications of LP in this setting. In 2021, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database showed a higher rate of cardiac/vascular perforations and tamponade with LP than with TVP, sometimes leading to death or emergency surgical repair. The occurrence was low, at 1%, but raised questions regarding the use of LP in a more “general population” or higher-risk population compared with early clinical trials.
      • Hauser R.G.
      • Gornick C.C.
      • Abdelhadi R.H.
      • et al.
      Major adverse clinical events associated with implantation of a leadless intracardiac pacemaker.
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