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Published on: January 6, 2023
A Leadless Intracardiac Transcatheter Pacing System
Dwight Reynolds1, Gabor Z Duray, Razali Omar
1From the Cardiovascular Section, University of Oklahoma Health Sciences Center, OU Medical Center, Oklahoma City (D.R.); Clinical Electrophysiology Department of Cardiology, Medical Center, Hungarian Defence Forces, Budapest, Hungary (G.Z.D.); Electrophysiology and Pacing Unit, National Heart Institute, Kuala Lumpur, Malaysia (R.O.); Department of Cardiology, Kyorin University Hospital, Tokyo (K. Soejima); Department of Cardiology, Na Homolce Hospital, Prague, Czech Republic (P.N.); Clinical EP Lab and Arrhythmia Center, Fuwai Hospital, Beijing (S.Z.); Division of Electrophysiology, Department of Cardiology, CARE Hospitals and CARE Foundation, Hyderabad, India (C.N.); Department of Cardiology, Linz General Hospital, Johannes Kepler University School of Medicine, Linz, Austria (C.S.); Hospital Universitari Clínic de Barcelona, Barcelona (J.B.); Emory University Hospital, Atlanta (M.L.); University of Southampton, Southampton, United Kingdom (P.R.R.); Baptist Heart Specialists, Jacksonville, FL (V.S.); Ohio State University, Columbus (J.H.); Azienda Ospedaliero Universitaria Pisana, Presidio Ospedaliero di Cisanello, Pisa, Italy (M.G.B.); Academisch Medisch Centrum, Amsterdam (R.E.K.); Vanderbilt University Medical Center, Nashville (C.R.E.); Minneapolis Heart Institute, Minneapolis (C.C.G.); Lancaster Heart and Vascular Institute, Lancaster, PA (M.A.B.); Medtronic, Mounds View, MN (V.L., K. Stromberg, E.R.W., J.H.H.); and Hôpital Cardiologique du Haut-Lévêque, Centre Hospitalier Universitaire Bordeaux, Université Bordeaux, IHU l'Institut de Rythmologie et Modélisation Cardiaque, Bordeaux, France (P.R.).
This study shows a new leadless transcatheter pacemaker is safe and effective, meeting performance goals. It offers a similar safety profile to traditional pacemakers with better outcomes.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Trials
Background:
- A novel leadless intracardiac transcatheter pacing system eliminates the need for a pacemaker pocket and transvenous lead.
- This system aims to improve patient outcomes by simplifying implantation and reducing complications associated with traditional pacemakers.
Purpose of the Study:
- To evaluate the safety and efficacy of a leadless intracardiac transcatheter pacing system.
- To compare the performance of the transcatheter pacemaker against predefined goals and a historical control cohort.
Main Methods:
- A prospective, multicenter study implanted transcatheter pacemakers in patients with indications for ventricular pacing.
- Primary endpoints included freedom from major complications (safety) and low, stable pacing thresholds at 6 months (efficacy).
- A post hoc analysis compared major complication rates with a control group of 2667 patients with transvenous pacemakers.
Main Results:
- Successful implantation was achieved in 99.2% of patients (719/725).
- The primary safety endpoint was met with a 96.0% success rate, exceeding the 83% goal (P<0.001).
- The primary efficacy endpoint was met in 98.3% of patients, surpassing the 80% goal (P<0.001), with significantly fewer major complications compared to transvenous pacemakers.
Conclusions:
- The transcatheter pacemaker met its prespecified safety and efficacy goals in a historical comparison.
- The system demonstrated a safety profile comparable to transvenous pacing systems.
- It provided low and stable pacing thresholds, indicating its potential as a viable alternative to traditional pacemakers.
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