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NL-EVDR: Netherlands-ExtraVascular Device Registry.

Fleur V Y Tjong1, Karel T N Breeman2, Lucas V A Boersma2,3

  • 1Department of Cardiology, Amsterdam University Medical Centres, location Academic Medical Centre; Amsterdam Cardiovascular Sciences, Heart Failure and Arrhythmias, Amsterdam, The Netherlands. f.v.tjong@amsterdamumc.nl.

Netherlands Heart Journal : Monthly Journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation
|March 2, 2023
PubMed
Summary
This summary is machine-generated.

Extravascular devices (EVDs) offer an alternative to traditional cardiac implantable electronic devices (CIEDs) by reducing complications. A new Dutch registry will collect long-term data on EVDs to assess their safety and efficacy.

Keywords:
ExtravascularLeadless pacemakerRegistrySubcutaneous implantable cardioverter-defibrillator

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Area of Science:

  • Cardiology
  • Medical Device Technology
  • Clinical Research

Background:

  • Conventional transvenous cardiac implantable electronic devices (CIEDs) carry risks of pocket and lead complications.
  • Extravascular devices (EVDs), including subcutaneous implantable cardioverter-defibrillators and leadless pacemakers, are emerging alternatives.
  • Evaluating new EVDs is challenging due to high costs, limited long-term data, and selected patient populations.

Purpose of the Study:

  • To establish a nationwide registry for collecting real-world, large-scale, long-term data on extravascular devices (EVDs).
  • To improve the evaluation of safety and efficacy of novel EVDs in a clinical setting.
  • To leverage the existing infrastructure of the Netherlands Heart Registration (NHR) for robust data collection.

Main Methods:

  • Initiation of the Netherlands-ExtraVascular Device Registry (NL-EVDR), a nationwide registry for EVDs.
  • Integration of the NL-EVDR into the existing Netherlands Heart Registration (NHR) device registry.
  • Collection of both retrospective and prospective EVD-specific data, with a pilot project underway to optimize data collection.

Main Results:

  • The establishment of the NL-EVDR aims to provide crucial long-term data on EVDs.
  • The registry will facilitate comprehensive analysis of EVD safety and efficacy.
  • A pilot project is in progress to refine data collection methodologies.

Conclusions:

  • The NL-EVDR is poised to become a vital resource for understanding the performance of extravascular devices.
  • This registry will enable evidence-based decision-making regarding the adoption of new cardiac electronic therapies.
  • Long-term, real-world data from the NL-EVDR are essential for advancing CIED technology.