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Related Experiment Video

Updated: Sep 20, 2025

A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
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Atrial helix-fixation leadless pacemaker: real-world single-chamber implant experience.

Devi G Nair1,2,3,4, Ken W Lee5, Nima Badie6

  • 1St. Bernards Healthcare, Jonesboro, AR, USA. drdevignair@gmail.com.

Journal of Interventional Cardiac Electrophysiology : an International Journal of Arrhythmias and Pacing
|May 28, 2025
PubMed
Summary

The novel atrial leadless pacemaker (LP) shows safe and effective use for treating sinus node dysfunction (SND). Initial real-world data confirm successful implantation and good electrical performance without acute complications.

Keywords:
Atrial pacemakerAveirHelix fixationImplant procedureLeadless pacemakerPacemaker complications

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Area of Science:

  • Cardiology
  • Electrophysiology
  • Medical Devices

Background:

  • Single-chamber ventricular leadless pacemakers (LPs) are established.
  • A dual-chamber LP system with separate atrial and ventricular devices is now available.
  • Single-chamber atrial pacing via transvenous leads is less common due to future upgrade concerns.

Purpose of the Study:

  • To evaluate the initial real-world use of the atrial LP as a standalone device for treating isolated sinus node dysfunction (SND).

Main Methods:

  • Consecutive implantation of atrial LPs in SND patients with normal PR interval and AV conduction post-US commercial release.
  • Evaluation of procedural characteristics and electrical parameters (capture threshold, sensed amplitude, impedance) at various stages.
  • Monitoring for acute and 30-day procedure- or device-related complications.

Main Results:

  • Successful implantation in 75 patients (100% success rate) with predominant placement in the right atrial appendage base.
  • Average procedure and fluoroscopy times were 36 ± 33 min and 7 ± 8 min, respectively.
  • Excellent electrical parameters were recorded, with significant improvement in capture threshold and sensed amplitude from LP release to discharge. No acute complications were observed.

Conclusions:

  • Initial real-world implantation of the helix-fixation, single-chamber atrial LP in SND patients is safe and efficient.
  • The device demonstrates clinically acceptable electrical metrics.
  • No acute complications were reported in this study cohort.