ArticleBioengineering (Basel, Switzerland)2025
A Self-Expanding Nitinol Fixation System for Atrial Leadless Pacemakers: Biomechanical Design and Evaluation.
Article in Bioengineering (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
Atrial leadless pacemakers (ALPMs) offer a minimally invasive solution for patients requiring atrial pacing, but current designs face significant challenges related to fixation stability, perforation risk, and retrievability. This study presents a novel self-expanding nitinol fixation system designed for deployment within the left atrial appendage (LAA), incorporating a flexible adapter for secure pacemaker engagement and retrieval. Finite-element simulations were conducted to assess gravitational displacement across different anatomical orientations, and fixture-expansion behavior was analyzed under various mesh configurations. The pacemaker drop analysis results demonstrated minimal displacement in neutral and upward-tilted LAA models, with increased instability observed in downward-tilted orientations. The fixture-expansion study showed that the 0.2 mm mesh design provided adequate mechanical strength and strain tolerance while maintaining a compact profile. This novel fixation system improves current ALPM limitations by providing stable, retrievable anchoring and favorable biomechanical performance. It may also serve as a dual-function platform for atrial pacing and stroke prevention when integrated with a left atrial appendage (LAA) occluder. These findings support further preclinical validation for clinical translation.
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