Design and Evaluation of a Novel Fixation Mechanism for a Transcatheter Pacemaker.

Goal: The purpose of this paper was to evaluate a nitinol tine fixation design for a transcatheter pacemaker in order to determine if the tines could be easily deployed and safely removed from the myocardium, enable low, stable pacing thresholds, and minimize the potential for dislodgment.

Methods: The penetration properties of 13 human hearts were compared to the deployment and fixation energy of the tines to determine if the tines could be easily deployed and removed from the myocardium. The safety factor for dislodgement was calculated by comparing the kinetic energy of the device to the fixation energy of the tines. The fixation stability was tested in 113 chronic implants across 89 animals via pacing threshold measurements or evidence of dislodgement at necropsy.

Results: Based on the tine fixation and tissue energy analysis, the tines can easily penetrate the heart. The tines can be safely removed from the myocardium based on the increased tine surface area during retraction. There were no dislodgements observed in the animals and the mean pacing threshold at implant was 0.59 +/- 0.21 V and at termination was 0.65 +/- 0.36 V. The safety factor for dislodgement was determined to be 15X during simulated exercise conditions.

Conclusion: The nitinol tine fixation design enabled the implant of a self-contained pacemaker within the right ventricle and was effective in meeting the design requirements.

Significance: This fixation technology provides a novel solution to enable the attachment of a transcatheter pacemaker directly within the heart.