Key result
Nitinol tine fixation for transcatheter pacemakers yields 0 dislodgements and stable pacing thresholds in animals.
Why the study?
A novel fixation mechanism for transcatheter pacemakers requires evaluation to determine ease of deployment, safety of removal, pacing stability, and dislodgement risk.
Population
13 human hearts ex vivo and 89 animals with 113 chronic implants in vivo
Comparison
Nitinol tine fixation design for transcatheter pacemaker deployment and removal
Design
Preclinical evaluation study
Follow-up
Chronic implant duration not specified
Authors
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Requires in vivo validation before clinical use; leaves open nitinol tine feasibility for leadless pacemakers.
The novel nitinol tine fixation mechanism for transcatheter pacemakers demonstrated safe deployment, stable pacing thresholds, and high resistance to dislodgement in preclinical models.
Eggen et al. (2015) studied Bradycardia (requiring pacemaker) (n=102). Nitinol tine fixation mechanism (Micra TPS) was evaluated on Device dislodgement and pacing threshold. The nitinol tine fixation design for a transcatheter pacemaker resulted in zero dislodgements and maintained low, stable pacing thresholds (0.59 V at implant to 0.65 V at termination) across 113 implants in 89 animals.
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