Analytical Modeling for Computing Lead Stress in a Novel Epicardial Micropacemaker

We report a pilot study in which two mechanical dummy pacemakers with epicardial leads were implanted into an adult pig modelvia a minimally invasive approach. Fluoroscopy was obtained on the animal on Post-Operative Days #9, #35 and #56 (necropsy). We then constructed an analytic model to estimate thein vivo stress conditions on the open-coil lead based on the analysis of orthogonal biplane radiographic images. We obtained geometric deformation data of the implanted lead including elongation magnitudes and bending radii from sequenced films of cardiac motion cycles. The lead stress distribution was investigated on each film frame and the point of maximum stress (Mean Stress  = 531.4 MPa; Alternating Stress = ± 216.4 MPa) was consistently where one of the leads exited the pericardial space, a deployment that we expected to be unfavorable. These results suggest the modeling approach can provide a basis for further design optimization. More animal tests and modeli ng will be needed to validate whether the novel lead design could meet the requirements to withstand ~200 million cardiac motion cycles over 5 years.
Source: Cardiovascular Engineering and Technology - Category: Cardiology Source Type: research