Purposes
Implantation and maintenance of a permanent cardiac pacing system in children remains challenging due to small patient size, congenital heart defects and somatic growth. We are developing a novel epicardial micropacemaker for children that can be implanted on the epicardium within the pericardial space via a minimally–invasive technique. The key design configurations include a novel open-coiled lead in which living tissue replaces the usual polymeric support for the coiled conductor. To better understand and be able to predict the behavior of the implanted lead, we performed a radiographic image-based modeling study on a chronic animal test.
Methods
We report a pilot study in which two mechanical dummy pacemakers with epicardial leads were implanted into an adult pig model via 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 the in vivo stress conditions on the open-coil lead based on the analysis of orthogonal biplane radiographic images.
Results
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.
Conclusions
These results suggest the modeling approach can provide a basis for further design optimization. More animal tests and modeling will be needed to validate whether the novel lead design could meet the requirements to withstand ~200 million cardiac motion cycles over 5 years.
This study was a retrospective cohort database study which looked at the relationship between myocardial reinfarction following lumbar spine surgery.Objective: Current study aimed to determine the risk of reinfarction associated with the time between initial myocardial infarction (MI) and lumbar spine surgery, type of lumbar surgical procedure, and other risk factors.Summary of Background Info: Several studies have demonstrated a strong temporal pattern between postoperative reinfarction rate and the period between previous MI and surgery. To the best of our knowledge, no study has looked specifically at the temporal relationship between previous MI, lumbar spine surgery and incidence of postoperative myocardial reinfarction.
Materials and Methods:The Humana database was analyzed from Q1 2007 through Q3 2016 and the Medicare database was analyzed from Q1 2005 through Q4 2014. Patients were placed into 1 of 5 groups based on time between MI and surgery: 0-3, 4-6, 7-12, 13-24, and 25+ months. Reinfarction rates were determined in these groups. Age, sex, and type of surgery were analyzed to determine association with postoperative reinfarction rates.Results: There was a strong correlation between postoperative myocardial reinfarction and lumbar spine surgery occurring 0-3 months after the patient's initial MI (P < 0.01). Those patients had a risk ratio > 3 (P < 0.01) compared with patients who underwent lumbar spine surgery after an interval > 3 months between initial MI and lumbar spine surgery. In addition, spinal fusion procedures were associated with a greater risk of postoperative myocardial reinfarction than nonfusion procedures.
Conclusion:In both databases, there was a clinically relevant and statistically significant increase in myocardial reinfarction in patients who experienced an MI 0-3 months before lumbar spine surgery. We believe that the current study helps in treatment planning for patients with a history of MI who are considering spine surgery.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.