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Item A novel in vitro stretch device for simulating in vivo conditions(2018-05) Akella, Arun; El-Mounayri, HazimBiological cells are constantly subjected to mechanical forces such as tension, compression and shear. The importance of these forces in mediating cell signals, maintenance of lineages, promoting embryonic cell differentiation and tissue engineering is only now coming into focus. It has been shown that stretch stimulus can influence growth, differentiation, as well as tissue strength and integrity. Most stretch systems built to understand more of these phenomena suffer from shortcomings, as accurately replicating the in vivo environment is quite challenging. Many of the devices currently available are very expensive as well as limited to a single application. The objective of this thesis is to design, manufacture, test, and validate a novel uniaxial cyclic cell stretch device that overcomes most of the major limitations of existing systems, and to experimentally demostrate that uniaxial cyclic stretch causes a shift towards in vivo characteristics of smooth muscle cells. The stretch mechanism is driven by a single servo motor which makes its operation simple and straight forward. Coolworks Lite, a proprietary software of the servo motor supplier, is used to control the motor and LabVIEW is used to obtain feedback from the sensors. Validation for the stretch machine was done by evaluating the performance of the device against engineering requirements. Methods were suggested to improve shortcomings that were encountered. Also, the machine's unique design allows its extension to a biaxial stretch unit while keeping the same driver platform, a concept for which has been discussed and illustrated.Item Periprocedural safety of saccular aneurysm embolization with the Penumbra SMART Coil System: a SMART registry subset analysis(BMJ, 2021-02) Starke, Robert M.; Park, Min S.; Bellon, Richard; Bohnstedt, Bradley; Schirmer, Clemens M.; Leacy, Reade De; Fiorella, David; Yoo, Albert J.; Spiotta, Alejandro M.; Neurological Surgery, School of MedicineBackground Using data from the SMART registry, we report on periprocedural safety of the Penumbra SMART Coil System for endovascular coil embolization of saccular intracranial aneurysms. Methods The SMART registry was a prospective, multi-center registry of site standard of care endovascular coiling procedures performed using at least 75% Penumbra SMART Coil, PC400, and/or POD coils. This subset analysis reports on the periprocedural safety outcomes of the saccular intracranial aneurysm cohort. Predictors of rupture/re-rupture or perforation (RRP), thromboembolic complications, and device- or procedure-related adverse events (AEs) were determined in univariate and multivariate analysis. Results Between June 2016 and August 2018, 851 saccular aneurysm patients (31.0%, 264/851 ruptured) were enrolled across 66 North American centers. Clinically significant (ie, a serious adverse event) RRP occurred in 2.0% (17/851) of cases – 1.9% (5/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Clinically significant thromboembolic events occurred in 3.1% (26/851) of cases – 5.3% (14/264) for the ruptured cohort and 2.0% (12/587) for the un-ruptured cohort. Multivariate predictors of periprocedural RRP were increased packing density and adjunctive treatment with a balloon. For periprocedural thromboembolic events, multivariate predictors were bifurcation location and ruptured status. For device- or procedure-related AEs, multivariate predictors were bifurcation location and adjunctive treatment with stent or balloon. Conclusion The low rates of thromboembolic complications and RRP events demonstrate the adequate safety profile of the SMART Coil System to treat cerebral aneurysms in routine clinical practice.