Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement
The purpose of this study is to compare the incidence of silent and apparent cerebral embolism between conventional and minimal-invasive transfemoral aortic valve repair.
Aortic Valve Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Incidence and Severity of Silent and Apparent Cerebral Embolism After Conventional and Minimal-invasive Transfemoral Aortic Valve Replacement|
- Silent cerebral embolism [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
- Apparent cerebral embolism [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Study Completion Date:||December 2013|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
conventional aortic valve replacement
transfemoral aortic valve replacement
transapical aortic valve replacement
Patients undergoing aortic valve repair (AVR) are included prospectively into the study. AVR techniques include the conventional technique, the transfemoral and the transapical approach. Before the intervention CT of the chest is performed preoperatively to assess the degree of aortic and aortic valve calcification. Patients undergo MRI of the brain, including diffusion weighted imaging (DWI) and neurological assessment (NIHSS score) within 48 h before and after the procedure to assess occurrence of cerebral embolism.