Experimental Evaluation of a New Apical Access and Closure Device

Abstract

Transapical aortic valve implantation (TA-AVI) has evolved as a treatment option for high-risk patients who have severe aortic stenosis. The aim of this study was to evaluate the feasibility of a novel apical closure device to allow for standardized apical access and closure. The Apica ASC system consists of three components: an introducer system, a left ventricular low-profile titanium coil, and a closure cap. The ASC introducer system is fixed to the myocardium by anchoring the titanium coil into the epicardium. After the TA-AVI procedure, the closure cap is introduced through the system and delivered onto the titanium coil for final sealing. After sternotomy, fixation of the introducer system was successfully performed in an acute pig model. The apex was safely secured in all attempts, and the titanium coil created an effective seal around the Ascendra sheath. Finally, the closure cap was shown to be secure even when the hearts were pressurized to 200 mm Hg. Postmortem examination showed a uniform depth of the titanium coil through the endocardium into the myocardial wall without penetration into the left ventricular cavity. Apical access and closure is feasible using the sutureless Apica ASC device. The system seems to have the potential to further standardize the TA-AVI procedure, allowing wider applicability and more generalizability.