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Experimental evaluation of a new apical access and closure device
Johannes Blumenstein1, Arnaud Van Linden1, Joerg Kempfert1, Mani Arsalan1, Helge Moellmann2, James Greene3, Jorge H. Jimenez3, Thomas Walther4.
1Kerckhoff Heart-Center, Department of Cardiac Surgery, Bad Nauheim, Germany, 2Kerckhoff Heart-Center, Department of Cardiology, Bad Nauheim, Germany, 3Apica Cardiovascular Limited, National University Ireland, Galway, Ireland, Ireland, 4Kerckhoff Heart-Center, Departement of Cardiac Surgery, Bad Nauheim, Germany.
OBJECTIVE: Transapical (TA) access for aortic valve implantation (AVI) has evolved as a standard and safe procedure using a conventional purse-string suturing technique. The aim of this study was to evaluate a simplified approach using a TA access and closure device to eventually allow for percutaneous left ventricular TA approach.
METHODS: The Apica access system (Apica Cardiovascular Ltd., Ireland) consists of an introducer system, which delivers a sealing coil and postprocedural sealing cap. The system accommodates multiple TA-AVI systems. In this study the Edwards Ascendra II™ system was used in an experimental pig model. Two different types of access coils (with or without a silicon flange for sealing) were evaluated. After partial sternotomy, apical puncture and positioning of the guide wire, the TA delivery sheath was inserted through the Apica introducer system. The introducer system engaged the myocardium by turning the access coil. At the end, the sealing device was inserted through the introducer into the access coil. Integrity of the closure was evaluated under high blood pressure conditions. Post mortem position of the coil was examined.
RESULTS: Eight different access sites were evaluated in 3 male, adult pigs (67±2.5kg). The Apical access site could be safely secured in all cases with the use of the coil without silicon flange. In all cases the access coil stabilized and created an effective seal around the device. Discreet blood loss was documented in all animals during insertion of the sealing cap. The access sites were sealed successfully in all cases. Minor seepage occurred at the edge of the access coil in two procedures which subsided after protamine was administered. Integrity of access site closure was demonstrated while heart was pressurized to 200mm/Hg in all cases. Post mortem examination showed a uniformed depth of the large coil extending to the endocardium and thus providing safe anchoring of the devices.
CONCLUSIONS: Apical access, stabilization and closure using the Apica access and closure system is feasible. The use of this system will lead to even easier and standardized apical access and could eventually allow for a percutaneous non rib-spreading TA-AVI procedure in the future.
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