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A Direct In Vitro Comparison of the Edwards SAPIEN and Medtronic CoreValve Transcatheter Aortic Valve implantation (TAVI) Devices and a Surgical Counterpart

Tzamtzis, S; Yap, J; Mullen, M; Burriesci, G; (2011) A Direct In Vitro Comparison of the Edwards SAPIEN and Medtronic CoreValve Transcatheter Aortic Valve implantation (TAVI) Devices and a Surgical Counterpart. In: (Proceedings) 6th Biennial Meeting of The Society for Heart Valve Disease.

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Abstract

OBJECTIVE: The Edwards SAPIEN and the Medtronic CoreValve are the only commercially available devices suitable for transcatheter aortic valve implantation (TAVI). Though their clinical results are continuously updated, there are no direct comparisons reported for their hydrodynamic performance, or with equivalent surgical solutions. This study is mainly targeted at providing, for the first time, a direct in vitro comparison of the performances of the SAPIEN and CoreValve devices; and an insight on the different operative mechanisms of TAVI devices and their surgical counterparts. METHODS: The two transcatheter valves (size 26 mm for both the SAPIEN and the CoreValve) and an equivalent surgical bioprosthesis (Sorin Pericarbon) were assessed conforming the requirements of the standard ISO 5840:2009, on a hydro-mechanical cardiovascular pulse duplicator system (Vivitro Superpump SP3891, Vivitro, BC, Canada). The TAVI devices were mounted on a silicone mock aortic root, including three rubber leaflets in order to replicate the presence of the native valve during the tests. The silicone leaflets were removed to test the surgical valve and the suture ring of the prosthesis was sealed to the annulus region. The cardiac chambers’ pressures and aortic flow were measured and the valve performances were compared in terms of mean transvalvular systolic pressure drop (ΔP), regurgitant volumes, effective orifice area (EOA) and fluid-mechanical left ventricular energy loss. RESULTS: The CoreValve performance in terms of ΔP and EOA, closing regurgitation and energy loss was slightly better than that of the SAPIEN. Both TAVI devices were characterized by significantly lower ΔP values compared to the surgical counterpart, but they resulted affected by considerably higher levels of paravalvular leakage (see figure). This rendered the overall performance of the surgical valve more efficient at low cardiac outputs (COs), while the transcatheter valves performed better at higher flow rates. CONCLUSIONS: Globally, the transcatheter and surgical valve performances were comparable, with the TAVI devices being superior at high physiological values of the cardiac output, and the surgical valve at low flow rates.

Type: Proceedings paper
Title: A Direct In Vitro Comparison of the Edwards SAPIEN and Medtronic CoreValve Transcatheter Aortic Valve implantation (TAVI) Devices and a Surgical Counterpart
Event: 6th Biennial Meeting of The Society for Heart Valve Disease
Location: Barcelona, Spain
Dates: 2011-06-25 - 2011-06-28
Publisher version: http://www.shvd.org/abstracts/2011/P171.html
UCL classification: UCL > School of BEAMS > Faculty of Engineering Science > Mechanical Engineering
URI: http://discovery.ucl.ac.uk/id/eprint/1314646
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