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In vitro haemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after Transcather Aortic Valve Implantation

Burriesci, G; Peruzzo, P; Susin, FM; Tarantini, G; Colli, A; (2016) In vitro haemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after Transcather Aortic Valve Implantation. International Journal of Cardiology , 203 pp. 1093-1099. 10.1016/j.ijcard.2015.11.106. Green open access

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Abstract

Objective: We aimed to in-vitro test Amplatzer devices (Amplatzer Vascular Plug II and Amplatzer Vascular Plug III, SJM St. Paul, MN) in closing PVL generated by transcatheter balloon expandable aortic valve prosthesis in order to quantify the effective treatment of PVL. Background: Transcatheter aortic valve replacement (TAVI) procedures represent the treatment of choice for high risk patients. Despite evolving technologies paravalvular leak (PVL) is still a major unaddressed issue. This severe complication significantly impair long-term survival. Percutaneous treatment of this complication is usually performed with the implantation of not specifically designed and not approved vascular devices. Methods: A 23mm Sapien XT (Edwards Lifesciences, Irvine, CA) was implanted in a rubber aortic root and a semi-elliptical shape PVL was created. The vascular occluder devices were implanted in the PVL and hemodynamic performance was tested in a pulse duplicator according to international standard ISO 5840-3:2013. Different type of comparison tests together with high speed camera recording allowed us to define the global efficiency of the occluders and their interaction with the transcatheter prosthesis. Results: The results revealed that the use of vascular plugs was not per se sufficient to produce an effective or substantial reduction of PVL with a maximum efficiency inferior of 50%. Recorded video showed clearly that the vascular plug always interfered with the leaflet of the prosthetic valve. Conclusions: Current used devices do not guarantee effective treatment of PVL and may otherwise compromise the structural integrity of the prosthetic valve implanted. Specific designed devices are required.

Type: Article
Title: In vitro haemodynamic testing of Amplatzer plugs for paravalvular leak occlusion after Transcather Aortic Valve Implantation
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.ijcard.2015.11.106
Publisher version: http://dx.doi.org/10.1016/j.ijcard.2015.11.106
Language: English
Additional information: Copyright Elsevier 2015. This article is published under a Creative Commons Attribution Non-commercial Non-derivative 4.0 International license (CC BY-NC-ND 4.0). This license allows you to share, copy, distribute and transmit the work for personal and non-commercial use providing author and publisher attribution is clearly stated. Further details about CC BY licenses are available at http://creativecommons.org/ licenses/by/4.0. Access may be initially restricted by the publisher.
Keywords: Transcatheter aortic valve implantation, Transcatheter aortic valve replacement, Paravalvular leak, Aortic regurgitation, Vascular occluder
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > UCL BEAMS
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science
UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Mechanical Engineering
URI: https://discovery.ucl.ac.uk/id/eprint/1472674
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