Journal of Cardiovascular Translational Research

, Volume 12, Issue 6, pp 551–559 | Cite as

In Vitro and Ex Vivo Hemodynamic Testing of an Innovative Occluder for Paravalvular Leak After Transcather Aortic Valve Implantation

  • Paolo PeruzzoEmail author
  • Gaetano Burriesci
  • Francesca Maria Susin
  • Andrea Colli
Original Article


This study aims at achieving a proof-of-concept for a novel device designed to occlude the orifices that may form between transcatheter valves and host tissues after TAVI. The device effect on the performance of a SAPIEN XT with a paravalvular gap was assessed into an in vitro and ex vivo pulse duplicator. The in vitro tests were performed complying with the standard international regulations, measuring the trasvalvular pressure and regurgitant volumes with and without the paravalvular gap, and with the occluder correctly positioned into the gap. In the second series of tests, the leakage reduction due to the presence of the occluder was assessed for the same setup, into a beating swine heart. The occluder implantation decreased the regurgitant fraction of about 50% for the in vitro assessment and 75% for the ex vivo test, under rest operating conditions. These results suggest that suitably designed occluders can lead to important benefit in the PVL treatment.


Transcatheter aortic valve implantation (TAVI) Transcatheter aortic valve replacement (TAVR) Paravalvular leakage (PVL) Aortic regurgitation Vascular plugs 



Cardiac output


Heart rate


Mean aortic pressure


Paravalvular leakage


Regurgitant fraction


Regurgitant volume


Stroke volume


Transcatheter aortic valve


Transcatheter aortic valve implantation


Mean diastolic transvalvular pressure


Device efficiency


Funding Sources

The study was funded by the Italian Ministry of Health (Research grant GR-2010-2320784)

Compliance with Ethical Standards

Conflict of Interest

The authors declare that they have no conflict of interest.

Ethical Approval

This article does not contain any studies with human participants or animals performed by any of the authors.


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.HER Lab, Department of Civil, Environmental, and Architectural EngineeringUniversity of PadovaPaduaItaly
  2. 2.Department of Civil, Environmental And ArchitecturalUniversity of PadovaPaduaItaly
  3. 3.UCL Cardiovascular Engineering Laboratory, UCL Mechanical EngineeringUniversity College LondonLondonUK
  4. 4.Bioengineering Group, Ri.MED FoundationPalermoItaly
  5. 5.Cardiac Surgery Unit, Department of Cardiology, Thoracic and Vascular SciencesUniversity of Padova Medical SchoolPaduaItaly

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