Valve-in-valve outcome: design impact of a pre-existing bioprosthesis on the hydrodynamics of an Edwards Sapien XT valve

Selected in European Journal of Cardio-Thoracic Surgery by R.L.J. Osnabrugge

References

Authors

Doose C, Kütting M, Egron S, Farhadi Ghalati P, Schmitz C, Utzenrath M, Sedaghat A, Fujita B, Schmitz-Rode T, Ensminger S, Steinseifer U

Reference

Eur J Cardiothorac Surg. 2016 Oct 23. pii: ezw317. [Epub ahead of print]

Published

October 2016

Link

Read the abstract

My Comment

Background

Valve in valve transcatheter aortic valve implantation (ViV-TAVI) is an alternative to redo surgical aortic valve replacement (SAVR) in inoperable patients and in patients at high operative risk. This has become even more important now that approximately 80% of all SAVR are bioprostheses, which are implanted at a younger age.

Several TAVI valves have received CE mark and premarket approval for use in degenerated bioprosthesis. This study analysed the effects of the design of four different surgical bioprostheses on the hydrodynamic function of an Edwards Sapien XT valve implanted as a ViV-TAVI.

Major findings

  • Although there was complete coaptation of the leaflets in all 23-mm label-size ViV combinations, there were considerable differences in regurgitation measurements. This means the differences are attributable to paravalvular leakage. The Sapien XT in the Trifecta and the Perimount had the largest paravalvular leakage compared to the Aspire and Mosaic valves.
  • The paravalvular leakages are most likely the result of different valve material as the porcine leaflets of the Aspire and the Mosaic are less stiff and provide better seal.
  • Surgical valves with externally mounted leaflets (Trifecta) have an increased risk of paravalvular leakage in the ViV combination.
  • On the other hand, mean pressure gradient (MPG) was lower in valves with a higher surgical inner diameter (the Perimount and Trifecta valves).
  • Higher MPG was the result of underexpansion of the Sapien XT in the Trifecta and Mosaic valves, leading to axial overlap of the leaflets.

My comment

Valve in Valve-TAVI is increasingly being performed. The choice of the first surgical valve should include considerations on future implantation of a TAVI valve. This is especially true now that bioprostheses are increasingly implanted in younger patients.

This study showed that surgical valves with a large valve area improved hemodynamics for future ViV-TAVI combinations. Moreover, internally mounted leaflets seem to decrease the risk of paravalvular leakage.

Although it is interesting, this bench test study was limited to 23mm surgical valves and no calcifications or pannus of the surgical valves were simulated. The use of the valve-in-valve app developed by Dr. Bapat remains helpful for clinicians making decisions on which TAVI valve is recommended in a specific surgical valve.

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            string(1869) "SOURCE 3 post-approval registry—One-year outcomes in 1,946 TAVI patients with a 3rd generation balloon transcatheter heart valve Speaker: O. WendlerAt 1 year, patients treated via the transfemoral access route had a high survival rate (88.2 percent) and a low disabling stroke rate (1.1 percent).Patients experienced a low rate (2.7 percent) of moderate paravalvular leak and no severe paravalvular leak. Watch the presentationCharacteristics and outcomes of patients ≤75 years old undergoing TAVI—Insights from the SOURCE 3 registry Speaker: D. FrankRead the presentationSurgical risk and outcomes of patients undergoing TAVI with the Edwards SAPIEN 3 bioprosthesis: A subanalysis of the SOURCE 3 registry Speaker: G. TarantiniRead the presentation TAVI with the Edwards SAPIEN 3TM Valve Visit SAPIEN3.com  to see how SAPIEN 3 TAVI is transforming treatment today.For professional use. See instructions for use for full prescribing information, including indications, contraindications, warnings, precautions, and adverse events.Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.Material for distribution only in countries with applicable health authority product registrations. Material not intended for distribution in USA or Japan. Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, PARTNER, PARTNER II, SAPIEN, and SAPIEN 3 are trademarks of Edwards Lifesciences Corporation.© 2017 Edwards Lifesciences Corporation. All rights reserved. E7165/07-17/THVEdwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com"
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