Balloon-Expandable Valve for Treatment of Evolut Valve Failure: Implications on Neoskirt Height and Leaflet Overhang

JACC Cardiovasc Interv. 2022 Feb 28;15(4):368-377. doi: 10.1016/j.jcin.2021.12.021.

Abstract

Objectives: This study sought to determine the degree of Evolut (Medtronic) leaflet pinning, diameter expansion, leaflet overhang, and performance at different implant depths of the balloon-expandable Sapien 3 (S3, Edwards Lifesciences LLC) transcatheter heart valve (THV) within the Evolut THV.

Background: Preservation of coronary access and flow is a major factor when considering the treatment of failed Evolut THVs.

Methods: An in vitro study was performed with 20-, 23-, 26-, and 29-mm S3 THVs deployed within 23-, 26-, 29-, and 34-mm Evolut R THVs, respectively. The S3 outflow was positioned at various depths at node 4, 5, and 6 of the Evolut R. Neoskirt height, leaflet overhang, performance, and Evolut R valve housing diameter expansion were assessed under physiological conditions as per ISO 5840-3 standard.

Results: The neoskirt height for the Evolut R was shorter when the S3 outflow was positioned at node 4 compared with node 6 (node 4 height for 23 mm = 16.3 mm, 26 mm = 17.1 mm, 29 mm = 18.3 mm, and 34 mm = 19.9 mm vs node 6 height for 23 mm = 23.9 mm, 26 mm = 23.4 mm, 29 mm = 24.7 mm, and 34 mm = 27 mm Evolut R). All configurations exhibited acceptable hydrodynamic performance irrespective of the degree of leaflet overhang, except the 29-mm S3 implanted in 34-mm Evolut R at node 4 (regurgitant fraction >20%). The valve housing radius of the index Evolut R increased when the S3 was implanted, with the increase ranging from 0 to 2.5 mm.

Conclusions: Placement of the S3 at a lower implant position within an index Evolut R reduces the neoskirt height with no significant compromise to S3 valve function despite a higher degree of leaflet overhang. Low S3 implantation may facilitate future coronary access after redo transcatheter aortic valve replacement.

Keywords: aortic stenosis; bench study; redo transcatheter aortic valve replacement.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aortic Valve / diagnostic imaging
  • Aortic Valve / surgery
  • Aortic Valve Stenosis* / surgery
  • Heart Valve Prosthesis*
  • Humans
  • Prosthesis Design
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Treatment Outcome