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Clinical Trial
. 2023 Jul 17;19(4):e330-e339.
doi: 10.4244/EIJ-D-22-01125.

Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy

Kendra J Grubb  1   2 , Nikoloz Shekiladze  1   2 , Julianne Spencer  3 , Emily Perdoncin  1   2 , Gilbert H L Tang  4 , Joe Xie  1   2 , John Lisko  1   2 , Jorge Zhingre Sanchez  3 , Lindsay M Lucas  5 , Janarthanan Sathananthan  6 , Toby Rogers  7 , G Michael Deeb  8 , Shinichi Fukuhara  8 , Philipp Blanke  6 , Jonathon A Leipsic  6 , John K Forrest  9 , Michael J Reardon  10 , Patrick Gleason  2   11
Affiliations
Clinical Trial

Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy

Kendra J Grubb et al. EuroIntervention. .

Abstract

Background: Transcatheter aortic valve implantation in an existing transcatheter valve (redo-TAVI) pins the index valve leaflets in the open position (neoskirt), which can cause coronary flow compromise and limit access. Whether anatomy may preclude redo-TAVI in self-expanding Evolut valves is unknown.

Aims: We aimed to evaluate the anatomical feasibility of redo-TAVI by simulating implantation of a balloon-expandable SAPIEN 3 (S3) within an Evolut or an Evolut within an Evolut.

Methods: A total of 204 post-TAVI computed tomography (CT) scans from the Evolut Low Risk CT substudy were analysed. Five redo-TAVI positions were evaluated: S3-in-Evolut inflow-to-inflow, S3 outflow at Evolut nodes 4, 5, and 6, and Evolut-in-Evolut inflow-to-inflow. Univariable modelling identified pre-TAVI clinical characteristics, CT anatomical parameters, and procedural variables associated with coronary flow compromise using the neoskirt height and post-TAVI aortic root dimensions.

Results: The risk of coronary flow compromise was lowest when the S3 outflow was at Evolut node 4 (20%) and highest when at Evolut node 6 (75%). The highest likelihood of preserving coronary accessibility occurred with the S3 outflow at Evolut node 4. Female sex and higher body mass index were associated with a higher risk of coronary flow compromise, as were a smaller annulus diameter, lower sinus of Valsalva height and width, shorter coronary height, smaller sinotubular junction diameter, and shallower Evolut implant depth.

Conclusions: The feasibility of redo-TAVI after Evolut failure is multifactorial and relates to the native annular anatomy, as well as the implantation depth of the index and second bioprostheses. Placement of an S3 at a lower Evolut position may reduce the risk of coronary flow compromise while preserving coronary access.

Clinicaltrials: gov: NCT02701283.

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Conflict of interest statement

K.J.Grubb is aproctor, principal investigator and serves on the advisory board for Medtronic; and also serves on the advisory board or is aconsultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, and Edwards Lifesciences. J.Spencer is an employee and shareholder of Medtronic. G.H.L.Tang is aphysician proctor and consultant for Medtronic, aconsultant and physician advisory board member for Abbott Structural Heart, and aphysician advisory board member for JenaValve. J.Zhingre Sanchez is an employee and shareholder of Medtronic. J.Sathananthan is aconsultant to Edwards Lifesciences and Medtronic; and has received speaker fees from Edwards Lifesciences and NVT.T.Rogers is aconsultant and physician proctor to Edwards Lifesciences, Medtronic, and Boston Scientific; is an advisory board member to Medtronic; has equity in Transmural Systems; and is aco-inventor on patents, assigned to NIH, for transcatheter electrosurgery devices. M.Deeb serves on an advisory board for Medtronic; and has received institutional grant support from Boston Scientific, Edwards Lifesciences, and Medtronic; he receives no personal remunerations. S.Fukuhara is aconsultant for Terumo Aortic, Medtronic, and Artivion. P.Blanke holds institutional research core lab agreements with Medtronic, Edwards Lifesciences, and Abbott, with no personal compensation. J.A.Leipsic holds institutional research core lab agreements with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, and Pi-Cardia, with no personal compensation. J.K.Forrest has received grant support/research contracts and consultant fees/honoraria/speakers’ bureau fees from Edwards Lifesciences and Medtronic. M.J.Reardon has received fees to his institution from Medtronic for consulting and providing educational services. P.Gleason’s employer receives institutional grants and educational funding from Edwards Lifesciences and Medtronic; he has no personal financial disclosures. The other authors have no conflicts of interest relevant to this paper to declare.

Figures

Central illustration
Central illustration. Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk trial substudy.
The initial analysis was completed with the inflow of the S3 approximately aligned with the inflow of the Evolut, with additional analyses based on node levels 4, 5, and 6 of the Evolut frame. An Evolut-in-Evolut was analysed inflow-to-inflow. *S3-in-Evolut inflow-to-inflow is an approximation, and the node level was dependent on the size. It correlates with S3 outflow at node 4 for the 26 mm Evolut and S3 outflow at node 5 for the 29 mm and 34 mm Evolut valves. CT: computed tomography; S3: SAPIEN 3 valve; TAVI: transcathether aortic valve implantation
Figure 1
Figure 1. Redo-TAVI criteria to determine the risk of coronary flow compromise and accessibility.
Measurements were determined based on the placement of a virtual second valve in an Evolut. CT: computed tomography; LCA: left coronary artery; RCA: right coronary artery; S3: SAPIEN 3 valve; STJ: sinotubular junction; VTA: valve-to-aortic wall distance at neoskirt plane; VTC: valve-to-coronary distance; VTSTJ: valve-to-sinotubular junction distance; TAVI: transcathether aortic valve implantation
Figure 2
Figure 2. CT-predicted risk of compromised coronary flow and access after redo-TAVI.
A) Based on the redo-TAVI criteria, the lowest risk for coronary flow compromise occurs when an S3 is placed at node 4 of the Evolut frame, and redo-TAVI is feasible 80% of the time. The risk of coronary flow compromise is variable based on the implantation depth of the S3. For Evolut-in-Evolut placed inflow-to-inflow, 29% of cases are at low risk for coronary flow compromise. B) Based on the redo-TAVI criteria, the lowest risk for coronary inaccessibility occurs when an S3 is placed at node 4 of the Evolut frame. S3-in-Evolut inflow-to-inflow is an approximation, and the node level is dependent on the size. It correlates with S3 outflow at node 4 for the 26 mm Evolut and S3 outflow at node 5 for the 29 mm and 34 mm Evolut valves. CT: computed tomography; S3: SAPIEN 3 valve; TAVI: transcathether aortic valve implantation
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