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. 2023 Nov;16(11):e013238.
doi: 10.1161/CIRCINTERVENTIONS.123.013238. Epub 2023 Nov 21.

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study

Gilbert H L Tang  1 , Julianne Spencer  2 , Toby Rogers  3 , Kendra J Grubb  4   5 , Patrick Gleason  5   6 , Hemal Gada  7 , Paul Mahoney  8 , Harold L Dauerman  9 , John K Forrest  10 , Michael J Reardon  11 , Philipp Blanke  12 , Jonathon A Leipsic  12 , Mohamed Abdel-Wahab  13 , Guilherme F Attizzani  14 , Rishi Puri  15 , Michael Caskey  16 , Christine J Chung  17 , Ying-Hwa Chen  18 , Dariusz Dudek  19 , Keith B Allen  20 , Adnan K Chhatriwalla  20 , Wah Wah Htun  21 , Daniel J Blackman  22 , Giuseppe Tarantini  23 , Jorge Zhingre Sanchez  2 , Greta Schwartz  2 , Jeffrey J Popma  2 , Janarthanan Sathananthan  24
Affiliations

Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study

Gilbert H L Tang et al. Circ Cardiovasc Interv. 2023 Nov.

Abstract

Background: Coronary accessibility following redo-transcatheter aortic valve replacement (redo-TAVR) is increasingly important, particularly in younger low-risk patients. This study aimed to predict coronary accessibility after simulated Sapien-3 balloon-expandable valve implantation within an Evolut supra-annular, self-expanding valve using pre-TAVR computed tomography (CT) imaging.

Methods: A total of 219 pre-TAVR CT scans from the Evolut Low-Risk CT substudy were analyzed. Virtual Evolut and Sapien-3 valves were sized using CT-based diameters. Two initial Evolut implant depths were analyzed, 3 and 5 mm. Coronary accessibility was evaluated for 2 Sapien-3 in Evolut implant positions: Sapien-3 outflow at Evolut node 4 and Evolut node 5.

Results: With a 3-mm initial Evolut implant depth, suitable coronary access was predicted in 84% of patients with the Sapien-3 outflow at Evolut node 4, and in 31% of cases with the Sapien-3 outflow at Evolut node 5 (P<0.001). Coronary accessibility improved with a 5-mm Evolut implant depth: 97% at node 4 and 65% at node 5 (P<0.001). When comparing 3- to 5-mm Evolut implant depth, sinus sequestration was the lowest with Sapien-3 outflow at Evolut node 4 (13% versus 2%; P<0.001), and the highest at Evolut node 5 (61% versus 32%; P<0.001).

Conclusions: Coronary accessibility after Sapien-3 in Evolut redo-TAVR relates to the initial Evolut implant depth, the Sapien-3 outflow position within the Evolut, and the native annular anatomy. This CT-based quantitative analysis may provide useful information to inform and refine individualized preprocedural CT planning of the initial TAVR and guide lifetime management for future coronary access after redo-TAVR.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02701283.

Keywords: balloon-expandable valve; coronary access; implant depth; self-expanding valve; transcatheter aortic valve replacement.

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Conflict of interest statement

Disclosures Dr Tang is a physician proctor, consultant, and physician advisory board member for Medtronic, a consultant and physician advisory board member for Abbott Structural Heart, a consultant for NeoChord, and a physician advisory board member for JenaValve and Boston Scientific. He has received Speaker Honoraria for Siemens Healthineers and East End Medical. Dr Spencer is an employee and shareholder of Medtronic. Dr Rogers is a consultant and physician proctor to Edwards Lifesciences, Medtronic and Boston Scientific; is an Advisory Board member to Medtronic; has equity in Transmural Systems; and is a co-inventor on patents, assigned to National Institutes of Health, for transcatheter electrosurgery devices. Dr Grubb is a proctor, principal investigator and on the advisory board for Medtronic, serves on the advisory board or is a consultant for Ancora Heart, Boston Scientific, Abbott, 4C Medical, Gore, BioVentrix, and Edwards Lifesciences. Dr Gleason’s employer receives institutional grants and educational funding from Edwards Lifesciences, Abbott and Medtronic; he has no personal financial disclosures. Dr Gada has served as a consultant to Abbott, Bard Medical Corporation, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Mahoney is a proctor and consultant for Medtronic, Edwards, and Boston Scientific. Dr Dauerman is a consultant for Boston Scientific and Medtronic, and has received grant support from Boston Scientific and Medtronic. Dr Forrest has received grant support/research contracts and consultant fees/honoraria/speakers’ bureau fees from Edwards Lifesciences and Medtronic. Dr Reardon has received fees to his institution from Medtronic for consulting and providing educational services. Dr Blanke holds institutional research core laboratory agreements with Medtronic, Edwards Lifesciences, and Abbott with no personal compensation. Dr Leipsic holds institutional research core laboratory agreements with Medtronic, Edwards Lifesciences, Abbott, Boston Scientific, and Pi CARDIA with no personal compensation. Dr Abdel-Wahab’s institution receives speaker’s honoraria and consultancy fees on his behalf from Abbott, Boston Scientific, and Medtronic. Dr Attizzani is a consultant, serves as a proctor and is on the advisory board of Medtronic and is a consultant for Abbott Vascular. Dr Puri is a consultant, speaker and proctor for Medtronic, consults for Centerline Biomedical, Boston Scientific, Abbott, Philips, Products & Features, Shockwave Medical, VDyne, VahatiCor, Advanced Nanotherapies, NuevoSono, TherOx, GE Healthcare, BioVentrix, Protembis, and has equity interest in Centerline Biomedical, VahatiCor and NuevoSono. Dr Caskey reports proctor fees from Medtronic. Dr Chen is a proctor and is an advisory board member for Medtronic. Dr Allen has received grant support, proctor and speakers’ bureau fees from Edwards Lifesciences, Medtronic and Abbott with no personal compensation. Dr Chhatriwalla is a proctor for Edwards Lifesciences and Medtronic Inc, is on the speakers bureau for Abbott Vascular, Edwards Lifesciences and Medtronic Inc, and has a research grant from Boston Scientific. Dr Htun is a consultant for Medtronic. Dr Blackman is a proctor and consultant for Medtronic and Abbott Vascular, and a consultant for Edwards Lifesciences and Boston Scientific. Dr Tarantini has received lecture fees from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr Zhingre Sanchez is an employee and shareholder of Medtronic. Dr Popma is an employee and shareholder of Medtronic. Dr Sathananthan is a consulta nt to Edwards Lifesciences and Medtronic; and has received speaking fees from Edwards Lifesciences and NVT. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.
Redo–transcatheter aortic valve replacement (TAVR) criteria to evaluate coronary access following Sapien-3 in Evolut. Criteria used to determine suitable and challenging coronary access and sinus sequestration. CT indicates computed tomography; NPLH, net pinned leaflet height; and STJ, sinotubular junction.
Figure 2.
Figure 2.
Anatomic and bioprosthesis measurements to evaluate coronary access following Sapien-3 in Evolut. A, Suitable coronary access, defined by superior coronary ostia height minus net pinned leaflet height (NPLH) ≥2 mm. B, Challenging coronary access, defined based on the position of the sinotubular junction (STJ) relative to the NPLH. C, Sinus sequestration, defined when the pinned leaflets create a stent graft leading to coronary inaccessibility, in particular, in the presence of a low STJ height and a small STJ diameter. DOI indicates depth of implant; LCA, left coronary artery; and RCA, right coronary artery.
Figure 3.
Figure 3.
Incremental improvements in coronary access by Evolut depth of implant and position of the Sapien-3. Green represents coronary arteries accessible at 3 and 5 mm Evolut depth of implant (DOI). Blue: coronary arteries accessible with Evolut DOI at 5 mm but not at 3 mm. Purple: challenging coronary access or sinus sequestration at 3 or 5 mm Evolut DOI.
Figure 4.
Figure 4.
Pre–transcatheter aortic valve replacement (TAVR) computed tomography (CT) case planning based on aortic root measurements. Case A: the perimeter-derived annulus is 22.3 mm, suggesting a 26-mm Evolut for initial implantation. The area-derived diameter is 21.8 mm, suggesting a 23-mm Sapien-3 for the second bioprosthesis. The left coronary artery has the lowest superior coronary height at 17.4 mm. Based on Table 3, with an initial Evolut implantation depth of 3 mm, the minimum superior coronary height for suitable coronary access is 16.1 mm for a Sapien-3 at node 4 (suitable coronary access). With an initial Evolut implantation depth of 5 mm, the minimum superior coronary height for suitable coronary access is 14.1 mm (suitable coronary access). Case B: the perimeter-derived annulus is 23.7 mm, suggesting a 29-mm Evolut for initial implantation. The area-derived diameter is 23.0 mm, suggesting a 23-mm Sapien-3 for the second bioprosthesis. The right coronary artery (RCA) has the lowest superior coronary height at 17 mm. Based on Table 3, with an initial Evolut implantation depth of 3 mm, the minimum superior coronary height for suitable coronary access is 17.3 mm for a Sapien-3 at node 4 (challenging coronary access/sinus sequestration). With an initial Evolut implantation depth of 5 mm, the minimum superior coronary height for suitable coronary access is 15.3 mm (suitable coronary access). Case C: the perimeter-derived annulus is 23.2 mm, suggesting a 29-mm Evolut for initial implantation. The area-derived diameter is 23.0 mm, suggesting a 23-mm Sapien-3 for the second bioprosthesis. The RCA has the lowest superior coronary height at 15.3 mm. Based on Table 3, with an initial Evolut implantation depth of 3 mm, the minimum superior coronary height is 17.3 mm for a Sapien-3 at node 4 (challenging coronary access/sinus sequestration). With an initial Evolut implantation depth of 5 mm, the minimum superior coronary height is 15.3 mm (borderline suitable coronary access).
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