@article{26565c1d269b48a7a2310fa1dad765c5,
title = "Alignment of Transcatheter Aortic-Valve Neo-Commissures (ALIGN TAVR): Impact on Final Valve Orientation and Coronary Artery Overlap",
abstract = "Objectives: The aim of this study was to evaluate the impact of initial deployment orientation of SAPIEN 3, Evolut, and ACURATE-neo transcatheter heart valves on their final orientation and neocommissural overlap with coronary arteries. Background: Coronary artery access and redo transcatheter aortic valve replacement (TAVR) following initial TAVR may be influenced by transcatheter heart valve orientation. In this study the impact of transcatheter heart valve deployment orientation on commissural alignment was evaluated. Methods: Pre-TAVR computed tomography and procedural fluoroscopy were analyzed in 828 patients who underwent TAVR (483 SAPIEN 3, 245 Evolut, and 100 ACURATE-neo valves) from March 2016 to September 2019 at 5 centers. Coplanar fluoroscopic views were coregistered to pre-TAVR computed tomography to determine commissural alignment. Severe overlap between neocommissural posts and coronary arteries was defined as 0° to 20° apart. The SAPIEN 3 had 1 commissural post crimped at 3, 6, 9, and 12 o'clock. The Evolut “Hat” marker and ACURATE-neo commissural post at deployment were classified as center back (CB), inner curve (IC), outer curve (OC), or center front (CF) and matched with final orientation. Results: Initial SAPIEN 3 crimped orientation had no impact on commissural alignment. Evolut “Hat” at OC or CF at initial deployment had less severe overlap than IC or CB (p < 0.001) against the left main (15.7% vs. 66.0%) and right coronary (7.1% vs. 51.1%) arteries. Tracking Evolut “Hat” at OC of the descending aorta (n = 107) improved OC at deployment from 70.2% to 91.6% (p = 0.002) and reduced coronary artery overlap by 36% to 60% (p < 0.05). ACURATE-neo commissural post at CB or IC during deployment had less coronary artery overlap compared to CF or OC (p < 0.001), with intentional alignment successful in 5 of 7 cases. Conclusions: This is the first systematic evaluation of commissural alignment in TAVR. More than 30% to 50% of cases had overlap with 1 or both coronary arteries. Initial SAPIEN 3 orientation had no impact on alignment, but specific initial orientations of Evolut and ACURATE improved alignment. Optimizing valve alignment to avoid coronary artery overlap will be important in coronary artery access and redo TAVR.",
keywords = "commissural alignment, coronary artery access, transcatheter aortic valve replacement",
author = "Tang, {Gilbert H.L.} and Syed Zaid and Andreas Fuchs and Tsuyoshi Yamabe and Farhang Yazdchi and Eisha Gupta and Hasan Ahmad and Kofoed, {Klaus F.} and Goldberg, {Joshua B.} and Cenap Undemir and Kaple, {Ryan K.} and Shah, {Pinak B.} and Tsuyoshi Kaneko and Lansman, {Steven L.} and Sahil Khera and Kovacic, {Jason C.} and Dangas, {George D.} and Stamatios Lerakis and Sharma, {Samin K.} and Annapoorna Kini and Adams, {David H.} and Khalique, {Omar K.} and Hahn, {Rebecca T.} and Lars S{\o}ndergaard and Isaac George and Kodali, {Susheel K.} and {De Backer}, Ole and Leon, {Martin B.} and Bapat, {Vinayak N.}",
note = "Funding Information: Dr. Hahn has received speaking fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, W. L. Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Khalique has served on the Speakers Bureaus for Edwards Lifesciences and Boston Scientific; and has served as a reader for a core laboratory that has contracts with Edwards Lifesciences. Dr. Kaneko has served as a proctor and an educator for Edwards Lifesciences. Dr. Kovacic has received research support from the National Institutes of Health (grants R01HL130423 and R01HL135093). Dr. Shah is a proctor and an educator for Edwards Lifesciences; and is an educator for St. Jude Medical. Dr. Adams has served as the national co–principal investigator of the Medtronic APOLLO Pivotal Trial, the NeoChord ReChord FDA Pivotal Trial, the Medtronic CoreValve US Pivotal Trial, and the Abbott TRILUMINATE Pivotal Trial. In addition, the Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr. Leon has served as a nonpaid member of the scientific advisory board of Edwards Lifesciences; and has served as a consultant for Abbott Vascular and Boston Scientific. Dr. Kodali is on the steering committee for Edwards Lifesciences; is a consultant for Medtronic and Claret Medical; and is on the scientific advisory board for Thubrikar Aortic Valve. Dr. George is a consultant for Edwards Lifesciences and Medtronic. Dr. Tang is a physician proctor for Edwards Lifesciences and Medtronic; and is a consultant for Medtronic. Dr. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C, and Boston Scientific. Dr. S{\o}ndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. De Backer has received consulting fees and institutional grants from Abbott and Boston Scientific. Dr. Dangas is on the advisory board and is a consultant for Boston Scientific; and has common stock with Medtronic that is fully divested. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Funding Information: Dr. Hahn has received speaking fees from Boston Scientific, Baylis Medical, Edwards Lifesciences, and Medtronic; is a consultant for Abbott Structural, Edwards Lifesciences, W. L. Gore & Associates, Medtronic, Navigate, and Philips Healthcare; has received nonfinancial support from 3mensio; holds equity in Navigate; and is the chief scientific officer for the Echocardiography Core Laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, for which she receives no direct industry compensation. Dr. Khalique has served on the Speakers Bureaus for Edwards Lifesciences and Boston Scientific; and has served as a reader for a core laboratory that has contracts with Edwards Lifesciences. Dr. Kaneko has served as a proctor and an educator for Edwards Lifesciences. Dr. Kovacic has received research support from the National Institutes of Health (grants R01HL130423 and R01HL135093). Dr. Shah is a proctor and an educator for Edwards Lifesciences; and is an educator for St. Jude Medical. Dr. Adams has served as the national co–principal investigator of the Medtronic APOLLO Pivotal Trial, the NeoChord ReChord FDA Pivotal Trial, the Medtronic CoreValve US Pivotal Trial, and the Abbott TRILUMINATE Pivotal Trial. In addition, the Icahn School of Medicine at Mount Sinai receives royalty payments from Edwards Lifesciences and Medtronic for intellectual property related to development of valve repair rings. Dr. Leon has served as a nonpaid member of the scientific advisory board of Edwards Lifesciences; and has served as a consultant for Abbott Vascular and Boston Scientific. Dr. Kodali is on the steering committee for Edwards Lifesciences; is a consultant for Medtronic and Claret Medical; and is on the scientific advisory board for Thubrikar Aortic Valve. Dr. George is a consultant for Edwards Lifesciences and Medtronic. Dr. Tang is a physician proctor for Edwards Lifesciences and Medtronic; and is a consultant for Medtronic. Dr. Bapat has served as a consultant for Medtronic, Edwards Lifesciences, 4C, and Boston Scientific. Dr. S{\o}ndergaard has received consulting fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and Symetis. Dr. De Backer has received consulting fees and institutional grants from Abbott and Boston Scientific. Dr. Dangas is on the advisory board and is a consultant for Boston Scientific; and has common stock with Medtronic that is fully divested. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Publisher Copyright: {\textcopyright} 2020 American College of Cardiology Foundation",
year = "2020",
month = may,
day = "11",
doi = "10.1016/j.jcin.2020.02.005",
language = "English",
volume = "13",
pages = "1030--1042",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier",
number = "9",
}