Author + information
- Received November 18, 2019
- Revision received January 27, 2020
- Accepted February 4, 2020
- Published online May 4, 2020.
- Gilbert H.L. Tang, MD, MSc, MBAa,∗ (, )
- Syed Zaid, MDb,
- Andreas Fuchs, MD, PhDc,
- Tsuyoshi Yamabe, MDd,
- Farhang Yazdchi, MD, MSe,
- Eisha Gupta, MDf,
- Hasan Ahmad, MDb,
- Klaus F. Kofoed, MDg,
- Joshua B. Goldberg, MDh,
- Cenap Undemir, MDh,
- Ryan K. Kaple, MDi,
- Pinak B. Shah, MDj,
- Tsuyoshi Kaneko, MDe,
- Steven L. Lansman, MD, PhDh,
- Sahil Khera, MDf,
- Jason C. Kovacic, MD, PhDf,
- George D. Dangas, MD, PhDf,
- Stamatios Lerakis, MDf,
- Samin K. Sharma, MDf,
- Annapoorna Kini, MDf,
- David H. Adams, MDa,
- Omar K. Khalique, MDk,
- Rebecca T. Hahn, MDk,
- Lars Søndergaard, MD, DMScc,
- Isaac George, MDd,
- Susheel K. Kodali, MDk,
- Ole De Backer, MD, PhDc,
- Martin B. Leon, MDk and
- Vinayak N. Bapat, MBBSd
- aDepartment of Cardiovascular Surgery, Mount Sinai Medical Center, New York, New York
- bDivision of Cardiology, Westchester Medical Center, Valhalla, New York
- cThe Heart Center, Rigshospitalet, Copenhagen, Denmark
- dDivision of Cardiac Surgery, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York
- eDivision of Cardiac Surgery, Brigham and Women’s Hospital, Boston, Massachusetts
- fDivision of Cardiology, Mount Sinai Medical Center, New York, New York
- gDepartment of Cardiology & Radiology, Rigshospitalet University of Copenhagen, Copenhagen, Denmark
- hSection of Cardiothoracic Surgery, Westchester Medical Center, Valhalla, New York
- iDivision of Cardiology, Yale University School of Medicine, New Haven, Connecticut
- jDivision of Cardiology, Brigham and Women’s Hospital, Boston, Massachusetts
- kDivision of Cardiology, NewYork-Presbyterian Hospital, Columbia University Medical Center, New York, New York
- ↵∗Address for correspondence:
Dr. Gilbert H.L. Tang, Mount Sinai Health System, Department of Cardiovascular Surgery, 1190 Fifth Avenue, GP2W, Box 1028, New York, New York 10029.
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.
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. Søndergaard 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.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received November 18, 2019.
- Revision received January 27, 2020.
- Accepted February 4, 2020.
- 2020 American College of Cardiology Foundation