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Impact of Initial Evolut Transcatheter Aortic Valve Replacement Deployment Orientation on Final Valve Orientation and Coronary Reaccess

2019; Lippincott Williams & Wilkins; Volume: 12; Issue: 7 Linguagem: Inglês

10.1161/circinterventions.119.008044

1941-7632

Gilbert H.L. Tang, Syed Zaid, Eisha Gupta, Hasan Ahmad, Nish Patel, Muhammad Zia Khan, Asaad Khan, Jason C. Kovacic, Steven Lansman, George Dangas, Sanjeev Sharma, Annapoorna Kini,

Cardiac Imaging and Diagnostics

HomeCirculation: Cardiovascular InterventionsVol. 12, No. 7Impact of Initial Evolut Transcatheter Aortic Valve Replacement Deployment Orientation on Final Valve Orientation and Coronary Reaccess Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBImpact of Initial Evolut Transcatheter Aortic Valve Replacement Deployment Orientation on Final Valve Orientation and Coronary ReaccessA Pilot Study Gilbert H.L. Tang, MD, MSc, MBA, Syed Zaid, MD, Eisha Gupta, MD, Hasan Ahmad, MD, Nish Patel, MD, Muhammad Khan, MD, Asaad Khan, MD, Jason C. Kovacic, MD, PhD, Steven L. Lansman, MD, PhD, George D. Dangas, MD, PhD, Samin K. Sharma, MD and Annapoorna Kini, MD Gilbert H.L. TangGilbert H.L. Tang Gilbert Tang, MD, MSc, MBA, Structural Heart Program, Department of Cardiovascular Surgery, Mt Sinai Health System, 1190 Fifth Ave, GP2W, Box 1028, New York, NY 10029. Email E-mail Address: [email protected] Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Syed ZaidSyed Zaid Division of Cardiology, Westchester Medical Center, Valhalla, NY (S.Z., H.A.) , Eisha GuptaEisha Gupta Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Hasan AhmadHasan Ahmad Division of Cardiology, Westchester Medical Center, Valhalla, NY (S.Z., H.A.) , Nish PatelNish Patel Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Muhammad KhanMuhammad Khan Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Asaad KhanAsaad Khan Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Jason C. KovacicJason C. Kovacic Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Steven L. LansmanSteven L. Lansman Section of Cardiothoracic Surgery, Westchester Medical Center, Valhalla, NY (S.L.L.) , George D. DangasGeorge D. Dangas Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) , Samin K. SharmaSamin K. Sharma Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) and Annapoorna KiniAnnapoorna Kini Department of Cardiovascular Surgery, Mount Sinai Medical Center, New York, NY (G.H.L.T.) Originally published5 Jul 2019https://doi.org/10.1161/CIRCINTERVENTIONS.119.008044Circulation: Cardiovascular Interventions. 2019;12:e008044Unlike surgery, transcatheter heart valve (THV) neo-commissures in transcatheter aortic valve replacement (TAVR) cannot be predictably aligned with native commissures and may interfere with coronary orifices and affect reaccess.1–3 We evaluate the impact of initial deployment orientation of EvolutR/Pro (ERP) transcatheter valve (Medtronic, Inc, Minneapolis, MN) on its final neo-commissural orientation and severity of overlap with the coronaries.From April 2018 to January 2019, among 118 transfemoral ERP TAVR performed at 2 centers, the capsule Hat orientation during initial ERP deployment was categorized as outer curve (OC), center front (CF), inner curve, and center back of the aortic root (Figure [A]). The resulting final C-tab (one of the neo-commissures) orientation was similarly categorized (Figure [B]). Per manufacturer recommendation, the ERP is loaded with C-tab facing up and 90° clockwise from the Hat, and this relationship is preserved during valve deployment. In our study, C-tab positions on fluoroscopy at the same coplanar view as the initial aortogram were co-registered onto computed tomography (CT) axial images of aortic annulus and sinus of valsalva using 3Mensio Valves software (Pie Medical Imaging, Masstricht, the Netherlands). Our co-registration technique is as follows (Figure [C]): first, aortogram and final valve orientation images were obtained at the 3-cusp coplanar view on fluoroscopy. Second, the 3-cusp view was identified on 3Mensio. Third, an orange circle with 15 spokes (corresponding to an ERP with 15 crowns including the C-tab) is projected onto CT axial images, with C-tab orientation of the depicted ERP on CT images matching the fluoroscopic image (co-registration). The ERP neo-commissural orientation (120° apart from the C-tab) and relationship to coronary orifices could, therefore, be identified (Figure [C]). Overlap between coronaries and neo-commissures were categorized as severe (0°–20.0°), moderate (20.1°–40.0°), and mild (40.1°–60.0°), as previously described (Figure [D]).1 A representative case example with post-TAVR CT confirmed the ERP orientation as predicted by our co-registration technique (Figure [E]). Our retrospective study was approved by the institutional review board, and patient consent was waived. Statistical analysis was performed on SPSS version 23 (IBM, Armonk, NY) using χ2 test or Fisher exact test as appropriate, 2-tailed with P<0.05 considered significant. The authors declare that all supporting data are available within the article.Download figureDownload PowerPointFigure. Impact of initial Hat orientation during EvolutR/Pro (ERP) deployment on final orientation and coronary reaccess. Capsule Hat orientation at initial ERP deployment and final C-tab orientation (white arrows) at the 3-cusp view were determined (A and B). The ERP C-tab orientation on fluoroscopy was co-registered to the computed tomography (CT) annular and sinuses of valsalva planes using 3Mensio Valves imaging software, with ERP depicted as an orange circle with 15 spokes and 3 dots (1 C-tab, white arrow), to determine its neo-commissural orientation relative to native commissures (N-R, N-L, R-L) and severity of overlap with coronaries (LM, RCA; C and D). Sample case showing the capsule Hat (white arrow) at the outer curve (OC) during deployment, resulting in the C-tab at the inner curve (IC) at the coplanar view (E). ERP neo-commissural orientation (orange arrows) in post-transcatheter aortic valve replacement (TAVR) CT matched that of our pre-TAVR CT-fluoro co-registration. Capsule Hat being at the IC or center back (CB) at initial deployment had a higher incidence of severe overlap with 1 or both coronaries after valve implantation (F). CAU indicates caudal; CRA, cranial; L, left sinus base; LAO, left anterior oblique; LM, left main; N, nonsinus base; N-L, nonleft commissure; N-R, nonright commissure; R, right sinus base; RCA, right coronary artery, and R-L, right-left commissure.Overall, severe neo-commissural overlap with left main was 33.1%, right coronary artery 20.3%, both 14.4%, and 1 or both 39.0%. With Hat position at OC/CF, severe overlap with left main was 19.5%, right coronary artery 6.1%, both 2.4%, and 1 or both 23.2% (Figure [F]). Having Hat position at inner curve/center back increased severe overlap with left main to 63.9%, right coronary artery 52.8%, both 41.7%, and 1 or both 75.0% (all P<0.001).Previous studies have shown that neo-commissural orientation after TAVR appeared random and may be associated with difficulty in coronary reaccess and THV dysfunction.1–3 The tall ERP neo-commissure, when facing a coronary orifice, creates a potential barrier to reaccess.3 Delayed coronary obstruction, although infrequent, carries significant risks and the incidence appeared higher after ERP TAVR.4 These findings have important implications as TAVR expands to younger and lower risk patients, where valve durability and CAD progression become important factors to consider, as ERP TAVR was shown noninferior to surgery at 2 years.5 Newer generation THV that align closer with native commissures (eg, JenaValve, J-valve) may better address above limitations but are not currently approved in the United States. The above concerns thus call for a need to evaluate the association of initial THV or catheter orientation during deployment with final THV orientation and coronary overlap. To the best of our knowledge, our study is the first to (1) use fluoro-CT co-registration to identify THV orientation after TAVR without postprocedural CT and (2) characterize how catheter orientation at initial THV deployment can be associated with its final orientation.Our study showed that the Hat orientation at initial deployment was associated with final ERP orientation, with OC/CF being most favorable in reducing the incidence of severe coronary overlap. The implication is that it may be possible to orient the Hat to OC/CF at initial ERP deployment to reduce coronary overlap. However, severe overlap even with the Hat at OC/CF remained at 23.2% in our study because of 3 following possible factors: (1) patient's vascular anatomy and tortuosity varies and can affect directionality of steering of the delivery catheter to aortic annulus; (2) once positioned across the annulus, the spines within the catheter limit the ability to preferentially orient the Hat to OC/CF. One may try to withdraw the catheter back to the descending aorta, re-orient, and then re-advance it to the annulus, but preferential orientation to OC/CF may still not be possible; and (3) initial ERP position at annulus and flowering direction vary from case to case, making it impossible to predict the exact final C-tab location after release. Our categorization scheme was a simplification and given the above factors there would be variability in the exact Hat and C-tab locations, but we felt our simplified scheme can be adopted by other implanters. In the future, improving delivery catheter design to better control ERP orientation and minimize neo-commissural overlap with coronaries will be important, as TAVR expands to younger patients.DisclosuresDr Tang is a physician proctor for Edwards Lifesciences and Medtronic. The other authors report no conflict.FootnotesPresented in part at the American College of Cardiology Annual Scientific Session in, New Orleans, LA, March 16–18, 2019.Gilbert Tang, MD, MSc, MBA, Structural Heart Program, Department of Cardiovascular Surgery, Mt Sinai Health System, 1190 Fifth Ave, GP2W, Box 1028, New York, NY 10029. Email gilbert.[email protected]orgReferences1. Tang GHL, Zaid S, Ahmad H, Undemir C, Lansman SL. Transcatheter valve neo-commissural overlap with coronary orifices after transcatheter aortic valve replacement.Circ Cardiovasc Interv. 2018; 11:e007263. doi: 10.1161/CIRCINTERVENTIONS.118.007263LinkGoogle Scholar2. Fuchs A, Kofoed KF, Yoon SH, Schaffner Y, Bieliauskas G, Thyregod HG, Makkar R, Søndergaard L, De Backer O, Bapat V. Commissural alignment of bioprosthetic aortic valve and native aortic valve following surgical and transcatheter aortic valve replacement and its impact on valvular function and coronary filling.JACC Cardiovasc Interv. 2018; 11:1733–1743. doi: 10.1016/j.jcin.2018.05.043CrossrefMedlineGoogle Scholar3. Yudi MB, Sharma SK, Tang GHL, Kini A. Coronary angiography and percutaneous coronary intervention after transcatheter aortic valve replacement.J Am Coll Cardiol. 2018; 71:1360–1378. doi: 10.1016/j.jacc.2018.01.057CrossrefMedlineGoogle Scholar4. 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Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.N Engl J Med. 2019; 380:1706–1715. doi: 10.1056/NEJMoa1816885CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited ByKaneko T, Hirji S, Yazdchi F, Sun Y, Nyman C, Shook D, Cohen D, Stebbins A, Zeitouni M, Vemulapalli S, Thourani V, Shah P and O'Gara P (2022) Association Between Peripheral Versus Central Access for Alternative Access Transcatheter Aortic Valve Replacement and Mortality and Stroke: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, Circulation: Cardiovascular Interventions, 15:9, (e011756), Online publication date: 1-Sep-2022. 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Fabris E, Vitrella G, Rakar S, Perkan A, Bedogni F and Sinagra G (2020) Hat-Marker Orientation to Minimize Neo-Commissural Overlap With Coronaries During CoreValve Evolut TAVR, JACC: Cardiovascular Interventions, 10.1016/j.jcin.2019.11.034, 13:6, (782-783), Online publication date: 1-Mar-2020. Barbanti M, Webb J, Dvir D and Prendergast B (2019) Residual challenges in TAVI: moving forward, EuroIntervention, 10.4244/EIJ-D-19-00788, 15:10, (857-866), Online publication date: 1-Nov-2019. July 2019Vol 12, Issue 7 Advertisement Article InformationMetrics © 2019 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.119.008044PMID: 31272225 Originally publishedJuly 5, 2019 Keywordstranscatheter aortic valve replacementincidenceaortic valve stenosisretrospective studiescoronary reaccessPDF download Advertisement SubjectsAortic Valve Replacement/Transcatheter Aortic Valve ImplantationComputerized Tomography (CT)Percutaneous Coronary Intervention