Coronary Access After Transcatheter Aortic Valve Replacement With Commissural Alignment: The ALIGN-ACCESS Study.

Giuseppe Tarantini, Luca Nai Fovino, Andrea Scotti, Mauro Massussi, Francesco Cardaioli, Giulio Rodinò, Alice Benedetti, Mauro Boiago, Yuji Matsuda, Saverio Continisio, Carolina Montonati, Luisa Cacciavillani, Andrea Pavei, Giulia Masiero, Massimo Napodano, Chiara Fraccaro, Tommaso Fabris, Sabino Iliceto
Author Information
  1. Andrea Scotti: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  2. Mauro Massussi: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  3. Francesco Cardaioli: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  4. Giulio Rodinò: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  5. Alice Benedetti: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.).
  6. Mauro Boiago: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  7. Yuji Matsuda: Department of Cardiovascular Medicine, Graduate School of General Medical and Dental Science, Tokyo Medical and Dental University, Tokyo, Japan (Y.M.).
  8. Saverio Continisio: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.).
  9. Carolina Montonati: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.).
  10. Luisa Cacciavillani: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.).
  11. Andrea Pavei: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  12. Giulia Masiero: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  13. Massimo Napodano: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.).
  14. Chiara Fraccaro: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  15. Tommaso Fabris: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.). ORCID
  16. Sabino Iliceto: Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Italy (G.T., L.N.F., A.S., M.M., F.C., G.R., A.B., M.B., S.C., C.M., L.C., A.P., G.M., M.N., C.F., T.F., S.I.).

Abstract

BACKGROUND: Coronary access (CA) after transcatheter aortic valve replacement (TAVR) with supra-annular transcatheter heart valves (THV) can be challenging. Specific Evolut R/Pro and Acurate Neo THVs orientations are associated with reduced neo-commissure overlap with coronary ostia, while SAPIEN 3 THV cannot be oriented. With the ALIGN-ACCESS study (TAVR With Commissural Alignment Followed by Coronary Access), we investigated the impact of commissural alignment on the feasibility of CA after TAVR.
METHODS: We performed coronary angiography after TAVR with intra-annular SAPIEN 3, supra-annular Evolut R/Pro, and Acurate Neo THVs in 206 patients. Evolut THVs were implanted aiming for commissure alignment. Alignment of Acurate Neo was retrospectively assessed in 36, intentionally attempted in 26 cases. The primary end point was the rate of unfeasible and nonselective CA after TAVR.
RESULTS: Thirty-eight percent of patients received SAPIEN 3, 31.1% Evolut Pro/R, 30.1% Acurate Neo THV. Final valve orientation was favorable to commissural alignment in 85.9% of Evolut and 69.4% of Acurate Neo cases (with intentional alignment successful in 88.5%). Selective CA was higher for SAPIEN 3 than for aligned and misaligned supra-annular THVs (95% versus 71% versus 46%, <0.001). Cannulation of at least one coronary was unfeasible with 11% misaligned supra-annular, 3% aligned supra-annular, and 0% SAPIEN 3 THVs. Independent predictors of unfeasible/nonselective CA were implantation of a misaligned supra-annular THV (odds ratio, 4.59 [95% CI, 1.81-11.61]; <0.01), sinus of Valsalva height (odds ratio, 0.83 [95% CI, 0.7-0.98]; =0.03), and THV-sinus of Valsalva relation (odds ratio, 1.06 [95% CI, 1.02-1.1]; <0.01).
CONCLUSIONS: Commissural alignment improves the rate of selective CA after TAVR with supra-annular THVs. Nevertheless, aligned supra-annular THVs carry higher risk of unfeasible/nonselective CA than SAPIEN 3. Patients with a misaligned supra-annular THV, low sinus of Valsalva, and higher THV-sinus of Valsalva relation are at highest risk of impaired CA after TAVR.

Keywords

MeSH Term

Aortic Valve
Aortic Valve Stenosis
Heart Valve Prosthesis
Humans
Prosthesis Design
Retrospective Studies
Transcatheter Aortic Valve Replacement
Treatment Outcome

Word Cloud

Created with Highcharts 10.0.0supra-annularCATAVRTHVsSAPIEN3valveTHVEvolutAcurateNeoalignmentValsalvacoronarymisalignedCoronarytranscatheteraorticCommissuralhigheraligned<0oddsratio[95%CI1sinusreplacementheartR/ProALIGN-ACCESSAlignmentAccesscommissuralangiographypatientscasesrateunfeasible1%versusunfeasible/nonselective010THV-sinusrelationriskBACKGROUND:accessvalvescanchallengingSpecificorientationsassociatedreducedneo-commissureoverlapostiaorientedstudyFollowedinvestigatedimpactfeasibilityMETHODS:performedintra-annular206implantedaimingcommissureretrospectivelyassessed36intentionallyattempted26primaryendpointnonselectiveRESULTS:Thirty-eightpercentreceived31Pro/R30Finalorientationfavorable859%694%intentionalsuccessful885%Selective95%71%46%001Cannulationleastone11%3%0%Independentpredictorsimplantation45981-1161]height837-098]=0030602-11]CONCLUSIONS:improvesselectiveNeverthelesscarryPatientslowhighestimpairedTranscatheterAorticValveReplacementAlignment:Study

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