Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:76

Article

Pibarot, Philippe¹  Temacle, Julien¹  Jaber, Wael A.²  Salaun, Erwan¹  Dahou, Abdellaziz^3,4  Asch, Federico M.⁵  Weissman, Neil J.⁵  Rodriguez, Leonardo²  Xu, Ke⁶  Annabi, Mohamed-Salah¹  Guzzetti, Ezequiel¹  Beaudoin, Jonathan¹  Bernier, Mathieu¹  Leipsic, Jonathon⁷  Blanke, Philipp⁷  Clavel, Marie-Annick¹  Rogers, Erin⁶  Alu, Maria C.^3,4  Douglas, Pamela S.^8,9  Makkar, Raj¹⁰  Miller, D. Craig¹¹  Kapadia, Samir R.²  Mack, Michael J.¹²  Webb, John G.⁷  Kodali, Susheel K.^3,4  Smith, Craig R.^3,4  Herrmann, Howard C.¹³  Thourani, Vinod H.¹⁴  Leon, Martin B.^3,4  Hahn, Rebecca T.^3,4 

[1] Laval Univ, Quebec Heart & Lung Inst, Inst Univ Cardiol & Pneumol Quebec, Quebec City, PQ, Canada

[2] Cleveland Clin, Heart & Vasc Inst, Cleveland, OH 44106 USA

[3] Columbia Univ, New York Presbyterian Hosp, Med Ctr, New York, NY USA

[4] Cardiovasc Res Fdn, New York, NY USA

[5] Washington Hosp Ctr, MedStar Hlth Res Inst, Washington, DC 20010 USA

[6] Edwards Lifesci, Irvine, CA USA

[7] St Pauls Hosp, Vancouver, BC, Canada

[8] Duke Univ, Med Ctr, Durham, NC USA

[9] Duke Clin Res Inst, Durham, NC USA

[10] Cedars Sinai Heart Inst, Los Angeles, CA USA

[11] Stanford Univ, Dept Med, Sch Med, Div Cardiovasc Med, Stanford, CA 94305 USA

[12] Baylor Scott & White Healthcare, Plano, TX USA

[13] Univ Penn, Perelman Sch Med, Philadelphia, PA 19104 USA

[14] Piedmont Heart Inst, Dept Cardiovasc Surg, Atlanta, GA USA

关键词: aortic stenosis;    bioprosthetic valve;    echocardiography;    structural valve deterioration;    transcatheter aortic valve replacement;   

DOI  :  10.1016/j.jacc.2020.08.049

来源: Elsevier

【 摘 要 】

BACKGROUND It is unknown whether transcatheter valves will have similar durability as surgical bioprosthetic valves. Definitions of structural valve deterioration (SVD), based on valve related reintervention or death, underestimate the incidence of SVD. OBJECTIVES This study sought to determine and compare the 5-year incidence of SVD, using new standardized definitions based on echocardiographic follow-up of valve function, in intermediate-risk patients with severe aortic stenosis given transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) in the PARTNER (Placement of Aortic Transcatheter Valves) 2A trial and registry. METHODS In the PARTNER 2A trial, patients were randomly assigned to receive either TAVR with the SAPIEN XT or SAVR, whereas in the SAPIEN 3 registry, patients were assigned to TAVR with the SAPIEN 3. The primary endpoint was the incidence of SVD, that is, the composite of SVD-related hemodynamic valve deterioration during echocardiographic follow-up and/or SVD-related bioprosthetic valve failure (BVF) at 5 years. RESULTS Compared with SAVR, the SAPIEN-XT TAVR cohort had a significantly higher 5-year exposure adjusted incidence rates (per 100 patient-years) of SVD (1.61 +/- 0.24% vs. 0.63 +/- 0.16%), SVD-related BVF (0.58 +/- 0.14% vs. 0.12 +/- 0.07%), and all-cause (structural or nonstructural) BVF (0.81 +/- 0.16% vs. 0.27 +/- 0.10%) (p <= 0.01 for all). The 5-year rates of SVD (0.68 +/- 0.18% vs. 0.60 +/- 0.17%; p = 0.71), SVD-related BVF (0.29 +/- 0.12% vs. 0.14 +/- 0.08%; p = 0.25), and all-cause BVF (0.60 +/- 0.15% vs. 0.32 +/- 0.11%; p = 0.32) in SAPIEN 3 TAVR were not significantly different to a propensity score matched SAVR cohort. The 5-year rates of SVD and SVD-related BVF were significantly lower in SAPIEN 3 versus SAPIEN XT TAVR matched cohorts. CONCLUSIONS Compared with SAVR, the second-generation SAPIEN XT balloon-expandable valve has a higher 5-year rate of SVD, whereas the third-generation SAPIEN 3 has a rate of SVD that was not different from SAVR. (C) 2020 by the American College of Cardiology Foundation.

【 授权许可】

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