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Canadian Journal of Cardiology

Should TAVR Replace Surgery for Aortic Stenosis in Low- to Intermediate-Risk Patients?

  • Colin M. Barker
    Correspondence
    Corresponding author: Colin M. Barker, MD, FACC, FSCAI, Department of Cardiology, Houston Methodist DeBakey Heart and Vascular Center, 6550 Fannin St, Ste 1901, Houston, TX 77030. Tel.: +1-713-441-1100; fax: +1-713-790-6334.
    Affiliations
    Houston Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas, USA
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  • Michael J. Reardon
    Affiliations
    Houston Methodist DeBakey Heart and Vascular Center, Houston Methodist Hospital, Houston, Texas, USA
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      Abstract

      Transcatheter aortic valve replacement (TAVR) was initially envisioned as a less invasive option for patients with severe symptomatic aortic stenosis who either were not candidates or were very high-risk candidates for surgical aortic valve replacement (SAVR). Based on data from the original Placement of Aortic Transcatheter Valve (PARTNER) trials as well as the CoreValve Pivotal trials, TAVR is now approved and accepted in the treatment of severe symptomatic aortic stenosis in extreme-risk and high-risk patient populations. Thus far, the randomized controlled trial data for TAVR have been noninferior or even superior to both medical therapy and SAVR. Recently, the US Food and Drug Administration expanded the indications for 2 balloon-expandable devices, and CE Mark status was awarded to a self-expanding device for use in patients at intermediate risk. Given all the data, the logical next step is to study low-risk patient groups. Anecdotal and nonrandomized data have been conflicting when comparing TAVR to SAVR in low-risk patients. Two low-risk randomized trials have started in the United States, and ultimately these trials will determine the feasibility of TAVR as an acceptable alternative to SAVR in low-risk patients with severe aortic stenosis.

      Résumé

      Le remplacement valvulaire aortique par cathéter (RVAC) était au départ perçu comme une option moins invasive pour les patients atteints d'une sténose aortique symptomatique grave qui n’étaient pas des candidats ou qui étaient des candidats exposés à un risque très élevé de chirurgie de remplacement valvulaire aortique (CRVA). Selon les données des études originales PARTNER (Placement of Aortic Transcatheter Valves) et des études pivots CoreValve, le RVAC est maintenant approuvé et accepté pour le traitement de la sténose aortique symptomatique grave chez les populations de patients exposés à un risque extrême et à un risque élevé. Jusqu’à maintenant, les données de l'essai clinique à répartition aléatoire sur le RVAC n'ont pas montré de résultats inférieurs, mais plutôt des résultats supérieurs au traitement médical et à la CRVA. Récemment, le US Food and Drug Administration (Secrétariat américain aux produits alimentaires et pharmaceutiques) a élargi les indications de 2 dispositifs à ballonnet gonflable. Ainsi, un dispositif à ballonnet autogonflable pour utilisation chez les patients exposés à un risque intermédiaire a obtenu le marquage CE. À la lumière de toutes ces données, l’étape logique suivante consiste à étudier les groupes de patients exposés à un risque faible. Les données empiriques et non aléatoires étaient contradictoires lorsqu'on comparait le RVAC à la CRVA chez les patients exposés à un risque faible. Deux essais à répartition aléatoire auprès de patients exposés à un risque faible sont en cours aux États-Unis. Ultimement, ils détermineront si le RVAC peut s'avérer une solution de rechange acceptable à la CRVA chez les patients atteints d'une sténose aortique grave qui sont exposés à un risque faible.
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