Evaluation of the safety and efficacy of a novel Anatomical classification and dUal anchoRing theory to Optimize the tavR strategy for pure severe Aortic regurgitation (AURORA): a prospective cohort study

BMC Cardiovasc Disord. 2022 Oct 15;22(1):445. doi: 10.1186/s12872-022-02883-4.

Abstract

Background: Success rate of transcatheter aortic valve replacement (TAVR) in aortic regurgitation (AR) patients is relatively low on account of the absence of calcified anchoring structures. Morphological classification and corresponding TAVR strategies for AR are lacking yet.

Methods: The AURORA study is a prospective, multicenter, single-arm cohort study to evaluate the safety and efficacy of transfemoral TAVR for severe AR in patients with high or prohibitive risk for surgery. Patients who are ≥ 65 years and diagnosed with severe pure AR as defined by the Echocardiographic Core Laboratory will be consecutively enrolled for further multidetector computed tomography (MDCT) scanning and multiplanar analyses. Based on a new anatomical classification and dual anchoring theory, patients will be classified into 4 types according to the level of the anchoring area. Types 1, 2 and 3 (at least 2 anchoring areas) will undergo the TAVR procedure with a domestic Chinese self-expanding valve (VitaFlow Valve, MicroPort, Shanghai, China), whereas type 4 (0 or 1 anchoring area) patients will be considered unsuitable for TAVR and will receive medical treatment. Our goal is to recruit 100 patients to account for 10% missing data or loss of patients to follow-up. Procedural, 30-day, 6-month and 12-month outcomes will be assessed according to Valve Academic Research Consortium-3 criteria.

Discussion: The AURORA study will establish a new AR anatomical classification based on dual anchoring theory through MDCT multiplanar measurement and assess the safety and efficacy of TAVR guided by this new classification and strategy in AR patients.

Trial registration: This Study was registered at Chinses Clinical Trial Registry. The registration number: ChiCTR2200055415; The date of registration: 9, January 2022; The URL of the registration: http://www.chictr.org.cn/showproj.aspx?proj=141209 .

Keywords: Anatomical characteristics; Aortic regurgitation; Computed tomography; Transcatheter aortic valve replacement.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aortic Valve / diagnostic imaging
  • Aortic Valve / surgery
  • Aortic Valve Insufficiency* / diagnostic imaging
  • Aortic Valve Insufficiency* / etiology
  • Aortic Valve Insufficiency* / surgery
  • Aortic Valve Stenosis* / surgery
  • China
  • Cohort Studies
  • Heart Valve Prosthesis*
  • Humans
  • Prospective Studies
  • Prosthesis Design
  • Risk Factors
  • Transcatheter Aortic Valve Replacement* / adverse effects
  • Treatment Outcome

Associated data

  • ChiCTR/ChiCTR2200055415