Key result
Cardiac magnetic resonance imaging (TAVR-CMR) will be evaluated for non-inferiority compared to computed tomography (TAVR-CT) for guiding transcatheter aortic valve replacement in a planned trial.
Why the study?
Many patients undergoing TAVR have chronic renal insufficiency, making contrast-sparing alternatives to standard TAVR-CT desirable; whether TAVR-CMR is non-inferior remains unproven.
Does TAVR-CMR provide non-inferior device implantation success compared to TAVR-CT in patients with symptomatic severe aortic stenosis scheduled for TAVR?
RCT (n=250)
Open-label
1:1
No
Does TAVR-CMR provide non-inferior device implantation success compared to TAVR-CT in patients with symptomatic severe aortic stenosis scheduled for TAVR?
This study protocol outlines a randomized trial to determine if cardiac magnetic resonance imaging is non-inferior to computed tomography for guiding transcatheter aortic valve replacement, potentially offering a contrast-sparing alternative for patients with renal insufficiency.
Answers are grounded in this paper and cite their sources.
CMR+NCCT TAVR planning showed similar outcomes to contrast CT in advanced CKD; leaves open routine adoption pending randomized confirmation.
BACKGROUND: The standard procedure for the planning of transcatheter aortic valve replacement (TAVR) is the combination of echocardiography, coronary angiography, and cardiovascular computed tomography (TAVR-CT) for the exact determination of the aortic valve dimensions, valve size, and implantation route. However, up to 80% of the patients undergoing TAVR suffer from chronic renal insufficiency. Alternatives to reduce the need for iodinated contrast agents are desirable. Cardiac magnetic resonance (CMR) imaging recently has emerged as such an alternative. Therefore, we aim to investigate, for the first time, the non-inferiority of TAVR-CMR to TAVR-CT regarding efficacy and safety end-points. METHODS: This is a prospective, randomized, open-label trial. It is planned to include 250 patients with symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision. Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within 2 weeks after inclusion. Follow-up will be performed at hospital discharge after TAVR and after 1 and 2 years. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 1 and 2 years, as well as a comparison of imaging procedure related variables. Endpoint definitions are based on the updated 2012 VARC-2 consensus document. DISCUSSION: TAVR-CMR might be an alternative to TAVR-CT for planning a TAVR procedure. If proven to be effective and safe, a broader application of TAVR-CMR might reduce the incidence of acute kidney injury after TAVR and thus improve outcomes. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (NCT03831087). The results will be disseminated at scientific meetings and publication in peer-reviewed journals.
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Klug et al. (2022) conducted an RCT in Symptomatic severe aortic stenosis (n=250). Cardiac magnetic resonance imaging (TAVR-CMR) vs. Computed tomography (TAVR-CT) was evaluated on Composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria. Cardiac magnetic resonance imaging (TAVR-CMR) will be evaluated for non-inferiority compared to computed tomography (TAVR-CT) for guiding transcatheter aortic valve replacement in a planned trial.
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