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Published on: June 3, 2018
Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A
Martin Reindl1, Ivan Lechner1, Magdalena Holzknecht1
1University Clinic of Internal Medicine III, Cardiology and Angiology (M.R., I.L., M.H., C.T., P.F., F.O., S.v.d.E., C.B., G.K., A.B., B.M., S.J.R.), Medical University of Innsbruck, Austria.
Insights
Cardiac magnetic resonance imaging (CMR) guided transcatheter aortic valve replacement (TAVR) is as effective as computed tomography (CT) guided TAVR. This study shows CMR is a viable alternative for TAVR planning, especially for patients with kidney disease.
Area of Science:
- Cardiology
- Medical Imaging
- Interventional Cardiology
Background:
- Computed tomography (CT) is standard for guiding transcatheter aortic valve replacement (TAVR).
- Iodinated contrast media used in CT poses risks for TAVR candidates with chronic kidney disease (CKD).
- Cardiac magnetic resonance imaging (CMR) offers a contrast-free alternative, but comparative data were lacking.
Purpose of the Study:
- To compare the effectiveness of CMR-guided versus CT-guided TAVR.
- To determine if CMR is noninferior to CT for TAVR planning.
- To evaluate CMR as an alternative imaging modality for TAVR procedures.
Main Methods:
- A prospective, randomized, open-label, noninferiority trial was conducted.
- Patients undergoing TAVR evaluation were randomized (1:1) to CMR or CT guidance.
- The primary outcome was Valve Academic Research Consortium-2 defined implantation success at discharge.
Main Results:
- CMR-guided TAVR demonstrated noninferiority to CT-guided TAVR.
- Implantation success was achieved in 93.5% of the CMR group and 90.7% of the CT group (modified intention-to-treat).
- The between-group difference in implantation success met the noninferiority margin (2.8% [90% CI, -2.7% to 8.2%]).
Conclusions:
- CMR-guided TAVR is noninferior to CT-guided TAVR regarding device implantation success.
- CMR is a safe and effective alternative for TAVR planning.
- This supports the use of CMR in TAVR candidates, particularly those with CKD.
Background:
Computed tomography (CT) is recommended for guiding transcatheter aortic valve replacement (TAVR). However, a sizable proportion of TAVR candidates have chronic kidney disease, in whom the use of iodinated contrast media is a limitation. Cardiac magnetic resonance imaging (CMR) is a promising alternative, but randomized data comparing the effectiveness of CMR-guided versus CT-guided TAVR are lacking.
Methods:
An investigator-initiated, prospective, randomized, open-label, noninferiority trial was conducted at 2 Austrian heart centers. Patients evaluated for TAVR according to the inclusion criteria (severe symptomatic aortic stenosis) and exclusion criteria (contraindication to CMR, CT, or TAVR, a life expectancy <1 year, or chronic kidney disease level 4 or 5) were randomized (1:1) to undergo CMR or CT guiding. The primary outcome was defined according to the Valve Academic Research Consortium-2 definition of implantation success at discharge, including absence of procedural mortality, correct positioning of a single prosthetic valve, and proper prosthetic valve performance. Noninferiority was assessed using a hybrid modified intention-to-treat/per-protocol approach on the basis of an absolute risk difference margin of 9%.
Results:
Between September 11, 2017, and December 16, 2022, 380 candidates for TAVR were randomized to CMR-guided (191 patients) or CT-guided (189 patients) TAVR planning. Of these, 138 patients (72.3%) in the CMR-guided group and 129 patients (68.3%) in the CT-guided group eventually underwent TAVR (modified intention-to-treat cohort). Of these 267, 19 patients had protocol deviations, resulting in a per-protocol cohort of 248 patients (121 CMR-guided, 127 CT-guided). In the modified intention-to-treat cohort, implantation success was achieved in 129 patients (93.5%) in the CMR group and in 117 patients (90.7%) in the CT group (between-group difference, 2.8% [90% CI, -2.7% to 8.2%]; P<0.01 for noninferiority). In the per-protocol cohort (n=248), the between-group difference was 2.0% (90% CI, -3.8% to 7.8%; P<0.01 for noninferiority).
Conclusions:
CMR-guided TAVR was noninferior to CT-guided TAVR in terms of device implantation success. CMR can therefore be considered as an alternative for TAVR planning.
Registration:
URL: https://www.
Clinicaltrials:
gov; Unique identifier: NCT03831087.
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