CMR vs. CT to Guide TAVR: The TAVR-CMR Trial
- CMR guidance was noninferior to CT guidance with respect to the primary outcome of device implantation success at hospital discharge according to VACR-2 criteria.
- Furthermore, there was no evident difference in the proportion of patients who ultimately underwent TAVR by randomized imaging strategy and no difference in the access route used.
- CMR-guided TAVR is associated with outcomes not significantly worse than conventional CT-guided TAVR and could be especially useful in patients with CKD.
How does a cardiac magnetic resonance (CMR)-guided transcatheter aortic valve replacement (TAVR) approach compare with a computed tomography (CT)-guided approach with respect to clinical efficacy?
The investigators conducted TAVR-CMR, a prospective, randomized, open-label, noninferiority trial at two Austrian heart centers. Patients evaluated for TAVR according to the inclusion (severe symptomatic aortic stenosis) and exclusion criteria (contraindication to CMR, CT, or TAVR, a life expectancy <1 year, chronic kidney disease [CKD] 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 (VARC)-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 (mITT)/per-protocol (PP) approach based on an absolute risk difference margin of 9%. For analyses of 6-month mortality, time-to-event was defined as time from the TAVR procedure to the outcome date; Nelson-Aalen curves were constructed and log-rank comparisons were used to evaluate between-group differences.
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 (mITT cohort). Of these 267, 19 patients had protocol deviations, resulting in a PP cohort of 248 patients (n = 121 CMR-guided, n = 127 CT-guided). In the mITT 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% confidence interval [CI], -2.7 to 8.2%; p < 0.01 for noninferiority). In the PP cohort (n = 248), the between-group difference was 2.0% (90% CI, -3.8 to 7.8%; p < 0.01 for noninferiority).
The authors report that CMR-guided TAVR was noninferior to CT-guided TAVR in terms of device implantation success.
This randomized study reports that CMR guidance was noninferior to CT guidance with respect to the primary outcome of device implantation success at hospital discharge according to VARC-2 criteria with no significant differences in key secondary outcomes. Furthermore, there was no evident difference in the proportion of patients who ultimately underwent TAVR by randomized imaging strategy and no difference in the access route used. These data suggest that CMR-guided TAVR is associated with TAVR outcomes not significantly worse than conventional CT-guided TAVR and could be especially useful in patients with CKD.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Magnetic Resonance Imaging
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Computed Tomography, Diagnostic Imaging, ESC Congress, ESC23, Heart Valve Diseases, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation, Magnetic Resonance Imaging, Patient Discharge, Renal Insufficiency, Chronic, Secondary Prevention, Transcatheter Aortic Valve Replacement
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