Bicuspid Valve Morphology and TAVR Outcomes
- Among patients with bicuspid aortic valve undergoing TAVR, raphe calcification and leaflet calcification were markers of worse clinical outcomes.
- The two calcific markers contributed separately and together to worse outcomes, with progressively higher 2-year all-cause mortality associated with neither, with one, or with both.
Is there an association between bicuspid aortic valve (BAV) morphology and clinical outcomes after transcatheter aortic valve replacement (TAVR) using newer-generation devices?
Patients from the International Bicuspid Aortic Valve Stenosis Registry, a registry containing retrospectively and prospectively collected data from 24 cardiovascular centers in eight countries (Denmark, France, Germany, Israel, Italy, the Netherlands, Switzerland, and the United States) with BAV confirmed by central core laboratory computed tomography (CT) and who underwent TAVR with a newer-generation device were included in the analysis. BAV morphology was assessed with CT and included the number of raphes, raphe calcification grade, and leaflet calcium volume. A calcified raphe was defined as either moderate (bulky calcification or linear calcification extending more than one-half of the raphe) or severe raphe calcification (bulky and linear calcification covering the entire raphe). Excess leaflet calcification was defined as leaflet calcium volume greater than the cohort median value. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications.
A total of 1,034 CT-confirmed patients with BAV (mean age 74.7 years, Society of Thoracic Surgeons score of 3.7%) underwent TAVR with a contemporary device (740 with SAPIEN 3, 188 with Evolut R/Pro, 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), who had significantly higher 2-year all-cause mortality than those with one or none of those morphological features (25.7% vs. 9.5% vs. 5.9%, log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016).
Outcomes of TAVR among patients with bicuspid aortic stenosis depend on valve morphology. A calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality.
TAVR is increasingly used for the treatment of severe calcific aortic stenosis, with expanding indications for patients at progressively lower predicted operative risk. However, patients with BAV were excluded from all TAVR pivotal trials, so the performance of TAVR among patients with BAV has been less well studied. This study used a multicenter registry to address echocardiographic and clinical outcomes after TAVR in patients with bicuspid aortic stenosis. Although CT images were interpreted at a central core laboratory, echocardiograms were not. The major findings are that leaflet and raphe calcification were predictors of all-cause mortality, aortic root injury, and paravalvular aortic regurgitation. There were a small number of patients (n = 107 [10%]) with Sievers type 0 BAV (no raphe), potentially limiting the ability to test for outcome differences based on that morphologic feature. In terms of applying the data to populations outside this registry cohort, it would have been helpful to define excess leaflet calcification using an objective criterion rather than the median for this registry population. There is no doubt that TAVR will be used among patients with BAV; based on this study, substantial leaflet and raphe calcification might be taken as potential markers of worse outcomes.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Computed Tomography, Echocardiography/Ultrasound, Nuclear Imaging
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Calcinosis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Heart Valve Diseases, Transcatheter Aortic Valve Replacement, Tomography, X-Ray Computed, Treatment Outcome
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