Background Bicuspid aortic valve (BAV) calcification affects clinical outcomes by causing transcatheter heart valve (THV) deformation after transcatheter aortic valve replacement (TAVR). However, a computed tomography (CT)–based scoring system for grading BAV calcification severity and predicting THV deformation has not been established. Objectives This study sought to develop a cardiac CT-based BAV TAVR-risk score for grading BAV calcification severity and predicting THV deformation. Methods This single-center retrospective study included consecutive patients with BAV who underwent TAVR using contemporary balloon-expandable valves between January 2016 and December 2024 and who had preprocedural and postprocedural CT imaging. The BAV TAVR-risk score integrated calcification severity and distribution across valve leaflets, raphe, annulus, and left ventricular outflow tract, quantified using a fixed HU-850 threshold of detection on contrast-enhanced CT scans. Score thresholds were derived by receiver operating curve analysis with Youden index optimization. Patients were categorized into low-, intermediate-, and high-risk score groups. Results Among 321 patients (median follow-up: 1,825 days; Q1-Q3: 765-1,825 days), 56 (17.4%) were classified into the high-risk score group. Both underexpansion and eccentricity of the THV occurred in 49 of the 321 patients (15.3%) and were predominantly observed in the high-risk score group. However, in the low-risk score group, 149 of 155 patients (96.1%) demonstrated no underexpansion or eccentricity of the THV. A high BAV TAVR-risk score independently predicted both underexpansion and eccentricity of the THV (OR: 89.13; 95% CI: 35.02-226.83; P < 0.001). Conclusions This CT-based BAV TAVR-risk score provides a systematic method to precisely quantify BAV severity which reliably predicts THV deformation for BAV patients with contemporary balloon-expandable valves and may help guide decision-making in this challenging population.
Background Prosthesis–patient mismatch (PPM) after transcatheter aortic valve replacement has been widely studied for its association with clinical outcomes, but its effect on patient-reported health status remains less defined. Objectives This study sought to evaluate the association between PPM severity and health status through 3-year follow-up after transcatheter aortic valve replacement. Methods This post hoc analysis of the SCOPE I (Safety and Efficacy of the ACURATE Neo/TF Compared to the SAPIEN 3 Bioprosthesis) randomized trial categorized patients according to PPM severity using Valve Academic Research Consortium-3 criteria. Endpoints included survival and patient-reported health status, with an integrated outcome defined as being alive with good health status (Kansas City Cardiomyopathy Questionnaire Overall Summary score ≥75 without a decline of >10 points from baseline). Results Among 662 patients, moderate and severe PPM occurred in 184 (27.8%) and 69 (10.4%), respectively. All-cause mortality at 1 and 3 years was 7.0% and 20.5%, with no differences across PPM categories. Kansas City Cardiomyopathy Questionnaire Overall Summary score was similar through 1 year but lower at 3 years in patients with severe vs no PPM (median 71.1 vs 83.9; P = 0.027). Fewer patients with severe PPM were alive with good health status at 3 years (30.6% vs 49.4%; P = 0.021). In multivariable analysis, severe PPM was associated with a lower likelihood of the integrated outcome (OR: 0.51; 95% CI: 0.27-0.96; P = 0.036), but this association was no longer statistically significant after adjustment for 30-day mitral regurgitation (OR: 0.59; 95% CI: 0.30-1.15; P = 0.121). Conclusions Among survivors, severe PPM was associated with a lower likelihood of good health status at 3 years. This association was attenuated after accounting for 30-day residual mitral regurgitation, suggesting a possible contributory role. Given the post hoc design, the findings are hypothesis-generating.
Background The current American College of Cardiology/American Heart Association valvular heart disease guidelines were published before several recent trials that provide greater support for early intervention in patients with asymptomatic severe aortic stenosis (AS). Objectives This study sought to investigate the prevalence and clinical impact of American College of Cardiology/American Heart Association Class II recommendations for AVR in the EARLY TAVR trial. Methods The EARLY TAVR trial randomized patients with asymptomatic severe AS to transfemoral transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve or clinical surveillance (CS) with conversion to TAVR based on development of ACC/AHA Class I indications. Patients in the intention-to-treat cohort were stratified by presence of a Class II indication for AVR at randomization. The primary endpoint of the present analysis was the composite of all-cause death, stroke, or heart failure hospitalization. Interaction tests were performed to assess whether the treatment effect differed by level of guideline recommendation. Timing of conversion to AVR in the CS group according to the presence/absence of Class II indications was also assessed. Results Of the 901 patients randomized to TAVR (N = 445) and CS (N = 446), 636 (70.6%) patients had no guideline recommendation, and 265 (29.4%) had at least1 1 Class II recommendation for AVR at the time of randomization. At a median follow-up of 3.8 years, patients with a Class II indication for AVR experienced higher rates of the primary endpoint (Class II: 24.5% vs no recommendation: 14.5%; HR = 1.78; 95% CI: 1.30-2.44; P < 0.001) and were more likely to have acute valve syndrome at the time of conversion. Compared with CS, the relative benefit of early TAVR on the primary endpoint was similar regardless of the presence or absence of a Class II guideline recommendation (HR = 0.62; 95% CI: 0.37-1.02 vs 0.61; 95% CI: 0.40-0.92; Pinteraction = 0.96). Conclusions Among patients in the EARLY TAVR trial, Class II indications for AVR were present in almost one-third of patients at baseline. The benefit of early TAVR was consistent regardless of the presence or absence of Class II indications. These findings support the strategy of early TAVR over CS in asymptomatic patients with severe AS, independent of guideline indications. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT03042104; Unique Identifier: NCT03042104
