Patients with bicuspid aortic valve (BAV) stenosis and high body mass index (BMI) were found to be at increased risk for high residual gradient (HRG) following transcatheter aortic valve replacement (TAVR), according to a study published in Clinical Research in Cardiology.
Patients (N=353; mean age, 77.8±8.3 years; 64.9%, men; average BMI, 26.1±5.2 kg/m2) who received Sapien 3 (n=242) or Evolut R/PRO (n=111) devices between 2013 and 2018 were included in the Balloon vs Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis (BEAT) registry, and were evaluated for early occurrence of device failure, HRG, and clinical outcomes for up to 1 year.
In this cohort, 77.7% had hypertension, 25.3% atrial fibrillation, 21.8% a previous percutaneous cardiac intervention, and 21.2% had diabetes.
HRG was observed in 20 of the participants (5.6%). Patients with vs without HRG had higher BMI (30.7±9.3 vs 25.9±4.8 kg/m2, respectively; P <.0001), were more likely to have BAV type 0 (30% vs 5.7%, respectively; P <.0001), and higher mean transvalvular gradient at baseline (57.6±13.4 vs 47.7±16.6 mmHg, respectively; P =.013).
In a majority of TAVR procedures, a transfemoral route was used for access (89.8%). Successful implantation was achieved in 86.7% of patients.
HRG was found to be predicted by: BAV type 0 (odds ratio [OR], 6.59; 95% CI, 2.30-18.90; P <.001), BMI (OR, 1.12; 95% CI, 1.06-1.20; P <.001), and left ventricular ejection fraction (OR, 1.04; 95% CI, 1.00-1.09; P =.046) in a univariate analysis. BAV type 0 (OR, 11.31; 95% CI, 3.45-37.06; P <.0001) and body mass index (OR, 1.12; 95% CI, 1.05-1.20; P =.001) were found to remain predictors of HRG in a multivariate analysis.
At 30 days post procedure, 2 patients with HRG had life-threatening bleeding (bleeding rate: HRG, 15.3% vs no HRG, 0.4%; P <.0001). At 1 year, no significant differences were observed between groups.
This study was limited by the small number of patients with HRG, which did not allow for the assessment of mortality differences between groups.
“Even if 30-day outcome and 1-year mortality seem not to be affected, further observational and randomized studies are needed to confirm our findings and to explore the impact of HRG on valve durability,” concluded the study authors.
Bugani G, Pagnesi M, Tchetchè D, et al. Predictors of high residual gradient after transcatheter aortic valve replacement in bicuspid aortic valve stenosis. [published online January 3, 2021] Clin Res Cardiol. doi:10.1007/s00392-020-01793-9