Assess the Outcomes of Transcatheter Aortic Valve Replacement in Bicuspid Valve with Mixed Disease versus Predominant Aortic Stenosis.

Purpose: In mixed aortic valve disease (MAVD), the results of transcatheter aortic valve replacement (TAVR) are conflicting. There is limited data on the outcomes of TAVR in patients with bicuspid aortic valve (BAV) and MAVD. The objective of this study is to compare outcomes after TAVR in BAV patients with MAVD and predominant aortic stenosis (PAS). Patients and Methods: Patients with BAV who underwent TAVR between January 2016 and April 2023 were included. The primary outcome was device success. The secondary endpoints were periprocedural mortality and other complications as defined by the Valve Academic Research Consortium-3 (VARC-3). Propensity score matching was used to minimize potential confounding. Results: A total of 262 patients were included in this study, 83 of whom had MAVD. The median age was 72 years, and 55.7% were male. The baseline comorbidity risk files were comparable between the two groups. Patients with MAVD had more mitral regurgitation, tricuspid regurgitation and pulmonary hypertension, larger annular and left ventricular outflow tract dimensions, and more severe calcification than PAS. In the unmatched population, MAVD patients had similar device success rate (69.9% vs 79.9%, P=0.075) and 30-day mortality (3.6% vs 3.4%, P=1) compared to PAS. Propensity score matching resulted in 66 patient pairs. Device success rate were still comparable in the matched population. Other clinical outcomes, including stroke, bleeding (type 2-4), major vascular complications, acute kidney injury (stage 2-4) and permanent pacemaker implantation, were comparable between the two groups. Multivariable logistic regression analysis did not show MAVD to be an independent negative predictor of device success. At one year, survival was similar between patients with MAVD and those with PAS. Conclusion: For the bicuspid valve, patients with MAVD had a more challenging anatomy. MAVD patients associated with comparable 30-day clinical outcomes after TAVR compared to PAS patients in patients with BAV.

Transcatheter aortic valve replacement with the VenusA-Pro and VenusA-Plus systems: preliminary experience in China.

Background: The outcomes of transcatheter aortic valve replacement (TAVR) employing the second-generation retrievable VenusA-Pro and VenusA-Plus delivery systems with the self-expanding VenusA-Valve have not been described yet. This study aims to report the outcomes of these two second-generation delivery systems. Methods: From January 2022 to April 2023, we prospectively enrolled patients with severe aortic stenosis undergoing TAVR with VenusA-Pro from three centers across China in this first-in-man study and retrospectively identified those undergoing TAVR with VenusA-Plus. All outcomes were reported according to the Valve Academic Research Consortium 3 definition. The primary outcome was 30-day all-cause mortality. Results: A total of 156 patients were included, of which 46 underwent TAVR with VenusA-Pro and 110 underwent TAVR with VenusA-Plus. The Society of Thoracic Surgeons median score was 2.1%, bicuspid anatomy prevalence rate was 55.1%, and the mean aortic root calcification volume was 693 mm3. The technical success rate was 91.7%, comparable between the VenusA-Pro and VenusA-Plus groups (87.0% vs. 93.6%, P = 0.169). The 30-day all-cause mortality was 2.6%, similar between the VenusA-Pro and VenusA-Plus groups (2.2% vs. 2.7%, P = 0.842). No myocardial infarction occurred. The incidences of stroke (0.6%), major bleeding (3.8%), major vascular complications (5.1%), acute kidney injury (9.0%), permanent pacemaker implantation (5.1%), new-onset atrial fibrillation (5.8%), and moderate-to-severe paravalvular aortic regurgitation (6.0%) were favorable and comparable between the two groups. The clinical outcomes were similar between the patients with bicuspid and tricuspid aortic valve, except that the incidence of permanent pacemaker implantation was lower in patients with bicuspid anatomy (1.2% vs. 10.6%, P = 0.010). Conclusions: The 30-day outcomes of TAVR with VenusA-Pro and VenusA-Plus were favorable and comparable.

Anatomical Predictors of Valve Malposition During Self-Expandable Transcatheter Aortic Valve Replacement.

Background: The consequence of valve malposition (VM) during transcatheter aortic valve replacement (TAVR) can be severe, but the determinants of VM with self-expandable TAVR have not been thoroughly evaluated. We aimed to investigate the anatomical predictors of VM during self-expandable TAVR. Methods: In this multicenter retrospective study, TAVR was performed using the Venus A-Valve. The baseline, computed tomography, and procedural characteristics along with clinical outcomes were collected. Multivariate logistic regression model and receiver operating characteristic (ROC) curve analyses were performed. Results: A total of 84 consecutive patients (23 with VM) were included. Stepwise regression showed that annulus perimeter/left ventricular outflow tract perimeter (AL ratio) and sinotubular junction (STJ) height were predictors of VM. The ROC curve indicated a moderate strength of AL ratio [area under the curve (AUC) 0.71, cutoff 0.96] and a weak strength of STJ height (AUC 0.69, cutoff 23.8 mm) to predict VM. The combination of both predictors revealed a higher predictive value of VM (AUC 0.77). In multivariate analysis, AL ratio <0.96 [odds ratio (OR) 3.98, p = 0.015] and STJ height ≥23.8 mm (OR 4.63, p = 0.008) were strong independent predictors of VM. The presence of both predictors was associated with a very high risk of VM (OR 10.67, p = 0.002). The rate of moderate-to-severe paravalvular regurgitation was higher in patients with VM at 30 days (26.1 vs. 4.9%, p = 0.011). Conclusions: A conical left ventricular outflow tract and tall aortic sinuses were strong anatomical predictors of VM during self-expandable TAVR.