BACKGROUND: Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography–diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke. After propensity score matching in 10 data sets generated by multiple imputation, outcomes from transcatheter aortic valve replacement to 3-year follow-up were computed by multivariable binomial logistic mixed-effects models, multivariable linear mixed-effects models, or multivariable frailty models accounting for center-related influences and residual confounding effects (doubly robust adjustment). The results were replicated by inverse probability of treatment weighting and multivariable adjustment. RESULTS: A total of 1443 consecutive patients with bicuspid aortic valve stenosis undergoing BE-THV (n=860) or SE-THV (n=583) implantation were included. In-hospital and 30-day death or stroke did not significantly differ between BE-THV and SE-THV groups (5.1% versus 6.1%; hazard ratio after propensity score matching, 1.02 [95% CI, 0.51–2.02]). BE-THV implantation was associated with higher annulus rupture and mean transvalvular gradient compared with SE-THV implantation. In contrast, SE-THV implantation was associated with higher additional valve implantation and paravalvular regurgitation compared with BE-THV implantation. The results were consistent across the statistical methods used and between early- and new-generation THVs. At 30 days, pacemaker implantation was lower in the BE-THV group compared with the SE-THV group (11.9% versus 18.6%; hazard ratio after propensity score matching, 0.58 [95% CI, 0.36–0.93]). This result did not depend on the statistical method used. At 3 years, consistent with the 1- and 2-year analyses, death or stroke was not significantly different between the BE-THV and SE-THV groups (23.7% versus 26.2%; hazard ratio after propensity score matching, 0.99 [95% CI, 0.65–1.51]). Death or stroke across major clinical, anatomical, functional, and procedural conditions was consistent with the main analysis. After inverse probability of treatment weighting and multivariable adjustment, these conclusions remained unchanged. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement for bicuspid aortic valve stenosis, death or stroke does not significantly differ between those receiving a BE-THV and those receiving an SE-THV over a follow-up of 3 years. BE-THV is associated with higher transvalvular mean gradient and more frequent annulus rupture, whereas SE-THV is associated with more frequent moderate to severe aortic regurgitation, additional THV implantation, and permanent pacemaker implantation.

Aims: To quantify extra-valvular cardiac damage associated with severe aortic valve stenosis (AS), a novel staging model was proposed. This study aimed to validate this model in patients undergoing transcatheter aortic valve replacement (TAVR) as well as to assess its prognostic impact.Methods and results: Based on echocardiographic findings, the following stages were applied: isolated AS (stage 0), left ventricular (LV) damage (stage 1), left atrial or mitral valve damage (stage 2), pulmonary hypertension or tricuspid regurgitation (stage 3), or right ventricular dysfunction (stage 4). The primary endpoint was 2-year all-cause mortality. The distribution across stages was 0.8% at stage 0, 7.5% at stage 1, 63.3% at stage 2, 18.3% at stage 3, and 10.1% at stage 4. All-cause mortality increased at all stages 1–4 (12.1%, 18.2%, 26.6%, and 28.2%; p = 0.023). In the multivariate model, the stage of cardiac damage, age, New York Heart Association (NYHA) class III/IV, peripheral artery disease, and previous pacemaker were independent predictors of the primary endpoint.Conclusions: Patients treated for severe AS show a high prevalence of extra-valvular cardiac damage. An increase in stage is associated with higher 2-year all-cause mortality. The application of this staging model may add value to current treatment algorithms.

Objectives: To investigate the feasibility and safety of percutaneous transluminal angioplasty (PTA) of the iliofemoral arteries (IFA) before transfemoral transcatheter aortic valve implantation (Tf‐TAVI) in patients with advanced peripheral artery disease (PAD).Background: Although Tf‐TAVI represents the access of choice, alternative vascular access routes are preferred for patients displaying advanced PAD. PTA of the IFA represents a less invasive option, broadening the spectrum of patients eligible for Tf‐TAVI.Methods: All patients requiring PTA of the IFA before Tf‐TAVI, between 2012 and 2021, were included. Primary efficacy endpoint was the rate of successful transcatheter heart valve (THV) delivery and implantation. Primary safety endpoint was the rate of PTA and access‐site‐related vascular complications, procedural‐ and in‐hospital complications.Results: Among 2726 Tf‐TAVI procedures, 59 patients required IFA predilation. Successful THV delivery and implantation was achieved in 57 (96.6%) patients, respectively. Sheath placement was achieved in 59 (100%) patients with only one minor dissection and no major vascular complications following iliofemoral PTA. Regarding access site complications, two (3.4%) vessel perforations and one (1.7%) vessel rupture were observed, with eight (13.5%) patients requiring unplanned endovascular interventions. There was one intraprocedural death due to THV‐induced vessel laceration, while in‐hospital all‐cause mortality was 8.5% in the present high‐risk patient cohort.Conclusions: Predilation of IFA is safe and effective in patients with advanced PAD. Careful preprocedural planning is paramount in improving procedural safety and efficacy. This strategy has the potential to broaden the spectrum of patients eligible for Tf‐TAVI.

It is unknown whether aortic valve calcium volume, as measured by contrast-enhanced computed tomography angiography (angio-CT), is associated with mortality in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to confirm that contrast-enhanced aortic valve calcium correlates with noncontrast-enhanced calcium score and provides useful prognostic information in patients undergoing TAVI. This retrospective observational study included patients from 2 high-volume TAVI centers in Germany, all of whom underwent high-quality angio-CT prior to TAVI. Calcium volume in contrast-enhanced angio-CT was calculated using 3Mensio software (Pie Medical, The Netherlands), while the calcium score from noncontrast-enhanced angio-CT was obtained using the Syngo.via (Siemens Healthineers, Germany) workstation to validate contrast-enhanced angio-CT values. Calcium volume was dichotomized using the median based on to sex-specific values from contrast-enhanced angio-CT, and the risk associated with increased calcium volume was determined using Cox proportional hazard regression analysis. We included 3318 TAVI patients. A good correlation was observed between noncontrast-enhanced and contrast-enhanced angio-CT (r² = 0.680; P < .001). The median values for sex-specific contrast-enhanced angio-CT calcium volume were 514 mm³ for women and 1025 mm³ for men. Patients with higher calcium volumes showed lower mortality at 1 year (8.8% vs 12.1%; adjusted hazard ratio [HR], 0.86; 95% confidence interval [95%CI], 0.75-0.98; P = .02) compared with those with lower calcium volumes. Calcium volume in contrast-enhanced angio-CT correlated well with noncontrast-enhanced angio-CT calcium score. Patients with higher calcium volume showed lower mortality at 1 year after TAVI.