Key result
Noncoaxial THV deployment is linked to ~33% lower 30-day device early safety versus coaxial positioning.
Why the study?
Noncoaxial placement of transcatheter heart valves relative to the native aortic annulus is occasionally detected on fluoroscopy after TAVR, but its impact on clinical outcomes was unclear.
Does noncoaxial TAVR deployment worsen device early safety and increase bioprosthetic valve failure in patients undergoing transfemoral TAVR?
Cohort (n=2,025)
No
Does noncoaxial TAVR deployment worsen device early safety and increase bioprosthetic valve failure in patients undergoing transfemoral TAVR?
Effect estimate: aHR 0.67 (95% CI 0.59-0.76)
Absolute Event Rate: 56.2% vs 82.7%
p-value: p=<0.001
Noncoaxial deployment of transcatheter heart valves during TAVR is associated with significantly reduced early safety and an increased risk of bioprosthetic valve failure at 1 year.
Noncoaxial TAVR deployment may reduce early safety; leaves open whether coaxial positioning improves outcomes in trials.
BACKGROUND: Noncoaxial placement of transcatheter heart valves (THVs) relative to the native aortic annulus is occasionally detected on fluoroscopy after transcatheter aortic valve replacement (TAVR). OBJECTIVES: This study aimed to evaluate the impact of noncoaxial TAVR deployment on clinical outcomes. METHODS: We retrospectively evaluated consecutive patients undergoing transfemoral TAVR in the Bern transcatheter aortic valve implantation registry. Coaxiality between the native annulus and the THV was measured using the 3-cusp view on fluoroscopic images and was defined as the angle between a line intersecting the lower points of native cusps and a line intersecting the lower hinge points of the prosthesis frame. Patients were categorized according to tertiles of coaxiality. RESULTS: Among 2,025 patients (mean age 81.6 ± 6.5 years, mean Society of Thoracic Surgeons Predicted Risk of Mortality 4.2% ± 3.3%) undergoing TAVR with contemporary devices between February 2014 and June 2023, the mean axial angulation of the device relative to the native annulus was 4.1°. According to Valve Academic Research Consortium-3 criteria, patients in the highest tertile of THV axial angle (range, 4.8-21.7°) had reduced device early safety (56.2% vs 82.7%; aHR: 0.67; 95% CI: 0.59-0.76; P < 0.001) and higher rates of stage-2 bioprosthetic valve failure at 1-year follow-up (1.5% vs 0.7%; HR: 3.47; 95% CI: 1.26-9.54; P = 0.016), compared to those with coaxial valve positioning (range, 0.1-3.0). Left ventricle outflow tract calcium volume, predilatation, and valve type were independent predictors of noncoaxial valve implantation. CONCLUSIONS: Noncoaxial THV deployment is associated with impaired valve early safety and increased risk of bioprosthetic valve failure 1 year after TAVR.
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Angellotti et al. (2025) conducted a cohort in Severe native aortic stenosis (n=2,025). Noncoaxial transcatheter heart valve implantation (highest tertile of axial angle) vs. Coaxial transcatheter heart valve implantation (lowest tertile of axial angle) was evaluated on VARC-3 device early safety at 30 days post-TAVR (aHR 0.67, 95% CI 0.59-0.76, p=<0.001). Noncoaxial transcatheter heart valve deployment was associated with reduced device early safety at 30 days (56.2% vs 82.7%; aHR 0.67) compared to coaxial positioning.
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