Incidence, predictors, and clinical impact of hypoattenuating leaflet thickening following SAPIEN 3 Ultra RESILIA implantation
Abstract
BACKGROUND
The latest-generation SAPIEN 3 Ultra RESILIA (S3UR) transcatheter heart valve (THV) incorporates several changes in leaflet design, including an improved anticalcification coating and modified commissural attachment. There are no established data on hypoattenuating leaflet thickening (HALT) following transcatheter aortic valve implantation (TAVI) using the S3UR.
AIMS
Our study aimed to elucidate the clinical features of HALT following S3UR implantation.
METHODS
As a subset of the OCEAN (Optimized CathEter vAlvular INtervention)-TAVI registry, we prospectively assessed patients who underwent cardiac computed tomography (CT) 30 days after S3UR implantation. HALT and potentially relevant THV geometry were analysed using four-dimensional CT data by an independent core laboratory.
RESULTS
Of the 445 patients studied, HALT was detected in 95 patients (21.3%) 30 days after TAVI. The modification of the commissural attachment specific to the 20 mm and 23 mm S3UR THVs did not affect the incidence of HALT (22.1% for ≤23 mm; 20.2% for ≥26 mm; p=0.636). The hourglass-shaped THV frame (p25% vs HALT ≤25%: 10.3 [interquartile range [IQR] 7.0-13.0] mmHg vs 8.6 [IQR 6.3-11.6] mmHg; p=0.007; HALT >50% vs HALT ≤50%: 11.5 [IQR 7.0-14.3] mmHg vs 8.9 [IQR 6.3-11.9] mmHg; p=0.002) was noted.
CONCLUSIONS
The incidence of HALT for the S3UR was comparable with the already reported incidences for the previous-generation SAPIEN 3 THV. Given the haemodynamic impact of HALT severity and…
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