Incidence and severity of paravalvular aortic regurgitation with multidetector computed tomography nominal area oversizing or undersizing after transcatheter heart valve replacement with the Sapien 3: a comparison with the Sapien XT

Tae-Hyun Yang, John G Webb, Philipp Blanke, Danny Dvir, Nicolaj C Hansson, Bjarne L Nørgaard, Christopher R Thompson, Martyn Thomas, Olaf Wendler, Alec Vahanian, Dominique Himbert, Susheel K Kodali, Rebecca T Hahn, Vinod H Thourani, Gerhard Schymik, Bruce Precious, Adam Berger, David A Wood, Philippe Pibarot, Josep Rodés-Cabau, Wael A Jaber, Martin B Leon, Thomas Walther, Jonathon Leipsic
JACC. Cardiovascular Interventions 2015, 8 (3): 462-471

OBJECTIVES: This study sought to compare the influence of the extent of multidetector computed tomography (MDCT) area oversizing on the incidence of paravalvular aortic regurgitation (PAR) between the Sapien 3 and the Sapien XT transcatheter heart valve (THV) to define a new MDCT sizing guideline suitable for the Sapien 3 platform.

BACKGROUND: The inverse relationship of PAR occurrence and oversizing has been demonstrated for the Sapien XT but the incidence of PAR with comparable oversizing with the Sapien 3 is not known.

METHODS: Sixty-one prospectively enrolled patients who underwent transcatheter aortic valve replacement with the Sapien 3 THV were compared with 92 patients who underwent transcatheter aortic valve replacement with the Sapien XT THV. Patients were categorized depending on the degree of MDCT area oversizing percentage: undersizing (below 0%), 0% to 5%, 5% to 10%, and above 10%. The primary endpoint was mild or greater PAR on transthoracic echocardiography.

RESULTS: Mild or greater PAR was present in 19.7% of patients (12 of 61) in the Sapien 3 group and in 54.3% of patients (50 of 92) in the Sapien XT group (p < 0.01). The Sapien 3 group, compared with the Sapien XT group, consistently demonstrated significantly lower rates of mild or greater PAR except for oversizing >10% (p for interaction = 0.54). Moderate or severe PAR rates were also lower in the Sapien 3 group than in the Sapien XT group (3.3% vs. 13.0%, p = 0.04). In the Sapien 3 group, a MDCT area oversizing percentage value of ≤4.17% was identified as the optimal cutoff value to discriminate patients with or without mild or greater PAR.

CONCLUSIONS: Our retrospective analysis suggests that the Sapien 3 THV displays significantly lower rates of PAR than does the Sapien XT THV. A lesser degree of MDCT area oversizing may be employed for this new balloon-expandable THV.

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