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.

Authors: Yang, Tae-Hyun; Webb, John G. (John Graydon); Blanke, Philipp; Dvir, Danny; Hansson, Nicolaj C.; Nørgaard, Bjarne Linde; Thompson, Chris; Thomas, Martyn; Wendler, Olaf; Vahanian, Alec; Himbert, Dominique; Kodali, Susheel; Hahn, Rebecca T.; Thourani, Vinod H.; Schymik, Gerhard; Precious, Bruce; Berger, Adam; Pibarot, PhilippeRodés-Cabau, Josep; Jaber, Wael A.; Leon, Martin B.; Walther, Thomas; Leipsic, Jonathon; Wood, David A.
Abstract: 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.
Document Type: Article de recherche
Issue Date: 1 March 2015
Open Access Date: 27 July 2016
Document version: VoR
This document was published in: JACC. Cardiovascular interventions, Vol. 8 (3), 462–471 (2015)
Alternative version: 10.1016/j.jcin.2014.10.014
Collection:Articles publiés dans des revues avec comité de lecture

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