Paravalvular Leak After Implantation of the ACURATE neo and the ACURATE neo2 Transcatheter Heart Valve

Abstract

BackgroundThe ACURATE neo has been associated with more paravalvular leak (PVL) than other transcatheter valves. The ACURATE neo2 is equipped with an extended sealing skirt, but data on this novel valve is scarce. The PREDICT PVL study aimed to assess PVL after implantation of the ACURATE neo and the ACURATE neo2. MethodsPatients undergoing transcatheter aortic valve implantation with the ACURATE neo (n = 30) and the ACURATE neo2 (n = 30) were enrolled in the prospective PREDICT PVL study. Postprocedural evaluation included transthoracic and transesophageal echocardiography and computed tomography. ResultsBaseline and procedural characteristics and short-term clinical outcomes were comparable between the two groups. More than 90 % of PVL was localized around the left coronary cusp. The ACURATE neo2 with its extended sealing skirt reduced the cumulative effective regurgitation orifice area (EROA) of the PVLs by 48 % from 13.7 ± 9.7 mm2 to 7.1 ± 5.7 mm2 (p < 0.001). The average number of PVL jets remained unchanged (2 jets per patient), but the sealing skirt reduced the size of the PVL jets. Multivariable predictors for less PVL were use of the ACURATE neo2, less valvular calcification, deeper valve implantation and valve size S or M as opposed to L. ConclusionsMore than 90 % of PVL occurred adjacent to the left coronary cusp. The sealing skirt of the ACURATE neo2 reduced PVL EROA by 48 % without an increase in conduction disorders. The best results with ACURATE neo2, in terms of low PVL, are achieved in patients with lower valve calcification, deeper implantation and with S or M sizes.