Transcatheter Aortic Valve Replacement With Self-Expanding ACURATE neo2: Postprocedural Hemodynamic and Short-Term Clinical Outcomes

BackgroundThe first-generation ACURATE neo transcatheter heart valve (THV) (Boston Scientific) was associated with a non-negligible occurrence of moderate or greater paravalvular aortic regurgitation (AR) following transcatheter aortic valve replacement. To overcome this issue, the ACURATE neo2 iteration, which incorporates a taller outer skirt aimed at reducing the occurrence of paravalvular AR, has recently been developed.ObjectivesThe aim of this study was to assess the efficacy and safety of the ACURATE neo2 (Boston Scientific) THV in patients with severe aortic valve stenosis.MethodsITAL-neo was an observational, retrospective, multicenter registry enrolling consecutive patients with severe aortic valve stenosis, treated with first- and second-generation ACURATE neo THVs, via transfemoral and trans-subclavian access, in 13 Italian centers. One-to-one propensity score matching was applied to account for baseline characteristics unbalance. The primary endpoint was the occurrence of moderate or greater paravalvular AR on predischarge echocardiographic assessment. Secondary endpoints included postprocedural technical success and 90-day device success and safety.ResultsAmong 900 patients included in the registry, 220 received the ACURATE neo2 THV, whereas 680 were treated with the first-generation device. A total of 410 patients were compared after 1:1 propensity score matching. The ACURATE neo2 THV was associated with a 3-fold lower frequency of postprocedural moderate or greater paravalvular AR (11.2% vs 3.5%; P < 0.001). No other hemodynamic differences were observed. Postprocedural technical success was similar between the 2 cohorts. Fewer adverse events were observed in patients treated with the ACURATE neo2 at 90 days.ConclusionsTransfemoral transcatheter aortic valve replacement using the ACURATE neo2 was associated with a significant lower frequency of moderate or greater paravalvular AR compared with the earlier generation ACURATE neo device, with encouraging short-term safety and efficacy.     

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

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.     

Transcatheter Aortic Valve Replacement in Oncology Patients With Severe Aortic Stenosis

Objectives

The authors sought to collect data on contemporary practice and outcome of transcatheter aortic valve replacement (TAVR) in oncology patients with severe aortic stenosis (AS).