Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2.

Scotti, Andrea; Pagnesi, Matteo; Kim, Won-Keun; Schäfer, Ulrich; Barbanti, Marco; Costa, Giuliano; Baggio, Sara; Casenghi, Matteo; De Marco, Federico; Vanhaverbeke, Maarten; Søndergaard, Lars; Wolf, Alexander; Schofer, Joachim; Ancona, Marco Bruno; Montorfano, Matteo; Kornowski, Ran; Assa, Hana Vaknin; Toggweiler, Stefan; Ielasi, Alfonso; Hildick-Smith, David; ... (2022). Haemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2. EuroIntervention, 18(10), pp. 804-811. Europa Digital & Publishing 10.4244/EIJ-D-22-00289

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BACKGROUND

Transcatheter aortic valve replacement (TAVR) with the ACURATE neo device has been associated with a non-negligible incidence of paravalvular aortic regurgitation (AR). The new-generation ACURATE neo2 has been designed to mitigate this limitation.

AIMS

The aim of the study was to compare TAVR with the ACURATE neo and neo2 devices.

METHODS

The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. Patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021) were included in this study. Predischarge and 30-day VARC-3 defined outcomes were evaluated. The primary endpoint was predischarge moderate or severe paravalvular AR. Subgroup analyses per degree of aortic valve calcification were performed.

RESULTS

A total of 2,026 patients (neo: 1,263, neo2: 763) were included. Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%; p<0.001), resulting in higher VARC-3 intended valve performance (96% vs 90%; p<0.001). Furthermore, more patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%; p<0.001). The reduction in paravalvular AR with neo2 was mainly observed with heavy aortic valve calcification. New pacemaker implantation and VARC-3 technical and device success rates were similar between the 2 groups; there were more frequent vascular and bleeding complications for the neo device. Similar 1-year survival was detected after TAVR (neo2: 90% vs neo: 87%; p=0.14).

CONCLUSIONS

TAVR with the ACURATE neo2 device was associated with a lower prevalence of moderate or severe paravalvular AR and more patients with none/trace paravalvular AR. This difference was particularly evident with heavy aortic valve calcification.

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