Use of new-generation ACURATE neo2 with TAVR tied to less paravalvular leak: Study
USA: Transcatheter aortic valve replacement (TAVR) with new-generation ACURATE neo2 is associated with a lower prevalence of moderate or severe paravalvular aortic regurgitation (AR), suggests a recent study. Also, it leads to more patients with none/trace paravalvular AR and the difference was particularly noticeable in patients with heavy aortic valve calcification.
The findings of the study were presented at TVT 2022 and subsequently published in EuroIntervention.
TAVR with the ACURATE neo device is shown to be associated with a non-negligible incidence of paravalvular aortic regurgitation. To mitigate this limitation, the new-generation ACURATE neo2 has been designed. Andrea Scotti, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA, and colleagues aimed to compare TAVR with the ACURATE neo and neo2 devices.
The NEOPRO and NEOPRO-2 registries retrospectively included patients undergoing transfemoral TAVR with self-expanding valves at 24 and 20 centres, respectively. The study included patients receiving the ACURATE neo and neo2 devices (from January 2012 to December 2021). A total of 2,026 patients (neo: 1,263, neo2: 763) were included. The evaluation of the predischarge and 30-day VARC–3 defined outcomes was done.
Predischarge moderate or severe paravalvular AR was the primary endpoint. Subgroup analyses per degree of aortic valve calcification were performed.
Based on the study, the researchers reported the following findings:
- Predischarge moderate or severe paravalvular AR was less frequent for the neo2 group (2% vs 5%), resulting in higher VARC-3 intended valve performance (96% vs 90%).
- More patients receiving the neo2 had none/trace paravalvular AR (59% vs 38%).
- 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%).
"The latest-generation ACURATE neo2 THV when compared to the first-generation ACURATE neo, is associated with a lower rate of moderate or severe paravalvular AR, in patients undergoing transfemoral TAVR," the researchers wrote.
"As a result, a greater percentage of patients receiving the neo2 THV have none/trace paravalvular AR. The superior performance of the neo2 device is particularly evident among patients with heavy aortic valve calcification,"
Reference:
Scotti A, Pagnesi M, Kim W-K, et al. Hemodynamic performance and clinical outcomes of transcatheter aortic valve replacement with the self-expanding ACURATE neo2. EuroIntervention. 2022;Epub ahead of print.
