| Title: |
Clinical outcomes of the ACURATE neo2 transcatheter heart valve: a prospective, multicentre, observational, post-market surveillance study |
| Authors: |
Kim W. -K.; Tamburino C.; Mollmann H.; Montorfano M.; Ellert-Gregersen J.; Rudolph T. K.; Van Mieghem N. M.; Hilker M.; Amat-Santos I. J.; Terkelsen C. J.; Petronio A. S.; Stella P. R.; Gotberg M.; Ruck A.; Kasel A. M.; Trillo R.; Appleby C.; Barbanti M.; Blanke P.; Modolo R.; Allocco D. J.; Sondergaard L. |
| Contributors: |
Kim, W. -K.; Tamburino, C.; Mollmann, H.; Montorfano, M.; Ellert-Gregersen, J.; Rudolph, T. K.; Van Mieghem, N. M.; Hilker, M.; Amat-Santos, I. J.; Terkelsen, C. J.; Petronio, A. S.; Stella, P. R.; Gotberg, M.; Ruck, A.; Kasel, A. M.; Trillo, R.; Appleby, C.; Barbanti, M.; Blanke, P.; Modolo, R.; Allocco, D. J.; Sondergaard, L. |
| Publisher Information: |
Europa Group |
| Publication Year: |
2023 |
| Subject Terms: |
aortic stenosis; femoral; MSCT; TAVI; transoesophageal echocardiogram |
| Description: |
Background: The next-generation ACURATE neo2 transcatheter aortic valve was designed for simplified implantation and to mitigate the risk of paravalvular leak (PVL) compared to the earlier device. Aims: We sought to collect clinical outcomes and device performance data, including echocardiography and 4-dimensional computed tomography (4D-CT) data, with the ACURATE neo2 transcatheter heart valve in patients with severe aortic stenosis (AS). Methods: The ACURATE neo2 Post-Market Clinical Follow-up (PMCF) Study is a single-arm, multicentre study of patients with severe AS treated in routine clinical practice. The primary safety endpoint was all-cause mortality at 30 days. The primary imaging endpoint was hypoattenuated leaflet thickening (HALT), measured by core laboratory-adjudicated 4D-CT at 30 days. Secondary endpoints included Valve Academic Research Consortium safety endpoints, procedural success, and evaluation of valve performance via core laboratory-adjudicated echocardiography. Results: The study enrolled 250 patients at 18 European centres (mean age: 80.8 years; 63.6% female; mean Society of Thoracic Surgeons score: 2.9±2.0%); 246 patients (98.4%) were successfully treated with the ACURATE neo2. The 30-day rates for mortality and disabling stroke were 0.8% and 0%, respectively. The new permanent pacemaker implantation rate was 6.5%. HALT >50% was present in 9.3% of patients at 30 days. Valve haemodynamics improved from baseline to 30 days (mean aortic valve gradient: from 47.6±14.5 mmHg to 8.6±3.9 mmHg; mean aortic valve area: from 0.7±0.2 cm2 to 1.6±0.4 cm2). At 30 days, PVL was evaluated as none/trace in 79.2% of patients, mild in 18.9%, moderate in 1.9%, and severe in 0%. Conclusions: The study results support the safety and efficacy of transcatheter aortic valve implantation with the ACURATE neo2 in patients in routine clinical practice. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/36440588; info:eu-repo/semantics/altIdentifier/wos/WOS:001000099500014; volume:19; issue:1; firstpage:83; lastpage:92; numberofpages:10; journal:EUROINTERVENTION; https://hdl.handle.net/20.500.11768/170417 |
| DOI: |
10.4244/EIJ-D-22-00914 |
| Availability: |
https://hdl.handle.net/20.500.11768/170417; https://doi.org/10.4244/EIJ-D-22-00914; https://eurointervention.pcronline.com/article/clinical-outcomes-of-the-acurate-neo2-transcatheter-heart-valve-a-prospective-multicentre-observational-post-market-surveillance-study |
| Rights: |
info:eu-repo/semantics/openAccess ; license:Altra licenza OA ; license uri:other-oa |
| Accession Number: |
edsbas.9FCCC1F |
| Database: |
BASE |