| Dokumentenart: | Artikel | ||||
|---|---|---|---|---|---|
| Titel eines Journals oder einer Zeitschrift: | EuroIntervention | ||||
| Verlag: | EUROPA EDITION | ||||
| Ort der Veröffentlichung: | TOULOUSE CEDEX 6 | ||||
| Band: | 19 | ||||
| Nummer des Zeitschriftenheftes oder des Kapitels: | 1 | ||||
| Seitenbereich: | S. 83-92 | ||||
| Datum: | 2023 | ||||
| Institutionen: | Medizin > Lehrstuhl für Herz-, Thorax- und herznahe Gefäßchirurgie | ||||
| Identifikationsnummer: |
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| Stichwörter / Keywords: | END-POINT DEFINITIONS; SAPIEN 3 ULTRA; AORTIC-VALVE; 30-DAY OUTCOMES; EVOLUT PRO; REPLACEMENT; IMPLANTATION; PROSTHESIS; aortic stenosis; femoral; MSCT; TAVI; transoesophageal echocardiogram | ||||
| Dewey-Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin | ||||
| Status: | Veröffentlicht | ||||
| Begutachtet: | Ja, diese Version wurde begutachtet | ||||
| An der Universität Regensburg entstanden: | Ja | ||||
| Dokumenten-ID: | 76162 |
Zusammenfassung
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 ...
Zusammenfassung
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 cm(2) to 1.6 +/- 0.4 cm(2)). 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.
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