Article, 2024

Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice: one-yearresults of the ACURATE neo2 PMCF Study.

EuroIntervention, ISSN 1774-024X, 1969-6213, Volume 20, 1, Pages 85-94, 10.4244/eij-d-23-00823

Contributors

Kim, Won-Keun 0000-0002-0799-7478 [1] Möllmann, Helge 0000-0002-6047-0990 [2] Montorfano, Matteo 0000-0001-9732-9459 [3] [4] Ellert-Gregersen, Julia 0000-0001-5985-5538 [5] Rudolph, Tanja Katharina [6] Van Mieghem, Nicolas M D A 0000-0002-2732-1205 [7] Hilker, Michael K [8] Amat-Santos, Ignacio Jesús 0000-0002-2311-4129 [9] Terkelsen, Christian Juhl J 0000-0003-0205-9551 [10] Petronio, Anna Sonia [11] Stella, Pieter R [12] Götberg, Matthias 0000-0002-0912-7927 [13] [14] Rück, Andreas 0000-0003-2920-6574 [15] Kasel, Albert Markus 0000-0002-1090-9213 [16] Trillo, Ramiro 0000-0002-9377-8254 [17] Appleby, Clare E 0000-0002-3838-1174 [18] Barbanti, Marco 0000-0002-4903-5437 [19] Blanke, Philipp [20] Asch, Federico Miguel 0000-0002-1744-5271 [21] Modolo, Rodrigo [22] Allocco, Dominic J 0000-0002-0577-1555 [22] Tamburino, Corrado 0000-0002-4940-9742 [23]

Affiliations

  1. [1] Kerckhoff Klinik
    2. [NORA names: Germany; Europe, EU; OECD];
  2. [2] St.-Johannes-Hospital Dortmund
    3. [NORA names: Germany; Europe, EU; OECD];
  3. [3] IRCCS Ospedale San Raffaele
    4. [NORA names: Italy; Europe, EU; OECD];
  4. [4] Vita-Salute San Raffaele University
    5. [NORA names: Italy; Europe, EU; OECD];
  5. [5] Odense University Hospital
    6. [NORA names: Region of Southern Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];

Abstract

BACKGROUND: Transcatheter aortic valve implantation is an effective treatment for patients with aortic stenosis; however, complications related to paravalvular leakage (PVL) persist, including increased risk of mortality, cardiovascular mortality, and rehospitalisation. AIMS: We sought to evaluate the clinical outcomes and valve performance at 1 year in patients with severe aortic stenosis treated with the ACURATE neo2 valve in a post-market clinical setting. METHODS: Valve Academic Research Consortium-2 safety events were assessed up to 1 year. Independent core laboratories evaluated echocardiographic measures of valve performance and hypoattenuated leaflet thickening (HALT; as measured by four-dimensional computed tomography). RESULTS: The study enrolled 250 patients (64% female; mean age: 81 years; baseline Society of Thoracic Surgeons risk score: 2.9±2.0%); 246 patients were implanted with ACURATE neo2. All-cause mortality was 0.8% at 30 days and 5.1% at 1 year. The 1-year rates for stroke and disabling stroke were 3.0% and 1.3%, respectively. Overall, HALT of >50% leaflet involvement of at least one leaflet was present in 9% of patients at 30 days and in 12% of patients at 1 year. No association was observed between the presence of HALT and 1-year clinical or haemodynamic outcomes. Early haemodynamic improvements were maintained up to 1 year (mean aortic valve gradient: 47.6±14.5 mmHg at baseline, 7.6±3.2 mmHg at 1 year; mean aortic valve area: 0.7±0.2 cm2 at baseline, 1.7±0.4 cm2 at 1 year). At 1 year, 99% of patients had mild or no/trace PVL (<1% had moderate PVL; no patient had severe PVL). CONCLUSIONS: The study outcomes confirm favourable performance and safety up to 1 year in patients treated with ACURATE neo2 in routine clinical practice. (ClinicalTrials.gov: NCT04655248).

Keywords

ACURATE, ACURATE neo2, all-cause mortality, aortic stenosis, aortic valve implantation, association, cardiovascular mortality, clinical outcomes, clinical practice, clinical setting, complications, core laboratory, days, disabling stroke, echocardiographic measurements, effective treatment, events, favorable performance, haemodynamic improvement, haemodynamic outcomes, halt, heart valves, hypoattenuated leaflet thickening, implantation, improvement, increased risk, increased risk of mortality, independent core laboratory, involvement, laboratory, leaflet, leaflet involvement, leaflet thickening, leakage, maintained up to 1 year, mortality, neo2, no/trace, outcomes, paravalvular leakage, patients, performance, practice, presence, rate, rehospitalisation, risk of mortality, safety, safety events, sets, severe aortic stenosis, stenosis, stroke, study, study outcomes, thickening, transcatheter, transcatheter aortic valve implantation, transcatheter heart valve, treatment, valve, valve implantation, valve performance, years

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