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  • Kim, Won KeunKerckhoff Klinik (författare)

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

  • Artikel/kapitelEngelska2024

Förlag, utgivningsår, omfång ...

  • 2024
  • 10 s.

Nummerbeteckningar

  • LIBRIS-ID:oai:lup.lub.lu.se:0a13ded5-c075-48dd-8857-816e5753e913
  • https://lup.lub.lu.se/record/0a13ded5-c075-48dd-8857-816e5753e913URI
  • https://doi.org/10.4244/EIJ-D-23-00823DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:237982152URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:155413746URI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

Ingår i deldatabas

Klassifikation

  • Ämneskategori:art swepub-publicationtype
  • Ämneskategori:ref swepub-contenttype

Anmärkningar

  • 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).

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Möllmann, HelgeSt.-Johannes-Hospital Dortmund (författare)
  • Montorfano, MatteoVita-Salute San Raffaele University (författare)
  • Ellert-Gregersen, JuliaOdense University Hospital (författare)
  • Rudolph, Tanja K. (författare)
  • Van Mieghem, Nicolas M.Erasmus University Medical Center (författare)
  • Hilker, MichaelUniversity Hospital Regensburg (författare)
  • Amat-Santos, IgnacioUniversity of Valladolid (författare)
  • Terkelsen, Christian JuhlAarhus University Hospital (författare)
  • Petronio, Anna SoniaUniversity Hospital of Pisa (författare)
  • Stella, PieterUniversity Medical Center Utrecht (författare)
  • Götberg, MatthiasLund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)kard-mgo (författare)
  • Rück, AndreasKarolinska Institutet (författare)
  • Kasel, A. MarkusUniversity Hospital of Zurich (författare)
  • Trillo, RamiroComplejo Hospitalario Universitario de Santiago (författare)
  • Appleby, ClareLiverpool Heart and Chest Hospital (författare)
  • Barbanti, MarcoKore University of Enna (författare)
  • Blanke, PhilippSt. Paul’s Hospital (författare)
  • Asch, Federico M. (författare)
  • Modolo, RodrigoBoston Scientific Corporation (författare)
  • Allocco, Dominic J.Boston Scientific Corporation (författare)
  • Tamburino, CorradoAzienda Ospedaliero Universitaria-Policlinico Duilio Casula (författare)
  • Kerckhoff KlinikSt.-Johannes-Hospital Dortmund (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology20:1, s. 85-941969-6213

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