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Outcomes and perfor...
Outcomes and performance of the ACURATE neo2 transcatheter heart valve in clinical practice : one-yearresults of the ACURATE neo2 PMCF Study
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- Kim, Won Keun (författare)
- Kerckhoff Klinik
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- Möllmann, Helge (författare)
- St.-Johannes-Hospital Dortmund
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- Montorfano, Matteo (författare)
- Vita-Salute San Raffaele University
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- Ellert-Gregersen, Julia (författare)
- Odense University Hospital
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Rudolph, Tanja K. (författare)
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- Van Mieghem, Nicolas M. (författare)
- Erasmus University Medical Center
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- Hilker, Michael (författare)
- University Hospital Regensburg
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- Amat-Santos, Ignacio (författare)
- University of Valladolid
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- Terkelsen, Christian Juhl (författare)
- Aarhus University Hospital
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- Petronio, Anna Sonia (författare)
- University Hospital of Pisa
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- Stella, Pieter (författare)
- University Medical Center Utrecht
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- Götberg, Matthias (författare)
- Lund 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
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- Rück, Andreas (författare)
- Karolinska Institutet
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- Kasel, A. Markus (författare)
- University Hospital of Zurich
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- Trillo, Ramiro (författare)
- Complejo Hospitalario Universitario de Santiago
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- Appleby, Clare (författare)
- Liverpool Heart and Chest Hospital
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- Barbanti, Marco (författare)
- Kore University of Enna
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- Blanke, Philipp (författare)
- St. Paul’s Hospital
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Asch, Federico M. (författare)
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- Modolo, Rodrigo (författare)
- Boston Scientific Corporation
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- Allocco, Dominic J. (författare)
- Boston Scientific Corporation
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- Tamburino, Corrado (författare)
- Azienda Ospedaliero Universitaria-Policlinico Duilio Casula
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Kerckhoff Klinik St-Johannes-Hospital Dortmund (creator_code:org_t)
- 2024
- 2024
- Engelska 10 s.
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Ingår i: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. - 1969-6213. ; 20:1, s. 85-94
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https://doi.org/10.4...
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Abstract
Ämnesord
Stäng
- 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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
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- Av författaren/redakt...
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Kim, Won Keun
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Möllmann, Helge
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Montorfano, Matt ...
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Ellert-Gregersen ...
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Rudolph, Tanja K ...
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Van Mieghem, Nic ...
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visa fler...
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Hilker, Michael
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Amat-Santos, Ign ...
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Terkelsen, Chris ...
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Petronio, Anna S ...
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Stella, Pieter
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Götberg, Matthia ...
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Rück, Andreas
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Kasel, A. Markus
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Trillo, Ramiro
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Appleby, Clare
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Barbanti, Marco
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Blanke, Philipp
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Asch, Federico M ...
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Modolo, Rodrigo
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Allocco, Dominic ...
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Tamburino, Corra ...
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kardiologi
- Artiklar i publikationen
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EuroIntervention ...
- Av lärosätet
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Lunds universitet
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Karolinska Institutet