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The Early neo2 Regi...
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Rück, AndreasKarolinska Institutet
(author)
The Early neo2 Registry : Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population
- Article/chapterEnglish2023
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Numbers
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LIBRIS-ID:oai:lup.lub.lu.se:63977c1e-e0ff-4230-9be4-9abcdacf8eee
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https://lup.lub.lu.se/record/63977c1e-e0ff-4230-9be4-9abcdacf8eeeURI
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https://doi.org/10.1161/JAHA.122.029464DOI
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http://kipublications.ki.se/Default.aspx?queryparsed=id:153432695URI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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Subject category:ref swepub-contenttype
Notes
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BACKGROUND: ACURATE neo2 is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate placement accuracy and reduce paravalvular regurgitation. METHODS AND RESULTS: The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE neo2. Data were collected from 554 consecutive patients treated with ACURATE neo2 at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory–adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. CONCLUSIONS: In this report of postmarket use of the ACURATE neo2 valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.
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Kim, Won KeunMax Planck Institute for Heart and Lung Research
(author)
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Abdel-Wahab, MohamedLeipzig University
(author)
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Thiele, HolgerLeipzig University
(author)
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Rudolph, Tanja K.Ruhr-University Bochum
(author)
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Wolf, AlexanderElisabeth Hospital Essen
(author)
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Wambach, Jan MartinElisabeth Hospital Essen
(author)
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Backer, Ole DeCopenhagen University Hospital
(author)
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Sondergaard, LarsCopenhagen University Hospital
(author)
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Hengstenberg, ChristianMedical University of Vienna
(author)
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Laine, MikaHelsinki University Central Hospital
(author)
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Miyashita, HirokazuHelsinki University Central Hospital
(author)
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Bjursten, HenrikLund University,Lunds universitet,Thoraxkirurgi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Skonsammare hjärtkirurgi,Forskargrupper vid Lunds universitet,Thoracic Surgery,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Less invasive cardiac surgery,Lund University Research Groups,Skåne University Hospital(Swepub:lu)thor-hjo
(author)
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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
(author)
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Pellegrini, CostanzaTechnical University of Munich
(author)
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Toggweiler, StefanCantonal Hospital Lucerne
(author)
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Wykrzykowska, Joanna J.University Medical Center Groningen
(author)
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Soliman, OsamaGalway University Hospital,National University of Ireland Galway
(author)
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Saleh, NawzadKarolinska University Hospital
(author)
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Meduri, Christopher U.Karolinska University Hospital
(author)
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Karolinska InstitutetMax Planck Institute for Heart and Lung Research
(creator_code:org_t)
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In:Journal of the American Heart Association12:152047-9980
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Rück, Andreas
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Kim, Won Keun
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Abdel-Wahab, Moh ...
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Thiele, Holger
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Rudolph, Tanja K ...
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Wolf, Alexander
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Wambach, Jan Mar ...
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Backer, Ole De
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Sondergaard, Lar ...
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Hengstenberg, Ch ...
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Laine, Mika
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Miyashita, Hirok ...
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Bjursten, Henrik
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Götberg, Matthia ...
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Pellegrini, Cost ...
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Toggweiler, Stef ...
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Wykrzykowska, Jo ...
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Soliman, Osama
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