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The Early neo2 Regi...
The Early neo2 Registry : Transcatheter Aortic Valve Implantation With ACURATE neo2 in a European Population
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- Rück, Andreas (author)
- Karolinska Institutet
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- Kim, Won Keun (author)
- Max Planck Institute for Heart and Lung Research
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- Abdel-Wahab, Mohamed (author)
- Leipzig University
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- Thiele, Holger (author)
- Leipzig University
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- Rudolph, Tanja K. (author)
- Ruhr-University Bochum
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- Wolf, Alexander (author)
- Elisabeth Hospital Essen
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- Wambach, Jan Martin (author)
- Elisabeth Hospital Essen
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- Backer, Ole De (author)
- Copenhagen University Hospital
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- Sondergaard, Lars (author)
- Copenhagen University Hospital
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- Hengstenberg, Christian (author)
- Medical University of Vienna
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- Laine, Mika (author)
- Helsinki University Central Hospital
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- Miyashita, Hirokazu (author)
- Helsinki University Central Hospital
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- Bjursten, Henrik (author)
- Lund 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
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- Götberg, Matthias (author)
- 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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- Pellegrini, Costanza (author)
- Technical University of Munich
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- Toggweiler, Stefan (author)
- Cantonal Hospital Lucerne
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- Wykrzykowska, Joanna J. (author)
- University Medical Center Groningen
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- Soliman, Osama (author)
- Galway University Hospital,National University of Ireland Galway
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- Saleh, Nawzad (author)
- Karolinska University Hospital
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- Meduri, Christopher U. (author)
- Karolinska University Hospital
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(creator_code:org_t)
- 2023
- 2023
- English 8 s.
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In: Journal of the American Heart Association. - 2047-9980. ; 12:15
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Abstract
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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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- aortic regurgitation
- aortic stenosis
- TAVI
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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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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show more...
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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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Saleh, Nawzad
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Meduri, Christop ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
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Journal of the A ...
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Lund University
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Karolinska Institutet