Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study
Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. Methods...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2021-10-01
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| Series: | International Journal of Cardiology: Heart & Vasculature |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352906721001500 |
| _version_ | 1818355551308873728 |
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| author | Andreas Holzamer Mirko Doss Rene Schramm Anno Diegeler Lenard Conradi Justus Strauch David Holzhey Magdalena Erlebach Holger Schröfel Mani Arsalan Dominic J Allocco Michael Hilker |
| author_facet | Andreas Holzamer Mirko Doss Rene Schramm Anno Diegeler Lenard Conradi Justus Strauch David Holzhey Magdalena Erlebach Holger Schröfel Mani Arsalan Dominic J Allocco Michael Hilker |
| author_sort | Andreas Holzamer |
| collection | DOAJ |
| description | Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. Methods and results: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe). Conclusions: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR. |
| first_indexed | 2024-12-13T19:43:07Z |
| format | Article |
| id | doaj.art-7188b8ed1b484debaa0818205802d2ec |
| institution | Directory Open Access Journal |
| issn | 2352-9067 |
| language | English |
| last_indexed | 2024-12-13T19:43:07Z |
| publishDate | 2021-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Cardiology: Heart & Vasculature |
| spelling | doaj.art-7188b8ed1b484debaa0818205802d2ec2022-12-21T23:33:38ZengElsevierInternational Journal of Cardiology: Heart & Vasculature2352-90672021-10-0136100862Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA studyAndreas Holzamer0Mirko Doss1Rene Schramm2Anno Diegeler3Lenard Conradi4Justus Strauch5David Holzhey6Magdalena Erlebach7Holger Schröfel8Mani Arsalan9Dominic J Allocco10Michael Hilker11Klinikum der Universität Regensburg, Regensburg, GermanyKerckhoff Klinik, Bad Nauheim, GermanyHerz-und Diabeteszentrum Nordrhein-Westfalen, Bad Oeynhausen, GermanyRhön-Klinikum Campus Bad Neustadt, Bad Neustadt, GermanyUniversitaetsklinik Hamburg Eppendorf, University Heart and Vascular Center Hamburg, Hamburg, GermanyKlinik Bergmannsheil GmbH, Bochum, GermanyHerzzentrum Universität Leipzig, Leipzig, GermanyDeutsches Herzzentrum Muenchen, München, GermanyUniversity Heart Center Freiburg, Bad Krozingen, GermanyUniversity Hospital Frankfurt, Frankfurt, GermanyBoston Scientific Corporation, Marlborough, MA, USAKlinikum der Universität Regensburg, Regensburg, Germany; Corresponding author at: Department of Cardiothoracic Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, 93053 Regensburg, Germany.Background: A transapical (TA) approach to transcatheter aortic valve replacement (TAVR) may be used when a transfemoral (TF) approach is not feasible. The CHANGE neo TA study evaluated patients treated in routine clinical practice via TA-TAVR with the ACURATE neo bioprosthetic aortic valve. Methods and results: This single-arm post-market study had a planned enrolment of 200 subjects; enrolment was terminated early due to declining TA-TAVR procedures at participating centers. Final enrolment was 107 patients (mean age: 79.3 years; 54.2% female; mean STS score at baseline: 6.2%). The mortality rate in the intent-to-treat population was 11.2% at 30 days (primary endpoint) and 25.6% at 12 months. The VARC-2 composite endpoint for 30-day safety occurred in 24.3% of patients. Six patients (5.6%) received a permanent pacemaker within 30 days. Site-reported echocardiographic data showed early improvements in mean aortic valve gradient (baseline: 38.8 [SD 13.1] mmHg, discharge: 6.7 [SD 3.7] mmHg) and effective orifice area (baseline: 0.7 [SD 0.2] cm2, discharge: 1.9 [SD 0.6] cm2), and the discharge rate of paravalvular regurgitation was low (74.7% none/trace, 24.2% mild, 1.1% severe). Conclusions: TA-TAVR with the ACURATE neo valve system yields acceptable clinical outcomes, providing an alternative for patients with aortic stenosis who are not candidates for TF-TAVR.http://www.sciencedirect.com/science/article/pii/S2352906721001500Aortic regurgitationAortic stenosisTAVR |
| spellingShingle | Andreas Holzamer Mirko Doss Rene Schramm Anno Diegeler Lenard Conradi Justus Strauch David Holzhey Magdalena Erlebach Holger Schröfel Mani Arsalan Dominic J Allocco Michael Hilker Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study International Journal of Cardiology: Heart & Vasculature Aortic regurgitation Aortic stenosis TAVR |
| title | Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study |
| title_full | Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study |
| title_fullStr | Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study |
| title_full_unstemmed | Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study |
| title_short | Clinical outcomes following transapical TAVR with ACURATE neo in the CHANGE neo TA study |
| title_sort | clinical outcomes following transapical tavr with acurate neo in the change neo ta study |
| topic | Aortic regurgitation Aortic stenosis TAVR |
| url | http://www.sciencedirect.com/science/article/pii/S2352906721001500 |
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