Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience
Objectives: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic out...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-05-01
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| Series: | Hellenic Journal of Cardiology |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1109966622000240 |
| _version_ | 1818231919078277120 |
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| author | Sebastian Barth Martina B. Hautmann Christian Muñoz Pérez Sebastian Kerber Jan Kikec Michael Zacher Borek Foldyna Lukas Lehmkuhl Philipp Halbfass Ulrich Lüsebrink Karsten Hamm |
| author_facet | Sebastian Barth Martina B. Hautmann Christian Muñoz Pérez Sebastian Kerber Jan Kikec Michael Zacher Borek Foldyna Lukas Lehmkuhl Philipp Halbfass Ulrich Lüsebrink Karsten Hamm |
| author_sort | Sebastian Barth |
| collection | DOAJ |
| description | Objectives: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. Methods: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. Results: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. Conclusion: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up. |
| first_indexed | 2024-12-12T10:58:02Z |
| format | Article |
| id | doaj.art-38839641545c4d60946154067a12fd90 |
| institution | Directory Open Access Journal |
| issn | 1109-9666 |
| language | English |
| last_indexed | 2024-12-12T10:58:02Z |
| publishDate | 2022-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Hellenic Journal of Cardiology |
| spelling | doaj.art-38839641545c4d60946154067a12fd902022-12-22T00:26:37ZengElsevierHellenic Journal of Cardiology1109-96662022-05-0165814Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experienceSebastian Barth0Martina B. Hautmann1Christian Muñoz Pérez2Sebastian Kerber3Jan Kikec4Michael Zacher5Borek Foldyna6Lukas Lehmkuhl7Philipp Halbfass8Ulrich Lüsebrink9Karsten Hamm10Department of Cardiology, Cardiovascular Center Bad Neustadt, Germany; Corresponding author. Sebastian Barth, MD, Department of Cardiology, Cardiovascular Center Bad Neustadt, Von-Guttenberg-Straße 11D, 97616, Bad Neustadt a. d. Saale, Germany. Tel.: +49-9771-66-25222 Fax +49-9771-66-9823235.Department of Cardiology, Cardiovascular Center Bad Neustadt, GermanyDepartment of Cardiology, Cardiovascular Center Bad Neustadt, GermanyDepartment of Cardiology, Cardiovascular Center Bad Neustadt, GermanyDepartment of Cardiology, Cardiovascular Center Bad Neustadt, GermanyDepartment of Medical Documentation, Cardiovascular Center Bad Neustadt, GermanyCardiovascular Imaging Research Center, Massachusetts General Hospital – Harvard Medical School, Boston, MA, USADepartment of Radiology, Cardiovascular Center Bad Neustadt, GermanyDepartment of Cardiology, University of Oldenburg, GermanyDepartment of Cardiology, University of Marburg, GermanyANregiomed Klinikum Ansbach, Department of Cardiology, GermanyObjectives: The PASCAL device is a transcatheter edge-to-edge repair system (TEER) for treatment of mitral regurgitation (MR). The PASCAL Ace as a newer version of the PASCAL device consists of a thinner profile without a spacer. The aim of the study was to examine the functional and hemodynamic outcome after TEER with the PASCAL Ace device in a real-world cohort. Methods: Between September 2020 and August 2021, all consecutive patients with MR 3+/4+ treated percutaneously with PASCAL Ace were included in this study. Primary endpoints included successful device implantation, device success, improvement of exercise capacity, quality of life, and a composite of all-cause mortality, non-fatal stroke, myocardial infarction, new need for renal replacement therapy or severe bleeding at 30 days and 5 month. Results: 49/66 patients had a functional etiology. Overall success rate was 98.5%. At follow-up, 84.7% of the patients had MR grade ≤ 1. TEER was associated with an improvement of LV ejection fraction (45% to 53%, p = 0.048). 86.5% were in NYHA class I or II. 6-minute-walking distance improved by 79m (p = 0.009). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 19 points (p = 0.012). NT-proBNP levels decreased from 4832 to 2137 pg/dl (p = 0.003). Mean pulmonary capillary wedge pressures improved from 21 to 15mmHg (p = 0.001). At 5 month, a total of 3 patients died, none of cardiovascular cause. Conclusion: PASCAL Ace is safe and effective in treating MR, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, NT-proBNP levels and hemodynamics at follow-up.http://www.sciencedirect.com/science/article/pii/S1109966622000240PASCAL Ace mitral valve repair systemmitral valve regurgitationhemodynamics |
| spellingShingle | Sebastian Barth Martina B. Hautmann Christian Muñoz Pérez Sebastian Kerber Jan Kikec Michael Zacher Borek Foldyna Lukas Lehmkuhl Philipp Halbfass Ulrich Lüsebrink Karsten Hamm Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience Hellenic Journal of Cardiology PASCAL Ace mitral valve repair system mitral valve regurgitation hemodynamics |
| title | Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience |
| title_full | Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience |
| title_fullStr | Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience |
| title_full_unstemmed | Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience |
| title_short | Functional and hemodynamic result with the PASCAL Ace percutaneous mitral valve repair: A single-center experience |
| title_sort | functional and hemodynamic result with the pascal ace percutaneous mitral valve repair a single center experience |
| topic | PASCAL Ace mitral valve repair system mitral valve regurgitation hemodynamics |
| url | http://www.sciencedirect.com/science/article/pii/S1109966622000240 |
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