Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study
Background: Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding comp...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-04-01
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| Series: | International Journal of Cardiology: Heart & Vasculature |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352906721002396 |
| _version_ | 1818320224831668224 |
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| author | Mariama Akodad Jessica Labour Erika Nogue Delphine Delseny Jean-Christophe Macia Richard Gervasoni Benoit Lattuca Nicolas Nagot François Roubille Guillaume Cayla Florence Leclercq |
| author_facet | Mariama Akodad Jessica Labour Erika Nogue Delphine Delseny Jean-Christophe Macia Richard Gervasoni Benoit Lattuca Nicolas Nagot François Roubille Guillaume Cayla Florence Leclercq |
| author_sort | Mariama Akodad |
| collection | DOAJ |
| description | Background: Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding complications may be reduced with BAV performed without heparin. Methods: This randomized, double-blind, placebo-controlled study was conducted from January 2013 to September 2016. Patients were randomly assigned to placebo or intravenous unfractionated heparin (UH) 50 IU/kg bolus during the procedure. The primary endpoint included major vascular, bleeding and ischemic complications (stroke, transient ischemic attack, myocardial infarction) according to VARC-2 criteria. Results: Among 89 randomized patients, 82 completed the study (n = 39 in the UH group and n = 43 in the placebo group). At baseline, diabetes, sex male and renal failure were more frequent in the UH group and peripheral artery disease was more frequent in the placebo group. The primary endpoint was achieved in 7 patients (8.5%), 1 in the placebo group (2.3%) versus 6 in the UH group (15.4%). After adjustment on diabetes, sex, renal failure, peripheral artery disease, percutaneous closure device and chronic obstructive pulmonary disease, UH utilization was associated with a significant risk of major vascular, bleeding and ischemic complications (primary endpoint) (adjOR: 11.9; 95%CI: 1.2–117.2; p = 0.03). Hospitalization length was lower in the placebo group compared to the UH group (p = 0.03). Conclusions: BAV without per procedural UH was associated with a reduction of major VC and bleeding events without increasing the ischemic risk and with a shorter hospitalization length. |
| first_indexed | 2024-12-13T10:21:37Z |
| format | Article |
| id | doaj.art-f18a26d2fbbe46b8b4c70d5a59f789a4 |
| institution | Directory Open Access Journal |
| issn | 2352-9067 |
| language | English |
| last_indexed | 2024-12-13T10:21:37Z |
| publishDate | 2022-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Cardiology: Heart & Vasculature |
| spelling | doaj.art-f18a26d2fbbe46b8b4c70d5a59f789a42022-12-21T23:51:11ZengElsevierInternational Journal of Cardiology: Heart & Vasculature2352-90672022-04-0139100951Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized studyMariama Akodad0Jessica Labour1Erika Nogue2Delphine Delseny3Jean-Christophe Macia4Richard Gervasoni5Benoit Lattuca6Nicolas Nagot7François Roubille8Guillaume Cayla9Florence Leclercq10Department of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, France; PhyMedExp, Uni Montpellier, INSERM, CNRS, FranceDepartment of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, FranceClinical Research and Epidemiology Unit, CHU Montpellier, Univ Montpellier, Montpellier, FranceDepartment of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, FranceDepartment of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, FranceDepartment of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, FranceDepartment of Cardiology, CHU Nimes, Univ Montpellier, Nimes, FranceClinical Research and Epidemiology Unit, CHU Montpellier, Univ Montpellier, Montpellier, FranceDepartment of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, France; PhyMedExp, Uni Montpellier, INSERM, CNRS, FranceDepartment of Cardiology, CHU Nimes, Univ Montpellier, Nimes, FranceDepartment of Cardiology, CHU Montpellier, Univ Montpellier, Montpellier, France; Corresponding author at: Department of cardiology, Arnaud de Villeneuve hospital, University of Montpellier, Avenue du doyen Giraud, 34295 Montpellier Cedex 5, France.Background: Vascular and bleeding events remain the main complications after balloon aortic valvuloplasty (BAV). While BAV is usually performed with per procedural heparin injection, BAV performed without heparin may reduce hemorrhagic events. We aimed to determine whether vascular and bleeding complications may be reduced with BAV performed without heparin. Methods: This randomized, double-blind, placebo-controlled study was conducted from January 2013 to September 2016. Patients were randomly assigned to placebo or intravenous unfractionated heparin (UH) 50 IU/kg bolus during the procedure. The primary endpoint included major vascular, bleeding and ischemic complications (stroke, transient ischemic attack, myocardial infarction) according to VARC-2 criteria. Results: Among 89 randomized patients, 82 completed the study (n = 39 in the UH group and n = 43 in the placebo group). At baseline, diabetes, sex male and renal failure were more frequent in the UH group and peripheral artery disease was more frequent in the placebo group. The primary endpoint was achieved in 7 patients (8.5%), 1 in the placebo group (2.3%) versus 6 in the UH group (15.4%). After adjustment on diabetes, sex, renal failure, peripheral artery disease, percutaneous closure device and chronic obstructive pulmonary disease, UH utilization was associated with a significant risk of major vascular, bleeding and ischemic complications (primary endpoint) (adjOR: 11.9; 95%CI: 1.2–117.2; p = 0.03). Hospitalization length was lower in the placebo group compared to the UH group (p = 0.03). Conclusions: BAV without per procedural UH was associated with a reduction of major VC and bleeding events without increasing the ischemic risk and with a shorter hospitalization length.http://www.sciencedirect.com/science/article/pii/S2352906721002396Balloon aortic valvuloplastyVascular and bleeding complicationsAortic stenosisPercutaneous interventions |
| spellingShingle | Mariama Akodad Jessica Labour Erika Nogue Delphine Delseny Jean-Christophe Macia Richard Gervasoni Benoit Lattuca Nicolas Nagot François Roubille Guillaume Cayla Florence Leclercq Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study International Journal of Cardiology: Heart & Vasculature Balloon aortic valvuloplasty Vascular and bleeding complications Aortic stenosis Percutaneous interventions |
| title | Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study |
| title_full | Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study |
| title_fullStr | Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study |
| title_full_unstemmed | Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study |
| title_short | Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study |
| title_sort | vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin hepavalve randomized study |
| topic | Balloon aortic valvuloplasty Vascular and bleeding complications Aortic stenosis Percutaneous interventions |
| url | http://www.sciencedirect.com/science/article/pii/S2352906721002396 |
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