Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device.

Autor:	Ali M; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Masood F; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Erickson L; Academic Affairs, Cardiovascular Research, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Adefisoye J; Academic Affairs, Aurora UW Medical Group, Center for Urban Population Health, Aurora Sinai Medical Center, Aurora Health Care, Milwaukee, Wisconsin, USA., Kanani J; Academic Affairs, Cardiovascular Research, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Walczak S; Academic Affairs, Cardiovascular Research, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Ajam T; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Kieu A; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Premjee M; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA., Jan MF; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Allaqaband SQ; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Bajwa T; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Khitha J; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Zilinski J; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Jahangir A; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Djelmami-Hani M; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Sra J; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Niazi I; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA., Mortada ME; Aurora Cardiovascular and Thoracic Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Aurora Health Care, Milwaukee, Wisconsin, USA.; Division of Cardiovascular Medicine, University of Wisconsin School of Medicine and Public Health, Milwaukee Clinical Campus, Milwaukee, Wisconsin, USA.
Jazyk:	angličtina
Zdroj:	Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2024 Oct; Vol. 104 (4), pp. 820-828. Date of Electronic Publication: 2024 Aug 01.
DOI:	10.1002/ccd.31173
Abstrakt:	Background: Perclose ProGlide (PPG) Suture-Mediated Closure System™ is safe and can reduce time to hemostasis following procedures requiring arterial access. Aims: We aimed to compare PPG to figure of 8 suture in patients who underwent interventional catheter procedures requiring large bore venous access (LBVA) (≥13 French). Methods: In this physician-initiated, randomized, single-center study [clinicaltrials.gov ID: NCT04632641], single-stick venous access was obtained under ultrasound guidance. Eligible patients were randomized 1:1, and 100 subjects received allocated treatment to either PPG (n = 47) or figure of 8 suture (n = 53). No femoral arterial access was used in any patient. Primary outcomes were time to achieve hemostasis (TTH) and time to ambulation (TTA). Secondary outcomes were time to discharge (TTD) and vascular-related complications and mortality. Wilcoxon rank-sum test was used to compare TTH, TTA, and TTD. Results: TTH (minutes) was significantly lower in PPG versus figure of 8 suture [median, (Q1, Q3)] [7 (2,10) vs. 11 (10,15) respectively, p < 0.001]. TTA (minutes) was significantly lower in PPG compared to figure of 8 suture [322 (246,452) vs. 403 (353, 633) respectively, p = 0.005]. TTD (minutes) was not significantly different between the PPG and figure of 8 suture arms [1257 (1081, 1544) vs. 1338 (1171,1435), p = 0.650]. There was no difference in minor bleeding or access site hematomas between both arms. No other vascular complications or mortality were reported. Conclusion: PPG use had lower TTH and TTA than figure of 8 suture in a population of patients receiving LBVA procedures. This may encourage same-day discharge in these patients. (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
Databáze:	MEDLINE
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