Comparison of the FemoSeal Vascular Closure Device With Manual Compression After Femoral Artery Puncture - Post-hoc Analysis of a Large-Scale, Randomized Clinical Trial.

Mankerious, Nader; Mayer, Katharina; Gewalt, Senta M; Helde, Sandra M; Ibrahim, Tareq; Bott-Flugel, Lorenz; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Schüpke, Stefanie

2018

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Title:: Comparison of the FemoSeal Vascular Closure Device With Manual Compression After Femoral Artery Puncture - Post-hoc Analysis of a Large-Scale, Randomized Clinical Trial.
Document type:: Article; Journal Article; Randomized Controlled Trial
Author(s):: Mankerious, Nader; Mayer, Katharina; Gewalt, Senta M; Helde, Sandra M; Ibrahim, Tareq; Bott-Flugel, Lorenz; Laugwitz, Karl-Ludwig; Schunkert, Heribert; Kastrati, Adnan; Schüpke, Stefanie
Abstract:: OBJECTIVES: To assess the safety and efficacy of arteriotomy closure with the intravascular FemoSeal vascular closure device (VCD; St. Jude Medical) compared to manual compression in patients undergoing diagnostic cardiac catheterization via the common femoral artery. BACKGROUND: There is limited evidence on the performance of individual contemporary VCDs compared to manual compression. METHODS: This is a subanalysis of 3018 patients who underwent transfemoral diagnostic coronary angiography and were randomly assigned to arteriotomy closure with either the intravascular FemoSeal VCD or manual compression within the investigator-initiated, large-scale, randomized, multicenter, open-label ISAR-CLOSURE trial. Primary endpoint was the composite of access-site related vascular complications at 30 days. Secondary endpoints were time to hemostasis and repeat manual compression. RESULTS: Vascular access-site complications were lower in patients assigned to the FemoSeal VCD compared to manual compression (6.0% vs 7.9%; P=.04), driven by a lower incidence of hematomas in the FemoSeal group (4.3% vs 6.8%; P<.01). Pseudoaneurysm rates were comparable in both groups (1.5% vs 1.5%; P=.88). Time to hemostasis was significantly shortened with the FemoSeal VCD compared to manual compression (0.5 min [IQR, 0.2-1.0 min] vs 10 min [IQR, 10-15 min]; P<.001). However, repeat manual compression was increased with the FemoSeal VCD (1.5% vs 0.7%; P=.03). CONCLUSION: In patients undergoing transfemoral diagnostic coronary angiography, the use of the FemoSeal VCD is associated with shortened time to hemostasis and a reduction in vascular access-site complications driven by fewer hematomas when compared to manual compression.
Journal title abbreviation:: J Invasive Cardiol
Year:: 2018
Journal volume:: 30
Journal issue:: 7
Pages contribution:: 235-239
Pubmed ID:: http://view.ncbi.nlm.nih.gov/pubmed/29760286
Print-ISSN:: 1042-3931
TUM Institution:: I. Medizinische Klinik und Poliklinik (Kardiologie); Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin I, Kardiologie (Prof. Laugwitz)2018

mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Lehr- und Forschungskooperationen mit den Kliniken und Instituten am Deutschen Herzzentrum Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (DHM) (Prof. Schunkert)2018