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- Titel:
Comparison of the FemoSeal Vascular Closure Device With Manual Compression After Femoral Artery Puncture - Post-hoc Analysis of a Large-Scale, Randomized Clinical Trial.
- Dokumenttyp:
- Article; Journal Article; Randomized Controlled Trial
- Autor(en):
- 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.
- Zeitschriftentitel:
- J Invasive Cardiol
- Jahr:
- 2018
- Band / Volume:
- 30
- Heft / Issue:
- 7
- Seitenangaben Beitrag:
- 235-239
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/29760286
- Print-ISSN:
- 1042-3931
- TUM Einrichtung:
- I. Medizinische Klinik und Poliklinik (Kardiologie); Klinik für Herz- und Kreislauferkrankungen im Erwachsenenalter (Prof. Schunkert)
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