First‐In‐Man Experience With a New 7F Vascular Closure Device (EXOSEAL™): The 7F ECLIPSE Study |
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| Authors: | MARCUS WIEMER MD CHRISTOPH LANGER MD STEPHAN FICHTLSCHERER MD CHRISTIAN FIRSCHKE MD FLORIAN HOFBAUER MD MARKUS LINS MD MICHAEL HAUDE MD CHRISTOF DEBÈFVE ir HANS‐PETER STOLL MD CHRISTOPH HANEFELD MD |
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| Institution: | 1. Department of Cardiology, Heart and Diabetes Center North Rhine‐Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany;2. Christian Albrechts University, Kiel, Germany;3. Division of Cardiology, Department of Medicine III, Goethe University Frankfurt, Frankfurt, Germany;4. Ilmtal Hospital, Pfaffenhofen, Germany;5. Lukas Hospital, Neuss, Germany;6. Cordis Clinical Research EMEA, Waterloo, Belgium;7. St. Josef‐Hospital, Ruhr University Bochum, Germany |
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| Abstract: | Objective: This feasibility study examined safety and effectiveness of the new EXOSEAL? Vascular Closure Device (VCD) designed to promote hemostasis and early ambulation after percutaneous procedures. Background: Most VCDs currently approved by the United States FDA have been associated with significantly shorter time‐to‐hemostasis (TTH) and time‐to‐ambulation (TTA) compared to standard manual or mechanical compression, but their ease of use, patient comfort during deployment, and safety profiles are variable. Methods: Patients underwent diagnostic or interventional procedures using 7F introducer sheaths. Primary safety endpoint was the 30‐day combined rate of access‐related complications and primary effectiveness endpoints were TTH and TTA. Results: Sixty patients were enrolled prospectively (mean age 63.3 ± 11.3 year, 17% diabetics). Device and procedural success was achieved in 92% and 93%, respectively. Mean TTH and TTA was 3.2 ± 3.0 minutes and 3.0 ± 6.2 hours, respectively. No deaths or serious access‐related adverse events occurred. A ≥6 cm access‐site hematoma was the only adverse event, observed in 3 patients. Conclusions: Use of the 7F EXOSEAL? VCD was associated with short TTH and TTA, as well as low rates of procedural and 30‐day access‐related complications. (J Interven Cardiol 2012;25:518–525) |
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