University of Witten/Herdecke, Department of Cardiology 2. University of Bochum, Department of Cardiology 3

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1 Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device Oliver Klein-Wiele 1, Maria Baliota 1, Kaffer Kara 2, Matthias Käunicke 1, Harald Schäfer 1, Marc Garbrecht 1, Marwan Abdulghafor 1, Marietta Garmer 3, Birgit Hailer 1 1 University of Witten/Herdecke, Department of Cardiology 2 University of Bochum, Department of Cardiology 3 University of Witten/Herdecke, Department of Radiology

2 Disclosure Speaker name: Oliver Klein-Wiele I do not have any potential conflict of interest.

3 Background - VCD are firmly established in femoral artery closure - Non-inferiority to manual compression 1 - Registry data indicate reduced bleeding with VCD 2 - Faster hemostasis and ambulation 1 1) Levine GN, Bates ER, Blankenship JC et al ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J. Am. Coll. Cardiol. 58, e44 e122 (2011). 2) Marso SP, Amin AP, House JA et al. Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention. JAMA 303, (2010).

4 - Direct comparison between specific VCDs is limited: - Few head-to-head studies - Recent Cochrane analysis 1 : - Largest metaanalysis oft prospective randomized trials patients - No difference between VCDs due high heterogeneity of studies evaluating complication rates - Different baseline characteristics, different definition of complications - Conclusion: Need for RCTs comparing VCDs 1) Robertson L, Andras A, Colgan F, Jackson R (2016) Vascular closure devices for femoral arterial puncture site haemostasis. Cochrane Database Syst Rev 3:CD doi: / cd pub2.

5 Perclose ProGlide Abbott Vascular - Complete penetration of vessel wall - Non resorbable suture - Commonly used - Different principles of action - No head-to-head analysis of complication rate and efficacy StarClose SE Abbott Vascular - No penetration of vessel wall - Permanent clip

6 Methods - Prospective randomized single center study, 538 procedures, 422 coronary, 122 peripheral, 1:1 randomization to StarClose/ProGlide - Inclusion criteria: - Age 18y - retrograde common femoral access for coronary or peripheral catheterizations - Exclusion criteria: - puncture through the posterior wall - multiple punctures at the same side < 90 days prior to the procedure - use of a VCD at the puncture site within the last 90 days - antegrade puncture - use of fibrinolytic drugs

7 Methods StarClose vs. ProGlide VCD - Colour Doppler ultrasound after 6h and pre discharge - In-hospital complications: bleeding, hematoma, pseudoaneurysm, vessel occlusion, dissection, and arteriovenous fistula. - Definition of complications and device failure according to previous studies 1 Major complications: Any complication needing surgical or endovascular therapy, bleeding requiring transfusion or decreasing hemoglobin >2 g/dl Minor complications: Palpable hematomas >3 cm in diameter, superficial hematomas with pain or impairment of joint mobility, small AV-fistula not needing endovascular or surgical treatment. Device failure: persistent bleeding requiring prolonged manual compression until hemostasis was achieved and the use of a compression bandage for 24 hours. 1) Ansel G, Yakubov S, Neilsen C, Allie D, Stoler R, Hall P, Fail P, Sanborn T, Caputo RP (2006) Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study. Catheter Cardiovasc Interv 67(4): doi: /ccd

8 Results StarClose vs. ProGlide VCD

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12 Major compliations: - 10 pseudoaneurysms (9 StarClose, 1 ProGlide) - 6 x thrombin injection (StarClose), - 3 x vascular surgery (2 StarClose, 1 ProGlide) - 1 femoral artery occlusion requiring endovascular therapy (StarClose) - 1 retroperitoneal bleeding treated surgically (ProGlide) - 8 hematomas (4 StarClose, 4 ProGlide) - conservative treatment Minor complications - 1 small AV-fistula not needing further intervention

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16 Summary - Overall complication rate 3.9% - Total cohort: more complications for StarClose compared to ProGlide (5.6% vs. 2.2%, p=0.064), 2.9-fold increased risk (p<0.05) - Coronary catheterizations: significantly more complications for StarClose compared to ProGlide (1.4% vs. 5.2%, p<0.05), 4.7-fold increased risk - PTA group: 1.7% major complications for ProGlide - Device failure rate was not significantly different

17 Conclusion This study indicates that ProGlide may be superior to StarClose concerning complications in 5 and 6F femoral closure We encourage larger head-to head studies for different VCDs

18 Thank you StarClose vs. ProGlide VCD

19 Safety and efficacy of clip-based vs. suture mediated vascular closure for femoral access hemostasis: A prospective randomized single center study comparing the StarClose and the ProGlide device Oliver Klein-Wiele 1, Maria Baliota 1, Kaffer Kara 2, Matthias Käunicke 1, Harald Schäfer 1, Marc Garbrecht 1, Marwan Abdulghafor 1, Marietta Garmer 3, Birgit Hailer 1 1 University of Witten/Herdecke, Department of Cardiology 2 University of Bochum, Department of Cardiology 3 University of Witten/Herdecke, Department of Radiology