Access Closure: Manual vs. Device
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1 Access Closure: Manual vs. Device Herbert D. Aronow, MD, MPH, FACC, FSCAI, FSVM Director, Interventional Cardiology, Cardiovascular Institute Director, Cardiac Cath Labs, Rhode Island &The Miriam Hospitals
2 None Disclosures
3 Rationale VCDs vs. Manual Compression Reduce complication rates Reduce time to hemostasis Reduce time to ambulation/hospital discharge Increase patient satisfaction
4 Real World PVI Data from BMC2 VIC Access Site Complications (n=7,769) Plaisance BR et al. J Am Coll Cardiol Intv 2011;4:
5 Real World PVI Data from SVS VQI Access Site Complications (n=22,226) 74% ASC (3.5%) 15% 11% Mild Mod Severe Ortiz D, et al. Circ Cardiovasc Interv 2014;7:
6 31 RCT Meta-Analysis (n=7,528) VCDs vs. Manual Compression: Risk of Pseudoaneurysm No difference in groin hematoma, bleeding, transfusion, limb ischemia, surgery Higher infection rates with VCD (0.6% vs. 0.2%, p = 0.02) Biancari F et al. Am Heart J 2010;159: Byrne RA, et al. Nat Rev Cardiol 2013;10:27 40
7 31 RCT Meta-Analysis (n=7,528) VCDs vs. Manual Compression: Time to Hemostasis Biancari F et al. Am Heart J 2010;159: Byrne RA, et al. Nat Rev Cardiol 2013;10:27 40
8 RCT Meta-Analysis (Vasoseal Excluded) VCDs vs. Manual Compression: Outcomes Biancari F et al. Am Heart J 2010;159:518-31
9 Guidelines and VCDs ACCF/AHA/SCAI 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention
10 Guidelines and VCDs SIR Further study of VCD safety/efficacy in interventional procedures needed Femoral angiography should be considered before VCD deployment VCDs are safe method to reduce time to hemostasis and ambulation Institutional VCD complication rates should be at least equivalent to those for manual compression VCDs should not be used to reduce risk of vascular complications Insufficient evidence to support VCDs in stents/arterial grafts Insufficient evidence to support VCDs for health care cost reduction Neither endorse nor discourage separate procedural consent, re-prep of access site, and/or use of prophylactic antibiotics SIR Quality Improvement Guidelines For Vascular Access and Closure. J Vasc Interv Radiol. 2014;25:73-84
11 ISAR-CLOSURE RCT of Coronary Angiography VCDs vs. Manual Compression (n=4,524) Manual compression vs. Intravascular VCD vs. Extravascular VCD (1:1:1) VCDs non-inferior to MC Schulz-Schupke S, et al. JAMA 2014;312:
12 CLOSE-UP RCT of Coronary Angiography VCDs vs. Manual Compression (n=1,014) Holm NR, et al. Eurointervenion 2014;10:183-90
13 VCD Mechanisms of Action Active approximators physically close the arteriotomy with a suture or clip Passive approximators - deploy a plug, sealant or gel at the arteriotomy External devices - provide mechanical pressure or accelerate clotting cascade
14 Select VCDs Angioseal Evolution (St. Jude Medical) Femoseal (St. Jude Medical) Perclose ProGlide (AbbottVascular) EXOSEAL (Cordis) StarClose (Abbott) Mynx (AccessClosure) Byrne RA, et al. Nat Rev Cardiol 2013;10:27-40
15 FDA-Approved VCDs Active Approximators Ward TJ, Weintraub JL. Endovascular Today January 2015
16 FDA-Approved VCDs Passive Approximators Ward TJ, Weintraub JL. Endovascular Today January 2015
17 FDA-Approved VCDs Passive Approximators Ward TJ, Weintraub JL. Endovascular Today January 2015
18 FDA-Approved VCDs Passive Approximators Ward TJ, Weintraub JL. Endovascular Today January 2015
19 Mass DOH Study (n=23,813 procedures) Nitinol clip vs. suture vs. collagen plug-based VCD Unadjusted VCD failure: collagen plug 2.1%; suture 6.1%; Nitinol clip 9.5% Vidi VD, et al. J Am Coll Intv 2012;5:837:44
20 ISAR-CLOSURE RCT of Coronary Angiography Extra- vs. Intravascular VCDs Manual compression vs. Intravascular VCD vs. Extravascular VCD (1:1:1) Femoseal time to hemostasis < Exoseal Femoseal device failure < Exoseal Schulz-Schupke S, et al. JAMA 2014;312:
21 Extra- vs. Intravascular VCD Mynx M5 vs. Angioseal Evolution RCT (n=64) Fargen KM, et al. J Neurointervent Surg 2011;3:219-23
22 Predictors of VCD Outcome Patient characteristics Vascular anatomic features Adjunctive anticoagulation Procedure type/sheath size Operator/institutional experience (learning curve) Device features (e.g., intra- vs. extravascular) Vidi VD, et al. J Am Coll Intv 2012;5:837:44; Smilowitz NR et al. Am J Caridol 2012;110:
23 CFA closure Appropriate Use of VCDs Follow the IFU Vessel diameter (4-6 mm) No severe athero No severe Ca++ Need to perform femoral angiography to determine appropriateness of VCD deployment
24 Unanswered Questions Small diameter (< 4-6 mm) Significant PAD Significant Ca++ High stick Arteriotomy at CFA bifurcation Prior VCD deployment
25 VCD Conclusions Reduce time to hemostasis/ambulation vs. manual compression Appear to reduce large hematomas vs. manual compression (ISAR-CLOSURE, CLOSE-UP) Comparative VCD data are largely observational and susceptible to selection bias Comparative VCD RCTs are few in number, and most are small in size, precluding definitive conclusions Whether certain VCDs are better suited for particular anatomic situations is unknown Ideally, operators should develop expertise with 1-2 VCDs which should dominate their practice
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