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Closure Devices
Derek S. Vien, MD; T. Gregory Walker, MD, FSIR
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KEY FACTS

  • Terminology

    • Preprocedure

      • Procedure

        • Post Procedure

          • Outcomes

            TERMINOLOGY

            • Definitions

              • Active closure devices
                • Suture-mediated closure
                  • Perclose ProGlide (Abbott Vascular; Redwood City, CA)
                    • Introduced over guidewire through arteriotomy
                    • Nonresorbable polypropylene monofilament suture closes arteriotomy
                    • Mechanism parallels surgical suture closure
                    • Can close arteriotomies ranging in size from 5 to 21 French; 2 devices using preclose technique available for > 8-French size
                    • ProStar XL available for arteriotomies up to 10 French in size
                • Nitinol clip
                  • StarClose SE (Abbott Vascular)
                    • Delivers nitinol clip to close access site
                    • Can close arteriotomies up to 6 French in size
                    • MR conditional following application
                • Arteriotomy tamponade
                  • Catalyst (Cardiva Medical; Santa Clara, CA)
                    • Device inserted through existing access sheath; sheath exchange not required
                    • Nitinol disc expanded within vessel, then collapsed, & pulled through arteriotomy/tract
                    • Extravascular tract exposed to hemostatic coating; promotes hemostasis, prevents oozing
                    • Brief manual compression after disc withdrawal
                    • Catalyst II & Catalyst III variants; Catalyst III adds protamine sulfate to neutralize heparin in access tract
                    • Compatible with 5-French, 6-French, & 7-French vascular sheaths (≤ 15.7 cm in length)
                • Mechanical seal
                  • Angio-Seal (St. Jude Medical; St. Paul, MN)
                    • Extravascular collagen sponge connected by self-tightening suture to intravascular polymer anchor (absorbable)
                    • Creates "sandwich" at arteriotomy between anchor & collagen sponge
                    • All components absorbed within 60-90 days
                    • 2 device sizes: Maximum 6-French or 8-French arteriotomy
                    • Access 1 cm proximal to previous access site if repuncture < 90 days
                  • MYNX ACE (AccessClosure; Mountain View, CA)
                    • Extravascular polyethylene glycol sealant deposited, seals access tract/arteriotomy
                    • Fully absorbed in 30 days
                    • Device inserted through existing access sheath; sheath exchange not required
                    • Compatible with 5-French, 6-French, & 7-French vascular sheaths (≤ 15.7 cm in length)
                    • Intravascular occlusion balloon used during sealant deployment
                  • ExoSeal (Cordis; Miami Lakes, FL)
                    • Extravascular polyglycolic acid plug sealant
                    • Fully absorbed in 60-90 days
                    • Device inserted through existing access sheath; sheath exchange not required
                    • Compatible with 5-French, 6-French, & 7-French vascular sheaths (≤ 12 cm in length)
                  • Femoral Introducer Sheath & Hemostasis (FISH) (Morris Innovative; Bloomington, IN)
                    • Closure device placed during initial access
                    • Ribbon of small intestinal submucosa mounted on sheath introducer; creates resorbable plug
                    • Can close arteriotomies up to 8 French in size
                    • Can be used in vessels as small as 3 mm
              • Assisted compression devices
                • Pressure-assisted devices
                  • Safeguard (Datascope; Mahwah, NJ)
                    • Pneumatic compression device
                    • Inflatable "bladder" with adhesive backing
                    • When inflated, applies direct pressure
                    • 12-mm & 24-mm sizes available
                  • FemoStop (St. Jude Medical)
                    • Pneumatic compression device
                    • Digital manometer; transparent, inflatable dome
                  • QuicKlamp (TZ Medical; Portland, OR)
                    • Mechanical compression clamp device
                    • Uses compression discs
                    • May attach hemostasis pad to disc
                • Radial artery compression devices
                  • Safeguard Radial (Merit Medical; South Jordan, UT)
                    • Pneumatic compression device
                    • Clear window for visualization of puncture site
                    • Uses standard Luer valve
                  • TR Band (Terumo Medical; Somerset, NJ)
                    • Pneumatic compression device
                    • Transparent structure for visual control of puncture site
                    • Velcro straps
                  • RadiStop (St. Jude Medical)
                    • Pneumatic compression device
                    • Support plate enables controlled positioning of patient’s wrist
                  • RadAR (Advanced Vascular Dynamics; Portland, OR)
                    • Strap with adjustment knob & movable compression pad that applies direct pressure to puncture site
                  • RADstat (Merit Medical)
                    • Support base & straps provide immobilization of wrist & adjustable direct pressure on puncture site
              • Topical hemostasis pads & patches
                • Chito-Seal (Abbott Vascular)
                  • Positively charged chitosan molecules attract negatively charged red blood cells/platelets
                • Clo-Sur P.A.D. (Scion Cardio-Vascular; Miami, FL)
                  • Chitosan (N-acetyl glucosamine-containing glycosaminoglycan)
                • D-Stat (Vascular Solutions; Minneapolis, MN)
                  • Lyophilized pad with thrombin, Na⁺ carboxymethyl cellulose, Ca⁺⁺ chloride
                • V+Pad (Angiotech; Vancouver, BC, Canada)
                  • D-glucosamine-enriched gauze fibers attract platelets for more rapid plug formation
                • Syvek patch (Marine Polymer Tech; Danvers, MA)
                  • Poly-N-acetyl glucosamine; promotes clot formation/local vasoconstriction
                • SafeSeal (Medrad/Possis; Warrendale, PA)
                  • Bioabsorbable desiccant; enhances clotting
              • Hybrid
                • Axera (Arstasis; Fremont, CA)
                  • Access/closure device placed during initial access
                  • Creates pathway traversing artery at shallow angle
                    • Uses hydrostatic forces to facilitate arterial closure when sheath withdrawn

            PREPROCEDURE

            • Indications

              • Contraindications

                • Preprocedure Imaging

                  • Getting Started

                    PROCEDURE

                    • Equipment Preparation

                      • Procedure Steps

                        • Findings and Reporting

                          • Alternative Procedures/Therapies

                            POST PROCEDURE

                            • Things to Do

                              • Things to Avoid

                                OUTCOMES

                                • Problems

                                  • Complications

                                    • Expected Outcomes

                                      Selected References

                                      1. Fargen KM et al: Occurrence of angiographic femoral artery complications after vascular closure with Mynx and AngioSeal. J Neurointerv Surg. 5(2):161-4, 2013
                                      2. Das R et al: Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol. 34(4):723-38, 2011
                                      3. Fargen KM et al: A prospective randomized single-blind trial of patient comfort following vessel closure: extravascular synthetic sealant closure provides less pain than a self-tightening suture vascular compression device. J Neurointerv Surg. 3(3):219-23, 2011
                                      4. Biancari F et al: Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 159(4):518-31, 2010
                                      5. Lee SW et al: Long term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention. Catheter Cardiovasc Interv. 75(3):345-8, 2010
                                      6. McTaggart RA et al: StarClose vascular closure device: safety and efficacy of deployment and reaccess in a neurointerventional radiology service. AJNR Am J Neuroradiol. 31(6):1148-50, 2010
                                      7. Franco J et al: Risk factors for infectious complications with angio-seal percutaneous vascular closure devices. Vascular. 17(4):218-21, 2009
                                      8. Garcia JA et al: Use of the Boomerang catalyst advantage closure device to facilitate complex multistaged percutaneous revascularization procedures for the treatment of critical limb ischemia. Catheter Cardiovasc Interv. 74(1):27-36, 2009
                                      9. Lima S et al: Femoral stenosis due to a collagen closure device treated percutaneously by peripheral stenting. Rev Port Cardiol. 28(7-8):877-80, 2009
                                      10. van der Steeg HJ et al: Acute arterial occlusion after deployment of the Angio-Seal closure device: is it as uncommon as we think? Eur J Vasc Endovasc Surg. 38(6):715-7, 2009
                                      11. Germing A et al: Femoral vascular closure device: the surgical view. Vascular. 16(5):295-6, 2008
                                      12. Lee WA et al: Midterm outcomes of femoral arteries after percutaneous endovascular aortic repair using the preclose technique. J Vasc Surg. 47(5):919-23, 2008
                                      13. Koreny M et al: Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 291(3):350-7, 2004
                                      14. Hofmann LV et al: Arteriographic and pathologic evaluation of two suture-mediated arterial closure devices in a porcine model. J Vasc Interv Radiol. 14(6):755-61, 2003
                                      Related Anatomy
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                                      Related Differential Diagnoses
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                                      References
                                      Tables

                                      Tables

                                      KEY FACTS

                                      • Terminology

                                        • Preprocedure

                                          • Procedure

                                            • Post Procedure

                                              • Outcomes

                                                TERMINOLOGY

                                                • Definitions

                                                  • Active closure devices
                                                    • Suture-mediated closure
                                                      • Perclose ProGlide (Abbott Vascular; Redwood City, CA)
                                                        • Introduced over guidewire through arteriotomy
                                                        • Nonresorbable polypropylene monofilament suture closes arteriotomy
                                                        • Mechanism parallels surgical suture closure
                                                        • Can close arteriotomies ranging in size from 5 to 21 French; 2 devices using preclose technique available for > 8-French size
                                                        • ProStar XL available for arteriotomies up to 10 French in size
                                                    • Nitinol clip
                                                      • StarClose SE (Abbott Vascular)
                                                        • Delivers nitinol clip to close access site
                                                        • Can close arteriotomies up to 6 French in size
                                                        • MR conditional following application
                                                    • Arteriotomy tamponade
                                                      • Catalyst (Cardiva Medical; Santa Clara, CA)
                                                        • Device inserted through existing access sheath; sheath exchange not required
                                                        • Nitinol disc expanded within vessel, then collapsed, & pulled through arteriotomy/tract
                                                        • Extravascular tract exposed to hemostatic coating; promotes hemostasis, prevents oozing
                                                        • Brief manual compression after disc withdrawal
                                                        • Catalyst II & Catalyst III variants; Catalyst III adds protamine sulfate to neutralize heparin in access tract
                                                        • Compatible with 5-French, 6-French, & 7-French vascular sheaths (≤ 15.7 cm in length)
                                                    • Mechanical seal
                                                      • Angio-Seal (St. Jude Medical; St. Paul, MN)
                                                        • Extravascular collagen sponge connected by self-tightening suture to intravascular polymer anchor (absorbable)
                                                        • Creates "sandwich" at arteriotomy between anchor & collagen sponge
                                                        • All components absorbed within 60-90 days
                                                        • 2 device sizes: Maximum 6-French or 8-French arteriotomy
                                                        • Access 1 cm proximal to previous access site if repuncture < 90 days
                                                      • MYNX ACE (AccessClosure; Mountain View, CA)
                                                        • Extravascular polyethylene glycol sealant deposited, seals access tract/arteriotomy
                                                        • Fully absorbed in 30 days
                                                        • Device inserted through existing access sheath; sheath exchange not required
                                                        • Compatible with 5-French, 6-French, & 7-French vascular sheaths (≤ 15.7 cm in length)
                                                        • Intravascular occlusion balloon used during sealant deployment
                                                      • ExoSeal (Cordis; Miami Lakes, FL)
                                                        • Extravascular polyglycolic acid plug sealant
                                                        • Fully absorbed in 60-90 days
                                                        • Device inserted through existing access sheath; sheath exchange not required
                                                        • Compatible with 5-French, 6-French, & 7-French vascular sheaths (≤ 12 cm in length)
                                                      • Femoral Introducer Sheath & Hemostasis (FISH) (Morris Innovative; Bloomington, IN)
                                                        • Closure device placed during initial access
                                                        • Ribbon of small intestinal submucosa mounted on sheath introducer; creates resorbable plug
                                                        • Can close arteriotomies up to 8 French in size
                                                        • Can be used in vessels as small as 3 mm
                                                  • Assisted compression devices
                                                    • Pressure-assisted devices
                                                      • Safeguard (Datascope; Mahwah, NJ)
                                                        • Pneumatic compression device
                                                        • Inflatable "bladder" with adhesive backing
                                                        • When inflated, applies direct pressure
                                                        • 12-mm & 24-mm sizes available
                                                      • FemoStop (St. Jude Medical)
                                                        • Pneumatic compression device
                                                        • Digital manometer; transparent, inflatable dome
                                                      • QuicKlamp (TZ Medical; Portland, OR)
                                                        • Mechanical compression clamp device
                                                        • Uses compression discs
                                                        • May attach hemostasis pad to disc
                                                    • Radial artery compression devices
                                                      • Safeguard Radial (Merit Medical; South Jordan, UT)
                                                        • Pneumatic compression device
                                                        • Clear window for visualization of puncture site
                                                        • Uses standard Luer valve
                                                      • TR Band (Terumo Medical; Somerset, NJ)
                                                        • Pneumatic compression device
                                                        • Transparent structure for visual control of puncture site
                                                        • Velcro straps
                                                      • RadiStop (St. Jude Medical)
                                                        • Pneumatic compression device
                                                        • Support plate enables controlled positioning of patient’s wrist
                                                      • RadAR (Advanced Vascular Dynamics; Portland, OR)
                                                        • Strap with adjustment knob & movable compression pad that applies direct pressure to puncture site
                                                      • RADstat (Merit Medical)
                                                        • Support base & straps provide immobilization of wrist & adjustable direct pressure on puncture site
                                                  • Topical hemostasis pads & patches
                                                    • Chito-Seal (Abbott Vascular)
                                                      • Positively charged chitosan molecules attract negatively charged red blood cells/platelets
                                                    • Clo-Sur P.A.D. (Scion Cardio-Vascular; Miami, FL)
                                                      • Chitosan (N-acetyl glucosamine-containing glycosaminoglycan)
                                                    • D-Stat (Vascular Solutions; Minneapolis, MN)
                                                      • Lyophilized pad with thrombin, Na⁺ carboxymethyl cellulose, Ca⁺⁺ chloride
                                                    • V+Pad (Angiotech; Vancouver, BC, Canada)
                                                      • D-glucosamine-enriched gauze fibers attract platelets for more rapid plug formation
                                                    • Syvek patch (Marine Polymer Tech; Danvers, MA)
                                                      • Poly-N-acetyl glucosamine; promotes clot formation/local vasoconstriction
                                                    • SafeSeal (Medrad/Possis; Warrendale, PA)
                                                      • Bioabsorbable desiccant; enhances clotting
                                                  • Hybrid
                                                    • Axera (Arstasis; Fremont, CA)
                                                      • Access/closure device placed during initial access
                                                      • Creates pathway traversing artery at shallow angle
                                                        • Uses hydrostatic forces to facilitate arterial closure when sheath withdrawn

                                                PREPROCEDURE

                                                • Indications

                                                  • Contraindications

                                                    • Preprocedure Imaging

                                                      • Getting Started

                                                        PROCEDURE

                                                        • Equipment Preparation

                                                          • Procedure Steps

                                                            • Findings and Reporting

                                                              • Alternative Procedures/Therapies

                                                                POST PROCEDURE

                                                                • Things to Do

                                                                  • Things to Avoid

                                                                    OUTCOMES

                                                                    • Problems

                                                                      • Complications

                                                                        • Expected Outcomes

                                                                          Selected References

                                                                          1. Fargen KM et al: Occurrence of angiographic femoral artery complications after vascular closure with Mynx and AngioSeal. J Neurointerv Surg. 5(2):161-4, 2013
                                                                          2. Das R et al: Arterial closure devices versus manual compression for femoral haemostasis in interventional radiological procedures: a systematic review and meta-analysis. Cardiovasc Intervent Radiol. 34(4):723-38, 2011
                                                                          3. Fargen KM et al: A prospective randomized single-blind trial of patient comfort following vessel closure: extravascular synthetic sealant closure provides less pain than a self-tightening suture vascular compression device. J Neurointerv Surg. 3(3):219-23, 2011
                                                                          4. Biancari F et al: Meta-analysis of randomized trials on the efficacy of vascular closure devices after diagnostic angiography and angioplasty. Am Heart J. 159(4):518-31, 2010
                                                                          5. Lee SW et al: Long term clinical outcomes after deployment of femoral vascular closure devices in coronary angiography and percutaneous coronary intervention. Catheter Cardiovasc Interv. 75(3):345-8, 2010
                                                                          6. McTaggart RA et al: StarClose vascular closure device: safety and efficacy of deployment and reaccess in a neurointerventional radiology service. AJNR Am J Neuroradiol. 31(6):1148-50, 2010
                                                                          7. Franco J et al: Risk factors for infectious complications with angio-seal percutaneous vascular closure devices. Vascular. 17(4):218-21, 2009
                                                                          8. Garcia JA et al: Use of the Boomerang catalyst advantage closure device to facilitate complex multistaged percutaneous revascularization procedures for the treatment of critical limb ischemia. Catheter Cardiovasc Interv. 74(1):27-36, 2009
                                                                          9. Lima S et al: Femoral stenosis due to a collagen closure device treated percutaneously by peripheral stenting. Rev Port Cardiol. 28(7-8):877-80, 2009
                                                                          10. van der Steeg HJ et al: Acute arterial occlusion after deployment of the Angio-Seal closure device: is it as uncommon as we think? Eur J Vasc Endovasc Surg. 38(6):715-7, 2009
                                                                          11. Germing A et al: Femoral vascular closure device: the surgical view. Vascular. 16(5):295-6, 2008
                                                                          12. Lee WA et al: Midterm outcomes of femoral arteries after percutaneous endovascular aortic repair using the preclose technique. J Vasc Surg. 47(5):919-23, 2008
                                                                          13. Koreny M et al: Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA. 291(3):350-7, 2004
                                                                          14. Hofmann LV et al: Arteriographic and pathologic evaluation of two suture-mediated arterial closure devices in a porcine model. J Vasc Interv Radiol. 14(6):755-61, 2003