Overview of Closure Devices – What's Out There, are ... - VascularWeb

Overview of Closure Devices – What’s OutThere, are They Warranted and if so, When?Ali Azizzadeh, MD, FACSAssociate ProfessorDirector of Endovascular SurgeryDepartment of Cardiothoracic and Vascular SurgeryThe University of Texas Medical School at HoustonMemorial Hermann Heart & Vascular InstituteSociety for Vascular SurgeryVascular Annual MeetingSan Francisco, CaliforniaMay 29, 2013

Disclosures• Consultant• WL Gore• Medtronic

• Sven Ivar Seldinger,Percutaneous Access,1953• Access sites managedwith ManualCompression (MC) fornext 30-40 yrs.Acta Radiologica (Stockholm) 39: 368-76. May 1953

Vascular Closure Devices (VCD’s)• Introduced in ‘80s• To limit the time, labor, bed rest, and patientdiscomfort• Incidence:• CathPCI Registry• 2005-2009• 1089 sites• 1,819,611 percutaneous coronary intervention(PCI) procedures• >60% VCD useTavris DR et al. J Invas Cardiol. 2012;24:328-334.

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Manual Compression• Easy, “ golden standard”• Need to interruptanticoagulation (wait forACT to decrease)• Patient and doctordiscomfort– 6 hours bedrest : backpain and urinaryretention– 15–30 min for a 6 FrsheathVascular Closure Devices• Improve patientcomfort• Free medical staffresources• Shortens the timeneeded forhemostasis,ambulation anddischarge• Risks of groin infectionand leg ischemia

Manual Compression• Remains the “gold standard” in achieving hemostasisof an arteriotomy site• The sheath can be removed:• immediately after a diagnostic procedure• delayed (often 2–4 hours) after an intervention: ACT

Vascular Closure DevicesPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• Femo Stop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Vascular Closure DevicesPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Enhance• NeptunehemostasisPadwithprothrombotic• D-StatmaterialDryormechanical compression• Do not achieve prompt hemostasisor•shortenCompressionthe time toDevicesambulation.• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Passive Vascular Closure DevicesSelf Sealing Arteriotomy: Axera (Arstasis)0.035’’ wire0.018” guidewire0.035’’ wire

Passive Vascular Closure DevicesSelf Sealing Arteriotomy: Axera (Arstasis)0.035’’ wire0.018” guidewire0.035’’ wireLong shallow-angle arteriotomy creates significant tissue-tissue overlap for hemostasis.

Passive Vascular Closure DevicesHemostasis PadsPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Passive Vascular Closure DevicesHemostasis PadsPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Passive Vascular Closure Devices- Hemostasis Pads• Chito-Seal: Abbott Vascular, Redwood City,California• Clo-Sur PAD: Scion Cardiovascular, Miami, Florida• SyvekPatch: Marine Polymer Technologies, Inc.,Dankers, Massachusetts• Neptune Pad: Biotronik, Berlin, Germany• D-Stat Dry: Vascular Solutions, Minneapolis,Minnesota

Pads are coated with procoagulant material to enhance coagulation and hemostasis.

Passive Vascular Closure Devices:Hemostasis Pads• Small randomized trials with patients undergoing:• Diagnostic or interventional coronary procedures:• Nguyen: RCT of topical hemostasis pad use for achieving vascularhemostasis after PCI. Catheter Cardiovasc Interv 2007• Mlekusch: Arterial puncture site management after PCI using ahemostatic wound dressing (Clo-Sur P.A.D.) versus conventional MC:A randomized controlled trial. J Endovasc Ther 2006• Balzer: Postinterventional percutaneous closure of femoral arteryaccess sites using the Clo-Sur PAD device: Initial findings. Eur Radiol2007• Peripheral percutaneous interventions• Mlekusch: Access site management after peripheral percutaneoustransluminal procedures: Neptune pad compared with conventionalmanual compression. Radiology 2008

Passive vascular closure deviceshemostasis pads• Technical failure:• 5–19% of Clo-Sur PAD cases• 8% of D-Stat Dry cases• Compared to MC:• Chito-Seal, Clo-Sur PAD or SyvekPatch: samecomplication rates• D-Stat Dry: reduced vascular complication rates• Neptune Pad: increased the risk of minor bleeding• Neptune Pad and Clo-Sur PAD: improved patient andphysician comfort• Hemostasis pads did not shorten the time to ambulationThe clinical utility of hemostasis pads is questionable sincetheir influence on hemostasis is small and they do notreduce the time to ambulation

Passive vascular closure deviceshemostasis pads• Technical failure:• 5–19% of Clo-Sur PAD cases• 8% of D-Stat Dry cases• Compared to MC:• Chito-Seal, Clo-Sur PAD or SyvekPatch: samecomplication rates• D-Stat Dry: reduced vascular complication rates• Neptune Pad: increased the risk of minor bleeding• Neptune Pad and Clo-Sur PAD: improved patient andphysician comfort• Hemostasis pads did not shorten the time to ambulationThe clinical utility of hemostasis pads is questionable sincetheir influence on hemostasis is small and they do notreduce the time to ambulation

Passive Vascular Closure DevicesCompression DevicesPASSIVEACTIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp Ease• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Passive Vascular Closure DevicesCompression DevicesPASSIVEACTIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp Ease• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Passive Vascular Closure Devices:Compression Devices• FemoStop plus Compression System: RadiMedical Systems, Inc., Reading, Massachusetts• The Clamp Ease device: Pressure Products Inc., RanchoPalos Verdes, California• High technical success rates approaching 100%• But do not shorten the time to hemostasis, ambulation or dischargecompared with MC; they simply replace human compression withmechanical compression

The FemoStop plus Compression SystemRadi Medical Systems, Inc., Reading, Massachusetts1. Inflated to ~70 mmHg while the sheath is removed,2. Then to suprasystolic pressure for ~2 minutes3. Deflated to the mean arterial pressure for 15 minutes (pedal pulse is palpable)4. Slowly deflated to 30 mmHg for 1–2 hours5. Finally carefully removed

The Clamp Ease devicePressure Products Inc., Rancho Palos Verdes, Californiaflat metal pad: placed under the patient for stability C-arm clampwith a translucent pressure pad

Vascular Closure DevicesPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Vascular Closure DevicesPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure DevicesUnder Tension UmbrellaThe Cardiva Catalyst(Cardiva Medical, Inc., Sunnyvale, California)• Through the existing arterial sheath• MC is still required• Sheath sizes up to 7 Fr• Hemostasis in 99% of 96 of diagnosticcatheterization with a 5 Fr sheath• Minor complications in 5% (rebleeding during bedrest)• Patients can ambulate 90 minutes after a diagnosticprocedure with this device.

does not leave any material behindcoated with protamine sulfate• Conformable 6.5 mm disk is deployed similar to an umbrella• Sheath is removed and the disk is gently pulled against the arterial wallwhere it is held in place by a tension clip• 15 minutes of “dwell time” (120 minutes for interventional cases) thedevice is withdrawn - light MC is held for 5 minutes

Active Vascular Closure DevicesPlug DevicePASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure DevicesPlug DevicePASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure DevicesCollagen Plug DeviceAngio-Seal deviceSt. Jude Medical, Minnetonka, MinnesotaBecause of its simple design and easy deployment, the Angio-Seal makesup more than half of the VCD market in the USA.

suturesutureanchorBioabsorbable anchorcollagencollagencollagenanchor

This device should not be used in patients due to have a femoral cut down,as there is an inadvertent risk of cutting through the sutures and causingembolization of the footplatesuturesuturecollagencollagenanchorBioabsorbable anchorcollagenanchor

used successfully to close 10 Fr arteriotomies utilizinga “double wire” technique• A second, additional wire is placed through the sheath• Angio-Seal is deployed in standard fashion using theAngio-Seal wire, leaving the second wire in place• If hemostasis is achieved, the second wire iscarefully removed while maintaining pressure on thecollagen plug

Angio-Seal• Compared with MC:• Improved patient comfort at the time ofdischarge• In Meta Analysis: reduced the risk of majorvascular complications• Compared with the FemoStop device:• Less discomfort at 4 and at 8 hours after theprocedure

Active Vascular Closure DevicesCollagen Plug DeviceVaso SealDatascope , Montvale, NJ

Active Vascular Closure DevicesCollagen Plug DeviceVaso SealDatascope , Montvale, NJMeasurement of the skin-to-vesseldistance with the needle measuring kit.Removed from market by manufacturersecondary to adverse events.

Active Vascular Closure DevicesCollagen Plug DeviceDuett Pro

Active Vascular Closure DevicesCollagen Plug DeviceDuett Proaccidental injection of the pro-coagulantinto the artery

Active Vascular Closure DevicesPGA Plug DeviceThe Mynx Vascular Closure DeviceAccessClosure, Mountain View, California

• Polyethylene glycol sealant (“hydrogel”) that deploys outside theartery• Balloon occludes the arteriotomy site within the artery

• Investigated• prospectively -190 patients (50% interventional,94% 6 Fr)• retrospectively - 238 patients (100% diagnosticand 6 Fr)• device success = 91–93%• mean time to hemostasis = 1.3 min• mean time to ambulation = 2.6 h• 6/190 patients (3.2%) developed a hematoma > 6cm• major complications = 2.1%

Active Vascular Closure DevicesPGA Plug DeviceThe ExoSeal deviceCordis Corporation, Miami Lakes, Florida• Delivers a synthetic, bioabsorbable plug to theextravascular space adjacent to the arteriotomyusing visual guidance for 6 Fr arteriotomyclosure.• A randomized trial of 401 patients (41%interventional) device success was 94%• Ambulation occurred in a mean of 2.5 h• Complication rates were not significantly differentfrom MC

Active Vascular Closure DevicesAnimal SubmucosaFISH deviceMorris Innovative, Bloomington, Indiana-diagnostic procedures ( 5–8 Fr )In a randomized trial of 297 patients (100% diagnostic,90% 5–6 Fr)device success = 98%did not include the 27 early withdrawalsmean time to ambulation = 2.4 h? safety patch resides on both sides of the vessel wall,meaning a portion of the patch remains intravascular

ioabsorbable extracellular matrix “patch”porcine small intestinal submucosa• Inserted through the arteriotomy so thatit straddles the arterial wall• Then a wire is pulled to release the“patch” from the device.• A compression suture is pulled whichincorporates the patch firmly in place.

Active Vascular Closure Devices: ClipPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure Devices: ClipPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure Devices: ClipStarcloseAbbott Vascular, Redwood City, California-4 mm nitinol clip implant

• Success = 87%–97% (majority interventional) ; 91% with 7–8 Frsheaths• Length of stay = 157 min.• Minor complications were observed in 4- 15%• Major complications were reported in 1- 3.5% (7–8 Fr sheaths)• Persistent oozing at the arteriotomy site = 38%• Significantly more than with Angio-Seal (21%; p = 0.001)• significantly lower rate of successful hemostasis• Starclose 94%, Angio-Seal 99%, MC 100%; p = 0.002• In some patients oozing persisted for over 24 hours• At 1 month : Starclose had less pain at the puncture ( versus MC)• Complications requiring surgical repair =0- 1.3%• Case reports : femoral artery laceration, arterial occlusion due todevice capture of the anterior and posterior arterial walls, and highgradestenosis causing debilitating symptoms 3 weeks after closure

• Success = 87%–97% (majority interventional) ; 91% with 7–8 Frsheaths• Length of stay = 157 min.• Minor complications were observed in 4- 15%• Major complications were reported in 1- 3.5% (7–8 Fr sheaths)• Persistent oozing at the arteriotomy site = 38%• Significantly more than with Angio-Seal (21%; p = 0.001)• significantly lower rate of successful hemostasisLimited in patients receiving anticoagulation• Starclose 94%, Angio-Seal 99%, MC 100%; p = 0.002• In some patients oozing persisted for over 24 hours• At 1 month : Starclose had less pain at the puncture ( versus MC)• Complications requiring surgical repair =0- 1.3%• Case reports : femoral artery laceration, arterial occlusion due todevice capture of the anterior and posterior arterial walls, and highgradestenosis causing debilitating symptoms 3 weeks after closure

Active Vascular Closure Devices: SuturesPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure Devices: SuturesPASSIVE• Long Angle Entry• Arstasis• Hemostasis Pads• Chito Seal• CloSur PAD• Syvek Patch• Neptune Pad• D-Stat Dry• Compression Devices• FemoStop• Clamp EaseACTIVE• Under Tension Umbrella• Plug• Collagen• AngioSeal• VasoSeal• Vascade• Polyglycolic Acid• Mynx• Exoseal• Intestine Submucosa• FISH• Clip• Starclip• Suture• Perclose ProGlide• Perclose Prostar

Active Vascular Closure DevicesSutures• Prostar in 1994• Techstar• Closer• Perclose A-T• ProGlidePercloseAbbott VascularOriginally, the Prostar and Techstar featured needles thatwere deployed within the arterial lumen and directedtowards the skin, through the arterial wall.The Closer - change : needles were deployed outside ofthe artery and directed inward.

6 Fr ProGlide is design used for 5–8 FrsheathsUsing the “pre-closure” technique, theProGlide can be used to close largerarteriotomiesProstar is used with 8.5–10 Frsheaths

Perclose ProStar(Abbott)

Perclose ProStar (Abbott)

ProGlide (Abbott)

Complications• Bleeding• Hematoma• Pseudoaneurysm• Arteriovenous fistula• Groin infection• Leg ischemia

Chronic leg ischemia

Bleeding and Vascular Complications at the Femoral AccessSite Following Percutaneous Coronary Intervention (PCI): AnEvaluation of Hemostasis Strategies• CathPCI Registry• 2005-2009• 1089 sites• 1,819,611 percutaneous coronary intervention(PCI) procedures• >60% VCD useTavris DR et al. J Invas Cardiol. 2012;24:328-334.

Bleeding and Vascular Complications at the Femoral AccessSite Following Percutaneous Coronary Intervention (PCI): AnEvaluation of Hemostasis Strategies• Any bleeding or vascular complication compared toMC controls• Multiple logistic regression analysis• Controlled for demographic factors, type ofhemostasis, several indices of co-morbidity, andother potential confounding variablesTavris DR et al. J Invas Cardiol. 2012;24:328-334.

Bleeding and Vascular Complications at the Femoral AccessSite Following Percutaneous Coronary Intervention (PCI): AnEvaluation of Hemostasis Strategies• MC: 723,859 (38.9%);• Mechanical Compression Devices (MCD):185,039 (9.9%);• Angio-Seal: 534,556 (28.7%);• Perclose: 155,279 (8.3%);• StarClose: 81,242 (4.4%);• Mynx: 23,690 (1.3%);• Boomerang Closure Wire: 10,950 (0.6%);• Patches: 146,951 (7.9%).Tavris DR et al. J Invas Cardiol. 2012;24:328-334.

Bleeding and Vascular Complications at the Femoral AccessSite Following Percutaneous Coronary Intervention (PCI): AnEvaluation of Hemostasis Strategies• 4 VCDs and patches showed significantly lowerbleeding or vascular complication rates than MCcontrols:• Angio-Seal (OR, 0.68; CI, 0.65-0.70)• Perclose (OR, 0.54; CI, 0.51-0.57)• StarClose (OR, 0.77; CI, 0.72-0.82)• Boomerang Closure Wire (OR, 0.63; CI, 0.53-0.75);• Hemostasis patches (OR, 0.70; CI, 0.67-0.74).Tavris DR et al. J Invas Cardiol. 2012;24:328-334.

Complication Rate of Different Types ofHemostasis StrategyTavris DR et al. J Invas Cardiol. 2012;24:328-334.

Multivariate Analysis of Complication Ratesby Device GroupTavris DR et al. J Invas Cardiol. 2012;24:328-334.

Conclusion• VCD’s are used in majority of femoral accesscases• Multiple devices available with proven safetyand efficacy• Significantly lower bleeding or vascularcomplication rates compared to MC• Findings support continued use of VCD’s inproperly selected patients

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