Peripheral vessel: mechanical or chemical closure

Cardiovascular Interventional laboratoratory, San Donato Milanese Hospital, MilanoDirector Prof. Luigi IngleseNadia Mollichelli

June 14th MEET 2007. Multidisciplinary European Endovascular therapy

Manual compression: the gold standard Seldinger technique, introduced in 1951, obtained the hemostasis at the end of the procedure by manual pressure for 10-15 minutes, followed by 6-8 hours of bed rest, in patients with normal coagulation parameters. Seldinger SI. Catheter placement of needles in percutaneous arteriography; a new technique. Acta Radiol 1953; 39: 368-76.

Later on the introduction of mechanical methods as Femostop, Compressar or Clamp easy facilitated the problem of manual compression but didnt reduce the time of patient bed rest and the rate of hematoma formation.

Mechanical compression

Vascular closure device The new interventional tecniques have increased the use of new devices that require large sheaths, periprocedural anticoagulation and most important double antiplatelet therapy with a consequent increase in the access site related complication of up to 17%. Waksman et Al. Predictors of groin complication after balloon and new device coronary intervention. Am J Cardiol 1995; 75: 886-889.

Ideal closure device Easy device application

High successful rate with short time to hemostasis

Low rates of complications

Possibility of repeated vascular access

Available closure devices and their mechanisms of action

Tabella 1

Device typeManufacturerSubstrate/mechanismRelation of VCD to vascular wall

Sealing devices

AngioSealDaig, Minnetonka, MN, USABovine collagenIntraluminal

VasoSealDatascope Corp., Montvale, NJ, USABovine collagenExtraluminal

DuettVascular Solutions, Inc., Minneapolis, MN, USACollage plus thrombinExtraluminal

QuickSealSUB-Q Inc., San Clemente, CA,USAGelatinExtraluminal

NeoMendMeoMend, Inc., Sunnyvale, CA, USABioadhesiveIntraluminal

Suture-mediated devices

PerclosePerclose, Abbott Lab., Redwood City, CA, USASutureIntraluminal

X-SITEX-SITE Medical, Blue Bell, PA, USASutureIntraluminal

SuperStitchSutura, Inc., Fountain Valley, CA, USASutureIntraluminal

Staple-mediated devices

EVS Vascular ClosureAngiolink Corporation, Taunton, MA, USATitanium stapleExtraluminal

StarcloseAbbott Laboratory, Redwood City, CA, USANitinol stapleExtraluminal

Foglio2

StudyNo. of patientsDF (%)Time to hemostatsis (min)Time to ambulationComplications (%)

VCDcontrolVCDVCDcontrolp-valueVCDcontrolp-valueVCDcontrolp-value

Randomized controlled studies

Kuesmaul st al.21621742.515.3

Major complications of VCDHematoma requiring trasfusion or surgeryPseudoaneurysmArteriovenous fistulaRetroperitoneal hematomaFemoral artery thrombosis Access site infectionDevice embolizationFailure

Predictors of vascular complicationsAge and GenderSevere PVDDiabetesSheath sizeFinal ACT levelPeri PCI pharmacotherapy (thrombolitics, GP IIb/IIIa inhibitors)Multiple arterial puncture attemptsOperator learning curve

AngioSeal The AngioSeal device was introduced in Europe 1994. It consists of an anchor, a collagen plug, and a suture. The biodegradable collagen plug induces platelet activation and aggregation, and releases coagulation factors. AngioSeal produces a sandwich closure of the arteriotomy site between the anchor and collagen plug

Co-polymer AnchorCollagen Sponge SutureAngioSeal: hemostasis mechanismsPRIMARY MECHANISMMECHANICAL: Anchor-Collagen Arteriotomy SandwichSECONDARY MECHANISMBIOCHEMICAL: Coagulation-inducing Properties of Collagen

Internal components of AngioSealAnchor: inside the artery, smooth, tapered dome shape, blend of lactide and glycolide polymers. Non thrombogenic. Breakdown via hydrolisis in less than 90 days.Collagen: bovine collagen, which is pressed on the outer surface of the artery. Break down through leukocytosis in less than 90 daysSuture: polyglicolic acid. Break down via hydrolisis, significant absorption at 30 days, complete in 60-90 days

AngioSeal deployment: step 1Thread the arteriotomy locator/insertion sheath assembly over the guidewireWhen blood begins to flow from the proximal drip hole the insertion sheath is in the arteryThe dilatator/sheath combination is withdrawn until flow ceases and then reinserted 1-2 cm.

The locator system is removed and the AngioSeal carrier tube is introduced through the hemostatic valve

Gently pullback on AngioSeal device cap until resistance felt,which deploys the anchor

AngioSeal deployment:step 2

Once the Device Cap is locked into rear position, fully withdraw device sheath assembly until resistance is felt, which indicates that the anchor is against the inner arterial wall. Grip Tamper Tube and slide it down to advance knot and collagen to the artery, while maintaining upward tension on suture. A marker on the suture indicates adequate depthAngioSeal deployment: step 3

Angiography of the femoral artery access site The routine use of a femoral angiogram through the original procedure sheath prior to puncture closure with a closure device can prevent complications associated with sub-optimal vascular access, unrecognized peripheral vascular disease, small diameter vessels and other anatomical variants

Femoral puncture close to the biforcationCollagen in arterial lumen, high risk of thrombosis

High FA biforcation

Artery diameterAngioSeal is controindicated if the artery diameter is less than 4mm because the anchor cannot deploy.

Femoral puncture close to a plaque No perfect anchor adherence, collagen in arterial lumen, high risk of thrombosis

Disadvantages of the collagen plugPotential risk of local infection in delayed closureRepeat puncture of the artery within 3 months is not recommended because of the theoretical possibility of disrupting or disloging the hemostatic plug.Applegate showed that restick of the artery in which Angioseal device has been deployed

Studies investigating AngioSeal vascular closure devices

Tabella 1

Device typeManufacturerSubstrate/mechanismRelation of VCD to vascular wall

Sealant devices

AngloSealDaig, Minnetonka, MN, USABovine collagenIntraluminal

VascoSealDatascope Corp., Montvale, NJ, USABovine collagenExtraluminal

DuettVascular Solutions, Inc., Minneapolis, MN, USACollage plus thrombinExtraluminal

QuickSealSUB-Q Inc., San Clemente, CA,USAGelatinExtraluminal

NeoMendMeoMend, Inc., Sunnyvale, CA, USABioadhesiveIntraluminal

Suture-mediated devices

PerclosePerclose, Abbott Laboratory, Redwood City, CA, USASutureIntraluminal

X-SITEX-SITE Medical, Blue Bell, PA, USASutureIntraluminal

SuperStitchSutura, Inc., Fountain Valley, CA, USASutureIntraluminal

Staple-mediated devices

EVS Vascular ClosureAngiolink Corporation, Taunton, MA, USATitanium stapleExtraluminal

StarcloseAbbot vascularExtraluminal

Tabella 2

StudyNo. of patientsDF (%)Time to hemostasis (m)Time to ambulation (h)Complications (%)

VCDcontrolVCDVCDcontrolp-valueVCDcontrolp-valueVCDcontrolp-value

Randomized controlled studies

Kuesmaul et al.21821742.515.3

Vascular closure devices vs manual compressionA Meta-analysis. Nikolsky et al. JACC 2004; 44: 1200-9.

Randomized, case control, cohort studies.A total of 30 studies, 37,066 patientsObjective: safety of arteriotomy closure device versus manual compressionPrimary endpoint: cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma.

Vascular closure device vs manual compressionA Meta-analysis. Nikolsky et al. JACC 2004; 44: 1200-9.

Starclose device

CLIP Made of Nitinol 4 mm diameter, 0.2 mm thick 2 long tines provide tissue apposition of arteriotomy 4 short tines keep the clip extravascular and secure it in place

Vessel locatorStarclose vessel locator isdesigned to provide tactile feedback for device positioning in the arteryMade of Nitinol

Starclose advantageVessel locator retracts completely before Clip fire with an extraluminar closure of the artery

Starclose: click 1

Starclose: click 2-Vessel locator deployment

Starclose: advance the thumb advancer

Starclose:click 3

Starclose: click 4-clip deploymentRaise the device less than 90And then press the trigger to deploy the clip

CLIP Study The Clip study is the first randomized multicenter trial that compares Starclose device to manual compression. - 596 patients The clinical results of this study demonstrate that starclose is non inferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedure Hermiller et al.Catheterization and Cardiovascular Interventions 2006. 68: 677-683.

Non randomized trial of manual compression, angioseal and starclose in common femoral artery punctureLakshmi et al. Cardiovasc.Intervent.Radiol.(2007) 30: 182-88

Peripheral vascular disease188 patients, 144 procedures were diagnostic, 76 were interventionTime to mobilization: within 1 h for 6 F, 3 hours for 8FSame day dischargeOnly two complications: one pseudoaneurysm and one femoral artery occlusion. The use of AngioSeal device for femoral artery closure. Abando et al. J Vasc Surg.2004; 40: 287-90.

Suture mediated percutaneous closure device in antegrade puncture. Duda et al. Radiology 1999; 210: 47-52

End PointsNo. of patients (%)Procedural success77 (96)Crossover to compression2 (2)Major complicationRetroperitoneal hematoma1 (1)

Minor complicationPseudoaneurysm1 (1)Groin hematoma3 (4)Localized infection0 (0)Lymphatic fistula1 (1)Distal embolization0 (0)

Peripheral artery disease: AngioSeal efficacy in antegrade puncture Mukhopadhyay et al. EJR 2005: 56: 409-12. 21 patients with antegrade puncture had a 6 F sheath angioseal for haemostasisOnly one small haematoma and one ischaemia in a 82 years old diabetic man.

Advantage: immediate removal of the introducer sheath without compromising blood flow to the distal extremity with prolonged manual compression for hemostasis

Off label used of VCDFrom december 2003 to May 2007, 50 patients with AAA were excluded with Gore Excluder in our cath. lab. The 12 F sheath introducer of the controlater leg was closed with AngioSeal 8 F, as well as 12 and 13 long sheath used for decoartation of thoracic aorta.

We recordered 100% success in acheiving hemostasis, only three minor complications (small hematoma).

Patch technology The patch improves the efficacy of manual compression, particularly in anticoagulated patients. It is applied externally and accelerates the coagulation process.

Patch technology

Where to Use the Patch Tecnology

Non-Femoral approachesFemoral approachdiagnostic angiography with 4 or 5 F sheath

Conclusion 1Vascular closure device can obtain hemostasis rapidly also in presence of fully anticoagulation and antiplatelet agents, with less discomfort and early mobilization of the patientThe existing evidence suggests that complication rates vs manual compression are not increased significantly.The use of a VCD has improved the efficiency and productivity of our Cath. Lab.

Conclusion 2None of the devices on the market is dramatically different with regard to efficacy and complicationsWe prefer AngioSeal to Starclose in calcified arteries, in a large arteriotomies and in obese patientsIn all other patients we generally use the Starclose device because in our experience the only complication observed is the immediate failure of the device (no pseudoaneurysm, retroperitoneal hematoma, femoral artery thrombosis or access site infection have been observed with starclose in our cath. lab.).

Good morning, dear prof and dear collegues topic of my presentation will beFreed the operator from manual compression, but didnt reduceManual compression is the traditional method of achieving hemostasis following an angiographic procedure. Groin compression must be maintained for 10-20 minutes, causing significant patient discomfort. Using manual compression access site complication have ranged from 1% to 5%With manual compression access site complications have ranged from 1% to 5%Percutaneous arterial closure device were introduced in 1990. They allow to have hemostasis with minimal or no compression also with continued anticoagulation, reduce the time to obtain the hemostasis and lenght of patints immobility but not the complication rates as It results in several studiesApplegate introduced a modification in the operative anticoagulation regimen: to keep ACT more stricltly close to 200-225 sec while infusing GP IIb/IIIa may have a large impact in decresing access bleeding complications .

An ideal closure device should have : A complication rate equal to or less than of manual compressionConsidering the principle mechanism of hemostasis vascular closer device can be classified in three groups:Instead Depending on the relation of the closing substrate to the vessels space should also be divided into intraluminal and extraluminal. Well concentrate on two particular deviceThe major complications that can be observed Anchor and collagen do a sandwichs closure af the arteriotomyThe working sheath is exchange for the 6 or 8 F devices sheath and arterial locator. The locator is a modified dilatator with holes that allow blood return to indicate when the sheath tip enters teh artery.We can see a colored bandBefore to use a VCD Its very important to As every one know the puncture should be located in the common femoral artery, dontt use a closer device if the puncture site is in the superficial or profunda femoral artery or to much closer to the byfurcation becuse the collagen can be cuased of artery thrombosisThis is an anatomical variant in which you can see a high femoral arterybyforcation, So Is likely to As You can see, just the placement of the procedure sheath reducethe vessels blood flowIf we do a puncture close to a plaque, we can have a no perferct anchor adherence to the inner wall of the artery with consequent presence of the collagen in arterial lumen with high rosk opf He had only thrre large ematoma, vessel occlusion, pseudoneurysm, or vascular repairAll studies compared angioseal with manual compression and demonstrated that the use of the vascular closer device was associated with significant reduction of time of hemostasis and time to ambulation. After diagnostic catheterization the overall complications was similar ranged from 1.2 to 1.9%. In PCI group the complications were higher than in diagnostic group, however the rate was similar in manual and in angioseal group from 1.14 to 19.4%. The differences between the two groups were documented in two studies: (chevaller and cremonesi studies less complication in angioseal groupThe meta-analysis showed a trend toward less complication using angioseal in PCI, no difference in diagnostic. No difference were observed regarding perclose in either diagnostic and PCI, an increse risk in PCI setting for vasoseal groupSD uses a flexible nitinol clip to for an extravascular arteriotomy closingIn the starclose package there is also an excange system that is necessary to introduce the starclose device. Sheath tube is PTFE and designed to be splitted radiallyShaft: Used to introduce the StarClose device into SheathDistal tip is rounded.Sheath slipper: Made of stainless steel Fixed in place never movesCovered by Sheath Hub when engagedClip delivery tube: located inside Body prior to sheath split Designed to continue the split of sheath and houses Clip. Splits sheath radially.Stays extravascular.Starts in the Body, travels the length of Sheath to deliver Clip to the artery.Made of stainless steel Finger post and finfer loop: Operator can hold the device in a gun-like fashion during the Sheath split. Used for stabilization.Thum advancer:Designed to advance Clip (located in Clip Delivery Tube) to the arteriotomy.Delivery Tube travels beyond the Sheath .Cannot be advanced until the Vessel Locator Button is depressed.Starts at Start Arrow and ends at Finish Arrow. Click is heard with complete advancement.Star arrow and finish arrow: Indicate beginning and end positions for Thumb Advancer.Trigger: Collapses & Retracts Vessel Locator and fires Clip (within thousandths of a second)Vessel locator button: Expands Vessel Locator when depressed (Can be reset in up position with the Safety Release Button until Clip fire ).Safety release button: Safety feature designed to retract the Vessel Locator when early termination of the StarClose procedure is necessary.

It is constituted of ..The clip id delivered to arteriotomy through Clip Delivery Tube in cylindrical configurationClip resumes its original memory shape position after release from the Clip Delivery TubeProperties of super-elastic Nitinol allow clip to close arteriotomy in extravascular way

Insert the sheath into the body of the starclose until a click will be heard. This is the first clickNow with the left hand against the patients body we hold the finger loop and with the right hand depress the vessel locator button to deploy the vessel locator, this is the second clickSlide the device out of the tissue track 1-2cm, then with the right hand in this way advance the thumb advancer 1-2cm. The initial splitting of the sheath can be seen above the skin levelWe withdraw the system untile we felt the resistance of the vessel locator against the inner wall Then with the index finger on the finger post and with the second and the third fingers holding the finger loop, we can complete the splitting of the sheath by pushing the thumb advancer until the arrow aligns with the finish arrow on the body. This is the third click.The clip study is the first randomized multicenter trial that compare Starclose device, nitinol clip based closure system, to manual compression. The device delivers the clip in a manner in which It remains extravascular and the endotelium is not exposed to foreign material.It is a prospective, randomized, multicenter trial the compare starclose device to manul compression on 596 patients, published in 2006 that showed the non inferiority of starclose device to muanual compression. In fact rthere were no difference in major vascular complication, or minor complication. In the starclose group no pseudoaneurysm or arteriovenous fistula or infection were observedThis study recently pubblishedThe results show no significant difference between the two device, They were significant more starclsoe patients that reqquiring additional manula compression th achieve the hemostasis In many study peripherical vascular disease has been considered a contro indication for the use of vascular closer device. On the contrary patients with peripherical vascular disease would benefit from vascular closer device particullarly if were obese, hypertensive or fully anticoagulated or after an exstensive angioplasty in whom femoral artery compression is best avoided. would particularly benefit from early ambulation partciurarly if I like to show this study because has been publeshed by a vascular suergeon. Vascular surgeons, in fact, have been always reluctant to accept vascular closer device instead of manula compression for acheving the hemostasis. This study was on 188 patients .so they conclude that angioseal is a safe method to acheave the hemostasis in the great majority of patients with PVD and that and angioseal allow early mobilization and discharge of patientsIntersting results were obtained not only in retrograde puncture but also in antegrade punture.,Case of critical ischemia have become more and more frequent given the increasing mean age of the elder population and the better survival of diabetic patients. Given the frequent distal site of arterial occlusion with involvement of infrapopliteal arteries, an ipsilateral antegrade common femoral artery is usually preferred to a controlateral approch with a crossover technique. Both the suture mediated percutanoeus closure device and the angioseal plug have been successfully used after antegrade common femoral artery puncture in small series of patients with vascular disease

Case of critical ischemia have become more and more frequent given the increasing mean age of the elder population and the better survival of diabetic patients. Given the frequent distal site of arterial occlusion with involvement of infrapopliteal arteries, an ipsilateral antegrade common femoral artery is usually preferred to a controlateral approch with a crossover technique. Both the suture mediated percutanoeus closure device and the angioseal plug have been successfully used after antegrade common femoral artery puncture in small series of patients with vascular disease

The first study was pubblished in 1999 about the use of vascular closer device in antegrade puncture after an interventional procedure, so in patients fully anticoagulated with eparin and with antiaggregating therapy in which manual compression of common femoral artery is very often difficult. They were 80 consecutive patients in whom was perfomed a femoropopliteal angioplasty and after the procedure they underwent a suture mediated percutaneous closure with 6, 7, 8 F devices. They were immobilized for 1 hour after the procedure. So they conclude that suture mediated closer device is feasiblePositive are also the results with the angioseal in antegrade punctureAboul chemical closer device