Peripheral vessel: mechanical or chemical closure

Cardiovascular Interventional laboratoratory, San Donato Milanese Hospital, Milano

Director Prof. Luigi Inglese

Nadia 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 didn’t 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

Device type Manufacturer Substrate/mechanismRelation of VCD to vascular wall

Sealing devices

AngioSeal Daig, Minnetonka, MN, USA Bovine collagen Intraluminal

VasoSeal Datascope Corp., Montvale, NJ, USA Bovine collagen Extraluminal

Duett Vascular Solutions, Inc., Minneapolis, MN, USA Collage plus thrombin Extraluminal

QuickSeal SUB-Q Inc., San Clemente, CA,USA Gelatin Extraluminal

NeoMend MeoMend, Inc., Sunnyvale, CA, USA Bioadhesive Intraluminal

Suture-mediated devices

Perclose Perclose, Abbott Lab., Redwood City, CA, USA Suture Intraluminal

X-SITE X-SITE Medical, Blue Bell, PA, USA Suture Intraluminal

SuperStitch Sutura, Inc., Fountain Valley, CA, USA Suture Intraluminal

Staple-mediated devices

EVS Vascular Closure Angiolink Corporation, Taunton, MA, USA Titanium staple Extraluminal

Starclose Abbott Laboratory, Redwood City, CA, USA Nitinol staple Extraluminal

Available closure devices and their mechanisms of action

Major complications of VCD

• Hematoma requiring trasfusion or surgery• Pseudoaneurysm• Arteriovenous fistula• Retroperitoneal hematoma• Femoral artery thrombosis • Access site infection• Device embolization• Failure

Predictors of vascular complications

• Age and Gender• Severe PVD• Diabetes• Sheath size• Final ACT level• Peri PCI pharmacotherapy (thrombolitics, GP

IIb/IIIa inhibitors)• Multiple arterial puncture attempts• Operator 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 Anchor

Collagen Sponge

Suture

AngioSeal: hemostasis mechanisms

PRIMARY MECHANISMMECHANICAL:Anchor-Collagen Arteriotomy Sandwich

SECONDARY 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 days

Suture: polyglicolic acid. Break down via hydrolisis, significant absorption at 30 days, complete in 60-90 days

AngioSeal deployment: step 1

•Thread the arteriotomy locator/insertion sheath assembly over the guidewire

•When blood begins to flow from the proximal drip hole the insertion sheath is in the artery

•The dilatator/sheath combination is withdrawn until flow ceases and then reinserted 1-2 cm.

Distal Blood Inlet Hole

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 depth

AngioSeal 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 plug

• Potential risk of local infection in delayed closure• Repeat 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 <90 days can be performed safely 1 cm above or below the original stick. Cathet Cardiovasc Intervent 2003; 58: 181-84.

Study No. of patients DF (%) Time to hemostasis (m) Time to ambulation (h) Complications (%)

VCD control VCD VCD control p-value VCD control p-value VCD control p-value

Randomized controlled studies

Kuesmaul et al. 218 217 4 2,5 15,3 <0,0001 NA NA 12 18 0,08

Ward et al. 202 102 4 0,9 17 0,001 NA NA 9 6 NS

Chevaller et al. 306 306 3,2 5 52 <0,001 7,3 15,8 <0,001 5,9 18 <0,001

Case-controlled and cohort studies

Cremonesi et al. 411 387 4 NA NA 6 19 <0,01 5,6 11,65 <0,01

Cura et al. 411 2099 5 NA NA NA NA 2,9 3,1 0,96

Dangas et. al. 516 5892 NA NA NA NA NA 19,4 11,5 <0,001

Duffin et al. 539 489 4,5 2 NA 2,6 NA 7,1 7,4 NS

Applegate et al. 524 1824 3 NA NA NA NA 1,5 2,5 <0,05

Assall et al. 123 39 15,4 NA NA NA NA 9 9 NS

Registries

Sesana et al. 827 8 NA NA 2,5

Kapadia et. al. 280 9 0,69 1,7 0,5

Eggebrecht et al. 1317 3,3-4,2 NA 13,2 0,53

Kirchhof et al. 350 NA NA NA 2,8

Am

J Cardiovasc D

rugs 2006

Studies investigating AngioSeal vascular closure devices

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 patients• Objective: safety of arteriotomy closure

device versus manual compression• Primary 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

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 locator

Starclose 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 deployment

Raise the device less than 90°And 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 puncture

Angioseal

(n=167)

Starclose

(n=151)

Manual

(n=108)

P-value

Deployment failure

10 (5.9%) 11(7.3%) NS

Deployed but hemostasis non achieved

4 (2.4%) 18(11.9%) <0.0001

Minor complications

7 (4.2%) 8 (5.3%) 4(3.7%) NS

Major complications

5 (2.9%) 3 (1.9%) 4 (3.7%) NS

Lakshmi et al. Cardiovasc.Intervent.Radiol.(2007) 30: 182-88

Peripheral vascular disease

• 188 patients, 144 procedures were diagnostic, 76 were intervention

• Time to mobilization: within 1 h for 6 F, 3 hours for 8F

• Same day discharge• Only 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 Points No. of patients (%)

Procedural success 77 (96)

Crossover to compression 2 (2)

Major complication

Retroperitoneal hematoma 1 (1)

Minor complication

Pseudoaneurysm 1 (1)

Groin hematoma 3 (4)

Localized infection 0 (0)

Lymphatic fistula 1 (1)

Distal embolization 0 (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 haemostasis

Only 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 VCD

• From 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 approaches Femoral approachdiagnostic angiography

with 4 or 5 F sheath

Conclusion 1• Vascular closure device can obtain hemostasis

rapidly also in presence of fully anticoagulation and antiplatelet agents, with less discomfort and early mobilization of the patient

• The 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 2

• None of the devices on the market is dramatically different with regard to efficacy and complications

• We prefer AngioSeal to Starclose in calcified arteries, in a large arteriotomies and in obese patients

• In 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.).