Peripheral vessel: mechanical or chemical closure

1. June 14th MEET 2007. Multidisciplinary European Endovascular therapy Peripheral vessel: mechanical or chemical closure Cardiovascular Interventional laboratoratory, San Donato Milanese Hospital, Milano Director Prof. Luigi Inglese Nadia Mollichelli

2. 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.

3. Mechanical compression 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.

4. 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.

5. Ideal closure device • Easy device application • High successful rate with short time to hemostasis • Low rates of complications • Possibility of repeated vascular access

6. Available closure devices and their mechanisms of action

7. Major complications of VCD • Hematoma requiring trasfusion or surgery • Pseudoaneurysm • Arteriovenous fistula • Retroperitoneal hematoma • Femoral artery thrombosis • Access site infection • Device embolization • Failure

8. 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

9. 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

10. AngioSeal: hemostasis mechanisms PRIMARY MECHANISM MECHANICAL:Anchor-Collagen Arteriotomy Sandwich Suture SECONDARY MECHANISM BIOCHEMICAL:Coagulation-inducing Properties of Collagen Collagen Sponge Co-polymer Anchor

11. Internal components of AngioSeal Anchor: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

12. Distal Blood Inlet Hole 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.

13. AngioSeal deployment:step 2 • 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

14. AngioSeal deployment: step 3 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

15. 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

16. Femoral puncture close to the biforcation Collagen in arterial lumen, high risk of thrombosis

17. High FA biforcation

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

19. Femoral puncture close to aplaque No perfect anchor adherence, collagen in arterial lumen, high risk of thrombosis

20. 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.

21. Studies investigating AngioSeal vascular closure devices

22. Vascular closure devices vs manual compressionAMeta-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.

23. Vascular closure device vs manual compression AMeta-analysis. Nikolsky et al. JACC 2004; 44: 1200-9.

24. StarClose Starclose device

25. 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 andsecure it in place

26. Vessel locator • Starclose vessel locator is • designed to provide tactile feedback for device positioning in the artery • Made of Nitinol • Starclose advantage • Vessel locator retracts completely before Clip fire with an extraluminar closure of the artery

27. Starclose: click 1

28. Starclose: click 2-Vessel locator deployment

29. Starclose: advance the thumb advancer

30. Starclose:click 3

31. Starclose: click 4-clip deployment Raise the device less than 90° And then press the trigger to deploy the clip

33. 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.

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

35. 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. Theuse of AngioSeal device for femoral artery closure. Abando et al. J Vasc Surg.2004; 40: 287-90.

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

37. Peripheral artery disease: AngioSeal efficacy in antegrade punctureMukhopadhyay 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

38. Off labelused 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).

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

40. Patch technology

41. Where to Use the Patch Tecnology

42. Femoral approach diagnostic angiography with 4 or 5 F sheath Non-Femoral approaches

43. 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.

45. 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.).