Percutaneous Insertion Use and Contraindications

1. Percutaneous InsertionUse and Contraindications

2. Background • Drive towards minimal invasive surgery • Advancement of endovascular techniques • Expanding indication • Larger device profiles required • More aggressive anticoagulation

3. Vascular Access • transfemoral most common • small sheath sizes (<9F) - manual compression • larger sheath sizes - open groin dissection • alternative routes: brachial, radial, carotid and popliteal

4. Haemostasis:factors • Affected by • 1) Patient factors • age • weight • comorbid conditions - hypertension, coagulopathies • 2) Procedural factors • use of anticoagulation • sheath sizes • puncture site

5. Percutaneous Access • has been limited by sheath size • can be achieved by • smaller device profiles • closure devices

6. External compression • external compression • manual or mechanical • disadvantages • patient discomfort, mobility restricted • labour intensive (time and effort) • prolonged compression - anticoagulation and large sheath sizes (>9F) • less effective with high punctures

7. Access Site Complications • angiogram 0.5-1.5% • balloon angioplasty 1-3% • coronary stenting 5-17% • endoluminal(open groin) 13-14%

8. Closure Devices • Developed over the last 10 years. • Driven by objectives to • reduce vascular complications • reduce time to ambulation/discharge • reduce patient discomfort

9. Closure Devices: Types • Extravascular • implantable collagen plug (Vasoseal) • collagen/thrombin injection • Intravascular • bio-absorbable haemostatic anchor (Angio-Seal) • percutaneous suture device (Prostar XL and Closer)

10. Advantages secure haemostasis - large bore/anticoagulation, high punctures minimal compression patient comfort and mobility Disadvantages high costs steep learning curve closure related complications delayed repuncture Closure Devices

11. Device Related Complications • persistent bleeding • arterial/venous occlusion • arterial dissection • arteriovenous fistula • pseudoaneurysm • foreign body embolism • infection

12. Closure Devices • emerging suggestions of new pattern of complications • no decrease in the incidence of complications • reduction in minor complications but no reduction in major complications • complications tend to occur later

13. Dangas, G. et al J Am Coll Cardiol 2001 retrospective review of closure devices (n=516)) versus manual compression (n=5892 more frequent haematoma (9.3% vs 5.1% p<0.001) higher significant haematocrit drop (5.2% vs 2.5% p<0.001) higher rate of surgery (2.5% vs 1.5%, p=0.03) similar rates of pseudoaneurysms and arteriovenous fistulae Closure Devices

14. VasoSeal (Datascope) • biodegradable purified bovine collagen sponge • deployed through an applicator sheath into the soft tissue tract, directly over the arterial puncture site • requires inflow compression during application • followed by manual compression

15. VasoSeal Trials

16. VasoSeal: Advantages • extravascular • does not enlarge arteriotomy • seals diseased arteries • early repuncture

17. VasoSeal: Disadvantages • relies solely on thrombus plug • limited to <9F • requires 2 operators • high failure rate in obese patients • ambulation delay (1-3hr) • infection - antibiotics, pseudoaneurysms • obstruction

18. Angio-Seal (Sherwood) • 3 bioabsorbable components - anchor, collagen plug and connecting suture • contained in a delivery sheath • deployed on wire at end of procedure • anchor in lumen holds collagen plug in place

19. Angio-Seal Trials

20. Angio-Seal: Advantages • easy to learn • one operator • secure plug • no external compression

21. Angio-Seal: Disadvantages • intraluminal anchor - obstruction, infection • limited to <9F • enlarges arteriotomy • ambulation delay (1-3hr) • repuncture delay (weeks)

22. Duett (Vascular Solutions) • temporary balloon occlusion and extravascular injection of collagen/thrombin through a sideport.

23. Duett: Advantages • does not enlarge arteriotomy • 1 operator • immediate repuncture • simple conversion to compression

24. Duett: disadvantages • intravascular administration • ambulation delay (1-3hr) • diseased vessels

25. Perclose Prostar and Closer • percutaneous suturing of vessel wall • closure of large sheath sizes (10F) • requries one operator • immediate repuncture possible • immediate ambulation • very steep learning curve

26. Sprouse, L.R. et al J Vasc Surg 2001 retrospective review of patients requiring vascular surgery admission following use of Prostar (n=11) and manual compression (n=14) pseudoaneurysm are larger and do not respond to ultrasound compression complications result in more blood loss and increased need for transfusions infections are more common abd require aggressive surgery Prostar Trial

27. Prostar Endoluminal Trials

28. Perth Prostar Experience • Aims • evaluate results of our early experience • Methods • 82 percutaneous closures in 44 patients • 10F Prostar XL PVS device • 1 iliac, 1 thoracic and 42 abdominal aortic aneurysms • product specialist present

29. Perth Prostar Experience • Preclose method (Haas, P. Et al. 1999) • limited (1cm) incision • subcutaneous tract dilatation • needles deployed prior to endoluminal stent • sutures tied at end of procedure

30. Perth Prostar Experience • Results • 12 failures requiring surgical intervention (14.6%) • reasons for failure • tortuous iliac artery (2) • scarred groin (1) • obesity (5) • sutures catching (1) • high CFA bifurcation (2) • pseudoaneurysm (1)

31. Perth Prostar Experience • Pitfalls • obesity • calcified, turtuous iliofemoral vessels • angled proximal necks

32. Conclusion • Open groin dissection remains the standard • Patient selection is vital • Tutorlage and experience vital • Monitor for late complications • Surgical skills to recognise and deal with complications