Percutaneous Insertion Use and Contraindications

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

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

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

Percutaneous Access n has been limited by sheath size n can be achieved by – smaller device profiles – closure devices

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

Access Site Complications n angiogram % n balloon angioplasty 1-3% n coronary stenting 5-17% n endoluminal(open groin) 13-14%

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

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

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

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

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

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

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

VasoSeal Trials

VasoSeal: Advantages n extravascular n does not enlarge arteriotomy n seals diseased arteries n early repuncture

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

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

Angio-Seal Trials

Angio-Seal: Advantages n easy to learn n one operator n secure plug n no external compression

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

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

Duett: Advantages n does not enlarge arteriotomy n 1 operator n immediate repuncture n simple conversion to compression

Duett: disadvantages n intravascular administration n ambulation delay (1-3hr) n diseased vessels

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

Prostar Trial n 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) n pseudoaneurysm are larger and do not respond to ultrasound compression n complications result in more blood loss and increased need for transfusions n infections are more common abd require aggressive surgery

Prostar Endoluminal Trials

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

Perth Prostar Experience n 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

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

Perth Prostar Experience n Pitfalls – obesity – calcified, turtuous iliofemoral vessels – angled proximal necks

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