Percutaneous InsertionUse and Contraindications

Background

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

Vascular Access

transfemoral most common small sheath sizes (<9F) - manual

compression larger sheath sizes - open groin dissection alternative routes: brachial, radial, carotid

and popliteal

Haemostasis:factors

Affected by– 1) Patient factors

age weight comorbid conditions - hypertension, coagulopathies

– 2) Procedural factors use of anticoagulation sheath sizes puncture site

Percutaneous Access

has been limited by sheath size can be achieved by

– smaller device profiles– closure devices

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

Access Site Complications

angiogram 0.5-1.5% balloon angioplasty 1-3% coronary stenting 5-17% endoluminal(open groin) 13-14%

Closure Devices

Developed over the last 10 years. Driven by objectives to

– reduce vascular complications– reduce time to ambulation/discharge– reduce patient discomfort

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)

Closure Devices

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

Device Related Complications

persistent bleeding arterial/venous occlusion arterial dissection arteriovenous fistula pseudoaneurysm foreign body embolism infection

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

Closure Devices

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

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

VasoSeal Trials

Schrader, R. et al. 1992 randomised trial n=100vs manual compression

decreased compressiontime(4 vs 42 min),bleeding(0 vs 6) andhaematomas (4 vs 11)

Edoardo, C. et al. 1994 randomised trial n=124vs manual compression

no significant differencein complications

Silber, S. et al. 1998 randomised n=150.vs manual compressionMatched sheath dwelltime and anticoagulation

significant reduction intime to haemostasis but nodifference in localcomplications

Carere, R. et al. 1999 retrospective study, 204applications in 182patients

complications in 31% ofapplicationssurgical rate 11.5%

VasoSeal: Advantages

extravascular does not enlarge arteriotomy seals diseased arteries early repuncture

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

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

Angio-Seal Trials

Aker, U. et al. 1994 case series n=32 91% deployment success35% required pressure

Henry, M. et al. 1995 case series n=84 96% deployment success2% required pressure

Kussmaul, WG. et al 1995 randomised trial angioseal(n=218) vs manual(n=217)

96% deployment success34% required pressurelower complication rates

Ward. SR. et al 1998 randomised trialamgioseal (n=202) vsmanual (n=102)

earlier haemostasisquicker time to dichargecomplications 9% vs 6%

Eidt, J. et al 1999 retrospective angio-seal(n=425) vs manual(n=1662)

8% failure6% obstruction1.6% surgical rate

Angio-Seal: Advantages

easy to learn one operator secure plug no external compression

Angio-Seal: Disadvantages

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

Duett (Vascular Solutions)

temporary balloon occlusion and extravascular injection of collagen/thrombin through a sideport.

Duett: Advantages

does not enlarge arteriotomy 1 operator immediate repuncture simple conversion to compression

Duett: disadvantages

intravascular administration ambulation delay (1-3hr) diseased vessels

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

Prostar Trial

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 Endoluminal Trials

Traul, D. et al. 2000 AneuRx stentgraft12 main body insertions(22F)14 contralateral limbinsertions (16F)

75% main body success71% contralateral limbsuccessbleeding (6)dissection (1)device failure (1)obstruction (1)

Howell, M. et al. 2001 AneuRx stentgraft144 insertions (16F)

94% successobesity (2)calcification (8)

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

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

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)

Perth Prostar Experience

Pitfalls– obesity– calcified, turtuous iliofemoral vessels– angled proximal necks

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