Access Site Complications. Nick Cheshire MD FRCS, Professor of Vascular Surgery Imperial College Healthcare St Mary s Hospital Campus

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1 Access Site Complications Nick Cheshire MD FRCS, Professor of Vascular Surgery Imperial College Healthcare St Mary s Hospital Campus

2 Surgeons & Cardiologists Interventional Cardiology 2008 Eye of a Hawk, Heart of a Lion & the Hand of a Lady

3 Annual Coronary Intervention 215,575 diagnostic angiograms in the UK in ,692 percutaneous coronary interventions in the UK in Over 1,000,000 coronary interventions in the United States 2,3 Probably greater than 2,000,000 worldwide 2,3 1. Ludman on behalf of the British Cardiac Intervention Society Audit Returns for Adult Interventional Procedures January 2006 to December American Heart Association Heart and Stroke Statistical Update 3. Smith, S.C., Jr., et al., ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention). J Am Coll Cardiol, (1): p. e1-121

4 Groin Haematoma, False aneurysm, Skin Necrosis

5 Lower Limb Ischaemia St Mary s Hospital

6 Predictors of Vascular Site Complications Advanced age Female gender Renal failure Lower extremity vascular disease Shock Longer time to sheath removal PCI within 24 hours of thrombolytic therapy Stent implantation Concomitant placement of venous sheath Higher heparin doses Use of thienopyridines and glycoprotein IIb/IIIa inhibitor therapy 1. Mandak, J.S., et al., Modifiable risk factors for vascular access site complications in the IMPACT II Trial of angioplasty with versus without eptifibatide. Integrilin to Minimize Platelet Aggregation and Coronary Thrombosis. J Am Coll Cardiol, (7): p Piper, W.D., et al., Predicting vascular complications in percutaneous coronary interventions. Am Heart J, (6): p

7 Types & Incidence of Complications Boston Experience Arora et al (Am Heart J 2007): Propensity Analysis

8 Does the use of a closure device reduce complications? Closure DeviceType Puncture Size Manufacturer AngioLink EVS Staple 6-8F Medtronic AngioSeal Collagen Plug 6-8F St. Jude Medical Duett Collagen Plug 5-9F Vascular Solutions Elite Collagen Plug 5-8F Vascular Solutions Perclose Suture 5-10F Abbott Vascular QuickSeal Gelatin Plug 6-8F Sub-Q Starclose Staple 6F Abbott Vascular Prostar XL Suture 8&10F Abbott Vascular Vasoseal Collagen Plug 4-8F Datascope X-site Suture 6F Datascope

9 American College of Cardiology National Cardiovascular Data Registry St Mary s Hospital Tavris et al. J Invasive Cardiol 2004;16: Largest series reported to date 166,200 patients with 53,655 devices Lower incidence of vascular complications with ACDs in diagnostic angiograms but NOT PCI cases Lower vascular complication rate with collagen-based and suture-based products than manual compression in all patients

10 Nikolsky et al: Systematic Review 30 Studies, 37,0766 Patients Identified Primary endpoint was cumulative vascular complications No difference in complication incidence between Angio-Seal and mechanical compression Diagnostic setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) PCI (OR 0.86, 95% CI 0.65 to 1.12) A trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p=0.062)

11 Arora et al (Am Heart J 2007): Propensity Analysis

12 Arora et al (Am Heart J 2007) Propensity Analysis Results St Mary s Hospital

13 Types & Incidence of Complications Boston Experience Arora et al (Am Heart J 2007): Propensity Analysis

14 Arora et al (Am Heart J 2007): Propensity Analysis

15 Arora et al (Am Heart J 2007): Propensity Analysis

16 Managing Complications Duplex Guided Thrombin Injection" " 1. Lennox, A.F., et al., Treatment of an iatrogenic femoral artery pseudoaneurysm with percutaneous duplex-guided injection of thrombin. Circulation, (6): p. e Lennox, A.F., et al., Duplex-guided thrombin injection for iatrogenic femoral artery pseudoaneurysm is effective even in anticoagulated patients. Br J Surg, (6): p " >300 Cases Imperial 1 in-situ thrombosis 2-3% failure/repeat rate

17 Managing Complications Surgery for leg ischaemia" Embolisation; ensure macro disease corrected

18 Summary & Conclusions Latest data: ACDs seem to be associated with a reduction in vascular complications Earlier data possibly reflected new devices, less experience etc Likely highest impact in PCI on bleeding Consider closure in higher risk interventions Multi-disciplinary approach and early referral