1. “Access Anxiety” John F Eidt MD Ahsan Ali MD Mohammed Moursi MD University of Arkansas for Medical Sciences

2. Primary access Think before you stick – case planning! Remember your lead Raise the table – be comfortable Identify topographic landmarks Feel pulse Fluoroscopic location of femoral head Limited amount of lidocaine Skin nick Micropuncture technique

6. SFA PFA CFA Deep circumflex iliac Inferior epigastric

8. 21 GA

9. Trouble-shooting Microcatheter will not advance

10. Trouble-shooting Microcatheter will not advance Sheath will not advance

11. Trouble-shooting Microcatheter will not advance Sheath will not advance –Stiffer wire (short Amplatz) –Serial dilators –New access site

12. Transradial Access for Coronary Angiography and Angioplasty: A Novel Approach V Y T Lim, C N S Chan, V Kwok, K H Mak, T H Koh Singapore Med J 2003 Vol 44(11) : 563-569 N=255 Radial approach successful 92.2% One arm hematoma No symptomatic radial artery occlusions Asymptomatic occlusions 5%

13. Eversion endarterectomy complicating radial artery access for left heart catheterization Catheterization & Cardiovascular Interventions. 58(4):478-80, 2003 Case report U Tenn No clinical consequence

14. Trouble-shooting Microcatheter will not advance Sheath will not advance –Stiffer wire (short Amplatz) –Serial dilators –New access site Absent pulse

15. Bony landmarks Vein landmark – leave wire in place Roadmap –Contrast –Wire Ultrasound –Transcutaneous –Smart needle

18. Ultrasound DVD

19. Trouble-shooting Microcatheter will not advance Sheath will not advance Absent pulse Antegrade puncture

20. Schneider Endovascular Skills 2nd ed.

28. Background data 5 million catheterizations per year in US 75000 surgical procedures for access site complications

29. Access site complications Bleeding Obstruction Infection

30. Access site complications Bleeding –External –Internal Retroperitoneal hematoma – puncture above inguinal ligament Groin hematoma – puncture below inguinal ligament Pseudoaneurysm Obstruction –Local injury –Embolism Infection –Local – arteritis –Systemic – endocarditis etc

31. Access site hemostasis Manual compression –How long? –Bed rest? Compression devices –Belt –C-clamp Sand bags

32. Access Site Hemostatic Devices Angio-Seal (Market leader – 70%) Perclose ProGlide, Closer, Prostar, Techstar Vasoseal (first approved by FDA 1993) Duett Vascular Solutions Staplers (Medtronic angiolink EVS, Abbott Starclose) Topicals (Syvek, Chito-seal))

33. Vasoseal Vascular Hemostasis Device Datascope Corp, Montvale, NJ Approved by FDA September 1995 5-8 Fr arteriotomy Contraindicated in obese patients (>2.5 in) Extravascular bovine collagen plug 80-100 mg 11.5 Fr delivery system No repuncture for 4-6 weeks

34. Vasoseal

35. Angio-Seal Hemostatic Puncture Closure Device Kensey-Nash Development Corporation(Patent)/ St Jude Medical/ Daig Corp distribution Approved by FDA Sept 1996 Intravascular 5-8 Fr. Delivery Sheath Absorbable anchor (polylactic and polyglycolic acid co-polymer) and collagen plug (24 mg.) with traction suture No contraindication to ipsilateral re-puncture

36. Perclose Techstar and Prostar: Percutaneous Vascular Surgery Systems Perclose, Inc., Redwood City CA (John Simpson) sold to Abbott 2000 Approved in April, 1997 6,8 and 10 Fr. delivery sheath Intravascular One or two non-absorbable 3-0 braided sutures directly into artery wall No contraindication to repuncture

37. Infection guidelines per IFU: Who’s at risk? diabetic patients renal dialysis patients, obese patients with skin folds, patients undergoing prolonged procedures, patients with multiple sheath exchanges and multiple device exchanges, patients with prolonged sheath insertion, immunocompromised patients, patients with prosthetic heart valves or significant valvular lesions, patients with prosthetic joints, patients with prolonged hospitalization, patients with ipsilateral groin access within two weeks, patients with poor hygiene, Patients with co-existent infection at a remote body site, patients with femoral grafts, and home health care patients/nursing home patients.

38. Duett Vascular Solutions, Minnetonka, Minn Approved June 2000 - 5-9 Fr arteriotomy Collagen and thrombin mixture Occlusive <4 Fr balloon intravascular Necrosis of muscle in animal model Not for use in <6mm CFA No contraindication to repuncture One MDR for popliteal thrombosis

42. Surgical Complications

43. Femoral Access Site Complications: AngioSeal vs. Manual Compression (not randomized)

44. Femoral Access Site Complications: Perclose vs. Manual Compression (not randomized)

45. MDRs for Hemostatic Devices thru 9/1999

46. Summary: Adverse Events (MDRs) Vasoseal - SQ infection rare –No harm – No foul –risk of graft/ patch infection unknown Angio-Seal - arterial occlusion – anchor should be retrieved Perclose - Device/ operator failure requiring surgical removal of device –Infection – infected pseudoaneurysm –New generation “Closer” may be improved Duett - one report of popliteal artery thrombosis Sutura - No MDRs at this time Biodisc - Europe only

47. Summary Arterial occlusive complications were more frequent following the use of Angio-Seal in comparison to manual compression at our institution Arterial infectious complications were more frequent following the use of Perclose in comparison to manual compression at our institution Vasoseal and Duett have not been associated with increased risk of surgical complications in our hands

48. Guidelines Check peripheral pulses before you start Stick CFA Use ultrasound for puncture Advance wire under fluoroscopy Point compression is more effective than diffuse compression Sandbags are useless Spasm is spelled “CLOT”

49. Guidelines Check pulses at the end of case Numerous lawsuits for access site complications Groin abnormality – get ultrasound Most small pseudoaneurysms thrombose Persistent pseudoaneurysms can usually be treated by thrombin injection

50. Guidelines for closure devices Have a reason to use (e.g. anticoagulation, large sheath) Avoid infection (change gloves, fresh drapes, antibiotics, sterile technique) A-gram femoral artery (all contraindicated if other than CFA) Know the device – be able to trouble shoot