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“Access Anxiety”. John F Eidt MD Ahsan Ali MD Mohammed Moursi MD University of Arkansas for Medical Sciences. Primary access. Think before you stick – case planning! Remember your lead Raise the table – be comfortable Identify topographic landmarks Feel pulse
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“Access Anxiety” John F Eidt MD Ahsan Ali MD Mohammed Moursi MD University of Arkansas for Medical Sciences
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
Deep circumflex iliac Inferior epigastric CFA PFA SFA
Trouble-shooting • Microcatheter will not advance
Trouble-shooting • Microcatheter will not advance • Sheath will not advance
Trouble-shooting • Microcatheter will not advance • Sheath will not advance • Stiffer wire (short Amplatz) • Serial dilators • New access site
Transradial Access for Coronary Angiography and Angioplasty: A Novel ApproachV Y T Lim, C N S Chan, V Kwok, K H Mak, T H KohSingapore 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%
Eversion endarterectomy complicating radial artery access for left heart catheterizationCatheterization & Cardiovascular Interventions. 58(4):478-80, 2003 • Case report U Tenn • No clinical consequence
Trouble-shooting • Microcatheter will not advance • Sheath will not advance • Stiffer wire (short Amplatz) • Serial dilators • New access site • Absent pulse
Absent pulse • Bony landmarks • Vein landmark – leave wire in place • Roadmap • Contrast • Wire • Ultrasound • Transcutaneous • Smart needle
Trouble-shooting • Microcatheter will not advance • Sheath will not advance • Absent pulse • Antegrade puncture
Schneider Endovascular Skills 2nd ed.
Background data • 5 million catheterizations per year in US • 75000 surgical procedures for access site complications
Access site complications • Bleeding • Obstruction • Infection
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
Access site hemostasis • Manual compression • How long? • Bed rest? • Compression devices • Belt • C-clamp • Sand bags
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))
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
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
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
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.
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
Femoral Access Site Complications: AngioSeal vs. Manual Compression (not randomized)
Femoral Access Site Complications: Perclose vs. Manual Compression (not randomized)
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
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
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”
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
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