“Access Anxiety”

John F Eidt MDAhsan Ali MD

Mohammed Moursi MDUniversity 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

SFA

PFA

CFA

Deep circumflex iliac

Inferior epigastric

21 GA

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

Ultrasound DVD

Trouble-shooting

• Microcatheter will not advance

• Sheath will not advance

• Absent pulse

• Antegrade puncture

Schneider Endovascular Skills2nd 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

Vasoseal

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

Surgical Complications

AngioSeal N=425 Manual N=1662

Overall Surgical Overall Surgical

Device Failure 34(8%) 0 - -

Bleeding 1(0.2%) 0 12(0.7%) 1 P=0.5

Pseudoaneurysm 2(0.5%) 1 8(0.5%) 4 P=0.99

Obstruction 6 (1.4%) 5 0 - p=<.001

Infection 1 (0.2%) 1 0 - p=0.2

Total surgical 7 (1.6%) 5 (0.3%) p=0.004

Femoral Access Site Complications:

AngioSeal vs. Manual Compression (not randomized)

Perclose Manual

N=319 N=1576 p

total surg Total surg

Malfunction 12(3.8%) 1 - -

Bleeding/ Hematoma 0 - 19 (1.2%) 1 0.06

Pseudoaneurysm 0 - 1 (.06%) 1 .34

Infection 5 (1.6%) 0 .0003

Mycotic aneuraneurysm

3 3

Cellulitis 2 2

Total (all) 17(5.3%) 20(1.3%) <.0001

(surgical) 6(1.9%) 2(0.13%) .0009

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

Vasoseal AngioSeal PercloseMalfunction 18 5 27

Intervention Removal 11(late) 0 55Pseudo -Surg 7 4 1Pseudo -USGC 8 0 0Bleeding 6 6 15Obstruction 17(2pta) 65(3pta) 1

6 (no Rx)

Transfusion 8 3 0

Infection 25 10 1

Other 1 (DVT)

Total 100 100 100

MDRs for Hemostatic Devices thru 9/1999

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