Vascular access

Vascular Access for Hemodialysis
A Programmatic Approach
Lee Kirksey MD MBA
Assistant Professor of Surgery Case Western Lerner School of
Medicine
Department of Vascular Surgery
The Cleveland Clinic Foundation
kirksel@ccf.org 216.296.3209
216.445.8079, 4508

Care of ESRD patient
• CKD team NPs, Physicians
• Vascular surgery team
• Dialysis center team
Nursing
Physicians
Technicians
• Access maintenance service

Background
• CKD/ESRD is the 9th
cause of death in the
US.
• One in ten Americans have some level of
CKD
• 341,000 patients on hemodialysis.
• 107,000 new ESRD patients in 2010

Vascular Access at initiation of HD
• 43% of incident patients had no prior
nephrology contact
• 80% begin HD with a CVC
• 16% AVF
• 3% AVG

Vascular access use at initiation
and on day of eligibility, 2010
Figure 1.18 (Volume 2)
Incident hemodialysis patients, July-December, 2010

Background
• Adjusted individual first year mortality for
newly initiated HD patient is 24%
compared to 5-7% annually for ensuing
years
• 20% annual mortality for prevalent
population

Fistula First
Breakthrough
Initiative
(FFBI)

Primary Goals
• Increase the placement of native fistulas.
• Detect access dysfunction before access
thrombosis.

Quality Standards
• Initial goal: AVF 50% Incident and 40%
Prevalent groups
• Current goal: 66% AVF overall
• TDC dependent <10% overall
• Incidence of thrombosis < 0.5 episodes/pt year
• Lifetime infection rates <1% for AVF’s and 10%
for AVG’s.
Source: http://esrdncc.org

0.02
0.08
0.03
0.08
0.25
0.10
0.24
0.22
0.09
0.18
0.17
0.25
0.0
0.1
0.2
0.3
0.4
0.5
Fistula Graft Catheter Fistula Graft Catheter
Admissionsperpatientyear
Infectious Other
0.12
0.32
0.47
0.12
0.26
0.42
With permission : Paul Eggers
Admissions by Access Type
1999 2003

Clinical abnormality
> 50% stenosis
Catheters are benign?

Non maturation rates for AVF
reported between 50-60%
Dialysis Access Consortium DAC Dember et al. JAMA
2008:299:2164-71.
Allon et al. Kidney Int 2002;62:1109-24.
Dhingra et al. Kidney Int 2001;60;1443-51.

Access Maturation Definition
• Rule of 6’s (Anatomic)
– 6 mm diameter
– 600 ml/min flow
– 6 cm accessible
– < 6mm depth
• 6 consecutive uses of new dialysis

What’s the goal: clinically
significant vs insignificant variables
• Patency
• Maturation
• Consistent Cannulation that permits
removal of tunneled catheter

Fistula First
Functioning prosthetic access/timely
removal of Dialysis Catheter
Catheter last

ESRD-chronologic stages of
Management
• Diagnosis of CKD: acute or chronic time course
• Initiation of referral for access creation: when to
whom
• TDC placement-initiation of dialysis
• Creation of Access: fistula/graft/PD/Txplt
• Maturation and initiation of dialysis per access-
when/who determines/--”fish or cut bait”

Timing of access
• GFR of 30 ml/min should prompt referral and
site protection.¹
• Access should be created 6 months in advance.¹
• Maturation of AV fistulas ideally requires 6 to 8
weeks.
• Incorporation of AV grafts takes 3 to 6 weeks.
1 KDOQI guidelines

Discussion Topics
• Barriers to timely access
• Find your vascular access champion. Vascular
access should not be second tier importance
• Hold your proceduralist accountable both for
quality and service
• 216.444.VEIN

OR> 3 wks> 6wks> Maturation> Cannulation
Stratify catheter dependent
/Low GFR patients relative
priority when OR access is
limited
Does 2 Staged approach add time
to access? No…..But

Discussion Topics
• Barriers to timely access
• When/how do we cannulate
• I release the fistula at 2/3 weeks post op with
visit/exam and prescription
• I reserve button hole for reliable home
cannulator/ limited access length in facility
• Cannulation team training—I’m happy to visit
and discuss anatomy

Discussion Topics
• Barriers to timely
access
• When do we
cannulate
• When do we abandon
a fistula
• How do we monitor
the fistula? exam,
flows, angio,
nihilism
You must have a good
access maintenance
team—After surgery,
the work has just
begun.
Limited use of stents
216.445.vein

Discussion Topics
access
• When do we
cannulate
a fistula
the fistula? exam,
flows, angio, nihilism
• Alternative sites in the
challenging pt

Preferred Access Sites
• Radiocephalic AV fistula.
• Brachiocephalic AV fistula.
• Basilic vein transposition.
• Forearm AV loop graft.
• Upper arm AV graft.
• Unconventional sites
– Chest wall, legs, right atrium
• Cuffed tunneled catheters should NOT be used as
definitive access….except in?

PTFE*
Graft
* Polytetrafluoroethylene
- requires 3 - 4 weeks
for maturation
- usually placed in the
nondominant forearm

Humacyte:
Autologous vein in a
bottle

Products listed may not be available in all markets.
GORE®
, and designs are trademarks of W. L. Gore & Associates. © 2011, 2013, 2014 W. L. Gore & Associates, Inc.
Accuseal Graft

Tri-Layer Design
• Outer Graft Layer
 Expanded polytetrafluoroethylene
• Middle Graft Layer
 Elastomeric membrane
• Inner Graft Layer
 Expanded polytetrafluoroethylene
• CBAS®
Heparin Surface
CARMEDA®
and CBAS®
are trademarks of Carmeda AB, a wholly owned subsidiary of W. L. Gore & Associates.
GORE®
and designs are trademarks of W. L. Gore & Associates. © 2011, 2013, 2014 W. L. Gore & Associates, Inc.

May Reduce Risk of Seroma/Aneurysm
Experienced
in Standard ePTFE grafts*
Seroma capsule
Ultrafiltration (fluid leakage) through the graft wall
GORE®
, and designs are trademarks of W. L. Gore & Associates. © 2011, 2013, 2014 W. L. Gore & Associates, Inc.
* Data on file

Brachial Access with Femoral Vein
• Primary patency 79% 12 mo
• Secondary patency 100% 12 mo
• Steal 27%
• 23% vein harvest site
complications.
• Indicated for vascular access
associate arm infection

General Principles
• Obtain complete access history.
• Delineate anatomy of the inflow and outflow
(venography).
• Exhaust upper extremity options.
• Anticipate/reduce complication
• Favor the use of autogenous conduits via
transposition and translocation.

Axillary-Axillary Grafts
• 24 month 40-80%
patency.
• Preserves contralateral
access.
• The venous limb should
be lateral.
• Not associated with
steal.

Femoral Vein Transposition
• 2 year primary patency of 75%.
• 2 year secondary patency of 94%.
• High risk of steal. Limit
anastomosis to 4-5mm.
• Patients with PVD are not
candidates.
• High flows (2000 ml/min) may
exacerbate CHF.

Caveat for leg access
• Exhaust all upper extremity-Last ditch
means last ditch
• Objective documentation of arterial
perfusion, pvrs with toe pressures
• Preserve CFV, profunda femoris
• Mild Chronic limb swelling is common
• Anticoagulate 3-4 months
• Amputation is not absolute
contraindication to leg access

SFA-SFV Grafts
• Comparable patency.
• 21% infection rate.
• Avoids some of the
pannus and lymphatics.
• Preserves more proximal
access.
• Complications are easier
to manage.

Brachial artery to right atrium
graft

Thanks for your attention!!Thanks for your attention!!

Femoro-Femoral Grafts
• 60% secondary
patency at 2 years.
• 8 to 41% infection
rate.
• Higher complications
in obese patients.

Axillary/Brachial- Jugular Grafts
• 60% secondary
patency at 2 years.
• No incidence of steal.
• 4-15% incidence of
infection lower than that
of thigh access.
• Difficult control in the
setting of
complications.

Arterial Interposition Grafts
• 87% secondary
patency at 3 years.
• 5% ischemia rate.
• Ischemia better
tolerated in the upper
extremity.
• May have a role in
CHF.
• Higher risk of bleeding.

Unconventional Procedures
• Axillary artery to left renal vein.
• External iliac artery to left renal vein.
• Axillary to right atrium.

• Tri layer
• Elastic membrane between 2 layers ePTFE
• Covalently bonded heparin

What’s Unique About Flixene:What’s Unique About Flixene:
Trilaminate StructureTrilaminate Structure

Incorporation ZoneIncorporation Zone
- 60 microns- 60 microns
 Flixene MembraneFlixene Membrane
- <5 microns- <5 microns
 Flow Interface ZoneFlow Interface Zone
(Hybrid(Hybrid Structure)Structure)
- 60/20 design- 60/20 design

Features of FlixeneFeatures of Flixene
• The graft has the sliderThe graft has the slider
capability with acapability with a
polyethylene clear, slidepolyethylene clear, slide
sheath that allows ease ofsheath that allows ease of
tunneling.tunneling.
• It has a pre-attachedIt has a pre-attached
tunneler tip.tunneler tip.

Features of Flixene:Features of Flixene:
Improved StrengthImproved Strength
• High Radial Tensile StrengthHigh Radial Tensile Strength
– Greater resistance to cannulationGreater resistance to cannulation
• BenefitBenefit
– Withstand repetitive cannulationsWithstand repetitive cannulations
– Fewer revisions and less pseudoaneurysmsFewer revisions and less pseudoaneurysms

Dangers of Weeping: SeromaDangers of Weeping: Seroma

Computational Fluid Dynamics (CFD)**
** CFD 600 mL / min, 4.8 mm 30°, t = 0.4s
Conventional End-to-side Anastomosis
Endoluminal Anastomosis with the GORE®
Hybrid Vascular Graft
* Data on file

ESRD stages of Management
• Cannulation technique: button hole/rope ladder
• Removal of catheter
• Monitoring of access
• Thrombosis of access- 2/month
• Maintenance intervention of access

Patients Dialyzing with
Catheters at Initiation

Nonmaturation vs Unusable
• 6 mm
• 600ml/mm
• 6 mm surface
• At least 6 mm in length

Discussion Topics
access
• When do we
cannulate
a fistula
the fistula? exam,
the fistula

Discussion Topics
access
• When do we
cannulate
a fistula
the fistula? exam,
the fistula
• Alternatives to
prosthetic

Post-PTA 10 minutes 15 minutes
Elastic Recoil of Central Veins

Immediately
Post-PTA
20 minutes
Post-PTA
stent
positioning
Return of original stenosis
due to elastic recoil phenomenon.

20 minutes
Post-PTA Post-Stent
Use of a stent to salvage a failed angioplasty

Instent Restenosis
Stenosis
within
stent

Arm straight Arm bent 90 degrees
Arm straight Flair implanted Arm bent with Flair implant

“We have met the enemy and he is
us”

Catheter events
& complications
Figure 5.48
Prevalent hemodialysis patients age 20 and older, ESRD CPM data; only includes patients who are also in the USRDS
database. Year represents the prevalent year & the year the CPM data were collected. Access is that listed as “current”
on the CPM data collection form.

Short-Term Catheters
Hohn Hemocath
Single lumen = 5 Fr
Double lumen = 7 Fr
Dual lumen 11 Fr
Short-term pheresis
PICC
Single or double lumen
4, 5, or 6 Fr
( Non-Tunneled Catheters )

Intraluminal
thrombus
“Saran-wrap” layer of thin fibrin and thrombus
Tunneled hemodialysis catheter
that had been used for 6 weeks

Management of Thrombosed
Catheters
Endoluminal thrombolytic agent
Exchange catheter
Four hour infusion of lytic agent
Fibrin sheath stripping
Brush catheter
New catheter at new site

Loop configuration PTFE graft
venous anastomosis
arterial anastomosis

Straight configuration PTFE graft
venous anastomosis
arterial anastomosis

The Problem
The rapid, progressive development
of intimal hyperplasia at the anastomosis
of hemodialysis fistulae and grafts.
anastomotic
stenosis
PTFE graft anastomotic
stenosis
AV fistula

Hemodialysis Graft Stenosis
stenosis
at the
venous
anastomosis

“ A well performed fistulogram is the
foundation for all percutaneous interventions ”
Thorough evaluation of the entire vascular access circuit
including the graft, native veins, and inflow arteries

Diagnostic Fistulogram
21 g butterfly needle
non-ionic contrast

multiple venous stenoses
Multiplicity of Lesions
multiple intragraft stenoses

Diffuse severe stenoses
stenoses stenoses
Multiplicity of Lesions

Blood Flow vs. Time
• Document baseline blood flow value
• Development of stenoses can be monitored

0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
No Monitoring Monitoring
ThrombosisRate
Grafts
Fistulae
Blood Flow Monitoring
McCarley et al. Kid Int 2001; 60:1164-1172
0.71
0.160.14
0.07

.
In Search of an Optimal Bedside Screening
Program
for Arteriovenous Fistula Stenosis
Nicola Tessitore,* Valeria Bedogna,* Edoardo Melilli,* Deborah
Millardi,* Giancarlo Mansueto,† Giovanni Lipari,‡
William Mantovani,§ Elda Baggio,‡ Albino Poli,§ and Antonio
Lupo*
Clin J Am Soc Nephrol 6: 819–826, 2011. doi: 10.2215/CJN.06220710

Angioplasty Procedure
Diagnostic fistulogram
access
vascular
sheath
position
angioplasty balloon
across stenosis
fully inflate
balloon
stenosis
Post-PTA

Selecting the Appropriate Angioplasty Balloon
• Length
• Diameter
In general, high pressure balloons are used
for angioplasty of neointimal hyperplastic stenoses
Primary selection criteria :

5.3 cm
4.5 cm
4.0 cm
DialEase
Arrow
Inner Lock
Vascular sheaths are color-coded
Vascular Sheaths for
Hemodialysis Access
Interventions
• short length
• high-flow sidearm
• ± stopcock

The length of the angioplasty balloon should
extend ~ 5mm beyond each end of the stenosis.
PTFE
graft
3cm
Use 4cm length balloon
Minimize the length of balloon within normal vein.
Angioplasty damage the venous endothelium
and can incite neointimal hyperplasia.

If angioplasty fails, stents may be useful
in the following situations:
Indications for Stents
• Angioplasty-induced venous rupture
• Surgically inaccessible lesions
- central venous stenoses

graft
venous
stenosis
contrast inject through
angioplasty balloon catheter

Philadelphia Facilities
0
10
20
30
40
50
60
70
Prevalence %
Phila.
Region 2 of Network
Fistula Average 40.5%

FlixeneFlixene
Lee Kirksey MD, MBALee Kirksey MD, MBA

Problem with Vascular AccessProblem with Vascular Access
• Not all patients are candidates for fistulas.Not all patients are candidates for fistulas.
• It has been reported that 30% of AVIt has been reported that 30% of AV
fistulas never mature or are able to befistulas never mature or are able to be
cannulated.cannulated.
• There are still a number of problemsThere are still a number of problems
associated with grafts.associated with grafts.

The Problem with GraftsThe Problem with Grafts
• Traditional vascular grafts are often complicatedTraditional vascular grafts are often complicated
by weeping during implantation.by weeping during implantation.
• Pseudoaneurysm formation after repeatedPseudoaneurysm formation after repeated
needle sticks, and poor or incomplete healingneedle sticks, and poor or incomplete healing
are common occurrences.are common occurrences.
• Ordinarily, grafts are cannulated anywhere fromOrdinarily, grafts are cannulated anywhere from
2 weeks to a month after implantation.2 weeks to a month after implantation.

The Problem with GraftsThe Problem with Grafts
• Bovine GraftsBovine Grafts
– Prone to aneurysms.Prone to aneurysms.
– When infected, tend to fall apart.When infected, tend to fall apart.

The Ideal Vascular Access GraftThe Ideal Vascular Access Graft
• Never clotsNever clots
• Never gets infectedNever gets infected
• Easy to implantEasy to implant
• Easy to cannulateEasy to cannulate
• Does not bleed after cannulationDoes not bleed after cannulation
• Never forms pseudoaneurysmsNever forms pseudoaneurysms

It is nice to dream!!It is nice to dream!!

The Attempt to Achieve anThe Attempt to Achieve an
Ideal GraftIdeal Graft
• Grafts are now being designed specificallyGrafts are now being designed specifically
for vascular access and dialysis.for vascular access and dialysis.
• Advances in design and technology areAdvances in design and technology are
overcoming many of the problems seen inovercoming many of the problems seen in
some of the older grafts.some of the older grafts.

What is Flixene?What is Flixene?
• FLIXENE* is a next generation “compositeFLIXENE* is a next generation “composite
graft”.graft”.
• This vascular graft has been engineeredThis vascular graft has been engineered
to overcome the major drawbacks ofto overcome the major drawbacks of
conventional grafts and is projected toconventional grafts and is projected to
become the new graft of choice.become the new graft of choice.
*Atrium Medical Corporation

Why Was Flixene Developed?Why Was Flixene Developed?
• Grafts are commonly placed in patientsGrafts are commonly placed in patients
who have no veins available for anwho have no veins available for an
autologous fistula because they have hadautologous fistula because they have had
many prior access procedures.many prior access procedures.
• Also many have spent inordinate time withAlso many have spent inordinate time with
double lumen catheters.double lumen catheters.
• Flixene is designed specifically for theseFlixene is designed specifically for these
patients.patients.

• Grafts are usually placed in the forearm,Grafts are usually placed in the forearm,
upper arm or thigh.upper arm or thigh.
• What is unique about these areas?What is unique about these areas?
– Higher flowsHigher flows
– More difficult turns and bendsMore difficult turns and bends
– Which leads to more weepingWhich leads to more weeping

• There is therefore a need for a graft thatThere is therefore a need for a graft that
will:will:
– Decrease weepingDecrease weeping
– Designed for better incorporationDesigned for better incorporation
– Can be cannulated within 72 hoursCan be cannulated within 72 hours
– Withstand needle sticksWithstand needle sticks

What’s Unique About Flixene?What’s Unique About Flixene?
• FLIXENE is a state-of-the-art PTFEFLIXENE is a state-of-the-art PTFE
vascular graft composed of three distinctvascular graft composed of three distinct
layers.layers.
• This layered design maximizes handling,This layered design maximizes handling,
strength, and implantation properties ofstrength, and implantation properties of
this graft.this graft.

Superior ResistanceSuperior Resistance
• Compression ResistanceCompression Resistance
– More resistance than any non-helixed graft.More resistance than any non-helixed graft.
– More compression resistant than thin-wallMore compression resistant than thin-wall
ringed grafts.ringed grafts.

Superior ResistanceSuperior Resistance
• Kink ResistanceKink Resistance
– Better than any non-helixed productBetter than any non-helixed product
• Torque ResistanceTorque Resistance
– Equal to the best in the industryEqual to the best in the industry

Features of Flixene: Non-WeepingFeatures of Flixene: Non-Weeping
• It has superior water entryIt has superior water entry
pressure (WEP)pressure (WEP)
• This tends to eliminatesThis tends to eliminates
blushing and weeping of theblushing and weeping of the
graft.graft.

Comparative BenefitsComparative Benefits
0
50
100
150
200
250
300
350
Water Entry Pressure
Flixene
Graft A
Graft B
Graft C

Improved StrengthImproved Strength
Impact of Cannulation on Radial Tensile Strength of
Vascular Grafts
168
131
113
84
62
46
27 20 15
0
50
100
150
200
0 10 20
Number of Punctures/CM
Lbsofforce
Flixene
Competetor A
Competetor B

Features of FlixeneFeatures of Flixene
• There is also an extra polyethylene sheathThere is also an extra polyethylene sheath
that covers the entire system and protectsthat covers the entire system and protects
the graft from coming into contact with thethe graft from coming into contact with the
skin and other items (Blue Transferskin and other items (Blue Transfer
Sleeve).Sleeve).

Summary:Summary:
The Goals of FlixeneThe Goals of Flixene
• Flixene was designed with the mostFlixene was designed with the most
complex dialysis patients in mind.complex dialysis patients in mind.
• It’s layered design helps to minimizeIt’s layered design helps to minimize
weeping.weeping.
• The graft also boasts excellent kink andThe graft also boasts excellent kink and
compression resistance.compression resistance.

Summary:Summary:
The Goals of FlixeneThe Goals of Flixene
• Decreased graft complications such asDecreased graft complications such as
seromas and pseudoaneurysms.seromas and pseudoaneurysms.
• Studies are in progress to evaluate theStudies are in progress to evaluate the
early stick potential of Flixene.early stick potential of Flixene.
• Early cannulation is perhaps the greatestEarly cannulation is perhaps the greatest
advantage for AV grafts.advantage for AV grafts.
• This decreases the time and need forThis decreases the time and need for
double-lumen catheter use and itsdouble-lumen catheter use and its
associated complications.associated complications.

Post-PTA
Elastic Recoil of Central Veins
Pre-PTA

Options
• Short term. <3 weeks.
– Non – Cuffed Catheters.
• Mid-Term. Weeks to months.
– Cuffed Catheters.
• Long Term. Months to years.
– Arteriovenous Grafts.
– Arteriovenous Fistulas.

Change in adjusted all-cause & cause-
specific hospitalization rates, by
modality
Figure 3.1 (Volume 2)
Period prevalent ESRD patients. Adj: age/gender/race/primary diagnosis; ref: ESRD patients, 2005.

Vein Preservation
• Do not access cephalic or basilic veins.
• Use dorsal hand veins.
• Avoid all subclavian access. 50% incidence of
stenosis after 2 weeks.
• 10% incidence of stenosis with internal jugular
access.

Patient Evaluation for Long Term
Access
• Expected time of hemodialysis.
• Previous venous and arterial access. Previous
pacemaker placement.
• Arm dominance.
• Physical exam.
• Duplex ultrasound and venography.
• Minimal diameters:
• Artery 2mm.
• Vein 2.5mm.

Historical findings
• Diabetic duration, upper or lower extremity
neuropathy
• Carpal tunnel syndrome

Social cues
• Know your patient
– Who can/can’t accept failure.
– Patient frustration/prior failed attempts in
secondary procedures
– Explain that all access ultimately fails…Duh?
– Take ownership of access

Altering remodeling…Biologics?

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