JVA

J Vasc Access 2017; 18 (2): 109-113

DOI: 10.5301/jva.5000550

ISSN 1129-7298 ORIGINAL RESEARCH ARTICLE

Early cannulation graft Flixene™ for conventional

and complex hemodialysis access creation
Carlos A. Hinojosa, Saul Soto-Solis, Sandra Olivares-Cruz, Hugo Laparra-Escareno, Zeniff Gomez-Arcive, Javier E. Anaya-Ayala

Department of Surgery, Section of Vascular Surgery and Endovascular Therapy, Instituto Nacional de Ciencias Médicas y Nutricion “Salvador
Zubirán”, Mexico City - Mexico

Abstract
Purpose: The Flixene™ (Atrium™, Hudson, NH) is a trilaminate composite polytetrafluoroethylene (PTFE) graft
that allows access within 72 hours. We evaluate our initial experience with this device for conventional and
complex hemodialysis access creation.
Methods: Retrospective review in end-stage renal disease (ESRD) patients who underwent access creation with
Flixene from January 2013 to July 2014. For our analysis, the patients were divided in two groups: those with
complex access configurations tunneled in the chest and/or abdominal wall (thoraco-abdominal wall access
[TAWA]), and those tunneled in conventional sites (extremity access [EA]). Patient’s demographics, indications,
complications, reinterventions, patency rates and factors influencing outcomes were evaluated.
Results: In 19 patients (54% men; mean age 44 years ± 18), 24 grafts were implanted, (13 EA [54%] vs. 11 TAWA),
all patent after surgery. Central venous occlusive disease (CVOD) was present in all patients with TAWA and in
7/13 (54%) EA patients (p = 0.016). Early cannulation (within 72 hours) was successful in 12 EA and 5 TAWA grafts
(p = 0.044). Complication rates including infection, thrombosis, bleeding and steal syndrome were 8/11 (73%) in
TAWA and 5/13 (38%) in EA (p = 0.02). At 12 months, primary patency rates for EA and TAWA were 25% and 41%;
secondary patency rates were 55% and 41%, respectively.
Conclusions: Early cannulation (EC) grafts are viable alternatives for conventional and complex access creation
that allowed early cannulation (<72 hours) in 17 (70%) of our cases. Primary and secondary patency rates at
12 months were equivalent to data reported on ePTFE grafts.
Keywords: Complex vascular access, Early cannulation graft, Flixene™

Introduction between 2 weeks to 1 month after implantation, due to wait-

It is estimated that the prevalence of chronic kidney dis-
ease (CKD) worldwide is 0.5 to 2.5%; and the end-stage renal
disease (ESRD) population requiring hemodialysis continues
to grow annually (1). Although, the National Kidney Founda-
tion (NKFDOQI) guidelines and Fistula First Initiative (FFI) rec-
ommend native arteriovenous fistulas (AVFs) to be created
initially, many patients are not candidates due to poor venous
vasculature (2). Vascular grafts are used in these patients with
inadequate vessels in order to accomplish a functional ac-
cess. However, on average, prosthetic grafts are cannulated
Accepted: February 6, 2016
Published online: February 6, 2017
Corresponding author:
Carlos A. Hinojosa
Instituto Nacional de Ciencias Médicas y Nutricion
“Salvador Zubiran”
Vasco De Quiroga 15
Tlalpan, Sección XVI
14080 Mexico City, Mexico
carlos.a.hinojosa@gmail.com
ing for tissue in-growth and graft maturity (3).
The initiation of hemodialysis is not always an anticipated
event and this presents a need for placement of an interim
central venous catheter (CVC) (3). Catheters have been shown
to have dangerous complications such as significant infection
rates, leading to septicemia, sub-acute bacterial endocarditis,
brain/spinal abscesses and possibly death. Additionally, central
venous occlusive disease (CVOD) (4), a condition associated to
the long-term use of CVC, will prevent use of that extremity
for any type of future access (5, 6); this represents a costly and
detrimental risk to the ESRD patients (7, 8). The ultimate goal
is to have an optimal graft with the ability to be cannulated
early, and to prevent the use of CVC, while also resulting in
fewer graft-related complications and maintaining acceptable
patency rates and durability. The Flixene™ (Atrium™, Hudson,
NH, USA) (9) is a composite graft, with a tri-laminate structure
that offers increased compression, kink, and torque resistance
compared with conventional PTFE grafts; its increased strength
may offer greater ability to withstand repeated cannulation as
well as better suture retention. Early experience with this de-
vice has demonstrated it to allow a safe early access compared
with the standard PTFE and potentially superior option to CVC
in patients requiring urgent dialysis (10).

© 2017 Wichtig Publishing

110 Early cannulation graft for conventional and complex vascular access

Our institution receives and evaluates patients with com-
plicated hemodialysis access issues with exhausted or limited
venous vasculature and multiple central venous occlusions.
The present study describes our experience using the early
cannulation (EC) Flixene graft for the creation of conventional
and complex hemodialysis accesses.
Methods
Study design
and the axillary artery to right atrium hemodialysis graft (13)
have been previously described.
Follow-up
The patients were examined in our clinic at 1-, 3-, 6- and
12-month intervals. Their dialysis data were also reviewed
at monthly intervals. Complications included in our analysis
were infection, thrombosis, bleeding, and the development
of steal syndrome.

A retrospective review was performed of all patients with Statistical analysis

end stage renal disease (ESRD) who underwent access cre-
ation with the (EC) graft from January 2013 to July 2014. For Descriptive statistics for demographic variables was con-
the purpose of our analysis, the patients were divided in two ducted. All tests were performed using the statistical program
groups, those with complex access configurations tunneled in STATA 14.0, with a 95% significance level and 80% statistical
the chest and/or abdominal wall (thoraco-abdominal wall ac- power. Kaplan-Meier analysis was used to estimate primary
cess [TAWA]) 10 axillary-femoral and 1 axillary-atrial arteriove- and secondary patency based on access service interval.
nous grafts (AVG) and those in whom the graft was tunneled Measured values are reported as percentages or mean ±
in upper or lower extremities (extremity access [EA]). Patient’s standard deviation (SD).
demographics, indications, complications, reinterventions,
patency rates and factors influencing the clinical outcomes Results
were evaluated. Access complications, re-interventions and
graft patency rates were reported according to the standards In 19 patients (54% men; mean age 44 years ± SD 18) a
developed by the Society of Vascular Surgery (SVS) (11). total of 24 Flixene 6 mm grafts were implanted, 13 (54%) in
Primary patency was defined as the interval of time from conventional sites (EA), and 11 (46%) in complex locations
access creation to the first intervention, while secondary pa- (TAWA). Patient’s demographics and characteristics are listed
tency as the interval of time from access creation to perma- in Table I. We found significant difference in patients with
nent access failure. Graft failure was defined as devices that
were not being used for hemodialysis due to complications
and were abandoned (e.g., removed or ligated). We defined TABLE I - Patient demographics and characteristics for both cohorts
“early cannulation” as a successful hemodialysis session with-
TAWA (%) EA (%) p value
in the 72-hour period following the implantation of the graft.
No. 11 No. 13
Institutional review board approved this study.
Mean age 45yo 48yo 0.25
Study setting Men 9 82 4 31 0.018
Diabetes mellitus 1 9 8 62 0.013
Academic medical center, which is a tertiary referral
facility serving a catchment area of approximately 20 million Arterial hypertension 5 45 10 77 0.2
people. IHD 3 27 1 8 0.3
Smoking 7 64 5 38 0.41
Preoperative assessment and surgical technique
Dyslipidemia 1 9 4 31 0.32
All patients underwent a thorough physical examina- Antiplatelet therapy 1 9 3 23 0.59
tion, including a peripheral vascular exam and preoperative
Anticoagulation therapy 3 27 3 23 1
­ultrasound (US) vein mapping. Indications for EA were inad-
equate venous vasculature for autologous access creation. Hypercoagulable 3 27 3 23 1
Unsuitable peripheral veins and multiple central venous Disorders (total)
occlusions were the indications for TAWA. In these cases,   - AT III deficiency 3 27
venous outflow was assessed by digital angiography. Subcla-   - SLE 2 15
vian and brachiocephalic veins were imaged by standard up-   - APS 1 8
per extremity venograms. In cases with bilaterally occluded
CVOD 11 100 7 54 0.016
or severely stenosed intrathoracic central veins, femoro-
iliocaval systems were imaged bilaterally. Following imag- Number of previous 7 64 4 31 0.21
ing, the best suitable outflow vein was selected; in one case, procedures
no patent central vein was encountered and a direct right Previous CVCs (>2) 11 100 7 54 0.015
atrium anastomosis was performed. The inflow artery was
TAWA = thoraco-abdominal wall access; EA = extremity access; IHD = isch-
selected according to previous access surgeries and optimal emic heart disease; AT III = antithrombin III deficiency; SLE = systemic lupus
pulse exam. Surgical techniques for complex access creation erythematosus; APS = antiphospholipid syndrome; CVOD = central venous
as the axillary artery-femoral vein arteriovenous graft (12) occlusive disease; CVC = central venous catheter.

© 2017 Wichtig Publishing

Hinojosa et al 111

diabetes mellitus (TAWA 9% vs. EA 62%, p = 0.013). All implanted

grafts were patent immediately after placement and there
was no procedure-related morbidity or mortality. CVOD was
present in all patients with TAWA (100%) and in 7/13 EA (54%)
patients (p = 0.016). We observed that history of more than 2
CVCs was present in 11 (100%) of patients in the TAWA group
(100%), compared with 7 (54%) in EA cohort (p = 0.015). Com-
plication rates including infection, thrombosis, bleeding and
steal syndrome were 8/11 (73%) in TAWA versus 5/13 (38%)
EA (p = 0.02). Three cases of graft thrombosis occurred in the
EA cohort (23%) and one (9%) in the TAWA group, all treated
by open thrombectomy. Significant bleeding associated with
hematoma formation at the groin that required incision and
drainage occurred in one patient in the TAWA group, and one
case of steal syndrome in the EA that underwent banding
(Tab. II). Infection occurred in seven (six TAWA and one EA)
cases and six grafts were removed (TAWA five grafts [45%] Fig. 1 - Kaplan-Meier curve on primary patency rates at 12 months
vs. EA one graft [8%] p = 0.02) secondary to infection. Four for conventional (EA) and complex access sites (TAWA).
(21%) patients died from causes non-related to the graft or in-
terventions during a mean follow up period of 10 months. At
12 months, primary patency rates for EA and TAWA were 25%
and 41% (Fig. 1), while secondary patency rate were 55% and
41%, respectively (Fig. 2). The number of reinterventions to
maintain patency was nine (four thrombectomies and five
balloon angioplasties).

Discussion
Native arteriovenous fistulas (AVFs) are the first option for
dialysis access as recommended by the “Fistula First” initia-
tive and the update of the Kidney Disease Outcomes Quality
Initiative (KDOQI) guidelines. Unfortunately, not all patients
are suitable candidates for the creation of native AVFs (14).
Typically, grafts are not cannulated until at least 2 weeks after
the implantation; this involves the need for CVC (7). The risk
of mortality of dialyzing from a catheter is much greater than
dialyzing with a graft or fistula; for this reason, KDOQI guide- Fig. 2 - Kaplan-Meier curve on secondary patency rates at 12 months
lines recommend that less than 10% of ESRD patients should for conventional (EA) and complex access sites (TAWA).
be maintained on catheter-based hemodialysis (9, 14).
The concept of early cannulation grafts is not a new ap-
plication (15); experience with non-autologous biological reports documented tunnel hematoma formation in as high
(bovine carotid heterograft and expanded ePTFE) accesses as 75% of patients, which led to abandonment of this practice
was not encouraging in the decade of the 1970s, several (15-17). Flixene is a trilaminate composite polytetrafluoroeth-
ylene (PTFE) graft. The unique structure and minimal weeping
allow access targeted at less than 72 hours. These character-
TABLE II - Graft complications compared in TAWA and EA groups istics make this graft an alternative to CVC in those requiring
urgent dialysis (10). In previous reports, the Flixene graft has
TAWA (%) EA (%) p value achieved comparable patency rates to other synthetic grafts
Complication rates 8 73 5 38 0.02 despite being used in patients who have failed prior access;
complications were also comparable to other synthetic grafts
Bleeding (hematoma) 1 9 0 0 0.15 and better results for other materials devised for early can-
Infection 6 55 1 8 0.02 nulation (18, 19). Schild et al (9), in 2011, published a study
that included 33 grafts with a follow-up of 6 months, primary
Thrombosis 1 9 3 23 NS
patency rate was 49% and primary assisted rate was 80%; in
Steal syndrome 0 - 1 8 NS this article the secondary patency rates were not reported
Pseudoaneurysms 0 - 0 - - (9). Lioupis et al (20) compared the outcome of 48 Flixene
grafts to autologous accesses (transposed brachial-brachial
Venous hypertension 0 - 0 - - and brachio-basilic AVF); in this study, primary patency for
TAWA = thoraco-abdominal wall access; EA = extremity access; NS = not Flixene at 18 months was 21%. Primary assisted patency 38%
significant. and secondary patency of 57%. Three Flixene grafts became

© 2017 Wichtig Publishing

112
infected that resulted in surgical exploration or removal (20).
In a retrospective study published by Chiang et al (10) that
compared 48 Flixene versus 19 PTFE grafts, the authors re-
ported successful early cannulation of the graft in 78% of pa-
tients within 3 days of implantation. At 18 months, primary
patency rates were 34% and 24% for the Flixene and PTFE co-
hort while the secondary patency rates were 51% versus 48%,
respectively. However, these results did not achieve statistical
difference. The authors concluded that the greatest benefit of
this graft was the avoidance and/or shorter duration of cath-
eter use, providing a functioning dialysis access soon after
implantation and with far less morbidity and mortality than
a catheter for up to 6 months (10). Tozzi et al (7) reported
their initial experience using another vascular graft in the
market designed for early cannulation, the authors reported
a mean time to first cannulation of 2.4 ± 1.7 days (range 1-15)
Primary patency rate was 68% and secondary patency 93.3%
at 6 and 12 months (7). Interestingly complications such as
pseudoaneurysm, bleeding, seroma and infection were not
observed. In our series, early cannulation was accomplished
in 17 (70%) of the patients (12 EA and 5 TAWA), avoiding the
need for CVC.
The paucity of available kidney transplant relative to the
growing ESRD population and their longer survival has led to
the necessity of unconventional approaches to extend the
viability of hemodialysis when no peripheral sites are avail-
able. Surgical options require innovative and complex surgical
techniques to find venous outflow for the creation of a hemo-
dialysis circuits; and there are no clear protocols for selecting
the type of access and when to create it, although algorithms
and flowcharts have been proposed (21, 22). Chemla et al
(23) reported their experience with early cannulation grafts
for complex access configurations (straight axillo-axillary an-
gioaccess), the Flixene was implanted in 10 patients whereas
the Rapidax (Vascutek Ltd. Renfrewshire, UK) in 6. In 12 cases,
grafts were cannulated after 12 hours, in 4 after 24 hours
(12 hours- 8 days mean 1.8 days). For the Flixene mean de-
lay of cannulation was 1.1 days whereas 2.71 for Rapidax
(p<0.05). Primary patency rates were 65.7% at 1 year. There
was no significant difference in patency rates between grafts.
The authors concluded that early cannulation grafts in com-
plex position were safe and efficient considering their patency
and complications rates.
The present series reports 11 cases where we used an
EC graft for complex access creation. In one case an axillary
artery to right atrium access; this patient had occluded in-
trathoracic central veins and iliocaval system, at present he
continues to use the chest wall graft as hemodialysis access.
In the remainder of patients, we opted for a long graft con-
figuration as the axillary artery-femoral vein AVG in an at-
tempt to avoid sharp angulations or kinks that we judge may
lead to frequent revisions secondary to thrombosis. How-
ever, the anastomosis in the femoral vein at the groin region
resulted in more cases of wound and graft infection, and 5
(50%) of the graft implanted in these anatomic regions were
removed. Since the analysis of this study, we have modified
this technique creating the venous anastomosis at the ex-
ternal iliac vein via a retroperitoneal approach and avoiding
the groin; until now, no cases of graft infection have been
observed. These patients typically undergo a thorough pre-
Early cannulation graft for conventional and complex vascular access
operative planning since this approach is reserved to those
who are otherwise not candidate for AV access creation at a
more distal location as the mid-thigh femoral-femoral AVG.
When performing an Axillary-Iliac AVG, we ideally use the
left side, leaving the pelvic vasculature on the right intact
and suitable for future kidney transplantation. In our experi-
ence, long and straight configurations as the axillary-femoral
or axillary-Iliac have allowed easier rotation of cannulation
sites because of the area available for access; chest wall can-
nulation seems to be better tolerated in our patients with
less bleeding and hematoma formation than in the abdomi-
nal wall.
Some recognized limitations in our study included, the
retrospectively nature, small sample size and a short follow
up. In this experience the EC graft in conventional access sites
(EA) showed superior secondary patency rates than in those
grafts in complex access sites (TAWA); thus, further clinical
experience and longer-term data are critical for determining
the proper utility of this graft in ESRD patients who are not
ideal candidates for either AVF creation or the placement of
a standard ePTFE graft.
Conclusion
EC graft is a viable alternative for complex and conven-
tional hemodialysis access that allowed safe early cannula-
tion (<72 hours) in 17 (70%) of our cases and its use reduced
the need for central venous catheter placement. Primary
and secondary patency rates at 12 months were equivalent
to other data reported on standard ePTFE grafts. TAWA was
associated higher rate of complications compared to EA.
Modifications in our approach for complex access creation
associated to intrathoracic CVOD have been made to reduce
the risk of infection.
Disclosures
Financial support: No grants or funding have been received for this
study.
Conflict of interest: None of the authors has financial interest related
to this study to disclose.
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