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2019 Immediate Access Grafts Provide Comparable Patency To Standard
2019 Immediate Access Grafts Provide Comparable Patency To Standard
2019 Immediate Access Grafts Provide Comparable Patency To Standard
ABSTRACT
Background: No independent comparisons, with midterm follow-up, of standard arteriovenous grafts (SAVGs) and
immediate-access arteriovenous grafts (IAAVGs) exist. The goal of this study was to compare “real-world” performance of
SAVGs and IAAVGs.
Methods: Consecutive patients who underwent placement of a hemodialysis graft between November 2014 and April
2016 were retrospectively identified from the electronic medical record and Vascular Quality Initiative database at two
tertiary centers. Only primary graft placements were included for analysis. Patients were divided into two groups based
on the type of graft implanted. Patients’ comorbidities, graft configuration, operative characteristics, and follow-up were
collected and analyzed with respect to primary and secondary patency. Additional outcomes included graft-related
complications, time to first cannulation, time to tunneled catheter removal, catheter-related complications, and over-
all survival. Patency was determined from the time of the index procedure; c2, Kaplan-Meier, and Cox regression analyses
were used, with the P value set as significant at < .05.
Results: There were 210 grafts identified, 148 SAVGs and 62 IAAVGs. At baseline, the patients’ characteristics were similar
between groups, except for a greater prevalence of preoperative central venous occlusions in the IAAVG group (16.3% vs
6.8%; P < .04). Of the IAAVG group, 50 were Acuseal (W. L. Gore & Associates, Flagstaff, Ariz) and 12 were Flixene (Atrium
Medical Corporation, Hudson, NH). Primary patency was similar at both 1 year (SAVG, 39.4%; IAAVG, 56.7%; P ¼ .4) and
18 months (SAVG, 29.0%; IAAVG, 43.7%; P ¼ .4). Secondary patency was similar at 1 year (SAVG, 50.7%; IAAVG, 52.1%; P ¼ .73)
and 18 months (SAVG, 42.3%; IAAVG, 46.3%; P ¼ .73). Overall survival was 48% at 24 months. IAAVG patients required fewer
overall additional procedures to maintain patency (mean number of procedures, 0.99 for SAVGs vs 0.61 for IAAVGs;
P ¼ .025). There was no difference in occurrence of steal syndrome (SAVG, 6.8%; IAAVG, 8.1%; P ¼ .74) or graft infection
(SAVG, 19.0%; IAAVG, 12.0%; P ¼ .276). Seventy-five percent of all grafts were successfully cannulated, with shorter median
time to first cannulation in the IAAVG group (6 days; interquartile range [IQR], 1-19 days) compared with the SAVG group
(31 days; IQR, 26-47 days; P < .01). Of all pre-existing catheters, 65.75% were removed, with a shorter median time until
catheter removal in the IAAVG cohort at 34 days (IQR, 22-50 days) vs 49 days (IQR, 39-67 days) in the SAVG group (P < .01).
Catheter-related complications occurred less frequently in the IAAVG group (16.4% vs 2.9%; P < .045).
Conclusions: IAAVGs allow earlier cannulation and tunneled catheter removal, thereby significantly decreasing catheter-
related complications. Patency and infection rates were similar between SAVGs and IAAVGs, but fewer secondary
procedures were performed in IAAVGs. (J Vasc Surg 2018;-:1-7.)
Keywords: Acuseal; Arteriovenous graft; Immediate-access graft; Dialysis catheter; Catheter infection; Flixene
For decades, arteriovenous fistulas (AVFs) have been companion publication of synonymous clinical practice
the favored access modality for patients reliant on hemo- guidelines by the Society for Vascular Surgery.1,2 Arterio-
dialysis (HD). This trend was bolstered in 2006 by the venous grafts (AVGs) are considered a second-line access
release of the National Kidney Foundation’s Kidney modality in comparison to AVFs. This is largely due to the
Disease Outcomes Quality Initiative guidelines, with AVG’s inferior patency rates and frequent reinterventions.
From the Division of Vascular Surgery, University of Pittsburgh Medical Center, The editors and reviewers of this article have no relevant financial rela-
Pittsburgha; and the Division of Vascular Surgery, Duke University Medical tionships to disclose per the JVS policy that requires reviewers to
Center, Durham.b decline review of any manuscript for which they may have a conflict
Author conflict of interest: none. of interest.
Presented at the 2017 Annual Meeting of the Society for Vascular Surgery, San 0741-5214
Diego, Calif, May 31-June 3, 2017. Copyright Ó 2018 by the Society for Vascular Surgery. Published by Elsevier Inc.
Correspondence: Jason K. Wagner, MD, MSc, Vascular Surgery, University of All rights reserved.
Pittsburgh, UPMC HVI, 200 Lothrop St, Pittsburgh, PA 15232 (e-mail: https://doi.org/10.1016/j.jvs.2018.06.204
wagnerjk@upmc.edu).
1
2 Wagner et al Journal of Vascular Surgery
--- 2018
Table III. Clinical outcomes criteria similar to those of our study, and it is the largest
SAVG IAAVG P identifiable comparison of SAVGs and IAAVGs outside
of our series. Their sample was composed of 78 SAVGs
Follow-up, months 10.5 (0.2-32.7) 8.0 (0.1-31.7) .09
and 44 IAAVGs, with significant heterogeneity of IAAVGs
Perioperative deaths 8 (5.4) 3 (4.8) .87
implanted (3 Vectra, 18 Flixene, and 23 Acuseal). They
Steal syndrome 10 (6.8) 5 (8.1) .74
found comparable patency rates between the SAVGs
AVG infection 20 (19.1) 6 (12.0) .27 and IAAVGs, with no differences in reintervention rates.
AVG use 103 (73.1) 50 (80.1) .25 The higher rates of reintervention in their IAAVG sample
AVG, Arteriovenous graft; IAAVG, immediate-access arteriovenous graft; can possibly be attributed to their inclusion of Vectra
SAVG, standard arteriovenous graft.
Categorical variables are presented as number (%). Continuous vari- grafts, with their aforementioned documented higher
ables are presented as mean (range). reintervention rates. The finding of the group from
Eastern Virginia Medical School of no reduction in cath-
eter dwell times in the IAAVG group could be related
Table IV. Graft maturation and catheter-related
complications to their earlier period of study, when IAAVGs were less
prevalent and targeted postoperative management
SAVG IAAVG P
and early cannulation were not yet pervasive, as was
Maturation, days 31 (26-47) 6 (1-19) .00 seen in our early experience. The 1-year secondary
Catheter removal 66 (64.7) 29 (65.9) .89 patency rate in their IAAVG sample (54%) is similar to
Catheter, days 49 (39-67) 34 (22-50) .00 that found in our series (52.1%).
TDC complications 12 (16.4) 1 (2.9) .04 In 2017, Aitken et al17 reported on the use of IAAVGs
Reinterventions 0.99 (0-7) 0.61 (0-3) .03 in place of TDCs as a means for urgent HD access. In
IAAVG, Immediate-access arteriovenous graft; SAVG, standard arterio- their randomized trial, IAAVGs were associated with
venous graft; TDC, tunneled dialysis catheter. significantly fewer infectious complications compared
Categorical variables are presented as number (%). Continuous vari-
ables are presented as median (interquartile range). with TDCs.15 In their series, they found cost equivalence
between the two accesses because the expenses of
infectious complications in the TDC arm balanced
within 24 hours of graft placement. The largest prospec- initial surgical expenditures in the IAAVG arm.15
tive series (138 grafts) was published by Glickman et al14 Although cost was not an end point in our study, the
in 2015 and reported primary and secondary graft IAAVG cohort does have a significantly lower rate of
patency at 12 months of 33% and 78%, respectively. infectious complications (12%) compared with historical
In comparing the results of our IAAVG cohort with controls of TDC use, therein supporting the notion that
the independent European series, there is congruity; such cost equivalence could also apply in this popula-
however, compared with the 1-year results of the tion of patients.18,19
industry-supported trial of Glickman et al, the primary With regard to TDC-related complications, our study’s
patency results are comparable, yet there was a signifi- results show that graft type can be associated with
cant disparity in the cumulative patency and the total decreased rates of untoward catheter-associated events.
number of reinterventions. The study of Glickman et al The meaningfully lower rate of TDC infections and
claims a cumulative patency rate of 79% but with a thromboses in our series’ IAAVG cohort was not surpris-
larger number of reinterventions (1.6 per access) to ing, given the significantly shorter catheter dwell times
achieve this outcome. By comparison, the patients in for those who underwent graft placement with an exist-
our series with Acuseal grafts underwent an average of ing TDC. The reduction in catheter days in the IAAVG
0.57 6 0.79 procedures per access. cohort is not surprising, but also the potential benefits
In comparison to recent industry trials, there is a notable of reduced catheter days were not fully realized on ac-
discrepancy in our 1-year survival rate. At 12 months, the count of variations in practice patterns and the evolving
overall survival rate of 57.9% in our IAAVG cohort is signifi- pervasive use of IAAVGs at our two centers. The approach
cantly lower than that reported by the Acuseal series of to assessing catheter removal after graft placement was
Glickman et al (87.7%) but is comparable to outcomes conservative, using the first date of documented (radio-
identified in the U.S. Renal Data System.15 We attribute graphic or clinical records) evidence of catheter absence
this difference to our heterogeneous sample of patients, as a surrogate date for catheter removal when no specific
many of whom were “end-stage dialysis patients” and documentation of catheter removal could be evidenced.
not just entering a state of end-stage renal disease with This in turn has likely led to an overestimation of catheter
new HD dependence. dwell time in this series.
The group from Eastern Virginia Medical School Despite 45% of all IAAVGs being accessed within 3 days
recently reported on their experience with IAAVGs and of placement, an overall median catheter dwell time
compared them with their SAVG cases.16 They reviewed around 1 month is indicative of a disconnect in the
a 14-month experience from 2011 to 2012, with exclusion outpatient setting during the postoperative period. Early
6 Wagner et al Journal of Vascular Surgery
--- 2018
requiring urgent vascular access for hemodialysis. J Vasc 19. Taylor G, Gravel D, Johnston L, Embil J, Holton D, Paton S.
Surg 2017;65:766-74. Prospective surveillance for primary bloodstream infections
18. Thomson PC, Stirling CM, Geddes CC, Morris ST, occurring in Canadian hemodialysis units. Infect Control
Mactier RA. Vascular access in haemodialysis patients: a Hosp Epidemiol 2002;23:716-20.
modifiable risk factor for bacteraemia and death. QJM
2007;100:415-22. Submitted Apr 5, 2018; accepted Jun 25, 2018.
DISCUSSION
Dr Fedor Lurie (Toledo, Ohio). You have identified sig- Dr Patrick Ryan (Nashville, Tenn). It’s a great study. I’ve
nificant differences between those two groups in this got some experience with the Flixene graft myself. I don’t
retrospective study. Do those differences reflect partici- use it anymore. I have two questions.
pating physicians’ preferences, institutional protocols, or You had a 20% infection rate on the Gore grafts and
both? How much did these differences influence the 10-ish percent infection rate on the Flixene, I believe.
study outcomes? That seems high. What do you do with an infected graft?
Dr Jason K. Wagner. Overall patient-specific factors I take it out. What do you do?
were very similar between the two groups. If the question Dr Wagner. Right. So the two groups were standard
is, Are you using the immediate-access grafts more for graft, just a normal, in this case Gore, like a Propaten or
access of last resort? Then yes, with some of the Flixene standard stretch wall, vs the immediate-access group,
grafts (about half of them, so maybe six), that was kind which is also mostly in that case Gore.
of the case. But when we looked at a subgroup analysis, With regard to management of the infection, usually
even though it was a really small sample, we really interposition if you can interpose around a focal area of
couldn’t find any differences between that. Some of an infected graft. Often we’re using immediate-access
the providers are now starting to move toward using graft as an interposition. But if it’s just grossly infected or
the immediate-access graft as their standard graft of at an anastomosis or something like that and you can’t
use. But we’re not placing these in the setting of delayed have a stickable segment, then we’ll just explant, go to a
planning for initiating dialysis down the road; these are catheter, either temporary or tunnel, depending on how
being placed at the time of need. systemically sick they are, and then plan for another access
Dr John Blebea (Saginaw, Mich). The entire argument in the very near term, usually during that admission.
for immediate access grafts is that they can be Dr Ryan. So all of the 19% of the regular arteriovenous
implanted and utilized urgently, without the need for graftsdwere they counted as revisions in your statistics,
tunneled catheters. However, in your own data, there or how?
was not a large difference in terms of the duration of Dr Wagner. No, we were actually d
catheter use. The median time was approximately Dr Ryan. Were they secondary patency? What did you
32 days vs 40 days for the standard grafts. In addition, do with them?
all of the patients implanted with immediate access Dr Wagner. So if someone had an infection, we consider
grafts had at least 3 weeks of catheter use. Therefore, that graft explanted and we removed that from the study.
the entire argument of having these grafts immediately So it almost artificially kind of gives it a lower patency rate.
available 24 hours later was never actually employed. Dr Ryan. And to my experience with the Vectra is that
So did it really clinically make any difference? when you put it in the patient’s skin, the patients don’t
Dr Wagner. That’s a great point. In actuality, we’ve tolerate it well, it hurts. I have put in about 10 of them
changed our practice pattern now so when we’re and quit. Have you had like a dense inflammation
placing immediate access grafts in our patients, around this graft, have you had any experience like that?
we’re notifying the patient that this graft can be Dr Wagner. I have never touched a Vectra graft, so I
accessed right away. We’re contacting the dialysis cen- can’t speak to that.
ter, the treating nephrologist, and we move up our Dr Anil Hingorani (Brooklyn, NY). Just two short ques-
follow-up period to be removing that catheter closer tions. What about the cost of the device? And did you
to a 1-week to 2-week period of time, after three to mention where you placed these grafts? Was it in the
five successful cannulations, rather than waiting until forearm or the upper arm? Was there a difference be-
1-month follow-up. So we’ve actually started to kind tween the two data sets?
of do a practice pattern shift with that and hopefully Dr Wagner. All the same. All were upper arm. Actually,
look to present those quality improvement results there were a couple that were lower extremity; most
down the road. were upper arm straight configuration.