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Endograft limb trimming and resheathing can be an alternative for emergent aortic repair without adequate stent graft availability

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Endograft limb trimming can be an easy customization to perform in some emergent setups and when alternative adequate covered stents are lacking. A man aged 74 years presented with aortoenteric fistula and hemodynamic instability years after an aortobifemoral bypass, and a 56-year-old woman was admitted with acute ischemia due to an aortic ulcer-like lesion. In both cases, tabletop deployment and removal of two stents from an Endurant iliac limb (Medtronic, Fridley, Minn), followed by resheathing and deployment, allowed successful repair as a bridging therapy for open surgery. Both patients are alive and without walking impairment 8 and 6 months later, respectively.
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Endograft limb trimming and resheathing can be
an alternative for emergent aortic repair without
adequate stent graft availability
Francisco Álvarez Marcos, MD, MSc, Delfín Couto Mallón, MD, Pilar Vilariño López-Barranco, MD,
Jorge Vilariño Rico, MD, PhD, Francisco José Franco Meijide, MD, and Santiago Caeiro Quinteiro, MD,
Coruña, Spain
Endograft limb trimming canbe an easy customization to perform in some emergent setups andwhen alternative adequate
covered stents are lacking. A managed 74 years presented with aortoenteric stula and hemodynamic instability years after
an aortobifemoral bypass, and a 56-year-old woman was admitted with acute ischemia due to an aortic ulcer-like lesion. In
both cases, tabletop deployment and removal of two stents from an Endurant iliac limb (Medtronic, Fridley, Minn),
followed by resheathing and deployment, allowed successful repair as a bridging therapy for open surgery. Both patients
are alive and without walking impairment 8 and 6 months later, respectively. (J Vasc Surg Cases 2016;2:88-91.)
The spread of endovascular techniques entails the need
of a vast armamentarium available for vascular surgeons
worldwide. Proper planning should offer good perfor-
mance and reliability for most cases,
1
although some situa-
tions require adaptive solutions because of the emergent
need of repair, delay in the materials availability, or both.
We present two cases in which a conventional endograft
component (iliac limb) was customized for a rapid endo-
vascular solution in the infrarenal aorta; both patients
signed a dedicated consent form before this report.
CASE REPORT
Case 1. A 74-year-old man was admitted to the emergency
department with abdominal pain and hemodynamic instability,
maintained with vasoactive drugs. The patients comorbidities
included Sjögren syndrome and autoimmune hepatitis. Previous
abdominal interventions included an aortobifemoral bypass
because of severe buttock claudication, a complicated appendec-
tomy 3 years later, a reintervention due to adhesions, and an
intestinal resection with colostomy, reconstructed a year later.
On admission, the main diagnostic suspicion was an aortoenteric
stula, although computed tomography showed no active extrava-
sation of contrast material (Fig 1).
The right limb of the previous aortobifemoral bypass was
exposed and punctured, and above-renal angiography conrmed
an 82-mm distance between the lowest renal artery and the bypass
bifurcation. On the back table, a 93-mm Medtronic Endurant iliac
extension (Medtronic, Fridley, Minn) was ushed and prepared in
the conventional way (16-mm proximal and 20-mm distal diame-
ters). While being held in place, the outer sheath was retracted and
the two proximal stents were deployed, holding the third inside the
delivery sheath (Fig 2). A scalpel was used to section the fabric
between the second and the third nitinol stents, resulting in a
length loss of 21 mm for a nal customized graft length of
72 mm. The outer delivery sheath was replaced in its original
position, and the iliac limb could be deployed under uoroscopy
without complications. The completion angiogram showed no
active bleeding or endoleaks. The patient recovered with immedi-
ate hemodynamic stability, no further drop in serum hemoglobin
level, and remarkable improvement in his abdominal pain.
Thirteen days after the procedure, the bifurcated graft was
removed and replaced by a silver-coated Dacron graft. A full
duodenectomy was performed, and the retroperitoneal area was
secured with a vast omentoplasty. Pseudomonas aeruginosa and
Candida glabrata were isolated in the microbiologic studies
performed on the graft, and the correspondent antimicrobial ther-
apy was administered. However, positron emission tomography
performed 10 weeks after the reconstruction showed active leuko-
cyte activity in the graft bifurcation, correlated with some collec-
tion-like images in the same area. Thus, in a new procedure, the
silver-coated graft was explanted and an axillobifemoral bypass
was performed, with good immediate results. The patient is active
and walking 8 months after the rst procedure, without fever or
inammatory symptoms.
Case 2. A 56-year-old woman previously observed at the
clinic for stable bilateral buttock claudication was admitted with
bilateral acute ischemia. A computed tomography scan identied
an infrarenal ulcer-like aortic lesion, which conditioned a signi-
cant stenosis of the aorta at that level, in the context of a hypoplas-
tic aortoiliac axis (Fig 3,Aand B). Her comorbidities and risk
From Complejo Hospitalario Universitario de A Coruña (CHUAC).
Author conict of interest: none.
Correspondence: Francisco Álvarez Marcos, MD, MSc, Servicio de Angio-
logía y Cirugía Vascular, Complejo Hospitalario Universitario de A
Coruña (CHUAC), 8
a
planta As Xubias 84, 15006 A Coruña, Spain
(e-mail: francisco.alvarez.marcos@sergas.es).
The editors and reviewers of thisarticle have no relevant nancial relationships
to disclose per the Journal policy that requires reviewers to decline review of
any manuscript for which they may have a conict of interest.
2468-4287
Ó2016 The Author(s). Published by Elsevier Inc. on behalf of Society for
Vascular Surgery. This is an open access article under the CC BY-NC-
ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
http://dx.doi.org/10.1016/j.jvscit.2016.04.003
88
factors included mild smoking, insulin-dependent type 2 diabetes,
and dyslipidemia.
After three-dimensional reconstruction and case planning,
nondeferrable endovascular treatment was completed by trimming
an 82-mm Medtronic Endurant iliac limb (13-mm proximal and
13-mm distal diameters). The centerline reconstruction and the sub-
sequent angiographic conrmation indicated a distance of 68 mm
from the lowest renal artery to the aortic bifurcation. Accordingly,
the two proximal stents were removed in a way similar to the
previously described case for an implant length of 61 mm
(Fig 3,Cand D). The patient recovered pedal pulses in the operating
room and was discharged under antiplatelet therapy the day after.
Three months after the procedure, some degree of buttock
claudication was reported at the follow-up visit, which correlated
with bilateral common iliac stenosis in the imaging studies per-
formed. To offer a long-lasting x, the previous repair was
explanted and an aortobifemoral Dacron bypass was performed,
allowing the patient to have full recovery of both pedal pulses
and no walking impairment 6 months after the surgery.
DISCUSSION
Endograft customization with resheathing has been
used as an alternative in select cases. Some authors have
performed successful hand-made fenestrations over stan-
dard infrarenal endografts, mainly Zenith (Cook Medical,
Bloomington, Ind)
2-7
and C3 (W. L. Gore & Associates,
Flagstaff, Ariz) devices.
8
Others have transformed a bifur-
cated graft into a uni-iliac conguration
9
or reversed the
disposition of an iliac limb to change it from a ared to a
tapered conguration.
10,11
Some degree of parallelism
with our technique can be found in the trimming of a
Valiant graft (Medtronic) deployed in an acute ascending
aortic penetrating ulcer, reported by Allen et al.
12
The main justication for this technique is a combina-
tion of anatomic constraints, the lack of large enough
covered stents, and the need of a quick repair. Both diam-
eter and length boundaries were found in our cases. The
Fig 1. Centerline reconstruction and measures performed over
computed tomography image showing the distance between the
lowest renal artery (A) and the bifurcation of the previous Dacron
graft, with identication of the possible bleeding point (B). The
thrombosed and calcied native aortic axis is right below (C).
Fig 2. Back-table limb partial deployment and trimming. A, Desired length conrmation with a radiopaque ruler.
B, The two proximal stents have been deployed while the third is still held in place by the outer delivery sheath.
C, Fabric cut out right under the second nitinol stent.
JOURNAL OF VASCULAR SURGERY CASES AND INNOVATIVE TECHNIQUES
Volume 2, Number 3 Álvarez Marcos et al 89
aorta was not small enough to be treated with available
covered stents and not big enough to accept standard
endografts; also, the distance between the renal arteries
and the bifurcation (82 mm for the rst case and 68 for
the second) forced the need of a cutback. The largest
covered stents offer diameters up to 13 to 14 mm because
iCAST/Advanta V12 balloon-expandable stent grafts
(Atrium-Maquet Getinge Group, Hudson, NH) have
availability problems as the company entered a voluntary
consent decree with the U.S. Food and Drug Administra-
tion. Precise anatomic measures, centerline reconstruction
of the target vessel, and intraoperative conrmation with
a sizing catheter were essential to avoid complications.
Our technique permitted quick and safe shortening of
the iliac limb length as Medtronic Endurant II arrange-
ment allows a stent-by-stent deployment for tabletop
modication. Special care should be taken to avoid damage
to the internal tubing of the graft delivery system. In our
cases, there was no need to constrain any portion of the
graft as all the remaining stents to be deployed stayed all
the time within the external delivery tube.
The long-term performance of these modications
remains to be seen; the rst graft was explanted 13 days
after implantation and the second needed a redo procedure
12 weeks after. In any case, routine use of this surgeon-
performed solution does not seem acceptable, and if it is
intended to last over time, it should undergo studies under
the Food and Drug Administrations investigational device
exemptions.
13
Nevertheless, advisory statements from the
Society for Vascular Surgery
14
discard any of these require-
ments in an emergent context or for compassionate
use, although the latter may require Institutional Review
Board approval.
CONCLUSIONS
Medtronic Endurants iliac limbs allow a quick and easy
tabletop modication for treating emergent cases when
alternative and more adequate materials are lacking,
although routine use should be avoided as any amendment
performed may vary the characteristics and performance of
the endograft.
REFERENCES
1. Arko FR, Murphy EH, Boyes C, Nussbaum T, Lalka SG, Holleman J,
et al. Current status of endovascular aneurysm repair: 20 years of
learning. Semin Vasc Surg 2012;25:131-5.
2. Oderich GS, Ricotta JJ. Modied fenestrated stent grafts: device
design, modications, implantation, and current applications. Perspect
Vasc Surg Endovasc Ther 2009;21:157-67.
3. Oderich GS, Farber MA, Sanchez LA. Urgent endovascular treatment
of symptomatic or contained ruptured aneurysms with modied stent
grafts. Perspect Vasc Surg Endovasc Ther 2011;23:186-94.
4. Oderich GS, Fatima J, Gloviczki P. Stent graft modication with mini-
cuff reinforced fenestrations for urgent repair of thoracoabdominal
aortic aneurysms. J Vasc Surg 2011;54:1522-6.
5. Stephen E, Joseph G, Sen I, Chacko S, Premkumar P, Varghese L, et al.
A novel cautery instrument for on-site fenestration of aortic stent-
grafts: a feasibility study of 18 patients. J Endovasc Ther 2013;20:
638-46.
6. Redlinger RE, Ahanchi SS, Panneton JM. In situ laser fenestration
during emergent thoracic endovascular aortic repair is an effective
method for left subclavian artery revascularization. J Vasc Surg
2013;58:1171-7.
Fig 3. Computed tomography scan centerline reconstructions before and after implantation (A and D) and intra-
operative angiograms (B and C) of case 2, showing the aortic ulcer and the result after the deployment of the
customized iliac limb.
JOURNAL OF VASCULAR SURGERY CASES AND INNOVATIVE TECHNIQUES
90 Álvarez Marcos et al September 2016
7. Haulon S, OBrien N. Commentary: customization of branched stent-
grafts for patients with complex abdominal aortic anatomies.
J Endovasc Ther 2010;17:268-70.
8. Coulter AH, Tan TW, Zhang WW. Physician modication of Gore C3
excluder endograft for treatment of abdominal aortic aneurysms
anatomically unsuitable for conventional endovascular repair. J Vasc
Surg 2014;59:1739-43.
9. Tsilimparis N, Lohrenz C, Pugradt A, Wipper S, Debus S, Kölbel T.
Back-table modication of a bifurcated infrarenal stent-graft to aorto-
monoiliac for emergencies. J Endovasc Ther 2014;21:348-52.
10. Hiramoto JS, Reilly LM, Schneider D, Rapp JH, Chuter TAM. The
upside-down Zenith stent graft limb. Vascular 2009;17:93-5.
11. Higashigawa T, Kato N, Hashimoto T, Inouchi M, Chino S,
Yamamoto N, et al. Upside down use of Gore Excluder or Cook
Zenith legs. Cardiovasc Intervent Radiol 2014;37:1068-72.
12. Allen KB, Davis JR, Cohen DJ. Critical aortic stenosis and acute
ascending aortic penetrating ulcer managed utilizing transapical TAVR
and TEVAR. Catheter Cardiovasc Interv 2015;86:768-72.
13. Waninger MS, Whirley RG, Smith LJ, Wolf BS. Manufacturer
evaluations of endograft modications. J Vasc Surg 2013;57:826-8.
14. White RA. Advisory statement on clinical use of modied aortic endog-
rafts from the Society for Vascular Surgery. J Vasc Surg 2013;57:832-3.
Submitted Feb 28, 2016; accepted Apr 8, 2016.
JOURNAL OF VASCULAR SURGERY CASES AND INNOVATIVE TECHNIQUES
Volume 2, Number 3 Álvarez Marcos et al 91
Article
Full-text available
Purpose: To report the bench-top evaluation and initial clinical use of an instrument for on-site fenestration of aortic stent-grafts. Methods: A stainless steel thermal cautery instrument was designed to create circular stent-graft fenestrations from 3 to 10 mm in diameter. Three operators independently bench-tested the instrument on thoracic stent-graft samples to evaluate size, shape, location, and quality of fenestrations created. For clinical use, on-site fenestration was performed 2 days before the endovascular procedure in a sterile room without access to supplemental oxygen. A fenestrator 1 or 2 mm smaller in diameter than the target vessel was used; the edges of the fenestrations were strengthened using flexible radiopaque nitinol wire. The aortic stent-graft was then re-sheathed and sterilized for added safety. Eighteen patients (17 men; mean age 51 years, range 18-80) with a variety of thoracic and juxtarenal pathologies were treated using Zenith TX2, Valiant Captivia, Zenith AAA, and Endurant stent-grafts modified in this manner. Results: After successful bench testing, the instrument was used to create 34 fenestrations in aortic stent-grafts deployed in the 18 patients. Size and location of fenestrations obtained were as desired. Subsequent catheterization of the fenestration/target vessel and covered stent deployment were successfully achieved in 31 (91%) fenestrations; 2 fenestrations had type III endoleaks and 1 fenestration was unused. There was no perioperative mortality, stroke, embolization, vessel dissection, renal failure, or graft infection. Follow-up to 1 year in the majority of patients has revealed no new fenestration-related problems. Conclusion: This simple-to-use instrument makes on-site creation of aortic stent-graft fenestrations easy, accurate, and precise. The instrument is inexpensive, robust, and easily sterilized.
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