- Email: [email protected]
Chimney Technique with the INCRAFT® AAA Stent Graft System to Treat Pararenal Aortic Aneurysm in Narrowed Iliac Axes
Accepted Manuscript Chimney Technique with the INCRAFT® AAA Stent Graft System to Treat Pararenal Aortic Aneurysm in Narrowed Iliac Axes Nunzio Montelione, Pasqualino Sirignano, Wassim Mansour, Martina Formiconi, Laura Capoccia, Francesco Speziale PII:
S0890-5096(17)30022-5
DOI:
10.1016/j.avsg.2017.03.199
Reference:
AVSG 3359
To appear in:
Annals of Vascular Surgery
Received Date: 9 January 2017 Revised Date:
11 March 2017
Accepted Date: 26 March 2017
Please cite this article as: Montelione N, Sirignano P, Mansour W, Formiconi M, Capoccia L, Speziale F, Chimney Technique with the INCRAFT® AAA Stent Graft System to Treat Pararenal Aortic Aneurysm in Narrowed Iliac Axes, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.03.199. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
CHIMNEY TECHNIQUE WITH THE INCRAFT® AAA STENT GRAFT SYSTEM
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TO TREAT PARARENAL AORTIC ANEURYSM IN NARROWED ILIAC AXES
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Nunzio Montelione *, Pasqualino Sirignano, Wassim Mansour,
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Martina Formiconi, Laura Capoccia, and Francesco Speziale
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6 Vascular and Endovascular Surgery Unit
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Departement of Surgery “Paride Stefanini”
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Policlinico Umberto I
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“Sapienza” University of Rome, Italy
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* Corresponding Author:
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Nunzio Montelione, MD
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Vascular and Endovascular Surgery Division
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Department of Surgery “Paride Stefanini”
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“Sapienza” University of Rome
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Policlinico Umberto I
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Viale del Policlinico, 155
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00161 – Rome, Italy
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Tel/Fax: +39 06 4940532
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Mobile: +39 3479598785
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email: [email protected]
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ACCEPTED MANUSCRIPT Abstract
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To report a case of pararenal aortic aneurysm (PAAA) with narrowed iliac arteries treated by the
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chimney technique combined with the INCRAFT® AAA stent graft system.
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A 75-year-old man was diagnosed with a 55mm PAAA. Patient was judged unfit for open repair
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and for standard endovascular repair (EVAR) due to its clinical and anatomical requirements.
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Custom-made fenestrated device (FEVAR) was excluded due to the presence of narrowed and
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heavily calcified iliac axes. Consequently, patient underwent auspicious endovascular aneurysm
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repair with the INCRAFT® System and chimney grafts in the superior mesenteric artery and both
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renal arteries. At 12 months’ follow-up, patient was in good clinical condition, with preserved renal
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function. Computed tomographic angiography revealed inceptive shrinkage of the aneurysm with
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patency of aortic and visceral grafts even in the presence of a low-flow type Ia endoleak.
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Chimney grafts (CGs) combined with the low profile INCRAFT® System seem to be feasible for
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treating PAAA, in high-risk patients unfit for standard EVAR or FEVAR devices.
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Keywords: Endovascular aneurysm repair - Chimney graft - Low profile endograft - Pararenal
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aortic aneurysm - Parallel graft
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ACCEPTED MANUSCRIPT Introduction
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Anatomical restrictions for endovascular aneurysm repair (EVAR) are characterized by
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“challenging neck” (non-cylindrical, extremely short and highly angulated) and “difficult access”
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(narrowed and severely angulated iliac arteries).1,2
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Since the first bailout application,3,4 the chimney technique has become established as expanding
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indication for EVAR in patients with challenging neck or pararenal aortic aneurysms (PAAA),5
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yielding promising short- and mid-term results, even in elective settings.6,7
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Distinct arrays of endografts are now routinely utilized, coupled with chimney grafts (CG),7 but
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only a paucity of data is available about new low profile systems and CGs, for overcoming
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difficulties related to iliac axes.8,9
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We report a case of a patient with PAAA electively treated by chimney technique and a new ultra-
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low profile device INCRAFT® AAA Stent Graft system.10
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Case Report
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A 75-year-old man was referred to our center for an asymptomatic PAAA. Patient’s medical history
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was positive for arterial hypertension, dyslipidemia, chronic obstructive pulmonary disease (FEV1
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<50%), coronary artery disease (previous PTCA; left ventricular ejection fraction <40%), previous
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urothelial cell carcinoma, and tobacco abuse. Pre-operative serum creatinine was 0.9 mg/dL with an
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estimated glomerular filtration rate (eGFR ) of 85 mL/min/1.73 m2.
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Because the patient’s comordibities precluded open surgical repair, an endovascular approach was
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considered.
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Pre-operative computed tomographic angiography (CTA) revealed a saccular PAAA (Fig. 1), with a
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maximum diameter of 55 mm and a total volume of 89,1 cm3. Aortic diameter just above the renal
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arteries was 21 mm, inter-renal aortic diameter was 28 mm, and aortic diameters 5, 10, 15, and 20
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mm below the lowest renal artery were 38, 43, 46, and 49 mm, respectively. The entire aorta
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presented a relatively straight anatomy with an α angle of 18°and β angle of 4°. In addition, highly
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calcified and narrowed iliac axes (narrowest right external iliac artery diameter: 5 mm; left: 4.6
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mm) were present (Fig. 2).
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A custom-made fenestrated graft (FEVAR) was excluded due to anatomical restrictions: short
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distance between the superior mesenteric and both renal arteries’ ostia, and the absence of adequate
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access vessels.
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An off-label chimney procedure was then planned. At center lumen line reconstruction, the distance
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between the superior mesenteric artery (SMA) and the lowest renal artery (RA) was found to be 3
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mm, while the distance from the celiac trunk to the lowest RA was 21 mm. Consequently,
ACCEPTED MANUSCRIPT considering the diameter of the iliac arteries, CGs to the SMA and both RAs were contemplated,
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combined with a low profile abdominal aortic device INCRAFT® AAA Stent Graft system (Cordis
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Corp, Bridgewater, NJ-USA).
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The procedure was performed under general anesthesia in an operating theater equipped with a
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portable fluoroscopy unit (Euroamplin Alien, Eurocolumbus – Milan, Italy).
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After systemic heparinization, percutaneous access was achieved via duplex ultrasound guidance to
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both common femoral arteries. Preclose technique was used with one Perclose ProGlide® Suture-
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Mediated Closure System (Abbot Vascular, Santa Clara, CA-USA) for each groin, after which,
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surgical exposures of the right brachial and left axillary arteries were performed.
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Two 7F × 90-cm Flexor® Shuttle® sheaths (Cook Medical, Inc.; Bloomington, IN-USA) were
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inserted into the left axillary artery, and a 10F × 90-cm Flexor® Shuttle® sheath (Cook Medical,
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Inc.) into the right brachial artery. All of those sheaths were advanced into the distal descending
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thoracic aorta and renovisceral branch cannulation was attained, employing a 5-F Chuang visceral
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reverse curve catheter (Cook Medical, Inc.), and a Rosen wire (Cook Medical, Inc.).
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From the right femoral access, the INCRAFT® AAA Stent Graft system (Cordis Corp) was
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advanced up to the level of the celiac trunk over 0.035-in SS Amplatz® wire (Boston Scientific
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Corporation; Natick, MA-USA),
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Diameter sizing of the aortic stent graft was 30 mm, based on the mean aortic neck diameter (21
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mm) and the mean diameter of each of the CGs, according to Lachat’s experience.6
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Once the main body was in place, all the shuttle sheaths were advanced toward their visceral target
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vessels and the CGs were positioned and deployed with the distal end ~2 cm into the target vessels.
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Viabahn® stent grafts (W.L. Gore & Associates, Inc.) were used in all cases: 7x50mm for the SMA
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and 6x50mm for both RAs.
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Bare-metal nitinol stents were employed to endoline the interior of the covered CGs (SMA:
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Everflex 7x60mm; RAs: Everflex 6x60 mm; Medtronic, Santa Rosa, CA-USA) and then post-
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dilated with non-compliant balloon catheters to attain secure anchoring. Once deflated, balloon
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catheters were left in the distal landing zone of all the CGs. During the main body stent graft
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deployment, balloons were reinflated and tensioned to hold the CGs straight and parallel to the
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aortic wall avoiding migration, as previously reported.6,11
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The procedure was finalized, deploying two iliac limb extensions from the femoral access (right
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side: 10x12 mm; left side: 10x12 mm; Cordis Corp).
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Ballooning of the docking zone and kissing balloon technique were performed in order to achieve
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simultaneous, complete expansion of the aortic graft and CGs, especially in the overlapping areas.
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ACCEPTED MANUSCRIPT In the completion angiography (Fig. 3), all grafts and visceral branches were patent, the aneurysm
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was satisfactorily excluded with the presence of a delayed low flow type Ia endoleak. New kissing
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balloon dilatations of grafts were performed as prompt corrective treatment with a significant
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diminution of the type Ia endoleak.
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Procedure time was 281 minutes, radiation dose area product was 62543 mGy*cm2 and total
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contrast amount was 155 mL.
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Intensive care unit stay was two days; postoperative course was uneventful and patient was
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discharged on the sixth postoperative day with double antiplatelet therapy (acetylsalicylic acid 100
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mg/d and clopidogrel 75 mg/d) for three months. Mono-antiplatelet therapy was continued
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indefinitely.
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At 12 months’ follow-up patient was in good clinical condition, with preserved renal function
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(eGFR 82mL/min/1.73m2). Scheduled CTA (Fig. 4) showed initial shrinkage of the aneurysm
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(maximum diameter 50 mm, volume 82,6 cm3), with patency of aortic and visceral grafts even with
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a low -flow type Ia endoleak.
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Patient gave consent for treatment and for publication of his clinical notes.
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151 Discussion
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Over the years, use of CGs has been reported to treat ruptured abdominal aortic aneurysms,
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expanding indication for EVAR even in the absence of a suitable proximal landing zone.5
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Nowadays, recent data confirm the efficacy of the procedure even in elective treatment of PAAAs
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and thoracoabdominal aortic aneurysms.6,7
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We reported the case of a patient considered unfit for open surgery in which standard EVAR was
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excluded for lack of infrarenal neck. Custom-made FEVAR devices were not considered an option
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because positioning of the graft requires the capability to advance and rotate a large delivery system
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(to correctly align the fenestrations with the visceral vessel orifices), which could be impaired by
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narrowed access vessels.12,13
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Unfavorable iliac anatomy is a well-known contraindication for endovascular aortic aneurysm
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repair. In 2000, the EUROSTAR registry reported iliac access problems in 13% of patients selected
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for EVAR due to iliac tortuosity, occlusive disease, or small-caliber.14 Even if the available
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technology has improved remarkably over the years,15 EVAR, and much more F-EVAR or B-
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EVAR, still represent challenging procedures in patients with small, calcified, or tortuous iliac
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vessels.16 Indeed, adequate iliac access for 18F to 20F delivery catheters is 6–7 mm and, according
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to these diameters, about 50% of patients are excluded from EVAR treatment.17 Moreover, insertion
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of large delivery catheters into small iliac vessels potentially increases the peril of iliac artery
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ACCEPTED MANUSCRIPT rupture with life-threatening bleeding. Some feasible solutions include highly flexible hydrophilic
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devices, iliac conduits, ‘‘cracking and paving,’’ and alternative access sites.18
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CGs in association with conventional endografts presenting an outer diameter ranging from 16 to
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20F were deemed unsuitable to treat the patient. Despite the fact that some authors have described
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the chimney technique combined with a polymer-based endograft, at that time, we had not
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performed enough of these procedures to have sufficient experience to use those grafts in
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combination with the chimney technique.9
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Considering all the aforementioned reasons, an off-label chimney technique was performed by
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placing CGs in the SMA and RAs, coupled with the low profile INCRAFT® device, to overcome
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technical limitations due to unfavorable iliac anatomy.
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The INCRAFT® Stent Graft System was designed to address some of the limitations of current
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devices. To increase the applicability of EVAR to a broader range of patients such as those with
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small or diseased access vessels, design enhancements allowed the device to be constrained within
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an ultra-low profile delivery system with a true 14F (4.7mm) outer diameter for main-body, and
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12.5F for iliac limbs.19
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The election of such a novel concept and low profile device allowed for successful treatment of
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the patient, even in the presence of a small type Ia endoleak in the completion angiography and
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follow-up images.
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Postoperative endoleaks after the adoption of CGs are a frequent event, occurring in as many as
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23% of cases and represent a potential cause of aneurysmal rupture.7,20-22 However, if endoleaks are
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addressed judiciously, by close clinical and radiological follow-up, related complications could be
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tempered by the lack of perseverence or clinical adverse sequelae .7,20
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The majority of the endoleaks were primarily due to “gutter ” occurrences, between the CGs and
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aortic endografts, the presence and size of which remain the main concern that compromises (the
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early or late) outcomes of this technique. Persistent or new-onset postoperative type Ia endoleaks
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seem to be linked to numbers of CGs implanted and length of the new landing zones.7,20 Indeed,
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data from the PERICLES registry showed a greater incidence of Type Ia endoleaks when more
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than three CGs were required.7 Incidence of endoleaks is reported to be rare provided an adequate
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proximal landing zone has been created (almost 20mm).7,20
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In the present case, it was necessary to implant three CG’s in order to achieve a satisfactory, new
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proximal landing zone (21mm). Considering previously reported data, by performing that
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procedure, we averted a clinically relevant, high-flow endoleak (with a new proximal landing zone
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of 21 mm created), but we were exposed to a higher risk of gutter occurrences (with three CGs
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ACCEPTED MANUSCRIPT performed). Furthermore, the necessity to use three CGs required two different brachial/axillary
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accesses to advance the guiding sheaths in order to minimize potential vessels damages11,23.
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The best combinations of aortic and branch stent grafts to potentially minimize gutter-related
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concerns are another important aspect for consideration. Even though both experimental24,25 and
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clinical studies6,7,20 have been performed in an endeavor to resolve this issue, no definitive data, in
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particular, using the new concept INCRAFT® device, are currently available. Self-expandable
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chimney grafts were preferred because profile and flexibility. Particularly Viabahn seems to
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represent a durable treatment for renovisceral arteries 20.
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Despite the fact that several techniques have been reported to correct type IA endoleaks after
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chimney graft procedures (coil embolization or “neck elongation ”),7,20 some experience seems to
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suggest that not all postoperative endoleaks should be invasively managed. In a report by Donas
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and co-workers, out of five perioperative type Ia endoleak, only one was treated during follow-up
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due to continuous aneurismal sac increase23. Indeed, delayed low-flow type IA endoleaks are
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reported as not propagating either aneurysmal enlargement or clinical adverse events in all
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published experiences.6,11,20 For these reasons, the patient is being strictly observed in the absence
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of further treatment.
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219 Conclusion
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In the present case, the use of CGs combined with the ultra-low profile INCRAFT® System has
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proven to be a feasible, safe, and viable approach in the treatment of PAAA.
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In our opinion, this solution represents a viable option for treating high-risk patients with a
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challenging iliac anatomy, unsuitable for fenestrated devices. Lengthier follow-up and greater
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numbers of cases are required.
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ACCEPTED MANUSCRIPT References
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[1] de Vries JP. The proximal neck: the remaining barrier to a complete EVAR world. Semin Vasc
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[2] Moise MA, Woo EY, Velazquez OC, Fairman RM, Golden MA, Mitchell ME, Carpenter JP.
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[5] Pecoraro F, Pfammatter T, Mayer D, Frauenfelder T, Papadimitriou D, Hechelhammer L, Veith
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[7] Donas KP, Lee JT, Lachat M, Torsello G, Veith FJ. Collected world experience about the
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[10] Greenberg RK. Aortic aneurysm, thoracoabdominal aneurysm, juxtarenal aneurysm,
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ACCEPTED MANUSCRIPT [11] Montelione N, Pecoraro F, Puippe G, Chaykovska L, Rancic Z, Pfammatter T, Mayer D,
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Amann-Vesti B, Husmann MJ, Veith FJ, Mangialardi N, Lachat M. A 12-year experience with
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chimney and periscope grafts for treatment of type I endoleaks. J Endovasc Ther 2015;22:568-74.
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[12] Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ, Prins TR, Bracale UM, van
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Galzerano G, Setacci C. Iliac and femoro-popliteal arteries morphological CTA features as
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determinants of outcome after standard EVAR procedures. J Cardiovasc Surg (Torino) 2016 Sep
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Z. Use of covered chimney stents for pararenal aortic pathologies is safe and feasible with excellent
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[24] de Bruin JL, Yeung KK, Niepoth WW, Lely RJ, Cheung Q, de Vries A, Blankensteijn JD.
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[25] Mestres G, Uribe JP, Garcìa-Madrid C, Miret E, Alomar X, Burrel M, Riambau V. The best
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Figure Legend
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Figure 1. - Multiplanar reconstruction of preoperative computed tomographic angiography (CTA)
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showing pararenal aortic aneurysm;
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Figure 2. - Three-dimensional reconstruction of preoperative CTA underlying the presence of
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narrowed and heavy calcified iliac arteries;
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Figure 3. - Completion angiography showing patency of all grafts and visceral branches,
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satisfactory exclusion of the aneurysm with the presence of a low flow type Ia endoleak (white
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arrows);
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Figure 4. - Three-dimensional reconstruction of 12 months’ CTA showing the good aneurysm
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exclusion.
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S0890-5096(17)30022-5
DOI:
10.1016/j.avsg.2017.03.199
Reference:
AVSG 3359
To appear in:
Annals of Vascular Surgery
Received Date: 9 January 2017 Revised Date:
11 March 2017
Accepted Date: 26 March 2017
Please cite this article as: Montelione N, Sirignano P, Mansour W, Formiconi M, Capoccia L, Speziale F, Chimney Technique with the INCRAFT® AAA Stent Graft System to Treat Pararenal Aortic Aneurysm in Narrowed Iliac Axes, Annals of Vascular Surgery (2017), doi: 10.1016/j.avsg.2017.03.199. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1
CHIMNEY TECHNIQUE WITH THE INCRAFT® AAA STENT GRAFT SYSTEM
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TO TREAT PARARENAL AORTIC ANEURYSM IN NARROWED ILIAC AXES
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Nunzio Montelione *, Pasqualino Sirignano, Wassim Mansour,
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Martina Formiconi, Laura Capoccia, and Francesco Speziale
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6 Vascular and Endovascular Surgery Unit
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Departement of Surgery “Paride Stefanini”
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Policlinico Umberto I
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“Sapienza” University of Rome, Italy
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* Corresponding Author:
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Nunzio Montelione, MD
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Vascular and Endovascular Surgery Division
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Department of Surgery “Paride Stefanini”
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“Sapienza” University of Rome
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Policlinico Umberto I
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Viale del Policlinico, 155
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00161 – Rome, Italy
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Tel/Fax: +39 06 4940532
23
Mobile: +39 3479598785
24
email: [email protected]
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ACCEPTED MANUSCRIPT Abstract
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To report a case of pararenal aortic aneurysm (PAAA) with narrowed iliac arteries treated by the
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chimney technique combined with the INCRAFT® AAA stent graft system.
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A 75-year-old man was diagnosed with a 55mm PAAA. Patient was judged unfit for open repair
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and for standard endovascular repair (EVAR) due to its clinical and anatomical requirements.
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Custom-made fenestrated device (FEVAR) was excluded due to the presence of narrowed and
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heavily calcified iliac axes. Consequently, patient underwent auspicious endovascular aneurysm
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repair with the INCRAFT® System and chimney grafts in the superior mesenteric artery and both
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renal arteries. At 12 months’ follow-up, patient was in good clinical condition, with preserved renal
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function. Computed tomographic angiography revealed inceptive shrinkage of the aneurysm with
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patency of aortic and visceral grafts even in the presence of a low-flow type Ia endoleak.
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Chimney grafts (CGs) combined with the low profile INCRAFT® System seem to be feasible for
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treating PAAA, in high-risk patients unfit for standard EVAR or FEVAR devices.
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Keywords: Endovascular aneurysm repair - Chimney graft - Low profile endograft - Pararenal
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aortic aneurysm - Parallel graft
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ACCEPTED MANUSCRIPT Introduction
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Anatomical restrictions for endovascular aneurysm repair (EVAR) are characterized by
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“challenging neck” (non-cylindrical, extremely short and highly angulated) and “difficult access”
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(narrowed and severely angulated iliac arteries).1,2
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Since the first bailout application,3,4 the chimney technique has become established as expanding
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indication for EVAR in patients with challenging neck or pararenal aortic aneurysms (PAAA),5
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yielding promising short- and mid-term results, even in elective settings.6,7
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Distinct arrays of endografts are now routinely utilized, coupled with chimney grafts (CG),7 but
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only a paucity of data is available about new low profile systems and CGs, for overcoming
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difficulties related to iliac axes.8,9
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We report a case of a patient with PAAA electively treated by chimney technique and a new ultra-
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low profile device INCRAFT® AAA Stent Graft system.10
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Case Report
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A 75-year-old man was referred to our center for an asymptomatic PAAA. Patient’s medical history
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was positive for arterial hypertension, dyslipidemia, chronic obstructive pulmonary disease (FEV1
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<50%), coronary artery disease (previous PTCA; left ventricular ejection fraction <40%), previous
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urothelial cell carcinoma, and tobacco abuse. Pre-operative serum creatinine was 0.9 mg/dL with an
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estimated glomerular filtration rate (eGFR ) of 85 mL/min/1.73 m2.
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Because the patient’s comordibities precluded open surgical repair, an endovascular approach was
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considered.
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Pre-operative computed tomographic angiography (CTA) revealed a saccular PAAA (Fig. 1), with a
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maximum diameter of 55 mm and a total volume of 89,1 cm3. Aortic diameter just above the renal
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arteries was 21 mm, inter-renal aortic diameter was 28 mm, and aortic diameters 5, 10, 15, and 20
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mm below the lowest renal artery were 38, 43, 46, and 49 mm, respectively. The entire aorta
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presented a relatively straight anatomy with an α angle of 18°and β angle of 4°. In addition, highly
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calcified and narrowed iliac axes (narrowest right external iliac artery diameter: 5 mm; left: 4.6
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mm) were present (Fig. 2).
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A custom-made fenestrated graft (FEVAR) was excluded due to anatomical restrictions: short
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distance between the superior mesenteric and both renal arteries’ ostia, and the absence of adequate
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access vessels.
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An off-label chimney procedure was then planned. At center lumen line reconstruction, the distance
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between the superior mesenteric artery (SMA) and the lowest renal artery (RA) was found to be 3
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mm, while the distance from the celiac trunk to the lowest RA was 21 mm. Consequently,
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combined with a low profile abdominal aortic device INCRAFT® AAA Stent Graft system (Cordis
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Corp, Bridgewater, NJ-USA).
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The procedure was performed under general anesthesia in an operating theater equipped with a
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portable fluoroscopy unit (Euroamplin Alien, Eurocolumbus – Milan, Italy).
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After systemic heparinization, percutaneous access was achieved via duplex ultrasound guidance to
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both common femoral arteries. Preclose technique was used with one Perclose ProGlide® Suture-
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Mediated Closure System (Abbot Vascular, Santa Clara, CA-USA) for each groin, after which,
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surgical exposures of the right brachial and left axillary arteries were performed.
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Two 7F × 90-cm Flexor® Shuttle® sheaths (Cook Medical, Inc.; Bloomington, IN-USA) were
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inserted into the left axillary artery, and a 10F × 90-cm Flexor® Shuttle® sheath (Cook Medical,
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Inc.) into the right brachial artery. All of those sheaths were advanced into the distal descending
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thoracic aorta and renovisceral branch cannulation was attained, employing a 5-F Chuang visceral
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reverse curve catheter (Cook Medical, Inc.), and a Rosen wire (Cook Medical, Inc.).
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From the right femoral access, the INCRAFT® AAA Stent Graft system (Cordis Corp) was
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advanced up to the level of the celiac trunk over 0.035-in SS Amplatz® wire (Boston Scientific
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Corporation; Natick, MA-USA),
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Diameter sizing of the aortic stent graft was 30 mm, based on the mean aortic neck diameter (21
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mm) and the mean diameter of each of the CGs, according to Lachat’s experience.6
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Once the main body was in place, all the shuttle sheaths were advanced toward their visceral target
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vessels and the CGs were positioned and deployed with the distal end ~2 cm into the target vessels.
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Viabahn® stent grafts (W.L. Gore & Associates, Inc.) were used in all cases: 7x50mm for the SMA
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and 6x50mm for both RAs.
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Bare-metal nitinol stents were employed to endoline the interior of the covered CGs (SMA:
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Everflex 7x60mm; RAs: Everflex 6x60 mm; Medtronic, Santa Rosa, CA-USA) and then post-
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dilated with non-compliant balloon catheters to attain secure anchoring. Once deflated, balloon
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catheters were left in the distal landing zone of all the CGs. During the main body stent graft
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deployment, balloons were reinflated and tensioned to hold the CGs straight and parallel to the
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aortic wall avoiding migration, as previously reported.6,11
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The procedure was finalized, deploying two iliac limb extensions from the femoral access (right
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side: 10x12 mm; left side: 10x12 mm; Cordis Corp).
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Ballooning of the docking zone and kissing balloon technique were performed in order to achieve
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simultaneous, complete expansion of the aortic graft and CGs, especially in the overlapping areas.
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ACCEPTED MANUSCRIPT In the completion angiography (Fig. 3), all grafts and visceral branches were patent, the aneurysm
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was satisfactorily excluded with the presence of a delayed low flow type Ia endoleak. New kissing
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balloon dilatations of grafts were performed as prompt corrective treatment with a significant
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diminution of the type Ia endoleak.
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Procedure time was 281 minutes, radiation dose area product was 62543 mGy*cm2 and total
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contrast amount was 155 mL.
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Intensive care unit stay was two days; postoperative course was uneventful and patient was
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discharged on the sixth postoperative day with double antiplatelet therapy (acetylsalicylic acid 100
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mg/d and clopidogrel 75 mg/d) for three months. Mono-antiplatelet therapy was continued
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indefinitely.
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At 12 months’ follow-up patient was in good clinical condition, with preserved renal function
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(eGFR 82mL/min/1.73m2). Scheduled CTA (Fig. 4) showed initial shrinkage of the aneurysm
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(maximum diameter 50 mm, volume 82,6 cm3), with patency of aortic and visceral grafts even with
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a low -flow type Ia endoleak.
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Patient gave consent for treatment and for publication of his clinical notes.
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151 Discussion
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Over the years, use of CGs has been reported to treat ruptured abdominal aortic aneurysms,
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expanding indication for EVAR even in the absence of a suitable proximal landing zone.5
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Nowadays, recent data confirm the efficacy of the procedure even in elective treatment of PAAAs
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and thoracoabdominal aortic aneurysms.6,7
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We reported the case of a patient considered unfit for open surgery in which standard EVAR was
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excluded for lack of infrarenal neck. Custom-made FEVAR devices were not considered an option
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because positioning of the graft requires the capability to advance and rotate a large delivery system
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(to correctly align the fenestrations with the visceral vessel orifices), which could be impaired by
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narrowed access vessels.12,13
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Unfavorable iliac anatomy is a well-known contraindication for endovascular aortic aneurysm
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repair. In 2000, the EUROSTAR registry reported iliac access problems in 13% of patients selected
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for EVAR due to iliac tortuosity, occlusive disease, or small-caliber.14 Even if the available
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technology has improved remarkably over the years,15 EVAR, and much more F-EVAR or B-
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EVAR, still represent challenging procedures in patients with small, calcified, or tortuous iliac
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vessels.16 Indeed, adequate iliac access for 18F to 20F delivery catheters is 6–7 mm and, according
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to these diameters, about 50% of patients are excluded from EVAR treatment.17 Moreover, insertion
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of large delivery catheters into small iliac vessels potentially increases the peril of iliac artery
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ACCEPTED MANUSCRIPT rupture with life-threatening bleeding. Some feasible solutions include highly flexible hydrophilic
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devices, iliac conduits, ‘‘cracking and paving,’’ and alternative access sites.18
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CGs in association with conventional endografts presenting an outer diameter ranging from 16 to
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20F were deemed unsuitable to treat the patient. Despite the fact that some authors have described
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the chimney technique combined with a polymer-based endograft, at that time, we had not
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performed enough of these procedures to have sufficient experience to use those grafts in
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combination with the chimney technique.9
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Considering all the aforementioned reasons, an off-label chimney technique was performed by
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placing CGs in the SMA and RAs, coupled with the low profile INCRAFT® device, to overcome
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technical limitations due to unfavorable iliac anatomy.
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The INCRAFT® Stent Graft System was designed to address some of the limitations of current
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devices. To increase the applicability of EVAR to a broader range of patients such as those with
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small or diseased access vessels, design enhancements allowed the device to be constrained within
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an ultra-low profile delivery system with a true 14F (4.7mm) outer diameter for main-body, and
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12.5F for iliac limbs.19
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The election of such a novel concept and low profile device allowed for successful treatment of
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the patient, even in the presence of a small type Ia endoleak in the completion angiography and
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follow-up images.
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Postoperative endoleaks after the adoption of CGs are a frequent event, occurring in as many as
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23% of cases and represent a potential cause of aneurysmal rupture.7,20-22 However, if endoleaks are
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addressed judiciously, by close clinical and radiological follow-up, related complications could be
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tempered by the lack of perseverence or clinical adverse sequelae .7,20
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The majority of the endoleaks were primarily due to “gutter ” occurrences, between the CGs and
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aortic endografts, the presence and size of which remain the main concern that compromises (the
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early or late) outcomes of this technique. Persistent or new-onset postoperative type Ia endoleaks
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seem to be linked to numbers of CGs implanted and length of the new landing zones.7,20 Indeed,
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data from the PERICLES registry showed a greater incidence of Type Ia endoleaks when more
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than three CGs were required.7 Incidence of endoleaks is reported to be rare provided an adequate
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proximal landing zone has been created (almost 20mm).7,20
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In the present case, it was necessary to implant three CG’s in order to achieve a satisfactory, new
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proximal landing zone (21mm). Considering previously reported data, by performing that
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procedure, we averted a clinically relevant, high-flow endoleak (with a new proximal landing zone
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of 21 mm created), but we were exposed to a higher risk of gutter occurrences (with three CGs
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ACCEPTED MANUSCRIPT performed). Furthermore, the necessity to use three CGs required two different brachial/axillary
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accesses to advance the guiding sheaths in order to minimize potential vessels damages11,23.
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The best combinations of aortic and branch stent grafts to potentially minimize gutter-related
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concerns are another important aspect for consideration. Even though both experimental24,25 and
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clinical studies6,7,20 have been performed in an endeavor to resolve this issue, no definitive data, in
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particular, using the new concept INCRAFT® device, are currently available. Self-expandable
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chimney grafts were preferred because profile and flexibility. Particularly Viabahn seems to
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represent a durable treatment for renovisceral arteries 20.
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Despite the fact that several techniques have been reported to correct type IA endoleaks after
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chimney graft procedures (coil embolization or “neck elongation ”),7,20 some experience seems to
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suggest that not all postoperative endoleaks should be invasively managed. In a report by Donas
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and co-workers, out of five perioperative type Ia endoleak, only one was treated during follow-up
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due to continuous aneurismal sac increase23. Indeed, delayed low-flow type IA endoleaks are
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reported as not propagating either aneurysmal enlargement or clinical adverse events in all
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published experiences.6,11,20 For these reasons, the patient is being strictly observed in the absence
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of further treatment.
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219 Conclusion
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In the present case, the use of CGs combined with the ultra-low profile INCRAFT® System has
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proven to be a feasible, safe, and viable approach in the treatment of PAAA.
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In our opinion, this solution represents a viable option for treating high-risk patients with a
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challenging iliac anatomy, unsuitable for fenestrated devices. Lengthier follow-up and greater
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numbers of cases are required.
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ACCEPTED MANUSCRIPT References
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[1] de Vries JP. The proximal neck: the remaining barrier to a complete EVAR world. Semin Vasc
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[3] Greenberg RK, Clair D, Srivastava S, Bhandari G, Turc A, Hampton J, Popa M, Green R, Ouriel
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[4] Larzon T, Eliasson K, Gruber G. Top-fenestrating technique in stent-grafting of aortic diseases
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[5] Pecoraro F, Pfammatter T, Mayer D, Frauenfelder T, Papadimitriou D, Hechelhammer L, Veith
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[12] Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ, Prins TR, Bracale UM, van
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[17] Kristmundsson T, Sonesson B, Dias N, Malina M, Resch T. Anatomic suitability for
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chimney technique in endovascular aortic aneurysm repair: late ruptures after successful single
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renal chimney stent grafts. Ann Vasc Surg 2013;27:835-43.
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[23] Donas KP, Pecoraro F, Torsello G, Lachat M, Austermann M, Mayer D, Panuccio G, Rancic
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Z. Use of covered chimney stents for pararenal aortic pathologies is safe and feasible with excellent
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patency and low incidence of endoleaks. J Vasc Surg. 2012;55:659-665.
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[24] de Bruin JL, Yeung KK, Niepoth WW, Lely RJ, Cheung Q, de Vries A, Blankensteijn JD.
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Geometric study of various chimney graft configurations in an in vitro juxtarenal aneurysm model.
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J Endovasc Ther 2013;20:184-90.
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[25] Mestres G, Uribe JP, Garcìa-Madrid C, Miret E, Alomar X, Burrel M, Riambau V. The best
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conditions for parallel stenting during EVAR: an in vitro study. Eur J Vasc Endovasc Surg
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2012;44:468-73.
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Figure Legend
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Figure 1. - Multiplanar reconstruction of preoperative computed tomographic angiography (CTA)
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showing pararenal aortic aneurysm;
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Figure 2. - Three-dimensional reconstruction of preoperative CTA underlying the presence of
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narrowed and heavy calcified iliac arteries;
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Figure 3. - Completion angiography showing patency of all grafts and visceral branches,
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satisfactory exclusion of the aneurysm with the presence of a low flow type Ia endoleak (white
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arrows);
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Figure 4. - Three-dimensional reconstruction of 12 months’ CTA showing the good aneurysm
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exclusion.
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