Early and Mid-term Efficacy of Fenestrated Endograft in the Treatment of Juxta-Renal Aortic Aneurysms

Journal Pre-proof Early and mid-term efficacy of fenestrated endograft in the treatment of juxta-renal aortic aneurysms Enrico Gallitto, Faggioli G. Gianluca, Jacopo Giordano, Rodolfo Pini, Chiara Mascoli, Cecilia Fenelli, Mohammad Abualhin, Stefano Ancetti, Antonino Logiacco, Mauro Gargiulo PII:

S0890-5096(19)30932-X

DOI:

https://doi.org/10.1016/j.avsg.2019.10.077

Reference:

AVSG 4739

To appear in:

Annals of Vascular Surgery

Received Date: 18 September 2019 Revised Date:

12 October 2019

Accepted Date: 13 October 2019

Please cite this article as: Gallitto E, Gianluca FG, Giordano J, Pini R, Mascoli C, Fenelli C, Abualhin M, Ancetti S, Logiacco A, Gargiulo M, Early and mid-term efficacy of fenestrated endograft in the treatment of juxta-renal aortic aneurysms, Annals of Vascular Surgery (2019), doi: https://doi.org/10.1016/ j.avsg.2019.10.077. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. 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. © 2019 Elsevier Inc. All rights reserved.

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Early and mid-term efficacy of fenestrated endograft in the treatment of juxta-

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renal aortic aneurysms

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Enrico Gallitto, Gianluca Faggioli G, Jacopo Giordano, Rodolfo Pini, Chiara Mascoli,

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Cecilia Fenelli, Mohammad Abualhin, Stefano, Ancetti, Antonino Logiacco, Mauro Gargiulo.

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Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine,

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University of Bologna, Sant’Orsola-Malpighi

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Bologna – Italy

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Presented at the 32th ESVS annual meeting

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25 – 28 September, Valencia, Spain

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Corresponding Author

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Gallitto Enrico MD, PhD

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Vascular Surgery, University of Bologna

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Azienda Policlinico S. Orsola-Malpighi

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Massarenti St 9th, 40138 Bologna, Italy

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Tel. 39-051-2145596

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E-mail: [email protected]

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28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55

ABSTRACT OBJECTIVE The aim of this study was to report early and mid-termoutcomes of fenestrated endografting (FEVAR) for juxta-renal aneurysm (J-AAAs). METHODS Between 2008 and 2017, all consecutive J-AAAs treated by FEVAR were prospectively collected. Early endpoints were technical success, renal function worsening and 30-day mortality. Follow-up endpoints were survival, freedom from reinterventions (FFRs), target visceral vessels (TVVs) patency, J-AAAs shrinkage and renal function worsening. RESULTS Among 181 cases underwent FB-EVAR, 66(36%) were J-AAAs. Endograft with 1,2,3 and 4 fenestrations were planned in 2(3%), 22(33%), 27(41%) and 15(23%) cases, respectively. Overall, 236 TVVs were treated by fenestrations and scallops. Technical success was achieved in 65(99%) cases. The only failure occurred for a type III endoleak requiring renal artery relining. No TVVs were lost. Renal function worsening occurred in 7(10%) cases: 4 returned to baseline within 30day, 1 required hemodialysis and died within 30-day (1.5%). This was the only case of 30-day mortality. The mean follow-up was 46±32months. Aneurysm sac shrinkage or stability was observed in 42(64%) and 22(33%) cases, respectively. Two patients (3%) with persistent type II endoleak had sac enlargement and required re-interventions. Freedom from reinterventions at 5year was 88%. An asymptomatic celiac trunk occlusion (accommodated by a scallop) occurred at 24-month in a case with a severe pre-operative stenosis. No late renal arteries occlusions or type IIII endoleaks occurred. Overall, renal function worsening was reported in 5(8%) patients during follow-up. Survival at 5-year was 67%, with no j-AAA related mortality. COPD was the only independent predictor for mortality at the multivariate analysis (p:.021;OR:5.3;95%CI,1.3-21.9)

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CONCLUSION

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FEVAR for J-AAAs is safe and effective at early and mid-termfollow-up. According with these results, it could be proposed as the first line treatment in high risk patients if anatomically fit. Long term survival is reduced in the presence of pre-operative COPD.

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INTRODUCTION

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Juxta-renal aortic aneurysm (J-AAA) is defined as an aneurysm extending up to but not

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involving the renal arteries, requiring suprarenal aortic clamping for open repair (OR) 1. By the

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endovascular point of view, it is also defined as AAA with an infra-renal neck < 10 mm 1, 2. Open

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repair, which is historically considered the gold standard in this setting, is associated with higher

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post-operative mortality and morbidities compared with infra-renal aneurysm 3 - 5.

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Fenestrated endografts (FEVAR) are nowadays safe and effective devices for the treatment 6 - 8

67

of aneurysms involving renal and splanchnic arteries

and allow lower 30-day mortality and

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renal function worsening compared with OR, with the disadvantage of a higher rate of

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reinterventions 9. According with these results, J-AAAs are increasingly repaired by endovascular

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means with FEVAR worldwide, however large dedicated long-term data are presently lacking. Aim

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of our study was therefore to evaluate early and follow-up outcomes of FEVAR in J-AAAs.

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METHODS

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Study design and patient selection. It is a single center, observational study approved by the local

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Institutional Review Boards. No funding was obtained from companies or other institutions.

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Between 2008 and 2017, all consecutive patients undergoing endovascular repair for complex aortic

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aneurysms by fenestrated and branched endograft (Cook-Zenith platform) were prospectively

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collected in a dedicated database. Preoperative, procedural and postoperative data of J-AAAs were

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selected and retrospectively analyzed. According to the European General Data Protection

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Regulation (GDPR), all cases were deidentified with a coding number. Juxta-renal aortic aneurysm

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was defined as: aneurysm extending up to but not involving the renal arteries, necessitating

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suprarenal aortic clamping in case of OR or AAA with infra-renal neck < 10 mm. The indication for

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FEVAR in J-AAA was proposed for both clinical and morphological reason. Clinical inclusion

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criteria were: asymptomatic patients and high surgical risk according with the SVS reporting 3

10

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standard

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para-visceral aortic angle < 60°, iliac and target visceral vessels anatomical feasibility for FEVAR.

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Patients with previous infra-renal aortic repair (endo & open) were not considered.

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Pre-operative

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thoracoabdominal computer tomography angiography (CTA). Post processing evaluations (multi-

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planar, 3-dimensional, centre-lumen-line reconstructions) were elaborated by a dedicated software

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for vessels analysis (3MensioTM, Vascular Imaging, Bilthoeven, Netherlands). The FEVAR implant

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was planned by the same surgical team who performed the procedure and confirmed by the Cook

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Zenith Planning Centre for fenestrated and branched endograft. The proximal sealing zone was

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evaluated measuring at least 2 cm length of healthy aortic wall (regular cylindrical shape – with no

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posterior bulging) in the multi-planar reconstructions (Fig 1). In this segment a circumferential

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apposition between endograft and aortic wall was considered (no scallop design in these 2

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centimetres) and the main-body oversize was usually about 20%. Target visceral vessels (TVVs)

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were analyzed at the preoperative CTA (diameter and main trunk length) in order to preoperatively

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select the length and diameter of balloon expandable bridging stents-graft. No oversizing of the

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stent diameter was usually performed. Small (6x6 mm or 6x8 mm) fenestrations were designed for

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renal arteries and large (8x8 mm) fenestrations for superior mesenteric and celiac arteries. Patency

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of hypogastric artery was always maintained by endovascular (1st choice) or surgical planned

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adjunctive manoeuvres.

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. Morphological inclusion criteria were: aneurysm diameter between 55 and 70 mm,

planning

&

Procedure.

Pre-operative

planning

was

The procedure details are accurately described in our previous reports

performed

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by

. Briefly,

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procedures were performed in an operating room with mobile angiographic C-arms (OEC 9800

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Plus, General Electric, Salt-Lake-City, USA or Ziehm Vision Hybrid RFD, Ziehm Imaging GmbH,

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Nürnberg, Germany) and since January 2016 in a Philiphs hybrid operating room

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(www.philiphs.it/healtcare). Bilateral common femoral artery cut down or percutaneous approach

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was performed according with the femoral arteries’ anatomy. An axillary or brachial access was 4

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used only in selected cases for inability to cannulate a TVVs from below. Procedures were

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performed under general anaesthesia with an activated coagulation time greater than 200 seconds.

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The FB-EVAR module was introduced through a common femoral artery access and positioned and

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deployed at the visceral vessels level, under the fusion imaging guidance (Philiphs, Vessel

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Navigator technology), angiography checks and the orientation of radiopaque markers. If the

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FEVAR implant has > 3 fenestrations, the pre-cannulation of superior mesenteric artery was usually

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performed to have an adjunctive anatomical marker during the endograft deployment. A 16 – 22 F

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sheath was inserted through the contra-lateral femoral artery and positioned at the aortic bifurcation.

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By using a floppy guide wire and angiographic catheters, the fenestrations and the relative visceral

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arteries were cannulated. By using a stiff guide-wire (Cook, Rosen) a 55-cm-long 7F sheath (Cook,

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Flexor) was positioned in each TVVs. Bridging balloon-expandable stent-grafts (Advanta; Atrium,

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Hudson, NH, USA) were then advanced inside the 7F sheaths. The reducing tie system and the

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proximal top cap were then deployed. The visceral bridging stent-grafts were deployed so that 4-

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5mm of each protrudes into the aortic lumen. Finally, these segments were flared by over dilatation

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using a 10/12mm diameter and 20mm length balloon. Deployment and flairing manoeuvres of the

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bridging stent are usually performed in the following order: lower renal artery, cranial renal artery,

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celiac trunk and superior mesenteric artery. After each stent graft deployment, the introducer is

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maintained inside the first segment of the stentgraft in order to protect it from any crash possibly

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caused by the manoeuvre of other stentgrafts deployment. After each stentgraft deployment,

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selective and multiplanar angiographic check are performed to evaluate the patency of the TVVs,

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the absence of bleeding, dissection, endoleak, stenosis/kinking or acute angulation between the

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distal end of the bridging stentgraft and the native vessels. The J-AAA exclusion was completed

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deploying the bifurcated module and contralateral iliac leg.

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Endpoints and definition. Early endpoints were: technical success, renal function worsening,

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cardio/pulmonary morbidities and 30-day mortality. Follow-up endpoints were: survival, freedom

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from re-intervention (FFR), TVVs-patency, J-AAA shrinkage and freedom from renal function

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worsening.

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Technical success was defined as the correct deployment of endograft with stenting and patency of

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TVVs, absence of type I-III endoleak, iliac leg stenosis/occlusion and 24-hour survival. Chronic

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kidney disease (CKD) was defined as eGFR < 60 mL/min/1.73 m2 based on the National Kidney

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Foundation/Kidney Disease Outcome Quality Initiative (NKF/KDOQI)

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function worsening was defined as e-GFR reduction >25% of the preoperative value according

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with the RIFLE (Risk, Injury, Failure, Loss of kidney function, End-stage renal disease)

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classification 14. Cardiac and pulmonary morbidity was defined as any cardiac or pulmonary events

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that required adjunctive surgical or medical therapies or a prolonged hospitalization. J-AAA

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shrinkage was defined if there was an AAA diameter reduction > 5 mm. Endoleaks were defined

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according with the classification reported by Davis et al 15.

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Follow-up. After the procedure, patients entered into a dedicated FEVAR follow-up protocol.

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Before the discharge, they underwent laboratory evaluation of renal, hepatic and pancreatic

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function, thoracoabdominal CTA and a contrast enhancement ultrasound (CEUS). The home

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surveillance program was performed by using plain X-ray, Doppler Ultrasound/CEUS at 6 months,

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CTA at 12 months and Doppler Ultrasound/CEUS or CTA yearly thereafter. In case of diagnostic

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doubts a CTA was always performed.

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Statistical analysis. Continuous data were reported as a mean ± standard deviation. Categorical

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data were expressed as frequency. Survival, FFR, TVVs-patency and freedom from renal function

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worsening were estimated by Kaplan-Meier. The correlation between clinical/morphological data

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and post-operative results was evaluated by Fisher’s test, Logistic regression and Uni/Multivariate

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analysis. P value was considered significant if < 0.05. Statistical analysis was performed by SPSS

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23.0 for Windows software (SPSS Inc., Chicago, IL, USA).

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. Perioperative renal

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159

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RESULTS

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Patient selection. Between 2008 and 2017, overall 181 cases underwent FB-EVAR repair. Sixty-

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six (37%) patients with J-AAA were enrolled in the present study. The mean age was 72 ± 6years,

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62 (94%) were male, 52 (79%) were ASA 3 and 14 (21%) ASA 4. The mean J-AAA diameter was

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58±6mm. Preoperative morbidities and cardiovascular risk factors are summarized in table 1.

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Endograft configuration. Endograft with 1, 2, 3 and 4 fenestrations were planned in 2 (3%), 22

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(33%), 27 (41%) and 15 (23%) cases, respectively. Overall, 236 TVVs were treated by fenestrations

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and scallops (3.6 ± 1 TVV/patient). Iliac branch and external-internal iliac surgical bypass were

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planned in 3 (5%) and 1 (1.5%) cases, respectively to treat a concomitant common iliac aneurysm.

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A surgical iliac conduit was planned in 4 (6%) cases due to a severe stenotic/obstructive iliac

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access.

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Procedure. Surgical or percutaneous femoral arteries access was used in 61 (92%) and 5 (8%)

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cases, respectively. Surgical access for axillary/brachial artery was performed in 24 (36%) cases.

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Procedural and fluoroscopy time were 320 + 99 minutes and 63 + 53 minutes, respectively. The

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mean amount of iodinated contrast media was 133 + 94 mL. Twenty-seven (41%) patients required

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intraoperative blood infusion (mean: 300 + 150 mL). In 10 (15%) cases iliac PTA stenting was

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performed. After the bridging stengrafting, relining with self-expandable bare metal stent was

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performed in 13 TVVs (renal artery: 4; superior mesenteric artery:9). The causes of TVVs relining

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were: acute angulation between stent graft and native TVV (10), TVV dissection (2) and TVV

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stenosis (1). In 3 (5%) cases a surgical reconstruction of the common femoral artery was necessary

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(endoarterectomy: 2; bypass:1) after device removal. All these cases had been approached by a

7

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primary femoral surgical cut-down. Technical success was achieved in 65 cases (99%). The only

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failure consists of a type III endoleak from a renal artery fenestration requiring renal

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artery/fenestration relining with stent-graft within 30 postoperative days (Fig 2).

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30-day results. Cardiac and pulmonary morbidities occurred in 3 (5%) and 4 (6%) cases,

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respectively. There were no cases of clinical acute splanchnic ischemia. Renal function worsening

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occurred in 7 cases (10%): 4 returned to baseline within 30-day. One required hemodialysis and

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died within 30-day (1.5%). This was the only case of 30-day mortality. It was a patient with a

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severe pre-operative chronic renal failure (e-GFR 30mL / min) underwent FEVAR (2 fenestrations)

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and iliac branch. The patient died due to a massive cardiac infarction. There were no cases of spinal

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cord ischemia or stroke.

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Follow-up results. The mean follow-up was 46±32 months. Aneurysm sac shrinkage or stability

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was observed in 42 (64%) and 22 (33%) cases, respectively. Two patients (3%) with persistent type

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II endoleak had sac enlargement and required re-interventions. They consisted of AAA sac

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embolization by trans-limb approach. Freedom from re-interventions at 1, 3 and 5 years was 97%,

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93% and 88%, respectively (Fig 3). Causes, timing, kind of reintervention and results are

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summarized in table 2. No late renal or superior mesenteric arteries events (occlusion, stenosis,

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bridging stent fractures) were detected during follow-up. There were no late type I-III endoleaks.

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The only TVV occlusion was asymptomatic and detected at 24-month CTA. It occurred in a celiac

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trunk with a severe pre-operative stenosis, accommodated by a scallop. Overall, late renal function

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worsening was reported in 5 patients (8%) during follow-up: 2 persisted from post-operative period

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and 3 with new onset. No late cases of hemodialysis were necessary. Freedom from renal function

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worsening was 95%, 85% and 85% at 1, 3 and 5 years, respectively (Fig 4). Survival at 1, 3 and 5

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years was 92%, 86% and 67%, respectively (Fig 5), with no J-AAA related mortality. At the

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univariate analysis, preoperative COPD (p:.006), BMI >31 (p:.048), preoperative chronic renal

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failure (p:0.44) and late renal function worsening (p:.050) were risk factors for mortality. COPD 8

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was the only independent predictor for mortality confirmed at the multivariate analysis (p:.021;

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OR:5.3; 95%CI, 1.3-21.9). Table 3 summarizes the overall causes of mortality during follow-up.

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DISCUSSION

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In the present experience we report early and follow-up outcomes of 66 consecutive J-AAAs

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submitted to FEVAR with Cook Zenith platform. All patients were at high surgical risk and account

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for 37% of our overall advanced endovascular aortic cases. Early results were satisfactory with

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technical success 99%, 30-day mortality 1.5% and post-operative renal function worsening 10%

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(dialysis 1.5%). During follow-up, survival and FFR at 5-year were 67% and 88%, respectively.

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Moreover, no late J-AAA related mortality occurred and sac enlargement was reported only in 2

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(3%) cases, both treated endovascularly for persistent type II endoleaks.

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Juxta-renal aortic aneurysms extend up to the renal arteries, without involving them, and

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require suprarenal aortic clamping in case of OR1. According with the literature, they account for

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approximately 15% of all AAAs

220

treatment, but it is associated with higher post-operative mortality and morbidities compared with

221

infra-renal AAA

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Jongkind et al 3 reported a mean renal ischemia time of 27 minutes, a 30-day mortality of 3% and a

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post-operative renal function worsening 18% (dialysis 3%). Even in high-volume centers the

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postoperative mortality and morbidity are not negligible. Knott et al 4 reported a 30-day mortality of

225

1%, a renal function worsening of 18% (dialysis 5%), cardiac and pulmonary complications in 14%

226

and 11% of cases respectively and bowel ischemia in 2%. Similar results were reported by Tsai et

227

al

228

worsening in 8%, requiring dialysis in 2% of cases.

5

1-5

1 - 5

. OR is historically considered the gold standard for their

. In a metanalysis of 21 papers (1256 patients underwent JAAs open repair),

with a 30-day mortality of 2%, 30-day reinterventions in 4% of cases and renal function

9

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Fenestrated endografts currently a valuable option for the treatment of complex aneurysms

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in high risk patients, due to their lower peri-operative mortality and morbidity 6 - 8. Nordon et al 9 in

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a systematic review published in 2009, reported that FEVAR allows lower 30-day mortality (1.4%

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vs 3.6%, RR 1.03) and postoperative renal function worsening (14.9% vs 20.0%, RR 1.06) in J-

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AAAs compared with OR, with a higher rate of reinterventions (15% vs 3%). In a more recent

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literature review 16, RAO et al reported no difference in terms of 30-day mortality (4%) and a lower

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postoperative renal function worsening in FEVAR compared with OR (11% vs 14%) 16 with less

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major complications (16% vs 25%) 16. On the other hand, FEVAR has higher rate of reinterventions

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(13% vs 5%), renal function deterioration during follow-up (20% vs 8%) and lower survival (55%

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vs 73% at 5 years) 16. The differences in the follow up outcomes can be explained by the difference

239

of patients treated by FEVAR or OR. FEVAR patients were significantly older and sicker, in term

240

of

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According with these results, J-AAAs are increasingly repaired by FEVAR worldwide, however

242

large dedicated long-term data are still lacking. Cross et al

243

2012, reported that JAAAs accounts for only 35% of FEVAR cases, without any further specific

244

analysis, since JAAA, PAAA and TAAA’s results are usually reported together. By evaluating the

245

literature experiences of series with > 50 JAAAs published between 2006 and 2017 (Table 4),

246

results are encouraging at early and midterm follow-up 2, 6 - 8, 18 - 22 with a 30-day mortality ranging

247

between 0 and 5% due a to a variety of causes (summarized in Table 5) 2, 6 - 8, 18 - 22. The mean range

248

of follow-up was between 6 and 67 months and only the paper by Kristmundsson et al 8 reported a

249

follow-up longer than our experience (67 months vs 48 months). Survival at 3 years ranges between

250

75% and 90% with an extremely low AAA related mortality (0 – 0.5%) 6 - 8, 18 - 22. The estimated

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survival at 5 years was 67% in our series, with no late AAA-related mortality. Although

252

preoperative COPD, BMI >31, preoperative chronic renal failure and late renal function worsening

253

were shown to be risk factors for mortality at univariate analysis only COPD was an independent

254

predictor for mortality at the multivariate analysis. Freedom from reinterventions at 3 years ranges

preoperative renal failure, coronary artery disease, COPD, diabetes and hypertension16.

17

in a literature review published in

10

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between 70% and 90% and TVVs patency between 90% and 99%. In our experience, we did not

256

detect renal or mesenteric arteries occlusion during follow-up. The only event was an asymptomatic

257

celiac trunk occlusion with a preoperative severe stenosis, accommodated with a scallop (Fig 6).

258

TVVs patency is crucial to guarantee technical and clinical success of FEVAR. The literature

259

reports a low rate of TVVs occlusion within 24 postoperative months 2, 6 - 8, 18- 22 and, as reported in

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the early experience of Verhoeven et al 2, it frequently occurs with unstented TVVs or in cases of

261

uncovered bridging stent in the early FEVAR experiences. For these reasons, it is important to

262

allow a greater FEVAR stability using covered balloon expandable stentgraft as bridging for TVVs

263

and choosing a safe and healthy proximal sealing zone.

264

The preoperative evaluation of the proximal sealing zone is essential to achieve technical

265

long-term clinical success. A minimum of 2 cm length is usually required but the distance between

266

each TVVs has also to be considered. In most cases, FEVAR requires the treatment of a longer

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segment of aorta compared with OR, with a frequent superior mesenteric and celiac arteries

268

reconstruction. In the present experience, only 36% of JAAAs received an endograft with < 2

269

fenestrations. Since 64 % of cases required fenestration and stenting for the superior mesenteric

270

artery and 23% for the celiac trunk, a potential risk of early and long-term bowel ischemic

271

complications may exist. However, no cases of early or follow up bowel ischemia or splanchnic

272

complications were reported but this aspect requires confirmation at a longer follow-up. On the

273

other hand, it is important to underline that according with this approach no proximal sealing

274

failures were detected at a mean follow up of 48 months.

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Postoperative renal function worsening is a common adverse event after the endovascular

276

repair of juxta/para-renal and thoracoabdominal aneurysms by FEVAR and it may occur in between

277

5% and 35% of cases

278

post-operative acute renal failure in 29% of cases and after 1 year only 41% of these patients

279

returned to their baseline renal function. In one of the largest recently published FEVAR series,

22 - 25

in series with both J/PAAA and TAAAs. Martinez et al

23

reported a

11

24

280

including 468 cases, Van Calster et al

281

common complication, occurring in 23% of cases. In our series the post-operative renal failure

282

occurred in 7 patients (10%) and four cases returned to baseline within 30 day. These results

283

compare favorably with the literature, however it should be considered that our series is limited to

284

JAAAs, and do not include PAAA or TAAA. De Sousa et al 25 in a series of JAAAs reported a 5%

285

of postoperative renal function worsening, and it was similar to standard EVAR cases. Our freedom

286

from renal function worsening was 95%, 85% and 85% at 1, 3 and 5 years, respectively (Fig 3)

287

similarly to Oderich et al 22 results (91% at 5 years). These follow-up data are infrequently reported

288

in previous literature series.

reported that postoperative acute renal failure is the most

289

According with the current ESVS guidelines 1, ‘‘in patients with JAAAs, open repair or

290

complex endovascular repair should be considered based on patient status, anatomy, local routines,

291

team experience, and patient preference’’. Based on the current study, complex endovascular repair

292

of JAAAs, with fenestrated stent grafts could be considered the preferred treatment option if

293

anatomically feasible.

294

The study has several limits. First, we have reported our 66 first consecutive cases, with

295

procedures performed by the same team during a study period of 10 years, without considering the

296

learning curve of the operators. This point is particularly important because the expertise is a key-

297

factor in treating challenging FEVAR cases. Next, the number of cases is small, because patients

298

are highly selected, however only few mono-centric experiences with larger experiences have been

299

published in the literature. Finally, follow-up is limited to early and mid-term, however it should be

300

considered that this is a relatively new technique and no long-term data are currently available in

301

any other series.

302

CONCLUSION

12

303

FEVAR for j-AAAs is safe and effective at early and mid-termfollow-up. Fenestration and

304

stenting for the superior mesenteric artery are required in 64% of cases. A low rate of TVVs

305

occlusion was detected at follow-up. According with the results of this series, FEVAR could be

306

proposed as the first line treatment for J-AAAs, in anatomically fit cases, if performed in high

307

volume centers. The results of the present series should be taken in consideration when considering

308

alternative open surgery technique in the treatment of J-AAAs.

309

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REFERENCES

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18. O'Neill S, Greenberg RK, Haddad F et al. A prospective analysis of fenestrated endovascular grafting: intermediate-term outcomes. Eur J Vasc Endovasc Surg. 2006 Aug;32(2):115-23. 19. Roy IN, Millen AM, Jones SM et al. Long-term follow-up of fenestrated endovascular repair for juxtarenal aortic aneurysm. Br J Surg. 2017 Jul;104(8):1020-1027. 20. Semmens JB, Lawrence-Brown MM, Hartley DE et al. Outcomes of fenestrated endografts in the treatment of abdominal aortic aneurysm in Western Australia (1997-2004). J Endovasc Ther. 2006 Jun;13(3):320-9. 21. Katsargyris A, Oikonomou K, Kouvelos G et al. Comparison of outcomes for double fenestrated endovascular aneurysm repair versus triple or quadruple fenestrated endovascular aneurysm repair in the treatment of complex abdominal aortic aneurysms. J Vasc Surg. 2017 Jul;66(1):29-36 22. Oderich G, Greenberg R, Farber M, et al. Results of the United States multicenter prospective study evaluating the Zenith fenestrated endovascular graft for treatment of juxtarenal abdominal aortic aneurysms. J Vasc Surg 2014;60:1420-8. 23. Martin-Gonzalez T, Pinçon C, Hertault A et al. Renal outcomes analysis after endovascular and open aortic aneurysm repair. J Vasc Surg. 2015 Sep;62(3):569-77. 24. Van Calster K, Bianchini A, Elias F, et al. Risk factors for early and late mortality after fenestrated and branched endovascular repair of complex aneurysms. J Vasc Surg. 2019 May;69(5):1342-1355 25. de Souza LR, Oderich GS, Farber MA, et al. Zenith Fenestrated and the Zenith Infrarenal Stent grafts Trial Investigators. Comparison of Renal Outcomes in Patients Treated by Zenith® Fenestrated and Zenith® Abdominal Aortic Aneurysm Stent grafts in US Prospective Pivotal Trials. Eur J Vasc Endovasc Surg. 2017 May;53(5):648-655.

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Figures legends. Figure 1. Proximal sealing zone evaluation. Coronal (A) and sagittal (B) view of the preoperative computed tomography angiography. The proximal sealing zone is evaluated measuring at least 2 cm length of healthy aortic wall - regular cylindrical shape – with no posterior bulging in the sagittal view (yellow arrow) Figure 2. Technical failure. A) Post-operative computed tomography angiography in coronal and axial view. A type III endoleak from the left renal artery fenestration (red arrow). B) Post-operative computed tomography angiography in coronal and axial view after left renal artery/fenestration relining with an adjunctive balloon expandable stentgraft within 30 postoperative days. The type III endoleak was sealed (red arrow) Figure 3. Freedom from reintervention (FFR) estimated by Kaplan Meyer analysis. Overall FFRs was 97%, 93% and 88% at 1, 3 and 5 years, respectively. The number of patients at risk and standard error (SE) for each interval are reported. Figure 4. Freedom from renal function worsening estimated by Kaplan Meyer analysis. Overall freedom from renal function worsening was 95%, 85% and 85% at 1, 3 and 5 years, respectively. The number of patients at risk and standard error (SE) for each interval are reported. Figure 5. Survival estimated by Kaplan Meyer analysis. Overall Survival was 92%, 86% and 67% at 1, 3 and 5 years, respectively. The number of patients at risk and standard error (SE) for each major interval are reported. Figure 6. Target visceral vessel occlusion during follow-up Sagittal view of the preoperative and postoperative (at 24-month) computed tomography angiography. Asymptomatic celiac trunk occlusion (B - yellow arrow) with a preoperative severe stenosis (A - yellow arrow) accommodated with a scallop

TABLES Table I. Demographics, preoperative comorbidities and cardiovascular risk factors.

Preoperative Features

n

%

Male

62

94

Hypertension

62

94

Dyslipidemia

45

68

Diabetes

8

12

Chronic Obstructive Pulmonary Disease (COPD)

22

33

Coronary Artery Disease (CAD)

24

36

Atrial fibrillation

11

17

BMI > 31

9

14

Peripheral Artery Occlusive Disease (PAOD)

8

12

Chronic Renal Failure (CRF)

20

30

Previous laparotomy

15

23

Cerebral – Vascular Insufficiency (CVI)

13

20

52 / 14

79 / 21

ASA III / IV

Table II. Causes, timing, kind of reintervention and results.

n

Cause

Timing

Reintervention

Results

1

CFA* occlusion

1-day

CFA* arterectomy

solved

2

ELIII

30-day

Renal stentgraft relining

sealed

3

ELII

30-month

Sac embolization

sealed

4

ELII

36-month

Sac embolization

sealed

*CFA: common femoral artery

1

Table III. Cause of the overall mortality

Cause of Mortality

n

%

Cancer

3

23

Cardiac

4

31

MOF/Sepsis

2

15

Pulmonary

2

15

Stroke

1

8

Unknow

1

8

Overall

13

100

Table IVa. Literature data: Series with > 50 JAAA. 2006 -2017.

Authors

Journal - Year

30-day Mortality

Mean FU

Estimated 3y-Survival

AAA-related mortality

(%)

(months)

(%)

(n)

O’Neill

EJVS - 2006

0.9

19

79

0

Semmens

JET - 2006

3.4

15

-

0

Verhoeven

EJVS - 2010

1.0

24

75

0

Amiot *

EJVS - 2010

2.0

15

86

0

Kristmundsson

JVS - 2009/14

3.5

67

76

5

Vallabhaneni *

Circulation - 2012

4.1

6

89

0

Oderich

JVS - 2014

1.5

37

90

0

Roy *

BJS - 2017

5.2

34

79

0

Katsargyris

JVS - 2017

0.5

20

83

0.5

* Multicenter experiences

2

Table IVb. Literature data: Series with > 50 JAAA. 2006 -2017.

Authors

Journal - Year

Estimated 3-y TVVs patency

Estimated 3-y FF Endoleaks

Estimated 3-y FFR

(%)

(%)

(%)

O’Neill

EJVS - 2006

-

-

-

Semmens

JET - 2006

-

-

-

Verhoeven

EJVS - 2010

93

-

90

Amiot *

EJVS - 2010

-

-

-

Kristmundsson

JVS - 2009/14

91

-

70

Vallabhaneni *

Circulation - 2012

95

-

70

Oderich

JVS - 2014

97

63

78

Roy *

BJS - 2017

90

85

80

Katsargyris

JVS - 2017

99

-

90

Table V. Literature data: causes of 30-day mortality

n Bowel ischemia (patent SMA)

6

Cardiac Infarct

2

Iliac artery rupture

1

Multi organ failure (after laparotomy)

4

Pneumonia

1

Retroperitoneal bleeding (TVV-lesion)

4

Not reported

15

Total

33

3