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Elective Multistaged Endovascular Repair of Thoraco-abdominal Aneurysms with Fenestrated and Branched Endografts to Mitigate Spinal Cord Ischaemia

Open ArchivePublished:December 20, 2019DOI:https://doi.org/10.1016/j.ejvs.2019.10.003

      Objective

      To evaluate the safety and effectiveness of a multistaged approach for elective thoraco-abdominal aneurysm (TAAAs) repair by means of endovascular fenestrated and/or branched (F/B-EVAR) grafts.

      Methods

      Between 2013 and 2018, 80 high risk surgical patients received elective F/B-EVAR for TAAAs with a protocolled multistaged approach (thoracic, visceral, and limb steps) and were enrolled in an ambispective single centre study called STEAR (STaged Endovascular Aortic Repair - NCT03342755). Data regarding all study participants, single step mortality and morbidity (systemic complications) rates were recorded and the overall results were considered for statistical analysis.

      Results

      Previous aortic interventions (61/80 cases, 76.3%) combined with the TAAA extents resulted in different staging strategies: 58 patients (73%) had a thoracic step and 33 (41%) a limb step. The median TAAA treatment time was 77 days (50–107). The overall mortality was six cases (8%) and 30 day clinical success rate 64 cases (80%). The overall rate of grade 2 or 3 (including death) systemic complications was 19 cases (24%) and 20 patients (25%) experienced grade 1 complications. Three patients with type II or III TAAAs (4%) had permanent and fatal spinal cord (SC) impairment. On multivariable analysis, SC ischaemia was associated with an aortic coverage ≥350 mm (OR: 9.15, p = .03, 95% CI: 1.3–66.4) and bovine arch (OR: 10.6, p = .01, 95% CI: 1.6–68.6). The overall short term (six month) clinical success was 72 cases (90%) and none experienced SC ischaemia after late endoleak resolution or treatment. At mid term (mean follow up: 13.3 ± 15.4 months), the overall freedom from conversions, re-interventions, late rupture, or type I and III endoleaks was 57 of 72 survivors (79%).

      Conclusion

      A multistaged approach with a third limb step in case of TAAAs is safe and technically feasible, with an acceptable rate of permanent spinal cord ischaemia. Different staging methods and protocols have been proposed and standardisation is required, especially for type I-II-III aneurysms.

      Keywords

      Different staging options have been suggested during endovascular repair of thoraco-abdominal aneurysms; however, few studies have reported the results of the uniform application of one protocol. Standardisation of staging methods is mandatory to improve results of complex aortic procedures.

      INTRODUCTION

      Morbidity and mortality rates following fenestrated and branched (F/B-EVAR) endovascular repair of thoraco-abdominal aortic aneurysms (TAAA) are acceptable and comparable to open repair, which is still considered the gold standard of treatment for fit patients.
      • Rocha R.V.
      • Friedrich J.O.
      • Elbatarny M.
      • Yanagawa B.
      • Al-Omran M.
      • Forbes T.L.
      • et al.
      A systematic review and meta-analysis of early outcomes after endovascular versus open repair of thoracoabdominal aortic aneurysms.
      As with open repair, however, the endovascular approach entails a significant risk of spinal cord (SC) injury, which is widely considered to be the most catastrophic complication, conferring low survival rates at one year and very poor quality of life in survivors.
      • Svensson L.G.
      • Crawford E.S.
      • Hess K.R.
      • Coselli J.S.
      • Safi H.J.
      Experience with 1509 patients undergoing thoracoabdominal aortic operations.
      High volume centres have reported SC injury rates with different degrees of severity after F/B-EVAR, varying from 4.8% to 27%,
      • Bisdas T.
      • Panuccio G.
      • Sugimoto M.
      • Torsello G.
      • Austermann M.
      Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
      • Katsargyris A.
      • Oikonomou K.
      • Kouvelos G.
      • Renner H.
      • Ritter W.
      • Verhoeven E.L.G.
      Spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms with fenestrated and branched stent grafts.
      • Ferrer C.
      • Cao P.
      • De Rango P.
      • Tshomba Y.
      • Verzini F.
      • Melissano G.
      • et al.
      A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
      • Dias N.V.
      • Sonesson B.
      • Kristmundsson T.
      • Holm H.
      • Resch T.
      Short-term outcome of spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
      • Sobel J.D.
      • Vartanian S.M.
      • Gasper W.J.
      • Hiramoto J.S.
      • Chuter T.A.M.
      • Reilly L.M.
      Lower extremity weakness after endovascular aneurysm repair with multibranched thoracoabdominal stent grafts.
      • Oderich G.S.
      • Ribeiro M.
      • Reis de Souza L.
      • Hofer J.
      • Wigham J.
      • Cha S.
      Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts.
      • Eagleton M.J.
      • Follansbee M.
      • Wolski K.
      • Mastracci T.
      • Kuramochi Y.
      Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms.
      and remarkably up to 87% of SC injuries present as late onset.
      • Bisdas T.
      • Panuccio G.
      • Sugimoto M.
      • Torsello G.
      • Austermann M.
      Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
      ,
      • Greenberg R.K.
      • Lu Q.
      • Roselli E.E.
      • Svensson L.G.
      • Moon M.C.
      • Hernandez A.V.
      • et al.
      Contemporary analysis of descending thoracic and thoracoabdominal aneurysm repair a comparison of endovascular and open techniques.
      A multistaged approach to the endovascular treatment of TAAA with the completion of aneurysm exclusion in consecutive steps is based on the concept of SC preconditioning and collateral network remodelling after acute blood supply alterations. Etz et al.
      • Etz C.D.
      • Zoli S.
      • Mueller C.S.
      • Bodian C.A.
      • Di Luozzo G.
      • Lazala R.
      • et al.
      Staged repair significantly reduces paraplegia rate after extensive thoracoabdominal aortic aneurysm repair.
      first demonstrated that staging in open TAAA repair annulled the incidence of SC injury events in a series of 35 patients who underwent staged repair, against eight permanent events in 55 single step procedures. Staged procedures have demonstrated encouraging results in the endovascular setting as well, and the Cleveland group reported overall rates of SC ischaemia of 37.5% vs. 11.1% in non-staged or staged procedures, respectively, in 87 Crawford type II and III TAAAs.
      • Eagleton M.J.
      • Follansbee M.
      • Wolski K.
      • Mastracci T.
      • Kuramochi Y.
      Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms.
      Different methods for endovascular staging have been reported in the literature. These include stent grafting of the thoracic aorta as a first separate step
      • O'Callaghan A.
      • Mastracci T.M.
      • Eagleton M.J.
      Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia.
      incorporating perfusion branches in the graft design as described by Jayia et al.,
      • Jayia P.
      • Constantinou J.
      • Hamilton H.
      • Ivancev K.
      Temporary perfusion branches to decrease spinal cord ischemia in the endovascular treatment of thoraco-abdominal aortic aneurysms based on a presentation at the 2013 VEITH Symposium, November 19–23, 2013 (New York, NY, USA).
      leaving a visceral branch unbridged according to Kasprzak et al.,
      • Kasprzak P.M.
      • Gallis K.
      • Cucuruz B.
      • Pfister K.
      • Janotta M.
      • Kopp R.
      Temporary aneurysm sac perfusion as an adjunct for prevention of spinal cord ischemia after branched endovascular repair of thoracoabdominal aneurysms.
      or selective spinal artery coil embolisation (MISACE) conceptualised by Branzan et al.
      • Branzan D.
      • Etz C.
      • Moche M.
      • von Aspern K.
      • Staab H.
      • Fuchs J.
      • et al.
      Ischemic preconditioning of the spinal cord to prevent spinal cord ischemia during endovascular repair of thoraco-abdominal aortic aneurysm - first clinical experience.
      However, all studies evaluating staging lack an homogeneous staging protocol because the evidence is gathered during conceptualisation of the method itself. This study aimed to describe an experience with a uniform protocol for systematic, multistaged endovascular elective TAAA repair with F/B-EVAR (STEAR study).

      METHODS

      Patients

      Between 2013 and 2018, 88 high risk surgical patients received F/B-EVAR for TAAAs (82 cases with aneurysm beginning above the coeliac trunk) and juxtarenal/suprarenal aneurysms (six cases). All (80 cases) consecutive elective (two emergencies excluded) TAAAs were treated with a protocolled (Fig. 1) multistaged approach and enrolled in an ambispective (37 prospective cases) single centre study called STEAR (STaged Endovascular Aortic Repair) (Table 1, Table 2). In the same study period, 443 fit patients with TAAAs were treated by open repair (84.7% of the elective aneurysms treated in the division). The study protocol complied with the Declaration of Helsinki. Local ethical committee approval was obtained and the trial was registered at clinicaltrials.gov (NCT03342755). All subjects gave informed consent to the aortic procedure itself and to the study protocol participation. All study participant data were recorded in a prospectively maintained database.
      Figure 1
      Figure 1Schematic drawing of the San Raffaele multi-staged endovascular repair protocol for thoraco-abdominal aneurysms. In case of Type I-II-III thoracoabdominal aneurysm (TAAA) extents, where one or more proximal thoracic components were necessary, the thoracic component was implanted as a first step (thoracic step) as soon as possible. Then, as soon as the custom-made device was delivered to the hospital or after at least three weeks in case of the t-branch graft use, the visceral step was performed: the endovascular fenestrated and/or branched (F/B-EVAR) device was implanted and all fenestration and branches were bridged with appropriate mating commercially available covered stents. Any distal straight component (type I TAAAs or in case of previous infrarenal open surgery) was also deployed at this stage, completing the exclusion of the aneurysm. In cases of native infrarenal abdominal aorta in which a bifurcated component was planned, the bifurcated distal component as well as the ipsilateral limb were deployed, and the contralateral gate was left open and unbridged creating an intentional type IB endoleak. Finally, after a minimum of two further weeks, the third step (limb step) was performed to complete the aneurysm exclusion by catheterizing the contralateral limb gate and bridging the contralateral iliac artery with the planned iliac stent-graft. In cases having had previous thoracic and abdominal aortic surgery (open or endovascular) (historical staging), and when no need for proximal or distal component use was planned, a single visceral step was performed (the image is publishable with the copyright holder's permission).
      Table 1Patient demographics of the 80 patients who received a multi-staged TAAA endovascular repair
      VariablesPatients (n = 80)
      Male56 (70)
      Age – y74.1 (67–78)
       < 7027 (34)
       70–7942 (53)
       ≥ 8011 (14)
      BMI – kg/m224.2 (27–29)
       ≥ 25 (overweight)37 (46)
       ≥ 30 (obesity)13 (16)
      Hypertension (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      77 (96)
       1 (controlled with one drug)21 (26)
       2 (controlled with two drugs)23 (29)
       3 (requires more than two drugs)33 (41)
      Smoking (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      55 (69)
       1 (none current, but smoked in last 10 y)28 (35)
       2 (current, including abstinence < 1 year, < 1 pack/day)22 (28)
       3 (current, > 1 pack/day)5 (6)
      Diabetes (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      12 (15)
       1 (adult onset, controlled with diet or oral agent)10 (13)
       2 (adult onset, insulin-controlled)2 (3)
       3 (juvinile onset)0
      Hyperlipidaemia (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      52 (65)
       1 (mild elevation, readily controlled by diet)3 (4)
       2 (moderate elevation requiring strict dietary control)19 (24)
       3 (severe elevation enough to require dietary and drug control)30 (38)
      Brain status (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      29 (36)
       1 (asymptomatic but with evidence of disease)20 (25)
       2 (transient or temporary stroke)3 (4)
       3 (complete stroke with permanent neurologic deficit or acute stroke)6 (8)
      Cardiac status (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      48 (60)
       1 (Asymptomatic but with either remote myocardial infarction by history (6 mo), occult myocardial infarction by electrocardiogram, or fixed defect on dipyridamole thallium or similar scan)40 (50)
       2 (Any one of the following: stable angina, no angina but significant reversible perfusion defect on dipyridamole thallium scan, significant silent ischaemia (1% of time) on Holter monitoring, ejection fraction 25% to 45%, controlled ectopy or asymptomatic arrhythmia, or history of congestive heart failure that is now well compensated)8 (10)
       3 (Any one of the following: unstable angina, symptomatic or poorly controlled ectopy/arrhythmia(chronic/recurrent), poorly compensated or recurrent congestive heart failure, ejection fraction < 25%, myocardial infarction within 6 mo)0
      Pulmonary status (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      58 (73)
       1 (Asymptomatic or mild dyspnoea on exertion, mild chronic parenchymal radiograph changes, pulmonary function tests 65% to 80% of predicted)33 (41)
       2 (Between 1 and 3)19 (24)
       3 (Vital capacity less than 1.85 L, FEV1 < 1.2 L or < 35% of predicted, maximal voluntary ventilation < 50% of predicted, PCO2 > 45 mmHg, supplemental oxygen use medically necessary, or pulmonary hypertension)6 (8)
      Renal status (Grade
      Risk factors were classified according to SVS reporting standards.19–22
      ≥ 1)
      38 (48)
       1 (Moderately elevated creatinine level, as high as 2.4 mg/dL)31 (39)
       2 (Creatinine level, 2.5-5.9 mg/dL)4 (5)
       3 (Creatinine level > 6.0 mg/dL, or on dialysis or with kidney transplant)3 (4)
      Median SVS score – points10 (7–13)
       < 10 points31 (39)
       10 ≤ points < 1537 (46)
       ≥ 15 points12 (15)
      ASA score (≥ 3)77 (96)
       359 (74)
       418 (23)
      Median risk of open TAAA adverse events – %11 (7–16)
       ≥ 15%14 (18)
       ≥ 20%7 (9)
      Data are presented as n (%) or median (interquartile range). ASA = American Society of Anaesthesiologists; BMI = body mass index; FEV1 = forced expiratory volume in 1 s; PCO2 = partial pressure of carbon dioxide; SVS = Society for Vascular Surgery; TAAA = thoracoabdominal aneurysms.
      Risk factors were classified according to SVS reporting standards.
      • Fillinger M.F.
      • Greenberg R.K.
      • McKinsey J.F.
      • Chaikof E.L.
      Reporting standards for thoracic endovascular aortic repair (TEVAR).
      • Chaikof E.L.
      • Blankensteijn J.D.
      • Harris P.L.
      • White G.H.
      • Zarins C.K.
      • Bernhard V.M.
      • et al.
      Reporting standards for endovascular aortic aneurysm repair.
      • Chaikof E.L.
      • Fillinger M.F.
      • Matsumura J.S.
      • Rutherford R.B.
      • White G.H.
      • Blankensteijn J.D.
      • et al.
      Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair.
      • Rutherford R.B.
      • Baker J.D.
      • Ernst C.
      • Johnston K.W.
      • Porter J.M.
      • Ahn S.
      • et al.
      Recommended standards for reports dealing with lower extremity ischemia: revised version.
      Table 2Aneurysm extension and target vessel anatomical characteristics of the 80 patients who received a multi-staged TAAA endovascular repair within the STEAR study
      VariablesPatients (n = 80)
      Median maximum aortic diameter – mm59 (54–70)
       Thoracic diameter55 (42–64)
       Abdominal diameter47 (37–58)
      Aetiology
       Degenerative62 (78)
       Post-dissecting18 (22)
      TAAA Crawford extent
       Type I12 (15)
       Type II29 (36)
       Type III25 (31)
       Type IV14 (18)
      Median aneurysm length – mm260 (191–352)
      Proximal landing zone location
       Zone 0–18 (10)
       Zone 28 (10)
       Zone 319 (24)
       Zone 416 (20)
       Zone 521 (26)
       Zone 68 (10)
      Distal landing zone location
       Zone 936 (45)
       Zone 1033 (41)
       Zone 1111 (14)
      Splanchnic arteries pre-operative status
       Celiac trunk occlusion5 (6)
       Celiac trunk stenosis > 75%11 (14)
       Superior mesenteric artery occlusion3 (4)
       Superior mesenteric artery stenosis > 75%1 (1)
      Renal arteries pre-operative status
       Accessory renal arteries15 (19)
       Left renal artery occlusion5 (6)
       Left renal artery stenosis > 75%3 (4)
       Right renal artery occlusion9 (11)
       Right renal artery occlusion > 75%0
      Minimum median left access vessels diameter – mm8 (7–10)
       Common iliac artery13 (11–17)
       External iliac artery9 (7–10)
       Common femoral artery9 (8–11)
      Minimum median right access vessels diameter – mm8 (7–9)
       Common iliac artery13 (11–16)
       External iliac artery9 (7–10)
       Common femoral artery9 (8–10)
      Data are presented as n (%) or median (interquartile range). STEAR = STaged Endovascular Aortic Repair; TAAA = thoracoabdominal aneurysms.

      Operative technique

      The pre-operative workup included a complete physical examination (neurologist included), aortic coronary and brain imaging, respiratory function tests, transthoracic echocardiography, and routine blood tests. The pre-operative computed tomography (CT) angiography scans were analysed on an Aquarius workstation (TeraRecon, Foster City, CA, USA) to plan the procedural strategy and decide whether to use a custom made (CMD) F/B-EVAR or an off the shelf Zenith t-branch device (Cook Medical, Bloomington, IN, USA) based on individual anatomy.
      According to aneurysm extent, previous aortic operations and planning, the staging strategy varied as described in Fig. 1. During the first thoracic step, surgical supra-aortic debranching was performed, if needed, to create a suitable proximal landing zone and/or to revascularise the left subclavian artery. Moreover, initial adjunctive endovascular procedures to improve the collateral spinal cord vasculature network were performed in this step (i.e. visceral or iliac artery stenting, hypogastric angioplasty or stenting). Meanwhile, technical drawings of the device were obtained, the procedure was approved administratively, and the CMD graft production started. All the steps and procedures were performed in an operating room with a portable C arm (Ziehm Vision RFD Hybrid edition; Ziehm Imaging, Nürnberg, Germany) or in the angiography suite (Philips Allura Xper FD10 single plane C arm; Philips Medical, Best, The Netherlands), or, since 2018, in a hybrid room (Artis Pheno, Siemens; Germany). All steps were performed preferably under local anaesthesia, through percutaneous femoral accesses (Perclose ProGlide technique - Abbott Vascular, Santa Clara, CA, USA) and transaxillary percutaneous access
      • Bertoglio L.
      • Mascia D.
      • Cambiaghi T.
      • Kahlberg A.
      • Melissano G.
      • Chiesa R.
      Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.
      when upper extremity access was required, and unfractionated heparin was administered intravenously before and during the procedure to maintain an activated clotting time >250 s.
      During the visceral step, an early limb and pelvic revascularisation protocol was employed: all vessels to be addressed from the femoral access were bridged first, then the large graft introducer sheaths were removed, and the femoral accesses were either closed or percutaneously downsised to a 10 F introducer by gently pulling the rail limb of the Perclose ProGlide devices.
      • Bertoglio L.
      • Mascia D.
      • Cambiaghi T.
      • Kahlberg A.
      • Melissano G.
      • Chiesa R.
      Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.
      The new preloaded device was employed whenever anatomically suitable.
      • Maurel B.
      • Resch T.
      • Spear R.
      • Roeder B.
      • Bracale U.M.
      • Haulon S.
      • et al.
      Early experience with a modified preloaded system for fenestrated endovascular aortic repair.
      Cerebrospinal fluid drainage (CSFD) was not employed routinely, but was inserted post-operatively in all the patients who developed symptoms of SC ischaemia and automatically drained with the Liquoguard (Möller Medical GmbH, Fulda, Germany) device (device settings: pressure below 10 cm H20 with a maximum flow of 20 mL/h).
      • Tshomba Y.
      • Leopardi M.
      • Mascia D.
      • Kahlberg A.
      • Carozzo A.
      • Magrin S.
      • et al.
      Automated pressure-controlled cerebrospinal fluid drainage during open thoracoabdominal aortic aneurysm repair.
      CSFD was inserted pre-operatively in all patients with a previous history of SC ischaemia and in those who experienced a SC ischaemia event (neurologist evaluation) during any of the planned procedural steps. All antihypertensive drugs, with the exception of beta blockers, were stopped on admission and before any step, to obtain post-operative permissive hypertension. Beta-adrenoceptor agonists (dopamine or noradrenaline) were selectively administered to obtain a mean arterial pressure > 75 mmHg. Packed red blood cell transfusions were performed to maintain a haematocrit >30%. During any graft deployment, no hypotensive drugs were used and rapid cardiac pacing in zone 0–3 proximal landings according to the operator's preferences was employied to induce hypotension.
      Patients were discharged, between steps, on single antiplatelet therapy and on double antiplatelet therapy (with acetylsalicylic acid and an adenosine diphosphate receptor antagonist) after the last step and for the first year. All patients received a CT scan within the first months after the last step and were subsequently evaluated with the same imaging modality at six and 12 months, and yearly thereafter. If a possible type I or III endoleak was detected on the one month CT scan, another scan was scheduled three months later.

      Reporting standards and results analysis

      Pre-operative demographics as well as the anatomy of the aortic pathology, status of all aortic side branches, and the spinal cord collateral network (i.e. vertebral and internal iliac arteries) were collected as risk factors. Single step mortality and morbidity (systemic complications) rates were recorded and the overall (all steps) results were considered for statistical analysis (primary endpoints). The overall (all steps) systemic complication rates were reported as the highest grade obtained for each and any complication in the single patient in all the steps necessary to treat the aneurysm. Reported risk factor and results definitions are in accordance with the current SVS/AAVS reporting standards.
      • Fillinger M.F.
      • Greenberg R.K.
      • McKinsey J.F.
      • Chaikof E.L.
      Reporting standards for thoracic endovascular aortic repair (TEVAR).
      • Chaikof E.L.
      • Blankensteijn J.D.
      • Harris P.L.
      • White G.H.
      • Zarins C.K.
      • Bernhard V.M.
      • et al.
      Reporting standards for endovascular aortic aneurysm repair.
      • Chaikof E.L.
      • Fillinger M.F.
      • Matsumura J.S.
      • Rutherford R.B.
      • White G.H.
      • Blankensteijn J.D.
      • et al.
      Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair.
      • Rutherford R.B.
      • Baker J.D.
      • Ernst C.
      • Johnston K.W.
      • Porter J.M.
      • Ahn S.
      • et al.
      Recommended standards for reports dealing with lower extremity ischemia: revised version.
      Grade 3 complications were included according to the SVS reporting standards, as well as mortality. Renal pre-operative status was also classified according to estimated creatinine clearance (CKD-EPI), and post-operative failure according to the revised AKIN classification for renal outcome analysis.
      • Lopes J.A.
      • Jorge S.
      The RIFLE and AKIN classifications for acute kidney injury: a critical and comprehensive review.

      Statistical analysis

      An independent epidemiologist (author RL) with extensive experience in designing, conducting, and analysing clinical studies, performed statistical analysis and was not involved in the study execution. In all subgroup analyses, heterogeneity was estimated by the chi-square test for heterogeneity and the I2 statistic. Continuous variables are expressed as median, first and third quartile (interquartile range, IQR = Q1-Q3) and differences were tested with the two sided t test or the Mann–Whitney U test. Categorical variables are expressed as counts and percentage and the chi-square or Fisher exact test used for analysis. Primary analysis was not adjusted for covariates. A logistic regression model using stepwise selection was used to identify predictors of the different overall systemic complications (renal, cardiac, pulmonary, bowel, cerebrovascular, and spinal cord) with a grade ≥ 1. Data were entered into the model if they had a univariable p value of < .05. Collinearity and over fitting were assessed using a stepwise regression model and Pearson correlation test. In the multivariable analyses, clinical factors or potential confounding variables were expressed as odds ratio (OR) with 95% confidence interval (CI).

      RESULTS

      The patients had received previous infrarenal, descending thoracic or thoraco-abdominal aortic procedures in 61 cases (76.3%) (Table 3): one in 37 cases (46%), two in 15 cases (19%), and three in nine cases (11%). The median interval between the F/B-EVAR procedure and the previous aortic procedure was 10 years (8–15) with the infrarenal repairs, and seven years (5–9) with the thoracic/thoraco-abdominal repairs. The previous aortic interventions combined with the different TAAA extents resulted in different staging planning (Table 4): 41 patients (51%) had their procedure split into two steps and 25 (31%) into three steps. Fourteen patients (18%) required only one step because of their previous aortic procedures (“historical staging”). The median interval between the thoracic and visceral step was 82 days (50–106) and between the visceral and limb step 20 days (17–28): the median total aneurysm treatment time (between the first admission and last discharge date) for the entire cohort was 77 days (50–107) (Table 4).
      Table 3Previous aortic history and spinal cord collateral network impairment of the study cohort (80 patients who received a multi-staged thoracoabdominal aortic aneurysm endovascular repair)
      TerritoryVariablesn (%)Overall (any impairment)
      Ascending aorta/archAscending open repair17 (21)
      Arch open repair10 (13)
      Descending thoracicOpen repair7 (9)25 (31)
      Endovascular repair9 (11)
      Thoraco-abdominalOpen repair11 (14)
      Endovascular0
      Abdominal aortaOpen repair35 (44)39 (49)
      Endovascular4 (5)
      Subclavian/vertebralLeft subclavian artery stenosis >75% or occlusion2 (3)16 (20)
      Left vertebral stenosis >75% or occlusion6 (8)
      Right subclavian artery stenosis >75% or occlusion1 (1)
      Right vertebral stenosis >75% or occlusion8 (10)
      Internal iliacLeft internal iliac artery stenosis >75% or occlusion19 (24)27 (34)
      Right internal iliac artery stenosis >75% or occlusion18 (23)
      Data are presented as n (%).
      Table 4Planning and design of the procedures employed during the STEAR study involving 80 patients with thoracoabdominal aortic aneurysm
      Variablesn (%)
      Steps planned
       1 step (“historical staging”)14 (18)
       2 steps41 (51)
       3 steps25 (31)
       Thoracic step58 (73)
       Limb step33 (41)
      Thoracic stent-graft
       Cook Zenith TX27 (9)
       Cook Zenith Alpha28 (35)
       Cook Zenith Alpha and TX28 (10)
       Custom-made Cook thoracic graft14 (18)
       Gore TAG Thoracic graft3 (4)
      Custom-made or off-the-shelf
       Off-the-shelf Cook Zenith t-branch7 (9)
       Custom-made Cook graft73 (91)
      Fenestrated or branched graft design
       All branches21 (26)
       Splanchnic branches and renal fenestrations12 (15)
       All fenestrations36 (45)
       Miscellaneous11 (14)
      Target vessel graft configuration
       Celiac trunk branch39 (49)
       Superior mesenteric branch33 (41)
       Left renal artery branch21 (26)
       Right renal artery branch23 (29)
       Adjunctive target vessels incorporated4 (5)
      Fenestrated or branched graft adjunctive features
       Low-profile fabric31 (39)
       Indwelling catheters23 (29)
       Preloaded system24 (30)
      Distal components
       None24 (30)
       Straight tube23 (29)
       Bifurcated graft25 (31)
       Bifurcated with inverted limb8 (10)
       Internal iliac branch4 (5)
      Mean waiting time for fenestrated or branched implant – days
       Graft planning and technical drawing delivery11 (7–17)
       Hospital administration approval4 (1–10)
       Graft manufacturing59 (41–84)
       Waiting time for admission (patient and surgeon availability related)14 (7–23)
      Data are presented as n (%) or median (interquartile range). STEAR = STaged Endovascular Aortic Repair.
      Six patients died (8%): one patient died of myocardial infarction during the first step, one with a 9 cm aneurysm and not suitable for an off the shelf implant, died from aneurysm rupture (at autopsy the rupture site was 6 cm from the distal edge of the previous TEVAR) in the interval between the thoracic and visceral steps (8 days after the first step), one died of bowel ischaemia after the visceral step, and all the three patients who experienced grade three spinal cord ischaemia (no recovery) died during the hospital stay or in the rehabilitation units (related deaths). One additional patient died at home from pneumonia (unrelated) in the interval between the thoracic and visceral steps on post-operative day 101 after the thoracic step and thus did not complete the aneurysm treatment. The overall 30-day clinical success (no all-step death or type I/III endoleaks on completion post-operative CT scan) was 64 cases (80%). One type IA endoleak, one type IB endoleak, two type IC endoleaks, six type IIIC endoleaks, and one type IIIA endoleak were observed. A type II endoleak occurred in 17 cases (21%).
      The overall rate of moderate (grade 2) or severe (grade 3 - including death) systemic complications was 19 cases (24%) and 20 patients (25%) experienced a mild (grade 1) systemic complication (Table 5). For SC ischaemia, 14 events were observed (reversible or permanent) in the different steps that affected 11 patients (Table S1) and resulted in three cases (4%) of fatal permanent impairment (Grade 3). Four cases completely resolved within one day (Grade 1) and the other four cases within the first week (Grade 2) after CSFD insertion (Table 5). Notably, two of three cases of grade 3 (permanent) spinal cord ischaemia occurred in the non-excluding step. The any-grade SC ischaemia rate was higher at 14% in type I-II-III Crawford extent and 20% in zone 0-3 proximal landing zone and all permanent cases (grade 3) were all type I-II-III Crawford extents (Table 6). The overall grade ≥2 cerebrovascular event rate was four (5%): two ischaemic embolic strokes (2.5%) and two haemorrhagic strokes in patients with symptomatic spinal cord ischaemia in whom pharmacologically induced hypertension was aggressively maintained. Univariable analysis identified different significant associations between outcomes and pre- and intra-operative risk factors, but the multivariable analysis identified few significant associations (Table 7): SC ischaemia was associated with aortic coverage ≥ 350 mm (OR: 9.15, p = .03, 95% CI 1.3–66.4).
      Table 5Different step outcomes and overall results of the 80 patients who received a multi-staged endovascular TAAA repair
      Outcomes1st step (n = 58)2nd step (n = 76)3rd step (n = 33)Overall (n = 80)
      Procedural data
       Local anaesthesia34 (59)42 (55)27 (82)34 (43)
       Complete percutaneous procedure43 (74)45 (59)26 (79)44 (55)
       Procedural time – min80 (49–98)301 (225–375)81 (54–127)486 (394–557)
       Fluoroscopic time – min4 (3–11)82 (66–97)3 (1–13)92 (86–113)
       DAP – Gycm260 (34–124)552 (323–960)61 (20–121)544 (399–1175)
       Contrast media – mL120 (85–135)270 (200–400)85 (45–210)645 (490–800)
      Need for ICU stay3 (5)15 (20)1 (3)15 (19)
       Related mortality3 (5)2 (3)1 (3)6 (8)
       30-day mortality1214
       Interstep related mortality2002
       Interstep non-related mortality1001
      Any systemic complications (Grade ≥2)7 (12)11 (14)1 (3)19 (24)
       Grade 1 (Mild)617320 (25)
       Grade 2 (Moderate)610015 (19)
       Grade 3 (Severe or Death)2518 (10)
      Pulmonary complications (Grade ≥2)3 (5)6 (8)1 (3)10 (13)
       Grade 1 (Prompt recovery with medical treatment)0516 (8)
       Grade 2 (Prolonged hospitalization or intravenous antibiotics)3407 (9)
       Grade 3 (Prolonged intubation, tracheostomy, O2 dependence, or fatal outcome)0213 (4)
      Cardiac complications (Grade ≥2)2 (3)3 (4)04 (5)
       Grade 1 (Little or no haemodynamic consequence)0516 (8)
       Grade 2 (Symptomatic necessitating intravenous medication, PCI)1202 (3)
       Grade 3 (Severe hemodynamic dysfunction necessitating resuscitation, cardiac arrest, or fatal outcome)1102 (3)
      Renal complications (Grade ≥2)04 (5)04 (5)
       Grade 1 (no dialysis, AKIN = 2)1515 (6)
       Grade 2 (temporary dialysis, prolonged hospitalization, permanently reduced renal function)0404 (5)
       Grade 3 (Permanent dialysis, transplant, or fatal outcome)0000
      Bowel complications (Grade ≥2)01 (1)01 (1)
       Grade 1 (Recovered without intervention)1203 (4)
       Grade 2 (Recovered with intravenous antibiotics or total parenteral nutrition)0000
       Grade 3 (Bowel resection, or fatal outcome)0101 (1)
      Cerebrovascular complications (Grade ≥2)03 (4)1 (3)4 (5)
       Grade 1 (Temporary deficit with recovery within 24 h)0202 (3)
       Grade 2 (Delayed recovery, infarct on CT or magnetic resonance, permanent deficit with mild impairment)0202 (3)
       Grade 3 (Severe impairment or fatal outcome)0112 (3)
      Spinal cord complications (Grade ≥2)3 (5)5 (7)07 (9)
       Grade 1 (Resolution within 24 h)4114 (5)
       Grade 2 (Resolution within 1 month or minor permanent deficit, able to walk without support)2304 (5)
       Grade 3 (Major permanent deficit)1203 (4)
      Need for postop. Blood transfusions – units17 (29)54 (71)11 (33)66 (83)
      Mean in hospital stay – days3 (3–4)5 (4–6)3 (2–4)11 (9–13)
      Data are presented as n (%) or median (interquartile range). AKIN = Acute Kidney Injury Network classification; CT = computer tomography; DAP = dose area product; ICU = intensive care unit; PCI = percutaneous coronary intervention; TAAA = thoracoabdominal aneurysms.
      Table 6Analysis of outcome (systemic complications grade ≥2 and any grade SCI) with regards to the aneurysm extension, previous aortic interventions, and staging strategies
      OutcomesnGrade ≥2 systemic complicationsAny Grade SCI
      Type I-II-III Crawford extent6617 (26)11 (14)
       Type I113 (25)3 (25)
       Type II199 (31)4 (14)
       Type III255 (20)4 (16)
      Type IV Crawford extent142 (14)0
      Disease thoracic aorta (%)
       ≤ 50% of the entire length327 (22)2 (6)
       > 50% of the entire length4812 (25)9 (19)
      Diseased abdominal aorta (%)
       ≤ 50% of the entire length276 (22)3 (11)
       > 50% of the entire length5313 (25)8 (15)
      Any aortic surgery4913 (27)8 (16)
       Isolated infrarenal repair247 (29)5 (21)
       Isolated thoracic or TAAA repair103 (30)1 (10)
       Both infrarenal and thoracic repair153 (20)2 (13)
      Intact aneurysms316 (19)3 (10)
       1 Step (“historical staging”)143 (21)1 (7)
       2 Steps4112 (29)6 (15)
      Thoracic and fenestrated step3310 (30)6 (18)
      Fenestrated and limb step82 (25)0
       3 steps254 (16)4 (16)
      No territory
      According to Eurec Definitions.37
      impaired
      182 (11)2 (11)
       1 territory impaired278 (30)4 (15)
       2 territories impaired255 (20)2 (8)
       3 territories impaired104 (40)(30)
      Proximal landing zone 0–33510 (29)7 (20)
       Zone 0–1801 (13)
       Zone 284 (50)1 (13)
       Zone 3196 (32)5 (26)
      Proximal landing zone 4–6459 (20)4 (9)
       Zone 4163 (19)2 (13)
       Zone 5215 (24)2 (10)
       Zone 681 (13)0
      Distal landing zone location
       Zone 93610 (28)6 (17)
       Zone 10339 (27)5 (15)
       Zone 111100
      Data are presented as n (%) unless stated otherwise. SCI = spinal cord ischaemia; TAAA = thoracoabdominal aneurysms.
      According to Eurec Definitions.
      • Czerny M.
      • Eggebrecht H.
      • Sodeck G.
      • Verzini F.
      • Cao P.
      • Maritati G.
      • et al.
      Mechanisms of symptomatic spinal cord ischemia after TEVAR: insights from the European registry of endovascular aortic repair complications (EuREC).
      Table 7Univariate and multivariate analysis of primary endpoints and risk factors in the STEAR study
      OutcomeUnivariate analysisMultivariate
      Risk factorpOR95% CIp
      Any systemic complications (Mild, Moderate, or Severe/Death)SVS score Class ≥ 2.01None
      Cardiac SVS score ≥ 1.04
      Previous CABG or PCI.003
      Distal landing zone 11.02
      Stenotic or occluded celiac trunk.04
      Concomitant open surgery I step.03
      Proximal distal neck = 11.02
      DAP II step.009
      Transfusion RBPC ≥3 II step.004
      Pulmonary complications (Mild, Moderate, or Severe/Death)Obesity ≥3.006
      Pulmonary SVS score ≥1.02
      ASA score = 4.03
      DAP II step.03
      Transfusion RBPC ≥3 II step.0046.721.45–31.32.02
      Cardiac complication (Mild, Moderate, or Severe/Death)Cardiac SVS score ≥1.05None
      Previous PCI or CABG<.001
      Aortic valve regurgitation = 2.02
      SVS score class ≥2.05
      ASA score = 4.03
      External iliac artery status ≥3.008
      Transfusion RBPC ≥3 II step.02
      Renal complications (Mild, Moderate, or Severe/Death)Previous PCI and CABG.005
      Renal class = 4.0075.711.70–9.72.005
      Previous open AAA repair.03
      % of healthy thoracic aorta.009
      Bovine arch.005
      Previous LIMA CABG.04
      Aortic coverage ≥350 mm.033.550.71–6.40.01
      Bilateral renal branch design.01
      Bowel complications (Mild, Moderate, or Severe/Death)Female sex.04None
      Diabetes ≥1.05
      Mitral insufficiency ≥2.03
      Any previous aortic surgery.01
      ASA = 4.01
      Aortic symptoms.04
      Cerebrovascular complications (Mild, Moderate, or Severe/Death)Cardiac SVS score ≥1.04None
      SVS score Class ≥2.04
      Spinal cord complications (Mild, Moderate, or Severe/Death)Age SVS class = 2.04
      Bovine arch.0210.591.64–68.58.01
      Aortic coverage ≥350 mm.0099.151.26–66.42.03
      Fluoroscopic time, min.04
      Transfusion RBPC ≥3 II step.02
      AAA = abdominal aortic aneurysm; ASA = American Society of Anaesthesiologists; CABG = coronary artery bypass graft; DAP = dose area product; LIMA = left internal mammary artery; PCI = percutaneous coronary intervention; RBPC = red blood packed cells; STEAR = STaged Endovascular Aortic Repair; SVS = Society of Vascular Surgery; OR = odds ratio; CI = confidence interval.
      In the short term (six months), seven endovascular re-interventions were performed to seal 30 day type I and III endoleaks.
      • Bertoglio L.
      • Loschi D.
      • Cambiaghi T.
      • Mascia D.
      • Kahlberg A.
      • Melissano G.
      • et al.
      Preliminary outcomes of the lifestream balloon-expandable covered stent in fenestrated and branched thoracoabdominal endovascular repairs.
      One IIIc and one IIIa spontaneously sealed at the three month CT reassessment. The patient with type IA endoleak had no more proximal neck to attempt more proximal thoracic endografting, and one patient with a type IIIC endoleak refused further endovascular re-interventions. None of the delayed aneurysm sealing patients experienced spinal cord ischaemia. The overall short term (six month) clinical success was 72 cases (90%). In the mid term (within five years) and with a mean follow up of 13.3 ± 15.4 months, the overall survival was 63 patients (79%): one related death was recorded because of a late onset type IB endoleak that led to aneurysm rupture. Five other endovascular re-interventions were performed: one patient received a thoracic stent graft for thoracic module disconnection (four year follow up); one patient had a re-stenting procedure to fix superior mesenteric branch disconnection and iliac branch deployment for the progression of aneurysmal disease in the common iliac artery (three year follow up); one patient experienced re-stenting of the coeliac trunk for a type III endoleak; and two patients had coil embolisation for type II endoleaks with enlarging aneurysm sac. No open conversions were recorded and the overall freedom from re-interventions, late rupture, or type I and III endoleaks was 57 of the 72 peri-operative survivors (79%).

      DISCUSSION

      Type I, II, and III TAAAs often require deployment of a proximal thoracic component to reach the proximal neck without excessively elongating the fenestrated/branched device. Proximal thoracic stent grafting has been thoroughly described in the setting of staging and, when a proximal landing zone has to be created, supra-aortic vessel debranching (i.e. left subclavian artery revascularisation) might be combined with thoracic component deployment. The Cleveland group first described their experience with proximal thoracic stenting as a staged option,
      • O'Callaghan A.
      • Mastracci T.M.
      • Eagleton M.J.
      Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia.
      and they reported one case of transient SC ischaemia (4%). Notably, they also recorded two cases of aneurysm rupture after the first stage in a total of 27 two stage procedures (7.4%), one of which was fatal, within the interprocedure interval. Thoracic stent grafting was performed in 58 cases (73%) in the present study cohort, mainly with commercially available devices while waiting for the customisation of the fenestrated and branched graft. Six temporary SC events (10%) were observed and one was permanent and fatal at follow up. The CMD waiting time, which was on average 82 days, was influenced by different factors: technical drawing delivery (11 days), administrative approval (4 days), graft manufacturing (59 days), and surgeon/patient availability (14 days).
      Despite the relative safety, simplicity, and worldwide experience on thoracic stent grafting, its use as the first step during F/B-EVAR should be tailored according to aortic anatomy, aneurysm extent, and in cases of post-dissection aetiology. Firstly, unnecessary thoracic coverage because of the lack of specific readily available thoracic devices should be avoided, especially for type IV TAAAs.
      • Bertoglio L.
      • Cambiaghi T.
      • Ferrer C.
      • Baccellieri D.
      • Verzini F.
      • Melissano G.
      • et al.
      Comparison of sacrificed healthy aorta during thoracoabdominal aortic aneurysm repair using off-the-shelf endovascular branched devices and open surgery.
      • Kasprzak P.
      The proximal 2-in-1 stent-graft for optimized thoracic endovascular anchoring in complex thoracoabdominal aneurysms.
      • Tsilimparis N.
      • Fiorucci B.
      • Debus E.S.
      • Rohlffs F.
      • Kölbel T.
      Technical aspects of implanting the t-branch off-the-shelf multibranched stent-graft for thoracoabdominal aneurysms.
      Moreover, because of lack of distal sealing, the aneurysm lumen is often completely perfused by the type IB endoleak jeopardising the thrombosis of the intercostal arteries and collateral network remodelling: in the future, specific devices might be designed to improve the intercostal artery thrombosis rate during the first step. Lastly, the beneficial effect of staging has not been proven in the setting of post-dissection aneurysms, because of residual false lumen perfusion from re-entry tears, which might prevent intercostal artery thrombosis. Recently, Oikonomou et al.
      • Oikonomou K.
      • Kasprzak P.
      • Katsargyris A.
      • Marques De Marino P.
      • Pfister K.
      • Verhoeven E.L.G.
      Mid-term results of fenestrated/branched stent grafting to treat post-dissection thoraco-abdominal aneurysms.
      reported a 15.5% SC rate in 71 post-dissection TAAAs treated with a F/B-EVAR with a staged approach in 40.8% of the cases. Thus, the use of false lumen occlusion techniques for achieving descending thoracic false lumen thrombosis (i.e. candy plug or Knickerbocker techniques) might be combined with F/B-EVAR in post-dissection TAAAs to maximise staging benefits.
      • Carta N.
      • Salvati S.
      • Melissano G.
      • Chiesa R.
      • Bertoglio L.
      • et al.
      Staged fenestrated or branched repair of post-dissecting thoraco-abdominal aneurysm with candy plug false lumen occlusion for spinal cord preconditioning.
      The temporary aneurysm sac perfusion (TASP) technique is based on the idea that residual perfusion of the aneurysm sac will prevent its complete thrombosis and preserve a degree of SC perfusion allowing collateral network remodelling to accommodate for the newly reduced SC blood supply. The theoretical benefit has been corroborated by the evidence that intentionally induced or untreated type I endoleaks were able to revert or mitigate the SC injury rate.
      • O'Callaghan A.
      • Mastracci T.M.
      • Eagleton M.J.
      Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia.
      ,
      • Reilly L.M.
      • Chuter T.A.
      Reversal of fortune: induced endoleak to resolve neurological deficit after endovascular repair of thoracoabdominal aortic aneurysm.
      Lioupis C et al.
      • Lioupis C.
      • Corriveau M.M.
      • MacKenzie K.S.
      • Obrand D.I.
      • Steinmetz O.K.
      • Ivancev K.
      • et al.
      Paraplegia prevention branches: a new adjunct for preventing or treating spinal cord injury after endovascular repair of thoracoabdominal aneurysms.
      proposed the incorporation of perfusion branches onto the CMD device, to be plugged at a second intervention, with encouraging results. Moreover, Kasprzak et al.
      • Kasprzak P.M.
      • Gallis K.
      • Cucuruz B.
      • Pfister K.
      • Janotta M.
      • Kopp R.
      Temporary aneurysm sac perfusion as an adjunct for prevention of spinal cord ischemia after branched endovascular repair of thoracoabdominal aneurysms.
      ,
      • Pfister K.
      • Kasprzak P.M.
      • Apfelbeck H.
      • Kopp R.
      • Janotta M.
      • Schierling W.
      Inferior mesenteric artery side branch for selected patients with endovascular aortic aneurysm repair.
      studied staging with non-completion of visceral branches, most often the coeliac trunk, and have reported less severe neurological deficits and earlier recovery when using this method: the SC injury rates were reduced from 21% to 2.5%. However, several drawbacks have been reported and questioned: the possibility of visceral vessel thrombosis from contact of the graft main body with the coeliac ostium (i.e. angulated anatomy or narrow intravascular aortic diameter), aneurysm growth (26%), aneurysm rupture (3%), and consumption coagulopathy from induced high flow endoleak.
      • Kasprzak P.M.
      • Gallis K.
      • Cucuruz B.
      • Pfister K.
      • Janotta M.
      • Kopp R.
      Temporary aneurysm sac perfusion as an adjunct for prevention of spinal cord ischemia after branched endovascular repair of thoracoabdominal aneurysms.
      Those limitations might be reduced by applying a selective TASP technique as proposed by the Mayo Clinic group; Oderich et al.
      • Banga P.V.
      • Oderich G.S.
      • De Souza L.R.
      • Hofer J.
      • Cazares Gonzalez M.L.
      • Pulido J.N.
      • et al.
      Neuromonitoring, cerebrospinal fluid drainage, and selective use of iliofemoral conduits to minimize risk of spinal cord injury during complex endovascular aortic repair.
      implemented motor evoked potential (MEP) monitoring during F/B-EVAR procedures deciding whether or not to completely exclude the aneurysm according to the presence of signs of SC ischaemia. Despite being very sensitive in detecting intra-operative SC ischaemia, MEP monitoring is not able to detect cases in which the SC collateral network is unstable, and thus vulnerable. It is well known, for example, that cardiopulmonary complications or anaemia can trigger delayed onset SC ischaemia even if the intra-operative MEP monitoring was negative for SC ischaemia. Moreover, routine or selective TASP by leaving a downward oriented branch requires the use of a second upper extremity access procedure, increasing the risk of cerebrovascular accidents, and might not be easily feasible in all centres in case of emergency because of intersurgical impending rupture onset.
      • Bertoglio L.
      • Mascia D.
      • Cambiaghi T.
      • Kahlberg A.
      • Melissano G.
      • Chiesa R.
      Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.
      ,
      • Mirza A.K.
      • Oderich G.S.
      • Sandri G.A.
      • Tenorio E.R.
      • Davila V.J.
      • Kärkkäinen J.M.
      • et al.
      Outcomes of upper extremity access during fenestrated-branched endovascular aortic repair.
      ,
      • Fiorucci B.
      • Kölbel T.
      • Rohlffs F.
      • Heidemann F.
      • Debus S.E.
      • Tsilimparis N.
      Right brachial access is safe for branched endovascular aneurysm repair in complex aortic disease.
      The present staging protocol entails a standard thoracic step, but the manufacturing process is the main cause for extending the interval between the thoracic and visceral step. Etz et al. demonstrated that, in animal models, it takes about five days for the SC collateral network to be structurally remodelled after the occlusion of segmental arteries and for those reasons it is hoped that in the future the customisation process will be reduced to two to three weeks.
      • Etz C.D.
      • Kari F.A.
      • Mueller C.S.
      • Brenner R.M.
      • Lin H.M.
      • Griepp R.B.
      The collateral network concept: remodeling of the arterial collateral network after experimental segmental artery sacrifice.
      Interestingly, when employing off-the-shelf devices, the median intersurgical interval was reduced to 28 days. However, the t-branch anatomical feasibility was quite limited in the present patient cohort. During the visceral step, attempts are made to reperfuse the limb and pelvis as quickly as possible and if possible, to perform a single femoral access procedure considering that the contralateral limb will not be deployed during this step.
      • Maurel B.
      • Delclaux N.
      • Sobocinski J.
      • Hertault A.
      • Martin-Gonzalez T.
      • Moussa M.
      • et al.
      Editor's choice - the impact of early pelvic and lower limb reperfusion and attentive peri-operative management on the incidence of spinal cord ischemia during thoracoabdominal aortic aneurysm endovascular repair.
      For a four branch design, the procedure can be performed with one femoral and one upper extremity access. The main aortic components are deployed first and the large introducer sheath is then removed before bridging the target vessels. For a four fenestration design, nowadays a preloaded delivery system is ordered that allows catheterisation of two vessels from the same main body access and the third vessel is bridged via a 7–8 F sheath either from the contralateral femoral access or an upper extremity access.
      • Maurel B.
      • Resch T.
      • Spear R.
      • Roeder B.
      • Bracale U.M.
      • Haulon S.
      • et al.
      Early experience with a modified preloaded system for fenestrated endovascular aortic repair.
      When an anatomical limitation is present for a preloaded design, the upper extremity access is used to limit the contralateral femoral access sheath size when not contraindicated (i.e. shaggy aorta).
      • Bertoglio L.
      • Mascia D.
      • Cambiaghi T.
      • Kahlberg A.
      • Melissano G.
      • Chiesa R.
      Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.
      ,
      • Banga P.V.
      • Oderich G.S.
      • De Souza L.R.
      • Hofer J.
      • Cazares Gonzalez M.L.
      • Pulido J.N.
      • et al.
      Neuromonitoring, cerebrospinal fluid drainage, and selective use of iliofemoral conduits to minimize risk of spinal cord injury during complex endovascular aortic repair.
      Incorporating a third excluding step in the planning also has other possible advantages. Lengthy endovascular procedures, such as the visceral step, have been associated with increased rates of SC ischaemia events because of the possible instability of the cardiopulmonary status of the patient, which can result in episodes of hypotension post-operatively.
      • Bisdas T.
      • Panuccio G.
      • Sugimoto M.
      • Torsello G.
      • Austermann M.
      Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
      ,
      • Pfister K.
      • Kasprzak P.M.
      • Apfelbeck H.
      • Kopp R.
      • Janotta M.
      • Schierling W.
      Inferior mesenteric artery side branch for selected patients with endovascular aortic aneurysm repair.
      A third stage for excluding the aneurysm allows for final exclusion to take place in stable conditions, without other clinical confounding factors, and under local anaesthesia with easy neuromonitoring to promptly adopt appropriate manoeuvres to try to revert SC ischaemia episodes (i.e. inotropes, selective CSFD drainage). Moreover, the interval between the visceral and limb steps (an average of 20 days) allows the SC circulation some extra time for preconditioning. The limb step, rather than an open visceral branch, through a femoral access is preferable because it avoids a second upper extremity access and can be performed, in an emergency, in any hospital with infrarenal aortic endovascular skills. Moreover, complications associated with visceral TASP, such as branch occlusion or visceral vessel thrombosis, are avoided. Finally, in the authors’ opinion, inducing a type IB endoleak with an adequate outflow pattern through the iliac and femoral axes (not only the intercostal arteries and an often stenotic coeliac trunk) is preferable to avoid sac turbulence triggering coagulopathy or pathological pressurisation with aneurysm growth/rupture.
      • Kasprzak P.M.
      • Gallis K.
      • Cucuruz B.
      • Pfister K.
      • Janotta M.
      • Kopp R.
      Temporary aneurysm sac perfusion as an adjunct for prevention of spinal cord ischemia after branched endovascular repair of thoracoabdominal aneurysms.
      Accordingly, the present authors have implemented this method for staging procedures. However, a complete three step procedure was needed in only 25 cases (31%), because of the aneurysm extent and because 49% of the patients had previously undergone open or endovascular aortic repair in the infrarenal or/and thoracic aorta with so called “historical staging” (Table 3). The role of “historical aortic staging” as a risk factor in simple thoracic stent grafting is clear but it does not seem to negatively affect F/B-EVAR procedures in more recent publications.
      • Czerny M.
      • Eggebrecht H.
      • Sodeck G.
      • Verzini F.
      • Cao P.
      • Maritati G.
      • et al.
      Mechanisms of symptomatic spinal cord ischemia after TEVAR: insights from the European registry of endovascular aortic repair complications (EuREC).
      • Spanos K.
      • Kölbel T.
      • Kubitz J.C.
      • Wipper S.
      • Konstantinou N.
      • Heidemann F.
      • et al.
      Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms.
      • Gallitto E.
      • Faggioli G.
      • Mascoli C.
      • Pini R.
      • Ancetti S.
      • Vacirca A.
      • et al.
      Impact of previous open aortic repair on the outcome of thoracoabdominal fenestrated and branched endografts.
      Interestingly, Kaushik et al. reported a possible SC protective effect of historical staging.
      • Kaushik S.
      • Gasper W.J.
      • Ramanan B.
      • Vartanian S.M.
      • Reilly L.M.
      • Chuter T.A.M.
      • et al.
      The impact of prior aortic surgery on outcomes after multibranched endovascular aortic aneurysm repair.
      This preliminary analysis seems to corroborate the idea that “historical staging” might not affect the SC rate. Results concerning SC ischaemia have been very promising, and even though overall 14 events (reversible or permanent) were recorded, only three patients (4%) suffered from permanent SC ischaemia and subsequently died at mid term. Notably, two of the three permanent SC ischaemia events occurred in a non-excluding step suggesting that the SC injury pathophysiology is multifactorial (i.e. embolic). The SC events have all been recorded in patients with extensive TAAAs (type I, II, III) and mainly in zone 0-3 proximal landing zones; however, the present multivariable analysis recorded only an association between an aortic coverage longer than 350 mm and SC ischaemia. Interestingly, the threshold value seems higher than expected suggesting that SC preconditioning by means of staging increases the SC tolerance to intercostal and lumbar artery loss.
      • Bisdas T.
      • Panuccio G.
      • Sugimoto M.
      • Torsello G.
      • Austermann M.
      Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
      ,
      • Czerny M.
      • Eggebrecht H.
      • Sodeck G.
      • Verzini F.
      • Cao P.
      • Maritati G.
      • et al.
      Mechanisms of symptomatic spinal cord ischemia after TEVAR: insights from the European registry of endovascular aortic repair complications (EuREC).
      ,
      • Scali S.T.
      • Wang S.K.
      • Feezor R.J.
      • Huber T.S.
      • Martin T.D.
      • Klodell C.T.
      • et al.
      Preoperative prediction of spinal cord ischemia after thoracic endovascular aortic repair.
      Strikingly, a high endoleak rate was registered at 30 days, and seven patients required secondary intervention to fix them but none of those with delayed aneurysm sealing experienced SC ischaemia.
      • Bertoglio L.
      • Loschi D.
      • Cambiaghi T.
      • Mascia D.
      • Kahlberg A.
      • Melissano G.
      • et al.
      Preliminary outcomes of the lifestream balloon-expandable covered stent in fenestrated and branched thoracoabdominal endovascular repairs.
      One case of interim rupture (1.3%) was recorded after eight days, and despite the rupture site being distal to the stented area, the role of the endomanipulation during proximal thoracic stent grafting in this intersurgical rupture needs further evaluation. Therefore, the risk of intersurgical rupture, intrinsic to any kind of staging protocols, should be balanced against the benefits of staged F/B-EVAR protocols and against the poor short term outcomes of non-walking SC ischaemic patients.
      • DeSart K.
      • Scali S.T.
      • Feezor R.J.
      • Hong M.
      • Hess Jr., P.J.
      • Beaver T.M.
      • et al.
      Fate of patients with spinal cord ischemia complicating thoracic endovascular aortic repair.
      The present study analysis has different limitations: the presence of previous aortic repairs in different aortic segments introduces an important bias that has also affected the staging methods, and at present the cohort size does not allow for appropriate subanalysis. However, because of these promising results, the present authors employ staging in every elective case when applicable and hope to enroll a larger sample of patients in the prospective arm of the study to increase the statistical power of the analysis. The final results of the PAPA-ARTiS randomised controlled trial are awaited, which aims to investigate the efficacy of the MISACE technique in reducing paraplegia and mortality in patients undergoing TAAA repair,
      • Branzan D.
      • Etz C.
      • Moche M.
      • von Aspern K.
      • Staab H.
      • Fuchs J.
      • et al.
      Ischemic preconditioning of the spinal cord to prevent spinal cord ischemia during endovascular repair of thoraco-abdominal aortic aneurysm - first clinical experience.
      and the present authors aim to incorporate this technique within the staging workflow of TAAAs F/B-EVAR treatment.

      CONFLICT OF INTEREST

      None.

      FUNDING

      None.

      ACKNOWLEDGEMENTS

      We thank Annie Campbell, medical illustrator, for anatomical sketches used in the illustrations to describe the methods.

      Appendix A. Supplementary data

      The following is the Supplementary data to this article:

      References

        • Rocha R.V.
        • Friedrich J.O.
        • Elbatarny M.
        • Yanagawa B.
        • Al-Omran M.
        • Forbes T.L.
        • et al.
        A systematic review and meta-analysis of early outcomes after endovascular versus open repair of thoracoabdominal aortic aneurysms.
        J Vasc Surg. 2018; 68: 1936-1945
        • Svensson L.G.
        • Crawford E.S.
        • Hess K.R.
        • Coselli J.S.
        • Safi H.J.
        Experience with 1509 patients undergoing thoracoabdominal aortic operations.
        J Vasc Surg. 1993; 17: 357-368
        • Bisdas T.
        • Panuccio G.
        • Sugimoto M.
        • Torsello G.
        • Austermann M.
        Risk factors for spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
        J Vasc Surg. 2015; 61: 1408-1416
        • Katsargyris A.
        • Oikonomou K.
        • Kouvelos G.
        • Renner H.
        • Ritter W.
        • Verhoeven E.L.G.
        Spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms with fenestrated and branched stent grafts.
        J Vasc Surg. 2015; 62: 1450-1456
        • Ferrer C.
        • Cao P.
        • De Rango P.
        • Tshomba Y.
        • Verzini F.
        • Melissano G.
        • et al.
        A propensity-matched comparison for endovascular and open repair of thoracoabdominal aortic aneurysms.
        J Vasc Surg. 2016; 63: 1201-1207
        • Dias N.V.
        • Sonesson B.
        • Kristmundsson T.
        • Holm H.
        • Resch T.
        Short-term outcome of spinal cord ischemia after endovascular repair of thoracoabdominal aortic aneurysms.
        Eur J Vasc Endovasc Surg. 2015; 49: 403-409
        • Sobel J.D.
        • Vartanian S.M.
        • Gasper W.J.
        • Hiramoto J.S.
        • Chuter T.A.M.
        • Reilly L.M.
        Lower extremity weakness after endovascular aneurysm repair with multibranched thoracoabdominal stent grafts.
        J Vasc Surg. 2015; 61: 623-628
        • Oderich G.S.
        • Ribeiro M.
        • Reis de Souza L.
        • Hofer J.
        • Wigham J.
        • Cha S.
        Endovascular repair of thoracoabdominal aortic aneurysms using fenestrated and branched endografts.
        J Thorac Cardiovasc Surg. 2017; 153: S32-S41
        • Eagleton M.J.
        • Follansbee M.
        • Wolski K.
        • Mastracci T.
        • Kuramochi Y.
        Fenestrated and branched endovascular aneurysm repair outcomes for type II and III thoracoabdominal aortic aneurysms.
        J Vasc Surg. 2016; 63: 930-942
        • Greenberg R.K.
        • Lu Q.
        • Roselli E.E.
        • Svensson L.G.
        • Moon M.C.
        • Hernandez A.V.
        • et al.
        Contemporary analysis of descending thoracic and thoracoabdominal aneurysm repair a comparison of endovascular and open techniques.
        Circulation. 2008; 118: 808-817
        • Etz C.D.
        • Zoli S.
        • Mueller C.S.
        • Bodian C.A.
        • Di Luozzo G.
        • Lazala R.
        • et al.
        Staged repair significantly reduces paraplegia rate after extensive thoracoabdominal aortic aneurysm repair.
        J Thorac Cardiovasc Surg. 2010; 139: 1464-1472
        • O'Callaghan A.
        • Mastracci T.M.
        • Eagleton M.J.
        Staged endovascular repair of thoracoabdominal aortic aneurysms limits incidence and severity of spinal cord ischemia.
        J Vasc Surg. 2015; 61: 347-354
        • Jayia P.
        • Constantinou J.
        • Hamilton H.
        • Ivancev K.
        Temporary perfusion branches to decrease spinal cord ischemia in the endovascular treatment of thoraco-abdominal aortic aneurysms based on a presentation at the 2013 VEITH Symposium, November 19–23, 2013 (New York, NY, USA).
        Aorta (Stamford). 2015; 3: 56-60
        • Kasprzak P.M.
        • Gallis K.
        • Cucuruz B.
        • Pfister K.
        • Janotta M.
        • Kopp R.
        Temporary aneurysm sac perfusion as an adjunct for prevention of spinal cord ischemia after branched endovascular repair of thoracoabdominal aneurysms.
        Eur J Vasc Endovasc Surg. 2014; 48 (Editor’s choice): 258-265
        • Branzan D.
        • Etz C.
        • Moche M.
        • von Aspern K.
        • Staab H.
        • Fuchs J.
        • et al.
        Ischemic preconditioning of the spinal cord to prevent spinal cord ischemia during endovascular repair of thoraco-abdominal aortic aneurysm - first clinical experience.
        EuroIntervention. 2018; 14: 828-835
        • Bertoglio L.
        • Mascia D.
        • Cambiaghi T.
        • Kahlberg A.
        • Melissano G.
        • Chiesa R.
        Percutaneous axillary artery access for fenestrated and branched thoracoabdominal endovascular repair.
        J Vasc Surg. 2018; 68: 12-23
        • Maurel B.
        • Resch T.
        • Spear R.
        • Roeder B.
        • Bracale U.M.
        • Haulon S.
        • et al.
        Early experience with a modified preloaded system for fenestrated endovascular aortic repair.
        J Vasc Surg. 2017; 65: 972-980
        • Tshomba Y.
        • Leopardi M.
        • Mascia D.
        • Kahlberg A.
        • Carozzo A.
        • Magrin S.
        • et al.
        Automated pressure-controlled cerebrospinal fluid drainage during open thoracoabdominal aortic aneurysm repair.
        J Vasc Surg. 2017; 66: 37-44
        • Fillinger M.F.
        • Greenberg R.K.
        • McKinsey J.F.
        • Chaikof E.L.
        Reporting standards for thoracic endovascular aortic repair (TEVAR).
        J Vasc Surg. 2010; 52: 1022-1033
        • Chaikof E.L.
        • Blankensteijn J.D.
        • Harris P.L.
        • White G.H.
        • Zarins C.K.
        • Bernhard V.M.
        • et al.
        Reporting standards for endovascular aortic aneurysm repair.
        J Vasc Surg. 2002; 35: 1048-1060
        • Chaikof E.L.
        • Fillinger M.F.
        • Matsumura J.S.
        • Rutherford R.B.
        • White G.H.
        • Blankensteijn J.D.
        • et al.
        Identifying and grading factors that modify the outcome of endovascular aortic aneurysm repair.
        J Vasc Surg. 2002; 35: 1048-1060
        • Rutherford R.B.
        • Baker J.D.
        • Ernst C.
        • Johnston K.W.
        • Porter J.M.
        • Ahn S.
        • et al.
        Recommended standards for reports dealing with lower extremity ischemia: revised version.
        J Vasc Surg. 1997; 26: 517-538
        • Lopes J.A.
        • Jorge S.
        The RIFLE and AKIN classifications for acute kidney injury: a critical and comprehensive review.
        Clin Kidney J. 2013; 6: 8-14
        • Bertoglio L.
        • Loschi D.
        • Cambiaghi T.
        • Mascia D.
        • Kahlberg A.
        • Melissano G.
        • et al.
        Preliminary outcomes of the lifestream balloon-expandable covered stent in fenestrated and branched thoracoabdominal endovascular repairs.
        J Endovasc Ther. 2018; 25: 230-236
        • Bertoglio L.
        • Cambiaghi T.
        • Ferrer C.
        • Baccellieri D.
        • Verzini F.
        • Melissano G.
        • et al.
        Comparison of sacrificed healthy aorta during thoracoabdominal aortic aneurysm repair using off-the-shelf endovascular branched devices and open surgery.
        J Vasc Surg. 2018; 67: 695-702
        • Kasprzak P.
        The proximal 2-in-1 stent-graft for optimized thoracic endovascular anchoring in complex thoracoabdominal aneurysms.
        ([in German])Paper presented at: the German society of vascular surgery and vacular medicine annual meeting; September 16–19. Münster, Germany2015
        • Tsilimparis N.
        • Fiorucci B.
        • Debus E.S.
        • Rohlffs F.
        • Kölbel T.
        Technical aspects of implanting the t-branch off-the-shelf multibranched stent-graft for thoracoabdominal aneurysms.
        J Endovasc Ther. 2017; 24: 397-404
        • Oikonomou K.
        • Kasprzak P.
        • Katsargyris A.
        • Marques De Marino P.
        • Pfister K.
        • Verhoeven E.L.G.
        Mid-term results of fenestrated/branched stent grafting to treat post-dissection thoraco-abdominal aneurysms.
        Eur J Vasc Endovasc Surg. 2019; 57: 102-109
        • Reilly L.M.
        • Chuter T.A.
        Reversal of fortune: induced endoleak to resolve neurological deficit after endovascular repair of thoracoabdominal aortic aneurysm.
        J Endovasc Ther. 2010; 17: 21-29
        • Lioupis C.
        • Corriveau M.M.
        • MacKenzie K.S.
        • Obrand D.I.
        • Steinmetz O.K.
        • Ivancev K.
        • et al.
        Paraplegia prevention branches: a new adjunct for preventing or treating spinal cord injury after endovascular repair of thoracoabdominal aneurysms.
        J Vasc Surg. 2011; 54: 252-257
        • Pfister K.
        • Kasprzak P.M.
        • Apfelbeck H.
        • Kopp R.
        • Janotta M.
        • Schierling W.
        Inferior mesenteric artery side branch for selected patients with endovascular aortic aneurysm repair.
        EJVES Short Rep. 2016; 31: 1-5
        • Banga P.V.
        • Oderich G.S.
        • De Souza L.R.
        • Hofer J.
        • Cazares Gonzalez M.L.
        • Pulido J.N.
        • et al.
        Neuromonitoring, cerebrospinal fluid drainage, and selective use of iliofemoral conduits to minimize risk of spinal cord injury during complex endovascular aortic repair.
        J Endovasc Ther. 2016; 23: 139-149
        • Mirza A.K.
        • Oderich G.S.
        • Sandri G.A.
        • Tenorio E.R.
        • Davila V.J.
        • Kärkkäinen J.M.
        • et al.
        Outcomes of upper extremity access during fenestrated-branched endovascular aortic repair.
        J Vasc Surg. 2019; 69: 635-643
        • Fiorucci B.
        • Kölbel T.
        • Rohlffs F.
        • Heidemann F.
        • Debus S.E.
        • Tsilimparis N.
        Right brachial access is safe for branched endovascular aneurysm repair in complex aortic disease.
        J Vasc Surg. 2017; 66: 360-366
        • Etz C.D.
        • Kari F.A.
        • Mueller C.S.
        • Brenner R.M.
        • Lin H.M.
        • Griepp R.B.
        The collateral network concept: remodeling of the arterial collateral network after experimental segmental artery sacrifice.
        J Thorac Cardiovasc Surg. 2011; 141: 1029-1036
        • Maurel B.
        • Delclaux N.
        • Sobocinski J.
        • Hertault A.
        • Martin-Gonzalez T.
        • Moussa M.
        • et al.
        Editor's choice - the impact of early pelvic and lower limb reperfusion and attentive peri-operative management on the incidence of spinal cord ischemia during thoracoabdominal aortic aneurysm endovascular repair.
        Eur J Vasc Endovasc Surg. 2015; 49: 248-254
        • Czerny M.
        • Eggebrecht H.
        • Sodeck G.
        • Verzini F.
        • Cao P.
        • Maritati G.
        • et al.
        Mechanisms of symptomatic spinal cord ischemia after TEVAR: insights from the European registry of endovascular aortic repair complications (EuREC).
        J Endovasc Ther. 2012; 19: 37-43
        • Spanos K.
        • Kölbel T.
        • Kubitz J.C.
        • Wipper S.
        • Konstantinou N.
        • Heidemann F.
        • et al.
        Risk of spinal cord ischemia after fenestrated or branched endovascular repair of complex aortic aneurysms.
        J Vasc Surg. 2019; 69: 357-366
        • Gallitto E.
        • Faggioli G.
        • Mascoli C.
        • Pini R.
        • Ancetti S.
        • Vacirca A.
        • et al.
        Impact of previous open aortic repair on the outcome of thoracoabdominal fenestrated and branched endografts.
        J Vasc Surg. 2018; 68: 1667-1675
        • Kaushik S.
        • Gasper W.J.
        • Ramanan B.
        • Vartanian S.M.
        • Reilly L.M.
        • Chuter T.A.M.
        • et al.
        The impact of prior aortic surgery on outcomes after multibranched endovascular aortic aneurysm repair.
        J Vasc Surg. 2018; 68: 325-330
        • Scali S.T.
        • Wang S.K.
        • Feezor R.J.
        • Huber T.S.
        • Martin T.D.
        • Klodell C.T.
        • et al.
        Preoperative prediction of spinal cord ischemia after thoracic endovascular aortic repair.
        J Vasc Surg. 2014; 60: 1481-1490
        • DeSart K.
        • Scali S.T.
        • Feezor R.J.
        • Hong M.
        • Hess Jr., P.J.
        • Beaver T.M.
        • et al.
        Fate of patients with spinal cord ischemia complicating thoracic endovascular aortic repair.
        J Vasc Surg. 2013; 58 (e2): 635-642
        • Carta N.
        • Salvati S.
        • Melissano G.
        • Chiesa R.
        • Bertoglio L.
        • et al.
        Staged fenestrated or branched repair of post-dissecting thoraco-abdominal aneurysm with candy plug false lumen occlusion for spinal cord preconditioning.
        J Endovasc Ther. 2020; ([In press])

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