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Evaluation of the Gore TAG thoracic branch endoprosthesis in the treatment of proximal descending thoracic aortic aneurysms

Published:April 30, 2021DOI:https://doi.org/10.1016/j.jvs.2021.04.025

      Abstract

      Background

      Thoracic endovascular aortic repair has radically transformed the treatment of descending thoracic aortic aneurysms. However, when aneurysms involve the aortic arch in the region of the left subclavian artery, branch vessel preservation must be considered. Branched aortic endografts have provided a new option to maintain branch patency.

      Methods

      Six investigative sites enrolled 31 patients in a nonrandomized, prospective investigational device exemption feasibility trial of a single branched aortic endograft for the management of aneurysms that include the distal aortic arch. The Gore TAG thoracic branch endoprosthesis (W. L. Gore & Associates, Inc, Flagstaff, Ariz), an investigational device, allows for graft placement proximal to the left subclavian artery and incorporates a single side branch for left subclavian perfusion.

      Results

      All 31 patients (100%) had undergone successful implantation of the investigational device in landing zone 2. Men slightly outnumbered women (51.6%). Their average age was 74.1 ± 10.4 years. The aneurysm morphology was fusiform in 12 and saccular in 19 patients, with a mean maximum aortic diameter of 54.8 ± 10.9 mm. The mean follow-up period for the cohort was 25.2 ± 11.1 months. We have reported the patient outcomes at 1 month and 1 year. At 1 month, the side branch patency was 100% and the freedom from core laboratory-reported device-related endoleak (types I and III) was 96.7%, without 30-day death or permanent paraplegia. One patient experienced a procedure-related stroke. Through 1 year, five patients had died; none of the deaths were related to the device or procedure (clinical endpoint committee adjudicated). One thoracic reintervention was required. No conversions were required, and no aneurysm growth (core laboratory) was reported. One case of the loss of side branch patency was diagnosed in the left subclavian artery in an asymptomatic individual from computed tomography at 6 months, with no reported subsequent adverse events due to loss of patency. Endoleaks were reported by the core laboratory in five patients at 12 months (two, type II; and three, indeterminate).

      Conclusions

      The present investigational device exemption feasibility study has reported the preliminary results of the use of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.

      Graphical abstract

      Keywords

      Article Highlights
      • Type of Research: A multicenter, prospective, nonrandomized cohort study
      • Key Findings: All 31 patients with proximal descending aortic aneurysms had undergone successful implantation of a single side branch endograft. At 1 month, side branch patency was 100%, and freedom from endoleak (types I and III) was 96.7% without 30-day death or permanent paraplegia. Through 1 year, five patients had died; however, none of the deaths were related to the device or procedure.
      • Take Home Message: The present investigational device exemption feasibility study has reported the preliminary results of the use of a single side branch endograft to treat patients with proximal descending thoracic aortic aneurysms.
      The development of endovascular techniques for the management of abdominal and thoracic aortic diseases during the past 20 years has dramatically changed clinical practice. Since its introduction, thoracic endovascular aortic repair (TEVAR) has progressed from an alternative therapy for patients at high risk of open surgical repair to a generally adopted procedure that is in widespread clinical use.
      • Erbel R.
      • Aboyans V.
      • Boileau C.
      • Bossone E.
      • Di Bartolomeo R.
      • Eggebrect H.
      • et al.
      2014 ESC guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The task force for the diagnosis and treatment of aortic diseases of the European Society of Cardiology (ESC).
      ,
      • Riambau V.
      • Bockler D.
      • Brunkwall J.
      • Cao P.
      • Chiesa R.
      • Coppi M.
      • et al.
      Management of descending thoracic aortic diseases: clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
      Its initial application was the treatment of patients with descending thoracic aortic (DTA) aneurysms. However, thoracic endografts are now approved for use for type B aortic dissection and traumatic injury.
      Enthusiasm for this less-invasive thoracic aortic therapy has fueled interest in extending its application to address disease in more proximal aortic segments, including the aortic arch where critical branch vessels exist. The lack of available endografts that incorporate an integrated branch graft led to the creation of hybrid procedures with bypass grafts to arch branches combined with TEVAR
      • Cao P.
      • De Rango P.
      • Czerny M.
      • Evangelista A.
      • Fattori R.
      • Nienaber C.
      • et al.
      Systemic review of clinical outcomes in hybrid procedures for aortic arch dissection and other diseases.
      • Moulakakis K.G.
      • Mylonas S.N.
      • Markatis F.
      • Kotsis T.
      • Kakisis J.
      • Liapis C.D.
      A systematic review and meta-analysis of hybrid aortic arch replacement.
      • Benrashid E.
      • Wang H.
      • Keenan J.E.
      • Andersen N.D.
      • Meza J.M.
      • McCann R.L.
      • et al.
      Evolving practice pattern changes and outcomes in the era of hybrid aortic arch repair.
      and the use of parallel branch vessel endografts, including chimney, periscope, or snorkel (ChimPS) devices, alongside,
      • Yang J.
      • Xiong J.
      • Liu X.
      • Jia X.
      • Zhu Y.
      • Guo W.
      Endovascular chimney technique for aortic arch pathologies: a systematic review.
      • Hogendoorn W.
      • Schlosser F.J.V.
      • Moll F.L.
      • Sumpio B.E.
      • Muhs B.E.
      Thoracic endovascular aortic repair with the chimney graft technique.
      • Mangialardi N.
      • Serrao E.
      • Kasemi H.
      • Alberti V.
      • Fazzini S.
      • Ronchey S.
      Chimney technique for aortic arch pathologies: an 11-year single-center experience.
      or via in situ fenestration,
      • Sonesson B.
      • Resch T.
      • Allers M.
      • Malina M.
      Endovascular total arch replacement by in situ stent graft fenestration technique.
      • Manning B.J.
      • Ivancev K.
      • Harris P.L.
      In situ fenestration in the aortic arch.
      • Tse L.W.
      • Lindsay T.F.
      • Roche-Nagle G.
      • Oreopoulos G.D.
      • Ouzounian M.
      • Tan K.T.
      Radiofrequency in situ fenestration for aortic arch vessels during thoracic endovascular repair.
      of standard aortic endografts for total endoluminal repair.
      A preferred solution to address aortic arch pathology would use a branched stent-graft created to allow for endovascular branch vessel reconstruction. The Gore TAG thoracic branch endoprosthesis (TBE; W.L. Gore & Associates, Flagstaff, Ariz) is a uniquely designed single side branch (SB) device. The initial perioperative results of the U.S. investigational device exemption (IDE) feasibility multicenter trial to study its use for the treatment of patients with distal arch and descending thoracic aortic aneurysms involving the left subclavian artery (LSA) were previously reported.
      • Patel H.J.
      • Dake M.D.
      • Bavaria J.E.
      • Singh M.J.
      • Filinger M.
      • Fischbein M.P.
      • et al.
      Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicenter trial of the Gore thoracic branch endoprosthesis.
      In the present report, we have described the 1-year follow-up outcomes for patients who had undergone TBE placement into Ishimaru landing zone 2.
      • Mitchell R.S.
      • Ishimaru S.
      • Ehrlich M.P.
      • Iwase T.
      • Lauterjung L.
      • Shimono T.
      • et al.
      First international summit on thoracic aortic endografting: roundtable on thoracic aortic dissection as an indication for endografting.

      Methods

       Study design

      A detailed description of the study design, device construction, inclusion criteria, methods, and primary and secondary endpoints at procedure conclusion and at 1 month have been previously reported.
      • Patel H.J.
      • Dake M.D.
      • Bavaria J.E.
      • Singh M.J.
      • Filinger M.
      • Fischbein M.P.
      • et al.
      Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicenter trial of the Gore thoracic branch endoprosthesis.
      In brief, this was a nonrandomized, multicenter, prospective IDE feasibility study of the Gore TBE in treating aneurysms that encompass the distal aortic arch. The Food and Drug Administration and each of six investigative sites in the United States approved the protocol and procedures of the trial. A total of 31 patients were enrolled in the present study from January 2014 to June 2016, with follow-up planned through 5 years.
      The primary endpoints of the study are successful access, defined as access to the aneurysm and target landing zone location obtained via conventional arterial access and endovascular techniques; deployment of the TBE device, defined as the absence of deployment failure of any TBE component introduced into the circulation that results in a serious adverse event; and procedural SB patency, assessed by angiography at the conclusion of the endovascular procedure. The secondary endpoints of the study are SB primary patency and the absence of device-related endoleaks as assessed by core laboratory (AortaCore Aortic Imaging Laboratory, University of Wisconsin, Madison, Wis) analysis of the computed tomography (CT) scans performed at 1 month after the procedure.

       Patient population

      Patients with DTA aneurysms that involved the distal aortic arch where it is required to place the proximal extent of the aortic stent graft in Ishimaru zone 2 with intentional coverage of the LSA were eligible for participation in the present study. The patients were screened using the inclusion and exclusion criteria (Supplementary Table I, online only), and only those meeting all the inclusion criteria and none of the exclusion criteria were enrolled. A total of 73 screening failures were documented, most of which had failed because of an inappropriate landing zone and the presence of concomitant dissection or other pathology that excluded enrollment in the present study. All the patients provided written informed consent before undergoing any study-related procedures. Once consent was obtained, CT angiography (CTA) of the chest, abdomen, and pelvis, with oblique, sagittal, and coronal reconstructions, was performed ≤90 days before treatment.

       Device description and procedure

      The TBE device consists of three modular components (Fig). The two primary system components are the aortic component (AC) and the SB component. The trailing portion of the SB component is deployed within a distally oriented portal inside the aortic component. This configuration enables retrograde perfusion of a branch vessel within the intended proximal aortic sealing zone. An optional aortic extender (AE) is intended to improve sealing of the AC and/or add seal length proximally within the aorta. All components are delivered from a single femoral access site. Each component consists of a graft of expanded polytetrafluoroethylene supported over its entire length by a nitinol wire frame. Guidewire access is obtained in both the aorta and the LSA. The AC is advanced over both wires into the DTA. Before entering the distal arch, the AC is torqued to remove any wrap between the aortic and SB guidewires before it is advanced into position in the proximal DTA. The AC is deployed, and the Gore DrySeal SB delivery sheath is then advanced through the deployed AC portal into the LSA. The dilator is removed from the SB delivery sheath, and the SB component is introduced and deployed in the LSA.
      Figure thumbnail gr1
      FigThe Gore TAG thoracic branch endoprosthesis (TBE) consists of three modular components: the aortic component (AC), the side branch (SB) component, and an optional aortic extender (AE).

       Follow-up

      Follow-up evaluations, including neck and chest CTA and left and right brachial blood pressure measurements, were performed at 1, 6, and 12 months and annually thereafter. The modified Rankin scale (MRS) score was recorded at 1 month. CTA of the neck and chest was performed to evaluate the aortic aneurysm diameter, SB patency, and the presence of endoleaks. SB patency, aneurysm enlargement, and the presence of endoleaks were assessed by independent core laboratory evaluation of the CT studies.

       Data collection and statistical analyses

      Subject data were collected using protocol-specific case report forms from the sites, with evaluation of the imaging studies by the core laboratory. Summary data are presented as proportions for categorical variables and the mean ± standard deviation for continuous variables (PASS 13; NCSS, LLC, Kaysville, Utah).

      Results

      The demographics, comorbidities, and lesion characteristics are detailed in Table I. A total of 31 patients were enrolled from six investigational sites (Supplementary Table II, online only). Enrollment was by site. Men outnumbered women (51.6%), and the average age was 74.1 ± 10.4 years. The pretreatment MRS score for most patients ranged from 0 to 1 (84%). The aneurysm morphology was fusiform in 12 patients and saccular in 19, with a mean maximum aortic diameter of 54.8 ± 10.9 mm. The treatment and procedural data are presented in Table II. Adjunctive use of an AE was necessary in four patients. In two cases, more than one AE was used. Distal extension was required for 21 patients, and 11 patients had required more than one distal endograft (conformable Gore TAG device; W. L. Gore & Associates, Inc) to completely cover the lesion. The mean total treatment length was 17.3 cm. All the patients survived the procedure. The median length of hospital stay for the TBE procedure was 4 days (range, 1-19 days). The mean follow-up for the cohort was 25.2 ± 11.1 months (range, 3.8-44.1 months), and the patient outcomes at 1 month and 1 year are presented.
      Table IBaseline patient and lesion characteristics (site reported)
      CharacteristicValue
      Patients31 (100)
      Age, years74.1 ± 10.4
      Male sex16 (51.6)
      Body mass index, kg/m228.7 ± 6.9
      Hypertension28 (90.3)
      Nicotine use16 (53.3)
      Hypercholesterolemia17 (54.8)
      History of stroke0 (0)
      Modified Rankin scale score
       0-126 (83.9)
       21 (3.2)
       33 (9.7)
       41 (3.2)
       5-60 (0)
      Pulmonary disease12 (38.7)
      Coronary artery disease12 (38.7)
      Lesion characteristics
       Aneurysm morphology
      Fusiform (diameter >55 mm or 2× native aortic diameter)12 (38.7)
      Saccular19 (61.3)
      Maximum aneurysm diameter, mm54.8 ± 10.9
      Aneurysm length, mm10.4 ± 8.3
      Data presented as mean ± standard deviation or number (%).
      Table IITreatment and procedural details
      VariableNo. (%) or mean ± SD
      Iliofemoral vascular access
       Percutaneous10 (32.3)
       Surgical exposure17 (54.8)
       Surgical exposure with access conduit graft4 (12.9)
      General anesthesia31 (100)
      Total treatment length, cm17.3 ± 8.2
      Procedure time, minutes204 ± 111.6
      Estimated blood loss, mL316 ± 607.8
      SD, Standard deviation.

       Endpoints

      The procedural primary endpoints were access, deployment, and SB patency. These were evaluated by each site at the conclusion of the procedure and were met with 100% success for all three (Table III). In one case, a device deployment event occurred when the AC had been deployed more proximally than intended and had partially covered the left common carotid artery (LCCA). During the procedure, the treating physician deployed a bare metal balloon-expandable stent in the LCCA. No associated clinical adverse events were reported.
      Table IIIPrimary (procedural) and secondary (1-month) endpoints
      EndpointSubjects, No. (%)95% CI,
      Computed for proportion.
      %
      Procedural (site reported)
       Successful access31 (100.0)89.0-100.0
       Successful deployment31 (100.0)89.0-100.0
       Side branch primary patency31 (100.0)89.0-100.0
      1 Month (core laboratory reported)
       Side branch primary patency
      Primary patency was not considered met if the core laboratory had assessed the vessel as not patent or reintervention had been performed to maintain patency or flow in the side branch at any point during the 1-month period.
      31 (100.0)89.0-100.0
       No device-related endoleaks29 (96.7)83.3-99.4
      CI, Confidence interval.
      a Computed for proportion.
      b Primary patency was not considered met if the core laboratory had assessed the vessel as not patent or reintervention had been performed to maintain patency or flow in the side branch at any point during the 1-month period.
      The outcomes for the secondary endpoints as determined by core laboratory analysis of the CT scans (Table III) obtained at 1 month include 100% SB patency and one device-related endoleak (3.4%), a type III endoleak that had developed between the AC and SB component. The core laboratory did not report a type III endoleak after 1 month; however, an indeterminate endoleak was reported for this patient from the 6- and 12-month follow-up imaging studies. No aneurysm enlargement was reported, and the patient did not undergo treatment.

       Early safety adverse events

      One procedure-related stroke had occurred. The patient awoke from the procedure with lateral visual field loss affecting the left eye. A CT scan of the head revealed a right parasagittal parieto-occipital infarct. The treating physician believed the stroke might have occurred during snaring of the SB wire to establish through and through guidewire access. The SB wire was snared in the aortic arch, which might have led to the right-sided stroke. At the 1-month follow-up visit, the patient was still experiencing continued visual impairment. Before treatment, the patient's MRS score was 0. After the procedure, the MRS score had improved from 4 on day 7 to 2 by day 43.
      Three cases of spinal cord ischemia occurred, two in the same patient. That patient had experienced right leg paresthesia on day 4. A lumbar catheter was placed for cerebrospinal fluid (CSF) drainage and pressure monitoring. The symptoms had completely resolved within 48 hours, with no recurrence of the spinal cord ischemia symptoms. The same patient had experienced left lower arm and hand ischemia periprocedurally. The event was not attributed to loss of SB patency but was related to the diagnosis of obstruction in a distal left brachial artery. The obstruction was treated immediately on the same day as the TBE procedure by surgical thrombectomy of the brachial artery at the site of vascular access. During follow-up, no recurrence of left hand or arm symptoms was reported. The second patient had developed spinal cord ischemia after reintervention on postoperative day 133, with a second TBE placed in zone 0. One day after the reintervention, the patient had experienced bilateral lower extremity weakness, which was treated the same day with insertion of a lumbar catheter and initiation of CSF drainage. All neurologic symptoms had successfully resolved within 5 days.

       One-year follow-up data

      The SB patency rate was 96.8% (30 of 31) through 1 year, with 31 patients evaluated at 1 month and 26 evaluated at 1 year. One SB occlusion was observed (reported by the site and core laboratory) on the routine, protocol-mandated, 6-month CT scan. No adverse events resulting from loss of SB patency and no reinterventions were reported. The left/right brachial artery blood pressure ratios over time are shown in Supplementary Table III (online only). For the single patient with SB occlusion, the left/right brachial ratio had decreased from 1.0 at 30 days to 0.5 at the 6-month visit. No statistically significant differences were found in the left/right brachial ratios of the patients during the 12-month period (P = .220).
      The device-related endoleaks that had occurred at 1 month were described previously in the “Endpoints” section. Eight additional patients had had core laboratory-identified endoleaks (Table IV). One patient had had a type II and a type III endoleak identified after the procedure between the AE and AC. At 1 month, only an indeterminate endoleak had been reported by the core laboratory, with no endoleak reported at 6 and 12 months. Another patient had had a type Ia endoleak observed on the postoperative CT scan; however, it was not noted on the 1-month follow-up CT scan. Four additional patients had had core laboratory–determined type II endoleaks and two additional patients had indeterminate endoleaks at various different times.
      Table IVCore laboratory–reported endoleaks
      All the patients had undergone computed tomography or, if contraindicated, another imaging modality at each follow-up point.
      VariableProcedureAfter the procedure
      Immediate1 Month6 Months12 Months
      Subjects31 (100)31 (100)31 (100)31 (100)30 (100)
      Evaluable subjects31 (100)7 (22.5)31 (100)29 (93.5)26 (83.8)
      Evaluable subjects with device event0/31 (0.0)3/7 (42.9)7/31 (22.6)7/29 (24.1)6/26 (23.1)
      EndoleakNA3/7 (42.9)6/30 (20.0)6/27 (22.2)5/26 (19.2)
       Aortic type IaNA1/7 (14.3)0/30 (0.0)0/27 (0.0)0/26 (0.0)
       Aortic type IbNA0/7 (0.0)0/30 (0.0)0/27 (0.0)0/26 (0.0)
       Side branch type IbNA0/7 (0.0)0/30 (0.0)0/27 (0.0)0/26 (0.0)
       Type IINA2/7 (28.6)2/30 (6.7)4/27 (14.8)2/26 (7.7)
       Type IIINA1/7 (14.3)1/30 (3.3)0/27 (0.0)0/26 (0.0)
      Type III TBE deviceNA1/7 (14.3)1/30 (3.3)0/27 (0.0)0/26 (0.0)
       Type IVNA0/7 (0.0)0/30 (0.0)0/27 (0.0)0/26 (0.0)
       IndeterminateNA1/7 (14.3)3/30 (10.0)2/27 (7.4)3/26 (11.5)
      NA, Not applicable; TBE, Gore TAG thoracic branch endoprosthesis.
      Data presented as number (%) or number/total (%).
      a All the patients had undergone computed tomography or, if contraindicated, another imaging modality at each follow-up point.
      The core laboratory assessed the mean change in the maximum aneurysm diameter as −4.8 ± 6.54 mm, with 100% of the patients (n = 25) having either no change or a decrease in the diameter of ≥5 mm at 1 year of follow-up (Table V). No reinterventions were performed for aneurysm enlargement, including none of the patients with a reported endoleak.
      Table VCore laboratory–determined aortic aneurysm diameter stratified by follow-up point
      VariableMaximum transverse aneurysm diameter
      Before the procedureAt 1 month (baseline)At 6 monthsAt 12 months
      Aneurysm, No.30302726
      Mean ± SD, mm56.3 ± 11.4856.5 ± 12.4853.9 ± 11.6749.9 ± 10.23
      Median, mm57.459.553.750.7
      Range, mm40.3-78.632.6-80.332.9-73.633.8-65.6
      Mean change from baseline within subject
      Positive numbers indicate an average increase in aneurysm size and negative numbers an average decrease.
      NANA−3.3 ± 5.98−4.8 ± 6.54
      Subjects with increase ≥5 mm from baselineNANA0/26 (0.0)0/25 (0.0)
      Subjects with no change from baselineNANA19/26 (73.1)15/25 (60.0)
      Subjects with decrease ≥5 mm from baselineNANA7/26 (26.9)10/25 (40.0)
      NA, Not applicable; SD, standard deviation.
      Data presented as number/total (%), unless otherwise noted.
      a Positive numbers indicate an average increase in aneurysm size and negative numbers an average decrease.
      No surgical conversions were required, and only one reintervention was performed. The reintervention was performed 133 days after the initial TBE placement. The deployment of the AC was inaccurate, which had resulted in the lack of the proximal seal. A review of the procedural images determined that the AC deployment had been initiated distally to the ideal target location and that distal movement during deployment had placed the inferior aspect of the device within the aneurysm sac. Post-treatment imaging studies revealed that the device had remained in the aneurysm without the intended seal. No aneurysm enlargement had occurred. The treating physician planned the reintervention with proximal extension using an additional TBE device in zone 0. The LCCA and LSA were surgically revascularized before the zone 0 TBE procedure. During the zone 0 TBE procedure, the proximal end of the AC had been prematurely partially deployed in the DTA and was then fully deployed in the DTA as a distal extension. The premature device deployment had resulted from the deployment line catching on the anchor of the previously deployed SB component in zone 2. Another AC was advanced to the zone 0 proximal landing zone and deployed successfully. Final angiography showed a patent SB with filling of all arch branch vessels and no endoleak. One day after the reintervention, the patient experienced bilateral lower extremity weakness (see the “Early safety adverse events” section). The event was treated the same day with insertion of a lumbar catheter and initiation of CSF drainage, which had successfully resolved all neurologic symptoms. A follow-up CT scan at 1 month confirmed SB patency and the absence of endoleaks. No neurologic symptoms had been reported through the 1-year follow-up period.

       Deaths

      Five patients had died. No periprocedural deaths were reported, and all the deaths were adjudicated by the clinical endpoint committee as unrelated to the device or procedure or unknown. One patient, previously reported by Patel et al,
      • Patel H.J.
      • Dake M.D.
      • Bavaria J.E.
      • Singh M.J.
      • Filinger M.
      • Fischbein M.P.
      • et al.
      Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicenter trial of the Gore thoracic branch endoprosthesis.
      had died of an aortic rupture at day 113, with the site reporting the relationship of the ascending aortic aneurysm rupture to the TBE device and procedure to be “unknown.” Another death reported had resulted from respiratory failure at day 348. A third death related to cardiac arrhythmia had occurred at day 363. The fourth death was attributed to cardiac failure at day 374. The fifth death at day 402 was due to pulmonary failure related to chronic obstructive pulmonary disease.

      Discussion

      TEVAR was initially described as a less-invasive alternative for the management of DTA aneurysms.
      • Dake M.D.
      • Miller D.C.
      • Semba C.P.
      • Mitchell R.S.
      • Walker P.J.
      • Liddell R.P.
      Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms.
      Since its introduction, TEVAR has also achieved general acceptance as a mainstream therapy for complicated type B aortic dissection and traumatic aortic injury.
      • Erbel R.
      • Aboyans V.
      • Boileau C.
      • Bossone E.
      • Di Bartolomeo R.
      • Eggebrect H.
      • et al.
      2014 ESC guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The task force for the diagnosis and treatment of aortic diseases of the European Society of Cardiology (ESC).
      ,
      • Riambau V.
      • Bockler D.
      • Brunkwall J.
      • Cao P.
      • Chiesa R.
      • Coppi M.
      • et al.
      Management of descending thoracic aortic diseases: clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
      However, extension to the aortic segments adjacent to the DTA has been limited owing to the presence in the aortic arch and proximal abdominal aorta of critical branch vessels.
      • Patel H.J.
      • Williams D.M.
      • Upchurch G.R.
      • Shillingford M.S.
      • Dasika N.L.
      • Proctor M.C.
      • et al.
      Long-term results from a 12-year experience with endovascular therapy for thoracic aortic disease.
      ,
      • Stone D.H.
      • Brewster D.C.
      • Kwolek C.J.
      • LaMuraglia G.M.
      • Conrad M.F.
      • Chung T.K.
      • et al.
      Stent-graft versus open-surgical repair of the thoracic aorta: mid-term results.
      Up to 40% of DTA aneurysms will extend proximally to include the distal aortic arch or even more proximal involvement.
      • Feezor R.J.
      • Martin T.D.
      • Hess P.J.
      • Klodell C.T.
      • Beaver T.M.
      • Huber T.S.
      • et al.
      Risk factors for peri-operative stroke during thoracic endovascular aortic repairs (TEVAR).
      Until recently, intentional coverage of the LSA with commercially available tube endografts was a relatively common practice to manage lesions that involve the distal arch and/or most proximal descending aorta.
      • Cooper D.G.
      • Walsh S.R.
      • Sadat U.
      • Noorani A.
      • Hayes P.D.
      • Boyle J.R.
      Neurological complications after left subclavian artery coverage during thoracic endovascular aortic repair: a systematic review and meta-analysis.
      • Maldonado T.S.
      • Dexter D.
      • Rockman C.B.
      • Veith F.J.
      • Garg K.
      • Arko F.
      • et al.
      Left subclavian artery coverage during thoracic endovascular aortic aneurysm repair does not mandate revascularization.
      • Wojciechowski J.
      • Znaniecki L.
      • Bury K.
      • Rogowski J.
      Thoracic endovascular aortic repair with left subclavian artery coverage without prophylactic revascularization—early and midterm results.
      However, sufficient evidence is now available to show that this exposes patients to an increased risk of neurologic complications without adjunctive revascularization of the LSA. Thus, LSA revascularization is now recommended for patients undergoing elective treatment.
      • Feezor R.J.
      • Martin T.D.
      • Hess P.J.
      • Klodell C.T.
      • Beaver T.M.
      • Huber T.S.
      • et al.
      Risk factors for peri-operative stroke during thoracic endovascular aortic repairs (TEVAR).
      ,
      • Matsumura J.S.
      • Rizvi A.Z.
      Left subclavian artery revascularization: Society for Vascular Surgery practice guidelines.
      • Patterson B.O.
      • Holt P.J.
      • Nienhaber C.
      • Fairman R.M.
      • Heijmen R.H.
      • Thompson M.M.
      Management of the left subclavian artery and neurologic complications after thoracic endovascular aortic repair.
      • Zamor K.C.
      • Eskandari M.K.
      • Rodriguez H.E.
      • Ho K.J.
      • Morasch M.D.
      • Hoel A.W.
      Outcomes of thoracic endovascular aortic repair and subclavian revascularization techniques.
      • Bradshaw R.J.
      • Ahanchi S.S.
      • Powell O.
      • Larion S.
      • Brandt C.
      • Soult M.C.
      • et al.
      Left subclavian artery revascularization in zone 2 thoracic endovascular aortic repair is associated with lower stroke risk across all aortic diseases.
      In these anatomic settings, the LSA can be surgically revascularized using extra-anatomic bypass grafts
      • Cao P.
      • De Rango P.
      • Czerny M.
      • Evangelista A.
      • Fattori R.
      • Nienaber C.
      • et al.
      Systemic review of clinical outcomes in hybrid procedures for aortic arch dissection and other diseases.
      • Moulakakis K.G.
      • Mylonas S.N.
      • Markatis F.
      • Kotsis T.
      • Kakisis J.
      • Liapis C.D.
      A systematic review and meta-analysis of hybrid aortic arch replacement.
      • Benrashid E.
      • Wang H.
      • Keenan J.E.
      • Andersen N.D.
      • Meza J.M.
      • McCann R.L.
      • et al.
      Evolving practice pattern changes and outcomes in the era of hybrid aortic arch repair.
      or endovascular parallel SB grafts, such as ChimPS,
      • Yang J.
      • Xiong J.
      • Liu X.
      • Jia X.
      • Zhu Y.
      • Guo W.
      Endovascular chimney technique for aortic arch pathologies: a systematic review.
      • Hogendoorn W.
      • Schlosser F.J.V.
      • Moll F.L.
      • Sumpio B.E.
      • Muhs B.E.
      Thoracic endovascular aortic repair with the chimney graft technique.
      • Mangialardi N.
      • Serrao E.
      • Kasemi H.
      • Alberti V.
      • Fazzini S.
      • Ronchey S.
      Chimney technique for aortic arch pathologies: an 11-year single-center experience.
      to allow for TEVAR extension across the LSA into Ishimaru zone 2. Surgical LSA revascularization does require an open procedure and can complicate management strategies in an emergent clinical situation (eg, ruptured aneurysm, aortic traumatic transection, type B aortic dissection with malperfusion). Endovascular LSA revascularization tactics, including ChimPS and in situ TEVAR fenestration, are complex and associated with complications, including stroke, endoleaks via perigraft gutters, and occasional branch endograft compression and occlusion.
      • Yang J.
      • Xiong J.
      • Liu X.
      • Jia X.
      • Zhu Y.
      • Guo W.
      Endovascular chimney technique for aortic arch pathologies: a systematic review.
      • Hogendoorn W.
      • Schlosser F.J.V.
      • Moll F.L.
      • Sumpio B.E.
      • Muhs B.E.
      Thoracic endovascular aortic repair with the chimney graft technique.
      • Mangialardi N.
      • Serrao E.
      • Kasemi H.
      • Alberti V.
      • Fazzini S.
      • Ronchey S.
      Chimney technique for aortic arch pathologies: an 11-year single-center experience.
      ,
      • Kalvenbach R.R.
      • Rabin A.
      • Karmeli R.
      • Alpasian A.
      • Schwierz E.
      Developments in parallel grafts for aortic arch lesions.
      A more ideal and efficient solution would include a purpose-engineered branched endoprosthesis designed to allow for a completely integrated endovascular approach to manage aortic arch pathologies. In the present study, we evaluated such a device with a single SB graft, TBE, as part of an IDE feasibility trial for the treatment of aortic arch lesions requiring TEVAR placement within Ishimaru zone 2.
      The primary endpoints of the present study were achieved for the 31 patients. Their average inpatient stay was <1 week, with a mean hospital stay of 5.1 ± 4.2 days (range, 1-19 days; median, 4 days). The feasibility results for procedural mortality and hospital stay were similar to previously reported outcomes of TEVAR for lesions involving the DTA with extra-anatomic reconstruction of the LSA and are favorable compared with open surgical outcome measures.
      • Makaroun M.S.
      • Dillavou E.D.
      • Kee S.T.
      • Sicard G.
      • Chaikof E.
      • Bavaria J.
      • et al.
      Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG endoprosthesis.
      • Matsumura J.S.
      • Cambria R.P.
      • Dake M.D.
      • Moore R.D.
      • Svensson L.G.
      • Snyder S.
      International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results.
      • Fairman R.M.
      • Criado F.
      • Farber M.
      • Kwolek C.
      • Mehta M.
      • White R.
      • et al.
      Pivotal results of the Medtronic vascular talent thoracic stent graft system: the VALOR trial.
      Similarly, the frequencies of early adverse events observed in the present initial feasibility study for TBE are similar to those reported for multiple commercially available tubular endografts used to treat aneurysms of the DTA without arch involvement.
      • Makaroun M.S.
      • Dillavou E.D.
      • Kee S.T.
      • Sicard G.
      • Chaikof E.
      • Bavaria J.
      • et al.
      Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG endoprosthesis.
      • Matsumura J.S.
      • Cambria R.P.
      • Dake M.D.
      • Moore R.D.
      • Svensson L.G.
      • Snyder S.
      International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results.
      • Fairman R.M.
      • Criado F.
      • Farber M.
      • Kwolek C.
      • Mehta M.
      • White R.
      • et al.
      Pivotal results of the Medtronic vascular talent thoracic stent graft system: the VALOR trial.
      • Jordan W.D.
      • Rovin J.
      • Moainie S.
      • Bavaria J.
      • Cambria R.
      • Fillinger M.
      • et al.
      Results of a prospective multicenter trial of CTAG thoracic endograft.
      The eventual determination of the range of periprocedural stroke rates associated with various branched endograft procedures involving Ishimaru zones 0, 1, and 2 will greatly contribute to the field in deciding how widespread a role branched TEVAR will play in the management of arch lesions. The procedural stroke rate in the present IDE feasibility study was 3.2%. The incidence of cerebral vascular accidents reported for multiple large TEVAR trials of the management of DTA without arch encroachment was within the range (2.5%-3.5%) and lower than that reported for open surgical case controls (range, 7.3%-8.6%).
      • Makaroun M.S.
      • Dillavou E.D.
      • Kee S.T.
      • Sicard G.
      • Chaikof E.
      • Bavaria J.
      • et al.
      Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG endoprosthesis.
      • Matsumura J.S.
      • Cambria R.P.
      • Dake M.D.
      • Moore R.D.
      • Svensson L.G.
      • Snyder S.
      International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results.
      • Fairman R.M.
      • Criado F.
      • Farber M.
      • Kwolek C.
      • Mehta M.
      • White R.
      • et al.
      Pivotal results of the Medtronic vascular talent thoracic stent graft system: the VALOR trial.
      With the use of branched TEVAR, limiting the risk of stroke by a strict focus on minimizing guidewire and catheter maneuvers in the aortic arch, proper patient selection could prove a key factor in limiting the risk of periprocedural stroke. Thus, it is increasingly sensible that the procedural stroke rate can be influenced by a meticulous assessment of high-quality CT imaging of the aortic arch performed to identify the degree of thrombus (sessile or polypoid) or atheroma (smooth or ulcerated), mobile or otherwise, that lines the aortic wall. This is highly relevant and requisite to properly screen and exclude patients at high risk of embolization and stroke.
      Paraplegia is a known complication of TEVAR and remains a critical clinical concern. In the present study, one early adverse event related to spinal cord ischemia had occurred on day 4. Although the overall rate of spinal neurologic deficits was generally reported as lower after TEVAR than that after open surgical repair, the delayed onset of symptoms has been relatively more common after TEVAR. As previously discussed, the partial deficit consisting of right leg paresthesia had resolved completely within 48 hours after initiation of the CSF drainage protocol. In addition, spinal cord ischemic symptoms were noted after reintervention in another patient. The symptoms had completely resolved with lumbar catheter insertion and CSF drainage, without recurrence.
      Branch component patency was an important concern and outcome measure for the present study. One patient had had a branch graft occlusion diagnosed by routine CT imaging at 6 months. Previously, the CT evaluation at 1 month had showed a patent graft. For this patient, revascularization was not recommended because no adverse events associated with the loss of patency were reported. The cause of the occlusion remains unknown. The branch component did not appear kinked or compressed at completion of the procedure; however, a post-procedure review of the completion aortography revealed branch graft diameters of <6 mm in some segments. In all other cases, the imaging studies had detailed graft diameters of >6 mm throughout the SB. It is now recommended to balloon dilate the entire length of the branch component to ensure full expansion.
      In the present report, no ruptures of the treated aortic aneurysms occurred. Five patients had died during follow-up; however, none of the deaths were found to have been device or procedure related. Additionally, no surgical conversions were required. One endovascular reintervention was performed on day 133 to extend graft coverage into zone 0 to manage an inadequate seal after placement of the zone 2 TBE device. Although the 12-month follow-up experience is relatively short, it is encouraging that no reinterventions were required for aneurysm growth. Further follow-up will focus on the long-term risk of aneurysm enlargement after TBE; however, the core laboratory finding of no growth in 100% of the patients is promising.
      The reported early results with branched aortic arch devices have detailed the use of single branch,
      • Patel H.J.
      • Dake M.D.
      • Bavaria J.E.
      • Singh M.J.
      • Filinger M.
      • Fischbein M.P.
      • et al.
      Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicenter trial of the Gore thoracic branch endoprosthesis.
      ,
      • Chuter T.A.M.
      • Schneider D.B.
      • Reilly L.M.
      • Lobo E.P.
      • Messina L.M.
      Modular branched stent graft for endovascular repair of aortic arch aneurysm and dissection.
      • Piffaretti G.
      • Rivolta N.
      • Fontana F.
      • Carrafiello G.
      • Mariscalco G.
      • Castelli P.
      Aortic arch aneurysm repair with a new branched device.
      • Botta L.
      • Fratto P.
      • Cannata A.
      • Bruschi G.
      • Rampoldi A.
      • Martinelli L.
      Aortic-arch reconstruction with Bolton medical branched thoracic stent graft.
      • Roselli E.E.
      • Arko F.R.
      • Thompson M.M.
      Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.
      dual branch,
      • Haulon S.
      • Greenberg R.K.
      • Spear R.
      • Eagleton M.
      • Abraham C.
      • Lioupis C.
      • et al.
      Global experience with an inner branched arch endograft.
      ,
      • Riambau V.
      Application of the Bolton Relay device for thoracic endografting in or near the aortic arch.
      and triple branch
      • Inoue K.
      • Hosokawa H.
      • Iwase T.
      • Sato M.
      • Yoshida Y.
      • Ueno K.
      • et al.
      Aortic arch reconstruction by transluminally placed endovascular branched stent graft.
      designs for arch aneurysms. The results from a single branch device (Valiant Mona LSA; Medtronic, Inc) in an early feasibility study had reported the results for nine subjects.
      • Roselli E.E.
      • Arko F.R.
      • Thompson M.M.
      Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.
      No deaths or disabling strokes had occurred at the 30-day follow-up point. However, four minor, nondisabling strokes had occurred in three subjects. During a review of the procedural implants, the physicians noted that an extended procedural time and increased manipulation in the aortic arch could increase the risk of stroke. At the time of publication, no left arm ischemia, paraplegia, rupture, conversion to open surgery, or secondary endovascular procedures had been reported.
      The initial report of experience with a dual branch device (Cook a-Branch; Cook Medical, Inc, Bloomington, Ind) described a marked reduction in procedural mortality from the early learning curve cases (first 10 patients) to that for their subsequent experience with an additional 28 patients.
      • Haulon S.
      • Greenberg R.K.
      • Spear R.
      • Eagleton M.
      • Abraham C.
      • Lioupis C.
      • et al.
      Global experience with an inner branched arch endograft.
      Other arch branch devices with different design concepts, both off-the-shelf and custom-fabricated, will be introduced and join the effort to provide a less-invasive endovascular therapeutic alternative for the repair of a variety of arch lesions, including dissection, trauma, and aneurysms involving Ishimaru zones 0, 1, and 2.

      Conclusions

      We have reported the preliminary results from an IDE feasibility study of a single SB endograft to treat patients with aortic aneurysms involving the distal arch. These early IDE feasibility study results of the TBE device should be viewed with cautious optimism because the experience with this device has broadened to include studies with a greater number of patients. These should produce a better understanding of the risk and benefits of arch branch endografts and contribute to defining the role this technology might ultimately play in the treatment of patients with arch pathologies.

      Author contributions

      Conception and design: MD, JB, GO, MF, JM, HP
      Analysis and interpretation: MD, MF, JB, ND, GO, MS, MF, BS, JM, HP
      Data collection: MD, MF, JB, ND, GO, MS, MF, BS, JM, HP
      Writing the article: MD, MF, JB, ND, GO, MS, MF, BS, JM, HP
      Critical revision of the article: MD, MF, JB, ND, GO, MS, MF, BS, JM, HP
      Final approval of the article: MD, MF, JB, ND, GO, MS, MF, BS, JM, HP
      Statistical analysis: Not applicable
      Obtained funding: Not applicable
      Overall responsibility: MD

      Appendix (online only).

      Supplementary Table I (online only)Inclusion and exclusion criteria
      Criteria
      Inclusion
       Presence of DTA aneurysm deemed to warrant surgical repair and requiring proximal graft placement in zone 2: fusiform and ≥55 mm, fusiform and >2× native aortic diameter, or saccular (no diameter criteria)
       Age ≥18 years at provision of informed consent
       Subject capable of complying with protocol requirements
       Informed consent form signed by subject or legal representative
       Appropriate proximal aortic landing zone in accordance with IFU
       Appropriate distal aortic landing zone in accordance with IFU
       Appropriate LSA landing zone in accordance with IFU
      Exclusion
       Concomitant aneurysm or disease of ascending aorta, aortic arch, or abdominal aorta requiring repair
       Previous endovascular repair of ascending aorta
       Previous endovascular repair of DTA with a non-Gore device
       Surgery within 30 days of treatment
       Infected aorta
       Dissection of DTA
       Intramural hematoma of DTA without DTA aneurysm
       Life expectancy <2 years
       Myocardial infarction or stroke within 6 weeks before treatment
       Systemic infection with possible increased risk of endovascular graft infection
       Pregnant woman at provision of informed consent
       Degenerative connective tissue disease (eg, Marfan syndrome, Ehlers-Danlos syndrome)
       Participation in another drug or medical device study within 1 year of study enrollment
       Known history of drug abuse within 1 year of treatment
       Significant thrombus or atheroma in aortic arch
       Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and inability to use a conduit for vascular access
       Planned coverage of left carotid artery or celiac artery
       Known sensitivities or allergies to device materials
       Known hypersensitivity or contraindication to anticoagulants or contrast media not amenable to pretreatment
      DTA, Descending thoracic aorta; IFU, instructions for use; LSA, left subclavian artery.
      Supplementary Table II (online only)Study enrollment stratified by site (n = 31)
      SiteSubjects enrolled, No. (%)
      Leland Stanford Junior University7 (22.6)
      University of Pittsburgh Medical Center3 (9.7)
      The Hitchcock Foundation2 (6.5)
      Mayo Clinic, Rochester4 (12.9)
      University of Pennsylvania7 (22.6)
      University of Michigan8 (25.8)
      Supplementary Table III (online only)Left/right brachial pressure index stratified by follow-up point
      Left/right brachial ratioEvaluation pointF test
      F test using repeated measures model.
      P value
      Before treatmentImmediately after treatmentAt 1 monthAt 6 monthsAt 12 months
      Number2915292723NA
      Mean ± SD1.0 ± 0.051.0 ± 0.081.0 ± 0.071.0 ± 0.110.9 ± 0.11.220
      Median1.01.01.01.01.0NA
      Range0.9-1.10.8-1.20.7-1.10.5-1.20.6-1.1NA
      Mean change from baseline within subject
      Positive numbers indicated an average increase and negative numbers, an average decrease.
      NA0.0 ± 0.080.0 ± 0.090.0 ± 0.140.0 ± 0.15NA
      NA, Not applicable; SD, standard deviation.
      Data presented as mean ± SD, unless noted otherwise.
      a F test using repeated measures model.
      b Positive numbers indicated an average increase and negative numbers, an average decrease.

      References

        • Erbel R.
        • Aboyans V.
        • Boileau C.
        • Bossone E.
        • Di Bartolomeo R.
        • Eggebrect H.
        • et al.
        2014 ESC guidelines on the diagnosis and treatment of aortic diseases: document covering acute and chronic aortic diseases of the thoracic and abdominal aorta of the adult. The task force for the diagnosis and treatment of aortic diseases of the European Society of Cardiology (ESC).
        Eur Heart J. 2014; 35: 2873-2926
        • Riambau V.
        • Bockler D.
        • Brunkwall J.
        • Cao P.
        • Chiesa R.
        • Coppi M.
        • et al.
        Management of descending thoracic aortic diseases: clinical practice guidelines of the European Society for Vascular Surgery (ESVS).
        Eur J Vasc Endovasc Surg. 2017; 53: 4-52
        • Cao P.
        • De Rango P.
        • Czerny M.
        • Evangelista A.
        • Fattori R.
        • Nienaber C.
        • et al.
        Systemic review of clinical outcomes in hybrid procedures for aortic arch dissection and other diseases.
        J Thorac Cardiovasc Surg. 2012; 144: 1286-1300
        • Moulakakis K.G.
        • Mylonas S.N.
        • Markatis F.
        • Kotsis T.
        • Kakisis J.
        • Liapis C.D.
        A systematic review and meta-analysis of hybrid aortic arch replacement.
        Ann Cardiothorac Surg. 2013; 2: 247-260
        • Benrashid E.
        • Wang H.
        • Keenan J.E.
        • Andersen N.D.
        • Meza J.M.
        • McCann R.L.
        • et al.
        Evolving practice pattern changes and outcomes in the era of hybrid aortic arch repair.
        J Vasc Surg. 2016; 63: 323-331
        • Yang J.
        • Xiong J.
        • Liu X.
        • Jia X.
        • Zhu Y.
        • Guo W.
        Endovascular chimney technique for aortic arch pathologies: a systematic review.
        Ann Vasc Surg. 2012; 26: 1014-1021
        • Hogendoorn W.
        • Schlosser F.J.V.
        • Moll F.L.
        • Sumpio B.E.
        • Muhs B.E.
        Thoracic endovascular aortic repair with the chimney graft technique.
        J Vasc Surg. 2013; 58: 502-511
        • Mangialardi N.
        • Serrao E.
        • Kasemi H.
        • Alberti V.
        • Fazzini S.
        • Ronchey S.
        Chimney technique for aortic arch pathologies: an 11-year single-center experience.
        J Endovasc Ther. 2014; 21: 312-323
        • Sonesson B.
        • Resch T.
        • Allers M.
        • Malina M.
        Endovascular total arch replacement by in situ stent graft fenestration technique.
        J Vasc Surg. 2009; 49: 1589-1591
        • Manning B.J.
        • Ivancev K.
        • Harris P.L.
        In situ fenestration in the aortic arch.
        J Vasc Surg. 2010; 52: 491-494
        • Tse L.W.
        • Lindsay T.F.
        • Roche-Nagle G.
        • Oreopoulos G.D.
        • Ouzounian M.
        • Tan K.T.
        Radiofrequency in situ fenestration for aortic arch vessels during thoracic endovascular repair.
        J Endovasc Ther. 2015; 22: 116-121
        • Patel H.J.
        • Dake M.D.
        • Bavaria J.E.
        • Singh M.J.
        • Filinger M.
        • Fischbein M.P.
        • et al.
        Branched endovascular therapy of the distal aortic arch: preliminary results of the feasibility multicenter trial of the Gore thoracic branch endoprosthesis.
        Ann Thorac Surg. 2016; 102: 1190-1198
        • Mitchell R.S.
        • Ishimaru S.
        • Ehrlich M.P.
        • Iwase T.
        • Lauterjung L.
        • Shimono T.
        • et al.
        First international summit on thoracic aortic endografting: roundtable on thoracic aortic dissection as an indication for endografting.
        J Endovasc Ther. 2002; 9: II98-II105
        • Dake M.D.
        • Miller D.C.
        • Semba C.P.
        • Mitchell R.S.
        • Walker P.J.
        • Liddell R.P.
        Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms.
        N Engl J Med. 1995; 331: 1729-1734
        • Patel H.J.
        • Williams D.M.
        • Upchurch G.R.
        • Shillingford M.S.
        • Dasika N.L.
        • Proctor M.C.
        • et al.
        Long-term results from a 12-year experience with endovascular therapy for thoracic aortic disease.
        Ann Thorac Surg. 2006; 82: 2147-2153
        • Stone D.H.
        • Brewster D.C.
        • Kwolek C.J.
        • LaMuraglia G.M.
        • Conrad M.F.
        • Chung T.K.
        • et al.
        Stent-graft versus open-surgical repair of the thoracic aorta: mid-term results.
        J Vasc Surg. 2006; 44: 1188-1197
        • Feezor R.J.
        • Martin T.D.
        • Hess P.J.
        • Klodell C.T.
        • Beaver T.M.
        • Huber T.S.
        • et al.
        Risk factors for peri-operative stroke during thoracic endovascular aortic repairs (TEVAR).
        J Endovasc Ther. 2007; 14: 568-573
        • Cooper D.G.
        • Walsh S.R.
        • Sadat U.
        • Noorani A.
        • Hayes P.D.
        • Boyle J.R.
        Neurological complications after left subclavian artery coverage during thoracic endovascular aortic repair: a systematic review and meta-analysis.
        J Vasc Surg. 2009; 49: 1594-1601
        • Maldonado T.S.
        • Dexter D.
        • Rockman C.B.
        • Veith F.J.
        • Garg K.
        • Arko F.
        • et al.
        Left subclavian artery coverage during thoracic endovascular aortic aneurysm repair does not mandate revascularization.
        J Vasc Surg. 2013; 57: 116-124
        • Wojciechowski J.
        • Znaniecki L.
        • Bury K.
        • Rogowski J.
        Thoracic endovascular aortic repair with left subclavian artery coverage without prophylactic revascularization—early and midterm results.
        Langenbecks Arch Surg. 2014; 399: 619-627
        • Matsumura J.S.
        • Rizvi A.Z.
        Left subclavian artery revascularization: Society for Vascular Surgery practice guidelines.
        J Vasc Surg. 2010; 52: 65S-70S
        • Patterson B.O.
        • Holt P.J.
        • Nienhaber C.
        • Fairman R.M.
        • Heijmen R.H.
        • Thompson M.M.
        Management of the left subclavian artery and neurologic complications after thoracic endovascular aortic repair.
        J Vasc Surg. 2014; 60: 1491-1497.e1
        • Zamor K.C.
        • Eskandari M.K.
        • Rodriguez H.E.
        • Ho K.J.
        • Morasch M.D.
        • Hoel A.W.
        Outcomes of thoracic endovascular aortic repair and subclavian revascularization techniques.
        J Am Coll Surg. 2015; 221: 93-100
        • Bradshaw R.J.
        • Ahanchi S.S.
        • Powell O.
        • Larion S.
        • Brandt C.
        • Soult M.C.
        • et al.
        Left subclavian artery revascularization in zone 2 thoracic endovascular aortic repair is associated with lower stroke risk across all aortic diseases.
        J Vasc Surg. 2017; 65: 1270-1279
        • Kalvenbach R.R.
        • Rabin A.
        • Karmeli R.
        • Alpasian A.
        • Schwierz E.
        Developments in parallel grafts for aortic arch lesions.
        J Cardiovasc Surg (Torino). 2016; 57: 448-456
        • Makaroun M.S.
        • Dillavou E.D.
        • Kee S.T.
        • Sicard G.
        • Chaikof E.
        • Bavaria J.
        • et al.
        Endovascular treatment of thoracic aortic aneurysms: results of the phase II multicenter trial of the GORE TAG endoprosthesis.
        J Vasc Surg. 2005; 41: 1-9
        • Matsumura J.S.
        • Cambria R.P.
        • Dake M.D.
        • Moore R.D.
        • Svensson L.G.
        • Snyder S.
        International controlled clinical trial of thoracic endovascular aneurysm repair with the Zenith TX2 endovascular graft: 1-year results.
        J Vasc Surg. 2008; 47: 247-257
        • Fairman R.M.
        • Criado F.
        • Farber M.
        • Kwolek C.
        • Mehta M.
        • White R.
        • et al.
        Pivotal results of the Medtronic vascular talent thoracic stent graft system: the VALOR trial.
        J Vasc Surg. 2008; 48: 546-554
        • Jordan W.D.
        • Rovin J.
        • Moainie S.
        • Bavaria J.
        • Cambria R.
        • Fillinger M.
        • et al.
        Results of a prospective multicenter trial of CTAG thoracic endograft.
        J Vasc Surg. 2015; 61: 589-595
        • Chuter T.A.M.
        • Schneider D.B.
        • Reilly L.M.
        • Lobo E.P.
        • Messina L.M.
        Modular branched stent graft for endovascular repair of aortic arch aneurysm and dissection.
        J Vasc Surg. 2003; 38: 859-863
        • Piffaretti G.
        • Rivolta N.
        • Fontana F.
        • Carrafiello G.
        • Mariscalco G.
        • Castelli P.
        Aortic arch aneurysm repair with a new branched device.
        J Vasc Surg. 2013; 57: 1664-1667
        • Botta L.
        • Fratto P.
        • Cannata A.
        • Bruschi G.
        • Rampoldi A.
        • Martinelli L.
        Aortic-arch reconstruction with Bolton medical branched thoracic stent graft.
        Eur J Vasc Endovasc Surg. 2013; 25: e38-e41
        • Roselli E.E.
        • Arko F.R.
        • Thompson M.M.
        Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.
        J Vasc Surg. 2015; 62: 1465-1472
        • Haulon S.
        • Greenberg R.K.
        • Spear R.
        • Eagleton M.
        • Abraham C.
        • Lioupis C.
        • et al.
        Global experience with an inner branched arch endograft.
        J Thorac Cardiovasc Surg. 2014; 148: 1709-1716
        • Riambau V.
        Application of the Bolton Relay device for thoracic endografting in or near the aortic arch.
        Aorta. 2015; 3: 16-24
        • Inoue K.
        • Hosokawa H.
        • Iwase T.
        • Sato M.
        • Yoshida Y.
        • Ueno K.
        • et al.
        Aortic arch reconstruction by transluminally placed endovascular branched stent graft.
        Circulation. 1999; 100: II316-II321