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Midterm Outcomes of Zone 0 Antegrade Endograft Implantation During Type I Hybrid Aortic Arch Repair

Open ArchivePublished:March 24, 2021DOI:https://doi.org/10.1016/j.ejvs.2021.02.044

      Objective

      Type I hybrid arch repair has become popular as a procedure that is less invasive than total arch replacement. The major advantage of this technique is that antegrade endograft implantation can be performed during the procedure, thereby avoiding the complications of introducing the endograft from the groin. The aim of this study was to assess the midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation.

      Methods

      Thirty consecutive patients who underwent type I hybrid repair with antegrade endograft implantation from 2009 to 2015 were reviewed retrospectively. Patient demographics, and peri-operative and late results were collected from a prospective database and analysed.

      Results

      Four patients (13%) were female and the median age was 78 years. Median aneurysm size was 64 mm. Six patients (20%) developed stroke, and the 30 day mortality rate was 3%. Two patients suffered aortic dissection at the site of debranching anastomosis. The median follow up was 5.2 years. All aneurysms remained stable or had decreased in size at three years, and 82% were stable at five years. Overall survival was 79% at three years and 71% at five years. The rates of freedom from aorta related death were 86% at three and five years, respectively. During the follow up period, three additional left subclavian artery embolisations and one endograft relining due to type IIIb endoleak were required.

      Conclusion

      Midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation for aortic arch aneurysms are reported. Although the incidence of peri-operative stroke was high, late sac behaviour was acceptable.

      Keywords

      Midterm outcomes of a type I hybrid aortic arch repair with antegrade endograft implantation were reported. Although the perioperative stroke rate was high, late sac behavior was acceptable.
      Type I hybrid aortic arch repair can offer an acceptable late outcome. If early complications can be reduced, this procedure may become an alternative again for patients with high risk for total arch replacement complications.

      Introduction

      Endovascular repair has become the first line therapeutic option for descending thoracic aortic aneurysms (TAAs).
      • Dake Michael 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.
      • Makaroun M.S.
      • Dillavou E.D.
      • Wheatley G.H.
      • Cambria R.P.
      Five-year results of endovascular treatment with the Gore TAG device compared with open repair of thoracic aortic aneurysms.
      • Chiu P.
      • Goldstone A.B.
      • Schaffer J.M.
      • Lingala B.
      • Miller D.C.
      • Mitchell R.S.
      • et al.
      Endovascular versus open repair of intact descending thoracic aortic aneurysms.
      • Kreibich M.
      • Mccarthy F.
      • Bavaria J.E.
      Thoracic endovascular aneurysm repair trends and outcomes in over 27, 000 Medicare patients for descending thoracic aneurysms.
      However, for managing aortic aneurysms involving arch vessels endovascularly, various adjunctive procedures, including debranching, parallel grafting or side branching, are needed to preserve cerebral perfusion. Zone 1 (Ishimaru classification) thoracic endovascular aortic repair (TEVAR) with debranching of two vessels and zone 2 TEVAR with debranching of one vessel are established techniques because of their low invasiveness (no need for sternotomy).
      • Konstantinou N.
      • Debus E.S.
      • Vermeulen C.F.W.
      • Wipper S.
      • Diener H.
      • Larena-Avellaneda A.
      • et al.
      Cervical debranching in the endovascular era: a single centre experience.
      By contrast, TEVAR requiring zone 0 proximal landing involves increased invasiveness owing to the requirement for sternotomy when total supra-aortic vessel debranching is applied.
      • Andrási T.B.
      • Grossmann M.
      • Zenker D.
      • Danner B.C.
      • Schöndube F.A.
      Supra-aortic interventions for endovascular exclusion of the entire aortic arch.
      Therefore, several endovascular procedures, such as parallel graft or fenestrated/branched techniques, have been developed to avoid sternotomy.
      • Pecoraro F.
      • Lachat M.
      • Cayne N.S.
      • Pakeliani D.
      • Rancic Z.
      • Puippe G.
      • et al.
      Mid-term results of chimney and periscope grafts in supra-aortic branches in high risk patients.
      • Roselli E.E.
      • Iii R.A.
      • Thompson M.M.
      Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.
      • 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.
      • Spear R.
      • Haulon S.
      • Ohki T.
      • Tsilimparis N.
      • Kanaoka Y.
      • Milne C.P.E.
      • et al.
      Editor’s Choice – Subsequent results for arch aneurysm repair with inner branched endografts.
      • Ferrer C.
      • Cao P.
      • Coscarella C.
      • Ferri M.
      • Lovato L.
      • Camparini S.
      • et al.
      iTalian RegIstry of doUble inner branch stent graft for arch PatHology (the TRIUmPH Registry).
      Regardless, a parallel graft technique is associated with uncertainty with regard to proximal sealing because gutters and fenestrated/branched endografts are currently custom made devices (not ready for use devices) in most countries, although they are commercially available. Accordingly, type I hybrid aortic arch repair still has a small but clear role in avoiding cardiopulmonary bypass and achieving a secure proximal seal length with off the shelf devices.
      • Pecoraro F.
      • Lachat M.
      • Hofmann M.
      • Cayne N.S.
      • Chaykovska L.
      • Rancic Z.
      • et al.
      Mid-term results of zone 0 thoracic endovascular aneurysm repair after ascending aorta wrapping and supra-aortic debranching in high-risk patients.
      In addition, the major advantage of this technique is that antegrade endograft implantation can be performed during the procedure, thereby avoiding complications of introducing the endograft from the groin.
      Initial results of zone 0 TEVAR using the “through and through bowing technique” have been reported previously.
      • Yamamoto K.
      • Komori K.
      • Narita H.
      • Morimae H.
      • Tokud Y.
      • Araki Y.
      • et al.
      A “through-and-through bowing technique” for antegrade thoracic endovascular aneurysm repair with total arch debranching: a technical note and the initial results.
      The aim of this study was to assess the midterm outcomes of antegrade endograft implantation using this technique during type I hybrid aortic arch repair.

      Methods

      Study population

      Thirty-nine patients who underwent type I hybrid aortic arch repair for TAAs between January 2009 and December 2015 at the authors’ institution were reviewed. Of those, 30 consecutive cases with antegrade endograft implantation were included in this study (the remaining six patients underwent retrograde endograft delivery). The indication for this procedure was a high risk associated with conventional open arch repair determined by important medical comorbidities, including chronic pulmonary disease, advanced age (≥ 75 years), or significant cerebrovascular disease. Patients who had not yet had treatment for malignant disease or patients who had recently been treated for advanced cancer that may have been disseminated by cardiopulmonary bypass were thought to be candidates for this procedure. Only patients whose prognosis was thought to be more than two years and met the indication of “concomitant malignant disease” were treated. Although a healthy ascending aorta for the landing zone (≤ 42 mm in diameter and ≥ 20 mm in length for proximal landing) and side clamping were mandatory for the procedure, patients without suitable iliofemoral access or severely calcified access were not excluded (during the study period, the basic principle of total debranching TEVAR was antegrade stent graft delivery, even in cases with good iliac vessels). The Institutional Review Board of Nagoya University approved this study (reference number: 2020-0096), and the need for individual patient consent was waived because all data were obtained for routine clinical care.

      Surgical procedures

      The details of the procedure have been described previously.
      • Yamamoto K.
      • Komori K.
      • Narita H.
      • Morimae H.
      • Tokud Y.
      • Araki Y.
      • et al.
      A “through-and-through bowing technique” for antegrade thoracic endovascular aneurysm repair with total arch debranching: a technical note and the initial results.
      Briefly, all procedures were performed under general anaesthesia with monitoring of both the right and left radial arterial pressure and cerebral oxygen saturation. After median sternotomy, the site of side biting clamp placement on the ascending aorta was carefully determined based on pre-operative computed tomography (CT) angiography (CTA) and intra-operative epi-aortic ultrasonography. After systemic heparinisation (activated clotting time [ACT] was maintained at > 250 seconds during debranching and TEVAR procedures), a trifurcated branched Dacron graft was anastomosed to the ascending aorta in a side to side fashion. The anastomotic diameter was large enough (up to 20 – 25 mm) to avoid disturbing the cerebral blood flow during the TEVAR procedure. The first branch was anastomosed to the innominate artery, and the second to the left carotid artery. Another 8 mm piece of the graft was anastomosed to the left axillary artery in an end to side fashion via an infraclavicular skin incision. This piece was rerouted through the second intercostal space to the mediastinum and anastomosed to the third branch. The origin of the left subclavian artery (LSA) was ligated via a median sternotomy. After completing the reconstruction of all supra-aortic vessels, the stent graft was inserted through the graft proximal to the anastomosis. A TAG thoracic stent graft (W. L. Gore & Associates, Flagstaff, AZ, USA) was used in this series. In the early period, the stent graft was deployed using an anterogradely placed stiff wire (Lunderquist Extra Stiff Wire Guide; Cook, Bloomington, IN, USA), but after applying the technique in several cases, the “through and through bowing technique” was applied to avoid endograft migration. Pushing both the proximal and distal ends of the stiff wire enabled the stent graft to be placed along the greater curvature of the aortic arch anatomy.

      Study and follow up protocol

      Patient baseline demographics, operative details, and outcomes were collected. All patients underwent CTA with three dimensional reconstruction before surgery. A standard follow up protocol was performed at 30 days and three, six, and 12 months after surgery and annually thereafter. Patients underwent CTA before discharge and at three, six, and 12 months and annually thereafter if renal function allowed; otherwise, CT without contrast was performed. At the authors’ institution, no antiplatelet therapy is applied after TEVAR, including hybrid repair.

      Definitions

      Pre-operative coronary artery disease (CAD) was defined as an abnormal result on coronary angiography and a history of myocardial infarction or open or percutaneous coronary artery revascularisation. Chronic pulmonary disease was identified by pulmonary function studies or active treatment with medication. Hypertension and dyslipidaemia were identified in patients undergoing active medical treatment or diet modification. Diabetes was defined as meeting at least one of the following criteria: (1) fasting glucose ≥ 126 mg/dL; (2) plasma glucose ≥ 200 mg/dL; (3) glycated haemoglobin ≥ 6.5%; or (4) active treatment. Cerebrovascular disease was defined as a history of stroke, transient ischaemic attack, carotid intervention, or significant disease detected by pre-operative tests. Stroke was defined as a neurological deficit that did not resolve within 72 hours, that occurred during the hospitalisation during which the operation was performed, and that was caused by brain damage. Spinal cord injury (SCI) was defined as any new neurological lower extremity motor or sensory deficit or bladder and rectal disturbance that was not present pre-operatively and that was not caused by stroke. According to the reporting standards, endoleak was defined from the incompletely ligated LSA as type Ic endoleak because type Ic endoleak is defined as a leak around a plug occluding a subclavian artery to prevent flow into an aneurysm sac.
      • Fillinger M.F.
      • Greenberg R.K.
      • McKinsey J.F.
      • Chaikof E.L.
      Reporting standards for thoracic endovascular aortic repair (TEVAR).

      Data analysis

      All statistical analyses were performed using SPSS statistical software, version 26 (IBM, Armonk, NY, USA). Categorical variables are presented as frequencies (%), and continuous variables as medians (ranges); according to Kolmogorov–Smirnov tests, no variables were normally distributed. Kaplan–Meier analysis was applied to analyse survival and other endpoints.

      Results

      Patient characteristics and demographics

      Four patients (13%) were female; and the median age was 78 years (range 70 – 87 years). Median aneurysm size was 64 mm (range 54 – 110 mm), and most were limited to the aortic arch. Aetiologies included 28 degenerative aneurysms and two post-dissection aneurysms. The main indications for the procedure were advanced age (≥ 75 years; n = 17), concomitant malignant disease (n = 4), cerebrovascular disease (n = 4), chronic pulmonary disease (n = 3), and multiple factors (n = 2; one patient with a shaggy aorta had multiple aortic aneurysms and a history of coronary intervention, and one with a shaggy aorta had significant CAD and a history of stroke) (Table 1). There were no patients with significant carotid artery stenosis requiring invasive management.
      Table 1Demographic and operative data of 30 patients who underwent type I hybrid aortic arch repair by antegrade endograft implantation
      Patients (n = 30)
      Female sex4 (13)
      Age –y78 (70–87)
      Comorbidities
       Hypertension28 (93)
       Dyslipidaemia8 (27)
       Diabetes6 (20)
       Chronic kidney disease
      No dialysis patients.
      13 (43)
       Coronary artery disease12 (40)
       Cerebrovascular disease4 (13)
       COPD7 (23)
      Aneurysm diameter – mm64 (54–110)
      Aneurysm extent
      Proximal zone
      01 (3)
      18 (27)
      221 (70)
      Distal zone
      32 (7)
      426 (87)
      52 (7)
      Main indications for hybrid procedure
       Advanced age17 (57)
       Concomitant malignant disease4 (13)
       Cerebrovascular disease4 (13)
       COPD3 (10)
       Multiple factors2 (7)
      Type of endograft
       TAG thoracic endoprosthesis30 (100)
      Number of endografts
       119 (63)
       29 (30)
       32 (7)
      Diameter of ascending aorta – mm38.5 (34–42)
      Diameter of proximal endograft – mm
       371 (3)
       406 (20)
       4523 (77)
      Oversizing – %12.5 (7–29)
      Operative duration – min456 (346–660)
      Contrast volume – mL85 (20–150)
      Concomitant procedure
       OPCAB5 (17)
       Wrapping of ascending aorta1 (3)
      Data are presented as n (%) or median (range). COPD = chronic obstructive pulmonary disease; OPCAB = off pump coronary artery bypass.
      No dialysis patients.

      Operative findings

      Three operations were performed in an urgent setting, owing to symptomatic aneurysms. The median duration of operation was 456 minutes (range 346 – 660 minutes), and a median of 85 mL (range 20 – 150 mL) of contrast was used. All devices used in this study were TAG (W.L. Gore) thoracic endoprostheses. The number of implanted endografts was one in two thirds of the cases, and in three quarters of cases the proximal device diameter was the largest (45 mm in diameter). Concomitant off pump coronary artery bypass was performed in five cases (graft conduits were all saphenous veins) and wrapping of the ascending aorta was performed in one case (Table 1). As a result, the primary technical success rate was 100%.

      Clinical outcomes

      30 day and in hospital outcomes

      Post-operative ischaemic stroke occurred in six patients (20%), and five of these stroke events occurred immediately after surgery (diagnosed at the time of awakening from anaesthesia). However, one patient developed stroke two weeks after surgery and was diagnosed with cardiogenic brain embolism due to paroxysmal atrial fibrillation. Infarction was detected in the anterior circulation in three patients, in the posterior circulation in two patients, and in both the territories in one patient. All infarcted lesions were multiple and diffuse, and the degrees of disability at discharge were severe (modified Rankin scale grade 3 in one patient, grade 5 in four patients, and grade 6 in one patient). Two patients (7%) developed SCI immediately after surgery (both recovered sufficiently to be able to walk alone). Two patients had aortic dissections at the anastomotic site, and both were observed conservatively. One of these patients did not develop any significant complications, but, unfortunately, the other patient developed ascending aortic rupture on post-operative day five. As a result, the 30 day mortality rate was 3% (n = 1/30 due to the abovementioned ascending aortic rupture). There were three (10%) in hospital deaths. Of the remaining two patients, one survived abdominal aortic aneurysm (55 mm in diameter at the time of TEVAR) rupture 14 days after TEVAR but died owing to the subsequent rupture of a descending thoracic aortic aneurysm (55 mm in diameter at the time of TEVAR) two months after initial TEVAR. Because the arch aneurysm was 65 mm in diameter, the arch was treated first of the three aneurysms. Moreover, the descending thoracic aneurysm was left untreated at the time of initial surgery because spinal cord circulation was a concern. The last patient developed severe cerebral infarction and died of pneumonia during hospitalisation one year after surgery (which means that this was not a 30 day death, but an in hospital death) (Table 2).
      Table 2Early and late outcomes of 30 patients who underwent type I hybrid aortic arch repair by antegrade endograft implantation
      Patients (n = 30)
      Clinical outcomes
      Early complication
      Stroke with permanent neurological deficit6 (20)
      Spinal cord injury1 (3)
      Type A aortic dissection
      Includes one ascending aortic rupture.
      2 (7)
      Non-occlusive mesenteric ischaemia1 (3)
      Pneumonia1 (3)
       30 day death
      Includes one ascending aortic rupture.
      1 (3)
       In hospital death
      Includes one ascending aortic rupture, one descending aortic aneurysm rupture, and one pneumonia.
      3 (10)
      Re-intervention procedure
      LSA embolisation3 (10)
      Relining TEVAR1 (3)
      Aneurysm related death
      Endograft infection
      Includes one possibly infected aneurysm.
      2 (7)
      Ascending aortic rupture1 (3)
      Descending aortic rupture1 (3)
      Procedure related stroke1 (3)
      Imaging results
      Endoleak at discharge
      Ia
      Type Ia endoleaks resolved spontaneously.
      2 (7)
      Ic1 (3)
      Unknown1 (3)
      Sac behaviour at 3 y (n = 15)
      Growth0 (0)
      Stable8 (53)
      Shrinkage7 (47)
      Sac behaviour at 5 y (n = 11)
      Growth2 (18)
      Stable3 (27)
      Shrinkage6 (55)
      Data are presented as n (%). LSA = left subclavian artery; TEVAR = thoracic endovascular aortic repair.
      Includes one ascending aortic rupture.
      Includes one ascending aortic rupture, one descending aortic aneurysm rupture, and one pneumonia.
      Includes one possibly infected aneurysm.
      § Type Ia endoleaks resolved spontaneously.

      Late outcomes

      The median duration of follow up was 5.2 years (range 0 – 7.1 years). There were four re-interventions. Three patients required additional embolisation of the LSA owing to incomplete ligation (the third branch was anastomosed to the left axillary artery in an end to side fashion, and the origin of the LSA was ligated at the time of initial surgery). Fortunately, all three were detected before aneurysm sac growth. In one patient, relining of the stent graft was performed due to type IIIb endoleak (Table 2). Overall survival was 79% three years and 71% five years after surgery (Fig. 1). The rate of freedom from aorta related death was 86% both three and five years after surgery (Fig. 2). Twelve patients died during the follow up period; aneurysm related death occurred in five. In detail, three patients died during their hospitalisation, and their cause of death has already been mentioned above. The remaining two patients died from a stent graft infection. On retrospective review one of these patients underwent surgery for an infected aneurysm. This case had an elevated C reactive protein and a rapidly increased irregularly shaped aneurysm, and the possibility of an infected aneurysm could not be ruled out. Because the prognosis of concomitant pancreatic cancer was expected to be several years, there was no choice. The remaining seven causes of death other than aneurysm related death were malignancy (n = 2), old age (n = 2), pneumonia (n = 2), and gastrointestinal bleeding (n = 1). There was no bypass occlusion, although it was confirmed by peripheral arterial pulsation in some cases.
      Figure 1
      Figure 1Cumulative Kaplan–Meier estimate of overall survival of the 30 patients undergoing type I hybrid aortic arch repair with antegrade endograft implantation. The overall survival was 79% at three years and 71% at five years after surgery.
      Figure 2
      Figure 2Cumulative Kaplan–Meier estimate of freedom from aorta related death in 30 patients undergoing type I hybrid aortic arch repair with antegrade endograft implantation. Eighty-six per cent of patients were free from aorta related death at both three and five years after surgery.

      Imaging results

      Post-operative CTA revealed type Ia endoleak in two patients (7%; both resolved spontaneously); type Ic endoleak from the ligated left subclavian artery was observed in one patient (3%). One patient did not undergo contrast enhanced CT owing to impaired renal function.
      Three years after surgery, all aneurysms remained stable or had decreased in size (stable: n = 8; shrinkage > 5 mm, n = 7); at five years, 82% of the aneurysms remained stable or had decreased in size (increase > 5 mm, n = 2 cases; stable, n = 3; decrease > 5 mm, n = 6 cases). There was no new onset type Ia endoleak, and the cases with an increased sac diameter were characterised by gradual sac growth due to type II endoleak.

      Discussion

      The midterm outcomes of type I hybrid repair of aortic arch aneurysms, with a particular focus on the technique of antegrade stent graft placement, are reported. Although there are several reports of hybrid repair for arch aneurysms, most include TEVAR with proximal landing zones 0 – 2, and the debranching technique is diverse.
      • Konstantinou N.
      • Debus E.S.
      • Vermeulen C.F.W.
      • Wipper S.
      • Diener H.
      • Larena-Avellaneda A.
      • et al.
      Cervical debranching in the endovascular era: a single centre experience.
      ,
      • Andrási T.B.
      • Grossmann M.
      • Zenker D.
      • Danner B.C.
      • Schöndube F.A.
      Supra-aortic interventions for endovascular exclusion of the entire aortic arch.
      ,
      • Chan Y.C.
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      • Ting A.C.
      • Ho P.
      Supra-aortic hybrid endovascular procedures for complex thoracic aortic disease: single center early to midterm results.
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      • et al.
      Late complications after hybrid aortic arch repair.
      In particular, there is a major difference for zone 0 and other areas regarding whether an invasive procedure (sternotomy) is required, and it is difficult to assess the results together. This is one of the largest studies to report midterm outcomes limited to type I hybrid arch repair with a single procedure of antegrade endograft implantation.
      Total arch replacement (TAR) is the gold standard procedure for aortic arch aneurysms,
      • Preventza O.
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      Total aortic arch replacement: a comparative study of zone 0 hybrid arch exclusion versus traditional open repair. Read at the 95th Annual Meeting of the American Association for Thoracic Surgery, Seattle, Washington, April 25–29, 2015.
      and the procedures used in this study were applied to cases thought to be unsuitable for TAR. Elderly patients with indications for the procedure were considered to be at high risk of TAR during the study period. In addition, as cardiopulmonary bypass is not suitable for patients with malignant disease, these patients were also advised to undergo the procedure. There are several other approaches for TAR in high risk patients with aortic arch aneurysms. A sternotomy is invasive for frail patients, and complex endovascular procedures are required to avoid sternotomy. The most widely used procedure would be a chimney graft technique for the innominate artery.
      • Voskresensky I.
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      • et al.
      Outcomes of thoracic endovascular aortic repair using aortic arch chimney stents in high-risk patients.
      This procedure has the advantage of being technically easy and possible with commercially available devices. However, a major problem is that the gutter leak between devices cannot theoretically be zero.
      • Lindblad B.
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      • Malina M.
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      According to existing reports, the incidence of type Ia endoleak and the re-intervention rate are higher than those after TEVAR for descending TAA.
      • Pecoraro F.
      • Lachat M.
      • Cayne N.S.
      • Pakeliani D.
      • Rancic Z.
      • Puippe G.
      • et al.
      Mid-term results of chimney and periscope grafts in supra-aortic branches in high risk patients.
      ,
      • Voskresensky I.
      • Scali S.T.
      • Feezor R.J.
      • Fatima J.
      • Giles K.A.
      • Tricarico R.
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      ,
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      • et al.
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      ,
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      • Sumpio B.E.
      • Muhs B.E.
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      Therefore, it is expected that the aneurysm will continue to be pressed through this gutter even in those without endoleak confirmed by imaging. Owing to such uncertainty, it is thought that this procedure should be strictly limited, despite its reduced invasiveness.
      Another method is a complex endovascular technique, such as fenestration and side branching. Although commercial devices can be used for in situ fenestration and physician modified fenestration, these procedures are outside of the instruction for use, and their long term results are uncertain.
      • Kopp R.
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      ,
      • Zhu J.
      • Dai X.
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      • Luo Y.
      Fenestrated thoracic endovascular aortic repair using physician-modified stent grafts (PMSGs) in zone 0 and zone 1 for aortic arch diseases.
      Ready made or custom made fenestration and side branch devices are still in the research stage and generally cannot be used.
      • Roselli E.E.
      • Iii R.A.
      • Thompson M.M.
      Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms.
      • 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.
      • Spear R.
      • Haulon S.
      • Ohki T.
      • Tsilimparis N.
      • Kanaoka Y.
      • Milne C.P.E.
      • et al.
      Editor’s Choice – Subsequent results for arch aneurysm repair with inner branched endografts.
      • Ferrer C.
      • Cao P.
      • Coscarella C.
      • Ferri M.
      • Lovato L.
      • Camparini S.
      • et al.
      iTalian RegIstry of doUble inner branch stent graft for arch PatHology (the TRIUmPH Registry).
      Among them are two models that provide relatively large scale outcomes. The Cook inner branched endograft is a custom made device with two inner side branches for the innominate and left common carotid arteries designed according to the patient’s anatomy. The early outcomes of 65 patients have been reported, and the authors suggested that the learning curve significantly influenced the outcome. The 30 day mortality decreased from 13% in the first 38 patients to 0% in the latter 27 patients. In terms of cerebrovascular events, the post-operative stroke rate was comparable (16% vs. 11%).
      • Spear R.
      • Haulon S.
      • Ohki T.
      • Tsilimparis N.
      • Kanaoka Y.
      • Milne C.P.E.
      • et al.
      Editor’s Choice – Subsequent results for arch aneurysm repair with inner branched endografts.
      Similarly, a Terumo double inner branch endograft is built on the Relay NBS platform using two parallel inner branches. Early outcomes from the Italian multicentre registry were reported, in which the in hospital mortality rate was 17% and cerebrovascular events occurred in 25% of patients.
      • Ferrer C.
      • Cao P.
      • Coscarella C.
      • Ferri M.
      • Lovato L.
      • Camparini S.
      • et al.
      iTalian RegIstry of doUble inner branch stent graft for arch PatHology (the TRIUmPH Registry).
      Based on these results, although total endovascular arch repair is significantly less invasive than surgical or hybrid procedures and can be expected to yield better late outcomes than the chimney technique, it is not yet stable and is currently developing.
      Therefore, type I hybrid arch repair is the only method that can secure a reliable proximal seal with commercially available devices for patients at high risk of TAR (branched endografts provide equivalent sealings when they become commercially available more widely).
      • Vallabhajosyula P.
      • Szeto W.
      • Desai N.
      • Bavaria J.E.
      Type I and Type II hybrid aortic arch replacement: postoperative and mid-term outcome analysis.
      In fact, the aneurysm sac behaviour in the late period was good, and no new type Ia endoleak occurred. In most cases requiring re-intervention, insufficient ligation of the LSA (not related to the sealing) was present, which must be improved by the learning curve (e.g., in cases where ligation is challenging owing to a large aneurysm, endovascular embolisation using plugs can be considered first). Moreover, cases with an increased sac diameter were characterised by gradual sac growth due to type II endoleak. Regarding late survival, Kaplan–Meier analysis showed that five year overall survival (71%) and freedom from aorta related death (86%) were comparable to those of conventional TAR (73% and 92%, respectively).
      • Ikeno Y.
      • Yokawa K.
      • Matsueda T.
      • Yamanaka K.
      Long-term outcomes of total arch replacement using a 4-branched graft.
      Unfortunately, the late results of this study cannot be compared with those of complex endovascular surgery, such as the chimney technique, because those reports include various sealing zones and aetiologies, with most involving relatively short term outcomes.
      As shown in Table 1, the proximal extent of the aneurysm was located in zone2 in 70% of cases. In those cases, there was a sufficient proximal sealing length (≥ 20 mm), which is why zone 1 TEVAR with two vessel debranching was not performed; the applied method was less invasive and associated with a lower stroke rate. The parallel graft technique was not applied for these reasons. However, good late results were achieved.
      In this study, all endografts were delivered anterogradely during type I hybrid aortic arch repair.
      • Yamamoto K.
      • Komori K.
      • Narita H.
      • Morimae H.
      • Tokud Y.
      • Araki Y.
      • et al.
      A “through-and-through bowing technique” for antegrade thoracic endovascular aneurysm repair with total arch debranching: a technical note and the initial results.
      The advantage of this procedure is that use of the access route is not necessary. In particular, the previous generation of stent grafts used at the time of the study period had a large profile, and frail patients at high risk from TAR (especially Asian patients or women) often have poor access. Thus, there has always been concern about access injury in the case of the femoral approach. This procedure has the great advantage of eliminating those risks. However, a causal relationship between the antegrade approach and the high incidence of peri-operative stroke cannot be ruled out. During the procedure, the cerebral oxygen saturation (rSO2) in the brain and the arterial pressure in the upper limbs were monitored continuously, and it was always confirmed that sufficient blood flow was maintained even when the 24 F sheath passed through the proximal anastomosis of the debranching bypass. It was also ensured that the anastomosis was large enough. Therefore, cerebral perfusion should have been sufficiently maintained. However, there is a theoretical possibility that the incidence of embolic events will increase. In fact, all cerebral infarctions were multiple and diffuse, and occurred in both the anterior and posterior circulations, indicative of embolic aetiology, although the embolic sources could not be identified because the ascending aorta was normal in all six patients who developed stroke. The original technique, the “through and through bowing technique”, might contribute to the development of this complication because the bowing wire over stresses the aortic arch wall (this stress, however, must be similar to the retrograde approach). In addition, there were possibilities of thrombus formation around the introducing sheath even with adequate heparinisation using ACT monitoring and air embolism. Air emboli have been proved as a pathophysiology of stroke during TEVAR.
      • Inci K.
      • Koutouzi G.
      • Chernoray V.
      • Jeppsson A.
      • Nilsson H.
      • Falkenberg M.
      Air bubbles are released by thoracic endograft deployment: an in vitro experimental study.
      According to this outcome, whether antegrade or retrograde device delivery was appropriate should have been decided depending on the case. For example, the paving and cracking method or application of a transient iliac branch could overcome problems arising from narrow access. In addition, because recent devices have a lower profile to allow for delivery via the femoral artery, even in patients with poor access, this problem can be solved in most cases. Alternatively, in cases requiring an antegrade approach due to poor access, the embolism rate through the debranching bypass can be reduced by appropriate graft clamping during the procedure or filter placement thorough the debranching graft to the carotid arteries. Furthermore, carbon dioxide insufflation in the operative field, which is widely used in cardiac surgery, and carbon dioxide flushing of the endograft may reduce the incidence of air embolism.
      • Kölbel T.
      • Rohlffs F.
      • Wipper S.
      • Carpenter S.W.
      • Debus E.S.
      • Tsilimparis N.
      Carbon dioxide flushing technique to prevent cerebral arterial air embolism and stroke during TEVAR.
      Nonetheless, in view of the high incidence of stroke, the indications for this procedure were made more stringent. For example, the procedure is not done by the authors solely because of advanced patient age.
      Regarding a high stroke rate after this technique, non-use of peri-operative antiplatelet therapy might have been another possible cause. During the study period, the policy for surgery requiring sternotomy was to discontinue or not give antiplatelet therapy. However, this policy should be revised according to current guidelines.
      Finally, as this series comprises a preliminary experience with type I hybrid arch repair with antegrade endograft implantation, the high stroke rate at least partially reflects the learning curve. Because antegrade endograft delivery is not a standard procedure and is only performed in very few centres worldwide, outcomes can be improved by learning from experience, for example in case selection, filter use, appropriate graft clamping, and peri-operative antiplatelet use.
      There were several cases of type Ic endoleak from the ligated LSA. Although it is known that the origin of LSA should be divided, it can be challenging, especially when large aneurysms involve the LSA origin. However, this complication could be resolved by an endovascular procedure when it happened.
      Although some patients underwent concomitant coronary bypass surgery, the total operation time was long. This long operating time may increase the invasiveness of this procedure.
      The limitation of this work was that it was a single centre, retrospective study that included a small number of cases only.

      Conclusions

      The midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation for aortic arch aneurysms have been reported. Although this procedure is beneficial, especially for patients with small or occluded iliac arteries, and late sac behaviour is acceptable, the incidence of peri-operative stroke is high. To make this procedure a standard alternative for patients at high risk of TAR complications, it is necessary not only to develop a procedure to reduce cerebrovascular complications similar to other endovascular approaches, but also to limit this procedure to dedicated and experienced centres until achieving this goal.

      Conflicts of interest

      None.

      Funding

      None.

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