ORIGINAL ARTICLE. Abstract INTRODUCTION

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1 European Journal of Cardio-Thoracic Surgery 49 (2016) doi: /ejcts/ezv313 Advance Access publication 15 September 2015 ORIGINAL ARTICLE Cite this article as: Yamamoto K, Komori K, Narita H, Morimae H, Tokuda 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. Eur J Cardiothorac Surg 2016;49: a A through-and-through bowing technique for antegrade thoracic endovascular aneurysm repair with total arch debranching: a technical note and the initial results Kiyohito Yamamoto a, *, Kimihiro Komori a, Hiroshi Narita a, Hirofumi Morimae a, Yoshiyuki Tokuda b, Yoshimori Araki b, Hideki Oshima b and Akihiko Usui b Division of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan b Department of Cardiac Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan * Corresponding author. Division of Vascular Surgery, Department of Surgery, Nagoya University Graduate School of Medicine, 65 Tsuruma-cho, Showa-ku, Nagoya , Japan. Tel: ; fax: ; kiyoto@med.nagoya-u.ac.jp (K. Yamamoto). Received 21 May 2015; received in revised form 25 July 2015; accepted 31 July 2015 Abstract OBJECTIVES: The aim of this study was to evaluate the deployment accuracy of a new through-and-through bowing technique that involves the deployment of the stent graft with total arch debranching via median sternotomy. METHODS: The migration distance, patients demographic characteristics, operative values and the postoperative complications were examined retrospectively. From November 2012 to February 2013, 5 patients with an aortic arch aneurysm underwent total debranching and antegrade thoracic endovascular aneurysm repair (TEVAR) (control group). Fifteen patients underwent placement using the throughand-through bowing technique (bowing group) from March to November The device was deployed as follows. A stiff guide wire was passed through the debranching prosthesis via the femoral artery. By pushing the bilateral ends of the wire against the aortic arch, the device was located along the greater curvature and bent like a bow. The migration distance, defined as the distance between the pre- and post-deployment positions of the distal end of the stent graft, was measured using fluoroscopic images. RESULTS: There were no significant differences with respect to the patients demographics or the operative variables between the two groups. The mean migration distance in the control group (9.4 ± 8.7 mm) was significantly longer than that in the bowing group (1.3 ± 1.5 mm). Although one major stroke occurred in the bowing group, there was no operative mortality in either group. CONCLUSIONS: The present paper demonstrated the precise positioning of a GORE TAG deployment using a through-and-through bowing technique with total arch debranching. Keywords: Aortic arch aneurysm Total debranching TEVAR Through-and-through bowing technique INTRODUCTION The open surgical treatment of aortic arch aneurysms remains challenging. They are associated with significant mortality and morbidity among elderly or high-risk patients [1 4]. In contrast, a hybrid approach that includes open branch vessel revascularization and TEVAR has enabled us to treat high-risk patients with challenging arch pathology. This surgical option has been reported to be safe, valid and cost-effective, although the longterm outcome is unknown [5 11]. Total debranching with TEVAR consists of the reimplantation of the aortic arch vessels using a prosthesis graft that is sewn to the native ascending aorta. The procedure is usually performed using a side clamp without cardiopulmonary bypass. The stent graft can be deployed in Zone 0 antegrade through the graft or via a retrograde iliofemoral approach. The problem of the placement of the endograft in the aortic arch, especially in Zone 0, is the movement of the endograft during deployment to the distal side due to high blood flow and the loss of the proximal landing zone, which is critical to achieving aneurysm exclusion. To control the movement during deployment by abolishing ejection forces, right ventricular rapid pacing or adenosine-induced asystole are options. However, these methods can cause circulatory disorder, and thus a more secure and stable method is desirable. In this article, we report a novel method of deployment called the through-and-through bowing technique that is designed to reduce the movement of an endograft deployed in an antegrade manner in Zone 0. The Author Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

2 K. Yamamoto et al. / European Journal of Cardio-Thoracic Surgery 1265 MATERIALS AND METHODS Surgical indication The inclusion criteria for this procedure were high risk for conventional open surgery determined by important medical comorbidities including renal disease, pulmonary disease, cardiac disease, advanced age or previous aortic surgery, and a healthy ascending aorta for landing zone and side-clamping. The exclusion criteria were a proximal or distal landing zone length <20 mm, a diameter of the ascending aorta >40 mm, circumferential calcifications or thrombus of the proximal or distal landing zones, an inverted funnel-shaped proximal neck and moderate aortic regurgitation. Patients without suitable iliofemoral access, i.e. less than 8 mm in diameter, or with severely calcified access were not excluded. Surgical procedure All procedures were performed in the operating theatre using an OEC 9800 C-arm (GE Healthcare, Buckinghamshire, UK). Under general anaesthesia, the right and left brachial artery pressures and cerebral oxygen saturation were monitored during the procedure. The ascending aorta and the aortic arch vessels were dissected through a median sternotomy, and the left axillary artery was exposed through an infraclavicular skin incision. After the completion of vessel dissection, units of heparin was systemically administered to maintain an activated coagulation time above 250 s. The aortic arch vessels were reimplanted through the median sternotomy using a three-branched Dacron graft, which is a commercially prepared trifurcated prosthetic graft (Gelweave trifurcate arch graft, VASCUTEK Ltd, a TERUMO Company, Renfrewshire, UK). This graft consisted of a main body that was 12 mm in diameter and 20 cm in length and two short-side branches that both measured 8 mm in diameter. The main body was sewn to the healthy ascending aorta under a side-biting clamp in a side-to-side fashion. A longitudinal incision mm in length was made on the ascending aorta, and the anastomotic diameter was made sufficiently large to avoid disturbing the blood flow to the brain, while a 24-Fr sheath was inserted through the anastomotic site during the TEVAR procedure. The proximal part of the graft was used for the insertion of the sheath to deploy the stent graft, which was closed with a suture after the procedure was completed. The first branch was anastomosed to the innominate artery, and the second branch was anastomosed 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 the infraclavicular skin incision. This piece was rerouted through the second intercostal space to the mediastinum and anastomosed to the third branch. Although the origin of the left subclavian artery was principally ligated through a median sternotomy, the subclavian artery was later embolized in 3 cases using metallic coils to treat type II endoleak due to incomplete ligation of the subclavian artery. The device used for this series was the GORE TAG (W. L. Gore & Associates, Inc., Flagstaff, AZ, USA), which was deployed antegradely through the proximal side of the debranching graft. We preferred GORE TAG for this hybrid procedure because of its close conformity to the anatomical curvature and the absence of a structural difference between the proximal and distal edges. The proximal end of the graft was clamped, and a 24-Fr sheath (dry seal sheath, W. L. Gore & Associates, Inc.) was inserted through a side hole in the graft. The top of the sheath was advanced to the ascending aorta through the proximal side-to-side anastomosis (Fig. 1A). AORTIC SURGERY Figure 1: Schematic illustration of surgical procedure. (A) The guide wire inserted from the femoral artery was pulled out of the chest, and the through-and-through wire was placed. (B) The GORE TAG was inserted to the aortic arch and bent like a bow by pushing the bilateral tips of the guide wire.

3 1266 K. Yamamoto et al. / European Journal of Cardio-Thoracic Surgery In early cases, a stiff guide wire was inserted antegradely through a 24-Fr sheath and the stent graft was deployed as quickly as possible. However, we experienced excessive distal movement of the stent graft during deployment because of high blood flow in the aortic arch. Accordingly, we introduced an original method called the through-and-through bowing technique to press the stent graft against the greater curvature of the aortic arch to minimize movement. After a 5-Fr sheath was inserted into the femoral artery, a in./300-cm guide wire (Radifocus Guide Wire M, Terumo Corp., Tokyo, Japan) was advanced into the descending aorta. The tip of the guide wire was caught by the snare catheter (EN Snare Endovascular Snare System, Merit Medical Systems, Inc., South Jordan, UT, USA) inserted through the 24-Fr sheath in the thoracic surgical field. After the guide wire was pulled out through the 24-Fr sheath and the through-and-through wire was placed, the guide wire was changed to a 120-cm catheter and replaced with a stiff wire (Lunderquist Extra Stiff Wire Guide, Cook, Bloomington, IN, USA) through the catheter (Fig. 1A). A pigtail catheter with markers (Centimeter Sizing Catheter, Cook) was inserted through the third branch of the trifurcated prosthetic graft, and the tip was advanced proximal to the ascending aorta beyond the anastomotic site. Digital subtraction angiography was obtained after the insertion of the stent graft through the 24-Fr sheath into the aortic arch. The distal end of the proximal anastomosis of the graft to the ascending aorta, or the position where the bird beak at the lesser curvature would occur to the lowest degree when the ascending aorta was bending, was marked on the display with a water-based pen. The endograft was inserted into the aortic arch, and the 24-Fr sheath was pulled out until the tip of the sheath was located in the prosthesis graft. Pushing both the proximal and distal ends of the stiff guide wire enabled the stent graft to be placed along the greater curvature of the aortic arch anatomy. In this way, the endograft was bent like a bow and fixed tightly to the greater curvature (Fig. 1B). The stent graft was deployed by pulling the deployment knob very quickly to prevent distal movement caused by blood flow. Balloon crimping was routinely performed using a balloon (tri-lobe balloon catheter, W. L. Gore & Associates, Inc.). Patients and methods Twenty-two cases of aortic arch aneurysms were treated using total arch debranching followed by antegrade TEVAR at Nagoya University Hospital. From November 2012 to February 2013, the first 5 patients with aortic arch aneurysms underwent total arch debranching and antegrade TEVAR without the throughand-through bowing technique (control group). The remaining 17 patients underwent placement using the through-and-through bowing technique from March to November Coronary bypass surgery was simultaneously performed on 1 patient in the bowing group, and cardiopulmonary bypass was used to avoid the side clamp on a calcified ascending aorta in the case of another patient in the bowing group. The bowing group consisted of 15 patients after excluding the 2 above-mentioned patients from the analysis in order to provide uniform data. The study was approved by the Nagoya University Ethical committee; the surgical procedures were explained, and written informed consent was obtained from all patients. A retrospective medical record review was performed for the patients who had undergone the elective hybrid approach of total arch debranching followed by antegrade TEVAR with a GORE TAG device. Demographic data and information regarding operative variables and postoperative complications were collected for both groups. Digitally stored intraoperative fluoroscopic images were uploaded onto a personal computer (PC), and the migration distance was calculated. The migration distance was defined as the distance between the pre- and post-deployment positions of the proximal end of the endograft on the side of the greater curvature (Fig. 2B). The migration distance shown on the PC was calibrated using an inserted pigtail catheter with measurement markers. The gap distance was defined as the distance between the distal edge of the anastomosis of the ascending aorta and the proximal position of the deployed endograft, and was measured using multiplanar reconstruction of postoperative CT images (Fig. 2C). The landing distance, defined as the distance between the landing zone on the greater curvature and lesser curvature sides, was measured using the same reconstructed CT image (Fig. 2D). The results are expressed as the mean ± the standard deviation. The difference in the mean values between the two groups was analysed using Student s t-test. The χ 2 test was used to compare the results of the two groups. P-values less than 0.05 were considered significant. RESULTS All procedures were electively performed. The mean age of the control group was 81.0 ± 3.4 years, and the mean age of the bowing group was 78.1 ± 3.1 years, which was significantly lower. The mean diameters of the aneurysms in each group were 66.4 ± 5.1 and 64.9 ± 7.5 cm, respectively. The male dominance for the control and bowing groups was 60 and 86.7%, respectively. All the aneurysms were degenerative; 60% of the aneurysms were saccular in shape, and the others were fusiform. There was no significant difference in the presence of comorbidities between the two groups in terms of coronary artery disease, cerebrovascular disease, chronic renal disease, lung disease, hypertension, hyperlipidaemia and diabetes mellitus (Table 1). There was no significant difference in the amount of bleeding, contrast medium used, fluoroscopic time or operation time between the two groups. There was no significant difference in the durations of the ICU and hospital stays (Table 2). One patient in each group experienced minor cerebral infarction, but recovered without any neurological deficits. One patient in the bowing group had a left brain infarction with disturbance of consciousness and hemiparesis with neurological sequelae. One cervical spinal cord ischaemic event occurred and was diagnosed by MRI scan in the bowing group, but it was minor and did not result in any permanent neurological deficits. A localized intimal tear at the site of proximal anastomosis was accidentally found in the control group during the postoperative CT, most likely as a result of side-clamping, but no surgical treatment was performed because the patient was high risk and his condition was stable. One case in the control group and 2 cases in the bowing group developed pneumonia, which required intubation for more than 3 days. There was no fatal case in either group. No endoleak was found on operative angiogram or postoperative CT in either group (Table 2). The distal movement of the endograft was observed during normal deployment procedures. In particular, the movement of the endograft was significant when the aneurysms were located on the greater curvature side (Fig. 3A and B). Almost no movement

4 K. Yamamoto et al. / European Journal of Cardio-Thoracic Surgery 1267 Figure 2: (A) The arrow shows the distal edge of the pre-deployed endograft on a fluoroscopic image. (B) The broken line indicates the pre-deployment position of the proximal end of the endograft, and the solid line indicates the post-deployment position. The distance between the two lines defines the migration distance as shown by the double arrow. (C) An open triangle indicates the distal edge of the anastomotic site, and a closed triangle indicates the proximal position of the deployed endograft in the postoperative multiplanar reconstruction computed tomography. The gap distance was defined as the distance between these positions as shown by the double arrow. (D) The landing distances of the greater curvature and lesser curvature in the proximal landing zone are shown by the thick and thin double arrows, respectively. Table 1: Variable Patient demographics and aneurysm characteristics Control group (N =5) Bowing group (N = 15) P-value Age (mean ± SD) 81.0 ± ± Male, n (%) 3 (60) 13 (86.7) 0.20 Aneurysm diameter (cm) 66.4 ± ± Aneurysm shape 3 (60) 9 (60) 1.0 (saccular), n (%) Cause of aneurysm All degenerative All degenerative CAD, n (%) 2 (40) 6 (40.0) 1.0 CVD, n (%) 2 (40) 4 (26.9) 0.57 CKD, n (%) 1 (20) 1 (6.7) 0.39 Lung disease, n (%) 1 (20) 1 (6.7) 0.39 Hypertension, n (%) 4 (80) 14 (93.3) 0.39 Hyperlipidaemia, n (%) 1 (20) 3 (20.0) 1.0 Diabetes mellitus, n (%) 1 (20) 4 (26.7) 0.77 Continuous data are expressed as the mean ± SD, and categorical data are expressed as number (%). CAD: coronary artery disease; CVD: cerebrovascular disease; CKD: chronic kidney disease; SD: standard deviation. Table 2: Operative variables and major postoperative complications Variable Control group (N =5) Bowing group (N = 15) P-value Operation time (min) 478 ± ± Bleeding (ml) 2425 ± ± Contrast medium (ml) 80 ± ± Fluoroscopy time (min) 22.4 ± ± ICU stay (days) 5.8 ± ± Hospital stay (days) 36.4 ± ± Major complications Cerebral infarction 1 (20%) 2 (13.3%) 0.72 Spinal cord ischaemia 0 (0%) 1 (6.7%) 0.55 Neurological sequelae 0 (0%) 1 (6.7%) 0.55 Intimal tear 1 (20%) 0 (0%) 0.25 Pneumonia 1 (20%) 2 (13.3%) 0.72 Mortality 0 (0%) 0 (0%) Endoleak 0 (0%) 0 (0%) Continuous data are expressed as the mean ± standard deviation, and categorical data are expressed as number (%). AORTIC SURGERY was observed in the bowing group, even when the aneurysm was located on the greater curvature side (Fig. 3C and D). The mean migration distance was 9.4 ± 8.7 mm in the control group and 1.3 ± 1.5 mm in the bowing group; there was a significant difference between the two values. The mean gap distance was 29.8 ± 9.8 mm in the control group and 17.3 ± 11.7 mm in the bowing group, the latter of which was significantly shorter. There was no significant difference between the two groups in the landing distance, either in the greater or lesser curvature (Table 3).

5 1268 K. Yamamoto et al. / European Journal of Cardio-Thoracic Surgery Figure 3: (A) The preoperative three-dimensional (3D) computed tomography (CT) angiogram without using the through-and-through bowing technique. (B) Migration occurred without using the through-and-through bowing method. The distance between the graft anastomosis and the proximal edge of the endograft increased as a result of migration. (C) The preoperative 3D CT angiogram using the through-and-through bowing method. (D) The postoperative 3D CT angiogram showing the precise positioning of the endograft just above the anastomosis of the debranching graft. Table 3: Stent graft measurement Variable Control group (N = 5) Bowing group (N = 15) P-value Migration distance (mm) 9.4 ± ± 1.5 <0.01 Gap distance (mm) 29.8 ± ± 11.7 (n = 14) 0.03 Landing distance in the greater curvature (mm) 42.6 ± ± 14.6 (n = 14) 0.12 Landing distance in the lesser curvature (mm) 31.4 ± ± 9.5 (n = 14) 0.29 Continuous data are expressed as the mean ± standard deviation. Postoperative computed tomography was not obtained from 1 patient in the bowing group because of renal insufficiency. The mean follow-up period was 27 months in the control group and 15 months in the bowing group. One patient in the bowing group died from pancreatic cancer 3 months after surgery. During follow-up, a type II endoleak from the subclavian artery caused sac expansion in 1 case in the control group, which was embolized using metallic coils 15 months after the initial surgery. The aneurysm sac size of other cases in both groups was stable during follow-up. DISCUSSION In this series, we demonstrated that by using the through-andthroughbowingtechnique, the GORE TAG device can be precisely positioned during a hybrid approach with total arch debranching. Thus, our method can utilize a longer proximal landing zone, which was extended by the debranching procedure, than traditional antegrade deployment. Although the design of GORE TAG has been changed and the mechanical characteristics on both ends of the new Conformable GORE TAG are different, this technique is potentially applicable to other devices. There are a few reports concerning the use of a deployment technique to place the endograft in a precise position. Blood pressure is traditionally lowered using various vasodilators to obtain stable haemodynamics during stent graft deployment, but this technique is not sufficient to control the movement of the endograft [11]. Adenosine-induced asystole and transvenous right

6 K. Yamamoto et al. / European Journal of Cardio-Thoracic Surgery 1269 ventricular rapid pacing have been introduced to temporarily abolish ejection forces during graft deployment [12, 13]. As the sternum in the patients of this study was open, rapid pacing can be obtained easily through epicardial wires in the same way as a transapical aortic valve implantation procedure. Although these methods completely remove the effect of blood flow and can place the stent graft at a specific position, they are likely unsafe, as circulatory disturbances that occur even briefly could conceivably prevent the heart from returning to a normal sinus rhythm. To fit the EVAR device to the angulated neck, a guide wire proceeds to the ascending aorta and the tip of the wire is inverted at the aortic valve. The stiff guide wire is pushed in with a fulcrum at the aortic valve. This procedure results in the bending of the wire, making the endograft lie parallel to the proximal neck. This technique is widely used in TEVAR, particularly when the GORE TAG is to be placed in the greater curvature of the aortic arch or the bend in the aorta. We applied this concept to antegrade positioning and deployment in combination with hybrid arch vessel procedures. With the greater force generated by pushing the bilateral tips of the guide wire, a more stable endograft placement can be achieved. However, mechanical manipulation at the supra-aortic branches has potential dangers. Therefore, it should not be used without a complete debranching of all supra-aortic branches. When the stent graft is placed in Zone 0, the graft s diameter is relatively large to match the thick ascending aorta and a largediameter delivery sheath is required. These requirements might cause access route injury when the endograft is retrogradely delivered using a femoro-iliac approach. Antegrade delivery concomitant with total supra-aortic vessel revascularization has the advantage of eliminating the risk of access route injury. In addition, antegrade delivery does not require the exposure of the femoral artery in the inguinal region. The radius of curvature of the aorta from the ascending aorta to the aortic arch varies. This variability is particularly relevant when the ascending aorta is bent to the right such that the proximal edge of the endograft, when placed at the ascending aorta, does not fit at the lesser curvature and exhibits the bird beak phenomenon. For this reason, our policy on the positioning of the device was not necessarily to place it at the position distal to the anastomosis but, rather, at the position where the bird beak at the lesser curvature would occur to the lowest degree. The migration distance was significantly decreased using this technique. More accurate positioning of the endograft can reduce the distance between the debranching graft anastomosis and the proximal edge of the endograft, thus decreasing the gap distance by utilizing the longer length of the proximal landing zone and potentially leading to improved long-term results. A transapical approach to TEVAR is feasible and might be an alternative to our procedures, especially when cardiopulmonary bypass is used for additional coronary bypass or for other reasons. However, our method is clearly less invasive, because it avoids cardiac injury [14]. Although there was no significant difference with respect to postoperative complications between the control group and the bowing group, the one stroke that caused neurological sequelae occurred in the bowing group. However, the bowing technique does not seem to be disadvantageous compared with the control technique. Although much information supporting total debranching with TEVAR for the treatment of aortic arch aneurysms has been collected, the sources of these data are primarily small and retrospective studies [6, 8, 15, 16]. Thus, the superiority of total debranching with TEVAR compared with open repair has not yet been proven. The current study has several limitations. This was neither a prospective nor a randomized study, and the patient population was small. Because we compared the bowing technique group with our historical control group, the difference observed in this study might have resulted from the learning curve. We believe that our technique can achieve results that are superior to those achieved with the control technique; however, further studies are needed to evaluate this possibility. Conflict of interest: none declared. REFERENCES [1] Svensson LG, Kim KH, Blackstone EH, Blackstone EH, Alster JM, McCarthy PM et al. Elephant trunk procedure: newer indications and uses. 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