Analysis of Risk Factors for Early Type I Endoleaks After Thoracic Endovascular Aneurysm Repair

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1 673326JETXXX / Journal of Endovascular TherapyKanaoka et al research-article2016 Clinical Investigation Analysis of Risk Factors for Early Type I Endoleaks After Thoracic Endovascular Aneurysm Repair Journal of Endovascular Therapy 2017, Vol. 24(1) The Author(s) 2016 Reprints and permissions: sagepub.com/journalspermissions.nav DOI: / Yuji Kanaoka, MD, PhD 1, Takao Ohki, MD, PhD 1, Koji Maeda, MD, PhD 1, and Takeshi Baba, MD 1 Abstract Purpose: To evaluate risk factors for early (<30 days) type I endoleak following thoracic endovascular aortic repair (TEVAR). Methods: A retrospective study was conducted of 439 consecutive patients (mean age 74.0±10.0 years; 333 men) who underwent TEVAR at a single center between June 2006 and June Pathologies included 237 aortic arch aneurysms and 202 descending thoracic aortic aneurysms (dtaa). Maximum TAA diameter was 63.6±13.7 mm. Among the distal aortic arch aneurysms, 124 required coverage of the left subclavian artery (LSA), while the remaining 113 arch aneurysms had debranching (n=40), the chimney technique (n=52), and a branched stent-graft (n=13). Eight patients with dilatation of the ascending aorta underwent arch replacement with elephant trunk prior to TEVAR. Predictive factors for type I endoleak were explored in univariate analysis and examined for each outcome using logistic regression models; results are given as the odds ratio (OR) and 95% confidence interval (CI). Results: Among 439 TEVAR cases, 37 (8.4%) had type I endoleaks on imaging at 1 month; 31 were in the 237 arch cases (13.1%). Endoleak investigation by site indicated a low incidence (3.0%) for dtaas and markedly low (1.4%) in zone 4. Significantly more endoleaks were observed in zones 0 2 than in zone 4 (p<0.001). On univariate analysis, significant associations were found between endoleak and LSA coverage (OR 5.8, 95% CI 2.4 to 14.4, p<0.001), operative time 240 minutes (OR 3.7, 95% CI 1.5 to 6.2, p=0.002), and 270 ml of contrast (OR 2.8, 95% CI 1.4 to 5.8, p=0.004). Among the aortic branch reconstruction procedures, the chimney technique was the only maneuver associated with a significant risk of endoleak (OR 5.3, 95% CI 2.3 to 11.2, p<0.001). Arch state was not correlated with endoleaks, but 38-mm proximal neck diameter (OR 3.6, 95% CI 1.2 to 10.8, p=0.023), stentgraft diameter 40 mm (OR 9.9, 95% CI 1.4 to 30.5, p=0.015), and excessively oversized ( 14%) stent-grafts (OR 3.5, 95% CI 1.2 to 10.3, p=0.020) were; the proximal neck length was not correlated with endoleaks if a proximal neck length >10 mm can be secured. Conclusion: Risks for early type I endoleaks after TEVAR for aneurysm were landing zone 0 2, LSA coverage, large proximal neck and stent-graft diameters, excessive oversizing, and the use of the chimney technique. Keywords aortic arch aneurysm, proximal landing zone, risk factor, stent-graft, thoracic aortic aneurysm, thoracic endovascular aortic repair, type I endoleak Introduction Thoracic endovascular aortic repair (TEVAR) is widely used because of its low invasiveness and may be the first line treatment for thoracic aortic aneurysms (TAAs) in the descending thoracic aorta (DTA). 1 3 However, TEVAR outcomes are unsatisfactory for aneurysms involving the aortic arch. The supra-aortic branches may limit the proximal landing zone or the stent-graft may accommodate poorly to the inner curve, leading to endoleaks. Blood flow to the arch branches must be maintained, so various adjuncts are commonly used even though some, such as the chimney technique, can cause endoleaks in the gutters between stent-grafts. Postoperatively, cases that develop endoleaks, type I in particular, often exhibit subsequent aneurysm expansion or rupture with poor prognosis, so arch replacement remains the gold treatment for this region. In the future, endoleaks must be resolved if TEVAR is to be the first selection for treatment of aortic arch aneurysms. To that end, this study examined TEVAR procedures performed at our hospital and investigated risk factors for endoleak development. 1 Division of Vascular Surgery, Department of Surgery, Jikei University School of Medicine, Tokyo, Japan Corresponding Author: Yuji Kanaoka, Division of Vascular Surgery, Department of Surgery, Jikei University School of Medicine, , Nishi-shinbashi, Minato-ku, Tokyo , Japan. yujikana@msn.com

2 90 Journal of Endovascular Therapy 24(1) Methods Study Design A retrospective study was conducted of 439 consecutive patients (mean age 74.0±10.0 years; 333 men) who underwent TEVAR at a single center over the 7 years from June 2006 through June Pathologies included 237 aortic arch and distal arch aneurysms and 202 descending TAAs; dissecting aneurysms and emergency surgical procedures were excluded. Maximum TAA minor axis diameter was 63.6±13.7 mm. Patient characteristics, comorbidities, 30-day mortality, causes of death, and type I endoleaks were comprehensively evaluated. The ethics review board at our institution waived the need for approval for use of the anonymized study data, but all patients signed informed consent for the TEVAR procedures. Imaging and Operative Strategy Contrast-enhanced computed tomography (CT) was performed for preoperative assessment of access routes and aneurysm pathology. CT data were transferred to the Aquarius workstation (TeraRecon Inc., Foster City, CA, USA) to create 3-dimensional image reconstructions, which were examined by a team of 3 surgeons to optimize the treatment protocol for the individual patient. Selection criteria for an endovascular approach included minimum 15-mm landing zones proximally and distally; in highly angulated aortic arches, the proximal landing zone was a minimum 20 mm. Left subclavian artery (LSA) coverage was planned when necessary to procure an adequate landing zone (Figure 1A). Carotid-subclavian bypass was considered if there was a potential for subclavian steal based on cerebral imaging. Common carotid artery (CCA) debranching with a carotid-carotid bypass (Figure 1B) was planned if a 20-mm proximal neck could not be obtained despite LSA coverage; if necessary, total debranching was used with a bypass from the ascending aorta (Figure 1C). Other adjunctive procedures included chimney grafting (Figure 1D) and the use of a retrograde in situ branched stent-graft (RIBS; Figure 1E) or a double inner-branched stent-graft [a-branch (Zenith Branched Thoracic Arch Graft); Cook Medical, Bloomington, IN, USA; Figure 1F]. Total arch replacement with elephant trunk was reserved for patients with a dilated ascending aorta. In a 2-stage operation, a Dacron graft (J Graft; Japan Lifeline, Tokyo, Japan) was used for arch replacement; stent-grafts were then deployed within the elephant trunk graft, including the distal anastomosis with the arch. Standard TEVAR All endovascular procedures were performed under general anesthesia and systemic heparinization (100 U/kg) to maintain an activated clotting time of 250 to 300 seconds. TEVAR Figure 1. Various adjuncts to thoracic endovascular aortic repairs (TEVAR) for aortic arch aneurysms: (A) coverage of the left subclavian artery, (B) carotid-carotid left subclavian artery bypass, (C) total debranching with a bypass from the ascending aorta, (D) the chimney technique, (E) a retrograde in-situ branched stentgraft (RIBS), or (F) a double inner-branched endograft (a-branch). was performed with TAG and C-TAG (W. L. Gore & Associates, Flagstaff, AZ, USA), Talent and Valiant (Medtronic Vascular, Santa Rosa, CA, USA), and TX-2 (Cook Inc) thoracic stent-grafts. The stent-grafts were unilaterally inserted into the common femoral or iliac artery via a stiff wire. In patients with an extremely tortuous aorta, the stent-grafts were inserted using a pull-through wire. The LSA was occluded with a 10-mm balloon and the carotid arteries were manually clamped bilaterally to prevent cerebral embolism when the stent-grafts were passed through the aortic arch. After stent-graft deployment, a Trilobe balloon (W. L. Gore & Associates) was used for remodeling. Associated Procedures For CCA debranching (Figure 1B), the artery was exposed via a 3-cm skin incision along the anterior border of the sternocleidomastoid muscle. The carotid arteries were anastomosed under simple clamping using 6- to 8-mm ringed polytetrafluoroethylene vascular grafts (W. L. Gore & Associates) and passed posterior to the esophagus via the shortest route possible. Total debranching (Figure 1C) was performed through a median sternotomy. The ascending aorta was partially clamped, and a 10-mm prosthetic graft (W. L. Gore & Associates) was anastomosed to the ascending aorta and to the innominate artery, left CCA, and LSA. For the chimney technique (Figure 1D), the CCA was exposed, and a sheath was inserted in a retrograde manner before stents or stent-grafts were inserted to secure blood flow. Bare stents were used for left CCAs in cases with a short proximal neck distal to the LSA. Stent-grafts were deployed from the proximal ascending aorta to minimize

3 Kanaoka et al 91 gutter endoleaks. When deploying from zone 0, an Excluder leg or leg extension (W. L. Gore & Associates) was used for the innominate and carotid arteries. With regard to the chimney technique, cases of carotid artery stenting were included as bailout after accidental coverage of the left CCA. In the RIBS technique (Figure 1E), sheaths were inserted retrogradely into the arch branches before thoracic stentgraft deployment from the ascending to descending aorta. After deployment, the thoracic stent-graft was punctured with an 18-G percutaneous transhepatic gallbladder drainage needle via the branch sheath, enabling the insertion of a guidewire from the needle into the thoracic stent-graft. Covered icast stents (Atrium Medical Corp/Maquet Getinge Group, Hudson, NH, USA) and Fluency stentgrafts (Bard, Inc, Murray Hill, NJ, USA) were deployed after dilation of the puncture site. The a-branch was originally designed with fenestrations for stenting of the innominate and carotid arteries and included sleeves in the fenestrated sections to reduce the development of type III endoleaks. The deployment sequence for these device is available elsewhere. 4,5 Patients were followed after 1, 6, and 12 months postoperatively and annually thereafter in uneventful cases. Follow-up consisted of physical examination, blood tests, radiography, and contrast-enhanced CT. Definitions Primary type I endoleaks were apparent on intraoperative control angiography or the first postoperative CT angiogram ( 30 days). 6 Persistent endoleaks lasted >6 months or until death or last follow-up. Sac shrinkage was defined as the 5-mm reduction of the maximum short axis diameter during follow-up. Among the patient risk factors, chronic kidney disease (CKD) was defined as an estimated glomerular filtration rate <45 ml/min/1.73 m 2. Chronic obstructive pulmonary disease (COPD) was defined as a 1-second forced expiratory volume <700 ml and/or requirement of home oxygen therapy with emphysematous changes on the chest CT. Shaggy aorta referred to the presence of a mural thrombus 5 mm thick and 2.5 cm long in a normal nonaneurysmal section of the aorta; this definition did not apply to mural thrombi associated with aneurysms or in the ascending aorta (the latter was not suitable for TEVAR). The proximal landing zones in the aortic arch were classified as 0 to 4 according to the Ishimaru 7 classification, and the type of arch was categorized as I, II, or III. 8 Statistical Analysis To determine predictive factors for post-tevar type I endoleak, the following patient-related factors were included in a univariate analysis: sex, aneurysm size, hypertension, dyslipidemia, diabetes, coronary artery disease, cerebrovascular disease, CKD, malignancy, COPD, smoking, atrial fibrillation, cerebral infarction history, current antiplatelet and/or anticoagulant agent use, and preoperative shaggy aorta. Procedure-related factors included in the univariate analysis were: surgery duration, intraoperative blood loss, fluoroscopy time, contrast volume, blood transfusion volume, carotid debranching, complete LSA coverage, LSA coil embolization, pull-through wire use, type of device, and landing zone. With regard to aortic arch aneurysm, proximal neck length, proximal neck diameter, aneurysm size, stent-graft diameter, and oversize percentage were analyzed. The association between endoleaks and shrinkage/expansion of the aneurysm sac was assessed. Postoperative endoleak risk factors were examined using logistic regression models for each outcome; results are given as the odds ratio (OR) and 95% confidence interval (CI). The level of statistical significance was set at p<0.05. All statistical analyses were performed using SPSS software (version 20.0; IBM Corporation, Somers, NY, USA). Results Early Outcomes All TAAs in the DTA were treated with TEVAR alone, while 124 of the distal aortic arch aneurysms underwent TEVAR with LSA coverage. The remaining 113 aortic arch aneurysms required aortic branch reconstruction: debranching in 40, the chimney technique in 52, and a branched stent-graft in 13 cases. Eight cases with dilatation of the ascending aorta underwent arch replacement using the elephant trunk procedure before undergoing TEVAR. There were 4 (0.9%) perioperative deaths from myocardial infarction, sudden death, multiple organ failure (embolic shower to the lower body), and ascending aortic dissection, respectively. A type I endoleak was observed in the case of the ascending aortic dissection; the other 3 patients were free of endoleaks at their death. Risk of Endoleak Other than the deaths, no patients were lost to follow-up, which averaged 23.9 months (1 84 months). Among 439 TEVAR cases, 37 (8.4%) had type I endoleaks on CT angiography at 1 month; 31 were in the 237 arch cases (13.1%). No preoperative patient factors were associated with endoleak, not even antiplatelet or anticoagulant agents (Table 1). Investigation by site indicated that endoleak incidence was low (3.0%) for DTA cases (zones 3 and 4) and markedly low (1.4%) for zone 4 in particular. Significantly higher numbers of endoleaks were noted in zones 0 2 compared to those in zone 4 (OR 10.9, 95% CI 2.6 to 46.3, p<0.001). Univariate analysis of the procedure variables (Table 2) found associations between endoleak and LSA coverage (OR 5.8, 95% CI 2.4 to 14.4, p<0.001), LSA coil or plug

4 92 Journal of Endovascular Therapy 24(1) Table 1. Patient-Related Risk Factors for Type I Endoleak 1 Month After TEVAR. Endoleaks a No Yes Endoleak Rate, % Odds Ratio 95% CI p Gender Female Male to Hypertension No Yes to Hyperlipidemia No Yes to Diabetes No Yes to CAD No Yes to CKD No Yes to Malignancy No Yes to CVD No Yes to COPD No Yes to Smoking No Yes to Atrial fibrillation No Yes to History of stroke No Yes to Antiplatelet agents No Yes to Anticoagulants No Yes to Shaggy aorta No Yes to Abbreviations: CAD, coronary artery disease; CI, confidence interval; CKD, chronic kidney disease: COPD, chronic obstructive pulmonary disease; CVD, cerebrovascular disease; TEVAR, thoracic endovascular aortic repair. a Incomplete data on some patient variables. embolization (OR 3.2, 95% CI 1.6 to 6.7, p=0.001), operative time 240 minutes (OR 3.7, 95% CI 1.5 to 6.2, p=0.002), and 270 ml of contrast used (OR 2.8, 95% CI 1.4 to 5.8, p=0.004). With regard to aortic branch

5 Kanaoka et al 93 Table 2. Procedure-Related Risk Factors for Type I Endoleaks 1 Month After TEVAR. Endoleak a No Yes Endoleak Rate, % Odds Ratio 95% CI p Debranching No Yes to LSA coverage No Yes to <0.001 LSA coil embolization No Yes to Device TAG TX to Talent to Valiant to Operative time <240 min min to Blood loss <250 ml to <800 ml to ml to Contrast agent <270 ml ml to Blood transfusion No Yes to Pull-through No Yes to Zone to to to to Procedures TEVAR alone Debranching to Chimney to <0.001 RIBS to Elephant +TEVAR to Aneurysm shrinkage No Yes to Aneurysm enlargement No Yes to <0.001 Death No Yes to Aneurysm-related death No Yes to <0.001 Abbreviations: CI, confidence interval; LSA, left subclavian artery; RIBS, retrograde in-situ branched stent-grafting; TEVAR, thoracic endovascular aortic repair. a Incomplete data on some procedure variables.

6 94 Journal of Endovascular Therapy 24(1) Table 3. Risk Factors for Type I Endoleak 1 Month After TEVAR for Aortic Arch Aneurysms. Endoleak No Yes Endoleak Rate, % Odds Ratio 95% CI p Type of aortic arch (zones 0 2, n=237) I II to III to TEVAR with vessel reconstruction (n=113) Proximal neck diameter <38 mm mm to Stent-graft diameter <40 mm mm to Stent-graft diameter post deployment <41 mm mm to Oversizing <14% % to Proximal neck length >10 mm mm to >15 mm mm to >20 mm mm to Abbreviation: CI, confidence interval; TEVAR, thoracic endovascular aortic repair. reconstruction, the chimney technique was the only maneuver associated with a significant risk of endoleak (OR 5.3, 95% CI 2.3 to 11.2, p<0.001). Arch type showed no correlation with endoleaks, but a proximal neck diameter 38 mm (OR 3.6, 95% CI 1.2 to 10.8, p=0.023) and stent-graft diameter 40 mm (OR 9.9, 95% CI 1.4 to 30.5, p=0.015) did. Excessive oversizing ( 14%) of stent-grafts was a risk factor for endoleak (OR 3.5, 95% CI 1.2 to 10.3, p=0.020), but the proximal neck length was not correlated with endoleaks (Table 3) if a proximal neck length >10 mm can be secured. However, when several procedure details were treated as continuous rather than categorical variables (Table 4), proximal neck diameter (OR 1.1, 95% CI 1.0 to 1.2, p=0.013) and the final diameter of the stent-graft (OR 1.2, 9% CI 1.0 to 1.3, p=0.001) were risk factors for type I endoleak. Endoleaks were a significant risk for subsequent aneurysm expansion. Of the 37 cases with persistent endoleak, the aneurysms expanded in 59.4%; no sac shrinkage was observed in 91.9%. Three (8.1%) of 37 patients with persistent endoleak suffered rupture. Furthermore, persistent endoleaks were a clear risk for aneurysm-related death (OR 10.9, 95% CI 3.4 to 34.4, p<0.001). Table 4. Risk Factors for Type I Endoleak Among Continuous Procedure Variables. Discussion Odds Ratio 95% CI p Proximal neck to diameter Proximal neck to length Stent-graft diameter to post deployment Oversizing to Aneurysm size to Operation time to Abbreviation: CI, confidence interval. In the TEVAR literature, endoleak development is generally considered to be affected by factors such as aneurysm site, aneurysm diameter, proximal neck length, and proximal neck diameter, 9,10 as well as a bird-beak configuration of the stent-graft. 11 The arch is a common site of endoleak, and LSA coverage is associated with endoleaks, but TEVAR

7 Kanaoka et al 95 in the DTA is considered relatively safe and effective. 18 Indeed, the results of this study showed that endoleaks after TEVAR in the DTA are extremely rare, supporting the opinion that it could be the first-line treatment for lesions in this area. With regard to aortic arch aneurysms, some authors have indicated good outcomes with a low number of endoleaks. 19 On the other hand, several reports have shown that the endoleak rate is ~10% to 15% An adequate proximal neck length seems to be the most important factor to prevent type I endoleaks. To obtain an adequate proximal neck, debranching with a variety of endovascular flow restoration techniques, including chimney grafting, have been performed to gain sufficient proximal landing length However, these methods are associated with adverse events such as stroke and endoleak. In our investigation, the endoleak rate in the arch cases was high at 13.1%; thus, a zone 0 2 landing site was a risk factor for endoleak, along with LSA coverage and prolonged operative time, both frequently encountered in TEVAR for arch aneurysms. With regard to the surgical procedure, debranching was not a risk for endoleaks, whereas the chimney technique was. It has been reported that endoleaks are less likely to occur if debranching is performed from the ascending aorta to create a zone 0 landing rather than a zone 1 landing. 22,23 In the present investigation, debranching was found to be useful with regard to lowering the risk of endoleaks, which were rarely observed either in zone 0 or 1 if a well-shaped neck was secured (the incidence of endoleak after debranching TEVAR was 7.5%). Because the chimney technique involves placing multiple stent-grafts, endoleaks commonly occur from the gutters between devices. 24,25 Our results confirmed that the incidence of endoleaks was high (27%) with the chimney technique. Although this procedure is primarily performed on patients at high risk for arch replacement, it can be improved. Stent-graft oversizing 14% was an endoleak risk factor. Too little oversizing is a cause of endoleaks, so we generally select 10% to 15% oversizing. Our results suggested that when selecting stent-grafts, oversizing of ~10% to 13% may be appropriate. Examination of TEVAR in the arch region indicated that there was no correlation between endoleaks and arch shape, but as expected, a large diameter proximal neck requiring larger stent-grafts frequently resulted in endoleaks. Although some stent-graft devices with diameters >40 mm are available from manufacturers, the use of such large-diameter stent-grafts is not recommended in Japan considering the potential for endoleak. On the other hand, a Dacron graft landing zone is advantageous in preventing type I endoleaks, so a good neck in the proximal region should be created with ascending aorta and arch replacement and elephant trunk before performing TEVAR. If the diameter of the ascending aorta is <38 mm, branched TEVAR with a commercially available branched stentgraft is beneficial with regard to reducing endoleaks; consequently, branched stent-grafts will be more commonly used in the future. 4,5 Moreover, our results reaffirmed that those patients with persistent type I endoleaks have a poor prognosis, with several developing aneurysm expansion over the course of observation, resulting in aneurysm rupture. Accordingly, if a type I endoleak is noted after TEVAR, additional treatment should swiftly be implemented. Limitations This was a retrospective investigation at a single institution, treatment devices and policies were determined by 3 attending surgeons, there was some degree of bias, and multivariate analysis was not performed to test correlations between factors, such as neck diameter and stent-graft size. Conclusion Risks for type I endoleaks during TEVAR for TAAs were landing zone 0 2, LSA coverage, large proximal neck and stent-graft diameters, excessive oversizing, and use of the chimney technique. The presence of endoleaks was a significant risk for aneurysm expansion. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Funding The author(s) received no financial support for the research, authorship, and/or publication of this article. References 1. 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