Left subclavian artery occlusion during endovascular repair of traumatic thoracic aortic injury, cohort study

Left subclavian artery occlusion during endovascular repair of traumatic thoracic aortic injury, cohort study

International Journal of Surgery Open 22 (2020) 47e51 Contents lists available at ScienceDirect International Journal of Surgery Open journal homepa...

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International Journal of Surgery Open 22 (2020) 47e51

Contents lists available at ScienceDirect

International Journal of Surgery Open journal homepage: www.elsevier.com/locate/ijso

Research Paper

Left subclavian artery occlusion during endovascular repair of traumatic thoracic aortic injury, cohort study Abdullah Alhaizaey a, *, Badr Aljabri b, d, Musaad Alghamdi a, Ali AlAhmary a, Ahmad G. karmota a, c, Mohammed Asiry a, Mohammed Al-Omran b, d, Barrag Alhazmi a, f, Ahmed Abulyazied e, Mustaffa Abbass e, Ahmed Azazy e a

Division of Vascular Surgery, Aseer Central Hospital-King Khalid University, Abha, Saudi Arabia Division of Vascular Surgery, King Khalid and King Saud University Hospitals, Riyadh, Saudi Arabia Division of Vascular Surgery, Kasr Alaini Hospital, Faculty of Medicine, Cairo University, Egypt d Division of Vascular Surgery, St. Michael Hospital, University of Toronto, Canada e Division of Vascular Surgery, Armed Forces Hospital-South Region, Saudi Arabia f Division of Surgical Department, King Fahad Central Hospital, Jizan, Saudi Arabia b c

a r t i c l e i n f o

a b s t r a c t

Article history: Received 26 July 2019 Accepted 1 November 2019 Available online 15 November 2019

Background: Thoracic endovascular aortic repair (TEVAR) is superior to open techniques, as it is a minimally invasive procedure with low morbidity and mortality rates. The aortic isthmus is usually the rupture site in aortic thoracic injuries. Therefore, the distance from the left subclavian artery (LSA) usually allows proximal stent graft fixation. The main challenge is the intentional coverage of the LSA without revascularization, which is necessary to expand the proximal landing zone and to achieve an adequate seal. Acute arm ischemia, claudication, stroke, and/or left subclavian steal syndrome may occur during intentional occlusion of the LSA without revascularization when performing thoracic aorta lesion endovascular repair. The present study was conducted to analyze the safety of coverage of the LSA without revascularization during the endovascular treatment of traumatic thoracic aorta injuries. Methods: A retrospectively collected data set from two trauma centers in Saudi Arabia was reviewed between April 2007 and January 2018 to analyze the safety of LSA coverage during TEVAR performed for traumatic thoracic aorta transection. In this data set, 69 patients presented with descending thoracic aortic injuries. All were treated urgently with TEVAR with intentional LSA occlusion without revascularization during aortic injury endovascular repair. Those who underwent thoracotomy and pre-TEVAR patients who died were excluded from this study. Results: A total of 69 patients underwent intentional left subclavian artery (LSA) coverage without revascularization during the procedure; the primary technical success reached 94.2% for patients who underwent TEVAR for traumatic aortic transection. The clinical success rate was 98.6%. Only 1 of 69 patients with LSA coverage developed a localized ischemic stroke (1.4%). The 30-day mortality rate was 4.3% due to multiple organ failure. Conclusion: Revascularization of LSA is not mandatory with TEVAR for treating traumatic thoracic aortic injury with an inadequate proximal landing zone. Extending the landing zone to zone 2 and coverage of LSA is considered safe and non-time-consuming, especially in urgent situations. It provides better fixation and a good sealing zone. © 2019 The Authors. Published by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Keywords: Subclavian artery occlusion Thoracic aorta injury repair Aortic endovascular repair

1. Introduction Thoracic endovascular aortic repair (TEVAR) is an attractive management approach for thoracic aortic injuries. It has better

* Corresponding author. Aseer Central Hospital, P.O. Box 34, 61321, Abha, Saudi Arabia. E-mail addresses: [email protected], [email protected] (A. Alhaizaey).

survival rate and lower complication rate than open techniques and non-operative management [1]. The aortic isthmus is usually the rupture site in aortic thoracic injuries. Therefore, the distance from the LSA usually allows proximal stent graft fixation. The main challenge is the intentional coverage of the LSA, which is necessary to expand the proximal landing zone and achieve an adequate seal [2]. It may cause various complications, including acute arm ischemia, claudication, stroke, and/or left subclavian steal syndrome [3,4].

https://doi.org/10.1016/j.ijso.2019.11.002 2405-8572/© 2019 The Authors. Published by Elsevier Ltd on behalf of Surgical Associates Ltd. This is an open access article under the CC BY-NC-ND license (http:// creativecommons.org/licenses/by-nc-nd/4.0/).

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Revascularization of the LSA either pre- or post-aortic pathology endovascular repair is a controversial procedure with no strong recommendation in the Society for Vascular Surgery Practice Guidelines for the management of the LSA with thoracic endovascular aortic repair [3e6]. As procedural experience has increased in recent years, the technical success rate of TEVAR with coverage of the LSA has reached up to 97% during the treatment of aortic pathology, particularly aneurysmal disease [6,7]. Studies in support of routine preoperative LSA revascularization show that the coverage of the LSA during TEVAR is associated with an increased risk of stroke, paraplegia, and arm ischemia. Other studies have shown that coverage of the LSA without prophylactic revascularization is not associated with increased morbidity, supporting results promoting selective LSA revascularization during TEVAR [8e12]. This study aimed to analyze the safety of intentional coverage of the LSA without revascularization during endovascular treatment of traumatic thoracic aorta injury at two trauma centers in Saudi Arabia. 2. Materials and methods 2.1. Data collection The medical records of patients who underwent TEVAR for traumatic aorta transection at two trauma centers in Saudi Arabia (ACH -Abha, and KKUH- Riyadh) were reviewed in a retrospective manner. Data were collected between April 2007 and January 2018 and subsequently reviewed. Patients who underwent thoracotomy and pre-TEVAR patients who died were excluded. Data were collected via a predesigned data collection sheet that included age, sex, time, type and site of trauma, other associated injuries, injury severity, anatomical distribution of aortic injury, level of injury, level of consciousness according to the GCS, operation time, and coverage of the LSA and its associated intra- or post-operative complications (left arm ischemia, arm claudication, subclavian steal syndrome, stroke, paraplegia, and/or immediate quadriplegia), 1 month, 6 months, and/or 12 months post-surgery. 2.2. Pre-operative planning We followed the standard management protocols for all trauma patients at both trauma centers according to the Advanced Trauma Life Support (ATLS) management guidelines. All hemodynamically stable patients with suspected mediastinal injury underwent arterial phase contrast-enhanced computed tomography (CT) to visualize the chest, supra-aortic arch, and bilateral upper limbs arteries. The CT findings were independently reviewed by vascular and radiologist teams to avoid any misdiagnosis and to identify arterial anatomical abnormalities. The CT images were reviewed for aortic arch angle, anatomy, level, site and extent of transection, landing zone, oversizing plan, and other associated injuries. In addition to these findings, the supra-aortic arch arteries were reviewed to identify any abnormal anatomy, including the apparent right subclavian artery, bovine aortic arch, and/or hypoplastic right vertebral artery. The exclusion criteria were extension of the traumatic aortic dissection proximal to the LSA abnormal supra-aortic arch arteries due to anatomical variations, history of left innominate artery cardiac bypass surgery, and hemodynamic instability. This study was conducted to analyze the safety of LSA coverage during TEVAR for traumatic thoracic aorta transection. A total of 69 patients underwent intentional left SCA occlusion without revascularization during aortic injury endovascular repair. The collected data were analyzed using SPSS software for IBM version 22 (IBM Corp., Chicago, IL, USA).

2.3. Procedure All surgical procedures were performed in a vascular operating theater equipped with vascular software C-arm fluoroscopic machine on a carbon fiber mobile operating table. All patients underwent pre- and post-stent deployment angiography using a pigtail angiographic catheter through a contralateral femoral six French artery sheath. The stent deployment site, size, over size, landing zone, aortic arch, and supra-aortic arch arteries anatomy were re-evaluated using pre-deployment intra-operative digital subtraction angiography (DSA). All vascular access was through the femoral arteries using one site for the stent sheath; 42 were percutaneously inserted using a ProGlide closure device, and 27 were applied through femoral artery exploration. The contralateral site was used for the angiography either pre- or post-deployment. All deployments occurred during the apnea mode with low mean arterial pressure (MAP; <80 mmHg) and low heart rate (<60/ min) to avoid stent migration or collapse during deployment. The proximal landing zone was 20 mm proximal to the medial edge of the aortic transection site. Primary technical success reached up to 92.8% (64 patients out of the total 69 patients who underwent TEVAR for traumatic aortic transection). In total, 5 of the 69 TEVARtreated patients (7.2%) exhibited endoleaks. Endoleak is defined by part of the blood flow remains outside the stent graft, it classified to five types according to the source of blood flow as the following; Type I occurs due to incomplete seal of stent graft to the aorta wall proximal is type IA & distal is type IB while type II which is the commonest type is due to blood flow through aortic branches & collaterals outside the stent graft, type III & IV endoleaks are rare types and was described in early stent graft generations as type III usually occurred due to disconnection of abdominal aorta stentgraft body from iliac branch while type IV usually due to graft fabric porosity that make blood penetrating outside the stent graft component. Type IV endoleak usually has no clinical significance as it has no clinical or radiological effect in native aorta aneurysm size but if such endoleak type lead to aneurysm sac growing, it will change to type V endoleak and this called endotension [4,25]. In our studied group; 2 had type I endoleaks (2.9%) and 3 exhibited type II endoleaks (4.3%). Both patients with type I endoleaks were treated immediately intra-operation; the first patient underwent ballooning with perfect attachment of the stent to the aorta wall and the second underwent another proximal stenting with more oversizing from 15% to 25%. Two patients with type II endoleaks were treated conservatively with complete resolution within six months during the regular follow-up. The third patient underwent left subclavian artery plug occlusion one year later as he had a continuous leak; It proceeded uneventfully and there was no neurological or ischemic complication following the occlusion. 2.4. Follow-up History taking, physical examination, and CT angiography scans were performed in all patients to gather data on the following complications: stroke, left subclavian steal syndrome, acute arm ischemia, arm claudication, tissue loss in the arm, and endoleak during each follow-up after 1 month, 6 months, and annually. 2.5. Ethical considerations Institutional approval from the local ethics committee was obtained for this study, and the patients’ medical records were reviewed retrospectively in the medical record department. Patient data were kept strictly confidential. Formal consent was not required for this type of study. Data were presented accurately without deception or misrepresentation.

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This manuscript has been reported in line with strengthening the Reporting of Cohort Studies in Surgery (STROCSS) criteria [13]. 3. Results Sixty-nine of the patients (mean age of 34.7 years) who underwent TEVAR for blunt traumatic aortic transection were included in the final analysis. We used Benjamin aortic injury grading systems and Ishimaru anatomical aortic arch zones in the radiological assessments for the traumatic aortic lesions [4,9 & 10]]. Grades of injury were variable: 2 patients were grade 1 (2.9%) who had minimal intimal tear, 34 were grade 2 (49.3%) with large intimal flap more than 10 mm length with sub-intimal thrombus, 32 were grade 3 (46.4%) with pseudo-aneurysm with abnormal aortic contour, and 1 was grade 4 (1.4%) with free contrast extravasation as per the new classification scheme for treating blunt aortic injuries was published by Benjamin et al. [4,10]. Ishimaru classification depend on the injury distance from the major aortic arch branches; zone I is injury proximal to the left carotid artery while the injury between left carotid artery and left subclavian artery consider as zone II injury. Most traumatic aortic lesions are distal to the left subclavian artery near to aortic isthmus at the ligmentum arteusum attachment with medial edge of aortic wall that is the junction between the mobile aortic arch and the fixed distal part, this is considered as zone III. Zone IV is 8 cm distal to the left subclavian artery (7 &11). According to the transected zone level, 9 patients had transection at zone II (13.1%), 57 at zone III (82.6%), and 3 at zone IV (4.3%). The technical success was identified as complete exclusion of pathology without immediate intra-operative complications, including endoleaks, left common carotid occlusion, migration, stent collapse, or sheath complication as distal artery dissection or thrombosis. Pre- and post-operative complications are presented in Table 1. The 30-day mortality rate for all endovascular-treated traumatic aortic transections was 4.3% (3/69). Three patients died post-TEVAR within 2 weeks of the trauma period due to multi-organ failure (MOF). Table 2 describes the subjective characteristics of all traumatic patients who underwent TEVAR. A patient's clinical condition, anatomical correlation of the supra-aortic arch arteries, level of transection, and operative technical factors may increase the risk of stroke. The clinical success was identified as complete exclusion of the pathology without arm ischemia, neurological complications including stroke or paraplegia, and early mortality within 24 h. The

Table 1 Complications of TEVAR. Mortality Mortality Mortality Mortality Endoleak

after repair within first 24 h after repair within 30 days within one year within five years

Migration Collapse Stroke Paraplegia Subclavian steal syndrome Left arm claudication Left arm acute ischemia Respiratory complications Renal failure Cardiac complications Groin wound complications Access vessel injury Conversion to open thoracotomy

I II III IV

0 3 0 0 2 3 0 0 0 3 1 0 0 0 0 1 1 0 1 0 0

(4.3%)

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clinical success rate with coverage of the LSA was 98.6%. The stroke rate was 1.4% (1/69) for traumatic aortic injury patients treated by TEVAR with LSA occlusion with stroke occurred in a 48-year-old man with leaked aortic transection at zone 3 and who was hypotensive prior to and during the procedure with a maximum systolic blood pressure of 70 mmHg. He experienced lateral medullary syndrome. A CT demonstrated that both carotid arteries were normal, despite a hypoplastic right vertebral artery and an occluded left vertebral artery. There was no ischemic change in the left arm or clinical evidence of left steal syndrome during the regular follow-up period.

4. Discussion Traumatic thoracic aortic injuries are uncommon but severe and life-threatening clinical entities. Without appropriate treatment, up to 50% of the initial survivors die within the first 72 h ([14]). Parmley et al. reported that 88% of patients died during the first hour and 10% died within two weeks ([15]). TEVAR has changed the way in which surgeons approach patients with aortic transection by using minimally invasive surgery, which is considered a safe and effective therapeutic tool provided that it is used in suitable patients. It is characterized by lower mortality and morbidity compared to standard surgical approaches such as full or partial cardiopulmonary bypass and is the first choice of management [16]. Our study was designed in a retrospective manner to determine and analyze the safety of TEVAR with coverage of the LSA “without revascularization” during the procedure between April 2007 and January 2018 at ACH, Abha, and KKUH, Riyadh, to elucidate the technical success rate and report our findings. Blunt trauma to the thoracic aorta typically occurs during a high-velocity accident due to a combination of sudden deceleration and shearing of the relatively immobile aortic isthmus, which is located distal to the LSA and proximal to the third intercostal artery and is the junction between the relatively mobile aortic arch and the fixed descending aorta. Therefore, the isthmus is the most common location for rupture (50e70% of cases), followed by the ascending aorta or aortic arch (18%) and the distal thoracic aorta (14%) [12,16]. Motor vehicle accidents are responsible for 96.7% of thoracic aortic injuries, and blunt trauma caused by a fall are responsible for the remaining 3.3% [17,18]. This corresponds to our study, with motor vehicle accidents responsible for 97.1% of injuries (67/69) and blunt trauma caused by a fall responsible for the remaining 2.9% (2/69). In up to 50% of cases of TEVAR, coverage of the LSA is necessary to obtain a seal and to prevent either type IA endoleaks or stentgraft migration [19e23]. In our study population, the extension of the landing zone to Ishimaru zones 1e2 allowed better graft fixation and prevented type IA endoleaks, which occurred in only 1 of

(2.9%) (4.35%) Table 2 Patient and lesion characteristics. (4.35%) (1.45%)

Age Gender Zone of injury

(1.45%) (1.45%) Grade of injury (1.45%)

Mean ± SD Median (range) Male Female Zone 1 Zone 2 Zone 3 Zone 4 I II III IV

34.7 ± 15.9 32 (18e85) 62 (89.9%) 7 (11.1%) 0 (0%) 9 (13.1%) 57 (82.6%). 3 (4.3%) 2 (2.9%) 34 (49.3%) 32 (46.4%) 1 (1.4%)

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69 patients (1.4%). Hoffer et al. reported a 95.8% technical success rate [24], which corresponds to our study with a primary technical success rate of 92.8% and endoleaks occurring in 5 of 69 patients. Due to the extensive circulation provided by the LSA, coverage of the LSA can theoretically lead to grave complications, such as spinal cord ischemia or cerebrovascular incidents, or to usually better tolerate chronic left arm ischemia or subclavian steal syndrome. Although infrequent, acute upper extremity ischemia has also been reported in the setting of LSA coverage [25]. However, such risks may be justified, especially in emergency situations, in order to prevent the aforementioned end leakage. The management of intentional LSA coverage, particularly in an elective setting, remains a matter of debate. Reports of a low incidence of left arm ischemia shifted the pendulum toward the liberal coverage of the LSA as an attractive means of extending the proximal landing zone in the early years of TEVAR [26]. This complication, if it occurs, is well-tolerated in the vast majority of cases and, if necessary, revascularization may be implemented in an elective setting [11,27]. The clinical success rate in our sample was 98.6% among all 69 patients who underwent TEVAR in urgent or emergency situations. The LSA was covered with one patient developing lateral medullary syndrome (1.4%) with partial improvement; CT was normal for both carotid arteries, with an occluded left vertebral artery. Lee et al. published a comparison study between two groups regarding the rate of stroke among patients who underwent TEVAR with coverage of the LSA (revascularized patients vs non-revascularized patients post-TEVAR); the rate of stroke was 3.1% in revascularized patients and 3.5% in non-revascularized patients [11,28]. In a systematic review of all published descending thoracic aorta aneurysms treated using an endovascular management approach, the pooled prevalence for stroke was 4.1% with 3.2% in non-covered LSA thoracic stent, 8% risk of stroke in non-revascularized LSA, and 5.3% in revascularized LSA during endovascular stent repair for descending thoracic aorta aneurysm. These findings demonstrated that revascularization does not offer protection against stroke [4,11]. Kotelis et al. found the success rate of TEVAR-treated patients was achieved in 97% of 220 descending thoracic aorta lesion treatments and only 3.6% were treated for acute traumatic aorta transection [8] and the overall stroke rate was 3.6%, including 3.4% of 88 covered LSA cases and 3.8% of 132 non-covered LSA-treated patients [8,28]. Although randomized trials are required to clarify this approach for the management of LSA during descending thoracic aorta lesion endovascular management, this study demonstrated the findings of intentional LSA occlusion during endovascular stent graft management for traumatic descending thoracic aorta transection. It showed promising results with regard to the success rate without revascularization in the form of low stroke risk (1.4%) and the absence of arm ischemia, arm claudication, and subclavian steal syndrome among 69 patients in which the LSA was covered intentionally without revascularization. Examination of the left arm was performed post-operatively by measuring the distal pulses, capillary refilling, temperature and blood pressure of both upper limbs, and sensory and motor neurological examinations. No changes were detected between the values obtained at admission and during the regular follow-up period. 5. Conclusions Revascularization of the LSA is not mandatory with TEVAR for treating traumatic thoracic aortic injury with inadequate proximal landing zones. Extending the landing zone to zone 2 and coverage of the LSA may be considered safe and non-time-consuming, especially in urgent traumatic aortic lesions. It provides better

fixation and a good sealing zone with low incidence of type 1 endoleaks. Ethical approval Ethical Approval was obtained for all involved cases, in Aseer Central Hospital and KKUH. Funding None. Author contribution Abdullah Alhaizaey: Main corresponding Author; involved in the title, concepts, data analysis, interpretations, wrote the first draft and revised it for other authors. Badr Aljabri: data analysis, interpretations. Ahmed Abulyazied: Data collection and analysis. Mohammed Asiry: Data collections and analysis. Mohammed Al-Omran: title, interpretations for data and data analysis. Ahmad G. Karmota, Mustafa Abbass, Barrag Alhazmi, Ahmed Azazy, Musaad Alghamdi and Ali Alahmary were included in data collection and reviewing for data. Declaration of Competing Interest There is no conflict of interest Guarantor Dr. Abdullah Alhaizaey Research registration number Research registry: researchregistry4782 and the link is: https:// www.researchregistry.com/browse-the-registry#home/ registrationdetails/5ca510a6d85d93357af6176a/ Limitation This study is retrospective data collection in two trauma centers in Saudi Arabia only. Appendix A. Supplementary data Supplementary data to this article can be found online at https://doi.org/10.1016/j.ijso.2019.11.002. References [1] Antonello M, Menegolo M, Maturi C, Dall'antonia A, Lepidi S, Frigo AC. Intentional coverage of the left subclavian artery during endovascular repair of traumatic descending thoracic aortic transection. J Vasc Surg 2013;57(3): 684e90. https://doi:10.1016/j.jvs.2012.08.119. [2] Lee CH, Huang JK, Yang TF. Experience of endovascular repair of thoracic aortic dissection after blunt trauma injury in a district general hospital. J Thorac Dis 2016 Jun;8(6):1149e54. https://doi:10.21037/jtd.2016.04.15. [3] Chung J, Kasirajan K, Veeraswamy RK, Dodson TF, Salam AA, Chaikof EL. Left subclavian artery coverage during thoracic endovascular aortic repair and risk of perioperative stroke or death. J Vasc Surg 2011;54(4):979e84. https://doi: 10.1016/j.jvs.2011.03.270. [4] Von Allman RS, Gahl B, Powell JT. Incidence of stroke following thoracic endovascular aortic repair for descending aortic aneurysm: a systematic review of the literature with meta-analysis. Eur J Vasc Endovasc Surg 2016;16. https://doi:10.1016/j.ejvs.2016.10.025. [5] Matsumura JS, Lee WA, Mitchell RS, Farber MA, Murad MH, Lumsden AB. The Society for Vascular Surgery Practice Guidelines: management of the left

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