- Email: [email protected]
Endovascular Versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a Chinese Population
Accepted Manuscript Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a Chinese Population Baolei Guo, Zhihui Dong, Weiguo Fu, Daqiao Guo, Xin Xu, Bin Chen, Junhao Jiang, Zhenyu Shi PII:
S0890-5096(16)30468-X
DOI:
10.1016/j.avsg.2016.03.006
Reference:
AVSG 2865
To appear in:
Annals of Vascular Surgery
Received Date: 16 October 2015 Revised Date:
26 February 2016
Accepted Date: 6 March 2016
Please cite this article as: Guo B, Dong Z, Fu W, Guo D, Xu X, Chen B, Jiang J, Shi Z, Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a Chinese Population, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2016.03.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a Chinese Population
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There are no financial support and sponsorship.
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This manuscript is a single journal submission and has not been submitted to another journal simultaneously.
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The corresponding author: WEIGUO FU, DEPARTMENT OF VASCULAR SURGERY, ZHONGSHAN HOSPITAL FUDAN UNIVERSITY 180# FENGLIN ROAD 200032, SHANGHAI, P.R.CHINA TEL: 8621-6404-1990*2359 FAX: 8621-6403-7183 EMAIL ADDRESS: [email protected]
Baolei Guo, Zhihui Dong, Weiguo Fu*, Daqiao Guo, Xin Xu, Bin Chen, Junhao Jiang, and Zhenyu Shi
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Authors Baolei Guo, MD, PhD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected] TEL: +86135-6424-0966; Zhihui Dong, MD, PhD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected]; *Weiguo Fu, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected] Daqiao Guo, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Xin Xu, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Bin Chen, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Junhao Jiang, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Zhenyu Shi, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected] Dr. Baolei Guo and Zhihui Dong contributed equally to the work.
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There are no conflicts of interest.
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Objective: To compare the perioperative outcomes and mid-term survival rate between open surgery repair (OSR) and endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs) in a Chinese population. Methods: A retrospective review was performed of the demographic characteristics and perioperative outcomes from 59 RAAA patients (mean 66.6 ± 13.3 years of age; 49 men) undergoing OSR or EVAR at our center between January 2003 and November 2014. The perioperative mortality and mid-term survival were assessed and compared between the OSR and EVAR groups. Results: Twenty-three patients underwent OSR, and 36 patients underwent EVAR. The overall 30-day mortality was 36.5% (47.8% OSR vs. 27.8% EVAR; P=0.14). Total surgical time, estimated blood loss, and blood transfusion in the OSR group were significantly greater than those in the EVAR group (P<0.001). Reintervention within 30 days and during the follow-up was more frequent in the EVAR group (36.1%) than in the OSR group (8.7%; P=0.026). The mean follow-up was 38.2 ± 29.3 months (range: 6 to 100 months). A KaplanMeier survival curves analysis showed no significant difference between the two groups (P=0.079). The overall survival rate at 1 year was 52.5% (31/59). Univariate and multivariate logistic regression analyses demonstrated that free intraperitoneal rupture (odds ratio: 0.143; 95% CI, 0.030–0.694; P=0.016) and cardiovascular disease (odds ratio: 0.072; 95% CI, 0.006–0.898; P=0.041) were independent risk factors for the 30-day mortality. Only intraperitoneal rupture was associated with the higher mid-term mortality (odds ratio: 4.852; 95% CI, 1.046–22.499; P=0.044). Conclusions: In an experienced vascular center in China, although the 30-day mortality and mid-term survival of RAAAs were not significantly different between the EVAR and OSR groups, EVAR has superior perioperative advantages. Consequently, EVAR is recommended as the first-line treatment for anatomically suitable RAAA. Keywords: Aneurysm; Ruptured aneurysm; Endovascular aneurysm repair; Surgery
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Abstract
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INTRODUCTION Data from the retrospective perioperative and early outcome investigations support endovascular repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs).1, 2 Hinchiliffe et al.3 published randomized controlled trials (RCTs) of comparisons between open surgical repair (OSR) and EVAR for the treatment of RAAA, which demonstrated equivalent results for the perioperative 30-day mortality and a lower complication rate in the EVAR group. However, the Immediate Management of the Patient with Ruptured Aneurysm: Open Versus Endovascular (IMPROVE) trial4 demonstrated that EVAR was not associated with significant reduction in either 30-day mortality or cost, despite a greater discharge rate than OSR. Contemporary studies evaluating mid- and late-term follow-up for EVAR compared to OSR are limited, and some reviews based on the RCTs have shown mixed results.5, 6 Nedeau et al.7 even recommended that EVAR should be considered as the first-line treatment of RAAA and practiced as the standard of care. Therefore, more studies are needed to determine if the improved early outcomes following EVAR are limited or can extend into long-term outcomes at all centers around the world.
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The purpose of this study is to determine if perioperative morbidity and mortality are lower after EVAR, compared with OSR, at our institute in a Chinese population. We also evaluated the incidents of hospital and the intensive care unit (ICU) stay, mid-term survival, and follow-up results of patients who survived the initial repair of RAAAs.
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METHODS
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We conducted a single-center, retrospective review of RAAA repairs at Zhongshan Hospital Fudan University from January 2003 to November 2014. Suprarenal and juxtarenal aneurysms were excluded. Perioperative characteristics were compared between EVAR and OSR, including age, sex, hypertension, diabetes, stroke, shock, cardiovascular disease, preoperative creatinine, lower limb ischemia, chronic obstructive pulmonary disease, aneurysm diameters, and intraperitoneal rupture. The Glasgow Aneurysm Score (GAS)8 was evaluated preoperatively.
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The management protocol of an RAAA patient (Figure 1) was followed during this period. Patients were differentiated based on their hemodynamics and mentation. The rupture protocol also involved notification of the RAAA repair team, including vascular surgeons, cardiovascular anesthesiologists, endovascular nurses with catheter-based experience, radiology technicians, and grafts providers. Various endografts from different companies were routinely available in inventory. The calibrated angiographic catheter, selected catheter, compliant angioplasty balloon (Coda, COOK), Super Stiff guidewire, and long sheaths were always prepared in an RAAA bag for emergency use.
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Anatomic suitability included (1) a minimum length of the infrarenal anchoring segment of 10–15 mm; (2) an infrarenal neck diameter of 20–32 mm; and (3) an ipsilateral iliac diameter of 6–20 mm; at least one iliac artery had to be able to accommodate an endograft system without obstructing calcifications, tortuosity, or thrombosis. The relative contraindication criteria for EVAR were specified as juxta- or suprarenal aneurysms, kidney transplant or horseshoe kidney, infected RAAA, connective tissue disease, and allergy to intravenous contrast.
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The permissive hypotension in the protocol was defined as systolic blood pressure (SBP) between 80 and 100 mmHg. A patient presenting with an intraperitoneal rupture was defined as bleeding from an RAAA that had broken away from the retroperitoneal compartment and extended into the abdominal cavity. RAAA patients were considered “unstable” if all of the following three criteria were met: 1) the operation was an emergency; 2) the patient had an American Society of Anesthesiologists (ASA) physical status classification of 4 or 5; and 3) the patient had one or more of the following: (1) preoperative shock (SBP<90mmHg), (2) preoperative packed red blood cell transfusion > 4 units, (3) preoperative intubation, or (4) preoperative impaired sensorium. Unstable patients who could not bear a CT scan were transferred directly to the hybrid suite and received aortic endovascular balloon occlusion (AEBO) under monitored anesthesia care (Figure 2). If the hemodynamics were stable, an angiography would be done of the visceral segment via the transfemoral arterial approach under local anesthesia. If necessary, a contrast-enhanced cone beam CT would be performed to evaluate the endovascular treatment options based on the aortic neck length, aortic neck or iliac artery diameter, and treatment length. All RAAA patients were treated under general anesthesia. We routinely used the preclose technique during elective EVAR to facilitate rapid and consistent technical results.
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Hemodynamic instability was not a contraindication for EVAR. For anatomically suitable patients with hemodynamic stability, EVAR with bifurcated endograft was performed (Figure 3, A-B). In the past few decades, the use of an aorto-uni-iliac (AUI) device followed by a femorofemoral crossover was considered to achieve more rapid control of hemorrhage and was, therefore, the preferred method for unstable patients (Figure 3, C-D). These days, however, the use of bifurcated endograft is increasing due to the universal applications of the AEBO technique (Figure 2). The double-balloon occlusion technique9 was used in patients without tortuosity of the aneurysm neck. After stent graft deployment and fixation, an angiogram was performed and reviewed for endoleaks. The sheath was removed over a wire, and the puncture was sutured using the preclose technique. If persistent bleeding occurred, an additional Perclose ProGlide device (Abbott Laboratories, Abbott Park, III) might be deployed, or a conversion to open repair might be undertaken.
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Five stent graft systems were used primarily to perform EVAR in this series: Endurant (Medtronic, Minneapolis, Minn), Zenith TX2 (Cook, Bjaeverskov, Denmark), Gore Excluder (W.L. Gore and Associates, Flagstaff, Ariz), Hercules (Microport, Shanghai, China), and Ankura (LifeTech, Shenzhen, China). The stent graft selection was based on the aortoiliac morphology, and surgeon experience and preference.
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OSR was performed using standard vascular and endovascular techniques and by following the SVERSUS/ISCVERSUS guidelines.10
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The primary endpoints included perioperative mortality (30-day) and mid-term survival. Secondary endpoints included intraoperative death, types of endoleaks, peripheral embolization or thrombosis, acute renal failure requiring dialysis, sepsis, wound infection, abdominal compartment syndrome (ACS), graft-related infection, and reintervention during a 30-day postoperative period and follow-up. Preoperative hemodynamic stability and intraoperative estimated blood loss, blood transfusion, duration of surgery, time of admission, and time in the ICU were assessed.
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Statistical analysis
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Results were analyzed with SPSS software version 20.0 (SPSS Inc., Chicago, IL). Data were assessed for normality and expressed as a number (%) for category, and mean ± standard deviation or median (range) for continuous variables. A two-tailed Student’s t test was used to analyze continuous variables, and the Chi-square test and Fisher’s exact test were used for the comparison of categorical variables between groups. A Kaplan-Meier analysis was performed to assess event-free survival. Univariate comparisons between patients with and without mortality were performed using the Chi-square test, Mann–Whitney U test, or Student’s t test as appropriate. Demographic and procedural variables with P< 0.1 in the univariate analysis were entered by stepwise forward selection in multivariate logistic regression models. A p-value of <0.05 was considered significant.
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RESULTS
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Patient demographics and comorbidities
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A total of 82 patients were admitted to our institute with a diagnosis of RAAA from January 2003 to November 2014. Thirteen patients (15.9%) underwent comfort care because of the patients’ personal will or their extreme fragility (mean age 85 years, multiple comorbidity). Ten patients (12.2%) died in the emergency room or during the transfer to the operating room. Fifty-nine patients survived the procedure: 36 underwent EVAR and 23 were treated with OSR. None of the patients in the EVAR group required surgical conversion. The demographic data, comorbidities, and preoperative characteristics in each treatment group are illustrated in Table 1. The average age of the EVAR group (70.5 ± 10.2 years) was significantly older than that of the OSR group (63.5 ± 12.8 years; P=0.023).
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The average diameter of the abdominal aortic aneurysms (AAAs) was similar between the EVAR and OSR groups (7.6 ± 4.8 vs 8.3 ± 3.2 cm; P=0.55). Preoperative shock was present in 31% (11/36) of the EVAR group and 30% (7/23) of the OSR group. All RAAA patients who underwent OSR and EVAR were evaluated according to the GAS, preoperatively. The average scores of GAS in the EVAR group did not show any statistical difference compared with the OSR group (79.1 ± 18.8 vs. 76.6 ± 20.7; P=0.64). The preoperative creatinine, hemodynamic instability, intraperitoneal rupture, and comorbidities did not differ between the two groups (Table 1).
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Perioperative and early results
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The perioperative outcomes are detailed in Table 2. The duration of procedure was significantly longer in the OSR group, with higher blood loss and blood transfusion requirements. Postoperative multiorgan failure was not statistically significant, but there was a greater trend toward the OSR group (P=0.063). Three patients (8.3%) who were undergoing EVAR died intraoperatively, while two patients (8.7%) died in the OSR group. The mean length of stay was prone to be longer in the OSR group (27.9 ± 21.9 days) than that in the EVAR group (17.9 ± 14.2 days; P=0.062). The 30-day mortality was not statistically different between the two groups (27.8% EVAR vs 47.8% OSR; P=0.14), but it tended to a lower mortality in the EVAR group. The overall 30-day mortality rate was 35.6%.
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Follow-up results
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The mean follow-up was 38.2 ± 29.3 months (range: 6 to 100 months). The median follow-up was 39.5 ± 26.8 months in the OSR group and 37.9 ± 28.9 months in the EVAR group
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(P=0.87). The reintervention rate within 30 days and during the follow-up in the EVAR group was significantly higher than in the OSR group (36.1% vs. 8.7%; P=0.026). The Kaplan-Meier survival curve (Figure 4) was analyzed for overall survival; no significant difference was found between the two groups (P=0.079). The probability of survival at 1, 2, and 3 years after EVAR was 66.7%, 63.3% and 63.3%, respectively. The corresponding figures for OSR were 43.5%, 43.5% and 38.0%, respectively. In the OSR group, two aneurysm-related deaths occurred in the first year after discharge. One died of renal failure with multiple organ failure at two months after operation, while the other died of systemic sepsis with multiple organ failure at nine months after operation. Three deaths during the follow-up stage were not aneurysm-related. In the EVAR group, two patients had ACS (intraabdominal pressure > 20mmHg) with new organ dysfunction after EVAR and underwent retroperitoneal decompression. Unfortunately, the two patients died of multiple organ failure 69 days and 52 days after EVAR, respectively. One patient suffered type Ia endoleaks at 12 months, received reintervention thrice, and finally died of a suspicious AAA rupture at home. One patient died of non-Hodgkin lymphoma at 48 months.
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Risk predictors
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The clinicopathologic factors associated with 30-day and mid-term mortality were analyzed via the univariate analysis. Preoperative shock (odds ratio: 4.871; 95% confidence interval [CI], 1.488–15.945; P=0.009), cardiovascular disease (odds ratio: 14.800; 95% CI, 1.639– 133.619; P=0.016), intraperitoneal rupture (odds ratio: 5.231; 95% CI, 1.343–20.376; P=0.017), and the average GAS (odds ratio: 1.038; 95% CI, 1.006–1.072; P=0.021) were related to a higher 30-day mortality rate, while intraperitoneal rupture (odds ratio: 4.421; 95% CI, 1.057–18.486; P=0.042) and the average GAS (odds ratio: 1.036; 95% CI, 1.004–1.068; P=0.025) were associated with a higher mid-term mortality rate (Table 3). However, the multivariate logistic regression revealed that cardiovascular disease (odds ratio: 0.072; 95% CI, 0.006–0.898; P=0.041) and intraperitoneal rupture (odds ratio: 0.143; 95% CI, 0.030– 0.649; P=0.016) were the independent predictors of 30-day mortality, while only intraperitoneal rupture (odds ratio: 4.852; 95% CI, 1.046–22.499; P=0.044) was associated with higher mid-term mortality (Table 4).
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DISCUSSION
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Despite a positive trend in the overall AAA mortality, the 30-day mortality after RAAA repair remains more than 30% in national and regional cohorts. A recently published report stated that the in-hospital mortality of all patients admitted with RAAA (including those that did not undergo repair) in the United States and in England was 53.05% and 65.90%, respectively, while the postintervention mortality was similar in both countries (41.65% in the United States and 41.77% in England).11 The MEDLINE, EMBASE, Cochrane, and the China National Knowledge Infrastructure (CNKI) databases were searched between January 2000 and January 2015, and 14 published articles on RAAA from China, either in English or in Chinese, were collected. To the best of our knowledge, the present study was the largest case series of RAAA in a Chinese population, and the proportion of EVAR increased steadily over time. The proportion of EVAR was 25% in 2003; in 2014, it was 71.4% (Figure 5).
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Currently, a growing number of studies reported superior results with EVAR,1, 2, 6, 7, 12, 13 while some have shown no difference in early outcomes between EVAR and OSR.4, 14, 15 However, a recent RCT from the Amsterdam Acute Aneurysm Trial (AJAX)16 on the treatment of RAAA with OSR and EVAR did not show any differences in outcome between
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the two techniques. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OSR. Because some of the unstable patients were excluded from the analysis, a relatively lower mortality than those reported in previous studies was found.16
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Moreover, in the IMPROVE trial4, 316 patients were randomized to EVAR (275 confirmed ruptures, 174 anatomically suitable for EVAR) and 297 to OSR (261 confirmed ruptures). Still, no statistical difference was found in the 30-day mortality (35.4% for EVAR vs 37.4% for OSR; P=0.62), while the discharged rate was significantly different between the two groups (94% for EVAR vs. 77% for OSR; P< 0.001). Similarly, in the present study, there tended to be a lower 30-day mortality in the EVAR group (27.8%), even though there were still no statistical differences between the EVAR and OSR groups (P=0.14). Compared with OSR, EVAR does not require laparotomy, retroperitoneal dissection, and aortic reconstruction with vascular graft. It is believed that EVAR is associated with less intraoperative blood loss, less operating time and transfusion, more stable perioperative hemodynamics, and lower postoperative mortality and complication rates. In our study, the duration of the procedure was significantly longer in the OSR group, with higher blood loss and blood transfusion requirements than in the EVAR group (P < 0.001).
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However, some unique complications are associated with EVAR. The development of early and late endoleaks can influence the therapeutic effect of EVAR. In our study, nine patients (25%) had endoleaks in both early and late follow-ups. One case with a type Ia endoleak (2.8%) was urgently treated with proximal aortic cuffs, and the type II endoleaks disappeared without reintervention during follow-up in the other eight patients (22%). These results were similar to the report by Fossaceca et al.17 However, the endograft selection may not be accurate as only intraoperative igital subtraction angiography was used for planning in unstable patients without CT findings. This was a reason for a relatively higher endoleak rate in our results. However, Broos et al.18 reported that the endoleak rate was only 14% in RAAA patients with hostile aortic neck anatomy. In our experience, type Ia endoleaks could be repaired using larger diameter cuffs and additional balloon expansion. Type Ib endoleaks could be treated with a compliant aortic balloon as the preferred strategy, reserving extensional iliac limbs for those in whom the balloon expansion failed. Type II endoleaks could be observed in the follow-up, and most disappeared after resolution of the hematoma.
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Moreover, due to the large size of hematomas in the abdomen, one patient had symptoms of sciatic nerve compression, while another patient developed hydronephrosis due to the compression of the ureter during the follow-up. The risk of reintervention and readmission was higher after EVAR than after OSR, particular in very elderly patients.6, 19, 20 Raats et al. reported significantly higher endovascular reintervention rates in a 5-year follow-up for patients with RAAA who were treated by EVAR (35%) compared with patients treated by OSR (6%).21 Similarly, in this study, we found a reintervention rate of 36.1% for patients treated by EVAR and 8.7% for those treated by OSR during a 30-day postoperative period and follow-up. It was reported that the higher postoperative reinterventions resulted in midterm mortality,20 which explained the similar survival rates in the mid-term follow-up of the two groups. A recent meta-analysis22 concluded that patients with a hostile neck anatomy required significantly more adjunctive procedures to resolve intraoperative endoleaks than those with a friendly anatomy (22% vs. 9%; P < 0.001). In our study, since OSR was performed only in patients whose anatomy precluded EVAR, the comparison is more between patients who could and could not be treated by EVAR. With advancements in devices and increased experience, the anatomic suitability of EVAR is expanding. Some relative
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contraindications, such as a short or angulated aortic neck, also could be successfully repaired by EVAR in emergency situations (see Figure 6).
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The IMPROVE trial suggested that local anesthesia should be the first choice32 because induction of general anesthesia in patients with RAAA is associated with cardiovascular
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Many studies of RAAA with EVAR from European and American populations have demonstrated improved results. However, whether EVAR is applicable for RAAAs in the Chinese population remains controversial. Previous studies have reported that in the Asian population, there were anatomical challenges for EVAR, such as shorter common iliac arteries (CIA), wider CIAs, shorter distances between the lowest renal artery and the CIA bifurcation, and a shorter aortic neck.23-25 Wu et al. found no significant difference in 30-day and mid-term mortality and morbidities between the OSR and EVAR groups (15.0% vs. 33.3%, P=0.201, and 20.0% vs. 46.7%, P=0.093, respectively). 25
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The present study is the first to report treatment of the Chinese population on the mainland. Although the 30-day mortality and mid-term survival were similar to previous results from studies on European and American populations, a large percentage of RAAA patients died outside of the operating room. Under the rupture protocol for RAAAs, the rupture repair team prioritized RAAA patients in the emergency department for operation. Of the 82 patients, a total of 23 patients (28.0%) died in the hospital before receiving operations, including 13 patients (15.9%) in comfort care and 10 deaths prior to or during transfer. Non-EVAR candidates with advanced age and multiple comorbidities preferred conservative management, although the patients’ selections and the advent of EVAR often confronted physicians with an ethical dilemma. This may be another cause for the high percentage of mortality before operations. Similarly, Mell et al. 26 demonstrated that either delays in emergency department arrival or delays in providing definitive care contributed to increased emergency department death rates. Therefore, reducing existing variation and inefficiencies in the transfer process by developing standard guidelines may improve the outcomes of RAAA patients.27
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In previous studies, GAS was considered an easy and quick method of risk stratification in patients with RAAAs, and as a good predictor of postoperative mortality and morbidity after urgent repair of symptomatic, non-ruptured AAA, either by OSR or EVAR. 28, 29 Starnes et al.13demonstrated that patients with advanced age (>70 years), preoperative shock (SBP < 80mmHg), elevated serum creatinine, decreased hematocrit, and blood transfusion were significant predictors of mortality. Factors of cerebrovascular disease and free rupture of AAA were also found to increase mortality in both the OSR and EVAR groups. 30 In our study, we found that preoperative shock (P=0.009), cardiovascular disease (P=0.016), intraperitoneal rupture (P=0.017), and the average GAS (P=0.021) were predictors of 30-day mortality based on a univariate analysis, while only cardiovascular disease (P= .041) and intraperitoneal rupture (P=0.016) were the independent predictors of 30-day mortality in the multivariate logistic regression model. For mid-term survival, only intraperitoneal rupture (P=0.044) was found to be associated with higher mid-term mortality upon multivariate logistic analysis. Because of rapid and massive blood loss, the intraperitoneal rupture of AAA frequently resulted in profound hypovolemic shock status, acute renal failure, and poor operative prognosis. In our study, we did not observe the influence of the type of stent graft used, but it was another factor that affected the survival rate after EVAR.31 Carrafiello et al. reported that a higher mortality rate was observed for the AUI configuration vs. bifurcated endograft (61.5% vs. 17.2%; P=0.008).31
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The major limitations of this study are the small sample size of patients and its retrospective nature. Even though the standard rupture protocol was used during the study period, there was still a selection bias for the choice of treatment due to the surgeon’s preference and graft availability. We also did not categorize the patients according to hemodynamic stability and instability for the data analysis. In addition, a large percentage of patients (16%) who selected comfort care also increased the overall mortality rate. Finally, since this retrospective study spanned a long period, the evolved indications of EVAR also represented a selection bias. Given the latest data provided by the studies of IMPROVE6 and AJAX16, the topic under discussion was a subject of interesting debate. We, therefore, thought it useful to report our experience in the treatment of RAAA. Moreover, to the best of our knowledge, this study was the largest case series of RAAA in the Asian population; it provided us with a useful experience in managing high-risk patients with potentially challenging anatomy in the given population.
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CONCLUSION There was no significant difference in the 30-day mortality and mid-term survival of RAAA between the EVAR and OSR groups in a Chinese population. While EVAR reduced the operation time, blood loss, and the volume of transfusion, it had a greater reintervention rate than OSR. Nevertheless, EVAR could be recommended as an alternative therapy for RAAA patients with a suitable anatomy or for those who are unsuitable for OSR.
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11. Karthikesalingam A, Holt PJ, Vidal-Diez A, et al. Mortality from ruptured abdominal aortic aneurysms: clinical lessons from a comparison of outcomes in England and the USA. Lancet 2014;383:963–9. 12. Veith FJ, Lachat M, Mayer D, et al. Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms. Ann Surg 2009;250:818–24. 13. Starnes BW, Quiroga E, Hutter C, et al. Management of ruptured abdominal aortic aneurysm in the endovascular era. J Vasc Surg 2010;51:9–17; discussion 17–18. 14. McHugh SM, Aherne T, Goetz T, et al. Endovascular versus open repair of ruptured abdominal aortic aneurysm. Surgeon 2015; doi:10.1016/j.surge.2015.05.004. 15. Peppelenbosch N, Geelkerken RH, Soong C, et al. Endograft treatment of ruptured abdominal aortic aneurysms using the Talent aortouniiliac system: an international multicenter study. J Vasc Surg 2006;43:1111– 23. 16. Reimerink JJ, Hoornweg LL, Vahl AC, et al. Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial. Ann Surg 2013;258:248–56. 17. Fossaceca R, Guzzardi G, Cerini P, et al. Endovascular treatment of ruptured abdominal aortic aneurysms: is now EVAR the first choice of treatment? Cardiovasc Intervent Radiol 2014;37:1156–64. 18. Broos PP, t Mannetje YW, Cuypers PW, et al. Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms with Hostile Aortic Neck Anatomy. Eur J Vasc Endovasc Surg 2015. doi:10.1016/j.ejvs.2015.04.017. 19. Giles KA, Landon BE, Cotterill P, et al. Thirty-day mortality and late survival with reinterventions and readmissions after open and endovascular aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg 2011;53:6–12,13 e11. 20. Edwards ST, Schermerhorn ML, O’Malley AJ, et al. Comparative effectiveness of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Medicare population. J Vasc Surg. 2014;59:575–82. 21. Raats JW, Flu HC, Ho GH, et al. Long-term outcome of ruptured abdominal aortic aneurysm: impact of treatment and age. Clin Interv Aging 2014;9:1721–32. 22. Antoniou GA, Georgiadis GS, Antoniou SA, et al. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2013;57:527–38. 23. Cheng SW, Ting AC, Ho P, et al. Aortic aneurysm morphology in Asians: features affecting stent-graft application and design. J Endovasc Ther 2004;11:605–12. 24. Lee JM, Lim C, Youn TJ, et al. Candidates and major determinants for endovascular repair of abdominal aortic aneurysms in Korean patients. Heart Vessels 2013;28:215–21. 25. Wu CY, Chan CY, Huang SC, et al. Outcomes following endovascular or open repair for ruptured abdominal aortic aneurysm in a Chinese population. Heart Vessels. 2014,29:71–7. 26. Mell MW, Callcut RA, Bech F, et al. Predictors of emergency department death for patients presenting with ruptured abdominal aortic aneurysms. J Vasc Surg 2012;56:651–5. 27. Mell MW, Schneider PA, Starnes BW. Variability in transfer criteria for patients with ruptured abdominal aortic aneurysm in the western United States. J Vasc Surg 2015;62:326–30. 28. Antonello M, Lepidi S, Kechagias A, et al. Glasgow aneurysm score predicts the outcome after emergency open repair of symptomatic, unruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2007;33:272–6. 29. Korhonen SJ, Ylonen K, Biancari F, et al. Glasgow Aneurysm Score as a predictor of immediate outcome after surgery for ruptured abdominal aortic aneurysm. Br J Surg 2004;91:1449–52. 30. von Meijenfeldt GC, Ultee KH, Eefting D, et al. Differences in mortality, risk factors, and complications after open and endovascular repair of ruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2014;47:79–486. 31. Carrafiello G, Piffaretti G, Lagana D, et al. Endovascular treatment of ruptured abdominal aortic aneurysms: aorto-uni-iliac or bifurcated endograft? Radiol Med 2012;117:410–25. 32. Powell JT, Hinchliffe RJ, Thompson MM, et al. Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm. Br J Surg 2014;101:216–24. 33. Raux M, Marzelle J, Kobeiter H, et al. Endovascular balloon occlusion is associated with reduced intraoperative mortality of unstable patients with ruptured abdominal aortic aneurysm but fails to improve other outcomes. J Vasc Surg 2015;61:304–8. 34. Karkos CD, Papadimitriou CT, Chatzivasileiadis TN, et al. The Impact of Aortic Occlusion Balloon on Mortality After Endovascular Repair of Ruptured Abdominal Aortic Aneurysms: A Meta-analysis and Metaregression Analysis. Cardiovasc Intervent Radiol 2015;38:1425–37.
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EVAR (n=36)
OSR (n=23)
P value
Age ± SD, years
70.5±10.2
63.5±12.8
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Sex, males
32 (88.9)
17 (73.9)
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Aneurysm diameter ± SD, cm
7.6±4.8
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COPD
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Lower limb ischemia
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Stroke
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2 (8.7)
Cardiovascular disease
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Hypertension
23 (63.9)
13 (56.5)
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Diabetes
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Table 1. Characteristics of the study population
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Hemodynamic instability
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Preoperative shock (SBP< 80 mmHg)
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0.64
0.42
0.18
10 (43.5)
0.14
7 (30.4)
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7 (19.4)
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0.76
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76.6±20.7
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RAAA: Ruptured Abdominal Aortic Aneurysm; COPD: Chronic Obstructive Pulmonary Disease; SBP: Systolic Blood Pressure; GAS: Glasgow Aneurysm Score; SD: Standard Deviation. Continuous data are given as median, and categorical data as numbers (%).
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Blood transfusion (mL), median (range) Intraoperative death, n (%) Endoleaks (type1/3), n (%) Peripheral embolization/thrombosis, n (%) Time in ICU, days ± SD Time of admission, days ± SD ARF requiring dialysis, n (%) Sepsis, n (%) Wound infection, n (%) ACS, n (%) Graft-related infection, n (%) Reintervention during 30-day postoperative period and follow-up, n (%) Multiorgan failure, n (%) Mortality (<30 days)
608.6 (0–5000) 3 (8.3) 9 (25.0) 3 (8.3) 6.7±7.6 17.9±14.2 6 (16.7) 6 (16.7) 1 (2.8) 2 (5.6) 0 (0) 13 (36.1)
<0.001 0.98 <0.001 0.54 0.15 0.062 0.98 0.67 0.33 0.82 0.22 0.026
9 (39.1) 11 (47.8)
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OSR (n=23) 303.2±53.9 3644.7 (800– 14000) 2287.3 (0–10000) 2 (8.7) 0 (0) 1 (4.3) 11.0±15.1 27.9±21.9 4 (17.4) 3 (13.0) 2 (8.7) 1 (4.3) 1 (4.3) 2 (8.7)
P value <0.001 <0.001
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EVAR (n=36) 122.4±54.3 418.6 (100–3000)
RAAA: Ruptured Abdominal Aortic Aneurysm; ARF: Acute Renal Failure; ACS: Abdominal Compartment Syndrome; ICU: Intensive Care Unit; SD: Standard Deviation. Continuous data are given as median (range) or mean ± standard deviation, and categorical data as numbers (%).
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Variable Duration of surgery ± SD, (min) Estimated blood loss (mL), median (range)
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Table 3. Univariate analysis of clinicopathologic factors predicting 30-day and mid-term mortality after repair of RAAA P value 0.959–1.040 0.122–1.919 0.923–1.228 0.235–5.143 0.088–2.481 1.488–15.945 1.639–133.619 0.478–4.425 0.267–4.074 0.599–63.521 0.996–1.014 1.343–20.376 1.006–1.072
0.954 0.302 0.388 0.904 0.371 0.009* 0.016* 0.509 0.953 0.126 0.290 0.017* 0.021*
Mid-term OR
95% CI
P value
1.008 0.885 1.087 0.624 0.264 3.125 8.182 1.739 0.571 3.600 1.006 4.421 1.036
0.969–1.048 0.227–3.449 0.922–1.281 0.135–2.890 0.050–1.396 0.976–10.005 0.918–72.911 0.601–5.032 0.148–2.210 0.352–36.800 0.997–1.016 1.057–18.486 1.004–1.068
0.694 0.860 0.319 0.547 0.117 0.055 0.060 0.308 0.417 0.280 0.203 0.042* 0.025*
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0.999 0.485 1.065 1.100 0.466 4.871 14.800 1.455 1.042 6.167 1.005 5.231 1.038
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30-day OR
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Table 4. Predictors of 30-day and mid-term mortality after repair of RAAA by multivariate logistic regression models
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OR
95% CI
P value
0.265 0.072 0.143 0.992
0.055–1.282 0.006–0.898 0.030–0.694 0.951–1.035
0.099 0.041* 0.016* 0.709
1.799 4.935 4.852 1.022
0.425–7.611 0.454–53.690 1.046–22.499 0.983–1.062
0.425 0.190 0.044* 0.268
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Variable 30-day mortality Preoperative shock Cardiovascular disease Intraperitoneal rupture Mean GAS Mid-term mortality Preoperative shock Cardiovascular disease Intraperitoneal rupture Mean GAS
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RAAA: ruptured abdominal aortic aneurysm; GAS: Glasgow Aneurysm Score; CI: confidence interval * Significant values defined by P value < 0.05.
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Figure legend Figure 1. Algorithm of RAAA patient management. RAAA: Ruptured Abdominal Aortic Aneurysm; OSH: Outside Hospital; CTA: Computed Tomographic Angiography; AEBO: Aortic Endovascular Balloon Occlusion; EVAR: Endovascular Aneurysm Repair.
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Figure 2. The technique of aortic balloon occlusion during the endovascular repair of RAAA. A: A compliant aortic balloon (Coda balloon, Cook), supported by a 14F×55-cm sheath, was placed over a Super Stiff guidewire at a location above the renal arteries. B: The endograft main body was delivered through the contralateral femoral artery and was ready to be deployed below the balloon. The infrarenal angiography was made via the 14F sheath to evaluate the anatomic suitability, while the proximal aorta was still controlled. C: The balloon was deflated and withdrawn through the sheath when the endograft main body was deployed. D–H: The compliant balloon was placed through the main body of the device to maintain proximal control below the renal arteries immediately after endograft deployment while (D) establishing the contralateral wire track with slight temporary deflation of the balloon (E) cannulating via a Super Stiff guidewire (F) positioning the internal iliac artery accurately (G) deploying the iliac limb (H). I: A second compliant balloon was dilated in the joints of endografts. J: A final angiogram was performed and reviewed for endoleaks.
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Figure 3. Bifurcated endografts and aorta-uni-iliac (AUI) endografts with a crossover bypass were performed in the EVAR group. A–B: Pre- and postoperative CTA of a stable RAAA case with bifurcated endograft repair. C–D: Pre- and postoperative CTA of an unstable RAAA patient with an AUI endograft with a crossover bypass.
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Figure 4. Kaplan-Meier curve showing mid-term survival during follow-up in patients treated by OSR and EVAR. P=0.079 by log-rank test. EVAR: Endovascular Aneurysm Repair; OSR: Open Surgical Repair.
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Figure 6. A hostile aortic anatomy of an RAAA successfully treated by bifurcated endograft repair in emergency. A: Preoperative CT scan. B: Follow-up at 16 months after endovascular repair.
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S0890-5096(16)30468-X
DOI:
10.1016/j.avsg.2016.03.006
Reference:
AVSG 2865
To appear in:
Annals of Vascular Surgery
Received Date: 16 October 2015 Revised Date:
26 February 2016
Accepted Date: 6 March 2016
Please cite this article as: Guo B, Dong Z, Fu W, Guo D, Xu X, Chen B, Jiang J, Shi Z, Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a Chinese Population, Annals of Vascular Surgery (2016), doi: 10.1016/j.avsg.2016.03.006. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
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Title: Endovascular versus Open Repair for Ruptured Abdominal Aortic Aneurysms in a Chinese Population
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There are no financial support and sponsorship.
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This manuscript is a single journal submission and has not been submitted to another journal simultaneously.
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The corresponding author: WEIGUO FU, DEPARTMENT OF VASCULAR SURGERY, ZHONGSHAN HOSPITAL FUDAN UNIVERSITY 180# FENGLIN ROAD 200032, SHANGHAI, P.R.CHINA TEL: 8621-6404-1990*2359 FAX: 8621-6403-7183 EMAIL ADDRESS: [email protected]
Baolei Guo, Zhihui Dong, Weiguo Fu*, Daqiao Guo, Xin Xu, Bin Chen, Junhao Jiang, and Zhenyu Shi
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Authors Baolei Guo, MD, PhD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected] TEL: +86135-6424-0966; Zhihui Dong, MD, PhD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected]; *Weiguo Fu, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected] Daqiao Guo, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Xin Xu, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Bin Chen, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Junhao Jiang, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Zhenyu Shi, MD, Department of Vascular Surgery, Zhongshan hospital Fudan University, 180# Fenglin road 200032, shanghai, China; Email: [email protected] Dr. Baolei Guo and Zhihui Dong contributed equally to the work.
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There are no conflicts of interest.
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Objective: To compare the perioperative outcomes and mid-term survival rate between open surgery repair (OSR) and endovascular aneurysm repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs) in a Chinese population. Methods: A retrospective review was performed of the demographic characteristics and perioperative outcomes from 59 RAAA patients (mean 66.6 ± 13.3 years of age; 49 men) undergoing OSR or EVAR at our center between January 2003 and November 2014. The perioperative mortality and mid-term survival were assessed and compared between the OSR and EVAR groups. Results: Twenty-three patients underwent OSR, and 36 patients underwent EVAR. The overall 30-day mortality was 36.5% (47.8% OSR vs. 27.8% EVAR; P=0.14). Total surgical time, estimated blood loss, and blood transfusion in the OSR group were significantly greater than those in the EVAR group (P<0.001). Reintervention within 30 days and during the follow-up was more frequent in the EVAR group (36.1%) than in the OSR group (8.7%; P=0.026). The mean follow-up was 38.2 ± 29.3 months (range: 6 to 100 months). A KaplanMeier survival curves analysis showed no significant difference between the two groups (P=0.079). The overall survival rate at 1 year was 52.5% (31/59). Univariate and multivariate logistic regression analyses demonstrated that free intraperitoneal rupture (odds ratio: 0.143; 95% CI, 0.030–0.694; P=0.016) and cardiovascular disease (odds ratio: 0.072; 95% CI, 0.006–0.898; P=0.041) were independent risk factors for the 30-day mortality. Only intraperitoneal rupture was associated with the higher mid-term mortality (odds ratio: 4.852; 95% CI, 1.046–22.499; P=0.044). Conclusions: In an experienced vascular center in China, although the 30-day mortality and mid-term survival of RAAAs were not significantly different between the EVAR and OSR groups, EVAR has superior perioperative advantages. Consequently, EVAR is recommended as the first-line treatment for anatomically suitable RAAA. Keywords: Aneurysm; Ruptured aneurysm; Endovascular aneurysm repair; Surgery
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Abstract
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INTRODUCTION Data from the retrospective perioperative and early outcome investigations support endovascular repair (EVAR) of ruptured abdominal aortic aneurysms (RAAAs).1, 2 Hinchiliffe et al.3 published randomized controlled trials (RCTs) of comparisons between open surgical repair (OSR) and EVAR for the treatment of RAAA, which demonstrated equivalent results for the perioperative 30-day mortality and a lower complication rate in the EVAR group. However, the Immediate Management of the Patient with Ruptured Aneurysm: Open Versus Endovascular (IMPROVE) trial4 demonstrated that EVAR was not associated with significant reduction in either 30-day mortality or cost, despite a greater discharge rate than OSR. Contemporary studies evaluating mid- and late-term follow-up for EVAR compared to OSR are limited, and some reviews based on the RCTs have shown mixed results.5, 6 Nedeau et al.7 even recommended that EVAR should be considered as the first-line treatment of RAAA and practiced as the standard of care. Therefore, more studies are needed to determine if the improved early outcomes following EVAR are limited or can extend into long-term outcomes at all centers around the world.
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The purpose of this study is to determine if perioperative morbidity and mortality are lower after EVAR, compared with OSR, at our institute in a Chinese population. We also evaluated the incidents of hospital and the intensive care unit (ICU) stay, mid-term survival, and follow-up results of patients who survived the initial repair of RAAAs.
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METHODS
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We conducted a single-center, retrospective review of RAAA repairs at Zhongshan Hospital Fudan University from January 2003 to November 2014. Suprarenal and juxtarenal aneurysms were excluded. Perioperative characteristics were compared between EVAR and OSR, including age, sex, hypertension, diabetes, stroke, shock, cardiovascular disease, preoperative creatinine, lower limb ischemia, chronic obstructive pulmonary disease, aneurysm diameters, and intraperitoneal rupture. The Glasgow Aneurysm Score (GAS)8 was evaluated preoperatively.
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The management protocol of an RAAA patient (Figure 1) was followed during this period. Patients were differentiated based on their hemodynamics and mentation. The rupture protocol also involved notification of the RAAA repair team, including vascular surgeons, cardiovascular anesthesiologists, endovascular nurses with catheter-based experience, radiology technicians, and grafts providers. Various endografts from different companies were routinely available in inventory. The calibrated angiographic catheter, selected catheter, compliant angioplasty balloon (Coda, COOK), Super Stiff guidewire, and long sheaths were always prepared in an RAAA bag for emergency use.
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Anatomic suitability included (1) a minimum length of the infrarenal anchoring segment of 10–15 mm; (2) an infrarenal neck diameter of 20–32 mm; and (3) an ipsilateral iliac diameter of 6–20 mm; at least one iliac artery had to be able to accommodate an endograft system without obstructing calcifications, tortuosity, or thrombosis. The relative contraindication criteria for EVAR were specified as juxta- or suprarenal aneurysms, kidney transplant or horseshoe kidney, infected RAAA, connective tissue disease, and allergy to intravenous contrast.
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The permissive hypotension in the protocol was defined as systolic blood pressure (SBP) between 80 and 100 mmHg. A patient presenting with an intraperitoneal rupture was defined as bleeding from an RAAA that had broken away from the retroperitoneal compartment and extended into the abdominal cavity. RAAA patients were considered “unstable” if all of the following three criteria were met: 1) the operation was an emergency; 2) the patient had an American Society of Anesthesiologists (ASA) physical status classification of 4 or 5; and 3) the patient had one or more of the following: (1) preoperative shock (SBP<90mmHg), (2) preoperative packed red blood cell transfusion > 4 units, (3) preoperative intubation, or (4) preoperative impaired sensorium. Unstable patients who could not bear a CT scan were transferred directly to the hybrid suite and received aortic endovascular balloon occlusion (AEBO) under monitored anesthesia care (Figure 2). If the hemodynamics were stable, an angiography would be done of the visceral segment via the transfemoral arterial approach under local anesthesia. If necessary, a contrast-enhanced cone beam CT would be performed to evaluate the endovascular treatment options based on the aortic neck length, aortic neck or iliac artery diameter, and treatment length. All RAAA patients were treated under general anesthesia. We routinely used the preclose technique during elective EVAR to facilitate rapid and consistent technical results.
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Hemodynamic instability was not a contraindication for EVAR. For anatomically suitable patients with hemodynamic stability, EVAR with bifurcated endograft was performed (Figure 3, A-B). In the past few decades, the use of an aorto-uni-iliac (AUI) device followed by a femorofemoral crossover was considered to achieve more rapid control of hemorrhage and was, therefore, the preferred method for unstable patients (Figure 3, C-D). These days, however, the use of bifurcated endograft is increasing due to the universal applications of the AEBO technique (Figure 2). The double-balloon occlusion technique9 was used in patients without tortuosity of the aneurysm neck. After stent graft deployment and fixation, an angiogram was performed and reviewed for endoleaks. The sheath was removed over a wire, and the puncture was sutured using the preclose technique. If persistent bleeding occurred, an additional Perclose ProGlide device (Abbott Laboratories, Abbott Park, III) might be deployed, or a conversion to open repair might be undertaken.
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Five stent graft systems were used primarily to perform EVAR in this series: Endurant (Medtronic, Minneapolis, Minn), Zenith TX2 (Cook, Bjaeverskov, Denmark), Gore Excluder (W.L. Gore and Associates, Flagstaff, Ariz), Hercules (Microport, Shanghai, China), and Ankura (LifeTech, Shenzhen, China). The stent graft selection was based on the aortoiliac morphology, and surgeon experience and preference.
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OSR was performed using standard vascular and endovascular techniques and by following the SVERSUS/ISCVERSUS guidelines.10
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The primary endpoints included perioperative mortality (30-day) and mid-term survival. Secondary endpoints included intraoperative death, types of endoleaks, peripheral embolization or thrombosis, acute renal failure requiring dialysis, sepsis, wound infection, abdominal compartment syndrome (ACS), graft-related infection, and reintervention during a 30-day postoperative period and follow-up. Preoperative hemodynamic stability and intraoperative estimated blood loss, blood transfusion, duration of surgery, time of admission, and time in the ICU were assessed.
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Statistical analysis
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Results were analyzed with SPSS software version 20.0 (SPSS Inc., Chicago, IL). Data were assessed for normality and expressed as a number (%) for category, and mean ± standard deviation or median (range) for continuous variables. A two-tailed Student’s t test was used to analyze continuous variables, and the Chi-square test and Fisher’s exact test were used for the comparison of categorical variables between groups. A Kaplan-Meier analysis was performed to assess event-free survival. Univariate comparisons between patients with and without mortality were performed using the Chi-square test, Mann–Whitney U test, or Student’s t test as appropriate. Demographic and procedural variables with P< 0.1 in the univariate analysis were entered by stepwise forward selection in multivariate logistic regression models. A p-value of <0.05 was considered significant.
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Patient demographics and comorbidities
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A total of 82 patients were admitted to our institute with a diagnosis of RAAA from January 2003 to November 2014. Thirteen patients (15.9%) underwent comfort care because of the patients’ personal will or their extreme fragility (mean age 85 years, multiple comorbidity). Ten patients (12.2%) died in the emergency room or during the transfer to the operating room. Fifty-nine patients survived the procedure: 36 underwent EVAR and 23 were treated with OSR. None of the patients in the EVAR group required surgical conversion. The demographic data, comorbidities, and preoperative characteristics in each treatment group are illustrated in Table 1. The average age of the EVAR group (70.5 ± 10.2 years) was significantly older than that of the OSR group (63.5 ± 12.8 years; P=0.023).
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The average diameter of the abdominal aortic aneurysms (AAAs) was similar between the EVAR and OSR groups (7.6 ± 4.8 vs 8.3 ± 3.2 cm; P=0.55). Preoperative shock was present in 31% (11/36) of the EVAR group and 30% (7/23) of the OSR group. All RAAA patients who underwent OSR and EVAR were evaluated according to the GAS, preoperatively. The average scores of GAS in the EVAR group did not show any statistical difference compared with the OSR group (79.1 ± 18.8 vs. 76.6 ± 20.7; P=0.64). The preoperative creatinine, hemodynamic instability, intraperitoneal rupture, and comorbidities did not differ between the two groups (Table 1).
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Perioperative and early results
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The perioperative outcomes are detailed in Table 2. The duration of procedure was significantly longer in the OSR group, with higher blood loss and blood transfusion requirements. Postoperative multiorgan failure was not statistically significant, but there was a greater trend toward the OSR group (P=0.063). Three patients (8.3%) who were undergoing EVAR died intraoperatively, while two patients (8.7%) died in the OSR group. The mean length of stay was prone to be longer in the OSR group (27.9 ± 21.9 days) than that in the EVAR group (17.9 ± 14.2 days; P=0.062). The 30-day mortality was not statistically different between the two groups (27.8% EVAR vs 47.8% OSR; P=0.14), but it tended to a lower mortality in the EVAR group. The overall 30-day mortality rate was 35.6%.
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Follow-up results
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The mean follow-up was 38.2 ± 29.3 months (range: 6 to 100 months). The median follow-up was 39.5 ± 26.8 months in the OSR group and 37.9 ± 28.9 months in the EVAR group
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(P=0.87). The reintervention rate within 30 days and during the follow-up in the EVAR group was significantly higher than in the OSR group (36.1% vs. 8.7%; P=0.026). The Kaplan-Meier survival curve (Figure 4) was analyzed for overall survival; no significant difference was found between the two groups (P=0.079). The probability of survival at 1, 2, and 3 years after EVAR was 66.7%, 63.3% and 63.3%, respectively. The corresponding figures for OSR were 43.5%, 43.5% and 38.0%, respectively. In the OSR group, two aneurysm-related deaths occurred in the first year after discharge. One died of renal failure with multiple organ failure at two months after operation, while the other died of systemic sepsis with multiple organ failure at nine months after operation. Three deaths during the follow-up stage were not aneurysm-related. In the EVAR group, two patients had ACS (intraabdominal pressure > 20mmHg) with new organ dysfunction after EVAR and underwent retroperitoneal decompression. Unfortunately, the two patients died of multiple organ failure 69 days and 52 days after EVAR, respectively. One patient suffered type Ia endoleaks at 12 months, received reintervention thrice, and finally died of a suspicious AAA rupture at home. One patient died of non-Hodgkin lymphoma at 48 months.
16
Risk predictors
17 18 19 20 21 22 23 24 25 26 27 28 29
The clinicopathologic factors associated with 30-day and mid-term mortality were analyzed via the univariate analysis. Preoperative shock (odds ratio: 4.871; 95% confidence interval [CI], 1.488–15.945; P=0.009), cardiovascular disease (odds ratio: 14.800; 95% CI, 1.639– 133.619; P=0.016), intraperitoneal rupture (odds ratio: 5.231; 95% CI, 1.343–20.376; P=0.017), and the average GAS (odds ratio: 1.038; 95% CI, 1.006–1.072; P=0.021) were related to a higher 30-day mortality rate, while intraperitoneal rupture (odds ratio: 4.421; 95% CI, 1.057–18.486; P=0.042) and the average GAS (odds ratio: 1.036; 95% CI, 1.004–1.068; P=0.025) were associated with a higher mid-term mortality rate (Table 3). However, the multivariate logistic regression revealed that cardiovascular disease (odds ratio: 0.072; 95% CI, 0.006–0.898; P=0.041) and intraperitoneal rupture (odds ratio: 0.143; 95% CI, 0.030– 0.649; P=0.016) were the independent predictors of 30-day mortality, while only intraperitoneal rupture (odds ratio: 4.852; 95% CI, 1.046–22.499; P=0.044) was associated with higher mid-term mortality (Table 4).
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DISCUSSION
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Despite a positive trend in the overall AAA mortality, the 30-day mortality after RAAA repair remains more than 30% in national and regional cohorts. A recently published report stated that the in-hospital mortality of all patients admitted with RAAA (including those that did not undergo repair) in the United States and in England was 53.05% and 65.90%, respectively, while the postintervention mortality was similar in both countries (41.65% in the United States and 41.77% in England).11 The MEDLINE, EMBASE, Cochrane, and the China National Knowledge Infrastructure (CNKI) databases were searched between January 2000 and January 2015, and 14 published articles on RAAA from China, either in English or in Chinese, were collected. To the best of our knowledge, the present study was the largest case series of RAAA in a Chinese population, and the proportion of EVAR increased steadily over time. The proportion of EVAR was 25% in 2003; in 2014, it was 71.4% (Figure 5).
42 43 44 45
Currently, a growing number of studies reported superior results with EVAR,1, 2, 6, 7, 12, 13 while some have shown no difference in early outcomes between EVAR and OSR.4, 14, 15 However, a recent RCT from the Amsterdam Acute Aneurysm Trial (AJAX)16 on the treatment of RAAA with OSR and EVAR did not show any differences in outcome between
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the two techniques. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OSR. Because some of the unstable patients were excluded from the analysis, a relatively lower mortality than those reported in previous studies was found.16
4 5 6 7 8 9 10 11 12 13 14 15 16
Moreover, in the IMPROVE trial4, 316 patients were randomized to EVAR (275 confirmed ruptures, 174 anatomically suitable for EVAR) and 297 to OSR (261 confirmed ruptures). Still, no statistical difference was found in the 30-day mortality (35.4% for EVAR vs 37.4% for OSR; P=0.62), while the discharged rate was significantly different between the two groups (94% for EVAR vs. 77% for OSR; P< 0.001). Similarly, in the present study, there tended to be a lower 30-day mortality in the EVAR group (27.8%), even though there were still no statistical differences between the EVAR and OSR groups (P=0.14). Compared with OSR, EVAR does not require laparotomy, retroperitoneal dissection, and aortic reconstruction with vascular graft. It is believed that EVAR is associated with less intraoperative blood loss, less operating time and transfusion, more stable perioperative hemodynamics, and lower postoperative mortality and complication rates. In our study, the duration of the procedure was significantly longer in the OSR group, with higher blood loss and blood transfusion requirements than in the EVAR group (P < 0.001).
17 18 19 20 21 22 23 24 25 26 27 28 29 30
However, some unique complications are associated with EVAR. The development of early and late endoleaks can influence the therapeutic effect of EVAR. In our study, nine patients (25%) had endoleaks in both early and late follow-ups. One case with a type Ia endoleak (2.8%) was urgently treated with proximal aortic cuffs, and the type II endoleaks disappeared without reintervention during follow-up in the other eight patients (22%). These results were similar to the report by Fossaceca et al.17 However, the endograft selection may not be accurate as only intraoperative igital subtraction angiography was used for planning in unstable patients without CT findings. This was a reason for a relatively higher endoleak rate in our results. However, Broos et al.18 reported that the endoleak rate was only 14% in RAAA patients with hostile aortic neck anatomy. In our experience, type Ia endoleaks could be repaired using larger diameter cuffs and additional balloon expansion. Type Ib endoleaks could be treated with a compliant aortic balloon as the preferred strategy, reserving extensional iliac limbs for those in whom the balloon expansion failed. Type II endoleaks could be observed in the follow-up, and most disappeared after resolution of the hematoma.
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Moreover, due to the large size of hematomas in the abdomen, one patient had symptoms of sciatic nerve compression, while another patient developed hydronephrosis due to the compression of the ureter during the follow-up. The risk of reintervention and readmission was higher after EVAR than after OSR, particular in very elderly patients.6, 19, 20 Raats et al. reported significantly higher endovascular reintervention rates in a 5-year follow-up for patients with RAAA who were treated by EVAR (35%) compared with patients treated by OSR (6%).21 Similarly, in this study, we found a reintervention rate of 36.1% for patients treated by EVAR and 8.7% for those treated by OSR during a 30-day postoperative period and follow-up. It was reported that the higher postoperative reinterventions resulted in midterm mortality,20 which explained the similar survival rates in the mid-term follow-up of the two groups. A recent meta-analysis22 concluded that patients with a hostile neck anatomy required significantly more adjunctive procedures to resolve intraoperative endoleaks than those with a friendly anatomy (22% vs. 9%; P < 0.001). In our study, since OSR was performed only in patients whose anatomy precluded EVAR, the comparison is more between patients who could and could not be treated by EVAR. With advancements in devices and increased experience, the anatomic suitability of EVAR is expanding. Some relative
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contraindications, such as a short or angulated aortic neck, also could be successfully repaired by EVAR in emergency situations (see Figure 6).
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The IMPROVE trial suggested that local anesthesia should be the first choice32 because induction of general anesthesia in patients with RAAA is associated with cardiovascular
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Many studies of RAAA with EVAR from European and American populations have demonstrated improved results. However, whether EVAR is applicable for RAAAs in the Chinese population remains controversial. Previous studies have reported that in the Asian population, there were anatomical challenges for EVAR, such as shorter common iliac arteries (CIA), wider CIAs, shorter distances between the lowest renal artery and the CIA bifurcation, and a shorter aortic neck.23-25 Wu et al. found no significant difference in 30-day and mid-term mortality and morbidities between the OSR and EVAR groups (15.0% vs. 33.3%, P=0.201, and 20.0% vs. 46.7%, P=0.093, respectively). 25
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The present study is the first to report treatment of the Chinese population on the mainland. Although the 30-day mortality and mid-term survival were similar to previous results from studies on European and American populations, a large percentage of RAAA patients died outside of the operating room. Under the rupture protocol for RAAAs, the rupture repair team prioritized RAAA patients in the emergency department for operation. Of the 82 patients, a total of 23 patients (28.0%) died in the hospital before receiving operations, including 13 patients (15.9%) in comfort care and 10 deaths prior to or during transfer. Non-EVAR candidates with advanced age and multiple comorbidities preferred conservative management, although the patients’ selections and the advent of EVAR often confronted physicians with an ethical dilemma. This may be another cause for the high percentage of mortality before operations. Similarly, Mell et al. 26 demonstrated that either delays in emergency department arrival or delays in providing definitive care contributed to increased emergency department death rates. Therefore, reducing existing variation and inefficiencies in the transfer process by developing standard guidelines may improve the outcomes of RAAA patients.27
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In previous studies, GAS was considered an easy and quick method of risk stratification in patients with RAAAs, and as a good predictor of postoperative mortality and morbidity after urgent repair of symptomatic, non-ruptured AAA, either by OSR or EVAR. 28, 29 Starnes et al.13demonstrated that patients with advanced age (>70 years), preoperative shock (SBP < 80mmHg), elevated serum creatinine, decreased hematocrit, and blood transfusion were significant predictors of mortality. Factors of cerebrovascular disease and free rupture of AAA were also found to increase mortality in both the OSR and EVAR groups. 30 In our study, we found that preoperative shock (P=0.009), cardiovascular disease (P=0.016), intraperitoneal rupture (P=0.017), and the average GAS (P=0.021) were predictors of 30-day mortality based on a univariate analysis, while only cardiovascular disease (P= .041) and intraperitoneal rupture (P=0.016) were the independent predictors of 30-day mortality in the multivariate logistic regression model. For mid-term survival, only intraperitoneal rupture (P=0.044) was found to be associated with higher mid-term mortality upon multivariate logistic analysis. Because of rapid and massive blood loss, the intraperitoneal rupture of AAA frequently resulted in profound hypovolemic shock status, acute renal failure, and poor operative prognosis. In our study, we did not observe the influence of the type of stent graft used, but it was another factor that affected the survival rate after EVAR.31 Carrafiello et al. reported that a higher mortality rate was observed for the AUI configuration vs. bifurcated endograft (61.5% vs. 17.2%; P=0.008).31
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The major limitations of this study are the small sample size of patients and its retrospective nature. Even though the standard rupture protocol was used during the study period, there was still a selection bias for the choice of treatment due to the surgeon’s preference and graft availability. We also did not categorize the patients according to hemodynamic stability and instability for the data analysis. In addition, a large percentage of patients (16%) who selected comfort care also increased the overall mortality rate. Finally, since this retrospective study spanned a long period, the evolved indications of EVAR also represented a selection bias. Given the latest data provided by the studies of IMPROVE6 and AJAX16, the topic under discussion was a subject of interesting debate. We, therefore, thought it useful to report our experience in the treatment of RAAA. Moreover, to the best of our knowledge, this study was the largest case series of RAAA in the Asian population; it provided us with a useful experience in managing high-risk patients with potentially challenging anatomy in the given population.
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CONCLUSION There was no significant difference in the 30-day mortality and mid-term survival of RAAA between the EVAR and OSR groups in a Chinese population. While EVAR reduced the operation time, blood loss, and the volume of transfusion, it had a greater reintervention rate than OSR. Nevertheless, EVAR could be recommended as an alternative therapy for RAAA patients with a suitable anatomy or for those who are unsuitable for OSR.
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1. Pini R, Faggioli G, Longhi M, et al. The influence of study design on the evaluation of ruptured abdominal aortic aneurysm treatment. Ann Vasc Surg 2014;28:1568–80. 2. Gupta PK, Ramanan B, Engelbert TL, et al. A comparison of open surgery versus endovascular repair of unstable ruptured abdominal aortic aneurysms. J Vasc Surg 2014;60:1439–45. 3. Hinchliffe RJ, Bruijstens L, MacSweeney ST, et al. A randomized trial of endovascular and open surgery for ruptured abdominal aortic aneurysm - results of a pilot study and lessons learned for future studies. Eur J Vasc Endovasc Surg 2006;32:506–13. 4. Powell JT, Sweeting MJ, Thompson MM, et al. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomized trial. BMJ 2014;348:f7661. 5. Saqib N, Park SC, Park T, et al. Endovascular repair of ruptured abdominal aortic aneurysm does not confer survival benefits over open repair. J Vasc Surg 2012;56:614–9. 6. Mehta M, Byrne J, Darling RC, 3rd, et al. Endovascular repair of ruptured infrarenal abdominal aortic aneurysm is associated with lower 30-day mortality and better 5-year survival rates than open surgical repair. J Vasc Surg 2013;57:368-75. 7. Nedeau AE, Pomposelli FB, Hamdan AD, et al. Endovascular vs open repair for ruptured abdominal aortic aneurysm. J Vasc Surg 2012;56:15–20. 8. Samy AK, Murray G, MacBain G. Glasgow aneurysm score. Cardiovasc Surg 1994;2(1):41–4. 9. Berland TL, Veith FJ, Cayne NS, et al. Technique of supraceliac balloon control of the aorta during endovascular repair of ruptured abdominal aortic aneurysms. J Vasc Surg 2013;57:272–5. 10. Chaikof EL, Brewster DC, Dalman RL, et al. The care of patients with an abdominal aortic aneurysm: the Society for Vascular Surgery practice guidelines. J Vasc Surg 2009;50:S2–S49.
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11. Karthikesalingam A, Holt PJ, Vidal-Diez A, et al. Mortality from ruptured abdominal aortic aneurysms: clinical lessons from a comparison of outcomes in England and the USA. Lancet 2014;383:963–9. 12. Veith FJ, Lachat M, Mayer D, et al. Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms. Ann Surg 2009;250:818–24. 13. Starnes BW, Quiroga E, Hutter C, et al. Management of ruptured abdominal aortic aneurysm in the endovascular era. J Vasc Surg 2010;51:9–17; discussion 17–18. 14. McHugh SM, Aherne T, Goetz T, et al. Endovascular versus open repair of ruptured abdominal aortic aneurysm. Surgeon 2015; doi:10.1016/j.surge.2015.05.004. 15. Peppelenbosch N, Geelkerken RH, Soong C, et al. Endograft treatment of ruptured abdominal aortic aneurysms using the Talent aortouniiliac system: an international multicenter study. J Vasc Surg 2006;43:1111– 23. 16. Reimerink JJ, Hoornweg LL, Vahl AC, et al. Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial. Ann Surg 2013;258:248–56. 17. Fossaceca R, Guzzardi G, Cerini P, et al. Endovascular treatment of ruptured abdominal aortic aneurysms: is now EVAR the first choice of treatment? Cardiovasc Intervent Radiol 2014;37:1156–64. 18. Broos PP, t Mannetje YW, Cuypers PW, et al. Endovascular Treatment of Ruptured Abdominal Aortic Aneurysms with Hostile Aortic Neck Anatomy. Eur J Vasc Endovasc Surg 2015. doi:10.1016/j.ejvs.2015.04.017. 19. Giles KA, Landon BE, Cotterill P, et al. Thirty-day mortality and late survival with reinterventions and readmissions after open and endovascular aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg 2011;53:6–12,13 e11. 20. Edwards ST, Schermerhorn ML, O’Malley AJ, et al. Comparative effectiveness of endovascular versus open repair of ruptured abdominal aortic aneurysm in the Medicare population. J Vasc Surg. 2014;59:575–82. 21. Raats JW, Flu HC, Ho GH, et al. Long-term outcome of ruptured abdominal aortic aneurysm: impact of treatment and age. Clin Interv Aging 2014;9:1721–32. 22. Antoniou GA, Georgiadis GS, Antoniou SA, et al. A meta-analysis of outcomes of endovascular abdominal aortic aneurysm repair in patients with hostile and friendly neck anatomy. J Vasc Surg 2013;57:527–38. 23. Cheng SW, Ting AC, Ho P, et al. Aortic aneurysm morphology in Asians: features affecting stent-graft application and design. J Endovasc Ther 2004;11:605–12. 24. Lee JM, Lim C, Youn TJ, et al. Candidates and major determinants for endovascular repair of abdominal aortic aneurysms in Korean patients. Heart Vessels 2013;28:215–21. 25. Wu CY, Chan CY, Huang SC, et al. Outcomes following endovascular or open repair for ruptured abdominal aortic aneurysm in a Chinese population. Heart Vessels. 2014,29:71–7. 26. Mell MW, Callcut RA, Bech F, et al. Predictors of emergency department death for patients presenting with ruptured abdominal aortic aneurysms. J Vasc Surg 2012;56:651–5. 27. Mell MW, Schneider PA, Starnes BW. Variability in transfer criteria for patients with ruptured abdominal aortic aneurysm in the western United States. J Vasc Surg 2015;62:326–30. 28. Antonello M, Lepidi S, Kechagias A, et al. Glasgow aneurysm score predicts the outcome after emergency open repair of symptomatic, unruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2007;33:272–6. 29. Korhonen SJ, Ylonen K, Biancari F, et al. Glasgow Aneurysm Score as a predictor of immediate outcome after surgery for ruptured abdominal aortic aneurysm. Br J Surg 2004;91:1449–52. 30. von Meijenfeldt GC, Ultee KH, Eefting D, et al. Differences in mortality, risk factors, and complications after open and endovascular repair of ruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg 2014;47:79–486. 31. Carrafiello G, Piffaretti G, Lagana D, et al. Endovascular treatment of ruptured abdominal aortic aneurysms: aorto-uni-iliac or bifurcated endograft? Radiol Med 2012;117:410–25. 32. Powell JT, Hinchliffe RJ, Thompson MM, et al. Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm. Br J Surg 2014;101:216–24. 33. Raux M, Marzelle J, Kobeiter H, et al. Endovascular balloon occlusion is associated with reduced intraoperative mortality of unstable patients with ruptured abdominal aortic aneurysm but fails to improve other outcomes. J Vasc Surg 2015;61:304–8. 34. Karkos CD, Papadimitriou CT, Chatzivasileiadis TN, et al. The Impact of Aortic Occlusion Balloon on Mortality After Endovascular Repair of Ruptured Abdominal Aortic Aneurysms: A Meta-analysis and Metaregression Analysis. Cardiovasc Intervent Radiol 2015;38:1425–37.
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EVAR (n=36)
OSR (n=23)
P value
Age ± SD, years
70.5±10.2
63.5±12.8
0.023
Sex, males
32 (88.9)
17 (73.9)
0.17
Aneurysm diameter ± SD, cm
7.6±4.8
8.3±3.2
0.55
COPD
6 (16.7)
3 (13.0)
1.00
Lower limb ischemia
6 (16.7)
2 (8.7)
Stroke
2 (5.6)
2 (8.7)
Cardiovascular disease
3 (8.3)
4 (17.4)
Hypertension
23 (63.9)
13 (56.5)
0.60
Diabetes
4 (11.1)
7 (30.4)
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Table 1. Characteristics of the study population
0.089
123.0±68.3
Hemodynamic instability
9 (25)
15
Preoperative shock (SBP< 80 mmHg)
11 (30.6)
0.64
0.42
0.18
10 (43.5)
0.14
7 (30.4)
1.00
7 (19.4)
5 (21.7)
0.76
79.1±18.8
76.6±20.7
0.64
RAAA: Ruptured Abdominal Aortic Aneurysm; COPD: Chronic Obstructive Pulmonary Disease; SBP: Systolic Blood Pressure; GAS: Glasgow Aneurysm Score; SD: Standard Deviation. Continuous data are given as median, and categorical data as numbers (%).
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Mean GAS ± SD
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Blood transfusion (mL), median (range) Intraoperative death, n (%) Endoleaks (type1/3), n (%) Peripheral embolization/thrombosis, n (%) Time in ICU, days ± SD Time of admission, days ± SD ARF requiring dialysis, n (%) Sepsis, n (%) Wound infection, n (%) ACS, n (%) Graft-related infection, n (%) Reintervention during 30-day postoperative period and follow-up, n (%) Multiorgan failure, n (%) Mortality (<30 days)
608.6 (0–5000) 3 (8.3) 9 (25.0) 3 (8.3) 6.7±7.6 17.9±14.2 6 (16.7) 6 (16.7) 1 (2.8) 2 (5.6) 0 (0) 13 (36.1)
<0.001 0.98 <0.001 0.54 0.15 0.062 0.98 0.67 0.33 0.82 0.22 0.026
9 (39.1) 11 (47.8)
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OSR (n=23) 303.2±53.9 3644.7 (800– 14000) 2287.3 (0–10000) 2 (8.7) 0 (0) 1 (4.3) 11.0±15.1 27.9±21.9 4 (17.4) 3 (13.0) 2 (8.7) 1 (4.3) 1 (4.3) 2 (8.7)
P value <0.001 <0.001
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EVAR (n=36) 122.4±54.3 418.6 (100–3000)
RAAA: Ruptured Abdominal Aortic Aneurysm; ARF: Acute Renal Failure; ACS: Abdominal Compartment Syndrome; ICU: Intensive Care Unit; SD: Standard Deviation. Continuous data are given as median (range) or mean ± standard deviation, and categorical data as numbers (%).
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Variable Duration of surgery ± SD, (min) Estimated blood loss (mL), median (range)
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Table 2. Perioperative outcomes for patients that survived their index procedure for RAAA
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Table 3. Univariate analysis of clinicopathologic factors predicting 30-day and mid-term mortality after repair of RAAA P value 0.959–1.040 0.122–1.919 0.923–1.228 0.235–5.143 0.088–2.481 1.488–15.945 1.639–133.619 0.478–4.425 0.267–4.074 0.599–63.521 0.996–1.014 1.343–20.376 1.006–1.072
0.954 0.302 0.388 0.904 0.371 0.009* 0.016* 0.509 0.953 0.126 0.290 0.017* 0.021*
Mid-term OR
95% CI
P value
1.008 0.885 1.087 0.624 0.264 3.125 8.182 1.739 0.571 3.600 1.006 4.421 1.036
0.969–1.048 0.227–3.449 0.922–1.281 0.135–2.890 0.050–1.396 0.976–10.005 0.918–72.911 0.601–5.032 0.148–2.210 0.352–36.800 0.997–1.016 1.057–18.486 1.004–1.068
0.694 0.860 0.319 0.547 0.117 0.055 0.060 0.308 0.417 0.280 0.203 0.042* 0.025*
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RAAA: Ruptured Abdominal Aortic Aneurysm; COPD: Chronic Obstructive Pulmonary Disease; GAS: Glasgow Aneurysm Score; OR: Odds Ratio * Significant values defined by P value < 0.05.
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0.999 0.485 1.065 1.100 0.466 4.871 14.800 1.455 1.042 6.167 1.005 5.231 1.038
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95% CI
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Age Male Aneurysm diameter Lower limb ischemia COPD Preoperative shock Cardiovascular disease Hypertension Diabetes Stroke Preoperative creatinine Intraperitoneal rupture Mean GAS
30-day OR
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Table 4. Predictors of 30-day and mid-term mortality after repair of RAAA by multivariate logistic regression models
5 6 7
OR
95% CI
P value
0.265 0.072 0.143 0.992
0.055–1.282 0.006–0.898 0.030–0.694 0.951–1.035
0.099 0.041* 0.016* 0.709
1.799 4.935 4.852 1.022
0.425–7.611 0.454–53.690 1.046–22.499 0.983–1.062
0.425 0.190 0.044* 0.268
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Variable 30-day mortality Preoperative shock Cardiovascular disease Intraperitoneal rupture Mean GAS Mid-term mortality Preoperative shock Cardiovascular disease Intraperitoneal rupture Mean GAS
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RAAA: ruptured abdominal aortic aneurysm; GAS: Glasgow Aneurysm Score; CI: confidence interval * Significant values defined by P value < 0.05.
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Figure legend Figure 1. Algorithm of RAAA patient management. RAAA: Ruptured Abdominal Aortic Aneurysm; OSH: Outside Hospital; CTA: Computed Tomographic Angiography; AEBO: Aortic Endovascular Balloon Occlusion; EVAR: Endovascular Aneurysm Repair.
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Figure 2. The technique of aortic balloon occlusion during the endovascular repair of RAAA. A: A compliant aortic balloon (Coda balloon, Cook), supported by a 14F×55-cm sheath, was placed over a Super Stiff guidewire at a location above the renal arteries. B: The endograft main body was delivered through the contralateral femoral artery and was ready to be deployed below the balloon. The infrarenal angiography was made via the 14F sheath to evaluate the anatomic suitability, while the proximal aorta was still controlled. C: The balloon was deflated and withdrawn through the sheath when the endograft main body was deployed. D–H: The compliant balloon was placed through the main body of the device to maintain proximal control below the renal arteries immediately after endograft deployment while (D) establishing the contralateral wire track with slight temporary deflation of the balloon (E) cannulating via a Super Stiff guidewire (F) positioning the internal iliac artery accurately (G) deploying the iliac limb (H). I: A second compliant balloon was dilated in the joints of endografts. J: A final angiogram was performed and reviewed for endoleaks.
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Figure 3. Bifurcated endografts and aorta-uni-iliac (AUI) endografts with a crossover bypass were performed in the EVAR group. A–B: Pre- and postoperative CTA of a stable RAAA case with bifurcated endograft repair. C–D: Pre- and postoperative CTA of an unstable RAAA patient with an AUI endograft with a crossover bypass.
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Figure 4. Kaplan-Meier curve showing mid-term survival during follow-up in patients treated by OSR and EVAR. P=0.079 by log-rank test. EVAR: Endovascular Aneurysm Repair; OSR: Open Surgical Repair.
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Figure 6. A hostile aortic anatomy of an RAAA successfully treated by bifurcated endograft repair in emergency. A: Preoperative CT scan. B: Follow-up at 16 months after endovascular repair.
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