Accepted Manuscript Outcomes and morphologic changes of immediate type Ia endoleak following endovascular repair of acute type B aortic dissection Wenhui Huang , MD, Fan Yang , MD, Jianfang Luo , MD, NianJin Xie , MD, Pengcheng He , MD, Songyuan Luo , MD, Yuan Liu , MD, Yingling Zhou , MD, Ruixin Fan , MD, Meiping Huang , MD, Jiyan Chen , MD PII:

S0890-5096(14)00666-9

DOI:

10.1016/j.avsg.2014.10.015

Reference:

AVSG 2190

To appear in:

Annals of Vascular Surgery

Received Date: 13 February 2014 Revised Date:

2 October 2014

Accepted Date: 6 October 2014

Please cite this article as: Huang W, Yang F, Luo J, Xie N, He P, Luo S, Liu Y, Zhou Y, Fan R, Huang M, Chen J, Outcomes and morphologic changes of immediate type Ia endoleak following endovascular repair of acute type B aortic dissection, Annals of Vascular Surgery (2014), doi: 10.1016/ j.avsg.2014.10.015. 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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ACCEPTED MANUSCRIPT Title Page Title: Outcomes and morphologic changes of immediate type Ia endoleak following

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endovascular repair of acute type B aortic dissection Authors: Wenhui Huang MD, Fan Yang MD, Jianfang Luo MD, NianJin Xie MD, Pengcheng He MD, Songyuan Luo MD, Yuan Liu MD, Yingling Zhou MD, Ruixin Fan MD, Meiping

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Huang MD, Jiyan Chen MD.

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Wenhui Huang MD, Fan Yang MD have contributed equally to this study and paper. Wenhui Huang MD, Fan Yang MD, Jianfang Luo MD, NianJin Xie MD, Pengcheng He MD, Songyuan Luo MD, Yuan Liu MD, Yingling Zhou MD, Ruixin Fan MD, Meiping Huang MD,

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Jiyan Chen MD are affiliated to Cardiology department, Guangdong General Hospital, Guangdong Academy of Medical Sciences in Guangzhou, China.

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Total words: 4,267 words.

Disclosure: No grants, contracts, or any other forms of financial support was involved in this

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study. There was no relationship between this study and any industry. Address for correspondence: Jianfang Luo, No. 96, Dongchuan Road, Guangzhou, Guangdong, China.

Psotal Code: 510100. Tel: 0086-13602833227 Email: [email protected] Outcomes and morphologic changes of immediate type Ia endoleak following endovascular

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ACCEPTED MANUSCRIPT repair of acute type B aortic dissection Abstract

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Objective: The clinical significance of immediate type Ia endoleaks after thoracic endovascular aortic repair (TEVAR) for aneurysms has been described in detail. However, this phenomenon is still controversial in TEVAR patients treated for acute type B aortic

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dissection.

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Methods: A single-institution study was conducted in 81 prospectively evaluated patients treated between January 2012 and June 2012 for acute type B aortic dissection. Preoperative and postoperative computed tomography angiography (CTA) images were analyzed using

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three-dimensional reconstruction to measure the areas and indices of the true lumen, false lumen, and total aorta in the proximal (p), middle (m), and distal (d) descending thoracic

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aorta. Data were analyzed and compared between the two groups of patients, with and without immediate type Ia endoleaks.

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Result: The average follow-up period was 12 months (range, 10-13months) after the procedure. TEVAR was successfully performed in all patients (mean age, 53 years; 86% men). Thirty-six of the 81 patients were diagnosed with complicated type B dissection, including persistent pain (19/36, 52.7%), refractory hypertension (4/36, 11.1%), and end-organ ischemia (13/36, 36.1%). Of all the patients, 37 (45.7%) were diagnosed with immediate type Ia endoleaks. The differences between the 30-day and 1-year all-cause mortality rates

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between the 2 groups were non-significant (13.5% vs. 2.2% P=0.08; 16.2% vs. 4.5%, P=0.13). No stroke or paraplegia occurred during the follow-up. Reintervention was performed in 2

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patients for delayed type I endoleaks in the group without immediate type Ia endoleaks. Preand postoperative CTA images were available for analysis in 54 patients. Among them, 24 patients had type Ia endoleaks. Patients with immediate type Ia endoleaks had a significantly

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larger preoperative distal false lumen area (498±274 vs. 284±213mm², P=0.02) and a larger

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distal aortic area (759±275 vs. 624±185mm², P=0.03). The 1-year follow-up CTA demonstrated significantly smaller true lumen indices (TLi) and larger false lumen areas and false lumen indices (FLi) in the proximal, middle, and distal sections in patients with

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immediate type Ia endoleaks. Differences in the postoperative morphological changes of the whole descending thoracic aorta were significant between the 2 groups, with the maximum

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area and the proximal, middle, and distal regions involved. The occurrence of endoleaks and the rates of postoperative false lumen thrombosis throughout the length of stent-grafts were

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not significant at 1-year follow-up.

Conclusion: The majority of immediate type Ia endoleaks following TEVAR in acute type B aortic dissections could seal spontaneously, without additional procedures needed. However, the appearance of such complications could be a risk factor of poorer aortic remodeling. Careful surveillance is recommended more frequently in patients with immediate type Ia endoleaks.

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Key words: TEVAR, acute type B aortic dissection, immediate type Ia endoleak, morphologic Text

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Introduction Acute type B aortic dissection (TBAD) is a severe disease with significant early and late morbidity and mortality. 1, 2 Owing to favorable 30-day and 1-year mortality rates, recent

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studies suggested that thoracic endovascular aortic repair(TEVAR)is an acceptable

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treatment option in the setting of acute complicated type B dissection with refractory pain and uncontrolled hypertension despite optimal medical therapies, malperfusion, rupture or impending rupture, and acute aortic enlargement. 3, 4A recent clinical study also revealed that,

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for uncomplicated type B dissections, TEVAR could improve the 5-year aorta-specific survival and delay disease progression.5 Exclusion and the thrombosis of the false lumen,

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with re-expansion of the true lumen, are the primary goals of TEVAR.6 According to previous studies, most patients undergoing TEVAR had significant

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shrinkage of the false lumen and expansion of the true lumen.7, 8 It is well-known that an increase in the aortic diameter raises the risk of rupture, which is the most common cause of aorta-related mortality.9 As a consequence, the imaging changes after TEVAR are important predictors of patient outcomes. Although type Ia endoleak following TEVAR for aortic thoracic aneurysms is considered as treatment failure, and requires immediate intervention 10, the clinical significance of the

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ACCEPTED MANUSCRIPT immediate type Ia endoleak in TBAD is unknown. The objectives of this study were to identify and compare the outcomes and the postoperative aortic morphological changes in

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the patients with and without immediate type Ia endoleaks following TEVAR for TBAD.

Methods

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Patients. Patients presenting to our institution from January 2012 to June 2012 with acute

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TBAD were treated with TEVAR and included in this prospective cohort. Demographic and clinical feature, including age, gender, medical history, indications for the procedure, operative details, 30-day and 1-year mortality, postoperative complications, and aortic

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morphological changes were collected retrospectively and analysed. Acute TBAD was defined as a dissection occurring ≤14 days from the onset of symptoms.

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For imaging comparisons, 54 of the 81 patients who had pre- and post- operative CTA were enrolled for imaging analyses. Patients with Stanford type A dissections were excluded from

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this study.

Data collection. Patients underwent CTA with and without contrast-enhanced, thin-sliced (range, 1-2.5 mm), spiral CT (64-Multidetector Light Speed VCT, General Electric), and 3-Dimensional reconstruction of the chest, abdomen, and pelvis for preoperative strategy-making. Patients were prospectively followed at 1, 6, and 12 months, unless follow-up findings required more frequent observation. CTA was performed to evaluate the

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ACCEPTED MANUSCRIPT aortic remodeling at the 1-year follow-up. Pre- and postoperative CTAs were analyzed using the TeraRecon Aquarius Intuition

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Edition software (TeraRecon, Foster City, CA). In patients with several postoperative CTAs, the most recent one was used for postoperative imaging calculations. The centerline of the true lumen (TL) and false lumen (FL) was established from the left subclavian artery (LSA)

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to the aortic bifurcation. On cross-sectional images, a series of manually placed points

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created an outline marking the edge of the true lumen, false lumen, and total aorta (Figure 1), allowing thereby the cross-sectional area to be measured. Three selected aortic segments were made distal to the left subclavian artery, at the carina level, and at the celiac artery level of the

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descending thoracic aorta (Figure 2). Indices of the true lumen (TLi) and the false lumen (FLi) were calculated by dividing their respective areas by the whole aortic area.

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Postoperative false lumen thrombosis was defined as observing an absolute lack of contrast flow in the false lumen throughout the level of stent-graft or the exclusion of the false lumen.

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Any contrast in the false lumen, even in the setting of partial thrombosis, was considered as showing false lumen patency. Operative details. The implantation protocol was previously published.11, 12 Stent-grafts were deployed proximally, with or without coverage of the left subclavian artery, to obtain an adequate landing zone for sealing the primary entry. Most patients were treated with one stent, unless the initial graft did not cover the entry tear and the expansion of the true lumen. In our

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ACCEPTED MANUSCRIPT institution, temporarily rapid artificial cardiac pacemaker was performed intra-operatively to lower the blood pressure when deploying the grafts and IVUS were not regularly utilized in

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the procedures. Routinely selected stentgrafts were at least 10%-15% oversized. Definitions. An immediate type Ia endoleak indicates leakage at the proximal stentgraft

attachment site that is observed via intraoperative angiography (Figure 3). All the definitions

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used in this study meet the reporting standards for TEVAR published in 2010 by the Society

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for Vascular Surgery 13 and the standardized definitions and clinical endpoints in the trials investigating endovascular repair of aortic dissections published in 2013 by the European Journal of Vascular and Endovascular Surgery. 14

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Statistical analysis. Data are expressed as means and standard deviations. Comparisons of continuous variables were made using Student t test for independent variables. Categorical

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variables were compared using Chi-square test. Fisher’s exact test was used when necessary. Differences were considered significant if the two-sided P value was<0.05. All statistical

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analyses were conducted using the SPSS 13.00 (SPSS Inc., Chicago, IL) statistical software. Results

From January 2012 to June 2012, a total of 81 consecutive patients underwent TEVAR for acuteTBAD at our institution. Available demographic and clinical features are detailed in Table I and show that the baseline information for the two patient groups was similar. Of the 81 patients, 37 (45.7%) were diagnosed with an immediate type Ia endoleak. Thirty-six of the

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ACCEPTED MANUSCRIPT 81 patients presented with complications, including persistent chest and/or back pain (19/36, 52.7%), refractory hypertension (4/36, 11.1%), and end-organ ischemia (13/36, 36.1%).

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TEVAR was successfully performed in all patients (mean age, 53 years; 86% men). The left subclavian artery (LSA) was intentionally covered in 52 out of the 81 (61.9%) patients. Among them, 24 patients had immediate type Ia endoleaks. No statistically significant

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differences were seen between the groups (p=0.98). Subclavian revascularization was

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performed in 19 out of the 81(23.4%) patients. Fifteen patients had immediate type Ia endoleaks, significantly more common than in the other group [15 (40%) vs. 4 (9%), p=0.001]. In the patients undergoing LSA coverage, angiogram via a pigtail catheter in LSA

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was performed following aortic stent-graft deployment. Ligation or coil embolization of the origin of LSA was not routinely performed, unless Type II endoleak from LSA was revealed.

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Operative details are summarized in Table II. The average postoperative follow-up was 12 months (range, 10-13months) after the initial procedure.

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Six out of the81 (6.5%) patient died within 30 days .Five of them died, giving a 30-day mortality of 13.5% in the group with immediate type Ia endoleaks. Among them, 2 people presented with aortic rupture post-operative day 2 and 3 days after discharge, respectively. The emergency echocardiogram showed a large amount of pleural effusion in the right hemithorax of the first patient. Two other people died of complications related to retrograde dissection before discharge. They presented with the same signs of pericardial tamponade

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ACCEPTED MANUSCRIPT confirmed by an echocardiogram. The last patient died of multiple organ dysfunction syndrome (MODS) in our intensive care unit (ICU). This patient presented with extensive

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acute mesenteric ischemia after the onset of dissection. He underwent emergency TEVAR and the angiography was unable to identify the superior mesenteric artery (SMA). The stent-graft was successfully deployed. However, the patient’s symptoms of mesenteric

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ischemia did not subside. Emergency exploratory laparotomy was performed, which revealed

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SMA thromboembolism, extensive bowel necrosis, and gangrenous cholecystitis. His post-operative courses, were complicated with refractory infections and acute renal failure, and the family eventually withdrew care. In the group without immediate type Ia endoleaks, 1

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patient died from rupture within 30 days following TEVAR. No statistically significant differences for the 30-day mortality were found between the 2 groups (13.5% vs. 2.2%,

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P=0.08). During the 1-year follow-up, 1 additional patient died in each group in 2 and 3 months, respectively. In comparison of the 1-year all-cause mortality, no significant

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differences were found between the 2 groups (16.2% vs. 4.5%, P=0.13). The in-hospital complications are summarized in Table III. Pre- and postoperative CTA images were available for analysis in 54 patients. The morphological changes of the proximal, middle, and distal areas of the TL, FL, and whole lumen during the follow-up period are presented in Table IV. Based on pre-operative CTA , the patients with an immediate type Ia endoleak had a significantly larger distal false lumen

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ACCEPTED MANUSCRIPT area (498±274 vs. 284±213mm², P=0.02) and a larger distal aortic area (759±275 vs. 624±185mm², P=0.03). Postoperatively, the distal area of the true lumen in the patients with

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type Ia endoleaks was significantly smaller, The false lumen area and whole lumen area, including the proximal, middle, and distal zone of the descending aorta, were significantly larger in the patients with type Ia endoleaks. Area index data assessed the relative area of the

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true and false lumen with respect to the whole aorta area (Table V). After eliminating

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interference by individual differences, the patients with immediate type Ia endoleaks had significantly smaller TLi and FLi at different levels of the aorta, which are consistent with the findings of the absolute area analysis. The postoperative maximal area of the whole lumen

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was statistically significant in patients with an immediate type Ia endoleak (Table VI). At the 1-year follow-up, 44 out of 81 (54.3%) patients developed false lumen thrombosis

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throughout the entire length of the stent graft. Among them, 19 patients had immediate type Ia endoleaks. No significant differences were found between the two groups [19(51.3%)vs.

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25(56.8%), P=0.69]. Ten patients had endoleak formation. Two of the 10 patients had type Ia endoleak and required a secondary endovascular intervention. In these cases, delayed type Ia endoleak was detected by postoperative CTA at the follow-up. The both patients came from the group of no immediate type Ia endoleak and did not present any symptoms and were treated with TEVAR, with stentgrafts deployed at the relative proximal zone of the aorta. No immediate endoleaks were found by intraoperative angiography. Three out of the 10 patients

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ACCEPTED MANUSCRIPT developed type II endoleaks that came from celiac trunk and intercostal arteries. The remaining 5 patients were categorized as type Ib endoleaks, and retrograde flow was clearly

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demonstrated from the distal landing zone of the stentgraft. The rates of postoperative endoleaks were not significant different between the two groups (Table VI).

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Discussion

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We attempted to investigate the outcomes and morphological changes after TEVAR in acute TBAD patients with or without immediate type Ia endoleaks, and to estimate the role of immediate type Ia endoleaks in postoperative remodeling of type B aortic dissection. Patients

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with acute type B aortic dissection with refractory pain, uncontrolled hypertension despite optimal medical therapy, malperfusion, rupture or impending rupture, and acute aortic

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enlargement often require urgent repair with mortality of 20% on POD(post-operation day) 2 and 25% at 1 month.14 In recent series, TEVAR has emerged as a safe and efficacious

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alternative for treating TBAD with lower morbidity and mortality than open surgery. 2-4, 6-9, 15 Nevertheless, owing to the etiology and pathology of aortic dissection, which are different from those of aortic aneurysms, the definition of technical success in the management of endoleaks is controversial. Based on the current body of knowledge, the absence of angiographically-detected type I or III endoleaks is regarded as a basic determinant of technical success in the management of

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ACCEPTED MANUSCRIPT aortic aneurysms. Therefore, in such circumstances, aggressive treatment with additional stent grafts or cuffs implanted to eliminate the leakage is recommended for type I and III

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endoleaks.16-21 However, according to Standardized Definitions and Clinical Endpoints in Trials Investigating Endovascular Repair of Aortic Dissections, excluding an endoleak during treatment of aortic dissection is unnecessary when assessing the success of the procedure.14

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As we mentioned above, the pathology of dissection is characterized by the rapid

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development of an intimal flap separating the true and the false lumen that communicate by “entrance” and “exit”. Therefore, an immediate type Ia endoleak would not result in the systemic pressurization of the cul-de-sac, and might not place the patient at the risk of rupture.

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Once patients present with malperfusion, restoring the arterial flow to the ischemic beds is the primary clinical objective. Therefore, the presence of an endoleak may not adversely

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impact technical success and short-term outcomes, which is distinctly different from treating patients with aneurysms.22 In addition, the conditions of acute separated aorta are unstable

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and vulnerable. Overpursuing the perfect of morphology by eliminate a brush of endoleak regardless the risk of dissection progress and rupture was unacceptable. We also reasoned that the apposition of self-expanded stentgrafts to the aortic wall was temporarily incomplete for a short time after the procedure (Figure 4). Therefore, the contrast material could flow into the false lumen through the microinterval between the stentgraft and the aorta. After the entry site is sealed with the hemodynamic changes, the space would be filled with thrombotic material.

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ACCEPTED MANUSCRIPT As a consequence, an intraoperatively visualized immediate type Ia endoleak would disappear spontaneously without additional procedures. Our follow-up data at the 1-year

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showed that the incidence of endoleaks was not significantly different between the two groups with and without immediate type Ia endoleaks [4 (10.8%) vs. 6 (13.6%), P=0.75]. We compared the 6 patients with immediate type Ia endoleaks who died in the peri- or

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postoperative period with the patients without endoleaks. Although the differences in the

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30-day and 1-year mortality rates were not significantly different between the 2 groups, the immediate appearance of an endoleak seems to be an indication of worse aortic condition. 16

The angulation and tortuosity of aortic arch and the frequently short proximal landing zones

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could result in the type Ia endoleak.

Analysis of our morphological data revealed that the distinction between the preoperative

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false and whole lumen areas between the 2 groups was not statistically significant. However, significantly larger false lumen and whole lumen areas were observed postoperatively in

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patients with immediate type Ia endoleaks. The index of the false lumen, was also consistent with the results of the absolute areas. These morphological changes indicated that aortic remodeling in patients with immediate type Ia endoleaks was unfavorable compared to patients without endoleaks. Nevertheless, because of remodeling process in patients with type Ia endoleaks, our current data with one year follow up could not determine “failure” versus “delay” remodeling. As mentioned above, the false lumen thrombosis throughout the entire

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ACCEPTED MANUSCRIPT length of the stentgraft was found not to be significantly different between the two groups. Previous study suggested the false lumen thrombosis was protective against aneurismal

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degeneration, dissection-related rupture, and death.23 Therefore, we would assume that persistent flow through unsealed endoleaks could delay thrombosis in the false lumen. Yearly CTA for long-term follow-up was arranged in these patients to observe the remodeling

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process.

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This study has several limitations. Being a single-institution and nonrandomized study, it has inherent deficiencies. The data collection and analysis were performed retrospectively, and incomplete imagine data limited the follow-up period. In most cases, follow-up could not

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be completed because of the economic and transportation issues in our country. Many of our patients underwent postoperative CTA at local medical facilities that only provide us

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diagnostic reports but not images. This resulted in the lack of imaging analysis during the follow-up period. However, a more detailed database has been build-up for the further studies.

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Besides, we have noticed the trend that the 30-day mortality between 2 groups almost reached statistical significance. However, with the sample size increased, the results would approach the reality at last. Although we used area measurements to assess the morphological changes of the aorta, which is more accurate than diametric measurements, volumetric data would be more detailed and comprehensive than area measurements and should be employed in the future.

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Conclusion. Immediate type Ia endoleaks are not a rare phenomenon following TEVAR in patients with TBAD. Most of these endoleak could seal spontaneously, without the need for

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additional procedures. However, the appearance of such complications could be an indication of worse aortic remodeling, Long term follow-up and careful surveillance of immediate type

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References:

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Ia endoleaks should be carried out.

1. Lee WA, Daniels MJ, Beaver TM, et al. Late outcomes of a single-center experience of 400 consecutive thoracic endovascular aortic repairs. Circulation 2011; 123(25):2938-45.

2. Umana JP, Miller DC, Mitchell RS. What is the best treatment for patients with acute type B aortic dissections--medical, surgical, or endovascular stent-grafting? Ann Thorac Surg 2002; 74(5):S1840-3; discussion S1857-63.

3. Andacheh ID, Donayre C, Othman F, et al. Patient outcomes and thoracic aortic volume and morphologic

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changes following thoracic endovascular aortic repair in patients with complicated chronic type B aortic dissection. J Vasc Surg 2012; 56(3):644-50; discussion 650. 4. Nienaber CA, Rousseau H, Eggebrecht H, et al. Randomized comparison of strategies for type B aortic

120(25):2519-28.

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dissection: the INvestigation of STEnt Grafts in Aortic Dissection (INSTEAD) trial. Circulation 2009;

5. Nienaber CA, Kische S, Rousseau H, et al. Endovascular repair of type B aortic dissection: long-term

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results of the randomized investigation of stent grafts in aortic dissection trial. Circ Cardiovasc Interv 2013; 6(4):407-16.

6. Eggebrecht H, Nienaber CA, Neuhauser M, et al. Endovascular stent-graft placement in aortic dissection: a meta-analysis. Eur Heart J 2006; 27(4):489-98. 7. Kusagawa H, Shimono T, Ishida M, et al. Changes in false lumen after transluminal stent-graft placement in aortic dissections: six years' experience. Circulation 2005; 111(22):2951-7. 8. Rodriguez JA, Olsen DM, Lucas L, et al. Aortic remodeling after endografting of thoracoabdominal aortic dissection. J Vasc Surg 2008; 47(6):1188-94. 9. Lopera J, Patino JH, Urbina C, et al. Endovascular treatment of complicated type-B aortic dissection with stent-grafts:: midterm results. J Vasc Interv Radiol 2003; 14(2 Pt 1):195-203. 10. Rajani RR, Arthurs ZM, Srivastava SD, et al. Repairing immediate proximal endoleaks during abdominal aortic aneurysm repair. J Vasc Surg 2011; 53(5):1174-7.

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11. Luo JF, Liu Y, Huang WH, et al. [Endovascular repair for patients with DeBakey III aortic dissection]. Zhonghua Xin Xue Guan Bing Za Zhi 2008; 36(2):132-6. 12. Huang WH, He PC, Luo JF, et al. [A randomized controlled trial of rapid artificial cardiac pacing in thoracic endovascular aortic repair]. Zhonghua Yi Xue Za Zhi 2011; 91(24):1668-72. 13. Fillinger MF, Greenberg RK, McKinsey JF, Chaikof EL. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vasc Surg 2010; 52(4):1022-33, 1033.e15.

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14. Diehm N, Vermassen F, van Sambeek MR. Standardized definitions and clinical endpoints in trials investigating endovascular repair of aortic dissections. Eur J Vasc Endovasc Surg 2013; 46(6):645-50.

15. Gysi J, Schaffner T, Mohacsi P, et al. Early and late outcome of operated and non-operated acute dissection of the descending aorta. Eur J Cardiothorac Surg 1997; 11(6):1163-9; discussion 1169-70.

thoracic aortic aneurysms. J Vasc Surg 2010; 52(4 Suppl):91S-9S.

of

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16. Ricotta JN. Endoleak management and postoperative surveillance following endovascular repair

17. Preventza O, Wheatley GR, Ramaiah VG, et al. Management of endoleaks associated with endovascular

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treatment of descending thoracic aortic diseases. J Vasc Surg 2008; 48(1):69-73.

18. Alsac JM, Khantalin I, Julia P, et al. The significance of endoleaks in thoracic endovascular aneurysm repair. Ann Vasc Surg 2011; 25(3):345-51.

19. Raithel D, Wu Z, Qu L. Regarding "Repairing immediate proximal endoleaks during abdominal aortic aneurysm repair". J Vasc Surg 2011; 54(6):1871-2; author reply 1872.

20. Dias NV, Resch T, Malina M, et al. Intraoperative proximal endoleaks during AAA stent-graft repair: evaluation of risk factors and treatment with Palmaz stents. J Endovasc Ther 2001; 8(3):268-73.

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21. Shah AA, Barfield ME, Andersen ND, et al. Results of thoracic endovascular aortic repair 6 years after United States Food and Drug Administration approval. Ann Thorac Surg 2012; 94(5):1394-9. 22. Sze DY, van den Bosch MA, Dake MD, et al. Factors portending endoleak formation after thoracic aortic stent-graft repair of complicated aortic dissection. Circ Cardiovasc Interv 2009; 2(2):105-12.

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23. Conrad MF, Crawford RS, Kwolek CJ, et al. Aortic remodeling after endovascular repair of acute

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complicated type B aortic dissection. J Vasc Surg 2009; 50(3):510-7.

ACCEPTED MANUSCRIPT Table I. Demographics of patients with type B aortic dissection Without type Ia EL n (%)

P value

Age

51±9

55±10Y

NS

Male

34( (91%) )

36( (82%) )

NS

20(54%)

Hypertension

27(79%)

Diabetes mellitus

2(5.4%)

Connective tissue disorders (Marfan) Preoperative creatinine (µ µmol/L)

0 173±153.2

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P< <0.05; EL, endoleak.

4(12.8%)

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Coronary artery disease

22(50%)

NS

33(75%)

NS

2(4.5%)

NS

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Smoking

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With type Ia EL n (%)

5(11.3%)

NS

1(2.2%)

NS

128.6±140

NS

ACCEPTED MANUSCRIPT Table II. Operative details With type Ia EL n (%)

Without type Ia EL n (%)

P value

Medtronic Talent

25(67.5%)

23(52.2%)

0.16

COOK TX2

3(8.1%)

6(13.6%)

0.49

Microport Hercules

9(24.3%)

15(34.1%)

0.3

Left subclavian artery covered

24(65%)

28( (64%) )

0.98

Subclavian revascularization

15(40%)

4(9%)

0.001

2(4.5%)

0.85

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Device

Spinal drain

2(5.4%)

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P<0.05; EL, endoleak.

ACCEPTED MANUSCRIPT Table III. Patient outcomes and complications Without type Ia EL n (%)

P value

30-day all-cause mortality

5(13.5%)

1(2.2%)

0.08

Rupture

2(5.4%)

1( (2.2%) )

0.59

Retrograde dissection

2(5.4%)

MODS

1( (2.7%) )

1-year all-cause mortality

6(16.2%)

Pneumonia

1( (2.7%) )

Pseudoaneurysm Rhabdomyolysis

0

0.2

0

0.45

2(4.5%)

0.13

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In-hospital complications

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With type Ia EL n (%)

0.45

1( (2.7%) )

0

0.45

0

1( (2.2%) )

1

0

1( (2.2%) )

1

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0

Acute renal failure

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P< <0.05; MODS, Multiple Organ Dysfunction Syndrome; EL, endoleak.

ACCEPTED MANUSCRIPT Table IV. Comparison of areas in patients with and without type Ia endoleaks TL(mm²)

Postoperative

P/3

With type

Without

Ia

type Ia

endoleak

endoleak

563±248

545±139

P

0.75

Whole lumen (mm²)

With type

Without

Ia

type Ia

endoleak

endoleak

707±406

522±321

With type

Without

Ia

type Ia

endoleak

endoleak

0.06

1269±494

1071±323

0.07

1216±545

P

P

0.09

M/3

355±247

379±136

0.65

861±527

642±258

1027±233

0.12

D/3

275±165

335±131

0.14

498±274

284±213

0.002

759±275

624±185

0.03

P/3

843±237

733±150

0.06

342±613

75±256

0.04

1186±724

809±297

0.02

M/3

740±231

672±151

0.22

421±643

126±243

0.04

1161±715

798±317

0.02

D/3

332±148

407±130

0.05

487±387

208±274

0.005

822±369

630±260

0.03

AC C

EP

TE D

M AN U

SC

P< <0.05; TL, true lumen; FL, false lumen.

RI PT

Preoperative

FL(mm²)

ACCEPTED MANUSCRIPT Table V. Comparison of indices in patients with and without type Ia endoleaks TLi Without type Ia endoleak

0.47±0.20 0.54±0.201 0.19 P/3 0.31±0.16 0.38±0.15 0.11 M/3 0.38±0.21 0.58±0.28 0.004 D/3 0.83±0.24 0.95±0.15 0.03 Postoperative P/3 0.76±0.29 0.90±0.18 0.02 M/3 0.49±0.32 0.75±0.31 0.005 D/3 P< <0.05; TLi, true lumen index; FLi, false lumen index.

Without type Ia endoleak

P

0.53±0.20

0.45±0.20

0.15

0.68±0.16

0.61±0.14

0.08

0.63±0.18

0.40±0.27

0.001

0.16±0.24

0.04±0.15

0.04

0.23±0.29

0.09±0.18

0.01

0.50±0.32

0.24±0.31

0.004

AC C

EP

TE D

M AN U

SC

Preoperative

P

With type Ia endoleak

RI PT

With type Ia endoleak

FLi

ACCEPTED MANUSCRIPT Table VI. Comparison of MAX area in patients with and without type Ia endoleaks MAX TL (mm²)

MAX FL (mm²)

MAX Whole lumen (mm²)

Without

type Ia

P

With type

Without

type Ia

Ia

endoleak

endoleak

Preoperative

605±428

599±185

Postoperative

904±226

799±155

With type

Without

type Ia

Ia

type Ia

endoleak

endoleak

endoleak

endoleak

0.94

1140±715

819±596

0.07

1619±795

1370±540

0.19

0.05

603±924

263±416

0.1

1531±1072

990±413

0.027

AC C

EP

TE D

M AN U

SC

P<0.05; TL, true lumen; FL, false lumen.

P

RI PT

With

P

ACCEPTED MANUSCRIPT Table VII. Complications in patients with and without type Ia endoleaks Without type Ia EL n (%)

P value

Reintervention rate

0

2 (4.5%)

0.49

False lumen thrombosis

19( (51.3%) )

25( ) (56.8%)

0.69

Endoleak

4( (10.8%) )

6( ) (13.6%)

AC C

EP

TE D

M AN U

SC

P<0.05; EL, endoleak.

RI PT

With type Ia EL n (%)

0.75

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

Outcomes and morphologic changes of immediate type Ia endoleak following endovascular repair of acute type B aortic dissection.

The clinical significance of immediate type Ia endoleaks after thoracic endovascular aortic repair (TEVAR) for aneurysms has been described in detail...
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