|Year : 2022 | Volume
| Issue : 4 | Page : 100-109
The choice of bridging stents in fenestrated endovascular aortic repair
Fang Niu1, Jiaxue Bi1, Peng Li1, Guangze Luo1, Hongrui Pan1, Yonghui Chen1, Chao Qu2, Zongwei Liu1, Xiaoxing Zhang1, Xiangchen Dai1
1 Department of General Surgery, Tianjin Medical University General Hospital; Department of Tianjin General Surgery Institute, Tianjin Medical University General Hospital, Heping, Tianjin, China
2 Department of General Surgery, Changzhou Cancer Hospital, Xinbei, Changzhou, Jiangsu, China
|Date of Submission||04-Nov-2022|
|Date of Decision||02-Feb-2023|
|Date of Acceptance||06-Feb-2023|
|Date of Web Publication||15-May-2023|
prof. Xiangchen Dai
Department of General Surgery, Tianjin Medical University General Hospital, 154 Anshan Road; Department of Tianjin General Surgery Institute, Tianjin Medical University General Hospital, 154 Anshan Road, Heping, Tianjin 300052
Source of Support: None, Conflict of Interest: None
PURPOSE: To study the medium and long-term patency and endoleak rate of visceral arteries in fenestrated endovascular aortic repair (fEVAR), and explore the strategies for bridging stent selection.
METHODS: The clinical data of 44 patients with thoracoabdominal aneurysms, infrarenal short-necked aortic aneurysms and aortic dissection involving the visceral artery treated using fEVAR were reviewed. The indications for stents for different visceral vessels were evaluated.
RESULTS: A total of 104 target vessels were revascularized with 7 scallops and 97 fenestrations. Among them, 12 were without stents and 92 were bridged with 96 stent-grafts, including 28 uncovered stents and 68 covered stents. The success rate of the one-time placement of bridging stents was 95.7% (88/92). The overall Type-I endoleak rate was 2.9% (3/104), and the overall visceral stent patency rate was 97.1%. The receiver operating characteristic curve revealed that the critical distances between the celiac trunk artery, superior mesenteric artery (SMA), renal artery, and aneurysm were 10.25 mm, 4.3 mm, and 10.05 mm, respectively, for selecting covered stents or uncovered stents and 12.4 mm for SMAs with or without stents.
CONCLUSION: The branch-to-aneurysm distance may be important for bridging stents choice in fEVAR.
Keywords: Covered stents, fenestrated endovascular aortic repair, uncovered stents, visceral stents
|How to cite this article:|
Niu F, Bi J, Li P, Luo G, Pan H, Chen Y, Qu C, Liu Z, Zhang X, Dai X. The choice of bridging stents in fenestrated endovascular aortic repair. Vasc Invest Ther 2022;5:100-9
|How to cite this URL:|
Niu F, Bi J, Li P, Luo G, Pan H, Chen Y, Qu C, Liu Z, Zhang X, Dai X. The choice of bridging stents in fenestrated endovascular aortic repair. Vasc Invest Ther [serial online] 2022 [cited 2023 Jun 4];5:100-9. Available from: https://www.vitonline.org/text.asp?2022/5/4/100/376924
| Introduction|| |
Fenestrated endovascular aortic repair (fEVAR) was first used in 1996, and after the accumulation of long-term experience, the Society for Vascular Surgery published a report on the endovascular aortic repair of aneurysms involving the renal-mesenteric arteries in 2020. This report standardized and popularized the application of this surgery, which benefited patients who were previously limited to open surgery for the treatment of abdominal aortic aneurysms (AAAs) involving visceral artery branches.
However, 9.4% of patients showed adverse renal events after fEVAR in recent years, such as renal artery (RA) stenosis and occlusion. The resulting renal insufficiency is a powerful factor in postoperative death. Bridging stents of different materials also show large differences in the rate of postoperative stenosis. Numerous observational studies systematically reported that covered stents were superior to un-covered stents in long-term patency rate, but little is known about the selection strategy and the key factors that affect this selection, including factors related to the circumference, area, and branch diameter of the aorta at the branches and branch-to-aneurysm distance.
Using a retrospective analysis of the clinical data of patients treated with external fenestration at our center, the present report discusses the short- and medium-term patency rates and visceral outcomes of bridging stents in the visceral artery during fEVAR, analyzes the factors affecting patency, and shares some branch stent selection strategies.
| Methods|| |
All patients treated with fenestrated stent grafts at our diagnosis and treatment center were enrolled in an investigational device protocol database. The clinical data of patients with thoracoabdominal aneurysms, infrarenal short-necked aortic aneurysms, and aortic dissection involving the visceral artery treated using fEVAR at the Department of Vascular Surgery of Tianjin Medical University General Hospital between July 2012 and August 2020 were analyzed retrospectively. The research ethics boards of our hospital approved the study protocol and required neither patient approval nor informed consent for the review of patients' images and medical records. The present study was performed in accordance with the Declaration of Helsinki. The general clinical data of the patients were collected as shown in [Table 1]. According to the difference in stent selection for visceral vessels, the patients were divided into a covered stent group and an uncovered stent group to evaluate the patency of target vessels and bridging stents.
Preoperative assessment and devices
All patients underwent spiral computerized tomography angiography (CTA) from the thoracic entrance to the beginning of the bilateral superficial femoral artery to evaluate the shape of the aneurysm and were diagnosed with thoracic-abdominal aortic lesions involving visceral arteries. Based on dedicated three-dimensional vascular software (3 mensio Vascular™, Maastricht, The Netherlands) using centerline luminal reconstructions, the position, distance, diameter, patency and abdominal aorta diameter, aneurysm size, neck length and angle of the visceral branches were determined, and the appropriate grafts and fenestration schemes were selected. Posterior diameter-reducing ties were added to the grafts to allow partial deployment before the catheterization of side branches and the final orientation of the stent graft to allow rotational and craniocaudal repositioning of the device for the catheterization of target vessels. Fenestrations included scallops and small and large fenestrations. Fenestrations had radiopaque markers for accurate location during the implantation process.
The methods of external fenestration of the Zenith TX2 thoracic aorta covered stent, Zenith TFFB abdominal main bifurcation covered stent, C3 stent, and extended stent were described in previously published studies from our center. The following two main surgical methods were used: Superselection of the visceral artery using the proximal cardiac approach and superselection of the visceral artery using the distal cardiac approach. The former method is suitable for more than triple fenestrations, while the latter method is suitable for less than triple external fenestrations of abdominal aortic bifurcation-covered stents. After each target vessel stent was implanted, selective angiography was performed using a flaring balloon catheter to show patency and outflow. Complete angiography was performed after surgery to confirm the patency of the entire vessel and aneurysm exclusion. The process data were recorded, including the operation time, radiation time, blood loss, and intraoperative complications.
Patients generally received double antiplatelet therapy after surgery, including lifelong aspirin and clopidogrel, for 2 months. The follow-up methods included outpatient care, hospitalization, and telephone follow-up. The main time points of follow-up were 3, 6, and 12 months after surgery, including survival condition, CTA (chest and abdominal computed tomography [CT] scan and ultrasonography in patients with renal insufficiency), and evaluation of adverse events. The patency, stent fracture, endoleak, migration of the main covered stent and visceral branch stent, and changes in the aneurysm sac, were evaluated. Serum creatinine was measured to monitor renal function during the surgery. When a severe endoleak or branch vascular perfusion was suspected, angiography was performed for further evaluation.
Definitions and statistics
The results were defined and analyzed according to the reporting standards of EVAR and RA stenting.,,,,, The term “fenestration” included small fenestrations (which are circular, have a comparable size to the target vessels, and lack crossing struts), large fenestrations (which are rectangular with crossing stent struts), and scallops (an opening in the top of the fabric, used for the top target vessel, generally the superior mesenteric artery [SMA]). Target vessels were defined as vessels that needed a scallop or fenestration. When the residual stenosis was <30%, and the stent was located in the target vessel, stenting of a target vessel was considered technically successful. fEVAR technical success was defined as a complete endovascular surgery with patent target vessels and no conversion or Type-I or Type-III endoleak. During the follow-up of target vessels and stents, the diameter of angiography was reduced by more than 50% (comparing the diameter of the proximal end of the stenosis and the stenosis) and was considered to have hemodynamic significance and was called “stenosis” or even occlusion.
SPSS (SPSS Inc., Chicago, IL, USA) for Windows version 26 was used for statistical analyses. The differences between groups were compared using analysis of variance, and P < 0.05 was considered statistically significant. Variables are expressed as the means ± standard deviation (SD) in cases of normal distribution and the median plus range when the data had a skewed distribution. The patency of visceral arteries and bridging stents was estimated using Kaplan–Meier survival analysis based on a per-artery approach. Based on the univariate analysis per patient (the mean ± SD of the measurement data was compared using t-tests, and count data were compared using the Chi-squared test), multivariate logistic regression analysis was used. The odds ratio (OR) and 95% confidence interval values were calculated to assess risk factors that affected the selection of visceral stents. The receiver operating characteristic curve was analyzed to explore the optimal distance between the visceral arteries and aneurysm cutoff value for affecting stent selection. The indications of stents for different visceral vessels, the patency rate of bridging stents and target vessels, endoleaks, technical success, and mortality were evaluated.
| Results|| |
Forty-four patients (33 male and 11 female patients) with a mean age of 68 ± 9.7 years underwent fEVAR. Preoperative complications and risk factors are listed in [Table 1]. Primary procedures were performed in 37 patients (84.1%), and 7 fEVAR procedures (22.5%) were performed after previous open surgical AAA repair (n = 1) and EVAR (n = 6). One case was converted to a chimney stent graft because the main graft could not be stented during the surgery. The median CT angiography follow-up time was 21 months.
Main body of the stent graft
A total of 104 fenestrations were observed in 44 patients, including 7 scallops, one fenestration in 14 cases, double fenestrations in 7 cases, triple fenestrations in 12 cases, and fourfold fenestrations in 10 cases. Thirteen fenestrations of the celiac trunk, 28 fenestrations of the SMA, 58 fenestrations of the renal arteries (RA), and 5 fenestrations of accessory RA (ARA) [Table 2] occurred. Common combinations included small fenestrations for the celiac trunk, SMA, and RAs (n = 10), one fenestrated RA (n = 9), large fenestrations for SMA, and small fenestrations for RAs (n = 8) [Table 2].
Outcome of fenestrated endovascular aortic repair
The technical success of fEVAR was 90.9% (40/44). Ten patients (22.7%) had intraoperative complications. Three cases of Type-I endoleak occurred during the surgery (2.9%; 3/104), and no significant difference was observed between the uncovered stent (4%; 1/25) and covered stent (1.5%; 1/67) (P = 0.463). The aneurysm sac was blocked with fibrin tissue adhesive in 1 case. The endoleak obviously disappeared during surgery, and no recurrence was observed during follow-up [Figure 1]a, [Figure 1]b, [Figure 1]c. A small amount of endoleak was observed at the stent connection in 1 patient with stent migration, and Type III endoleak and RA occlusion occurred at the 17-month follow-up. Although the RA was recanalized after successful embolization of the leak with coils [Figure 1]d, [Figure 1]e, [Figure 1]f, renal function did not improve. No spinal cord ischemia or intraoperative death occurred. The remaining complications and intraoperative management are shown in [Table 3].
|Figure 1: A proximal Type-I endoleak after AAA stent release. (a) A Type-I endoleak at the arrow, (b) After injection of fibrin tissue adhesive, the contrast medium remained (red arrow), which indicates the absence of blood flow in the aneurysm cavity, (c) The proximal endoleak disappeared after re-angiography. A type III endoleak occurred in the migration of the stent, (d) A Type-III endoleak at the arrow, (e) A balloon was used to expand the connection between the visceral stent and the main stent to seal the leak (red arrow), (f) The endoleak disappeared after re-angiography|
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No deaths occurred 30 days after the surgery. During follow-up, 5 patients (11.4%) died, but none of these patients died of aneurysm-related death. There was 1 case of respiratory and heart failure caused by intestinal obstruction and septic shock 5 months after surgery. The patient took anticoagulant platelet drugs after surgery and chose conservative treatment when abdominal CT suggested intestinal obstruction. Sulperazon was actively used to prevent the occurrence of septic shock, but the baseline level of the patient was poor. After the occurrence of septic shock, the family re-fused rescue, and the patient was declared clinically dead. Before surgery, the left nephrectomy was performed with permanent renal failure, and 1 patient died of renal failure 6 months after surgery. One patient died of sudden myocardial infarction 1 year after surgery. Tumor-related deaths occurred in 2 patients. The cumulative survival probabilities of patients at 1 and 3 years after surgery were 92.2% and 81.3%, respectively [Figure 2]d. The overall median postoperative hospital stay was 8 days (5–99 days), and the total median hospitalization stay was 16 days (2–62 days).
|Figure 2: The Kaplan–Meier survival curve showing the overall patency rate of (a) all target vessels and the patency rate of stents used in target vessels and freedom from the combined outcome of occlusion and stenosis in uncovered and covered stents in (b) all stents and (c) renal vessel stents. The Kaplan–Meier estimate of the cumulative overall patient survival for all-cause mortality during follow-up. (d) The Kaplan–Meier estimate of the cumulative overall patient survival for all-cause mortality during follow-up|
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Of the 104 target vessels in 44 patients, 7 vessels were scallops and 97 were fenestrations, including 10 large fenestrations and 87 small fenestrations. Among the 104 target vessels, 92 vessels were bridged with 96 stent-grafts, including 28 uncovered stents, 68 covered stents, and no stents in the remaining target vessels. The success rates were 95.7% (88/92) for the one-time placement of bridging stents and 94.1% (63/67) for covered stents. Three target vessels were narrowed because of an insufficient sup-porting force of the covered stent during surgery, and 1 uncovered stent was added for each vessel. One additional covered stent was placed due to the migration of 1 stent. The uncovered stents were placed successfully at one time, and no significant difference was found between the groups (P = 0.176).
The total target vessel patency rate (no occlusion or stenosis) was 97.4%, and the overall visceral stent patency rate was 97.1% [Figure 2]a. The visceral stent patency rate was significantly lower in uncovered stents (90.4%) than in covered stents (100%) [P = 0.03; [Figure 2]b]. The renal vessel (RA and ARA) stent patency rate was 95.7% (82.5% for uncovered stents and 100% for covered stents), and a significant difference was found between groups [P = 0.011, [Figure 2]c]. No stenosis, occlusion, or reintervention of the bridging stents occurred in the celiac trunk artery (CA) or SMA during the follow-up.
One case of arterial occlusion occurred due to RA stent migration 17 months after surgery. Although the reintervention was completed successfully [Figure 1]d, [Figure 1]e, [Figure 1]f, renal function did not recover because the patient had previous renal insufficiency for 4 years. Three months after surgery, 1 case of ARA stent occlusion occurred. The patient chose medical treatment, and creatinine was maintained at the normal level.
To further clarify the selection strategy for bridging stents in different visceral arteries, we found that the circumference, area, and branch diameter of the aorta at the branches had little effect on the selection of stents for CA and RA [P > 0.05, [Figure 3]], but these factors significantly affected the selection of stents for the SMA [Table 4] and [Figure 3]. We performed multivariate logistic regression analysis on the distance between the SMA and aneurysm (P < 0.001), diameter of the SMA (P = 0.035), aortic circumference (P = 0.021), and area (P = 0.038) at the SMA. The above indicators had no significant effect on the selection of bridging stents for the SMA (P > 0.05). The branch-to-aneurysm distance significantly affected the selection of stents for the CA (P = 0.008), SMA (P < 0.001), and RA (P < 0.001). The ROC curve also confirmed this result [Figure 4]. Using the Youden index, the critical distances between the CA, SMA, RA, and aneurysm were 10.25 mm, 4.3 mm, and 10.05 mm, respectively, for the selection of covered stents or uncovered stents and 12.4 mm for SMAs with or without stents.
|Figure 3: The (a) circumference and (b) area of the aorta at the target vessels, (c) branch-to-aneurysm distance and its (d) diameter under different stent selection strategies|
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|Figure 4: The circumference, area of the aorta, branch diameter and branch-to-aneurysm distance at the (a) CA, (b) RA and (c) SMA for the selection strategy of covered stents or uncovered stents and the selection strategy for the use of stents or no stents for (d) the SMA. CA: Celiac trunk artery, RA: Renal artery, SMA: Superior mesenteric artery|
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Fifty-eight RAs and 5 ARAs were targeted. One scallop (no stent implantation) and 62 fenestrations (62 stents were implanted, including 48 covered stents and 14 uncovered stents) occurred. Preoperative renal insufficiency occurred in 9 cases (20.45%). In addition to the 1 case of renal function damage due to RA stent migration, 5 patients had varying degrees of renal function impairment (13.64%). One patient had hemodialysis-dependent renal function loss 2 years after surgery, and 3 patients had permanent renal insufficiency before surgery. One patient died of renal failure 6 months after surgery, and 1 patient died of intestinal obstruction, septic shock, and renal failure 5 months after surgery. However, postoperative renal insufficiency was significantly related to mortality (P = 0.013).
Forty-one mesenteric vessels (13 CAs and 28 SMAs) in 29 patients were targeted. Six scallops (3 uncovered stents and 3 nonstent implants) and 35 fenestrations [20 covered stents, 9 uncovered stents, and 6 nonstent implants; [Table 3]] occurred. During surgery, the covered stent bridging the CA narrowed because of insufficient support in 2 cases (6.90%) and developed smoothly after the end-to-side extension of the uncovered stent. During follow-up, no stenosis, occlusion, or reintervention occurred in the bridged stents in the CA or SMA in any patient. One patient (3.45%) died of septic shock after a sudden onset of acute intestinal obstruction of unknown origin, which resulted in Clostridium labile infection and renal failure.
| Discussion|| |
Although global experience with fenestrated stent graft technology is entering its 3rd decade, knowledge of the long-term durability of this technique relative to successful aneurysm exclusion and target vessel patency is lacking.
During the postoperative follow-up, 2 occlusions (2.08%) in 96 stents occurred, accompanied by target vessel occlusion and target organ dysfunction, including 1 case of endoleak and reintervention. Because stenosis and occlusion of visceral stents are closely related to the loss of renal function, and postoperative renal insufficiency is significantly related to all-cause mortality (P < 0.013), findings consistent with the conclusion of Haddad et al., when the stent structure changes, percutaneous transluminal angioplasty or new stent implantation is recommended.
Although no stenosis, occlusion, or reintervention of bridging stents occurred in the CA and SMA in our study, no symptoms of gastrointestinal discomfort or loss to follow-up were observed in some patients. Native SMA or SMA in-stent stenosis/occlusion may be clinically silent or lead to catastrophic intestinal necrosis. The critical value of the SMA that is needed to provide clinical evidence of mesenteric ischemia is likely patient-dependent and may be affected by the status of mesenteric collateral circulation and the magnitude and acuity of visceral malperfusion.
Endovascular surgery is recommended as a first-line treatment for AAA. However, few studies focused on the visceral artery at the fenestration of the main body stent, and few studies closely examined the type of stent in this specific location and compared it by groups. The present study found that the short-and medium-term patency rates of visceral artery bridging covered stents were significantly better than the uncovered stents (P = 0.03), and the same trend was obtained in renal vessels (the RA and ARA) (P = 0.011).
The superiority of covered stents over uncovered stents was demonstrated in aortic-iliac occlusive lesions and innominate arteries.,, The covered versus balloon expandable stent trial randomized controlled trial found that the rates of restenosis and reintervention of the common iliac artery (CIA) with covered stents were significantly lower than uncovered stents, after 18 months of follow-up. The covered stent also had better patency after a 5-year follow-up in the same population, likely because of the high radial strength of the PTFE layer by connecting the stent struts, which highlights its durability and target vessel stability without affecting flexibility. The inherent protective mechanism of the covered stent is also applicable to RA, particularly when the CIA, innominate artery, and RA have commonalities. These stents are short, relatively fixed, support important blood pathways, and are affected by severe atheromatous lesions. These similarities may explain why similar results are beneficial for covered stents. The material affected the long-term patency of the stent, and the covered stent was significantly better than the uncovered stent, but no significant difference was found in the success rate of intraoperative release between the two stents (P = 0.176). This finding highlights the importance of the materials used.
Bridging stents are mostly necessary for fEVAR with retained branches, but no bridging stents may be considered when the fenestration is large, the sealing zone is sufficient, the branch artery is unsuitable for stenting, and the opening of the branch artery is not at the same clock as the rupture of the dissection or aneurysm. Twelve target vessels had no stenting in the present study, and no visceral artery stenosis or endoleak occurred. The bridging stent does not have to be a covered stent, and an un-covered stent prevents the migration of the main body stent, corrects the inaccuracy of alignment, and dilates the stenosis of the branch artery. The bridging stent is used only when the sealing zone is sufficient, or the opening of the branch artery is not in the same clock as the rupture of dissection or aneurysm. The combination of a lower postoperative complication rate and a higher patency rate in this study confirmed that CA, SMA, and RA to aneurysm distances within 10.25 mm, 4.3 mm, and 10.05 mm, respectively, were recommended for use with covered stents, and uncovered stents may be used for greater distances. The SMA may be used without stents at distances >12.4 mm from the aneurysm. The uncovered stent may be placed at the distal and proximal ends of the bridge-covered stent to improve the poor angiography outcome of the target vessels caused by insufficient support. The present study used this method in 3 patients, all of whom exhibited satisfactory improvement and were followed up after surgery. Self-expanding and balloon-expandable covered stents have their own advantages and disadvantages as bridging stents. The first type of stent has more advantages in branch support technology, such as sandwich/octopus techniques and hybrid techniques, and the second type of stent was more suitable for fenestration and chimney techniques.
The minimum catheter sheath delivery system of the existing balloon-expandable covered stent in China is 7F. Therefore, the over-selection process will be limited by the diameter of the fenestration and target vessels or the fenestration angle, which increases the operation time and difficulty. A few patients chose uncovered stents because of the small fenestration aperture. Postoperative stenosis or endoleak of the stent that would have been avoided with covered stents occurred, which seriously affected the quality of life of the patients. Therefore, we look forward to the introduction of 6F or even smaller diameter catheter delivery systems in China, at which point the bridging stent will not be used as much because of fenestration conditions. Therefore, the patency rate of bridging stents and visceral vessels, and the rate of avoidance of reintervention and endoleak, will be greatly increased. However, current research results showed no significant difference in the incidence of endoleaks between uncovered stents and covered stents (P = 0.463). Although the patency rate of covered stents was slightly superior, an appropriate sealing zone occurred between the target vessels and aneurysms, and uncovered stents still showed significance, likely because of their advantages of small diameter, easy transportation, small space occupation, and low price.
There are some limitations in the current study. First, this was a small-sample, retrospective, single-center study. It is necessary to conduct prospective research in a large multicenter study to verify the practicality of the branch-to-aneurysm cutoff value for affecting stent selection. Furthermore, due to the limited number of patients, we did not distinguish between the self-expanding and the balloon-expandable covered stents, which could be studied in a larger cohort in the future. Finally, all fEVAR procedure was performed by only 2 operators with extensive experience.
| Conclusion|| |
The current single-center retrospective study found that materially affected the short-and medium-term patency of fEVAR visceral artery stents, and the patency rate of covered stents was higher than uncovered stents. However, when an appropriate sealing zone between the target vessels and the aneurysms was present, an uncovered stent, or no stent, may be used to replace the covered stent. The branch-to-aneurysm distance may be important for bridging stents choice in fEVAR. This observation requires further analysis, including a prospective series of studies examining baseline indications and hydrodynamic characteristics.
Institutional Review Board statement
This retrospective study involving human participants was performed in accordance with the ethical standards of the institutional and national research committee and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The local Ethics Committee of Tianjin Medical University General Hospital approved this study (IRB2019-WZ-061).
Informed consent statement
The research ethics boards of our hospital approved the study protocol and required neither patient approval nor informed consent for the review of patients' images and medical records.
Financial support and sponsorship
This work was supported by grants to Xiangchen Dai from the National Natural Science Foundation of China (no. 82070489).
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4]