The efficacy and safety of castor single-branch stent graft implantation in the treatment of type B acute aortic dissection: a retrospective analysis

Introduction

Acute aortic syndrome encompasses a group of critical cardiovascular diseases involving the aortic intima and media, including aortic dissection, intramural hematoma, and penetrating atherosclerotic ulcer, with chest pain as the main symptom (1-3). Among these, those without involvement of the ascending aorta are classified as Stanford B type, with a clinical incidence of 0.5 to 2.95 per 100,000, typically presenting with significant hypertension and severe chest or back pain (4,5). The occurrence and progression of acute type B aortic dissection are closely related to the intimal and medial lesions of the aorta and the intraluminal hemodynamic characteristics (hypertension, high cardiac output) (6-8). The acute phase mortality rate is approximately 25–30%, highlighting the critical importance of timely and effective treatments to alleviate symptoms and slow disease progression, ultimately improving patient prognosis (9).

Traditional management involves medical therapy and thoracic endovascular aortic repair (TEVAR), which aims to seal the primary entry tear and promote false lumen thrombosis (10,11). In recent years, with continuous advancements in medical technology, endovascular aortic repair has been rapidly developed and is increasingly accepted as a treatment option for patients with acute type B aortic dissection. Castor single-branch covered-stent implantation is a novel treatment technique within endovascular aortic repair, previous studies have reported the short-term safety and efficacy of the Castor single-stent (12,13), but there is a need for more comprehensive evaluations of its impact on patient outcomes, particularly in comparison to conventional TEVAR.

The aim of this study is to analyze the efficacy and safety of Castor single-branch covered-stent implantation in the treatment of acute type B aortic dissection. Specifically, we sought to compare the early postoperative recovery, incidence of early postoperative complications, long-term prognosis, and long-term effectiveness of the Castor single-branch covered-stent implantation vs. traditional TEVAR. This analysis aims to provide guidance for clinical decision-making, with the potential to enhance patient outcomes, improve prognosis, and reduce complications and mortality through the development of rational treatment strategies. We present this article in accordance with the STROBE reporting checklist (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2024-2102/rc).

Methods

Study population

A retrospective analysis was conducted on the clinical data of patients with acute type B aortic dissection who were treated at our hospital between January 2020 and November 2021. Patients were divided into a control group (35 patients undergoing TEVAR) and a Castor single-branch covered-stent implantation surgery group (38 patients) based on the different treatment methods. Inclusion criteria were as follows: (I) diagnosed with acute type B aortic dissection based on clinical symptoms, aortic computed tomography (CT) angiography, and echocardiography; (II) aged between 32 and 77 years; (III) treated at our hospital; and (IV) complete clinical data. Exclusion criteria were: (I) type A aortic dissection; (II) altered consciousness or mental disorder; (III) patients who were moribund on admission, precluding imaging examinations, or had malignant tumors or other chronic debilitating diseases with a life expectancy of less than 1 year; and (IV) lack of contact information or inability to reach family members or patients themselves. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the ethics committee of Shenzhen Baoan People’s Hospital (No. BYL20250156) and individual consent for this retrospective analysis was waived.

Treatment methods

Upon admission, all patients underwent strict blood pressure and heart rate control, with the initial administration of beta-blockers such as esmolol and calcium channel blockers like diltiazem and nicardipine, and additional antihypertensive medications as necessary. Absolute bed rest, morphine for pain relief, bowel movement facilitation, and oxygen therapy were provided symptomatically to rapidly lower blood pressure to below 120/80 mmHg (1,596/1,064 kPa) and maintain heart rate below 70 beats per minute. Close monitoring of peripheral blood circulation, bowel sounds, level of consciousness, lower limb activity, and urine output was performed to assess the presence of new-onset significant organ malperfusion.

The control group underwent TEVAR. Using CT scans, the dissection flap, cerebral perfusion, anchoring zone conditions, and the true and false lumens were assessed to determine the location of the dissection entry site and select the appropriate covered stent model and specifications. After strict disinfection, the patient was placed in a supine position under general anesthesia with endotracheal intubation. The stent was then advanced to the target position, and angiography was repeated to check the stent’s position and confirm the absence of endoleak. The arterial puncture site and incision were then sutured, and the patient’s incision and limb circulation were closely monitored postoperatively.

The experimental group underwent treatment with the implantation of Castor single-branch stent graft implantation. Prior to surgery, chest and abdominal aortic CT angiography with three-dimensional reconstruction was conducted, and the nature, location, extent of aortic lesions, involvement of branch vessels, and the diameter of the aortic arch were analyzed and diagnosed by at least two experienced clinical physicians. Standard anesthesia, tracheal intubation, and monitoring of right radial artery blood pressure were performed. A 6-F sheath was inserted into the left brachial artery, and 5-F sheaths were inserted into both femoral arteries. A 5-F pigtail catheter was guided by a guidewire from the true lumen to perform aortography from the right femoral artery to measure the diameter of the proximal anchoring zone of the descending aorta, diameter of the opening of the left subclavian artery, distance from the posterior edge of the left carotid artery to the anterior edge of the left subclavian artery, and to identify the specific location of the intimal tear. Another 5-F catheter A was guided by a guidewire from the left brachial artery through the true lumen to the right femoral artery, and then pulled out from the right femoral artery. A guidewire was advanced from the right femoral artery, through the true lumen to the ascending aorta, to establish the route. The branch wire at the front end of the Castor single-branch covered-stent was guided by catheter A from the right femoral artery to the left brachial artery. The main body of the Castor single-branch covered-stent was guided by the guidewire from the right femoral artery into the descending thoracic aorta. Catheter A and the branch wire were pulled out simultaneously as the main body of the stent entered the descending aorta. At the position of the descending aorta, the stent was adjusted based on the markers on the stent to avoid entanglement with the branch wire of the left subclavian artery. After confirming the correct position, the stent sheath and sheath membrane were removed, and the branch of the main stent was pulled into the left subclavian artery via catheter A and the branch wire. A 5-F sheath was again inserted into the left femoral artery for aortography of the ascending aorta to reassess the position of the main body and the branch. Once confirmed, the main body was released through the release wire and the branch was released through the branch wire; a further angiography through the pigtail catheter was performed to confirm the successful closure of the proximal tear and patency of the left subclavian artery. After confirmation, the surgery was completed. Postoperatively, oral aspirin 100 mg and clopidogrel hydrogen sulphate tablet 75 mg were administered daily for antiplatelet therapy.

Observational parameters

Baseline data: collection of baseline data for all patients, including gender, age, height, weight, preoperative personal history and comorbidities, smoking history, alcohol consumption history, and preoperative medication usage. Early postoperative recovery indicators: collection of intensive care unit (ICU) stay, postoperative hospital stays, and total hospital stay for all patients. Incidence of early postoperative complications and mortality: collection of in-hospital mortality, 30-day mortality, new-onset stroke, paraplegia or multiple organ dysfunction syndrome, and branch occlusion occurrences for all patients. Long-term prognosis: integration of 2-year postoperative follow-up results for patients, including statistical analysis of secondary intervention and stent positioning, formation of new intimal tears at the stent edge, and branch occlusion occurrences. Long-term efficacy: calculation of the proportion of patients whose condition improved and did not deteriorate based on 2-year postoperative follow-up results. Maximum descending aortic diameter: collection of the maximum diameter of the descending aortic dissection from aortic CT angiography before and after surgery for all patients.

Statistical analysis

Statistical analysis was performed using SPSS version 25.0 software (SPSS Inc., Chicago, IL, USA). Categorical variables were presented as [n (%)] and analyzed using Fisher’s exact probability test. Continuous variables were tested for normal distribution using the Shapiro-Wilk method. Normally distributed continuous variables were expressed as mean ± standard deviation (SD) and analyzed using the t-test with adjusted variance. A two-sided P value less than 0.05 was considered statistically significant.

Results

Baseline characteristics of all patients

A total of 73 patients with acute type B aortic dissection underwent surgical treatment, with 35 patients receiving TEVAR and 38 patients undergoing treatment with single-branch covered-stent implantation surgery. Comparison of baseline data between the two groups showed no significant differences in demographics, comorbidities, and preoperative medication use (P>0.05) (Table 1), indicating comparability between the two groups.

Postoperative early recovery indicators

The early postoperative recovery indicators for the two groups are shown in Table 2, and the analysis revealed significant differences between the two groups. The Castor single-branch covered-stent implantation surgery group had significantly shorter ICU stay (44.02±6.62 vs. 47.26±6.14 hours, t=2.164, P=0.03), postoperative hospital stays (12.53±2.14 vs. 13.87±2.23 days, t=2.623, P=0.01), and total hospital stay (20.47±3.38 vs. 22.59±3.28 days, t=2.709, P=0.008) compared to the control group. This indicates that Castor single-stent implantation can significantly reduce the recovery time for patients.

Postoperative early complication incidence and mortality rate

Comparing the incidence of early postoperative complications and mortality between the two groups, the results showed no significant differences in the incidence of various complications (P>0.05), but the total complication rate was significantly higher in the control group compared to the Castor single-branch covered-stent implantation surgery group (31.43% vs. 10.53%, χ²=4.876, P=0.03) (Table 3). Additionally, there were no significant differences in in-hospital mortality and 30-day mortality between the two groups (P=0.94). This indicates that the Castor single-stent implantation group had a lower overall incidence of early postoperative complications.

Long-term prognosis

The long-term prognosis of the two groups of patients is shown in Table 4. The results showed that the number of patients requiring secondary intervention (25.71% vs. 2.63%, χ²=6.375, P=0.01) and the formation of new intimal tears at the stent edges (25.71% vs. 5.26%, χ²=5.594, P=0.02) were significantly higher in the control group, and the proportion of stents in position was significantly lower (80.00% vs. 100.00%, χ²=6.257, P=0.01). These findings indicate that the overall long-term prognosis of patients with acute type B aortic dissection who underwent Castor single-branch covered-stent implantation treatment is promising.

Long-term effectiveness

There were significant differences in long-term efficacy between the two groups (Table 5; χ²=3.993, P=0.046). Specifically, the number of patients whose condition improved was significantly higher in the Castor single-branch covered-stent implantation surgery group compared to the control group (97.37% vs. 80.00%), and the number of patients whose condition further deteriorated was significantly lower (2.63% vs. 20.00%). These results suggest that the overall long-term effectiveness of Castor single-branch covered-stent implantation treatment for patients with acute type B aortic dissection is promising.

Comparison of descending aortic diameter before and after surgery

Both groups of patients showed significant changes in the descending aortic diameter before and after surgery (Table 6). Specifically, there were no significant differences in the descending aortic diameter between the two groups before surgery (P=0.69), but both groups showed a significant increase postoperatively (P<0.001), with a greater increase in the Castor single-branch covered-stent implantation surgery group. There were significant differences in the descending aortic diameter postoperatively between the two groups (25.37±3.26 vs. 20.47±3.12 mm, t=6.546, P<0.001). This indicates that Castor single-branch covered-stent implantation surgery has a significant effect on the elongation of the descending aorta in acute type B aortic dissection.

Comparison of preoperative complication rates

The patients of control and Castor groups have no significant differences in preoperative complication rates (Table 7). Specifically, there were no significant differences in the total complication rates about renal insufficiency, hepatic insufficiency, and hypertension between the two groups before surgery (P=0.95), which indicates the two groups are randomly divided, and the effectiveness of Castor single-branch covered-stent implantation method is reliable.

Discussion

With the advancement of endovascular vascular surgery, covered stent graft treatment for aortic dissection has exhibited higher success rates and fewer severe acute complications, gradually replacing open surgical procedures to become the preferred treatment option for acute type B aortic dissection (14-16). This study retrospectively analyzed the clinical data of patients with acute type B aortic dissection treated with either TEVAR or the Castor single-branch covered-stent implantation. Our findings provide valuable insights into the comparative effectiveness and safety of these two approaches.

Ogami et al.’s (17) study found that the overall incidence of complications and mortality rate post-covered stent implantation surgery for acute type B aortic dissection patients were relatively low, with an average hospital stay of 18.56±2.98 days. Similarly, we observed significantly shorter ICU stay, postoperative hospital stays, and total hospital stay in the Castor single-branch covered-stent implantation group compared to the control group. The overall complication rate was significantly lower in the Castor single-branch covered-stent implantation group. These findings suggest that the Castor single-branch covered-stent may facilitate fast recovery and reduced healthcare resource utilization, which could be attributed to the streamlined surgical procedure and the integrated design of the stent graft. The Castor single-branch covered-stent may offer a safer alternative, particularly in terms of reducing the risk of complications during the early postoperative period. The design of the Castor branched aortic covered stent and delivery system has undergone careful optimization of structure and shape, leading to minimal trauma, easier implantation and positioning, and improved stability during use, effectively reducing the occurrence of unnecessary complications such as paraplegia and cerebrovascular diseases (18,19). In our case series, one case experienced early postoperative multiple organ dysfunction syndrome, while three cases had branch occlusion. This may be due to the deposition of clotting factors in the blood on the stent surface after Castor single-branch covered stent implantation. These clots may sometimes detach and travel with the blood flow to other organs, leading to multiple organ dysfunction syndrome (20). Additionally, during Castor single-branch covered stent implantation, the stent may occlude the branches of the coronary artery, causing obstructed blood supply and resulting in branch occlusion (18). Therefore, it is essential for clinicians to conduct a detailed assessment of patients before surgery, to ensure the selection of suitable stent types and surgical plans and to take preventive measures against these complications.

Research by Samanidis et al. (21) found that the long-term prognosis of patients with acute type B aortic dissection treated with Castor single-branch covered-stent implantation surgery is generally favorable, with only isolated cases experiencing stent displacement, formation of new intimal tears at the stent edge, or requiring secondary surgery, where their condition did not improve or worsened. Our study similarly indicated the long-term prognosis of the Castor single-branch covered-stent implantation group was more favorable, with a significantly lower rate of secondary interventions, formation of new intimal tears at the stent edges, and a higher proportion of stents remaining in position. Our results also showed a significantly higher proportion of patients whose condition improved and a lower proportion of patients whose condition deteriorated in the Castor single-branch covered-stent implantation group. These findings suggest that the long-term effectiveness and prognosis of Castor single-branch covered-stent implantation surgery are generally favorable. In some cases, patients may experience allergic reactions to the stent material or adverse tissue responses, leading to vascular wall inflammation, fibrosis, and other changes, resulting in new intimal tear formation at the stent edge and necessitating secondary intervention, without improvement in their condition (22,23).

Research by Xu et al. (24) and others found that the descending aortic diameter increases after stent placement in patients with acute type B aortic dissection compared to before the surgery. Our study indicated that both groups showed a significant increase in the descending aortic diameter postoperatively, with a greater increase observed in the Castor single-branch covered-stent implantation group. This finding may reflect the beneficial effects of the Castor single-branch covered-stent on the remodeling of the aortic wall and the potential for improved long-term outcomes. Studies have indicated potential mechanisms for postoperative aortic elongation in acute type B aortic dissection (25,26), suggesting that when such self-expanding stents are placed in highly curved arteries (such as the aortic arch), the inner prosthetic behavior resembles that of a spring, with a tendency to recoil. This rebound force can lead to increased stress on the aortic arch wall, ultimately resulting in aortic arch elongation and, in some cases, vascular injury related to the implant (27). Branched stents can disperse this rebound force, preventing proximal stent migration towards the distal (28). Additionally, the design of the Castor stent eliminates the presence of a stent spine (a type of longitudinal connecting rod), while reducing the damage from elasticity to the aortic wall. However, the extension of the aortic arch or the longitudinal elasticity of the stent, leading to a larger angle in the descending part of the arch, may improve the hemodynamics of the descending arch, such as reducing wall shear stress and velocity, which are considered to be one of the risk factors for arterial aneurysmal degeneration in acute type B aortic dissection (29,30). Therefore, aortic arch stent reconstruction may also be a protective or beneficial factor in improving hemodynamics.

There are some limitations in this study. First, it is a retrospective analysis, which may introduce selection bias. Second, the sample size is relatively small, limiting the generalizability of our findings. Third, the study was conducted at a single center, which may affect the external validity of the results. Future prospective, multicenter trials with larger sample sizes are needed to confirm these findings and to further evaluate the long-term outcomes associated with the Castor single-branch covered-stent implantation.

Conclusions

The Castor single-branch covered-stent implantation appears to offer advantages over traditional TEVAR in terms of early postoperative recovery, lower complication rates, and improved long-term prognosis and effectiveness. These findings support the use of the Castor single-branch covered-stent as a promising treatment option for patients with acute type B aortic dissection. Further research is warranted to validate these results and to explore the optimal indications for this novel device.

Acknowledgments

The authors are grateful to all participants in the present study.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2024-2102/rc

Data Sharing Statement: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2024-2102/dss

Peer Review File: Available at https://jtd.amegroups.com/article/view/10.21037/jtd-2024-2102/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://jtd.amegroups.com/article/view/10.21037/jtd-2024-2102/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the ethics committee of Shenzhen Baoan People’s Hospital (No. BYL20250156) and individual consent for this retrospective analysis was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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