Endoleak Rate Research Articles

Clinical Application of n-Butyl-2- Cyanoacrylate (NBCA) in the Transarterial Embolization for Type I/II Endoleak During and After EVAR Surgery

Exploring the effectiveness and safety of n-butyl-2-cyanoacrylate (NBCA) in the transarterial embolization for common endoleak during and after endovascular repair of aortic aneurysm (EVAR). A total of 226 patients with abdominal aortic aneurysm (AAA) were treated with EVAR in 4 years August 2019 to February 2023, including 46 patients with ruptured aneurysms (rAAA). Account 37 cases developed endoleak during EVAR surgery and follow-up period, 28 non-ruptured AAA patients and 9 rAAA patients, then treated with NBCA for transarterial embolization. Follow up for at least six months to observe its clinical efficacy and adverse reactions. Among 37 cases of endoleak, there were eight cases of primary type Ia endoleak and one cases of primary right type Ib endoleak in the rAAA group, one case of primary type Ib endoleak, two cases of secondary type Ia endoleak and 25 cases of Postoperative type II endoleak in the non-ruptured AAA group. Three patients with primary type Ia endoleak were treated with coil assisted NBCA in the rAAA group, while the remaining 34 patients with type I and type II endoleaks were treated with NBCA alone. All transarterial embolization achieved technical success and the endoleak disappeared. Postoperative hospitalization observation showed that three cases patients in the rAAA group who experienced primary type Ia endoleak during emergency EVAR surgery died within 4 days after surgery due to hemorrhagic shock and multiple organ failure. Two patients experienced non-AAA related deaths during the follow-up period. Transartrial embolization with NBCA for the treatment of primary and secondary endoleak is a safe and effective method. It can achieve more dense embolization of the aneurysm sac and more complex endoleaks embolization. And it showed a low recurrence rate of endoleak and the incidence of perioperative complications after surgery, which is worthy of clinical promotion and application. Even in emergency EVAR combined with primary type I endoleak treatment in rAAA patients, patients can still benefit.

Stent-Induced Inflammation: A Comparative Cross-Sectional Study of Post-Implantation Syndrome in Venous and Arterial Procedures

Background: Postimplantation syndrome (PIS) is a known inflammatory response following endovascular stent placement, yet comparative data between venous and arterial stenting remains limited. This study seeks to evaluate the incidence, characteristics, and clinical implications of PIS across these two distinct vascular territories. Methods: We retrospectively analyzed 191 patients who underwent either venous (n = 36) or arterial (n = 155) stent placement. Data collection encompassed demographic profiles, perioperative laboratory findings, and clinical outcomes. The primary endpoint was the incidence of PIS, defined as the presence of fever (≥38 °C), leukocytosis, and elevated C-reactive protein (CRP) within 30 days postprocedure. Secondary outcomes included length of hospital and ICU stay, incidence of endoleaks, reintervention rates, and 30-day mortality. Comparative statistical analyses were conducted to assess differences between the venous and arterial stent groups. Results: PIS was observed more frequently in arterial stent patients, as evidenced by significantly elevated postoperative white blood cell counts at 24 and 48 h (p = 0.046 and p = 0.014, respectively), along with borderline CRP increases (p = 0.052). Fever occurrence peaked at 72 and 96 h postprocedure, predominantly in the arterial cohort. Furthermore, patients with arterial stents had significantly longer hospital stays (5.59 ± 0.46 days vs. 3.42 ± 0.36 days; p = 0.0018) and a higher rate of 30-day endoleaks (7.1% vs. 0%; p = 0.005). Despite similar mortality and major adverse cardiac event (MACE) rates between groups, arterial stent patients exhibited a greater need for reintervention. While PIS was less common among venous stent recipients, its potential impact on postoperative recovery warrants careful monitoring. Conclusions: Arterial stenting is associated with a higher incidence of PIS and a more pronounced systemic inflammatory response, contributing to longer hospitalization and increased postoperative complications. Although venous stent patients experience PIS less frequently, its occurrence should not be overlooked, as it may influence overall recovery and clinical outcomes. Recognition and management of PIS in both venous and arterial stent patients are critical to improving patient care and optimizing procedural success.

Comparison of branched, fenestrated, and parallel strategies for endovascular treatment of thoracoabdominal aortic pathologies involving visceral regions.

To compare the long-term efficacy of the parallel stent graft (PSG), fenestrated stent graft (FSG), and branched stent graft (BSG) techniques to treat thoracoabdominal aortic pathologies. In total, 291 patients with thoracic aortic aneurysm (TAA) and dissection (TAD) involving visceral arteries who underwent PSG (n = 85; 15 TAA and 70 TAD), FSG (n = 107; 47 TAD and 60 TAA), or BSG (n = 99; 37 TAD and 62 TAA) were included from multiple centers from January 2015 to December 2022, and a total of 1,108 visceral aortic branches were reconstructed. The average reconstruction time of each visceral aortic branch for FSG, BSG, and PSG is 27.5 ± 12.1, 23.2 ± 11.9, and 18.8 ± 11.8 min, respectively (P < 0.01). The free-from-endoleak rate at the last follow-up for FSG, BSG, and PSG was 86.9%, 91.9%, and 60.0%, respectively. The last follow-up patency rate for FSG, BSG, and PSG was 85.0%, 91.9%, and 94.1%, respectively. The average reconstruction price of each visceral aortic branch for FSG, BSG, and PSG was 41.40 ± 3.22 thousand RMB, 41.84 ± 3.86 thousand RMB, and 42.35 ± 4.52 thousand RMB, respectively (P = 0.24). To treat the aortic pathologies involving the visceral segment, BSG had a lower endoleak rate and higher branch patency rate when compared with the FSG and PSG techniques. The expense of BSG was comparable to the other two techniques.

Early and Mid-Term Results of Endovascular Aneurysm Repair with the Cordis Incraft Ultra-Low Profile Endograft: A High-Volume Center Experience.

Background/Objectives: In recent years, manufacturers have developed new low-profile stent grafts to allow endovascular treatment of abdominal aortic aneurysms (AAA) in patients with small access vessels. We evaluated the early and mid-term outcomes of the Incraft (Cordis Corp, Bridgewater, NJ, USA) ultra-low profile endograft implantation in a high-volume single center. Methods: Between 2014 and 2023, 133 consecutive endovascular aneurysm repair (EVAR) procedures performed using the Incraft endograft were recorded in a prospective database. Indications included infrarenal aortic aneurysms, common iliac aneurysms, and infrarenal penetrating aortic ulcers. Mid-term results were analyzed using the Kaplan-Meier method. Results: During the study period, 133 patients were treated with the Cordis Incraft endograft, in both elective and urgent settings. The Incraft graft was the first choice for patients with hostile iliac accesses, a feature characterizing at least one side in 90.2% of the patients in the study cohort. The immediate technical success rate was 78.2%. The intraoperative endoleak rate was 51.9% (20.3% type 1 A, 0.8% type 1 B, and 30.8% type 2 endoleak). Within 30 days, technical and clinical success rates were both 99.3%; all type 1A and 1B endoleaks were resolved at the 30-day follow-up CT-angiogram. After a mean follow-up of 35.4 months, the actuarial freedom from the re-intervention rate was 96.0%, 91.1%, and 84.0% at 1, 3, and 5 years, respectively. The iliac leg patency rate was 97.1%, 94.1%, and 93.1% at 1, 3, and 5 years, respectively. No statistically significant differences were observed between hostile and non-hostile access groups, nor between the groups with grade 1, grade 2, and grade 3 access hostility. Conclusions: The ultra-low profile Cordis Incraft endograft represents a valid option for the endovascular treatment of AAA in patients with hostile iliac accesses. The procedure can be performed with high rates of technical and clinical success at 30 days and the rates of iliac branch occlusion observed during the follow-up period appear acceptable in patients with poor aorto-iliac outflow.

In situ fenestration (ISF) versus single-branched stent graft (SBSG) implantation in the management of acute Stanford type B aortic dissection involving the left subclavian artery.

With the advances in medical technology and materials, thoracic endovascular aortic repair has become the mainstay of treatment for aortic dissection. In situ fenestration (ISF) and single-branch stent graft (SBSG) implantation are commonly used methods, with each having its own advantages and disadvantages. The study aimed to compare the perioperative outcomes and one-year follow-up results of patients who underwent ISF or SBSG in the treatment of acute Stanford type B aortic dissection involving the left subclavian artery (LSA). From January 2018 to December 2022, consecutive patients with Stanford type B aortic dissection were retrospectively recruited and divided into ISF group and SBSG group according to the type of surgery. The patient's aortic physiology was evaluated by computed tomography angiography at 1, 3, 6, and 12 months after discharge. This study included 67 patients in the SBSG group and 21 patients in the ISF group. The baseline and preoperative indices were similar between the groups. The success rate of perioperative treatment was 100%, and no adverse consequences occurred in either group. No spinal cord ischemia, stroke, or paraplegia occurred in either group during the one-year follow-up. The rate of endoleak in the SBSG group was significantly lower (3%, all type I endoleaks) than that in the ISF group (9.5% type I and 14.3% type II endoleaks) (P=0.005). Type II endoleak mainly occurred in the LSA. In addition, complete thrombosis of the false lumen was achieved in 95.5% of the SBSG group versus 81.0% of the ISF group, but this was not a significant difference (P=0.091). The maximum diameter of the true lumen increased significantly in the ISF (P<0.001) and SBSG (P<0.001) groups. Meanwhile, the maximum diameter of the false lumen was significantly reduced in the ISF (P<0.001) and SBSG (P<0.001) groups, but the difference in the maximum diameter change of the true or false lumen between the two groups was not statistically significant (P>0.05). SBSG was associated with a significantly lower incidence of endoleak than was ISF. However, there were no differences observed in complete thrombosis of the false lumen. Further studies with larger sample sizes are needed to definitively establish which treatment is superior in terms of complete thrombosis of the false lumen.

Impact of class of obesity on clinical outcomes following fenestrated-branched endovascular aneurysm repair

BackgroundObesity represents a prevalent and escalating health concern among vascular surgery patients. Evidence pertaining to the influence of body mass index (BMI) on clinical outcomes after fenestrated-branched endovascular aneurysm repair (B/FEVAR) remains unclear. This study aims to assess the effect of obesity on short- and midterm clinical outcomes among individuals undergoing B/FEVAR. MethodsThis was a single-center retrospective analysis of all patients who underwent B/FEVAR from 2007 to 2020, with a median follow-up of 3.3 years (interquartile range, 1.6-5.3 years). Obesity was defined as a BMI of ≥30 kg/m2. Patients were divided into nonobese (NO) and obese cohorts according to their BMI. Outcomes were compared between the two groups subsequently. ResultsA total of 264 patients, 96 obese and 168 NO, were included. Patients with obesity were younger (72.8 ± 6.9 years vs 76.0 ± 7.3 years; P < .001), but had a higher prevalence of diabetes mellitus (27.1% vs 12.0%; P = .01) and dyslipidemia (80.2% vs 68.5%; P = .03). Both cohorts had similar rates of percutaneous access (37.5% for obese vs 35.1%; P = .7), and no significant differences in the rate of conversion to open access (8.3% for obese vs 4.2% for NO; P = .16). Technical success was similar between the cohorts (89% for obese vs 86%; P = .59). Major adverse events (MAEs) were higher in the NO group (13.1% vs 4.2%; P = .02). Patients in the obese cohort suffered more access site related infections (7.3% vs 1.2%; P = .01). All-cause mortality over 5 years was significantly higher in the NO group (35.1% vs 21.9%; P = .02). No statistical differences were found in spinal cord injury or dialysis requirement rates. Furthermore, on follow-up at 5 years, endoleak, branch instability, and reintervention rates were not statistically different between the two cohorts. ConclusionsPatients with obesity are on average younger; however, they were more likely to suffer access site infections compared with NO patients. They had increased survival rates on follow-up, although rates of reinterventions and endoleaks were similar between the two cohorts. Our study demonstrates that, despite higher comorbidities, patients with obesity had similar intraoperative success with decreased postoperative mortality; however, access site infections remains a significant clinical concern.

The Enzen Trial: Analysis of EVAR Endoprosthesis Zenith and Endurant for Infrarenal Aortoiliac Aneurysms Regarding Outcomes, Endoleaks, and Reinterventions.

The main objective of this paper is to analyze the outcomes regarding endoleaks, reinterventions, and death related to aneurysm complications in patients submitted to endovascular repair (EVAR) for abdominal aortoiliac aneurysm (AAA) using Endurant II (Medtronic) and Zenith Flex (Cook) endografts. This was a prospective, consecutive cohort study of patients with AAA who underwent EVAR between January 2019 and December 2022. Two groups of patients were evaluated: Group Endurant (patients submitted to EVAR with the use of Endurant II) and Group Zenith (patients submitted to EVAR with the use of Zenith Flex). A total of 156 patients were evaluated. Group Zenith (67 patients, 42.9%) and Group Endurant (89 patients, 57.1%). The perioperative mortality was 5.1%, eight patients (six patients Group Zenith, and two patients Group Endurant, p=0.054). There were 28 patients (17.9%) submitted to urgent repair of the aneurysm (expansion or rupture), with no differences among the groups. There were 36 cases (23.1%) of later endoleak, with a higher incidence in Zenith group (23 patients, 34.3%) than Endurant group (13 patients, 14.6%, p=0.002), most of them Type II endoleak (21 patients, 13.4%). There were 12 cases of Type I endoleak, also with a higher prevalence in Zenith group (13.4%) than Endurant group (3.4%, p=0.002). Moreover, regarding limb graft occlusion (LGO), there were nine patients (5.8%), with a higher prevalence in Zenith group (9%) than Endurant group (3.4%, p=0.045). The overall survival in a Kaplan-Meier at 720 days was 82.3% in the Zenith group and 89.1% in the Endurant group, with no statistical significance among the groups (p=0.09). The freedom from reintervention rates in a Kaplan-Meier at 720 days was 82.8% in the Zenith group and 93.2% in the Endurant group (p=0.001). In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, LGO and reinterventions than patients submitted to Endurant II endografts. The linear regression analysis showed that the presence of endoleaks, type of endograft device (Zenith graft) and limb graft occlusion were related to higher reintervention rates. In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, limb graft occlusions and reinterventions than patients submitted to Endurant II endografts. The main impact and the innovation that this article provides is an opportunity to evaluate and choose the best endograft suitable for the patient with AAA during EVAR.

TREO Aortic Endograft Demonstrates Superior Aneurysmal Sac Regression Over Mid-Term Follow-Up

IntroductionAneurysmal sac regression is a predictor of long-term outcomes after endovascular aneurysm repair (EVAR). This study aimed to compare a large cohort of TREO and non-TREO endografts over a mid-term follow-up and compare abdominal aortic aneurysm sac regression. The hypothesis was that TREO endografts have an increased sac regression by 24 mo. MethodsThis is a retrospective analysis of all EVARs completed at a single institution between 2015 and 2024. Clinical and imaging data were collected from an institutional database and patients’ records. The analysis included all TREO and age, sex, anticoagulation use and current smoking-matched non-TREO endografts that satisfied anatomic indications for use of the TREO graft. The primary outcomes were sac regression at 12 and 24 mo, and secondary outcomes were rates of mortality, endoleak, and reintervention. ResultsTwenty-one TREO grafts were matched to 68 non-TREO grafts. The groups were similar in demographics, comorbidities, and preoperative anatomy. Preoperative abdominal aortic aneurysm sac size was larger in the TREO cohort. The mean reduction in sac size in mm was greater in the TREO cohort compared to the non-TREO cohort (−12.6 ± 8.95 versus −7.83 ± 7.74 mm, P = 0.039) over the study period. Cox regression analysis identified the TREO stent graft to be associated with 1-y sac regression (hazard ratio = 2.42, P = 0.019). The incidence of all-cause endoleaks, reintervention, and mortality were similar between cohorts. ConclusionsThese findings suggest that the TREO endograft offers better mid-term outcomes with respect to sac regression with no differences in the incidence of endoleak, mortality, or reintervention.

Comparative Efficacy and Safety of Self-Expandable vs. Balloon-Expandable Stent Grafts in Visceral Artery Aneurysm Management.

This study assesses the efficacy and safety of self-expandable (SE) versus balloon-expandable (BE) stent grafts for managing visceral artery aneurysms (VAAs), focusing on procedural success and complication rates. We conducted a retrospective analysis of VAA patients treated at our institution from April 2006 to September 2021. The study reviewed patient demographics, aneurysm characteristics, treatment details, and outcomes, including endoleaks. Among the 23 patients analyzed, splenic artery aneurysms represented 44% of cases. Fifteen patients were treated with balloon-expandable stent grafts (BE SGs), and eight patients were treated with self-expandable stent grafts (SE SGs). For saccular aneurysms, the average neck size was 10.10 ± 8.70 mm in the BE group versus 18.50 ± 3.40 mm in the SE group (p = 0.23), with an average sac size of 20.10 ± 18.9 mm in the BE group versus 15.60 ± 12.7 mm in the SE group (p = 0.16). The average sac-to-neck ratio was 1.69 ± 2.23 in the BE group versus 1.38 ± 0.33 in the SE group (p = 0.63). The BE group exhibited a significantly higher endoleak rate (60%) compared to the SE group (12.5%; p = 0.03). While further investigation is needed to fully assess the outcomes of stent graft treatment for VAAs, initial data show a significantly higher endoleak rate with BE SGs compared to SE SGs. The SE SGs may offer better outcomes due to their superior ability to conform to tortuous and mobile visceral arteries.

Outcomes using inverted iliac limb bifurcate components in fenestrated/branched endografting

BackgroundThe use of standard bifurcate pieces in fenestrated/branched endovascular aortic repair (F/BEVAR) requires adequate length from the lowest branch or fenestration to the aortic bifurcation. In patients with prior aortic surgery, the aortic bifurcation is often artificially established in a more proximal position, compromising the infrarenal length, which hinders the placement of a standard bifurcate component below the fenestrated/branched component. Short bifurcate bodies using an inverted contralateral limb have been purpose-built to address this challenge. However, reported outcomes for this device remain limited, with specific concerns about the durability of the inverted iliac limb sealing region. We sought to evaluate outcomes of F/BEVAR using an investigational inverted iliac limb bifurcate, manufactured by Cook Medical. MethodsThis study was a retrospective review of prospectively maintained data from the US-Aortic Research Consortium from 2005 to 2022. Patients were included if they underwent F/BEVAR for thoracoabdominal or complex abdominal aortic aneurysms. Patients were excluded if they did not have a bifurcate device placed. Patients were then compared based on the use of an inverted iliac limb or standard bifurcate component. The primary outcome for this study was technical success. Secondary outcomes included 30-day mortality, freedom from ischemic leg complications, freedom from type I endoleaks (TIELs), freedom from type II endoleaks (TIIELs), freedom from type III endoleaks (TIIIELs), and graft component separations. ResultsA total of 1944 patients met study criteria with 442 (22.8%) inverted iliac limb bifurcates and 1502 (77.2%) standard bifurcates. Patients who received inverted iliac limbs were more likely to have had prior aortic surgery (63.8% vs 28.5%; P < .001). Patients receiving inverted iliac limbs had longer procedure times (265 minutes; interquartile range [IQR], 201-342 minutes vs 241 minutes; IQR, 186-313 minutes; P < .001), more contrast use (89 mL [IQR, 55-135 mL] vs 109 mL [IQR, 75-156 mL]; P < .001), and higher estimated blood loss (250 mL [IQR, 150-500 mL] vs 250 mL [IQR, 110-400 mL]; P = .042). There were no differences in rates of technical success (97.3% vs 96.1%; P = .310), rates of endoleaks upon completion of the case (18.0% vs 21.4%; P = .123), or 30-day mortality rates (1.8% vs 2.5%; P = .466) between patients receiving inverted iliac limb and standard bifurcated components. There were no differences in cumulative survival, freedom from limb ischemia, freedom from aneurysm rupture, and freedom from TIIIELs over the course of 5 years between patients receiving inverted bifurcates and standard bifurcated components. Patients with inverted iliac limb bifurcate components had decreased freedom from reinterventions, TIELs, and TIIELs. After adjustment for potential confounders, the use of an inverted iliac limb was not associated with reinterventions (hazard ratio,1.044; 95% confidence interval, 0.849-1.285; P = .682). There was a total of 2 component separations (0.1%) of the bifurcate component from the fenestrated/branched component over the study period, both of which occurred in the standard bifurcate components. ConclusionsThe use of investigational inverted iliac limb bifurcate components is a safe option with favorable mid-term outcomes in patients who are not anatomical candidates for standard bifurcate components. Patients undergoing investigational inverted iliac limb bifurcate component implantation had decreased freedom from reinterventions, which likely corresponds with the complexity of repair associated with them.

Three-year outcomes of off-the-shelf Gore thoracoabdominal multibranch endoprosthesis and physician-modified endografts for complex abdominal and thoracoabdominal aortic aneurysms

ObjectiveFenestrated-branched endovascular aortic repair (FB-EVAR) has shown favorable outcomes for repair of complex aneurysms and thoracoabdominal aortic aneurysms. Physician-modified endografting (PMEG) and the Gore thoracoabdominal multibranch endoprosthesis (TAMBE) provide custom and off-the-shelf devices for FB-EVAR, respectively. This study compares the outcomes of TAMBE and PMEG at a single institution. MethodsA retrospective review of patients who underwent TAMBE as part of the multicenter pivotal trial or PMEG as part of a prospective physician-sponsored investigational device exemption at a single institution between 2020 and 2022 were completed. Patient demographics, characteristics, and perioperative and midterm outcomes were compared. ResultsA total of 68 patients were included, with 12 in the TAMBE group and 56 in the PMEG group. Baseline characteristics were comparable between groups. Aneurysm type was most often thoracoabdominal aortic aneurysm in both groups (58% TAMBE and 52% PMEG). TAMBE had a higher rate of upper extremity access (100% vs 63%; P = .013) and longer mean procedure time (247 ± 36 minutes vs 189 ± 49 minutes; P < .001). Other intraoperative metrics were similar between groups. Technical success was 100% in TAMBE and 95% in PMEG (P = .412). There was no 30-day mortality in either group. No major adverse events occurred with TAMBE, whereas in PMEG cases, 2% had respiratory failure, 2% required dialysis, and 4% experienced spinal cord ischemia. Although the overall endoleak rates were similar (50% of TAMBE vs 41% of PMEG; P = .57), type II endoleaks accounted for all of the endoleaks in the TAMBE group, whereas type I or III endoleaks were seen in 11% of PMEG patients. At a median follow-up of 26.7 months for the TAMBE group and 21.2 months for the PMEG group, target vessel instability was seen in 10.4% of TAMBE, and 6.9% of PMEG targeted branches (P = .401). Reintervention was required in 33% of TAMBE patients and 27% of PMEG patients (P = .646). Estimated freedom from reintervention rates at 3 years were similar (56% TAMBE vs 62% PMEG, log-rank P = .910). Freedom from visceral renal target vessel instability at 3 years was 89% for both groups (log-rank P = .459). The Kaplan-Meier 3-year estimated survival was 100% for patients in the TAMBE group and 77% for patients in the PMEG group (log-rank P = .157). ConclusionsAt experienced centers, FB-EVAR can be completed with PMEG or TAMBE with comparable, excellent perioperative and midterm outcomes. Reinterventions are frequently needed for both TAMBE and PMEG.

Outcomes of endovascular intervention for infrarenal abdominal aortic aneurysm with hostile necks

Overview: Currently, endovascular intervention of the abdominal aortic aneurysm is considered the standard treatment method. Aneurysm neck’s morphology can affect 60% of the success or failure of endovascular intervention. Many advanced techniques to treat hostile necks have gradually become popular. However, endovascular intervention of the abdominal aortic aneurysms with hostile aneurysm necks are still considered a challenge. Objectives: Describe the characteristics of patients with infrarenal abdominal aortic aneurysms with hostile necks. Evaluate the perioperative and mid-term outcomes of endovascular intervention to treat infrarenal abdominal aortic aneurysms with hostile necks. Methods: The patients were diagnosed with infrarenal abdominal aortic aneurysms at the Vascular Surgery Department of Cho Ray Hospital, and were treated by endovascular intervention, from January 2020 to August 2023, and met the including criteria. Results: The technical success rate was 95.12%. The early death rate was 2.44%. There were no aneurysm-related deaths. Early endoleak rate was low at 4.88%. Late type I endoleak was 7.5%. The mid-term mortality rate was 9.76%. The mid-term mortality rate recorded in the aneurysm necks length ≤ 15mm group was significantly higher than the other group. Late type I endoleak had no significant difference, when comparing the short neck groups and the angulated neck groups. Conclusion: Endovascular intervention to treat infrarenal abdominal aortic aneurysms with hostile necks is a safe and effective method.

Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft

ObjectiveThis study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. MethodsAll consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. ResultsDuring the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The proximal landing zone was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to III ELs and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) from nonaortic causes. ConclusionsOur early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

Long-term outcomes of TEVAR for thoracic aortic diseases: a retrospective single-center study

BackgroundThe outcomes of Thoracic Endovascular Aortic Repair (TEVAR) vary depending on thoracic aortic pathologies, comorbidities. This study presents our comprehensive endovascular experience, focusing on exploring the outcome in long term follow-up.MethodsFrom 2006 to 2018, we conducted TEVAR on 97 patients presenting with various aortic pathologies. This retrospective cohort study was designed primarily to assess graft durability and secondarily to evaluate mortality causes, complications, reinterventions, and the impact of comorbidities on survival using Kaplan-Meier and Cox regression analyses.ResultsThe most common indication was thoracic aortic aneurysm (n = 52). Ten patients had aortic arch variations and anomalies, and the bovine arch was observed in eight patients. Endoleaks were the main complications encountered, and 10 of 15 endoleaks were type I endoleaks. There were 18 reinterventions; the most of which was TEVAR (n = 5). The overall mortality was 20 patients, with TEVAR-related causes accounting for 12 of these deaths, including intracranial bleeding in three patients. Multivariant Cox regression revealed chronic renal diseases (OR = 11.73; 95% CI: 2.04–67.2; p = 0.006), previous cardiac operation (OR = 14.26; 95% CI: 1.59-127.36; p = 0.01), and chronic obstructive pulmonary diseases (OR = 7.82; 95% CI: 1.43–42.78; p = 0.001) to be independent risk factors for 10-year survival. There was no significant difference in the survival curves of the various aortic pathologies. In the follow-up period, two non-symptomatic intragraft thromboses and one graft infection were found.ConclusionComorbidities can increase the risk of TEVAR-related mortality without significantly impacting endoleak rates. TEVAR is effective for severe aortic pathologies, though long-term graft durability may be compromised by its thrombosis and infection.

Five-year outcomes of endovascular treatment for aortic dissection from the Global Registry for Endovascular Aortic Treatment

ObjectiveThe Global Registry for Endovascular Aortic Treatment (GREAT) is an International prospective multicenter registry collecting real-world data on performance of Gore aortic endografts. The purpose was to analyze the long-term outcomes and patient survival rates, as well as device performance in patients undergoing thoracic endovascular aortic repair for acute and chronic and complicated or uncomplicated type B aortic dissection (TBAD). MethodsFrom August 2010 to October 2016, 5014 patients were enrolled in the GREAT registry. The study population were patients treated with thoracic endovascular aortic repair for TBAD through 5-year follow-up (days 0-2006). The primary outcomes for this analysis were all-cause and aortic-related mortality, stroke, aortic rupture, endoleaks, migration, fracture, compression, and any reintervention through 5 years. ResultsWe identified 265 patients. The mean age was 60.9 ± 11.9 years (range, 19-84 years; 211 males [79.6%]). Devices used were the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis. There were 228 patients (86.0%) who underwent primary endovascular treatment (144 off-label [54.3%]); 22 (8.3%) underwent reintervention after prior endovascular procedure and 15 (5.7%) underwent reintervention after prior open procedure. Kaplan-Meier estimated freedom from all-cause mortality at 5 years was 71.1%. Freedom from aortic-related mortality through 5 years was 95.8%. There was no significant difference in freedom from all-cause mortality during the follow-up period in complicated or uncomplicated disease. At 30 days and through 5 years, respectively, for all the following outcomes, the aortic rupture rate was 1.1% (n = 3) and 1.9% (n = 5). The stroke rate was 1.1% (n = 3) and 4.2% (n = 11). The spinal cord ischemic event rate was 1.5% (n = 4) and 2.6% (n = 7). Reinterventions were required in 6.4% (n = 17) and 21.1% (n = 56) of patients. The need for conversion to open repair was 0.4% (n = 1) and 2.6% (n = 7). Additional graft placement was required in 3 patients (1.1%) and 16 patients (6.0%). The endoleak rate at 30 days was 3.4% (n = 9); type IA (n = 1 [0.4%]), type IB (n = 4 [1.5%]), type II (n = 1 [0.4%]), type III (n = 1 [0.4%]), and unspecified (n = 4 [1.6%]). Through 5 years, the endoleak rate was 12.1% (n = 32); type IA (n = 7 [2.6%]), type IB (n = 10 [3.8%]), type II (n = 9 [3.4%]), type III (n = 2 [0.8%]), and unspecified (n = 12 [4.5%]). There were no cases of stent migration, compression or fracture through 5 years. ConclusionsResults at the 5-year follow-up demonstrate that the use of the Gore TAG and Conformable Gore TAG Thoracic Endoprosthesis can be supported in treatment of TBAD (acute, chronic, complicated, and uncomplicated). These data demonstrate strong device durability, beneficial patient outcomes, and support for the treatment of thoracic aortic dissection with an endovascular approach. Complete 10-year follow-up in GREAT as planned will be advantageous.

Five-Year Results for Abdominal Aortic Aneurysm Repair with the GORE® EXCLUDER® Device: Insights from the Gore Global Registry for Endovascular Aortic Treatment (GREAT)

ObjectivesThe early postoperative benefits of EVAR have been well established but questions remain regarding its durability at mid and long-term timepoints. Long-term results in real-world use of EVAR outside of randomized trial data are limited. This study utilized the GREAT Registry to explore the 5-year outcomes with the GORE® EXCLUDER® device in real-world clinical circumstances. MethodsAll patients within the GREAT registry that underwent an infrarenal AAA repair with the GORE® EXCLUDER® device were included in this study. Baseline characteristics and demographic information of the cohort were collected. Endpoints included mortality (all-cause and aneurysm related), serious endoleaks, aneurysm sac diameter, endograft integrity (fracture, compression, migration), post-EVAR aortic rupture, device-related reintervention, conversion to open repair, graft explantation, and major adverse cardiovascular events (MACE). ResultsA total of 3216 patients were included in this analysis. The cohort reflected a significantly comorbid population with 46% of patients reaching a Charlson comorbidity index score of ≥ 5. Follow-up at 5 years was 60% of eligible participants. The freedom from aortic-related mortality was at 98.8% and overall survival was 71.2%. Post-operative MACE occurred in 49 (1.5%) patients. Device-related intervention through 5 years was 7.2% and the overall serious endoleak rate was 6.8%. Less than 1% of patients required an open conversion/revision and aortic rupture following device placement occurred in 15 (0.5%) patients. Aneurysm sac regression was achieved in 58.1% of patients at 5 years, and stability/absence of growth was observed in 83.6% at 5 years. ConclusionsThis study supports the durability of the GORE® EXCLUDER® device though 5 years with negligible incidence of graft integrity compromise and low aortic/device-related reintervention rates. Furthermore, the efficacy of the device is highlighted with low aortic-related mortality and high sac regression/stability diameter though 5 years.

Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience.

Aim: To assess the medium and long-term performance of the Endurant stent graft in a cohort of consecutive patients treated with this device for an abdominal aortic aneurysm (AAA) both inside and outside of the instructions for use (IFU) and to find factors influencing the outcomes. Methods: Our observational, retrospective, single-center study included all patients who consecutively underwent endovascular aneurysm repair with the Endurant stent graft from February 2009 to January 2023. Patients with an AAA to treat according to current guidelines were included. Patients were divided into two groups: Group 1 inside of the IFUs and Group 2 outside of the IFUs for the proximal aortic neck. Patients were followed up after the procedure with computed angiography tomography, ultrasound examination, and interviews. Aneurysm-related mortality, procedure-related reinterventions, and type IA and III endoleaks were considered primary endpoints. Secondary endpoints included aneurysmal sac variations and graft thrombosis. Results: A total of 795 patients were included, 650 in Group 1 and 145 in Group 2; 732 were males, and the mean age was 74 ± 8. Anamnestic baseline did not differ between the two groups. Neck length, width, and angulation were different between the two groups (all p < 0.001). A total of 40 patients had a ruptured AAA, while 56 were symptomatic. At a mean follow-up of 43 ± 39 months, aneurysm-related mortality was less than 1%, and 82 endoleak (10.5%) were observed. Overall endoleak rate and type 1A endoleak, as well as procedure-related reintervention, were significantly more frequent in Group 2. Sac regression of at least 5 mm was observed in 65.9% of cases. AAAs larger than 60.5 mm carried a higher risk of endoleak (HR: 1.025; 95% CI: 1.013-1.37; p < 0.001) and proximal necks shorter than 13.5 mm carried a higher type 1A risk (HR: 0.890; 95% CI: 0.836-0.948; p < 0.001). Patients without chronic obstructive pulmonary disease and taking lipid-lowering drugs had an overall more consistent sac-shrinking rate. Conclusions: The Endurant stent graft proves safe and reliable. Out-of-IFU treatment has poorer medium and long-term outcomes. Some conditions influence medium and long-term reintervention risk and sac behavior. Patients with bigger aneurysms, proximal necks shorter than 13.5 mm, and chronic obstructive pulmonary disease should be more carefully evaluated during follow-up. Consistent follow-up is in keeping low aneurysm-related mortality. Personalized risk profiles and peri and postoperative management strategies are needed.

Effectiveness and Safety of Endoanchors in Abdominal and Thoracic Endovascular Aneurysm Repair: A Systematic Review and Meta-analysis

Purpose: This systematic review aimed to summarize the effectiveness and safety of endoanchor, a stabilizing device for the proximal endograft designed to prevent endoleak and stent migration in endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR). Materials and methods: A systematic review and meta-analysis was conducted per the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guideline. Literature up to May 31, 2023 was searched and independently screened from 4 databases. Data were pooled for meta-analysis. Primary outcomes included intraoperative and follow-up endoleak, stent migration, and reintervention rates; sac regression; and 30-day all-cause mortality. Results: Sixteen EVAR (n=1145) and 6 TEVAR studies (n=163) using the Heli-Fx EndoAnchor system were included from 2225 retrieved records. For EVAR patients (mean follow-up=11.9 months), the endoleak, graft migration, and reintervention rates were 3.97% (95% confidence interval [CI]=0.36%-1.99%), 0.004% (95% CI=0.00%-0.76%), and 5.43% (95% CI=0.86%-12.54%), respectively. The endoleak rates for primary and revision EVAR were 0.16% (95% CI=0.00%-1.65%) and 3.60% (95% CI=0.14%-9.72%), respectively. Only 4 cases of 30-day mortality (n=4) were reported in the literature. For TEVAR patients, the endoleak, stent migration, and reintervention rates were 7.4% (95% CI=0.03%-0.13%), 0.2% (95% CI=0.00%-0.06%), and 17.1% (95% CI=0.01%-0.45%), respectively. The 30-day mortality was 0.9% (95% CI=0%-0.12%). Conclusions: Endoanchor fixation in EVAR and TEVAR is effective and safe in preventing and treating endoleak and stent migration. The mortality is minimal in EVAR but higher in TEVAR. Clinical Impact Endoleak, graft migration, and reintervention in EVAR and TEVAR with endoanchor use were rare. Mortality in EVAR was low. The adjunctive deployment of endoanchors is an effective and safe means to prevent and treat endoleak and stent migration in EVAR and TEVAR. Yet, long-term efficacy and safety data and randomized controlled trials would be required to definitively recommend endoanchor use in routine clinical practice.

Clinical Outcomes and Quality of Life Following TEVAR with or without Revascularization of the Left Subclavian Artery

Objectives: This study aims to evaluate the clinical outcomes and quality of life of patients with or without the left subclavian artery (LSA) revascularization in patients with thoracic aortic diseases undergoing endovascular repair of the ishimaru zone 2. Methods: A total of 48 patients with the closure of the LSA after thoracic endovascular aortic repair (TEVAR) were enrolled in the study between 2014 and 2018, of whom 21 had undergone the LSA (revascularization group), and the remaining 27 cases (non-revascularization group). The study was planned as a single-center retrospective design. Data were retrieved from the patients’ files. Short form-36 scales were administered to assess quality of life. Results: There was no difference between the two groups with and without LSA revascularization in 30-day paraplegia (4.8% vs. 0.0%, p=0.449), 4-year cerebrovascular events (0.0% vs. 3.8%, p=0.998), upper extremity ischemia (9.6% vs. 0.0%, p=0.207), death (28.6% vs. 25.9%, p=0.887), rate of endoleak (23.8% vs. 29.6%, p=0.896), and length of intensive care unit stay (2.3±2.1 days vs. 2.1±1.8 days, p=0.645). Regarding the quality of life, only physical functioning was improved slightly more in the group that underwent LSA without revascularization (90.7±26.7 vs. 82.3±14.9, p=0.032). Conclusion: The current study showed no significant differences with respect to neurological outcomes, upper extremity ischemia, quality of life, and mortality among patients undergoing TEVAR with or without revascularization of the LSA.

Early outcomes of fenestrated and/or branched endovascular repair of complex aortic aneurysms (F/B-EVAR); A single-center experience

Background: Open surgical repair of juxta-, para- and thoracoabdominal aortic aneurysms (TAAA) has been the gold-standard for patients fit for surgery. However, endovascular repair of complex aortic aneurysms using devices implementing directional branches or fenestrations for incorporation of reno-visceral target vessels (TV) has gained widespread attention, due to its lower mortality and complication rate and its more attractive profile for high-risk patients. Nonetheless, complex endovascular technologies require meticulous abidance to protocols for successful application. Methods: A retrospective analysis of prospectively collected data from a single, tertiary center was undertaken, including all patients undergoing complex aortic endovascular repair with fenestrated (F-EVAR) of branched devices (B-EVAR) from a 5-year time period (2018-2023). Primary outcomes included 30-day mortality, while secondary outcomes included primary TV patency, acute kidney injury (AKI), spinal cord ischemia (SCI), myocardial infarction (MI) and stroke rates. Results: Of 74 patients (mean age: 69 ± 5.6 years-old, 98% males), 31 (42.6) and 43 (57.6%) were treated by F-EVAR and B-EVAR, respectively. Mean aneurysm diameter was 68 ± 1.8cm, with 15 (20.5%) juxtarenal AAA, 27 (35.6%) pararenal AAA, 16 (21.9%) type IV TAAA, 6 (8.2%) type III TAAA, and 10 (13.7%) type II TAAA treated. Sixteen (21.6%) patients were treated due to failed-EVAR. In total, 272 TV were successfully revascularized. Thirty-day mortality was 8.1%. Primary TV patency rate was 99.2% (270/272). Endoleak rate was 8.1% (6/74). No cases of AKI or MI were observed. One (1.3%) case of hemorrhagic stroke was observed. Three cases (4%) of SCI were observed, including one temporary paraparesis and two permanent paraplegia cases. Reintervention rate was 5.4%, including two cases of renal artery stent thrombosis revascularization procedures. Conclusions: Endovascular repair of complex aortic aneurysms is feasible, with good perioperative outcomes. Adherence to precise protocols covering every technical aspect of patient care is warranted for satisfactory outcomes.