Long-term outcomes of the Endurant endograft in patients undergoing endovascular abdominal aortic aneurysm repair.

OBJECTIVE/BACKGROUND: To investigate the long-term outcomes after endovascular aneurysm repair (EVAR) in a real-world setting using the Endurant endograft (EG). METHODS: 184 EVAR candidates treated with the Endurant family EGs in a single vascular center were prospectively enrolled from January 2009 to December 2016. Kaplan-Meir estimates of long-term standardized primary and secondary outcome measures were performed. Per protocol, subgroup comparison analysis was performed in three groups: patients treated within instructions for use (in-IFU) vs patients treated outside IFU (outside-IFU), EVAR in patients receiving the Endurant proximal diameter 32 or 36 mm EG vs those receiving the <32 mm diameter EG and EVAR with various Endurant EG versions. RESULTS: The mean follow-up was 75.09 ± 37.9 months (range: 4.1-172 months). The median age of the patients was 72.96 ± 7.03 years (range: 55-88 years). A total of 177 patients were male (96.2%). Compliance with IFU was followed in 107 patients (58.2%). Overall survival was 69.5% and 48% at 5 and 8 years, respectively. Of the 102 all-cause deaths, 7 (6.9%) were aneurysm related. Six of these postimplant deaths occurred in patients presented with aneurysm rupture from type Ia or/and type Ib endoleak. At 5, 8, and 10 years of observation, freedom from aneurysm rupture, open surgical conversion, type I/III endoleak, any type of endoleak, aneurysm-related secondary intervention probabilities, and neck-related events were as follows: 98.1%, 95%, and 89.4%; 95.1%, 91.2%, and 85.7%; 93.6%, 87.3%, and 83.9%; 83.4%, 74%, and 70.9%; 89.8%, 76.7%, and 72%; and 96.3%, 90%, and 87.6%, respectively. Corresponding clinical success was 90%, 77.4%, and 68.4%, respectively. Patients treated outside-IFU had significantly higher risk of aneurysm rupture, open surgical conversion probability, occurrence of type I/III endoleak, and chance of reinterventions and lower clinical success probabilities compared with the in-IFU counterparts at 5 and 8 years. This statistical difference remained when type Ia endoleak or endoleak of any type was considered independently. In addition, it was stronger in patients having extreme anatomic boundaries (>1 hostile anatomic condition), when aneurysm-related death, aneurysm rupture, and clinical success at 5 years were considered. Overall proximal migration and limb occlusion were recorded in 1.1% and 4.9% of the patients, respectively. Overall reintervention rate was 17.4%. An increase in aneurysm sac diameter was observed in 12.5% of patients and was not related to IFU status. The Endurant version or the proximal EG diameter had no significant association with the chance of any complication or adverse event. CONCLUSIONS: The data confirmed the durability of the Endurant EG, achieving promising long-term outcomes in a real-world setting. However, its positive performance must be interpreted with caution in patients treated off-label especially those with extreme anatomic boundaries. In this cohort, some of EVAR advantages might be lost in the late future. Further similar studies are warranted.

Treatment Outcomes of Patients With Ruptured Abdominal Aortic Aneurysms.

BACKGROUND: Ruptured abdominal aortic aneurysm (rAAA) is a serious complication of abdominal aortic aneurysm associated with high operative mortality and morbidity rates. The present study evaluated the perioperative and long-term outcomes of Korean patients with rAAA based on national health insurance claims data. METHODS: The National Health Insurance Service (NHIS) database was searched retrospectively to identify patients with rAAA who underwent endovascular aneurysm repair (EVAR) and open surgical repair (OSR) from 2009 to 2018. Perioperative (≤ 30 days), early postoperative (≤ 3 month), and long-term (> 3 month) survival, reinterventions, and complications were assessed. RESULTS: The search identified 1,034 patients with rAAA, including 594 who underwent EVAR and 440 who underwent OSR. When the study period was divided into two, the total numbers of patients with rAAA, patients who underwent EVAR, and octogenarians were higher during the second half. The perioperative mortality rate was 29.8% in the EVAR and 35.0% in the OSR group (P = 0.028). Hartmann's procedure for bowel infarction was performed more frequently in the OSR than in the EVAR group (adjusted odds ratio, 6.28; 95% confidence interval [CI], 2.33-21.84; P = 0.001), but other complication rates did not differ significantly. All-cause mortality during the entire observation period did not differ significantly in the EVAR and OSR groups (adjusted hazard ratio, 1.17; 95% CI, 0.98-1.41; P = 0.087). Abdominal aortic aneurysm-related reintervention rate was significantly lower in the OSR group (adjusted hazard ratio, 0.31; 95% CI, 0.14-0.70; P = 0.005). CONCLUSION: Although EVAR showed somewhat superior perioperative outcomes for rAAA, the long-term outcomes of EVAR after excluding initial 3 months were significantly worse than OSR. When anatomically feasible for both treatments, the perioperative mortality risk and reasonable prospects of long-term survival should be considered in rAAA.

Effect of the urgency and landing zone on rates of in-hospital death, stroke, and paraplegia after thoracic endovascular aortic repair in Japan.

OBJECTIVE: The present study used data from the Japanese Committee for Stentgraft Management's national registry, which contains unique surgical data, including surgical timing, anatomic factors, and pathologic factors, to determine the generalized community experience with thoracic endovascular abdominal aortic repair (TEVAR). METHODS: The medical background and short-term outcomes were reviewed for patients who had undergone TEVAR for a thoracic aortic aneurysm (TAA; 14,235 cases) or aortic dissection (AD; 990 type A and 4259 type B) from 2008 to 2015. TEVAR for AD was separated from that for TAAs; only the background and short-term outcomes were evaluated. The technical outcomes of TEVAR for TAA were also evaluated. All the cases were categorized as follows: elective, urgent (within 24 hours after admission), or emergent (immediately after admission). The outcomes included in-hospital mortality and persistent stroke and paraplegia diagnosed at discharge. The number of debranching bypasses, proximal landing zone (0, 1, 2, ≥3), and zone length were included in the logistic regression analysis. RESULTS: The mortality, stroke, and paraplegia rates in the TAA and AD groups were 4.4%, 4.6%, and 3.7% and 4.0%, 2.9%, and 2.8%, respectively. After analyzing the TAA cohort, we found that urgent and emergent cases were associated with all adverse outcomes. The rate of paraplegia increased drastically in the patients with stent graft coverage that extended for six or more zones. Massive atheroma was associated with stroke and paraplegia. The cumulative survival rate of the TAA group was stratified by the urgency (ie, elective, urgent, emergent; P < .001). We found that the more proximal (0, 1, and 2) the landing zone, the greater the risk of stroke. Likewise, the longer (six or more zones) the coverage, the greater the risk of paraplegia. CONCLUSIONS: Urgency was strongly associated with mortality, stroke, and paraplegia, and the classification of urgent and emergent, according to the surgical timing after admission, successfully stratified the population in the long-term overall survival analysis. A proximal landing zone involving the aortic arch and debranching bypasses were associated with the occurrence of stroke, and the length of stent graft coverage for six or more zones was associated with paraplegia. Identifying these risk factors will help operators of TEVAR develop appropriate operative strategies to mitigate patient risk.

Aneurysm rupture from blunt abdominal trauma after endovascular repair.

We present a case of aneurysm rupture from severe blunt abdominal trauma due to fight in a patient who had endovascular aneurysm repair. The patient presented to the emergency service with computed tomography evidence of an endoleak and a large retroperitoneal hematoma. The contrast abdominal computed tomography demonstrated a type Ib endoleak, increase in the aneurysm diameter and hematoma in the retroperitoneum. The patient has been taken under interventional procedure for endovascular aneurysm repair revision under urgent condition. Type Ib endoleak was treated by placement of a covered iliac extension limb, but a second leakage from graft body was found in control computed tomography images and open surgical conversion was necessary. Operative findings included a type III endoleak from graft body, defect on fabric. It was seen that the aneurysm sac anterior and posterior parts were ruptured. Upon reviewing the literature, we found that it was an interesting case as the first rupture case which had been developed after severe blunt abdominal trauma during the follow-up period of a patient on which endovascular aneurysm repair procedure had been performed and progressed in this manner.

Factors affecting the occurrence of proximal endoleak after endovascular abdominal aortic repair for abdominal aneurysms.

OBJECTIVE: This retrospective study was performed to assess the clinical and radiological variables associated with proximal type IA endoleak (EL) in patients treated with elective endovascular repair for abdominal aortic aneurysms. METHODS: The chi-square test, t-test, and logistic regression analysis were performed as appropriate. A P value of <0.05 was considered statistically significant. RESULTS: The data of 79 patients were analyzed. No mortality occurred. During follow-up (median, 28.5 months; interquartile range, 12.8-43.0 months), 10 patients developed type IA EL. In the logistic regression analysis, undersizing of the endograft diameter by <10% significantly affected the occurrence of type IA EL. When the diameter was used for measurements, less oversizing was significantly associated with a higher risk of type IA EL. When the area was used for measurements, oversizing of >20% significantly affected the occurrence of type IA EL. CONCLUSION: When sizing endografts, a discrepancy was noted between the measurements of the diameter and area of the proximal neck. The area might represent a more accurate measurement than the axial diameter to optimize the proximal sealing and lower the risk of developing type IA EL.

Transgraft embolization by using long needle for the treatment of type II endoleaks after endovascular abdominal aortic repair.

We used a long custom needle (LCN) to improve transgraft embolization (TGE) in 10 reported cases that underwent TGE with LCN for type II endoleak (T2E) treatment after endovascular abdominal aortic aneurysm repair. TGE was performed with a LCN enabling the usage of microcatheter and embolization coils in 10 cases with T2E after endovascular abdominal aortic aneurysm repair. Embolization was successfully achieved in the nidus in all 10 cases. The aneurysmal sac diameter significantly decreased by TGE, and none of the 7 of 10 cases exhibited recurrence of sac expansion or T2E throughout the 2-year follow-up period.

Successful hybrid management of a ruptured abdominal aortic aneurysm induced by type II and IIIB endoleaks after endovascular aortic repair.

Ruptured abdominal aortic aneurysm after endovascular abdominal aortic repair is a relatively rare condition. The management of this type of a rupture is challenging and controversial. We report here a case of ruptured abdominal aortic aneurysm 6 months after endovascular abdominal aortic repair. Although the main cause of this rupture was initially believed to be a type II endoleak, it was also a type IIIB endoleak practically. The patient was successfully treated via the hybrid approach. He recovered well, with no endoleaks for the next 6 months.

Kilt Technique as an Angle Modification Method for Endovascular Repair of Abdominal Aortic Aneurysm with Severe Neck Angle.

PURPOSE: Kilt technique can be useful for overcoming the severe angle in endovascular abdominal aortic repair. Thus, we investigate the utility of the Kilt technique as an angle modification method. METHODS: This study included 16 patients with abdominal aortic aneurysm having severe neck angle (over 60°). Of these, eight were treated using Kilt technique, whereas the remaining eight were by the conventional endovascular method. We investigated the pre- and post-procedural differences in neck angle between the two groups using aortic computed tomography (CT) angiography. RESULTS: Mean pre-procedural neck angles in the conventional group and the Kilt group were 70° ± 13° and 93° ± 14° (p = 0.007) and supra-renal neck angles were 54° ± 16° and 89° ± 26°, respectively (p = 0.016). However, the angle differences disappeared between the two groups after the procedure. Consequently, the Kilt group showed greater angle change than the conventional group (p value for ∆ supra-renal angle and ∆ neck angle were 0.015 and 0.021, respectively). There was no type 1 endoleak during 16 ± 16 months of CT follow-up. CONCLUSION: Kilt technique may be an effective tool for modifying the neck angle without leaving increased risk of type 1 endoleak in this subset of patients.

Systolic Sac Pressure Index for the Prediction of Persistent Type II Endoleak for 12 Months After Endovascular Abdominal Aortic Aneurysm Repair.

PURPOSE: To assess the relationship between the systolic sac pressure index (SPI) and the presence of endoleaks 12 months after endovascular abdominal aortic aneurysm repair (EVAR). MATERIALS AND METHODS: We performed a single-center prospective trial of consecutively treated patients. SPI (calculated as systolic sac pressure/systolic aortic pressure) was measured by catheterization immediately after EVAR. Contrast-enhanced computed tomography was scheduled 12 months after EVAR to detect possible endoleaks. RESULTS: Data were available for 34 patients who underwent EVAR for an AAA. Persisting type II endoleak was found in 8 patients (endoleak-positive group) but not in the other 26 patients (endoleak-negative group). The mean ± standard deviation SPI was significantly greater in the endoleak-positive group than in the endoleak-negative group (0.692 ± 0.048 vs. 0.505 ± 0.081, respectively; P = .001). Receiver-operating characteristic curve analysis revealed that an SPI of 0.638 was the optimum cutoff value for predicting a persistent endoleak at 12 months with high accuracy (0.971; 33/34), sensitivity (1.00), and specificity (0.962) values. The mean change in AAA diameter was -4.28 ± 5.03 mm and 2.22 ± 4.54 mm in patients with SPI of <0.638 or ≥0.638, respectively (P = .002). CONCLUSION: Patients with an SPI of ≥0.638 immediately after EVAR were more likely to have a persistent type II endoleak at 12 months with an accuracy of 0.971, and showed increases in aneurysm sac diameter compared with patients with an SPI of <0.638.

A multi-institutional survey of interventional radiology for type II endoleaks after endovascular aortic repair: questionnaire results from the Japanese Society of Endoluminal Metallic Stents and Grafts in Japan.

PURPOSE: To investigate the current status of interventional radiology (IR) procedures for a type II endoleak (T2EL) in Japan, and to identify the technical aspects that affect treatment results. MATERIALS AND METHODS: A retrospective survey was conducted by distributing questionnaires to 25 institutions. The eligibility criteria were endovascular aortic repair (EVAR) performed using commercial stent grafts and IR performed for T2EL between January 2007 and December 2013. Technical success was defined as disappearance of the EL on digital subtraction angiography immediately after embolization, and imaging success was defined as no EL on contrast-enhanced computed tomography within 6 months. Statistical comparisons of the number of involved branches, embolization level, embolic material, and changes in aneurysm size were made between the imaging success and imaging failure groups. The technical and imaging success rates were also compared between the initial therapy and repeat groups. RESULTS: A total of 166 cases were investigated. Initial therapy was performed in 147 cases (88.6 %), with repeat therapy in 19 cases (11.4 %). Transcatheter arterial embolization (TAE) was used most frequently, in 161 cases (97 %), with direct puncture (DP) used in 5 cases (3 %). Both coil embolization for the branches and NBCA embolization for the sac were frequently chosen. The technical success rate was 83.2 % (TAE group), and the imaging success rate was 46.5 % (TAE + DP groups). Branch + sac embolization was performed more frequently in the imaging success group. There was no significant difference in the number of involved branches or embolic material between the imaging success and imaging failure groups. Enlargement of the aneurysm was more frequently seen in the imaging failure group. There were no significant differences in the technical success and imaging success rates between the initial therapy and repeat groups. CONCLUSION: This is the first report of a multi-institutional questionnaire survey of IR procedures for T2EL after EVAR in Japan that was conducted to determine the current status. Enlargement of aneurysm size after embolization was more frequently seen in the imaging failure group. It is important to embolize both branch and sac to achieve imaging success, regardless of embolic material. Long-term outcomes need to be investigated.