Early Clinical Results From the Japanese Prospective Multicenter Study to Evaluate Zenith Alpha Abdominal Stent Graft for Abdominal Aortic Aneurysm (JUSTICE) Registry Demonstrate Acceptable Limb Patency at 12 Months.

PURPOSE: Recent reports of the Zenith Alpha abdominal endovascular graft (Zenith Alpha AAA, Cook, Inc., Bloomington, Indiana) have demonstrated an unexpectedly high incidence of limb graft occlusion (LGO). The purpose of this study was to prospectively evaluate the performance of the Zenith AAA in Japan, with a specific focus on LGO. MATERIALS AND METHODS: All endovascular aneurysm repairs (EVARs) for abdominal aortic aneurysms performed using the Zenith Alpha AAA from July 2020 to October 2021 in 23 Japanese hospitals were prospectively evaluated. All computed tomographic images were analyzed in the core laboratory. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reintervention were excluded as late complications. RESULTS: During the study period, 147 EVARs were performed using the Zenith Alpha AAA. The mean patient age was 76.5±7.7 years, 84.4% of patients were male, and the mean aneurysm diameter was 52.4±9.2 mm. Instruction-for-use violations were observed in 76 patients (51.7%), primarily associated with a severely angulated proximal neck (>60°). There were six intraoperative complications and 62 additional intraoperative treatments reported, most of which involved preemptive coil embolization of the inferior mesenteric artery (37 cases). Technical success, defined as the absence of type 1 or 3 endoleaks on final angiography, was achieved in 99.3% of patients. At 12 months, there was only one case of type 1/3 endoleak (0.8%) and one aneurysm sac enlargement exceeding 5 mm (0.8%); however, a high incidence of type 2 endoleaks was observed in 35.2% of patients, and aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients. Nine late complications were observed, and the rate of freedom from late complications at 12 months was 93.5%, encompassing four LGOs and one limb graft stenosis (3.4%). CONCLUSIONS: In contrast to recent reports, our Japanese multicenter prospective study demonstrated satisfactory early clinical results, including an acceptable LGO rate, for the low-profile Zenith Alpha AAA. Long-term follow-ups will be performed to confirm the persistence of these outcomes. CLINICAL IMPACT: This study prospectively evaluated the performance of 147 Zenith Alpha AAAs used for endovascular aneurysm repair with core-lab adjudication focusing especially on limb graft occlusion (LGO). At 12 months, aneurysm sac regression exceeding 5 mm was achieved in 30.1% of patients, and there was only one type 1/3 endoleak, one aneurysm sac enlargement (>5 mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg." 5mm), and nine late complications including five LGOs (3.4%), resulting in rate of freedom from late complications at 93.5%. Satisfactory early clinical results, including an acceptable rate of LGO can be achieved, particularly with cautious usage of the Zenith Alpha Spiral-Z Endovascular Leg.

Optimal D-Dimer Cutoff Values for Diagnosing Deep Vein Thrombosis in Patients with Comorbid Malignancies.

BACKGROUND: Patients with malignancy are at high risk of venous thromboembolism, and early diagnosis is important. The Khorana score is known as a risk assessment for cancer-related thrombosis during chemotherapy, but there are still few reports on its diagnostic potential, the optimal D-dimer cutoff values for indications other than chemotherapy and the use of the Khorana score in combination with D-dimers. In this study, we examined the clinical appropriateness of increasing the D-dimer cutoff value. METHODS: We retrospectively studied 208 malignancies out of 556 patients who underwent lower extremity venous ultrasonography at our hospital over a 2-year period from January 2018 to December 2019. The optimal D-dimer cutoff value for predicting deep vein thrombosis (DVT) in patients with malignancy was calculated by the Youden index. The usefulness of the Khorana score alone and the model combining the Khorana score with D-dimer for predicting DVT diagnosis was compared using receiver operating characteristic analysis. RESULTS: Of 208 eligible patients, 59 (28.4%) had confirmed DVT. The optimal D-dimer cutoff value for predicting DVT comorbidity in patients with malignancy was 3.96 µg/mL. When the new D-dimer cutoff value was set at 4.0 µg/mL, the odds ratio (OR) for DVT diagnosis was 4.23 (95% confidence interval (CI) 2.10-8.55, P < 0.001), which was higher than the OR of 1.33 (95% CI: 0.98-1.81, P = 0.064) for the Khorana score. The area under the curve for the Khorana score and D-dimer was 0.714, which was significantly higher than the 0.611 for the Khorana score alone, with the difference being significantly higher at 0.103 (P = 0.004, 95% CI: 0.033-0.173). CONCLUSIONS: The optimal D-dimer cutoff value for the diagnosis of DVT in patients with malignancy was 4.0 µg/mL. It was also suggested that the combination of the Khorana score with the D-dimer level was more accurate in diagnosing DVT than the Khorana score alone.

Endovascular Treatment as an Alternative to Bypass Surgery for Juxtarenal Aortic Occlusion: Results from the CHAOS (CHronic Abdominal Aortic Occlusion, ASian Multicenter) Registry.

BACKGROUND: Juxtarenal aortic occlusion (JRAO), in which the occlusion of the aorta extends to just below the renal artery, is often treated by bypass surgery because of concerns about the risk of procedural failure and fatal embolization to abdominal organs when treated with endovascular treatment (EVT). This study assessed the outcome of EVT for JRAO compared with aorto-biiliac /aorto-bifemoral (AOB) or axillo-bifemoral (AXB) bypass. METHODS: A retrospective review of an international database created by 30 centers in Asia (CHronic Abdominal Aortic Occlusion, ASian Multicenter registry) was performed for patients who underwent revascularization for chronic total occlusion of the infrarenal aorta from 2007 to 2017. Of the 436 patients, 130 with JRAO (Forty-seven AOBs, 32 AXBs, and 51 EVTs) from 25 institutions were included in this study. RESULTS: Patients were significantly older in the AXB and EVT groups and more malnourished in the EVT group than the AOB group. EVT was attempted but failed in 1 patient. Seven patients (1 [2.1%] in the AOB group, 1 [3.1%] in the AXB group, and 5 [9.8%] in the EVT group) died during hospitalization, but most of the causes in the EVT group were not related to the revascularization procedure. No visceral embolism was observed, which had been concerned, even though protection was performed only in 2 cases of the EVT group. At the latest follow-up (median duration 3.0 years), the ankle-brachial pressure index was significantly higher in the order of AOB, EVT, and AXB. At 4 years, the estimated primary and secondary patency rates of the AOB group (87.5% and 90.3%, respectively) were significantly higher than the AXB group (66.7% and 68.6%, respectively). CONCLUSIONS: AOB remains the gold standard and should be the first choice for acceptable risk patients. For frail patients, EVT is a good option and likely preferable as a first-line treatment compared to AXB.

One-year sac regression is associated with freedom from fatal adverse events after endovascular aneurysm repair.

OBJECTIVE: Although the predictors of long-term prognosis after endovascular aneurysm repair (EVAR) have been investigated, several reports have suggested that early sac shrinkage (ESS) is associated with superior long-term prognosis. However, it was not clear whether ESS was associated with aneurysm-related mortality. The aim of this study was to define fatal adverse events and to examine their association with ESS. METHODS: All consecutive patients who underwent EVAR for an abdominal aortic aneurysm at Nagoya University Hospital between June 2007 and August 2018 were identified. We defined ESS as an aneurysm diameter decrease of 10 mm or more at 1 year after EVAR, and we defined fatal adverse events as aneurysm-related death, aneurysm sac rupture, open conversion, secondary type Ia endoleak, or secondary type IIIa/b endoleak. Then, we evaluated the association between ESS and fatal adverse events and identified predictors of ESS. RESULTS: During the study period, 553 patients were identified and included. Fatal adverse events occurred in 42 patients (7.6%), and the details of the fatal adverse events were as follows: 13 aneurysm-related deaths, 17 aneurysm sac ruptures, 14 open conversions, 13 type Ia endoleaks, and 6 type III endoleaks. ESS occurred in 146 patients (26.4%). Kaplan-Meier curves showed that the ESS group had a significantly lower incidence of fatal adverse events (P < .001). Multivariate analysis showed that there were significant differences in terms of 5 or more preoperatively patent lumbar arteries (odds ratio [OR], 0.67; P = .049; 95% confidence interval [CI], 0.45-1.00), chronic kidney disease (OR, 0.49; P < .01; 95% CI, 0.29-0.84), and Zenith endograft use (OR, 1.76; P < .01; 95% CI, 1.16-2.67). Furthermore, the percentage of cases that achieved an aneurysm diameter of less than 40 mm was significantly higher in the ESS group (76.0% vs 15.5%; P < .01). The use of Zenith endografts showed a significantly higher rate of aneurysm disappearance than the use of Endurant endografts (P < .01) and Excluder endografts (P < .01). In addition, it was found that ESS was more likely to occur with the use of Zenith endografts, even when propensity score matching was performed for the neck morphology. CONCLUSIONS: ESS was associated with a lower rate of life-threatening adverse events after EVAR. The use of Zenith endografts was a predictor of ESS and was associated with increased rates of long-term sac shrinkage and aneurysm disappearance compared with the Endurant and Excluder endografts. Using the predictors of ESS identified in this study, we may be able to expand the indications for EVAR to patients with a longer life expectancy.

Postendovascular Aneurysmal Repair Increase in Local Energy Loss for Fusiform Abdominal Aortic Aneurysm: Assessments With 4D flow MRI.

BACKGROUND: Although endovascular aneurysmal repair (EVAR) is a preferred treatment for abdominal aortic aneurysm (AAA) owing to its low invasiveness, its impact on the local hemodynamics has not been fully assessed. PURPOSE: To elucidate how EVAR affects the local hemodynamics in terms of energy loss (EL). STUDY TYPE: Prospective single-arm study. FIELD STRENGTH/SEQUENCE: A 3.0 T/4D flow MRI using a phase-contrast three-dimensional cine-gradient-echo sequence. POPULATION: A total of 13 consecutive patients (median [interquartile range] age: 77.0 [73.0, 78.8] years, 11 male) scheduled for EVAR as an initial treatment for fusiform AAA. ASSESSMENT: 4D flow MRI covering the abdominal aorta and bilateral common iliac arteries and the corresponding stent-graft (SG) lumen was performed before and after EVAR. Plasma brain natriuretic peptide (BNP) was measured within 1 week before and 1 month after EVAR. The hemodynamic data, including mean velocity and the local EL, were compared pre-/post-EVAR. EL was correlated with AAA neck angle and with BNP. Patients were subdivided into deformed (N = 5) and undeformed SG subgroups (N = 8) and pre-/post-EVAR BNP compared in each. STATISTICS: Parametric or nonparametric methods. Spearman's rank correlation coefficients (r). The interobserver/intraobserver variabilities with Bland-Altman plots. A P value < 0.05 is considered significant. RESULTS: The mean velocity (cm/sec) at the AAA was five times greater after EVAR: 4.79 ± 0.32 vs. 0.91 ± 0.02. The total EL (mW) increased by 1.7 times after EVAR: 0.487 (0.420, 0.706) vs. 0.292 (0.192, 0.420). The total EL was proportional to the AAA neck angle pre-EVAR (r = 0.691) and post-EVAR (r = 0.718). BNP (pg/mL) was proportional to the total EL post-EVAR (r = 0.773). In the deformed SG group, EL (0.349 [0.261, 0.416]) increased 2.4-fold to 0.848 (0.597, 1.13), and the BNP 90.3 (53.6, 105) to 100 (67.2, 123) post-EVAR. CONCLUSION: The local EL showed a 1.7-fold increase after EVAR. The larger increase in the EL in the deformed SG group might be a potential concern for frail patients. EVIDENCE LEVEL: 1 TECHNICAL EFFICACY: Stage 2.

The Association Between the D-dimer Level at 1 Year After EVAR and Sac Diameter Change in Patients With Persistent Type 2 Endoleak.

PURPOSE: Recent studies suggested that continuous clotting renewal in thrombi plays a central role in sac enlargement after endovascular aneurysm repair (EVAR). We reviewed patients with persistent type 2 endoleak (T2EL) to estimate the impact of D-dimer level on sac enlargement. METHODS: A retrospective review of elective EVAR for infrarenal abdominal aortic aneurysm performed between June 2007 and February 2020. Persistent T2EL was defined as T2EL confirmed at both the 6 and 12 month contrast-enhanced computed tomography (CECT) follow-ups. "Isolated" T2EL was defined as T2EL without other types of endoleak within 12 months. Patients with >2 year follow-up, persistent isolated T2ELs, and D-dimer level data at 1 year (DD1Y) were included. Patients with any reintervention within 12 months were excluded. The association between DD1Y and aneurysm enlargement (AnE), defined as a ≥5 mm diameter increase, within 5 years was analyzed. Among 761 conventional EVAR, 515 patients had >2 years of follow-up. Thirty-three patients with any reintervention within 12 months and 127 patients without CECT at either 6 or 12 months were excluded. Among 131 patients with persistent isolated T2ELs, 74 patients with DD1Y data were enrolled. During a 37 month median follow-up [25-60, IQR], 24 AnEs were observed. In the AnE patients, the median DD1Y was significantly higher than that in the other patients (12.30 [6.88-21.90] vs 7.62 [4.41-13.00], P=0.024). ROC curve analysis indicated that the optimal cutoff point of DD1Y for AnE was 5.5 µg/mL (AUC=0.681). In univariate analysis, angulated neck, occlusion of the inferior mesenteric artery, and DD1Y≥5.5 µg/mL were significantly associated with AnE (P= 0.037, 0.038, and 0.010). Cox regression analysis revealed that DD1Y≥5.5 µg/mL was correlated with AnE (P=0.042, HR [95% CI] 4.520 [1.056-19.349]). CONCLUSION: A 1 year higher D-dimer level can potentially predict AnE within 5 years in persistent T2EL patients. AnE was considered improbable when the D-dimer level was low enough. CLINICAL IMPACT: The present study suggests that a 1-year higher D-dimer level could potentially predict aneurysm expansion within 5 years in patients with persistent type 2 endoleak (T2EL). On the other hand, aneurysm expansion was considered unlikely if the D-dimer level was low enough.As there are many patients with T2EL who require regular follow-up, any predictor of future aneurysm expansion could be of great help in conserving medical resources. In patients with a low likelihood of future expansion, we might consider delaying follow-up, similar to patients with sac shrinkage.

Factors Associated With Spontaneous Sac Shrinkage in Patients With Persistent Type 2 Endoleaks After EVAR.

PURPOSE: Despite controversy surrounding the management of type 2 endoleaks (T2ELs) after endovascular aortic aneurysm repair (EVAR), the current European guidelines recommend reintervention for T2ELs when the aneurysm expands by ≥10 mm. Meanwhile, sac shrinkage ≥10 mm can be considered low risk for failure even with T2ELs, and the guidelines suggest less frequent follow-up delayed until 5 years after EVAR. This study reviewed patients with persistent T2ELs to identify predictors of spontaneous sac shrinkage (SpS) within 5 years. METHODS: A retrospective review of elective EVAR for infrarenal aortic aneurysms between June 2007 and December 2017. Patients with >1 year follow-up and persistent T2ELs, defined as T2ELs confirmed at both the 6 and 12 month follow-up with contrast-enhanced computed tomography (CT), were included. Any reintervention or type 1 or 3 endoleaks within 12 months were excluded. SpS was defined as a ≥10 mm reduction in diameter without any reintervention. Aneurysm enlargement (AnE) was defined as a ≥5 mm increase in diameter. Factors associated with SpS within 5 years were analyzed. The clinical outcomes were reviewed. RESULTS: Among 726 patients, 162 patients had persistent isolated T2ELs. After excluding 21 patients, 141 patients were enrolled. During a median follow-up of 43 months (interquartile range [IQR], 26-60), 28 SpS and 39 AnE were observed, and 31 reinterventions were performed. The cumulative rates of SpS were 14.2%±2.9% and 25.6%±5.1% at 1 and 5 years. Cox regression analysis revealed that the presence of ≥6 patent lumbar arteries had a significant negative correlation with SpS (p=0.036). During further follow-up after SpS, 2 reinterventions for type 1a and 3b endoleaks were required at 49 and 45 months. CONCLUSIONS: Patients with fewer patent lumbar arteries were likely to experience SpS within 5 years, even in the presence of persistent T2ELs. Follow-up imaging studies were advisable earlier than 5 years, even after SpS.

Comparison of Aortobifemoral Bypass and Endovascular Treatment for Chronic Infrarenal Abdominal Aortic Occlusion From the CHAOS (CHronic Abdominal Aortic Occlusion, ASian Multicenter) Registry.

PURPOSE: To directly compare the clinical outcomes of aortobifemoral bypass surgery (ABF) and endovascular treatment (EVT) for chronic total occlusion (CTO) of the infrarenal abdominal aorta (IAA). MATERIALS AND METHODS: In this retrospective, multicenter study, we used an international database of 436 patients who underwent revascularization for CTO of the IAA between 2007 and 2017 at 30 Asian cardiovascular centers. After excluding 52 patients who underwent axillobifemoral bypass surgery, 384 patients (139 ABFs and 245 EVTs) were included in the analysis. Propensity score-matched analysis was performed to compare clinical results in the periprocedural period and the long-term. RESULTS: Propensity score matching extracted 88 pairs. Procedure time (ABF; 288 [240-345] minutes vs EVT; 159 [100-205] minutes, p<0.001) and length of hospital stay (17 [12-23] days vs 5 [4-13] days, p<0.001) were significantly shorter in the EVT group than in the ABF group, while the proportions of procedural success (98.9% versus 96.6%, p=0.620), complications (9.1% versus 12.3%, p=0.550), and mortality (2.3% versus 3.8%, p=1.000) were not different between the groups. At 1 months, ABI significantly increased more in the ABF group for both in a limb with the lower (0.56 versus 0.50, p=0.018) and the higher (0.49 versus 0.34, p=0.001) baseline ABI, while the change of the Rutherford category was not significantly different between the groups (p=0.590). At 5 years, compared with the EVT group, the ABF group had significantly better primary patency (89.4±4.3% versus 74.8±4.3%, p=0.035) and survival rates (86.9±4.5% versus 66.2±7.5%, p=0.007). However, there was no significant difference between the groups for secondary patency (100.0%±0.0% versus 93.5%±3.9%, p=0.160) and freedom from target lesion revascularization (TLR) (89.3±4.3% vs 77.3±7.3%, p=0.096). CONCLUSION: Even with recent advancements in EVT, primary patency was still significantly better for ABF in CTO of the IAA. However, there was no difference between the groups in terms of secondary patency and freedom from TLR at 5 years. Furthermore, there was no difference in procedural success, complications, mortality, and improvement in the Rutherford classification during the periprocedural period, with significantly shorter procedure time and hospital stay in the EVT group.

Two-step arterial reconstruction technique for en bloc resection of a large retroperitoneal liposarcoma involving the common iliac artery.

Retroperitoneal liposarcoma (RPLS) is a rare but challenging neoplasm, which is frequently associated with iliac vessel invasion. We describe how we used a two-step arterial reconstruction technique to perform en bloc resection of a large RPLS involving the iliac arteries in three patients. A temporal long in situ graft bypass was established using a prosthetic vascular graft during dissection of the tumor. This bypass provided an unobscured surgical field, while maintaining blood flow in the lower limb during the operation. After removal of the tumor and washing out the abdominal cavity, the new prosthetic vascular graft of a suitable length was placed. No graft-related complications, including vascular graft infection or graft occlusion, occurred during the follow-up period. This novel technique appears to provide a safe and effective way to remove large RPLSs involving the retroperitoneal major vessels.

Epicardial adipose tissue volume is associated with abdominal aortic aneurysm expansion.

BACKGROUND: The epicardial adipose tissue volume (EATV) is associated with cardiovascular diseases such as coronary artery disease. However, no information is available regarding the relationship between the EATV and abdominal aortic aneurysm (AAA) expansion. In the present study, we evaluated the association between the EATV and AAA growth and sought to identify the predictors of AAA expansion. METHODS: Between June 2009 and December 2019, 906 patients had undergone endovascular or open repair of AAAs at our institution. Patients with previous cardiac surgery, previous ascending thoracic aortic surgery, a ruptured AAA, an infected AAA, an inflammatory AAA, a saccular aneurysm, a solitary iliac aneurysm, or reintervention after treatment of the AAA were excluded. A total of 237 patients with at least two preoperative computed tomography (CT) scans performed >180 days apart were included in the present study. The EATV within the pericardium was retrospectively quantified from the preoperative non-contrast-enhanced CT images using a three-dimensional workstation. The EATV index was defined as the EATV divided by the body surface area. The AAA expansion rate was defined as an increase in the AAA diameter annually, and the patients were divided into the slow-expansion group (expansion rate, <5 mm/y) and the fast-expansion group (expansion rate, ≥5 mm/y). The correlation between the expansion rate and the EATV index was analyzed, and the cutoff value for the EATV index was determined using a receiver operating characteristics curve. Multivariate analysis was used to assess the predictors of the AAA expansion rate. RESULTS: The expansion rate of AAA correlated positively with the EATV index (R = 0.237; P < .001). The initial aneurysm diameter (P < .001) and EATV index (P = .009) differed significantly between the two groups. The cutoff for the EATV index was 60.3 cm3/m2 (area under the curve, 0.658; 95% confidence interval [CI], 0.568-0.749; sensitivity, 1.000; specificity, 0.309). Multivariate analysis revealed that the initial aneurysm diameter and an EATV index of >60.3 cm3/m2 were significantly associated with the AAA expansion rate. CONCLUSIONS: The results of the present study have demonstrated that the EATV index is associated with AAA expansion.

Severe Tortuosity of the Distal Descending Thoracic Aorta Affects the Accuracy of Distal Deployment During a Thoracic Endovascular Aortic Repair.

PURPOSE: An accurate distal deployment is essential for successful thoracic endovascular aortic repair (TEVAR) of a paradiaphragmatic aortic aneurysm. This study aimed to investigate the anatomical and intraoperative factors that affect the accuracy of distal deployment during TEVAR. METHODS: We conducted a retrospective review of preoperative and postoperative computed tomography scans of 426 patients undergoing TEVAR at our institution between October 2008 and May 2021, of which the stent-graft was attempted to be deployed just above the celiac axis or the superior mesenteric artery in 56 patients. Based on the anatomical factors related to the malposition (deployed >10 mm away from the target vessel) and the greater curve to the straight-line ratio (G/S ratio), the patients were categorized as severe tortuosity (n=21) and mild tortuosity (n=35) groups to compare the operative and clinical outcomes. RESULT: Stent-graft malpositioning occurred in 21 cases. Among all anatomical variables, only the G/S ratio was significantly larger in the malpositioned cases (p=0.049). A cutoff G/S ratio value of 1.15 was determined using the receiver operating curve analysis. In the severe tortuosity group, the distal end of the stent-graft was significantly farther (median: 10.0 [interquartile range (IQR): 2.5-19.5] mm vs 3.0 [0-8.0] mm; p=0.015) from the target vessel, and the tilt angle of the stent-graft's distal edge was larger (median: 21.4 [IQR: 15.8-24.5] vs 9.5 [5.5-12.5] degree; p<0.01) than that in the mild tortuosity group. Both groups were comparable for the incidence of a primary type Ib endoleak (p=0.454), a secondary type Ib endoleak (p=1.0), and the rate of distal reintervention (p=0.276). CONCLUSION: Severe tortuosity in the distal descending thoracic aorta is associated with a malpositioned and tilted distal end of the stent-graft. CLINICAL IMPACT: Thoracic endovascular aortic repair (TEVAR) for paradiaphragmatic thoracic aortic aneurysms requires accurate distal landing. In this paper, a retrospective CT analysis revealed that the greater curve to the straight-line ratio (G/S ratio) was associated to affects the malposition of the stent graft, defined as being deployed more than 10 mm away from the target vessel. Further, a comparative analysis based on the G/S ratio demonstrated that severe aortic tortuosity was associated with a more distal and tilted deployment of the stent graft.

Outcomes of the Gore Excluder Iliac Branch Endoprosthesis for Japanese Patients With Aortoiliac Aneurysms: A Study Based on J-Preserve Registry.

PURPOSE: To evaluate the clinical utility of the Gore Excluder iliac branch endoprosthesis (IBE) for Japanese patients with aortoiliac aneurysms. MATERIALS AND METHODS: This was a multicenter retrospective cohort study (J-Preserve Registry). Patients undergoing endovascular aortic repair using the Gore Excluder IBE for aortoiliac aneurysms between August 2017 and June 2020 were enrolled. Data pertaining to the baseline and anatomical characteristics, technical details, and clinical outcomes were collected from each institution. The primary endpoints were technical success, IBE-related complications, and reinterventions. Secondary endpoints were mortality, aneurysm size change, and reintervention during follow-up. Technical success was defined as accurate deployment of the IBE without type Ib, Ic, or III endoleaks on the IBE sides on completion angiography. A change in aneurysm size of 5 mm or more was taken to be a significant change. RESULTS: We included 141 patients with 151 IBE implantations. Sixty-five IBE implantations (43.0%) had at least one instruction for use violation. Twenty-two patients (15.6%) required internal iliac artery (IIA) embolization for external iliac artery extension on the contralateral side. Of 151 IBE implantations, 19 exhibited IIA branch landing zones due to IIA aneurysms. Mean maximum and proximal common iliac artery (CIA) diameters were 32.9±9.9 mm and 20.5±6.9 mm, respectively. The mean CIA length was 59.1±17.1 mm. The IIA landing diameter and length were 9.0±2.3 mm and 33.8±14.6 mm. The overall technical success rate was 96.7%. There were no significant differences in IBE-related complications (2.3% vs 5.3%, p=0.86) or IBE-related reinterventions (1.5% vs 5.3%, p=0.33) between the IIA trunk and IIA branch landing groups. The mean follow-up period was 635±341 days. The all-cause mortality rate was 5.0%. There were no aneurysm-related deaths or ruptures during the follow-up. Most patients (95.7%) had sac stability or shrinkage. CONCLUSION: The Gore Excluder IBE was safe and effective for Japanese patients in the midterm. Extending the IIA device into the distal branches of the IIA was acceptable, which may permit extending indications for endovascular aortic aneurysm repair of aortoiliac aneurysms to more complex lesions. CLINICAL IMPACT: This study suggests clinical benefits of the Gore Excluder IBE for Japanese patients, despite 43% of the IBE implantations having at least one IFU violation.

Impact of Serum Zinc Level and Oral Zinc Supplementation on Clinical Outcomes in Patients Undergoing Infrainguinal Bypass for Chronic Limb-Threatening Ischemia.

BACKGROUND: Zinc (Zn) has been reported to play an important role in wound healing (WH). Nevertheless, the effect of Zn in chronic limb-threatening ischemia (CLTI) patients is unclear. This study investigated the effect of Zn on the clinical outcomes of CLTI patients undergoing bypass surgery.Methods and Results: This study reviewed 111 consecutive patients who underwent an infrainguinal bypass from 2012 to 2020. Patients with Zn deficiency (serum Zn level <60 µg/dL) received oral Zn supplementation and maintained a normal level until WH. This study aimed to explore: (1) the effect of Zn deficiency; and (2) Zn supplementation in Zn-deficient patients on the clinical outcomes of this cohort. Patients with Zn deficiency, Zn supplementation, and no Zn supplementation despite Zn deficiency accounted for 48, 21, and 42 patients, respectively. (1) Zn deficiency was associated with WH (HR, 0.47; 95% CI, 0.29-0.78: P=0.003), major adverse limb events (MALE) (HR, 2.53; 95% CI, 1.26-5.09: P=0.009), and major amputation or death (HR, 3.17; 95% CI, 1.51-6.63: P=0.002). (2) Zn supplementation was positively related to WH (HR, 2.30; 95% CI, 1.21-4.34: P=0.011). This result was confirmed using propensity score matching (HR, 2.24; 95% CI, 1.02-4.87: P=0.043). CONCLUSIONS: The current study revealed that Zn level was associated with clinical outcomes in CLTI patients after bypass surgery. Oral Zn supplementation could improve WH in these patients.

New Morphological Factor for Predicting Late Proximal Type I Endoleak after Endovascular Aneurysm Repair.

BACKGROUND: Although we have witnessed several cases of late proximal type I endoleak (T1AEL) after endovascular aneurysm repair (EVAR), most patients did not have "hostile neck" preoperatively. We hypothesized that the distance between the lowest renal artery and the neck angulation point and neck length are the 2 most important factors for maintaining long-term proximal sealing. This study evaluated "neck hostility," which is the product of the distance to the angulation point and the neck length, as a preoperative morphological risk factor for the development of late T1AEL after EVAR. METHODS: A retrospective review of a prospectively assembled database was performed for all patients who had undergone EVAR at a single institution from June 2007 to May 2017. Patient demographics and preoperative imaging data were collected, and Cox regression analysis was performed to identify the risk factors for late T1AEL. RESULTS: Of the 655 patients who underwent EVAR during the study period, 115 were excluded due to complex EVAR (n = 14), primary indications for iliac aneurysms (n = 86), primary T1AEL (n = 3), or other reasons (n = 15). Of the remaining 537 patients, twelve patients (2.2%) developed late T1AEL a median of 3.2 (interquartile range [IQR]; 3.0, 5.4) years after EVAR. Receiver operating characteristic (ROC) curve analysis revealed a neck hostility cutoff value of 8. Cox regression analysis revealed that a neck hostility value ≤8 and conical neck anatomy were risk factors for the development of late T1AEL after EVAR. Well-known hostile neck factors such as short neck, severe angulated neck, and severe calcification/thrombus in the proximal neck were not significantly different. CONCLUSIONS: The present study demonstrated a correlation between late T1AEL and the product of the angulation distance and the neck length. This factor may be useful for predicting poor late proximal outcomes after EVAR.

Predictors of infrapopliteal vein bypass graft revision in patients with chronic limb-threatening ischemia.

PURPOSE: Surgical revascularization is the standard treatment for chronic limb-threatening ischemia (CLTI). However, some patients may require reintervention. The Global Anatomic Staging System (GLASS), which evaluates the complexity of infrainguinal lesions, was proposed. This study aimed to identify predictors for graft revision and evaluate whether GLASS impacts vein graft revision. METHODS: Between 2011 and 2018, CLTI patients who underwent de novo infrapopliteal bypass using autogenous veins were retrospectively analyzed. To assess anatomic complexity with GLASS, femoropopliteal, infrapopliteal, and inframalleolar/pedal (IM) disease grades were determined. The outcomes of patients with or without graft revision were compared. Cox regression analysis was performed. RESULTS: Thirty-six of the 80 patients underwent reintervention for graft revision. Compared to the non-graft revision group, the graft revision group exhibited significantly higher rates of GLASS stage III (66% vs 81%, p = 0.046) and grade P2 IM disease (25% vs 58%, p = 0.009). Multivariate analysis revealed that IM grade P2 (hazard ratio [HR], 3.35; 95% confidence interval [CI], 1.66-6.75; p = 0.001) and spliced vein grafts (HR, 3.18; 95% CI, 1.43-7.06; p = 0.005) were significantly associated with graft revision. CONCLUSIONS: This study demonstrated that IM grade P2 and spliced vein grafts were predictors of graft revision. The GLASS stratification of IM disease grade may be useful in optimizing treatment for CLTI.

Preoperative sarcopenia and malnutrition are correlated with poor long-term survival after endovascular abdominal aortic aneurysm repair.

PURPOSE: Sarcopenia and malnutrition are often used as surrogates for frailty, which is predictive of poor prognosis after surgery. We investigated the effects of sarcopenia and malnutrition on mortality after endovascular aneurysm repair (EVAR). METHODS: The subjects of this study were patients who underwent EVAR at our hospital between June 2007 and December 2013, excluding those who underwent reintervention. The psoas muscle area at the L4 level was used as an indicator of sarcopenia. The Geriatric Nutritional Risk Index was used as an indicator of malnutrition. RESULTS: There were 324 patients included in the study, with a mean age of 78.1 years and a median follow-up period of 56.7 months. Multivariate analysis revealed that sarcopenia (HR, 1.79; p = .042) and malnutrition (HR, 1.78; p = .043) were independent prognostic factors. Patients with both factors were classified as the high-risk group and others were classified as the low-risk group. The survival rate was significantly lower in the high-risk group than in the low-risk groups (p < .001). Even after propensity score matching, the high-risk group had a significantly lower survival rate (p < .001). CONCLUSION: Both sarcopenia and malnutrition were associated with long-term mortality after EVAR. Patients with both indicators had a poor mid-term survival.

Impella5.0 "ILIPELLA" Approach for a Fulminant Myocarditis Patient With a Small Peripheral Artery.

Cardiogenic shock with fulminant myocarditis is a life-threatening diagnosis. Extracorporeal membrane oxygenation (ECMO) with an Impella for left ventricle unloading is often required to maintain the haemodynamics. However, the small peripheral vascularity in small-bodied patients interrupts the upgrade from ECMO to Impella5.0, which usually requires grafting to a femoral artery or subclavian artery of at least 7 mm in size. This report outlines the external iliac artery approach, named the "ILIPELLA" technique, which uses a reconstructed external iliac artery to introduce Impella5.0 in patients with small peripheral vascularity.

The association between perioperative embolization of hypogastric arteries and type II endoleaks after endovascular aortic aneurysm repair.

OBJECTIVE: Type II endoleaks (T2ELs) are the most common type of endoleak after endovascular aneurysm repair (EVAR). The iliolumbar artery arising from the hypogastric artery is often a major source of T2ELs, and transarterial embolization of the iliolumbar artery through the hypogastric artery is sometimes performed to interrupt sac expansion during follow-up. Considering the equivocal results of an association between hypogastric embolization and T2ELs in previous studies, this topic has re-emerged after the advent of iliac branch devices. This study reviewed our series to clarify whether hypogastric embolization is associated with T2ELs at 12 months after EVAR. METHODS: Patients who underwent elective EVAR between June 2007 and May 2017 at our institution were retrospectively reviewed. Patients with postoperative computed tomography angiography (CTA) at 12 months were included. Patients in whom CTA revealed type I or type III endoleaks during follow-up, who required reinterventions before 12 months, and who had solitary iliac aneurysms were excluded. The primary outcome was the incidence of T2ELs at 12 months after EVAR. The associations of patients' characteristics, anatomic factors, hypogastric embolization, and type of endograft with the primary outcome were analyzed. RESULTS: In total, 375 patients were enrolled. During the median follow-up of 59.5 months (interquartile range, 19-126 months), 40 patients died, and 50 reinterventions were performed. In 108 patients (28.8%), either hypogastric artery was embolized to extend distal landings to the external iliac artery. Bilateral and unilateral embolization was performed in nine and 99 patients, respectively. In total, 153 patients (40.8%) had T2ELs found by CTA at 12 months. In the univariate analysis, the status of hypogastric artery occlusion or embolization was not significantly different between patients with and without T2ELs. However, there were not enough patients to detect a 10% difference in T2ELs with >80% statistical power. In the multivariate analysis, significant associations with T2EL were observed for female sex (P = .049), patent inferior mesenteric artery (P = .006), and presence of five or more patent lumbar arteries (P < .001) but not for hypogastric embolization. In addition, compared with the Zenith (Cook Medical, Bloomington, Ind) endograft, the Excluder (W. L. Gore & Associates, Flagstaff, Ariz) endograft was significantly related to T2EL (P = .001). CONCLUSIONS: No significant association between hypogastric embolization and T2EL was demonstrated in this retrospective study, which lacked adequate statistical power.

Low-density vulnerable thrombus/plaque volume on preoperative computed tomography predicts for spinal cord ischemia after endovascular repair for thoracic aortic aneurysm.

BACKGROUND: Similar to open surgical repair, thoracic endovascular aortic repair (TEVAR) carries a risk of spinal cord ischemia (SCI). However, the generally lower incidence of SCI after TEVAR compared with that after open surgical repair, despite the inability to preserve the intercostal arteries, indicates different pathophysiologic mechanisms with the two procedures. We hypothesized that a microembolism from an aortic mural thrombus is the main cause of SCI. Thus, we evaluated the association between the density of a mural thrombus in the descending thoracic aorta and the development of SCI. METHODS: A retrospective review of a prospectively assembled database was performed for all patients who had undergone surgery at a single institution from October 2008 to December 2018. Patient demographics and procedure-related variables were collected. The volume and Hounsfield unit (HU) value of mural thrombi in the whole descending thoracic aorta were estimated on preoperative computed tomography using a three-dimensional workstation. Logistic regression analysis was performed to identify the risk factors for SCI development. RESULTS: Of the 367 patients who had undergone TEVAR during the study period, 155 were excluded because of previous arch surgery (n = 59), previous descending thoracic aortic surgery (n = 6), previous TEVAR (n = 6), unavailability of optimal preoperative computed tomography data (n = 17), double-barreled dissection (n = 40), and other reasons. The mean ± standard deviation age of the remaining 212 patients was 75.8 ± 6.4 years, and 42 (19.8%) were women. Of the 212 patients, 14 (6.6%) developed SCI after TEVAR. The low mean density of the mural thrombus, total thrombus volume, low-density (≥-100 HU but <30 HU) thrombus volume, intermediate-density (≥30 HU but <150 HU) thrombus volume, treatment length, urgent surgery, and baseline dialysis differed significantly between patients with and without SCI. Although subsequent multivariate analysis could not be performed owing to the small number of SCI events, vulnerable low-density thrombus/plaque was a stronger predictor among the aneurysm-related factors of SCI after TEVAR on univariate analysis. Well-known risk factors, such as distal coverage between T8 and L1, left subclavian artery coverage, previous abdominal aortic surgery, and prophylactic spinal drainage, did not show significant differences. CONCLUSIONS: The results from the present study have demonstrated that among aneurysm-related factors, a lower density mural thrombus/plaque in the descending thoracic aorta is a predictor of SCI development after TEVAR. These results suggest that microembolism is one of the important mechanisms of SCI after TEVAR, which might change the prophylactic strategy.

Midterm Outcomes of Zone 0 Antegrade Endograft Implantation During Type I Hybrid Aortic Arch Repair.

OBJECTIVE: Type I hybrid arch repair has become popular as a procedure that is less invasive than total arch replacement. The major advantage of this technique is that antegrade endograft implantation can be performed during the procedure, thereby avoiding the complications of introducing the endograft from the groin. The aim of this study was to assess the midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation. METHODS: Thirty consecutive patients who underwent type I hybrid repair with antegrade endograft implantation from 2009 to 2015 were reviewed retrospectively. Patient demographics, and peri-operative and late results were collected from a prospective database and analysed. RESULTS: Four patients (13%) were female and the median age was 78 years. Median aneurysm size was 64 mm. Six patients (20%) developed stroke, and the 30 day mortality rate was 3%. Two patients suffered aortic dissection at the site of debranching anastomosis. The median follow up was 5.2 years. All aneurysms remained stable or had decreased in size at three years, and 82% were stable at five years. Overall survival was 79% at three years and 71% at five years. The rates of freedom from aorta related death were 86% at three and five years, respectively. During the follow up period, three additional left subclavian artery embolisations and one endograft relining due to type IIIb endoleak were required. CONCLUSION: Midterm outcomes of type I hybrid aortic arch repair with antegrade endograft implantation for aortic arch aneurysms are reported. Although the incidence of peri-operative stroke was high, late sac behaviour was acceptable.