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.

Limb graft occlusion after endovascular aneurysm repair with the Cook Zenith Alpha abdominal graft.

OBJECTIVE: Prior reports of the low profile Zenith Alpha abdominal graft (Cook Medical Inc, Bloomington, IN) have shown impaired limb graft patency to be the primary causes of reintervention. Special notices from the manufacturer have indicated certain instructions for use (IFU) violations as the main reasons for these complications. In the present study, we assessed the incidence of limb graft occlusion (LGO) and analyzed the effects of the detailed anatomic risk factors for LGO highlighted in the IFU and previously reported studies. METHODS: A retrospective study was performed of 241 patients treated with the low profile Zenith Alpha at a single institution from October 1, 2015 to September 30, 2018. All computed tomography angiograms were analyzed using three-dimensional software. Data were extracted from the electronic medical records until the end of the study period (December 31, 2020). The cumulative incidence of LGO and LGO-related reinterventions were assessed. A regression analysis was performed to evaluate the possible risk factors associated with the development of LGO at specified time points. These included aortic and iliac diameters, graft component oversizing, iliac tortuosity and calcification, overlap of graft components, proximal alignment of ipsilateral and contralateral legs, and sealing zone in the external iliac artery. Reader agreement of iliac calcification and tortuosity was assessed in patients with LGO. RESULTS: A total of 33 limbs (7%) in 27 patients (11%) had become occluded. The cumulative incidence of LGO was 7% (95% confidence interval [CI], 5%-9%) per limb up to 3 years postoperatively. The previously described risk factors for LGO were studied using regression analysis; however, no positive association with LGO was identified. Heavily calcified common iliac arteries (CIAs) and external iliac arteries were protective against LGO compared with noncalcified vessels up to 3 years postoperatively (decreased risk, 17% [95% CI, -27% to -7%]; P = .001; and 15% [95% CI, -26 to -5]; P = .005, respectively). The reader agreement of iliac calcification and tortuosity showed substantial agreement (CIA intrareader kappa = 0.75; CIA interreader kappa = 0.62) and almost perfect agreement (intrareader kappa = 0.85; interreader kappa = 0.84), respectively. CONCLUSIONS: The cumulative incidence of LGO after endovascular aneurysm repair with the Zenith Alpha graft was 7% per limb up to 3 years postoperatively. None of the analyzed risk factors suggested by the IFUs or current literature were positively associated with LGO.

Geometrical Changes of the Aorta as Predictors for Thromboembolic Events After EVAR With the Anaconda Stent-Graft.

PURPOSE: Thromboembolic events (TE), including limb graft occlusion (LGO) and distal limb embolization (DLE), are common complications after endovascular aneurysm repair (EVAR). The aim of this study was to find predictors for TE in patients treated with the Anaconda stent-graft for infrarenal aneurysms. MATERIALS AND METHODS: Geometrical and anatomical variables were retrospectively analyzed in a consecutive Anaconda cohort. Pre- and postoperative CT scans were used to derive geometrical parameters length, curvature, torsion, and tortuosity index (TI) from the center lumen lines (CLLs). Limb characteristics, pre-to-post EVAR and mid-term-follow-up changes in the parameters were evaluated for their predictive value for TE. RESULTS: Eighty-four patients (mean age 74±8.3 years, 74 men) were enrolled. The risk of TE was lowered with pre-to-post implant decreasing TI (steps of 0.05: OR: 1.30, 95% CI: 1.01-1.66, p=0.04), pre-to-post implant decreasing mean curvature (OR: 1.08, 95% CI: 1.01-1.16, p=0.03), and a larger degree of circumferential common iliac artery (CIA) calcification (OR: 0.98, 95% CI: 0.97-1.00, p=0.03). The only LGO predictor was the caudal relocation of maximal curvature after EVAR (OR: 1.01, 95% CI: 1.00-1.01, p=0.04). Preventors of DLE were CIA diameter (OR: 0.87, 95% CI: 0.76-0.99, p=0.04), circumferential CIA calcification (OR: 0.97, 95% CI: 0.95-1.00, p=0.03), mean and maximal curvature of the preoperative aortoiliac trajectory (OR: 0.86, 95% CI: 0.79-0.94, p<0.01 and OR: 0.97, 95% CI: 0.95-1.00, p=0.03, respectively) and pre-to-postoperative decrease in mean curvature (OR: 1.11, 95% CI: 1.02-1.21, p=0.02). Midterm TE predictors were length (OR: 0.95, 95% CI: 0.89-1.01, p=0.08) and torsion maximum location (OR: 1.01, 95% CI: 0.99-1.01, p=0.10). CONCLUSION: The present study confirms that treatment of infrarenal AAA with an Anaconda stent-graft is related to a relatively high TE rate which decreases with a pre-to-postoperative reduction in curvature and TI, and a larger degree of circumferential CIA calcification. In other words, more aortoiliac straightening and more circumferential CIA calcification may prevent TE development after EVAR with this stent-graft.

Percutaneous mechanical thrombectomy for limb graft occlusion after endovascular aneurysm repair: Results of a case series.

OBJECTIVE: Limb graft occlusion (LGO) is a recognised complication after endovascular aneurysm repair (EVAR). We present outcomes of a case series of LGO treated by percutaneous mechanical thrombectomy (PMT). METHODS: Six male patients (mean age 70.5 ± 7.5 years) presented with LGO after EVAR (n = 4), fenestrated EVAR with an iliac branch device (n = 1), branched EVAR (n = 1). Median time to occlusion was 28.5(IQR 90) weeks; all occlusions were unilateral. The presenting symptom was intermittent claudication (n = 4), chronic limb-threatening ischaemia (n = 1) or acute limb ischaemia (n = 1). PMT was undertaken using the 10F Rotarex Rotational Excisional Atherectomy System (Becton, Dickinson and Company, Franklin Lakes, USA) with optional stenting/reline of the affected limb. RESULTS: LGO was cleared in all 6 cases by PMT with limb stenting (n = 4)/limb reline (n = 2)/outflow stenting (n = 2). Post-operatively, novel oral anticoagulant therapy supplemented prior antiplatelet therapy in all cases. Length of stay was 2 (IQR 19) days. All cleared limbs remain patent at median 15 (IQR 185) weeks follow-up. CONCLUSION: This case series indicates that percutaneous mechanical thrombectomy is associated with high technical success rates and subsequent acceptable ensuing short-to-midterm patency. This approach is a valid alternative to surgical interventions in such cases, and represents our primary approach when LGO is encountered after EVAR.

Hybrid Approach: Combining Surgical Thrombectomy and AngioJet™ Aspirational Thrombectomy in Limb Graft Occlusion Post-FEVAR with Fenestrated Anaconda™ and in ePTFE Bypass Graft Occlusion.

Acute limb ischemia due to limb-graft occlusion (LGO) after fenestrated endovascular aneurysm repair (FEVAR) and acute bypass graft occlusion with an ePTFE graft pose critical challenges, necessitating prompt intervention to prevent limb loss. This paper discusses two cases of acute limb ischemia treated with a hybrid approach using the AngioJet™ Ultra Thrombectomy System as an adjunct to Fogarty thrombectomy. Case I involved a 69-year-old male post-FEVAR with contralateral iliac limb graft occlusion of the fenestrated Anaconda™, while Case II featured a 70-year-old male (ASA IV) post-bypass surgery (iliopopliteal arterial bypass with ePTFE Graft) with acute bypass graft occlusion. Both cases underwent successful recanalization using the AngioJet™ Ultra Thrombectomy System (ZelanteDVT™ 8F catheter, Solent™ Proxi 6F catheter) (Boston Scientific, Marlborough, MA, USA), combined with adjunctive techniques including Fogarty thrombectomy, balloon angioplasty, stenting, and local lysis. Immediate postoperative and follow-up assessments after 6 months revealed restored limb perfusion and improved clinical outcomes, with palpable pulses and improved ulcer healing. The aim of this treatment strategy is not only to alleviate limb ischemia but also to preserve future options in the event of graft failure. The use of the AngioJet™ Thrombectomy System in cases of LGO aims not only to clear the thrombus load but also to avoid the need for graft relining. In the case of acute arterial bypass graft occlusion in a patient with ASA IV, the goal of using the thrombectomy device is to preserve the native vessels for future procedures, such as long infragenual bypass, in addition to limb salvage. These cases demonstrate the efficacy of a hybrid surgical approach in managing acute limb ischemia following graft occlusion following FEVAR and bypass surgery. Long-term follow-up will further elucidate the durability of these interventions and their impact on limb salvage and overall patient outcomes. By combining mechanical thrombectomy with adjunctive techniques, such as balloon angioplasty and stenting, this hybrid approach offers a comprehensive solution to acute limb ischemia, addressing both the underlying occlusive pathology and ensuring optimal limb perfusion. Furthermore, the utilization of the AngioJet™ Ultra Thrombectomy System provides a minimally invasive yet effective method for thrombus removal, reducing procedural time and potential complications associated with open surgical techniques. As such, this approach represents a valuable addition to the armamentarium of treatments for acute limb ischemia, particularly in cases of graft occlusion following complex endovascular and bypass procedures.

Limb graft occlusion following endovascular aortic repair: Incidence, causes, treatment and prevention in a study cohort.

The present study investigated the incidence, causes, treatment and prevention of limb graft occlusion following endovascular aortic repair (EVAR). A total of 66 cases of abdominal aortic aneurysm receiving EVAR at our department from January 2005 to December 2013 were enrolled. After EVAR, patients received routine antiplatelet therapy of 75 mg PLAVIX for 6 months and then 100 mg Aspirin for another 6 months by oral administration. According to previous clinical experiences, antiplatelet therapy is able to effectively reduce the incidence of iliac occlusion after EVAR. A total of 61 bifurcated grafts and 5 aortauniilac grafts (127 limbs in total) were used. Physical examination, ankle-brachial-index and computer tomographic angiography were performed at 10 days, at 3, 6 and 12 months and annually thereafter. It was found that 7 limbs in 7 patients (10.6% of patients, 5.5% of limbs) were occluded between 20 days and 12 months (average, 7.8±5.3 months) after EVAR. Acute and severe ischemia was found in 2 cases, claudication was in found 3 cases, asthenia in both legs was found in 1 case and 1 case was asymptomatic. Femoral-femoral bypass, femoral-femoral bypass and stenting, aorto-iliac/femoral bypass, thrombectomy and conservative treatment were performed in 1 patient each and thrombectomy together with stenting was performed in 2 cases. Limb graft occlusion was not rare after EVAR. Treatment of this complication included surgery and endovascular therapy such as bypass, thrombectomy and thrombolysis. In conclusion, aggressive pre-emptive treatment including angioplasty and stenting prevented occlusion in certain cases.