Cook Zenith Alpha Endograft: A Protocol to Minimise Limb Graft Occlusion.

OBJECTIVE: Numerous articles have reported an increased incidence of limb graft occlusion (LGO) with the Cook Zenith Alpha endograft compared with other endografts in endovascular aortic aneurysm repair (EVAR). The present study aimed to assess the rate of LGO after EVAR in particular with the Cook Zenith Alpha device when adhering to a standardised protocol designed to prevent limb related complications. METHODS: This was a non-sponsored retrospective study performed in two university vascular surgery centres employing the same protocol for limb complication prevention during EVAR from 2016 to 2019. The protocol encompassed: (1) angioplasty of any common or external iliac artery with > 50% stenosis before endograft navigation; (2) proximal sealing zone of limbs at the same level of the flow divider with minimum overlap, which is more restrictive than the Cook Zenith Alpha instructions for use; (3) semi-compliant kissing ballooning of limbs; (4) limb stenting for any residual tortuosity, kinking, or stenosis; and (5) adjunctive common and external iliac stenting for residual stenosis or dissection after EVAR. Patients enrolled in this study were treated with standard aortobi-iliac EVAR. Follow up was performed by clinical visit and duplex ultrasonography at discharge, six months, and yearly thereafter. The primary endpoint was to evaluate the LGO rate with different EVAR devices (Cook Zenith Alpha, Gore C3, and Medtronic Endurant) and to determine potential risk factors for LGO associated with the Zenith Alpha. RESULTS: In the study period, 547 EVARs were considered: 233 (42.6%) Cook Zenith Alpha, 196 (35.8%) Gore Excluder, and 118 (21.6%) Medtronic Endurant. The mean follow up was 44 ± 23 months, and the five year freedom from LGO was 97 ± 3%, without differences between groups (97 ± 2%, 95 ± 3%, and 100% with Cook Zenith Alpha, Medtronic Endurant, and Gore Excluder, respectively; p = .080). In the Zenith Alpha group, intra-operative adjunctive iliac artery angioplasty, iliac artery stenting, or iliac limb stenting was performed in 8%, 3.4%, and 9.7% of cases, respectively. Analysis of potential risk factors for LGO identified external iliac artery distal landing and large main bodies (ZIMB 32 - 36) to be independently associated with LGO during follow up (hazard ratio [HR] 18, 95% confidence interval [CI] 3 - 130, p = .004; and HR 12, 95% CI 1.2 - 130, p = .030, respectively). CONCLUSION: The present experience with a protocol for limb complication prevention allows achievement of a low rate of LGO at five years with Zenith Alpha endografts similar to other endografts. Specific risk factors for the Cook Zenith Alpha endograft are external iliac artery distal landing and the use of a large main body (ZIMB 32 - 36).

Penumbra Indigo Percutaneous Aspiration Thrombectomy System in the treatment of Aortic Endograft Iliac Limb Occlusion: Results from an Italian Multicentre Registry.

OBJECTIVE: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR). METHODS: A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete or complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at one, six, and 12 months. RESULTS: From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 ± 8% and 90 ± 9%, respectively. CONCLUSION: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year.

[Clinical Analysis of the Treatment of Iliac Limb Occlusion Following Endovascular Abdominal Aortic Aneurysm Repair].

Objective To explore the cause and the treatment strategies of iliac limb occlusion after endovascular abdominal aortic aneurysm repair(EVAR). Methods The patients receiving EVAR in PUMC Hospital from January 2015 to December 2020 were retrospectively analyzed.Sixteen(2.7%)cases of iliac limb occlusion were identified,among which 6,9,and 1 cases underwent surgical bypass,endovascular or hybrid procedure,and conservative treatment,respectively. Results Fifteen cases were successfully treated.During the 10.6-month follow-up,2 cases receiving hybrid treatment underwent femoral-femoral bypass due to re-occlusion of the iliac limb. Conclusions Iliac limb occlusion mostly occurs in the acute phase after EVAR,and endovascular or hybrid treatment can be the first choice for iliac limb occlusion.It is suggested to focus on the risk factors for prevention.

Meta-analysis and meta-regression analysis of iliac limb occlusion after endovascular aneurysm repair.

OBJECTIVE: Our objective was to investigate the incidence, interventions and outcomes of iliac limb occlusion after endovascular aneurysm repair (EVAR). METHODS: We performed a systematic review that conformed to the Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines using a registered protocol (CRD42017064375). We considered studies reporting patients with iliac limb occlusion after EVAR. We interrogated electronic information sources and bibliographic reference lists using a combination of free text and controlled vocabulary searches. We conducted a proportion meta-analysis of outcomes applying a random effects model. We used mixed effects (methods of moments) regression models to investigate whether the incidence of iliac limb occlusion changed over time. RESULTS: We identified 13 studies reporting a total of 5454 patients who underwent EVAR from 1995 to 2014. The pooled incidence estimate of primary iliac limb occlusion was 5.6% (95% confidence interval [CI], 4.0-7.8). The incidence of iliac limb occlusion was more pronounced in old studies and declined in more recently published studies (slope P = .022; Q=5.279). Forty-four percent (95% CI, 36%-52%) had an acute presentation. One-half of the patients (48%; 95% CI, 41%-56%) presented within 30 days of EVAR. Seventeen percent (95% CI, 13%-23%) underwent endovascular treatment, 8% (95% CI, 5%-13%) received hybrid procedures, and 61% (95% CI, 54%-67%) had open surgery. The 30-day mortality was 0.036 (95% CI, 0.018-0.070; heterogeneity: P = .999, I2 = 0%). The rate of limb loss within 30 days and during follow-up was 0.031 (95% CI, 0.015-0.063; heterogeneity: P = .999; I2 = 0%) and 0.045 (95% CI, 0.024-0.083; heterogeneity: P = .978; I2 = 0%), respectively. Reintervention was undertaken in 0.080 (95% CI, 0.048-0.130; heterogeneity P = .919; I2 = 0%) over a follow-up ranging from 7 to 39 months. The mortality during follow-up was 0.056 (95% CI, 0.031-0.099; heterogeneity: P = .866; I2 = 0%). CONCLUSIONS: Iliac limb occlusion occurred in 5.6% of patients after EVAR. One-half of these patients presented early. Even though surgical treatment has been used more frequently, there is insufficient evidence to suggest its superiority over endovascular/hybrid repair. A considerable number of patients will require reintervention. Future research is needed in identifying patients at risk of iliac limb occlusion.

Sequential Graft Limb Occlusion Following Endovascular Aneurysm Repair: A Case Report and Literature Review.

Limb graft occlusion (LGO) is a common complication that can occur after endovascular aneurysm repair (EVAR). There are many factors that can contribute to LGO, including patient-related variables, device-related considerations, and factors associated with the procedural technique. Patients with LGO may exhibit no symptoms, have intermittent claudication, or suffer from acute limb ischemia. In this manuscript, we present a case of a 64-year-old male who experienced sequential LGOs after EVAR accompanied by a comprehensive review of the pertinent literature.

Predictive Factors for Iliac Limb Occlusions After Endovascular Abdominal Aneurysm Repair: Determined from Aortoiliac Anatomy, Endovascular Procedures, and Aneurysmal Remodeling.

Purpose: Iliac limb occlusion (ILO) is a serious complication of endovascular abdominal aneurysm repair (EVAR). This study aimed to identify predictive factors for ILO derived from aortoiliac morphology, endovascular procedure-related parameters, and aneurysmal remodeling characteristics. Patients and Methods: Patient demographics, pre-EVAR anatomical characteristics of the aneurysm, endovascular procedure details, and post-EVAR aneurysmal remodeling outcomes were analyzed and compared using univariate analysis. Statistically significant factors were subsequently subjected to Cox regression and Kaplan-Meier analyses. Results: Between January 2013 and April 2022, 66 patients were included in this study. Fourteen patients presented with ILO and were compared with 52 control patients with patent endograft limb over at least 1-year of follow-up. The tortuosity indices of the common iliac artery (CIA) and endograft iliac limb to vessel oversizing were significantly larger in the ILO group than in the patent endograft limb group. The CIA index of tortuosity ≥1.08, and endograft iliac limb to vessel oversizing ≥18.8% were independent predictors for ILO. During the follow-up of all patients, the proximal aortic neck and CIA diameters increased, aneurysm sac diameter decreased, and aortic neck and aortic length increased. The aortoiliac length increased over time in patients with patent endograft limb but not in patients with ILO. A change in the lowest renal artery-left iliac bifurcation distance ≦0.07 mm increased the risk of ILO. Conclusion: ILO is predisposed to occur when the CIA index of tortuosity ≥1.08 and endograft iliac limb to vessel oversizing ≥18.8% are present. Significant aortoiliac remodeling, including proximal aortic neck dilatation, neck straightening, aneurysmal sac regression, iliac artery enlargement, and aortic lengthening, occurs after EVAR. Aortoiliac elongation was observed in patients with patent endograft limb, but not in patients with ILO. ILO was associated with a change in the lowest renal artery-left iliac bifurcation from the postoperative measurements ≦ 0.07 mm.

Endovascular Treatment of Iliac Limb Occlusion After Endovascular Repair of Abdominal Aortic Aneurysm / 中国微创外科杂志

Objective To explore the effect of endovascular re-operation on iliac limb occlusion(ILO)after endovascular aneurysm repair(EVAR).Methods Clinical data of 6 patients with ILO after EVAR from March 2018 to March 2023 were retrospectively analyzed.All the patients underwent ipsilateral femoral artery incision with Fogaty balloon thrombectomy and iliac artery balloon dilation,3 of which were combined with stent implantation and 1 of which with popliteal artery thrombectomy of Rotarex.Results The recanalization rate of the 6 patients with iliac branch occlusion was 100%(6/6).The median follow-up time was 24 months(range,6-48 months).The symptoms of lower extremity ischemia disappeared in 5 patients(Rutherford 0 grade).One patient had limb ischemia and dry gangrene(RutherfordⅢgrade).Conclusion It is necessary to carefully analyze the causes and choose personalized endovascular treatment plans for ILO after EVAR.

Clinical Analysis of the Treatment of Iliac Limb Occlusion Following Endovascular Abdominal Aortic Aneurysm Repair / 中国医学科学院学报

Objective To explore the cause and the treatment strategies of iliac limb occlusion after endovascular abdominal aortic aneurysm repair(EVAR). Methods The patients receiving EVAR in PUMC Hospital from January 2015 to December 2020 were retrospectively analyzed.Sixteen(2.7%)cases of iliac limb occlusion were identified,among which 6,9,and 1 cases underwent surgical bypass,endovascular or hybrid procedure,and conservative treatment,respectively. Results Fifteen cases were successfully treated.During the 10.6-month follow-up,2 cases receiving hybrid treatment underwent femoral-femoral bypass due to re-occlusion of the iliac limb. Conclusions Iliac limb occlusion mostly occurs in the acute phase after EVAR,and endovascular or hybrid treatment can be the first choice for iliac limb occlusion.It is suggested to focus on the risk factors for prevention.