Iliac Limb Occlusion Research Articles

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

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. 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. 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. 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.

Rotational Mechanical Thrombectomy to Treat Iliac Limb Occlusion after Endovascular Aortic Aneurysm Repair: The Rotational Mechanical Thrombectomy Italian Study

PurposeTo assess the safety and effectiveness of a rotational mechanical atherothrombectomy device in patients with symptomatic iliac limb occlusion after abdominal endovascular aneurysm repair (EVAR). Materials and MethodsA retrospective analysis was conducted on patients who underwent rotational mechanical thrombectomy using the Rotarex S device for symptomatic acute, subacute, or chronic graft limb thrombosis at 5 vascular centers between 2017 and 2021. This study comprised 23 male patients with a mean age of 74.5 years (SD ± 7.2) at the time of the procedure. The clinical presentation of the patients varied, with 1 patient experiencing acute limb ischemia and 11 patients (47.8%) experiencing disabling intermittent claudication. The remaining patients developed chronic limb-threatening ischemia after iliac limb occlusion. Early outcomes included technical success, postprocedural complications, and periprocedural mortality. Follow-up evaluations encompassed primary patency, patient survival, freedom from reintervention, and the need for surgical conversion. ResultsTechnical success was achieved in all cases, with no occurrences of distal embolization during or after the procedure, and no periprocedural deaths were reported. Endograft relining was performed in 82.6% of patients to establish a new, nonthrombogenic surface within the graft. Over a median follow-up period of 8 months (interquartile range, 3–16 months), 2 patients experienced iliac limb reocclusion. No deaths or other reinterventions occurred during the observational follow-up period. ConclusionsRotational mechanical thrombectomy for iliac limb occlusion after EVAR appears to be both safe and effective. This technique may uncover intraluminal defects contributing to graft occlusion and enable their resolution within the same procedure.

Novel Surgeon-Modified Fenestrated Iliac Stent Graft.

We describe the feasibility and early results of a novel endovascular approach with a surgeon-modified fenestrated iliac stent graft to preserve pelvic perfusion in patients with iliac aneurysms not suitable for iliac branch devices (IBDs). Seven high-risk patients, median age 76 years (range 63-83), with a complex aortoiliac anatomy with contraindications for commercially available IBDs were treated with a novel surgeon-modified fenestrated iliac stent graft between August 2020 and November 2021. The modified device was built using an iliac limb stent graft (Endurant II Stent Graft; Medtronic), which was partially deployed, surgically fenestrated with a scalpel, reinforced, re-sheathed, and inserted via femoral access. The internal iliac artery was cannulated and bridged with a covered stent. Technical success rate was 100%. After a median follow-up period of 10 months, there was 1 type II endoleak and no migrations, stent fractures, or loss of device integrity. One iliac limb occlusion occurred after 7 months, which needed a secondary endovascular intervention, restoring patency. Surgeon-modified fenestrated iliac stent graft is feasible and might be used as an alternative in patients with a complex iliac anatomy not suitable to commercially available IBDs. Long-term follow-up is needed to evaluate stent graft patency and potential complications. Surgeon modified fenetrated iliac stent grafts might be a promising alternative to iliac branch devices, extending endovascular solutions to a broader patient population with complex aorto-iliac anatomies preserving antegrade internal iliac artery perfusion. It is possible to treat small iliac bifurcations and large angulations of the iliac bifurcation safely and there is no need for a contralateral or upper-extremity access.

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

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). 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. 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. 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.

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft

ObjectiveOutcome reports after endovascular aneurysm repair (EVAR) using the low-profile Zenith Alpha Abdominal Endovascular grafts (Cook Medical, Bjæverskov, Denmark) are sparse. We present results from a single-center cohort treated with the Zenith Alpha, from a period where the graft was the primary EVAR device choice. The aim of the study was to evaluate short- and midterm outcomes of patients treated with the Zenith Alpha. MethodsA retrospective single-center study was performed including all patients treated with the Zenith Alpha graft from October 1, 2015 to September 30, 2018. All patients underwent computed tomography angiography (CTA) imaging preoperatively as well as at 3 and 12 months postoperatively. Hereafter, patients were followed yearly with duplex ultrasound and clinical exams. Additional imaging was performed on indication. All CTAs were analyzed using three-dimensional reconstruction software (Aquarius, TeraRecon, Durham, NC). Data was extracted from electronic charts according to a protocol that remained unchanged until the end of the study (December 31, 2020). The following outcomes were assessed according to Society for Vascular Surgery/International Society of Cardiovascular Surgeons reporting criteria: aortic-related and all-cause mortality, reinterventions, instruction for use (IFU) violations, endoleaks (ELs), and aneurysm shrinkage. ResultsA total of 241 patients were treated with the Zenith Alpha, and 214 (89%) were asymptomatic repairs. Technical success was achieved in 238 patients (99%). One hundred fifty-seven patients (65%) received implantation outside IFU. The median hospital length of stay was 2 days (interquartile range, 2-3 days). The median clinical follow-up was 35.1 months (interquartile range, 28.8-47.5 months). The 4-year Kaplan-Meier estimate of freedom from reintervention was 66% (95% confidence interval, 59%-73%). The main reasons for reinterventions were iliac limb stenosis and occlusion (n = 30; 12%) and type 2 EL (n = 13; 5%). Overall, significantly more patients with grafts implanted outside distal IFU developed type 1B ELs (n = 10/11; P = .009). Aneurysm sac shrinkage was observed in 48 patients (25%) 1 year postoperatively. The Kaplan-Meier estimate of freedom from aortic-related mortality was 99% (95% confidence interval, 98%-100%) 4 years postoperatively. ConclusionsEVAR with the Zenith Alpha shows acceptable freedom from aortic-related mortality up to 4 years postoperatively. The majority of patients were treated outside IFU, and significantly more type 1B ELs appeared in this subgroup of patients. The leading cause for reintervention was impaired limb patency. The root cause for impaired limb patency requires further investigation.

Early and Midterm Results after Endovascular Repair of Non-infected Saccular Lesions of the Infrarenal Aorta

The aim was to report short and midterm outcomes of a cohort of consecutive patients treated by endovascular aortic repair (EVAR) for saccular lesion of the abdominal aorta (sl-AA). This was a multicentre, retrospective, financially unsupported physician initiated, observational cohort study that involved tertiary referral from Italian hospitals. For this study, between January 2010 and December 2020, only those patients treated by EVAR for non-infected sl-AA, namely blister/ulcer like projection and/or penetrating aortic ulcer, were analysed. Primary outcomes of interest were overall survival and freedom from aorta related mortality (ARM). The final cohort included 120 of 3 982 eligible aortic lesions. There were 103 (85.8%) males and 17 (14.2%) females. The median age was 76 years (interquartile range [IQR] 69, 80). Rupture on admission was observed in 10 (8.3%) cases. Early (≤ 30 days) death occurred in two (1.7%) patients. There were five (4.2%) complications requiring surgical re-intervention (iliac limb occlusion n= 4; groin haematoma, n= 1). The median duration of follow up was 20 months (IQR 4, 59.5): the estimated overall survival was 85.5% (standard error [SE] 0.035; 95% confidence interval [CI] 77.3 - 91.1) at 12 months, 78.7% (SE 0.044; 95% CI 69.0 - 86.0) at 36 months, and 74% (SE 0.050; 95% CI 63.2 - 82.5) at 60 months. Only one (0.8%) patient required aortic re-intervention during follow up because of a late endograft infection. The estimated freedom from ARM was 96% (SE 0.050; 95% CI 90.3 - 98.2) at 36 and 60 months. Cox's regression analysis identified that death was associated with age > 70 years (hazard ratio [HR] 1.10; 95% CI 1.04 - 1.17, p= .001), and coronary artery disease (HR 1.14; 95% CI 1.04 - 1.26, p= .006). EVAR for sl-AA proved to be safe and effective. The mortality rate was low for a group of patients known to be at high risk from open repair, and EVAR remained stable with no ARM during midterm follow up, and an acceptably low 0.8% endograft related re-intervention rate.

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.

Application of the AngioJet Ultra Thrombectomy Device for the Percutaneous Mechanical Treatment (PMT) of Iliac Limb Occlusion after Endovascular Aneurysm Repair (EVAR)

To investigate the safety and efficacy of applying the AngioJet Ultra thrombectomy device in treating endograft occlusions in the iliac arteries following endovascular aneurysm repair (EVAR). This study utilized a retrospective analysis of 452 patients with infrarenal abdominal aortic aneurysm (AAA). Twelve of the patients experienced iliac limb occlusion during their follow-up period, and the AngioJet Ultra thrombectomy device was used in tandem with iliac angioplasty to treat these patients. The safety of the device was assessed through the amount of blood drawn, the duration of the procedure, and the occurrence of post-operative complications, while its efficacy was assessed through aortic computed tomography angiography (CTA) imaging and post-operative symptomatology results. All 12 patients were male, and they had a mean age of 62.8 ± 11.8 years. Iliac limb occlusion occurred on the left side of 4 patients and on the right side of 8 patients. The AngioJet Ultra thrombectomy device was used together with iliac angioplasty during surgery, with a success rate of 100%. A bifurcated endograft was successfully implanted in 9 patients following AngioJet Ultra thrombectomy and balloon dilation angioplasty, while a unibody endograft was successfully implanted in 3 patients following AngioJet Ultra thrombectomy and balloon dilation angioplasty. The mean surgery duration was 2.4 hrs, and the patients were hospitalized for an average of 4.5 days. After surgery, the patients' intermittent claudication/buttock claudication gradually vanished. Two patients experienced hemoglobinuria, with one of them developing mild renal dysfunction. Currently, the twelve patients have been followed up for an average of 12 months, and none have experienced any lower extremity ischemia. The use of the AngioJet Ultra thrombectomy device as a supplementary treatment for iliac limb occlusion following abdominal EVAR is safe, effective, and minimally invasive.

Analysis of prognosis factors for reintervention after endovascular aneurysm repair in patients with abdominal aortic aneurysm

Objectives: To examine the prognosis factors for readmission after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm (AAA) patients in the Chinese population. Methods: A total of 1 129 AAA patients who underwent EVAR at Department of Vascular Surgery, Zhongshan Hospital, Fudan University, from January 2010 to December 2017 were enrolled. There were 948 males and 181 females, with an age of (71.2±9.6) years (range: 18 to 93 years). Comorbidities included primary hypertension found in 630 patients, diabetes mellitus in 129 patients and coronary heart disease in 163 patients. A total of 214 patients had a history of smoking, and 11 patients had a history of previous aortic intervention.Clinical data including baseline information, laboratory examinations and follow-up data before December 31, 2019 were retrospectively collected. The primary end point was readmission. Cox regression analysis was used to analyze the prognosis factors for the end point. Results: All patients completed at least one follow-up with a follow-up time of 22.7(42.6) months (range: 1 to 120 months). The readmission rate of 1 year post-operation was 4.52% (51/1 129). The overall readmission rate was 11.34% (128/1 129) during the whole follow-up duration. The main reasons of readmission included endoleak in 60 patients with readmission, iliac limb occlusion in 25 patients and distal iliac aneurysm in 12 patients. Age (HR=0.972, 95%CI: 0.956 to 0.987, P<0.01) and elevated pre-operative fibrinogen level (HR=2.213, 95%CI: 1.185 to 4.134, P=0.013) were found to be the prognosis factors for the survival time free from aortic-related readmission in univariate Cox regression analysis. Elevated pre-operative fibrinogen level (HR=2.542, 95%CI: 1.353 to 4.776, P=0.004) was found to be the prognosis factor for the survival time free from aortic-related readmission in multivariate Cox regression analysis. Conclusions: The most common reason for readmission was endoleak, followed by iliac limb occlusion and distal iliac aneurysm. Elevated pre-operative fibri nogen level was the risk factor for the survival time free from aortic-related readmission, though further researches were warranted for exploring the underlying mechanism.

The Efficacy of a Protocol of Iliac Artery and Limb Treatment During EVAR in Minimising Early and Late Iliac Occlusion

Iliac limb occlusion (ILO) is a complication of endovascular aortic repair (EVAR) and requires re-intervention in most cases. Attention to any intra-operative defect of iliac limbs and arteries may prevent ILO. The study aimed to analyse the long term effect of an intra-operative protocol of iliac limb treatment during EVAR on ILO. Patients treated from 2012 to 2017 for abdominal aortic aneurysm (AAA) with standard EVAR were collected prospectively. Pre-operative computed tomography angiography anatomical characteristics were evaluated. The protocol for intra-operative iliac limb management was: a. pre-EVAR angioplasty of common/external iliac artery stenosis; b. precise contralateral iliac limb deployment at the same level of the flow divider; c. iliac limb kissing ballooning with high pressure non-compliant balloons; d. iliac limb stenting for residual tortuosity/kink and adjunctive external iliac stenting for residual stenosis/dissection after EVAR. ILO was evaluated at 30 days and at follow up, which was performed by duplex ultrasonography before discharge, at three, six, and 12 months and yearly thereafter. Kaplan-Meier and Cox linear regression were used. Four hundred and forty-two patients and 884 iliac limbs were included in the study. Severe iliac tortuosity and calcification were present in 15% (132/884) and 8% (70/884), respectively. External iliac angioplasty and stenting of iliac limb were performed in 2% (18/884) and 9.5% (84/884) of limbs. The thirty day mortality was 1.6%, with no ILO. At a mean follow up of 33±12 months, ILO occurred in 7/884 (0.8%) limbs of six patients. Five ILO were treated by endovascular relining, two surgically: one by femorofemoral bypass and one by surgical explant. On univariable analysis, sac shrinkage was significantly associated with ILO (HR 1, 95% CI 0.8-2.5, p=.043). A protocol of aggressive iliac limb treatment in EVAR leads to a very low rate of late ILO. The role of sac shrinkage in ILO should be investigated further.

Fenestrated and Branched Thoraco-abdominal Endografting after Previous Open Abdominal Aortic Repair

Proximal para-anastomotic aneurysms, or aneurysmal degeneration of the native aorta above a previous open abdominal aortic repair (Pr-AAAs), are challenging scenarios. The aim of this study was to report the early and mid term outcomes of endovascular repair of Pr-AAAs by fenestrated and branched endovascular aneurysm repair (FB-EVAR). From 2006 to 2017, pre-operative, intra-operative, and post-operative data from patients undergoing FB-EVAR for Pr-AAAs at two European vascular surgery units were prospectively collected and retrospectively analysed. Early results were considered in terms of technical success (target visceral vessel cannulation and stenting, absence of type I - III endoleak, iliac limb occlusion and 24h mortality); spinal cord ischaemia (SCI) and 30 day and in hospital mortality. Survival, target visceral vessel (TVV) patency, and freedom from re-interventions were also considered at the mid term follow up. Five hundred and forty-four patients underwent FB-EVAR to treat juxta/pararenal or thoraco-abdominal aneurysms. Of these patients, 108 (19.8%) cases were Pr-AAAs (94% male; mean±standard deviation [SD] age 71±4 years; American Society of Anesthesiologists' grade 3-4 in 74% and 26%, respectively). The previous open aortic repair (OR) was performed 10±2 years before FB-EVAR. It was a tubular aorto-aortic repair in 63 (58.3%) cases, a bifurcated aortobi-iliac repair in 37 (34.2%) cases, and an aortobifemoral bypass repair in eight (7.4%) cases. A previous thoracic endovascular aneurysm repair (TEVAR) had been performed in seven patients (6.5%). The aortic lesion at the time of FB-EVAR was, according to the Crawford classification, a type I - III in 69 (63.9%) or a type IV 39 (36.1%) thoraco-abdominal aneurysm. The mean±SD aneurysm diameter was 64±6mm. Overall, 390 TVVs (3.6±1 TVV/case) were revascularised by an endograft with fenestrations (n=63 [58.3%]), with branches (n=26 [24.1%]), or with both fenestrations and branches (n=19 [17.6%]). Tubular, trimodular, or aorto-uni-iliac implants were planned in 68 (63.0%), 38 (35.2%), and two (1.8%) patients, respectively. Proximal TEVAR, carotid-subclavian bypass, and iliac branch devices were planned as adjunctive procedures in 41 (38.0%), five (4.6%), and three (2.8%) cases, respectively. Overall technical success was 93%, with technical failures including five TVV losses (coeliac trunk, n=1; renal arteries, n=4) and three deaths within 24h. Post-operative SCI occurred in seven patients (6.5%), four of which (3.7%) were permanent. SCI was more frequent in category I - III TAAAs (p=.042) and in endografts incorporating both fenestrations and branches (p=.023). Cardiac, pulmonary, and renal complications (reduction in glomerular filtration rate of ≥30% compared with baseline) occurred in 9%, 10%, and 20%, respectively. Bowel ischaemia was seen in three (2.8%) patients. Thirty day mortality was 4% and was associated with pre-operative chronic renal failure (p=.034), post-operative cardiac morbidity (p=.041), and bowel ischaemia (p=.003). Overall in hospital mortality was 5.5% (n=6). Mean±SD follow up was 38±18 months. Survival was 82%, 64%, and 54% at one, three, and five years, respectively, and target visceral vessel patency was 93%, 91%, and 91%, respectively. Permanent haemodialysis was needed in four patients (3.7%). There was no late aneurysm related mortality. Survival during follow up was statistically significantly affected by pre-operative chronic renal failure (p=.022), post-operative cardiac morbidity (p=.042), SCI (p=.044), and bowel ischaemia (p=.003). Freedom from re-intervention at one, three, and five years was 89%, 77%, and 74%, respectively. Endovascular treatment of aneurysmal aortic degeneration above a previous open abdominal repair with FB-EVAR is safe and effective. If those promising results are confirmed at later follow up, FB-EVAR should be considered a prominent therapeutic option, especially in high risk patients.

Risk Factors for Early and Late Iliac Limb Occlusions of Stent Grafts Extending to the External Iliac Artery after Endovascular Abdominal Aneurysm Repair

Iliac limb stent grafting to the external iliac artery (EIA) is a commonly performed procedure in various situation during endovascular abdominal aneurysm repair (EVAR). However, this procedure is associated with a risk of graft occlusion. We evaluated risk factors affecting occlusion among patients who underwent iliac limb stent-graft extension to the EIA. We compared occluded limbs with patent limbs during the follow-up period using variables, including anatomical values, demographics, and other factors. Thereafter, we divided the occluded limbs into early and late occlusion subgroups. The main and subgroup analyses used the same variables. Survival analysis was performed to evaluate time-dependent risk factors for late limb occlusion. From 2007 to 2016, 766 iliac limbs from 383 patients who underwent EVAR were initially included in our analysis. Among them, 134 iliac limbs underwent limb extension to the EIA. The limb extension was a significant risk factor for occlusion (hazard ratio=6.34, P<0.001). Occlusion occurred in 10 patients who underwent iliac limb extension. The size of common iliac artery (CIA) was associated with occlusion. The most significant factor was iliac bifurcation diameter (patent vs. occluded limbs, 21.6±7.6 vs. 27.5±9.5mm, P=0.005). Subgroup analysis revealed that the CIAs of the early occlusion subgroup were generally more tortuous (1.16±0.33 vs. 1.47±0.25, P=0.091) and longer (53±24 vs. 74±9, P=0.01) than those of the patent limb group. In addition, the EIA diameters of the late occlusion subgroup were narrower than those of the patent limb group (10.9±1.6mm vs. 9.1±0.8mm, P=0.011). Using the log-rank test, those patients with an EIA diameter narrower than 10.1mm had a higher risk for late limb occlusion (log-rank χ2=5.73, P=0.017) and the patients who did not take at least a single antiplatelet agent had a significantly higher chance of limb occlusion (log-rank χ2=11.029, P=0.001). In addition, the patients who did not take a statin had a higher risk for late limb occlusion (log-rank χ2=7.41, P=0.007). Among patients who underwent EVAR with iliac limb extension, the CIA length affected early limb occlusion and predisposed patients to vessel injury or stent-graft kinking, and there was the possibility that CIA tortuosity was associated with a higher risk. The late occlusion subgroup had narrower EIAs than the patent limb group. Appropriate antiplatelet and statin therapy is expected to play a key role in the prevention of late limb occlusion after EVAR.

Final results from a postmarket registry of an iliac leg graft with a continuous, spiral nitinol stent

ObjectiveTo evaluate clinical outcomes from a postmarket registry of the Zenith Spiral-Z abdominal aortic aneurysm iliac leg graft with a continuous, spiral nitinol stent that was designed for improved conformability, kink, and migration resistance. MethodsThis prospective, multicenter registry was designed to evaluate physician-reported outcomes of the Spiral-Z leg graft in up to 600 patients who underwent endovascular repair of abdominal aortic or aortoiliac aneurysms at up to 30 investigative sites in the United States and Canada. Study outcomes were focused on iliac limb occlusion, limb-related reintervention, limb-related endoleak, component separation, and device integrity. Short-term data were collected during an interval of 1 to 6 months, with longer term data collected at 12 months. ResultsBetween March 2012 and March 2015, 599 patients (mean age 74 ± 8 years; 87% male; 26% with aortoiliac aneurysm) were treated, with Spiral-Z iliac leg grafts placed in 564 left iliac arteries and 559 right iliac arteries. The mean iliac inner diameters (both left and right) were 9 ± 3 mm; moderate/severe occlusive disease, calcification, and vessel tortuosity were present in 14%, 25%, and 36% and 15%, 25%, and 34% of the left and right iliac arteries, respectively. Iliac artery adjunctive procedures (iliac artery angioplasty and/or stent placement) were performed intraoperatively in 112 patients (19%; bilateral in 52 patients). Mortality within 30 days was 1.7% (10/599); cumulative mortality at 1 year was 6.2% (37/599). There were no aortic ruptures and only one open conversion (0.2%). Limb occlusions occurred in 11 of 599 patients (2%; 3 within 30 days and 8 after 30 days, all unilateral, none had received procedural iliac artery adjuncts at implantation); of these, 7 patients underwent reinterventions. Other limb-related reinterventions were performed on eight patients for nonocclusive kink, compression, or thrombus (six within 30 days and three after 30 days). In total, 13 patients (2%) underwent 15 limb-related reinterventions (7 for occlusions and 8 for nonocclusive causes). In one patient, a distal type I endoleak and device migration (>10 mm) involving a right iliac leg was noted at the 12-month follow-up visit. No other limb-related endoleak, migration, component separation, or stent fracture was reported during a mean follow-up of 11 ± 6 months. ConclusionsThe Spiral-Z leg graft demonstrated excellent patency and required infrequent limb-related reinterventions in routine clinical care in a postmarket registry.

Graft-related complications after open surgery of abdominal aortic aneurysm – An 8-year follow-up study

Introduction: Open surgery repair (OSR) is generally considered as a single definitive procedure and requires minimal postoperative follow-up once immediate survival is established. There are many studies which focus on endovascular aneurysm repair reintervention, only few contemporary studies report graft-related reinterventions after open repair. The present study describes the incidence of graft-related complications following OSR for abdominal aortic aneurysm (AAA) and its management. This study also analyse the factors which can preoperatively predict the occurrence of graft related complications, so that necessary steps can be taken to prevent such complications. Materials and Methods: This is a single-center prospective analysis of 165 patients who underwent elective open repair for AAA over a period of 8 years from January 2008 to December 2016. Demographics, preoperative, perioperative, and postoperative data were recorded in a structured data collection sheet after reviewing patient records and institutional electronic medical records after obtaining clearance from the Institutional Ethics Committee. Results: The overall incidence of graft-related complications in our study was 6.6%. The most common graft-related complication in our study is iliac graft limb occlusion 3.6% followed by graft infection of 1.5% and anastomotic pseudo aneurysm of 1.5%. The graft-related reintervention rate is 5.1% and graft-related mortality is 1.5% in 8-year follow-up. The risk factors for graft-related complications are preoperative uncontrolled DM, aorto-iliac aneurysms, use of bifurcated graft, and postoperative wound infection. Conclusions: This study showed that aggressive control of DM preoperatively and anastomosing distal Y-limb of graft to femoral artery rather than external iliac artery may decrease the complications. The majority of graft-related complications occurred 2 years after surgery. Hence, we suggest that those patients with above risk factors should be put on a short-interval surveillance program.

Fenestrated and Branched Endografting After Previous Open Infra-renal Aortic Aneurysm Repair

Introduction - Proximal para-anastomotic aneurysms, or aneurysmal degenerations of the native aorta above a previous infra-renal aortic open repair (P-AAAs), are not rare challenging scenarios. The aim of this study was to report the early and mid-term outcomes following endovascular repair of P-AAAs with fenestrated and branched endografts (FB-EVAR) Methods - From 2006 to 2017, we prospectively collected and retrospectively analyzed pre, intra and postoperative data of patients undergoing FB-EVAR for P-AAAs at two European vascular surgery units. Early outcomes were: technical success (target visceral vessels cannulation and stenting, absence of Type I-III endoleak, iliac limb occlusion and 24-h mortality), spinal cord ischemia (SCI), and 30-day mortality. Mid-term outcomes were: survival, target visceral vessels (TVV) patency, and freedom from re-interventions. Fisher’s exact test, Kaplan Mayer and Log rank were used for the statistical analysis Results - During the study period, 108 patients (M:94%; age:71±4years; ASA 3-4:74%>26%) were enrolled. The previous aortic OR was a tubular aorto-aortic 63(58%), a bifurcated aorto bi-iliac 37(34%) or an aorto bi-femoral 8(8%) bypass. The OR was performed 10±2years prior to the FB-EVAR. A previous TEVAR had also been performed in 7 patients (6%). The aortic lesions at the time of FB-EVAR was a type I-III 69(64%) or type IV 39(36%) thoracoabdominal aneurysm according to the Crawford’s classification. The mean aneurysm diameter was 64±6mm. Overall, 390 TVVs (3.6±1 TVV/case) were perfused by endograft fenestrations (63;58%), branches (26;24%) or both fenestrations and branches (19;18%). Tubular, tri-modular or aorto-monoiliac implants were planned in 68 (63%), 38 (35%) and 2 (2%) patients, respectively. Proximal TEVAR, carotid-subclavian bypass and iliac branch devices were planned adjunctive procedures in 41 (38%), 5 (5%) and 3 (3%) cases, respectively. Technical success was 93%. Technical failures included 5 TVV-loss (celiac trunk:1; renal arteries:4) and 3 deaths within 24 hours (cardiac aetiology). Post-operative SCI was diagnosed in 7 patients (7%), including 4 (4%) permanent. Type I-III TAAAs (p .04) and endograft incorporating both fenestrations and branches (p .04) were associated with SCI. Cardiac and pulmonary morbidity was 9% and 10%, respectively. Post-operative renal failure (GFR reduction >30% of baseline) was diagnosed in 22 patients (20%). Bowel ischemia was depicted in 3 (3%) patients. The 30-day mortality was 4%. Preoperative chronic renal failure (p .03), post-operative cardiac morbidity (p .04), and bowel ischemia (p .003) were associated with 30-day mortality. The mean follow-up was 38±18 months. Survival at 1, 3 and 5 years was 82%, 64% and 54%, respectively. There was no late aneurysm-related mortality. Survival during follow-up was significantly impacted by pre-operative chronic renal failure (p .005), post-operative cardiac morbidity (p .04), and SCI (p .04). Target visceral patency at 1, 3 and 5 years was 93%, 91% and 91%, respectively. New onset of hemodialysis was required in 4 patients (4%). Aneurysm enlargement (>5mm) was detected in 6 (5.5%) cases. Freedom from re-interventions at 1, 3 and 5 years was 89%, 77% and 74%, respectively Conclusion - Endovascular treatment of aortic aneurysmal evolution above a prior open AAA repair with FB-EVAR is safe and effective. If those promising results are confirmed during late follow-up, FB-EVAR should be considered as a therapeutic option, especially in high-risk patients

Impact of Common Iliac Artery’s Anatomy on the Risk of Endograft Limb Occlusion after EVAR

Introduction - The aim of the study was to evaluate incidence and outcome of iliac limb occlusion (ILO) in patients undergoing endovascular aneurysm repair (EVAR) and to identify potential predictors in respect of the anatomy of common iliac artery.

AAA 19. Midterm Results of Parallel Grafts in Patients With Pararenal and Type IV Thoracoabdominal Aortic Aneurysms Unsuitable for Fenestrated or Branched Endografts

The objective of this study was to evaluate the midterm outcomes of parallel grafts (PGs) in patients presenting with pararenal or type IV thoracoabdominal aortic aneurysms unsuitable for off-the-shelf or custom-made fenestrated or branched endografts. Between February 2011 and July 2019, there were 41 consecutive patients presenting with pararenal or type IV thoracoabdominal aortic aneurysms who were treated by implantation of PGs. Reasons for use of PGs were the following: patients judged unfit for open surgery; urgent or emergent procedures in which off-the-shelf graft was not applicable; and elective patients refused for manufacture of custom device because of anatomy. Different commercially available endografts and covered balloon or self-expandable stents were used. Outcomes included intraoperative technical success and early (30-day) and midterm all-cause mortality and morbidity as well as freedom from reintervention, endoleaks, and occlusions of PGs. Technical success was defined as a procedure completed as intended, without secondary interventions within 30 days. Forty-one patients were included (mean age, 76.3 ± 7.1 years; 34 male). Mean aortic aneurysm diameter was 67.2 ± 18.6 mm. Twenty-three patients were treated electively; the remaining patients were treated in emergency. Previous infrarenal aneurysm repair was reported in 11 patients (26.8%). Ninety-two target aortic branches (TABs) were treated (2.2/patient). Technical success was obtained in all patients. At 30 days, mortality was 7.4%, accounting for three emergently treated patients (two aortic infections and one rupture), and TAB occlusion rate was 2.1% (2/92). One patient required an additional embolization procedure because of a persistent gutter endoleak. At a mean follow-up of 29 ± 7 (2-96) months, freedom from mortality was 89.5%; four more patients died (one new infection, one aneurysm rupture, and two myocardial infarctions). Rate of TAB new occlusion was 1.1% (1/92). Reintervention was performed in four patients, in three for endoleaks and in one for iliac limb occlusion. During the entire study period, cumulative TAB occlusion rate was 3.2%, all renal branches. Aneurysm sac shrinkage was observed in 59.5% of patients, with a mean aneurysm diameter reduction 3.8 ± 2.1 mm. The technique of PGs seems to represent a reasonable option in patients at high risk for open surgery who are not able to be treated by fenestrated or branched endografts. Despite high clinical and anatomic risk of treated patients, TAB patency remains high at midterm follow-up.

Single-Center Experience and Preliminary Results of Intravascular Ultrasound in Endovascular Aneurysm Repair

Intravascular ultrasound (IVUS) has been introduced as diagnostic adjunct to provide new insights into the diagnosis and therapy of vascular disease. Herein, we compared the outcomes of conventional endovascular aneurysm repair (EVAR) and EVAR with IVUS in patients presenting with infrarenal abdominal aortic aneurysm using a propensity-matched cohort. From May 2013 to August 2017, 221 patients were retrospectively analyzed. Of that, 122 patients were eligible for inclusion and underwent propensity score matching. Perioperative mortality and morbidity, renal function impairment, endoleak incidence, mean contrast medium usage, operative time, radiation exposure (including fluoroscopy time, dose-area product [DAP], and digital subtraction angiography [DSA] runs), survival, and freedom from reintervention were the outcomes measured. After matching, 52 patients were included, 26 in the conventional EVAR group and 26 in the EVAR with IVUS group. No perioperative mortality or type I/III endoleak were registered. One perioperative lymphatic fistula and one iliac limb occlusion were observed. In the EVAR with IVUS group, a significant reduction of contrast medium (92 [vs. 51±17] vs. 51 [20-68] mL; P=0.003) and radiation exposure including fluoroscopy time (12 [9-16] vs. 20 [12-25] min; P=0.001), DAP (15 [9-21] vs. 32 [16-44] G*cm2; P=0.002), and DSA runs (2 [1-3] vs. 3 [2-4]; P=0.04) was reported. No differences were observed in terms of glomerular filtration rate (86 [45-121] vs. 90 [38-117] mL/min; P=0.14) and operation time (176 [124-210] vs. 179 [120-210]; P=0.48). Survival at 36months was 93% for standard EVAR and 92% for EVAR with IVUS (P=0.845). Freedom from reintervention at 36months was 85.5% in both the groups (P=0.834). In this preliminary experience, the use of IVUS during EVAR was feasible with no registered postoperative complications. A significant reduction of contrast medium usage and radiation exposure was observed with the use of IVUS. The IVUS is an adjunctive tool to consider in the vascular surgeon armamentarium, especially in centers where advanced radiological tools of imaging fusion are not available.

Use of Bilateral Cook Zenith Iliac Branch Devices to Preserve Internal Iliac Artery Flow During Endovascular Aneurysm Repair

Iliac branch devices (IBD) have become a widespread option to preserve antegrade internal iliac artery (IIA) flow during endovascular aneurysm repair (EVAR). Reported experience with bilateral implantation of IBDs is limited. This study aimed to describe the indications, technical options, and outcomes with the use of bilateral IBDs. All patients undergoing elective implantation of bilateral Cook Zenith IBD between January 2010 and September 2017 in a single centre were included. Bilateral IBD was indicated in physically active, anatomically suitable patients and those with previous or concomitant surgery for a thoraco-abdominal aortic aneurysm or impaired collateral circulation to the IIA. Data were collected prospectively. Twenty-nine patients (29 male, mean age 64.1±10 years) were included. Of the 58 IBDs, 48 (83%) were implanted in one procedure and 10 (17%) in two procedures (mean time between procedures 30.4±9 months). Nineteen patients (65%) had a previous or simultaneous EVAR and the remaining 10 (35%) a previous or simultaneous complex aortic repair. Mean CIA diameter was 35.2±8mm. Technical success was achieved in 55 of the 58 IBDs (95%) with no mortality. Axillary artery access was used in 13 (38%) procedures. During follow up, four (7%) IIA branches occluded (1 bilateral occlusion and 2 unilateral). Estimated IIA branch patency at one and three years was 97.8%±2% and 88.5%±7%, respectively. All patients with late IIA occlusion remained asymptomatic. Re-intervention was needed in four patients (14%): two bridging stent graft extensions for type Ib endoleak, one relining of the external iliac artery because of mural in-stent thrombus and one femoro-femoral crossover bypass to treat an external iliac limb occlusion. Bilateral implantation of IBDs is a safe and effective technique to preserve IIA flow in selected patients with suitable anatomy, showing similar technical success and mid-term outcomes to the unilateral use of the device.

Outcomes of Endovascular Aneurysm Repair using the Ovation Stent Graft System in Adverse Anatomy

The aim was the evaluation of mid-term efficacy and safety outcome measures for the Ovation (Endologix, Santa Rosa, CA, USA) stent graft system in the management of infrarenal abdominal aortic aneurysms (iAAA) with adverse anatomy. A retrospective observational study of all patients undergoing elective iAAA repair was carried out from 2012 to 2017 using Ovation Prime or iX stent grafts with a minimum of 3 months follow-up at a single UK vascular centre. Post-operative surveillance involved computed tomography scans at 3 months and 1 year, with duplex ultrasound yearly thereafter. Outcome measures were established with retrospective analysis of pre- and post-operative imaging, and included peri-operative mortality, major adverse events, limb complications, aneurysm diameter change, and endoleak rates. All patients were within Ovation instructions for use (IFU), and assessment was made to determine whether aneurysms had anatomical features considered adverse for other commonly used stent graft platforms. Ovation stent grafts were implanted in 52 patients (79% male, mean age 75.7 years) with a mean aneurysm diameter of 62.5mm (range 55-107mm). There was 100% technical deployment success. The 30 day mortality was 0% and there was no aneurysm related mortality during follow-up (median 24 months, range 3-48 months). There were no type I or III endoleaks, but 19% developed type II endoleaks with one patient requiring re-intervention. No iliac limb occlusions were identified but one case required relining for limb kinking. All 52 cases were within the IFU for Ovation but only 12% met the IFU criteria for the Cook and Medtronic devices. The mid-term experience with Ovation demonstrates safe, durable treatment of iAAAs, including those with unfavourable anatomy, frequently off IFU for other commonly used devices.