Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up.

BACKGROUND: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. RESULTS: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). CONCLUSIONS: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%). CLINICAL TRIAL REGISTRATION: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device.

BACKGROUND: The use of flow diversion to treat intracranial aneurysms has increased in recent years. OBJECTIVE: To assess the safety and angiographic efficacy of the p64 flow modulation device. METHODS: Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography. RESULTS: A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10). CONCLUSIONS: Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity.

Hybrid Repair of an Aneurysm of the Innominate Artery.

INTRODUCTION: Innominate artery aneurysms (IAAs) are rare. They are notorious for causing thromboembolic events. Modern imaging modalities make early detection in an asymptomatic phase possible. In Kieffer group B aneurysms the origin of the innominate artery is affected. Thanks to the combination of open and endovascular techniques, off pump repair is feasible in patients with a fragile aortic arch. During this hybrid procedure the aortic arch is debranched and reinforced with a stent graft. REPORT: A 73 year old white man with a history of extensive thoraco-abdominal aortic reconstructions for aneurysmal disease presented with a progressive Kieffer B IAA of 35 mm. He underwent an off pump hybrid repair. A bifurcated Dacron prosthesis was used for the debranching. The main body originated from the ascending aorta. The right limb was anastomosed to the common ostium of the right carotid and subclavian arteries. The left limb was anastomosed to the left subclavian and carotid artery. The aortic arch was reinforced with a 40 × 162 mm Zenith TX2 endoprosthesis. The endoprosthesis was inserted through a temporary conduit on the main body and deployed during rapid ventricular pacing. The endoprosthesis lined the ascending aorta distal to the debranching up to Ishimaru zone 3. The antegrade insertion prevented excessive manipulation of the aortic arch and the tortuous aorta, which was lined with mural thrombus. Post-operative computed tomography showed a patent debranching with excellent alignment of the endoprosthesis without endoleak. DISCUSSION: Hybrid repair of the aortic arch is well described in literature. This technique was adapted in the treatment of a Kieffer group B IAA. The tortuous aorta and mural thrombus led to the antegrade placement of the endoprosthesis through the main body of the debranched aorta. This approach seems safe and feasible.

The Woven EndoBridge for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center.

BACKGROUND AND PURPOSE: The Woven EndoBridge (WEB) is an intrasaccular flowdisruptor that is increasingly used for the treatment of (wide-necked) aneurysms. We present our experience with the WEB for unruptured aneurysms. MATERIALS AND METHODS: Between April 2014 and August 2019, 93 patients with 95 unruptured aneurysms were primarily treated with the WEB. There were 69 women and 24 men, mean age 61 years (median 58, range 37-80). RESULTS: Of 95 aneurysms, 86 had been discovered incidentally, 3 were symptomatic and 6 were additional to another ruptured aneurysm. Location was anterior communicating artery 33, middle cerebral artery 29, basilar tip 19, carotid tip 8, posterior communicating artery 4, posterior inferior cerebellar artery 1, superior cerebellar artery 1. Mean aneurysm size was 6 mm (median 6, range 3-13 mm).In one aneurysm additional coils were used and in another, a stent was placed. There was one procedural rupture without clinical sequelae. There were two thrombo-embolic complications leading to permanent deficit in one patient (mRS 2). Morbidity rate was 1.0% (1 of 93, 95%CI 0.01-6.5%) and mortality was 0% (0 of 93, 95%CI 0.0-4.8%). Angiographic follow-up at six months was available in 85 patients with 87 aneurysms (91%). Of 87 aneurysms, 68 (78%) were completely occluded, 14 (16%) had a neck remnant and 5 were incompletely occluded. Four aneurysms were retreated. Retreatment rate was 4.5% (4 of 87, 95%CI 1.7-13.6%). CONCLUSION: WEB treatment of unruptured aneurysms is safe and effective. Additional devices are needed only rarely and retreatment at follow-up is infrequent.

The external carotid artery as a rare feeder of a spinal dural arteriovenous fistula causing cervical myelopathy: A review of the literature.

Introduction: A causal relationship between SDAVF's and cervical myelopathy is exceedingly rare. 1-2% of these lesions are located at the craniocervical junction of which 12% are caused by arterial feeders from the external carotid artery. A correct diagnosis can be challenging with a high rate of initial misdiagnosis. Research question: Which aspects constitute the most important potential pitfalls in the diagnostic workup and treatment of SDAVF's with feeders from the external carotid artery causing cervical myelopathy? Material and methods: We performed a PRISMA-guided review of the literature in which fourteen articles were included. We illustrate the diagnostic hazards through one of our own cases. Results: SDAVF's at the cervical segment contain unique clinical and radiographic characteristics which differ from those elsewhere. Cervical myelopathy is caused by a SDAVF in 2.3% of cases. Pitfalls are numerous and diagnosis can be challenging, due to a broad differential diagnosis, potential isolated lower extremity involvement and absence of spinal cord edema on MRI. MR-alterations not always correlate with fistula localization. Discussion and conclusion: A SDAVF should be part of the differential diagnosis in patients with subacute tetraparesis. When MRI shows signal alterations in combination with enlarged perimedullary vessels, a SDAVF should be suspected. Spinal angiography should include the vertebrobasilar system, as well as the internal and external carotid arteries. Early and adequate occlusion by means of an endovascular or neurosurgical approach of the draining radicular veins should be pursued. A multidisciplinary approach is key in the diagnostic workup and treatment of these patients.

Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up.

BACKGROUND: WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%. CONCLUSIONS: This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Prediction of Functional Outcome After Acute Ischemic Stroke: Comparison of the CT-DRAGON Score and a Reduced Features Set.

Background and Purpose: The CT-DRAGON score was developed to predict long-term functional outcome after acute stroke in the anterior circulation treated by thrombolysis. Its implementation in clinical practice may be hampered by its plethora of variables. The current study was designed to develop and evaluate an alternative score, as a reduced set of features, derived from the original CT-DRAGON score. Methods: This single-center retrospective study included 564 patients treated for stroke, in the anterior and the posterior circulation. At 90 days, favorable [modified Rankin Scale score (mRS) of 0-2] and miserable outcome (mRS of 5-6) were predicted by the CT-DRAGON in 427 patients. Bootstrap forests selected the most relevant parameters of the CT-DRAGON, in order to develop a reduced set of features. Discrimination, calibration and misclassification of both models were tested. Results: The area under the receiver operating characteristic curve (AUROC) for the CT-DRAGON was 0.78 (95% CI 0.74-0.81) for favorable and 0.78 (95% CI 0.72-0.83) for miserable outcome. Misclassification was 29% for favorable and 13.5% for miserable outcome, with a 100% specificity for the latter. National Institutes of Health Stroke Scale (NIHSS), pre-stroke mRS and age were identified as the strongest contributors to favorable and miserable outcome and named the reduced features set. While CT-DRAGON was only available in 323 patients (57%), the reduced features set could be calculated in 515 patients (91%) (p < 0.001). Misclassification was 25.8% for favorable and 14.4% for miserable outcome, with a 97% specificity for miserable outcome. The reduced features set had better discriminative power than CT-DRAGON for both outcomes (both p < 0.005), with an AUROC of 0.82 (95% CI 0.79-0.86) and 0.83 (95% CI 0.77-0.87) for favorable and miserable outcome, respectively. Conclusions: The CT-DRAGON score revealed acceptable discrimination in our cohort of both anterior and posterior circulation strokes, receiving all treatment modalities. The reduced features set could be measured in a larger cohort and with better discrimination. However, the reduced features set needs further validation in a prospective, multicentre study. Clinical Trial Registration: http://www.clinicaltrials.gov. Identifiers: NCT03355690, NCT04092543.

Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of 3 Prospective, Multicenter Series: 2-Year Follow-Up.

BACKGROUND: Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2). OBJECTIVE: To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials. METHODS: In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%. CONCLUSION: This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%).

Minimally Invasive Aneurysm Clipping: The Extent of the Supraorbital Approach.

BACKGROUND: The supraorbital keyhole craniotomy is a well-established minimally invasive approach for the treatment of intracranial aneurysms. However, the surgical range of exposure using this technique for treatment of intracranial aneurysms has not been studied. METHODS: We retrospectively reviewed the data of all clipped aneurysm cases using the supraorbital approach (SO) between 2006 and 2016 in our center. Most importantly, we determined the location of the treated aneurysms in the axial 2-dimensional plane, with the anterior clinoid process (ACP) as the point of reference: the ACP to aneurysm distance. Finally, we extracted data on patient age, aneurysm size, size of the craniotomy, length of hospital stay, and surgery-related complications. RESULTS: We included 142 patients for this series. A total of 170 aneurysms were clipped by means of the SO, and in 18 cases multiple aneurysms were treated during the same surgery. The mean aneurysm size was 7 mm (3.5-22 mm) and the mean craniotomy size was 28 mm (19-41 mm). The aneurysm location ranged from 14.4 mm medially to 35 mm laterally, measured with the ipsilateral ACP as the zero reference. CONCLUSIONS: Although the SO is conventionally used in the treatment of anterior circulation aneurysms, we were able to treat aneurysms over a range of 50 mm over the skull base. With its low complication risk, relatively short hospital stay, and excellent cosmetic results, SO remains a valuable treatment option for both young and aged patients.

Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

PURPOSE: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year. RESULTS: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment. CONCLUSIONS: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs. TRIAL REGISTRATION NUMBER: NCT02390037.

Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

BACKGROUND: Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy. PURPOSE: To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2. METHODS: WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%. CONCLUSIONS: This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment. CLINICAL TRIAL REGISTRATION: French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322).

Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study.

BACKGROUND AND PURPOSE: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. MATERIALS AND METHODS: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes. RESULTS: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period. CONCLUSIONS: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. CLINICAL TRIAL REGISTRATION: NCT02390037.

Express LD vascular stent in the treatment of iliac artery lesions: 24-month results from the MELODIE trial.

PURPOSE: To report the 2-year results of the MELODIE trial, which evaluated the safety and effectiveness of the balloon-expandable Express LD Vascular stent for the treatment of atherosclerotic iliac artery disease. METHODS: This prospective, multicenter, single-arm trial enrolled 151 patients (113 men; mean age 60.1±8.4 years) with 163 de novo or restenotic iliac lesions. The primary endpoint, 6-month angiographic mean percent loss of luminal diameter, was compared to an objective performance criterion (OPC) based on published results with the Palmaz stent. Follow-up included ankle-brachial index (ABI) measurement and symptom assessment (Fontaine classification) at discharge, 30 days, and 6, 12, and 24 months. Arteriography was performed at 6 months and computed tomographic angiography (CTA) at 1 and 2 years. RESULTS: The primary endpoint of 6-month mean percent luminal diameter loss was 16.2% (upper 95% confidence boundary of 19.1%) and non-inferior to the 20% OPC (p = 0.006). Primary patency was 92.1% at 6 months and 87.8% at 2 years. The rate of major adverse events (MAE) was 6.3% at 6 months and 10.2% at 2 years. Of the 3 event types included in the definition of MAE, only target lesion revascularization occurred; no distal embolization or device- or procedure-related deaths were recorded. The percent of patients with Fontaine stage IIb symptoms or worse improved from 84.1% before the procedure to 16.8% at 2 years (p<0.0001). The 2-year ABI remained significantly improved compared to baseline (0.85 versus 0.63, p<0.0001). CONCLUSION: The Express LD Vascular stent is safe, effective, and non-inferior to the Palmaz stent for treatment of iliac artery stenosis.

Does carotid stent cell design matter?

BACKGROUND AND PURPOSE: Carotid stent cell design has recently been suggested to be a determinant of periprocedural and early postprocedural neurologic complications. We investigated the impact of closed- versus open-cell stent design on neurologic adverse events and mortality after carotid artery stenting. METHODS: We studied 1684 consecutive patients (1010 asymptomatic, 674 symptomatic) from 10 European centers who underwent carotid artery stenting with either closed-cell (n=859, 51%) or open-cell (n=825, 49%) design stents. Rates of transient ischemic attack, stroke, and death on the day of the procedure (acute events) and from day 1 to day 30 after the procedure (subacute events) were analyzed (95% CIs). RESULTS: Combined transient ischemic attack, stroke, or death rates, and stroke or death rates within 30 days of treatment were 6.1% (95% CI, 5.0 to 7.2) and 3.1% (95% CI, 2.3 to 3.9) for the closed-cell design versus 4.1% (95% CI, 3.2 to 5.0) and 2.4% (95% CI, 1.7 to 3.1) for the open-cell design stents (P=0.077, P=0.38), respectively, without significant differences in asymptomatic and symptomatic patients. By propensity-score-adjusted multivariable analysis, the open-cell carotid stent design was not associated with a differential risk for combined acute and subacute neurologic complications compared with closed-cell stents (adjusted odds ratio=0.84, P=0.53). When analyzed separately, the risk for acute events on the day of the procedure (adjusted odds ratio=0.83, P=0.57) and the risk for subacute events at days 1 to 30 (adjusted odds ratio=1.61, P=0.51) also were not significantly different between the groups. CONCLUSIONS: Current data do not support the superiority of a specific carotid stent cell design with respect to neurologic complications, stroke, and mortality risk.

Techniques in carotid artery stenting.

Endovascular carotid artery interventions are unforgiving of mistakes and poor technique. The approach should be team based where all members of the team are experienced and know their jobs perfectly. This, combined with a deep knowledge of the equipment and the anatomy will reduce complications to a minimum. Patient selection and the experience of knowing how to "get out of jail" are also vital.

Endovascular treatment of a ureteroiliac fistula associated with ureteral double J-stenting and an aortic-bifemoral stent graft for an inflammatory abdominal aortic aneurysm.

We report an unusual case of a ureteroiliac fistula due to prolonged ureteral stenting for hydronephrosis combined with an aortic-bifemoral stent graft in an inflammatory abdominal aortic aneurysm (AAA), treated with an endovascular stent graft. In a 77-year-old man ureteral J-stents were placed for bilateral hydronephrosis due to retroperitoneal fibrosis caused by an inflammatory AAA. The aneurysm was treated with an endovascular aortic-bifemoral stent graft. Three months later, the patient suffered from severe hypovolemic shock. Emergency angiography showed a fistula between the right ureter and the right common iliac artery just distal to the right leg of the stent graft. The ureteroiliac fistula was treated with a wall graft (10F). The patient recovered well and remained asymptomatic. Ureteroiliac fistula remains a rare complication of ureteral stenting. Several risk factors have been described before. This case emphazes the increased risk of an arterial-ureteral fistula due to an indwelling ureteral stent and an inflammatory AAA, especially in combination with an additional stent graft for this inflammatory AAA.

European carotid PROCAR Trial: prospective multicenter trial to evaluate the safety and performance of the ev3 Protégé stent in the treatment of carotid artery stenosis--1- and 6-month follow-up.

BACKGROUND: The purpose of the European PROCAR Trial was to evaluate the safety and performance of the Protégé stent in the treatment of common and/or internal carotid artery stenoses with adjunctive use of a filter embolic protection device. METHOD: The Protégé GPS stent is a self-expanding Nitinol stent system mounted on a 6 Fr 0.018'' (6-9 mm stent) or 7 Fr 0.035'' (10 mm stent) over-the-wire delivery system. Study patient assessments were conducted at baseline, periprocedure, discharge, and 1 and 6 months postprocedure. A total of 77 patients have been enrolled in the trial. RESULTS: In the 77 lesions treated (31 symptomatic, 46 asymptomatic), the procedure was technically successful in 76 (99%), with an average residual stenosis of less than 30%. One procedure failed because the embolic protection device could not be retrieved and the patient was sent to surgery. Within 30 days, there were four (5.2%) major adverse neurological events (MANEs). Three of the MANEs were major strokes (3.9%), one a minor stroke. The fifth MANE occurred prior to the 6-month follow-up visit; this patient had a major stroke 75 days after the procedure and died 36 days later. One additional death occurred because of urosepsis. CONCLUSIONS: The PROCAR trial shows that the Protégé stent with adjuvant use of a filter embolic protection device satisfies safety and performance criteria for the treatment of carotid artery stenosis. The incidence of MANEs for the Protégé stent is comparable to the incidence of these events in other recent carotid stent studies and standard carotid endarterectomy (CEA).