Saruhan Cekirge

Pipeline for Uncoilable or Failed Aneurysms: Results from a Multicenter Clinical Trial

PURPOSE To evaluate the safety and effectiveness of the Pipeline Embolization Device (PED; ev3/Covidien, Irvine, Calif) in the treatment of complex intracranial aneurysms. MATERIALS AND METHODS The Pipeline for Uncoilable or Failed Aneurysms is a multicenter, prospective, interventional, single-arm trial of PED for the treatment of uncoilable or failed aneurysms of the internal carotid artery. Institutional review board approval of the HIPAA-compliant study protocol was obtained from each center. After providing informed consent, 108 patients with recently unruptured large and giant wide-necked aneurysms were enrolled in the study. The primary effectiveness endpoint was angiographic evaluation that demonstrated complete aneurysm occlusion and absence of major stenosis at 180 days. The primary safety endpoint was occurrence of major ipsilateral stroke or neurologic death at 180 days. RESULTS PED placement was technically successful in 107 of 108 patients (99.1%). Mean aneurysm size was 18.2 mm; 22 aneurysms (20.4%) were giant (>25 mm). Of the 106 aneurysms, 78 met the studys primary effectiveness endpoint (73.6%; 95% posterior probability interval: 64.4%-81.0%). Six of the 107 patients in the safety cohort experienced a major ipsilateral stroke or neurologic death (5.6%; 95% posterior probability interval: 2.6%-11.7%). CONCLUSION PED offers a reasonably safe and effective treatment of large or giant intracranial internal carotid artery aneurysms, demonstrated by high rates of complete aneurysm occlusion and low rates of adverse neurologic events; even in aneurysms failing previous alternative treatments.

International Retrospective Study of the Pipeline Embolization Device: A Multicenter Aneurysm Treatment Study

BACKGROUND AND PURPOSE: Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting. MATERIALS AND METHODS: We retrospectively evaluated all patients with intracranial aneurysms treated with the Pipeline Embolization Device between July 2008 and February 2013 in 17 centers worldwide. We defined 4 subgroups: internal carotid artery aneurysms of ≥10 mm, ICA aneurysms of <10 mm, other anterior circulation aneurysms, and posterior circulation aneurysms. Neurologic complications included spontaneous rupture, intracranial hemorrhage, ischemic stroke, permanent cranial neuropathy, and mortality. Comparisons were made with t tests or ANOVAs for continuous variables and the Pearson χ2 or Fisher exact test for categoric variables. RESULTS: In total, 793 patients with 906 aneurysms were included. The neurologic morbidity and mortality rate was 8.4% (67/793), highest in the posterior circulation group (16.4%, 9/55) and lowest in the ICA <10-mm group (4.8%, 14/294) (P = .01). The spontaneous rupture rate was 0.6% (5/793). The intracranial hemorrhage rate was 2.4% (19/793). Ischemic stroke rates were 4.7% (37/793), highest in patients with posterior circulation aneurysms (7.3%, 4/55) and lowest in the ICA <10-mm group (2.7%, 8/294) (P = .16). Neurologic mortality was 3.8% (30/793), highest in the posterior circulation group (10.9%, 6/55) and lowest in the anterior circulation ICA <10-mm group (1.4%, 4/294) (P < .01). CONCLUSIONS: Aneurysm treatment with the Pipeline Embolization Device is associated with the lowest complication rates when used to treat small ICA aneurysms. Procedure-related morbidity and mortality are higher in the treatment of posterior circulation and giant aneurysms.

Percutaneous Retrieval of Foreign Bodies: Experience with the Nitinol Goose Neck Snare

PURPOSE The authors present their experience with the nitinol Goose Neck snare system in the retrieval of retained foreign bodies in 20 patients. PATIENTS AND METHODS Foreign bodies were located in the vascular system in 13 patients, urinary tract in four, biliary system in one, gastrointestinal tract in one, and the peritoneal space in one. All retrievals were performed with use of standard angiographic/interventional techniques. RESULTS Success was achieved in all cases without attendant complications. Foreign bodies removed included catheter and guide-wire fragments, an embolization coil, broken or occluded double pigtail catheters, a Wallstent, and a surgical laparotomy sponge. CONCLUSION All procedures were performed quickly, safely, and without difficulty. Because of its excellent torque control, positive grasping capacity, excellent radiopacity, lack of traumatic effect, and availability in different sizes appropriate for use in a wide variety of difficult anatomic spaces, the authors recommend that this device be considered the first choice for all foreign body retrieval procedures.

Endovascular parent artery occlusion in large-giant or fusiform distal posterior cerebral artery aneurysms

Posterior cerebral artery aneurysms are amenable to deconstructive surgical treatment because of the rich collateral supply of the distal posterior cerebral artery. This report retrospectively analyses the outcome of endovascular parent artery occlusion for large or fusiform distal posterior cerebral artery aneurysms. Medical records and cerebral angiograms from two endovascular centres were analysed retrospectively. Eight patients with large or fusiform distal posterior cerebral artery (PCA) aneurysms were treated by endovascular occlusion of the segment of the PCA at the site of the aneurysm. Three of those were treated urgently after acute subarachnoid haemorrhage, the remainder had elective treatment. The clinical and angiographic outcomes in seven patients were assessed at 6 to 12 months. A single case of occipital infarction resulting in permanent homonymous hemianopia was the only permanent complication. Of the remaining patients, six made excellent recoveries and one was lost to follow-up. No recurrence or re-bleeding was noted. Endovascular parent artery occlusion may be an alternative to surgical parent artery occlusion in distal PCA aneurysms which are not convenient for selective endovascular treatment or surgical clipping.

Endovascular Stent-Graft Applications in Iatrogenic Vascular Injuries

AbstractPurpose: To report the results of covered stent applications in iatrogenic vascular injuries. Methods: We report 17 patients (11 men, 6 women; age range 20–59 years, mean age 40 years) who underwent repair of different iatrogenic vascular lesions by means of endovascular covered stents. The patient population consisted of 8 femoral arteriovenous fistulae, 4 common femoral artery pseudoaneurysms, 1 subclavian artery pseudoaneurysm, 1 abdominal aortic aneurysm, 1 iliac artery perforation, 2 porto-biliary fistulae that developed during TIPS procedure. Balloon-expandable stent-grafts were used in all patients except one. Control studies were performed with angiography. Results: Technical success was achieved in all 17 patients. The mean clinical follow-up period for all 17 patients was 8 months. There were no signs of stent migration or leaks in the control studies. Only one patient developed a hemodynamically insignificant stenosis at the proximal end of the stent. There have been no stent deformations or related complications during the follow-up period. Conclusion: Our short-term results suggest that endovascular treatment is a low-risk procedure and appears less invasive than surgery for the treatment of different types of iatrogenic vascular injuries. Intermediate and long-term results are not available.

Cerecyte Coil Trial: Procedural Safety and Clinical Outcomes in Patients with Ruptured and Unruptured Intracranial Aneurysms

BACKGROUND AND PURPOSE: This study arose from a need to systematically evaluate the clinical and angiographic outcomes of intracranial aneurysms treated with modified coils. We report the procedural safety and clinical outcomes in a prospective randomized controlled trial of endovascular coiling for ruptured and unruptured intracranial aneurysms, comparing polymer-loaded Cerecyte coils with bare platinum coils in 23 centers worldwide. MATERIALS AND METHODS: Five hundred patients between 18 and 70 years of age with a ruptured or unruptured target aneurysm planning to undergo endovascular coiling were randomized to receive Cerecyte or bare platinum coils. Analysis was by intention to treat. RESULTS: Two hundred forty-nine patients were allocated to Cerecyte coils and 251 to bare platinum coils. Baseline characteristics were balanced. For ruptured aneurysms, in-hospital mortality was 2/114 (1.8%) with Cerecyte versus 0/119 (0%) bare platinum coils. There were 8 (3.4%) adverse procedural events resulting in neurological deterioration: 5/114 (4.4%) with Cerecyte versus 3/119 (2.5%) with bare platinum coils (P = .22). The 6-month mRS score of ≤2 was not significantly different in 103/109 (94.5%) patients with Cerecyte and 110/112 (98.2%) patients with bare platinum coils. Poor outcome (mRS score of ≥3 or death) was 6/109 (5.5%) with Cerecyte versus 2/112 (1.8%) with bare platinum coils (P = .070). For UIAs, there was no in-hospital mortality. There were 7 (2.7%) adverse procedural events with neurological deterioration, 5/133 (3.8%) with Cerecyte versus 2/131 (1.5%) with bare platinum coils (P = .13). There was a 6-month mRS score of ≤2 in 114/119 (95.8%) patients with Cerecyte versus 123/123 (100%) patients with bare platinum coils. There was poor outcome (mRS ≥3 and 1 death) in 5/119 (4.2%) patients with Cerecyte versus 0/123 (0%) patients with bare platinum coils (P = .011). CONCLUSIONS: There was a statistical excess of poor outcomes in the Cerecyte arm at discharge in the ruptured aneurysm group and at 6-month follow-up in the unruptured group. Overall adverse clinical outcomes and in-hospital mortality were exceptionally low in both groups.

Transvenous injection of Onyx for casting of the cavernous sinus for the treatment of a carotid-cavernous fistula

A complex case of carotid-cavernous fistula was treated transvenously by injection of ethyl vinyl alcohol co-polymer into the cavernous sinus after an unsuccessful embolization attempt with detachable coils and liquid adhesive agents. There were no complications. At 3 months the patient’s symptoms had resolved completely, and a control angiogram revealed persistent occlusion. The physical properties of ethyl vinyl alcohol polymer justify further investigation of this agent for the treatment of carotid-cavernous fistula.

Long-Term Clinical and Angiographic Outcomes Following Pipeline Embolization Device Treatment of Complex Internal Carotid Artery Aneurysms: Five-Year Results of the Pipeline for Uncoilable or Failed Aneurysms Trial

BACKGROUND Early and mid-term safety and efficacy of aneurysm treatment with the Pipeline Embolization Device (PED) has been well demonstrated in prior studies. OBJECTIVE To present 5-yr follow-up for patients treated in the Pipeline for Uncoilable or Failed Aneurysms clinical trial. METHODS In our prospective, multicenter trial, 109 complex internal carotid artery (ICA) aneurysms in 107 subjects were treated with the PED. Patients were followed per a standardized protocol at 180 d and 1, 3, and 5 yr. Aneurysm occlusion, in-stent stenosis, modified Rankin Scale scores, and complications were recorded. RESULTS The primary endpoint of complete aneurysm occlusion at 180 d (73.6%) was previously reported. Aneurysm occlusion for those patients with angiographic follow-up progressively increased over time to 86.8% (79/91), 93.4% (71/76), and 95.2% (60/63) at 1, 3, and 5 yr, respectively. Six aneurysms (5.7%) were retreated. New serious device-related events at 1, 3, and 5 yr were noted in 1% (1/96), 3.5% (3/85), and 0% (0/81) of subjects. There were 4 (3.7%) reported deaths in our trial. Seventy-eight (96.3%) of 81 patients with 5-yr clinical follow-up had modified Rankin Scale scores ≤2. No delayed neurological deaths or hemorrhagic or ischemic cerebrovascular events were reported beyond 6 mo. No recanalization of a previously occluded aneurysm was observed. CONCLUSION Our 5-yr findings demonstrate that PED is a safe and effective treatment for large and giant wide-necked aneurysms of the intracranial ICA, with high rates of complete occlusion and low rates of delayed adverse events.

Retrieval of prolapsed coils during endovascular treatment of cerebral aneurysms

One of the feared complications during detachable coil embolization of cerebral aneurysms is herniation of a coil loop into the parent artery. Although coil protrusion of one or two loops into the parent vessel may not cause adverse events and in some instances can be ignored, the authors believe that coil retrieval is indicated if a free end is seen pulsating along the blood flow stream to prevent migration of the entire coil mass. In one patient, a microballoon was inflated across the neck of the aneurysm during retrieval of a herniated coil to prevent further coil herniation from the aneurysm sac. We present two cases in which prolapsed coils were successfully retrieved either using a microsnare and balloon combination or a microsnare alone. This report focuses on the efficacy of the Amplatz microsnare for such retrievals and the circumstances in which a herniated coil needs to be retrieved. We report two cases in which embolization coils partially migrated into the parent artery during endovascular treatment of cerebral aneurysm and were retrieved using the Amplatz Nitinol microsnare.

Percutaneous transcatheter ethanol sclerotheraphy of postoperative pelvic lymphoceles

Although percutaneous procedures have been used for the treatment of lymphoceles, transcatheter sclerosing therapy has not been widely applied. We present the results of transcatheter sclerotherapy of lymphoceles with 96% absolute ethanol in 7 patients who had developed lymphocele after pelvic lymphadenectomy for uterine cancer. Seven of the eight lymphoceles (88%) completely disappeared after treatment. The duration of catheter drainage ranged from 4 to 21 days. Although one lymphocele did not resolve completely, it did not require surgery as the patient’s symptoms resolved.