Initial Clinical Experience With AneuFix Injectable Biocompatible Elastomer for Translumbar Embolization of Type 2 Endoleaks.

PURPOSE: The aim of this study was to assess the initial experience, technical success, and clinical benefit of AneuFix (TripleMed, Geleen, the Netherlands), a novel biocompatible and non-inflammatory elastomer that is directly injected into the aneurysm sac by a translumbar puncture in patients with a type II endoleak and a growing aneurysm. MATERIALS AND METHODS: A multicenter, prospective, pivotal study was conducted (ClinicalTrials.gov:NCT02487290). Patients with a type II endoleak and aneurysm growth (>5 mm) were included. Patients with a patent inferior mesenteric artery connected to the endoleak were excluded for initial safety reasons. The endoleak cavity was translumbar punctured with cone-beam computed tomography (CT) and software guidance. Angiography of the endoleak was performed, all lumbar arteries connected to the endoleak were visualized, and AneuFix elastomer was injected into the endoleak cavity and short segment of the lumbar arteries. The primary endpoint was technical success, defined as successful filling of the endoleak cavity with computed tomography angiography (CTA) assessment within 24 hours. Secondary endpoints were clinical success defined as the absence of abdominal aortic aneurysm (AAA) growth at 6 months on CTA, serious adverse events, re-interventions, and neurological abnormalities. Computed tomography angiography follow-up was performed at 1 day and at 3, 6, and 12 months. This analysis reports the initial experience of the first 10 patients treated with AneuFix. RESULTS: Seven men and 3 women with a median age of 78 years (interquartile range (IQR), 74-84) were treated. Median aneurysm growth after endovascular aneurysm repair (EVAR) was 19 mm (IQR, 8-23 mm). Technical success was 100%; it was possible to puncture the endoleak cavity of all treated patients and to inject AneuFix. Clinical success at 6 months was 90%. One patient showed 5 mm growth with persisting endoleak, probably due to insufficient endoleak filling. No serious adverse events related to the procedure or AneuFix material were reported. No neurological disorders were reported. CONCLUSION: The first results of type II endoleak treatment with AneuFix injectable elastomer in a small number of patients with a growing aneurysm show that it is technically feasible, safe, and clinically effective at 6 months. CLINICAL IMPACT: Effective and durable embolization of type II endoleaks causing abdominal aortic aneurysms (AAA) growth after EVAR is challenging. A novel injectable elastic polymer (elastomer) was developed, specifically designed to treat type II endoleaks (AneuFix, TripleMed, Geleen, the Netherlands). Embolization of the type II endoleak was performed by translumbar puncture. The viscosity changes from paste-like during injection, into an elastic implant after curing. The initial experience of this multicentre prospective pivotal trial demonstrated that the procedure is feasible and safe with a technical success of 100%. Absence of AAA growth was observed in 9 out of 10 treated patients at 6 months.

Aortic arch thrombus caused by nitrous oxide abuse.

Nitrous oxide is a recreational drug gaining in popularity for its deemed innocence. However, side effects have recently been reported. In this case, a patient suffered major aortic arch thrombus resulting in arterial occlusion of his arm and temporary cerebral infarction and later deep venous thrombosis and pulmonary embolism. No common causes for thrombus in this high-flow vessel were identified. The authors state that the patient's chronic nitrous oxide abuse might have led to this thrombus, although it has never been described previously. This hypothesis is supported with laboratory tests at several presentations.

Hemodynamic changes in ipsi- and contralateral cerebral arterial territories after carotid endarterectomy using positron emission tomography.

BACKGROUND: The purpose of this study was to characterize ipsi- and contralateral cerebral hemodynamics before and after CEA. METHODS: Cerebral blood flow, CBV, and MVTT were measured in 10 patients before and after CEA using PET. Absolute and relative values of these parameters were calculated bilaterally for the entire arterial territories and hemispheres. RESULTS: For all territories in both hemispheres, the mean absolute postoperative CBF was significantly increased compared with preoperative CBF (P < .05). Only in MCA was this increase higher in the ipsilateral than in the contralateral hemisphere (P = .02). Cerebral blood volume was unaffected, whereas MVTT decreased in ipsilateral MCA (P = .05). CONCLUSIONS: The present findings suggest that, on the first day after CEA, absolute CBF is increased in all arterial territories on both ipsi- and contralateral sides, but that there are only minor changes in the relative distribution, whereas the CBV was unaffected.

Differentiation of multiple sclerosis from other inflammatory disorders and cerebrovascular disease: value of spinal MR imaging.

PURPOSE: To determine the value of magnetic resonance (MR) imaging in the spinal cord to differentiate multiple sclerosis (MS) from other inflammatory disorders and cerebrovascular diseases (together, other neurologic disease [OND]). MATERIALS AND METHODS: The study population included 66 patients with OND and 25 patients with MS, who were matched for age, sex, and symptom duration or severity. Brain MR imaging included gadolinium-enhanced T1-weighted and dual-echo T2-weighted spin-echo sequences to assess the number, size, and appearance of lesions, contrast enhancement, and compatibility with diagnostic criteria for MS. Spinal cord MR imaging included cardiac-triggered gadolinium-enhanced sagittal T1-weighted spin-echo and dual-echo T2-weighted sequences to assess the general appearance (normal, focal lesion, diffuse abnormality) and number or size of focal lesions. Images obtained in MS and OND patients were compared. Specificity, sensitivity, accuracy, and positive and negative predictive values with MR images were calculated. RESULTS: Brain images were abnormal in all MS patients and in 65% of OND patients. Abnormal cord images were found in 92% of MS and 6% of OND patients. The combination of brain and spinal cord images increased accuracy of diagnosis compared with use of brain images alone. CONCLUSION: In contrast to MS, cord lesions are very uncommon in OND. This finding can help differentiate these disorders.