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Purpose To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population. Materials and Methods This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints. Results The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for ≥120 seconds (P = .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P = .0005). Conclusions The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas.

Background The oral administration of the gum resin extracts of Indian frankincense (Boswellia serrata Roxb. ex Colebr) results in very low plasma concentrations of boswellic acids (BAs), being far below the pharmacologically active concentrations required in vitro for anti-inflammatory activity. For that reason the use of Indian frankincense in clinical practice and pharmaceutical development has substantially lagged behind. Recently the application of new formulation technologies resulted in a formulation of frankincense extract with lecithin, which revealed improved absorption and tissue penetration of BAs in a rodent study, leading for the first time to plasma concentrations of BAs in the range of their anti-inflammatory activity. Purpose In order to verify these encouraging results in humans, the absorption of a standardized Boswellia serrata extract (BE) and its lecithin formulation (CSP) was comparatively investigated in healthy volunteers. Study design According to a randomized cross-over design with two treatments, two sequences and two periods, 12 volunteers alternatively received the lecithin-formulated Boswellia extract (CSP) or the non-formulated Boswellia extract (BE) at a dosage of 2 × 250 mg capsules. Methods The plasma concentrations of the six major BAs (KBA, AKBA, βBA, αBA, AβBA, AαBA) were determined using LC/MS. Results With the exception of KBA, a significantly higher (both in terms of weight-to-weight and molar comparison) and quicker absorption of BAs from the lecithin formulation was observed, leading to Cmax in the range required for the interaction with their molecular targets. Conclusion These findings pave the way to further studies evaluating the clinical potential of BAs, and verify the beneficial effect of lecithin formulation to improve the absorption of poorly soluble phytochemicals.

The Venous Window Needle Guide (VWING™) has recently been proposed for patients with difficult arteriovenous fistula (AVF) access for hemodialysis due to deep vessels or other cannulation-related problems. This totally subcutaneous titanium device is sutured onto the upper wall of the matured fistula and may facilitate cannulation by the button-hole technique. We describe our initial experience with nine implants in six patients with a cumulative follow-up of 83 months, and make some experience-based technical suggestions for implant and surveillance radiological imaging. The indication for implantation was deep vessel, previous failure of cannulation or unsuitable site for direct cannulation. No infectious complications were observed during follow-up and proper blood flow was constantly achieved. Some difficulties were occasionally encountered with regard to cannulation; nonetheless, patient satisfaction was not significantly affected. VWING seems to be an interesting option in some patients provided that surgical implantation is carefully carried out and preventive measures against infections are strictly observed.

// Roberto Bini 1 , Simone Comelli 2 , Renzo Leli 1 , Giacomo Paolo Vaudano 2 , Daniele Savio 2 , Tiziana Viora 1 , Alfredo Addeo 3 1 General Surgery Department, SG Bosco Hospital, Turin, Italy 2 Interventional Radiology- Neuroradiology Department, SG Bosco Hospital, Turin, Italy 3 Oncology Department, Bristol Cancer Center, Bristol, UK Correspondence to: Roberto Bini, email: rebinidoc@gmail.com Keywords: debiri, rectal cancer, chemoembolization, cancer recurrence Received: November 09, 2015 Accepted: May 20, 2016 Published: June 10, 2016 ABSTRACT Purpose: Assess the feasibility, safety and efficacy of TACE with irinotecan loaded micro particles (debiri) for the treatment of locally advanced rectal cancer patients. Results: We assessed the Edmonton Symptom Assessment System (ESAS). The tool is designed to assess nine common symptoms in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath. The ESAS score was 7 in 10/12 (83%) patients before treatment and 6 in 2/12 (16.5%) patients. After treatment in 6/12 (50%) patients the score dropped to 3; 3/12 (33%) reported 4, 1/12 (8%) reported 2. All patients experienced local control disease with a degree of citoreduction; in 4 cases (33%) we observed outstanding responses with a dramatic reduction in the tumors size which led us to surgical radical resections. Materials and methods: We run a prospective mono-institutional study where we recruited, 12 non- consecutive patients with histology confirmation of rectal cancer, inoperable and not treatable due to severe comorbidities, or pelvic recurrence/progression after curative treatment, chemotherapy, radiotherapy and/or surgery. Their performance status (PS) ECOG was 2-3 . Twelve patients (10 male and 2 female) with a median age 71 (range 56-89) were recruited in the study. Conclusions: The study has met the primary endpoint and showed encouraging activity. Debiri could be a possible option for locally advanced/inoperable or recurred rectal cancer patients. Further trials are warranted to validate this methodic in early stages.

Evaluate Magnetic Resonance (MR) and Magnetic Resonance Angiography (MRA) sensibility in the diagnosis and follow-up of dissection of Internal Carotid and Vertebral Artery (ICA/VA). We revalued MR examination of 36 patients, 24 men, 12 women, aged 18-69 years. All patients underwent brain TC and MR (GE 1 Tesla); in 16 subjects 3D Time-of-Flight (TOF-3D) MRA was performed and in 20 subjects a Contrast-Enhanced MRA (CEMRA) of neck and head arteries. Thirty-one patients underwent a MRA follow-up. Dissection involved ICA in 30 and VA in 8. MR showed ischemic signs in 25 cases, wall hematoma in 19, and was normal in 11. MRA showed 25 vessels stenosis, 12 occlusions, and 9 aneurysm. Follow-up MRA showed 6 cases of complete resolution of stenosis, 17 partial resolution, 2 aneurysmal dissecanting, 6 luminal alteration unchanged, 1 aneurysma enlarged. MRA represented a non-invasive technique as investigation in suspected cervicocephalic arteries dissection.

Patients with advanced and incurable colorectal cancer have a very poor prognosis. Curative-intent resection was performed in 70%–90% of cases in reported series of colorectal cancer, sometimes after neoadjuvant chemotherapy and radiotherapy. The remaining 10%-30% of patients are treated with palliative intent, where treatment is aimed at relieving disease-related symptoms and improving quality of life. The provision of palliative care for these patients is complicated and outcomes are often disappointing. Although there are many available options including a variety of surgical and nonsurgical interventions, the best management remains controversial. Transarterial chemoembolization with irinotecan-loaded drug-eluting beads (DEBIRI) is an effective, minimally invasive procedure performed by interventional radiologists that allows intra-arterial drug delivery to stop vascular feeding and exert local cytotoxic effects. We here report on a patient treated with DEBIRI followed by systemic chemotherapy with the FOLFOX regimen for locally advanced, inoperable colorectal cancer.

To evaluate the feasibility of percutaneous treatment of iliac aneurysms, a covered stent was inserted in nine men suffering from common iliac artery aneurysms (six cases), external iliac aneurysms (one case), or pseudoaneurysms (two cases). Placement of the stent was successful in all patients. In one patient, an endoprosthesis thrombosed after 15 days, but was successfully treated by thrombolysis and additional stent placement. At the follow-up examinations (mean period 22 months) all stent-grafts had remained patent. No late leakage or stenosis was observed.

Objective: We sought to evaluate the feasibility and results of intraoperative balloon angioplasty and additional stent placement of isolated stenosis of the brachiocephalic trunk. Patients and methods: Between May 1993 and October 1996, we treated eight patients with local stenosis of the innominate artery. Seven lesions were situated in the proximal and one in the middle third of the brachiocephalic trunk. Five patients were men and three were women, with ages ranging from 55 to 72 years (mean 59.5 years). All stenoses provoked severe blood flow reduction and caused clinical symptoms. Procedures were performed in an operating suite with fluoroscopic imaging capabilities. Through an anterolateral cervical approach the right common carotid artery was surgically exposed and then clamped to avoid atheroembolization during the subsequent procedure. Retrograde catheterization was performed to reach the stenosis of the brachiocephalic trunk. The lesion was dilated with a balloon catheter and successively stented. Follow-up examinations (color-coded duplex sonography, accompanied by clinical inspection and systolic blood pressure) were scheduled every 6 months. Results: In all patients the dilation of the stenosis of the innominate artery and the stent placement were successful without any side effects. No embolic events or other complications occurred. The postintervention angiography showed successfully dilated stenoses and patent stents in all cases. The technical success rate was 100%. Conclusions: On the basis of our preliminary data, we believe that, in selected patients, intraoperative balloon angioplasty of stenosis of the innominate artery with stent placement from the right common carotid artery approach is a safe and effective alternative to conventional operations. (J Thorac Cardiovasc Surg 1998;115:1316-20)

Keywords: aortic aneurism; atherosclerosis; endo-prothesis; daily haemodialysis; long-term RRTThe impressive calcifications seen in the computedtomography (CT) reconstruction of an aortic aneur-ysm of the abdominal aorta in Figure 1 belong to a 48-year-old male, on renal replacement therapy (RRT)from the age of 22. His end-stage renal diseasewas membrano-proliferative glomerulonephritis withsevere and prolonged nephrotic syndrome. In 1981,3 years after diagnosis, he started RRT on peritonealdialysis; he was switched to haemodialysis in 1985 dueto functional exhaustion of the peritoneum, and acadaveric graft was performed in 1993. Haemodialysiswas resumed in 1996 after graft failure due to recurrentmembranous and proliferative glomerulonephritis,again with severe nephrotic syndrome. He hadhypertension, usually well controlled by multipledrug therapy, parathyroidectomy because of severehyperparathyroidism unresponsive to conservativetreatment (1993) and a coronary by-pass (1997). Theaortic aneurysm shown in Figure 1 was first diagnosedin 1991: at that time, the maximum diameter was4.2cm. The diameter was stable until March 2000,when it increased to 4.6cm and further to 4.8cmin November 2000, despite a daily haemodialysisschedule (started in 1999), minimizing weight lossper dialysis and with a good blood pressure controlwithout need for drug therapy.Balancing the young age of the patient and thesurgical risks due to the diffuse arterial calcificationstypical of uraemic patients (Figure 2), a percutaneousendoluminal approach was chosen and successfullyperformed in January 2001, employing a modular