Clinical Evaluation of the Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter for Treatment of Hemodialysis Fistula Stenoses: A Feasibility Study.

PURPOSE: A prospective, single-center, single-arm feasibility study evaluated procedural and short-term performance of the Advance Enforcer 35 focal-force percutaneous transluminal angioplasty (PTA) balloon catheter in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuits. MATERIALS AND METHODS: Twenty-eight patients undergoing treatment for stenosis of a mature native AV hemodialysis access circuit were enrolled at a single institution. Angiographic assessments of the study lesion were required at baseline and after the procedure. Adjunctive procedures for significant residual stenosis were permitted, and patients had clinical and imaging follow-up for as long as 6 months. RESULTS: Treatment with the study balloon was effective in reducing the average percent diameter stenosis of the treated lesion from 66.3% (range, 43.8%-93.3%) before the procedure to 23.7% (range, -6.7% to 51.4%) after the procedure. The average inflation pressure required was 12.3 atm. Only 1 patient required an adjunctive procedure, and all patients could resume normal dialysis following the study procedure. At 3 months, 62.0% of study lesions remained patent, and the 6-month patency rate was 25.1%. Two adverse events associated with the study procedure were reported: access-site hematoma and forearm pain (3.6% each). CONCLUSIONS: The results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients.

PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries.

PURPOSE: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. RESULTS: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory-adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. CONCLUSION: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Intention-to-treat analysis of liver transplantation, resection and thermal ablation for hepatocellular carcinoma in a single centre.

BACKGROUND: potentially curative treatment options for hepatocellular carcinoma (HCC) include liver transplantation (LT), liver resection (LR) and thermal ablation (TA). Long term intent-to-treat (ITT) analysis from a single-centre using all three modalities contemporaneously has not been published. METHODS: An ITT analysis was undertaken of all patients with HCC listed for LT, or have undergone LR or TA. RESULTS: 444 patients were identified; 145 were listed for LT (121 underwent LT), 190 underwent LR and 109 underwent TA. One and 3-year overall survival (OS) was similar among LT, LR and TA (88/77%, 88/64% and 95/72%) whereas 5-year OS was higher following LT than LR or TA (73% vs. 54% vs. 49%). Disease-free survival at 1- and 5-years was higher for LT (97% and 84%) than LR (66% and 35%) or TA (73%, and 19%). CONCLUSION: LT offered the lowest rate of cancer recurrence and highest chance of long-term survival. Differences in outcome likely reflect a combination of cancer-related factors (AFP, micro- and macrovascular invasion), patient-related factors (performance status, co-morbidities and psychosocial issues) and treatment type. Two thirds of patients treated by LR and three quarters treated by TA had HCC recurrence by 5 years, reinforcing the need for close long-term surveillance.

First-in-Human Experience With the Gore Balloon-Expandable Covered Endoprosthesis in Iliac Artery Occlusive Disease.

PURPOSE: To report the first-in-human iliac artery experience of a new balloon-expandable covered endoprosthesis. METHODS: A prospective, single-center pilot study recruited 30 symptomatic patients (mean age 64 years; 18 men) to evaluate the safety and early efficacy of the new Gore balloon-expandable covered endoprosthesis for the treatment of de novo or restenotic common and/or external iliac artery lesions. According to protocol, up to 2 discrete lesions could be treated with a maximum total treated length ≤110 mm. Follow-up included clinical evaluation with duplex ultrasound at 1, 6, and 12 months. Data are presented through 12-month follow-up. The primary safety endpoint was a composite of device- or procedure-related death, myocardial infarction, or amputation in the treated leg within 30 days of the index procedure. Multiple performance outcomes were also evaluated. RESULTS: The primary 30-day safety endpoint was 0%. Per-subject estimates of primary patency, freedom from target lesion revascularization, and freedom from target vessel revascularization were 100% at 1 and 6 months and 96.6% at 12 months. Estimates of assisted primary and secondary patency were both 100% at 12 months. Freedom from major adverse events at 12 months was 100%. Most patients experienced improvements in Rutherford category, ankle-brachial index, and functional status that were sustained to 12 months. CONCLUSION: This positive first-in-human experience with the Gore balloon-expandable covered endoprosthesis suggests this device will have an important role in the management of aortoiliac occlusive disease.

Magnetic resonance imaging of popliteal artery pathologies.

This paper illustrates examples of popliteal artery pathologies imaged with contrast enhanced magnetic resonance angiography (CE-MRA) and magnetic resonance imaging (MRI) at a single tertiary referral centre. Popliteal artery pathologies were identified in 1710 patients referred over a 6-year period with symptoms suggesting lower limb arterial occlusive disease. Common pathologies such as atherosclerotic occlusive disease, thromboemboli and aneurysm disease are discussed as well as unusual pathologies such as cystic adventitial disease, mycotic aneurysm and arterial entrapment. The combination of CE-MRA and the excellent soft tissue resolution of MRI allow detailed evaluation of arterial and peri-arterial pathologies, and facilitate appropriate management decisions.