IN.PACT AV Access Trial: Economic Evaluation of Drug-Coated Balloon Treatment for Dysfunctional Arteriovenous Fistulae Based on 12-Month Clinical Outcomes.

PURPOSE: To study, from a U.S. payer's perspective, the economic consequences of drug-coated balloon (DCB) versus standard percutaneous transluminal angioplasty (PTA) use for the treatment of stenotic lesions in dysfunctional hemodialysis arteriovenous fistulae. MATERIALS AND METHODS: Cost differences between DCBs and PTA at year 1 and beyond were calculated via 2 methods. The first approach used the mean absolute number of trial-observed access circuit reinterventions through 12 months (0.65 ± 1.05 vs 1.05 ± 1.18 events per patient for DCBs and PTA, respectively) and projected treatment outcomes to 3 years. The second approach was based on the trial-observed access circuit primary patency rates at 12 months (53.8% vs 32.4%) and calculated the cost difference on the basis of previously published Medicare cost for patients who maintained or did not maintain primary patency. Assumptions regarding DCB device prices were tested in sensitivity analyses, and the numbers needed to treat were calculated. RESULTS: Using the absolute number of access circuit reinterventions approach, the DCB strategy resulted in an estimated per-patient savings of $1,632 at 1 year and $4,263 at 3 years before considering the DCB device cost. The access circuit primary patency approach was associated with a per-patient cost savings of $2,152 at 1 year and $3,894 at 2.5 years of follow-up. At the theoretical DCB device reimbursement of $1,800, savings were $1,680 and $2,049 at 2.5 and 3 years, respectively. The one-year NNT of DCB compared to PTA was 2.48. CONCLUSIONS: Endovascular therapy for arteriovenous access stenosis with the IN.PACT AV DCB can be expected to be cost-saving if longer follow-up data confirm its clinical effectiveness.

In vivo nanoparticle assessment of pathological endothelium predicts the development of inflow stenosis in murine arteriovenous fistula.

OBJECTIVE: In vivo assessment of pathological endothelium within arteriovenous fistula (AVF) could provide new insights into inflow stenosis, a common cause of AVF primary failure in end-stage renal disease patients. Here we developed nanoparticle-based imaging strategies to assess pathological endothelium in vivo and elucidate its relationship to neointimal hyperplasia formation in AVF. APPROACH AND RESULTS: Jugular-carotid AVFs were created in C57BL/6 mice (n=38). Pathological endothelium in the AVF was visualized and quantified in vivo using dextranated magnetofluorescent nanoparticles (CLIO-VT680 [cross-linked iron oxide-VivoTag680]). At day 14, CLIO-VT680 was deposited in AVF, but only minimally in sham-operated arteries. Transmission electron microscopy revealed that CLIO-VT680 resided within endothelial cells and in the intimal extracellular space. Endothelial cells of AVF, but not control arteries, expressed vascular cell adhesion molecule-1 and showed augmented endothelial permeability near the anastomosis. Intravital microscopy demonstrated that CLIO-VT680 deposited most intensely near the AVF anastomosis (P<0.0001). The day 14 intravital microscopy CLIO-VT680 signal predicted the subsequent site and magnitude of AVF neointimal hyperplasia at day 42 (r=0.58, P<0.05). CLIO-VT680 deposition in AVF was further visualized by ex vivo MRI. CONCLUSIONS: AVF develop a pathological endothelial response that can be assessed in vivo via nanoparticle-enhanced imaging. AVF endothelium is activated and exhibits augmented permeability, offering a targeting mechanism for nanoparticle deposition and retention in pathological endothelium. The in vivo AVF nanoparticle signal identified and predicted subsequent inflow neointimal hyperplasia. This approach could be used to test therapeutic interventions aiming to restore endothelial health and to decrease early AVF failure caused by inflow stenosis.

Non-contrast-enhanced 4D MR angiography with STAR spin labeling and variable flip angle sampling: a feasibility study for the assessment of Dural Arteriovenous Fistula.

INTRODUCTION: This study aimed to evaluate the feasibility of non-contrast-enhanced 4D magnetic resonance angiography (NCE 4D MRA) with signal targeting with alternative radiofrequency (STAR) spin labeling and variable flip angle (VFA) sampling in the assessment of dural arteriovenous fistula (DAVF) in the transverse sinus. METHODS: Nine patients underwent NCE 4D MRA for the evaluation of DAVF in the transverse sinus at 3 T. One patient was examined twice, once before and once after the interventional treatment. All patients also underwent digital subtraction angiography (DSA) and/or contrast-enhanced magnetic resonance angiography (CEMRA). For the acquisition of NCE 4D MRA, a STAR spin tagging method was used, and a VFA sampling was applied in the data readout module instead of a constant flip angle. Two readers evaluated the NCE 4D MRA data for the diagnosis of DAVF and its type with consensus. The results were compared with those from DSA and/or CEMRA. RESULTS: All patients underwent NCE 4D MRA without any difficulty. Among seven patients with patent DAVFs, all cases showed an early visualization of the transverse sinus on NCE 4D MRA. Except for one case, the type of DAVF of NCE 4D MRA was agreed with that of reference standard study. Cortical venous reflux (CVR) was demonstrated in two cases out of three patients with CVR. CONCLUSION: NCE 4D MRA with STAR tagging and VFA sampling is technically and clinically feasible and represents a promising technique for assessment of DAVF in the transverse sinus. Further technical developments should aim at improvements of spatial and temporal coverage.

MicroNester coils as an adjunct to endovascular embolization.

OBJECTIVES/BACKGROUND: In June 2003, detachable balloons were removed from the US market and were supplanted with coil embolization for parent artery sacrifice in difficult or nonsurgical aneurysms and other vascular pathologies. The current series examines the use of MicroNester pushable coils (Cook Medical, Bloomington, IN) as a low-cost and effective adjunct to detachable coils in the treatment of selected neurovascular pathologies. METHODS: A retrospective analysis of all patients undergoing neurointerventional procedures from November 2003 through May 2008 was performed to identify patients in whom MicroNester coils were used as part of treatment. Analysis of coil type and number as well as pathology was performed. RESULTS: MicroNesters were used in 26 cases, of which 21 were for arterial sacrifice--19 for the internal carotid artery and 2 for the vertebral artery. Fourteen were performed for intracranial aneurysms, 3 for pseudoaneurysms, 2 for carotid cavernous fistulae, 1 for a carotid blowout, and 1 for an arteriovenous malformation. Five additional procedures were transvenous, for treatment of dural arterial venous fistulae. The mean number of coils for artery sacrifice was 13, with an average of 10 MicroNesters. For transvenous embolizations, the means were 30 and 6, respectively. CONCLUSION: MicroNesters are not the coil of choice for most neurointerventional procedures because they are not retrievable. However, when parent artery sacrifice or transvenous occlusion of dural arteriovenous fistulas is the goal, MicroNesters are a relatively inexpensive and equally effective alternative to more expensive, detachable coils and can reduce the procedural costs by $3600 to $6000 for the current series.

Assessment of wall shear stress changes in arteries and veins of arteriovenous polytetrafluoroethylene grafts using magnetic resonance imaging.

The purpose of the study was to determine simultaneously the temporal changes in luminal vessel area, blood flow, and wall shear stress (WSS) in both the anastomosed artery (AA) and vein (AV) of arteriovenous polytetrafluoroethylene (PTFE) grafts. PTFE grafts were placed from the iliac artery to the ipsilateral iliac vein in 12 castrated juvenile male pigs. Contrast-enhanced magnetic resonance angiography with cine phase-contrast magnetic resonance imaging was performed. Luminal vessel area, blood flow, and WSS in the aorta, AA, AV, and inferior vena cava were determined at 3 days (D3), 7 days (D7), and 14 days (D14) after graft placement. Elastin von Gieson staining of the AV was performed. The average WSS of the AA was highest at D3 and then decreased by D7 and D14. In contrast, the average WSS and intima-to-media ratio of the AV increased from D3 to D7 and peaked by D14. Similarly, the average area of the AA was highest by D7 and began to approximate the control artery by D14. The average area of the AV had decreased to its lowest by D7. High blood flows through the AA causes a decrease in average WSS and increase in the average luminal vessel area, whereas at the AV, the average WSS and intima-to-media ratio both increase while the average luminal vessel area decreases.