Evaluation and Treatment of Patients With Lower Extremity Peripheral Artery Disease Consensus Definitions From Peripheral Academic Research Consortium (PARC)

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease

Chemoembolization with drug-eluting microspheres (DEM-TACE) for hepatocellular carcinoma: single-center review of safety and efficacy

VL Bishay,1 K Maglione,1 R Khanna,2 KM Lee,1 AM Fischman,1 RA Lookstein,1 E Kim1 1Department of Radiology, Icahn School of Medicine at the Mount Sinai Hospital, New York, NY, USA; 2Department of Radiology, Queens Hospital Center, Jamaica, NY, USA Purpose: This study examines the safety and efficacy of transarterial chemoembolization using doxorubicin-loaded 30–60 µm QuadraSphere microspheres (DEM-TACE) for the treatment of hepatocellular carcinoma. Materials and methods: Over 10 weeks, patients with hepatocellular carcinoma. (Child–Pugh A/B: 65%/35%) were embolized with 30–60 µm QuadraSphere microspheres. Excluded patients had previous locoregional therapy, macrovascular invasion, extrahepatic disease, Child–Pugh score >B7, ECOG performance status >0, and total bilirubin >3 mg/dL. Technical success, minor and major complications, 30-day hospital readmission rate, and 30-day mortality were assessed. α-Fetoprotein levels before and after treatment were compared. Local response was evaluated by radiologic tumor response per modified Response Evaluation Criteria in Solid Tumors 1 month after treatment. Results: Thirty tumors (mean size, 2.3 cm; range, 1.0–4.9 cm) were treated in 20 patients (16 male and 4 female; mean age, 64.7 years). There were no major complications. Thirty-day mortality was 0%. Minor complications included postembolization syndrome in 16.7% of cases and transient rise in liver enzymes requiring no therapy. Mean a-fetoprotein levels trended down following treatment (71.8±201.9 ng/mL vs 53.4±116.7 ng/mL), but were not statistically significant. Complete response was achieved in 30% of patients, partial response in 35%, stable disease in 30%, and progression of disease in 5%. Overall objective response was 65%. Mean follow-up was 10.4 months (range, 2–16.4 months). Conclusion: DEM-TACE with doxorubicin-loaded 30–60 µm QuadraSpheres is feasible, well tolerated, and associated with promising tumor response in early and intermediate stage disease. Keywords: microspheres, carcinoma, liver, tumo