Randomized clinical trial of cutting balloon angioplasty versus high-pressure balloon angioplasty in hemodialysis arteriovenous fistula stenoses resistant to conventional balloon angioplasty.

PURPOSE: To compare the efficacy and safety of cutting balloon angioplasty (CBA) versus high-pressure balloon angioplasty (HPBA) for the treatment of hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty (PTA). MATERIALS AND METHODS: In a prospective, randomized clinical trial involving patients with dysfunctional, stenotic hemodialysis arteriovenous fistulas (AVFs), patients were randomized to receive CBA or HPBA if conventional PTA had suboptimal results (ie, residual stenosis > 30%). A total of 516 patients consented to participate in the study from October 2008 to September 2011, 85% of whom (n = 439) had technically successful conventional PTA. The remaining 71 patients (mean age, 60 y; 49 men) with suboptimal PTA results were eventually randomized: 36 to the CBA arm and 35 to the HPBA arm. Primary and secondary target lesion patencies were determined by Kaplan-Meier analysis. RESULTS: Clinical success rates were 100% in both arms. Primary target lesion patency rates at 6 months were 66.4% and 39.9% for CBA and HPBA, respectively (P = .01). Secondary target lesion patency rates at 6 months were 96.5% for CBA and 80.0% for HPBA (P = .03). There was a single major complication of venous perforation following CBA. The 30-day mortality rate was 1.4%, with one non-procedure-related death in the HPBA group. CONCLUSIONS: Primary and secondary target lesion patency rates of CBA were statistically superior to those of HPBA following suboptimal conventional PTA. For AVF stenoses resistant to conventional PTA, CBA may be a better second-line treatment given its superior patency rates.

Image-guided personalized predictive dosimetry by artery-specific SPECT/CT partition modeling for safe and effective 90Y radioembolization.

UNLABELLED: Compliance with radiobiologic principles of radionuclide internal dosimetry is fundamental to the success of (90)Y radioembolization. The artery-specific SPECT/CT partition model is an image-guided personalized predictive dosimetric technique developed by our institution, integrating catheter-directed CT hepatic angiography (CTHA), (99m)Tc-macroaggregated albumin SPECT/CT, and partition modeling for unified dosimetry. Catheter-directed CTHA accurately delineates planning target volumes. SPECT/CT tomographically evaluates (99m)Tc-macroaggregated albumin hepatic biodistribution. The partition model is validated for (90)Y resin microspheres based on MIRD macrodosimetry. METHODS: This was a retrospective analysis of our early clinical outcomes for inoperable hepatocellular carcinoma. Mapping hepatic angiography was performed according to standard technique with the addition of catheter-directed CTHA. (99m)Tc-MAA planar scintigraphy was used for liver-to-lung shunt estimation, and SPECT/CT was used for liver dosimetry. Artery-specific SPECT/CT partition modeling was planned by experienced nuclear medicine physicians. RESULTS: From January to May 2011, 20 arterial territories were treated in 10 hepatocellular carcinoma patients. Median follow-up was 21 wk (95% confidence interval [CI], 12-50 wk). When analyzed strictly as brachytherapy, (90)Y radioembolization planned by predictive dosimetry achieved index tumor regression in 8 of 8 patients, with a median size decrease of 58% (95% CI, 40%-72%). Tumor thrombosis regressed or remained stable in 3 of 4 patients with baseline involvement. The best α-fetoprotein reduction ranged from 32% to 95%. Clinical success was achieved in 7 of 8 patients, including 2 by sublesional dosimetry, in 1 of whom there was radioembolization lobectomy intent. Median predicted mean radiation absorbed doses were 106 Gy (95% CI, 105-146 Gy) to tumor, 27 Gy (95% CI, 22-33 Gy) to nontumorous liver, and 2 Gy (95% CI, 1.3-7.3 Gy) to lungs. Across all patients, tumor, nontumorous liver, and lungs received predicted ≥91 Gy, ≤51 Gy, and ≤16 Gy, respectively, via at least 1 target arterial territory. No patients developed significant toxicities within 3 mo after radioembolization. The median time to best imaging response was 76 d (95% CI, 55-114 d). Median time to progression and overall survival were not reached. SPECT/CT-derived mean tumor-to-normal liver ratios varied widely across all planning target volumes (median, 5.4; 95% CI, 4.1-6.7), even within the same patient. CONCLUSION: Image-guided personalized predictive dosimetry by artery-specific SPECT/CT partition modeling achieves high clinical success rates for safe and effective (90)Y radioembolization.