To quantify radiation dose and associated risks for prostatic artery embolization (PAE) when performed by experienced operators at high-volume centers. Fluoroscopy time (FT), cumulative air kerma (CAK), and field of view area (FoV) data were retrospectively collected for 1387 PAE procedures performed on fixed interventional fluoroscopic units from January 2014 to January 2022, by operators with >10 years of PAE experience from 10 high-volume centers ( >75 procedures) worldwide. CAK, FT, and kerma-area product (KAP) were plotted against sequential procedure number for each site. Piecewise linear segmented regression identified optimal curve breakpoints as cutoffs to exclude operator learning curve procedures that might skew data1. Mean/median effective dose (ED) were calculated and radiation-related adverse events tabulated for all included procedures. Excess relative risk of cancer-related death from PAE was calculated using the International Commission on Radiological Protection extrapolation model of 4.1-4.8%/Sv of ED2. 42 learning curve procedures from 1 center were excluded. Radiation dose data were analyzed for 1345 PAE procedures (Table 398.1). Mean values across all centers were FT=40.2±12.0 min, CAK=1315±510 mGy, KAP=194±75 Gy×cm2, and ED=21.4±8.2 mSv. Median overall ED was 18.0 mSv, with no reported 90-day deterministic-type adverse events. Calculated median excess relative risk of cancer-related death from PAE was 0.08–0.09%. PAE performed by experienced operators at high-volume centers resulted in low patient radiation doses with no deterministic adverse events and minimal excess risk for stochastic events.
The purpose of our study was to evaluate the reproducibility of Modified Response Evaluation Criteria in Solid Tumors (mRECIST) in hepatocellular carcinoma (HCC) lesions undergoing transarterial radioembolization (TARE) therapy and to determine whether mRECIST reproducibility is affected by the enhancement pattern of HCC. One hundred and three HCC lesions from 103 patients treated with TARE were evaluated. The single longest diameter of viable tumor tissue was measured by two radiologists at baseline; response to therapy was evaluated according to mRECIST. The enhancement pattern of HCC lesions was correlated with their mRECIST response. The response rate between mRECIST and RECIST 1.1 was compared. Wilcoxon signed-rank test, paired t test, Lin's concordance correlation coefficient (ρc ), Bland-Altman plot, kappa statistics, and Fisher's exact test were used to assess intra- and interobserver reproducibilities and to compare response rates. There were better intra- than interobserver agreements in the measurement of single longest diameter of viable tumor tissue (bias = 0 cm intraobserver versus bias = 0.3 cm interobserver). For mRECIST, good intraobserver (ĸ = 0.70) and moderate interobserver (ĸ = 0.56) agreements were noted. The mRECIST response for HCC lesions with homogeneous enhancement at both baseline and follow-up imaging showed better intra- and interobserver agreements (ĸ = 0.77 and 0.60, respectively) than lesions with heterogeneous enhancement at both scans (ĸ = 0.54 and 0.40, respectively). In the early follow-up period mRECIST showed a significantly higher response rate than RECIST (40.8% versus 3.9%; P = 0.025). In HCC patients treated with TARE, mRECIST captures a significantly higher response rate compared with RECIST; it also demonstrates acceptable intra- and interobserver reproducibilities for HCC lesions treated with TARE, and mRECIST reproducibility may be lower for HCC lesions with heterogeneous distribution of the viable tumor tissue.