Safety and Outcomes of Transradial Access in Patients with International Normalized Ratio 1.5 or above.

PURPOSE: To examine the safety and outcomes for patients undergoing transradial noncoronary interventions with international normalized ratio (INR) ≥1.5. MATERIALS AND METHODS: A retrospective review of 2,271 transradial access (TRA) cases performed from July 2012 to July 2016 was conducted. Criteria for inclusion were moderate bleeding risk cases with preprocedure INR ≥1.5. Within the study period, there were 176 moderate bleeding risk procedures (transarterial chemoembolization: 70/176 [39.8%]; Barbeau B: 121/176 [68.8%]; 5-F sheath: 157/176 [89.2%]) performed on 122 patients (age 61.6 ± 12.1 years, 68.9% male, body mass index 28.0 kg/m2) with INR ≥1.5. RESULTS: Technical success was achieved in 98.9% of cases. Grade 1/2 hematomas developed in 10 cases (5.7%). Age ≥65 years (P = .042) and female sex (P = .046) were predictive of access site bleeding complications. Fresh frozen plasma (FFP) transfusion was administered in 11.4% of cases (n = 20). Baseline INR and creatinine were significantly different between transfused and nontransfused cases (P values .006 and .028, respectively). Minor access site bleeding occurred in 3/20 cases (15%) receiving prior FFP transfusion and 7/156 nontransfused cases (4.5%), with no significant difference between these 2 groups (P = .072). CONCLUSIONS: TRA in patients with elevated INR appears to be safe in our experience. Age ≥65 years and female sex were associated with increased incidence of access site bleeding. Although INR correction was not standardized in this cohort, preprocedure FFP transfusion did not decrease bleeding complications.

Radiation Segmentectomy versus Selective Chemoembolization in the Treatment of Early-Stage Hepatocellular Carcinoma.

PURPOSE: To compare outcomes of radiation segmentectomy (RS) and segmental transarterial chemoembolization in treatment of unresectable, solitary hepatocellular carcinoma (HCC) ≤ 3 cm. MATERIALS AND METHODS: From January 2012 to January 2016, 534 and 877 patients were treated with radioembolization and transarterial chemoembolization, respectively. A cohort of 112 (radiation segmentectomy [RS], 55; chemoembolization, 57) locoregional therapy-naïve patients with solitary HCC ≤ 3 cm without vascular invasion or metastasis was retrospectively identified and stratified according to baseline patient demographics, tumor characteristics, and laboratory values. Propensity score matching (PSM) was conducted using a nearest neighbor algorithm (1:1). Outcomes analyzed included laboratory toxicities, imaging response, time to secondary therapy (TTST), and overall survival. RESULTS: Before PSM, complete response (CR) rate was 81.2% for RS and 49.1% for chemoembolization (odds ratio 2.2; 95% confidence interval [CI], 1.4-3.3; P < .001). Median (95% CI) TTST after initial therapy was 246 days (135-250 d) in chemoembolization group and 700 days (308-812 d) in RS group (hazard ratio 0.71; 95% CI, 0.55-0.92; P = .009). Overall survival before PSM was not significantly different between the 2 groups (P = .29). Overall CR rate after PSM was 92.1% in RS group and 52.6% in chemoembolization group (P = .005). Median (95% CI) TTST after matching was 161 days (76-350 d) in chemoembolization group and 812 days (363-812 d) in RS group (P = .001). Overall survival after matching was not significantly different between the 2 groups (P = .71). CONCLUSIONS: RS results in improved imaging response and longer TTST compared with transarterial chemoembolization in treatment of early-stage HCC.

Radiation Segmentectomy versus TACE Combined with Microwave Ablation for Unresectable Solitary Hepatocellular Carcinoma Up to 3 cm: A Propensity Score Matching Study.

Purpose To compare the outcomes of radiation segmentectomy (RS) and transarterial chemoembolization (TACE) combined with microwave ablation (MWA) in the treatment of unresectable solitary hepatocellular carcinoma (HCC) up to 3 cm. Materials and Methods This retrospective study was approved by the institutional review board, and the requirement to obtain informed consent was waived. From January 2010 to June 2015, a total of 417 and 235 consecutive patients with HCC underwent RS and TACE MWA, respectively. A cohort of 121 patients who had not previously undergone local-regional therapy (RS, 41; TACE MWA, 80; mean age, 65.4 years; 84 men [69.4%]) and who had solitary HCC up to 3 cm without vascular invasion or metastasis was retrospectively identified. Outcomes analyzed included procedure-related complications, laboratory toxicity levels, imaging response, time to progression (TTP), 90-day mortality, and survival. Propensity score matching was conducted by using a nearest-neighbor algorithm (1:1) to account for pretreatment clinical, laboratory, and imaging covariates. Postmatching statistical analysis was performed with conditional logistic regression for binary outcomes and the stratified log-rank test for time-dependent outcomes. Results Before matching, the complication rate was 8.9% and 4.9% in the TACE MWA and RS groups, respectively (P = .46). The overall complete response (CR) rate was 82.9% for RS and 82.5% for TACE MWA (odds ratio, 1.0; 95% confidence interval [CI]: 0.4, 2.8; P = .95). There were 41 (RS, 11; TACE MWA, 30) instances of progression occurring after an initial CR, of which 10 (24%) were classified as target progression (RS, one; TACE MWA, nine). Median overall TTP was 11.1 months (95% CI: 8.8 months, 25.6 months) in the RS group and 12.1 months (95% CI: 7.7 months, 19.1 months) in the TACE MWA group (P > .99). After matching, the overall CR rate (P = .94), TTP (P = .83), and overall survival (P > .99) were not significantly different between the two groups. The 90-day postoperative mortality rate was 0% in both groups. Conclusion Imaging response and progression outcomes of patients with solitary HCC up to 3 cm treated with RS were not significantly different when compared with those of patients treated with TACE MWA. © RSNA, 2016 Online supplemental material is available for this article.

Transfemoral Filter Eversion Technique following Unsuccessful Retrieval of Option Inferior Vena Cava Filters: A Single Center Experience.

This report describes the technical feasibility of using the filter eversion technique after unsuccessful retrieval attempts of Option and Option ELITE (Argon Medical Devices, Inc, Athens, Texas) inferior vena cava (IVC) filters. This technique entails the use of endoscopic forceps to evert this specific brand of IVC filter into a sheath inserted into the common femoral vein, in the opposite direction in which the filter is designed to be removed. Filter eversion was attempted in 25 cases with a median dwell time of 134 days (range, 44-2,124 d). Retrieval success was 100% (25/25 cases), with an overall complication rate of 8%. This technique warrants further study.

Transradial Approach for Noncoronary Interventions: A Single-Center Review of Safety and Feasibility in the First 1,500 Cases.

PURPOSE: To review safety and feasibility in a single center using transradial access (TRA) for noncoronary interventions. MATERIALS AND METHODS: Retrospective analysis was performed of 946 patients evaluated for 1,531 consecutive TRA procedures from April 2012 to July 2015. Exclusion criteria included sheath > 6 F, Barbeau D waveform, radial artery (RA) diameter < 2 mm on ultrasound, history of severe aortic tortuosity or RA occlusion, and dialysis. TRA was attempted in 936 patients (62% men; median age, 62.4 y) who underwent 1,512 consecutive procedures (chemoembolization [n = 485], yttrium-90 mapping [n = 391] and infusion [n = 293], renal/visceral intervention [n = 172], uterine artery embolization [n = 116], peripheral intervention [n = 43], endoleak repair [n = 10], and other [n = 2]). Patients were evaluated for complications during follow-up at ~30 days. RESULTS: Technical success was 98.2% (1,485/1,512). Major complications (0.13%) included pseudoaneurysm (n = 1) and seizure (n = 1). Minor complications (2.38%) included hematoma/bleeding (n = 13), RA occlusion (n = 11), arm pain (n = 6), and RA spasm (n = 6). Univariate analysis demonstrated a lower rate of adverse events in African American patients (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.07-0.86; P = .027). Twenty-seven cases (1.8%) required crossover to transfemoral access (TFA). Crossover rates were higher in female patients (P = .0055), height < 1.7 m (P = .024), renal/visceral interventions (P = .0003), and endoleak interventions (P = .0357). Multivariate analysis demonstrated intervention type to be the only significant predictor of TFA crossover (renal/visceral [HR, 4.48; 95% CI, 1.84-10.9; P = .001]; endoleak repair [HR, 9.54; 95% CI, 1.09-83.8; P = .042]). CONCLUSIONS: TRA was safe and well tolerated in a heterogeneous patient population across a range of peripheral vascular interventions.

Outcomes of Radioembolization in the Treatment of Hepatocellular Carcinoma with Portal Vein Invasion: Resin versus Glass Microspheres.

PURPOSE: To compare outcomes of yttrium-90 radioembolization performed with resin-based ((90)Y-resin) and glass-based ((90)Y-glass) microspheres in the treatment of hepatocellular carcinoma (HCC) with associated portal vein invasion. MATERIALS AND METHODS: A single-center retrospective review (January 2005-September 2014) identified 90 patients ((90)Y-resin, 21; (90)Y-glass, 69) with HCC and ipsilateral portal vein thrombosis (PVT). Patients were stratified according to age, sex, ethnicity, Child-Pugh class, Eastern Cooperative Oncology Group status, α-fetoprotein > 400 ng/mL, extent of PVT, tumor burden, and sorafenib therapy. Outcome variables included clinical and laboratory toxicities (Common Terminology Criteria Adverse Events, Version 4.03), imaging response (modified Response Evaluation Criteria in Solid Tumors), time to progression (TTP), and overall survival (OS). RESULTS: Grade 3/4 bilirubin and aspartate aminotransferase toxicities developed at a 2.8-fold (95% confidence interval [CI], 1.3-6.1) and 2.6-fold (95% CI, 1.1-6.1) greater rate in the (90)Y-resin group. The disease control rate was 37.5% in the (90)Y-resin group and 54.5% in the (90)Y-glass group (P = .39). The median (95% CI) TTP was 2.8 (1.9-4.3) months in the (90)Y-resin group and 5.9 (4.2-9.1) months in the (90)Y-glass group (P = .48). Median (95% CI) survival was 3.7 (2.3-6.0) months in the (90)Y-resin group and 9.4 (7.6-15.0) months in the (90)Y-glass group (hazard ratio, 2.6; 95% CI, 1.5-4.3, P < .001). Additional multivariate predictors of improved OS included age < 65 years, Eastern Cooperative Oncology Group status < 1, α-fetoprotein ≤ 400 ng/mL, and unilobar tumor distribution. CONCLUSIONS: Imaging response of (90)Y treatment in patients with HCC and PVT was not significantly different between (90)Y-glass and (90)Y-resin groups. Lower toxicity and improved OS were observed in the (90)Y-glass group.

Transradial Approach for Hepatic Radioembolization: Initial Results and Technique.

OBJECTIVE: The transradial approach (TRA) has been shown to reduce the morbidity and mortality associated with arterial coronary interventions. Selective internal radiation therapy (SIRT) performed via the TRA can enhance patient comfort, compared with the traditional transfemoral approach (TFA), by allowing immediate ambulation and precluding potential complications associated with the TFA, such as closure device injury or retroperitoneal hematoma. We report our initial experience with and technique for using the TRA for SIRT. MATERIALS AND METHODS: Between May 1, 2012, and April 30, 2015, a total of 574 procedures, including planning angiograms (n = 329) and infusions of 90Y (n = 245), were performed for 318 patients (mean age, 64.5 years). Of the 245 patients who received 90Y infusions, 52 had SIRT performed with the use of a permanent single-use implant of 90Y resin microspheres and 193 had SIRT performed with the use of millions of small glass microspheres containing radioactive 90Y. Procedural details, technical success, the radial artery (RA) occlusion rate noted at 30 days (as assessed via pulse examination), and the major and minor adverse events noted at 30 days were evaluated. RESULTS: Technical success was achieved in 561 of 574 cases (97.7%). The reasons for crossover to use of the TFA included an RA loop (n = 2), RA occlusion (n = 9), and type D response as determined by use of a Barbeau test (n = 2). Patients had undergone between zero and six previous TRA procedures. The mortality rate at 30 days was 0%. Superficial bruising occurred in 13 of 574 cases (2.3%). A grade 2 hematoma that required a second nonocclusive hemostasis cuff occurred in one case. Transient forearm numbness or pain occurred in two of 574 cases. One patient had a transient convulsive event occur after receiving intraarterial infusion of verapamil. RA occlusion occurred in nine of 574 cases (1.6%). CONCLUSION: Use of the TRA for SIRT is safe, feasible, and well tolerated and is associated with high rates of technical success and rare complications.

Yttrium-90 Glass-Based Microsphere Radioembolization in the Treatment of Hepatocellular Carcinoma Secondary to the Hepatitis B Virus: Safety, Efficacy, and Survival.

PURPOSE: To evaluate outcomes of yttrium-90 radioembolization performed with glass-based microspheres in the treatment of hepatocellular carcinoma (HCC) secondary to the hepatitis B virus (HBV). MATERIALS AND METHODS: A total of 675 patients treated between January 2006 and July 2014 were reviewed, of which 45 (age 62 y ± 10; 91% male) received glass-based radioembolization for HCC secondary to HBV. All patients were stratified according to previous therapy (naive, n = 14; 31.1%), Child-Pugh class (class A, n = 41; 91%), Eastern Cooperative Oncology Group (ECOG) performance status (PS; < 1, n = 21; 47%), solitary (n = 26; 58%) and unilobar (n = 37; 82%) tumor distribution, tumor size < 5 cm (n = 29; 64%), portal vein thrombosis (n = 14; 31%), α-fetoprotein level > 400 ng/mL (n = 17; 38%), and Barcelona Clinic Liver Cancer stage (A, n = 8; B, n = 9; C, n = 28). RESULTS: A total of 50 radioembolization treatments were performed, with a 100% technical success rate (median target dose, 120 Gy). Clinical toxicities included pain (16%), fatigue (12%), and nausea (4%). Grade 3/4 laboratory toxicities included bilirubin (8%) and aspartate aminotransferase (4%) toxicities. Observed toxicities were independent of treatment dose. The objective response rates were 55% per modified Response Evaluation Criteria In Solid Tumors and 21% per World Health Organization criteria, and the disease control rate was 63%. Disease progression was secondary to new, nontarget HCC in 45% of cases. Median time to progression and overall survival were 6.0 mo (95% confidence interval [CI], 4.4-8.0 mo) and 19.3 mo (95% CI, 11.2-22.7 mo), respectively. Multivariate analysis demonstrated ECOG PS ≥ 1 and AFP level > 400 ng/mL to be independent predictors of inferior overall survival. CONCLUSIONS: Glass-based radioembolization for HCC secondary to HBV can be safely performed, with favorable target lesion response and overall survival.

Outcomes of radioembolization for unresectable hepatocellular carcinoma in patients with marginal functional hepatic reserve.

PURPOSE: To evaluate the outcomes of radioembolization (RE) as a therapy for unresectable hepatocellular carcinoma (HCC) in patients with marginal functional hepatic reserve. METHODS: A retrospective review of 471 patients (1/2010-7/2015) treated with RE (Therasphere, BTG, UK) was performed. A total of 36 patients (mean age: 66.1±9.3, male: 86.1%) underwent therapy for HCC with a MELD≥15 (median: 16, range: 15-22). Baseline demographics of the study cohort were as follows: etiology (HCV: 26, 72.2%), cirrhosis (n=32, 88.9%), ECOG 0 (n=16, 44.4%), Child-Pugh class (A=15, B=19, C=2), unilobar distribution (n=27, 75%), AFP>200 (n=11, 30.6%), portal vein thrombosis (PVT, n=7, 19.4%), metastasis (n=3, 8.3%). Outcomes analyzed included CTCAEv4.03 laboratory toxicities (120-day), imaging response (mRECIST), progression-free survival (PFS), and overall survival (OS). RESULTS: A total of 42 treatments were performed with mean dose of 2.02±1.23GBq. The cumulative grade 3/4 toxicity was 28% overall and 21% for bilirubin at 120-days. The objective response and disease control rates were 48.3% (14/29) and 69% (20/29) respectively. The median (95% CI) PFS was 5.9 (4.4-7.7) months. Ten (27.8%) patients received additional locoregional therapy at a median (IQR) of 138 (102-243) days post RE. The mean (95% CI) OS was 21.9 (14.8-29.0) months. The absence of PVT was associated with improved OS (p=0.005) Disease control at 90-days was also associated with an OS benefit (p=0.037). CONCLUSIONS: Patients with unresectable HCC and marginal functional hepatic reserve treated with RE had favorable objective response and disease control rates, both predictive of overall survival.

Radioembolization for Unresectable Intrahepatic Cholangiocarcinoma: Review of Safety, Response Evaluation Criteria in Solid Tumors 1.1 Imaging Response and Survival.

The optimal palliative treatment for unresectable intrahepatic cholangiocarcinoma (ICC) remains controversial. While selective internal radiation therapy (SIRT) using yttrium-90 microspheres is a well-accepted treatment for hepatocellular carcinoma, data related to its use for locally advanced ICC remain relatively scarce. Twenty-nine patients (mean age 66 ± 11 years; 15 female) with unresectable biopsy-proven ICC treated with SIRT between June 2008 and April 2015 were retrospectively evaluated for post-treatment toxicity, overall survival, and imaging response using response evaluation criteria in solid tumors (RECIST) 1.1 criteria. RECIST 1.1 response was evaluable following 26 treatments [complete response (CR):0, partial response (PR):3; stable disease (SD):16, progression of disease (PD):7]. Objective response rate (CR+PR) was 12%. Disease control rate (CR+PR+SD) was 73%. Median time to progression was 5.6 [95% confidence interval (CI): 0-12.0] months. Median survival following SIRT was 9.1 (95% CI: 1.7-16.4) months. Post-treatment survival was prolonged in patients with absence of extrahepatic disease (p = 0.03) and correlated with RECIST 1.1 response (p = 0.02). Toxicities were limited to grade I severity and occurred following 27% of treatments. These findings support the safe, effective use of SIRT for unresectable ICC. Post-treatment survival is prolonged in patients with absence of extrahepatic disease at baseline. RECIST 1.1 response following SIRT for ICC is predictive of survival.

Transradial access for visceral endovascular interventions in morbidly obese patients: safety and feasibility.

PURPOSE: Transradial access (TRA) has been shown to lower morbidity and bleeding complications compared to transfemoral access in percutaneous coronary interventions. Morbid obesity, commonly defined as a body mass index (BMI) ≥40 kg/m2, has been shown to be a risk factor for access site complications irrespective of access site. This study evaluates the safety and feasibility of performing visceral endovascular interventions in morbidly obese patients via TRA. METHODS: Procedural details, technical success, and 30-day major and minor access site, bleeding, and neurological adverse events were prospectively recorded in a database of 1057 procedures performed via the radial artery. From this database we identified 22 visceral interventions performed with TRA in 17 morbidly obese patients (age: 53 ± 11 years, female: 71%) with a median BMI of 42.7 kg/m2. RESULTS: Interventions included radio-embolization (n = 7, 31.8%), chemo-embolization (n = 6, 27.3%), uterine fibroid embolization (n = 4, 18.2%), renal embolization (n = 2, 9.1%), hepatic embolization (n = 1, 4.5%), lumbar artery embolization (n = 1, 4.5%), and renal angioplasty (n = 1, 4.5%). The technical success was 100%. There were no major or minor adverse access site, bleeding, or neurological complications at 30 days. CONCLUSIONS: This study suggests visceral endovascular interventions performed in morbidly obese patients are safe and feasible.