Stent Graft Placement for Injured Visceral Artery.

Injury of the visceral artery is a potentially fatal complication of iatrogenic procedures, trauma, and tumors. A stent graft can achieve rapid exclusion of the injured arterial portion and minimize the risk of ischemic complications by preserving arterial flow to organs. Although various types of stent grafts are available worldwide, Viabahn has only been approved for visceral arterial injury in Japan. The reported technical and clinical success rates, including cases with injured pelvic or thoracic arterial branches, are 80%-100% and 66.7%-100%, respectively. Severe ischemic complications are rare; however, fatal ischemia occurs when the stent graft is immediately occluded. The necessity of antiplatelet therapy is controversial, and a target artery diameter ≤ 4 mm is a significantly higher risk factor of stent-graft occlusion.

Virulence of Shigatoxigenic and Enteropathogenic Escherichia coli O80:H2 in Galleria mellonella Larvae: Comparison of the Roles of the pS88 Plasmids and STX2d Phage.

The invasiveness properties of Shigatoxigenic and enteropathogenic Escherichia coli (STEC and EPEC) O80:H2 in humans and calves are encoded by genes located on a pS88-like ColV conjugative plasmid. The main objectives of this study in larvae of the Galleria mellonella moth were therefore to compare the virulence of eight bovine STEC and EPEC O80:H2, of two E. coli pS88 plasmid transconjugant and STX2d phage transductant K12 DH10B, of four E. coli O80:non-H2, and of the laboratory E. coli K12 DH10B strains. Thirty larvae per strain were inoculated in the last proleg with 10 µL of tenfold dilutions of each bacterial culture corresponding to 10 to 106 colony-forming units (CFUs). The larvae were kept at 37 °C and their mortality rate was followed daily for four days. The main results were that: (i) not only the STEC and EPEC O80:H2, but also different E. coli O80:non-H2 were lethal for the larvae at high concentrations (from 104 to 106 CFU) with some variation according to the strain; (ii) the Stx2d toxin and partially the pS88 plasmid were responsible for the lethality caused by the E. coli O80:H2; (iii) the virulence factors of E. coli O80:non-H2 were not identified. The general conclusions are that, although the Galleria mellonella larvae represent a useful first-line model to study the virulence of bacterial pathogens, they are more limited in identifying their actual virulence properties.

Escherichia coli O80 in Healthy Cattle: Absence of Shigatoxigenic and Enteropathogenic E. coli O80:H2 and (Phylo) Genomics of Non-Clonal Complex 165 E. coli O80.

The origin of human and calf infections by Shigatoxigenic (STEC) and enteropathogenic (EPEC) Escherichia coli O80:H2 is still unknown. The aim of this study was to identify E. coli O80 in healthy cattle with an emphasis on melibiose non-fermenting E. coli O80:H2. Faecal materials collected from 149 bulls at 1 slaughterhouse and 194 cows on 9 farms were tested with O80 antigen-encoding gene PCR after overnight growth in enrichment broths. The 53 O80 PCR-positive broths were streaked on different (semi-)selective agar plates. Five E. coli colonies from 3 bulls and 11 from 2 cows tested positive with the O80 PCR, but no melibiose non-fermenting E. coli was isolated. However, these 16 E. coli O80 were negative with PCR targeting the fliCH2, eae, stx1, stx2 and hlyF genes and were identified by WGS to serotypes and sequence types O80:H6/ST8619 and O80:H45/ST4175. They were phylogenetically related to E. coli O80:H6 and O80:H45 isolated from different animal species in different countries, respectively, but neither to STEC and EPEC O80:H2/ST301, nor to other serotypes of the clonal complex 165. As a conclusion, healthy adult cattle were not identified as a source of contamination of humans and calves by STEC or EPEC O80:H2.

Percutaneous sclerotherapy using a 4 F pigtail catheter and 40 milliliters of 5% ethanolamine oleate for symptomatic large hepatic cysts.

PURPOSE We retrospectively evaluated the efficacy of percutaneous sclerotherapy using a 4 F catheter and 40 mL of 5% ethanolamine oleate (EO) for symptomatic large hepatic cysts. METHODS Twenty-four patients, including 10 with polycystic liver disease (PLD), were eligible. The mean long- and short-axis diameters of the cyst on computed tomography (CT) were 145.0 ± 35.5 mm (range, 72-216 mm) and 110.5 ± 21.4 mm (range, 63-150 mm), respectively. After aspiration of the fluid contents using a 4 F pigtail catheter, 40 mL of 5% EO was injected into the cyst for 30 min. Then, the catheter was withdrawn after EO removal. Symptomatic relief and complications were evaluated. The percentage reductions at the early (1-3 months later) and late (at the final follow-up) responses were evaluated using an estimated cyst volume calculated by using the following formula: volume = π/6 × long-axis diameter × (short-axis diameter)2 on the maximum cross-section image on CT. Spearman's rank correlation coefficient (ρ) was used to evaluate the correlation between the pretreatment estimated cyst volume and percentage reduction of early and late responses and between the percentage reduction of the late response and length of the follow-up period after sclerotherapy. RESULTS The symptoms disappeared in 23 patients and improved in 1 patient with PLD. The mean aspirated fluid volume was 1337.8 ± 845.4 mL (range, 140-3200 mL). In 1 patient, EO injection was postponed until the second procedure was performed 40 days later due to intraperitoneal leakage of contrast material. In another patient, the EO volume was reduced to 20 mL because of a small cyst size. The mean early and late percentage reductions of the treated cyst were 52.3% ± 23.8% and 87.5% ± 20.4% (mean follow-up period: 48.0 ± 42.4 months), respectively. The symptom recurred in 2 patients with PLD and 1 underwent additional sclerotherapy 14 months later due to re-enlargement of the treated cyst. Another patient underwent transarterial embolization 5 years and 4 months later for other enlarged cysts, although the treated cyst markedly shrank. There were significant negative correlations between the pretreatment estimated cyst volume and percentage reduction of early (P = .027, ρ = - 0.46) and late (P= .007, ρ = - 0.52) responses. However, there were no significant correlations between the percentage reduction and length of the follow-up period (P = .19, ρ = 0.31). Transient pain developed in 1 patient and low-grade fever in 3. CONCLUSION Sclerotherapy using a 4 F catheter and 40 mL of 5% EO is safe and effective for symptomatic large hepatic cysts.

Efficacy of Superselective Conventional Transarterial Chemoembolization Using Guidance Software for Hepatocellular Carcinoma within Three Lesions Smaller Than 3 cm.

The indication of transarterial chemoembolization (TACE) has advanced to hepatocellular carcinoma (HCC) of Barcelona Clinic Liver Cancer (BCLC) stage A when surgical resection (SR), thermal ablation, and bridging to transplantation are contraindicated; however, TACE for small HCC is frequently difficult and ineffective because of less hypervascularity and the presence of tumor portions receiving a dual blood supply. Here, we report outcomes of superselective conventional TACE (cTACE) for 259 patients with HCCs within three lesions smaller than 3 cm using guidance software. Automated tumor feeder detection (AFD) functionality was applied to identify tumor feeders on cone-beam computed tomography during hepatic arteriography (CBCTHA) data. When it failed, the feeder was identified by manual feeder detection functionality and/or selective angiography and CBCTHA. Regarding the technical success in 382 tumors (mean diameter, 17.2 ± 5.9 mm), 310 (81.2%) were completely embolized with a safety margin (5 mm wide for HCC ≤25 mm and 10 mm wide for HCC >25 mm). In 61 (16.0%), the entire tumor was embolized but the safety margin was not uniformly obtained. The entire tumor was not embolized in 11 (2.9%). Regarding the tumor response at 2-3 months after cTACE in 303 tumors excluding those treated with combined radiofrequency ablation (RFA) or SR and lost to follow-up, 287 (94.7%) were classified into complete response, seven (2.3%) into partial response, and nine (3.0%) into stable disease. The mean follow-up period was 44.9 ± 27.6 months (range, 1-109) and the cumulative local tumor progression rates at 1, 3, 5, and 7 years were 17.8, 27.8, 32.0, and 36.0%, respectively. The 1-, 3-, 5-, and 7-year overall and recurrence-free survival rates in 175 patients, excluding those with Child-Pugh C class, who died of other malignancies, or who underwent combined RFA or hepatic resection, were 97.1 and 68.7, 82.8 and 34.9, 64.8 and 20.2, and 45.3 and 17.3%, respectively. Our results indicate the efficacy of superselective cTACE using guidance software for HCC within three lesions smaller than 3 cm.

Excretion of Necrotic Hepatocellular Carcinoma Tissues into Hepatic Lymphatic Vessels after Conventional Transarterial Chemoembolization.

We report a case of necrotic hepatocellular carcinoma tissue excretion into the hepatic lymphatic system after conventional transarterial chemoembolization (cTACE) in an 80-year-old man with liver cirrhosis. A tumor measuring 19 mm in diameter in segment 5 was successfully treated with superselective cTACE. Hepatic lymphatic vessels were not opacified with iodized oil during the procedure. Computed tomography (CT) performed 1 week after cTACE showed dense accumulation of iodized oil in the tumor and in the surrounding liver without opacification of the hepatic lymphatics. Excretion of necrotic tumor tissues containing iodized oil into the lymphatic system was initially observed on CT 9 months after cTACE and the amount of excreted tumor tissues had increased 2 years and 2 months after cTACE without tumor recurrence or any clinical symptoms.

Cerebral Embolism as a Rare Complication of Balloon-Occluded Retrograde Transvenous Obliteration for Gastric Varices: A Case Report.

We report a case of cerebral embolism caused by balloon-occluded retrograde transvenous obliteration (BRTO) for gastric varices in a 77-year-old woman with liver cirrhosis. Balloon-occluded retrograde venography demonstrated multiple collaterals between the efferent and systemic veins, and some of them could not be embolized with metallic coils. Therefore, they were embolized with ethanol, 50% glucose solution, gelatin sponge particles, and ethanolamine oleate, and BRTO was completed. After BRTO, however, the patient complained of mild aphagia and paralysis of the right fingers, and magnetic resonance imaging demonstrated cerebral embolism. The symptoms gradually improved after the administration of ozagrel sodium and rehabilitation. The varices were also completely thrombosed. Patent foramen ovale was suspected as a cause of cerebral embolism.

Fibrin Glue in Interventional Radiology: How to Use It.

A fibrin glue kit consists of separate solutions of fibrinogen and thrombin that instantly coagulate when mixed together and can be used as an embolic agent and tissue adhesive in several interventional procedures, such as the closure of enterocutaneous, postoperative pancreatic, and bronchopulmonary fistulas, embosclerosis of biloma, and portal vein embolization. Separate and simultaneous injections of fibrinogen and thrombin solutions at the target site are necessary; therefore, insertion of two catheters or a balloon catheter with multiple lumen is required. The combined use of metallic coils is also effective for a large fistula as the coils can provide a matrix for retaining the fibrin glue, in addition to partially occluding the fistulous tract. Mixing contrast medium or iodized oil with a thrombin solution is also key to achieving radiopacity.

Usefulness of virtual parenchymal perfusion software visualizing embolized areas to determine optimal catheter position in superselective conventional transarterial chemoembolization for hepatocellular carcinoma.

AIM: To determine the optimal catheter position during superselective conventional transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) using virtual parenchymal perfusion software. METHODS: Patients who had newly developed HCC nodules ≤6 cm and five or fewer lesions were eligible. The virtual catheter tip was placed on a tumor-feeder identified by TACE guidance software using cone-beam computed tomography during hepatic arteriography to minimize the virtual embolized area (VEA), including the tumor with a safety margin. Conventional transarterial chemoembolization was then carried out at the same position. The VEA and real embolized area where iodized oil was retained on cone-beam computed tomography after cTACE were compared using the dice similarity coefficient, linear regression analysis, and mean surface distance. Technical success of cTACE and therapeutic effects by the modified Response Evaluation Criteria in Solid Tumors were also evaluated. RESULTS: Ninety-one tumors in 56 patients were embolized. The mean dice similarity coefficient values in 80 VEAs and real embolized areas were 0.78 ± 0.01. Both volumes were well correlated (r = 0.957, p < 0.001) with a mean surface distance of 2.78 ± 2.11 mm. Eighty-four (92.3%) tumors were embolized with a safety margin. Regarding the early response of 82 tumors, complete response was achieved in 72 (87.8%), partial response in six (7.3%), and stable disease in four (4.9%). Regarding responses of 81 tumors during the follow-up (mean, 20 ± 4.9 months), complete response was maintained in 62 (76.5%), whereas 19 (23.5%), including six that were incompletely embolized, locally progressed. CONCLUSION: Virtual parenchymal perfusion software can determine the optimal catheter position in superselective cTACE.

Blood supply to the caudate lobe of the liver from the right inferior phrenic artery: observation by cone-beam computed tomography during arteriography.

PURPOSE: To retrospectively evaluate blood supply to the caudate lobe of the liver from the right inferior phrenic artery (RIPA) using cone-beam computed tomography during arteriography (CBCTA-RIPA). METHODS: CBCTA-RIPA examinations during transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC) were collected from 2448 procedures in 787 patients. The exclusion criteria were (1) major artifacts, (2) TACE of hepatic arterial branches before performing CBCTA-RIPA, and (3) repeated CBCTA-RIPA studies in the same patient. Blood supply to three subsegments, the Spiegel lobe (SP), paracaval, and caudate process, was evaluated on CBCTA-RIPA images. The origins and routes of branches supplying the caudate lobe were also evaluated by three-dimensional vessel-tracking software. RESULTS: Forty-seven CBCTA-RIPA examinations in 47 patients (38 with a history of TACE [repeated TACE group] and nine without it [initial TACE group]) were eligible, including five who had previously undergone hepatectomy. Seven had caudate lobe HCCs. Blood supply to the caudate lobe was demonstrated in 21 (44.7%) patients: in 50% (19/38) and 22.2% (2/9) of the repeated and initial TACE groups, respectively. The caudate arteries had previously been embolized in eight patients, the RIPA branch in three, and both in one. Forty-one proximal branches mainly supplied the dorsal part of the SP. All branches but five reached there through the inferior vena cava (IVC) ligament. The RIPA supplied eight of nine caudate lobe HCCs, totally (n = 7) or partially (n = 1). CONCLUSION: The proximal RIPA branches mainly supply the dorsal SP through the IVC ligament, especially in the repeated TACE group.

Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes and Renal Dysfunction: a Post-Marketing Surveillance Study.

INTRODUCTION: International clinical trials have shown that linagliptin significantly improves glycemic control and can be used at a single dose regardless of renal function in patients with type 2 diabetes (T2D). However, to date, no studies have evaluated the use of linagliptin in Japanese patients with T2D by renal function in routine clinical care. METHODS: This was a subgroup analysis of data from a prospective observational post-marketing surveillance (PMS) study of linagliptin conducted in Japan that evaluated the safety and effectiveness of linagliptin in routine clinical care for 3 years in Japanese patients with T2D. The subgroup analysis examined the patient population of this PMS study according to renal function using estimated glomerular filtration rate (eGFR) data. The incidence of linagliptin-related adverse events (adverse drug reactions [ADRs]) was the primary endpoint, and the change in glycated hemoglobin (HbA1c) from baseline to last observation was the secondary endpoint. RESULTS: Of the 2235 patients included in the safety analysis, eGFR was ≥ 90 mL/min/1.73 m2 (defined as group G1) in 16.9% (n = 377), ≥ 60 to < 90 mL/min/1.73 m2 (group G2) in 44.5% (n = 995), ≥ 30 to < 60 mL/min/1.73 m2 (group G3) in 21.7% (n = 486), ≥ 15 to < 30 mL/min/1.73 m2 (group G4) in 2.6% (n = 58) and < 15 mL/min/1.73 m2 (group G5) in 1.7% (n = 37). No eGFR data were available for 12.6% (n = 282) of patients. In these GFR groups, the incidence of ADRs with linagliptin was 6.9% in group G1, 11.1% in group G2, 13.8% in group G3, 15.5% in group G4 and 16.2% in group G5; the change in HbA1c from baseline to the last observation was - 1.11, - 0.64, - 0.35, - 0.46 and - 0.54% in the respective subgroups. CONCLUSIONS: Long-term linagliptin use showed sustained improvements in glycemic control with no new safety concerns regardless of renal function. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01650259). FUNDING: This study was funded by Nippon Boehringer Ingelheim Co., Ltd. and Eli Lilly Japan K.K.

Intraoperative Bile Duct Disruption Treated Using Intrahepatic Biliary Ablation with Ethanol: A Report of Two Cases.

We report two cases of intraoperative bile duct disruption. In case 1, an isolated bile duct in the remnant of the anterosuperior liver segment after right hepatic lobectomy for cholangiocarcinoma caused bile leakage. In case 2, bile leakage continued from a disrupted accessory hepatic duct during pancreaticoduodenectomy for pancreatic carcinoma. In both patients, a mixture of ethanol and iodized oil at a 10:1 ratio was injected into the disrupted bile duct under balloon occlusion. In case 1, the mixture was injected through a balloon catheter under balloon occlusion overnight. No severe complications developed in either case. Bile leakage stopped postoperatively and did not recur until the patients' death from tumor progression 14 and 16 months after surgery, respectively.

Transarterial Interventional Therapy for Non-functioning Hemodialysis Access.

Transarterial vascular access interventional therapy (VAIVT) for non-functioning hemodialysis access has advantages over the venous approach because natural venous outflow through the fistula as well as the stump at the fistula site in total occlusion can be observed, and most strictures and/or occlusions can be treated via one access route. The brachial arterial approach is essential, but the radial arterial approach at the wrist is also necessary for certain patients. The transarterial approach can be applied to all VAIVTs; however, additional venous access is necessary in cases requiring a large device and those with unsuccessful traversal of the occluded segment via the arterial route. The high origin of the radial artery is a disadvantage of the transbrachial approach, and local hematomas are the most frequent complications.

Safety and effectiveness of empagliflozin in Japanese patients with type 2 diabetes: interim analysis from a post-marketing surveillance study.

Background: Sodium-glucose cotransporter-2 (SGLT2) inhibitors are effective treatments for type 2 diabetes mellitus (T2DM). We present the interim findings of an ongoing post-marketing surveillance (PMS) study in Japanese patients with T2DM receiving empagliflozin.Research design and methods: This 3-year, prospective, observational, multicenter PMS evaluated the safety and effectiveness of empagliflozin in Japanese clinical practice. Patients with T2DM who had not been treated with empagliflozin before enrollment were eligible. Assessments, including the primary endpoint of incidence of adverse drug reactions (ADRs), were based on electronic case report forms (eCRF).Results: Of 8,180 registered patients from 1,103 sites, 7,618 patients had an eCRF including a follow-up visit and were treated (mean age, 58.8 years; 10.5% aged ≥75 years; 63.2% male; mean HbA1c, 8.01%; 41.8% with HbA1c ≥8.0%; 24.8% and 61.8% with at least mild hepatic and renal impairment, respectively). Mean treatment duration was 98.4 weeks; 644 (8.5%) patients had ≥1 ADR, including 8.5% of patients aged ≥75 years. Hypoglycemia, urinary tract infection, genital infections, volume depletion, diabetic ketoacidosis, and lower limb amputation occurred in 0.28%, 0.62%, 0.53%, 0.33%, 0%, and 0.03% of patients, respectively.Conclusions: The reported ADRs were consistent with the known safety profile of empagliflozin.Trial registration: ClinicalTrials.gov identifier: NCT02489942.

Long-Term Safety and Effectiveness of Linagliptin in Japanese Patients with Type 2 Diabetes Mellitus: A 3-Year Post-Marketing Surveillance Study.

INTRODUCTION: Clinical trials of linagliptin in Japanese patients conducted to date have had limited observational periods; therefore, there is a need for additional longer-term real-world data. The aim of this study was to investigate the long-term safety and effectiveness of linagliptin in routine clinical practice. METHODS: This was a prospective, observational, post-marketing surveillance study conducted over 156 weeks in patients with type 2 diabetes mellitus who started linagliptin monotherapy. The primary endpoint was the incidence of adverse drug reactions (ADRs). The secondary endpoint was the change in glycated hemoglobin (HbA1c) from baseline to last available observation. Other effectiveness endpoints included the change in HbA1c and change in fasting plasma glucose (FPG) from baseline to week 26 and over the course of the treatment period. RESULTS: Overall, 2235 and 2054 patients were included in the safety and effectiveness analysis sets, respectively. Patients were mostly male (58.4%), and the mean age was 66.7 years. The incidence of ADRs was 10.7% (n = 240). The most frequent ADRs according to MedDRA preferred terms were diabetes mellitus (n = 35 patients, 1.6%), constipation (n = 21, 0.9%), diabetes mellitus inadequate control (n = 13, 0.6%) and hypertension (n = 13, 0.6%). The mean change in HbA1c from baseline to last observation was - 0.67% [standard deviation (SD) 1.27%, 95% confidence interval - 0.72, - 0.61]. At week 26, HbA1c and FPG showed mean ± SD changes from baseline of - 0.73 ± 1.20% and - 21.02 ± 44.33 mg/dL, respectively, that were sustained until week 156. CONCLUSIONS: In Japanese patients with type 2 diabetes mellitus, linagliptin produced sustained reductions in HbA1c and had a safety profile consistent with the established safety profile of linagliptin. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01650259).

Correction to: Real-world treatment of over 1600 Japanese patients with EGFR mutation-positive non-small cell lung cancer with daily afatinib.

The original article can be found online.

Real-world treatment of over 1600 Japanese patients with EGFR mutation-positive non-small cell lung cancer with daily afatinib.

BACKGROUND: This prospective, post-marketing observational study in Japanese patients aimed to evaluate the safety and effectiveness of daily afatinib use in general practice. METHODS: This non-interventional study (NCT02131259) enrolled treatment-naïve and pre-treated patients with inoperable/recurrent EGFR mutation-positive NSCLC, eligible for afatinib treatment as per the afatinib label in Japan. Patients received afatinib at the approved dose (20, 30, 40, or 50 mg/day; physician decision), and were observed following treatment initiation for 52 weeks or until premature discontinuation. Primary endpoint was the incidence of adverse drug reactions (ADRs). Secondary endpoints included ADRs of special interest, and objective response rate (ORR). Post hoc Cox multivariate analyses were used to assess prognostic factors associated with the incidence of ADRs. RESULTS: 1602 patients, at 374 sites (April 2014-March 2015), were included in the analysis; 307 (19%) were aged ≥ 75 years. The most frequently reported ADRs (all/grade 3-4) were diarrhea (78%/15%), rash/acne (59%/6%), stomatitis (31%/4%), and nail effects (38%/4%). Serious ADRs resulting in death occurred in 18 patients (1%). 762 patients (48%) had ≥ 1 afatinib dose reduction and 366 (23%) discontinued due to ADRs; the most common reason for both was diarrhea (8.2% and 6.7%, respectively). ORR was 40.1%. CONCLUSIONS: Real-world treatment of 1602 Japanese patients with afatinib was associated with a predictable ADR profile. Afatinib showed effectiveness in inoperable/recurrent EGFR mutation-positive NSCLC, especially as first-line treatment. As with other EGFR TKIs, prompt management of adverse events is needed in the Japanese population, to reduce serious events and outcomes, including interstitial lung disease.

Outcomes of conventional transarterial chemoembolization for hepatocellular carcinoma ≥10 cm.

AIM: To retrospectively evaluate the outcomes of conventional transarterial chemoembolization (cTACE) for hepatocellular carcinoma (HCC) ≥10 cm. METHODS: Twenty-five patients with naïve HCC ≥10 cm (mean maximum tumor diameter, 130 ± 27.6 mm; single [n = 12], 2-9 [n = 6], and ≥10 [n = 7]) without extrahepatic spread treated with cTACE were eligible. Five (20%) had vascular invasion. Two to three stepwise cTACE sessions using iodized oil ≤10 mL in one cTACE session were scheduled. When the tumor recurred, additional cTACE was repeated on demand, if possible. Overall survival (OS) rates were calculated using the Kaplan-Meier method. The prognostic factors were evaluated using uni- and multivariate analyses. RESULTS: Stepwise cTACE sessions were completed for 20 (80%) patients, but could not be completed for four (16%). In the remaining (4%) patient, the whole tumor was embolized in one session. Additional treatment, mainly cTACE, was undertaken for 19 (76%) patients. The OS rates at 1, 3, and 5 years were 68, 34.7, and 23.1%, respectively. A tumor number of three was a significant prognostic factor (P = 0.020) and the 1-, 3-, and 4-year OS rates in patients with ≤3 and ≥4 tumors were 81.3 and 33.3, 55.6 and 11.1, and 38.9% and 0%, respectively. Whole tumor embolization and the serum level of protein induced by vitamin K absence or antagonist-II were also significant prognostic factors (P < 0.001 and P = 0.042, respectively). Bile duct complications requiring additional interventions developed in two (8%) patients. CONCLUSION: Conventional TACE is safe and effective for huge HCCs, but has limited effects in cases with four or more tumors.

Preferential prescribing of linagliptin in type 2 diabetes patients in an expanded post-marketing surveillance study in Japan.

AIMS/INTRODUCTION: To evaluate linagliptin prescribing in type 2 diabetes mellitus patients with different comorbidities, an expanded Japanese post-marketing surveillance also collected baseline data for patients initiating other glucose-lowering drugs. MATERIALS AND METHODS: Patients initiating linagliptin monotherapy were enrolled, then the next patient starting monotherapy with another glucose-lowering drug was enrolled (2012-2014). Baseline data were collected and analyzed by the Medical Dictionary for Regulatory Activities system organ class. Analyses were descriptive, and meaningful differences defined as absolute standardized difference >10%. RESULTS: Over 4,200 type 2 diabetes mellitus patients were enrolled. Most system-organ class comorbidities were more common in patients initiating linagliptin versus other glucose-lowering drugs, with meaningful differences observed for metabolism/nutritional (50.5 vs 45.5%, respectively), cardiac (12.2 vs 8.6%, respectively), vascular (56.4 vs 51.3%, respectively) and renal/urinary disorders (9.9 vs 5.7%, respectively). CONCLUSIONS: Expanding the linagliptin Japanese post-marketing surveillance revealed linagliptin prescribing to a type 2 diabetes mellitus population with more comorbidities versus other glucose-lowering drugs. Although such preferential prescribing might be expected, as linagliptin requires no dose adjustment or monitoring in renally or hepatically impaired patients, this innovative post-marketing surveillance approach generated important evidence that could only be shown in such a non-randomized comparative study. These data generated insights important for the design and interpretation of observational studies and spontaneous reports, which are key for public health.

Outcomes of Patients with Hepatocellular Carcinoma Treated with Conventional Transarterial Chemoembolization Using Guidance Software.

PURPOSE: To evaluate the outcomes of conventional transarterial chemoembolization using guidance software for hepatocellular carcinoma (HCC) patients. MATERIALS AND METHODS: One hundred two patients with treatment-naïve HCC with ≤ 7-cm and ≤ 5 lesions treated with conventional transarterial chemoembolization using guidance software were selected. Technical success was classified into 3 grades by computed tomography performed 1 week after transarterial chemoembolization: (i) A, complete embolization with a safety margin; (ii) B, entire tumor embolization without a safety margin; and (iii) C, incomplete embolization. Intrahepatic tumor recurrence was classified into 2 categories: local tumor progression (LTP) and intrahepatic distant recurrence (IDR). Overall survival (OS) and tumor recurrence rates were calculated by the Kaplan-Meier method. Additionally, the incidences of LTP between grade A and B tumors, IDR with/without LTP, and OS with/without LTP were compared by the log-rank test. RESULTS: One hundred fifty-six (82.1%) tumors were determined to be grade A, 26 (13.7%) were determined to be grade B, and 8 (4.2%) were determined to be grade C. The 1-, 3-, and 5-year LTP and IDR rates were 31.7%, 49.4%, and 59.4% and 33.9%, 58.2%, and 73.3%, respectively. LTP developed more frequently in grade B tumors than grade A tumors (P = .0016). IDR developed more frequently in patients with LTP than without LTP (P = .0004). The 1-, 3-, and 5-year OS rates were 96.1%, 71.1%, and 60%, respectively; the 1-, 3-, and 5-year OS rates in patients with/without LTP were 95.7%, 69.8%, and 59.3% and 96.2%, 71.6%, and 59.4%, respectively (P = .9984). CONCLUSIONS: Transarterial chemoembolization guidance software promotes the technical success of transarterial chemoembolization and excellent OS in HCC patients.