Role of Hypertension and Other Clinical Variables in Prognostication of Patients Presenting to the Emergency Department With Major Bleeding Events.

BACKGROUND: Clinical variables including hypertension could be linked with major bleeding events and death beyond vitamin K antagonist (warfarin) or direct oral anti-coagulants (DOACs) treatment strategy. METHODS: Subgroup analysis of major bleeding (primary endpoint) associated with clinical variables, site of bleeding, ongoing antithrombotics, reversal treatment or blood transfusion, outcomes (secondary endpoints) was performed in patients with bleeding events submitted to hard 5:1 propensity-score matching for hypertension. RESULTS: Enrolled patients were 2,792 (mean age, 65.6 ± 19.9 years) during 2-year survey including 166,000 visits, of 200,000 inhabitants catchment area; 8,239 patients received warfarin and 3,797 DOACs. Hypertension account for 1,077 (39%) patients; major bleeding for 474 (17%); death for 29 (1%), and 72 (3%) on 1-month and 1-year, respectively. Hypertension, age, glucose, cancer, ischemic vascular disease, and CHA2D2VASc score were more likely to link with major bleeding. On multivariate analysis, only age (odds ratio [OR], 1.02; P < 0.001), CHA2DS2VASc score ≥ 2 (OR, 2.14; P = 0.001), and glucose (OR, 1.01; P = 0.005) were predictors of major bleeding. Kaplan-Meier analysis demonstrated patients with hypertension as compared with patients without showed 60% versus 20% death on 1-month (P < 0.001). Warfarin compared with DOACs was more likely to present with major bleeding (0.7% versus 0.2%; OR, 2.8; P = 0.005). Receiver operator characteristics analysis showed high value (0.61) of age and glucose over creatinine and systolic arterial pressure (P = NS). CONCLUSIONS: Four in 10 patients with major bleeding showed hypertension; of these 8 in 10 will die within 1 month. Warfarin compared with DOACs was more likely to present with major bleeding.

Gallstone ileus: literature review.

Gallstone ileus is a rare case of mechanical intestinal obstruction observed in patients with history of cholelithiasis or cholecystitis. Its diagnosis is difficult and it is characterized by high mortality rate. Diagnostic Imaging plays an important role in the management of patients with suspected gallstone ileus because an early diagnosis could reduce the mortality. Abdominal Computed Tomography (CT) is the preferred modality because of its rapid diagnosis. Surgery remains the gold standard treatment.

Embolization of the periprostatic venous plexus for erectile dysfunction resulting from venous leakage.

PURPOSE: To evaluate retrospectively the safety and efficacy of anterograde embolization of the periprostatic venous plexus (AEPV) via percutaneous access of the deep dorsal vein of the penis for erectile dysfunction (ED) resulting from veno-occlusive dysfunction (VOD). MATERIALS AND METHODS: From September 2009 through December 2012, 18 patients with moderate to severe ED secondary to insufficiency of physiologic venous occlusion as diagnosed by color Doppler evaluation of the penis after direct pharmacologic stimulation were treated. Preliminary diagnoses were also confirmed with dynamic cavernosography. Selective AEPV was achieved using a combination of N-butyl cyanoacrylate and endovascular coils. Follow-up consisted of collecting International Index of Erectile Function questionnaire (IIEF-6) scores and repeated color Doppler evaluation. RESULTS: Immediate technical success was achieved in 16 of 18 patients (88.8%). Follow-up data were obtained at a mean of 13.3 months ± 7.5. In 12 of the patients with technical success, the mean IIEF-6 score improved from 10.5 ± 5.2 to 20.6 ± 8.4 after the procedure (P = .0069). At 3-month short-term follow-up, clinical success defined by an end-diastolic velocity of < 5 cm/s on color Doppler was noted in 81% (13 of 16 patients). Of these 13 patients, 7 patients had continued erectile function at the end of follow-up, and the other 6 patients reported progressive diminishment in the benefit over time. No major complications and two minor complications were encountered. CONCLUSIONS: AEPV for ED secondary to VOD is a safe alternative to surgical treatment that demonstrates promising short-term and midterm efficacy.

The impact of training on diagnostic accuracy with computed tomography coronary angiography.

AIM: The aim of this study is to assess the image quality and diagnostic accuracy of computed tomography (CT) coronary angiography (CTCA) in different hospital settings with the same trained team. MATERIALS AND METHODS: Four hundred patients were consecutively enrolled for CTCA in a large academic hospital (Group 1; Sensation 64 Cardiac, Siemens - Iomeprol 400, Bracco; 200 patients) and in a small local hospital (Group 2; VCT, GE Healthcare - Iodixanol 320, GE Healthcare; 200 patients). All patients were enrolled for suspected coronary artery disease (CAD) and patients with stents or who had previously undergone coronary bypass were excluded. Scan protocols (retrospectively ECG-gated; no dose reduction modulation applied) were performed in accordance with standards reported in the international literature with the best solution available on site. Image quality was assessed in each coronary segment with a 4-point Likert scale: 0, not assessable; 1, low; 2, average; 3, good. Diagnostic accuracy was calculated against conventional coronary angiography with a threshold of at least 50% for significant stenosis. RESULTS: There was no significant difference between demographics, BMI, prevalence of obstructive CAD, calcium score and heart rate between the two populations. The average image quality was 2.83 ± 0.37 for Group 1 and 2.86 ± 0.31 for Group 2 (P > 0.05). Per-segment sensitivity, specificity, positive and negative predictive values were 92.6% (87-95), 97.9% (97-98), 75.9% (69-81) and 99.5% (99-99), respectively, for Group 1, and 90.4% (85-93), 98.6% (98-99), 84.2% (78-88) and 99.2% (98-99), respectively, for Group 2 (P > 0.05). CONCLUSION: There is no significant difference in image quality and diagnostic accuracy of CTCA when the investigation is performed by the same properly trained team. CTCA is a robust imaging modality for the detection of coronary artery stenosis.

Plaque imaging with CT coronary angiography: Effect of intra-vascular attenuation on plaque type classification.

AIM: To assess the attenuation of non-calcified atherosclerotic coronary artery plaques with computed tomography coronary angiography (CTCA). METHODS: Four hundred consecutive patients underwent CTCA (Group 1: 200 patients, Sensation 64 Cardiac, Siemens; Group 2: 200 patients, VCT GE Healthcare, with either Iomeprol 400 or Iodixanol 320, respectively) for suspected coronary artery disease (CAD). CTCA was performed using standard protocols. Image quality (score 0-3), plaque (within the accessible non-calcified component of each non-calcified/mixed plaque) and coronary lumen attenuation were measured. Data were compared on a per-segment/per-plaque basis. Plaques were classified as fibrous vs lipid rich based on different attenuation thresholds. A P < 0.05 was considered significant. RESULTS: In 468 atherosclerotic plaques in Group 1 and 644 in Group 2, average image quality was 2.96 ± 0.19 in Group 1 and 2.93 ± 0.25 in Group 2 (P ≥ 0.05). Coronary lumen attenuation was 367 ± 85 Hounsfield units (HU) in Group 1 and 327 ± 73 HU in Group 2 (P < 0.05); non-calcified plaque attenuation was 48 ± 23 HU in Group 1 and 39 ± 21 HU in Group 2 (P < 0.05). Overall signal to noise ratio was 15.6 ± 4.7 in Group 1 and 21.2 ± 7.7 in Group 2 (P < 0.01). CONCLUSION: Higher intra-vascular attenuation modifies significantly the attenuation of non-calcified coronary plaques. This results in a more difficult characterization between lipid rich vs fibrous type.

Gemcitabine-capecitabine plus intra-arterial epirubicin-cisplatin in pretreated pancreatic cancer patients: a phase I study.

BACKGROUND: Gemcitabine plus capecitabine are active in patients (pts) with advanced pancreatic cancer (APC). Intra-arterial chemotherapy showed activity and low toxicity. Combination of systemic and intra-arterial chemotherapy was investigated. PATIENTS AND METHODS: Patients with APC, progressed after a first-line chemotherapy, were included. Fixed doses of epirubicin 35 mg/m(2) and cisplatin 42 mg/m(2) intra-arterially every 28 days, and capecitabine 650 mg/m(2) twice a day on days 2-15; gemcitabine systemically in increasing doses on day 2. The purpose was to find maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT). RESULTS: Fifteen patients were enrolled. DLT occurred at 1300 mg/m(2) of gemcitabine and consisted of myelotoxicity (grade 4 febrile neutropenia and grade 4 thrombocytopenia). CONCLUSION: Limiting toxicity was hematological. For further studies intra-arterial epirubicin 35 mg/m(2) and cisplatin 42 mg/m(2); systemic gemcitabine at 1,000 mg/m(2) on day 2, and capecitabine at 650 mg/m(2) twice a day PO on days 2-15 are suggested.

Prognostic factors in patients with advanced pancreatic adenocarcinoma treated with intra-arterial chemotherapy.

OBJECTIVES: The aim of this study is to identify the prognostic factors of a large group of patients with pancreatic cancer who underwent the same regimen of intra-arterial chemotherapy. METHODS: 5-fluorouracil (1000 mg/m2), leucovorin (100 mg/m2), epirubicin (60 mg/m2), and carboplatin (300 mg/m2) were administered every 3 weeks into celiac axis (FLEC regimen). Kaplan-Meyer survival curve for univariate analysis and Cox regression model for multivariate one were used to determine factors predictive of survival. RESULTS: Data of 211 patients with advanced pancreatic cancer who underwent FLEC regimen were analyzed. Eighty-nine had locally advanced disease, and 112 had distant metastases. Median overall survival was 9.2 months. In both univariate and multivariate analyses, pain reduction after treatment (< or =30% of baseline level vs >30%; overall survival, 7.6 vs 11.5 months), stage of disease (III vs IV; overall survival, 10.5 vs 6.6 months), and number of administered cycles (< or =3 vs >3; overall survival, 5.9 vs 12.3 months) were significant and independent predictors of survival. CONCLUSIONS: Pain reduction, stage of disease, and number of administered cycles are independent prognostic factors of overall survival in a multivariate analysis of patients with advanced pancreatic cancer receiving FLEC regimen intra-arterially.

Capecitabine plus hepatic intra-arterial epirubicin and cisplatin in unresectable biliary cancer: a phase II study.

UNLABELLED: The aim of the present study was to evaluate the activity of hepatic intra-arterial infusion of epirubicin and cisplatin combined with oral capecitabine, in patients with unresectable biliary carcinomas. PATIENTS AND METHODS: Twenty patients were treated by bolus infusion of epirubicin 50 mg/m2 and cisplatin 60 mg/m2 in the hepatic artery on day 1, combined with oral capecitabine 1000 mg/m2 bid, from day 2 to day 15. RESULTS: Partial responses (PR) were observed in 6 patients (31.5%), stable disease (SD) in 9 (47.5%) and progression (PD) in 4 (21%). The median progression-free and overall survival periods were 11.6 and 18.0 months, respectively, and 1-year survival was 74%. One patient died after the first cycle because of G4 diarrhea. The other patients had good tolerance, with minimal hematological toxicity and only 1 G3 vomiting. CONCLUSION: This combined intra-arterial and oral approach to patients with biliary carcinomas was found to be active and safe and seems to produce an encouraging survival response.

Adjuvant intra-arterial 5-fluoruracil, leucovorin, epirubicin and carboplatin with or without systemic gemcitabine after curative resection for pancreatic adenocarcinoma.

BACKGROUND: The role of adjuvant therapy in pancreatic cancer remains controversial. Gemcitabine given systemically seems to be effective; intra-arterial chemotherapy (IAC) has a deep rationale. PATIENTS AND METHODS: The goal was to evaluate the impact of postoperative IAC followed or not by systemic gemcitabine in patients after curative resection for pancreatic adenocarcinoma. 5-fluoruracil 750 mg sq m(-1), leucovorin 75 mg sq m(-1), epirubicin 45 mg sq m(-1), carboplatin 225 mg sq m(-1) were administered every 3 weeks into celiac axis for three cycles (FLEC regimen), then gemcitabine at the dosage of 1 g sq m(-1) on days 1, 8 and 15 every 4 weeks for 3 months (FLECG regimen). RESULTS: Forty-seven patients entered the study. The first 24 received only IAC (FLEC regimen), the other 23 received the same intra-arterial regimen followed by systemic gemcitabine (FLECG regimen). After a median follow-up of 16.9 months, 29 patients recurred (61.7%). Median disease free survival (DFS) was 18 months and median overall survival (OS) was 29.7 months. One-year DFS was 59.4% and 1-year OS was 75.5%. Main grade 3 toxicity related to IAC was only nausea/vomiting in 4%; regarding gemcitabine, grade 3 toxicities were anaemia 8%, leukopenia 8%, thrombocitopenia 17%, nausea/vomiting 4%. CONCLUSIONS: FLEC regimen with or without gemcitabine is active with a very mild toxicity and results are very encouraging in an adjuvant setting.

Hepatic arterial chemotherapy with oxaliplatin, folinic acid and 5-fluorouracil in pre-treated patients with liver metastases from colorectal cancer.

BACKGROUND: Hepatic arterial chemotherapy (HAC) is an effective treatment of liver metastases from colorectal cancer (CRC). Phase I and II studies have already shown the feasibility and efficacy of intra-arterial oxaliplatin (OXA). PATIENTS AND METHODS: Twenty-one pre-treated patients with liver metastases who received HAC with OXA/folinic acid (FA)/5-fluorouracil (5-FU) at our Division between March 2000 and November 2003, were clinically examined. Most patients were heavily pre-treated with two or more systemic chemotherapeutic regimes. All patients received a percutaneously implanted catheter into the hepatic artery through femoral or transaxillary access. Treatment was administered every 14 days: OXA 100 mg/m2 as a 12-hour infusion on day 1; FA 100 mg/m2 as a 2-hour infusion on days 2 and 3; 5-FU 2600 mg/m2 as a continuous infusion on days 2 and 3. RESULTS: Grade 3-4 toxicities were: asthenia (2 out of 21), transaminase elevation (2 out of 21) and pain (2 out of 21), nausea and vomiting (1 out of 21), neutropenia (1 out of 21), thrombocytopenia (1 out of 21) and neurotoxicity (1 out of 21). Main dose limiting toxicity was right upper quadrant pain. Response rates were: 5% complete response, 19% partial response, 28% stable disease and 48% progressive disease. Two patients became operable and underwent complete resection of liver disease. The median overall survival was 36.1 months. Two-year and 3-year survival rates were 62% and 52%, respectively. CONCLUSION: This regimen is feasible with low toxicity and with an encouraging overall tumor growth control (52%) in a subset of heavily pre-treated patients. Intra-arterial OXA/FA/5-FU should be considered for the treatment of patients pre-treated with systemic chemotherapies with liver metastases from CRC.