Chemoembolization of hepatocellular carcinoma with HepaSphere 30-60 µm. Safety and efficacy study.

BACKGROUND: This study examined the safety, pharmacokinetics, and efficacy of transarterial chemoembolization of hepatocellular carcinoma (HCC) using a newly developed size of a superabsorbent polymer drug-eluting embolic material. METHODS: Forty-five patients with documented HCC (Child-Pugh score A/B: 55.5 %/44.5 %) were embolized with HepaSphere microspheres 30-60 µm with escalation of lesion, dose, and frequency of re-embolization. Local response was evaluated with modified response evaluation criteria in solid tumors (mRECIST). Plasma levels of doxorubicin were measured in 24 patients at baseline and at 5, 20, 40, 60, and 120 min, at 6, 24, and 48 h, and at 7 days, respectively, to determine doxorubicin in plasma (Cmax) and area under the curve (AUC). Measurements of three patients who underwent lipiodol-based conventional chemoembolization (c-TACE) were also performed. RESULTS: TACE with HepaSphere was well tolerated with an acceptable safety profile and no 30-day mortality. Response rates were calculated on intention-to-treat basis with complete response (CR) in 17.8 % reaching 22.2 % for the target lesion. Overall partial response (PR) was seen in 51.1 %, stable disease in 20 %, and progressive disease in 11.1 % of patients. Overall objective response (CR + PR), including patients treated at all dosages of doxorubicin, was seen in 68.9 % of cases. After a median follow-up of 15.6 months, 1-year survival is 100 %. Doxorubicin AUC was significantly lower in patients with HepaSphere 30-60 µm (35,195 ± 27,873 ng × min/ml) than in patients with conventional TACE (103,960 ± 16,652 ng × min/ml; p = 0.009). Cmax was also significantly lower with HepaSphere 30-60 µm (83.9 ± 32.1 ng/ml) compared with c-TACE (761.3 ± 58.8 ng/ml; p = 0.002). CONCLUSION: HepaSphere 30-60 µm is an effective drug-eluting embolic material with a favourable pharmacokinetic profile.

Long term recurrence analysis post drug eluting bead (deb) chemoembolization for hepatocellular carcinoma (hcc).

UNLABELLED: BACKROUND-AIMS: To determine long term outcomes, regarding recurrence and survival, in patients with HCC that achieved complete response after initial treatment with drug eluting beads (DEB) using DC Bead loaded with doxorubicin (DEB-DOX). METHODOLOGY: Forty-five patients with HCC, not suitable for curative treatments that exhibited complete response (EASL criteria) to initial DEB-DOX treatment were retrospectively analyzed after a median follow up period of 63 months. Child-Pugh class was A/B (62.2/37.8%) and mean lesion diameter 5.36 ± 1.1 cm. Lesion morphology was one dominant ≤5cm (53.3%), one dominant >5cm (31.1%) and multifocal (15.6%). RESULTS: At 5 years, overall survival was 62.2% and recurrence-free survival 8.9%. All deaths that occurred were related to tumor progression (31.1%) or complications of underlying liver disease (28.9%). Median time of initial recurrence from baseline treatment was 18 months (range 8-52). When recurrence occurred, a mean time interval between additional DEB-DOX procedures less than 9 months was correlated to a poorer prognosis (p=0.025). Multivariate analysis identified Child-Pugh class at baseline (p=0.048), combined therapy of recurrences with local ablation (p=0.03) and number of DEB-DOX procedures (p=0.037) as significant prognostic factors of 5-year survival. Lesion morphology displayed significance for recurrence-free survival (p=0.014). Child-Pugh class at baseline, additional local ablation, pattern of initial recurrence and initial sum of recurrent tumor diameters all displayed statistical significance for post-recurrence survival (median 40 months), with the first two variables maintaining statistical significance in multivariate analysis (p=0.015 and p=0.014 respectively). CONCLUSION: Initial complete response to DEB-DOX ensures a favorable prognosis. However, management of recurrent tumors, which occur frequently mostly as new lesions, and preservation of underlying liver function appear to play a key role in prolonging survival.

Image-guided radiofrequency ablation (RFA) of unresectable hepatic tumors using a triple-spiral-shaped electrode needle: initial experience in 34 patients.

We evaluated the safety and efficacy of image-guided radiofrequency ablation (RFA) using a triple-spiral-shaped electrode needle for unresectable primary or metastatic hepatic tumors. Thirty-four patients with 46 index tumors were treated. Ablation zone, morbidity, and complications were assessed. The lesions were completely ablated with an ablative margin of about 1 cm. Five patients (14.7%) with a lesion larger than 4.5 cm had local tumor progression after 1 month and were retreated. Hemothorax, as a major complication, occurred in 1 of 34 patients (3.0%) or 1 of 46 lesions ablated (2.2%). RFA using this new electrode needle can be effective in the treatment of large unresectable hepatic tumors.

Image-guided radiofrequency ablation of a pancreatic tumor with a new triple spiral-shaped electrode.

Image-guided, minimally invasive treatment modalities have become an area of considerable interest and research during the last few years for the treatment of primary and secondary liver tumors. We report our experience with an unresectable pancreatic tumor, treated with application of radiofrequency ablation under CT guidance that even though a complication occurred during the procedure, had excellent results on follow-up CT scans.

Endovascular stenting for the management of port-a-cath associated superior vena cava syndrome.

Port-a-cath systems are often essential for the administration of long-term chemotherapy in the treatment of malignancies because they improve venous access, but they are associated with complications, mainly thrombosis of central veins. In the present report, we describe a case of right subclavian and superior vena cava port-a-cath-related thrombosis causing superior vena cava syndrome (SVCS) in a patient affected by Hodgkin's disease. The patient underwent percutaneous revascularization with stent positioning, experiencing immediate relief of symptoms. Endovascular procedures for the treatment of nonmalignant SVCS seem to represent a challenging therapeutic option.

Lower gastrointestinal bleeding treated with transcatheter arterial embolization. Case report and review of the literature.

Acute lower gastrointestinal bleeding, is often a dramatic situation, associated with mortality rate up to 28%. Currently transcatheter alternatives have found their place in the therapeutic spectrum of this situation. An interesting question is when should this procedure be performed and which are the difficulties when performing it. We present the case of a 75-year old woman with acute massive lower gastrointestinal bleeding on the tenth post-operative day of a colic and partial ileal resection. Superselective angiography of the superior mesenteric artery was obtained that disclosed marked contrast extravasation of distal branches of the left colic artery as well as from a small branch feeding the distal enteric anastomoses. Clinical success was achieved after superselective embolization which was accomplished by using polyvinyl alcohol particles. The patient was discharged 5 days later and there were no procedure-related complications during 6-month follow-up period. So, especially in post-operative patients who are considered to be poor candidates for surgical treatment, arterial embolotherapy should be established not only as treatment option, but also as first line therapy for LGI bleeding.

Patient radiation exposure measurements during interventional procedures: a prospective study.

This is a prospective study with the purpose of assessing patient radiation dose and stochastic risk (risk for fatal cancer) in a patient population undergoing interventional radiological (IR) procedures. Measurements were performed on 36 consecutive patients undergoing percutaneous transluminal angioplasty (PTA, n=18), transjugular intrahepatic portosystemic shunt (TIPS, n=3), diagnostic angiography (DA, n=6), arterial embolization (AE, n=3), and hepatic neoplasm chemoembolization (HCE, n=6). Kerma area product (KAP) was used as a measure of x-ray exposure to the patient. Mean KAP value per procedure was 79+/-50 Gy cm for PTA, 139+/-55 Gy cm for TIPS, 110+/-44 Gy cm for DA, 325+/-145 Gy cm for AE, and 150+/-76 Gy cm for HCE. Forty-six percent of total KAP value was attributed to fluoroscopy. In conclusion, we showed that a linear correlation between effective dose and KAP was found (r=0.84), which could be used for estimating patient effective dose using KAP measurements. Small changes to the number of digital frames acquired result in substantial change of the total KAP in interventional radiological procedures. Stochastic risk from IR procedures is quite low for the patient. Measuring KAP is a simple and accurate method, which provides the interventional radiologist with a good estimation of the patient's relative risk for stochastic effects.

Evaluation of spiral computed tomography versus ventilation/perfusion scanning in patients clinically suspected of pulmonary embolism.

OBJECTIVE: To prospectively evaluate the diagnostic accuracy of spiral computed tomography (CT) versus ventilation/perfusion (V/Q) scanning in the examination of patients clinically suspected of having pulmonary embolism (PE). PATIENTS AND METHODS: Sixty-three patients, presenting to the emergency department and departments of radiology and nuclear medicine of a large hospital, highly suspected of having PE, underwent sequential imaging testing with V/Q scanning and contrast-enhanced spiral CT, in addition to other clinical and laboratory tests. RESULTS: PE was diagnosed in 42 (66.7%) of the 63 patients. Thirty-nine of these 42 patients had positive findings in their CT scans, while 18 of the remaining 21 patients without PE had negative findings in their spiral CT [sensitivity, 92.9%, specificity, 85.7% Positive Predictive Value (PPV), 92.9%, Negative Predictive Value (NPV), 85.7%]. V/Q scans showed high-probability of PE in 24 of the 42 patients with PE and were negative in 9 of the remaining 21 patients without PE (sensitivity, 571%, specificity, 42.9%, PPV, 66.7%, NPV, 33.3%). There were statistically significant differences in specificity and sensitivity favoring spiral CT among men and women patients or patients > 50 years old. Fifty-four patients (85.7%) rated their satisfaction towards spiral CT as 'good' or 'very good', whereas the respective rate for V/Q scanning was only 14.3%. CONCLUSION: Spiral CT has an excellent sensitivity, specificity, PPV and NPV for the diagnosis of PE and it could be used as the first-line imaging modality in patients suspected of PE.

Rare right ventricular myxoma detected incidentally on a FAST examination.

A young man underwent Focused Assessment with Sonography in Trauma (FAST) scan for blunt abdominal trauma. An incidental finding on the pericardial view was the presence of a tumor in the right ventricle. Detailed cardiac imaging and subsequent excision revealed the presence of a myxoma. The patient had no obvious cardiac symptoms, but the awareness and experience of the examiner during the FAST examination detected this rare heart tumor at a latent stage, preventing serious, irreversible complications. This case demonstrates the potential importance of looking above the diaphragm during routine abdominal sonography, especially in patients who are critically ill.

Transjugular intrahepatic portosystemic shunt in cavernomatous portal vein occlusion.

A 72-year-old patient with liver cirrhosis and cavernomatous portal vein occlusion presented with refractory ascites. We treated the patient with transjugular intrahepatic portosystemic shunt: transjugular transhepatic puncture of an intrahepatic hilar collateral vein was performed; transjugular intrahepatic portosystemic shunt was created between the right hepatic vein and the patent superior mesenteric vein using this hilar collateral vein as the connecting pathway. The ascites was resolved and the patient remains asymptomatic, while shunt patency is maintained 16 months after the intervention.

Giant adrenal myelolipoma with minimal fat content in a patient with homozygous beta-thalassemia: appearance on MRI.

Giant adrenal myelolipoma is an uncommon entity. We present the atypical MR imaging findings of a giant adrenal myelolipoma in a patient with homozygous beta-thalassemia with histopathology correlation. The tumor showed a drop in signal on the opposed-phase images, with no evidence of macroscopic fat contents, and demonstrated very high signal intensity on T2-weighted images. Giant adrenal myelolipoma should be considered in the differential diagnosis of tumors with the combination of the above MR imaging characteristics.

Ultrasonographic detection of regional lymph node metastases in patients with intermediate or thick malignant melanoma.

Careful monitoring of regional lymph nodes and early detection of metastases in malignant melanoma patients has an impact on their survival, since it may permit beneficial surgical therapy. Palpation is routinely used in clinical practice. The value of ultrasonography for routine follow-up of melanoma patients, still, is not generally accepted. The aim of our study was to assess the sensitivity and specificity of ultrasound and clinical examination respectively, in the detection of melanoma regional node metastases. Additionally, we evaluated whether early detection of metastases improved overall survival. One hundred and forty-eight melanoma patients with an intermediate or thick primary lesion were followed between January 1997 and May 2001. Clinical examination and concomitant regional lymph node ultrasonography were performed, every 3-4 months. If suspicious findings were identified, regional lymph node dissection was undertaken. Forty-four from the initial 148 patients relapsed with regional lymph nodal metastases. In 11 patients (25%) palpation failed to reveal the disease and metastases were depicted only by ultrasonography. In only 1 patient ultrasonography was false-negative. The sensitivity and specificity of palpation were 72.7 and 97% respectively, while those of ultrasonography were 97.7 (p<0.001) and 98% respectively. Ultrasonography was more sensitive in detecting lymph node metastases in the axilla (100%) and the groin (93.3%). When overall survival of patients presenting with local-regional recurrence was calculated--depending on the number of involved lymph nodes--a survival benefit (p<0.05) was found for patients with only one lymph node metastasis. In conclusion, ultrasonography is superior to clinical examination in the early detection of regional lymph node metastases from an intermediate or thick malignant melanoma and should be a part of those patients' surveillance.

Internal iliac artery aneurysm embolization with fibrin sealant: a simple and effective solution.

Endovascular treatment of internal iliac artery (IIA) aneurysms is an attractive alternative to surgical management, because the former is associated with less morbidity and mortality. Embolization with coils or exclusion of the IIA orifice with stent-grafts are the preferred techniques. Although uncommon, technical failures occur with reported aneurysm rupture. Two patients with IIA aneurysms are reported here, where we describe successful occlusion of their IIA aneurysms with the use of fibrin sealant, after initial failure of coil embolization.

Pancreatitis-associated splenic artery pseudoaneurysm: endovascular treatment with self-expandable stent-grafts.

We present a patient with a splenic artery pseudoaneurysm (SAPA) treated with placement of self-expandable stent-grafts. The procedure was complicated by stent-graft migration, but successful management resulted in lasting exclusion of the SAPA, while the patency of the splenic artery was preserved. This is the first report of self-expandable stent-graft treatment of SAPA.

"Absent" pulmonary artery in one adult and five pediatric patients: imaging, embryology, and therapeutic implications.

OBJECTIVE: The purpose of this article is to present serial clinical and imaging findings for the "absent" pulmonary artery. Data from six patients with this condition (five unilateral cases and one bilateral case) provide evidence concerning its embryology and illustrate the therapeutic implications of surgical intervention. CONCLUSION: In our series, we found the anatomy of the absent pulmonary artery to be consistent with a distal ductal origin and involution of the proximal sixth aortic arch. The absent pulmonary artery is a distinct embryologic entity that requires early detection and detailed investigation. Early surgical intervention may be justified in selected patients.

Mammographic changes associated with raloxifene and tibolone therapy in postmenopausal women: a prospective study.

OBJECTIVE: The prolonged use of estrogen therapy is associated with a slightly increased risk of breast cancer. Alternative therapies that are effective in the prevention of menopause, having associated morbidities but no unwanted effects, are of primary interest in the pharmacologic research. The aim of this study was to evaluate the effect of two alternative to estrogens drugs, the selective estrogen receptor modulator raloxifene and the tissue-specific tibolone, on the mammographic appearance of the breast. DESIGN: The study group comprised 131 postmenopausal women aged 41 to 67 years. The women were at least 2 years postmenopausal, free of climacteric symptoms, and at the time of entry to the study had not had therapy for at least 9 months. Women with risk factors for osteoporosis or cardiovascular disease were allocated either to tibolone (n = 56) or raloxifene (n = 48) therapy. Women with no risk factors and women who either did not qualify for or denied treatment (n = 27) served as controls. The study duration was 12 months. Women received a baseline mammogram before commencing therapy and a repeat mammogram at the end of the study period. Mammogram findings were classified according to the modified Wolfe criteria by two expert radiologists. RESULTS: No difference was identified between groups with respect to baseline characteristics associated with breast cancer risk. Similarly, no difference was detected between groups concerning the modified Wolfe classification of baseline mammographic findings. In the tibolone group, 10.7% of the women showed an increase in breast density in the 12-month reevaluation. The respective figure in the raloxifene group was 6.3%, whereas no woman in the control group showed an increase in breast density. Differences in the increase in breast density between groups did not, however, reach statistical significance. Accordingly, 10.7% of women in the tibolone group and 18.8% of women in the raloxifene group exhibited involutionary changes in the repeat mammogram, whereas 25.9% of women in the control group revealed a decrease in breast density in the 12-month examination. The percentages were not significantly different between groups. CONCLUSIONS: Breast density as shown by mammography was stable in a majority of patients and changed in a minority of cases for both tibolone and raloxifene. In most patients, these drugs are not likely to interfere with mammogram interpretation. Larger long-term studies are needed to confirm the impact of prolonged tibolone or raloxifene administration on mammography.