Antonio Nicolini

Randomized controlled study of TIPS versus paracentesis plus albumin in cirrhosis with severe ascites

The transjugular intrahepatic portosystemic shunt (TIPS) has been shown to be effective in the control of refractory or recidivant ascites. However, the effect of TIPS on survival as compared with that of large‐volume paracentesis plus albumin is uncertain. A multicenter, prospective, clinical trial was performed in 66 patients with cirrhosis and refractory or recidivant ascites (16 Child‐Turcotte‐Pugh class B and 50 Child‐Turcotte‐Pugh class C) randomly assigned to treatment with TIPS (n = 33) or with large‐volume paracentesis plus human albumin (n = 33). The primary endpoint was survival without liver transplantation. Secondary endpoints were treatment failure, rehospitalization, and occurrence of complications. Thirteen patients treated with TIPS and 20 patients treated with paracentesis died during the study period, 4 patients in each group underwent liver transplantation. The probability of survival without transplantation was 77% at 1 year and 59% at 2 years in the TIPS group as compared with 52% and 29% in the paracentesis group (P = .021). In a multivariate analysis, treatment with paracentesis and higher MELD score showed to independently predict death. Treatment failure was more frequent in patients assigned to paracentesis, whereas severe episodes of hepatic encephalopathy occurred more frequently in patients assigned to TIPS. The number and duration of rehospitalizations were similar in the two groups. In conclusion, compared to large‐volume paracentesis plus albumin, TIPS improves survival without liver transplantation in patients with refractory or recidivant ascites. (HEPATOLOGY 2004;40:629–635.)

MELD score is better than Child-Pugh score in predicting 3-month survival of patients undergoing transjugular intrahepatic portosystemic shunt

BACKGROUND/AIMSnPatients undergoing transjugular intrahepatic portosystemic shunt (TIPS) are at risk of early death due to end-stage liver failure. The aim of this study was to compare model of end-stage liver disease (MELD) and Child-Pugh scores as predictors of survival after TIPS.nnnMETHODSnWe studied 140 cirrhotic patients treated with elective TIPS. Concordance (c)-statistic was used to assess the ability of MELD or Child-Pugh scores to predict 3-month survival. The prediction of overall survivals was estimated by comparing actuarial curves of subgroups of patients stratified according to either Child-Pugh scores or MELD risk scores.nnnRESULTSnDuring a median follow-up of 23.7 months, 55 patients died, 14 underwent liver transplantation and seven were lost to follow-up. For 3-month survival, the discrimination power of MELD score was superior to Child-Pugh score (0.84 vs. 0.70, z=2.07; P=0.038). Unlike Pugh score, MELD score identified two subgroups of Child C patients with different overall survivals (P=0.027). The comparison between observed and predicted survivals showed that MELD score overrates death risk.nnnCONCLUSIONSnMELD score is superior to Child-Pugh score as predictor of short-term outcome after TIPS. Its accuracy, however, decreases for long-term predictions.

Transarterial chemoembolization for hepatocellular carcinoma with drug-eluting microspheres: preliminary results from an Italian multicentre study.

The purpose of this article is to present the early results of a multicentre trial using HepaSphere microspheres loaded with chemotherapeutic agents for transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma. From December 2005 to March 2007, 50 patients (36 male and 14 female, mean age 68.4xa0years) were treated by selective TACE using HepaSphere microspheres loaded with doxorubicin or epirubicin. The diameter of the treated lesions ranged from 20 to 100xa0mm (mean 42.5; maximum of 4 tumor nodules). Tumor response was evaluated by computed axial tomography according to the World Health Organization criteria as modified by the European Association for the Study of Liver Diseases. All of the procedures were technically successful, and there were no major complications. At 1-month follow-up, complete tumor response was observed in 24 of 50 (48%), partial response in 18 of 50 (36%), and stable disease in 8 of 50 (16%) patients, and there were no cases of disease progression. At 6-month follow-up (31 of 50 patients), complete tumor response was obtained in 16 of 31 (51.6%), partial response in 8 of 31 (25.8%), and progressive disease in 7 of 31 (22.6%) patients. Within the initial 9-month follow-up, TACE with HepaSphere was successfully repeated twice in 3 patients, whereas 3 patients underwent the procedure 3 times. Our initial multicentre experience demonstrates that TACE using HepaSphere is feasible, is well tolerated, has a low complication rate, and is associated with promising tumor response. When complete tumor response in not achieved, additional treatments can be performed without difficulties. Longer follow-up on larger series is mandatory to confirm these preliminary results.

Transarterial chemoembolization with epirubicin-eluting beads versus transarterial embolization before liver transplantation for hepatocellular carcinoma.

PURPOSEnTo retrospectively compare radiologic tumor response and degree of necrosis in explanted livers after chemoembolization with epirubicin-loaded DC Bead versus bland embolization in patients on a transplant waiting list.nnnMATERIALS AND METHODSnFrom 2003 to 2007, 49 patients with hepatocellular carcinoma (HCC) underwent transplantation at a single center. Sixteen patients were treated with bland embolization (n = 8) with 100-300-microm Embosphere particles or chemoembolization with epirubicin-loaded 100-300-microm DC Bead particles (n = 8) every other month until complete tumor devascularization. Computed tomography was performed every 3 months until recurrence. Explanted livers were analyzed to evaluate the degree of necrosis in the nodules. After orthotopic liver transplantation (OLT), patients were followed up for survival and disease status.nnnRESULTSnThe groups were comparable for baseline characteristics. Most patients had Child-Pugh class A disease. Solitary HCC was found in 75% of patients. Mean target lesion size was 32 mm +/- 15.4. Chemoembolization with drug-eluting beads achieved complete necrosis in 77% of lesions whereas bland embolization achieved complete necrosis in 27.2% of lesions. There was a significant difference between bland embolization and chemoembolization with DC Bead with regard to histologic necrosis (P = .043). No significant treatment-related complications were observed for either group. Fifteen patients are alive with no tumor recurrence.nnnCONCLUSIONSnChemoembolization with drug-eluting beads before OLT achieved higher rates of complete histologic response than bland embolization, with no serious adverse events observed. Because of the retrospective data analyses and small sample size, further studies are warranted to confirm these promising results.

Angioplasty of atherosclerotic and fibromuscular renal artery stenosis: Time course and predicting factors of the effects on renal function

The effects of percutaneous transluminal renal angioplasty (PTRA) on the renal function of stenotic kidneys are usually assessed by evaluating the changes in serum creatinine, which is quite a rough indicator of glomerular filtration rate (GFR). In 27 hypertensive patients with 19 atherosclerotic and 11 fibromuscular significant renal artery stenoses, we investigated with renal scintigraphy the short-term (5 days) and long-term (10 months) effects of a technically successful PTRA (in seven cases combined with a stent implantation) on GFR of the stenotic and contralateral kidneys; these measurements were combined with those of plasma renin activity (PRA) and of angiotensin II (AII). We found that in short-term studies after PTRA GFR rose from 29.7 +/- 3.5 to 34.6 +/- 3.1 mL/min and from 36.9 +/- 4.0 to 45.1 +/- 4.3 mL/min, respectively, in atherosclerotic and fibromuscular poststenotic kidneys. In long-term studies GFR further and significantly increased, to 37.8 +/- 3.2 mL/min in the former group, whereas it stabilized in the latter group (46.0 +/- 3.6 mL/min). In patients with fibromuscular stenosis these changes in GFR were associated with clear-cut reductions in blood pressure (BP), PRA, and AII; these decrements also occurred in patients with atherosclerotic stenosis but to a much lesser extent. We also found that in short- and long-term studies the percent of PTRA-induced increments of GFR in the poststenotic kidneys were inversely correlated with the baseline values of GFR. In addition, the absolute and percent increments of GFR were positively correlated with the basal levels of AII. Thus the time course of the improvement in GFR after angioplasty may differ in kidneys, depending on the etiology of the stenosis, in that in those with fibromuscular stenosis it was entirely apparent within a few days whereas in those with atherosclerotic stenosis it required several months to be fully expressed. Also, it appears that the more compromised kidneys are those that benefit most from the dilatation and that AII levels are useful indicators of the possibility that the stenotic kidney will have a favorable functional outcome in terms of restoration of renal blood flow.

Segmental transcatheter arterial chemoembolization treatment in patients with cirrhosis and inoperable hepatocellular carcinomas

PURPOSEnTo establish whether segmental transcatheter arterial chemoembolization (TACE) treatment may improve the rates of survival in patients with compensated cirrhosis and inoperable hepatocellular carcinoma (HCC).nnnMATERIALS AND METHODSnFifty-six patients with compensated cirrhosis and inoperable HCC were treated with segmental TACE. One hundred forty treatments (mean, 2.5 per patient; 30-60 mg Epirubicin, 4-10 mL Lipiodol, and Gelfoam particles) were administered.nnnRESULTSnDuring the 69-month study, 25 patients (45%) died of tumor progression, 12 (21%) of liver failure, nine (16%) of gastrointestinal hemorrhage, and three (5%) of other causes; seven patients (13%) are still alive. The 3-year rate of survival was 32%. Intention-to-treat analysis determined that patients with Child-Pugh class A disease (n = 44; 79%) or a single <5-cm HCC (n = 21; 37%) had a higher rate of survival than those with Child-Pugh class B disease (n = 12; 21%; P <.002) or a larger HCC (n = 35; 63%; P <.02) and patients (n = 41) who were treated with more than one course of TACE had a higher rate of survival than those who were treated with a single TACE procedure (n = 15; P <.0003). Multivariate analysis was used to predict rates of survival by number of treatments (hazard ratio, 0.6; CI, 0.48-0.86; P <.004), Child-Pugh class (hazard ratio, 2.8; CI, 1.41-5.74; P <.003), and tumor size (hazard ratio, 3.8; CI, 1.81-8.01; P <.001). The 3-year rate of survival in patients with Child-Pugh class A disease and a < or =5-cm-HCC (n = 16) was 56%. This result was similar to the 50% 3-year rate of survival in untreated historic controls with similar characteristics.nnnCONCLUSIONnThe rate of survival in patients with compensated cirrhosis and inoperable HCC did not appear to improve with use of TACE therapy.

Percutaneous Treatment of Iliac Aneurysms and Pseudoaneurysms with Cragg Endopro System 1 Stent-Grafts

AbstractPurpose: To evaluate the feasibility and short-term follow-up results of treating iliac aneurysms by the Cragg Endopro System 1 stent-graft.n Methods: Nine lesions (two pseudoaneurysms and seven atherosclerotic aneurysms) were treated in eight patients by percutaneous implantation of a total of 10 stent-grafts. The procedure was followed by anticoagulation with heparin for 6 days, then antiplatelet therapy. Follow-up was by color Doppler ultrasound scan at 2 days and 3 months after the procedure for all patients, and by venous digital subtraction angiography and/or angio-CT up to 12 months later for four patients.n Results: Initial clinical success rate was 100% and there were two minor complications. In one case the delivery system was faulty resulting in failure to deploy the stent-graft. An additional device had to be used. At 3–12 months all prostheses were patent but one patient (12.5%) had a minimal pergraft leak.n Conclusion: Percutaneous stent-grafting with this device is a safe and efficacious treatment of iliac artery aneurysms.

Drug delivery embolization systems: a physician's perspective

Introduction: The number of patients suffering from primary and secondary liver tumoral diseases is on the increase worldwide. The development of new technologies and drugs requires an increasingly multidisciplinary approach in the management of these diseases. Therapies should be based on scientifically supported guidelines and at the same time should be designed to suit the individual patient. In this decision-making process, an understanding of the advantages and disadvantages of every treatment is very important. The efficacy of transarterial chemoembolization (TACE) in improving survival and its role in the management of hepatocellular carcinoma (HCC) have been demonstrated in several clinical trials. The introduction of drug-eluting beads seems to have overcome some of the limitations of conventional TACE. Areas covered: This review provides an overview of the spread of primary and secondary liver cancers, then it explains the basis for the use of conventional TACE and its potential benefits and, finally, outlines its clinical application and possible future uses. Expert opinion: The management of the treatment of focal liver lesions is a difficult process, which must involve various specialists such as the interventional radiologist. The use of drug-eluting microspheres seems to improve the results of TACE both in HCC and in colorectal liver metastases.

Four-Year Survival After Trans-jugular Intrahepatic Porto-systemic Shunt for Veno-occlusive Disease Following Autologous Bone Marrow Transplantation

Severe hepatic veno-occlusive disease is still a potentially lethal complication after bone marrow transplantation. We here report the case of a patient who developed liver veno-occlusive disease with severe hemodynamic dysfunction and was successfully treated by means of a trans-jugular intrahepatic portosystemic shunt. After three years, he is still disease-free with a functioning shunt and a normal laboratory liver profile. A trans-jugular intrahepatic portosystemic shunt is a treatment option that has been used in very few patients affected by hepatic veno-occlusive disease; its indications and timing remain to be established.