Duration of response after DEB-TACE compared to lipiodol-TACE in HCC-naïve patients: a propensity score matching analysis.

OBJECTIVES: To retrospectively compare long-term outcomes of first-line drug-eluting particle (DEB)- transarterial chemoembolization (TACE) and lipiodol-TACE, in patients with unresectable hepatocellular (HCC). METHODS: We retrospectively reviewed our database to identify adult patients with treatment-naïve unresectable HCC, who underwent TACE from 2006 to 2013. Patients were excluded in the absence of complete medical records relative to first TACE, 1-month follow-up, and/or sufficient follow-up data. Periprocedural complications, duration of hospitalization, 1-month tumor response by mRECIST, time to tumor progression (TTP) and target tumor progression (TTTP), and overall survival (OS) were evaluated. RESULTS: Out of an initial series of 656 patients, 329 patients were excluded for unavailability of sufficient baseline and/or follow-up data. The remaining 327 patients underwent either lipiodol-TACE (n = 160) or DEB-TACE (n = 167). Patients treated with lipiodol-TACE had a significantly higher tumor burden. By propensity score, patients were matched according to baseline differences (BCLC stage, uninodular or multinodular HCC, and unilobar or bilobar HCC), resulting in 101 patients in each treatment group. Lipiodol-TACE was associated with a significantly higher incidence of adverse events (p = 0.03), and longer hospitalization (mean, 2.5 days vs 1.9 days; p = 0.03), while tumor response, TTP, and OS were comparable. In patients achieving 1-month complete response (CR) of target tumor, TTTP was significantly (p = 0.009) longer after DEB-TACE compared to lipiodol-TACE (median, 835 vs 353 days), resulting in a lower number of re-treatments during the entire follow-up (0.75 vs 1.6, p = 0.01). CONCLUSION: Compared to lipiodol-TACE, DEB-TACE offers higher tolerability, reduced hospitalization, and more durable target tumor response after CR. KEY POINTS: • Compared to lipiodol-TACE, DEB-TACE is better tolerated and has reduced side effects, which translates into shorter hospitalization. • When complete radiological response according to the mRECIST is obtained 1 month after the procedure, DEB-TACE offers a more durable local tumor control compared to lipiodol-TACE. • In these patients, the longer duration of response after DEB-TACE translates into a lower number of re-interventions.

Effect of Direct Endovascular Revascularization Based on the Angiosome Model on Risk of Major Amputations and Life Expectancy in Type 2 Diabetic Patients with Critical Limb Ischemia and Foot Ulceration.

BACKGROUND: We evaluated whether direct or indirect endovascular revascularization based on the angiosome model affects outcomes in type 2 diabetes and critical limb ischemia. METHODS: From 2010 to 2015, 603 patients with type 2 diabetes were admitted for critical limb ischemia and submitted to endovascular revascularization. Among these patients, 314 (52%) underwent direct and 123 (20%) indirect revascularization, depending on whether the flow to the artery directly feeding the site of ulceration, according to the angiosome model, was successfully acquired; 166 patients (28%) were judged unable to be revascularized. Outcomes were healing, major amputation, and mortality rates. RESULTS: An overall healing rate of 62.5% was observed: patients who did not receive percutaneous transluminal angioplasty presented a healing rate of 58.4% (P < .02 versus revascularized patients). A higher healing rate was observed in the direct versus the indirect group (82.4% versus 50.4%; P < .001). The major amputation rate was significantly higher in the indirect versus the direct group (9.2% versus 3.2%; P < .05). The overall mortality rate was 21.6%, and it was higher in the indirect versus the direct group (24% versus 14%; P < .05). CONCLUSIONS: These data show that direct revascularization of arteries supplying the diabetic foot ulcer site by means of the angiosome model is associated with a higher healing rate and lower risk of amputation and death compared with the indirect procedure. These results support use of the angiosome model in type 2 diabetes with critical limb ischemia.

Ultrasound in the Modern Management of the Diabetic Foot Syndrome: A Multipurpose Versatile Toolkit.

Ultrasound (US) is a noninvasive and versatile technology that in recent years found acceptance in almost all the medical specialties, with diagnostic and interventional applications. In the diabetic foot syndrome (DFS), US found specific indications mainly in the screening, quantification, and follow-up of the vascular component of the pathology, but also in the study of the deformities and structural modifications induced by neuropathy and in the diagnosis and surgical management of infections, especially those that induce anatomical changes, like abscesses and fasciitis. This review will summarize all these application of US, giving special attention to the vascular aspects, and on the predominant role that US gained in recent times to guide the indication to revascularization, on the new standardized approach to the study of the arterial tree of the limb and the foot, the so-called duplex ultrasound arterial mapping, which significantly increased the utilization of US to plan the revascularizations in this complex pathology. Outside the vascular fields, the diagnosis of neuropathy and infection and the intraoperative use of US in the surgical management of abscesses and fasciitis will be discussed, leaving the last part to the new and interesting applications of US in the management of DFU, a field that is still in evolution, offering new possibilities to the health care professionals involved in the management of these chronic wounds. The variety of applications both in diagnostic and operative fields makes US a rather versatile technology-a toolkit-that should have a special place among those at reach of the specialists of DFS care.

Predictive value of angiographic scores for the integrated management of the ischemic diabetic foot.

OBJECTIVE: To retrospectively evaluate the agreement between the angiographic scores and the clinical outcomes after endoluminal revascularization in diabetic patients with Fontaine stage IV critical limb ischemia (CLI). METHODS: Clinical and procedural data were retrospectively collected of consecutive diabetic patients with Fontaine stage IV CLI who underwent percutaneous lower limb endoluminal revascularization from January 2009 to June 2011. Pre- and postprocedural angiographic images were retrospectively reviewed to classify lower limb arterial involvement according to four systems: (1) TransAtlantic Inter-Society Consensus [TASC] I; (2) TASC II; (3) Graziani's morphologic classification; and (4) Joint Vascular Society Council calf and foot scores. Foot lesions were graded according to the University of Texas wound classification system. Clinical results (healing, nonhealing, or major amputation) were compared with baseline clinical data and angiographic results. RESULTS: In the study period, 202 percutaneous procedures were performed, with an immediate technical success rate of 94%. Preprocedurally, the mean ± standard deviation calf and foot scores were 7.8 ± 1.6 and 7.3 ± 2.3, respectively; 132 patients (65%) were in Graziani's morphologic classes from 4 to 7; in 112 (55%) cases, TASC II was considered inapplicable, for the absence of femoropopliteal lesions; and finally, 93% of limbs were classified as TASC I type D lesions. After the procedure, mean calf and foot scores were 4.8 ± 2.3 and 5.9 ± 2.6, respectively, and 87% of cases were in Graziani's classes 1 and 2; TASC II was inapplicable in all cases, whereas 80% of cases remained TASC I type D lesions. Healing rate was 67% and major amputation rate was 4%. Among all the clinical and angiographic variables included in the analysis, only pre- and postprocedural foot scores were significantly associated to the clinical outcome (P < .05). CONCLUSIONS: Endoluminal revascularization represents a valuable treatment option in diabetic patients with CLI. TASC classifications are inadequate to describe peripheral arterial involvement in the vast majority of diabetic patients with CLI. Pre- and postprocedural foot scores represent the most significant angiographic parameters to evaluate treatment success.

Efficacy and safety of a novel vascular closure device (Glubran 2 seal) after diagnostic and interventional angiography in patients with peripheral arterial occlusive disease.

PURPOSE: To prospectively evaluate safety and efficacy of a novel vascular closure device (Glubran 2 Seal) after peripheral angiography in patients with peripheral arterial occlusive disease (PAOD). METHODS: From December 2010 to June 2011, all consecutive patients with PAOD undergoing peripheral angiography were prospectively enrolled onto the study after percutaneous antegrade or retrograde puncture of the common femoral artery. After angiography, the Glubran 2 Seal device was used to achieve hemostasis. The following data were registered: technical success and manual compression duration, patients' discomfort (scale 0-5), operators' technical difficulty (scale 0-5), and vascular complications. The site of hemostasis was evaluated by clinical inspection and color-coded Duplex ultrasound performed 1 day and 1 month after the procedure. RESULTS: One hundred seventy-eight patients were enrolled (112 male, mean age 70.8 years) with a total of 206 puncture sites, including 104 (50.5 %) antegrade accesses. The device was successful in 198(96.1 %) of 206 procedures, with 8 cases of manual compression lasting longer than 5 min (maximum 20 min). No major vascular complications were observed, resulting in 100 % procedural success. Minor complications occurred in seven procedures (3.4 %), including two cases of pseudoaneurysms, successfully treated by ultrasound-guided glue injection. The mean ± standard deviation score for patients' discomfort was 0.9 ± 0.7, whereas the mean score for operators' difficulty was 1.2 ± 0.9. CONCLUSION: In patients with PAOD, the Glubran 2 Seal represents a simple, painless, and efficient vascular closure device, able to achieve hemostasis both in antegrade and retrograde accesses.

Image fusion of preprocedural CTA with real-time fluoroscopy to guide proper hepatic artery catheterization during transarterial chemoembolization of hepatocellular carcinoma: a feasibility study.

PURPOSE: To assess feasibility of proper hepatic artery catheterization using a 3D model obtained from preprocedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, during transarterial chemoembolization of hepatocellular carcinoma. METHODS: Twenty consecutive cirrhotic patients with hepatocellular carcinoma undergoing transarterial chemoembolization were prospectively enrolled onto the study. The early arterial phase axial images of the preprocedural CTA were postprocessed on an independent workstation connected to the angiographic system (Innova 4100; GE Healthcare, Milwaukee, WI), obtaining a 3D volume rendering image (VR) that included abdominal aorta, splanchnic arteries, and first and second lumbar vertebrae. The VR image was manually registered to the real-time X-ray fluoroscopy, with the lumbar spine used as the reference. The VR image was then used as guidance to selectively catheterize the proper hepatic artery. The procedure was considered successful when performed with no need for intraarterial contrast injections or angiographic acquisitions. RESULTS: The procedure was successful in 19 (95 %) of 20 patients. In one patient, celiac trunk angiography was required for the presence of a significant ostial stenosis that was underestimated at computed tomography. Time for image reconstruction and registration was <10 min in all cases. CONCLUSION: The use of preprocedural CTA model with fluoroscopy enables confident and direct catheterization of the proper hepatic artery with no need for preliminary celiac trunk angiography, thus reducing radiation exposure and contrast media administration.

Transjugular intrahepatic portosystemic shunt for hepatitis C virus-related portal hypertension after liver transplantation.

This is a single center retrospective review of 19 consecutive liver transplant (LT) patients with hepatitis C virus (HCV)-related graft recurrent hepatitis who underwent transjugular intrahepatic portosystemic shunt (TIPS) at a median interval of 21 months (range: 5-50) from LT. Indications were refractory ascites in 11 patients (57.9%), hydrothorax in six (31.6%), and both in two (10.5%). TIPS was successful in 94.7% of cases (18/19) with only one procedure-related mortality (5.3%) owing to sepsis on day 35. At a median follow-up of 23 months (range: one month-nine yr), TIPS allowed for symptoms resolution in 16 patients (84.2%), with ascites resolving in all cases and hydrothorax persisting in 2. Post-TIPS patient survival at six months, one yr, and three yr was 84.2%, 73.7%, and 56.8%, respectively. We compared these results with a control group of 29 patients with HCV recurrence but without unresponsive ascites or hydrothorax. Patients in the control group had better survival than patients undergoing TIPS placement. However, survival of TIPS patients with a MELD score lower than or equal to 12 was similar to that of the control group. We conclude that TIPS may be used to treat complications secondary to HCV.

Transarterial chemoembolization in very early and early-stage hepatocellular carcinoma patients excluded from curative treatment: a prospective cohort study.

AIM: To assess clinical outcome of transarterial chemoembolization (TACE) in a series of patients with early-stage hepatocellular carcinoma (HCC), within Milan criteria, but clinically unfit for liver transplantation (OLT). METHODS: From January 2006 to May 2009, 67 patients (43 males, mean age 70 ± 7.6 years) with very early or early-stage unresectable HCC, within Milan selection criteria but clinically unfit for OLT, underwent TACE. The primary endpoint of the study was overall survival. Secondary endpoints were: safety, liver toxicity, 1-month tumour response according to the amended RECIST criteria, time to local and distant intrahepatic tumour recurrence and time to radiological progression. RESULTS: Two major periprocedural complications occurred (3%), consisting of liver failure. Periprocedural mortality rate was 1.5% (1 patient). A significant increase in ALT and bilirubin levels 24h after treatment was reported, with progressive decrease at discharge. At 1-month follow-up, complete and partial tumour response rates were 67.2% and 29.8%, respectively, with two cases of progressive disease. Mean follow-up was 37.3 ± 15 months. The 1-, 2-, and 3-year overall survival rates were 90.9%, 86.1%, and 80.5%, respectively. Median expected time to local tumour recurrence and intrahepatic tumour recurrence were 7.9 and 13.8 months, respectively. Radiological disease progression was observed in 12 patients (17.9%) with a mean expected time of 26.5 months. CONCLUSION: In patients with early-stage HCC, clinically excluded from OLT and unfit for surgery or percutaneous ablation, TACE is a safe and effective option, with favourable long-term survival.

Hepatocellular carcinoma: CT for tumor response after transarterial chemoembolization in patients exceeding Milan criteria--selection parameter for liver transplantation.

PURPOSE: To retrospectively evaluate the clinical outcome of patients with hepatocellular carcinoma (HCC) who exceeded the Milan criteria, who underwent transarterial chemoembolization (TACE) before orthotopic liver transplantation (OLT), to determine the value of computed tomography (CT)-based tumor response to TACE as a preoperative selection criterion for OLT. MATERIALS AND METHODS: The study included 33 patients with HCC who exceeded the Milan criteria and underwent OLT after TACE. Informed written consent was obtained before TACE and OLT. Institutional review board approval was not required. Tumor response to TACE was evaluated at 1 month with CT according to amended Response Evaluation Criteria in Solid Tumours (RECIST) guidelines. In the explanted liver, degree of tumor necrosis (> or = 90%, 50%-89%, or < 50%), residual tumor stage and grade, and presence of microvascular invasion were assessed. Follow-up after OLT ranged from 1 to 143 months. RESULTS: After TACE, CT showed complete tumor response (CR) in 18 (55%) patients. On the explanted liver, tumor necrosis was rated 90% or greater in 20 (61%) patients, with a good correlation with CT. Microvascular invasion was observed in nine (27%) of 33 patients; none of them were reported to have a CR at CT. The 5-year cumulative survival rate after OLT was 72.5%; it was significantly (P = .003) higher in patients with a CR (94.4%) compared with patients with a partial response (PR) (45.4%) and stable disease (50%). The 5-year cumulative recurrence-free rate after OLT was 74.4%; it was not affected by the tumor nodule size and number, whereas it was significantly (P = .008) higher in patients with a CR (94.4%) compared with patients with a PR (46.7%) and stable disease (50%). CONCLUSION: In patients with HCC who exceeded the Milan criteria, a CR after TACE, on the basis of amended RECIST guidelines, is associated with excellent posttransplantation outcomes. Therefore, 1-month response to TACE assessed at CT may represent a valid selection criterion for OLT.

Ultrasonographic surveillance with selective CTA after endovascular repair of abdominal aortic aneurysm.

PURPOSE: To evaluate the agreement between color-coded duplex ultrasound (US) and computed tomographic angiography (CTA) in monitoring aneurysm diameter and detecting endoleaks after endovascular aneurysm repair (EVAR). METHODS: From November 1998 to January 2007, 196 patients (191 men; mean age 72.4 years, range 52-88) underwent EVAR and were followed by CTA and US over a mean 3.9+/-2.4 years (range 0-8.9, median 3.4). Annual paired CTA and US examinations were reviewed to assess agreement in measuring maximum aneurysm transverse diameter and to evaluate diagnostic accuracy of US in detecting endoleak. RESULTS: The 5-year cumulative endoleak incidence was 43.8% (72 patients). At first diagnosis, US detected 55/72 (76.4%) endoleaks; of the remaining 17, only 3 (4.3%) were clinically significant in terms of aneurysm enlargement. Pairing 709 annual CTA and US examinations from 184 patients showed a high agreement (k = 0.96) between examinations in measuring maximum transverse diameter, with a mean difference between US and CTA of -2.5 mm. CONCLUSION: After the first year of follow-up, EVAR surveillance costs can be reduced by performing annual US examinations only. Keeping in mind that US underestimates diameter measurements, CTA can be reserved for patients with increasing or persistently stable aneurysm diameters.

Primary infrainguinal subintimal angioplasty in diabetic patients.

The aim of this study was to prospectively evaluate technical and clinical results of infrainguinal subintimal angioplasty in a series of diabetic patients with limb-threatening ischemia. From July 2003 to December 2007, 60 consecutive diabetic patients (M/F = 41/19; mean age, 69.4 +/- 9.4 years) with Fontaine stage IV critical limb ischemia, not suitable for surgical recanalization, underwent primary infrainguinal subintimal angioplasty. The technical success, perioperative morbidity and mortality, and clinical success (defined by ulcer healing) were evaluated. Kaplan-Meier life-table analysis was obtained for cumulative clinical success, limb salvage, and survival rates. The procedure was technically successful in 55 of 60 (91.7%) patients; in 5 cases we were not able to achieve a reentry. Periprocedural mortality was 5% (3 patients); three patients (5%) required major amputation periprocedurally. Mean follow-up was 23 months (range, 0-48 months). On an intention-to-treat basis, the limb salvage rate was 93.3% (56/60 patients); ulcer healing was observed in 45 of 60 (75%) patients and it was significantly (p < 0.05) associated with serum creatinine and HbA1c levels, diabetes duration, and infrapopliteal recanalization. One- and three-year cumulative survival rates were 91.5% and 83.1%, respectively; serum creatinine levels, patient age, and clinical success were significant predictors of survival. In conclusion, infrainguinal primary subintimal angioplasty is a safe and effective treatment in diabetic patients with limb-threatening ischemia not suitable for surgical recanalization. This procedure is aimed to create a "temporary bypass" that facilitates ulcer healing.