Ultrasonographic assessment and clinical outcomes after deployment of a suture-mediated femoral vascular closure device.

INTRODUCTION: Data regarding changes in the arterial vascular wall after the deployment of suture-mediated vascular closure devices (VCD) at the femoral site in patients undergoing percutaneous coronary angiography (CAG) or percutaneous coronary intervention (PCI) are sparse. This study investigated the occurrence of structural vascular changes or adverse vascular complications at the access site in the short term after the deployment of a suture-mediated intravascular VCD. METHODS: Ninety-three patients (72% males) with a mean age of 62 ± 11 years were enrolled. Duplex sonography was conducted at the access site at baseline, 24 hours and 30 days after femoral puncture in patients with successful VCD deployment. Vessel diameter, flow velocities, the severity of atherosclerosis, and the intravascular or perivascular tissue alterations in both the right common femoral artery (RCFA) and right external iliac artery (REILA) were assessed. Vascular complications were documented. RESULTS: There were no significant changes regarding the diameter of the RCFA in the transverse and longitudinal view, peak systolic velocity (PSV) of the RCFA, PSV ratio of the RCFA to REILA, the resistive index of the RFCA and the severity of arterial wall abnormalities before femoral puncture, the day following VCD deployment and 30 days after (p = NS for all) in the general population and in patients with diabetes mellitus, on oral anticoagulants or with mild peripheral artery disease (p = NS for all markers). Device failure was observed in four cases. Few (4.4%) patients had vascular complications, which included exclusively major or minor haematomas, most of which did not persist at the 30-day follow up. CONCLUSION: The use of a suture-mediated VCD was safe and was not associated with adverse vascular wall changes at the femoral access site 30 days after deployment in patients undergoing CAG and/or PCI.

Ultrasonographic evaluation of abdominal organs after cardiac surgery.

BACKGROUND: Disturbances of the hepatosplanchnic region may occur after cardiac operations. Experimental studies have implicated impairment of splanchnic blood supply in major abdominal organ dysfunction after cardiopulmonary bypass (CPB). We investigated the impact of the cardiac operation and CPB on liver, kidney, and renal perfusion and function by means of ultrasonography and biochemical indices in a selected group of cardiac surgery patients. MATERIALS AND METHODS: Seventy five patients scheduled for a major cardiac operation were prospectively included in the study. Criteria for selection were moderate or good left ventricular ejection fraction and absence of previous hepatic or renal impairment. Ultrasound examination of the hepatic and renal vasculature and examination of biochemical parameters were performed on the day preceding the operation (T0), on the first postoperative day (T1), and on the seventh postoperative day (T2). RESULTS: Portal vein velocity and flow volume increased significantly, whereas hepatic artery velocity and flow volume decreased at T1 in comparison with T0. Hepatic vein indices remained unaffected throughout the observation period. Renal artery velocity and flow decreased, whereas renal pulsatility index and renal resistive index increased at T1 as compared with T0. Aspartate aminotransferase and alanine aminotransferase values were increased as compared with baseline values 24 h postoperatively. All parameters displayed a trend to approach preoperative levels at T2. Strong negative correlations between alanine aminotransferase values at T1 and hepatic artery velocity and flow volume at the same time point were also demonstrated (R = 0.638, P < 0.001 and r = 0.662, P < 0.001, respectively). CONCLUSIONS: The increase in portal vein flow and velocity and the decrease in hepatic artery flow and velocity in the period after CPB might be attributed to the hypothermic bypass technique and the hepatic arterial buffer response, respectively. The decrease in renal blood flow and velocity and the parallel increase in Doppler renal pulsatility index and renal resistive index could be considered as markers of kidney hypoperfusion and intrarenal vasoconstriction. Maintaining a high index of suspicion for the early diagnosis of noncardiac complications in the period after CPB and institution of supportive care in case of compromised splanchnic perfusion are warranted.

mRECIST criteria and contrast-enhanced US for the assessment of the response of hepatocellular carcinoma to transarterial chemoembolization.

PURPOSE: We aimed to evaluate the combination of the modified Response Evaluation Criteria In Solid Tumors (mRECIST) and contrast-enhanced ultrasonography (CEUS) as a tool for the assessment of hepatocellular carcinoma treated with transarterial chemoembolization. MATERIALS AND METHODS: Forty-seven hepatocellular carcinoma patients (80 target tumors suitable for mRECIST measurements) were studied. They were treated with scheduled transarterial chemoembolization with doxorubicin-eluting microspheres every 5-7 weeks. Imaging follow-up (performed one month after each transarterial chemoembolization) included a standard, contrast-enhanced modality (computed tomography [CT] in 12 patients or magnetic resonance imaging [MRI] in 35 patients) and CEUS. The study focused on response evaluation after the third transarterial chemoembolization. CEUS required a bolus injection of an echo-enhancer and imaging with a dedicated, low mechanical index technique. The longest diameters of the enhancing target tumors were measured on the CEUS or CT/MRI, and mRECIST criteria were applied. Radiologic responses were correlated with overall survival and time to progression. RESULTS: The measurements of longest diameters of the enhancing target tumors were easily performed in all patients. According to mRECIST-CEUS and mRECIST-CT/MRI, complete response was recorded in five and six patients, partial response in 22 and 21 patients, stable disease in 16 and 14 patients, and progressive disease in four and six patients, respectively. There was a high degree of concordance between CEUS and CT/MRI (kappa coefficient=0.84, P < 0.001). Responders (complete+partial response) according to mRECIST-CEUS had a significantly longer mean overall survival and time to progression compared to nonresponders (37.1 vs. 11.0 months, P < 0.001 and 24.6 vs. 10.9 months, P = 0.007, respectively). CONCLUSION: The mRECIST-CEUS combination is feasible and has prognostic value in the assessment of hepatocellular carcinoma following transarterial chemoembolization.

Chemoembolization with doxorubicin-eluting beads for unresectable hepatocellular carcinoma: five-year survival analysis.

PURPOSE: The purpose of this study was to report on the 5-year survival of hepatocellular carcinoma (HCC) patients treated with DC Bead loaded with doxorubicin (DEB-DOX) in a scheduled scheme in up to three treatments and thereafter on demand. MATERIALS AND METHODS: 173 HCC patients not suitable for curable treatments were prospectively enrolled (mean age 70.4 ± 7.4 years). Child-Pugh (Child) class was A/B (102/71 [59/41 %]), Okuda stage was 0/1/2 (91/61/19 [53.2/35.7/11.1 %]), and mean lesion diameter was 7.6 ± 2.1 cm. Lesion morphology was one dominant ≤5 cm (22 %), one dominant >5 cm (41.6 %), multifocal ≤5 (26 %), and multifocal >5 (10.4 %). RESULTS: Overall survival at 1, 2, 3, 4, and 5 years was 93.6, 83.8, 62, 41.04, and 22.5 %, with higher rates achieved in Child class A compared with Child class B patients (95, 88.2, 61.7, 45, and 29.4 % vs. 91.5, 75, 50.7, 35.2, and 12.8 %). Mean overall survival was 43.8 months (range 1.2-64.8). Cumulative survival was better for Child class A compared with Child class B patients (p = 0.029). For patients with dominant lesions ≤5 cm 1-, 2-, 3-, 4-, and 5-year survival rates were 100, 95.2, 71.4, 66.6, and 47.6 % for Child class A and 94.1, 88.2, 58.8, 41.2, 29.4, and 23.5 % for Child class B patients. Regarding DEB-DOX treatment, multivariate analysis identified number of lesions (p = 0.033), lesion vascularity (p < 0.0001), initially achieved complete response (p < 0.0001), and objective response (p = 0.046) as significant and independent determinants of 5-year survival. CONCLUSION: DEB-DOX results, with high rates of 5-year survival for patients, not amenable to curative treatments. Number of lesions, lesion vascularity, and local response were significant independent determinants of 5-year survival.

Transarterial chemoembolization of unresectable hepatocellular carcinoma with drug eluting beads: results of an open-label study of 62 patients.

The purpose of this study was to assess the safety and efficacy of doxorubicin-loaded beads (DC Beads) delivered by transarterial embolization for the treatment of unresectable hepatocellular carcinoma (HCC). This open-label, single-center, single-arm study included 62 cirrhotic patients with documented single unresectable HCC. Mean tumor diameter was 5.6 cm (range, 3-9 cm) classified as Okuda stages 1 (n = 53) and 2 (n = 9). Patients received repeat embolizations with doxorubicin-loaded beads every 3 months (maximum of three). The maximum doxorubicin dose was 150 mg per embolization, loaded in DC Beads of 100-300 or 300-500 microm. Regarding efficacy, overall, an objective response according to the European Association for the Study of the Liver criteria was observed in 59.6%, 81.8%, and 70.8% across three treatments. A complete response was observed in 4.8% after the first procedure and 3.6% and 8.3% after the second and third procedures, respectively. At 9 months a complete response was seen in 12.2%, an objective response in 80.7%, progressive disease in 6.8%, and 12.2% showed stable disease. Mean tumor necrosis ranged from 77.4% to 83.9% (range, 28.6%-100%) across three treatments. alpha-Fetoprotein levels showed a mean decrease of 1123 ng/ml (95% CI = 846-1399; p = 3 x 10(-11)) after the first session and remained stable after the second and third embolizations (42 and 70 ng/ml decrease, respectively). Regarding safety, bilirubin, gamma-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase showed only transient increases during the study period. Severe procedure-related complications were seen in 3.2% (cholecystitis, n = 1; liver abscess, n = 1). Postembolization syndrome was observed in all patients. We conclude that hemoembolization using doxorubicin-loaded DC Beads is a safe and effective treatment of HCC as demonstrated by the low complication rate, increased tumor response, and sustained reduction of alpha-fetoprotein levels.