Hepatic Toxicity After Selective Chemoembolization Is Associated With Decreased Survival Among Patients With Hepatocellular Carcinoma.

OBJECTIVE. The purpose of this study was to identify risk factors for and outcomes of hepatotoxicity after selective chemoembolization of hepatocellular carcinoma. MATERIALS AND METHODS. This retrospective study included 182 patients (136 men and 46 women; median age, 63 years [interquartile range, 57-70 years]) who underwent 338 consecutive doxorubicin drug-eluting bead (DEB) chemoembolization procedures between 2011 and 2014. Outcomes were assessed until November 2019. In 97% of procedures, two or fewer segments were targeted. The Barcelona Clinic Liver Cancer (BCLC) stage was 0 or A for 77 procedures (22.8%), B for 75 (22.2%), C for 122 (36.1%), and D for 64 (18.9%). Hepatotoxicity was defined as worsened ascites or encephalopathy or as grade 3 or 4 elevations in liver function test results, creatinine levels, or the international normalized ratio within 30 days. Risk factors were assessed by univariate and multivariable generalized estimating equations. Transplant-free survival was assessed using Cox proportional hazard models. RESULTS. Hepatotoxicity was observed after 84 of 338 procedures (24.9%) performed for 70 of 182 patients (38.5%) and was irreversible for 40 procedures (11.8%). On multivariable analysis, risk factors for irreversible toxicity included Child-Pugh class C liver function (odds ratio [OR], 4.4; 95% CI, 1.0-19.0; p = .04), BCLC stage C (OR, 5.0; 95% CI, 1.6-16.0; p = .006) or D (OR, 7.4; 95% CI, 2.1-25.5; p = .002) disease, TIPS or hepatofugal portal venous flow (OR, 6.3; 95% CI, 2.3-17.0; p < .001), and a serum α-fetoprotein level of 200 ng/mL or greater (OR, 2.6; 95% CI, 1.1-6.1; p = .03). Irreversible toxicity was associated with reduced transplant-free survival among patients who were ineligible for liver transplant (hazard ratio, 2.5; standard error, 0.42; p = .03). CONCLUSION. Irreversible hepatotoxicity was common after selective chemoembolization in patients with advanced stage disease, an elevated serum α-fetoprotein level, or reduced hepatic portal venous perfusion, and it may hasten death among patients who are ineligible for liver transplant.

Non-operative management of biliary complications after Liver Transplantation in pediatric patients: A 30-year experience.

BACKGROUND: To evaluate the efficacy of percutaneous and endoscopic therapeutic interventions for biliary strictures and leaks following LT in children. METHODS: Retrospective analysis of 49 consecutive pediatric liver transplant recipients (27 girls, 22 boys, mean age at transplant 3.9 years) treated at our institution from 1989 to 2019 for biliary leak and/or biliary stricture was performed. Minimally invasive approach was considered clinically successful if it resulted in patency of the narrowed biliary segment and/or correction of the biliary leak. RESULTS: Forty-two patients had a stricture at the biliary anastomosis; seven had a biliary leak. After an average 13.8 years of follow-up, long-term clinical success with minimally invasive treatment (no surgery or re-transplant) was achieved for 24 children (57%) with biliary stricture and 4 (57%) with biliary leaks. Eight patients required re-transplant; however, only one was due to failure of both percutaneous and surgical management. For biliary strictures, failure of non-surgical management was associated with younger age at stricture diagnosis (p < .02). CONCLUSIONS: Percutaneous and endoscopic management of biliary strictures and leaks after LT in children is associated with a durable result in >50% of children.

Intermediate to Long-Term Clinical Outcomes of Percutaneous Cryoablation for Renal Masses.

PURPOSE: The purpose of this study was to evaluate the effectiveness and adverse outcomes of percutaneous cryoablation (CA) for treatment of renal masses in a large cohort of patients. MATERIALS AND METHODS: This retrospective analysis included 299 CA procedures (297 masses in 277 patients) performed between July 2007 and May 2018 at a single institution. The mean patient age was 66.1 years (range, 30-93 years) with 65.8% being male. A total of 234 (78.8%) masses were biopsy-proven renal cell carcinoma (RCC). The mean maximal tumor diameter was 2.5 cm (range, 0.7-6.6 cm). Efficacy was assessed only for ablations of biopsy-proven RCC, whereas the evaluation of adverse events and renal function included all masses. Complications were graded according to the Society of International Radiology classification. RESULTS: Major complications occurred in 3.0% of procedures (n = 9), none of which resulted in death or permanent disability. The mean imaging follow-up period was 27.4 months (range, 1-115) for the 199 RCC patients (204 ablated tumors) with follow-up imaging available. Complete response on initial follow-up imaging at mean 4.2 months (range, 0.3-75.6) was achieved in 195 of 204 tumors (95.6%) after a single session and in 200 of 204 tumors (98.0%) after 1 or 2 sessions. Of the RCC patients achieving complete response initially, local recurrence during the follow-up period occurred in 3 of 200 tumors (1.5%). Metastatic progression occurred in 10 of 193 (5.2%) RCC patients without prior metastatic disease during follow-up. CONCLUSIONS: CA for renal masses is safe and remains efficacious through intermediate- and long-term follow-up.

90Y Radioembolization for Hepatic Malignancy in Patients with Previous Biliary Intervention: Multicenter Analysis of Hepatobiliary Infections.

Purpose To determine the frequency of hepatobiliary infections after transarterial radioembolization (TARE) with yttrium 90 (90Y) in patients with liver malignancy and a history of biliary intervention. Materials and Methods For this retrospective study, records of all consecutive patients with liver malignancy and history of biliary intervention treated with TARE at 14 centers between 2005 and 2015 were reviewed. Data regarding liver function, 90Y dosimetry, antibiotic prophylaxis, and bowel preparation prophylaxis were collected. Primary outcome was development of hepatobiliary infection. Results One hundred twenty-six patients (84 men, 42 women; mean age, 68.8 years) with primary (n = 39) or metastatic (n = 87) liver malignancy and history of biliary intervention underwent 180 procedures with glass (92 procedures) or resin (88 procedures) microspheres. Hepatobiliary infections (liver abscesses in nine patients, cholangitis in five patients) developed in 10 of the 126 patients (7.9%) after 11 of the 180 procedures (6.1%; nine of those procedures were performed with glass microspheres). All patients required hospitalization (median stay, 12 days; range, 2-113 days). Ten patients required percutaneous abscess drainage, three patients underwent endoscopic stent placement and stone removal, and one patient needed insertion of percutaneous biliary drains. Infections resolved in five patients, four patients died (two from infection and two from cancer progression while infection was being treated), and one patient continued to receive suppressive antibiotics. Use of glass microspheres (P = .02), previous liver resection or ablation (P = .02), and younger age (P = .003) were independently predictive of higher infection risk. Conclusion Infectious complications such as liver abscess and cholangitis are uncommon but serious complications of transarterial radioembolization with 90Y in patients with liver malignancy and a history of biliary intervention.

Radiation Dose Reduction during Uterine Fibroid Embolization Using an Optimized Imaging Platform.

PURPOSE: To assess radiation dose reduction during uterine fibroid embolization (UFE) using an optimized angiographic processing and acquisition platform. MATERIALS AND METHODS: Radiation dose data for 70 women (mean age, 46 y; range, 34-67 y) who underwent UFE were retrospectively analyzed. Twenty-one patients underwent UFE using the baseline fluoroscopic and angiographic image acquisition platform, and 49 underwent UFE after implementing an optimized imaging platform in otherwise identical angiography suites. Cumulative kerma-area product (CKAP), cumulative air kerma (CAK), total fluoroscopy time, and image exposure number were collected for each procedure. Image quality was assessed by 3 interventional radiologists blinded to the platform used for image acquisition and processing. RESULTS: Patients undergoing UFE using the new x-ray fluoroscopy platform had significantly lower CKAP and CAK indicators than patients for whom baseline settings were used. Mean CKAP decreased by 60% from 438.5 Gy · cm2 (range, 180.3-1,081.1 Gy · cm2) to 175.2 Gy · cm2 (range, 47.1-757.0 Gy · cm2; P < .0001). Mean CAK decreased by 45% from 2,034.2 mGy (range, 699.3-5,056.0 mGy) to 1,109.8 mGy (range, 256.6-4,513.6 mGy; P = .001). No degradation of image quality was identified through qualitative evaluation. CONCLUSIONS: Significant reduction in patient radiation dose indicators can be achieved with use of an optimized image acquisition and processing platform.

Downstaging of hepatocellular cancer before liver transplant: long-term outcome compared to tumors within Milan criteria.

UNLABELLED: We report on the long-term intention-to-treat (ITT) outcome of 118 patients with hepatocellular carcinoma (HCC) undergoing downstaging to within Milan/United Network for Organ Sharing T2 criteria before liver transplantation (LT) since 2002 and compare the results with 488 patients listed for LT with HCC meeting T2 criteria at listing in the same period. The downstaging subgroups include 1 lesion >5 and ≤8 cm (n = 43), 2 or 3 lesions at least one >3 and ≤5 cm with total tumor diameter ≤8 cm (n = 61), or 4-5 lesions each ≤3 cm with total tumor diameter ≤8 cm (n = 14). In the downstaging group, 64 patients (54.2%) had received LT and 5 (7.5%) developed HCC recurrence. Two of the five patients with HCC recurrence had 4-5 tumors at presentation. The 1- and 2-year cumulative probabilities for dropout (competing risk) were 24.1% and 34.2% in the downstaging group versus 20.3% and 25.6% in the T2 group (P = 0.04). Kaplan-Meier's 5-year post-transplant survival and recurrence-free probabilities were 77.8% and 90.8%, respectively, in the downstaging group versus 81% and 88%, respectively, in the T2 group (P = 0.69 and P = 0.66, respectively). The 5-year ITT survival was 56.1% in the downstaging group versus 63.3% in the T2 group (P = 0.29). Factors predicting dropout in the downstaging group included pretreatment alpha-fetoprotein ≥1,000 ng/mL (multivariate hazard ratio [HR]: 2.42; P = 0.02) and Child's B versus Child's A cirrhosis (multivariate HR: 2.19; P = 0.04). CONCLUSION: Successful downstaging of HCC to within T2 criteria was associated with a low rate of HCC recurrence and excellent post-transplant survival, comparable to those meeting T2 criteria without downstaging. Owing to the small number of patients with 4-5 tumors, further investigations are needed to confirm the efficacy of downstaging in this subgroup.

Safety and Efficacy of Doxorubicin Drug-Eluting Embolic Chemoembolization of Hepatocellular Carcinoma Supplied by Extrahepatic Collateral Arteries.

PURPOSE: To assess safety and efficacy of doxorubicin drug-eluting embolic (DEE) transarterial chemoembolization of hepatocellular carcinoma (HCC) by extrahepatic collateral arteries. MATERIALS AND METHODS: Records of 177 patients with HCC who underwent 338 consecutive DEE chemoembolization procedures from 2011 to 2014 were retrospectively reviewed. A subgroup of 16 patients (13 men, 3 women, median age 66 y) underwent 24 procedures for 17 HCCs via extrahepatic arteries and was included in the study. Median tumor size was 3.1 cm (range, 1.0-10.3 cm). Extrahepatic collaterals included right inferior phrenic (19 procedures; 12 patients), adrenal (4 procedures; 3 patients), and cystic arteries (2 procedures; 2 patients). Radiographic response was assessed by Modified Response Evaluation Criteria in Solid Tumors criteria. Complications were defined by National Cancer Institute Common Terminology Criteria for Adverse Events. RESULTS: DEE chemoembolization achieved stable disease in 6 (35.3%), partial response in 6 (35.3%), and complete response in 4 (23.5%) HCCs. Disease progression was ultimately observed in 8 tumors (47.1%), with mean time to progression of 8.3 months after chemoembolization (range, 2-13 mo). Three minor and 5 major complications occurred in 8 patients; 2 minor complications were rash in vascular distribution after right inferior phrenic artery DEE chemoembolization. The 5 major complications were transient hepatotoxicity that resolved within 4-80 days; 1 was accompanied by pleural effusion requiring hospitalization. A mean 13.4 months after DEE chemoembolization, 67% of transplant candidates proceeded to liver transplant. CONCLUSIONS: DEE transarterial chemoembolization via extrahepatic collaterals was effective and facilitated bridging to transplant. It was generally well tolerated; transient hepatotoxicity was the most common major complication.

Implications of discordant findings between hepatic angiography and cross-sectional imaging in transplant candidates with hepatocellular carcinoma.

The goal of this study was to determine whether the detection of discordant numbers of hypervascular foci at hepatic angiography versus contrast-enhanced (CE) cross-sectional imaging [computed tomography (CT) or magnetic resonance imaging (MRI)] is associated with adverse clinical outcomes in patients with hepatocellular carcinoma (HCC) who are listed for liver transplantation. We retrospectively reviewed the records of 218 consecutive patients with HCC who were listed for a liver transplant and who underwent transarterial chemoembolization at our institution between January 1, 2006 and December 31, 2010. Patients were grouped into 3 categories: (1) the number of nodules at CT/MRI was concordant with the number of hypervascular foci detected at angiography (n=136), (2) the number of nodules at CT/MRI was greater than the number of hypervascular foci at angiography (n=45), and (3) the number of nodules at CT/MRI was fewer than the number of hypervascular foci at angiography (n=37). The study outcomes were liver transplantation and tumor recurrence after transplantation. The detection of at least 3 more hypervascular foci at angiography versus the number of HCC nodules on CT/MRI was associated with a significantly lower rate of transplantation [multivariate subhazard ratio (SHR), 0.39; 95% confidence interval (CI), 0.17-0.92]. The detection of fewer hypervascular foci at angiography versus the number of HCC nodules on CT/MRI was associated with a significantly higher rate of tumor recurrence after transplantation (multivariate SHR, 3.49; 95% CI, 1.27-9.56). In conclusion, liver transplant candidates with HCC who demonstrate discordant findings between angiography and CE CT or MRI may be at a higher risk for dropout from the transplant list and for tumor recurrence after transplantation.

Intraprocedural Safety and Technical Success of the MVP Micro Vascular Plug for Embolization of Pulmonary Arteriovenous Malformations.

This case series describes early experience, intraprocedural safety, and technical success of the MVP Micro Vascular Plug (MVP; Covidien, Irvine, California) for embolization of 20 pulmonary arteriovenous malformations (PAVMs) using 23 plugs in seven patients with hereditary hemorrhagic telangiectasia. There was no device migration, and all devices were successfully detached electrolytically. Immediate cessation of flow through the feeding artery was achieved in 21 of 23 (91%) deployments. There was one minor complication. This series demonstrates the MVP to be safe and technically successful in the treatment of PAVMs.

Imaging Predictors of Elevated Lung Shunt Fraction in Patients Being Considered for Yttrium-90 Radioembolization.

PURPOSE: To identify imaging findings associated with elevated lung shunt fraction (LSF) in patients being considered for yttrium-90 ((90)Y) radioembolization. MATERIALS AND METHODS: During the period 2009-2014, 152 consecutive patients underwent planning hepatic arteriography with technetium-99m ((99m)Tc) macroaggregated albumin (MAA) injection. Computed tomography (CT) or magnetic resonance imaging performed before the procedure for each patient was assessed for hepatic vein (HV) tumor thrombus or occlusion from external compression by tumor. When imaging was a multiphase CT scan (117 patients), the arterial phase was evaluated for evidence of early HV opacification (relative to unaffected HVs), indicating hepatic venous shunting. These factors were correlated with LSF determined by (99m)Tc-MAA imaging. RESULTS: Median LSF was 6.7% (range, < 0.1%-71%), significantly higher for HCC (8.0% vs 6.3% for other tumors, P = .048). Larger tumor size was associated with higher LSF in univariate analysis (P = .001). There was high interobserver agreement for determining hepatic venous shunting (97%, κ = 0.847), which was associated with higher LSF (P < .001; 78% sensitivity, 93% specificity). Of 5 cases of HV tumor thrombus, all had high (> 20%) LSF (P < .001). HV occlusion was also associated with higher LSF (P = .039). Multivariate analysis confirmed that early HV opacification and either HV tumor thrombus or occlusion were associated with higher LSF. CONCLUSIONS: Early HV opacification and HV tumor thrombus or occlusion on cross-sectional imaging performed before radioembolization are associated with elevated LSF, which may contraindicate or limit the dose delivered in (90)Y radioembolization. This information could be helpful during patient counseling for anticipating the most appropriate mode of liver-directed therapy.

Patient Radiation Dose Reduction during Transarterial Chemoembolization Using a Novel X-Ray Imaging Platform.

PURPOSE: To evaluate radiation dose reduction in patients undergoing transarterial chemoembolization with the use of a new image acquisition and processing platform. MATERIALS AND METHODS: Radiation-dose data were obtained from 176 consecutive chemoembolization procedures in 135 patients performed in a single angiography suite. From January 2013 through October 2013, 85 procedures were performed by using our institution's standard fluoroscopic settings. After upgrading the x-ray fluoroscopy system with an image acquisition and processing platform designed to reduce image noise and reduce skin entrance dose, 91 chemoembolization procedures were performed from November 2013 through December 2014. Cumulative dose-area product (CDAP), cumulative air kerma (CAK), and total fluoroscopy time were recorded for each procedure. Image quality was assessed by three interventional radiologists blinded to the x-ray acquisition platform used. RESULTS: Patient radiation dose indicators were significantly lower for chemoembolization procedures performed with the novel imaging platform. Mean CDAP decreased from 3,033.2 dGy·cm(2) (range, 600.3-9,404.1 dGy·cm(2)) to 1,640.1 dGy·cm(2) (range, 278.6-6,779.9 dGy·cm(2); 45.9% reduction; P < .00001). Mean CAK decreased from 1,445.4 mGy (range, 303.6-5,233.7 mGy) to 971.7 mGy (range, 144.2-3,512.0 mGy; 32.8% reduction; P < .0001). A 20.3% increase in mean total fluoroscopy time was noted after upgrading the imaging platform, but blinded analysis of the image quality revealed no significant degradation. CONCLUSIONS: Although a small increase in fluoroscopy time was observed, a significant reduction in patient radiation dose was achieved by using the optimized imaging platform, without image quality degradation.

Transarterial Chemoembolization and (90)Y Radioembolization for Hepatocellular Carcinoma: Review of Current Applications Beyond Intermediate-Stage Disease.

OBJECTIVE: The practice guideline of the American Association for the Study of Liver Diseases currently recommends transarterial chemoembolization (TACE) for the treatment of intermediate-stage hepatocellular carcinoma (HCC). The use of transarterial radioembolization (TARE) using (90)Y microspheres is not formally recommended. This article discusses the current clinical applications of TACE and TARE and compares the clinical utility of these techniques for various subpopulations of patients with HCC. CONCLUSION: For most clinical scenarios, the efficacy and safety of TACE and TARE are probably equivalent. However, TARE appears to have an advantage over TACE in the facilitation of surgical resection by resulting in compensatory hypertrophy of the future liver remnant and possibly in the treatment of patients with portal vein tumor thrombus. On the contrary, TACE is the transarterial treatment of choice for patients with marginal hepatic reserve (i.e., hyperbilirubinemia, ascites) who may be candidates for transplant.

The inferior emissary vein: a reliable landmark for right adrenal vein sampling.

BACKGROUND: Right adrenal vein (RAV) catheterization can be a very challenging step in adrenal venous sampling (AVS). Visualization of the inferior emissary vein (IEV) may be an indication of successful RAV catheterization. PURPOSE: To compare the rate of successful RAV sampling in the presence of the IEV. MATERIAL AND METHODS: Retrospective review of all consecutive patients with PA who underwent AVS between April 2009 and April 2012 was performed. A total of 30 patients were identified. Procedural images, cortisol, and aldosterone values obtained from sampling of the RAV and inferior vena cava (IVC) were reviewed. Cortisol measurements obtained from RAV samples were divided by measurements from the infra-renal IVC blood samples in order to calculate the selectivity index (SI). An SI >3 was considered indicative of technically successful RAV sampling. RESULTS: RAV sampling was considered technically successful in 29 out of 30 cases (97%). In cases of successful RAV sampling (29 patients), the IEV was identified in 25 patients (86%). The IEV was visualized in isolation in 16 patients (64%), and in conjunction with visualization of the RAV or right adrenal gland stain in nine patients (36%). The IEV was not visualized in the one case of unsuccessful RAV sampling. Visualizing the IEV had a sensitivity of 86.2% for successful RAV sampling. CONCLUSION: The IEV may serve as a reliable landmark for the RAV during RAV sampling.

Percutaneous interventions in failing "necklace" hemodialysis grafts: long-term outcomes.

PURPOSE: To determine primary and secondary patency after percutaneous interventions for malfunctioning anterior chest wall ("necklace") arteriovenous grafts (AVGs) for hemodialysis. MATERIALS AND METHODS: Records of six consecutive patients with subclavian artery-to-contralateral subclavian vein necklace AVGs were reviewed. Patients underwent 34 procedures, including 28 balloon angioplasties, 24 pharmacomechanical thrombolyses, and six stent placements. Patency intervals after graft placement and after first intervention were calculated. RESULTS: After 3 months, primary and secondary patency rates were 33% (two of six grafts) and 67% (four of six grafts), respectively. At 12 months, primary and secondary patency rates were 17% (one of six grafts) and 50% (three of six grafts), respectively. Median and mean primary patency times were 49 and 374 days, and median and mean secondary patency times were 293 and 575 days, respectively. The anatomic success rate of percutaneous interventions in malfunctioning AVGs was 97% (33 of 34 cases). At 3 years after implantation, the graft patency rate was 57% (four of seven grafts). CONCLUSIONS: Percutaneous interventions were effective at maintaining patency in failing necklace AVGs. However, their primary and secondary patency were inferior to those cited in extremity AVG guidelines set forth by the Society of Interventional Radiology.

Morbidity and mortality following transarterial liver chemoembolization in patients with hepatocellular carcinoma and synthetic hepatic dysfunction.

The purpose of this study was to determine the rate and risk factors for the development of irreversible hepatotoxicity after transarterial chemoembolization (TACE) in patients with hepatocellular carcinoma (HCC) and synthetic hepatic dysfunction. Two hundred fifty-one consecutive patients with HCC and hepatic dysfunction who underwent 443 TACE procedures from 2005 to 2010 were retrospectively reviewed. The included patients met one of the following criteria: a pre-TACE bilirubin level ≥ 2 mg/dL, an international normalized ratio (INR) > 1.5, a creatinine level > 1.2 mg/dL, a platelet count ≤ 60,000/mL, a Model for End-Stage Liver Disease (MELD) score > 15, Child-Turcotte-Pugh class B or C, ascites, or portal vein thrombosis. Hepatotoxicity was defined as new or worsening ascites, encephalopathy, or grade 3 or 4 toxicity (bilirubin, aspartate aminotransferase, alanine aminotransferase, creatinine, or INR) according to the National Cancer Institute Common Terminology Criteria for Adverse Events. The rate and risk factors for death or urgent liver transplantation within 6 weeks of TACE and irreversible hepatotoxicity were determined with a generalized estimating equation analysis. Reversible hepatotoxicity developed after 90 procedures (20%) in 78 patients (31%). Irreversible hepatotoxicity developed after 41 procedures (9%) in 37 patients (15%). Six patients (2%) underwent urgent liver transplantation, and 11 (4%) died within 6 weeks of TACE. Patients at increased risk for procedure-related mortality or urgent liver transplantation within 6 weeks of TACE had a baseline serum bilirubin level ≥ 4.0 mg/dL (P = 0.01), an elevated INR (P < 0.001), hypoalbuminemia with an albumin level < 2.0 g/L (P = 0.01), a serum creatinine level > 2.0 mg/dL (P = 0.02), large ascites (P = 0.002), encephalopathy (P = 0.005), or a MELD score ≥ 20 (P < 0.001). In conclusion, TACE can be performed safely in patients with baseline hepatic dysfunction. However, a poor hepatic reserve increases the risk of irreversible hepatotoxicity, which may lead to death or the need for urgent liver transplantation.

The changing face of percutaneous image-guided biopsy: molecular profiling and genomic analysis in current practice.

Oncology is undergoing a revolutionary change. Image-guided biopsy is expected to play an increasingly important role in this radical transformation. Current concepts of disease and treatment are based on an established set of physical signs and symptoms and laboratory tests broken down by organ system. However, soon diseases will be categorized and treated based on much more specific and detailed molecular and genetic information. This transformation in how disease is categorized and treated will depend on the ability to harvest tissue from tumors and analyze it appropriately.

Prospective evaluation of absorbable gastropexy anchor indwelling time in 33 patients.

PURPOSE: To evaluate the time to absorbable suture gastropexy anchor release and gastropexy-related complications in patients receiving percutaneous image-guided transabdominal gastrostomy or gastrojejunostomy tube placement. MATERIALS AND METHODS: Thirty-three consecutive patients (16 women; mean age, 63.5 y; range, 25-92 y) undergoing fluoroscopically guided (n = 32) or computed tomography-guided (n = 1) percutaneous transabdominal gastrostomy (n = 26) or gastrojejunostomy (n = 7) were prospectively enrolled in a single-center study. Each patient had three synthetic absorbable suture T-fasteners inserted and were followed until all gastropexy button-locks released naturally, were cut by a health care provider, or were lost to follow-up. Patients or caregivers were contacted weekly to determine timing of gastropexy button-lock release and assess for postprocedural complications. RESULTS: All three T-fastener button-type suture locks released naturally in 14 of 33 patients (42.4%) at a median of 29.5 days (mean, 26.7 d; range, 8-40 d). One or more T-fastener sutures were cut in 10 of 33 patients (30.3%), and nine patients (27.3%) were lost to follow-up. Accounting for patient censorship, T-fasteners in all 33 patients remained intact for a median of 35 days. Local infections developed in three patients (9%) on days 22, 25, and 34. CONCLUSIONS: Relative to nonabsorbable gastropexy sutures, absorbable suture gastropexy anchors offer the potential to reduce complications associated with long gastropexy indwelling times. However, absorbable gastropexy anchor buttons usually remain intact for longer than 3 weeks after insertion. A postprocedural plan for gastropexy inspection and removal within 3 weeks should continue to be emphasized to avoid local complications, even for absorbable suture kits.

Outcomes of metallic biliary stent insertion in patients with malignant bilobar obstruction.

PURPOSE: To assess clinical outcomes of metal stent insertion in patients with bilobar bile duct obstruction by malignant tumors. MATERIALS AND METHODS: Records of 120 consecutive patients who underwent placement of metallic stents for palliation of malignant bilobar biliary obstruction between 1995 and 2010 were retrospectively reviewed. Single-duct stent insertion was performed in 44 patients with one liver lobe that accounted for more than 70% of total liver volume or only one patent lobar portal vein (group 1). Bilobar stent insertion was performed in 60 patients with approximately equal lobe sizes, patent lobar portal veins, or cholangitis at presentation (group 2). In 16 patients with discontiguous right anterior and posterior segmental ducts (group 3), three stents were deployed in the left lobar and right anterior and posterior segmental ducts. Overall survival, primary patency, and patient morbidity rates following stent insertion were assessed. RESULTS: No significant differences in mean overall survival (group 1, 7.3 mo; group 2, 10.3 mo; group 3, 6.5 mo; P = .21) or mean primary stent patency (group 1, 4.2 mo; group 2, 5.9 mo; group 3, 3.5 mo; P = .17) were demonstrated. However, patients in group 3 were significantly more likely to require hospitalizations for cholangitis and additional invasive procedures for recurrent biliary obstruction than patients in groups 1 and 2. CONCLUSIONS: Unilobar and bilobar metal stent insertion led to similar outcomes when treatment decision was based on relative liver lobe volumes, lobar portal vein patency, and presence of cholangitis on presentation.

Distribution of reported StarClose SE vascular closure device complications in the manufacturer and user facility device experience database.

PURPOSE: To evaluate the type and frequency of complications associated with the StarClose SE vascular closure device reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for comparison with complications reported in clinical trials. MATERIALS AND METHODS: Complications reported in the MAUDE database related to use of the StarClose SE vascular closure device were reviewed. Keyword searches by device and manufacturer were performed for a 16-month period from July 2009-October 2010. Reports were analyzed according to complication type, frequency, and resolution, if specified. These data were compared with data on StarClose SE device complications, which included three prospective randomized trials and five prospective nonrandomized trials. RESULTS: Keyword searches returned 1,107 total records and 1,118 categorizable StarClose SE device complications from the 16-month MAUDE database-reporting period. Complications in order of frequency (absolute number and relative frequency, respectively) included failure to achieve hemostasis (409, 36.6%), inability to complete the deployment sequence (268, 24.0%), entrapped deployment device (224, 20%), clip not deployed (151,13.5%), late bleeding or oozing from dermatotomy site (25, 2.2%), vessel occlusion (19, 1.7%), retroperitoneal hematoma (12, 1.1%), pseudoaneurysm formation (6, 0.5%) and death (4, 0.4%). The distribution of complications differed appreciably from the combined adverse events compiled from the published trials evaluating the StarClose SE device. There were no records describing inability to remove the deployment device in the published trials, whereas this represented the third most common complication reported to the MAUDE database. Bleeding or oozing from the dermatotomy site, the most frequent relative complication reported in the published literature (53.4%), represented 2.2% of the total complications reported to the MAUDE database. CONCLUSIONS: The type and frequency of complications reported in the MAUDE database on the StarClose SE vascular closure device differ from those published in clinical trials both in relative distribution and in type. Although these differences may reflect in part reporting biases, the distribution of complications reported to the MAUDE database may represent useful information in the use of this device.