Research into an Association between Anhedonia and Decreased REM Latency in Moderately to Severely Depressed Patients.

Anhedonia stands as a core symptom and potential trait marker of major depressive disorder (MDD). The importance of rapid eye movement sleep latency (REML) as a biological marker of depression has previously and repeatedly been studied. The aim of this paper is to analyse the relationship between anhedonia and REML in moderately to severely depressed patients. The shortened Beck Depression Inventory (BDI-13) was chosen to assess depressive symptoms and, among them, more particularly, anhedonic symptoms. Two-way ANCOVA was used for statistical analyses. A significant association between anhedonic symptoms and REML was found when the number of sleep cycles (NCy) and the severity of depression were added as covariates. Our findings suggest that REML may be a useful variable to differentiate some diagnostic subtypes of depression related to anhedonia.

Hyperarousal during sleep in untreated, major depressed subjects with prodromal insomnia: A polysomnographic study.

In primary insomnia, specific dynamics of hyperarousal are evident during the night. Similarly, in major depression, many elements also favor of the presence of hyperarousal. Thus, it would be interesting to investigate if hyperarousal presents the same dynamic in major depression. Polysomnographic data from 30 healthy controls, 66 patients with major depression and prodromal insomnia, and 86 primary insomnia sufferers recruited from the sleep laboratory database were studied for whole night and thirds of the night. Insomnia sufferers and patients with depression exhibit a similar polysomnographic pattern both for whole night (increased sleep latency and WASO and reduced SWS and REM) and thirds of night (increased WASO at first and last thirds, reduced SWS in first third, and reduced in REM in first and last third). No alterations were detected during the second third of the night. Just as in primary insomnia, the hyperarousal phenomenon is found mainly in major depression with prodromal insomnia during the sleep-onset period and the first and last thirds of the night, but lesser during the second third of the night. These specific dynamics of hyperarousal may aid in the understanding of the particular relationship between insomnia and depression.

Hyperarousal during sleep in untreated primary insomnia sufferers: A polysomnographic study.

Because some evidence favors the hyperarousal model of insomnia, we sought to learn more about the dynamics of this phenomenon during sleep. Polysomnographic data from 30 normative subjects and 86 untreated primary insomnia sufferers recruited from the database of the sleep laboratory were studied for whole nights and in terms of thirds of the night. Untreated primary insomnia sufferers had an increased sleep latency and excess of WASO, together with a deficit in REM and NREM sleep during the entire night. In terms of thirds of the night, they presented a major excess of WASO during the first and last thirds of the night but an excess of lesser importance during the middle third. A deficit in SWS was found during the first third of the night, but for REM, the deficit was present during both the first and last thirds. Primary insomnia sufferers had no SWS or REM deficit during the second third of the night. We found that the hyperarousal phenomenon occurs mainly during the sleep-onset period of the first and last thirds of the night and is less important during the middle third. These results open new avenues for understanding the pathophysiology of primary insomnia.

Effects of state and trait anxiety on sleep structure: A polysomnographic study in 1083 subjects.

Anxiety affects millions of people and has been shown to co-occur in combination with sleep disturbances, generating heavy medical costs and a huge socio-medico-economic burden. Sleep-studies in anxiety disorders are inconsistent and the effects of state and trait anxiety are unexplored. We selected 1083 patients from the database of a hospital sleep laboratory. The patients had polysomnography for different sleep disorders; their sleep initiation (sleep onset latency), sleep maintenance (total sleep time), non-rapid eye movement sleep-, and rapid eye movement sleep parameters; as well as their State-Trait Anxiety Inventory and Beck depression scale were measured. In order to be included in our study, individuals needed to score in the low or high range on the State and/or Trait Subscales of the State-Trait Anxiety Inventory. We found that both state and trait anxiety affected non-rapid eye movement sleep parameters. Sleep onset latency changes predominantly associated to state anxiety while rapid eye movement parameters related to trait anxiety.

[Individual differences in sleep macrostructure: effects of anxiety, depression, aging and gender]. / Egyéni különbségek az alvási makrostruktúrában: a szorongás, a depresszió, az öregedés és a nem hatása.

OBJECTIVE: Anxiety is one of the most common psychiatric symptoms frequently associated with sleep disorders. Despite the intensive research, the role of sleep in the patomechanism of anxiety has remained unclear. The aim of the study was to investigate the anxiety-related changes in the sleep macrostructure and the impact of ageing, gender and the presence of depression. METHODS: 1083 patients with sleep symptoms were enrolled in the study. All patients have all night polysomnographies. The effect of anxiety, depression, aging and gender on the sleep initiation, maintenance and sleep stages respectively; were analysed in 4 different statistical approaches. RESULTS: Anxiety increased the latency of sleep and REM sleep; and decreased the length of REM sleep and slow-wave sleep; while depressive symptoms were associated with reduced REM latency, slow-wave sleep and increased REM duration. The length of slow-wave sleep, REM phase decreased with ageing and the sleep was fragmented. Women had more slow-wave sleep and less REM sleep than men. CONCLUSION: Normal order of sleep stages is essential in the cognitive processing of the brain. Changes in sleep macrostructure may have an impact in the impairment of cognitive functions of patients suffering from anxiety or depression.

Dimensions of pure chronic fatigue: psychophysical, cognitive and biological correlates in the chronic fatigue syndrome.

OBJECTIVES: To investigate associated dimensions of fatigue regarding cognitive impairment, psychomotor performances, muscular effort power and circulating cytokine levels and their relations to symptom intensity in a sample of pure chronic fatigue syndrome (CFS) patients without overlapping objective sleepiness or sleep disorders. METHODS: 16 CFS patients were compared to 14 matched controls. We assessed structured symptom-scales, polysomnography, multiple sleep latency tests, attention (Zazzo-Cancellation ZCT, digit-symbol-substitution DSST), psychomotor vigilance and speed (PVT, finger tapping test, FTT), dynamometer handgrip force (tonic and phasic trials) and circulating cytokines (IFN-γ, IL-1b, IL-6, IL-8, IL-10, TNF-α). RESULTS: In addition to fatigue, CFS patients presented with higher affective symptom intensity and worse perceived sleep quality. Polysomnography showed more slow-wave sleep and microarousals in CFS but similar sleep time, efficiency and light-sleep durations than controls. Patients presented with impaired attention (DSST, ZCT), slower reaction times (PVT) but not with lower hit rates (FTT). Notwithstanding lower grip strength during tonic and phasic trials, CFS also presented with higher fatigability during phasic trials. Cytokine levels were increased for IL-1b, IL-8, IL-10 and TNF-α and fatigue intensity was correlated to grip strength and IL-8. CONCLUSIONS: In contrast to sleepiness, chronic fatigue is a more complex phenomenon that cannot be reduced to one single measured dimension (i.e., sleep propensity). Showing its relations to different measurements, our study reflects this multidimensionality, in a psychosomatic disorder such as CFS. To obtain objective information, routine assessments of fatigue should rule out sleepiness, combine aspects of mental and physical fatigue and focus on fatigability.

Observational study of surveillance based on the combination of online dialysance and thermodilution methods in hemodialysis patients with arteriovenous fistulas.

BACKGROUND/AIMS: Online dialysance (Kt) and thermodilution (BTM-Qa) methods could be important components in vascular access monitoring programs. This study evaluated the efficiency of these two methods in reducing the thrombosis rate and access-related costs compared with a historic control group. METHODS: We studied 148 hemodialysis patients with arteriovenous fistulas (control group, n = 74) for 2 years. During the study period, the indications for vascular treatments were the Kt reduction ≥20% with respect to baseline values or Qa <500 ml/min (or a decrease in flow >20%). RESULTS: During the study period, we detected 16 cases of vascular dysfunction. The Kt value after vascular treatment was 71.1 liters (59 liters; p = 0.001) and BTM-Qa was 1,218.6 ml/min (519.7 ml/min; p = 0.001). Compared with the control group, the thrombosis rate was 0.027 versus 0.148 episodes/patient-year (p = 0.009) and the total access-related cost was EUR 22,293 versus 47,467 (p = 0.033). CONCLUSIONS: This study suggests that a combined monitoring program based on Kt and BTM-Qa represents an effective screening method that significantly reduces the thrombosis rate and economic costs of vascular treatments.

Pancreas transplants venous graft thrombosis: endovascular thrombolysis for graft rescue.

PURPOSE: To retrospectively assess the efficacy and safety of percutaneous endovascular treatment in patients with pancreas venous graft thrombosis (PVGT). MATERIALS AND METHODS: Between 2001 and 2009, 206 pancreas transplants were performed at our institution. A retrospective review of pancreas graft recipients who underwent endovascular therapy for PVGT was performed. The study group included 17 patients (10 men, 7 women; mean age 38 years) with PVGT (<60 % [9 patients]; 30-60 % [8 patients]) 6.6 ± 5.7 days after grafting. The angiographic studies, type of endovascular procedure, endovascular procedural and postprocedural effectiveness, and patient and graft outcomes were assessed. RESULTS: In 16 of 17 cases (94 %), significant (87.5 %) or partial (12.5 %) lysis of thrombi was achieved. One patient had external compression of the portal vein due to a hematoma, which hindered mechanical removal of the thrombi. This patient required graft pancreatectomy for extensive areas of parenchymal necrosis 2 days after the endovascular procedure. No complications related to endovascular treatment were observed. Postprocedural bleeding episodes related to anticoagulation were observed in five patients. Patient and pancreas graft survival rates at 12 months were 94 and 76 %, respectively. CONCLUSION: Catheter-directed thrombectomy is an effective treatment for patients with PVGT. Percutaneous thrombectomy, followed by anticoagulation, appears to be an effective therapy to remove the thrombus and is associated with a low complication rate.

Evaluation of abdominal aortic aneurysm after endovascular repair: prospective validation of contrast-enhanced US with a second-generation US contrast agent.

PURPOSE: To prospectively assess the accuracy of contrast agent-enhanced (CE) ultrasonography (US) with a second-generation US contrast agent in the detection and classification of endoleaks after endovascular repair of abdominal aortic aneurysms (EVAR), with computed tomographic (CT) angiography as the reference standard. MATERIALS AND METHODS: Institutional review board and written informed consent were obtained. Thirty-five patients who underwent EVAR were enrolled in a prospective study that consisted of CT angiography and CE US studies performed at 1- and 6-month follow-up and performed yearly thereafter. CE US was performed after bolus injection of 2.4 mL of sulfur hexafluoride by using equipment with specific software for contrast studies. Angiography was performed in patients who had type II endoleaks with an increase in aneurysm sac size and in patients with type I or III endoleaks. CE US sensitivity, specificity, positive and negative predictive values, and accuracy were determined for endoleak detection, and Cohen κ statistic was used to assess agreement of CE US and CT angiographic findings for endoleak classification. RESULTS: A total of 126 CT angiographic and CE US studies were performed. CT angiography depicted 34 endoleaks in 16 patients (type IA, n=1; type IB, n=1; type II inferior mesenteric artery, n=2; type II lumbar artery, n=28; type II complex, inferior mesenteric, and lumbar arteries, n=2). CE US depicted 33 endoleaks. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of CE US in endoleak detection were 97%, 100%, 100%, 98%, and 99%, respectively. CE US enabled correct classification of 26 of 33 endoleaks. No clinically important endoleak was missed at CE US. CONCLUSION: CE US yields good sensitivity, specificity, and accuracy in endoleak detection, and it might represent a noninvasive tool that can be used in the follow-up of patients who undergo EVAR.

Tratamiento endovascular de las úlceras penetrantes de aorta torácica: seguimiento a medio plazo / Endovascular treatment of penetrating aortic ulcers: mid-term follow-up

Introducción y objetivos. Se presentan los resultados a corto y medio plazo del tratamiento endovascular de las úlceras penetrantes de aorta torácica. Métodos. Entre 1998 y 2010, se trató a 22 pacientes con úlceras penetrantes de aorta torácica mediante endoprótesis (media de edad, 69,8 años; el 91% varones). La indicación se realizó por un síndrome aórtico agudo (el 50%: dolor torácico en 8, rotura en 1, fístula aortobronquial en 1, embolización en 1) o por el diámetro aórtico o de la úlcera (50%). Todos los datos preoperatorios, intraoperatorios y de seguimiento fueron analizados prospectivamente siguiendo el protocolo EUROSTAR. Resultados. El éxito técnico fue del 100%, sin muertes ni conversiones intraoperatorias; 6 casos (27,3%) requirieron revascularización previa de troncos supraaórticos, y se utilizaron 1,3 dispositivos por paciente; el 27,3% tuvo complicaciones intrahospitalarias, y el 9,1% requirió reintervenciones antes del alta. La mortalidad acumulada a 30 días fue del 4,5%. Tras un seguimiento medio de 52,3 (0,1-122) meses, la supervivencia acumulada libre de complicaciones y reintervenciones a 100 meses fueron del 61,7 y el 79,5% respectivamente, con un 95,5% de supervivencia acumulada libre de mortalidad relacionada con la aorta o el procedimiento. No se han identificado factores pronósticos significativos de mala evolución clínica intraoperatoria o postoperatoria. Conclusiones. El tratamiento endovascular de las úlceras penetrantes de la aorta torácica es posible y eficaz, a pesar de tratarse de pacientes con elevadas comorbilidades. Aunque se asocia a una considerable tasa de complicaciones y reintervenciones (el 38,3 y el 20,5% a 100 meses), sobre todo intrahospitalarias, la tasa de mortalidad relacionada a largo plazo es baja (4,5%) (AU)

Introduction and objectives. The aim of this work is to describe the short- and mid-term results of endovascular treatment of penetrating ulcers in the thoracic aorta. Methods. Between 1998 and 2010, 22 patients with penetrating ulcers in the thoracic aorta received endografts (mean age 69.8 years, 91% male); 50% were indicated for acute aortic syndrome (8 chest pain, 1 aortic rupture, 1 aortobronchial fistula, 1 distal embolization) and 50% for aortic or ulcer diameter. All preoperative, operative and follow-up data were recorded prospectively and met EUROSTAR criteria. Results. Technical success was 100% with no intraoperative deaths or open conversions; 6 (27.3%) required preoperative supraaortic trunk debranching and 1.3 endografts were used per patient; 27.3% developed complications in-hospital and 9.1% required reintervention prior to discharge. Mortality at 30 days was 4.5%. After a mean 52.3 month follow-up (range 0.1-122), cumulative survival free from complications and reinterventions at 100 months was 61.7% and 79.5% respectively, with 95.5% cumulative survival free from aorta- or procedure-related death. We identified no factors significantly related to poor intra- or postoperative clinical course. Conclusions. Endovascular treatment of penetrating aortic ulcers is both possible and effective despite high patient comorbidity. Although a substantial rate of complications and reinterventions can be expected -especially in-hospital- (38.3% and 20.5% respectively at 100 months), long-term mortality is low (4.5%) (AU)

Endovascular treatment of penetrating aortic ulcers: mid-term follow-up.

INTRODUCTION AND OBJECTIVES: The aim of this work is to describe the short- and mid-term results of endovascular treatment of penetrating ulcers in the thoracic aorta. METHODS: Between 1998 and 2010, 22 patients with penetrating ulcers in the thoracic aorta received endografts (mean age 69.8 years, 91% male); 50% were indicated for acute aortic syndrome (8 chest pain, 1 aortic rupture, 1 aortobronchial fistula, 1 distal embolization) and 50% for aortic or ulcer diameter. All preoperative, operative and follow-up data were recorded prospectively and met EUROSTAR criteria. RESULTS: Technical success was 100% with no intraoperative deaths or open conversions; 6 (27.3%) required preoperative supraaortic trunk debranching and 1.3 endografts were used per patient; 27.3% developed complications in-hospital and 9.1% required reintervention prior to discharge. Mortality at 30 days was 4.5%. After a mean 52.3 month follow-up (range 0.1-122), cumulative survival free from complications and reinterventions at 100 months was 61.7% and 79.5% respectively, with 95.5% cumulative survival free from aorta- or procedure-related death. We identified no factors significantly related to poor intra- or postoperative clinical course. CONCLUSIONS: Endovascular treatment of penetrating aortic ulcers is both possible and effective despite high patient comorbidity. Although a substantial rate of complications and reinterventions can be expected-especially in-hospital-(38.3% and 20.5% respectively at 100 months), long-term mortality is low (4.5%).

Pulmonary artery pseudoaneurysm after Swan-Ganz catheter placement: embolization with vascular plugs.

Three patients who presented with massive hemoptysis after the insertion of a Swan-Ganz catheter for cardiac surgery are reported. Pulmonary artery pseudoaneurysms were diagnosed and successfully treated by embolization with a vascular plug. Follow-up at 15 months showed no recurrence of hemoptysis, and computed tomography helped confirm complete occlusion of the pseudoaneurysms.

Stent grafting-related acute type B redissection.

The purpose of this article is to report two distal dissections resulting as a complication of endovascular aneurysm repair (EVAR) in two cases of type B aortic dissection (TBAD) and its relationship with prosthetic alignment at the distal landing zone. Two patients affected by aneurysm formation of a chronic type B dissection underwent EVAR. During postoperative follow-up, at 48 and 39 months, respectively, a new chest pain episode recommended a new computed tomographic angiography examination. New false lumen reperfusion and increased aortic diameter distally to the prosthesis were demonstrated. The distal end of each stent graft showed an angulated alignment to the proximal descending aorta at the point of the secondary entry site. Both patients were successfully treated after deployment of a distal endograft. Prosthetic alignment with the aortic axis is important to avoid wall stress and secondary perforation in patients treated for TBAD. The distal landing point at the descending aortic straight segment is recommended.

[Abdominal aortic aneurysm and renovascular disease]. / Aneurisma de aorta abdominal y enfermedad vascular renal.

Recent technological advances in the diagnosis and therapy of abdominal aortic aneurysm and renovascular disease are continuing to bring about changes in the way patients suffering from these conditions are treated. The prevalence of both these conditions is increasing. This is due to greater life-expectancy in patients with arteriosclerosis, a pathogenetic factor underlying both conditions. The application of diagnostic imaging techniques to non-vascular conditions has led to the early diagnosis of abdominal aortic aneurysm. Clinical suspicion of reno-vascular disease can be confirmed easily using high-resolution diagnostic imaging modalities such as CT angiography and magnetic resonance angiography. Endovascular intervention is successfully replacing conventional surgical repair techniques, with the result that it may be possible to improve outcome in both conditions using effective and minimally invasive approaches. Future technological developments will enable these endovascular techniques to be applied in the large majority of patients with abdominal aortic aneurysm or renovascular disease.

Aneurisma de aorta abdominal y enfermedad vascular renal / Abdominal aortic aneurysm and renovascular disease

Los recientes avances tecnológicos aplicados al diagnóstico y tratamiento del aneurisma de aorta abdominal (AAA) y la enfermedad vascular renal (EAR) están ocasionando un cambio en el abordaje terapéutico de los pacientes que experimentan estas enfermedades. La prevalencia de ambas enfermedades tiene tendencia a aumentar. Ello se debe a la prolongación de la esperanza de vida en los pacientes que presentan arteriosclerosis, factor etiopatogénico fundamental de ambas enfermedades. La aplicación de métodos de diagnóstico por la imagen en enfermedades no vasculares permite el diagnóstico precoz de AAA. La sospecha de EAR se puede confirmar fácilmente con el uso de elementos diagnósticos de alta definición, como la angiotomografía o la angiorresonancia. El tratamiento intervencionista endovascular está sustituyendo con éxito a los tratamientos de reparación quirúrgica convencionales. Todo ello abre la posibilidad de mejorar el pronóstico de ambas enfermedades con actuaciones efectivas y poco cruentas. Las futuras innovaciones tecnológicas permitirán la aplicación de técnicas endovasculares en la amplia mayoría de los pacientes con AAA o EAR (AU)

Recent technological advances in the diagnosis and therapy of abdominal aortic aneurysm and renovascular disease are continuing to bring about changes in the way patients suffering from these conditions are treated. The prevalence of both these conditions is increasing. This is due to greater life-expectancy in patients with arteriosclerosis, a pathogenetic factor underlying both conditions. The application of diagnostic imaging techniques to non-vascular conditions has led to the early diagnosis of abdominal aortic aneurysm. Clinical suspicion of reno-vascular disease can be confirmed easily using high-resolution diagnostic imaging modalities such as CT angiography and magnetic resonance angiography. Endovascular intervention is successfully replacing conventional surgical repair techniques, with the result that it may be possible to improve outcome in both conditions using effective and minimally invasive approaches. Future technological developments will enable these endovascular techniques to be applied in the large majority of patients with abdominal aortic aneurysm or renovascular disease (AU)

Chemoembolization of hepatocellular carcinoma with drug eluting beads: efficacy and doxorubicin pharmacokinetics.

BACKGROUND/AIMS: This study assesses the safety, pharmacokinetics and efficacy of transarterial chemoembolization using drug eluting beads (DEB), an embolizing device that slowly releases chemotherapy to decrease systemic toxicity. METHODS: Twenty-seven Child-Pugh A cirrhotics (76% male, 59% HCV) with untreated large/multifocal HCC received chemoembolization with doxorubicin loaded DEBs at doses adjusted for bilirubin and body surface (range: 47-150 mg). Clinical and analytical data were recorded at 24 and 48 h, 7, 14 and 30 days after first and second TACE. Response rate was assessed by CT at 6 months. Blood samples were obtained in 13 patients at 5, 20, 40, 60, 120 min, 6, 24, 48 and 168 h to determine doxorubicin Cmax and AUC. RESULTS: DEB-TACE was well tolerated with an acceptable safety profile. Two cases developed liver abscess, one leading to death. Response rate was 75% (66.6% on intention-to-treat). Doxorubicin Cmax and AUC were significantly lower in DEB-TACE patients (78.97+/-38.3 ng/mL and 662.6+/-417.6 ng/mLmin) than in conventional TACE (2341.5+/-3951.9 ng/mL and 1812.2+/-1093.7 ng/mLmin, p=0.00002 and p=0.001, respectively). After a median follow-up of 27.6 months, 1- and 2-year survival is 92.5% and 88.9%, respectively. CONCLUSIONS: Chemoembolization using DEBs is an effective procedure with a favorable pharmacokinetic profile.

MRA is useful as a follow-up technique after endovascular repair of aortic aneurysms with nitinol endoprostheses.

PURPOSE: To evaluate whether MR angiography (MRA) is a useful tool for the follow-up of aortic aneurysms treated with nitinol endoluminal grafts. MATERIALS AND METHODS: We examined 28 patients treated with nitinol endovascular stents to repair an aortic aneurysm with CT angiography (CTA) and MRA. Eleven patients (group 1) underwent an MRA after a positive CTA for endoleak was observed. Afterwards, 17 patients (group 2) were scheduled for both follow-up examinations. The kind of endoleak that occurred and the maximum aortic diameter were compared. The sensitivity of CTA relative to MRA for detecting endoleaks in group 2 was calculated. Signal-to-noise ratios (SNRs) were measured in the aortoiliac lumen at the arterial phase in, above, and below the endoprostheses. Student's t-test was used to compare aneurysm dimensions and SNR measurements. RESULTS: Three type III leaks were correctly assessed at both examinations; however, CTA was less sensitive (50%) than MRA in depicting type II or unclassified leaks. No differences in aneurismal size were observed between the two examinations or between arterial SNRs observed in or out of the devices. CONCLUSION: MRA can provide all relevant information necessary for the follow-up of patients treated with nitinol endoprostheses, and performs better than CTA in detecting endoleaks.

Endovascular treatment of a giant intracranial aneurysm with a stent-graft.

This report describes a giant intracavernous carotid aneurysm successfully treated by the placement of a single covered stent. A 40-year-old woman was admitted with a progressive diplopia in relation with palsy of the IV and VI cranial nerves. Magnetic resonance imaging revealed an intracavernous giant aneurysm located at the bifurcation between the origin of a trigeminal artery and the intracavernous portion of the right internal carotid artery. A covered stent was successfully placed, and complete exclusion of the aneurysm was confirmed at 11-month follow-up angiography. The use of covered stents in intracranial vascular structures can now be a feasible way of treating selected cases of wide-necked intracranial aneurysms.

Effects of contrast media on renal function in patients with cirrhosis: a prospective study.

Patients with cirrhosis are frequently submitted to radiological procedures that require the administration of contrast media. Contrast media is a well-known cause of renal failure, particularly in the presence of some predisposing conditions. However, it is not known whether cirrhosis constitutes a risk factor for contrast media-induced renal failure. The aim of this study was to assess the possible nephrotoxicity of contrast media in patients with cirrhosis. In a first protocol, renal function was evaluated with sensitive methods (glomerular filtration rate using iothalamate I 125 clearance and renal plasma flow using iodohippurate I 131 clearance) before and 48 hours after the administration of contrast media in 31 patients with cirrhosis (20 with ascites, 5 with renal failure). Solute-free water clearance, urine sodium, prostaglandins, and markers of tubular damage were also measured. The administration of contrast media was not associated with significant changes in renal function tests, neither in the whole group of patients nor in patients with ascites or renal failure. Urinary prostaglandin E2 and N-acetyl-beta-D-glucosaminidase increased significantly, but sodium and solute-free water excretion remained unchanged. In a second protocol, a different series of 60 patients with cirrhosis and renal failure were examined prospectively. No patient had renal failure due to contrast media. Only in 1 patient with septic shock was contrast media a possible contributing factor. In conclusion, the administration of contrast media is not associated with adverse effects on renal function in patients with cirrhosis. Cirrhosis does not appear to be a risk factor for the development of contrast media-induced nephrotoxicity.

Percutaneous self-expanding metal stents versus endoscopic polyethylene endoprostheses for treating malignant biliary obstruction: randomized clinical trial.

PURPOSE: To compare percutaneous self-expanding metal stents with conventional endoscopic polyethylene endoprostheses for treatment of malignant biliary obstruction by means of a prospective randomized clinical trial. MATERIALS AND METHODS: Patients with biliary obstruction due to inoperable primary carcinoma of the pancreas, gallbladder, or bile ducts or regional lymph node metastases were included. Evaluated outcomes included technical and therapeutic success rates, morbidity and 30-day mortality rates, hospital stay length and readmission, biliary reobstruction, and overall survival rates. Data were analyzed according to both the intention-to-treat principle and the treatment actually administered. Univariate (Kaplan-Meier method) and multivariate (Cox model) analyses were performed. RESULTS: After randomization, 28 patients were assigned to receive a percutaneous self-expanding metal stent and 26 patients to receive a 12-F endoscopic polyethylene prosthesis. The technical success rates of both implantation procedures were similar (percutaneous, 75% [21 of 28 patients]; endoscopic, 58% [15 of 26 patients]; P =.29), whereas therapeutic success was higher in the percutaneous group (71% [20 of 28 patients] vs 42% [11 of 26 patients]; P =.03). However, major complications were more common in the percutaneous group (61% [17 of 28 patients] vs 35% [nine of 26 patients]; P =.09) but did not account for differences in 30-day mortality rates (percutaneous, 36% [10 of 28 patients]; endoscopic, 42% [11 of 26 patients]; P =.83). Overall median survival was significantly higher in the percutaneous group than in the endoscopic group (3.7 vs 2.0 months; P =.02). Cox regression analysis enabled identification of placement of the percutaneous self-expanding metal stent as the only independent predictor of survival (relative risk, 2.19; 95% CI: 1.11, 4.31; P =.02). CONCLUSION: Placement of a percutaneous self-expanding metal stent is an alternative to placement of an endoscopic polyethylene endoprosthesis in patients with malignant biliary obstruction.