Pharmacokinetic Evaluation of Two Paclitaxel-Coated Balloons with Different Drug Load in a Short-Term Porcine Study.

PURPOSE: The aim of the study was to evaluate the pharmacokinetics and tissue absorption of 2 paclitaxel (PTX) drug-coated balloons (DCB) using different drug loads in a porcine-injured iliac artery model. MATERIALS AND METHODS: Twenty-eight pigs were randomized into 2 groups. In group B1, angioplasty was performed with a 1.0 µg/mm(2) DCB with PTX and in group B3, with a 3.0 µg/mm(2) DCB with PTX. An overstretched model of the iliac artery was used for angioplasty under fluoroscopy. Blood and vessel wall PTX were measured with liquid-chromatography mass spectrometry at 1, 5, 30 min, 1, 7, and 28 days. Remaining drug in the balloon was analyzed. RESULTS: Mean PTX in blood was significantly higher in the group B3 0.269 ± 0.085 µg/ml compared with the B1 0.218 ± 0.085 µg/ml; p = 0.01. Peak blood PTX concentration was detected at 1 min, and PTX was undetectable 24 h post-angioplasty. There were no statistically significant differences in the mean arterial wall concentration from the treated iliac artery between group-B1 (15.24 ± 21.29 ng/mg) and B3 (15.68 ± 16.33 ng/mg), or in the PTX wall concentration measured at different time points. Mean remaining drug in assayed balloons was lower for group-B1 and represented 8 % of the initial dose. CONCLUSIONS: Blood PTX was higher when using 3.0 µg/mm(2) DCB, with a peak drug concentration at 1-min, although the drug was undetectable at 24 h, independently of the loading dose. This study demonstrates no difference in arterial wall uptake of a low dose DCB (1.0 µg/mm(2)), when compared to a common dose DCB (3.0 µg/mm(2)) suggesting that the dose of drug in the DCB could be reduced obtaining a similar clinical effect.

Long-term follow-up of patients with post-traumatic refractory high intracranial pressure treated with lumbar drainage.

Drainage of cerebrospinal fluid by means of external lumbar drainage (ELD) is controversial in the adult population with traumatic brain injury. We report our experience with ELD in the treatment of post-traumatic high intracranial pressure (ICP) and the results of the long-term follow-up in these patients. We undertook clinical evaluation of 30 patients with traumatic brain injury and high ICP treated with second-tier measures or with first-tier measures if second-tier measures were contraindicated. The study involved a retrospective review of collected data. Outcome at intensive care unit discharge and three to five years after injury were evaluated with the Glasgow Outcome Scale. The mean age of patients was 34.9 +/- 12.5 years and 25 (83%) were male. The median (interquartile range) Glasgow Coma score was 8 (7 to 10). ICP before and one hour after ELD placement was 33.7 +/- 9.0 and 12.5 +/- 4.8 mmHg respectively, a decrease in 21.2 +/- 8.3 mmHg (P < 0.0001). ELD was placed after a mean of 8.6 +/- 3.9 days. Cerebrospinal fluid drainage was maintained for a mean of 6.6 +/- 3.5 days. Four patients (13%) required ELD replacement and one patient developed a cerebrospinal fluid infection (3%). No pupillary changes were noted within 48 hours of ELD placement. Long-term outcome was favourable (good recovery or moderate disability) in 62% of the patients studied. The use of ELD resulted in a marked decrease in ICP These patients presented a good outcome in 62% of the cases in the long-term evaluation. Few complications related with ELD use were noted.

Correlation between brain interstitial and total serum cortisol levels in traumatic brain injury. A preliminary study.

INTRODUCTION: Brain cortisol availability has never been evaluated in patients with traumatic brain injury (TBI). Cerebral microdialysis is a well-established technique for monitoring brain metabolism in neurocritically ill patients, which may be used to measure interstitial cortisol. The objective of this preliminary study was to measure brain interstitial cortisol and its correlation with total serum cortisol in patients with TBI. METHODS: We prospectively studied 6 patients with severe TBI admitted to the Intensive Care Unit of our tertiary University Hospital in which multimodal neuromonitoring including cerebral microdialysis with a high cut-off of 100 k-Da and 20-mm long membrane was used. Serum and brain interstitial cortisol microdialysis samples were obtained every 8 h and analyzed afterwards. RESULTS: Linear regression analysis of total serum cortisol and brain interstitial cortisol in the whole population showed a moderate correlation (R2=0.538, p<0.001, no.=118). However, intra-individual correlation showed a great variability, with correlation coefficients ranging from a R2=0.091 to R2=0.680. CONCLUSION: Our prospective and preliminary study showed a moderate correlation of brain interstitial cortisol and total serum cortisol values in patients with diffuse TBI. However, intra-individual analysis showed a great variability. These results suggest that total serum cortisol may not reflect brain cortisol availability in half of TBI patients.

Contrast-enhanced transcranial color sonography in the diagnosis of cerebral circulatory arrest.

OBJECTIVE: We sought to determine the utility of constrat-enhanced transcranial color sonography (TCCS) in the diagnosis of cerebral circulatory arrest in cases of difficult acoustic window. MATERIALS AND METHODS: From January 2007 to July 2008, we prospectively studied 50 patients who fulfilled clinical criteria of brain death. In all cases, we performed TCCS aiming to insonate both middle cerebral arteries (MCA) and the basilar artery (BA). In those case in which insonation of any vessel was not possible, we repeated the exploration after injecting a 2.5-mL bolus of sulphurhexafluoridedispersion. Afterward, we compared the rate of insonation of the vessels and the number of conclusive studies. RESULTS: The mean patient age was 53.2 +/- 15.9 years. Thirty-two were men (64%). The most frequent neurologic injury was hemorrhagic stroke and traumatic brain injury. Contrast-enhanced TCCS resulted in an increased rate of insonation in both MCA and in BA, and in the number of conclusive studies. CONCLUSIONS: Contrast-enhanced TCCS increased the number of conclusive studies with cerebral circulatory arrest, which minimized the importance of a previous study in cases with a poor acoustic window.

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Aplicaciones del dúplex transcraneal codificado en color en la monitorización del enfermo neurocrítico / Applications of transcranial color-coded duplex sonography in monitoring neurocritical patients

La sonografía transcraneal constituye una herramienta de monitorización habitual en el paciente neurocrítico. El dúplex transcraneal codificado en color permite un estudio hemodinámico y estructural del parénquima cerebral de estos pacientes. Sus ventajas sobre la sonografía convencional son evidentes, y se deben a una visualización directa del vaso que se quiere estudiar y a un correcto ajuste del volumen de muestra y del ángulo de insonación. La utilización de ecopotenciadores supone realizar estudios concluyentes prácticamente en el 100% de los casos, y permite estudiar de modo semicuantitativo la perfusión cerebral a la cabecera del paciente. El objetivo de esta revisión es exponer las aplicaciones del dúplex transcraneal codificado en color en la monitorización del enfermo neurocrítico en la Unidad de Cuidados Intensivos

Transcranial sonography is a common tool for monitoring neurocritical patients. Transcranial color-coded duplex ultrasonography enables hemodynamic and structural study of the cerebral parenchyma in these patients. Its advantages over conventional ultrasonography are evident and are derived from direct visualization of the vessel to be studied and appropriate adjustment of the sample volume and angle of insonation. The use of ultrasonographic contrast agents enables conclusive findings in practically 100% of cases and allows cerebral perfusion to be studied at the bedside using semiquantitative methods. This review aims to show the applications of transcranial color-coded duplex ultrasonography for monitoring neurocritical patients in intensive care units

[Applications of transcranial color-coded duplex sonography in monitoring neurocritical patients]. / Aplicaciones del dúplex transcraneal codificado en color en la monitorización del enfermo neurocrítico.

Transcranial sonography is a common tool for monitoring neurocritical patients. Transcranial color-coded duplex ultrasonography enables hemodynamic and structural study of the cerebral parenchyma in these patients. Its advantages over conventional ultrasonography are evident and are derived from direct visualization of the vessel to be studied and appropriate adjustment of the sample volume and angle of insonation. The use of ultrasonographic contrast agents enables conclusive findings in practically 100% of cases and allows cerebral perfusion to be studied at the bedside using semiquantitative methods. This review aims to show the applications of transcranial color-coded duplex ultrasonography for monitoring neurocritical patients in intensive care units.

[Cerebral hemodynamics in patients with traumatic brain injury evaluated by transcranial Doppler and transcranial color coded sonography. A comparison study]. / Hemodinámica cerebral en pacientes con traumatismo craneoencefálico evaluadapor doppler transcraneal y duplex transcraneal con codificación en color. Estudiocomparativo.

OBJECTIVE: To compare the number of vessels identified and mean velocity and pulsatility index values obtained by transcranial doppler (TCD) and transcranial color coded sonography (TCCS) in patients with traumatic brain injury (TBI). METHODS: Thirty patients suffering from TBI admitted in our neurocritical Intensive Care Unit (ICU) were studied. We performed consecutive studies by TCD and TCCS. The number of Circle of Willis vessels insonated and the hemodynamic parameters were compared. RESULTS: Mean age was 50 years. Twenty patients were male. By using TCCS, internal carotid artery was insonated in 95%, middle cerebral artery (MCA) in 95%, anterior cerebral artery (ACA) in 91% and posterior cerebral artery (PCA) in 92% of the studies. Using conventional TCD they were insonated in 29%, 93% 67% and 35% of the studies respectively. Mean velocity values measured by CCS and TCD in MCA were 79 cm/sec vs 59 cm/sec respectively (p< 0.0001), in ACA were 61 cm/sec vs 42 cm/sec (p< 0.0001) and in PCA were 43 cm/sec vs 33 cm/sec (p< 0.0001). CONCLUSION: TCCS allows a high quality hemodynamic study of TBI patients admitted to the ICU. Further studies must define its impact on outcome of TBI patients.

Effect of barbiturate coma on adrenal response in patients with traumatic brain injury.

INTRODUCTION: Barbiturate coma is the second tier measure recommended by guidelines to treat post-traumatic refractory intracranial pressure. Systemic hypotension is its most important side effect. Recent evidence suggests that low-dose corticosteroid therapy may be used in a subset of patients with traumatic brain injury (TBI) to avoid hypotension. We evaluated adrenal function in TBI patients undergoing barbiturate coma, as treatment of their refractory intracranial hypertension. MATERIALS AND METHODS: We prospectively studied 40 patients with moderate to severe TBI. Group A (17 patients) were treated with barbiturate coma. Group B (23 patients) presented intracranial hypertension controlled with first tier measures, and acted as a control. Adrenal function was evaluated by using the high-dose corticotropin stimulation test within 24 h after brain injury and after barbiturate coma induction. RESULTS: Within 24 h after TBI, adrenal function was similar in both groups. Once barbiturate coma was induced, patients in group A treated with barbiturate coma presented a higher incidence of adrenal insufficiency compared with the control group B (53% vs 22%, p=0.03). Patients treated with barbiturates, who developed adrenal impairment, required higher doses of norepinephrine to maintain cerebral perfusion pressure than patients treated with barbiturates without adrenal impairment (1.07+/-1.04 microg/kg/min vs 0.31+/-0.32 mug/kg/min, p=0.03). CONCLUSIONS: Patients with TBI treated with barbiturate coma are at higher risk of developing adrenal insufficiency. This subset of patients presented higher requirements of vasoactive support to avoid hypotension. In these patients corticosteroid therapy may have potential therapeutic implications to treat hemodynamic instability.

Hemodinámica cerebral en pacientes con traumatismo craneoencefálico evaluada por doppler transcraneal y duplex transcraneal con codificación en color. Estudio comparativo / Cerebral hemodynamics in patients with traumatic brain injury evaluated by transcranial doppler and transcranial color coded sonography. A comparison study

Objetivos. Comparar el número de vasos identificados y las velocidades e índices de pulsatilidad de los mismos mediante doppler transcraneal (DTC) y dúplex transcrane al codificado en color (DTCC) en una población de enfermos con traumatismo craneoencefálico (TCE). Material y métodos. Se estudiaron 30 enfermos ingresados por TCE en una Unidad de Cuidados Intensivos (UCI) neurocríticos. Consecutivamente se realizaron estudios mediante DTC y DTCC. Se compararon la tasa de insonación de las arterias del polígono de Willis y los parámetros hemodinámicos obtenidos. Resultados. La edad media fue de 50 años. El 67%fueron varones. En el estudio mediante DTCC se insonóla arteria carótida interna en un 95% de los casos, la arteria cerebral media (ACM) en el 95% de las ocasiones, la arteria cerebral anterior (ACA) en un 91%y la arteria cerebral posterior (ACP) en un 92% de los estudios. Mediante DTC convencional se hallaron en un29%, 93%, 67% y 35% respectivamente. La velocidad media mediante DTCC y DTC en la ACM fue de 79 cm/seg vs 59 cm/seg respectivamente (p<0.0001), en la ACA de 61 cm/seg vs 42 cm/seg (p<0.0001) y en la ACP de 43cm/seg y 33 cm/seg (p<0.0001). Conclusiones. El DTCC permite un estudio hemodinámico más completo en los enfermos con TCE ingresados en la UCI. Su impacto en el pronóstico del TCE deberá determinarse en próximos estudios

Objective. To compare the number of vessels identified and mean velocity and pulsatility index values obtained by transcranial doppler (TCD) and transcranial color coded sonography (TCCS) in patients with traumatic brain injury (TBI).Methods. Thirty patients suffering from TBI admitted in our neurocritical Intensive Care Unit (ICU) were studied. We performed consecutive studies by TCD and TCCS. The number of Circle of Willis vessels insonated and the hemodynamic parameters were compared. Results. Mean age was 50 years. Twenty patients were male. By using TCCS, internal carotid artery was insonated in 95%, middle cerebral artery (MCA)in 95%, anterior cerebral artery (ACA) in 91% and posterior cerebral artery (PCA) in 92% of the studies. Using conventional TCD they were insonated in 29%,93% 67% and 35% of the studies respectively. Mean velocity values measured by CCS and TCD in MCA were 79 cm/sec vs 59 cm/sec respectively (p<0.0001),in ACA were 61 cm/sec vs 42 cm/sec (p<0.0001) and in PCA were 43 cm/sec vs 33 cm/sec (p<0.0001). Conclusion. TCCS allows a high quality hemodynamic study of TBI patients admitted to the ICU. Further studies must define its impact on outcome of TBI patients

[Early non-invasive diagnosis of posttraumatic carotid-cavernous fistula diagnosed by transcranial color-coded duplex sonography: analysis of 4 patients]. / Diagnóstico precoz no invasivo de la fístula carótido-cavernosa postraumática por dúplex transcraneal color. Análisis de 4 pacientes.

Posttraumatic carotid-cavernous fistula (PtCCF) is an uncommon complication after cranioencephalic trauma. It is usually diagnosed with a cerebral arteriography when the clinical symptoms have already appeared. The transcranial color-coded duplex sonography (TCDS) is a non-invasive technique at the patient's bedside that permits visualization of the circle of Willis and the intracavernous segment of the internal carotid artery. The initial sonographic patterns that suggest the presence of a PtCCF by TCDS are a mosaic image in color mode, presence of arterial and venous flows mixed with high velocity and low resistances. We present our experience in the early and non-invasive diagnosis of PtCFF in an Intensive Care Unit.

Diagnóstico precoz no invasivo de la fístula carótido-cavernosa postraumática por dúplex transcraneal color. Análisis de 4 pacientes / Early non-invasive diagnosis of posttraumatic carotid-cavernous fistula diagnosed by transcranial color-coded duplex sonography: analysis of 4 patients

La fístula carótido-cavernosa postraumática (FCCt) es una complicación poco frecuente tras un traumatismo craneoencefálico (TCE). Se diagnostica mediante la arteriografía cerebral habitualmente cuando ya ha aparecido la sintomatología clínica. El dúplex transcraneal codificado en color (DTCC) es una técnica no invasiva que en la cabecera del paciente permite la visualización del polígono de Willis (PW) y del segmento intracavernoso de la arteria carótida interna (ACIi). Los patrones sonográficos iniciales que sugieren la presencia de una FCCt mediante DTCC son una imagen en mosaico en el modo color, la presencia de flujos arteriales y venosos mezclados con elevadas velocidades y bajas resistencias. Exponemos nuestra experiencia en el diagnóstico precoz y no invasivo de la FCCt en una Unidad de Cuidados Intensivos

Posttraumatic carotid-cavernous fistula (PtCCF) is an uncommon complication after cranioencephalic trauma. It is usually diagnosed with a cerebral arteriography when the clinical symptoms have already appeared. The transcranial color-coded duplex sonography (TCDS) is a non-invasive technique at the patient's bedside that permits visualization of the circle of Willis and the intracavernous segment of the internal carotid artery. The initial sonographic patterns that suggest the presence of a PtCCF by TCDS are a mosaic image in color mode, presence of arterial and venous flows mixed with high velocity and low resistances. We present our experience in the early and non-invasive diagnosis of PtCFF in an Intensive Care Unit

Tratamiento de miomas uterinos sintomáticos mediante embolización de arterias uterinas: resultados clínicos / Symptomatic myomas treatment with uterine artery embolization: clinical outcomes

Objetivo: Evaluar los primeros resultados de la embolización de arterias uterinas en pacientes con miomas uterinos sintomáticos, en cuanto a control de la sintomatología y disminución del volumen del mioma dominante, medido mediante RMN o ecografía. Material y métodos: Se analiza los resultados de un estudio prospectivo de 23 pacientes en el periodo 2000-2004 en el Hospital Severo Ochoa (Leganés). Todos los casos presentaban miomas uterinos sintomáticos. Se incluyeron pacientes con deseo genésico y con miomas mayores de 10 cm. Las variables principales han sido la mejoría del síntoma predominante en la paciente, la reducción del volumen del mioma dominante, y la frecuencia y tipo de complicaciones relacionadas con la técnica. Resultados: Se consiguió embolización de ambas arterias uterinas en un 91,6%. Registramos un total de 11 casos de complicaciones (43.82%), de las cuales, en 7 casos (30,43%) fueron mayores. Se objetivó una reducción del volumen del mioma dominante del 71%, así como una mejoría de la sintomatología motivo de consulta en un 86,4%, a los 12 meses. Conclusiones: La embolización de arterias uterinas es un tratamiento seguro, pudiendo ser una opción de tratamiento en pacientes con miomas uterinos sintomáticos

Objective: To evaluate the first results of embolization of the uterine arteries in patients with symptomatic uterine myomas, about control of their symptoms and reduction in dominant myoma volume, using NMR or ultrasound. Material and method: We analyse the results of a prospective study about 23 patients between 2000 and 2004 at Severo Ochoa Hospital (Leganés). All of them had symptomatic uterine myomas. Patients who wished to conserve their fertility and women with myomas over 10 cm were included. The main variables measured were improvement in the dominant symptom, reduction in dominant myoma volume and frequency and type of complications related with the intervention. Results: Bilateral uterine artery embolization was achieved in 91,6%. Of all patients, eleven (43,82%) had complications, of these, seven (30,43%) had a mayor complication. The mean dominant myoma volume reduction were 71%, and the improvement of the dominant symptom were 86,4%, at 12 months. Conclusions: Embolization of the uterine arteries is a safe and effective treatment, which can be an alternative therapy in patients with symptomatic uterine myomas

[Comparison of the effectiveness of pentobarbital and thiopental in patients with refractory intracranial hypertension. Preliminary report of 20 patients]. / Comparación de la eficacia del pentobarbital y el tiopental en el control de la hipertensión intracraneal refractaria. Resultados preliminares en una serie de 20 pacientes.

OBJECTIVE: To assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury. MATERIAL AND METHODS: Prospective, randomized study to compare the effectiveness between two treatments: pentobarbital and thiopental. The patients will be selected from those admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to first level measures according to the Brain Trauma Foundation guidelines. The adverse effects of both treatments were also collected. RESULTS: We present the results of the first 20 patients included. Ten received pentobarbital and the other ten thiopental. There were no statistically significance differences in patients'characteristics (age, sex, severity of the trauma at admission and comorbilities). There were no differences between both groups neither in the Glasgow Coma Scale at admission (thiopental six points; pentobarbital seven points; P=0.26) nor in the admission Cranial Tomography, according to the Traumatic Coma Data Bank Classification. Thiopental treatment controlled raised ICP in five cases and pentobarbital in two cases (P=0.16). Five patients in the thiopental group died and eight in the pentobarbital group (P=0.16). There were no statistically differences between both groups regarding to the presence of hypotension (P=1) or infectious complications. CONCLUSIONS: These preliminary results indicate that thiopental could be more effective than pentobarbital in patients with refractory intracranial hypertension. These results support previous experimental findings that show that both treatments are not equal and justify to continue this study.

Jugular venous oxygen monitoring: a helpful technique in the early diagnosis of a traumatic carotid-cavernous sinus fistula.

This report describes the early diagnosis of a right traumatic carotid-cavernous sinus fistula (CCSF) in a patient with head injury manifested as an acute increase in right jugular venous oxygen saturation and with no ophthalmic clinical signs. High values of jugular venous oxygen saturation must be cautiously interpreted with the clinical examination and computed tomographic findings to establish an accurate diagnosis of hyperemia with or without a CCSF.

[Analysis of data from a database of patients submitted to cardiac catheterization]. / Aportes de una base de datos de pacientes sometidos a sondeo cardiaco.

77 variables with data from clinical, non invasive and invasive findings in 591 adult patients submitted to cardiac catheterization and/or coronary arteriography from 1988 to 1991 were analyzed. 51% had coronary arteriography for suspected coronary artery disease: 15% had no or insignificant disease and 8% had main left disease. Among 92 patients with valvular heart disease, coronary angiography ruled out coronary disease in 80%. In this group, 3 vessel disease was found only in patients older than 62 years of age and main left disease was rare. The etiology of valve disease was rheumatic in 72%. Congenital heart disease was the indication for invasive study in 8% of patients, atrial septal defect being the most common entity.