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The cost-effectiveness of basiliximab induction in "old-to-old" kidney transplant programs: Bayesian estimation, simulation, and uncertainty analysis.

INTRODUCTION: Markov models are employed in economic analyses to evaluate all possible expectations in a dilemna. The introduction of a new clinical protocol (Basiliximab induction with calcineurin-sparing protocols) for a group of kidney transplant recipients receiving organs from marginal donors was validated with a Markov simulation model, demonstrating the usefulness of combining simulation with Bayesian estimation methods for analysis of cost-effectiveness data collected alongside a clinical trial. We sought to determine whether calcineurin-sparing protocols using anti-interleukin-2/antibody induction (Simulect) would show a beneficial effect on initial kidney function and reduce transplantation costs upon admission, clinical incidences, graft function, and complications during the first month after transplant. PATIENTS AND METHODS: A Markov Chain Monte Carlo (MCMC) was used to estimate a system of generalized linear models relating costs and outcomes to a kidney transplant process affected by treatment under alternative therapies. The Markov simulation model was established following three chains: a calcineurin-free regimen with Basiliximab induction (chain A); a calcineurin-sparing protocol with Basiliximab induction (chain B); and a conventional immunosuppressive regimen (chain C). The MCMC draws were used as parameters in simulations that yielded inferences about the relative cost-effectiveness of the novel therapy under a variety of scenarios. After designing the Markov chain and cohorts, 31 patients from the "old-to-old" program were assigned; eight to chain A; eight to chain B; and 15 to chain C. A year after transplantation a cost-benefit study was performed guided by the three branches of the Markov model. RESULTS: The Markov model showed a benefit of induction therapies in elderly patients. A cost-benefit model showed that after a year, there was a clear benefit from calcineurin-free plus Basiliximab induction therapies, with a slight benefit from calcineurin-sparing protocols. CONCLUSIONS: Markov models are extremely useful when introducing new clinical therapies. The approach allows flexibility in assessing treatment using various premises and quantifies the global effect of parametric uncertainty on a decision maker's confidence to adopt one therapy over another. In our transplant program, a cost-effective analysis of outcomes in old patients using the Markov model showed a clear benefit of calcineurin-sparing protocols with Basixilimab induction.

Long-term results of calcineurin-free protocols with basiliximab induction in "old-to-old" programs.

INTRODUCTION: EuroTransplant old-to-old program allows patients older than 60 years to receive offers from donors older than 60. The long-term results of kidney transplantation in this model are still under discussion, due to the impaired kidney function of the donor and cumulative diseases in the recipient. HYPOTHESIS: Calcineurin-sparing protocols with IL-2 antibody induction (Simulect) may benefit long-term kidney function in these patients avoiding overimmunosuppression. The main outcome measures are: graft function and rejection rate during the first year after transplant. PATIENTS AND METHODS: A cohort of 15 consecutive older subjects were prospectively compared with 30 conventional cadaveric kidney transplants. Study patients were induced with Simulect (20 mg, 30 minutes before reperfusion and 4 days after transplantation) and steroids allowing the introduction of CsA to be delayed to the time at which the creatinine is below 3 mg/dL. Conventional patients were immunosuppresed with Tacrolimus (trough 8-12 ng/mL), MMF (1 g/d) and identical steroid tape. The graft and patient survival, kidney function in terms of diuresis, creatinine clearance, rejection episodes and grades were compared between both groups during the first year posttransplantation. RESULTS: Except for the age of the donors and recipients in both groups (72 vs 54 in donors, and 67 versus 52 years in recipients), no significant differences were observed. Patient survival rates were 97% in control patients and 100% in the Simulect group. Graft survival was 97% in the control group and 100% in the old-to-old study group. Acute rejection episodes were decreased among study patients (6.6% vs 13.2%), and corticoid sparing protocols were applied in 75% of Simulect patients but only 50% of control patients. All 44 patients and grafts showed excellent kidney function after one year with equal creatinine levels in both groups (mean 1.42). CONCLUSIONS: Calcineurin free protocols with IL-2 therapy as the main initial suppression allows patients in an old-to-old ET program to have superior results to conventional cadaveric kidney transplants.

Endometriosis sobre cicatriz de episiotomía y cesárea previa: 2 casos clínicos / Endometriosis in a surgical scar after prior episiotomy and cesarean section. Two case reports

La endometriosis localizada en tejido cicatrizal tras cirugía pélvica del aparato genital, se presenta como una lesión nodular acompañada de dolor cíclico catamenial en el área cicatrizal, y no se asocia de forma habitual a endometriosis genital. Presentamos 2 casos de endometriosis localizada en tejido cicatrizal tras intervenciones obstétricas (episiotomía y cesárea, respectivamente) diagnosticados en nuestro hospital. El diagnóstico, basado en la sospecha clínica, fue histológico tras biopsia-exéresis de la lesión que resultó terapéutica, y las mujeres presentaron remisión completa de la sintomatología. En ambos casos, se asoció tratamiento hormonal postoperatorio, aunque su eficacia está discutida (AU)

Cost-effectiveness analysis of basixilimab induction and calcineurin-sparing protocols in "old to old" programs using Markov models.

INTRODUCTION: Markov models are employed in economic analyses to evaluate all possible expectations in a dilemna. The introduction of a new clinical protocol (basiliximab induction with calcineurin-sparing protocols) for a group of kidney transplant recipients receiving organs from marginal donors was validated with a Markov simulation model. HYPOTHESIS: Calcineurin-sparing protocols using anti-IL-2/antibody induction (Simulect) show a beneficial effect on initial kidney function, reducing transplantation costs reception based upon mean length of stay, mean admission cost, and incidences of delayed graft function and complications during the first month after transplant. PATIENTS AND METHODS: A Markov simulation model was established following three different chains. A calcineurin-free regimen with basiliximab induction (chain A), a calcineurin-sparing protocol with basiliximab induction (chain B), and a conventional immunosuppressive regimen (chain C). After designing the Markov chain and cohorts, 31 patients from the "old to old" program were assigned to each chain eight to chain A, (eight to chain B, and 15 to chain C). A month after transplantation a cost-benefit study was performed guided by the three branches of the Markov model. RESULTS: The Markov model showed a benefit of induction therapies in elderly patients. A cost-benefit model showed that after a month there was a clear benefit from Calcineurin=free plus basiliximab induction therapies, with a slight benefit from calcineurin-sparing protocols. CONCLUSIONS: Markov models are extremely useful when introducing new clinical therapies. In our transplant program, a cost-effective analysis of outcomes in old patients using the Markov model showed a clear benefit of calcineurin-sparing protocols with basixilimab induction.

Calcineurin-free protocols with basiliximab induction allow patients included in "old to old" programs achieve standard kidney transplant function.

INTRODUCTION: The EuroTransplant "old to old" program establishes that patients older than 60 years can receive offers of organs from donors older than 60 years. The compromised function of these organs makes it a priority to preserve their initial kidney function. HYPOTHESIS: Calcineurin-sparing protocols using anti-IL-2 receptor (IL-2R) antibody induction (Simulect) may benefit initial kidney function in these patients, as assessed by the rates of delayed graft function and of rejection during the first month after transplant. PATIENTS AND METHODS: A cohort of 15 consecutive elderly patients were prospectively compared with 30 cadaveric kidney transplants in younger recipients. Study patients were induced with Simulect (20 mg, 30 minutes before reperfusion and 4 days after transplantation) and steroids, delaying the introduction of CsA until the serum creatinine was below 3 mg/dL. The other cohort of patients were immunosuppressed with tacrolimus (trough 8 to 12), mycophenolats mofetil (MMF, 1 g/d), and an identical taper of steroids. The analysis compared donor and recipient ages, mean cold ischemic time, incidence of initial kidney function (diuresis in the first 24 h) serum creatinine levels, glomerular filtration rate (GFR), number of dialysis sessions, and rejection rate in the two groups. RESULTS: Except for the donor and recipient ages (72 vs 54 in donors, and 67 versus 52 years in recipients), no significant differences were observed between the groups among the rates of acute rejection (6.6% vs 13.2%), delayed graft function (13.2% required dialysis), or infection (6.6%). Within 1 month all 45 grafts showed primary function with equal creatinine levels (mean 1.65). CONCLUSIONS: Calcineurin-free protocols using IL-2 therapy as the initial suppression allow patients in the "old to old" ET program to display equal results to cadaveric kidney transplants with initial treatment with calcineurin antagonists.

Surgical microbiology in risk patients undergoing abdominal surgery.

INTRODUCTION: Incidence of surgical infection is greater among elderly patients undergoing surgery than among the general population, with a serious compromise regarding morbidity and mortality in this group of patients with increased risk. AIM OF THE STUDY: To determine the microbiological features of surgical infections in patients over 65 years of age compared with those younger than 65. PATIENTS AND METHODS: Over the past 2 years, 2,064 patients underwent surgery in our Department. One thousand three hundred sixty seven of those patients (66.7%) had 65 years of age or less and 688 (33.3%) were over 65. Patient characteristics regarding the type of surgery (degree of contamination) and the nature and type of the condition requiring surgery are reported. One hundred five hundred sixty two samples were submitted for microbiological study. The microbiological infectious pathogens and their characteristics were determined. The Chi-square test was used for the analysis of potential differences related to the age of the patient. RESULTS: The rate of samples sent for microbiological study is higher among patients over 65. In addition, these patients show both quantitative and qualitative differences in their infectious microbiological spectrum, mainly in clean-contaminated, contaminated and dirty surgical procedures. Fungal infections play a significant role in this group of patients. CONCLUSIONS: Facultative gram-negative bacilli, aerobic gram-positive cocci, and fungi are the main pathogens responsible of surgical infections in elderly patients, compared to all other patients, thus requiring specific antibiotic prophylactic and therapeutic regimes.

Complicaciones quirúrgicas debidas al drenaje vesical en las distintas modalidades de trasplante pancreático / Surgical complications due to bladder drainage in the different modalities of pancreatic transplantation

Introducción. Desde que en 1987 se introdujo la técnica de drenaje vesical en el manejo de la secreción exocrina del injerto pancreático, esta modalidad terapéutica se popularizó hasta el punto de que el 87 por ciento de los centros estadounidenses la realizan en la actualidad como alternativa de primera elección. No obstante, esta técnica quirúrgica no está exenta de complicaciones debidas a su anastomosis a la vejiga. Pacientes y métodos. En la Unidad de Trasplante Pancreático de la Universidad de Texas-Houston se han realizado, desde marzo de 1997 hasta agosto de 1998, 30 trasplantes pancreáticos con drenaje vesical (15 simultáneos con riñón, siete tras un trasplante renal y ocho solitarios). La anastomosis duodenovesical se realizó de forma laterolateral con una sutura automática circular del diámetro que permitiese la luz duodenal y se sobresuturó con sutura continua reabsorbible. Veintiocho de estos pacientes recibieron tratamiento inmunosupresor de continuidad con tacrolimus, micofenolato mofetil y corticoides, y dos con ciclosporina, rapamicina y corticoides. En este estudio se recogieron prospectivamente todas las complicaciones vesical, urinaria o del injerto debidas a la técnica de anastomosis duodenovesical, prestando especial atención a cada modalidad de trasplante empleada. Resultados. La tasa de supervivencia de los pacientes al primer año fue del 96 por ciento y la supervivencia del injerto durante el primer año del 93 por ciento. La tasa de complicaciones debida al drenaje vesical fue del 23,3 por ciento y se corresponde con: 2 pancreatitis infecciosas por reflujo vesical (un paciente falleció y otro requirió extirpación del injerto), 2 pancreatitis recidivantes por reflujo vesical que requirieron conversión a drenaje entérico, una duodenitis por reflujo vesical que requirió asimismo conversión a drenaje entérico, una hematuria por infección urinaria y uretritis recidivantes, y 2 hematurias debidas a las grapas de la anastomosis vesical que fueron extraídas por cistoscopia. La tasa de mortalidad debida al drenaje fue del 3,3 por ciento, la tasa de pérdidas del injerto al año fue del 6,6 por ciento y la tasa de conversiones de injertos funcionantes del 14,28 por ciento. Aproximadamente un 20 por ciento de los injertos pancreáticos drenados a la vejiga presentan complicaciones en el primer año del postoperatorio. Conclusiones. La técnica de drenaje vesical es enormemente segura a la hora de realizar el trasplante pancreático simultáneo, secuencial o solitario; sin embargo, durante el primer año de postoperatorio induce una considerable morbilidad e incluso mortalidad, lo que debe hacer considerar la conversión electiva a drenaje enteral tras los primeros 6 meses postrasplante. Cada modalidad de trasplante de páncreas presenta distintos tipos de complicaciones postoperatorias debidas al drenaje vesical, lo que debe hacer considerar cada uno de ellos de forma diferente (AU)

Microbiología quirúrgica en pacientes de riesgo sometidos a cirugía abdominal / Surgical microbiology in risk patients undergoing abdominal surgery

Introducción: la infección quirúrgica en el paciente de edad avanzada sometido a cirugía, presenta una incidencia superior a la del resto de la población, con serio compromiso de la morbimortalidad de este grupo de pacientes de riesgo. Objetivo del estudio: conocer las particularidades microbiológicas de la infección en el grupo de pacientes >65 años, en comparación con el resto de la población. Pacientes y métodos: estudio realizado en 2.064 pacientes, 1.367 (66,7 por ciento) 65 años. Se detallan las características de los enfermos con relación al tipo de cirugía (grado de contaminación), naturaleza de la patología intervenida y carácter de la misma. Se remitieron a estudio microbiológico 1.562 muestras. Se estableció el espectro microbiológico responsable de la infección y las particularidades del mismo, analizándose mediante el test de Chi cuadrado, posibles diferencias con relación a la edad del enfermo. Resultados: los pacientes de más de 65 años generan una mayor tasa de muestras a estudio microbiológico, además evidencian diferencias tanto cuantitativas como cualitativas en el patrón microbiológico responsable de la infección, básicamente en las cirugías limpia-contaminada, contaminada y sucia. Los hongos adquieren especial relevancia en este grupo de pacientes, como res ponsables de la infección. Conclusiones: los bacilos gramnegativos facultativos, los cocos grampositivos aerobios y los hongos, constituyen la principal flora responsable de infección quirúrgica del paciente de edad avanzada, en comparación con el resto de los pacientes, lo que condicionará regímenes de profilaxis y tratamiento antibiótico específicos (AU)

Los gérmenes anaerobios como responsables de la infección quirúrgica / Anaerobic microorganisms responsible for surgical infection

Objetivo. Establecer la frecuencia de los gérmenes anaerobios en la aparición de la infección quirúrgica. Señalar cuáles son los principales responsables de los mismos. Valorar las posibles particularidades de la infección por anaerobios en nuestro medio. Material y métodos. Se estudian un total de 4.997 especímenes quirúrgicos de 6.599 pacientes intervenidos en nuestro servicio a lo largo de 6 años. Se analizan los gérmenes responsables, se establece la frecuencia de los anaerobios, destacando los más frecuentes, y las particularidades de los mismos. Resultados. Los aislamientos de gérmenes anaerobios constituyeron el 18,6 por ciento del total de los microorganismos aislados por el laboratorio. La mayor parte de los aislamientos se obtuvieron en líquido peritoneal, seguido de muestras de abscesos y herida quirúrgica, y el carácter de los mismos fue polimicrobiano. La patología de índole isquémica, seguida de la inflamatoria, fueron las principales responsables del aislamiento de estos microorganismos. Por familias, fueron los bacilos gramnegativos los más frecuentes, seguidos a distancia por los cocos grampositivos y los bacilos grampositivos, mientras que los cocos gramnegativos presentan escasa incidencia. Los gérmenes más frecuentes fueron Bacteroides fragilis, que junto con otros bacteroides (ovatus, uniformis, tetaiotaomicron) y Prevotella melaninogenica constituyen cerca del 50 por ciento del total de los anaerobios aislados. Conclusiones. Cabe destacar el importante significado clínico que en nuestra experiencia tiene el aislamiento de estos gérmenes (bacteroides y prevotelas), tanto por su relativa alta incidencia como por la elevada tasa de resistencias antimicrobianas de alguno de estos microorganismos (AU)

Gallbladder bile tumor marker quantification for detection of pancreato-biliary malignancies.

BACKGROUND: The pre-operative differentiation of tumors of the pancreas, Papilla of Vater and the biliary tract is still unsatisfactory. Tumor marker analysis of the pancreatic juice did not improve the pre-operative diagnosis by a great deal. METHODS: Bile from resected gallbladders of patients suffering from carcinomas of the pancreato-biliary system was analysed for CA 19-9, CEA, CA 72-4, CA 125 and AFP concentrations. The results were compared to patients suffering from acute cholecystitis, cholecystolithiasis as well as those suffering from benign tumors of the pancreato-biliary region. RESULTS: Extreme high CA 19-9 concentrations were found in bile. Evaluations of the tumor-antigens CA 19-9, CA 72-4 and CEA in gallbladder bile were superior to any serum and pancreatic juice examination with respect to sensitivity and specificity. Observed sensitivities amounted to 100% for patients suffering from bile duct carcinoma (CA 19-9) and papillary carcinoma (CEA) at a specificity of 100%. CA 19-9 showed a sensitivity of 76.5% for pancreatic carcinomas at a specificity of 96.4%. CA 19-9 showed significant differences for the local tumor burden and for the degree of lymph node metastasis. Examination of tumor antigens in the gallbladder results in a high degree of discrimination for malignant and benign lesions of the subhepatic pancreato-biliary system. CONCLUSIONS: CA 19-9 must follow a entero-hepatic circulation, since it showed raised bile concentrations (factor: 10(4)) compared to serum analysis. Analysis of CA 19-9, CEA and CA 72-4 gives an opportunity for improvement in the detection of cancers of the pancreato-biliary system. Since the clinical important differentiation of tumors of the head of the pancreas (carcinoma vs. pancreatitis) remains unclear, an improvement by bile analyses must be assumed.

Acute necrotizing Meckel diverticulitis due to biliary enterolithiasis.

BACKGROUND: Acute abdominal pain due to complicated Meckel's diverticulum is an unusual event. Even the presence of biliary enterolithiasis at the onset of inflamed congenital diverticulum has rarely been reported previously. RESULTS: Despite this unusual presentation, an episode of gallstone passage through the biliary tract has not yet been described. CONCLUSIONS: Whether the stones were primarily formed in the diverticulum as enterolithiasis, or secondary to gallstone passage is discussed. The complications of Meckel's diverticulum requiring surgical treatment are reviewed, focusing on the unusual finding of biliary stones in Meckel's diverticulum and the etiogenic mechanism of enterolithiasis.

Infective complications after abdominal surgery in patients infected with human immunodeficiency virus: role of CD4+ lymphocytes in prognosis.

Risk factors associated with surgical infections are related to many events that modulate the immune system and affect the surgical procedure. The aim of this study was to determine the influence of low CD4+ lymphocyte counts in 24 patients with human immunodeficiency virus (HIV) undergoing abdominal surgery. Blood samples were obtained, and the lymphocyte population was evaluated perioperatively, as was the nutritional status of the patient. All the patients received selective antibiotic prophylaxis depending on the surgical procedure performed: (1) clean surgery: splenectomies (n = 8); (2) clean-contaminated: cholecystectomy and biliary tract surgery (n = 8); and (3) contaminated: appendectomy (n = 8). Depending on their CD4 count, two groups were formed: one with 200 to 500 cells/ml (n = 11) and the other with < 200 cells/ml (n = 13). When surgical infection was suspected, surgical drainage and microbiologic cultures were undertaken. For statistical evaluation of the groups ANOVA and the chi-square test were used; p < 0.05 was considered significant. Altogether 14 patients (58.3%) had a wound infection, and the mean (+/- SD) CD4 count in those patients was decreased (221.7 +/- 75.1) compared with that of the 10 patients in the uneventful group (386 +/- 81.2). Surgical infection rates were 50% for clean procedures, 62.5% for clean-contaminated procedures, and 62.5% for contaminated surgery. The group of patients with CD4 counts of < 200 cell/ml had an increased incidence of surgical infection, regardless of the type of surgery (p = 0.002). Thus the surgical infection rates with HIV patients undergoing abdominal surgery are dramatically increased. The CD4 and subsequently depressed neutrophil populations increase the risk of surgical infection during major procedures regardless of the type of surgery performed.

Idiopathic megacolon associated with oesophageal achalasia.

We report a rare case of achalasia coexistent with megacolon. The patient, a 25-year-old woman, presented at our hospital with a history of abdominal pain with distension, and was finally operated on for a megacolon. Five months later she presented symptoms of progressive dysphagia and heartburn. Oesophageal manometry of the upper and lower oesophageal sphincter and X-ray studies showed images compatible with achalasia. Oesophagomyotomy of the oesophagogastric junction (Heller procedure with Dor haemifundoplication technique) was performed. In the specimens taken for biopsy, neither pathology of the myenteric plexuses, nor atrophy of the muscle fibres was evident. Chagas' disease serological diagnosis for Trypanosoma cruzii, neurological disease, diabetes and all the pathological events related with neuromuscular disorders of the gastrointestinal tract proved negative. We believe that the pathological findings are related to a dysfunction of the physiological mediators of the upper and lower digestive tract motility. The present case is extraordinary and, to our knowledge, extremely rare. The association of the two pathological diseases is questionable, and the literature is reviewed.

Common biliary-pancreatic conduit stenosis induces pancreobiliary reflux.

A striking pancreatic juice reflux toward the biliary tree (PR) has frequently been found in subjects with common bile-pancreatic conduit (CBPC) and gallstone-induced acute pancreatitis (SAP). Our aim was to determine the role of the CBPC functional diameter as a potential trigger of PR. The CBPC was calibrated in three groups of patients: (A) patients with gallbladder stones using intraoperative direct cholangiometry (n = 24), (B) patients after surgical removal of common bile duct stones using postoperative cholangiometry via T-drain (n = 6), and (C) patients with SAP using the same procedures as in group B (n = 6). In all patients in groups B and C, aliquots of bile were collected and assayed for pancreatic amylase content. The mean functional diameter of the CBPC varied from 0.80 mm in patients in groups A and B to 0.47 mm in group C (p < 0.001). The bile samples of group B contained low concentrations of amylase, whereas high values could be found in all samples of group C. We conclude that PR is a frequent event occurring after bile duct revision concerning small amounts of pancreatic juice. However, CBPC functional stenosis as seen in patients with SAP obviously induces PR with high amounts of pancreatic juice.

Infective complications after minor operations in patients infected with HIV: role of CD4 lymphocytes in prognosis.

OBJECTIVE: To find out the incidence of wound infection in patients with HIV and reduced counts of CD4 lymphocytes. DESIGN: Open study. SETTING: University hospital, Spain. SUBJECTS: 70 patients with HIV infection and enlarged lymph nodes. INTERVENTIONS: Biopsy of lymph nodes and withdrawal of a sample of blood for counts of CD4 lymphocytes and neutrophils. MAIN OUTCOME MEASURE: Development of infection at the biopsy site, and correlation of infecting organism with culture taken at the time of biopsy. RESULTS: Patients were divided into three groups depending on their CD4 count: more than 500 cells/ml (n = 26), 200-500 cells/ml (n = 24), and less than 200 cells/ml (n = 20). Their neutrophil counts were 5.1, 3.8, and 2.5 x 10(9)/1, respectively. There were found four wound infections (6%); 2 were in the group with more than 500 CD4 cells/ml, and these were caused by Staphylococcus aureus (which had been grown from nodes in 6 patients at the time of biopsy). The other 2 were in the group with less than 500 cells/ml and these were caused by Mycobacterium tuberculosis; cultures of the nodes had shown Staphylococcus epidermidis (n = 3) and M tuberculosis (n = 17). There were no infections in the group with 200-500 CD4 cells/ml, in which S epidermidis (n = 5) and M tuberculosis (n = 8) had been cultured from the lymph nodes. CONCLUSIONS: The CD4 count was of no prognostic importance in the development of wound infection, but severe depression of the CD4 count may increase the risk of atypical wound infections.