Progestogens to prevent preterm birth in twin pregnancies: an individual participant data meta-analysis of randomized trials.

BACKGROUND: Preterm birth is the principal factor contributing to adverse outcomes in multiple pregnancies. Randomized controlled trials of progestogens to prevent preterm birth in twin pregnancies have shown no clear benefits. However, individual studies have not had sufficient power to evaluate potential benefits in women at particular high risk of early delivery (for example, women with a previous preterm birth or short cervix) or to determine adverse effects for rare outcomes such as intrauterine death. METHODS/DESIGN: We propose an individual participant data meta-analysis of high quality randomized, double-blind, placebo-controlled trials of progestogen treatment in women with a twin pregnancy. The primary outcome will be adverse perinatal outcome (a composite measure of perinatal mortality and significant neonatal morbidity). Missing data will be imputed within each original study, before data of the individual studies are pooled. The effects of 17-hydroxyprogesterone caproate or vaginal progesterone treatment in women with twin pregnancies will be estimated by means of a random effects log-binomial model. Analyses will be adjusted for variables used in stratified randomization as appropriate. Pre-specified subgroup analysis will be performed to explore the effect of progestogen treatment in high-risk groups. DISCUSSION: Combining individual patient data from different randomized trials has potential to provide valuable, clinically useful information regarding the benefits and potential harms of progestogens in women with twin pregnancy overall and in relevant subgroups.

Nine-year follow up of the omnicarbon prosthesis in the aortic position.

BACKGROUND AND AIM OF THE STUDY: Clinical experience with the Omnicarbon mechanical valve implanted in the aortic position is reported in this retrospective survey. METHODS: A total of 110 patients (mean age 56 years) undergoing isolated aortic valve replacement with Omnicarbon mechanical prostheses at the authors' institution between November 1991 and October 2000 was included. Follow was available in 94.5% of patients (mean follow up 4 years per patient; total follow up was 415 patient-years (pt-yr)). RESULTS: Hospital mortality was 3.6%. There were no instances of valve thrombosis or structural failure. The incidence of valve-related complications (linearized rates in events per 100 pt-yr/actuarial freedom at 9 years, in %) was: valve-related mortality 2.4+/-0.7 / 80.3+/-8.0; non-structural failure 0.7+/-0.4 / 93.8+/-4.2; thromboembolism 0.2+/-0.2 / 99.0+/-1.0; anticoagulant-related hemorrhage 0.9+/-0.5 / 93.7+/-3.3; prosthetic valve endocarditis 0.2+/-0.2 / 99.0+/-1.0; and reoperation 0.7+/-0.4 / 93.8+/-4.2. CONCLUSION: In the authors' experience the Omnicarbon mechanical prosthesis provides a good clinical performance for up to nine years in the aortic position.

[A comparative study of the follow-up and hemodynamics in vivo of 21 mm Carpentier-Edwards supra-annular and perimount bioprostheses]. / Estudio comparativo del comportamiento clínico y hemodinámico de las bioprótesis aórticas de Carpentier-Edwards Supra-Annular y Perimount de 21 mm.

INTRODUCTION AND OBJECTIVES: Analysis and comparison of the clinical performance and hemodynamics in vivo of 21 mm Carpentier-Edwards supra-annular (CESA) and Perimount (CEPM) aortic bioprostheses. METHODS: A follow-up study was made of 40 patients implanted a 21 mm CESA (n = 21) or CEPM (n = 19) prosthesis between October 1992 and September 1997. All eligible survivors (14 CESA, 12 CEPM) were assessed echocardiographically. RESULTS: There were no significant differences between models in the effective orifice area (1.6 cm2 for CESA, 1.44 cm2 for CEPM), peak flow rate (rest: 2.5 m/s for CESA, 2.3 m/s for CEPM; post-dobutamine: 3.4 m/s for CESA, 3.3 m/s for CEPM), mean flow rate (rest: 1.7 m/s for CESA, 1.6 m/s for CEPM; post-dobutamine: 2.5 m/s for CESA, 2.2 m/s for CEPM), peak gradient (rest: 28.3 mmHg for CESA, 21.6 mmHg for CEPM; post-dobutamine: 48.4 mmHg for CESA, 41.6 mmHg for CEPM), and mean gradient (rest: 15.8 mmHg for CESA, 12.0 mmHg for CEPM; post-dobutamine: 28.5 mmHg for CESA, 22.5 mmHg for CEPM). CONCLUSION: In our experience, these two prosthetic models have similar hemodynamic characteristics in small aortic annuli.

Optimal location for temporary epicardial pacing leads following open heart surgery.

Temporary epicardial pacing wires are routinely placed in patients undergoing cardiac surgery. Eighteen suitable patients undergoing elective surgery were prospectively studied. Their sensing and stimulating characteristics were studied at various locations. Subepicardial pacing leads were applied to the lateral wall of the LV, apex of the LV, anterior wall of the RV, diaphragmatic wall of the RV, and diaphragmatic wall of the LV. Impedance, R wave amplitude, slew rate, and stimulation thresholds were measured on postoperative days 1 and 5. Impedance remained unchanged in time with no significant differences between locations. R waves and slew rates were significantly lower in the anterior RV wall. Stimulation thresholds displayed no differences on day 1, but they increased significantly in all locations on day 5. These thresholds were significantly lower in the lateral and diaphragmatic LV walls on day 5, and the rate of voltage increase was also lower in these two locations. Five patients presented phrenic nerve stimulation when stimulating the lateral LV wall. The authors advocate the diaphragmatic wall of the LV as the best location for placing temporary leads. The anterior wall of the RV is not recommended for pacing purposes.

[Improvement of anemia and quality of life of patients with prostate cancer by treatment with human recombinant erythropoietin]. / Mejora de la anemia y calidad de vida de pacientes con cáncer de próstata mediante la administración de eritropoyetina humana recombinante.

OBJECTIVES: Anemia is a frequent finding in patients with prostate cancer. Reduction of erythropoiesis caused by androgenic blockade is among its etiologies. Therefore, quality of life of these patients results decreased, being origin of significant morbidity and mortality. Recombinant forms of human erythropoietin have demonstrated their effectiveness improving quality of life of patients with various solid tumors, but specific studies in prostate cancer are a few. Our objective is to evaluate the efficacy of human recombinant erythropoietin (EPO) correcting anemia and improving the quality of life of patients with prostate cancer. METHODS: Prospective study of patients with prostate cancer under combined androgenic blockade treatment having hemoglobin levels lower than 11 g/dl. We analyze clinical characteristics and quality of life prior to EPO dispense. We used the Triple Linear Analogical Scale for patients with cancer (CLAS) to evaluate quality of life. EPO was administered during 12 weeks (10.000 units subcutaneously, three times a week). We study the evolution of different parameters compared to baseline. RESULTS: We included a total of 17 patients. Average age was 75.5 +/- 5.9 yr. Average time of neoplasia evolution was 57.6 +/- 13.9 months. Eleven patients presented active disease (PSA > 1 ng/ml). Mean initial haemoglobin level was 10.3 +/- 0.4 mg/dl, reaching 12.2 +/ - 1.0 after treatment (p < 0.001). Patients with active disease and levels of initial haemoglobin smaller than 10.2 g/dl presented worse outcomes. There were not adverse events attributable to EPO. CONCLUSIONS: We consider that the administration of EPO increases significantly the levels of haemoglobin and the quality of life of patients with prostate adenocarcinoma, being the response worse in patients with low levels of baseline haemoglobin.

[Cystocele repair with a polypropylene mesh: our experience]. / Nuestra experiencia en la reparación del cistocele con malla de polipropileno.

OBJECTIVES: To evaluate the efficacy of the polypropilene mesh shaped in a T, with a circular area (to repair the cystocele) and an anterior extension (to function as a tension free sling), for the combined treatment of cystocele and urinary incontinence. METHODS: Retrospective study including 31 female patients with cystocele, with or without urinary incontinence, undergoing mesh repair. Mean age was 62.3 yr. (range 55-72). All patients were multiparous. Number of childbirths varied between 1 and 4. Mean follow-up was 23.5 months (range 12 to 29 months). 80% had grade III cystocele and 20% grade IV. 28 patients (90.3%) presented with urinary incontinence and 3 (9.67%) urgency without incontinence. 16 patients had previously undergone hysterectomy and another 6 surgery for urinary incontinence (2 Raz and 4 Burch operations). 11 patients (33.6%) needed a combination technique in the same operation: associated vaginal hysterectomy in 4 patients and posterior mesh colporrhaphy for grade III symptomatic rectocele in 7 patients. RESULTS: No patient had prolapse recurrence, 1 patient needed clean intermittent catheterizations for 3 months, and 3 suffered de novo urgency (with good response to anticolinergic drugs). The worsening of stress urinary incontinence (SUI) in one patient was solved by suburethral sling insertion; another patient who had prolonged postoperative vaginal bleeding requiring blood transfusions and subsequent mesh erosion of the vaginal wall (she underwent re-operation to cut off the mesh). 3 patients complained of intercourse discomfort which disappeared after an average of 3 months. No other remarkable intra or postoperative complications appeared. CONCLUSIONS: The polypropilene mesh associated with a sling is an effective treatment to repair cystocele with or without SUI, although long-term studies with a greater number of patients are required to validate the technique.

Estudio comparativo del comportamiento clínico y hemodinámico de las bioprótesis aórticas de Carpentier-Edwards Supra-Annular y Perimount de 21 mm / A comparative study of the follow-up and hemodynamics in vivo of 21 mm Carpentier-Edwards Supra-Annular and Perimount bioprostheses

Introducción y objetivos. Se pretende analizar y comparar el comportamiento clínico y las características hemodinámicas in vivo de las bioprótesis aórticas de Carpentier-Edwards Supra-annular (CESA) y Perimount (CEPM) de 21 mm.Métodos. Se realizó un estudio de seguimiento clínico a todos los pacientes (n = 40) que habían recibido una prótesis aórtica CESA (n = 21) o CEPM (n = 19) de 21 mm entre octubre de 1992 y septiembre de 1997. Asimismo, se realizó un estudio ecocardiográfico, en reposo y con dobutamina, a todos los supervivientes que autorizaron la prueba y cuya prótesis resultó ser normofuncionante (CESA, n = 14; CEPM, n = 12).Resultados. No encontramos diferencias significativas entre ambos modelos en lo que se refiere a área efectiva del orificio protésico (1,6 cm2 para CESA y 1,44 cm2 para CEPM), velocidad pico (reposo: 2,5 m/s para CESA, 2,3 m/s para CEPM; posdobutamina: 3,4 m/s para CESA, 3,3 m/s para CEPM), velocidad media (reposo: 1,7 m/s para CESA, 1,6 m/s para CEPM; posdobutamina: 2,5 m/s para CESA, 2,2 m/s para CEPM), gradiente pico (reposo: 28,3 mmHg para CESA, 21,6 mmHg para CEPM; posdobutamina: 48,4 mmHg para CESA, 41,6 mmHg para CEPM) y gradiente medio (reposo: 15,8 mmHg para CESA, 12,0 mmHg para CEPM; posdobutamina: 28,5 mmHg para CESA, 22,5 mmHg para CEPM).Conclusión. En nuestra experiencia, estos dos modelos bioprotésicos muestran un comportamiento hemodinámico similar en anillos aórticos pequeños (AU)

Mejora de la anemia y calidad de vida de pacientes con cáncer de próstata mediante la administración de eritropoyetina humana recombinante / Improvement of anemia and quality of life of patients with prostate cancer by treatment with human recombinant erythropoietin

OBJETIVOS: La anemia es un hecho frecuente en pacientes con carcinoma prostático. Entre sus causas está la reducción de la eritropoyesis provocada por el propio bloqueo androgénico. La calidad de vida de estos pacientes se siente por ello mermada, siendo origen de una importante morbimortalidad. Las formas recombinantes de eritropoyetina humana han demostrado, en diversos tumores sólidos, su eficacia en la mejora de la calidad de vida de estos pacientes; pero los estudios específicos en cáncer de próstata son muy escasos. Nuestro objetivo es evaluar la eficacia de la eritropoyetina humana recombinante (EPO) en la corrección de la anemia y mejora de la calidad de vida de los pacientes con carcinoma prostático. MÉTODOS: Estudio prospectivo de pacientes con adenocarcinoma prostático sometidos a bloqueo androgénico completo, con niveles de hemoglobina inferiores a 11 g/dL. Analizamos las características clínicas y calidad de vida previas a la administración de la EPO. Para evaluar la calidad de vida utilizamos la Triple Escala Analógica Lineal para pacientes con Cáncer (CLAS). Administramos EPO durante 12 semanas (10.000 Unidades, vía subcutánea, 3 veces por semana). Comparamos la evolución de los distintos parámetros analizados, respecto de la visita basal. RESULTADOS: Incluimos un total de 17 pacientes. La edad media fue de 75,5 +/- 5,9 años. El tiempo medio de evolución de la neoplasia ha sido de 57,6 +/- 13,9 meses. Presentaban enfermedad activa (PSA > 1 ng/mL) 11 pacientes. El nivel medio de hemoglobina (Hb) inicial fue de 10,3 +/- 0,4 mg/dL, alcanzando los 12,2 +/- 1,0 tras el tratamiento (p<0,001). En cuanto a la calidad de vida, pasamos de una puntuación inicial media de 6,5 +/- 2,2 a 14,4 +/- 3,3 (p<0,001). Presentaron peor respuesta aquellos pacientes con enfermedad activa y niveles de Hb inicial menores a 10,2 g/dL. No aparecieron efectos secundarios atribuibles a la EPO.CONCLUSIONES: Consideramos que la administración de EPO incrementa de forma significativa los niveles de hemoglobina y la calidad de vida de los pacientes con adenocarcinoma de próstata, presentando peor respuesta cuanto menor es el nivel de Hb inicial (AU)