Superparamagnetic iron oxide as a tracer for sentinel node biopsy in breast cancer: A comparative non-inferiority study.

AIMS: The gold standard for detection of Sentinel Lymph Nodes (SLN) is a combined radioisotope and blue dye breast injection, using a gamma probe (GP). A new, non-radioactive method was developed, using a tracer (Sienna+(®)) of superparamagnetic iron oxide (SPIO) nanoparticles and a manual magnetometer (SentiMag(®)) (SM). The IMAGINE study was designed to show the non-inferiority of SM compared to GP, for the detection of SLN in breast cancer patients with SLN biopsy indication. METHODS: From November 2013 to June 2014, 181 patients were recruited, and 321 nodes were excised and assessed ex-vivo. Readings from both SM and GP devices were recorded during transcutaneous, intraoperative, and ex-vivo detection attempts. RESULTS: At the patient level, ex-vivo detection rates (primary variable) with SM and GP were 97.8% and 98.3% (concordance rate 99.4%). Transcutaneous and intraoperative detection rates were 95.5% vs 97.2%, and 97.2% vs 97.8% for SM and GP respectively (concordance rates > 97%). At the node level, intraoperative and ex-vivo detection rates were 92.5% vs 89.3% and 91.0% vs 86.3% for SM and GP respectively. In all cases the non-inferiority of SM compared to SM was shown by ruling out a predefined non-inferiority margin of 5%. CONCLUSIONS: Our study showed the non-inferiority of SM as compared to GP. Moreover, the ex-vivo and intraoperative detection rates at the node level were slightly higher with SM.

Factores asociados a complicaciones, reingresos y otros episodios adversos en cirugía biliar / Factors associated with complications, readmissions and other adverse outcomes in biliary surgery

Objetivos. Describir los episodios adversos (complicaciones postoperatorias, mortalidad, reintervenciones y reingresos) tras la cirugía biliar y analizar las asociaciones entre estos resultados y determinadas características del paciente y del ingreso hospitalario. Material y métodos. Cohorte de 692 pacientes intervenidos de cirugía biliar -no oncológica- entre 1992 y 1996 en un hospital comarcal, en la que se registraron prospectivamente las complicaciones postoperatorias, las reintervenciones y otros resultados de interés, y se identificaron retrospectivamente los reingresos en el período de estudio. Además del análisis descriptivo y bivariante, se utilizó la regresión logística para valorar las asociaciones entre complicaciones y características de los pacientes, y un modelo de regresión de riesgos proporcionales respecto al riesgo de reingreso. Resultados. El 19,5 por ciento de los pacientes desarrolló alguna complicación posquirúrgica (herida: 6,9 por ciento; intraabdominales: 3,6 por ciento; insuficiencias orgánicas: 3,0 por ciento), un 0,7 por ciento fueron reintervenidos en el ingreso, un 1,4 por ciento requirieron ingreso en cuidados intensivos y el 0,6 por ciento fallecieron intrahospitalariamente. El 4,2 por ciento de los pacientes reingresaron en el servicio de cirugía, en el año siguiente a la intervención, por un problema relacionado con la cirugía previa, y un 1,7 por ciento por coledocolitiasis residual (en todo el período de seguimiento). Las complicaciones posquirúrgicas se asociaron al sexo masculino (OR: 1,69; p < 0,05), al ingreso urgente (OR: 2,09; p < 0,05), a la cirugía urgente (OR: 6,59; p < 0,05), a los procedimientos de colecistectomía abierta simple (OR: 2,56; p < 0,05) y cirugía de la vía biliar principal (OR: 3,53; p < 0,05) respecto a la colecistectomía laparoscópica. Los casos complicados duplicaron en cuanto a la estancia media a los no complicados. El reingreso relacionado con el episodio previo tan sólo se asoció con la presencia de complicaciones durante el ingreso (OR: 3,44; p < 0,001).Conclusiones. Las tasas de acontecimientos adversos en la serie analizada, similares a otras series publicadas, señalan la importancia de las complicaciones en esta enfermedad y su impacto sobre la estancia media y los reingresos. Aunque la mayor parte de los factores de riesgo identificados quedan fuera del control del cirujano, configuran un subgrupo de pacientes de alto riesgo en los que debería incrementarse la vigilancia (AU)

Seudoaneurisma esplénico, complicación del seudoquiste en la pancreatitis crónica / Splenic artery pseudoaneurysms, a complication of pseudocyst in chronic pancreatitis

La pancreatitis crónica puede complicarse en su evolución con la formación de seudoquistes pancreáticos que serán intraglandulares, a diferencia de lo que ocurre en las pancreatitis agudas; en su evolución pueden acabar provocando la erosión y destrucción de los elementos anatómicos circundantes. Entre los de mayor importancia por el riesgo vital para el paciente se encuentra la afectación de las arterias peripancreáticas. Se presenta un caso de seudoaneurisma esplénico secundario a un seudoquiste pancreático que se fistulizó al colon transverso, produciendo una hemorragia digestiva baja que obligó a una esplenopancreatectomía distal asociada a una colectomía segmentaria de urgencia. El diagnóstico se realizó mediante eco-Doppler, TAC y endoscopia. Se comenta la utilidad de las diversas opciones diagnósticas y terapéuticas existentes, en función de la urgencia, gravedad y condiciones generales del paciente, ya que esta enfermedad está gravada con una alta mortalidad (AU)

[The home treatment of deep venous thromboses with low-molecular-weight heparin]. / Tratamiento domiciliario de las trombosis venosas profundas con heparina de bajo peso molecular.

Low-molecular-weight heparins (LMWH) have shown to be at least as safe and efficient as non-fractionated heparin in the treatment of deep-vein thrombosis (DVT). Moreover, no serial laboratory controls are required. Therefore, LMWH allow the patients to be treated at home. From July 1995 to July 1996, 30 consecutive patients with DVT were enrolled in a prospective study and treated with nadroparin. Ambulatory treatment was feasible in 24 patients (9 patients did not require admission and 15 patients were discharged in less than 6 days). The main causes for admission were the inability to obtain a diagnosis, the severity of symptoms in the involved limb, and the presence of associated disease. None of the 24 patients to whom the possibility of home therapy was offered desired to remain at hospital. The ambulatory care of these patients increased the burden on primary care teams. There was no case of clinical recurrent thromboembolism nor a major hemorrhagic complication. Ambulatory treatment of DVT with nadroparin seems to be feasible, efficient and safe. Nevertheless, before using this therapeutic alternative a series of factors should be considered, which include the severity of clinical presentation, the embolic and hemorrhagic risks, and the presence of associated diseases.

[Peroperative myocardial infarction and myocardial ischemia in non cardiac surgery: prevalence and predictive factors]. / Infarto e isquemia miocárdica peroperatoria en cirugía no cardíaca: prevalencia y factores predictivos.

BACKGROUND: The decrease in the prevalence of infarction in the population has not been accompanied by a reduction in postinfarct mortality, particularly in the population segment which does not present major symptoms of coronary disease. The aim of the present study was to determine the incidence and predictive factors of cardiac complications in patients undergoing non cardiac surgery. METHODS: Eight hundred seventy-five patients undergoing elective surgery from May 1990-1991 had some of the following criteria: history of heart disease, major surgery, and medical risk other than cardiac. A sample of 328 patients was selected to whom an ECG an CK-MB isoenzyme test were performed on admission, every 8 h, and at the second and third days. Infarction or ischemia were diagnosed by electrocardiographic and enzymatic criteria. Minimum follow up was 72 hours. RESULTS: IAM was diagnosed in 10 cases (3%, confidence interval 95%, 2 to 4%) and ischemia in 47 cases (14%, CI 95%, 11 to 18%). Operative mortality of cardiac origin was 4% (CI 95%, 2 to 6%). Arrhythmia not preoperatively present was detected in 11%, hemodynamic instability in 25%, and sinusal tachycardia in 21%. Other complications were: abdominal 12%, respiratory 14%, neurologic 6% and renal 4%. The appearance of cardiac complications was related with: ASA classification (p < 0.05), previous history of heart disease (p < 0.01), cardiovascular drug administration (p < 0.01) and changes in preoperative electrocardiogram (p < 0.001). CONCLUSIONS: The present study suggests that patients with changes of the ST-T segment in the preoperative ECG should undergo examination to determine the degree of cardiac involvement. A strict peroperative hemodynamic control may reduce the prevalence of cardiac complications in those patients at high risk.