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INTRODUCTION: The long-term survival and low complication rate of autogenous fistulas for hemodialysis access is often offset by early thrombosis and slow or failed maturation leading to the use of central venous catheters. A regenerative material may have the potential to overcome these limitations. A completely biological acellular vascular conduit was investigated in this first-in-human clinical study. METHODS: With approval of the ethics board and patients' informed consent, five subjects were enrolled based on predetermined inclusion criteria. Five patients underwent implant of a novel acellular, biological tissue conduit (TRUE AVC™) in the upper arm in a curved configuration between brachial artery and axillary vein. After maturation, standard dialysis was commenced through the new access. Patients were followed up to 26 weeks with ultrasound and physical exam. Serum samples were evaluated for an immune response to the novel allogeneic human tissue implant. RESULTS: This new tissue conduit handled well surgically, with properties similar to that of native human vein. Post procedure conduit flow was excellent in all cases, averaging 1098 ± 388 ml/min at week 4 and remaining stable through 1248 ± 355 ml/min at 26 weeks. Surgical site healing was normal with no edema or erythema by week 4. Six-month primary assisted patency was 80% and secondary patency was 100%. Prescribed dialysis was successfully delivered without infection, and there was no significant change in conduit diameter. Serum testing showed no increase in PRA or IgG specific to the TRUE AVC. One implant required intervention at 5 months with thrombectomy and covered stent procedure. CONCLUSION: This first-in-human 6-month study with favorable patency and low complication rate establishes the initial safety and feasibility of this novel biological tissue conduit for dialysis access in patients with end-stage kidney disease. Its mechanical durability and lack of immune response establishes TRUE AVC as a potential regenerative material for clinical use.
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A pesar de los avances en las técnicas quirúrgicas para las resecciones esofágicas en el cáncer de esófago y en los cuidados perioperatorios a los pacientes en este tipo de cirugía, los resultados continúan siendo heterogéneos y variados los procedimientos en la terapéutica quirúrgica de esta enfermedad. Se exponen las principales controversias sobre el tratamiento quirúrgico y las evidencias científicas relevantes respecto a cada caso en particular y se realiza un análisis crítico de cada una de ellas. Finalmente se presentan los resultados obtenidos por nuestros grupos de trabajo en el tratamiento de esta afección(AU)
In spite of the advances in the surgical techniques for the resections esofágicas in the esophagus cancer and in the cares perioperatorios to the patients in this surgery type, the results continue being heterogeneous and varied the procedures in the surgical therapy of this illness. The main controversies are exposed in particular on the surgical treatment and the excellent scientific evidences regarding each case and he/she is carried out a critical analysis of each one of them. Finally the results are presented obtained by our work groups in the treatment of this affection(AU)
Assuntos
Humanos , Neoplasias Esofágicas/cirurgia , Cárdia/patologia , Neoplasias GástricasRESUMO
Se presenta la estrategia ante el cáncer de esófago irresecable y se exponen los resultados en 24 enfermos con mal estado general, en los que se utilizó prótesis transtumorales, combinada en 8 casos previamente con infiltración de alcohol absoluto al tumor, sin presentar mortalidad quirúrgica y una supervivencia del 75 por ciento a los 6 meses y del 33,3 por ciento al año. Todos los enfermos tuvieron control endoscópico previo, utilizando el método de tracción en la colocación de la prótesis(AU)
The authors present the strategy used in the non-resectable esophagus cancer and show the results obtained in 24 patients with a poor general state, among whom transtumor prostheses were utilized. These prostheses were previously combined with infiltration of absolute alcohol to the tumor in 8 cases. There was no surgical mortality and it was attained a survival of 75 percent at 6 months and of 33.3 percent at a year. All patients had a previous endoscopic control. Prostheses were placed by using the traction method(AU)
Assuntos
Humanos , Masculino , Feminino , Idoso , Idoso de 80 Anos ou mais , Próteses e Implantes/efeitos adversos , Neoplasias Esofágicas/cirurgia , Neoplasias Esofágicas/diagnóstico , Cárdia/cirurgia , Etanol/uso terapêutico , Taxa de Sobrevida , Estudos ProspectivosRESUMO
Plantea el concepto de la evaluación científica de riesgo (riesgo real) versus la percepción de riesgos (riesgo aparente). Este último tiene que ver con las costumbres, cultura y mitos de cada sociedad. Sostienen los autores que si bien es cierto que la energía nuclear ha provocado en los últimos años una sensibilidad especial del público, ningún análisis serio puede dudar (ante la creciente escasez de recursos energéticos), que la energía nuclear será en las próximas décadas el principal recurso de generación de energía eléctrica. Da cifras sobre generación neta del mercado eléctrico
Assuntos
Argentina , Energia NuclearRESUMO
Plantea el concepto de la evaluación científica de riesgo (riesgo real) versus la percepción de riesgos (riesgo aparente). Este último tiene que ver con las costumbres, cultura y mitos de cada sociedad. Sostienen los autores que si bien es cierto que la energía nuclear ha provocado en los últimos años una sensibilidad especial del público, ningún análisis serio puede dudar (ante la creciente escasez de recursos energéticos), que la energía nuclear será en las próximas décadas el principal recurso de generación de energía eléctrica. Da cifras sobre generación neta del mercado eléctrico