RESUMEN
BACKGROUND: Immobilizing skin microbes is a rational approach to reducing contamination of surgical sites by endogenous microorganisms. METHODS: This randomized, controlled, parallel-group, multicenter, open-label clinical trial (ClinicalTrials.gov NCT00467857) enrolled 300 adults scheduled for elective coronary artery bypass graft surgery. Patients received iodine-based skin preparations followed by a cyanoacrylate-based skin sealant or skin preparations alone. Microbiological samples collected from sternal and graft incision sites immediately before any skin preparation, at the wound border after skin incision, and at the incision after fascial closure were evaluated quantitatively. RESULTS: In evaluable patients, mean microbial counts in collected samples increased at the sternal site after fascial closure compared with after skin incision by 0.37 log10 colony-forming units (CFU)/mL in the skin sealant group (n=120) and by 0.57 log10 CFU/mL in the control group (n=132) (p=0.047, Wilcoxon rank sum test). At the graft site, mean microbial counts increased by 0.09 (n=119) and 0.27 (n=127) log10 CFU/mL, respectively (p=0.037). There was a 35.3% relative risk reduction in surgical site infection (SSI) occurring in the skin sealant group (9 of 146 patients, 6.2%) versus the control group (14 of 147 patients, 9.5%). In obese patients (body mass index [BMI]>30.0 to ≤37.0 kg/m2), the relative risk reduction for SSI associated with skin sealant was 83.3%. CONCLUSIONS: Pretreatment with skin sealant protects against contamination of the surgical incision by migration of skin microbes. Further data are needed to confirm the impact of this technology on SSI rates in clinical practice.
Asunto(s)
Puente de Arteria Coronaria , Cianoacrilatos/administración & dosificación , Esternotomía , Infección de la Herida Quirúrgica/prevención & control , Adhesivos Tisulares/administración & dosificación , Anciano , Carga Bacteriana , Ensayo de Unidades Formadoras de Colonias , Femenino , Humanos , Masculino , Persona de Mediana Edad , Piel/microbiología , Infección de la Herida Quirúrgica/microbiologíaRESUMEN
OBJETIVO: Avaliar os resultados de médio prazo do uso de homoenxertos decelularizados na Operação de Ross. MÉTODOS: Entre janeiro de 2003 e fevereiro de 2007, 68 pacientes foram submetidos à Operação de Ross com homoenxertos decelularizados. Quarenta e oito pacientes eram do sexo masculino, com idade media de 30,3±11,2 anos. A decelularização foi feita com Ácido Deoxicólico (DOA), em 35 casos, e com Dodecilsulfato de Sódio (SDS), em 33. Para a comparação dos gradientes, foram selecionados 68 pacientes pareados pela idade, e que usaram homoenxertos criopreservados. Todos os pacientes realizaram ecocardiograma antes da alta e estão sendo avaliados anualmente. Oito pacientes tiveram controle por ressonância nuclear. Em dois pacientes reoperados, foi possível fazer análise histológica de um segmento do conduto pulmonar. RESULTADOS: Houve um (1,4 por cento) óbito imediato. Na evolução tardia, houve duas reoperações e um óbito. Os gradientes imediatos variaram de 4 a 29mmHg (m=10,3±5,5), e apresentaram elevação para 16,5± 12,2mmHg (min= 4, max = 45) aos 24 meses. Quando comparados com o grupo criopreservado, não houve diferenças significativas. Entretanto, houve tendência a melhores resultados em homoenxertos decelularizados com SDS após 12 meses de evolução. A análise histológica revelou reendotelização e repovoamento parcial da camada média com células autógenas. Não houve insuficiência pulmonar progressiva. Os dados de ressonância magnética demonstraram menor tendência de retração dos condutos decelularizados. CONCLUSÕES: O uso de homoenxertos decelularizados foi seguro, com bons resultados até quatro anos de evolução. Houve tendência a menores gradientes tardios nos homoenxertos decelularizados com SDS após 12 meses.
OBJECTIVE: To evaluate the medium-term results (4 years) of decelularized allografts during Ross Operation. METHODS: From January 2003 to February 2007, 68 patients underwent Ross Operation with decelularized allografts. Forty eight were male and the mean age was 30.3±11.2 years. Decelularization was done with deoxicolic acid (DOA) in 35 cases and with sodium dodecylsulfate (SDS) in 33. For comparison of the gradients, 68 patients with cryopreserved allografts and matched for age were selected. All patients had a control echo before hospital discharge and annually thereafter. In addition, eight patients had MRI studies. In two patients, samples of the conduit wall were analyzed by histological analysis. RESULTS: There was one (1.4 percent) early death. In the late follow-up, there were two reoperations for endocarditis and one late death. The early gradients varied between 4 29 mmHg (m= 10.3± 5.5mmHg) and exhibited an increase to 16.5±12.2 mmHg (min=4, max=45) at 24 months postoperatively. There were no significant differences when compared to the cryopreserved group. There was, however, a tendency towards lesser gradients in the SDS decelularized group after 12 months. Histological analysis revealed partial reendothelization and progressive repopulation of the tunica media with autogenous cells. There was no progressive pulmonary insufficiency. The MRI results showed a lesser tendency to shrinkage in the decelularized conduits. CONCLUSIONS: The use of decelularized allografts was safe and with good medium-term results up to 4 years. There was a tendency to lower late gradients in the SDS decelularized allografts after 12 months.
Asunto(s)
Adolescente , Adulto , Niño , Femenino , Humanos , Masculino , Persona de Mediana Edad , Válvula Aórtica/cirugía , Enfermedades de las Válvulas Cardíacas/cirugía , Válvula Pulmonar , Trasplante de Tejidos/normas , Válvula Aórtica , Criopreservación , Ecocardiografía Doppler , Enfermedades de las Válvulas Cardíacas , Espectroscopía de Resonancia Magnética , Válvula Pulmonar/citología , Válvula Pulmonar/trasplante , Reoperación/estadística & datos numéricos , Dodecil Sulfato de Sodio , Factores de Tiempo , Resultado del Tratamiento , Trasplante de Tejidos/métodos , Trasplante de Tejidos/mortalidadRESUMEN
OBJECTIVE: To evaluate the medium-term results (4 years) of decellularized allografts during Ross Operation. METHODS: From January 2003 to February 2007, 68 patients underwent Ross Operation with decellularized allografts. Forty eight were male and the mean age was 30.3+/-11.2 years. Decellularization was done with deoxicolic acid (DOA) in 35 cases and with sodium dodecylsulfate (SDS) in 33. For comparison of the gradients, 68 patients with cryopreserved allografts and matched for age were selected. All patients had a control echo before hospital discharge and annually thereafter. In addition, eight patients had MRI studies. In two patients, samples of the conduit wall were analyzed by histological analysis. RESULTS: There was one (1.4%) early death. In the late follow-up, there were two reoperations for endocarditis and one late death. The early gradients varied between 4 29 mmHg (m= 10.3+/- 5.5 mmHg) and exhibited an increase to 16.5+/-12.2 mmHg (min=4, max=45) at 24 months postoperatively. There were no significant differences when compared to the cryopreserved group. There was, however, a tendency towards lesser gradients in the SDS decellularized group after 12 months. Histological analysis revealed partial reendothelization and progressive repopulation of the tunica media with autogenous cells. There was no progressive pulmonary insufficiency. The MRI results showed a lesser tendency to shrinkage in the decellularized conduits. CONCLUSIONS: The use of decellularized allografts was safe and with good medium-term results up to 4 years. There was a tendency to lower late gradients in the SDS decellularized allografts after 12 months.
Asunto(s)
Válvula Aórtica/cirugía , Enfermedades de las Válvulas Cardíacas/cirugía , Válvula Pulmonar , Trasplante de Tejidos/normas , Adolescente , Adulto , Válvula Aórtica/diagnóstico por imagen , Niño , Criopreservación , Ecocardiografía Doppler , Femenino , Enfermedades de las Válvulas Cardíacas/diagnóstico por imagen , Humanos , Espectroscopía de Resonancia Magnética , Masculino , Persona de Mediana Edad , Válvula Pulmonar/citología , Válvula Pulmonar/trasplante , Reoperación/estadística & datos numéricos , Dodecil Sulfato de Sodio , Factores de Tiempo , Trasplante de Tejidos/métodos , Trasplante de Tejidos/mortalidad , Resultado del TratamientoRESUMEN
OBJECTIVE: Compare the immunological and echocardiographic data of decellularized versus cryopreserved allografts used for RVOT reconstruction during Ross operation. METHODS: From 16/01/03 thru 07/10/03, 20 Ross operations were performed using decellularized (n=11) or cryopreserved (n=9) allografts. Echocardiography was done at discharge, 1, 3, 6 and 12 months and annually thereafter. Samples for determination of antibodies against HLA class I and II were obtained preoperatively and at days 5, 10, 30, 90 and 180 postoperatively. These samples were tested by the ELISA method in LAT-M dishes (unspecific) for identification of circulating antibodies and the results expressed as mean sample values (Is=DO/cutoff). If positive, LAT-E (specific) was performed and PRA levels determined. RESULTS: There was no mortality. Cryopreserved allografts showed marked Is values elevations for class I and II antibodies which started at the first month and remained elevated up to 6 months. In contrast, of the patients receiving decellularized allografts, seven remained negative, two patients had only marginal elevation of class I antibodies and two patients showed abnormal elevations of PRA levels. This response happened earlier than in the cryopreserved group, starting on the 5th postoperative day and has returned to baseline levels in one case. Echocardiography showed mild, but significant, elevation of gradients in cryopreserved valves but none in the decellularized. CONCLUSIONS: Decellularized allografts had normal function up to 18 months and showed important reduction of the immunogenic response when compared to cryopreserved valves.
Asunto(s)
Válvula Aórtica/cirugía , Enfermedades de las Válvulas Cardíacas/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Prótesis Valvulares Cardíacas , Adolescente , Adulto , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/fisiología , Bioprótesis , Niño , Criopreservación , Femenino , Antígenos HLA/inmunología , Enfermedades de las Válvulas Cardíacas/fisiopatología , Humanos , Isoanticuerpos/biosíntesis , Masculino , Periodo Posoperatorio , Válvula Pulmonar/inmunología , Válvula Pulmonar/patología , Válvula Pulmonar/trasplante , Ultrasonografía , Obstrucción del Flujo Ventricular Externo/cirugíaRESUMEN
This study evaluated cryopreserved homografts (Group 1) and porcine heterografts decellularized with deoxicholic acid (Group 2), implanted in the right ventricular outflow tract of juvenile sheep. Two groups with four animals in each were used and all animals survived with good outcome. Animals were sacrificed 90 or more days after surgery (90-150 days). On the third and fifth postoperative months they were submitted to echocardiographic examination with normal function and appearance observed for both groups. Explants were evaluated through histological analysis, atomic spectrophotometry and radiological examination. Calcium content was higher in the cusps of cryopreserved homografts, despite an otherwise similar macroscopic appearance between grafts of both groups. Decellularized heterografts were progressively repopulated by autologous cells suggesting some regenerative ability and longer durability than conventional homografts.
Asunto(s)
Bioprótesis , Criopreservación , Prótesis Valvulares Cardíacas , Válvula Pulmonar/cirugía , Ingeniería de Tejidos/métodos , Animales , Calcinosis/diagnóstico por imagen , Calcio/análisis , Matriz Extracelular/fisiología , Fibroblastos/metabolismo , Radiografía , Ovinos , PorcinosRESUMEN
OBJETIVO: Avaliar, comparativamente, o comportamento de homoenxertos valvares criopreservados e de heteroenxertos descelularizados implantados na via de saída do ventrículo direito de carneiros jovens, assim como relatar a experiência clínica inicial com homoenxertos descelularizados em pacientes submetidos à operação de Ross. MÉTODO: No grupo A, foram implantados quatro homoenxertos pulmonares criopreservados e no Grupo B, quatro heteroenxertos porcinos valvares descelularizados com ácido deoxicólico. Em cada grupo, dois animais foram sacrificados no 3º mês e dois no 5º mês de pós-operatório. As peças foram avaliadas macroscopicamente e por radiografias, além de exame microscópico com colorações HE, Tricrômico de Mallory e Sirius Red. A experiência clínica com quatro pacientes submetidos à operação de Ross com emprego de homoenxertos valvares descelularizados é relatada. RESULTADOS: Todos os animais sobreviveram. Os ecocardiogramas demonstraram boa função valvar nos dois grupos. Embora as cúspides valvares em ambos os grupos tivessem aspecto macroscópico normal, a mensuração de cálcio e o estudo radiológico demonstraram início de calcificação focal nos homoenxertos criopreservados, mas não nos heteroenxertos descelularizados. Esses achados foram confirmados por exames microscópicos. Os homoenxertos criopreservados demonstraram perda de sua celularidade, enquanto que os heteroenxertos descelularizados demonstraram repopulação progressiva da matriz colágena com fibroblastos, assim como reendotelização. Os quatro pacientes operados tiveram evolução pós-operatória imediata satisfatória, com função normal dos homoenxertos. CONCLUSÕES: Heteroenxertos valvares descelularizados foram progressivamente repopulados por células autógenas e exibiram mínima tendência à calcificação no modelo estudado. Esses resultados sugerem que homoenxertos descelularizados possam ter alguma capacidade regenerativa e com isso ter durabilidade superior aos homoenxertos criopreservados convencionais.