RESUMEN
OBJECTIVE: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). METHODS: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure. RESULTS: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days. CONCLUSION: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.
OBJETIVO: Relatar o plano de análise estatística (primeira versão) para o estudo Balanced Solutions versus Saline in Intensive Care Study (BaSICS). MÉTODOS: O estudo BaSICS é um ensaio multicêntrico fatorial e randomizado que avaliará os efeitos da administração dos fluidos Plasma-Lyte 148 em comparação com solução salina 0,9% como fluido de escolha em pacientes críticos, assim como os efeitos de uma velocidade de infusão lenta (333mL/hora) em comparação com uma velocidade de infusão rápida (999mL/hora) durante desafios com volume, em importantes desfechos do paciente. O tipo de fluido será mantido cego para os investigadores, pacientes e nas análises. Não será possível, entretanto, ocultar dos investigadores a velocidade de infusão, mas os procedimentos de análise serão mantidos cegos quanto a esse aspecto. RESULTADOS: O estudo BaSICS terá como parâmetro primário a mortalidade em 90 dias, que será testada com utilização de modelos de risco proporcional de Cox de efeitos mistos, considerando os centros de estudo como variável randômica (modelos de fragilidade) ajustada por idade, disfunção de órgãos e tipo de admissão. Os parâmetros secundários importantes incluem terapia de substituição renal até 90 dias, insuficiência renal aguda, disfunção de órgãos nos dias 3 e 7 e dias sem ventilação mecânica em 28 dias. CONCLUSÃO: Este artigo fornece detalhes referentes à primeira versão do plano de análise estatística para o estudo BaSICS e orientará a análise do estudo após a conclusão do seguimento.
Asunto(s)
Cuidados Críticos , Solución Salina , Enfermedad Crítica , Humanos , Terapia de Reemplazo Renal , Respiración ArtificialRESUMEN
RESUMO Objetivo: Relatar o plano de análise estatística (primeira versão) para o estudo Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Métodos: O estudo BaSICS é um ensaio multicêntrico fatorial e randomizado que avaliará os efeitos da administração dos fluidos Plasma-Lyte 148 em comparação com solução salina 0,9% como fluido de escolha em pacientes críticos, assim como os efeitos de uma velocidade de infusão lenta (333mL/hora) em comparação com uma velocidade de infusão rápida (999mL/hora) durante desafios com volume, em importantes desfechos do paciente. O tipo de fluido será mantido cego para os investigadores, pacientes e nas análises. Não será possível, entretanto, ocultar dos investigadores a velocidade de infusão, mas os procedimentos de análise serão mantidos cegos quanto a esse aspecto. Resultados: O estudo BaSICS terá como parâmetro primário a mortalidade em 90 dias, que será testada com utilização de modelos de risco proporcional de Cox de efeitos mistos, considerando os centros de estudo como variável randômica (modelos de fragilidade) ajustada por idade, disfunção de órgãos e tipo de admissão. Os parâmetros secundários importantes incluem terapia de substituição renal até 90 dias, insuficiência renal aguda, disfunção de órgãos nos dias 3 e 7 e dias sem ventilação mecânica em 28 dias. Conclusão: Este artigo fornece detalhes referentes à primeira versão do plano de análise estatística para o estudo BaSICS e orientará a análise do estudo após a conclusão do seguimento.
Abstract Objective: To report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS). Methods: BaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure. Results: BaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days. Conclusion: This manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.
Asunto(s)
Humanos , Cuidados Críticos , Solución Salina , Respiración Artificial , Enfermedad Crítica , Terapia de Reemplazo RenalRESUMEN
AbstractIntroduction:Mitral valve repair is the treatment of choice to correct mitral insufficiency, although the literature related to mitral valve annulus behavior after mitral repair without use of prosthetic rings is scarce.Objective:To analyze mitral annulus morphology and function using real time tridimensional echocardiography in individuals submitted to mitral valve repair with Double Teflon technique.Methods:Fourteen patients with mitral valve insufficiency secondary to mixomatous degeneration that were submitted to mitral valve repair with the Double Teflon technique were included. Thirteen patients were in FC III/IV. Patients were evaluated in preoperative period, immediate postoperative period, 6 months and 1 year after mitral repair. Statistical analysis was made by repeated measures ANOVA test and was considered statistically significant P<0.05.Results:There were no deaths, reoperation due to valve dysfunction, thromboembolism or endocarditis during the study. Posterior mitral annulus demonstrated a significant reduction in immediate postoperative period (P<0.001), remaining stable during the study, and presents a mean of reduction of 25.8% comparing with preoperative period. There was a significant reduction in anteroposterior and mediolateral diameters in the immediate postoperative period (P<0.001), although there was a significant increase in mediolateral diameter between immediate postoperative period and 1 year. There was no difference in mitral internal area variation over the cardiac cycle during the study.Conclusion:Segmentar annuloplasty reduced the posterior component of mitral annulus, which remained stable in a 1-year-period. The variation in mitral annulus area during cardiac cycle remained stable during the study.
ResumoIntrodução:A plastia valvar mitral é o tratamento de escolha para a insuficiência mitral, porém, a literatura é escassa em relação ao comportamento do anel mitral após a plástica mitral sem utilização de anéis protéticos.Objetivo:Realizar a análise morfofuncional do anel mitral de indivíduos submetidos à plastia valvar mitral pela Técnica de Duplo Teflon, sem utilização de anel protético, por meio da ecocardiografia tridimensional em tempo real.Métodos:Foram incluídos 14 pacientes com insuficiência mitral mixomatosa submetidos à plástica mitral pela técnica de Duplo Teflon. Treze pacientes encontravam-se em classe III/IV. Os pacientes foram avaliados nos períodos pré-operatório, pós-operatório imediato, 6 meses e 1 ano. Foi utilizado teste de análise de variância de medidas repetidas para o estudo estatístico, sendo considerado estatisticamente significante P<0,05.Resultados:Não houve óbito, reoperação por disfunção valvar, tromboembolismo ou endocardite durante o estudo. A planimetria posterior do anel mitral demostrou uma redução significativa (P<0,001) no pós-operatório imediato, que se manteve estável durante o estudo, apresentando redução média de 25,8% com 1 ano em relação ao pré-operatório. Houve uma redução significativa dos diâmetros ântero-posterior e médio-lateral no pós-operatório imediato (P<0,001), porém, houve um aumento significativo no diâmetro médio-lateral entre pós-operatório imediato e 1 ano. Não houve diferença na variação da área interna mitral ao longo do estudo.Conclusão:A anuloplastia segmentar reduziu significativamente o componente posterior do anel mitral, permanecendo estável no período de um ano. A variação da área valvar durante o ciclo cardíaco permaneceu estável durante o estudo.
Asunto(s)
Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Ecocardiografía Tridimensional/métodos , Anuloplastia de la Válvula Mitral/métodos , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral , Análisis de Varianza , Fibrilación Atrial/fisiopatología , Implantación de Prótesis de Válvulas Cardíacas/métodos , Ilustración Médica , Válvula Mitral/patología , Tamaño de los Órganos , Periodo Perioperatorio , Valores de Referencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
INTRODUCTION: Mitral valve repair is the treatment of choice to correct mitral insufficiency, although the literature related to mitral valve annulus behavior after mitral repair without use of prosthetic rings is scarce. OBJECTIVE: To analyze mitral annulus morphology and function using real time tridimensional echocardiography in individuals submitted to mitral valve repair with Double Teflon technique. METHODS: Fourteen patients with mitral valve insufficiency secondary to mixomatous degeneration that were submitted to mitral valve repair with the Double Teflon technique were included. Thirteen patients were in FC III/IV. Patients were evaluated in preoperative period, immediate postoperative period, 6 months and 1 year after mitral repair. Statistical analysis was made by repeated measures ANOVA test and was considered statistically significant P<0.05. RESULTS: There were no deaths, reoperation due to valve dysfunction, thromboembolism or endocarditis during the study. Posterior mitral annulus demonstrated a significant reduction in immediate postoperative period (P<0.001), remaining stable during the study, and presents a mean of reduction of 25.8% comparing with preoperative period. There was a significant reduction in anteroposterior and mediolateral diameters in the immediate postoperative period (P<0.001), although there was a significant increase in mediolateral diameter between immediate postoperative period and 1 year. There was no difference in mitral internal area variation over the cardiac cycle during the study. CONCLUSION: Segmentar annuloplasty reduced the posterior component of mitral annulus, which remained stable in a 1-year-period. The variation in mitral annulus area during cardiac cycle remained stable during the study.
Asunto(s)
Ecocardiografía Tridimensional/métodos , Anuloplastia de la Válvula Mitral/métodos , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/diagnóstico por imagen , Adulto , Anciano , Análisis de Varianza , Fibrilación Atrial/fisiopatología , Femenino , Implantación de Prótesis de Válvulas Cardíacas/métodos , Humanos , Masculino , Ilustración Médica , Persona de Mediana Edad , Válvula Mitral/patología , Tamaño de los Órganos , Periodo Perioperatorio , Valores de Referencia , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Off-pump coronary bypass grafting (OPCAB) has become a widely used technique. Coronary flowmetry is the most common method employed to assess graft patency, nevertheless, few studies compare flow patterns between ONCAB and OPCAB surgery. The objective of this study was to compare flowmetry data in left internal mammary artery grafts bypasses to the left anterior descendent artery. METHODS: From March to September of 2010, thirtyfive consecutive, non-randomized patients underwent CABG and were retrospectively evaluated. Ten patients were located on group A (On Pump), and twenty-five on group B (Off Pump). The mean graft flow (MGF), pulsatile index (PI) and diastolic filling (DF) were obtained using Transit Time Flowmetry (TTFM). The Fisher exact test, and Mann Whitney test were used, and a P value of < 0.05 was considered to indicate statistical significance. RESULTS: There were no deaths, AMI, re-interventions or PTCA in a 30-day period. The number of bypasses performed per patient was 2.3 ± 0.8 in the OPCAB group, and 2.2 ± 0.6 in the ONCAB group, with no significant difference (P=0.10). The median of mean flow was 23 ml/min on group A, and 25 ml/min on group B (P=0.34). Diastolic filling percentage was 56% on group A, and 56.9% on group B (P=0.86). Pulsatile Index was 2.3 on group A, and 2.2 on group B (P=0.82). CONCLUSIONS: There was no difference between TTFM values (MF, PI and DF) in patients operated with or without cardiopulmonary bypass.
Asunto(s)
Puente de Arteria Coronaria/métodos , Circulación Extracorporea/métodos , Arterias Mamarias/fisiología , Reología/métodos , Anciano , Puente de Arteria Coronaria Off-Pump/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Flujo Pulsátil , Estudios Retrospectivos , Estadísticas no Paramétricas , Factores de TiempoRESUMEN
INTRODUÇÃO: A cirurgia de revascularização do miocárdio (RM) sem circulação extracorpórea (CEC) é uma técnica amplamente utilizada. A fluxometria coronariana é a técnica mais usada para avaliação dos enxertos, porém, poucos estudos comparam os dados fluxométricos na RM com e sem CEC. O objetivo deste estudo foi comparar as variáveis fluxométricas dos enxertos de artéria torácica interna esquerda para a artéria descendente anterior em pacientes submetidos à RM com e sem CEC. MÉTODOS: Entre março e setembro de 2010, foram analisados retrospectivamente 35 pacientes consecutivos, não randomizados, submetidos à RM. Foram alocados 10 pacientes no grupo A (com CEC) e 25 no grupo B (sem CEC). O fluxo médio do enxerto (FME), o índice pulsátil (PI) e a porcentagem de enchimento diastólico (ED) foram obtidos por meio da fluxometria por tempo de trânsito. Foi utilizado o teste exato de Fisher e Mann-Whitney, sendo considerado estatisticamente significante P<0,05. RESULTADOS: Não houve óbito, infarto agudo do miocárdio ou necessidade de angioplastia em 30 dias de pós-operatório. O número médio de anastomoses distais foi 2,3 ± 0,8 por paciente no grupo sem CEC, e de 2,2 ± 0,6 no grupo com CEC (P=0,10). A mediana do fluxo médio do enxerto foi 23 ml/min, no grupo A, e 25 ml/min, no grupo B (P=0,34). A percentagem de enchimento diastólico foi 56%, no grupo A, e 59,5%, no grupo B (P=0,86). O índice pulsátil foi 2,3, no grupo A, e 2,2, no grupo B (P=0,82). CONCLUSÃO: Não houve diferença nos parâmetros fluxométricos (FME, ED e PI) encontrados nos pacientes submetidos à revascularização do miocárdio com e sem CEC.
BACKGROUND: Off-pump coronary bypass grafting (OPCAB) has become a widely used technique. Coronary flowmetry is the most common method employed to assess graft patency, nevertheless, few studies compare flow patterns between ONCAB and OPCAB surgery. The objective of this study was to compare flowmetry data in left internal mammary artery grafts bypasses to the left anterior descendent artery. METHODS: From March to September of 2010, thirtyfive consecutive, non-randomized patients underwent CABG and were retrospectively evaluated. Ten patients were located on group A (On Pump), and twenty-five on group B (Off Pump). The mean graft flow (MGF), pulsatile index (PI) and diastolic filling (DF) were obtained using Transit Time Flowmetry (TTFM). The Fisher exact test, and Mann Whitney test were used, and a P value of < 0.05 was considered to indicate statistical significance. RESULTS: There were no deaths, AMI, re-interventions or PTCA in a 30-day period. The number of bypasses performed per patient was 2.3 ± 0.8 in the OPCAB group, and 2.2 ± 0.6 in the ONCAB group, with no significant difference (P=0.10). The median of mean flow was 23 ml/min on group A, and 25 ml/min on group B (P=0.34). Diastolic filling percentage was 56% on group A, and 56.9% on group B (P=0.86). Pulsatile Index was 2.3 on group A, and 2.2 on group B (P=0.82). CONCLUSIONS: There was no difference between TTFM values (MF, PI and DF) in patients operated with or without cardiopulmonary bypass.
Asunto(s)
Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Puente de Arteria Coronaria/métodos , Circulación Extracorporea/métodos , Arterias Mamarias/fisiología , Reología/métodos , Puente de Arteria Coronaria Off-Pump/métodos , Flujo Pulsátil , Estudios Retrospectivos , Estadísticas no Paramétricas , Factores de TiempoRESUMEN
INTRODUÇÃO: A plastia valvar mitral é o tratamento de escolha para a insuficiência mitral, porém a literatura é escassa em relação ao comportamento do átrio e ventrículo esquerdos após a plastia mitral sem utilização de anéis protéticos. OBJETIVO: Analisar a morfologia e a função cardíaca de indivíduos submetidos à plastia valvar mitral pela técnica de Duplo Teflon, por meio da ecocardiografia tridimensional. MÉTODOS: Foram incluídos 14 pacientes com insuficiência mitral mixomatosa, submetidos à plastia mitral pela técnica de Duplo Teflon. Treze pacientes encontravam-se em classe III/IV. Os pacientes foram avaliados nos períodos pré-operatório, pós-operatório imediato (POI), 6 meses e 1 ano após a plastia mitral. Foi utilizado teste de análise de variância de medidas repetidas para o estudo estatístico, sendo considerado estatisticamente significante P<0,05. RESULTADOS: A análise dos volumes sistólicos, atrial e ventricular demonstrou redução volumétrica significativa entre POI e 1 ano (P=0,028 e P=0,020, respectivamente). Entre o pré-operatório e 1 ano, houve redução média de 19,9 por cento e 15,4 por cento nos volumes atrial e ventricular, respectivamente. Os volumes diastólicos atrial e ventricular apresentaram redução significativa no POI (P<0,001 e P=0,024, respectivamente), permanecendo estáveis ao longo do estudo. Houve aumento na fração de ejeção do átrio esquerdo após 6 meses (P<0,001), porém não houve variação na função ventricular esquerda. CONCLUSÕES: Os pacientes submetidos à plastia valvar mitral por meio da técnica de Duplo Teflon apresentaram remodelamento reverso do átrio esquerdo e do ventrículo esquerdo. Esta redução nos volumes cavitários esteve associada à melhora da função atrial esquerda durante o estudo.
INTRODUCTION: Mitral valve repair is the treatment of choice to correct mitral insufficiency. Although the literature related to left atrial and ventricular behavior after mitral repair without use of prosthetic rings is scarce. OBJECTIVE: To analyze cardiac morphology and function using real time tridimensional echocardiography in individuals submitted to mitral valve repair with Double Teflon technique. METHODS: Were included 14 patients with mixomatous mitral valve insufficiency that were submitted to mitral valve repair with the Double Teflon technique. Of them, 13 patients were in class III/IV. Patients were evaluated in preoperative period, immediate postoperative period, 6 months and 1 year after mitral repair. Statistic analysis was made by repeated measures ANOVA test and was considered statistically significant P < 0.05. RESULTS: The analysis of systolic volumes, atrial and ventricular, demonstrated a significant volumetric reduction between immediate postoperative period and 1 year (P=0.028 and P=0.020, respectively). Between preoperative period and 1 year, there was a mean reduction in atrial and ventricle volumes of 19.9 percent and 15.4 percent, respectively. Atrial and ventricle diastolic volumes presented a significant reduction in immediate postoperative period (P <0.001 and P =0.024, respectively), remaining stable during the study. There was an increase in left atrial ejection fraction after 6 months (P<0.001), although there was no significant variation in left ventricle ejection fraction. CONCLUSIONS: Patients submitted to mitral valve repair by the Double Teflon technique demonstrated a left atrial and ventricle reverse remodeling. These reductions were associated with an improvement in left atrial function during the study.
Asunto(s)
Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Función del Atrio Izquierdo/fisiología , Válvula Mitral/cirugía , Función Ventricular Izquierda/fisiología , Remodelación Ventricular/fisiología , Análisis de Varianza , Ecocardiografía Tridimensional , Atrios Cardíacos , Ventrículos Cardíacos , Periodo Posoperatorio , Periodo PreoperatorioRESUMEN
INTRODUCTION: The right anterolateral thoracotomy is an alternative technique for surgical approach of mitral valve. In these cases, femoral-femoral bypass still has been used, rising occurrence of complications related to femoral cannulation. OBJECTIVE: Describe the technique and results of mitral valve treatment by right anterolateral thoracotomy using aortic cannulation for cardiac pulmonary bypass (CPB). METHODS: From 1983 e 2008, 100 consecutive female patients, with average age 35 ±13 years, 96 (96%) underwent mitral valve surgical treatment in the Heart Institute of São Paulo. A right anterolateral thoracotomy approach associated with aortic cannulation was used for CPB. Eighty (80%) patients had rheumatic disease and 84 (84%) patients presented functional class III or IV. RESULTS: Were performed 45 (45%) comissurotomies, 38 (38%) valve repairs, 7(7%) mitral valve replacements, seven (7%) recomissurotomies and three (3%) prosthesis replacement. Sparing surgery was performed in 90 (90%) patients. The average CPB and clamp time were 57 ± 27 min e 39 ± 19 min, respectively. There were no in-hospital death, reoperation due to bleeding and convertion to sternotomy. Introperative complications were related to heart harvest (5%), especially in reoperations (3%). The most important complications in postoperative period were related to pulmonary system (11%), followed by atrial fibrilation (10%) but without major systemic repercussions. The mean inhospital length of stay was 8 ± 3 days. Follow-up was 6.038 patients/month. Actuarial survival was 98.0 ± 1.9% and freedom from reoperation was 81.4 ± 7.8% in 180 months. CONCLUSION: The right anterolateral thoracotomy associated with aortic cannulation in mitral valve surgery is a simple technique, reproducible and safety.
Asunto(s)
Cateterismo Cardíaco/métodos , Puente de Arteria Coronaria/métodos , Insuficiencia de la Válvula Mitral/cirugía , Toracotomía/métodos , Adulto , Cateterismo Cardíaco/efectos adversos , Puente de Arteria Coronaria/efectos adversos , Circulación Extracorporea , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación , Masculino , Índice de Severidad de la Enfermedad , Toracotomía/efectos adversosRESUMEN
INTRODUÇÃO: A toracotomia ântero-lateral direita tem sido utilizada como uma alternativa para a abordagem cirúrgica da valva mitral. Nestes casos, a canulação femoral continua sendo utilizada, possibilitando a ocorrência de complicações. OBJETIVO: Descrever a técnica e os resultados do tratamento da valva mitral via toracotomia ântero-lateral direita, utilizando a canulação aórtica para instalação da circulação extracorpórea. MÉTODOS: Entre 1983 e 2008, 100 pacientes consecutivos, com média de idade 35 13 anos, 96 (96 por cento) do sexo feminino, foram submetidos ao tratamento cirúrgico da valva mitral no InCor-HC-FMUSP, através da toracotomia ântero-lateral direita associada à canulação aórtica. Destes, 80 (80 por cento) pacientes apresentavam etiologia reumática e 84 (84 por cento) classe funcional III ou IV. RESULTADOS: Foram realizadas 45 (45 por cento) comissurotomias, 38 (38 por cento) plásticas, sete (7 por cento) substituições da valva mitral, sete (7 por cento) re-comissurotomias e três (3 por cento) substituição de prótese mitral. Cirurgia conservadora foi realizada em 90 (90 por cento) dos pacientes. O tempo médio de CEC e pinçamento foi 57 27 min e 39 19 min, respectivamente. Não ocorreram óbitos hospitalares, reoperações por sangramento ou conversão para esternotomia. Complicações intraoperatórias foram relacionadas à dissecção cardíaca (5 por cento), principalmente nas reoperações (3 por cento). As principais complicações pós-operatórias foram relacionadas ao sistema pulmonar (11 por cento), seguidas de fibrilação atrial (10 por cento), porém sem repercussões sistêmicas graves. A média de internação hospitalar foi de 8 3 dias. O seguimento foi 6.038 pacientes/mês. A sobrevida atuarial e livre de reoperação foi de 98,0 ± 1,9 por cento e 81,4 ± 7,8 por cento em 180 meses, respectivamente. CONCLUSÃO: A utilização da toracotomia ântero-lateral direita associada a canulação aórtica na abordagem cirúrgica da valva mitral é uma técnica simples, reprodutível e segura.
INTRODUCTION: The right anterolateral thoracotomy is an alternative technique for surgical approach of mitral valve. In these cases, femoral-femoral bypass still has been used, rising occurrence of complications related to femoral cannulation. Objective: Describe the technique and results of mitral valve treatment by right anterolateral thoracotomy using aortic cannulation for cardiac pulmonary bypass (CPB). METHODS: From 1983 e 2008, 100 consecutive female patients, with average age 35 ±13 years, 96 (96 percent) underwent mitral valve surgical treatment in the Heart Institute of São Paulo. A right anterolateral thoracotomy approach associated with aortic cannulation was used for CPB. Eighty (80 percent) patients had rheumatic disease and 84 (84 percent) patients presented functional class III or IV. RESULTS: Were performed 45 (45 percent) comissurotomies, 38 (38 percent) valve repairs, 7(7 percent) mitral valve replacements, seven (7 percent) recomissurotomies and three (3 percent) prosthesis replacement. Sparing surgery was performed in 90 (90 percent) patients. The average CPB and clamp time were 57 ± 27 min e 39 ± 19 min, respectively. There were no in-hospital death, reoperation due to bleeding and convertion to sternotomy. Introperative complications were related to heart harvest (5 percent), especially in reoperations (3 percent). The most important complications in postoperative period were related to pulmonary system (11 percent), followed by atrial fibrilation (10 percent) but without major systemic repercussions. The mean inhospital length of stay was 8 ± 3 days. Follow-up was 6.038 patients/month. Actuarial survival was 98.0 ± 1.9 percent and freedom from reoperation was 81.4 ± 7.8 percent in 180 months. CONCLUSION: The right anterolateral thoracotomy associated with aortic cannulation in mitral valve surgery is a simple technique, reproducible and safety.
Asunto(s)
Adulto , Femenino , Humanos , Masculino , Puente de Arteria Coronaria/métodos , Cateterismo Cardíaco/métodos , Insuficiencia de la Válvula Mitral/cirugía , Toracotomía/métodos , Puente de Arteria Coronaria/efectos adversos , Circulación Extracorporea , Estudios de Seguimiento , Cateterismo Cardíaco/efectos adversos , Tiempo de Internación , Índice de Severidad de la Enfermedad , Toracotomía/efectos adversosRESUMEN
INTRODUCTION: Mitral valve repair is the treatment of choice to correct mitral insufficiency. Although the literature related to left atrial and ventricular behavior after mitral repair without use of prosthetic rings is scarce. OBJECTIVE: To analyze cardiac morphology and function using real time tridimensional echocardiography in individuals submitted to mitral valve repair with Double Teflon technique. METHODS: Were included 14 patients with mixomatous mitral valve insufficiency that were submitted to mitral valve repair with the Double Teflon technique. Of them, 13 patients were in class III/IV. Patients were evaluated in preoperative period, immediate postoperative period, 6 months and 1 year after mitral repair. Statistic analysis was made by repeated measures ANOVA test and was considered statistically significant P <0.05. RESULTS: The analysis of systolic volumes, atrial and ventricular, demonstrated a significant volumetric reduction between immediate postoperative period and 1 year (P = 0.028 and P = 0.020, respectively). Between preoperative period and 1 year, there was a mean reduction in atrial and ventricle volumes of 19.9% and 15.4%, respectively. Atrial and ventricle diastolic volumes presented a significant reduction in immediate postoperative period (P <0.001 and P = 0.024, respectively), remaining stable during the study. There was an increase in left atrial ejection fraction after 6 months (P <0.001), although there was no significant variation in left ventricle ejection fraction. CONCLUSIONS: Patients submitted to mitral valve repair by the Double Teflon technique demonstrated a left atrial and ventricle reverse remodeling. These reductions were associated with an improvement in left atrial function during the study.
Asunto(s)
Función del Atrio Izquierdo/fisiología , Válvula Mitral/cirugía , Función Ventricular Izquierda/fisiología , Remodelación Ventricular/fisiología , Adulto , Anciano , Análisis de Varianza , Ecocardiografía Tridimensional , Femenino , Atrios Cardíacos/diagnóstico por imagen , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Masculino , Persona de Mediana Edad , Periodo Posoperatorio , Periodo PreoperatorioRESUMEN
INTRODUÇÃO: A plastia valvar mitral é o tratamento de escolha para a correção da insuficiência mitral mixomatosa. Estudos ecocardiográficos tridimensionais demonstram que a plastia mitral com implante de anéis protéticos altera a morfologia e a função do anel valvar mitral, porém a literatura é escassa em relação ao comportamento do anel mitral após a plastia mitral sem utilização de anéis protéticos. OBJETIVO: Analisar a morfologia e a função cardíaca de indivíduos submetidos à plastia valvar mitral pela técnica de Duplo Teflon, através da ecocardiografia tridimensional em tempo real. CASUÍSTICA: Foram incluídos 14 pacientes portadores de insuficiência mitral secundária a degeneração mixomatosa, que foram submetidos à plastia valvar mitral pela técnica de Duplo Teflon. Destes, 10 pacientes eram do sexo masculino e a idade média foi de 61,3 ± 11,2 anos. Em relação à classe funcional, 13 pacientes encontravam-se em classe III ou IV no período pré-operatório. Na análise ecocardiográfica pré-operatória, o valor médio do volume diastólico final do ventrículo esquerdo foi 156,57 ± 46,61ml, e a fração de ejeção do ventrículo esquerdo variou de 38 a 68%, com média de 57,93 ± 6,67%. O valor médio do anel mitral posterior foi 6,97 ± 0,13 cm. MÉTODOS: Os pacientes foram avaliados nos períodos pré-operatório, pós-operatório imediato (POI), 6 meses e 1 ano após a plastia mitral. A ecocardiografia tridimensional avaliou a morfologia do anel mitral através das medidas do anel anterior e posterior, dos diâmetros transversos e da área valvar. A função anular foi avaliada pela relação entre as áreas valvares internas durante a sístole e diástole. Foram avaliados os volumes e a função do átrio e do ventrículo esquerdos. Foi utilizado teste de análise de variância de medidas repetidas para o estudo estatístico, sendo considerado estatisticamente significante p < 0,05. RESULTADOS: O anel mitral posterior demonstrou uma redução significativa (p<0,001) no POI, que manteve-se...
INTRODUCTION: Mitral valve repair is the treatment of choice to correct mixomatous mitral insufficiency. Tridimensional echocardiography studies demonstrate that mitral repair using prosthetic ring implant modifies mitral valve annulus morphology and function, although the literature related to mitral valve annulus behavior after mitral repair without use of prosthetic rings is scarce. OBJECTIVE: Analyze cardiac morphology and function using real time tridimensional echocardiography in individuals submitted to mitral valve repair with Double Teflon technique. CASUISTIC: Were included 14 patients with mitral valve insufficiency secondary to mixomatous degeneration that were submitted to mitral valve repair with the Double Teflon technique. Of them, 10 patients were male and the mean age was 61.3 ± 11.2 years. According to preoperatively functional class, 13 patients were in class III or IV. In preoperative echocardiographic analysis, the mean value of left ventricle end diastolic volume was 156.57 ± 46.61ml, and the left ventricle ejection fraction ranged between 38 and 68%, with average of 57.93 ± 6.67%. The mean value of the posterior annulus was 6.97 ± 0.13 cm. METHODS: Patients were evaluated in preoperative period, immediate postoperative period, 6 months and 1 year after mitral repair. Tridimensional echocardiography evaluated mitral annulus morphology by anterior and posterior measurements, transverse diameters and valve area. The annular function was evaluated through the ratio between internal valve areas during systole and diastole. Were evaluated left atrial and ventricle volumes and function. Statistic analysis was made by repeated measures ANOVA test and was considered statistically significant p < 0.05. RESULTS: Posterior mitral annulus demonstrated a significant reduction in immediate postoperative period (p<0.001), remaining stable during the study. There was no significant variation in valve area during the study. There was a significant...
Asunto(s)
Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Ecocardiografía Tridimensional , Válvula Mitral , Insuficiencia de la Válvula Mitral , Prolapso de la Válvula Mitral , Procedimientos de Cirugía Plástica/métodosRESUMEN
Objetivo: A plástica da valva mitral em pacientes reumáticos permanece um desafio. O objetivo deste estudo é analisar a técnica e os resultados da plástica da valva mitral em pacientes com insuficiência mitral reumática. Métodos: Foram analisados, retrospectivamente, 330 pacientes portadores de insuficiência mitral reumática submetidos à plástica da valva mitral no Instituto do Coração do HC-FMUSP, entre 1985 e 2005. A idade média foi de 26,9 ± 15,4 anos e 57,6 por cento dos pacientes eram do sexo feminino. No pré-operatório, 39,5 por cento dos pacientes estavam em classe funcional IV. As técnicas de plástica mais comumente utilizadas foram a anuloplastia posterior com tira de pericárdio bovino em 48,4 por cento dos pacientes e a anuloplastia com anel de Carpentier em 22,6 por cento. As técnicas associadas foram empregadas em 55,2 por cento dos pacientes, sendo as mais comuns: encurtamento de cordas (20 por cento) e papilarotomias múltiplas (17,8 por cento). Plástica da valva tricúspide (26,7 por cento) e substituição da valva aórtica (27,2 por cento) foram os procedimentos associados mais frequentes. Resultados: A mortalidade hospitalar foi 0,9 por cento (três pacientes), sendo dois deles crianças em atividade reumática. As taxas linearizadas de tromboembolismo, endocardite, reoperação e óbito tardio foram de 0,2 por cento, 0,2 por cento, 3,5 por cento e 0,5 por cento pacientes-ano, respectivamente. A sobrevida actuarial foi de 86,4 ± 6,6 por cento em 20 anos. A curva livre de reoperação foi de 30,3 ± 11,1 por cento em 20 anos. Conclusões: A plástica da valva mitral em pacientes reumáticos é uma técnica factível na correção da insuficiência mitral, com baixa mortalidade operatória.
Objective: Mitral valve repair in rheumatic patients is still a challenge. The purpose of this study is to analyze the results of mitral valve repair in rheumatic patients in the Heart Institute University of Sao Paulo Medical School. Methods: Were analyzed retrospectively, between 1985 and 2005, 330 patients submitted to mitral valve repair in the Heart Institute of São Paulo. The mean age was 26.9 ± 15.4 years and 57.6 percent were female. According do clinical evaluation, 39.5 percent of patients were in NYHA functional class IV. The most common techniques employed were bovine pericardial strip annuloplasty in 48.4 percent patients and Carpentier ring annuloplasty in 22.6 percent. Shortening of chordae (20 percent) and papillary muscle splitting (17.8 percent) were the most common associated techniques performed. Tricuspid valve repair (26.7 percent) and aortic valve replacement (27.2 percent) were the most common associated procedures. Results: The hospital mortality was 0.9 percent (three patients), two of them in children with active rheumatic fever. Linearized rates of thromboembolism, endocardite, reoperation and late death were 0.2 percent, 0.2 percent, 3.5 percent and 0.5 percent patients-year, respectively. Actuarial survival in 20 years was 86.4 ± 6.6 percent. Freedom from reoperation in 20 years was 30.3 ± 11.1 percent. Conclusion: Mitral valve conservative surgery in rheumatic patients is a feasible procedure with low operative mortality.
Asunto(s)
Adolescente , Adulto , Niño , Preescolar , Femenino , Humanos , Masculino , Persona de Mediana Edad , Adulto Joven , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Cardiopatía Reumática/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Estimación de Kaplan-Meier , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
A técnica da sutura única foi desenvolvida para obter estabilização e exposição de todos os ramos coronarianos durante a cirurgia de revascularização do miocárdio, mantendo a estabilidade hemodinâmica durante o procedimento. Nós descrevemos a utilização desta técnica durante a correção de uma fístula arterial coronariana associada à dilatação coronariana direita, sem a utilização da circulação extracorpórea. A técnica sugerida é mais rápida e menos complexa do que a utilização do desvio cardiopulmonar. Além disso, essa técnica pode ser uma ferramenta útil para a correção de fístulas arteriais coronarianas em casos selecionados, permitindo a prática de abordagens menos invasivas nesses pacientes.
The single suture technique was developed to obtain stabilization and exposure of all all coronary branches during off-pump coronary artery bypass, while maintaining hemodynamic stabilily during the procedure. We describe the use of this technique during an off-pump correction of a coronary artery fistula associated with right coronary dilatation. The suggested technique is quicker and less complex than on-pump surgery. Furthermore, it can be a useful tool for congenital fistula correction in select cases, stimulating the practice of less invasive heart surgery in these patients.
Asunto(s)
Humanos , Lactante , Masculino , Puente de Arteria Coronaria Off-Pump , Anomalías de los Vasos Coronarios/cirugía , Ventrículos Cardíacos/cirugía , Técnicas de Sutura , Fístula Vascular/cirugía , Ventrículos Cardíacos/anomalías , Fístula Vascular/congénitoRESUMEN
OBJECTIVE: Mitral valve repair in rheumatic patients is still a challenge. The purpose of this study is to analyze the results of mitral valve repair in rheumatic patients in the Heart Institute University of Sao Paulo Medical School. METHODS: Were analyzed retrospectively, between 1985 and 2005, 330 patients submitted to mitral valve repair in the Heart Institute of São Paulo. The mean age was 26.9 +/- 15.4 years and 57.6% were female. According do clinical evaluation, 39.5% of patients were in NYHA functional class IV. The most common techniques employed were bovine pericardial strip annuloplasty in 48.4% patients and Carpentier ring annuloplasty in 22.6%. Shortening of chordae (20%) and papillary muscle splitting (17.8%) were the most common associated techniques performed. Tricuspid valve repair (26.7%) and aortic valve replacement (27.2%) were the most common associated procedures. RESULTS: The hospital mortality was 0.9% (three patients), two of them in children with active rheumatic fever. Linearized rates of thromboembolism, endocardite, reoperation and late death were 0.2%, 0.2%, 3.5% and 0.5% patients-year, respectively. Actuarial survival in 20 years was 86.4 +/- 6.6%. Freedom from reoperation in 20 years was 30.3 +/- 11.1%. CONCLUSION: Mitral valve conservative surgery in rheumatic patients is a feasible procedure with low operative mortality.
Asunto(s)
Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Insuficiencia de la Válvula Mitral/cirugía , Válvula Mitral/cirugía , Cardiopatía Reumática/cirugía , Adolescente , Adulto , Niño , Preescolar , Femenino , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
The single suture technique was developed to obtain stabilization and exposure of all all coronary branches during off-pump coronary artery bypass, while maintaining hemodynamic stabilily during the procedure. We describe the use of this technique during an off-pump correction of a coronary artery fistula associated with right coronary dilatation. The suggested technique is quicker and less complex than on-pump surgery. Furthermore, it can be a useful tool for congenital fistula correction in select cases, stimulating the practice of less invasive heart surgery in these patients.
Asunto(s)
Puente de Arteria Coronaria Off-Pump , Anomalías de los Vasos Coronarios/cirugía , Ventrículos Cardíacos/cirugía , Técnicas de Sutura , Fístula Vascular/cirugía , Ventrículos Cardíacos/anomalías , Humanos , Lactante , Masculino , Fístula Vascular/congénitoRESUMEN
OBJECTIVE: This study aims to analyze the embolic activity in patients with calcified aortic stenosis who underwent aortic valve replacement using intra-aortic filtration with an EMBOL-X System device (Edwards Lifesciences Inc., Mountain View, CA, USA). METHODS: From January 2007 to July 2007, 13 consecutive patients with calcified aortic stenosis, who underwent isolated aortic valve replacement using intra-aortic filtration by an EMBOL-X System for 5 minutes after aortic clamp release, were evaluated. Mean patient age was 63.7 years (range 34 to 79 years) and 61.5% were female. The mean bypass time was 60.2 +/- 7.5 minutes (range 45 to 72 minutes) and the mean cross-clamp time was 50 +/- 7.5 minutes (range 35 to 63 minutes). Following removal, each filter was fixed in formalin and analyzed macroscopically with the captured fragments being counted. Histological examinations of the captured material were performed. RESULTS: There were no strokes or gross neurological events. There were no cases of postoperative renal failure. No deaths were reported during hospitalization. Particulate emboli were found in five (38.5%) of the filters. On histological analysis of the particulate emboli captured, two (40%) contained fibrin, two (40%) presented conjunctive tissue, one (20%) contained red blood cells and in one it was not possible to determine the nature of the particulates captured. CONCLUSION: The EMBOL-X System device was effective in particulate emboli capture in aortic valve replacement surgery of patients with calcified aortic stenosis.
Asunto(s)
Estenosis de la Válvula Aórtica/cirugía , Calcinosis/cirugía , Embolia/prevención & control , Filtración/instrumentación , Implantación de Prótesis de Válvulas Cardíacas , Adulto , Anciano , Embolia/patología , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
OBJETIVO: O objetivo deste estudo foi avaliar a atividade embólica de pacientes portadores de estenose aórtica calcificada submetidos a troca valvar aórtica por meio da filtração intra-aórtica com dispositivo EMBOL-X® System (Edwards Lifesciences Inc., Mountain View, CA, USA). MÉTODOS: De janeiro de 2007 a julho de 2007, foi utilizado o filtro intra-aórtico EMBOL-X após o despinçamento aórtico em 13 portadores de estenose aórtica calcificada submetidos a troca valvar aórtica consecutivamente. A média de idade dos pacientes foi 63,7 anos (34-79) e 61,5% eram do sexo feminino. A média do tempo de CEC foi 60,2±7,5 (45-72) minutos e a média do tempo despinçamento aórtico foi 50±7,5 (35-63) minutos. Após a retirada dos filtros, eles foram fixados em formalina, analisados macroscopicamente e quantificados os fragmentos capturados. Foi realizado exame histológico do material capturado. RESULTADOS Não foi observado nenhum caso de complicação neurológica. Nenhum paciente apresentou insuficiência renal pós-operatória. Não houve óbitos hospitalares. Partículas embólicas foram encontradas em cinco (38,5%) dos filtros. Das partículas embólicas capturadas, em dois (40%) filtros havia fibrina, dois (40%) apresentavam tecido conjuntivo, um (20%) continha hemácias e em um não foi possível determinar a natureza. CONCLUSÃO: O dispositivo EMBOL-X® System foi efetivo na captação de fragmentos intra-aórticos na substituição da valva aórtica em pacientes com estenose aórtica calcificada.
OBJECTIVE: This study aims to analyze the embolic activity in patients with calcified aortic stenosis who underwent aortic valve replacement using intra-aortic filtration with an EMBOL-X® System device (Edwards Lifesciences Inc., Mountain View, CA, USA). METHODS: From January 2007 to July 2007, 13 consecutive patients with calcified aortic stenosis, who underwent isolated aortic valve replacement using intra-aortic filtration by an EMBOL-X® System for 5 minutes after aortic clamp release, were evaluated. Mean patient age was 63.7 years (range 34 to 79 years) and 61.5% were female. The mean bypass time was 60.2 ± 7.5 minutes (range 45 to 72 minutes) and the mean cross-clamp time was 50 ± 7.5 minutes (range 35 to 63 minutes). Following removal, each filter was fixed in formalin and analyzed macroscopically with the captured fragments being counted. Histological examinations of the captured material were performed. RESULTS: There were no strokes or gross neurological events. There were no cases of postoperative renal failure. No deaths were reported during hospitalization. Particulate emboli were found in five (38.5%) of the filters. On histological analysis of the particulate emboli captured, two (40%) contained fibrin, two (40%) presented conjunctive tissue, one (20%) contained red blood cells and in one it was not possible to determine the nature of the particulates captured. CONCLUSION: The EMBOL-X® System device was effective in particulate emboli capture in aortic valve replacement surgery of patients with calcified aortic stenosis.
Asunto(s)
Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estenosis de la Válvula Aórtica/cirugía , Calcinosis/cirugía , Embolia/prevención & control , Filtración/instrumentación , Implantación de Prótesis de Válvulas Cardíacas , Embolia/patologíaRESUMEN
OBJETIVO: O objetivo deste trabalho é apresentar os resultados clínicos tardios da plástica da valva mitral com a técnica do "Duplo Teflon". MÉTODOS: A plástica de "Duplo Teflon" consiste em técnica de reparo mitral com ressecção quadrangular da cúspide posterior, anuloplastia segmentar com plicatura do anel com de fios com "pledgets" sobre uma tira de Teflon, e sutura borda a borda da cúspide. Entre abril de 1994 e dezembro de 2003, 133 pacientes com diagnóstico de insuficiência mitral degenerativa com alongamento ou rotura de cordas da cúspide posterior foram submetidos à plástica com esta técnica. A idade média foi de 60,4 anos e 60,9 por cento eram do sexo feminino. Quanto à avaliação clínica no pré-operatório, 29,3 por cento dos pacientes estavam em classe funcional IV, 55,7 por cento em classe III e 15,0 por cento em classe II. Técnicas associadas de plástica mitral foram utilizadas em 15,2 por cento dos pacientes, sendo a mais comum o encurtamento de cordas. Vinte e seis (19,5 por cento) pacientes foram submetidos a operações associadas. RESULTADOS: Houve um (0,75 por cento) óbito hospitalar. No período pós-operatório tardio, 95,5 por cento dos sobreviventes estavam em classe funcional I. As taxas linearizadas de tromboembolismo, reoperação e óbito foram 0,9 por cento, 0,3 por cento e 0,6 por cento pacientes/ano, respectivamente. A sobrevida atuarial em 10 anos foi de 94,1 por cento ± 3,6 por cento. As sobrevidas atuariais livre de tromboembolismo e reoperação foram de 97,3 ± 1,5 por cento e 99,2 ± 0,8 por cento, respectivamente. Não houve casos de endocardite ou hemólise. CONCLUSÃO: A plástica da valva mitral com a técnica do "Duplo Teflon" apresenta baixa morbi-mortalidade e boa evolução clínica tardia.
OBJECTIVE: The purpose of this paper is to present the late clinical results of mitral valve repair with the "Double Teflon" technique. METHODS: "Double Teflon" technique consists of a quadrangular resection of the posterior leaflet, annulus plication with "pledgetted" stitches over a Teflon patch, and leaflet suture. Between 1994 and 2003, 133 patients with degenerative mitral insufficiency due to ruptured or elongated chordae in the posterior leaflet underwent repair with this technique. The mean patient age was 60.4 years and 60.9 percent patients were male. According to clinical evaluation, 29.3 percent of the patients were in New York Heart Association functional class IV, 55.7 percent in class III and 15.0 percent in class II. Associated techniques of mitral valve repair were used in 15.2 percent of the patients; the most common was chordal shortening. Twenty six (19.5 percent) patients had associated procedures. RESULTS: There was one (0.75 percent) operative death. In the late postoperative period, 95.5 percent of the surviving patients were in New York Heart Association functional class I. Linearized rates of thromboembolism, reoperation and death were 0.9 percent, 0.3 percent and 0.6 percent patient/year, respectively. The actuarial survival at 10 years was 94.7 percent ± 3.6 percent. Actuarial freedom from thromboembolism and reoperation were 97.3 ± 1.5 percent and 99.2 ±0.8 percent, respectively. There were no episodes of hemolysis or endocarditis. CONCLUSION: Mitral valve repair with "Double Teflon" technique presents low morbimorbidity and good clinical late evolution.