RESUMEN
We developed methodology for prospective randomized effectiveness studies using a demonstration project at a multispecialty practice, health maintenance organization, and hospital in academic medical center. An operational unit called the effectiveness registry was developed to design and support comparisons of potential practice improvements with standard care. The studies differ from observational effectiveness studies in that they provide long-term follow-up of randomized comparison groups. Physician involvement in data collection is limited. No tests or observations are made other than those required for clinical care. Follow-up and data collection are modeled after tumor registry procedures. Patients who refuse randomization enter the study in whichever treatment arm they choose. The protocol for each study is approved by the institutional review board (IRB) before recruitment begins, and all patients, randomized and nonrandomized, sign an informed consent document. Between its beginning on October 7, 1993 and April 7, 1997, the IRB approved 14 trials. Four were terminated after entering at most a few patients. Recruitment is complete in four trials and continues in six. Randomization was accepted by 74% (596/804) of the patients. Over 800 patients in 10 studies are being followed at least annually. Major peer-reviewed journals have accepted reports of initial findings for two studies. Prospective randomized effectiveness studies are feasible in the multipractice setting and have potential to provide useful and reliable assessment of treatment outcomes. Collaborative arrangements between several institutions are needed to provide larger sample sizes.
Asunto(s)
Evaluación de Resultado en la Atención de Salud , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Centros Médicos Académicos , Recolección de Datos , Estudios de Factibilidad , Estudios de Seguimiento , Práctica de Grupo , Sistemas Prepagos de Salud , Humanos , Consentimiento Informado , Estudios Longitudinales , Estudios Multicéntricos como Asunto , Atención al Paciente , Participación del Paciente , Selección de Paciente , Revisión de la Investigación por Pares , Comité de Profesionales , Estudios Prospectivos , Edición , Sistema de Registros , Reproducibilidad de los Resultados , Proyectos de Investigación , Tamaño de la Muestra , Resultado del TratamientoRESUMEN
UNLABELLED: Amrinone and milrinone are phosphodiesterase inhibitors with positive inotropic effects useful for the treatment of ventricular dysfunction after cardiac surgery. Forty-four patients undergoing elective cardiac surgery at four centers received either amrinone (n = 22) or milrinone (n = 22) in a randomized, blind fashion. Immediately after separation from cardiopulmonary bypass (CPB), two bolus doses of either amrinone 0.75 mg/kg or milrinone 25 microg/kg were administered over 30 s, separated by 5 min. Hemodynamic measurements were recorded before each dose and at the end of the 10-min study. Both amrinone and milrinone increased the cardiac index (48% vs 52%, P = not significant [NS] for amrinone and milrinone, respectively). There was a small increase in mean arterial pressure (MAP) after amrinone administration (from 68 +/- 3 to 72 +/- 3 mm Hg at 10 min, P < 0.05) with no significant change in MAP after milrinone administration. Central venous pressure was significantly higher in the amrinone group at baseline and 5 min (12 vs 10 mm Hg and 11 vs 10 mm Hg, respectively; P < 0.05). Systemic and pulmonary vascular resistances decreased significantly and to a similar extent after either amrinone or milrinone administration. Phenylephrine was required in 11 of 22 patients receiving amrinone and in 11 of 22 patients receiving milrinone to maintain arterial blood pressure. The proportion of patients requiring an intravascular volume infusion (15 of 22 vs 17 of 22, P = NS) and the total fluid volume infused were similar (402 +/- 57 vs 350 +/- 49 mL, P = NS for amrinone and milrinone, respectively). Amrinone and milrinone seem to have similar hemodynamic effects after CPB, with the exception of blood pressure, although the need for vasopressor support of blood pressure did not differ. Selection between these two drugs may include nonhemodynamic considerations such as cost. IMPLICATIONS: Amrinone and milrinone are drugs that improve cardiac contraction. Their effects have never been directly compared in patients. We found that amrinone and milrinone produced similar hemodynamic effects in adult patients undergoing cardiac surgery. Choice between the two drugs can be based on nonhemodynamic considerations such as cost.
Asunto(s)
Amrinona/uso terapéutico , Procedimientos Quirúrgicos Cardíacos , Cardiotónicos/uso terapéutico , Inhibidores de Fosfodiesterasa/uso terapéutico , Piridonas/uso terapéutico , Adulto , Anciano , Amrinona/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Gasto Cardíaco/efectos de los fármacos , Puente Cardiopulmonar , Cardiotónicos/administración & dosificación , Presión Venosa Central/efectos de los fármacos , Costos de los Medicamentos , Procedimientos Quirúrgicos Electivos , Femenino , Fluidoterapia , Hemodinámica/efectos de los fármacos , Humanos , Inyecciones Intravenosas , Pulmón/irrigación sanguínea , Masculino , Persona de Mediana Edad , Milrinona , Contracción Miocárdica/efectos de los fármacos , Fenilefrina/uso terapéutico , Inhibidores de Fosfodiesterasa/administración & dosificación , Sustitutos del Plasma/uso terapéutico , Piridonas/administración & dosificación , Método Simple Ciego , Resistencia Vascular/efectos de los fármacos , Vasoconstrictores/uso terapéutico , Disfunción Ventricular/prevención & controlRESUMEN
OBJECTIVE: To determine whether postoperative forced-air warming of cardiac bypass patients in the intensive care unit (ICU) results in faster rate of warming and improved outcomes compared with more conventional ICU warming methods. DESIGN: Prospective randomized effectiveness study. SETTING: Three hundred fifty-bed university-affiliated hospital. PARTICIPANTS: Sixty consenting randomized patients from a consecutive series of 84 patients undergoing routine adult cardiac surgery. INTERVENTIONS: One group of patients received usual patient care, which includes warm blankets and overhead heat lamps. Patients in the other group were placed under forced-air warming devices on arrival in the ICU. Sixty consenting patients (30 in each group) were randomly assigned to one or the other method of warming. The remaining 24 patients refused randomization and self-selected a treatment group. MEASUREMENTS AND MAIN RESULTS: Results are presented for the randomized groups. Core temperature, measured by pulmonary artery catheter thermistor, increased in both groups at the rate of 0.25 degree C per hour. No statistically or clinically significant differences were found between the group for whom the warming device was used and the standard care group in the incidence of postoperative cardiac arrhythmia, duration of time in the ICU, or any other clinical variable. CONCLUSIONS: There is no evidence from this study to warrant use of forced-air warming devices for the care of postoperative cardiac surgical patients in the ICU.
Asunto(s)
Temperatura Corporal , Procedimientos Quirúrgicos Cardíacos , Calor , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
Axillary artery-to-coronary artery bypass using reversed saphenous vein provides a simple method of applying the minimally invasive coronary bypass grafting procedure when the internal thoracic artery is not an adequate conduit. Although this may allow extended use of the minimally invasive coronary bypass procedure, the long-term patency of this technique is unknown.
Asunto(s)
Arteria Axilar/cirugía , Puente de Arteria Coronaria/métodos , Anastomosis Quirúrgica/métodos , Humanos , Juicio , Vena Safena/trasplante , Grado de Desobstrucción VascularRESUMEN
BACKGROUND: For years the standard access to the thorax has been by posterolateral or other muscle cutting thoracotomy incisions. These are accompanied by significant discomfort and often limitation of shoulder girdle movement. To obviate these distressing features, the less traumatic median sternotomy was recommended. In the last ten years, several types of mini or axillary thoracotomies have been described. We believe that the vertical axillary thoracotomy is the best of these incisions as no major muscles are divided, it can be created rapidly, and exposure is excellent. STUDY DESIGN: We compared the operative approaches from the point of view of the duration of postoperative hospitalization, the length of the operating time, the incidence of postoperative atelectasis, and persistence of incisional pain. RESULTS: The vertical axillary thoracotomy showed a definite advantage in all these categories. CONCLUSIONS: These findings suggest that the vertical axillary thoracotomy is the incision of choice for most thoracic procedures as the incision is small and quickly made. Because there is limited division of muscles, the convalescence is smooth and uncomplicated.
Asunto(s)
Toracotomía/métodos , Axila/cirugía , Estudios de Seguimiento , Hospitalización , Humanos , Tiempo de Internación , Pulmón/cirugía , Músculos/cirugía , Dolor Postoperatorio/etiología , Neumonectomía/métodos , Atelectasia Pulmonar/etiología , Estudios Retrospectivos , Esternón/cirugía , Técnicas de Sutura , Toracotomía/efectos adversos , Factores de TiempoRESUMEN
Postoperative fistula from left ventricle to right atrium is a rare complication of mitral valve surgery. We describe a case identified by ultrafast computed tomography (CT) and we review the literature regarding this entity.
Asunto(s)
Cardiomiopatías/diagnóstico por imagen , Enfermedad Coronaria/diagnóstico por imagen , Fístula/diagnóstico por imagen , Prótesis Valvulares Cardíacas/efectos adversos , Válvula Mitral/cirugía , Tomografía Computarizada por Rayos X , Anciano , Cardiomiopatías/etiología , Enfermedad Coronaria/etiología , Femenino , Fístula/etiología , Ventrículos Cardíacos , Humanos , Insuficiencia de la Válvula Mitral/cirugía , ReoperaciónRESUMEN
Infections occurred in 52 of 400 patients (13%) undergoing coronary artery bypass operations from January 1987 to December 1990. The hospital courses of 5 patients (1.3%) in whom occult infections of the paranasal sinuses developed were reviewed. Only 1 patient had specific clinical findings of acute sinusitis (purulent nasal discharge). Computed tomography showed wall thickening, opacification, or air-fluid levels in one or more paranasal sinuses in each patient. All patients were successfully treated with surgical drainage and antibiotics. Risk factors for development of postoperative acute sinusitis include: prolonged tracheal intubation, airway colonization with nosocomial bacteria, inability to clear nasal secretions, sinus ostial obstruction, and critical organ system dysfunction. Physical examination and roentgenographic evaluation of the paranasal sinuses should be considered when postoperative sepsis of obscure etiology occurs.
Asunto(s)
Puente de Arteria Coronaria , Complicaciones Posoperatorias , Sinusitis/diagnóstico , Enfermedad Aguda , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo , Sinusitis/etiología , Sinusitis/terapiaRESUMEN
Pericardial fluid has been implicated as a causative factor in hemolysis during cardiopulmonary bypass operations. Preoperative blood samples were obtained from 10 patients undergoing coronary artery bypass grafting for ischemic myocardial disease. Whole blood samples were separately incubated with autogenous pericardial fluid, pericardium, pleura, vein, skeletal muscle, and fat harvested during the operative intervention. The plasma fraction was separated by centrifugation and assayed for serum free hemoglobin. Statistical analysis was accomplished by the Bonferroni technique to adjust for multiple comparisons. Pericardial fluid-induced hemolysis was least (20.7 mg/dL). Pleura and muscle contributed significantly to the serum free hemoglobin level (56.3 and 112.3 mg/dL, respectively; p < 0.05). Pericardium, vein, and fat did not cause significant elevations of the serum free hemoglobin level. Postbypass hemolysis is an important management consideration that may be minimized by delicate tissue manipulation and attention to minimizing tissue trauma. Avoidance of aspiration of pericardial fluid into the autotransfusion system is not supported.
Asunto(s)
Puente Cardiopulmonar/efectos adversos , Puente de Arteria Coronaria , Hemólisis , Tejido Adiposo/fisiología , Anciano , Femenino , Hemoglobinas/análisis , Humanos , Técnicas In Vitro , Masculino , Persona de Mediana Edad , Músculos/fisiología , Derrame Pericárdico/fisiopatología , Pericardio/fisiología , Pleura/fisiología , Vena Safena/fisiologíaRESUMEN
Postoperative infections may originate from a patient's gastrointestinal tract. We studied infections after coronary artery revascularization. Three hundred twenty-nine patients underwent coronary artery revascularization from January 1987 to March 1990. Eight of the 329 (2.4%) died; none of the deaths were infection related. Fifty-five culture-proven infections were identified in 22 of 321 survivors (6.8%); 9 infections (16%) were gram-positive, 5 (9%) were fungal, and 41 (75%) were gram-negative. Site of infections were respiratory tract, 58%; urinary tract, 18%; blood, 13%; and mediastinum, 11%. Ninety-six percent of respiratory tract and all urinary tract infections were gram-negative or fungal. There was no significant difference between infected and noninfected groups in sex, age, smoking history, preoperative hematocrit or leukocyte count, serum albumin level, or time on extracorporeal bypass. The infected group required intubation and nasogastric suction for a significantly longer time than the noninfected group (p less than 0.001). Time to enteral alimentation was significantly longer in the infected group (p less than 0.02). We were unable to correlate the number of infections with the lengths of intubation, nasogastric suction, or time to enteral alimentation. This study supports the concept of postoperative infections arising from bacterial translocation across the patient's gastrointestinal tract. The most significant risk factor is the length of the gastrointestinal tract disuse.
Asunto(s)
Puente de Arteria Coronaria , Sistema Digestivo/microbiología , Sistema Digestivo/fisiopatología , Infecciones/etiología , Complicaciones Posoperatorias/etiología , Adulto , Anciano , Anciano de 80 o más Años , Sistema Digestivo/patología , Femenino , Humanos , Infecciones/microbiología , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/microbiologíaRESUMEN
The case of a 68-year-old man with advanced symptomatic coronary artery disease and large aneurysm of the diverticulum of the ductus arteriosus is presented. Both the coronary artery disease and the aneurysm were successfully repaired at the same time via median sternotomy using cardiopulmonary bypass and a brief period of profound hypothermic circulatory arrest. To our knowledge, this is the 27th reported case of such an aneurysm in an adult.
Asunto(s)
Aneurisma/cirugía , Enfermedad Coronaria/cirugía , Conducto Arterial , Paro Cardíaco Inducido , Anciano , Aneurisma/complicaciones , Aneurisma/diagnóstico por imagen , Puente Cardiopulmonar , Enfermedad Coronaria/complicaciones , Conducto Arterial/diagnóstico por imagen , Conducto Arterial/cirugía , Humanos , Masculino , RadiografíaRESUMEN
Left ventricular pseudoaneurysm complicating myocardial infarction is extremely rare. A case of left ventricular anterolateral pseudoaneurysm with its initial presentation mimicking septic shock is reported. The need for urgent resection is stressed due to the high incidence of spontaneous rupture and death regardless of the age or the size of the pseudoaneurysm.
Asunto(s)
Aneurisma Cardíaco/diagnóstico , Rotura Cardíaca Posinfarto/diagnóstico , Rotura Cardíaca/diagnóstico , Choque Séptico/diagnóstico , Diagnóstico Diferencial , Rotura Cardíaca Posinfarto/terapia , Humanos , Contrapulsador Intraaórtico , Masculino , Persona de Mediana Edad , Factores de TiempoRESUMEN
Tc-99m labeled RBC imaging was used to conclusively demonstrate continuing intrathoracic hemorrhage from the anastomotic site of a coronary artery bypass graft. Demonstration of continuing hemorrhage and localization of the most likely site of bleeding resulted in timely and appropriate surgical intervention, which resulted in hemostasis and eventual patient recovery. Tc-99m RBC imaging may be an ideal noninvasive technique to investigate the site and activity of intrathoracic hemorrhage after coronary bypass surgery and other thoracic procedures.
Asunto(s)
Puente de Arteria Coronaria/efectos adversos , Hemotórax/diagnóstico por imagen , Anciano , Eritrocitos , Femenino , Hemotórax/etiología , Humanos , Complicaciones Posoperatorias , Cintigrafía , Reoperación , TecnecioRESUMEN
The incidence and the sites of rib fractures during open-heart operations through a median sternotomy incision were studied in 36 consecutive patients divided into two groups. In Group 1 (24 patients), a conventional Ankeney retractor was used to expose the heart, and in Group 2 (12 patients), a similar retractor was used but with its uppermost pair of blades removed. Thorough physical examinations and preoperative and postoperative chest roentgenograms were obtained, and postoperative bone scans were done in all patients. No rib fractures were detected on the routine chest roentgenograms in patients in either group. Bone scans, however, showed 44 rib fractures (15 of the first rib, 13 of the second rib, 4 of the third rib, 6 of the fourth rib, 3 of the fifth rib, and 3 of the sixth rib) in 16 patients in Group 1. Six patients in Group 2 had 9 rib fractures (2 of the first rib, 4 of the second rib, and 1 each of the third, fifth, and sixth ribs). None of the patients in Group 2 had brachial plexus injury and neither of the first rib fractures in this group were located posteriorly, whereas 3 patients in Group 1 had both brachial plexus injury and posterior first rib fractures.
Asunto(s)
Plexo Braquial/lesiones , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Fracturas de las Costillas/etiología , Esternón/cirugía , Plexo Braquial/diagnóstico por imagen , Puente de Arteria Coronaria , Femenino , Humanos , Complicaciones Intraoperatorias , Masculino , Persona de Mediana Edad , Radiografía , Fracturas de las Costillas/diagnóstico por imagenRESUMEN
Sternal retraction can cause the first rib to be fractured posteriorly, injuring the brachial plexus. The authors conducted bone scans of 24 consecutive open-heart surgery patients and found an unexpectedly high number of rib fractures which in all but one case had not been seen on the chest radiograph. Bone scans are recommended whenever there is unexplained non-incisional pain in a patient who has undergone sternal retraction.