Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis.

BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases. Percutaneous closure is the preferred treatment, but certain complications remain a concern. The most common devices are AMPLATZER™ (ASO) (St. Jude Medical, St. Paul, MN, USA) and Figulla Flex® septal occluders (FSO) (Occlutech GmbH, Jena, Germany). The present study aimed to assess main differences in outcomes. METHODS: A systematic search in Pubmed and Google scholarship was performed by two independent reviewers for any study comparing ASO and FSO. Searched terms were "Figulla", "Amplatzer", and "atrial septal defect". A random-effects model was used. RESULTS: A total of 11 studies including 1770 patients (897 ASO; 873 FSO) were gathered. Baseline clinical and echocardiographic characteristics were comparable although septal aneurysm was more often reported in patients treated with ASO (32% vs. 25%; p = 0.061). Success rate (94% vs. 95%; OR: 0.81; 95% CI: 0.38-1.71; p = 0.58) and peri-procedural complications were comparable. Procedures were shorter, requiring less fluoroscopy time with an FSO device (OR: 0.59; 95% CI: 0.20-0.97; p = 0.003). Although the global rate of complications in long-term was similar, the ASO device was associated with a higher rate of supraventricular arrhythmias (14.7% vs. 7.8%, p = 0.009). CONCLUSIONS: Percutaneous closure of ASD is a safe and effective, irrespective of the type of device. No differences exist regarding procedural success between the ASO and FSO devices but the last was associated to shorter procedure time, less radiation, and lower rate of supraventricular arrhythmias in follow-up. Late cardiac perforation did not occur and death in the follow-up was exceptional.

Effect of direct intramyocardial autologous stem cell grafting in the sub-acute phase after myocardial infarction.

BACKGROUND: To assess the efficacy and safety of intramyocardial autologous bone marrow mononuclear stem cells (BMMNC) grafting combined with coronary artery bypass grafting (CABG) on ventricular remodeling and global and regional wall motion after acute transmural myocardial infarction (AMI). METHODS: Randomized controlled trial including 20 patients with non-revascularized transmural AMI, left ventricular ejection fraction (LVEF) lower than 50% and surgical indication for CABG. The stem cell group was treated with BMMNC grafting by direct intramyocardial injection between the 10th and 15th days after AMI (subacute phase) combined with CABG under cardiopulmonary bypass; the control group was only treated with CABG. Magnetic resonance imaging with gadolinium and stress echocardiography were performed presurgery and 9 months postsurgery. RESULTS: Seventeen patients completed the follow-up. The baseline characteristics of both groups were homogeneous. No significant differences were found in the increase in LVEF (control: 6.99±4.60, cells: 7.47±6.61, P=0.876) or in the decrease in global (control: 0.28±0.39, cells: 0.22±0.28, P=0.759) or regional (control: 0.52±0.38, cells: 0.74±0.60, P=0.415) wall motion indices between the control and stem cell groups of AMI patients. No differences were found in the recovered non-viable segments (control: 1.29±1.11, cells: 2.50±1.41, P=0.091) or in the decrease in end-diastolic (control: 14.05±19.72, cells: 18.40±29.89, P=0.725) or end-systolic (control: 15.42±13.93, cells: 23.06±25.03, P=0.442) volumes. No complications from stem cell grafting were observed. CONCLUSIONS: The results from our study reported herein suggest that intramyocardial BMMNC administration during CABG in patients with AMI causes no medium- to long-term improvement in ventricular remodeling.

Comparison of Different Bone Marrow-Derived Stem Cell Approaches in Reperfused STEMI. A Multicenter, Prospective, Randomized, Open-Labeled TECAM Trial.

BACKGROUND: Stem cell-based therapy has emerged as a potential therapy in acute myocardial infarction (AMI). Although various approaches have been studied, intracoronary injection of bone marrow autologous mononuclear cells (BMMC) and the ability of granulocyte colony-stimulating factor (G-CSF) to mobilize endogenous cells have attracted the most attention. OBJECTIVES: This study compares, for the first time, the efficacy of BMMC injection, G-CSF mobilization, and the combination of both with standard treatment. METHODS: On Day 1 after primary percutaneous coronary intervention, 120 patients were randomized to a 1) intracoronary BMMC injection; 2) mobilization with G-CSF; 3) both (BMMC injection plus G-CSF); or 4) conventional treatment (control group). G-CSF, 10 µg/kg/day subcutaneously, was started Day 1 and maintained for 5 days. BMMC injection was performed on Days 3 to 5. Our primary endpoint was absolute change in 12-month left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) relative to baseline measured by cardiac magnetic resonance. RESULTS: The mean change in LVEF between baseline and follow-up for all patients was 4 ± 6% (p = 0.006). Change in LVEF and LVESV over time did not differ significantly among the 4 groups. Patients actively treated with any stem cell approach showed similar changes in LVEF and LVESV versus control subjects, with a small but significant reduction in infarct area (p = 0.038). CONCLUSIONS: In our study, 3 different bone marrow-derived stem cell approaches in AMI did not result in improvement of LVEF or volumes compared with standard AMI care (Trial of Hematopoietic Stem Cells in Acute Myocardial Infarction [TECAM]; NCT00984178).

Coronary stent implantation in patients older than 75 years of age: clinical profile and initial and long-term (3 years) outcome.

OBJECTIVE: The objective of this study was to compare the initial and long-term outcome of elderly and younger patients after coronary stent implantation. METHODS: The evolutions of 76 patients aged >75 years and of 860 patients aged < or =75 years who underwent consecutive stenting (from June 1991 to June 1997) were compared in a cohort study. RESULTS: The elderly patients had lower left ventricular ejection fractions (0.58 +/- 0.14 vs 0.61 +/- 0.13; P =.03) and more frequently had unstable angina (78.9% vs 55.3%; P <.0001), previous heart failure (10.5% vs 4.9%; P =.03), and multivessel disease (68.4% vs 58.3%; P =.08). After the procedure, the elderly patients showed a higher inhospital mortality rate (6.6% vs 2.4%; P =.03) and myocardial infarction rate (5.3% vs 1.7%; P =.04). The long-term follow-up period (mean, 3.2 +/- 1.4 years; median, 3.0 years) showed in the elderly a higher mortality rate (15.4% vs 5.8%; P =.006), a lower rate of repeat revascularization (9.2% vs 19.7%; P =.04), and a similar incidence rate of major adverse cardiac events (27.7% vs 28.2%; P =.93). Multivariate analysis of the elderly group identified female gender (hazard ratio, 2.19; 95% CI, 1.18 to 4.06; P =.012) and presence of multivessel disease (hazard ratio, 2.35; 95% CI, 1.05 to 5.26; P =.037) as independent predictors of further events. CONCLUSION: Patients aged >75 years have a less favorable baseline profile and higher inhospital and 3-year mortality rates. However, the incidence rate of major adverse cardiac events in the long term is acceptable and similar to that of younger patients.

[Coronary angioplasty in diabetic patients. Current and future perspectives]. / Angioplastia coronaria en el paciente diabético. Situación actual y perspectivas futuras.

It has been estimated that 15-25% of patients who undergo percutaneous or surgical coronary angioplasty are diabetics. The indications for coronary revascularization and initial results of the procedure do not differ substantially between patients with diabetes mellitus and non-diabetics. However, the long-term results of both percutaneous and surgical coronary angioplasty are less favorable in diabetics in terms of mortality and the need for new revascularization procedures. The development and widespread use of stents and glycoprotein IIb/IIIa receptor inhibiting drugs have improved the clinical evolution of diabetics treated with angioplasty. Currently available data show that the administration of glycoprotein IIb/IIIa inhibitors to patients undergoing coronary angioplasty is especially useful in diabetics and improves short-term and long-term results, decreasing one-year mortality by 45%. There seem to be indications for the routine use of glycoprotein IIb/IIIa inhibitors in diabetics treated with angioplasty. While the use of stents has improved long-term and short-term results in diabetics, the success rates of angioplasty in diabetics are still lower than in non-diabetics. Diabetes is still an independent predictor of restenosis and long-term events after stenting interventions. Analysis of the studies comparing percutaneous and surgical revascularization in diabetic patients with multivessel disease shows that surgery is superior in terms of long-term mortality and need for new revascularization procedures. Stenting has improved, but not substantially, the results of multivessel angioplasty in diabetics. Therefore, the indications for angioplasty in multivessel diabetics should be evaluated individually. Factors that contribute to the less favorable post-angioplasty evolution of diabetic patients are more rapid progression of atherosclerosis and, especially, a higher rate of restenosis. New angioplasty techniques, such as brachytherapy and drug-eluting stents, are likely to significantly improve the results of percutaneous interventions in diabetics, thus allowing the indications for angioplasty in diabetics to be extended even further in the near future.

Comparison of neointimal hyperplasia with drug-eluting stents versus bare metal stents in patients undergoing intracoronary bone-marrow mononuclear cell transplantation following acute myocardial infarction.

The aims of this study were to assess the safety of drug-eluting stent (DES) use and to compare the incidence of in-stent restenosis (ISR) and neointimal hyperplasia formation according to the type of stent implanted (DES vs bare-metal stents [BMS]) in patients who underwent intracoronary bone marrow mononuclear cell transplantation after acute ST elevation myocardial infarction. Fifty-nine patients with successfully revascularized ST elevation myocardial infarction (37 using BMS and 22 using DES) underwent paired angiographic examinations at baseline and 6 to 9 months after the intracoronary injection of 91 million +/- 56 million autologous bone marrow mononuclear cells. A subgroup of 30 patients also underwent serial intravascular ultrasound examinations. Off-line angiographic assessment showed 4 cases of binary ISR, primarily in BMS (3 cases), and no major adverse cardiac events were associated with stent type (mean follow-up period 41 +/- 10 months). At follow-up, angiographic late luminal loss was significantly lower in patients with DES than in those patients with BMS (0.35 +/- 0.66 vs 0.71 +/- 0.38 mm, p = 0.011). Multivariate analysis identified the use of DES (beta = -0.32, 95% confidence interval [CI] -0.57 to -0.26, p = 0.03) and a smaller baseline reference vessel diameter (beta = 0.29, 95% CI 0.04 to 0.54, p = 0.02) as independent predictors of lower late loss. Moreover, intravascular ultrasound showed a significant reduction of in-stent neointimal hyperplasia formation related to DES use compared with BMS use (Delta neointimal hyperplasia volume 5.4 mm(3) [95% CI 2.7 to 28.1] vs 35.9 mm(3) [95% CI 22.0 to 43.6], p = 0.035). In conclusion, these findings suggest that the use of DES is safe and may prevent ISR and neointimal hyperplasia formation in patients who undergo intracoronary bone marrow mononuclear cell transplantation after a successfully revascularized ST elevation myocardial infarction.

Optical coherence tomography. Initial experience in patients undergoing percutaneous coronary intervention.

Optical coherence tomography is a new intracoronary diagnostic technique that has a higher resolution than other techniques, such as intravascular ultrasound. We used optical coherence tomography to study outcomes after stent implantation in six patients who had undergone percutaneous coronary intervention, and in whom angiography showed normal results after revascularization. Material was observed to protrude through the stent struts in all patients, small dissections were seen at the stent edges in four patients, and there was incomplete stent apposition in four patients. In two patients, small amounts of thrombus were observed to form around the tomography catheter. With optical coherence tomography, it was possible to detect areas in which the results of percutaneous coronary intervention were suboptimal, despite a satisfactory appearance on angiography.

Diagnósticos clínicos al ingreso y al egreso de pacientes hospitalizados en Medicina Interna, Geriatría e Infecciosos / Clinical diagnoses in admission and in discharge of patients admitted to Internal Medicine, Geriatrics and Infection wards

A partir de asumir que una coincidencia entre el diagnóstico inicial al ingreso y el definitivo al egreso, refleja alta calidad en el cumplimiento de ese paso esencial del método clínico, se revisaron los resultados de dos series de pacientes hospitalizados en Medicina Interna, Geriatría e Infecciosos, para precisar factores asociados con dicha correspondencia. Se constató total coincidencia en más de las dos terceras partes de los casos, con porcentajes elevados en los más jóvenes, los que tuvieron menor estadía y los que ingresaron en el horario de las guardias. Se destacan los altos valores para enfermedades respiratorias e infecciosas y más bajos para diagnósticos menos precisos, como anemias, síntomas y signos mal definidos y para los ingresados en Geriatría. Se hacen consideraciones sobre el error diagnóstico y la trascendencia de estos resultados para los pacientes y la organización de la atención hospitalaria

The assumption that there is a coincidence between the initial diagnosis at admission and the definite at discharge reflects a high quality in fulfillment of this essential step of clinical method. Results from two series of patients admitted in Internal Medicine, Geriatrics and infectiuos diseases departments were reviewed to specify exactly the factors associated with such correspondence. Authors verified the total coincidence in more than the two third of cases with high percentages in younger, which had a minor stage and those admitted in the medical duty times. Emphasized are the higher values for the respiratory and infectious diseases and lower for fewer accurate diagnoses including anemias, ill-defined symptoms and signs and for those admitted in Geriatrics department. We took into account on the diagnostic error and the importance of these results for patients and the organization of hospital care

Safety of coronary stenting early after thrombolysis in patients with acute myocardial infarction: one- and six-month clinical and angiographic evolution.

To determine the feasibility and safety of early posthrombolysis coronary stenting and the incidence of further reocclusion, we followed 99 consecutive patients with acute myocardial infarction thrombolyzed with rt-PA 2.0 +/- 0.8 hr after onset. Culprit artery was stented 14.0 +/- 7.0 hr after thrombolysis. All patients underwent clinical and angiographic follow-up at 1 and 6 months. Angiographic success was achieved in 99% of cases. Neither major cardiac events nor bleeding or vascular complications occurred during hospital stay. At 30 days, no events occurred and normal flow persisted in all stented arteries. At 6 months, only one artery reoccluded (1%), resulting in a nonfatal reinfarction. Restenosis rate was 21%. Contribution of the infarcted area to left ventricular function significantly increased from baseline to 30-day and to 6-month evaluations. Thus, early posthrombolysis stenting is a safe strategy with a low reocclusion rate, which seems to allow functional recovery of the infarcted area. Further studies are necessary to define its impact on survival and cost-effectiveness.

Vinculación de los fundamentos filosóficos del método de simulación con la modelación como método científico general de investigación / Linking of the philosophic foundations of the simulation method with modelling as a general scientific research method

La modelación es un método de obtención del conocimiento, de aplicación en varias ciencias, en el cual se opera con un objeto, no en forma directa sino utilizando cierto sistema intermedio auxiliar conocido como modelo. El presente trabajo profundiza en los fundamentos filosóficos de la simulación como método de enseñanza a partir de su relación con el método de la modelación. Se expone cómo la modelación, un método científico general, logra una importante aplicación en una ciencia específica mediante la simulación de casos, en la cual se utiliza un modelo del proceso de atención médica para la ejercitación de los estudiantes en la solución de problemas de salud individuales. Se reconocen las limitaciones del uso de estos modelos y se enfatiza la importancia del empleo de estos métodos en la formación de los profesionales médicos

Modelling is a method to acquire knowledge that may be applied in several sciences and where you work with an object, not in a direct way, but using some auxiliary intermediate system known as model. The present paper goes deep into the philosophical foundations of simulation as a teaching method, starting from its relation with the modelling method. It is explained how modelling, a general scientific method, is significantly applied to a specific science by case simulation, where a model of the medical attention process is used for exercising students in the solution of individual health problems,. The limitations of the use of these models is recognized and emphasis is made on the utilization of these methods to train medical proffesionals

Monitoreo de la presión intraabdominal (PIA) en el paciente quirúrgico grave / Monitoring of intraabdominal pressure (IAP) in the severe surgical patient

Se realizó un estudio prospectivo-investigativo sobre el valor de la medición de la presión intraabdominal (PIA) en nuestro medio para determinar su valor como diagnóstico y pronóstico en los pacientes quirúrgicos admitidos en la Unidad de Terapia Intensiva del Hospital Universitario Clinicoquirúrgico Gustavo Aldereguía Lima, del 1ro. de marzo al 31 de diciembre de 1998 (n:80). A la totalidad de los casos se le realizó medición y aplicó encuesta para determinar valores al ingreso y a las 6, 12, 24 y 48 horas y cierre de su evolución, así como la presencia de complicaciones y aparición de signos clínicos. Se aplicó método de significación estadística de la t de student y análisis de riesgo absoluto y relativo con media y desviación estándar. Se determinó que la PIA tiene un alto valor predictivo en la aparición de complicaciones de pacientes quirúrgicos, y su aumento estableció un pronóstico desfavorable en cuanto a complicaciones y riesgo de muerte, su elevación antecede a la aparición de signos clínicos como fiebre, taquicardia o taquipnea y el valor de su lectura se incrementa en la medida en que transcurre el tiempo de evolución(AU)

A prospective and investigative study was made to determine the diagnostic and prognostic value in our environment of the measurement of intraabdominal pressure (IAP) in surgical patients admitted in the Intensive Care Unit of the "Gustavo Aldereguia Lima" Clinical and Surgical Teaching Hospital from March 1st to December 3lst, 1998 (n:80). All the cases were measured and surveyed in order to determine values on admission and at 6, 12, 24, and 48 hours and at the end of their evolution. The complications and the appearance of clinical signs were also determined. The t of student method of statistical significance and the analysis of relative and absolute risk with mean and standard deviation were applied. It was observed that IAP has a high predictive value in the appearance of surgical patients and that its increase produced an unfavorable prognosis regarding complications and death risk. Its rise preceeds the appearance of clinical signs such as fever, tachycardia, or tachypnea and the value of its reading increases as the time of evolution goes by(AU)

Síndrome de munchausen: un reto para el clínico / Munchausen's syndrome: a challenge for the clinician

Se afirmó que en las últimas décadas, y por la creciente medicalización de la sociedad, se ha descrito la aparición de pacientes con enfermedades ficticias ®complejas¼, que durante años son atendidos en diversas instituciones, demandan gran cantidad de recursos e increpan a los profesionales de la salud por no resolver sus quejas y enfermedades. No es posible demostrar las abigarradas entidades que se buscan afanosamente y que la mayoría de los médicos no se atreven a descartar totalmente por diversos motivos. No son histéricos ni simuladores en el sentido clásico, aunque conscientes de sus actos, tal parece como si los realizaran impelidos por razones que ni ellos mismos comprenden. Para ellos se ha introducido la denominación de síndrome de Munchausen. Se hizo un breve recuento sobre los criterios diagnósticos, grupos de riesgo, cuadro clínico, modus operandi, consecuencias adversas, tratamiento y pronóstico de este moderno desafío que pone a prueba la sagacidad clínica del médico contemporáneo

Correlación clínico-patológica en pacientes fallecidos con diagnóstico clínico o anatomopatológico de enfermedad cerebrovascular durante los años 1997 al 2001 / Clinical and pathological correlation in dead patients with clinical or anatomopathological diagnosis of cerebrovascular disease from 1997 to 2001

Se realizó un estudio descriptivo correlacional, retrospectivo de 969 pacientes fallecidos en el Hospital "Dr. Gustavo Aldereguía Lima" de Cienfuegos durante los años 1997 al 2001 para determinar el comportamiento de la correlación clínico-patológica en pacientes con diagnóstico clínico o anatomopatológico de enfermedad cerebrovascular. Se halló que en el 51 por ciento de los casos hubo correlación total, en el 23 por ciento la correlación fue parcial y no hubo correlación en el 26 por ciento de los pacientes. Hubo mayor correlación en los pacientes que presentaron toma de la conciencia y/o focalización neurológica motora, y cefalea, como formas de presentación clínica. En los casos de no correlación, fue más frecuente el sobrediagnóstico clínico de enfermedad cerebrovascular, que el hallazgo de ésta en la necropsia; la bronconeumonía fue la principal responsable de ambas situaciones

Mortalidad por neoplasias malignas en la población adulta de la provincia de Cienfuegos durante el decenio 1988-1997 / Mortality from malignant neoplasias in the adult population of Cienfuegos province during 1988-1997

Se realizó una serie cronológica que estudió 5 096 pacientes fallecidos por cáncer para caracterizar la mortalidad por neoplasias malignas en la población adulta de la provincia de Cienfuegos durante el decenio 1988-1997. Se analizaron las variables edad, sexo, lugar del fallecimiento y tipo de tumor; se calcularon los años potenciales de vida perdidos y la tendencia lineal de las tasas de mortalidad (estandarizadas) mediante el método de los semipromedios. Se observó que la razón de mortalidad proporcional por cáncer se mantuvo alrededor del 20 por ciento anualmente, mientras que el número de fallecidos y la tasa general de mortalidad por esa causa mostraron tendencias al incremento. Fallecieron en este período 1 166 pacientes por cáncer de pulmón, tráquea y bronquios (22,8 por ciento del total); se constató una franca tendencia al fallecimiento extrahospitalario y una discreta tendencia al aumento de los años de vida potenciales perdidos por cáncer