Pharmaceutical cost savings from the treatment of oncology patients in clinical trials.

OBJECTIVE: The aim of this study was twofold: to assess the annual pharmaceutical savings associated with the treatment of cancer patients at Marqués de Valdecilla University Hospital and to estimate the cost of innovative antineoplastic therapies that patients receive as experimental treatment, both during clinical trials throughout 2020. MATERIAL AND METHODS: An observational and financial analysis of the drug cost related to clinical trials was applied. Direct cost savings to the Regional Health System of Cantabria and the cost of innovative therapies used as an experimental treatment in clinical trials were quantified. RESULTS: This study includes 38 clinical trials with a sample of 101 patients. The clinical trials analyzed provide a total cost savings of €603,350.21 and an average cost saving of €6,630.22 per patient. Furthermore, the total investment amounts to €789,892.67, with an average investment of €15,488.09 per patient. CONCLUSIONS: Clinical trials are essential for the advancement of science. Furthermore, clinical trials can be a significant source of income for both hospitals and Regional Health Systems, contributing to their financial sustainability.

Hipernatremia en pacientes con estado crítico por afecciones neurológicas

Fundamento: los trastornos del sodio son los más comunes y menos entendidos en pacientes con lesión cerebral aguda debido al papel principal que desempeña el sistema nervioso central en la regulación de la homeostasis del sodio y agua lo que puede llevar a complicaciones graves y resultados adversos, incluyendo la muerte. Objetivo: determinar la contribución a la mortalidad de la hipernatremia en pacientes con estado crítico por afecciones neurológicas. Métodos: estudio observacional analítico sobre 55 pacientes que ingresaron en las unidades de atención al grave del Hospital Universitario Arnaldo Milián Castro, entre octubre del 2020 y mayo del 2022, con independencia del valor del sodio plasmático a su admisión en el servicio, así como durante su estadía en las unidades de atención al grave. Se emplearon métodos estadísticos univariados y bivariados en el análisis de los datos. Resultados: el promedio de edad fue de 60±16 años. Los diagnósticos más relevantes fueron la hemorragia intraparenquimatosa (56,37 %), el trauma craneoencefálico y el accidente cerebrovascular isquémico (ambos 30 %). Las concentraciones plasmáticas de sodio mostraron diferencias significativas (pX2= 0,000), siendo la media mayor a las 24 horas de ingreso (174,2±133,6) y la menor al 5to día (102,9±72,9). Existió correlación significativa entre las concentraciones plasmáticas de sodio al ingreso ( 24 h y 72 h) y el estado al egreso. En el análisis bivariado individual por período, solo a las 24 horas hubo relación significativa, en este periodo la hipernatremia contribuyó a la mortalidad en 1,78 veces más que en aquellos que no tenían el sodio elevado (OR=1,78 con IC: 1,39-3,4). Conclusiones: la hipernatremia en el paciente con estado crítico por afecciones neurológicas se asocia con incremento de la mortalidad.

Background: sodium disorders are the most common and least understood in patients with acute brain injury due to the major role played by the central nervous system in regulating sodium and water homeostasis, which can lead to serious complications and adverse outcomes, including death. Objective: to determine the hypernatremia contribution to mortality in patients with neurological conditions in critical state. Methods: longitudinal analytical observational study on 55 patients who were admitted to the acute care units at the Arnaldo Milián Castro University Hospital, between October 2020 and May 2022, regardless of the plasma sodium value upon admission to the service, as well as during their stay in the critical care units. Univariate and bivariate statistical methods were used in data analysis. Results: the average age was 60 ± 16 years. The most relevant diagnoses were intraparenchymal hemorrhage (56.37%), head trauma, and ischemic stroke (both 30%). Plasma sodium concentrations showed significant differences (pX2= 0.000), with the highest average at 24 hours of admission (174.2 ± 133.6) and the lowest at the 5th day (102.9 ± 72.9). There was a significant correlation between plasma sodium concentrations at admission, 24h and 72h with the state at discharge. In the individual bivariate analysis by period, there was only a significant relationship after 24 hours. In this period, hypernatremia contributed 1.78 times more to mortality than in those who did not have elevated sodium (OR=1.78 with CI: 1,39-3,4). Conclusions: hypernatremia in critically ill patients with neurological conditions is associated with increased mortality.

Towards the Search for Potential Biomarkers in Osteosarcoma: State-of-the-Art and Translational Expectations.

Osteosarcoma represents a rare cause of cancer in the general population, accounting for <1% of malignant neoplasms globally. Nonetheless, it represents the main cause of malignant bone neoplasm in children, adolescents and young adults under 20 years of age. It also presents another peak of incidence in people over 50 years of age and is associated with rheumatic diseases. Numerous environmental risk factors, such as bone diseases, genetics and a history of previous neoplasms, have been widely described in the literature, which allows monitoring a certain group of patients. Diagnosis requires numerous imaging tests that make it possible to stratify both the local involvement of the disease and its distant spread, which ominously determines the prognosis. Thanks to various clinical trials, the usefulness of different chemotherapy regimens, radiotherapy and surgical techniques with radical intent has now been demonstrated; these represent improvements in both prognosis and therapeutic approaches. Osteosarcoma patients should be evaluated in reference centres by multidisciplinary committees with extensive experience in proper management. Although numerous genetic and rheumatological diseases and risk factors have been described, the use of serological, genetic or other biomarkers has been limited in clinical practice compared to other neoplasms. This limits both the initial follow-up of these patients and screening in populations at risk. In addition, we cannot forget that the diagnosis is mainly based on the direct biopsy of the lesion and imaging tests, which illustrates the need to study new diagnostic alternatives. Therefore, the purpose of this study is to review the natural history of the disease and describe the main biomarkers, explaining their clinical uses, prognosis and limitations.

The Economic Burden of Localized Prostate Cancer and Insights Derived from Cost-Effectiveness Studies of the Different Treatments.

Prostate cancer has huge health and societal impacts, and there is no clear consensus on the most effective and efficient treatment strategy for this disease, particularly for localized prostate cancer. We have reviewed the scientific literature describing the economic burden and cost-effectiveness of different treatment strategies for localized prostate cancer in OECD countries. We initially identified 315 articles, studying 13 of them in depth (those that met the inclusion criteria), comparing the social perspectives of cost, time period, geographical area, and severity. The economic burden arising from prostate cancer due to losses in productivity and increased caregiver load is noticeable, but clinical decision-making is carried out with more subjective variability than would be advisable. The direct cost of the intervention was the main driver for the treatment of less severe cases of prostate cancer, whereas for more severe cases, the most important determinant was the loss in productivity. Newer, more affordable radiotherapy strategies may play a crucial role in the future treatment of early prostate cancer. The interpretation of our results depends on conducting thorough sensitivity analyses. This approach may help better understand parameter uncertainty and the methodological choices discussed in health economics studies. Future results of ongoing clinical trials that are considering genetic characteristics in assessing treatment response of patients with localized prostate cancer may shed new light on important clinical and pharmacoeconomic decisions.

Thoracic Epithelioid Hemangioendothelioma: clinical demonstration and therapeutic procedures.

Epithelioid hemangioendotheliomais a low to intermediate grade malignant vascular tumors that can involve any organ. About 60-80%of patients are women, patient ages range 7 to 81 years, with a median age of 38 years. Four cases of thoracic epithelioid hemangioendotheliomas with different clinical presentation and disease progression are reported. Cases 1 and 2 are pulmonary epithelioid hemangioendotheliomas diagnosed at different advanced stages and patients died after 6 and 2,5 months of medical treatment, respectively. Case 3 corresponds to pleural epithelioid hemangioendothelioma, submit- ted to left lung decortication and pleuro-pericardial window; patient is free either from symptoms and radiographic manifestations for 10 months of follow-up. Case 4, of mediastinal epithelioid hemangioendothelioma, represented by a mass in the upper left mediastinum adherent to the aortic arch; patient underwent block excision of the mass followed by chemotherapy; subsequent recurrence 41 months later and the patient died 8 months after. The reported 4 cases reveal the heterogeneous clinical presentation of epithelioid hemangioendotheliomas with behavior in between benign and high-grade tumors, raising difficulty in either differentiating from other vascular tumors and previewing clinical outcome.

Patient deaths during the period of prolonged stay in cases of delayed discharge for nonclinical reasons at a university hospital: a cross sectional study.

Background: Delayed discharge for non-clinical reasons also affects patients in need of palliative care. Moreover, the number of people dying in hospitals has been increasing in recent years. Our aim was to describe characteristics of patients who died during prolonged stay, in comparison with the rest of patients with delayed discharge, in terms of length of hospital stay, patient characteristics and the context of care. Methods: A descriptive cross-sectional study at a high complexity public hospital in Northern Spain (2007-2015) was conducted. To compare the differential characteristics of the groups of patients died during delayed discharge with the rest, Student's T test and Pearson's chi-square test (χ 2) were used. Results: A total of 198 patients died (6.57% of the total), with a mean total stay of 27.45 days and a prolonged stay of 10.69 days. Mean age 77.27 years. These were highly complex cases, 77.79% resided in the urban area, were admitted urgently (95.45%), to internal medicine or oncology wards, and the most common diagnosis was pneumonia. In people with terminal illness, clinicians can better identify when therapeutic possibilities are exhausted and acute hospitalization is not an adequate resource for their needs. Living in an urban area with the availability of palliative care hospital beds is related to the decision to die in hospital.

THE MALIGNANCY OF A BENIGN TUMOR.

A 67-year-old man with fatigue and dyspnea, in NYHA class IV, was admitted to our hospital. His evaluation, physical examination, and other investigations were carried out. An atypical finding was found and he was referred for cardiac surgery.

Patrones hemodinámicos cerebrales en pacientes con trauma craneoencefálico y su relación con la mortalidad

RESUMEN Fundamento: la mortalidad por traumatismo craneoencefálico grave es elevada y se debe a los disturbios hemodinámicos intracraneales que este provoca. Objetivo: determinar los patrones de flujo sanguíneo cerebral en el paciente con traumatismo craneoencefálico y su relación con la mortalidad. Métodos: estudio descriptivo, transversal realizado en las Unidades de Atención al Grave del Hospital Clínico-Quirúrgico Arnaldo Milían Castro, de Santa Clara, provincia Villa Clara, desde el año 2004 al 2007 y del 2018 al 2020. El ultrasonido Doppler transcraneal se le realizó a 82 pacientes, en las primeras 24 horas del ingreso, posterior a la estabilidad hemodinámica y respiratoria. Se determinaron las variables escala de coma de Glasgow, patrones de flujo sanguíneo cerebral y la mortalidad. La información fue procesada mediante el programa estadísticos SPSS/PC versión 15 para Windows, se aplicó un procesamiento estadístico con análisis univariado. Resultados: se estudiaron 82 pacientes, con una letalidad del 37,8 % del total; la mayor letalidad ocurrió entre los pacientes mayores de 65 años(60 %)(p=0,01). La escala de coma de Glasgow de 8 o menos puntos incluyó a 67 pacientes, con mortalidad del 43 % (p=0.00). El patrón isquémico cerebral fue el más diagnosticado (43,9 %) con una mortalidad del 74 %(p=0.03). Conclusiones: el patrón de flujo sanguíneo isquémico es el más frecuente y tiene una significativa relación con la mortalidad. La escala de coma de Glasgow tiene una relación significativa con la mortalidad del paciente con traumatismo craneoencefálico.

ABSTRACT Background: mortality from severe head trauma is high and is due to the intracranial hemodynamic disorders that it causes. Objective: to determine the patterns of cerebral blood flow in the patient with head trauma and its relationship with mortality. Methods: descriptive, cross-sectional study carried out in the Arnaldo Milían Castro Clinical-Surgical Hospital Serious Care Units, Santa Clara, Villa Clara province, from 2004 to 2007 and from 2018 to 2020. The transcranial Doppler ultrasound was performed in 82 patients, in the first 24 hours after admission, after hemodynamic and respiratory stability. The Glasgow coma scale variables, cerebral blood flow patterns and mortality were determined. The information was processed using the statistical program SPSS / PC version 15 for Windows, statistical processing with univariate analysis was applied. Results: 82 patients were studied, with mortality of 37.8% of the total; the highest fatality occurred among patients older than 65 years (60%) (p = 0.01). The Glasgow coma scale of 8 or less points included 67 patients, with a mortality of 43% (p = 0.00). The cerebral ischemic pattern was the most diagnosed (43.9%) with a mortality of 74% (p = 0.03). Conclusions: the ischemic blood flow pattern is the most frequent and has a significant relationship with mortality. The Glasgow coma scale has a significant relationship with the mortality of patients with head trauma.

Resultados Clínicos e Hemodinâmicos de Longo Prazo após o Transplante de Coração em Pacientes Pré-Tratados com Sildenafil / Long-Term Clinical and Hemodynamic Outcomes after Heart Transplantation in Patients Pre-Treated with Sildenafil

Resumo Fundamento A resistência vascular pulmonar elevada ainda é um grande problema na seleção de candidatos ao transplante cardíaco. Objetivo Nosso objetivo foi avaliar o efeito da administração de sildenafila pré-transplante cardíaco em pacientes com hipertensão pulmonar fixa. Métodos O estudo retrospectivo, de centro único, incluiu 300 candidatos a transplante cardíaco consecutivos tratados entre 2003 e 2013. Destes, 95 pacientes tinham hipertensão pulmonar fixa e, dentre eles, 30 pacientes foram tratados com sildenafila e acabaram passando pelo transplante, formando o Grupo A. O Grupo B incluiu 205 pacientes sem hipertensão pulmonar que passaram pelo transplante cardíaco. A hemodinâmica pulmonar foi avaliada antes do transplante, 1 semana e 1 ano após o transplante. A taxa de sobrevivência foi comparada entre os grupos. Neste estudo, um P valor < 0,05 foi considerado estatisticamente significativo. Resultados Após o tratamento com sildenafila, mas antes do TxC, a RVP (-39%) e a PAPs (-10%) diminuíram significativamente. A PAPs diminuiu após o TxC em ambos os grupos, mas permaneceu significativamente alta no grupo A em relação ao grupo B (40,3 ± 8,0 mmHg versus 36,5 ± 11,5 mmHg, P=0,022). Um ano após o TxC, a PAPs era 32,4 ± 6,3 mmHg no Grupo A versus 30,5 ± 8,2 mmHg no Grupo B (P=0,274). O índice de sobrevivência após o TxC 30 dias (97% no grupo A versus 96% no grupo B), 6 meses (87% versus 93%) e um ano (80% versus 91%) após o TxC não foi estatisticamente significativo (Log-rank P=0,063). Depois do primeiro ano, o índice de mortalidade era similar entre os dois grupos (sobrevivência condicional após 1 ano, Log-rank p=0,321). Conclusão Nos pacientes com HP pré-tratados com sildenafila, a hemodinâmica pós-operatória inicial e o prognóstico são numericamente piores em pacientes sem HP, mas depois de 1 ano, a mortalidade em médio e longo prazo são semelhantes. (Arq Bras Cardiol. 2021; 116(2):219-226)

Abstract Background Elevated pulmonary vascular resistance remains a major problem for heart transplant (HT) candidate selection. Objective This study sought at assess the effect of pre-HT sildenafil administration in patients with fixed pulmonary hypertension. Methods This retrospective, single-center study included 300 consecutive, HT candidates treated between 2003 and 2013, in which 95 patients had fixed PH, and of these, 30 patients were treated with sildenafil and eventually received a transplant, forming Group A. Group B included 205 patients without PH who underwent HT. Pulmonary hemodynamics were evaluated before HT, as well as 1 week after and 1 year after HT. Survival was compared between the groups. In this study, a p value < 0.05 was considered statistically significant. Results After treatment with sildenafil but before HT, PVR (-39%) and sPAP (-10%) decreased significantly. sPAP decreased after HT in both groups, but it remained significantly higher in group A vs. group B (40.3 ± 8.0 mmHg vs 36.5 ± 11.5 mmHg, p=0.022). One year after HT, sPAP was 32.4 ± 6.3 mmHg in group A vs 30.5 ± 8.2 mmHg in group B (p=0.274). The survival rate after HT at 30 days (97% in group A versus 96% in group B), at 6 months (87% versus 93%) and at one year (80% vs 91%) were not statistically significant (Log-rank p=0.063). After this first year, the attrition rate was similar among both groups (conditional survival after 1 year, Log-rank p=0.321). Conclusion In patients with severe PH pre-treated with sildenafil, early post-operative hemodynamics and prognosis are numerically worse than in patients without PH, but after 1 year, the medium to long-term mortality proved to be similar. (Arq Bras Cardiol. 2021; 116(2):219-226)

A DOUBLE DOSE OF AORTIC STENOSIS: AN UNUSUAL CASE.

Supravalvular aortic stenosis is a rare congenital anomaly (less than 0.05% of all congenital heart defects). This aortic root anomaly consists in a narrow aortic lumen immediately above the aortic valve and represents the least common form of left ventricular outflow tract obstruction. Clinical presentation is usually in the first decades of life. In most cases, the aortic valve leaflets are morphologically normal. However, aortic insufficiency due the high systolic pressure proximal to the sinotubular junction is the most commonly abnormality described. There are very few cases described in the literature with concomitant valvular and supra-valvular aortic stenosis.

Quadricuspid aortic valve with a hidden left ostium: Case report and literature review.

Quadricuspid aortic valve (QAV) is a rare congenital condition that frequently progresses to aortic regurgitation with clinical impact in adulthood. Surgical treatment is required in the fifth to sixth decade of life in about one fifth of patients. We describe the case of a 64-year-old woman with regular cardiological follow-up for severe aortic valve regurgitation who had suffered recent clinical and echocardiographic deterioration. Conventional open surgery was indicated. During the procedure, a QAV with leaflet retraction and central orifice was observed. The aortic valve was successfully replaced.

[Very elderly institutionalised population of Barcelona: Evaluation of frailty according to the Frail-VIG index and analysis of therapeutic appropriateness according to the STOPP-frail criteria]. / Población muy anciana institucionalizada de Barcelona: valoración de la fragilidad según el índice frágil-VIG y análisis de la adecuación terapéutica según los criterios STOPP-frail.

INTRODUCTION: As frailty and multiple drug therapy often coexists in institutionalised elderly patients, it is important to assess the level of frailty and therapeutic appropriateness in this population group. The aim of the study is to: assess the frailty level of institutionalised elderly patients and to analyse their prescriptions. MATERIAL AND METHODS: An observational and cross-sectional study of a geriatric population of 85 years or older, institutionalised in a nursing home in Barcelona. Frailty was assessed using the Frail-VIG index, and the adequacy of the prescription of each group was done according to the STOPP-Frail Criteria. RESULTS: The study included 79 patients, with a mean age of 90.9±4.2 years. Most of them (96.2%) had some degree of frailty. Slight frailty was observed in 21.5%, moderate in 37.7%, and advanced in 38%. The patients were prescribed a median of 7 drugs. No statistically significant differences were found in the majority of the prescriptions of the frailty groups. Differences were only found for those who had difficulty taking the medication, those who took medication for prostatic hypertrophy, and nutritional supplements. In all 3 groups, it was found that up to one third of the prescription was inappropriate, and some were even contraindicated in the most frail patients. CONCLUSION: The elderly study population has a high frailty index with a high prevalence of multiple drug therapy with inappropriate prescription. The poor individualisation of these prescriptions in relation to the level of frailty, especially in those with short life prognosis, is a situation that should be improved.

Presión intraabdominal y ventilación artificial mecánica. Hospital "Arnaldo Milián Castro". 2014-2015 / Intra-abdominal pressure and mechanical artificial ventilation. Arnaldo Milián Castro Hospital. 2014-2015

Introducción: La cavidad abdominal y la caja torácica se encuentran separadas por el diafragma, por lo que las variaciones en las presiones dentro de una, repercuten sobre las presiones de la otra. La hipertensión intraabdominal es hoy una entidad frecuente en el paciente crítico en el que constituye un factor de riesgo importante de complicaciones y mortalidad, ya que influye sobre órganos y sistemas. Objetivo: Relacionar la presión intraabdominal con presiones de la ventilación artificial mecánica y parámetros de la función respiratoria, cardiovascular y renal. Material y Métodos: Se realizó un estudio descriptivo y prospectivo de la presión intraabdominal en pacientes sometidos a ventilación mecánica, con enfermedades clínicas y quirúrgicas, en las Unidades de Cuidados Intensivos del Hospital Clínico Quirúrgico Arnaldo Milán Castro, durante el período comprendido entre enero 2014 hasta diciembre 2015. Resultados: Los pacientes clínicos con presiones de la vía aérea elevadas mostraron valores más altos de presión intraabdominal, y aquellos pacientes postquirúrgicos que cursaron con niveles altos de presión dentro del abdomen también presentaron los valores más elevados de presión pico y media registradas en el ventilador mecánico. Conclusiones: La tensión arterial media, el ritmo diurético y la saturación periférica de oxígeno disminuyeron, mientras que la presión venosa central, la presión parcial de dióxido de carbono en sangre y la creatinina aumentó ante los aumentos de la presión dentro del abdomen(AU)

Introduction: The abdominal cavity and the thoracic cage are separated by the diaphragm; therefore, the variations in the pressures within one of them have an effect on the pressures of the other. At present, intra-abdominal hypertension is a frequent entity in the critically ill patient, which constitutes an important risk factor for complications and mortality since it influences on different organs and systems. Objective: To relate intra-abdominal pressure with mechanical artificial ventilation pressures and parameters of respiratory, cardiovascular and renal function. Material and Methods: A descriptive prospective study of intra-abdominal pressure was conducted in patients undergoing mechanical ventilation with clinical and surgical diseases in the Intensive Care Units of the Arnaldo Milán Castro Hospital, during the period between January 2014 until December 2015. Results: Clinical patients with high values of airway pressures showed higher values of intra-abdominal pressure, and those post-surgical patients who presented with high levels of pressure inside the abdomen indicated the highest values of peak and average pressure recorded in the mechanical ventilator. Conclusions: Mean arterial pressure, diuretic rate and peripheral oxygen saturation decreased, whereas the central venous pressure, the partial pressure of carbon dioxide in blood, and creatinine increased due to raises in pressure within the abdomen(AU)

Primary graft failure after cardiac transplantation: prevalence, prognosis and risk factors.

OBJECTIVES: Primary graft failure (PGF) is a common and devastating complication, despite the advances in perioperative treatment. We aim to evaluate the prevalence of PGF and its impact on survival and to explore associated risk factors. METHODS: From November 2003 through December 2015, 290 patients submitted to cardiac transplantation were classified into non-PGF (243; 84%) and PGF (47; 16%) groups. The characteristics of the recipients were similar regarding age (54.6 ± 10.6 vs 54.0 ± 9.4 years; P = 0.74), male gender (78.2% vs 72.3%; P = 0.38) and transpulmonary gradient (9.4 ± 4.2 vs 10.5 ± 5.6 mmHg; P = 0.15); donors to the PGF group had similar age (35.5 ± 11.4 vs 37.5 ± 10.7 years; P = 0.27) but were predominantly female (21% vs 42.6%; P = 0.002). RESULTS: Mean ischaemic (89.0 ± 36.8 vs 103.3 ± 44.7 min; P = 0.019) and cardiopulmonary bypass (92.8 ± 14.5 vs 126.3 ± 62.4 min; P < 0.001) times were longer in the PGF group. Length of hospital stay was 13.5 ± 7.5 vs 28.9 ± 35.2 days (P= 0.005). Hospital mortality was 4.1% [1.6% for non-PGF and 17% for PGF (P < 0.001)]. Survival at 1, 5 and 10 years was 95.5 ± 1.3% vs 55.3 ± 7.3%, 84.1 ± 2.5% vs 47.4 ± 7.6% and 67.1 ± 3.8% vs 14.4 ± 12%, respectively (P < 0.001). Risk factors for PGF were female donor [odds ratio (OR): 2.56; 95% confidence interval (CI): 1.29-5.09; P = 0.007], total ischaemic time (OR: 1.01; 95% CI: 1.00-1.02; P = 0.032) and preoperative mechanical extracorporeal circulatory support (OR: 11.90; 95% CI: 2.62-54.12; P = 0.001). CONCLUSIONS: Our results demonstrate that PGF is associated with poor outcomes that extend beyond the 1st month and the 1st year after heart transplantation. We found female donor, total ischaemic time and preoperative mechanical extracorporeal circulatory support to be risk factors for PGF.

Heart transplantation for Chagas cardiomyopathy.

Chagas disease is an endemic disease in Latin America that is increasingly found in non-endemic areas all over the world due to the flow of migrants from Central and South America. We present the case of a Brazilian immigrant in Portugal who underwent orthotopic heart transplantation for end-stage Chagas cardiomyopathy. Immunosuppressive therapy included prednisone, mycophenolate mofetil and tacrolimus. Twelve months after the procedure she is asymptomatic, with good graft function, and with no evidence of complications such as graft rejection, opportunistic infections, neoplasms or reactivation of Trypanosoma cruzi infection. By reporting the first case in Portugal of heart transplantation for Chagas cardiomyopathy, we aim to increase awareness of Chagas disease as an emerging global problem and of Chagas cardiomyopathy as a serious complication for which heart transplantation is a valuable therapeutic option.

Heart transplantation: Early Results of Two Different Regimes of Immnunosuppression.

INTRODUCTION: The management of induction and maintenance immunosuppression therapy after heart transplantation (HT) remains a controversial issue. The dosage and the timing has been a changing target. We aimed at evaluate the incidence of acute cellular rejection (ACR) [≥1R grade], major infection and survival in first year after HT in patients receiving two different induction immunosuppression regimes and with a reduction in intensity of triple maintenance immunosuppression dose. METHODS: From November-2003 to June-2016, 317 patients were submitted to HT. After excluding those with pediatric age (n=8), those with previous renal or hepatic transplantation (n=2), those submitted to retransplantation (n=2), patients with early death without endomiocardial biopsy (n=10) and those in a transition maintenance regime (n=26), the study population resulted in 269 patients. These patients were divided in two groups: patients receiving the previous regime of two doses of basiliximab (group A, n=211) and those receiving a single dose of basiliximab (group B, n=58). All the patients were treated with a maintenance standard triple immunosuppressive regimen of corticosteroids, an inhibitor of calcineurin and mycophenolate mofetil but more immunosuppressive load in group A. RESULTS: Mean age of the recipients (group A vs. group B) was 54.6±10.6vs.55.0±9.8 years (p=0.808); 77.3%vs.75.9% were male (p=0.861); 28.4%vs.28.1% were diabetic (p=0.957); and ischemic etiology was present in 39.8%vs 41.0% of the patients (p=0.798), respectively. No differences were found, at first year, between the two groups concerning global ACR incidence (55.0%vs.56.9%, p=0.882, respectively) but major ACR (≥2R grade) was slightly superior in group B (16.6%vs.27.6%, p=0.080, respectively). Time-free from major ACR at 3rd, 6th and 12th months was, respectively 91.0±2.0%vs.84.5%±4.8%; 86.7±2.3%vs.74.1±5.7%; and 83.4±2.6%vs.72.4±5.9% (p=0.048). Time-free from major infection at 3rd, 6th and 12th months was, respectively 89.6±2.1%vs.82.8±5.0%; 87.7±2.3%vs.79.3±5.3%; and 84.4±2.5%vs.79.3±5.3% (p=0.253). No differences were found concerning survival at 3rd, 6th and 12th months (94.3±1.6%vs.94.8±2.9%; 92.4±1.8%vs.93.1±3.3%; and 90.0±2.1%vs.91.4±3.7%, (p=0.771) respectively). CONCLUSION: With this study, we verified that lowering doses of induction and maintenance therapy was responsible for increase cases of major ACR at first year of heart transplant. However, no differences were found concerning the incidence of major infection and early survival. Hence, effective immunosuppression induction regimen can apparently be done safely with a single dose regime without compromising survival at first year after HT.

Coronary Allograft Vasculopathy after Cardiac Transplantation: Prevalence, Prognostic and Risk Factors.

INTRODUCTION: Coronary allograft vasculopathy (CAV) is still a serious long-term complication after cardiac transplantation. PURPOSE: To evaluate the prevalence of CAV in a single institution, its impact on survival and to explore associated risk factors. METHODS: From November-2003 through June-2016, 316 patients were submitted to cardiac transplantation. After excluding those with paediatric age (n=8), those with previous renal or hepatic transplantation (n=2) and those who didn't survive the first year after cardiac transplantation (n=40), the study population resulted in 266 patients. Forty two patients (15.8%) with CAV, diagnosed by a new >50% coronary artery stenosis in any vessel during follow-up, were compared with a non-CAV group. RESULTS: Both groups share de same median age (54+10years). Recipient male sex predominated in the CAV group (93% vs. 74%), as did ischemic etiology (52% vs. 37%). Although not reaching statistical significance, CAV patients also had more dyslipidemia (60% vs. 50%), history of smoking (52% vs. 44%) and peripheral vascular disease (45% vs. 29%). The incidence of celular acute rejection 1R is more frequent in CAV group (69% vs. 60%) such as 2R or 3R (29% vs. 27%). Prolonged use of inotropic support and mechanical assistance after cardiac transplantation were comparable between both groups. The survival of this patients, who were submitted to cardiac transplantation and had lived at least 1 year, between CAV and non-CAV group was comparable at 5-year (91% vs. 85%), but tended to be lower for CAV patients in 10-year interval (52% vs. 73%). CONCLUSION: This data confirms CAV as a common long-term complication following cardiac transplantation. Although short to mid-term survival seems not to be affected by CAV, long-term survival appears lower, hence a longer follow-up is needed.

Coronary artery bypass surgery without cardioplegia: hospital results in 8515 patients†.

OBJECTIVES: Cardioplegic myocardial protection is used in most cardiac surgical procedures. However, other alternatives have proved useful. We analysed the perioperative results in a large series of patients undergoing coronary artery bypass (CABG) using cardiopulmonary bypass (CPB) and non-cardioplegic methods. METHODS: From January 1992 to October 2013, 8515 consecutive patients underwent isolated CABG with CPB without cardioplegia, under hypothermic ventricular fibrillation and/or an empty beating heart. The mean age was 61.9 ± 9.5 years, 12.4% were women, 26.3% diabetic, 64% hypertensive; and 9.6% had peripheral vascular disease, 7.8% cerebrovascular disease and 54.3% previous acute myocardial infarction (AMI). One-third of patients were in Canadian Cardiovascular Society Class III/IV. Three-vessel disease was present in 76.5% of the cases and 10.9% had moderate/severe left ventricle (LV) dysfunction (ejection fraction <40%). A multivariate analysis was made of risk factors associated to in-hospital mortality and three major morbidity complications [cerebrovascular accident, mediastinitis and acute kidney injury (AKI)], as well as for prolonged hospital stay. RESULTS: The mean CPB time was 58.2 ± 20.7 min. The mean number of grafts per patient was 2.7 ± 0.8 (arterial: 1.2 ± 0.5). The left internal thoracic artery (ITA) was used in 99.4% of patients and both ITAs in 23.1%. The in-hospital mortality rate was 0.7% (61 patients), inotropic support was required in 6.6% and mechanical support in 0.8, and 2.0% were re-explored for bleeding and 1.3% for sternal complications (mediastinitis, 0.8%). AKI, the majority transient, occurred in 1595 patients (18.9%). The incidence rates of stroke/transient ischemic attack (TIA) and acute myocardial infarction (AMI) were 2.6 and 2.5%, respectively, and atrial fibrillation/flutter occurred in 22.6% of cases. Age, LV dysfunction, non-elective surgery, previous cardiac surgery, peripheral vascular disease and CPB time were independent risk factors for mortality and major morbidity. The mean hospital stay was 7.2 ± 5.7 days. CONCLUSIONS: Isolated CABG with CPB using non-cardioplegic methods proved very safe, with low mortality and morbidity. These methods are simple and expeditious and remain as very useful alternative techniques of myocardial preservation.