Utilidad de la electroestimulación muscular funcional y el entrenamiento de la musculatura inspiratoria en pacientes con insuficiencia cardiaca con función sistólica preservada. Ensayo clínico TRAINING-HF.

“UTILIDAD DE LA ELECTROESTIMULACIÓN MUSCULAR Y ENTRENAMIENTO DE LA MUSCULATURA INSPIRATORIA EN PACIENTES CON INSUFICIENCIA CARDIACA Y FUNCIÓN SISTÓLICA PRESERVADA” ENSAYO CLÍNICO TRAINING HF La insuficiencia cardiaca con función sistólica preservada (ICFSp) es un síndrome clínico bien definido que representa al menos el 50% del total de insuficiencias cardiacas, aunque se estima incluso un aumento de su prevalencia relacionada con el envejecimiento de la población. Desde el punto de vista epidemiológico estos pacientes presentan una mayor edad, existe un predominio femenino y asocian un importante número de comorbilidades como hipertensión arterial, diabetes mellitus y sobrepeso. La característica clínica fundamental es la severa limitación de la capacidad de ejercicio que a su vez repercute en su calidad de vida. Hasta la fecha, la terapia farmacológica ha demostrado eficacia en mejorar la capacidad funcional y pronóstico en pacientes con insuficiencia cardiaca con función sistólica reducida (ICFSr). En cambio, el tratamiento farmacológico en pacientes con ICFSp no ha demostrado de forma consistente mejoría de capacidad funcional, calidad de vida ni pronóstico. La rehabilitación cardiaca convencional está indicada para la mejoría de la capacidad funcional de pacientes con ICFSp. Estos programas suelen ser costosos, emplean numerosos recursos y un gran número de pacientes con ICFSp quedan excluidos por edad avanzada o problemas osteoarticulares. Existen otras formas “no convencionales” de rehabilitación cardiaca menos extendidas en la práctica clínica como son el entrenamiento de la musculatura inspiratoria (EMI) y la electroestimulación muscular funcional (EMF). Estas dos terapias presentan potenciales beneficios como son que pueden ser aplicadas en todos los pacientes con ICFSp y tras un breve entrenamiento, el paciente puede implementarlas incluso de forma domiciliara. Además, pueden actuar como terapias puente que permitan a los pacientes continuar con programas de rehabilitación convencional. Nuestra hipótesis de trabajo fue que en congruencia con una limitada evidencia de pequeños ensayos clínicos en pacientes con ICFSp y basada en aspectos fisiopatológicos plausibles, hipotetizamos que el EMI o EMF empleados de forma aislada o conjunta (EMI+EMF) pueden mejorar en estos pacientes parámetros de capacidad funcional y calidad. El objetivo del estudio fue evaluar el efecto del EMI y la EMF de miembros inferiores como coadyuvante al tratamiento estándar en pacientes con IC avanzada (NYHA basal II-III/IV) y función sistólica preservada en relación con la capacidad funcional y otros marcadores de severidad de la enfermedad tras finalizar el entrenamiento (3 meses) y a los 6 meses tras la inclusión. El objetivo primario del estudio fue la valoración del cambio en los parámetros objetivos de capacidad funcional. La capacidad funcional se determinó en la ergoespirometría a través de las modificaciones del VO2 máx respecto a los valores basales a los 3 y 6 meses. Los objetivos secundarios fueron: ■ Cambio en la distancia recorrida en el test de 6 minutos a los 3 y 6 meses. ■ El cambio en la puntuación de calidad de vida a los 3 y 6 meses determinado mediante el cuestionario de Minnesota. ■ El cambio absoluto de biomarcadores pronósticos de insuficiencia cardiaca (NT-proBNP y CA 125) a los 3 y 6 meses. ■ La modificación de parámetros ecocardiográficos a los 3 y 6 meses (relación E/e’ y el volumen de la aurícula izquierda ajustada por superficie corporal). Para ello, se diseñó el ensayo clínico aleatorizado y controlado “TRAINING-HF” que reclutó un total de 59 pacientes con ICFSp procedentes de la Unidad de Insuficiencia Cardiaca del Hospital Clínico Universitario de Valencia. Estos pacientes fueron aleatorizados 1:1:1:1 a tratamiento médico habitual (TMH), EMI, EMF y EMI + EMF. Las determinaciones se realizaron en el momento de la inclusión y se repitieron tras 3 meses de entrenamiento y posteriormente a los 6 meses de la inclusión con el objetivo de analizar el mantenimiento de los resultados a medio plazo tras 3 meses sin entrenamiento. En lo que respecta a los resultados obtenidos, los 3 brazos de entrenamiento mejoraron significativamente de forma objetiva su VO2 máx tanto a los 3 meses como a los 6 meses. En cambio, el grupo de TMH no presentó modificaciones en su capacidad funcional determinada mediante el VO2 máx. Además, los 3 grupos de entrenamiento experimentaron un incremento en la distancia recorrida en el test de 6 minutos y una reducción en la puntuación del cuestionario de calidad de vida de Minnesota que implica una mejoría de su percepción subjetiva. Por otra parte, la terapia combinada (EMI + EMF) no presentó superioridad respecto a EMI ó EMF en cuanto a mejoría de capacidad funcional o calidad de vida. El grupo asignado a TMH no mejoró la distancia en el test de 6 minutos ni la puntuación en el cuestionario de calidad de vida. Adicionalmente, se analizaron parámetros ecocardiográficos de disfunción diastólica y biomarcadores de insuficiencia cardiaca que no presentaron modificaciones significativas en ninguno de los 4 grupos. En este ensayo clínico aleatorizado (TRAINING-HF) que incluyó pacientes con ICFSp y reducción de la capacidad aeróbica podemos extraer las siguientes conclusiones: 1- Un programa de 3 meses de EMI, EMF o la combinación de ambos se ha asociado a una mejoría significativa en la capacidad funcional y calidad de vida a corto y medio plazo. 2- Los efectos beneficiosos sobre la capacidad funcional y calidad de las distintas modalidades de entrenamiento se reducen parcialmente tras el cese de las intervenciones, aunque persisten significativas respecto a los valores basales y respecto al grupo de TMH. 3- La terapia combinada no demostró superioridad respecto a EMI o EMF de forma aislada en nuestra muestra de pacientes. 4- Se precisan estudios adicionales para la confirmación de los resultados y elucidar los mecanismos fisiopatológicos subyacentes responsables de estos beneficios. 5- Por otra parte, tanto el EMI como el EMF podrían generalizarse como terapias no farmacológicas efectivas y prometedoras dentro de los programas de rehabilitación cardiaca en la ICFSp

Sex differences on peak oxygen uptake in heart failure

Women represent nearly half of the adult heart failure (HF) population and they remain underrepresented in HF studies. We aimed to evaluate the evidence about peak oxygen uptake (peak VO2) for clinical stratification in women with HF. This narrative review summarizes (i) the evidence endorsing the value of cardiopulmonary exercise testing for clinical stratification and phenotyping HF population; (ii) the determinants of a person’s functional aerobic capacity to understand predicted values for patients with chronic HF; and (iii) sex differences on peak VO2 data in different forms of HF. Lastly, based on existing data in patients with HF, we provide a perspective on how to improve existing gaps about the utility of peak VO2 in clinical stratification in women. Peak VO2 provides prognosis information in patients with HF; however, its use has been limited for a reduced number of patients excluding women, elderly, and HF patients with preserved ejection fraction. Further studies will help to fill the wide gender gap about the utility of cardiopulmonary exercise testing in the risk assessment and management in women with HF

A model-driven transformation approach for the modelling of processes in clinical practice guidelines

Clinical Practice Guidelines (CPGs) include recommendations aimed at optimising patient care, informed by a review of the available clinical evidence. To achieve their potential benefits, CPG should be readily available at the point of care. This can be done by translating CPG recommendations into one of the languages for Computer-Interpretable Guidelines (CIGs). This is a difficult task for which the collaboration of clinical and technical staff is crucial. However, in general CIG languages are not accessible to non-technical staff. We propose to support the modelling of CPG processes (and hence the authoring of CIGs) based on a transformation, from a preliminary specification in a more accessible language into an implementation in a CIG language. In this paper, we approach this transformation following the Model-Driven Development (MDD) paradigm, in which models and transformations are key elements for software development. To demonstrate the approach, we implemented and tested an algorithm for the transformation from the BPMN language for business processes to the PROforma CIG language. This implementation uses transformations defined in the ATLAS Transformation Language. Additionally, we conducted a small experiment to assess the hypothesis that a language such as BPMN can facilitate the modelling of CPG processes by clinical and technical staff.Funding for open access charge: CRUE-Universitat Jaume

Los desafíos del profesorado clínico en la educación médica

Background: There is a unique particularity of clinical teaching in medical education that isbeyond knowledge, skills or teaching methods of each clinician: this is clinical teaching context.This study aimed to analyze the main barriers in clinical teaching in a single medical school in Spain. Methods: This was a descriptive study in which all the clinical teachers (all of them associateprofessors) of a single and novel faculty of medicine were asked to answer an online, anonymousand voluntary questionnaire about aspects of support to clinical work, promotion of clinicalresearch and recognition of their professional careers. The questionnaires were organized andanalyzed into these three main issues.Results: 61 clinical teachers (42%) answered the questionnaire. The main findings that emergedwere: (i) lack of protected time for practical teaching at hospital; (ii) lack of support for clinicalresearch from hospital or faculty; and (iii) lack of recognition of their professional careers.Conclusions: The clinical teaching in medical education is a continuing challenge for busyclinicians. Further studies on this topic are needed.Antecedentes: La enseñanza clínica en la educación médica tiene una particularidad única:el contexto clínico. Este estudio tiene como objetivo analizar las principales barreras de laense˜nanza clínica en una facultad joven de Medicina de Espa˜na.Métodos: Se trata de un estudio transversal descriptivo en el que se solicitó a todos losprofesores clínicos (todos ellos profesores asociados) de una facultad joven de Medicina que res-pondieran a un cuestionario en línea, anónimo y voluntario sobre aspectos de carga asistencial,promoción de la investigación clínica y reconocimiento de sus carreras profesionales.Resultados: Sesenta y un profesores (42%) respondieron al cuestionario. Los principales hallaz-gos que se obtuvieron fueron: 1) la falta de tiempo protegido para la ense˜nanza práctica en lainstitución sanitaria; 2) el escaso apoyo para la investigación clínica por parte de la instituciónsanitaria o de la facultad; y 3) el escaso de reconocimiento de la carrera profesional.Conclusiones: La ense˜nanza clínica en la educación médica es un desafío continuo para elclínico. Son necesarios futuros estudios que analicen estos aspectos de forma más exhaustiva

Heart rate response and functional capacity in patients with chronic heart failure with preserved ejection fraction

Aims: The mechanisms of exercise intolerance in heart failure with preserved ejection fraction (HFpEF) are not yet elucidated. Chronotropic incompetence has emerged as a potential mechanism. We aimed to evaluate whether heart rate (HR) response to exercise is associated to functional capacity in patients with symptomatic HFpEF. Methods and results We prospectively studied 74 HFpEF patients [35.1% New York Heart Association Class III, 53% fe- male, age (mean ± standard deviation) 72.5 ± 9.1 years, and 59.5% atrial fi brillation]. Functional performance was assessed by peak oxygen consumption (peak VO 2 ). The mean (standard deviation) peak VO 2 was 10 ± 2.8 mL/min/kg. The following chronotropic parameters were calculated: Delta-HR (HR at peak exercise - HR at rest), chronotropic index (CI) = (HR at peak exercise - resting HR)/[(220 - age) - resting HR], and CI according to the equation developed by Keteyian et al . (CIK) (HR at peak exercise - HR at rest)/[119 + (HR at rest/2) (age/2) - 5 - HR at rest]. In a bivariate setting, peak VO 2 was positively and signi fi cantly correlated with Delta-HR ( r = 0.35, P = 0.003), CI ( r = 0.27, P = 0.022), CIK ( r = 0.28, P = 0.018), and borderline with HR at peak exercise ( r = 0.22, P = 0.055). In a multivariable linear regression analysis that included clinical, analytical, echocardiographic, and functional capacity covariates, the chronotropic parameters were positively associated with peak VO 2 . We found a linear relationship between Delta-HR and peak VO 2 ( β coef fi cient of 0.03; 95% con fi dence interval: 0.004 – 0.05; P = 0.030); conversely, the association among CIs and peak VO 2 was exponen- tially shaped. Conclusions In patients with chronic HFpEF, the HR response to exercise was positively associated to patient ’ s functional capacity

Effect of β-Blocker Withdrawal on Functional Capacity in Heart Failure and Preserved Ejection Fraction

BACKGROUND Chronotropic incompetence has shown to be associated with a decrease in exercise capacity in heart failure with preserved ejection fraction (HFpEF), yet b-blockers are commonly used in HFpEF despite the lack of robust evidence. OBJECTIVES This study aimed to evaluate the effect of b-blocker withdrawal on peak oxygen consumption (peak VO2) in patients with HFpEF and chronotropic incompetence. METHODS This is a multicenter, randomized, investigator-blinded, crossover clinical trial consisting of 2 treatment periods of 2 weeks separated by a washout period of 2 weeks. Patients with stable HFpEF, New York Heart Association functional classes II and III, previous treatment with b-blockers, and chronotropic incompetence were first randomized to withdrawing from (arm A: n ¼ 26) versus continuing (arm B: n ¼ 26) b-blocker treatment and were then crossed over to receive the opposite intervention. Changes in peak VO2 and percentage of predicted peak VO2 (peak VO2%) measured at the end of the trial were the primary outcome measures. To account for the paired-data nature of this crossover trial, linear mixed regression analysis was used. RESULTS The mean age was 72.6 13.1 years, and most of the patients were women (59.6%) in New York Heart Association functional class II (66.7%). The mean peakVO2 and peak VO2% were 12.4 2.9 mL/kg/min, and 72.4 17.8%, respectively. No significant baseline differences were found across treatment arms. Peak VO2 and peak VO2% increased significantly after b-blocker withdrawal (14.3 vs 12.2 mL/kg/min [D þ2.1 mL/kg/min]; P < 0.001 and 81.1 vs 69.4% [D þ11.7%]; P < 0.001, respectively). CONCLUSIONS b-blocker withdrawal improved maximal functional capacity in patients with HFpEF and chronotropic incompetence. b-blocker use in HFpEF deserves profound re-evaluation. (b-blockers Withdrawal in Patients With HFpEF and Chronotropic Incompetence: Effect on Functional Capacity [PRESERVE-HR]; NCT03871803; 2017-005077-39) (J Am Coll Cardiol 2021;78:2042–2056) © 2021 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation

Sacubitril/valsartan and short-term changes in the 6-minute walk test: A pilot study

Background Impaired exercise capacity is the most disabling symptom in patients with heart failure with reduced ejection fraction (HFrEF). Despite sacubitril/valsartan showing reduced long-term morbidity and mortality over enalapril in HFrEF, its effects on short-term functional capacity remain uncertain. We sought to evaluate the effects of sacubitril/valsartan on a 30-day six-minute walk test in eligible patients with HFrEF. Methods and results From November 1, 2016 to February 1, 2017, a total of 58 stable symptomatic patients with HFrEF were eligible for sacubitril/valsartan and underwent 6-MWT before and 30 days after initiation of sacubitril/valsartan therapy. A mixed-effects model for repeated-measures was used to analyze the changes. Mean age was 70 ± 11 years. 72.4% males, 46.6% with ischemic heart disease, and 51.7% on NYHA functional class III were included. The mean (SD) values of baseline LVEF and 6MWT were 30 ± 7%, and 300 ± 89 m, respectively. The median (IQR) of NT-proBNP at baseline was 2701 pg/ml (1087–4200). Compared with baseline, the 6-MWT distance increased significantly at 30 days by 13.9% (+∆ = 41.8 m (33.4–50.2); p < 0.001). Conclusions In this pilot study, sacubitril/valsartan was associated with an improvement in exercise tolerance in symptomatic patients with HFrEF

Maximal functional capacity in subjects with isolated left bundle branch block: A pilot study

Background Left bundle branch block (LBBB) has been commonly associated with adverse cardiovascular (CV) events, but the effect of an isolated LBBB on maximal functional capacity is not well characterized. Objective To evaluate maximal functional capacity in adults with isolated LBBB and compare it to healthy population-derived predicted values (adjusted for sex, age, weight, and height). Methods This descriptive pilot study included subjects with isolated LBBB derived from outpatient clinics of two academic hospitals. All subjects underwent maximal cardiopulmonary exercise testing (CPET) and a Global Physical Activity Questionnaire (GPAQ). The primary outcome was to evaluate maximal functional capacity according to population-derived predicted values of peak oxygen consumption (peakVO2): pp-peakVO2. The secondary outcome was to report adverse CV events (CV deaths or hospitalizations) at follow-up. Results A total of 27 (18 women and 9 men) participants were included. The median (interquartile range) age of the sample and time to screening from the first LBBB diagnosis were 62 (51−71) and 3.4 (1.1−8.4) years, respectively. The results of the GPAQ score showed that 19 patients were highly active, and 8 were moderately active. The median of peakVO2 and pp-peakVO2 were 19.3 (15−22.5) ml/kg/min and 88% (79.3%−104.4%), respectively. There were no adverse CV events at a median follow-up after CPET of 3.1 (2.7−3.4) years. Conclusion In this pilot study, adults with isolated LBBB showed reduced maximal functional capacity, despite the absence of cardiac disease and a baseline moderate to highly active lifestyle

Six-minute walk test in moderate to severe heart failure with preserved ejection fraction: Useful for functional capacity assessment?

Despite improvements in medical treatment and prevention, heart failure (HF) remains a major cause of morbidity and mortality worldwide [1]. Currently, HF with preserved ejection fraction (HFpEF) has become the most prevalent form of HF in elderly patients [2,3]. The cardinal features in HF, aside from left ventricular systolic function, are exertional dyspnea and reduced aerobic capacity. Although the most accurate expression of exercise tolerance and severity in HF is measured by peak oxygen uptake (peak VO2), its assessment is not widely available in daily clinical practice. This work was supported in part by grants from: Sociedad Española de Cardiología: Investigación Clínica en Cardiología, Grant SEC 2015 and Red de Investigación Cardiovascular; Programa 7 (RD12/0042/0010) FEDER

Isolated Partial Congenital Absence of the Pericardium: A Familial Presentation

Congenital defects of the pericardium are uncommon heart abnormalities. Most of the patients are asymptomatic and are usually diagnosed incidentally. Complications are more common in partial absence than in complete absence of the pericardium; thus, this congenital defect should be identified because of the associated risk of sudden death. We report the first mention in the literature, to our knowledge, of a 3-generation familial presentation of isolated congenital partial absence of the pericardium with similar physical examination and radiological findings