- Email: [email protected]
Does nutritional intervention maintain its prognostic benefit in the long term for malnourished patients hospitalised for heart failure?
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ARTICLE IN PRESS
Rev Clin Esp. 2017;xxx(xx):xxx---xxx
Revista Clínica Española www.elsevier.es/rce
BRIEF ORIGINAL
Does nutritional interventions maintain their prognostic benefit in the long term for malnourished patients hospitalised for heart failure?夽 J.L. Bonilla-Palomas a,∗ , A.L. Gámez-López a , J.C. Castillo-Domínguez b , nez c , M. Anguita-Sánchez b M. Moreno-Conde c , M.C. López-Ibᘠa
Área de Cardiología, Unidad de Gestión Clínica de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain Unidad de Gestión Clínica de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain c Unidad de Gestión Clínica de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain b
Received 1 July 2017; accepted 30 October 2017
KEYWORDS Heart failure; Nutritional intervention; Clinical trial; Long-term events
Abstract Objective: To assess the long-term effect of nutritional intervention on malnourished, hospitalised patients with heart failure (HF). Methods: A total of 120 malnourished patients hospitalized for HF were randomized to undergo (or not) an individual nutritional intervention for 6 months. The primary event was the combination of all-cause death and readmission for HF. We performed an intent-to-treat analysis and assessed the effect of the intervention at 24 months. Results: The combined event occurred in 47.5% of the intervention group and in 73.8% of the control group (hazard ratio: 0.45; 95% confidence interval: 0.28---0.72; p = .001). Thirty-nine percent of the intervention group and 59% of the control group died (hazard ratio: 0.53; 95% confidence interval: 0.31---0.89; p = .017). Conclusion: A nutritional intervention for malnourished patients hospitalised for HF maintains its prognostic benefit in the long-term follow-up. © 2017 Elsevier Espa˜ na, S.L.U. and Sociedad Espa˜ nola de Medicina Interna (SEMI). All rights reserved.
夽 Please cite this article as: Bonilla-Palomas JL, Gámez-López AL, Castillo-Domínguez JC, Moreno-Conde M, López-Ibᘠnez MC, AnguitaSánchez M. ¿Mantiene la intervención nutricional en pacientes hospitalizados por insuficiencia cardiaca desnutridos su beneficio pronóstico a largo plazo? Rev Clin Esp. 2017. https://doi.org/10.1016/j.rce.2017.10.005 ∗ Corresponding author. E-mail address: [email protected] (J.L. Bonilla-Palomas).
2254-8874/© 2017 Elsevier Espa˜ na, S.L.U. and Sociedad Espa˜ nola de Medicina Interna (SEMI). All rights reserved.
RCENG-1447; No. of Pages 3
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ARTICLE IN PRESS
2
J.L. Bonilla-Palomas et al.
PALABRAS CLAVE Insuficiencia cardiaca; Intervención nutricional; Ensayo clínico; Eventos a largo plazo
¿Mantiene la intervención nutricional en pacientes hospitalizados por insuficiencia cardiaca desnutridos su beneficio pronóstico a largo plazo? Resumen Objetivo: Evaluar el efecto a largo plazo de una intervención nutricional en pacientes hospitalizados con insuficiencia cardiaca (IC) y desnutridos. Métodos: Un total de 120 pacientes hospitalizados por IC y desnutridos fueron aleatorizados a recibir o no una intervención nutricional individualizada durante 6 meses. El evento primario fue el combinado de muerte por cualquier causa o reingreso por IC. Se realizó un análisis por intención de tratar y se evaluó el efecto de la intervención a los 24 meses. Resultados: El evento combinado ocurrió en el 47,5% de los pacientes del grupo de intervención y en el 73,8% del grupo control (hazard ratio: 0,45; intervalo de confianza del 95%: 0,28-0,72; p = 0,001). Fallecieron el 39% en el grupo de intervención y el 59% en el grupo control (hazard ratio: 0,53; intervalo de confianza del 95%: 0,31-0,89; p = 0,017). Conclusión: Una intervención nutricional en pacientes hospitalizados por IC que están desnutridos mantiene su beneficio pronóstico en el seguimiento a largo plazo. © 2017 Elsevier Espa˜ na, S.L.U. y Sociedad Espa˜ nola de Medicina Interna (SEMI). Todos los derechos reservados.
Background Malnutrition is a common comorbidity in patients hospitalized for heart failure (HF) and represents a potent predictor of mortality, such that 2 years after the hospital discharge, malnourished patients have almost 4 times the risk of dying than patients who have a normal nutritional status.1 The results of the Nutritional Intervention Program for Malnourished Patients Hospitalized for Heart Failure (PICNIC) study showed that a nutritional intervention for malnourished patients hospitalized for HF reduces the risk of all-cause death and readmission for HF during the 12 months after hospital discharge.2 The objective of the present study was to assess the long-term effects of the nutritional intervention on patients included in the PICNIC study.
Methods The design of the PICNIC study has already been published.2,3 Briefly, this was a multicenter clinical trial in which the malnourished patients hospitalized for HF were assigned (using a simple randomization process) to undergo (or not) an individual nutritional intervention, added to the conventional treatment for HF. The patients signed the informed consent document and participated in the study according to the protocol approved by the ethics committees of the participating centers. The diagnosis of malnutrition was established after obtaining a score of <17 points on the Mini Nutritional Assessment survey. In accordance with the protocol, the intervention was extended for 6 months and was based on 3 points: diet optimization, specific recommendations and nutritional supplements (prescribed for 12% of the patients) when the nutritional objectives were not reached with the diet. The primary endpoint was the combined event of all-cause death or readmission for HF. The analysis was performed by intention to treat. PICNIC is registered
in ClinicalTrial.gov (NCT01472237). In this analysis, we assessed the effects of the intervention at 2 years of follow-up.
Results Between March 2012 and April 2014, a total of 120 patients were included in the study. The 2 groups were homogeneous in terms of their baseline characteristics.2 At 2 years, the combined event occurred in 47.5% of the intervention group and in 73.8% of the control group (hazard ratio, 0.45; 95% confidence interval 0.28---0.72; p = .001) (Fig. 1). Thirty-nine percent of the intervention group and 59% of the control group died (hazard ratio, 0.53; 95% confidence interval 0.31---0.89; p = .017). The readmission rate for HF was also lower in the intervention group (18.6% vs. 39.3%, respectively; log-rank test, p = .001).
Discussion The results of this analysis demonstrate that the benefit of a nutritional intervention applied for 6 months in malnourished patients hospitalized for HF is maintained in the long term. It is possible that a nutritional intervention can help optimize energy intake and thereby moderate the imbalance between anabolism/catabolism, which is the result of the neurohormonal and inflammatory activation of HF itself.1 Nutritional measures can also optimize the protein supply and increase protein synthesis, which is necessary for maintaining muscle mass and serum albumin concentrations. The catabolic state,4 the reduction in muscle mass5 and hypoalbuminemia6 are predictors of mortality in HF. Early modification of these factors could change the disease progression in malnourished patients and explain the benefit of the nutritional intervention.
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Does nutritional interventions maintain their prognostic benefit
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Kaplan---Meier curves of the 2 patient groups (intervention and control) for the study events.
In summary, a nutritional intervention for 6 months in malnourished patients hospitalized for HF improved the prognosis, not only immediately but also after the intervention ended. It is essential to include a nutritional state assessment in the comprehensive of patients with HF and act early when malnutrition is detected.
Funding The PICNIC study was funded as a Clinical Research Project in Cardiology by the Spanish Society of Cardiology.
References 1. Bonilla-Palomas JL, Gamez-Lopez AL, Anguita-Sanchez MP, Castillo-Dominguez JC, Garcia-Fuertes D, Crespin-Crespin M, et al. Influencia de la desnutrición en la mortalidad a largo plazo de pacientes hospitalizados por insuficiencia cardiaca. Rev Esp Cardiol. 2011;64:752---8.
2. Bonilla-Palomas JL, Gámez-López AL, Castillo-Domínguez JC, nez M, Alhambra-Expósito R, et al. Moreno-Conde M, López-IbᘠNutritional intervention in malnourished hospitalized patients with heart failure. Arch Med Res. 2016;47:535---40. 3. Gámez-López AAL, Bonilla-Palomas JL, Anguita-Sanchez MP, Moreno-Conde M, López-Ibᘠnez C, Alhambra-Expóstico R, et al. Rationale and design of PICNIC study: nutritional intervention program in hospitalized patients who are malnourished. Rev Esp Cardiol. 2014;67:277---82. 4. Brink M, Anwar A, Delafontaine P. Neurohormonal factors in the development of catabolic/anabolic imbalance and cachexia. Int J Cardiol. 2002;85:111---21. 5. Cicoira M, Davos CH, Francis DP, Doehner W, Zanolla L, Franceschini L, et al. Prediction of mortality in chronic heart failure from peak oxygen consumption adjusted for either body weight or lean tissue. J Card Fail. 2004;10:421---6. 6. Bonilla-Palomas JL, Gamez-Lopez AL, Moreno-Conde M, LopezIbanez MC, Anguita-Sanchez M, Gallego de la Sacristana A, et al. Hypoalbuminemia in acute heart failure patients: causes and its impact on hospital and long-term mortality. J Card Fail. 2014;20:350---8.
ARTICLE IN PRESS
Rev Clin Esp. 2017;xxx(xx):xxx---xxx
Revista Clínica Española www.elsevier.es/rce
BRIEF ORIGINAL
Does nutritional interventions maintain their prognostic benefit in the long term for malnourished patients hospitalised for heart failure?夽 J.L. Bonilla-Palomas a,∗ , A.L. Gámez-López a , J.C. Castillo-Domínguez b , nez c , M. Anguita-Sánchez b M. Moreno-Conde c , M.C. López-Ibᘠa
Área de Cardiología, Unidad de Gestión Clínica de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain Unidad de Gestión Clínica de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain c Unidad de Gestión Clínica de Medicina Interna, Hospital San Juan de la Cruz, Úbeda, Jaén, Spain b
Received 1 July 2017; accepted 30 October 2017
KEYWORDS Heart failure; Nutritional intervention; Clinical trial; Long-term events
Abstract Objective: To assess the long-term effect of nutritional intervention on malnourished, hospitalised patients with heart failure (HF). Methods: A total of 120 malnourished patients hospitalized for HF were randomized to undergo (or not) an individual nutritional intervention for 6 months. The primary event was the combination of all-cause death and readmission for HF. We performed an intent-to-treat analysis and assessed the effect of the intervention at 24 months. Results: The combined event occurred in 47.5% of the intervention group and in 73.8% of the control group (hazard ratio: 0.45; 95% confidence interval: 0.28---0.72; p = .001). Thirty-nine percent of the intervention group and 59% of the control group died (hazard ratio: 0.53; 95% confidence interval: 0.31---0.89; p = .017). Conclusion: A nutritional intervention for malnourished patients hospitalised for HF maintains its prognostic benefit in the long-term follow-up. © 2017 Elsevier Espa˜ na, S.L.U. and Sociedad Espa˜ nola de Medicina Interna (SEMI). All rights reserved.
夽 Please cite this article as: Bonilla-Palomas JL, Gámez-López AL, Castillo-Domínguez JC, Moreno-Conde M, López-Ibᘠnez MC, AnguitaSánchez M. ¿Mantiene la intervención nutricional en pacientes hospitalizados por insuficiencia cardiaca desnutridos su beneficio pronóstico a largo plazo? Rev Clin Esp. 2017. https://doi.org/10.1016/j.rce.2017.10.005 ∗ Corresponding author. E-mail address: [email protected] (J.L. Bonilla-Palomas).
2254-8874/© 2017 Elsevier Espa˜ na, S.L.U. and Sociedad Espa˜ nola de Medicina Interna (SEMI). All rights reserved.
RCENG-1447; No. of Pages 3
+Model
ARTICLE IN PRESS
2
J.L. Bonilla-Palomas et al.
PALABRAS CLAVE Insuficiencia cardiaca; Intervención nutricional; Ensayo clínico; Eventos a largo plazo
¿Mantiene la intervención nutricional en pacientes hospitalizados por insuficiencia cardiaca desnutridos su beneficio pronóstico a largo plazo? Resumen Objetivo: Evaluar el efecto a largo plazo de una intervención nutricional en pacientes hospitalizados con insuficiencia cardiaca (IC) y desnutridos. Métodos: Un total de 120 pacientes hospitalizados por IC y desnutridos fueron aleatorizados a recibir o no una intervención nutricional individualizada durante 6 meses. El evento primario fue el combinado de muerte por cualquier causa o reingreso por IC. Se realizó un análisis por intención de tratar y se evaluó el efecto de la intervención a los 24 meses. Resultados: El evento combinado ocurrió en el 47,5% de los pacientes del grupo de intervención y en el 73,8% del grupo control (hazard ratio: 0,45; intervalo de confianza del 95%: 0,28-0,72; p = 0,001). Fallecieron el 39% en el grupo de intervención y el 59% en el grupo control (hazard ratio: 0,53; intervalo de confianza del 95%: 0,31-0,89; p = 0,017). Conclusión: Una intervención nutricional en pacientes hospitalizados por IC que están desnutridos mantiene su beneficio pronóstico en el seguimiento a largo plazo. © 2017 Elsevier Espa˜ na, S.L.U. y Sociedad Espa˜ nola de Medicina Interna (SEMI). Todos los derechos reservados.
Background Malnutrition is a common comorbidity in patients hospitalized for heart failure (HF) and represents a potent predictor of mortality, such that 2 years after the hospital discharge, malnourished patients have almost 4 times the risk of dying than patients who have a normal nutritional status.1 The results of the Nutritional Intervention Program for Malnourished Patients Hospitalized for Heart Failure (PICNIC) study showed that a nutritional intervention for malnourished patients hospitalized for HF reduces the risk of all-cause death and readmission for HF during the 12 months after hospital discharge.2 The objective of the present study was to assess the long-term effects of the nutritional intervention on patients included in the PICNIC study.
Methods The design of the PICNIC study has already been published.2,3 Briefly, this was a multicenter clinical trial in which the malnourished patients hospitalized for HF were assigned (using a simple randomization process) to undergo (or not) an individual nutritional intervention, added to the conventional treatment for HF. The patients signed the informed consent document and participated in the study according to the protocol approved by the ethics committees of the participating centers. The diagnosis of malnutrition was established after obtaining a score of <17 points on the Mini Nutritional Assessment survey. In accordance with the protocol, the intervention was extended for 6 months and was based on 3 points: diet optimization, specific recommendations and nutritional supplements (prescribed for 12% of the patients) when the nutritional objectives were not reached with the diet. The primary endpoint was the combined event of all-cause death or readmission for HF. The analysis was performed by intention to treat. PICNIC is registered
in ClinicalTrial.gov (NCT01472237). In this analysis, we assessed the effects of the intervention at 2 years of follow-up.
Results Between March 2012 and April 2014, a total of 120 patients were included in the study. The 2 groups were homogeneous in terms of their baseline characteristics.2 At 2 years, the combined event occurred in 47.5% of the intervention group and in 73.8% of the control group (hazard ratio, 0.45; 95% confidence interval 0.28---0.72; p = .001) (Fig. 1). Thirty-nine percent of the intervention group and 59% of the control group died (hazard ratio, 0.53; 95% confidence interval 0.31---0.89; p = .017). The readmission rate for HF was also lower in the intervention group (18.6% vs. 39.3%, respectively; log-rank test, p = .001).
Discussion The results of this analysis demonstrate that the benefit of a nutritional intervention applied for 6 months in malnourished patients hospitalized for HF is maintained in the long term. It is possible that a nutritional intervention can help optimize energy intake and thereby moderate the imbalance between anabolism/catabolism, which is the result of the neurohormonal and inflammatory activation of HF itself.1 Nutritional measures can also optimize the protein supply and increase protein synthesis, which is necessary for maintaining muscle mass and serum albumin concentrations. The catabolic state,4 the reduction in muscle mass5 and hypoalbuminemia6 are predictors of mortality in HF. Early modification of these factors could change the disease progression in malnourished patients and explain the benefit of the nutritional intervention.
+Model
ARTICLE IN PRESS 3
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All-cause mortality or readmission for heart failure
Does nutritional interventions maintain their prognostic benefit
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Figure 1
Kaplan---Meier curves of the 2 patient groups (intervention and control) for the study events.
In summary, a nutritional intervention for 6 months in malnourished patients hospitalized for HF improved the prognosis, not only immediately but also after the intervention ended. It is essential to include a nutritional state assessment in the comprehensive of patients with HF and act early when malnutrition is detected.
Funding The PICNIC study was funded as a Clinical Research Project in Cardiology by the Spanish Society of Cardiology.
References 1. Bonilla-Palomas JL, Gamez-Lopez AL, Anguita-Sanchez MP, Castillo-Dominguez JC, Garcia-Fuertes D, Crespin-Crespin M, et al. Influencia de la desnutrición en la mortalidad a largo plazo de pacientes hospitalizados por insuficiencia cardiaca. Rev Esp Cardiol. 2011;64:752---8.
2. Bonilla-Palomas JL, Gámez-López AL, Castillo-Domínguez JC, nez M, Alhambra-Expósito R, et al. Moreno-Conde M, López-IbᘠNutritional intervention in malnourished hospitalized patients with heart failure. Arch Med Res. 2016;47:535---40. 3. Gámez-López AAL, Bonilla-Palomas JL, Anguita-Sanchez MP, Moreno-Conde M, López-Ibᘠnez C, Alhambra-Expóstico R, et al. Rationale and design of PICNIC study: nutritional intervention program in hospitalized patients who are malnourished. Rev Esp Cardiol. 2014;67:277---82. 4. Brink M, Anwar A, Delafontaine P. Neurohormonal factors in the development of catabolic/anabolic imbalance and cachexia. Int J Cardiol. 2002;85:111---21. 5. Cicoira M, Davos CH, Francis DP, Doehner W, Zanolla L, Franceschini L, et al. Prediction of mortality in chronic heart failure from peak oxygen consumption adjusted for either body weight or lean tissue. J Card Fail. 2004;10:421---6. 6. Bonilla-Palomas JL, Gamez-Lopez AL, Moreno-Conde M, LopezIbanez MC, Anguita-Sanchez M, Gallego de la Sacristana A, et al. Hypoalbuminemia in acute heart failure patients: causes and its impact on hospital and long-term mortality. J Card Fail. 2014;20:350---8.