- Email: [email protected]
Mediterranean diet and heart rate: The PREDIMED randomised trial
Letters to the Editor
device over the free end of the catheter. To the best of our knowledge, there is only one similar case described previously [7], where the authors used an Amplatz GooseNeck Snare to remove an entrapped catheter in the radial artery. In the case of tight catheter knots that do not respond to standard maneuvers, we would recommend the use of this safe and easily applied technique, saving the patient from unplanned surgical intervention. References [1] Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989;16:3–7.
299
[2] Ratib K, Mamas MA, Routledge H, Fraser D, Nolan J. Access site selection for primary PCI: the evidence for transradial access is strong. Heart 2012;98:1392 [author reply3]. [3] Carrillo X, Mauri J, Fernandez-Nofrerias E, Rodriguez-Leor O, Bayes-Genis A. Safety and efficacy of transradial access in coronary angiography: 8-year experience. J Invasive Cardiol 2012;24:346–51. [4] Schueler A, Black SR, Shay N. Management of transradial access for coronary angiography. J Cardiovasc Nurs 2013;28:468–72. [5] Cohen HR, Deutsch AM, Ryvicker MJ, Schatz SL. Reduction of catheter knots. Radiology 1980;134:243–5. [6] Tanner MA, Ward D. Percutaneous technique for the reduction of knotted coronary catheters. Heart 2003;89:1132–3. [7] Kim JY, Moon KW, Yoo KD. Entrapment of a kinked catheter in the radial artery during transradial coronary angiography. J Invasive Cardiol 2012;24:E3–4.
0167-5273/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.11.075
Mediterranean diet and heart rate: The PREDIMED randomised trial☆ M. García-López a,b, E. Toledo b,c, J.J. Beunza b,c, F. Aros c,d, R. Estruch c,e, J. Salas-Salvadó c,f, D. Corella c,g, E. Ros c,h, M.I. Covas c,i, E. Gómez-Gracia j, M. Fiol c,k, R.M. Lamuela-Raventós c,l, J. Lapetra c,m, P. Buil-Cosiales b,c,n, S. Carlos b, L. Serra-Majem c,o, X. Pintó c,p, V. Ruiz-Gutiérrez c,q, M.A. Martínez-González b,c,⁎ a
Department of Cardiology, Clinic University of Navarra, Pamplona, Spain Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain c CIBER Fisiopatologia de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain d Department of Cardiology, University Hospital of Alava, Vitoria, Spain e Department of Internal Medicine, Institut d'Investigacions Biomèdiques Augusti Pi Sunyer (IDIBAPS), Hospital Clinic, Barcelona, Spain f Human Nutrition Unit, Biochemistry and Biotechnology Department, Hospital Universitari de Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, Reus, Spain g Department of Preventive Medicine and Public Health, University of Valencia, Valencia, Spain h Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, Barcelona, Spain i Cardiovascular Epidemiology Unit, Municipal Institut for Medical Research (IMIM), Barcelona, Spain j Department of Preventive Medicine, School of Medicine, University of Malaga, Málaga, Spain k University Institute for Health Sciences Investigation, Hospital Son Espases, Palma de Mallorca, Spain l Nutrition and Food Science Department, CaRTA, INSA Pharmacy School, University of Barcelona, Spain m Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla, Spain n Servicio Navarro de Salud, Osasunbidea, Pamplona, Spain o Department of Clinical Sciences, University of Las Palmas de Gran Canaria, Spain p Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain q Instituto de la Grasa, Consejo Superior de Investigaciones Cientificas, Sevilla, Spain b
a r t i c l e
i n f o
Article history: Received 27 August 2013 Accepted 23 November 2013 Available online 4 December 2013 Keywords: Mediterranean diet Clinical trial Heart rate
A higher heart rate (HR) has been associated with increased total and cardiovascular mortality [1,2]. Clinical trials support the beneficial effect of decreasing HR in patients with heart failure [3] and ischaemic heart disease [4]. A recent cross-sectional study showed that closer adherence to the Mediterranean diet (MeDiet) was related to lower HR [5]. We evaluated the association between adherence to the ☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. ⁎ Corresponding author at: Department of Preventive Medicine and Public Health, University of Navarra, CP. 31008, Pamplona, Spain. Tel.: +34 948 425 600; fax: + 34 948 425 740. E-mail address: [email protected] (M.A. Martínez-González).
MeDiet (measured with a score from 0 to 14 obtained by a validated screener [6]) and HR using both a cross-sectional and a longitudinal analysis of the PREDIMED trial [7,8]. We assessed 7447 men and women (55–80 years) initially free of cardiovascular disease who had either type 2 diabetes or three or more cardiovascular risk factors, as previously described [7,8]. Participants were randomly assigned to one of three diets: MeDiet supplemented with extra virgin olive oil (MeDiet + EVOO), MeDiet supplemented with mixed nuts (MeDiet + nuts), or control diet. Blood pressure and HR were measured by trained nurses in triplicate using a validated semiautomatic oscillometer (Omron HEM-705CP, Hoofddorp, the Netherlands) with a 5-min interval between each measurement. The study complies with the Declaration of Helsinki, the study protocol was approved by the Institutional Review Board of all participating centres and all participants provided written informed consent. Out of the 7447 trial participants, 7128 had available data for analyses. We used analysis of covariance and ordinary least squares regression for the cross-sectional analyses. For the longitudinal analyses, we used generalized estimating equations (GEE) with STATA 12.1 assuming an unstructured correlation matrix. The dependent variable was HR during follow-up (yearly repeated measurements). We assessed 3 exposures: baseline adherence to
300
Letters to the Editor
Table 1 Characteristics of participants (n = 7128) by baseline adherence to the MeDiet.a
N Age, years Female, % Body mass index, kg/m2 Physical activity, METs hours/week Total energy intake, Kcal/day Systolic blood pressure, mm Hg Current smoker, % Diabetes, % Hypertension, % Hypercholesterolemia, % Arrhythmia, % Use of cardiovascular drugs, % Baseline HR, bpm
Low (0–5 points)
Moderate (6–9 points)
High (10–14 points)
P value
416 67 (6) 60 31 (4) 23 (25)
4260 67 (6) 58 30 (4) 26 (26)
2452 67 (6) 55 30 (4) 31 (30)
b 0.01 0.02 b 0.01 b 0.01
2278 (637)
2221 (604)
2273 (603)
b 0.01
149 (18)
149 (19)
149 (19)
0.94
Table 2 Longitudinal analyses (generalized estimating equations): effects on repeated yearly measurements of heart rate during follow-up. Difference in HR (95% CI)
18 50 84 76 8 67
14 50 84 72 7 67
13 45 82 73 9 65
0.03 b 0.01 0.16 0.28 0.09 0.22
71.8 (11.4)
71.5 (10.9)
70.3 (10.4)
b 0.01
MET: metabolic equivalents. HR: heart rate. bpm: beats per minute. a Mean (standard deviation) unless otherwise stated.
MeDiet, updated adherence to MeDiet (the mean of all available repeated measurements), and the randomly allocated intervention group (a fixed exposure during follow-up). For the 2 first exposures we estimated the adjusted difference in HR (bpm) for each additional increment in 5 points in adherence to the MeDiet. For the third exposure we used the control group as a reference and estimated two adjusted differences in HR versus control: a) for the MeDiet + EVOO, and b) for the MeDiet + nuts. In the cross-sectional analysis (Table 1), participants were stratified by 3 categories of baseline adherence to the MeDiet: low (≤5 points); moderate (6–9 points) or high (≥10 points). In models of analysis of covariance adjusted for sex and age, the average HR (bpm) for these 3 categories were 71.70 (95% confidence interval [95% CI]: 70.68 to 72.72), 71.42 (95% CI: 71.10 to 71.74) and 70.31 (95% CI: 69.89 to 70.73). In sex- and age-adjusted models we observed a statistically significant inverse linear association between higher baseline adherence to the MeDiet and lower HR with an average of −1.08 bpm (95% CI: −1.70 to − 0.46, p b 0.001) for each 5 additional points in the 14 point score of adherence to the MeDiet. Further multivariable adjustments for BMI, physical activity, total energy intake, baseline blood pressure, smoking, history of arrhythmia, baseline diabetes and use of cardiovascular medication at baseline slightly reduced this inverse association (− 0.93 bpm, 95% CI: − 1.53 to −0.33 for 5 additional points), although it remained statistically significant (p b 0.002). In longitudinal analyses, using multivariable GEE, we found that greater baseline adherence to the MeDiet continued to be inversely associated with the average of repeated HR measurements during follow-up (− 1.09 bpm per 5 additional points in baseline adherence, 95%CI: − 1.47 to − 0.37). As shown in Table 2, after adjusting for relevant confounders, the yearly updated measurements of adherence to the MeDiet were not significantly associated with the corresponding average repeated measurements of HR. None of the two MeDiet interventions was associated with a significantly lower average HR in comparison with the control group. In this randomised clinical trial, baseline adherence to the MeDiet was associated with lower average HR. This result is in line with those of a previous cross-sectional study [5]. Though the MeDiet is rich in omega-3 fatty acids, especially when supplemented with walnuts, and omega-3 fatty acids could reduce HR
Exposure
Adjusted for
Dif. (bpm)
95% CI
P value
Baseline adherence to MeDiet (+5 points) Baseline adherence to MeDiet (+5 points) Updated adherence to MeDiet (+5 points) Updated adherence to MeDiet (+5 points) Allocated intervention MeDiet + EVOO Allocated intervention MeDiet + nuts
Sex, age
− 0.92
0.001
Multivariablea
− 0.67
Sex, age
− 0.58
(− 1.47 to − 0.37) (− 1.19 to − 0.14) (− 1.02 to − 0.13) (− 0.79 to + 0.08) (− 0.66 to + 0.34) (− 0.66 to + 0.36)
Multivariablea
− 0.35
Multivariable
a
− 0.16
Multivariable
a
− 0.15
0.013 0.011 0.114 0.54 0.56
a Adjusted for age, sex, body mass index, systolic blood pressure, diastolic blood pressure, physical activity, total energy intake, smoking, baseline diabetes, previous history of arrhythmia and use of cardiovascular medication.
automatism [9], we only found an inverse association for baseline adherence to MeDiet, not for repeated measurements of adherence during follow-up or for the intervention groups [8,10]. A potential explanation for this lack of association is that the intervention effect was not large enough to decrease HR during a 5 year follow up period. Furthermore if subjects with a higher HR were given cardiovascular drugs in order to achieve an ideal HR (50– 70 bpm) an association of small magnitude between the intervention with MeDiet and HR could have been blurred. In conclusion, 1) baseline adherence to the MeDiet was associated with lower average HR, 2) no significant difference in HR among the three dietary interventions of the PREDIMED trial was observed. This study was funded by the Spanish Ministry of Health (ISCIII), CIBEROBN, PI1001407, PI11/02505, G03/140, RD06/0045, the Autonomous Government of Catalonia, Caixa Tarragona (10-1343) and by the Generalitat Valenciana (ACOMP/2013/165). The Fundación Patrimonio Comunal Olivarero and Hojiblanca SA (Málaga, Spain), California Walnut Commission (Sacramento, CA), Borges SA (Reus, Spain) and Morella Nuts SA (Reus, Spain) donated the olive oil, walnuts, almonds and hazelnuts, respectively. None of the funding sources played a role in the design, collection, analysis, interpretation or publication of the data. ET is supported by a Rio Hortega fellowship (ISCIII, Spanish Government). None of the authors have any conflict of interest. The authors thank the participants and the PREDIMED staff.
References [1] Greenland P, Daviglus ML, Dyer AR, et al. Resting heart rate is a risk factor for cardiovascular and noncardiovascular mortality: the Chicago Heart Association Detection Project in Industry. Am J Epidemiol 1999;149:853–62. [2] Jensen MT, Marott JL, Jensen GB. Elevated resting heart rate is associated with greater risk of cardiovascular and all-cause mortality in current and former smokers. Int J Cardiol 2011;151:148–54. [3] Fox K, Ford I, Steg PG, Tendera M, Ferrari R. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:807–16. [4] Ekman I, Chassany O, Komajda M, et al. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study. Eur Heart J 2011;32:2395–404. [5] García-López M, Martinez-Gonzalez MA, Basterra-Gortari FJ, Barrio-López MT, Gea A, Beunza JJ. Adherence to the Mediterranean dietary pattern and heart rate in the SUN project. Eur J Prev Cardiol Nov 9 2012 [Epub ahead of print]. [6] Schröder H, Fitó M, Estruch R, et al. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr 2011;141:1140–5. [7] Estruch R, Ros E, Salas-Salvado J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med 2013;368:1279–90.
Letters to the Editor [8] Martínez-González MÁ, Corella D, Salas-Salvadó J, et al. Cohort profile: design and methods of the PREDIMED study. Int J Epidemiol 2012;41:377–85. [9] Kang JX. Reduction of heart rate by omega-3 fatty acids and the potential underlying mechanisms. Front Physiol 2012;3:416.
301
[10] Zazpe I, Sanchez-Tainta A, Estruch R, et al. A large randomized individual and group intervention conducted by registered dietitians increased adherence to Mediterranean-type diets: the PREDIMED study. J Am Diet Assoc 2008;108:1134–44.
0167-5273/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.11.074
Comment on: Idiopathic pericarditis presenting large hemorrhagic pericardial effusion George Lazaros ⁎, Christodoulos Stefanadis From the First Cardiology Department, University of Athens, Hippokration Hospital, Greece
a r t i c l e
i n f o
Article history: Received 28 August 2013 Accepted 23 November 2013 Available online 3 December 2013 Keywords: Cardiac tamponade Hemorrhagic effusion Idiopathic pericarditis Malignancy
Dear Editor, We have read with interest the ‘Letter to the Editor’ by Pyung Chun Oh et al. entitled ‘Idiopathic pericarditis presenting large hemorrhagic pericardial effusion’ [1]. In the case reported, extensive diagnostic work up excluded malignancy and tuberculosis and effusion was finally attributed to idiopathic pericarditis. As ‘take home message’ the authors emphasize that the detection of large hemorrhagic pericardial effusion does not per se definitely preclude a diagnosis of idiopathic pericarditis. In our opinion some points of this paper need to be clarified further. Although we certainly agree with the authors' concept, we wish to stress that clinicians should be very cautious in ‘labeling’ the underlying pericardial disease according to the nature, hemorrhagic or not, of pericardial effusion. Actually, when iatrogenic causes of bloody pericardial effusion in patients presenting with tamponade have been excluded, malignant tumors, idiopathic pericarditis and complications of acute myocardial infarction appear as the most common underlying causes [2]. In patients with hemorrhagic effusions leading to tamponade, malignancy is unveiled only in ~2% of cases [2]. On the contrary, when a malignancy has been previously diagnosed, this percentage increases to 26% [2]. The relevant prevalence of tuberculosis highly depends on local epidemiology, but it is fairly low when Western countries are taken into consideration. ⁎ Corresponding author at: First Cardiology Department, University of Athens, Hippokration Hospital, 114 Vas. Sofias Ave., 115 27 Athens, Greece. Tel.: + 30 2132088099; fax: + 30 2132088676. E-mail address: [email protected] (G. Lazaros). 0167-5273/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.11.073
Taking into account the aforementioned data, the detection of hemorrhagic fluid in the case described is rather not surprising. Actually, our group has also previously reported a similar case of idiopathic pericarditis presenting with cardiac tamponade in which 2000 ml of sanguineous fluid were percutaneously drained [3]. The etiologic assessment of patients presenting with cardiac tamponade and hemorrhagic effusions is a clinical challenge [4]. Although patients with tamponade and bloody effusions should in any case be triaged for malignancies and tuberculosis, it should not be overlooked that idiopathic pericarditis is a quite common underlying etiology, in particular when we deal with patients without a history of malignancy. Thus, although massive bloody pericardial effusions should alert physicians to exclude secondary causes of pericardial effusion, it should not be misleading, since the diagnosis of idiopathic pericarditis is not exceptional. Awareness of this piece of information would prevent from ordering unnecessary diagnostic procedures in those patients. We hope that the above comment will add to the unquestionable value of the manuscript of Pyung Chun Oh et al. and will contribute to the optimal management of patients presenting with large hemorrhagic pericardial effusions. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology.
References [1] Oh PC, Baek SJ, Moon J, Han SH, Park KY, Koh KK. Idiopathic pericarditis presenting large hemorrhagic pericardial effusion. Int J Cardiol 2013;168:4467–9. [2] Atar S, Chiu J, Forrester JS, Siegel RJ. Bloody pericardial effusion in patients with cardiac tamponade: is the cause cancerous, tuberculous, or iatrogenic in the 1990s? Chest 1999;116:1564–9. [3] Lazaros G, Tsiachris D, Stefanadis C. Swinging without feeling. Int J Cardiol 2011;148:389–91. [4] Burazor I, Imazio M, Markel G, Adler Y. Malignant pericardial effusion. Cardiology 2013;124:224–32.
device over the free end of the catheter. To the best of our knowledge, there is only one similar case described previously [7], where the authors used an Amplatz GooseNeck Snare to remove an entrapped catheter in the radial artery. In the case of tight catheter knots that do not respond to standard maneuvers, we would recommend the use of this safe and easily applied technique, saving the patient from unplanned surgical intervention. References [1] Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn 1989;16:3–7.
299
[2] Ratib K, Mamas MA, Routledge H, Fraser D, Nolan J. Access site selection for primary PCI: the evidence for transradial access is strong. Heart 2012;98:1392 [author reply3]. [3] Carrillo X, Mauri J, Fernandez-Nofrerias E, Rodriguez-Leor O, Bayes-Genis A. Safety and efficacy of transradial access in coronary angiography: 8-year experience. J Invasive Cardiol 2012;24:346–51. [4] Schueler A, Black SR, Shay N. Management of transradial access for coronary angiography. J Cardiovasc Nurs 2013;28:468–72. [5] Cohen HR, Deutsch AM, Ryvicker MJ, Schatz SL. Reduction of catheter knots. Radiology 1980;134:243–5. [6] Tanner MA, Ward D. Percutaneous technique for the reduction of knotted coronary catheters. Heart 2003;89:1132–3. [7] Kim JY, Moon KW, Yoo KD. Entrapment of a kinked catheter in the radial artery during transradial coronary angiography. J Invasive Cardiol 2012;24:E3–4.
0167-5273/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.11.075
Mediterranean diet and heart rate: The PREDIMED randomised trial☆ M. García-López a,b, E. Toledo b,c, J.J. Beunza b,c, F. Aros c,d, R. Estruch c,e, J. Salas-Salvadó c,f, D. Corella c,g, E. Ros c,h, M.I. Covas c,i, E. Gómez-Gracia j, M. Fiol c,k, R.M. Lamuela-Raventós c,l, J. Lapetra c,m, P. Buil-Cosiales b,c,n, S. Carlos b, L. Serra-Majem c,o, X. Pintó c,p, V. Ruiz-Gutiérrez c,q, M.A. Martínez-González b,c,⁎ a
Department of Cardiology, Clinic University of Navarra, Pamplona, Spain Department of Preventive Medicine and Public Health, University of Navarra, Pamplona, Spain c CIBER Fisiopatologia de la Obesidad y Nutrición (CIBERobn), Instituto de Salud Carlos III, Madrid, Spain d Department of Cardiology, University Hospital of Alava, Vitoria, Spain e Department of Internal Medicine, Institut d'Investigacions Biomèdiques Augusti Pi Sunyer (IDIBAPS), Hospital Clinic, Barcelona, Spain f Human Nutrition Unit, Biochemistry and Biotechnology Department, Hospital Universitari de Sant Joan de Reus, IISPV, Universitat Rovira i Virgili, Reus, Spain g Department of Preventive Medicine and Public Health, University of Valencia, Valencia, Spain h Lipid Clinic, Endocrinology and Nutrition Service, Institut d'Investigacions Biomèdiques August Pi Sunyer (IDIBAPS), Hospital Clinic, Barcelona, Spain i Cardiovascular Epidemiology Unit, Municipal Institut for Medical Research (IMIM), Barcelona, Spain j Department of Preventive Medicine, School of Medicine, University of Malaga, Málaga, Spain k University Institute for Health Sciences Investigation, Hospital Son Espases, Palma de Mallorca, Spain l Nutrition and Food Science Department, CaRTA, INSA Pharmacy School, University of Barcelona, Spain m Department of Family Medicine, Primary Care Division of Sevilla, San Pablo Health Center, Sevilla, Spain n Servicio Navarro de Salud, Osasunbidea, Pamplona, Spain o Department of Clinical Sciences, University of Las Palmas de Gran Canaria, Spain p Lipids and Vascular Risk Unit, Internal Medicine, Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Spain q Instituto de la Grasa, Consejo Superior de Investigaciones Cientificas, Sevilla, Spain b
a r t i c l e
i n f o
Article history: Received 27 August 2013 Accepted 23 November 2013 Available online 4 December 2013 Keywords: Mediterranean diet Clinical trial Heart rate
A higher heart rate (HR) has been associated with increased total and cardiovascular mortality [1,2]. Clinical trials support the beneficial effect of decreasing HR in patients with heart failure [3] and ischaemic heart disease [4]. A recent cross-sectional study showed that closer adherence to the Mediterranean diet (MeDiet) was related to lower HR [5]. We evaluated the association between adherence to the ☆ All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. ⁎ Corresponding author at: Department of Preventive Medicine and Public Health, University of Navarra, CP. 31008, Pamplona, Spain. Tel.: +34 948 425 600; fax: + 34 948 425 740. E-mail address: [email protected] (M.A. Martínez-González).
MeDiet (measured with a score from 0 to 14 obtained by a validated screener [6]) and HR using both a cross-sectional and a longitudinal analysis of the PREDIMED trial [7,8]. We assessed 7447 men and women (55–80 years) initially free of cardiovascular disease who had either type 2 diabetes or three or more cardiovascular risk factors, as previously described [7,8]. Participants were randomly assigned to one of three diets: MeDiet supplemented with extra virgin olive oil (MeDiet + EVOO), MeDiet supplemented with mixed nuts (MeDiet + nuts), or control diet. Blood pressure and HR were measured by trained nurses in triplicate using a validated semiautomatic oscillometer (Omron HEM-705CP, Hoofddorp, the Netherlands) with a 5-min interval between each measurement. The study complies with the Declaration of Helsinki, the study protocol was approved by the Institutional Review Board of all participating centres and all participants provided written informed consent. Out of the 7447 trial participants, 7128 had available data for analyses. We used analysis of covariance and ordinary least squares regression for the cross-sectional analyses. For the longitudinal analyses, we used generalized estimating equations (GEE) with STATA 12.1 assuming an unstructured correlation matrix. The dependent variable was HR during follow-up (yearly repeated measurements). We assessed 3 exposures: baseline adherence to
300
Letters to the Editor
Table 1 Characteristics of participants (n = 7128) by baseline adherence to the MeDiet.a
N Age, years Female, % Body mass index, kg/m2 Physical activity, METs hours/week Total energy intake, Kcal/day Systolic blood pressure, mm Hg Current smoker, % Diabetes, % Hypertension, % Hypercholesterolemia, % Arrhythmia, % Use of cardiovascular drugs, % Baseline HR, bpm
Low (0–5 points)
Moderate (6–9 points)
High (10–14 points)
P value
416 67 (6) 60 31 (4) 23 (25)
4260 67 (6) 58 30 (4) 26 (26)
2452 67 (6) 55 30 (4) 31 (30)
b 0.01 0.02 b 0.01 b 0.01
2278 (637)
2221 (604)
2273 (603)
b 0.01
149 (18)
149 (19)
149 (19)
0.94
Table 2 Longitudinal analyses (generalized estimating equations): effects on repeated yearly measurements of heart rate during follow-up. Difference in HR (95% CI)
18 50 84 76 8 67
14 50 84 72 7 67
13 45 82 73 9 65
0.03 b 0.01 0.16 0.28 0.09 0.22
71.8 (11.4)
71.5 (10.9)
70.3 (10.4)
b 0.01
MET: metabolic equivalents. HR: heart rate. bpm: beats per minute. a Mean (standard deviation) unless otherwise stated.
MeDiet, updated adherence to MeDiet (the mean of all available repeated measurements), and the randomly allocated intervention group (a fixed exposure during follow-up). For the 2 first exposures we estimated the adjusted difference in HR (bpm) for each additional increment in 5 points in adherence to the MeDiet. For the third exposure we used the control group as a reference and estimated two adjusted differences in HR versus control: a) for the MeDiet + EVOO, and b) for the MeDiet + nuts. In the cross-sectional analysis (Table 1), participants were stratified by 3 categories of baseline adherence to the MeDiet: low (≤5 points); moderate (6–9 points) or high (≥10 points). In models of analysis of covariance adjusted for sex and age, the average HR (bpm) for these 3 categories were 71.70 (95% confidence interval [95% CI]: 70.68 to 72.72), 71.42 (95% CI: 71.10 to 71.74) and 70.31 (95% CI: 69.89 to 70.73). In sex- and age-adjusted models we observed a statistically significant inverse linear association between higher baseline adherence to the MeDiet and lower HR with an average of −1.08 bpm (95% CI: −1.70 to − 0.46, p b 0.001) for each 5 additional points in the 14 point score of adherence to the MeDiet. Further multivariable adjustments for BMI, physical activity, total energy intake, baseline blood pressure, smoking, history of arrhythmia, baseline diabetes and use of cardiovascular medication at baseline slightly reduced this inverse association (− 0.93 bpm, 95% CI: − 1.53 to −0.33 for 5 additional points), although it remained statistically significant (p b 0.002). In longitudinal analyses, using multivariable GEE, we found that greater baseline adherence to the MeDiet continued to be inversely associated with the average of repeated HR measurements during follow-up (− 1.09 bpm per 5 additional points in baseline adherence, 95%CI: − 1.47 to − 0.37). As shown in Table 2, after adjusting for relevant confounders, the yearly updated measurements of adherence to the MeDiet were not significantly associated with the corresponding average repeated measurements of HR. None of the two MeDiet interventions was associated with a significantly lower average HR in comparison with the control group. In this randomised clinical trial, baseline adherence to the MeDiet was associated with lower average HR. This result is in line with those of a previous cross-sectional study [5]. Though the MeDiet is rich in omega-3 fatty acids, especially when supplemented with walnuts, and omega-3 fatty acids could reduce HR
Exposure
Adjusted for
Dif. (bpm)
95% CI
P value
Baseline adherence to MeDiet (+5 points) Baseline adherence to MeDiet (+5 points) Updated adherence to MeDiet (+5 points) Updated adherence to MeDiet (+5 points) Allocated intervention MeDiet + EVOO Allocated intervention MeDiet + nuts
Sex, age
− 0.92
0.001
Multivariablea
− 0.67
Sex, age
− 0.58
(− 1.47 to − 0.37) (− 1.19 to − 0.14) (− 1.02 to − 0.13) (− 0.79 to + 0.08) (− 0.66 to + 0.34) (− 0.66 to + 0.36)
Multivariablea
− 0.35
Multivariable
a
− 0.16
Multivariable
a
− 0.15
0.013 0.011 0.114 0.54 0.56
a Adjusted for age, sex, body mass index, systolic blood pressure, diastolic blood pressure, physical activity, total energy intake, smoking, baseline diabetes, previous history of arrhythmia and use of cardiovascular medication.
automatism [9], we only found an inverse association for baseline adherence to MeDiet, not for repeated measurements of adherence during follow-up or for the intervention groups [8,10]. A potential explanation for this lack of association is that the intervention effect was not large enough to decrease HR during a 5 year follow up period. Furthermore if subjects with a higher HR were given cardiovascular drugs in order to achieve an ideal HR (50– 70 bpm) an association of small magnitude between the intervention with MeDiet and HR could have been blurred. In conclusion, 1) baseline adherence to the MeDiet was associated with lower average HR, 2) no significant difference in HR among the three dietary interventions of the PREDIMED trial was observed. This study was funded by the Spanish Ministry of Health (ISCIII), CIBEROBN, PI1001407, PI11/02505, G03/140, RD06/0045, the Autonomous Government of Catalonia, Caixa Tarragona (10-1343) and by the Generalitat Valenciana (ACOMP/2013/165). The Fundación Patrimonio Comunal Olivarero and Hojiblanca SA (Málaga, Spain), California Walnut Commission (Sacramento, CA), Borges SA (Reus, Spain) and Morella Nuts SA (Reus, Spain) donated the olive oil, walnuts, almonds and hazelnuts, respectively. None of the funding sources played a role in the design, collection, analysis, interpretation or publication of the data. ET is supported by a Rio Hortega fellowship (ISCIII, Spanish Government). None of the authors have any conflict of interest. The authors thank the participants and the PREDIMED staff.
References [1] Greenland P, Daviglus ML, Dyer AR, et al. Resting heart rate is a risk factor for cardiovascular and noncardiovascular mortality: the Chicago Heart Association Detection Project in Industry. Am J Epidemiol 1999;149:853–62. [2] Jensen MT, Marott JL, Jensen GB. Elevated resting heart rate is associated with greater risk of cardiovascular and all-cause mortality in current and former smokers. Int J Cardiol 2011;151:148–54. [3] Fox K, Ford I, Steg PG, Tendera M, Ferrari R. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet 2008;372:807–16. [4] Ekman I, Chassany O, Komajda M, et al. Heart rate reduction with ivabradine and health related quality of life in patients with chronic heart failure: results from the SHIFT study. Eur Heart J 2011;32:2395–404. [5] García-López M, Martinez-Gonzalez MA, Basterra-Gortari FJ, Barrio-López MT, Gea A, Beunza JJ. Adherence to the Mediterranean dietary pattern and heart rate in the SUN project. Eur J Prev Cardiol Nov 9 2012 [Epub ahead of print]. [6] Schröder H, Fitó M, Estruch R, et al. A short screener is valid for assessing Mediterranean diet adherence among older Spanish men and women. J Nutr 2011;141:1140–5. [7] Estruch R, Ros E, Salas-Salvado J, et al. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med 2013;368:1279–90.
Letters to the Editor [8] Martínez-González MÁ, Corella D, Salas-Salvadó J, et al. Cohort profile: design and methods of the PREDIMED study. Int J Epidemiol 2012;41:377–85. [9] Kang JX. Reduction of heart rate by omega-3 fatty acids and the potential underlying mechanisms. Front Physiol 2012;3:416.
301
[10] Zazpe I, Sanchez-Tainta A, Estruch R, et al. A large randomized individual and group intervention conducted by registered dietitians increased adherence to Mediterranean-type diets: the PREDIMED study. J Am Diet Assoc 2008;108:1134–44.
0167-5273/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.11.074
Comment on: Idiopathic pericarditis presenting large hemorrhagic pericardial effusion George Lazaros ⁎, Christodoulos Stefanadis From the First Cardiology Department, University of Athens, Hippokration Hospital, Greece
a r t i c l e
i n f o
Article history: Received 28 August 2013 Accepted 23 November 2013 Available online 3 December 2013 Keywords: Cardiac tamponade Hemorrhagic effusion Idiopathic pericarditis Malignancy
Dear Editor, We have read with interest the ‘Letter to the Editor’ by Pyung Chun Oh et al. entitled ‘Idiopathic pericarditis presenting large hemorrhagic pericardial effusion’ [1]. In the case reported, extensive diagnostic work up excluded malignancy and tuberculosis and effusion was finally attributed to idiopathic pericarditis. As ‘take home message’ the authors emphasize that the detection of large hemorrhagic pericardial effusion does not per se definitely preclude a diagnosis of idiopathic pericarditis. In our opinion some points of this paper need to be clarified further. Although we certainly agree with the authors' concept, we wish to stress that clinicians should be very cautious in ‘labeling’ the underlying pericardial disease according to the nature, hemorrhagic or not, of pericardial effusion. Actually, when iatrogenic causes of bloody pericardial effusion in patients presenting with tamponade have been excluded, malignant tumors, idiopathic pericarditis and complications of acute myocardial infarction appear as the most common underlying causes [2]. In patients with hemorrhagic effusions leading to tamponade, malignancy is unveiled only in ~2% of cases [2]. On the contrary, when a malignancy has been previously diagnosed, this percentage increases to 26% [2]. The relevant prevalence of tuberculosis highly depends on local epidemiology, but it is fairly low when Western countries are taken into consideration. ⁎ Corresponding author at: First Cardiology Department, University of Athens, Hippokration Hospital, 114 Vas. Sofias Ave., 115 27 Athens, Greece. Tel.: + 30 2132088099; fax: + 30 2132088676. E-mail address: [email protected] (G. Lazaros). 0167-5273/$ – see front matter © 2013 Elsevier Ireland Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijcard.2013.11.073
Taking into account the aforementioned data, the detection of hemorrhagic fluid in the case described is rather not surprising. Actually, our group has also previously reported a similar case of idiopathic pericarditis presenting with cardiac tamponade in which 2000 ml of sanguineous fluid were percutaneously drained [3]. The etiologic assessment of patients presenting with cardiac tamponade and hemorrhagic effusions is a clinical challenge [4]. Although patients with tamponade and bloody effusions should in any case be triaged for malignancies and tuberculosis, it should not be overlooked that idiopathic pericarditis is a quite common underlying etiology, in particular when we deal with patients without a history of malignancy. Thus, although massive bloody pericardial effusions should alert physicians to exclude secondary causes of pericardial effusion, it should not be misleading, since the diagnosis of idiopathic pericarditis is not exceptional. Awareness of this piece of information would prevent from ordering unnecessary diagnostic procedures in those patients. We hope that the above comment will add to the unquestionable value of the manuscript of Pyung Chun Oh et al. and will contribute to the optimal management of patients presenting with large hemorrhagic pericardial effusions. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology.
References [1] Oh PC, Baek SJ, Moon J, Han SH, Park KY, Koh KK. Idiopathic pericarditis presenting large hemorrhagic pericardial effusion. Int J Cardiol 2013;168:4467–9. [2] Atar S, Chiu J, Forrester JS, Siegel RJ. Bloody pericardial effusion in patients with cardiac tamponade: is the cause cancerous, tuberculous, or iatrogenic in the 1990s? Chest 1999;116:1564–9. [3] Lazaros G, Tsiachris D, Stefanadis C. Swinging without feeling. Int J Cardiol 2011;148:389–91. [4] Burazor I, Imazio M, Markel G, Adler Y. Malignant pericardial effusion. Cardiology 2013;124:224–32.