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ACC/AHA 2008 Performance Measures for Adults With ST-Elevation and Non-ST-Elevation Myocardial Infarction

ACC/AHA 2008 Guidelines for the Management of Adults With Congenital Heart Disease
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J Am Coll Cardiol, 2004; 43:1584-1589, doi:10.1016/j.jacc.2003.11.059
© 2004 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: BNP AND HEART FAILURE

B-type natriuretic peptide and peak exercise oxygen consumption provide independent information for risk stratification in patients with stable congestive heart failure

Pascal de Groote, MD*,*, Joël Dagorn, MD*, Benoit Soudan, MD{dagger}, Nicolas Lamblin, MD*, Eugene McFadden, FRCPI, FACC{ddagger} and Christophe Bauters, MD, FACC*

* Service de Cardiologie C, Hôpital Cardiologique, Lille Cedex, France
{dagger} Laboratoire d'endocrinologie, Clinique Linquette, CHRU, 59037 Lille Cedex, France
{ddagger} Thoraxcenter, Erasmus Medical Centre, Rotterdam, The Netherlands

Manuscript received October 13, 2003; accepted November 12, 2003.

* Reprint requests and correspondence: Dr. Pascal de Groote, Service de cardiologie C, Hôpital cardiologique, Boul Prof J. Leclercq, CHRU de Lille, 59037 Lille Cedex, France.
pdegroote{at}chru-lille.fr


   Abstract
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 Abstract
Methods
 Results
 Discussion
 References
 
OBJECTIVES: The aim of this study was to compare the prognostic value of peak oxygen consumption (VO2) and B-type natriuretic peptide (BNP) in patients with stable congestive heart failure (CHF).

BACKGROUND: Previous studies have demonstrated that both peak VO2 and BNP are useful for risk stratification in patients with CHF. No study has compared the respective prognostic value of these two parameters in a large series of patients receiving a combination of angiotensin-converting enzyme inhibitors and of beta-blockers.

METHODS: Patients with stable CHF underwent radionuclide angiography, echocardiography, 24-h Holter monitoring, and a cardiopulmonary exercise test. Blood samples were drawn for standard measurements and for hormonal determinations.

RESULTS: After a median follow-up period of 787 days, there were 75 cardiac-related deaths and three urgent transplantations. Independent predictors of cardiac survival were percent of maximal predicted VO2 (%VO2, relative risk [RR] = 2.84 [95% confidence interval, CI = 1.73 to 4.65], p < 0.00001), BNP (RR = 3.17 [95% CI 1.68 to 5.96], p = 0.0004), left atrial diameter (LAD) (RR = 2.04 [95% CI 1.25 to 3.34], p = 0.004), age (RR = 1.93 [95% CI 1.22 to 3.05], p = 0.005), and aldosterone (RR = 1.84 [95% CI 1.12 to 3.00], p = 0.015). In patients with infra-median levels of BNP (<109 pg/ml), age was the only independent predictor of cardiac survival. However, in patients with supra-median levels of BNP, independent predictors of cardiac survival were %VO2 (RR = 3.76 [95% CI 2.19 to 6.45], p < 0.00001) and LAD (RR = 1.90 [95% CI 1.10 to 3.28], p = 0.02).

CONCLUSIONS: B-type natriuretic peptide, in combination with %VO2, improves risk stratification of patients with stable CHF.

Abbreviations and Acronyms
  ACE-I = angiotensin-converting enzyme inhibitors
  BNP = B-type natriuretic peptide
  CHF = congestive heart failure
  CI = confidence interval
  LAD = left atrial diameter
  LVEF = left ventricular ejection fraction
  NYHA = New York Heart Association
  RR = relative risk
  UNOS = United Network for Organ Sharing
  VO2 = peak oxygen consumption
  %VO2 = percent maximal predicted VO2

Risk stratification is an integral part of management in patients with congestive heart failure (CHF) and is an important step before defining the optimal treatment strategy, particularly given the limited availability of some therapies such as cardiac transplantation. Previous studies have demonstrated that variables such as New York Heart Association (NYHA) classification , left ventricular ejection fraction (LVEF), or peak oxygen consumption (VO2) were powerful, independent predictors of survival in CHF patients (1,2). In recent years, exercise testing has become an increasingly important tool in the selection of patients for heart transplantation. It has been shown that ambulatory CHF patients who can achieve a peak VO2 >14 ml/kg/min or a percent maximal predicted VO2 (%VO2) >50% are at low risk of cardiac mortality, and thus cardiac transplantation can safely be deferred (2,3). Other studies have focused on hormonal activation and in particular on B-type natriuretic peptide (BNP). Several studies have demonstrated that BNP was an independent predictor of cardiac survival (4–6). Because there is a correlation between BNP and exercise capacity, it has been suggested that BNP assay might be an easy alternative to peak VO2 for the selection of high-risk patients (7). However, to the best of our knowledge, no study has compared the prognostic value of peak VO2 or BNP in a population of patients with a modern treatment of CHF, that includes both angiotensin-converting enzyme inhibitors (ACE-I) and beta-blockers.

Accordingly, we designed the present study in 407 consecutive CHF patient who underwent a prognostic evaluation in our institution and who had systematic determination of a large set of prognostic variables, including peak VO2 and BNP.


   Methods
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Protocol.   All patients referred to our department for a non-invasive evaluation of left ventricular systolic dysfunction were prospectively considered for inclusion in the study. Before inclusion, treatment of the patients was optimized with introduction and/or up-titration to maximal tolerated doses of ACE-I and/or beta-blockers. Patients with recent introduction of beta-blockers were included three months after maximal tolerated doses were reached. During optimization of the treatment, patients had systematic coronary angiography to help define the etiology of left ventricular systolic dysfunction. Patients were included after optimization of their treatment if they were ambulatory, stable for at least two months, and had a LVEF ≤ 45%. Patients were excluded if they had a myocardial infarction, an episode of unstable angina, or had undergone coronary revascularization in the previous three months.

All the patients included in this analysis underwent echocardiography, radionuclide angiography, 24-h Holter monitoring, and a cardiopulmonary exercise test as previously described (8). Blood samples were drawn in the morning in the supine position for standard measurements and hormonal determinations. For hormonal determination, samples were immediately put on ice, centrifuged at 4°C within 20 min, and the supernatant was immediately stored at –70°C until assayed. Plasma BNP concentrations were measured by radioimmunoassay (Shionoria BNP kit; Shionogi & Co. Ltd., Osaka, Japan). Normal values were <21.1 pg/ml with inter-assay and intra-assay coefficients of variation of 4.2% and 2.7%, respectively, for the concentration of 21.1 pg/ml and 2.1% and 2%, respectively, for the concentration of 520 pg/ml. Plasma endothelin-1 concentrations were measured by radioimmunoassay (Nichols Institute Diagnostics BV, San Clemente, California) after extraction on a Sep-Pak C-18 cartridge. The normal range of endothelin-1 was 1.1 to 2.3 pmol/l with inter-assay and intra-assay coefficients of variation of 6.8% and 4.5%, respectively. Plasma aldosterone concentrations were measured by radioimmunoassay (Beckman Coulter Immunotech, Villepinte, France). The normal range was 10 to 160 pg/ml with inter-assay and intra-assay coefficients of variation below 9.9% and 9.5%, respectively. Plasma levels of norepinephrine were determined by high-performance liquid chromatography. The normal range was 100 to 600 pg/ml with inter-assay and intra-assay coefficients of variation of 5.2% and 7.5%, respectively.

Definitions.   Ischemic cardiomyopathy was defined as patients with a proven history of myocardial infarction (significant Q waves on the electrocardiogram and/or significant increase in creatinine kinase levels during a previous hospitalization) and/or stenosis >50% in one of the major coronary arteries. Patients who did not fulfill these criteria were considered to have a non-ischemic cardiomyopathy. If coronary angiography was not performed or if the patient did not have a proven history of myocardial infarction, patients were considered to have undetermined cardiomyopathy, except for young patients (<30 years old) without any risk factor for atherosclerosis. These patients were considered to have non-ischemic cardiomyopathy. Patients were classified as diabetic if they were treated by oral hypoglycemic drugs or insulin or if they had a previous history, documented on their medical chart, of elevated (126 mg/dl) fasting blood glucose on at least two separate occasions in conjunction with adhering to ongoing dietary measures to control their glucose level. The qualitative classification of doses of ACE-I was defined using the recommendations of the European Society of Cardiology (9). High doses were defined as the highest recommended doses, intermediate doses as the lowest recommended doses, and low doses as the non-recommended doses of ACE-I. Restrictive mitral inflow patterns were defined as a ratio of early transmitral flow velocity to atrial flow velocity (E/A ratio) ≥2 or an E/A ratio between 1 and 2 with a mitral deceleration time ≤140 ms (10,11). In patients with atrial fibrillation, restrictive mitral inflow pattern was defined as a mitral deceleration time ≤140 ms (12). Severe ventricular arrhythmias were defined by the number of single ventricular ectopic beats and the number of non-sustained ventricular tachycardia (>3 consecutive ventricular ectopic beats at a rate of ≥100/min).

Patients.   From March 1998 to December 2001, 424 ambulatory patients were referred to our department for non-invasive evaluation of left ventricular systolic dysfunction with a LVEF ≤ 45%. Of these patients, 17 (4%) were not included because of technical reasons involving either radionuclide angiography (n = 7), cardiopulmonary exercise test (n = 4), or hormonal determinations (n = 6). During the follow-up period of these 17 patients, there were four cardiovascular deaths and two non-cardiac deaths.

Statistics.   Results are expressed as mean ± SD except for hormonal values and ventricular ectopic beats presented as median with 95% confidence intervals (CI). Discrete variables were compared using chi-square analysis. Continuous variables were compared by unpaired Student t test or by the non-parametric Mann-Whitney test. Follow-up was performed either by direct examination or by contact with the general practitioner. Cardiac mortality was defined as cardiac-related death or urgent cardiac transplantation (United Network for Organ Sharing [UNOS] status 1) (13), and patients who had non-urgent transplantation (UNOS status 2) (13) were censored at the time of transplantation. Cardiac event was defined as cardiac-related death or cardiac transplantation (UNOS status 1 and 2). The Kaplan-Meier method was performed to estimate the cumulative survival. Differences in survival were compared with a log-rank test. Cutoff values were determined by receiver operating characteristic curves analysis. Several multivariate Cox proportional hazard analyses were performed to determine the independent predictors of cardiac survival and of cardiac events free survival for the entire population and in subgroups of patients. Variables significant in univariate analysis at a p level of 0.1 were entered in our Cox analysis. Independent relative risks (RR) are presented with 95% CI. A value of p < 0.05 was considered statistically significant. Statistics were performed with SPSS software version 9 (SPSS, Chicago, Illinois).


   Results
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Clinical characteristics of the study population are summarized in Table 1. Of the 407 patients included in the study, 5 refused coronary angiography and were classified as having an undetermined etiology. Most of the patients were receiving ACE-I (95%), of whom 16 patients were receiving low doses, 54 moderate doses, and 315 high doses; 5% of the patients were receiving angiotensin II type I receptor blockers; 93% were receiving beta-blockers (bisoprolol: n = 220, mean dose: 8.5 ± 2.7 mg by day; carvedilol: n = 98, 52 ± 28 mg by day; others beta-blockers: n = 61), 81% diuretics, 26% spironolactone, and 40% digoxin.


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  		Table 1 Major Characteristics of the Entire Population and of Survivors and of Non-Survivors

 
During a median follow-up period of 787 days, there were 75 cardiac-related deaths, 3 UNOS status 1 transplantations, 13 UNOS status 2 transplantations, and 11 non-cardiovascular deaths. No patient was lost to follow-up. Differences in clinical characteristics between survivors and non-survivors are presented in Table 1. Mortality rates at one and two years were 11% and 16%, respectively.

Independent predictors of cardiac survival and of cardiac event free survival are summarized in Table 2. Most powerful predictors were %VO2, BNP, and left atrial diameter (LAD). If %VO2 is not included in the multivariate analysis, NYHA classification (RR = 1.63 [95% CI 1.02 to 2.63], p = 0.04) is selected as an independent predictor of cardiac survival. Similarly, if both %VO2 and BNP are not included in the analysis, NYHA classification (RR = 2.04 [95% CI 1.28 to 3.25], p = 0.003) and LVEF (RR = 1.76 [95% CI 1.08 to 2.87], p = 0.02) are selected in the final model. All results were similar if we excluded from the analysis patients in atrial fibrillation.


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  		Table 2 Results of the Multivariate Analyses: Independent Predictors of Cardiac Survival and of Cardiac Event–Free Survival

 
Subgroup analyses.   Peak VO2 is a helpful prognostic parameter for risk stratification of CHF patients. We thus performed analyses to determine if BNP remained an independent predictor of cardiac survival in subgroups of patients divided according to peak VO2 (Table 3). In all the analyses, BNP was selected as an independent predictor of cardiac survival.


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  		Table 3 Independent Predictors of Cardiac Survival in Subgroups of Patients Divided According to Peak VO2

 
We then analyzed whether determination of plasma BNP may help to identify patients who need more extensive risk stratification. Table 4 shows independent predictors of cardiac survival in subgroups of patients divided according to plasma BNP levels. In the subgroup of patients with infra-median levels of BNP (<109 pg/ml), the only independent predictor of cardiac survival was age; other variables were not useful for risk stratification in this subgroup with a very low cardiac mortality (2% at 1 year, 3% at 2 years). By contrast, in the subgroup of patients with plasma BNP ≥109 pg/ml, %VO2 and LAD were strong independent predictors of cardiac survival; when BNP was entered into the model as a quantitative variable or as a qualitative variable, it was not an independent predictor of cardiac survival in this subgroup.


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  		Table 4 Independent Predictors of Cardiac Survival in Subgroups of Patients Divided According to Plasma BNP

 
Figure 1 shows the survival curves of subgroups divided according to %VO2 and BNP. Patients with BNP ≥109 pg/ml and %VO2 ≤50% had the worse prognosis with a mortality rate at 1 and 2 years of 30% and 45%, respectively. In patients with BNP ≥109 pg/ml and %VO2 >50%, mortality rates were 9% and 13%, respectively (independent RR between these two subgroups was 3.14 [95% CI 1.8 to 5.5], p = 0.0001). In patients with plasma levels of BNP <109 pg/ml, there was no significant difference in subgroups divided according to %VO2. However, there was a significant difference between patients with BNP < 109 pg/ml and patients with BNP ≥109 pg/ml and %VO2 >50% (RR = 2.32 [95% CI 1.1 to 4.8], p = 0.03).



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  		Figure 1 Kaplan-Meier survival curves in subgroups of patients divided according to cutoff values of plasma levels of B-type natriuretic peptide (BNP) and of percentage of maximal predicted VO2 (%VO2).

 

   Discussion
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 Methods
 Results
 Discussion
References
 
In recent years, several studies have demonstrated the interest of BNP determination for the management of CHF patients. B-type natriuretic peptide is associated with cardiac survival (4–6), and is also a helpful parameter for the diagnosis of CHF and for the therapeutic monitoring of CHF patients (14,15). Krüger et al. (7) found a correlation between BNP and VO2, suggesting that BNP could be an alternative to VO2 for risk stratification. Similarly, Koglin et al. (16) demonstrated that BNP was as useful as the heart failure survival score, validated by Aaronson et al. (17), to predict survival. The emerging concept for the management of CHF patients is to determine the plasma levels of BNP for risk stratification because it is easier, more cost-effective, and less time-consuming than other sophisticated techniques, such as cardiopulmonary exercise testing.

The present study highlights the importance of combining BNP and %VO2 for an optimal risk stratification in CHF patients. We demonstrated that these two parameters give independent prognostic information. The highest mortality rate was observed in patients who had both BNP ≥109 pg/ml and %VO2 ≤50%; they had an almost threefold increase in cardiovascular mortality at two years compared with patients with BNP ≥109 pg/ml and %VO2 >50%. Moreover, the risk of dying from a cardiovascular cause was double in patients with BNP ≥109 pg/ml and %VO2 >50% compared with patients with BNP <109 pg/ml. Patients with BNP <109 pg/ml have an excellent prognosis: in this low-risk subgroup, the only independent predictor of cardiac survival is age, and thus a more sophisticated prognostic evaluation is not required. In contrast, patients with BNP ≥109 pg/ml benefit from a subsequent prognostic evaluation, including cardiopulmonary exercise testing and echocardiography. In this subgroup, BNP is not useful for risk stratification and %VO2 and LAD are the independent predictors of cardiac survival.

A strength of this study is related to the determination of a number of well-known prognostic parameters, such as serum sodium, serum creatinine, norepinephrine, endothelin-1, or mitral deceleration time (1,11,18,19). In our population, LAD is a more powerful prognostic parameter than the restrictive mitral pattern. Previous studies have demonstrated that left atrial enlargement (defined using either area or volume) was an independent predictor of cardiac events in patients with CHF (11,12,20,21) but also in the general population (22).

Study limitations.   Our conclusions cannot be extended to all CHF patients. We studied ambulatory patients after optimization of their treatment, including maximal tolerated doses of both ACE-I and beta-blockers. Hemodynamic parameters were not included in our multivariate analyses because we performed a non-invasive evaluation in ambulatory CHF patients. Hemodynamic parameters may be useful to refine risk stratification, especially in a subgroup of patients with both BNP ≥109 pg/ml and %VO2 ≤50% (18). Similarly, new echocardiographic parameters analyzing left ventricular diastolic function and information regarding heart rate variability were not available for all the patients. Previous studies have demonstrated the usefulness of such parameters in risk stratification (23–25).

In conclusion, BNP determination and peak VO2 provide independent information for risk stratification in patients with stable CHF. The results of the present study suggest that a two-step prognostic evaluation could be performed in CHF patients, with initial determination of plasma BNP in all patients and a subsequent, more complete prognostic evaluation, including a cardiopulmonary exercise test, for patients with BNP ≥109 pg/ml.


   Footnotes
 
Dr. Carl V. Leier acted as Guest Editor.


   References
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