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Overall prognosis as the primary criterion of outcome in a clinical trial.

In a randomized trial on premature infants, with follow-up to 1 year of age only, the goal is to identify which one among the compared strategies of intervention affords the best outcome throughout life. This requires the assessment of lifetime prognosis at the end of follow-up as the primary criterion of outcome. Moreover, with the treatments potentially influencing a variety of organ systems, it is necessary to combine their separate prospects into an overall prognosis as a basis for identifying the preferable mode of intervention. The development of the scheme of rating overall prognosis posed considerable challenges, in theory as well as in application.

Clinical Trials as Topic↗

Improving prognosis of Hodgkin's disease in Scotland.

Time trends in mortality from Hodgkin's disease have been studied in Great Britain for the 70-year period, 1911-1980, and incidence in Scotland since 1959. In both Scotland and England and Wales, in each sex, mortality from Hodgkin's disease rose steadily from 1911 until 1970 and thereafter dropped substantially; the greatest fall was apparent in Scottish males. While mortality rates continue to decline in Scotland the incidence has remained fairly constant over the last 25 years suggesting a major change in prognosis for this disease. The introduction of effective chemotherapy and improved techniques of radiotherapy appear to have improved prognosis sufficiently, and to have been made adequately widely available, as to influence overall mortality rates at a national level as well as at the level of the clinical trial. No such improvement in prognosis, however, explains the declines observed in mortality rates among children of each sex in both areas which have taken place since the 1930s. In view of the current knowledge of the aetiology of Hodgkin's disease this fall may have been brought about by changes in socioeconomic factors.

Age Factors↗

Public opinion regarding end-of-life decisions: influence of prognosis, practice and process.

The purpose of this study was to examine the effect of changing key factors in survey questions on public opinion regarding end-of-life decisions. These factors were: (a) patient prognosis (likely vs unlikely to recover from the illness); (b) end-of-life practice (foregoing treatment vs assisted suicide vs euthanasia); and (c) and decision making process (competent patient vs incompetent patient based on living will vs incompetent patient based on family wishes). A representative quota sample of 2019 Canadians 18 years of age or older were surveyed using a 13-item questionnaire with 12 items eliciting attitudes towards end-of-life decisions. The questions were systematically varied according to three key factors; patient prognosis, end-of-life practice and decision making process. One item assessed whether respondents had completed a living will. In the case of a decision to forgo life-sustaining treatment in a competent patient, public approval was 85% if the person was unlikely to recover and 35% if the person was likely to recover. In the case of a competent patient unlikely to recover, public approval was 85% for forgoing life-sustaining treatment, 58% for assisted suicide, and 66% for euthanasia. In the case of forgoing life-sustaining treatment for a patient unlikely to recover, public approval was 85% for a competent patient, 88% for an incompetent patient who had expressed his/her wishes in advance through a living will, and 76% for an incompetent patient based on a family's request. The influence of these key factors was similar in other cases examined. Ten percent of Canadians said they had completed a living will. It was concluded that patient prognosis has a major effect, end-of-life practice a moderate effect, and decision making process a minor effect on public opinion regarding end-of-life decisions.

Adult↗

Effect of balloon occluded arterial infusion of anticancer drugs on the prognosis of cervical cancer treated with radiation therapy.

PURPOSE: The effect of local injection of anticancer drugs by balloon catheter, i.e., balloon occluded arterial infusion (BOAI), on the prognosis of cervical cancer treated with radiotherapy were retrospectively estimated. METHODS AND MATERIALS: Sixty-five patients with cervical cancer (Stage I-IV) treated by irradiation were included in the study. Among the 65 cases, 2 were in Stage I, 13 in Stage II, 40 in Stage III, and 10 in Stage IV. Patients who received surgical resection were excluded. Thirty-nine patients received BOAI and 44 received brachytherapy. Twenty-six patients were not indicated for BOAI because of insufficient renal function, hepatic complications, hematological complications, and refusal from the patients. Cisplatin (0.9-1.7 mg/kg), Adriamycin (0.7-0.9 mg/kg), and Pepleomycin (0.4-0.6 mg/kg) were administered simultaneously into the bilateral internal iliac arteries by BOAI. External irradiation was given by 10 MV x-ray. Total dose administered to the regional lymph nodes by the external irradiation was 48.3 +/- 8.7 Gy. Radium was used at brachytherapy. The dose delivered by the brachytherapy at point A was 45.3 +/- 14.9 Gy. Patients without brachytherapy received 26.1 +/- 19.1 Gy of boost irradiation by the external photon beam. The survival probabilities of the patients were calculated by Kaplan-Meier method. RESULTS: The 5-year survival rates of the Stage III patients with and without BOAI were 53 +/- 13% and 24 +/- 18%, respectively (p = 0.036). By multivariate analyses using Cox's proportional hazard model, stage and BOAI were selected as significant predictors of the prognosis. Transient bone marrow suppression was observed in about half of the patients with BOAI. No significant increase of the incidence of the late radiation damage by BOAI in rectum or in urinary bladder was observed. CONCLUSION: Balloon occluded arterial infusion of anticancer drugs may improve the prognosis of the patients with cervical cancer without increasing the incidence of the late radiation damage. A larger scale prospective randomized study is desired.

Actuarial Analysis↗

Prognosis of left ventricular geometric patterns in the Framingham Heart Study.

OBJECTIVES: The goal of this study was to determine the incremental prognostic value of left ventricular geometric patterns beyond that provided by cardiovascular disease risk factors, including left ventricular mass. BACKGROUND: Left ventricular geometry may be classified into the following four mutually exclusive groups on the basis of left ventricular mass and relative wall thickness: concentric hypertrophy (increased mass and increased relative wall thickness), eccentric hypertrophy (increased mass and normal relative wall thickness), concentric remodeling (normal mass and increased relative wall thickness) and normal geometry (normal mass and normal relative wall thickness). The prognosis associated with these patterns in a population-based sample is not known. METHODS: Proportional hazards regression models were used to evaluate the prognostic importance of left ventricular geometry in 3,216 subjects in the Framingham Heart Study who were > or = 40 years old and free of clinically apparent cardiovascular disease, after adjustment for traditional cardiovascular risk factors and left ventricular mass. The follow-up period was 8 years. RESULTS: Subjects with concentric hypertrophy had the worst prognosis, followed by those with eccentric hypertrophy, concentric remodeling and normal geometry. Subjects with concentric hypertrophy also had the highest left ventricular mass. The association between type of geometry and prognosis was largely attenuated by adjustment for baseline differences in left ventricular mass. The odds ratio for incident cardiovascular disease in subjects with concentric hypertrophy compared with those who had normal geometry was 1.3 (95% confidence interval [CI] 0.8 to 2.1) in men and 1.2 (95% CI 0.6 to 2.3) in women after adjustment for other cardiovascular risk factors, including left ventricular mass. CONCLUSIONS: In a population-based sample of subjects without cardiovascular disease, knowledge of left ventricular geometry provided little prognostic information beyond that available from left ventricular mass and traditional cardiovascular risk factors.

Adult↗

Clinical and biochemical factors associated with prognosis after myocardial infarction at a young age.

OBJECTIVES: This study examined the effect of metabolic disturbances, hemostatic function, coronary artery disease severity and left ventricular function on the long-term prognosis after myocardial infarction in men < 45 years old. BACKGROUND: Heavy smoking; dyslipoproteinemias involving very low density lipoprotein (VLDL), low density lipoprotein (LDL) and high density lipoprotein (HDL); a family history of premature coronary artery disease; hyperinsulinemic responses to oral and intravenous glucose challenges; and defective fibrinolytic function characterize the young postinfarction patient, but the influence of these features on the long-term prognosis is virtually unknown. METHODS: Measurements of hemostatic function and metabolic and angiographic indicators of risk were included in a prospective cohort study of variables predictive of reinfarction, cardiac death and major coronary events within 6 to 9 years in 108 unselected nondiabetic men with a first myocardial infarction before age 45 years. RESULTS: During follow-up, 20 patients had sudden cardiac death, and 53 had a major coronary event (reinfarction, sudden cardiac death, bypass surgery or intervention by catheterization). In multivariate analysis, VLDL and global coronary atherosclerosis score predicted reinfarction; plasma plasminogen activator inhibitor-1 (PAI-1) activity and global coronary stenosis score predicted cardiac death; and VLDL triglyceride levels, global coronary atherosclerosis score and age predicted any major coronary event. CONCLUSIONS: This prospective cohort study shows that hypertriglyceridemia, impaired fibrinolytic capacity secondary to plasma PAI-1 activity elevation and extensive coronary artery disease increase the risk of recurrences in men with a first myocardial infarction before age 45 and contribute to the relatively poor long-term prognosis in this patient group.

Adult↗

One-year mortality prognosis in heart failure: a neural network approach based on echocardiographic data.

OBJECTIVES: This study sought to assess the usefulness and accuracy of artificial neural networks in the prognosis of 1-year mortality in patients with heart failure. BACKGROUND: Artificial neural networks is a computational technique used to represent and process information by means of networks of interconnected processing elements, similar to neurons. They have found applications in medical decision support systems, particularly in prognosis. METHODS: Clinical and Doppler-derived echocardiographic data from 95 consecutive patients with diffuse impairment of myocardial contractility were studied. After 1 year, data regarding survival or death were obtained and produced the prognostic variable. The data base was divided randomly into a training data set (47 cases, 8 deaths) and a testing data set (48 cases, 7 deaths). Results of artificial neural network classification were compared with those from linear discriminant analysis, clinical judgment and conventional heuristically based programs. RESULTS: The study group included 57 male (47 survivors) and 38 female patients (33 survivors). Linear discriminant analysis was not efficient for separating survivors from nonsurvivors because the accuracy at the ideal cutoff value was only 67.4%, with a sensitivity of 67.5%, positive predictive value of 27.8% and negative predictive value of 91.5%. In contrast, all artificial neural networks were able to predict outcome with an accuracy of 90%, specificity of 93% and sensitivity of 71.4%, for the best artificial neural network. Both clinical judgment and automatic heuristic methods were also inferior in performance. CONCLUSIONS: The artificial neural network method has proved to be reliable for implementing quantitative prognosis of mortality in patients with heart failure. Additional studies with larger numbers of patients are required to better assess the usefulness of artificial neural networks.

Adolescent↗

Late assessment of thrombolytic efficacy (LATE) study: prognosis in patients with non-Q wave myocardial infarction. (LATE Study Investigators)

OBJECTIVES: We examined the impact of thrombolytic therapy and the prognosis of patients with non-Q wave myocardial infarction in a randomized placebo-controlled trial known as the Late Assessment of Thrombolytic Efficacy (LATE) study. BACKGROUND: Patients with non-Q wave as compared with Q wave myocardial infarction in the era before thrombolytic therapy were traditionally thought to have a higher rate of reinfarction and death between hospital discharge and 1 year such that the overall prognosis for outcome at 1 year was similar in the two groups. METHODS: The study patients began treatment with either recombinant tissue-type plasminogen activator (rt-PA) or matching placebo, 6 to 24 h after the onset of chest pain. Post hoc analysis of mortality and reinfarction was carried out by comparing rt-PA and placebo in various subsets of patients based on the presenting electrocardiogram (ECG) and the evolution of the ECG with respect to the development of Q waves. RESULTS: Among 5,711 participants, 4,759 had a confirmed myocardial infarction, including 1,309 classified as having a non-Q wave infarction at hospital discharge. Irrespective of treatment assignment, all patients with non-Q wave versus Q wave infarction had a lower 1-year mortality rate (13.3% vs. 17.1%, p = 0.001) and a similar 1-year reinfarction rate (8.6% vs. 7.9%, p = 0.7). Of the 4,759 patients with confirmed myocardial infarction, 2,973 presented with ST segment elevation or bundle branch block, 528 with ST depression and 1,258 with neither ST elevation nor depression. No overall benefit from rt-PA versus placebo with respect to mortality rate at 1 year was seen among patients presenting with ST elevation (21.2% vs. 22.4%, p = 0.5 [90% power to detect 20% relative difference]). Patients with ST elevation who were treated with rt-PA versus placebo <3 h after hospital admission had a lower mortality rate at 1 year (15.8% vs. 19.6%, p = 0.028) than did those treated after 3 h (17.6% vs. 13.0%, p = 0.055). Patients presenting initially with ST depression >2 mm had significant benefit from treatment with rt-PA with respect to 1 year mortality rate (20.1% vs. 31.9%, p = 0.006). CONCLUSIONS: Patients with non-Q wave myocardial infarction constitute a heterogeneous group of patients. Although the observations presented here are limited by post hoc analysis, it is apparent that patients classified as having a non-Q wave infarction after thrombolytic therapy have a better prognosis than do those given placebo. Late admission of thrombolytic therapy (after 6 h) may also be beneficial in patients presenting with ST depression >2 mm and confirmed myocardial infarction. These hypotheses require prospective testing in a larger number of patients.

Electrocardiography↗

Insertion/deletion polymorphism in the angiotensin-converting enzyme gene and risk of and prognosis after myocardial infarction.

OBJECTIVES: We sought to prospectively investigate whether genetic variation at the angiotensin-converting enzyme gene locus defined by an insertion (I)/deletion (D) polymorphism influences the risk of myocardial infarction or prognosis after infarction, or both. BACKGROUND: It has been suggested that the deletion allele of the angiotensin-converting enzyme gene, and specifically the DD genotype, may increase the risk of myocardial infarction, although previous studies have produced conflicting reports. No studies have yet examined the effect of I/D polymorphism on survival after infarction. METHODS: Angiotensin-converting enzyme genotypes in 684 patients with myocardial infarction recruited at the time of the acute event through coronary care units in two centers were compared with those of 537 control subjects recruited from the base populations. All patients were followed up to assess the impact of the angiotensin-converting enzyme genotype on prognosis. RESULTS: We found no difference (p = 0.89) in the genotype distribution between patients and control subjects (patients DD 31%, ID 47%, II 22%; control subjects DD 30%, ID 48%, II 22%). The odds ratio for myocardial infarction for DD compared with II/ID genotype adjusted for age, gender and center was 1.16 (95% confidence interval [CI] 0.82 to 1.65, p = 0.44). The study had 90% power to detect a 1.5-fold increase in risk of myocardial infarction associated with the DD genotype. For one center, data were available for other risk factors (hypertension, diabetes, angina, previous myocardial infarction, smoking, body mass index, total and high density lipoprotein cholesterol) in both patients and control subjects. In a stepwise logistic regression analysis the odds ratio for DD versus ID/II genotypes remained nonsignificant (1.44, 95% CI 0.84 to 2.46, p = 0.20) for these subjects. Over a median follow-up period of 15 months (range 3 to 22), 155 patients (22.7%) died. There was no difference in mortality between subjects with the DD genotype and those with ID/II genotypes. (21.8% vs. 23.1%, p = 0.25). Likewise, there was no difference in the distribution of survival times in the two groups (p = 0.62). The study had 70% power to detect a 1.5-fold increase in mortality during follow-up associated with the DD genotype. CONCLUSIONS: We conclude that in the groups studied, genetic variation at the angiotensin-converting enzyme gene locus defined by I/D polymorphism does not significantly influence either the risk of or the short- to medium-term prognosis after myocardial infarction.

Aged↗

The clinical course and prognosis of patients with severe, moderate or mild sarcoidosis.

During 1978-1990, 346 patients with sarcoidosis were enrolled in our institute. Of 346 patients, 295 patients were eligible for evaluation on the clinical course and prognosis. According of their clinical presentations, they were classified into 3 groups; severe, moderate and mild sarcoidosis. Of the 295 patients, 27 (9.2%) were classified as severe sarcoidosis who developed serious illness including involvement of the heart (8), lung (6), muscles (5), eyes (3), central nervous system (CNS) (3) or liver (2). The mean interval between the onset of disease to severe disability was 58.3 months. The interval was particularly long in those patients who presented with either pulmonary (100.8 months) or liver sarcoidosis (108 months). Of the 27 patients with severe sarcoidosis, 8 (29.6%) gradually became worse towards the end of their clinical course despite only mild clinical signs and symptoms at the first presentation. Therefore, the initial clinical symptoms and findings, including ocular involvement. ECG abnormalities, negative reaction to PPD, high value of serum angiotensin converting enzyme (ACE) and a small number of lymphocytes in peripheral blood, were not useful in predicting prognosis. The relationship between the maximum serum ACE value during the clinical course and the duration of the active phase was statistically significant in the 123 patients who were monitored throughout their course, suggesting that the maximum serum ACE may be a marker for assessing prognosis. Corticosteroid was administered to 76 patients (22%) with serious systemic involvement. They included 26 (96.4%) of the 27 severe sarcoidosis and 50 (37.9%) of the 132 moderate sarcoidosis. Patients with mild sarcoidosis did not receive corticosteroids.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗

Seizure prognosis for partial epilepsies in India.

The long-term prognosis and factors associated with good and poor prognosis were studied in 95 patients with partial seizures. Thirty-nine per cent of the patients became seizure free. Significant prognostic factors were: male sex, most attacks while awake, attacks precipitated by a hot-water bath, presence of autonomic phenomena and complex symptoms, chronicity and severity of the illness, and seizure activity and the presence of symmetric synchronous EEG foci in the initial EEG records. Regularity of medication, duration of illness and autonomic phenomena were 3 predictive factors for long-term prognosis.

Adolescent↗

Information about diagnosis and prognosis related to anxiety and depression in children with cancer aged 8-16 years.

The aim of this study was to test the hypothesis that being openly informed about the diagnosis and prognosis benefits the emotional well-being of children with cancer. A stratified sample of 56 children with cancer aged 8-16 years and their parents participated. The parents were interviewed about the information they had given to their child. Self-report questionnaires were administered to the children measuring anxiety and depression. Children who received open information about their diagnosis and prognosis at the initial stage of the disease showed significantly less anxiety and depression. Our findings suggest that parents should be advised to inform their child with cancer openly and soon after the initial diagnosis. Physicians should offer help to the parents in dealing with the difficult task of confronting the child with the diagnosis, prognosis and treatment.

Adolescent↗

Prognosis of patients with breast cancers up to 1 cm in diameter.

The prognosis of patients with tumours measuring up to 1 cm diameter was examined. 336 patients treated at Guy's Hospital between 1975 and 1994 were reviewed. Of these, 103 (31%) were lymph node-positive, with approximately one third of these having one node involved, one third two to three nodes and one third four nodes or more. A similar proportion of those with palpable and impalpable tumours had axillary node involvement. Patients with axillary node involvement had a significantly worse prognosis and those node-positive patients with impalpable cancers had a significantly worse outcome compared with node-positive palpable cases. When patients were subdivided on a basis of nodal status and age (< or = 50 or > 50), node-positive women aged > 50 fared significantly better than younger women. These data suggest the need to know accurately the axillary nodal status of patients with small breast cancers, whether symptomatic or detected by screening. This knowledge will allow women with curable cancers to be identified together with those who have a worse prognosis and who will be likely to benefit from systemic adjuvant therapy.

Age Factors↗

EGFR and PCNA expression in oral squamous cell carcinomas--a valuable tool in estimating the patient's prognosis.

We investigated 100 cases of oral squamous cell carcinomas immunohistologically with respect to the expression of the epidermal growth factor receptor (EGFR) and the proliferating cell nuclear antigen (PCNA). The results were correlated with a new malignancy grading of the invasive tumour areas and the clinical outcome of the patients to estimate the individual prognosis. In conclusion, the amount of antigen expression of both antigens increases with the increasing grade of malignancy of the oral squamous cell carcinoma. Furthermore, there is a statistically significant correlation between the amount of antigen expression and the patient's prognosis. An overexpression of EGFR and PCNA is associated with a short survival of the patient. Both antigens detect relevant tumour biological parameters and are worthy factors in estimating the individual prognosis in patients suffering from oral squamous cell carcinomas.

Adult↗

Changing trends in the long-term prognosis of patients with acute myocardial infarction: a population-based perspective.

BACKGROUND: Little contemporary data exist describing changes over time in the postdischarge prognosis of hospital survivors of acute myocardial infarction (AMI). The purpose of our study was to examine recent and multidecade-long (1975-2001) trends in the long-term prognosis of greater Worcester (MA) residents discharged from all metropolitan Worcester hospitals after confirmed AMI. METHODS: A total of 9827 greater Worcester residents with independently validated AMI discharged from all metropolitan Worcester hospitals during 13 annual periods between 1975 and 2001 comprised the study population. A variety of follow-up approaches were used to ascertain the survival status of discharged patients through the end of 2003. RESULTS: Crude unadjusted 1-year postdischarge survival rates declined over time. Suggestions of modest improvements in the multivariable adjusted 1-year postdischarge survival rates were noted, however, in patients discharged from greater Worcester hospitals in the more recent (2001) (adjusted odds of surviving 1.23, 95% CI 0.97-1.55) as compared with earliest study periods (1975/1978). Advancing age, female sex, presence of prior diabetes, stroke, heart failure, or myocardial infarction and occurrence of several clinical complications during hospitalization were significantly related to an adverse postdischarge prognosis. CONCLUSIONS: The results of this investigation provide contemporary insights into the long-term survival of patients with AMI from a more generalizable population-based perspective. Multivariable adjusted analyses revealed slight improvements in postdischarge survival over time. Our data identify several high-risk groups that should be targeted for more aggressive surveillance and increased use of effective cardiac therapies and interventions.

Aged↗

How do different indicators of cardiac pump function impact upon the long-term prognosis of patients with chronic heart failure?

BACKGROUND: The prognosis of patients with mild-moderate chronic heart failure (CHF) over a long-term follow-up period is more difficult to predict than for patients with more severe CHF in the short term. This study assessed the prognostic value of various indicators of cardiac pump function to gain insight into how different aspects of organ function impact upon prognosis. METHODS: Unselected, consecutive patients with CHF (n = 219, 166 men, mean [+/-SD] age 56 +/- 13 years) who underwent symptom limited cardiopulmonary treadmill exercise testing with noninvasive estimation of cardiac output using carbon dioxide rebreathing techniques were followed up for a median period of 8.6 +/- 1.0 years in survivors. Cardiac power output (CPO) was calculated from the product of cardiac output and mean arterial pressure and cardiac reserve was estimated by subtracting resting from peak exercise CPO or cardiac output (CO). RESULTS: All-cause mortality was 36% (78 deaths). Survivors had a significantly greater cardiac pumping reserve with the greatest difference seen in CPO reserve (+57%) and CO reserve (+49%) (both P < .001). Although various direct and indirect indicators of cardiac function were predictive of outcome on univariate analyses, multivariate analysis using the Cox proportional hazards model identified CO reserve to be the independent variable predictive of all-cause mortality, with a hazard ratio (95% CI) of 0.682 (0.612-0.757, P < .001) for each L/min increase in cardiac output reserve. Survival at 10 years in patients with tertiles of good, moderate, or poor cardiac output reserve was 89%, 63%, and 36.1%, respectively (P < .001). CONCLUSION: In this long-term follow-up study involving a cohort of unselected ambulatory patients with mild-moderate CHF, cardiac pumping reserve measured noninvasively by cardiopulmonary exercise testing was found to be the strongest independent predictor of prognosis.

Chronic Disease↗

Long-term follow-up and prognosis of orbital apex syndrome resulting from nasopharyngeal rhabdomyosarcoma.

PURPOSE: Nasopharyngeal rhabdomyosarcoma may present with a variety of ophthalmic symptoms. Direct extension of the tumor into the orbital apex can lead to ophthalmoplegia and loss of vision. The prognosis for recovery of vision and ocular motility in patients with an orbital apex syndrome due to nasopharyngeal rhabdomyosarcoma is examined. DESIGN: Retrospective case series. METHODS: Six eyes from four patients with nasopharyngeal rhabdomyosarcoma who presented to the Children';s Hospital of Philadelphia with a clinical orbital apex syndrome were identified. Complete ophthalmic examination, including visual acuity and extraocular motility at the time of presentation, was reviewed. Tumor extension into the orbital apex was confirmed radiographically. Follow-up ophthalmic evaluations were reviewed for all patients with an average follow-up of 5.5 +/- 3.1 years (range 1 to 8 years). RESULTS: Six eyes of four patients had limited ocular ductions along with marked loss of vision at presentation. All patients were treated with chemotherapy and radiation, with reduction of tumor mass. Ocular motility recovered in all patients, occurring by an average of 2.2 +/- 1.8 months after initiation of therapy. Four of six eyes had little or no recovery of visual acuity detected at long-term follow-up. CONCLUSIONS: Patients with ocular motor deficits in orbital apex syndromes caused by extension of nasopharyngeal rhabdomyosarcoma have an excellent prognosis for recovery after treatment of the tumor. The long-term prognosis for visual recovery, however, is poor.

Child, Preschool↗

Peak exercise oxygen pulse and prognosis in chronic heart failure.

Cardiopulmonary variables, particularly peak oxygen consumption (peak VO(2)) corrected for total and lean body weight, have been confirmed to predict prognosis in patients with chronic systolic heart failure (HF). Only limited data are available on the prognostic ability of maximal oxygen (O(2)) pulse, an indicator of stroke volume and arteriovenous O(2) difference, especially when corrected for lean body mass. Cardiopulmonary exercise tests were performed in 209 consecutive patients with mild-to-moderate HF (mean ejection fraction 23%), followed for 19 +/- 12 months to determine the impact of maximal O(2) pulse in relation to other cardiopulmonary variables on major clinical events (13 cardiovascular deaths and 15 urgent transplantations). Compared with patients with clinical events, those without major events had a higher peak O(2) pulse (11.4 +/- 4.1 vs 9.2 +/- 2.3 ml/beat, p <0.0001) and body fat-adjusted peak O(2) pulse (15.6 +/- 5.6 vs 11.9 +/- 3.4 ml/beat, p <0.0001). In multivariate analysis, a low peak O(2) pulse was the strongest independent predictor of clinical events (chi-square 10.5, p <0.01). Although peak O(2) pulse was a stronger predictor for clinical events than any other exercise cardiopulmonary variable, including peak VO(2), peak VO(2) lean (defined as the VO(2) corrected for lean body mass), and percentage of predicted peak VO(2), this relation was further strengthened by correcting peak O(2) pulse for percent body fat (chi-square 12.4, p <0.001). In most subgroups (including women, obese subjects, those receiving beta blockers, and those with class III HF), peak O(2) pulse lean was similar to or superior to peak VO(2) lean for predicting major clinical events. Especially in patients who were class III HF and who were receiving beta blockers, peak VO(2) (cutoff 14 ml/kg/min) poorly predicted prognosis; risk stratification was best with peak O(2) pulse lean (cutoff 14 ml/beat). These data indicate the potential usefulness of peak O(2) pulse and lean body mass-adjusted O(2) pulse for predicting prognosis in patients with systolic HF.

Adult↗