Association between spironolactone added to beta-blockers and ACE inhibition and survival in heart failure patients with reduced ejection fraction: a propensity score-matched cohort study.

PURPOSE: Heart failure (CHF) guidelines recommend mineralocorticoid receptor antagonists for all symptomatic patients treated with a combination of ACE inhibitors/angiotensin receptor blockers (ARBs) and beta-blockers. As opposed to both eplerenone trials, patients in RALES (spironolactone) received almost no beta-blockers. Since pharmacological properties differ between eplerenone and spironolactone, the prognostic benefit of spironolactone added to this baseline combination therapy needs clarification. METHODS: We included 4,832 CHF patients with chronic systolic dysfunction from the Norwegian Heart Failure Registry and the heart failure outpatients' clinic of the University of Heidelberg. Propensity scores for spironolactone receipt were calculated for each patient and used for matching to patients without spironolactone. RESULTS: During a total follow-up of 17,869 patient-years, 881 patients (27.0 %) died in the non-spironolactone group and 445 (28.4 %) in the spironolactone group. Spironolactone was not associated with improved survival, neither in the complete sample (HR 0.82; 95 % CI 0.64-1.07; HR 1.03; 95 % CI 0.88-1.20; multivariate and propensity score adjusted respectively), nor in the propensity-matched cohort (HR 0.98; 95 % CI 0.82-1.18). CONCLUSION: In CHF outpatients we were unable to observe an association between the use of spironolactone and improved survival when administered in addition to a combination of ACE/ARB and beta-blockers.

Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

BACKGROUND: Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. METHODS: We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). RESULTS: At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. CONCLUSIONS: Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care.

HMGB1 is an independent predictor of death and heart transplantation in heart failure.

BACKGROUND: High-Mobility-Group Box 1 (HMGB1) has been established as an important mediator of myocardial inflammation and associated with progression of heart failure (HF). The aim of this study was to analyze the prognostic value of systemic HMGB1 levels in HF patients with ischemic and non-ischemic cardiomyopathy. METHODS AND RESULTS: We conducted an analysis (median follow-up time 2.5 years) of HMGB1 plasma concentration in 154 patients with systolic HF and correlated the results with disease severity and prognosis. HMGB1 in HF patients with severe symptoms (NYHA III/IV; 5.35 ng/ml; interquartile range (IQR) = 3.48-8.42 ng/ml) was significantly elevated compared with that in patients with mild symptoms (NYHA I/II; 3.37 ng/ml, IQR = 2.31-5.22 ng/ml, p < 0.0001) and with controls (3.25 ng/ml, IQR = 3.04-3.67 ng/ml, p < 0.0001). HMGB1 levels correlated with other markers of heart failure indicating an association of HMGB1 with disease severity in HF. In a univariate cox regression model for the combined endpoint of death and heart transplantation, HMGB1 proved to be a predictor at cut-off values based on HMGB1 terciles of either 3.4 or 6.1 ng/ml (p = 0.001 and p < 0.0001, respectively). In a multivariate cox regression model, which included NT-proBNP, creatinine, age, NYHA class, white blood cell count, anemia, and age, HMGB1 remained an independent predictor of the combined endpoint (hazard ratio (HR) = 2.48, 95% confidence interval (CI) = 1.06-5.83, p = 0.037 and HR = 2.48, 95% CI = 1.31-4.71, p = 0.005, respectively). CONCLUSION: Our findings demonstrate that HMGB1 plasma concentration is elevated in HF and correlates with disease severity and that is an independent predictor of the combined endpoint death and heart transplantation in HF patients.

Derivation and validation of a simple clinical risk-model in heart failure based on 6 minute walk test performance and NT-proBNP status--do we need specificity for sex and beta-blockers?

BACKGROUND: It is unclear whether risk prediction strategies in chronic heart failure (CHF) need to be specific for sex or beta-blockers. We examined this problem and developed and validated the consequent risk models based on 6-minute-walk-test and NT-proBNP. METHODS: The derivation cohort comprised 636 German patients with systolic dysfunction. They were validated against 676 British patients with similar aetiology. ROC-curves for 1-year mortality identified cut-off values separately for specificity (none, sex, beta-blocker, both). Patients were grouped according to number of cut-offs met (group I/II/III - 0/1/2 cut-offs). RESULTS: Widest separation between groups was achieved with sex- and beta-blocker-specific cut offs. In the derivation population, 1-year mortality was 0%, 8%, 31% for group I, II and III, respectively. In the validation population, 1-year rates in the three risk groups were 2%, 7%, 14%, respectively, after application of the same cut-offs. CONCLUSION: Risk stratification for CHF should perhaps take sex and beta-blocker usage into account. We derived and independently validated relevant risk models based on 6-minute-walk-tests and NT-proBNP. Specifying sex and use of beta-blockers identified three distinct sub-groups with widely differing prognosis. In clinical practice, it may be appropriate to tailor the intensity of follow-up and/or the treatment strategy according to the risk-group.

The prognostic value of individual NT-proBNP values in chronic heart failure does not change with advancing age.

BACKGROUND: It is unclear whether age-related increases in N-terminal pro-brain natriuretic peptide (NT-proBNP) represent a normal physiological process-possibly affecting the prognostic power-of NT-proBNP-or reflect age-related subclinical pathological changes. OBJECTIVE: To determine the effect of age on the short-term prognostic value of NT-proBNP in patients with chronic heart failure (CHF). DESIGN: Prospective observational study with inclusion and matching of consecutive patients aged >65 years (mean (SD) 73.1 (6.0) years) to patients <65 years (53.7 (8.6) years) with respect to NT-proBNP, New York Heart Association stage, sex and aetiology of CHF (final n = 443). SETTING: University hospital outpatient departments in the UK and Germany. PATIENTS: Chronic stable heart failure due to systolic left ventricular dysfunction. INTERVENTION: None. OUTCOME MEASURE: All-cause mortality. RESULTS: In both age groups, NT-proBNP was a significant univariate predictor of mortality, and independent of age, sex and other established risk markers. The prognostic information given by NT-proBNP was comparable between the two groups, as reflected by the 1-year mortality of 9% in both groups. The prognostic accuracy of NT-proBNP as judged by the area under the receiver operating characteristics curve for the prediction of 1-year mortality was comparable for elderly and younger patients (0.67 vs 0.71; p = 0.09). CONCLUSION: NT-proBNP reflects disease severity in elderly and younger patients alike. In patients with chronic stable heart failure, the NT-proBNP value carries the same 1-year prognostic information regardless of the age of the patient.

Gender and age related predictive value of walk test in heart failure: do anthropometrics matter in clinical practice?

BACKGROUND: The six-minute walk test (6 WT) is a valid and reliable predictor of morbidity and mortality in chronic heart failure (CHF) patients, frequently used as an endpoint or target in clinical trials. As opposed to spiroergometry, improvement of its prognostic accuracy by correction for height, weight, age and gender has not yet been attempted comprehensively despite known influences of these parameters. METHODS: We recorded the 6 WT of 1035 CHF patients, attending clinic from 1995 to 2005. The 1-year prognostic value of 6 WT was calculated, alone and after correction for height, weight, BMI and/or age. Analysis was performed on the entire cohort, on males and females separately and stratified according to BMI (<25, 25-30 and >30 kg/m(2)). RESULTS: 6 WT weakly correlated with age (r=-0.32; p<0.0001), height (r=0.2; p<0.0001), weight (r=0.11; p<0.001), not with BMI (r=0.01; p=ns). The 6 WT was a strong predictor of 1-year mortality in both genders, both as a single and age corrected parameter. Parameters derived from correction of 6 WT for height, weight or BMI did not improve the prognostic value in univariate analysis for either gender. Comparison of the receiver operated characteristics showed no significant gain in prognostic accuracy from any derived variable, either for males or females. CONCLUSION: The six-minute walk test is a valid tool for risk prediction in both male and female CHF patients. In both genders, correcting 6 WT distance for height, weight or BMI alone, or adjusting for age, does not increase the prognostic power of this tool.

Guideline adherence for pharmacotherapy of chronic systolic heart failure in general practice: a closer look on evidence-based therapy.

BACKGROUND: There is robust evidence for effective pharmacotherapy of chronic (systolic) heart failure (CHF) which has led to the creation of guidelines, but many surveys evaluating CHF treatment show an under-utilisation of relevant drugs, while setting and patient population appear to be crucial for adequate appraisal of treatment patterns. AIMS: To evaluate the guideline adherence (GA) of general practitioners (GPs) in a well-defined patient population with CHF in primary care (PC). METHODS: A cross-sectional analysis was performed with the data of 167 patients enrolled in 37 GP practices (Germany) with documented left ventricular systolic dysfunction (LVEF: 33.3 +/- 6.9%). GA was assessed as usual (prescribing "yes" or "no"), through evaluation of target dosing, while adjusting for potential clinical contraindications, and through a modified Guideline Adherence Indicator-3 (mGAI-3), which assesses three relevant groups of substances according to New York Heart Association (NYHA) functional class: ACE-Inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers (BB) and aldosterone-antagonists (AA). RESULTS: Prescription rates for ACE-I/ARB, BB or both were 80%, 75% and 62%, respectively. The proportion of target doses reached for ACE-I was 16%, for BB only 8%. When adjusted for potential (mainly relative) contraindications (COPD, heart rate <60/min, hypotension, hyperkalaemia and renal dysfunction), the percentage of target doses reached increased to 49% for ACE-I/ARBs and 46% for BB. Application of the mGAI-3 showed moderate to perfect GA for usual assessment, proportion of target dose reached and adjusted in 83%, 16% and 55% of the patients, respectively. CONCLUSION: In the context of this patient and doctor setting, life-saving treatment was provided above average when assessed by usual criteria. The application of additional criteria showed further room for improvement. Future interventions aiming at optimisation should be tailored to the needs of doctors and patients likewise.

Prognostic impact of peakVO2-changes in stable CHF on chronic beta-blocker treatment.

BACKGROUND: Peak oxygen uptake (pVO2) is used for risk stratification in chronic heart failure (CHF), but little is known about the prognostic impact of pVO2-changes in patients on chronic beta-blocker (BBL) therapy. We therefore prospectively evaluated individual pVO2-changes at a 6-month interval in patients all receiving BBL. METHODS: 194 patients with stable CHF on stable medication were included (V1) and underwent clinical evaluation and exercise testing. Testing was repeated (V2) at 5.7+/-1.5 months after V1 and patients were followed >12 months after V2. Death or hospitalisation due to cardiac reasons was the predefined EP (EPP, end-point positive; n=62; EPN, end-point negative; n=113). RESULTS: Initial characteristics did not differ between EPP and EPN. Multivariate cox regression analysis revealed that change of pVO2 (EPP: -0.6+/-2.6 ml/kg min; EPN: +2.5+/-3.3 ml/kg min; p<0.001) was independent to pVO2, LVEF, NTproBNP and NYHA at V2 for prediction of the combined end-point during follow-up. An increase of pVO2 by 10% was identified as an adequate cut-off value for risk stratification and ROC-analysis showed the significant incremental prognostic value of the determination of pVO2 changes in combination with pVO2. CONCLUSIONS: Serial measurements of pVO2 yield additional information for risk stratification in clinically homogenous CHF patients receiving BBL. This is the first study demonstrating this fact within a narrow predefined interval with all patients on BBL.

[Evaluation of traditional German undergraduate surgical training. An analysis at Heidelberg University]. / Evaluation der traditionellen studentischen Ausbildung in der Chirurgie. Eine Heidelberger Bestandsaufnahme.

BACKGROUND: The medical faculty of Heidelberg University implemented a new problem-based clinical curriculum (Heidelberg Curriculum Medicinale, or Heicumed) in 2001. The present study analyses the evaluation data of two student cohorts prior to the introduction of Heicumed. Its aim was to specify problems of the traditional training and to draw conclusions for implementation of a new curriculum. METHODS: The evaluation instrument was the Heidelberg Inventory for the Evaluation of Teaching (HILVE-I). The data were analysed calculating differences in the means between defined groups, with the 13 primary scales of the HILVE I-instrument as dependent variables. RESULTS: Teaching method and subject had no systematic influence on evaluation results. Thus, didactic lecture in orthopedic surgery achieved better results than small group tutorials, while the data on vascular and general surgery showed opposite results. Major factors for success were continuity and didactic training of lecturers and tutors. This is convincingly reflected by the results of the lecture course "Differential diagnosis in general surgery". The good evaluation data on small group tutorials resulted largely from the "participation" and "discussion" scales, which represent interactivity in learning. CONCLUSION: The results of the present study suggest the importance of two major pedagogic ideas: continuity and didactic training of lecturers and tutors. These principles were widely implemented in Heicumed and have contributed to the success of the new curriculum.

Cardiac parasympathetic regulation in obese women with binge eating disorder.

OBJECTIVE: Obese individuals with a binge eating disorder (BED) differ from obese non-binge eaters (NBED) with respect to (a) eating behaviour, (b) psychiatric comorbidity and (c) level of psychosocial distress. The aim of the study was to explore whether these three factors have an influence on cardiac parasympathetic function, that is independent of obesity: as alterations in cardiac parasympathetic function may have a role in the higher cardiovascular mortality that is present in obese individuals. METHODS: In total, 38 obese women (BMI>30 kg/m(2)), with a BED and 34 age and BMI matched healthy controls (NBED) completed a laboratory stress protocol that incorporated a baseline resting period, Head-up Tilt Testing (HUT) and two challenging mental tasks. Heart rate and blood pressure were measured continuously during the protocol. Parasympathetic cardiac regulation was assessed as the high frequency component of heart rate variability (HRV-HF). RESULTS: Mental challenge led to an augmented reduction of HRV-HF in obese binge eaters, which was linked to the binge eating frequency and hunger perception, but not to psychiatric comorbidity. During baseline conditions and HUT, no significant differences in parasympathetic measures were observed between the two subject groups. CONCLUSION: Subjects with a BED showed greater reduction in parasympathetic cardiac control (HRV-HF) during mental stress, suggesting higher stress vulnerability in women with a BED. Longitudinal investigations are necessary to evaluate whether this is associated with an increased cardiovascular mortality.

Usefulness of myocardial parametric imaging to evaluate myocardial viability in experimental and in clinical studies.

OBJECTIVE: To evaluate whether myocardial parametric imaging (MPI) is superior to visual assessment for the evaluation of myocardial viability. METHODS AND RESULTS: Myocardial contrast echocardiography (MCE) was assessed in 11 pigs before, during, and after left anterior descending coronary artery occlusion and in 32 patients with ischaemic heart disease by using intravenous SonoVue administration. In experimental studies perfusion defect area assessment by MPI was compared with visually guided perfusion defect planimetry. Histological assessment of necrotic tissue was the standard reference. In clinical studies viability was assessed on a segmental level by (1) visual analysis of myocardial opacification; (2) quantitative estimation of myocardial blood flow in regions of interest; and (3) MPI. Functional recovery between three and six months after revascularisation was the standard reference. In experimental studies, compared with visually guided perfusion defect planimetry, planimetric assessment of infarct size by MPI correlated more significantly with histology (r2 = 0.92 versus r2 = 0.56) and had a lower intraobserver variability (4% v 15%, p < 0.05). In clinical studies, MPI had higher specificity (66% v 43%, p < 0.05) than visual MCE and good accuracy (81%) for viability detection. It was less time consuming (3.4 (1.6) v 9.2 (2.4) minutes per image, p < 0.05) than quantitative blood flow estimation by regions of interest and increased the agreement between observers interpreting myocardial perfusion (kappa = 0.87 v kappa = 0.75, p < 0.05). CONCLUSION: MPI is useful for the evaluation of myocardial viability both in animals and in patients. It is less time consuming than quantification analysis by regions of interest and less observer dependent than visual analysis. Thus, strategies incorporating this technique may be valuable for the evaluation of myocardial viability in clinical routine.

Role-playing for more realistic technical skills training.

Clinical skills are an important and necessary part of clinical competence. Simulation plays an important role in many fields of medical education. Although role-playing is common in communication training, there are no reports about the use of student role-plays in the training of technical clinical skills. This article describes an educational intervention with analysis of pre- and post-intervention self-selected student survey evaluations. After one term of skills training, a thorough evaluation showed that the skills-lab training did not seem very realistic nor was it very demanding for trainees. To create a more realistic training situation and to enhance students' involvement, case studies and role-plays with defined roles for students (i.e. intern, senior consultant) were introduced into half of the sessions. Results of the evaluation in the second term showed that sessions with role-playing were rated significantly higher than sessions without role-playing.

[Integrated skills laboratory concept for undergraduate training in internal medicine]. / Integriertes Skills-Lab-Konzept für die studentische Ausbildung in der Inneren Medizin.

BACKGROUND AND OBJECTIVE: An amendment to the German medical curriculum in April 2002 will place basic practical skills at the centre of medical training. We report here on the implementation and evaluation of an obligatory, tutor-guided, and integrated skills laboratory concept in the field of internal medicine. METHODS: To test the effectiveness of a skills laboratory training on OSCE performance a pilot study was carried out. The experimental group, of 77 students, participated in seven sessions of communication training, skills laboratory training, and bedside teaching, each lasting one and a half hours. The control group of 66 students had as many sessions but was only offered bedside-teaching. The evaluation of acceptance of skills' training as well as the related increase in individual competence is on-going (summer term 2004: n = 176 students). RESULTS: The integrated skills laboratory concept was rated at 3.5 (SD = 1.2) on a 5-point scale and was acknowledged as practice-oriented (M = 4.2; SD = 1.0) and relevant for doctors' everyday lives (M = 3.6; SD = 1.1). Increased levels of competence according to individual self-evaluations proved to be highly significant (p<.001), and results of the pilot study showed that the experimental group had a significantly better OSCE performance than the control group (p<.001). CONCLUSION: This pilot study shows that curriculum changes promoting basic clinical skills are effective and lead to an improved practical education of tomorrow's physicians. The integrated skills laboratory concept is well accepted and leads to a relevant increase in competence in the practice of internal medical. The presented skills laboratory concept in internal medicine is proving to be a viable and efficient learning tool.

Predictability of a favorable outcome in anorexia nervosa.

OBJECTIVE: In a long-term follow-up of anorexia nervosa (AN) patients, somatic, psychological and social variables at clinical presentation should be investigated using a multilevel approach. METHODS: This study isolated predictors known from the literature over longer time periods and carried out a separate investigation of predictors in a sample of 81 AN patients of the Heidelberg-Mannheim study over a mean period of 12 years (range 9-19 years). Separate hierarchic regression analyses on the basis of the course of the Morgan-Russell categories were calculated for four individually recorded areas: anamnestic, psychological, somatic and social data sets. RESULTS: Age at the onset of the disease, purging behavior, low serum albumin, high glutamic-oxalo acetic transaminase (GOT) psychopathology (ANSS) and social pathology had the highest predictive value qualities. In survival analysis overall assessment of all six main predictors at clinical presentation could differentiate all patients who recovered from those who remained ill (log-rank test P = 0.019). CONCLUSION: A small number of variables were important for detecting a good or poor long-term course of AN. At onset of the disease, it seems necessary to evaluate these psychological, somatic and social predictors.

[Stress and autonomic dysregulation in patients with fibromyalgia syndrome]. / Stress und autonome Dysregulation bei Patienten mit einem Fibromyalgiesyndrom.

AIM: The aim of the present study was to evaluate to what extent the orthostatic dysregulation of FMS patients can be attributed primarily to reduced baroreceptor-mediated activation of the sympathetic nervous system and whether a hyporeactive sympathetic nervous system can also be confirmed for mental stress. PATIENTS AND METHODS: A total of 28 patients with primary FMS were examined and compared with 15 healthy subjects. Diagnostic investigations of the autonomic nervous system were based on measuring HRV in frequency range and assessing spontaneous baroreflex sensitivity (sBRS) under mental stress and passive orthostatism. RESULTS: Both under orthostatic and mental stress FMS patients exhibited reduced activation of the sympathetic nervous system as measured by the spectral power of HRV in the low-frequency range and the mean arterial blood pressure or heart rate. The present study provided no indications for dysregulation of sBRS. CONCLUSION: The results obtained confirm the hypothesis of a hyporeactive stress system in FMS patients for both peripherally and centrally mediated stimulation of the sympathetic nervous system.

[Treatment of recurrent neurocardiogenic syncope with cardiac inhibitors with ipratropium bromide]. / Behandlung rezidivierender neurokardiogener Synkopen vom kardioinhibitorischen Typ mit Ipratropiumbromid.

Pharmacological approaches for the treatment of cardioinhibitory vasovagal syncope are controversially discussed in the literature. In acute treatment of neurocardiogenic syncope, anticholinergics (atropine) are used effectively. Randomised and placebo-controlled clinical trials evaluating the preventive significance of anticholinergic agents in the therapy of cardioinhibitory vasovagal syncope are still missing. We report the case of an 18-year-old male patient with recurrent convulsive, cardioinhibitory neurocardiogenic syncope. Vasovagal syncope occurred predominantly as centrally induced syncope triggered by negative emotions such as fear or by seeing blood. Under resting conditions, the patient revealed increased parasympathetic tone with nocturnal bradycardia of 38 beats/min. In the course of head-up tilt table testing a cardioinhibitory syncope with an asystolic pause of 10 seconds occurred without any prodromes after 10 minutes of upright positioning. In order to inhibit parasympathetic tone, medication with ipratropiumbromide was initiated. Time-variant analysis of heart rate variability (autoregressive model) during head-up tilt table testing showed under the medication with ipratropiumbromide a vagal mediated cardioinhibition to 56 beats/min, but no further sinus arrest. Throughout clinical follow-up of 6 months the patient remained syncope-free under the medication. The usefulness of ipratropiumbromide in inhibiting vagal mediated cardioinhibition will be discussed referring to the case report and to studies evaluating anticholinergic agents in the treatment of neurocardiogenic syncope.

Heart rate variability enhances the prognostic value of established parameters in patients with congestive heart failure.

This prospective study evaluated whether heart rate variability (HRV) assessed from Holter ECG has prognostic value in addition to established parameters in patients with congestive heart failure (CHF). The study included 222 patients with CHF due to dilated or ischemic cardiomyopathy (left ventricular ejection fraction LVEF 21+/-1%; mean+/-SEM). During a mean follow-up of 15+/-1 months, 38 (17%) patients died and 45 (20%) were hospitalized due to worsening of CHF. The HRV parameter SDNN (standard deviation of all intervals between normal beats) was significantly lower in non-surviving or hospitalized than in event-free patients (118+/-6 vs 142+/-5 ms), as were LVEF (18+/-1 vs 23+/-1%), and peak oxygen uptake during exercise (peak VO(2)) (12.8+/-0.5 vs 15.6+/-0.5 ml/min/kg). While each of these parameters was a risk predictor in univariate analysis, multivariate analysis revealed that HRV provides both independent and additional prognostic information with respect to the risk 'cardiac mortality or deterioration of CHF'. It is concluded that the determination of HRV enhances the prognostic power given by the most widely used parameters LVEF and peak VO(2) in the prediction of mortality or deterioration of CHF and thus enables to improve risk stratification.

Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables.

OBJECTIVE: To assess health related quality of life of patients with congestive heart failure; to compare their quality of life with the previously characterised general population and in those with other chronic diseases; and to correlate the different aspects of quality of life with relevant somatic variables. SETTING: University hospital. PATIENTS AND DESIGN: A German version of the generic quality of life measure (SF-36) containing eight dimensions was administered to 205 patients with congestive heart failure and systolic dysfunction. Cardiopulmonary evaluation included assessment of New York Heart Association (NYHA) functional class, left ventricular ejection fraction, peak oxygen uptake, and the distance covered during a standardised six minute walk test. RESULTS: Quality of life significantly decreased with NYHA functional class (linear trend: p < 0.0001). In NYHA class III, the scores of five of the eight quality of life domains were reduced to around one third of those in the general population. The pattern of reduction was different in patients with chronic hepatitis C and major depression, and similar in patients on chronic haemodialysis. Multiple regression analysis showed that only the NYHA functional class was consistently and closely associated with all quality of life scales. The six minute walk test and peak oxygen uptake added to the explanation of the variance in only one of the eight quality of life domains (physical functioning). Left ventricular ejection fraction, duration of disease, and age showed no clear association with quality of life. CONCLUSIONS: In congestive heart failure, quality of life decreases as NYHA functional class worsens. Though NYHA functional class was the most dominant predictor among the somatic variables studied, the major determinants of reduced quality of life remain unknown.

Risk stratification in middle-aged patients with congestive heart failure: prospective comparison of the Heart Failure Survival Score (HFSS) and a simplified two-variable model.

AIMS: The performance of a US-American scoring system (Heart Failure Survival Score, HFSS) was prospectively evaluated in a sample of ambulatory patients with congestive heart failure (CHF). Additionally, it was investigated whether the HFSS might be simplified by assessment of the distance ambulated during a 6-min walk test (6'WT) instead of determination of peak oxygen uptake (peak VO(2)). METHODS AND RESULTS: In 208 middle-aged CHF patients (age 54+/-10 years, 82% male, NYHA class 2.3+/-0.7; follow-up 28+/-14 months) the seven variables of the HFSS: CHF aetiology; heart rate; mean arterial pressure; serum sodium concentration; intraventricular conduction time; left ventricular ejection fraction (LVEF); and peak VO(2), were determined. Additionally, a 6'WT was performed. The HFSS allowed discrimination between patients at low, medium and high risk, with mortality rates of 16, 39 and 50%, respectively. However, the prognostic power of the HFSS was not superior to a two-variable model consisting only of LVEF and peak VO(2). The areas under the receiver operating curves (AUC) for prediction of 1-year survival were even higher for the two-variable model (0.84 vs. 0.74, P<0.05). Replacing peak VO(2) with 6'WT resulted in a similar AUC (0.83). CONCLUSION: The HFSS continued to predict survival when applied to this patient sample. However, the HFSS was inferior to a two-variable model containing only LVEF and either peak VO(2) or 6'WT. As the 6'WT requires no sophisticated equipment, a simplified two-variable model containing only LVEF and 6'WT may be more widely applicable, and is therefore recommended.