Erik Badings

Added value of a physician-and-nurse-directed heart failure clinic: results from the Deventer–Alkmaar heart failure study

Aim: To determine whether an intensive intervention at a heart failure (HF) clinic by a combination of a clinician and a cardiovascular nurse, both trained in HF, reduces the incidence of hospitalisation for worsening HF and/or all-cause mortality (primary end point) and improves functional status (including left ventricular ejection fraction, New York Heart Association (NYHA) class and quality of life) in patients with NYHA class III or IV. Setting: Two regional teaching hospitals in The Netherlands. Methods: 240 patients were randomly allocated to the 1-year intervention (n = 118) or usual care (n = 122). The intervention consisted of 9 scheduled patient contacts—at day 3 by telephone, and at weeks 1, 3, 5, 7 and at months 3, 6, 9 and 12 by a visit—to a combined, intensive physician-and-nurse-directed HF outpatient clinic, starting within a week after hospital discharge from the hospital or referral from the outpatient clinic. Verbal and written comprehensive education, optimisation of treatment, easy access to the clinic, recommendations for exercise and rest, and advice for symptom monitoring and self-care were provided. Usual care included outpatient visits initialised by individual cardiologists in the cardiology departments involved and applying the guidelines of the European Society of Cardiology. Results: During the 12-month study period, the number of admissions for worsening HF and/or all-cause deaths in the intervention group was lower than in the control group (23 vs 47; relative risk (RR) 0.49; 95% confidence interval (CI) 0.30 to 0.81; p = 0.001). There was an improvement in left ventricular ejection fraction (LVEF) in the intervention group (plus 2.6%) compared with the usual care group (minus 3.1%; p = 0.004). Patients in the intervention group were hospitalised for a total of 359 days compared with 644 days for those in the usual care group. Beneficial effects were also observed on NYHA classification, prescription of spironolactone, maximally reached dose of β-blockers, quality of life, self-care behaviour and healthcare costs. Conclusion: A heart failure clinic involving an intensive intervention by both a clinician and a cardiovascular nurse substantially reduces hospitalisations for worsening HF and/or all-cause mortality and improves functional status, while decreasing healthcare costs, even in a country with a primary-care-based healthcare system.

Added value of a physician-and-nurse-directed heart failure clinic. Results from the DEAL-HF study

Aim: To determine whether an intensive intervention at a heart failure (HF) clinic by a combination of a clinician and a cardiovascular nurse, both trained in HF, reduces the incidence of hospitalisation for worsening HF and/or all-cause mortality (primary end point) and improves functional status (including left ventricular ejection fraction, New York Heart Association (NYHA) class and quality of life) in patients with NYHA class III or IV. Setting: Two regional teaching hospitals in The Netherlands. Methods: 240 patients were randomly allocated to the 1-year intervention (n = 118) or usual care (n = 122). The intervention consisted of 9 scheduled patient contacts—at day 3 by telephone, and at weeks 1, 3, 5, 7 and at months 3, 6, 9 and 12 by a visit—to a combined, intensive physician-and-nurse-directed HF outpatient clinic, starting within a week after hospital discharge from the hospital or referral from the outpatient clinic. Verbal and written comprehensive education, optimisation of treatment, easy access to the clinic, recommendations for exercise and rest, and advice for symptom monitoring and self-care were provided. Usual care included outpatient visits initialised by individual cardiologists in the cardiology departments involved and applying the guidelines of the European Society of Cardiology. Results: During the 12-month study period, the number of admissions for worsening HF and/or all-cause deaths in the intervention group was lower than in the control group (23 vs 47; relative risk (RR) 0.49; 95% confidence interval (CI) 0.30 to 0.81; p = 0.001). There was an improvement in left ventricular ejection fraction (LVEF) in the intervention group (plus 2.6%) compared with the usual care group (minus 3.1%; p = 0.004). Patients in the intervention group were hospitalised for a total of 359 days compared with 644 days for those in the usual care group. Beneficial effects were also observed on NYHA classification, prescription of spironolactone, maximally reached dose of β-blockers, quality of life, self-care behaviour and healthcare costs. Conclusion: A heart failure clinic involving an intensive intervention by both a clinician and a cardiovascular nurse substantially reduces hospitalisations for worsening HF and/or all-cause mortality and improves functional status, while decreasing healthcare costs, even in a country with a primary-care-based healthcare system.

Incremental Prognostic Power of Novel Biomarkers (Growth-Differentiation Factor-15, High-Sensitivity C-Reactive Protein, Galectin-3, and High-Sensitivity Troponin-T) in Patients With Advanced Chronic Heart Failure

Elevated natriuretic peptides provide strong prognostic information in patients with heart failure (HF). The role of novel biomarkers in HF needs to be established. Our objective was to evaluate the prognostic power of novel biomarkers, incremental to the N-terminal portion of the natriuretic peptide (NT-proBNP) in chronic HF. Concentrations of circulating NT-proBNP, growth differentiation factor 15 (GDF-15), high-sensitivity C-reactive protein (hs-CRP), galectin-3 (Gal-3), and high-sensitivity troponin T (hs-TnT) were measured and related to all-cause long-term mortality. Of 209 patients (age 71 ± 10 years, 73% male patients, 97% New York Heart Association class III), 151 (72%) died during a median follow-up of 8.7 ± 1 year. The calculated area under the curve for NT-proBNP was 0.63, GDF-15 0.78, hs-CRP 0.66, Gal-3 0.68, and hs-TnT 0.68 (all p <0.01). Each marker was predictive for mortality in univariate analysis. In multivariate analysis, elevated concentrations of GDF-15 (hazard ratio [HR] 1.41, confidence interval [CI] 1.1 to 178, p = 0.005), hs-CRP (HR 1.38, CI 1.15 to 1.67, p = 0.001), and hs-TnT (HR 1.27, CI 1.06 to 1.53, p = 0.008) were independently related to mortality. All novel markers had an incremental value to NT-proBNP, using the integrated discrimination improvement. In conclusion, in chronic HF, GDF-15, hs-CRP, and hs-TnT are independent prognostic markers, incremental to NT-proBNP, in predicting long-term mortality. In this study, GDF-15 is the most predictive marker, even stronger than NT-proBNP.

Fast assessment and management of chest pain patients without ST-elevation in the pre-hospital gateway (FamouS Triage): ruling out a myocardial infarction at home with the modified HEART score:

Background: The first study of the FamouS Triage project investigates the feasibility of ruling out a myocardial infarction in pre-hospital chest pain patients without electrocardiographic ST-segment elevation by using the modified HEART score at the patient’s home, incorporating only a single highly sensitive troponin T measurement. Methods: A venous blood sample was drawn in the ambulance from 1127 consecutive chest pain patients for measurement of the pre-hospital highly sensitive troponin T levels, in order to establish a pre-hospital HEART score (i.e. the modified HEART score) and evaluate the possibility of triage at the patient’s home. The primary endpoint was the occurrence of a major adverse cardiac event (MACE) i.e. acute myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting or death within 30 days after initial presentation. Results: Two hundred and six patients (18%) developed a MACE during 30 days of follow-up. Thirty-six per cent of the patients (n=403) had a low modified HEART score (0–3 points) and none of them developed a MACE during follow-up. Forty-four per cent of the patients (n=494) had an intermediate modified HEART score (4–6 points) and 18% of them developed a MACE. Twenty per cent of the patients (n=230) had a high modified HEART score (7–10 points) of which 52% developed a MACE during follow-up. Conclusion: It seems feasible to rule out a myocardial infarction at home in chest pain patients without ST-segment elevation by using the modified HEART score. TRIAL ID: NTR4205. Dutch Trial Register [http://www.trialregister.nl]: trial number 4205.

Randomised comparison of drug-eluting versus bare-metal stenting in patients with non-ST elevation myocardial infarction

Objective The superiority of drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ST elevation myocardial infarction (STEMI) is well studied; however, randomised data in patients with non-ST elevation myocardial infarction (NSTEMI) are lacking. The objective of this study was to investigate whether stenting with everolimus-eluting stents (EES) safely reduces restenosis in patients with NSTEMI as compared to BMS. Methods ELISA-3 patients were asked to participate in the angiographic substudy and were randomised to DE (Xience V) or BM (Vision) stenting (ELISA-3 group). The primary end point was minimal luminal diameter (MLD) at 9-month follow-up angiography. In addition, 296 patients with NSTEMI who were excluded or did not want to participate in the ELISA-3 trial (RELI group) were randomised to DE or BM stenting and underwent clinical follow-up only (major adverse cardiac events (MACE), stent thrombosis (ST)). A pooled analysis was performed to assess an effect on clinical outcome. Results 178 of 540 ELISA-3 patients participated in the angiographic substudy. MLD at 9 months angiography was 2.37±0.63 mm (DES) versus 1.84±0.62 mm (BMS), p<0.001. Binary restenosis occurred in 1.9% in the DES group versus 16.7% in the BMS group (RR 0.11, 95% CI 0.02 to 0.84, p=0.007). In the pooled analysis, the incidence of MACE, target vessel revascularisation and ST at 2 years follow-up in the DES versus BMS group was 12.5% versus 16.0% (p=0.28), 4.0% versus 10.4% (p=0.009) and 1.3% versus 3.0% (p=0.34), respectively. Conclusions In patients with NSTEMI, use of EES is safe and decreases both angiographic and clinical restenosis as compared to BMS http://www.isrctn.com/search?q=39230163. Trial registration number 39230163; Post-results.

Early or late intervention in patients with transient ST-segment elevation acute coronary syndrome: Subgroup analysis of the ELISA-3 trial

To investigate incidence and patient characteristics of transient ST‐segment elevation (TSTE) ACS and to compare outcome of early versus late invasive treatment.

Strategies to detect abnormal glucose metabolism in people at high risk of cardiovascular disease from the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial population

Background:  To investigate whether the combination of HbA1c and fasting plasma glucose (FPG) can be used for the diagnosis of diabetes and impaired glucose tolerance (IGT) in people at high risk of cardiovascular disease (CVD).

Two-year outcome after early or late Intervention in non-ST elevation acute coronary syndrome

Objective To compare long-term outcome of an early to a delayed invasive strategy in high-risk patients with non-ST elevation acute coronary syndrome (NSTE-ACS). Methods This prospective, multicentre trial included patients with NSTE-ACS and at least two out of three of the following high-risk criteria: (1) evidence of extensive myocardial ischaemia on ECG, (2) elevated biomarkers for myocardial necrosis and (3) age above 65 years. Patients were randomised to either an early (angiography and revascularisation if appropriate <12 hours) or a delayed invasive strategy (>48 hours after randomisation). Endpoint for this prespecified long-term follow-up was the composite incidence of death or reinfarction after 2 years. Data collection was performed by telephone contact with the patients, their relatives or general practitioner and by review of hospital records. Results Endpoint status after 2-year follow-up was collected in 521 of 542 initially enrolled patients. Incidence of death or reinfarction was 11.8% in the early and 13.1% in the delayed treatment group (relative risk (RR)=0.90, 95% CI 0.57 to 1.42). No significant differences were found in occurrence of the individual components of the primary endpoint: death 6.1% vs 8.9%, RR 0.69 (95% CI 0.37 to 1.27), reinfarction 6.5% vs 5.4%, RR 1.20 (95% CI 0.60 to 2.38). Post-hoc subgroup analysis showed statistical significant interaction between age and treatment strategy on outcome (p=0.02). Conclusions After 2 years follow-up, no difference in incidence of death or reinfarction was seen between early to late invasive strategy. These findings are in line with results of other studies with longer follow-up. Older patients seem to benefit more from early invasive treatment.

Value of Prehospital Troponin Assessment in Suspected Non-ST-Elevation Acute Coronary Syndrome

There is an increasing awareness that prehospital risk stratification in patients with suspected non-ST-elevation acute coronary syndrome (NSTE-ACS) is important. The HEART score accurately identifies patients at low risk and is nowadays fully assessable outside the hospital after the development of point-of-care (POC) troponin tests. However, the added value of the troponin component to the prehospital HEART score has not yet been assessed. This is a prospective cohort study including 700 patients with suspected NSTE-ACS in which prehospital risk stratification using the HEART score was performed by paramedics. Low risk was defined as HEAR or HEART score ≦3. Troponin was measured by a POC troponin T Test device (Roche Cobas h232). Troponin <40 ng/l scored 0 point, troponin ≥40 ng/l scored 2 points. Primary end point was major adverse cardiac events (MACE) within 45 days after inclusion. Mean HEAR score was 4.5 ± 1.6, mean HEART score was 4.7 ± 1.7. Using the HEAR score, a total of 183 patients (26%) were stratified as low risk, whereas using the HEART score, 172 patients (25%) were stratified as low risk (p = 0.001). In both low-risk groups, there were no deaths within 45 days. Using HEAR, MACE occurred in 13 patients (7%) in the low-risk group, whereas using HEART, MACE occurred in 5 patients in the low-risk group (3%, p <0.001). The use of HEART (Area under the curve 0.74) obtained a higher predictive value compared to HEAR (Area under the curve 0.65, p <0.001) for MACE. In conclusion, in patients with suspected NSTE-ACS, the prehospital troponin component of the HEART score has important added predictive value.

Comparison of Outcomes and Intervention Among Patients With Non-ST-Segment Elevation Acute Myocardial Infarction of Those With a Left Circumflex Versus Those With a Non-Left Circumflex-Related Coronary Artery (From the ELISA-3 Trial)

Previous studies found that patients with an acute coronary syndrome (ACS) due to occlusion of the left circumflex (LC) coronary artery often present without ST-elevation, leading to a delay in diagnosis and revascularization, a larger infarct size, and a worse prognosis. In this subgroup analysis of the ELISA-3 study (early or late intervention in high-risk non-ST-segment elevation acute coronary syndromes [NSTE-ACS]) incidence, characteristics and prognosis of LC-related NSTE-ACS was investigated, and the outcome of early versus late invasive strategy was compared. In 383 of 542 patients the culprit vessel could be identified, with the LC artery in 112 (29%) of them. Patients with LC-related ACS had more often single vessel disease and underwent percutaneous coronary intervention more and CABG less frequently. The primary end point of the combined incidences of death, myocardial infarction, and recurrent ischemia at 30-day follow-up occurred in 9.0% of LC versus 16.5% of non-LC-related ACS (p = 0.057). Enzymatic infarct size and incidence of bleeding were comparable. Of patients with LC-related ACS, 62 were assigned to an early and 50 to a late invasive treatment with a median time from admission to angiography of 5.5 and 65.7 hours, respectively. The primary end point occurred in 9.7% and 8.0%, respectively (p = 1.00) with comparable enzymatic infarct size and bleeding. In conclusion, no significant differences in outcome were found between patients with an LC- and a non-LC-related NSTE-ACS. In LC-related NSTE-ACS, angiography within 12 hours of admission is feasible but not superior to angiography after more than 48 hours.