Extended heart failure clinic follow-up in low-risk patients: a randomized clinical trial (NorthStar).

BACKGROUND: Outpatient follow-up in specialized heart failure clinics (HFCs) is recommended by current guidelines and implemented in most European countries, but the optimal duration of HFC programmes has not been established. Nor is it known whether all or only high-risk patients, e.g. identified by NT-proBNP, might benefit from an extended HFC follow-up. METHODS AND RESULTS: In a multi-centre setting, we randomly assigned 921 clinically stable systolic heart failure (HF) outpatients on optimal medical therapy to undergo either an extended follow-up in the HFC (n = 461) or referral back to their general practitioner (GP) (n = 460). The primary composite endpoint was death or a cardiovascular admission. Secondary endpoints included mortality, an HF admission, quality of life, number of days admitted, and number of admissions. The median age of the patients was 69 years; 23% were females; the median left ventricular ejection fraction was 0.30; and the median NT-proBNP was 801 pg/mL; 89% were in NYHA class I-II. The median follow-up was 2.5 years. Time-to-event did not differ between groups (HFC vs. GP) (HR: 1.17, 95% CI: 0.95-1.45, P = 0.149). The two groups did not differ with respect to any of the secondary endpoints at the follow-up (P> 0.05 for all). In high-risk patients identified by NT-proBNP ≥1000 pg/mL, no benefit from HFC follow-up was found (P = 0.721). CONCLUSION: Irrespective of the level of NT-proBNP stable HF patients on optimal medical therapy do not benefit from long-term follow-up in a specialized HFC in a publicly funded universal access healthcare system. Heart failure patients on optimal medical therapy with mild or moderate symptoms are safely managed by their personal GP. TRIAL REGISTRATION: www.Centerwatch.com: 173491 (NorthStar).

Design and methodology of the NorthStar Study: NT-proBNP stratified follow-up in outpatient heart failure clinics -- a randomized Danish multicenter study.

BACKGROUND: Randomized clinical trials have shown that newly discharged and symptomatic patients with chronic heart failure (CHF) benefit from follow-up in a specialized heart failure clinic (HFC). Clinical stable and educated patients are usually discharged from the HFC when on optimal therapy. It is unknown if risk stratification using natriuretic peptides could identify patients who would benefit from longer-term follow-up. Furthermore, data on the use of natriuretic peptides for monitoring of stable patients with CHF are sparse. AIMS: The aims of this study are to test the hypothesis that clinical stable, educated, and medical optimized patients with CHF with N-terminal pro-brain natriuretic peptide (NT-proBNP) levels > or = 1,000 pg/mL benefit from long-term follow-up in an HFC and to assess the efficacy of NT-proBNP monitoring. METHODS: A total of 1,250 clinically stable, medically optimized, and educated patients with CHF will be enrolled from 18 HFCs in Denmark. The patients will be randomized to treatment in general practice, to a standard follow-up program in the HFC, or to NT-proBNP monitoring in the HFC. The patients will be followed for 30 months (median). RESULTS: Data will be collected from 2006 to 2009. At present (March 2008), 720 patients are randomized. Results expect to be presented in the second half of 2010. CONCLUSIONS: This article outlines the design of the NorthStar study. If our hypotheses are confirmed, the results will help cardiologists and nurses in HFCs to identify patients who may benefit from long-term follow-up. Our results may also indicate whether patients with CHF will benefit from adding serial NT-proBNP measurements to usual clinical monitoring.

Prevalence and prognostic significance of atrial fibrillation in outpatients with heart failure due to left ventricular systolic dysfunction.

INTRODUCTION: Atrial fibrillation (AF) is common in patients with heart failure (HF) due to left ventricular systolic dysfunction (LVSD), with conflicting prognostic data. The aim of our study was to assess the prevalence and incidence of AF in patients with HF and to determine the prognostic impact of baseline AF and the development of new onset AF. METHODS AND RESULTS: We included 1019 outpatients with HF due to LVSD; follow-up time ranged from 3 to 64 months. At baseline 26.4% of patients had AF. Of the 284 patients with a follow-up ECG and baseline SR, 18.7% developed new onset AF. Patients with AF were older (p<0.001), more often male (p=0.04), and more likely to have a history of stroke (p=0.03), but were less likely to have IHD (p<0.001). Baseline rhythm was independent of LVEF and NYHA-class. Baseline AF was associated with increased all-cause mortality (HR 1.38; CI 1.07-1.78, p=0.01) and all-cause mortality/hospitalisation (HR 1.43; CI 1.22-1.68, p<0.001). When adjusted for baseline covariates, baseline AF was independently associated with an increased risk of experiencing the combined endpoint (HR 1.29; CI 1.05-1.58; p=0.02), but did not predict all-cause mortality. By multivariable analyses, new-onset AF was associated with increased risk of all-cause mortality/hospitalisation (HR 1.45; CI 1.05-2.00; p=0.02). CONCLUSION: In outpatients with HF due to LVSD, AF is a common co-morbidity, which adversely affects morbidity and mortality outcomes.

Treatment with beta-blockers in nurse-led heart failure clinics: titration efficacy and predictors of failure.

BACKGROUND: Beta-blockers (BBs) are a cornerstone in the treatment of chronic heart failure (HF), but several surveys have documented that many patients are not offered treatment or are not titrated to target doses. In part to address this problem, specialized, nurse-led HF clinics have been initiated in many countries. However, little information is available to describe if such programs are successful in initiating and up-titrating BBs in daily clinical practice. AIMS: To assess the proportion of patients with HF due to left ventricular systolic dysfunction on BB treatment three months after referral to a nurse-led HF clinic, and to identify baseline predictors of treatment failure. METHODS: Consecutive records from 14 Danish nurse-led HF clinics were used. RESULTS: 1533 patients met inclusion criteria. Mean age was 68.7 years and 72% were men. Three months after the initial HF clinic visit 63% of the patients were being treated with a BB. Mean dose (relative to target dose) was 63 (+/-35)% in patients receiving a BB and target dose was reached by 21%. Patients who were not on BBs were more often female, elderly and in NYHA class III-IV. In a multivariable model only lower age predicted BB use at three months (P<0.05). Younger age (P<0.001) and higher systolic blood pressure (P<0.001) were associated with higher doses of BB. CONCLUSION: BB up-titration continues to be a challenge even in specialized clinics dedicated to this task. Elderly patients appear to be less likely to receive treatment.

Effects on costs of frontline diagnostic evaluation in patients suspected of angina: coronary computed tomography angiography vs. conventional ischaemia testing.

AIMS: The aim of this study was to investigate in patients with stable angina the effects on costs of frontline diagnostics by exercise-stress testing (ex-test) vs. coronary computed tomography angiography (CTA). METHODS AND RESULTS: In two coronary units at Lillebaelt Hospital, Denmark, 498 patients were identified in whom either ex-test (n = 247) or CTA (n = 251) were applied as the frontline diagnostic strategy in symptomatic patients with a low-intermediate pre-test probability of coronary artery disease (CAD). During 12 months of follow-up, death, myocardial infarction and costs associated with downstream diagnostic utilization (DTU), treatment, ambulatory visits, and hospitalizations were registered. There was no difference between cohorts in demographic characteristics or the pre-test probability of significant CAD. The mean (SD) age was 56 (11) years; 52% were men; and 96% were at low-intermediate pre-test probability of CAD. All serious cardiac events (n = 3) during follow-up occurred in patients with a negative ex-test result. Mean costs per patient associated with DTU, ambulatory visits, and cardiovascular medication were significantly higher in the ex-test than in the CTA group. The mean (SD) total costs per patient at the end of the follow-up were 14% lower in the CTA group than in the ex-test group, € 1510 (3474) vs. €1777 (3746) (P = 0.03). CONCLUSION: Diagnostic assessment of symptomatic patients with a low-intermediate probability of CAD by CTA incurred lower costs when compared with the ex-test. These findings need confirmation in future prospective trials.

Frontline diagnostic evaluation of patients suspected of angina by coronary computed tomography reduces downstream resource utilization when compared to conventional ischemia testing.

It has been proposed that the increasing use of coronary computed tomographic angiography (CTA) may introduce additional unnecessary diagnostic procedures. However, no previous study has assessed the impact on downstream test utilization of conventional diagnostic testing relative to CTA in patients suspected of angina. The purpose of this study was to investigate the consequences of frontline exercise-stress testing (Ex-test) versus CTA on downstream test utilization in clinical practice. In two collaborating departments using either Ex-test (n = 247) or CTA (n = 251) as the frontline diagnostic test in patients suspected of angina, comparable cohorts of consecutive patients were retrospectively identified (Jan. 2007-Feb. 2008). Downstream test utilization (invasive coronary angiography, ICA; myocardial perfusion scintigraphy, and CTA) during 12 months after the index diagnostic test was recorded. Mean age was 56 years (51% men), and 96% of the total study cohort were at low-intermediate pretest risk of significant coronary disease. Overall, downstream test utilization was more frequent in the Ex-test group than in the CTA group, 32% versus 21% (P = 0.003). Subsequent myocardial scintigraphy was more frequent used (9% versus 4%, P = 0.03), whereas ICA tended to be more frequent applied in the Ex-test versus CTA group (23% vs. 18%, P = 0.15). A frontline diagnostic use in symptomatic patients of Ex-test in comparison to CTA leads to more downstream diagnostic test utilization. Future prospective trials are needed in order to define the most cost-effective diagnostic use of CTA relative to conventional ischemia testing.

[Thrombolysis in treatment of cardiac arrest caused by pulmonary embolism]. / Trombolyse som led i behandling af hjertestop forårsaget af lungeemboli.

Some cases of pulmonary embolism are complicated by cardiac arrest. We report such a case in which treatment included thrombolysis during cardiopulmonary resuscitation. Complete recovery was achieved. This supports the fact that--as stated in the European Resuscitation Council Guidelines for Resuscitation 2005--treatment with a thrombolytic agent should be considered when cardiac arrest is considered to be caused by pulmonary embolism.

[Educational project at the medical department, Fredericia Hospital]. / Uddannelsesprojekt på Medicinsk Afdeling, Fredericia Sygehus.

INTRODUCTION: The purpose of this project was to introduce a newly developed educational program consisting of a new concept with metacompetences. Our aim was to evaluate the need for new educational methods and to clarify the educational capacity of our clinic. MATERIALS AND METHODS: The duration of the project was two years; it was allocated to pre-registration house officers. Part one of the project was a systematic evaluation of the functions of each department, with a focus on educational capacity. The next stage was to introduce new methods into the departments. The project focused on the metacompetences for communication and collaboration evaluated, using a system of supervised rounds. A newly developed questionnaire using a visual analogue scale was used for feedback to the officers in training. RESULTS: The new educational methods scored high in the evaluation, and the pre-registration house officers were able to achieve all the competences in the education program. CONCLUSION: The implementation of the system took place without major difficulties, and the extra workload allocated to the department was minimal.

[Dilated cardiomyopathy as a side effect of treatment with infliximab]. / Dilateret kardiomyopati som bivirkning af infliximabbehandling.

We report a case of heart failure after infusion of Remicade (infliximab) in a patient without heart insufficiency. The patient, a 25-year-old woman with inflammatory bowel disease, developed new-onset heart failure after receiving TNF antagonist therapy. After the treatment was discontinued and heart failure therapy was started, the patient improved significantly. The U.S. Food and Drug Administration has published 47 case reports of heart failure after therapy with a tumor necrosis factor antagonist, where 38 patients developed new-onset heart failure and 9 patients experienced heart failure exacerbation. There are no published reports of heart failure after TNF antagonist therapy in the Danish literature.

Effects of a nurse-based heart failure clinic on drug utilization and admissions in a community hospital setting.

OBJECTIVE: To evaluate the effect of a nurse-led heart failure clinic on drug therapy and hospitalization in a community hospital setting. DESIGN: Prospective, observational study of outpatients referred to a heart failure clinic. Nurses directed drug uptitration and delivered patient education. Utilization and doses of ACE inhibitors and beta-blockers were analyzed as were heart failure related admissions in the years before and after establishing the clinic. RESULTS: 138 patients (median age 68.5 years) were enrolled. After three months 94% of patients were taking an ACE inhibitor and beta-blockade was prescribed for 91%. Mean ACE inhibitor dose relative to target dose after three months was 77+/-30% and mean beta-blocker dose was 53+/-31% of the target dose. Heart failure admissions decreased by 45% after the clinic was established. CONCLUSIONS: Community hospital based heart failure clinics may promote utilization of evidence based drug therapy and cause a substantial decrease in heart failure admissions, producing results comparable to those obtained in studies of university hospital based heart failure management programs.