Patient education in chronic heart failure in primary care (ETIC) and its impact on patient quality of life: design of a cluster randomised trial.

BACKGROUND: Chronic heart failure, is increasing due to the aging population and improvements in heart disease detection and management. The prevalence is estimated at ~10% of the French general practice patient population over 59 years old. The primary objective of this study is to improve the quality of life for heart failure patients though a complex intervention involving patient and general practitioner (GP) education in primary care. METHODS: A randomised, cluster controlled trial, stratified over 4 areas of the Auvergne region in France comparing intervention and control groups. The inclusion criteria are: patients older than 50 years with New York Heart Association (NYHA) stage I, II, or III heart failure, with reduced ejection fraction or with preserved ejection fraction. Heart failure should be confirmed by the patient's cardiologist according to the European Society of Cardiology guidelines criteria. The exclusion criteria include: severe cognitive disorders, living in an institution, participating in another clinical trial, having NYHA stage IV heart failure, or a lack of French language skills. The complex intervention consists of training at the GP practice with an interactive 2-day workshop to provide a patient's education programme. GPs are trained to perform case management, lifestyle counselling and motivational interviewing, to educate patients on the main topics including clinical alarm signs, physical activity, diet and cardiovascular risk factors. The patients' education sessions are scheduled at 1, 4, 7, 10, 13 and 19 months following the start of the trial. The primary outcome to be assessed is the impact on the quality of life as determined using two questionnaires: the Minnesota Living with Heart Failure Questionnaire and SF-36. To detect a difference in the mean quality of life at 19 months, we anticipate studying a minimum of 400 patients from 80 GPs. DISCUSSION: This trial will provide insight into the effectiveness of a complex intervention to educate patients with heart failure including a 2-day GP workshop and patients' education programme in the setting of a GP consultation to improve the quality of life in patients with chronic heart failure. This complex intervention tool could be used during initial and further medical training. TRIAL REGISTRATION: ETIC is a cluster-randomised, controlled trial registered on ClinicalTrials.gov [ NCT01065142 , 2010, Feb 8] and the French drug agency [Agence Nationale de Sécurité du Médicament et des produits de santé; registration number: 2009-A01142-55, on March 5th, 2010].

[The limits of patient education in short-term hospitalization: the case of cardiovascular patients]. / Éducation thérapeutique en court séjour : quelles limites ? Cas de patients cardiovasculaires.

The purpose of this study was to examine the limitations of therapeutic education for patients with cardiovascular risk factors during short hospital stays. The paper presents the results of a qualitative study conducted over the course of a year involving 18 case studies of professional practices and 18 interviews with 5 health professionals and 13 patients. The results show that professionals and patients have conflicting views about the time spent in hospital, as well as conflicting concerns and expectations, thus limiting the effectiveness of educational care. The findings suggest that after acute myocardial infarction or a stroke, patients tend to view themselves as survivors during their experience of short-term hospitalization in a care unit. As a result, short-term hospitalization may not be conducive to the mobilization of patients' cognitive and emotional capacities in a therapeutic education program.

High-resolution coronary imaging by optical coherence tomography: Feasibility, pitfalls and artefact analysis.

BACKGROUND: Optical coherence tomography is an imaging method that enables cardiologists to study atheromatous plaques, and to check the implantation and evolution of coronary stents. It is an invasive technique, providing high-resolution (10 microm) in vivo images, but with limitations and artefacts that need to be understood before the field of application can be extended. AIM: To determine the feasibility and limitations of optical coherence tomography coronary imaging from a single-centre experience. METHODS: We analysed the first 301 optical coherence tomography (version M2, LightLab Imaging) sequences obtained in our department from examination of 73 patients. RESULTS: Results showed that 92% of sequences for selected lesions were usable, with a mean examination time of 17 min. Only one complication occurred (ventricular fibrillation, reduced by external electroshock). In our registry, sequence quality depended on operator experience (improving after 20 examinations), and was impaired by artefacts, especially in right coronary analysis and in arteries of greater than 3.5 mm calibre. CONCLUSIONS: Proximal coronary occlusion and the distal flush quality currently required for quality imaging should no longer be indispensable with the new generation of optical coherence tomography systems.

Comparative analysis of neointimal coverage with paclitaxel and zotarolimus drug-eluting stents, using optical coherence tomography 6 months after implantation.

BACKGROUND: Intrastent thrombosis, while rare, has a poor prognosis. Strut non-coverage is one causal factor, especially in cases of resistance to or premature discontinuation of dual antiplatelet therapy. AIM: To compare neointimal coverage with paclitaxel and zotarolimus drug-eluting stents, using optical coherence tomography (OCT). METHODS: Twenty-two drug-eluting stents (11 paclitaxel-eluting stents and 11 zotarolimus-eluting stents) were examined by OCT, 6 months after implantation. Mean neointimal strut-coverage thickness and percentage neointimal hyperplasia were measured every millimetre. On each OCT image, struts were classified into one of four categories: well-apposed to vessel wall with apparent neointimal coverage; well-apposed to vessel wall without neointimal coverage; malapposed to the vessel wall; or located on a major side branch. RESULTS: OCT analysis showed a lower percentage of neointimal hyperplasia with paclitaxel-eluting stents than with zotarolimus-eluting stents (17% vs 38% and mean thickness 154 microm vs 333 microm, respectively; p<0.0001). The rate of strut-coverage was greater with zotarolimus-eluting stents than with paclitaxel-eluting stents (99.1% vs 87.1%, respectively; p<0.0001). A non-covered/covered strut ratio greater than 0.3 was observed in 0.5% of zotarolimus-eluting stent OCT images compared with 18% of paclitaxel-eluting stent OCT images (p<0.0001). CONCLUSION: Six months after implantation, neointimal hyperplasia was greater with zotarolimus-eluting stents compared with paclitaxel-eluting stents. Conversely, neointimal strut-coverage was better with zotarolimus-eluting stents.

Comparison of INR stability between self-monitoring and standard laboratory method: preliminary results of a prospective study in 67 mechanical heart valve patients.

INTRODUCTION: Thromboembolic accidents and haemorrhage are the main complications observed during long-term follow-up of mechanical heart valve patients. Several suggestions for improving anticoagulation quality have been made, including international normalised ratio (INR) self-monitoring. OBJECTIVES: We report the preliminary results of a single-centre, open, randomised study (scheduled population of 200 patients), which compares monthly laboratory monitoring (group A) versus weekly self-monitoring of INR (group B). The primary aim is INR stability improvement within the target range, and the secondary aim is adverse events reduction. PATIENTS AND METHODS: Between May 2004 and June 2005, 67 patients with an average age of 56.6 years (+/-9.6), were enrolled in the study (group A: 34 patients, group B: 33 patients). The mean follow-up was 47 weeks (+/-11.5). The two groups differed only in the sex ratio (44.1 and 21.2% of women in groups A and B respectively, p=0.0459). Mechanical heart valves were aortic in 73% of patients, mitral in 13.5%, and multiple in 13.5%. Sixty-five patients (97%) were treated with fluindione, the others with acenocoumarol. The intraclass correlation coefficient between the self- and laboratory-monitored INR was 0.75. RESULTS: The time spent in the INR target range (group A: 53+/-19%, group B: 57+/--19%, p=0.45) and the time spent in the INR therapeutic range, between 2 and 4.5, (group A: 86+/-14%, group B: 91+/-7%, p=0.07) are longer in group B, but not significantly so. For patients outside the range, the absolute mean deviation of INR from the target or therapeutic range (range standardized between 0 and 100) is lower for the self-monitoring group (41.1+/-39.3 and 11.27+/-11.2) than for the control group (62.4+/-72.6 and 39.2+/-52.8). This difference is significant (p=0.0004 and p=0.0005). Eighteen adverse events were reported: 17 haemorrhages, 13 in group A (9 mild, 4 serious) and four in group B (all mild), and one sudden death in group B, two days after the patient's discharge. No thromboembolic events were reported. Six patients (8.8 %), 3 in each group, dropped out of the study. CONCLUSION: This first study evaluating INR self-monitoring in France shows that this method leads to better stability of the INR within the target range. On the basis of these preliminary data, this appears to be related to a decrease in serious haemorrhages (11.8% serious haemorrhage cases in group A versus 0% in group B, p=0.06, NS).

Right atrial tear associated with a tumour in the right atrium after blunt chest trauma.

Occult cardiac injury following blunt trauma is more common than generally suspected. Myocardial contusion is not rare, however, it is generally a benign disorder which often remains undiagnosed. We report a case of a right atrial rupture after blunt chest trauma causing a tamponade. A 24-year-old man was involved in a violent car accident and he presented in a state of collapse. A multislice computed tomography indicated a pericardial effusion (Figure 1). A transthoracic echocardiography was performed and confirmed pericardial effusion which was hyperechoic (Figure 2, Movie 1). Concerns about a possible mass in the right atrium led to examination with transesophageal echocardiography (Figure 3, Movie 2) which revealed the presence of a voluminous mass in the right atrium. The patient successfully underwent cardiac surgery to remove the mass, identified as a blood clot, and to repair the atrial tear. The present case is of special interest because of the rarity of documented incidents of blunt chest trauma causing right atrial tear and illustrates the usefulness of transesophageal echocardiography in completing the diagnosis in the event of haemopericardium.

Comparison of transthoracic echocardiography using second harmonic imaging, transcranial Doppler and transesophageal echocardiography for the detection of patent foramen ovale in stroke patients.

AIMS: The comparison of three imaging methods to determine which is the most accurate and reliable for the detection of right-to-left shunt. METHODS AND RESULTS: One hundred and seven patients who were hospitalized for stroke underwent: a transthoracic echocardiography (TTE) using second harmonic, a transcranial Doppler (TCD) and a transesophageal echocardiography (TEE) from August 2003 to April 2004. All studies were recorded on a videotape and were studied by a physician blinded to the study. With TTE and TEE, we found 44 (41%) patent foramen ovales. All contrast tests were positive with TCD for these 44 patients. For two patients, the contrast test was positive only with TTE and TCD. We found four false negative contrast tests with TTE. Among the 63 patients who had a negative contrast test with TEE and TTE, the results were the same with TCD for 59 of them; we were not able to determine a cause for the four positive tests. CONCLUSION: This study confirms that transesophageal echocardiography has limitations in the diagnosis of patent foramen ovale. In this study, the negative predictive value of transcranial Doppler was excellent. Therefore, this examination is able to exclude a patent foramen ovale with a high level of confidence.

Regressive aortic valve and infundibular tumors during idiopathic hypereosinophilic syndrome.

Fibroblastic endocarditis is a classic complication of prolonged hypereosinophilic syndrome, whatever the cause. In France, it is most frequently encountered in cases of idiopathic hypereosinophilic syndrome. It commonly involves the apex of the ventricles, with a clinical picture of restrictive cardiomyopathy of unfavorable prognosis, and the auriculoventricular valves. We report the case of a 77-year-old man in whom atypical cardiac involvement disclosed idiopathic hypereosinophilic syndrome. In addition to the usual features of obliteration of the apex and restrictive cardiomyopathy, echocardiographic examination showed severe left ventricular dysfunction and intracardiac tumors, one of which was unusually localized to an aortic valve. Treatment, which comprised strict control of the eosinophilic process, standard treatment for cardiac failure, and anticoagulation therapy, produced rapid and long-lasting improvement of his clinical status and left systolic and diastolic ventricular function, and on echocardiography the intracardiac tumors had totally disappeared. The patient suddenly died of septic shock 16 months after first being seen.

Primary angioplasty is cost-minimizing compared with pre-hospital thrombolysis for patients within 60 min of a percutaneous coronary intervention center: the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) cost-efficacy sub-study.

OBJECTIVES: This ancillary study of the Comparison of Angioplasty and Pre-hospital Thrombolysis in Acute Myocardial Infarction (CAPTIM) trial sought to assess the cost-efficacy ratio of primary coronary angioplasty (PCA) and pre-hospital thrombolysis (PHT) in patients suffering from an acute myocardial infarction (AMI) (<6 h) close to (<60 min journey) a percutaneous coronary intervention (PCI) center. BACKGROUND: In the CAPTIM study, at 30 days follow-up PCA was as equally effective as PHT with rescue angioplasty if needed. The cost efficacy of these two strategies has not yet been compared. METHODS: Data were prospectively collected for 299 patients in three centers. The efficacy analysis was extended at one-year follow-up for those patients. Direct fixed and variable actual costs were assessed with a piggyback data collection. RESULTS: The one-year primary end point event-rate (death, non-fatal myocardial infarction, and stroke) was not different after PCA or PHT (14% vs. 16. 4%, p = NS). Costs were lower in the PCA group either during the in-hospital period (8,287 vs. 9,170 $, p = 0.0001) and after one-year follow-up, in relation to a higher rate of subsequent revascularizations in the PHT group (49% vs. 23%, p < 0. 01), leading to a longer hospital stay (10 vs. 9.1 days, p = 0. 03). CONCLUSIONS: After AMI in patients less than 1 h from a PCI center, PCA is as effective and less costly than a combined strategy of PHT followed by rescue angioplasty.

Primary angioplasty versus prehospital fibrinolysis in acute myocardial infarction: a randomised study.

BACKGROUND: Although both prehospital fibrinolysis and primary angioplasty provide a clinical benefit over in-hospital fibrinolysis in acute myocardial infarction, they have not been directly compared. Our aim was to find out whether primary angioplasty was better than prehospital fibrinolysis. METHODS: We did a randomised multicentre trial of 840 patients (of 1200 planned) who presented within 6 h of acute myocardial infarction with ST-segment elevation, initially managed by mobile emergency-care units. We assigned patients to prehospital fibrinolysis (n=419) with accelerated alteplase or primary angioplasty (n=421), and transferred all to a centre with access to emergency angioplasty. Our primary endpoint was a composite of death, non-fatal reinfarction, and non-fatal disabling stroke at 30 days. Analyses were by intention to treat. FINDINGS: The median delay between onset of symptoms and treatment was 130 min in the prehospital-fibrinolysis group and 190 min (time to first balloon inflation) in the primary-angioplasty group. Rescue angioplasty was done in 26% of the patients in the fibrinolysis group. The rate of the primary endpoint was 8.2% (34 patients) in the prehospital-fibrinolysis group and 6.2% (26 patients) in the primary-angioplasty group (risk difference 1.96, 95% CI -1.53 to 5.46). 16 (3.8%) patients assigned prehospital fibrinolysis and 20 (4.8%) assigned primary angioplasty died (p=0.61). INTERPRETATION: A strategy of primary angioplasty was not better than a strategy of prehospital fibrinolysis (with transfer to an interventional facility for possible rescue angioplasty) in patients presenting with early myocardial infarction.