Health status measured by Kansas City Cardiomyopathy Questionnaire-12 in primary prevention implantable cardioverter defibrillator patients with heart failure.

BACKGROUND: Self-reported health status as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) in patients with primary prevention implantable cardioverter defibrillators (ICDs) has mainly been reported from randomized trials. However, these studies are often limited to short follow-up and are subject to selection bias. The aim of this study was to assess KCCQ-12 in patients with primary prevention ICD due to either ischemic or nonischemic heart failure. METHODS: This cross-sectional observational study included all patients in Region Gävleborg, Sweden, who because of primary prevention due to heart failure, had an ICD or underwent device replacement between 2007 and 2017. After validation using medical records patients were sent and returned the KCCQ-12 by regular mail. RESULTS: A total of 118 questionnaires were analyzed (response rate 71.1%). The mean age was 70.9 ± 9.8 years, and a minority was female (n = 20, 16.9%). The mean overall summary score was 71.5 ± 22.4, there was no significant difference between ischemic and nonischemic heart failure (69.5 ± 23.1 vs. 74.4 ± 21.3; p = 0.195). Atrial fibrillation at baseline was associated with lower score for the domains Symptom frequency (70.2 ± 23.2 vs. 82.2 ± 19.2; p = 0.006) and Social limitation (62.1 ± 26.0 vs. 75.6 ± 26.6; p = 0.006) as well as the overall summary score (63.9 ± 21.3 vs. 74.8 ± 22.2; p = 0.004). CONCLUSION: In a real-world setting, primary prevention ICD patients with heart failure report an acceptable disease-specific health status at long-term follow-up. Ischemic and nonischemic etiology showed similar health status whereas atrial fibrillation was associated with worse outcome.

Diagnostic yield of chest and thumb ECG after cryptogenic stroke, Transient ECG Assessment in Stroke Evaluation (TEASE): an observational trial.

OBJECTIVE: In stroke survivors, atrial fibrillation (AF) is typically evaluated solely by short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring or insertable cardiac monitors require substantial resources. Chest and thumb ECG could provide an alternative means of AF detection, which in turn could allow prompt anticoagulation to prevent recurrent stroke. The objective of this study was to assess the yield of newly diagnosed AF during 28 days of chest and thumb ECG monitoring two times per day in cryptogenic stroke. METHODS: This study, Transient ECG Assessment in Stroke Evaluation, included patients who had a stroke from Region Gävleborg, Sweden, between 2017 and 2019. Patients with a recent ischaemic stroke without documented AF (or other reasons for anticoagulation) before or during ECG evaluation in the stroke unit were evaluated using the Coala Heart Monitor connected to a smartphone application for remote monitoring. RESULTS: The prespecified number of 100 patients (mean age 67.6±10.8 years; 60% men) was analysed. In nine patients (9%, number needed to screen 11) AF but no other significant atrial arrhythmias (>30 s) was diagnosed. The mean CHA2DS2-VASc score was similar among patients with AF and no AF (4.9±1.1 vs 4.3±1.3; p=0.224) and patients with AF were older (74.3±9.0 vs 66.9±10.8; p=0.049). Patients performed on average 90.1%±15.0% of scheduled transmissions. CONCLUSION: In evaluation of cryptogenic stroke, 9% of patients had AF detected using chest and thumb ECG two times per day during 1 month. In many stroke survivors, this is a feasible approach and they will be potentially protected from recurrent stroke by anticoagulation treatment. TRIAL REGISTRATION NUMBER: NCT03301662.

Health economic evaluation of implantable cardioverter defibrillators in hypertrophic cardiomyopathy in adults.

BACKGROUND: Hypertrophic cardiomyopathy is a heterogeneous disease in which an implantable cardioverter defibrillator (ICD) effectively prevents sudden cardiac death in at-risk individuals. Nevertheless, the cost-effectiveness of ICDs in this specific patient group has not been evaluated. METHODS: A Markov cohort model was constructed to simulate the course of identified adult persons with hypertrophic cardiomyopathy with and without an ICD over the course of 12 years based on Swedish disease-specific unit costs. The age distribution was based on empirical data from the nationwide cohort of HCM patients with ICDs (mean age at the time of implant was 51.8 years). The outcomes were costs per saved life and cost per gained quality adjusted life year (QALY). RESULTS: Of 1000 simulated patients, 402 lives were saved after 12 years with an ICD at a cost of 646,000 Swedish krona (SEK), which corresponds to 57,118 Euro per saved life from the health care sector viewpoint. The cost per gained QALY (the incremental cost effectiveness ratio (ICER)) was 171,000 SEK (15,119 Euro). From a societal viewpoint, including effects on productivity losses, the use of an ICD was absolutely dominant (both cheaper and better, and thus an ICER is of no interest). Both the one-way sensitivity analyses and the probabilistic sensitivity analyses supported the findings in the base option. CONCLUSION: For identified patients with hypertrophic cardiomyopathy deemed at high risk of sudden cardiac death, the use of an ICD is extremely cost effective, both in terms of the cost for saved lives and gained QALY.

A protocol for a prospective observational study using chest and thumb ECG: transient ECG assessment in stroke evaluation (TEASE) in Sweden.

INTRODUCTION: Atrial fibrillation (AF) causes ischaemic stroke and based on risk factor evaluation warrants anticoagulation therapy. In stroke survivors, AF is typically detected with short-term ECG monitoring in the stroke unit. Prolonged continuous ECG monitoring requires substantial resources while insertable cardiac monitors are invasive and costly. Chest and thumb ECG could provide an alternative for AF detection poststroke.The primary objective of our study is to assess the incidence of newly diagnosed AF during 28 days of chest and thumb ECG monitoring in cryptogenic stroke. Secondary objectives are to assess health-related quality of life (HRQoL) using short-form health survey (SF-36) and the feasibility of the Coala Heart Monitor in patients who had a stroke. METHODS: Stroke survivors in Region Gävleborg, Sweden, will be eligible for the study from October 2017. Patients with a history of ischaemic stroke without documented AF before or during ECG evaluation in the stroke unit will be evaluated by the chest and thumb ECG system Coala Heart Monitor. The monitoring system is connected to a smartphone application which allows for remote monitoring and prompt advice on clinical management. Over a period of 28 days, patients will be monitored two times a day and may activate the ECG recording at symptoms. On completion, the system is returned by mail. This system offers a possibility to evaluate the presence of AF poststroke, but the feasibility of this system in patients who recently suffered from a stroke is unknown. In addition, HRQoL using SF-36 in comparison to Swedish population norms will be assessed. The feasibility of the Coala Heart Monitor will be assessed by a self-developed questionnaire. ETHICS AND DISSEMINATION: The study was approved by The Regional Ethical Committee in Uppsala (2017/321). The database will be closed after the last follow-up, followed by statistical analyses, interpretation of results and dissemination to a scientific journal. TRIAL REGISTRATION NUMBER: NCT03301662; Pre-results.

Living with hypertrophic cardiomyopathy and an implantable defibrillator.

BACKGROUND: ICDs efficiently terminate life-threatening arrhythmias, but complications occur during long-term follow-up. Patients' own perspective is largely unknown. The aim of the study was to describe experiences of hypertrophic cardiomyopathy (HCM) patients with implantable defibrillators (ICDs). METHODS: We analyzed 26 Swedish patient interviews using hermeneutics and latent content analysis. RESULTS: Patients (aged 27-76 years) were limited by HCM especially if it deteriorates into heart failure. The ICD implies safety, gratitude, and is accepted as a part of the body even when inappropriate ICD shocks are encountered. Nobody regretted the implant. Both the disease and the ICD affected professional life and leisure time activities, especially at younger ages. Family support was usually strong, but sometimes resulted in overprotection, whereas health care focused on medical issues. Despite limitations, patients adapted, accepted, and managed challenges. CONCLUSION: HCM patients with ICDs reported good spirit and hope even though they had to adapt and accept limitations over time.

3He MRI-based assessment of posture-dependent regional ventilation gradients in rats.

A recently developed method for quantitative assessment of regional lung ventilation was employed for the study of posture-dependent ventilation differences in rats. The measurement employed hyperpolarized (3)He MRI to detect the build-up of the signal intensity after increasing numbers of (3)He breaths, which allowed for computation of a regional ventilation parameter. A group of six anesthetized rats was studied in both supine and prone postures. Three-dimensional maps of the ventilation parameter were obtained with high spatial resolution (voxel volume approximately 2 mm(3)). Vertical (dorsal-ventral) gradients of the ventilation index, defined as the regional ventilation normalized by the average ventilation within the whole lung, were investigated. Variations in the regional distribution of the ventilation parameter, as well as of the ventilation index, could be detected, depending on the posture of the rats. In supine posture, ventilation was elevated in the dependent parts of the lungs, with a linear gradient of the ventilation index of -0.11 +/- 0.03 cm(-1). In prone posture, the distribution of ventilation was more uniform, with a significantly (P < 0.001) smaller gradient of the ventilation index of -0.01 +/- 0.02 cm(-1). It is concluded that the (3)He MRI-based method can detect and quantify regional ventilation gradients in animals as small as the rat and that these gradients depend on prone or supine posture of the animal.