Effectiveness of the European Society of Cardiology/Heart Failure Association website 'heartfailurematters.org' and an e-health adjusted care pathway in patients with stable heart failure: results of the 'e-Vita HF' randomized controlled trial.

BACKGROUND: Efficient incorporation of e-health in patients with heart failure (HF) may enhance health care efficiency and patient empowerment. We aimed to assess the effect on self-care of (i) the European Society of Cardiology/Heart Failure Association website 'heartfailurematters.org' on top of usual care, and (ii) an e-health adjusted care pathway leaving out 'in person' routine HF nurse consultations in stable HF patients. METHODS AND RESULTS: In a three-group parallel-randomized trial in stable HF patients from nine Dutch outpatient clinics, we compared two interventions ( heartfailurematters.org website and an e-health adjusted care pathway) to usual care. The primary outcome was self-care measured with the European Heart Failure Self-care Behaviour Scale. Secondary outcomes were health status, mortality, and hospitalizations. In total, 450 patients were included. The mean age was 66.8 ± 11.0 years, 74.2% were male, and 78.8% classified themselves as New York Heart Association I or II at baseline. After 3 months of follow-up, the mean score on the self-care scale was significantly higher in the groups using the website and the adjusted care pathway compared to usual care (73.5 vs. 70.8, 95% confidence interval 0.6-6.2; and 78.2 vs. 70.8, 95% confidence interval 3.8- 9.4, respectively). The effect attenuated, until no differences after 1 year between the groups. Quality of life showed a similar pattern. Other secondary outcomes did not clearly differ between the groups. CONCLUSIONS: Both the heartfailurematters.org website and an e-health adjusted care pathway improved self-care in HF patients on the short term, but not on the long term. Continuous updating of e-health facilities could be helpful to sustain effects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID NCT01755988.

Effect of Using the HEART Score in Patients With Chest Pain in the Emergency Department: A Stepped-Wedge, Cluster Randomized Trial.

BACKGROUND: The HEART (History, Electrocardiogram, Age, Risk factors, and initial Troponin) score is an easy-to-apply instrument to stratify patients with chest pain according to their short-term risk for major adverse cardiac events (MACEs), but its effect on daily practice is unknown. OBJECTIVE: To measure the effect of use of the HEART score on patient outcomes and use of health care resources. DESIGN: Stepped-wedge, cluster randomized trial. (ClinicalTrials.gov: NCT01756846). SETTING: Emergency departments in 9 Dutch hospitals. PATIENTS: Unselected patients with chest pain presenting at emergency departments in 2013 and 2014. INTERVENTION: All hospitals started with usual care. Every 6 weeks, 1 hospital was randomly assigned to switch to "HEART care," during which physicians calculated the HEART score to guide patient management. MEASUREMENTS: For safety, a noninferiority margin of a 3.0% absolute increase in MACEs within 6 weeks was set. Other outcomes included use of health care resources, quality of life, and cost-effectiveness. RESULTS: A total of 3648 patients were included (1827 receiving usual care and 1821 receiving HEART care). Six-week incidence of MACEs during HEART care was 1.3% lower than during usual care (upper limit of the 1-sided 95% CI, 2.1% [within the noninferiority margin of 3.0%]). In low-risk patients, incidence of MACEs was 2.0% (95% CI, 1.2% to 3.3%). No statistically significant differences in early discharge, readmissions, recurrent emergency department visits, outpatient visits, or visits to general practitioners were observed. LIMITATION: Physicians were hesitant to refrain from admission and diagnostic tests in patients classified as low risk by the HEART score. CONCLUSION: Using the HEART score during initial assessment of patients with chest pain is safe, but the effect on health care resources is limited, possibly due to nonadherence to management recommendations. PRIMARY FUNDING SOURCE: Netherlands Organisation for Health Research and Development.

New quantitative three-dimensional echocardiographic indices of mitral valve stenosis: new 3D indices of mitral stenosis.

BACKGROUND: We studied the value of quantitative three-dimensional echocardiography (3DE) in the evaluation of mitral valve stenosis using the measurement of the mitral valve area (MVA) with two new indices: the doming volume and mitral valve volume. METHODS AND RESULTS: A total of 45 consecutive patients with mitral valve stenosis were studied. MVA was measured using Doppler with the pressure half-time (PHT) method. Following a diagnostic multiplane transesophageal (TEE) examination, data for 3DE were acquired with a rotational mode of acquisition. MVA was assessed by anyplane echocardiography (APE) and from surface rendered images. Moreover, the doming volume, i.e., the volume subtended by the anterior and posterior mitral valve and annular cut plane was measured by APE. Comparing PHT-derived with 3DE-derived MVA's, using both APE and surface rendered images, only moderate correlations were observed: PHT-derived MVA versus APE-derived MVA: r = 0.74, P < 0.0001; PHT-derived area versus 3DE-surface rendered MVA: r = 0.70, P < 0.0001. Multiple linear regression analysis showed a relation of atrial fibrillation to the doming volume (P = 0.04), but not to PHT-derived MVA (P = 0.28), APE-derived area (P = 0.33) and mitral valve volume (P = 0.08). Comparison of patients with MVA < 1 cm(2) and MVA > 1 cm(2) revealed significant difference in mitral valve volume: mean mitral valve volume in critical stenosis was 3.7 ml versus 1.4 ml in non-critical stenosis (P = 0.04). CONCLUSIONS: Only moderate correlations between 3DE and Doppler-derived MVA's were observed. Measurement of the doming volume allows quantification of the 3DE geometry of the mitral apparatus. Patients with conical or funnel-like geometry are more likely to have sinus rhythm, whereas, patients with flat geometry are likely to have atrial fibrillation. Mitral valve volume can be used for the evaluation of mitral stenosis severity. These new 3DE indices might be used for selection of patients for balloon valvuloplasty.

Percutaneous transcatheter closure of atrial septal defects: initial single-centre experience and follow-up results. Initial experience with three-dimensional echocardiography.

OBJECTIVE: Registry to report our single-centre experience in closing defects of the atrial septum. METHODS: Between 1996 and 2001, transcatheter device closure of significant atrial septal defects was performed in 32 adults (mean age 45.1 years, range from 15 to 76 years), using different device types. Six patients had a patent foramen ovale (PFO) and 26 patients had a secundum atrial septal defect (ASD II). Defects were selected by means of two-dimensional transoesophageal echocardiography (2D TOE). For 12 defects additional three-dimensional transoesophageal echocardiography (3D TOE) was performed. RESULTS: Mean balloon-stretched diameter was 19.3 mm (range from 11 to 24 mm). A device was successfully placed in all PFO patients (100%) without complications at follow-up. Successful immediate device placement occurred in 24 out of 26 ASD patients. Two immediate placement failures, 1 device embolisation and 1 device non-fixation, occurred and required urgent surgery. There was 1 patient with pericardial effusion after the intervention, requiring pericardiocentesis. Three late placement failures occurred: 2 device embolisations and 1 device dislocation. Clinical success after 3 to 6 months follow-up, defined as the absence of shunt or small shunt, was achieved in all 6 PFO patients and in 21 out of 23 ASD patients (1 device embolisation, requiring surgery, occurred before follow-up was completed). Two patients with significant shunt, 1 late device dislocation and 1 late device embolisation, underwent elective surgery. For patient selection, 3D TOE proved useful in the evaluation of large and/or complex defects. CONCLUSION: Transcatheter device closure of carefully selected atrial septal defects is an alternative to surgery. Although the results are promising, surgical back-up is often needed.

Early identification of left ventricular remodelling after myocardial infarction, assessed by transthoracic 3D echocardiography.

AIMS: The usefulness of 3D echocardiography (3DE) for accurate evaluation of left ventricular (LV) remodelling after acute myocardial infarction (AMI), and early identification of remodelling in the subacute phase, was assessed. METHODS AND RESULTS: Thirty-three AMI patients (21 anterior AMIs) underwent 3DE prospectively at baseline (6+/-4 days) and at 3, 6, and 12 months post-AMI. Remodelling was defined as >20% increase in end-diastolic volume (EDV) at 6 or 12 months in relation to baseline. In patients with remodelling (n = 13) at baseline, EDV and end-systolic volume (ESV), but not ejection fraction (EF), were significantly increased compared to patients without subsequent remodelling (n = 20). At 12 months, EDV and ESV increased further and significantly, and EF was unchanged in patients with remodelling, whilst LV volumes were unchanged and EF slightly increased in patients without remodelling. Clinical, electrocardiographic, and echocardiographic variables were analysed for the early identification of LV remodelling. Of these, at baseline the 3D sphericity index (EDV divided by the volume of a sphere, the diameter of which is the LV major end-diastolic long axis) was, by far, the most predictive variable with a sensitivity, specificity, and positive and negative predictive value for a cutoff value of >0.25 of 100%, 90%, 87% and 100%, respectively. CONCLUSIONS: Three-dimensional echocardiography can differentiate patients with and without subsequent development of LV remodelling accurately and early on the basis of the 3D sphericity index, a new and highly predictive variable.

Additional value of three-dimensional transesophageal echocardiography for patients with mitral valve stenosis undergoing balloon valvuloplasty.

The objective of this study was to validate the additional value of 3-dimensional (3D) transesophageal echocardiography (TEE) for patients with mitral valve stenosis undergoing percutaneous mitral balloon valvotomy (PTMV). Therefore, in a series of 21 patients with severe mitral valve stenosis selected for PTMV, 3D TEE was performed before and after PTMV. The mitral valve area was assessed by planimetry pre- and post-PTMV; the mitral valve volume was assessed and attention was paid to the amount of fusion of the commissures. These results were compared with findings by 2-dimensional transthoracic echocardiography using pressure half-time method for assessment of mitral valve area, and were analyzed for the prediction of successful outcome. Pre-PTMV the mitral valve area assessed by 3D TEE was 1.0 +/- 0.3 cm(2) vs 1.2 +/- 0.4 cm(2) assessed by 2-dimensional transthoracic echocardiography (P =.03) and post-PTMV it was 1.8 +/- 0.5 cm(2) vs 1.9 +/- 0.6 cm(2) (not significant), respectively. The mitral valve volume could be assessed by 3D TEE (mean 2.4 +/- 2.5 cm(3)) and was inversely correlated to a successful PTMV procedure (P <.001). The 3D TEE method enabled a better description of the mitral valvular anatomy, especially post-PTMV. We conclude that 3D TEE will have additional value over 2-dimensional echocardiography in this group of patients, for selection of patients pre-PTMV, and for analyzing pathology of the mitral valve afterward.

Quantification of left ventricular volumes and ejection fraction using freehand transthoracic three-dimensional echocardiography: comparison with magnetic resonance imaging.

OBJECTIVES: Our aim was to validate 3-dimensional echocardiography (3DE) for assessment of left ventricular (LV) end-diastolic volume, end-systolic volume (ESV), stroke volume, and ejection fraction (EF) using the freehand-acquisition method. Furthermore, LV volumes by breath hold-versus free breathing-3DE acquisition were assessed and compared with magnetic resonance imaging (MRI). METHODS: From the apical position, a fan-like 3DE image was acquired during free breathing and another, thereafter, during breath hold. In 27 patients, 28 breath hold- and 24 free breathing-3DE images were acquired. A total of 17 patients underwent both MRI and 3DE. MRI contours were traced along the outer endocardial contour, including trabeculae, and along the inner endocardial contour, excluding trabeculae, from the LV volume. RESULTS: All 28 (100%) breath hold- and 86% of free breathing-3DE acquisitions could be analyzed. Intraobserver variation (percentual bias +/- 2 SD) of end-diastolic volume, ESV, stroke volume, and EF for breath-hold 3DE was, respectively, 0.3 +/- 10.2%, 0.3 +/- 14.6%, 0.1 +/- 18.4%, and -0.1 +/- 5.8%. For free-breathing 3DE, findings were similar. A significantly better interobserver variability, however, was observed for breath-hold 3DE for ESV and EF. Comparison of breath-hold 3DE with MRI inner contour showed for end-diastolic volume, ESV, stroke volume, and EF, a percentual bias (+/- 2 SD) of, respectively, -13.5 +/- 26.9%, -17.7 +/- 47.8%, -10.6 +/- 43.6%, and -1.8 +/- 11.6%. Compared with the MRI outer contour, a significantly greater difference was observed, except for EF. CONCLUSIONS: 3DE using the freehand method is fast and highly reproducible for (serial) LV volume and EF measurement, and, hence, ideally suited for clinical decision making and trials. Breath-hold 3DE is superior to free-breathing 3DE regarding image quality and reproducibility. Compared with MRI, 3DE underestimates LV volumes, but not EF, which is mainly explained by differences in endocardial contour tracing by MRI (outer contour) and 3DE (inner contour) of the trabecularized endocardium. Underestimation is reduced when breath-hold 3DE is compared with inner contour analysis of the MRI dataset.

Importance of transducer displacement and tilting on three-dimensional echocardiographic volume assessment using apical or off-axis rotational acquisition: an in vitro study.

OBJECTIVE: The goal of this study was to assess effects of translation (horizontal displacement) and angulation (transducer tilting) on 3-dimensional (3D) echocardiographic volumes of both balloons and human left ventricles after autopsy. METHODS: Six water-filled (non-) aneurysmatic balloons of 150, 250, and 350 mL and 3 hearts of different sizes and shapes were suspended upright in a water bath. Angulation and/or translation was performed respectively by tilting the transducer with a mechanical arm in a vertical plane relative to the balloon tip or true apex of the hearts and by shifting the water bath in the same vertical plane. For balloon and left ventricular (LV) volume assessment, a 3D conical data set was obtained by TomTec rotational acquisition in combination with a HP Sonos 5500 ultrasound machine. RESULTS: For the 6 balloons, translation from 1 to 4 cm yielded volumes of up to 74% of the optimal volume (100%); angulation of 10 degrees or 20 degrees, volumes of up to 80% and 34%. Translation with 10-degree angulation yielded volumes up to 64%; for 20-degree angulation and translation, there was no volume loss. Results were similar for the left ventricles. CONCLUSIONS: Even minor angulation or translation of the transducer yields substantial underestimation of the true volume. Off-axis para-apical views, however, defined as angulation of 20 degrees and greater than 0.5 cm translation in this in vitro model, obviate volume underestimation. Such views in patients, if obtainable, may be an attractive alternative for conventional apical 3D acquisition, especially in dilated and aneurysmatic hearts.