Echocardiography

The VIAMI-trial was conducted to investigate the differences in clinical outcome between an invasive and a conservative strategy in patients with demonstrated viability in the infarct-area. The expected event rate in the viability positive group was estimated to be 35 percent. To demonstrate with a power of 80% (α = 0.05, two-sided) that PCI leads to a 50% reduction in event rate in the invasive group compared to the conservative group, 200 patients would be needed in each group.
As a formal stopping rule for the study the following was used: if one of the treatment strategies appeared significantly superior at interim analysis (p ≤ 0.01), the study would be stopped. Interim analysis was performed each time another 100 patients were included.
Baseline descriptive data are presented as a mean ± standard deviations (SD). Differences in clinical and echocardiographic variables are assessed by unpaired Student's t-test. Differences between proportions are assessed by chi-square analysis; a Fisher's exact test is used when appropriate. Event-free survival curves are computed with the Kaplan-Meier method, and the differences between these curves are tested with a log-rank test. The Cox proportional hazards regression analysis was used to estimate the treatment effect as hazard ratio (HR) with 95% confidence intervals. Besides the "crude" effects, adjustments were made for DM, hypertension, hypercholesterolemia, current smoking, family history of CAD (model a), clinical history (angina, myocardial infarction, PCI or CABG) and medication use at baseline (aspirin, beta-blocker, Ca-inhibitor, statins, ACE-I and AT II antagonist) (model b) and for all covariates (model c).
All analyses were performed on an intention-to-treat basis. Outcome per-protocol was also evaluated, since this would reflect the true influence of PCI on clinical outcome. Because after randomization there was a median waiting-time of two days before a revascularization procedure was performed inevitably some events occurred. In the per-protocol analysis these events are excluded from analysis, because they occurred before the by protocol demanded intervention. To make a fair comparison between the two groups in the per-protocol analysis we also excluded the events in the conservative group occurring during the first two days after randomization. All analyses were performed with the use of SPSS software, version 16.0 (SPSS, Inc., Chigago, Illinois).

Echocardiography was conducted by experienced sonographers using the Vivid E95 ultrasound system (GE Vingmed Ultrasound, Horten, Norway). Images in cine loop format were analyzed offline using the EchoPAC software (EchoPAC 204, GE Vingmed Ultrasound). All indices were measured according to ASE guidelines [15 , 16 (link)]. Pulse Doppler imaging was used to measure the mitral valve peak early (E) and late (A) diastolic velocities, E/A ratio, and LV isovolumic relaxation time (IVRT). LVEF was calculated using the biplane Simpson’s method. LV global longitudinal strain (GLS) was defined as the average peak longitudinal strains obtained from three apical views [17 (link)]. Peak strain dispersion (PSD) was the standard deviation of the time-to-peak longitudinal strains for all segments [18 (link)].
According to the criteria of ASE [19 (link)], the cut-offs for abnormal LV diastolic performance were, as follows: (1) septal mitral annular e′ velocity of < 7 cm/s or lateral mitral annular e′ velocity of < 10 cm/s; (2) average E/e′ ratio of > 14; (3) LAVI of > 34 ml/m²; (4) peak tricuspid regurgitation velocity of > 2.8 m/s. The patients were diagnosed, as follows: LVDD, when > 50% of the indexes met the above criteria; indeterminate LVDD, when merely 50% of the criteria were positive; with risk of developing LVDD but not LVDD yet, when < 50% of the indexes met the above criteria [19 (link)]. For patients with LVDD, the severity of LVDD was defined according to the 2016 EACVI criteria [19 (link), 20 (link)], as follows: mild, when E/A ≤ 0.8 and E ≤ 50 cm/s or ≥ 2 negative criteria (LAVI > 34 ml/m², average E/e’ > 14, or TR > 2.8 m/s); moderate, when E/A ≤ 0.8 and E > 50 cm/s or 0.8 < E/A < 2 + ≥ 2 positive criteria (LAVI > 34 ml/m², average E/e’ > 14, or TR > 2.8 m/s); severe, when E/A ≥ 2. Based on the above two criteria, the patients in the present study were categorized into three subgroups: patients with risks for LVDD but without LVDD (n = 237), patients with indeterminate or mild LVDD (n = 113), and patients with moderate or severe LVDD (n = 98). Among these patients, three patients met the criteria for mild LVDD, and seven patients met the criteria for severe LVDD.

In this cross-sectional study, 1272 pediatric patients under 16 years who were referred for follow-up of a known congenital heart defect (before or after a corrective surgery) or for evaluation of a possible congenital heart disease between April 2021 and February 2022, to a pediatric cardiology clinic in Mofid Children Hospital, Tehran, Iran were enrolled. Characteristics of the patients, including their medical histories and diagnosis, were obtained from the parents and if needed from the electronic medical record system of our center. All the patients were examined by a single experienced pediatric cardiologist using a conventional stethoscope at the first step and a Doppler Phonolyser device at the second step. In this regard, while the patient was in the supine position, an Ultrasound 2 MHz probe of a Doppler Phonolyser device was firmly secured on the chest for 30 s in each of four usual auscultatory areas. The Doppler Phonolyser’s results were interpreted based on the Doppler graph (Fig. 2). A checklist in which the patients were classified based on the auscultation findings as well as Doppler Phonolyser findings in three groups (normal, innocent murmur and pathologic murmur) was completed. A second pediatric cardiologist blindly re-examined 120 patients of the total patients with the Doppler Phonolyser device and the findings were recorded in a second checklist. Afterward, the patient underwent trans-thoracic echocardiography with either a GE Vivid S60 or a Samsung HS70 echocardiographic system. The echocardiogram was interpreted without the knowledge of Doppler Phonolyser results. The echocardiogram was considered normal if there was no pathologic finding other than mild tricuspid or pulmonary regurgitation.
Consent for participation was obtained from the parents of the participants and the protocol was conducted in compliance with the Declaration of Helsinki and approved by the Ethical committee of Shahid Beheshti University of Medical Science (Ethics approval number: IR.SBMU.MSP.REC.1400.641).