Cost-effectiveness of adding a non-invasive acoustic rule-out test in the evaluation of patients with symptoms suggestive of coronary artery disease: rationale and design of the prospective, randomised, controlled, parallel-group multicenter FILTER-SCAD trial.

INTRODUCTION: Most patients with symptoms suggestive of chronic coronary syndrome (CCS) have no obstructive coronary artery disease (CAD) and better selection of patients to be referred for diagnostic tests is needed. The CAD-score is a non-invasive acoustic measure that, when added to pretest probability of CAD, has shown good rule-out capabilities. We aimed to test whether implementation of CAD-score in clinical practice reduces the use of diagnostic tests without increasing major adverse cardiac events (MACE) rates in patients with suspected CCS. METHODS AND ANALYSIS: FILTER-SCAD is a randomised, controlled, multicenter trial aiming to include 2000 subjects aged ≥30 years without known CAD referred for outpatient assessment for symptoms suggestive of CCS. Subjects are randomised 1:1 to either the control group: standard diagnostic examination (SDE) according to the current guidelines, or the intervention group: SDE plus a CAD-score. The subjects are followed for 12 months for the primary endpoint of cumulative number of diagnostic tests and a safety endpoint (MACE). Angina symptoms, quality of life and risk factor modification will be assessed with questionnaires at baseline, 3 months and 12 months after randomisation. The study is powered to detect superiority in terms of a reduction of ≥15% in the primary endpoint between the two groups with a power of 80%, and non-inferiority on the secondary endpoint with a power of 90%. The significance level is 0.05. The non-inferiority margin is set to 1.5%. Randomisation began on October 2019. Follow-up is planned to be completed by December 2022. ETHICS AND DISSEMINATION: This study has been approved by the Danish Medical Agency (2019024326), Danish National Committee on Health Research Ethics (H-19012579) and Swedish Ethical Review Authority (Dnr 2019-04252). All patients participating in the study will sign an informed consent. All study results will be attempted to be published as soon as possible. TRIAL REGISTRATION NUMBER: NCT04121949; Pre-results.

Ultrasound-assisted thrombolysis for acute intermediate-high-risk pulmonary embolism.

INTRODUCTION: Eustachian tube dysfunction (ETD) may result in hearing loss, chronic otitis and cholesteatoma. With advances in treatment options, the identification of patients with obstructive ETD is becoming increasingly important. The objective of this study was to validate a Danish translation of the 7-item Eustachian Tube Dysfunction Questionnaire (ETDQ-7). METHODS: All participants underwent tympanometry, otomicroscopy and completed the ETDQ-7. We included 34 ears from patients with obstructive ETD who had abnormal tympanometry curves but no history of cholesteatoma or adhesive otitis. As a control group, 48 otherwise healthy ears with a normal tympanometry curve were included from patients with known sensorineural hearing loss or normal hearing. RESULTS: A Cronbach's alpha of 0.77 indicated a good internal consistency reliability of the questionnaire. The mean ETDQ-7 score in the obstructive ETD group was 31 versus 13.5 in the control group (p = 0.00). A receiver operating characteristics analysis produced an area under the curve of 94%, showing excellent discriminatory abilities between the groups. CONCLUSIONS: The ETDQ-7 has previously been validated in English, German, Dutch and Portuguese, demonstrating good clinical relevance. The Danish translation of the ETDQ-7 has produced similar results and may be valuable in diagnosing obstructive ETD and in monitoring the effect of balloon dilation of the Eustachian tube. FUNDING: none. The study was approved by the Danish Data Protection Agency (VD-2018-33, I-Suite 6229).

Jeopardized Myocardium and Survival in Patients Presenting to the Catheterization Laboratory With ST-Elevation Myocardial Infarction and Shock.

OBJECTIVE: We aimed to relate the amount of jeopardized myocardium to mortality in shocked patients presenting to the catheterization laboratory with ST-elevation myocardial infarction (STEMI) and cardiogenic shock. BACKGROUND: In contrast with historical data and previous professional guidance, contemporary randomized data suggest that multi-vessel revascularization in such patients does not improve survival; mechanistic insight is incomplete. METHODS: Clinical databases identified cases of STEMI and shock triaged for primary percutaneous coronary intervention (PPCI) in Eastern Denmark from June 2011 to December 2014 (n = 128). British Cardiovascular Intervention Society (BCIS)-1 jeopardy scores were calculated from angiography. The study endpoint was 30-day mortality. RESULTS: Median lactate values were 6.0 [2.9-10.7] mmol/L. 30-day mortality was 53.9%. 68% of patients had multi-vessel coronary disease. Median pre-PCI BCIS-1 myocardial jeopardy scores were 8 [6-10]. After multiple logistic regression increasing age (p = 0.008; odds ratio [OR] 1.06), lactate values (p = 0.017; OR 1.02), mechanical ventilation (p = 0.011; OR 1.25) and a systolic blood pressure ≤ 90 mmHg at end-case (p = 0.005; OR 1.26) were predictive of 30-day mortality. Post-PPCI culprit vessel TIMI 3 flow was associated with reduced mortality (p < 0.001; OR 0.66). There was no association between pre-PCI jeopardy scores and the primary endpoint. CONCLUSIONS: In patients with STEMI and shock, myocardial jeopardy scores do not relate to patient outcomes. Jeopardy scores may be applied to existing datasets in order to understand why multi-vessel revascularization does not lead to the anticipated clinical benefits in cardiogenic shock.

Long-term survival and causes of death in patients with ST-elevation acute coronary syndrome without obstructive coronary artery disease.

Aims: We aimed to study survival and causes of death in patients with ST-elevation acute coronary syndrome (STE-ACS) with and without obstructive coronary artery disease (CAD). Methods and results: We included 4793 consecutive patients with STE-ACS triaged for acute coronary angiography at a large cardiac invasive centre (2009-2014). Of these, 88% had obstructive CAD (stenosis ≥50%), 6% had non-obstructive CAD (stenosis 1-49%), and 5% had normal coronary arteries. Patients without obstructive CAD were younger and more often female with fewer cardiovascular risk factors. Median follow-up time was 2.6 years. Compared with patients with obstructive CAD, the short-term hazard of death (≤30 days) was lower in both patients with non-obstructive CAD [hazard ratio (HR) 0.49, 95% confidence interval (CI) 0.27-0.89, P = 0.018] and normal coronary arteries (HR 0.31, 95% CI 0.11-0.83, P = 0.021). In contrast, the long-term hazard of death (>30 days) was similar in patients with non-obstructive CAD (HR 1.15, 95% CI 0.77-1.72, P = 0.487) and higher in patients with normal coronary arteries (HR 2.44, 95% CI 1.58-3.76, P < 0.001), regardless of troponin levels. Causes of death were cardiovascular in 70% of patients with obstructive CAD, 38% with non-obstructive CAD, and 32% with normal coronary arteries. Finally, patients without obstructive CAD had lower survival compared with an age and sex matched general population. Conclusions: STE-ACS patients without obstructive CAD had a long-term risk of death similar to or higher than patients with obstructive CAD. Causes of death were less often cardiovascular. This suggests that STE-ACS patients without obstructive CAD warrant medical attention and close follow-up.

The acquisition and retention of ECG interpretation skills after a standardized web-based ECG tutorial-a randomised study.

BACKGROUND: Electrocardiogram (ECG) interpretation is of great importance for patient management. However, medical students frequently lack proficiency in ECG interpretation and rate their ECG training as inadequate. Our aim was to examine the effect of a standalone web-based ECG tutorial and to assess the retention of skills using multiple follow-up intervals. METHODS: 203 medical students were included in the study. All participants completed a pre-test, an ECG tutorial, and a post-test. The participants were also randomised to complete a retention-test after short (2-4 weeks), medium (10-12 weeks), or long (18-20 weeks) follow-up. Intragroup comparisons of test scores were done using paired-samples t-test. Intergroup comparisons of test scores were performed using independent-samples t-test and ANOVA, whereas demographic data were compared using ANOVA and Chi-squared test. RESULTS: The overall mean test score improved significantly from 52.7 (SD 16.8) in the pre-test to 68.4 (SD 12.3) in the post-test (p < 0.001). Junior and senior students demonstrated significantly different baseline scores (45.5 vs. 57.8 points; p < 0.001), but showed comparable score gains (16.5 and 15.1 points, respectively; p = 0.48). All three follow-up groups experienced a decrease in test score between post-test and retention-test: from 67.4 (SD 12.3) to 60.2 (SD 8.3) in the short follow-up group, from 71.4 (SD 12.0) to 60.8 (SD 8.9) in the medium follow-up group, and from 66.1 (SD 12.1) to 58.6 (SD 8.6) in the long follow-up group (p < 0.001 for all). However, there were no significant differences in mean retention-test score between the groups (p = 0.33). Both junior and senior students showed a decline in test score at follow-up (from 62.0 (SD 10.6) to 56.2 (SD 9.8) and from 72.9 (SD 11.4) to 62.5 (SD 6.6), respectively). When comparing the pre-test to retention-test delta scores, junior students had learned significantly more than senior students (junior students improved 10.7 points and senior students improved 4.7 points, p = 0.003). CONCLUSION: A standalone web-based ECG tutorial can be an effective means of teaching ECG interpretation skills to medical students. The newly acquired skills are, however, rapidly lost when the intervention is not repeated.

Association between endovascular performance in a simulated setting and in the catheterization laboratory.

INTRODUCTION: Simulation-based assessment studies have related simulator performance to clinical experience instead of actual clinical performance. This study validates a novel rating scale for coronary angiography (CA) performance and at the same time explores the association between CA performance in a simulated setting and in the catheterization laboratory. METHODS: Ten cardiologists and cardiology residents with varying degrees of CA experience performed 2 CAs in the catheterization laboratory and 2 CAs in a simulated setting. The residents had prior simulator experience opposite cardiologists. Two raters assessed the operators' video-recorded performances using the novel CA rating scale (CARS). RESULTS: The correlation between CARS scores in the catheterization laboratory and the simulated setting was R = 0.20 (P = 0.195). Residents' scores were higher in the simulated setting than in the catheterization laboratory. The correlation between operators' previous clinical experience in CA and CARS scores was R = 0.65 (P = 0.005) in the catheterization laboratory and R = 0.11 (P = 0.353) in the simulated setting. CONCLUSIONS: The association between CA performance in a simulated setting and actual performance in the catheterization laboratory is not linear. The novel rating scale for CA (CARS) seems to be a valid proficiency assessment instrument in the catheterization laboratory. Familiarity with the simulator may overestimate proficiency, which means that simulator performance as a predictor of clinical performance should be interpreted with caution.

A study of the effect of dyad practice versus that of individual practice on simulation-based complex skills learning and of students' perceptions of how and why dyad practice contributes to learning.

PURPOSE: The aims of this study were (1) to explore the effectiveness of dyad practice compared with individual practice on a simulator for learning a complex clinical skill and (2) to explore medical students' perceptions of how and why dyad practice on a simulator contributes to learning a complex skill. METHOD: In 2011, the authors randomly assigned 84 medical students to either the dyad or the individual practice group to learn coronary angiography skills using instruction videos and a simulator. Two weeks later, participants each performed two video-recorded coronary angiographies on the simulator. Two raters used a rating scale to assess the participants' video-recorded performance. The authors then interviewed the participants in the dyad practice group. RESULTS: Seventy-two (86%) participants completed the study. The authors found no significant difference between the performance scores of the two groups (mean±standard deviation, 68%±13% for individual versus 63%±16% for dyad practice; P=.18). Dyad practice participants noted that several key factors contributed to their learning: being equal-level novices, the quality of the cooperation between partners, observational learning and overt communication, social aspects and motivation, and meta-cognition. CONCLUSIONS: Dyad practice is more efficient and thus more cost-effective than individual practice and can be used for costly virtual reality simulator training. However, dyad practice may not apply to clinical training involving real patients because learning from errors and overt communication, both keys to dyad practice, do not transfer to clinical practice.

Use of performance curves in estimating number of procedures required to achieve proficiency in coronary angiography.

BACKGROUND: Current guidelines in cardiology training programs recommend 100-300 coronary angiography procedures for certification. We aimed to assess the number of procedures needed to reach sufficient proficiency. METHODS: Procedure time, fluoroscopy time, dose area product (DAP), and contrast media volume were used as indicators of quality of performance. We analyzed data from 4,200 coronary angiographies. Performance curves of seven trainees were compared with recommended reference levels and to those of seven interventional cardiologists. RESULTS: On average, the number of procedures needed for trainees to reach recommended reference levels was estimated as 226 and 353, for DAP and use of contrast media, respectively. After 300 procedures, trainees' procedure time, fluoroscopy time, DAP, and contrast media volume were significantly higher compared with experts' performance, P < 0.001 for all parameters. To approach the experts' level of DAP and contrast media use, trainees need 394 and 588 procedures, respectively. Performance curves showed large individual differences in the development of competence. CONCLUSION: On average, trainees needed 300 procedures to reach sufficient level of proficiency, and this is in accordance with current guidelines. However, because of large individual differences, performance curves might be useful in monitoring individual trainees' progress and ensure documentation of sufficient competence when dealing with patients at risk.

Making post-mortem implantable cardioverter defibrillator explantation safe.

AIMS: The aim of this study is to investigate whether protection with rubber or plastic gloves during post-mortem explantation of an implantable cardioverter defibrillator (ICD) offers enough protection for the explanting operator during a worst-case scenario (i.e. ICD shock). METHODS AND RESULTS: We investigated the insulating properties of rubber and plastic gloves (double layer) within the first 60 min exposure (mimicking the maximum time of an explantation procedure) to saline (simulating the effects of body fluids on the gloves). For latex gloves, we measured an increase in voltage up to 68.1 V (P < 0.0001), for neoprene a maximum voltage of 5.3 V (P = 0.245), and for plastic a voltage of 2.3 V within the first hour. If the exposure time to fluid did not exceed 50 min, a double pair of intact gloves made of latex, neoprene, or plastic constituted such a large resistance that the resting voltage over the operating person would not exceed 50 V. CONCLUSION: The use of intact medical gloves made of latex, neoprene, or plastic eliminates the potential electrical risk during explantation of an ICD. Two gloves on each hand offer sufficient protection. We will recommend the use of neoprene gloves.