Analysis of conflicts of interest among authors and researchers of European clinical guidelines in cardiovascular medicine.

OBJECTIVES: We aimed to assess the frequency and nature of financial conflicts of interest among both the guideline committee authors and the authors of research studies used to support the European Society of Cardiology (ESC) guidelines. DESIGN: We evaluated the competing interests of the doctors that write five of the key ESC clinical practice guidelines (CPG): valvular heart disease (VHD), atrial fibrillation (AF), pericardial diseases (PD), heart failure (HF) and myocardial revascularisation (IHD). In addition, we examined the funding sources of studies cited in the recommendations that were related to pharmaceutical agents. If a study was sponsored by industry, the disclosures of all authors were reviewed to assess whether there was a financial conflict of interest with the study funder. RESULTS: In total, there were 603 recommendations (PD 112, VHD 111, HF 169, IHD 97 and AF 114) across the five guidelines, of which, 271 (45% (PD 26, VHD 23, HF 72, IHD 84 and AF 66)) related to pharmaceutical agents. At least 80% of guideline committee authors, except for the PD guidelines, had a relevant financial conflict of interest, with the most frequent being a direct personal payment (68-82%). Industry support for studies varied across the guidelines from 5% (PD) to 65% (IHD). If a study was funded by industry, authors were frequently (55-90%) conflicted with the industry sponsor. CONCLUSIONS: The majority of the doctors that write clinical guidelines have a relevant financial conflict of interest. In addition, industry sponsorship of studies is frequent, and authors are often conflicted with the study funder. We propose that physicians that write clinical guidelines should be free of such financial conflicts of interest to maintain scientific integrity and independence in the clinical guidelines.

Echocardiographic assessment of aortic stenosis: a practical guideline from the British Society of Echocardiography.

The guideline provides a practical step-by-step guide in order to facilitate high-quality echocardiographic studies of patients with aortic stenosis. In addition, it addresses commonly encountered yet challenging clinical scenarios and covers the use of advanced echocardiographic techniques, including TOE and Dobutamine stress echocardiography in the assessment of aortic stenosis.

Screening for Atrial Fibrillation Using Economical and Accurate Technology (From the SAFETY Study).

The prevalence of atrial fibrillation (AF) is estimated at more than 3% in the adult population and there has been increased interest in screening for AF. In the SAFETY trial we chose to evaluate if inexpensive, wearable, consumer electrocardiography (ECG) sensing devices (Polar-H7 [PH7] and Firstbeat Bodyguard 2 [BG2]), could be used to detect AF accurately. We undertook a case-control study of 418 participants aged >65 (82 with AF and/or flutter at the study visit and 336 without) attending 3 general practice surgeries in Hampshire, UK for a single screening visit. The PH7 and BG2 devices were tested alongside 2 established AF detection devices (AliveCor and WatchBP) in random order and the diagnosis of AF was confirmed by 12-Lead ECG interpreted by a panel of cardiologists. The sensitivity (95% confidence interval [CI] range), specificity (95% CI range), and overall accuracy (95% CI range) of the 4 devices were: AliveCor: 87.8% (78.7% to 94.0%), 98.8% (97.0% to 99.7%), 96.7% (94.4% to 98.2%); WatchBP: 96.3% (89.7% to 99.2%), 93.5% (90.3% to 95.9%), 94.0% (91.3% to 96.1%): PH7: 96.3% (89.7% to 99.2%), 98.2% (96.2% to 99.3%), 97.9% (96.0% to 99.0%). BG2: 96.3% (89.7% to 99.2%), 98.5% (96.6% to 99.5%), 98.1% (96.3% to 99.2%). The PH7 and BG2 devices were highly reliable (the devices acquired sufficient data and obtained a diagnostic result in all but 1 participant on the first attempt). In conclusion, inexpensive, consumer heart rate monitoring devices (PH7 and BG2) can be used to detect AF accurately with sensitivity and specificity >95%. The consumer devices performed as well or better than WatchBP and AliveCor and have the capability to store or transmit ECG data which could be used to confirm AF.

Relative clinical and economic impact of exercise echocardiography vs. exercise electrocardiography, as first line investigation in patients without known coronary artery disease and new stable angina: a randomized prospective study.

AIMS: Exercise electrocardiography (ExECG) is widely used in suspected stable angina (SA) as the initial test for the evaluation of coronary artery disease (CAD). We hypothesized that exercise stress echo (ESE) would be efficacious with cost advantage over ExECG when utilized as the initial test. METHODS AND RESULTS: Consecutive patients with suspected SA, without known CAD were randomized into ExECG or ESE. Patients with positive tests were offered coronary angiography (CA) and with inconclusive tests were referred for further investigations. All patients were followed-up for cardiac events (death, myocardial infarction, and unplanned revascularization). Cost to diagnosis of CAD was calculated by adding the cost of all investigations, up to and including CA. In the 194 and 191 patients in the ExECG vs. ESE groups, respectively, pre-test probability of CAD was similar (34 ± 23 vs. 35 ± 25%, P = 0.6). Results of ExECG were: 108 (55.7%) negative, 14 (7.2%) positive, 72 (37.1%) inconclusive and of ESE were 181 (94.8%) negative, 9 (4.7%) positive, 1 (0.5%) inconclusive, respectively. Patients with obstructive CAD following positive ESE vs. Ex ECG were 9/9 vs. 9/14, respectively (P = 0.04). Cost to diagnosis of CAD was £266 for ESE vs. £327 for ExECG (P = 0.005). Over a mean follow-up period of 21 ± 5 months, event rates were similar between the two groups. CONCLUSION: In this first randomized study, ESE was more efficacious and demonstrated superior cost-saving, compared with ExECG when used as the initial investigation for the evaluation of CAD in patients with new-onset suspected SA without known CAD.

A unique case of "double-orifice aortic valve"-comprehensive assessment by 2-, 3-dimensional, and color Doppler echocardiography.

Transesophageal echocardiography (TEE) is a powerful imaging tool for the comprehensive assessment of valvular structure and function. TEE may be of added benefit when anatomy is difficult to delineate accurately by transthoracic echocardiography. In this article, we present 2-, 3-dimensional, and color Doppler TEE images from a male patient with aortic stenosis. A highly unusual and complex pattern of valvular calcification created a functionally "double-orifice" valve. Such an abnormality may have implications for the accuracy of continuous-wave Doppler echocardiography, which assumes a single orifice valve in native aortic valves.

The clinical impact of contemporary stress echocardiography in morbid obesity for the assessment of coronary artery disease.

OBJECTIVE: Non-invasive cardiac imaging may suffer from poor image quality in morbidly obese individuals. This study aimed to determine the clinical value of contemporary stress echocardiography (SE) in morbidly obese patients referred for assessment of suspected coronary artery disease (CAD). METHODS: This prospective, multicentre observational study was conducted in two district hospitals and one tertiary centre in London, UK. Individuals with body mass index ≥35 kg/m(2) referred for SE were evaluated. The percentage of patients with obstructive CAD on coronary angiography, following abnormal SE, was assessed. Patient outcomes were determined with follow-up for the composite end-point of all-cause mortality, myocardial infarction and late revascularisation. RESULTS: Over a 13-month period, 209 morbidly obese patients underwent SE, and contrast agent was used in 96% of patients. A diagnostic result was obtained in 200/209 (96%) patients. Of 32 (15%) patients with inducible ischaemia, 25 underwent angiography, 22 (88%) had corresponding significant CAD and, of these, 16 (77%) underwent revascularisation. Conversely, only 2/157 patients (1.3%) with normal SE underwent angiography, and none underwent revascularisation. Over a mean follow-up period of 17.8±5.4 months, there were nine events. The annualised cardiac event rate after a normal SE was 0.95%. Events were more frequent in patients with inducible ischaemia versus those without ischaemia (5/32 (15.6%) vs 4/153 (2.6%); p=0.002). Ejection fraction <50% (HR 9.5; 95% CI 2.4 to 38.0; p=0.002) and inducible ischaemia (HR 9.4; 95% CI 2.5 to 35.8; p=0.001) were predictors of outcome on univariable Cox regression analysis. CONCLUSIONS: Contemporary SE has excellent feasibility and positive predictive value and resulted in appropriate risk stratification of symptomatic patients with significant obesity. A normal SE portends an excellent outcome over the short-intermediate term in this high-risk patient population.

The incremental prognostic value of the incorporation of myocardial perfusion assessment into clinical testing with stress echocardiography study.

BACKGROUND: The authors recently demonstrated that simultaneous assessment of myocardial perfusion (MP) and wall motion (WM) by myocardial contrast echocardiography (MCE) is feasible and accurate when incorporated into a clinical stress echocardiography (SE) service. However, it is unknown whether the incremental prognostic value of MP beyond WM, previously shown in research studies, is reproducible when MCE is performed in the clinical arena. METHODS: In this prospective study, MCE was performed by multiple operators during routine clinical SE, whose results were classified as normal WM and MP, abnormal WM and MP, or normal WM but abnormal MP. Patients were followed for the prospectively determined combined primary outcome of all-cause mortality, nonfatal myocardial infarction, and late revascularization. Cox regression analyses were performed to identify predictors of outcome. RESULTS: Of 220 patients undergoing simultaneous MCE during SE, 197 patients (90%) with interpretable WM and MP images were available for follow-up at a mean time period of 17 ± 7 months. There were 35 events (six deaths, six myocardial infarctions, and 23 revascularizations). Among prognostic clinical variables, resting left ventricular function, and WM and MP data, abnormal MP at peak stress was the only independent predictor of primary outcome (hazard ratio, 4.41; 95% confidence interval, 1.37-14.20; P = .02). Sequential Cox regression models showed that abnormal MP also carried incremental prognostic value over clinical variables, resting left ventricular function and abnormal WM. CONCLUSIONS: In keeping with previous research studies, this prospective study demonstrates the incremental prognostic benefit of MP assessment beyond WM when MCE is incorporated into a clinical SE service.

Relative diagnostic, prognostic and economic value of stress echocardiography versus exercise electrocardiography as initial investigation for the detection of coronary artery disease in patients with new onset suspected angina.

OBJECTIVES: We hypothesised that stress echocardiography (SE), may be superior to exercise ECG (ExECG), for predicting CAD and outcome, and cost-beneficial, when performed as initial investigation in newly suspected angina. METHODS: All patients seen in 2011, with suspected angina, no history of CAD, pre-test likelihood of CAD of > 10% and who underwent SE or ExECG as first line were identified retrospectively. Cost to diagnosis was calculated by adding the cost of all tests, up to and including coronary angiography (CA), on an intention-to-treat basis. Follow-up data on cardiac death and myocardial infarction (MI) were collected, 26 months after the presentation of the last study patient. RESULTS: A total of 456 patients underwent ExECG (224 (49%) negative, 93 (20%) positive, 139 (31%) inconclusive) and 241 underwent SE (200 (83%) negative, 35 (15%) positive, 6 (2%) inconclusive) as first line. In patients subsequently undergoing CA, CAD was present in 46% (37/80) of patients with positive ExECG vs. 72% (23/32) patients with positive SE (p = 0.01). Mean cost to diagnosis was £456 for the ExECG vs. £360 for the SE group (p = 0.002). Over a mean follow-up period of 31 ± 5 months, cardiac events were 2% each in negative SE vs. negative ExECG (p = 0.9). CONCLUSIONS: SE is superior to ExECG for prediction of CAD and is cost-beneficial when used as initial test in patients with no history of CAD presenting with suspected angina.

Role of simultaneous carotid ultrasound in patients undergoing stress echocardiography for assessment of chest pain with no previous history of coronary artery disease.

BACKGROUND: We prospectively explored prevalence of carotid disease (CD), its independent association with coronary artery disease (CAD) and outcome as well as potential impact on management, in patients undergoing stress echocardiography (SE) for new onset chest pain without known CAD. METHODS: Accordingly, 591 consecutive patients referred for SE underwent carotid ultrasound. Carotid disease was defined as carotid intima-media thickness (C-IMT) >75th percentile for age and sex and/or presence of plaque. RESULTS: Myocardial ischemia was demonstrated in only a minority (11%), but there was a high prevalence of CD (70%). Incidence of CD was similar in patients with and without ischemia (76% versus 69%, P = .26). Carotid data led to reclassification of Framingham risk score categories in 65% of patients as well as more than a third of negative SE patients potentially benefitting from primary prevention therapy. Of the 83 patients undergoing coronary arteriography, 59 (71%) demonstrated coronary atherosclerosis (any atheroma) and 33 (40%) CAD. Positive predictive value of SE for CAD was 56%, but presence of carotid plaque improved it to 70%. Although both CD and plaque showed association with CAD and revascularization, after adjustment for conventional risk factors, only carotid plaque maintained significant association (P = .024 and P = .023, respectively). CONCLUSIONS: There is significantly higher prevalence of CD compared with myocardial ischemia in patients undergoing SE and carotid ultrasound for suspected CAD. This can lead to significant Framingham risk score reclassification with important primary prevention implications. Carotid plaque is superior to clinical assessment for the prediction of CAD and improves positive predictive value of SE for CAD in these patients.

The feasibility and clinical utility of myocardial contrast echocardiography in clinical practice: results from the incorporation of myocardial perfusion assessment into clinical testing with stress echocardiography study.

BACKGROUND: This prospective study investigated whether the incorporation of myocardial contrast echocardiography (MCE) into a clinical stress echocardiography service reproduces the benefits of assessing myocardial perfusion proved previously in research studies. METHODS: MCE was performed during physiologic and pharmacologic clinical stress echocardiographic studies, and the value of myocardial perfusion to the reporting echocardiologists was categorized as of benefit (subclassified as incremental benefit over wall motion [WM] or greater confidence with WM) or of no added benefit. The presence and extent of inducible ischemia by WM and myocardial perfusion were documented and correlated with angiographic results in patients who underwent cardiac catheterization. RESULTS: In total, 220 patients underwent simultaneous MCE during stress echocardiography by eight different operators. Overall, MCE was of benefit in 193 patients (88%), providing incremental benefit over WM in 25% and greater confidence with WM evaluation in 62%. MCE provided no added benefit in 27 patients (12%). MCE detected significantly more cases of ischemia than WM in the left anterior descending coronary artery territory (65% vs 53%, P = .02) and detected a greater ischemic burden than WM on a per patient basis (median, 5 [interquartile range, 3-8] vs 4 [interquartile range, 2-7] segments; P < .001) and across all coronary territories. MCE correctly identified a greater proportion of patients with multivessel disease than WM (76% vs 56%, P = .02) and a greater ischemic burden in patients with multivessel disease (median, 7 [interquartile range, 4-9] vs 5 [interquartile range, 1-8] segments; P < .001). CONCLUSIONS: This prospective study is the first to demonstrate that the excellent feasibility and diagnostic utility of MCE, which have been documented in the research arena, are reproducible in the clinical arena.