The importance of patient characteristics, operators, and image quality for the accuracy of heart failure diagnosis by general practitioners using handheld ultrasound devices.

Aims: To evaluate whether the characteristics of patients, operators, and image quality could explain the accuracy of heart failure (HF) diagnostics by general practitioners (GPs) using handheld ultrasound devices (HUDs) with automatic decision-support software and telemedical support. Methods and results: Patients referred to an outpatient cardiac clinic due to symptoms indicating HF were examined by one of five GPs after dedicated training. In total, 166 patients were included [median (inter-quartile range) age 73 (63-78) years; mean ± standard deviation ejection fraction 53 ± 10%]. The GPs considered whether the patients had HF in four diagnostic steps: (i) clinical examination, (ii) adding focused cardiac HUD examination, (iii) adding automatic decision-support software measuring mitral annular plane systolic excursion (autoMAPSE) and ejection fraction (autoEF), and (iv) adding telemedical support. Overall, the characteristics of patients, operators, and image quality explained little of the diagnostic accuracy. Except for atrial fibrillation [lower accuracy for HUD alone and after adding autoEF (P < 0.05)], no patient characteristics influenced the accuracy. Some differences between operators were found after adding autoMAPSE (P < 0.05). Acquisition errors of the four-chamber view and a poor visualization of the mitral plane were associated with reduced accuracy after telemedical support (P < 0.05). Conclusion: The characteristics of patients, operators, and image quality explained just minor parts of the modest accuracy of GPs' HF diagnostics using HUDs with and without decision-support software. Atrial fibrillation and not well-standardized recordings challenged the diagnostic accuracy. However, the accuracy was only modest in well-recorded images, indicating a need for refinement of the technology.

Clinical Influence of Handheld Ultrasound, Supported by Automatic Quantification and Telemedicine, in Suspected Heart Failure.

Early and correct heart failure (HF) diagnosis is essential to improvement of patient care. We aimed to evaluate the clinical influence of handheld ultrasound device (HUD) examinations by general practitioners (GPs) in patients with suspected HF with or without the use of automatic measurement of left ventricular (LV) ejection fraction (autoEF), mitral annular plane systolic excursion (autoMAPSE) and telemedical support. Five GPs with limited ultrasound experience examined 166 patients with suspected HF (median interquartile range = 70 (63-78) y; mean ± SD EF = 53 ± 10%). They first performed a clinical examination. Second, they added an examination with HUD, automatic quantification tools and, finally, telemedical support by an external cardiologist. At all stages, the GPs considered whether the patients had HF. The final diagnosis was made by one of five cardiologists using medical history and clinical evaluation including a standard echocardiography. Compared with the cardiologists' decision, the GPs correctly classified 54% by clinical evaluation. The proportion increased to 71% after adding HUDs, and to 74 % after telemedical evaluation. Net reclassification improvement was highest for HUD with telemedicine. There was no significant benefit of the automatic tools (p ≥ 0.58). Addition of HUD and telemedicine improved the GPs' diagnostic precision in suspected HF. Automatic LV quantification added no benefit. Refined algorithms and more training may be needed before inexperienced users benefit from automatic quantification of cardiac function by HUDs.

Real-time automatic quantification of left ventricular function by hand-held ultrasound devices in patients with suspected heart failure: a feasibility study of a diagnostic test with data from general practitioners, nurses and cardiologists.

OBJECTIVES: To evaluate the feasibility and reliability of hand-held ultrasound (HUD) examinations with real-time automatic decision-making software for ejection fraction (autoEF) and mitral annular plane systolic excursion (autoMAPSE) by novices (general practitioners), intermediate users (registered cardiac nurses) and expert users (cardiologists), respectively, compared to reference echocardiography by cardiologists in an outpatient cohort with suspected heart failure (HF). DESIGN: Feasibility study of a diagnostic test. SETTING AND PARTICIPANTS: 166 patients with suspected HF underwent HUD examinations with autoEF and autoMAPSE measurements by five novices, three intermediate-skilled users and five experts. HUD results were compared with a reference echocardiography by experts. A blinded cardiologist scored all HUD recordings with automatic measurements as (1) discard, (2) accept, but adjust the measurement or (3) accept the measurement as it is. PRIMARY OUTCOME MEASURE: The feasibility of automatic decision-making software for quantification of left ventricular function. RESULTS: The users were able to run autoEF and autoMAPSE in most patients. The feasibility for obtaining accepted images (score of ≥2) with automatic measurements ranged from 50% to 91%. The feasibility was lowest for novices and highest for experts for both autoEF and autoMAPSE (p≤0.001). Large coefficients of variation and wide coefficients of repeatability indicate moderate agreement. The corresponding intraclass correlations (ICC) were moderate to good (ICC 0.51-0.85) for intra-rater and poor (ICC 0.35-0.51) for inter-rater analyses. The findings of modest to poor agreement and reliability were not explained by the experience of the users alone. CONCLUSION: Novices, intermediate and expert users were able to record four-chamber views for automatic assessment of autoEF and autoMAPSE using HUD devices. The modest feasibility, agreement and reliability suggest this should not be implemented into clinical practice without further refinement and clinical evaluation. TRIAL REGISTRATION NUMBER: NCT03547076.

Reliability and agreement of point-of-care carotid artery examinations by experts using hand-held ultrasound devices in patients with ischaemic stroke or transitory ischaemic attack.

OBJECTIVES: To investigate the reliability and agreement of hand-held ultrasound devices (HUDs) compared with conventional duplex ultrasound (HIGH) in examination for carotid stenosis in patients with suspected transitory ischaemic attack (TIA) or ischaemic stroke. METHODS: Cardiologists, experienced in carotid ultrasound, examined patients admitted to a community hospital with suspected stroke or TIA. Patients were first examined by an HUD and second by HIGH as per usual care. Different operators performed HUD and HIGH blinded to each other. On clinical discretion, CT angiography (CTA) was performed, and analysed by a radiologist blinded to the results from the ultrasound. RESULTS: Of 80 patients included, 9 (11%) were found to have >50% internal carotid artery (ICA) stenosis on reference examination. Agreement for classification of the degree of ICA stenosis was good for HUD versus HIGH (weighted Kappa 0.76) and HUD versus CTA (weighted Kappa 0.66). Agreement between HUD and HIGH examinations was excellent when ICA was classified as <50% diameter stenosis by HUD (99% agreement), but significantly lower when ICA diameter stenosis was classified as >50% by HUD (OR 0.15, 95% CI 0.06 to 0.42). Overall, HUD tended to overestimate the degree of carotid stenoses rather than underestimate (p=0.048). CONCLUSION: Hand-held carotid ultrasound performed by experts demonstrated good agreement with conventional duplex ultrasound. The use of HUDs was reliable for ruling out significant carotid artery disease, but less reliable for ruling in significant disease.

Feasibility and Clinical Impact of Point-of-Care Carotid Artery Examinations by Experts using Hand-Held Ultrasound Devices in Patients with Ischemic Stroke or Transitory Ischemic Attack.

BACKGROUND AND PURPOSE: To evaluate the feasibility and clinical influence of carotid artery examinations in patients admitted with stroke or TIA with hand-held ultrasound by experts, to identify individuals not in need of further carotid artery diagnostics. MATERIALS AND METHODS: Cardiologists experienced in carotid ultrasound examined 80 patients admitted to a stroke unit with suspected stroke or TIA with hand-held ultrasound devices (HUD). Grey scale and color Doppler images were stored using a GE Vscan with dual probe (phased array and linear transducer). High-end triplex ultrasound performed by a cardiologist, blinded to the details of the HUD study, was performed in all patients and used as reference. Computer tomography angiography was performed when clinically indicated. RESULTS: Stroke or TIA was diagnosed in 62 (78%) patients. Age was median (range) 72 (23-93) years. A significant stenosis (> 50% diameter reduction) was ruled out in 61 (76%) of patients by the HUD examinations. Sensitivity and specificity for diagnosing a significant stenosis was 92% and 93%, respectively. One of 12 significant stenoses was missed by HUD. All four patients in need of surgery were identified by the HUD examination. Sensitivity and specificity to identify a significant stenosis by HUD was 87% and 83%, respectively, compared to CT angiography. CONCLUSION: HUD examinations of the carotid arteries by experts, using hand-held ultrasound devices, were feasible and may reduce the need for high-end diagnostic imaging of the carotid vessels in patients with stroke and TIA. Thus, HUD may improve diagnostic workflow in stroke units in the future.

Feasibility and Accuracy of Tele-Echocardiography, With Examinations by Nurses and Interpretation by an Expert via Telemedicine, in an Outpatient Heart Failure Clinic.

OBJECTIVES: To study the feasibility and accuracy of focused echocardiography by nurses supported by near-real-time interpretation via telemedicine by an experienced cardiologist. METHODS: Fifty consecutive patients were included from an outpatient heart failure (HF) clinic. Limited echocardiography was performed by 1 of 3 specialized nurses. The echocardiograms were transferred by a secure transfer model for near-real-time interpretation to 1 out-of-hospital cardiologist, assessing, among others, the left ventricular (LV) internal diameter, end-diastolic volume, ejection fraction, left atrial (LA) indexed end-systolic volume, mitral early inflow velocity (E), the ratio of E to mitral late inflow, and the ratio of E to the mitral annular early diastolic velocity. The reference method was echocardiography by 1 of 4 experienced cardiologists. RESULTS: The median age of the population (46% women) was 79 (range, 33-95) years. The assessment and quantification of LA and LV dimensions, volumes, and functional indices were feasible in 94% or more via the telemedical approach. The agreement with reference measurements was very high by the telemedical approach. The mean duration ± SD of the complete telemedical approach from the start of echocardiography until the cardiologist's report was received by the caregiving nurse was 1.32 ± 0.36 (range, 1.58) hours. The correlations with reference to the above-specified indices were r = 0.75 to 0.94. CONCLUSIONS: Limited echocardiography by nurses in an outpatient heart failure clinic, supported by interpretation by an out-of-hospital cardiologist, was feasible and reliable. This may reduce geographic disparities and allow more patients to benefit from the advantages of implementing focused echocardiography by noncardiologists in diagnostics and follow-up.

Adding point of care ultrasound to assess volume status in heart failure patients in a nurse-led outpatient clinic. A randomised study.

OBJECTIVES: Medical history, physical examination and laboratory testing are not optimal for the assessment of volume status in heart failure (HF) patients. We aimed to study the clinical influence of focused ultrasound of the pleural cavities and inferior vena cava (IVC) performed by specialised nurses to assess volume status in HF patients at an outpatient clinic. METHODS: HF outpatients were prospectively included and underwent laboratory testing, history recording and clinical examination by two nurses with and without an ultrasound examination of the pleural cavities and IVC using a pocket-size imaging device, in random order. Each nurse worked in a team with a cardiologist. The influence of the different diagnostic tests on diuretic dosing was assessed descriptively and in linear regression analyses. RESULTS: Sixty-two patients were included and 119 examinations were performed. Mean±SD age was 74±12 years, EF was 34±14%, and N-terminal pro-brain natriuretic peptide (NT-proBNP) value was 3761±3072 ng/L. Dosing of diuretics differed between the teams in 31 out of 119 consultations. Weight change and volume status assessed clinically with and without ultrasound predicted dose adjustment of diuretics at follow-up (p<0.05). Change of oedema, NT-proBNP, creatinine, and symptoms did not (p≥0.10). In adjusted analyses, only volume status based on ultrasound predicted dose adjustments of diuretics at first visit and follow-up (all ultrasound p≤0.01, all other p≥0.2). CONCLUSIONS: Ultrasound examinations of the pleural cavities and IVC by nurses may improve diagnostics and patient care in HF patients at an outpatient clinic, but more studies are needed to determine whether these examinations have an impact on clinical outcomes. TRIAL REGISTRATION NUMBER: NCT01794715.

Focused ultrasound of the pleural cavities and the pericardium by nurses after cardiac surgery.

OBJECTIVES: We aimed to study the feasibility and reliability of focused ultrasound (US) examinations to quantify pericardial (PE)- and pleural effusion (PLE) by a pocket-size imaging device (PSID) performed by nurses in patients early after cardiac surgery. DESIGN: After a 3-month training period, with cardiologists as supervisors, two nurses examined 59 patients (20 women) with US using a PSID at a median of 5 days after cardiac surgery. The amount of PE and PLE was classified in four categories by US (both) and chest x-ray (PLE only). Echocardiography, including US of the pleural cavities, by experienced cardiologists was used as reference. RESULTS: Focused US by the nurses was more sensitive than x-ray to detect PLE. The correlations of the quantification of PE and PLE by the nurses and reference was r (95% confidence interval) 0.76 (0.46-0.89) and 0.81 (0.73-0.89), both p < 0.001. PE and PLE were drained in one and six (eight cavities) patients, all classified as large amount by the nurses. CONCLUSIONS: Cardiac nurses were able to obtain reliable measurements and quantification of both PE and PLE bedside by focused US and outperform the commonly used chest x-ray regarding PLE after cardiac surgery.

Feasibility and reliability of point-of-care pocket-size echocardiography performed by medical residents.

AIMS: To study the feasibility and reliability of pocket-size hand-held echocardiography (PHHE) by medical residents with limited experience in ultrasound. METHODS AND RESULTS: A total of 199 patients admitted to a non-university medical department were examined with PHHE. Six out of 14 medical residents were randomized to use a focused protocol and examine the heart, pericardium, pleural space, and abdominal large vessels. Diagnostic corrections were made and findings were confirmed by standard diagnostics. The median time consumption for the examination was 5.7 min. Each resident performed a median of 27 examinations. The left ventricle was assessed to satisfaction in 97% and the pericardium in all patients. The aortic and atrioventricular valves were assessed in at least 76% and the abdominal aorta in 50%, respectively. Global left-ventricular function, pleural, and pericardial effusion showed very strong correlation with reference method (Spearman's r ≥ 0.8). Quantification of aortic stenosis and regurgitation showed strong correlation with r = 0.7. Regurgitations in the atrioventricular valves showed moderate correlations, r = 0.5 and r = 0.6 for mitral and tricuspid regurgitation, respectively, similar to dilatation of the left atrium (r = 0.6) and detection of regional dysfunction (r = 0.6). Quantification of the abdominal aorta (aneurysmatic or not) showed strong correlation, r = 0.7, while the inferior vena cava diameter correlated moderately, r = 0.5. CONCLUSION: By adding a PHHE examination to standard care, medical residents were able to obtain reliable information of important cardiovascular structures in patients admitted to a medical department. Thus, focused examinations with PHHE performed by residents after a training period have the potential to improve in-hospital diagnostic procedures.

Routinely adding ultrasound examinations by pocket-sized ultrasound devices improves inpatient diagnostics in a medical department.

BACKGROUND: We aimed to investigate the potential benefit of adding a routine cardiac and abdominal diagnostic examination by pocket-sized ultrasound device in patients admitted to a medical department. METHODS: A random sample of 196 patients admitted to the medical department at a non-university hospital in Norway between March and September 2010 was studied. The patients underwent cardiac and abdominal screening with a pocket-sized ultrasound device with B-mode and color flow imaging after a principal diagnosis was set. Three internists/cardiologists experienced in ultrasonography performed the examinations. Diagnostic corrections were made and findings were confirmed by high-end echocardiography and examinations at the radiologic department. RESULTS: 196 patients were included (male=56.6%, mean±SD; 68.1±15.0 years old). The time spent doing the ultrasound screening was mean±SD 4.3±1.6 min for the cardiac screening and 2.5±1.1 min for the abdominal screening. In 36 (18.4%) patients this examination resulted in a major change in the primary diagnosis. In 38 (19.4%) patients the diagnosis was verified and in 18 (9.2%) patients an important additional diagnosis was made. CONCLUSION: By adding a pocket-sized ultrasound examination of <10 min to usual care, we corrected the diagnosis in almost 1 of 5 patients admitted to a medical department, resulting in a completely different treatment strategy without delay in many of the patients. Routinely adding a cardiac and abdominal ultrasound screening has the potential to rearrange inpatients workflow and diagnosis.

Diagnostic influence of cardiovascular screening by pocket-size ultrasound in a cardiac unit.

AIMS: We aimed to study the diagnostic influence of adding a routine cardiovascular ultrasound screening of the cardiac anatomy and function, the pericardium, the pleura and the abdominal great vessels by the new pocket-size ultrasound device (pUS) with grey scale and colour Doppler imaging. METHODS AND RESULTS: In 119 randomly selected patients admitted to a cardiac unit at a non-university hospital, routinely adding a cardiovascular ultrasonography of only 4.4 min with a pocket-size device corrected the primary diagnosis in 16% of patients. In addition, 29% had the primary diagnosis verified and in 10% an additional important diagnosis was made. Higher age predicted any diagnostic influence of pUS screening with an increase of 61% (P=0.003) per 10 years of higher age. Overall, the pUS screening had a sensitivity and specificity with respect to detecting at least moderate pathology of 97 and 93%. Positive and negative predictive values were 93 and 87%, respectively. In the sub-group of subjects with a change in the primary diagnosis following pUS there was no false-negative or false-positive findings. CONCLUSION: Screening by pUS assessed vascular and cardiac anatomy and function accurately and enabled correction of the diagnosis in 16% of patients admitted to a cardiac unit. In 55% of the participants, the cardiovascular ultrasound screening had important diagnostic influence. We suggest that it would be appropriate to implement strategies and systems for routinely adding an ultrasound cardiovascular examination to patients in cardiac units.