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Hand-Carried Echocardiography in Heart Failure and Heart Failure Risk Population: A Community Based Prospective Study
Hand-Carried Echocardiography in Heart Failure and Heart Failure Risk Population: A Community Based Prospective Study Magdalena Lipczy nska, MD, Piotr Szyma nski, MD, Anna Klisiewicz, MD, and Piotr Hoffman, MD, Warsaw, Poland
Background: The basic reservation concerning the use of hand-carried echocardiographic devices by general practitioners has been a lack of data demonstrating that they would provide clinically important information on patients’ outcomes. Methods: One hundred seventy-five patients with heart failure and/or heart failure risk factors were selected from a general community outpatient clinic. They underwent simplified hand-carried echocardiography performed by an internist with basic echocardiographic experience and N-terminal pro–B-type natriuretic peptide measurements. Patients were followed for the occurrence of the combined end point, consisting of death or hospitalization for cardiovascular causes. Results: Hand-carried echocardiographic results were abnormal in 90 patients (55%). During 48 6 7 months of follow-up, the combined end point occurred in 41 patients (25%). On multivariate analysis, only abnormal echocardiography (hazard ratio, 5.55; 95% confidence interval, 2.04–14.28; P = .0004) was an independent predictor of outcomes. Conclusions: Hand-carried echocardiographic examinations performed by an internist with basic echocardiographic training can provide important prognostic information, independent of N-terminal pro–B-type natriuretic peptide levels. (J Am Soc Echocardiogr 2011;24:125-31.) Keywords: Hand-carried echocardiography, Internist, Heart failure, Community
In recent years, progress in ultrasound technology has led to the development and dissemination of fully portable and truly handcarried devices, or ‘‘echocardiographic stethoscopes.’’1 The accuracy and reproducibility of hand-carried echocardiography for the detection of left ventricular (LV) systolic dysfunction, LV hypertrophy, and valvular regurgitation by experienced sonographers or cardiologists have been demonstrated both in the hospital setting and in the community.1-4 However, their use by noncardiologists has been debated.5 One of the basic reservations concerning the use of hand-carried devices by general practitioners and internists—so-called anyone, anytime, anywhere echocardiography—has been a lack of data demonstrating that examinations performed by inexperienced physicians would provide reliable and clinically important information on patients’ outcomes. Therefore, we hypothesized that use of an echocardiographic stethoscope by a primary care provider would provide useful prognostic data on clinical outcome in addition to standard clinical measures and serum B-type natriuretic peptide levels in patients with heart failure and heart failure risk factors. We undertook a community-based, From the Echocardiographic Laboratory and Department of Adult Congenital Heart Disease, Institute of Cardiology, Warsaw, Poland. ska, MD, Department of Adult Congenital Reprint requests: Magdalena Lipczyn Heart Disease, Institute of Cardiology, Alpejska 42, 04-628 Warsaw, Poland (E-mail: [email protected]). 0894-7317/$36.00 Copyright 2011 by the American Society of Echocardiography. doi:10.1016/j.echo.2010.10.010
prospective study to evaluate the clinical utility and prognostic value of hand-carried echocardiography, with a simplified imaging protocol, performed by an internist with basic training in echocardiography.
METHODS Study Population The medical records of 5,521 patients, all Caucasians, from a community outpatient clinic, which provides health care services for the population of inhabitants of a small town (I1_za, Poland) were screened. The study selection criteria were age $ 55 years and either a diagnosis of heart failure (n = 56 [32%]) or at least one of the following heart failure risk factors: ischemic heart disease (n = 32 [34%]), hypertension with complications (n = 73 [78%]), or diabetes mellitus (n = 32 [34%]). Two hundred eighteen patients who met the selection criteria were invited to participate in the study. One hundred seventy-five patients (80.3%) responded to a written invitation. During an initial visit, all patients underwent comprehensive physical and simplified echocardiographic examinations with the hand-carried device (OptiGo; Philips Medical Systems, Andover, MA), performed by an internist with basic training in echocardiography. In addition N-terminal pro–B-type natriuretic peptide (NT-pro-BNP) levels were measured. A study flowchart is presented in Figure 1. The study complied with the Declaration of Helsinki, and the research protocol was approved by the ethics committee at our institution. Each patient gave written informed consent to participate in the study. 125
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Doppler showed at least moderate regurgitation or two-dimensional imaging demonstrated visibly abnormal valve morphology and movement or when prosthetic valves were present. A ratio of jet area to left atrial area < 20% and no or minimal flow convergence defined nonsignificant mitral regurgitation. Larger jets were considered significant. Results were defined as abnormal if at least one of the following was present: a visually estimated ejection fraction < 50%, LV enlarge-
Hand-Carried Echocardiography LV = Left ventricular The hand-carried machine was equipped with a 2.5-MHz NT-pro-BNP = N-terminal pro–B-type natriuretic peptide phased-array broadband transducer and weighed 3 kg. The device provided basic two-dimensional imaging, color Doppler, freeze Abbreviations
5521 adult primary care patients screened 5303 excluded (<55 years old and ≥ 55 years old & without HF/HF risk factors: IHD, DM, complicated HTN)
218 patients selected
43 did not respond to invivation 175 patients included physical examination & history, hand-carried ECHO, NT-pro-BNP
11 inadequate hand-carried ECHO quality
164 followed up (48±7 months)
90 abnormal hand-carried ECHO
74 normal hand-carried ECHO
(EF < 50 , LVEDD≥ 56 mm, LVH≥ 12 mm, LA > 40 mm, any valve pathology)
35 events
55 no events
6 events
68 no events
Figure 1 Study flowchart. frame, and linear distance measurement. The machine was equipped neither with spectral Doppler nor image-storing capability. The physician (M.L.), without previous experience in echocardiography, underwent a 4-week training in a busy referral echocardiographic laboratory that performs approximately 1,500 examinations/month. The training covered theory, operating a hand-carried device, and performing 75 complete echocardiographic examinations under the supervision of an experienced cardiologist, which corresponded to basic-level training recommended by the American Society of Echocardiography.6 The trainee focused in particular on a simplified imaging protocol that included (1) three standard measurements in the long-axis parasternal view (LV diastolic diameter, left atrial diameter, and LV posterior wall thickness, according to the recommendations of the American Society of Echocardiography6); (2) assessment of LV function in a binary way, as preserved or impaired (on the basis of a visually estimated LV ejection fraction); and (3) assessment of normal versus abnormal valvular function. Valvular function was defined as abnormal when color
ment (end-diastolic dimension $ 56 mm), LV hypertrophy (posterior wall thickness $ 12 mm), left atrial enlargement > 40 mm, or any valve pathology. In 11 of 175 patients (6%), the quality of the hand-carried echocardiographic images was considered inadequate for the analysis, so the presented data are from the remaining 164 patients. The average duration of the hand-carried echocardiographic studies was 10 6 3 minutes. Serum NT-Pro-BNP Measurement Blood samples for assessment of serum NT-pro-BNP levels were collected during the initial visit. The specimen collection and preparation were performed with kits available commercially, following the manufacturers’ instructions. Plasma was separated and stored at 70 C until analysis. Serum NT-pro-BNP levels were analyzed by an independent laboratory, blinded to the study results, using an Elecsys NT-pro-BNP sandwich-type immunoassay (Roche Diagnostics GmbH, Mannheim,
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Germany). The measuring range was 5 to 35,000 pg/mL, with an analytical sensitivity of 5 pg/mL and a functional sensitivity of 50 pg/mL. Receiver operating characteristic analyses were used to define the best cutoff value of NT-pro-BNP level to predict the occurrence of the combined end point. Clinical Follow-Up Patients were followed up prospectively for 48 6 7 months (range, 5–50 months) by their primary care physicians. Follow-up was complete in all patients. The combined end point of the study was defined as death of any cause, hospital admission for heart failure, acute coronary syndromes, or any cardiac surgery (not planned at the time of baseline evaluation). The events were verified and adjudicated from chart review by an independent researcher, blinded to the results of echocardiographic assessment and NT-pro-BNP levels. Statistical Analysis Results are presented as mean 6 SD for continuous variables and as percentages for categorical data. Categorical data were analyzed using c2 tests and normally distributed continuous data using Student’s t tests (or Mann-Whitney U tests when data were not normally distributed). Cox regression analysis using a multivariate logistic regression model was used to examine the independent prognostic value of abnormal hand-carried echocardiographic examination and NT-pro-BNP levels. Variables statistically significant (P < .05) on univariate analyses and additionally sex and age (as important demographic variables) were included in multivariate analysis. Event-free (combined end point) survival curves for patients with normal versus abnormal echocardiographic results and normal versus abnormal NT-pro-BNP levels were constructed using the Kaplan-Meier method. The comparisons were made using the log-rank test. P values < .05 were considered significant.
RESULTS Hand-Carried Echocardiography Hand-carried echocardiographic results were abnormal in 90 of 164 patients (54%; Table 1). The most frequent abnormalities were LV hypertrophy (n = 47 [29%]) and LV systolic dysfunction (n = 45 [27%]). Of the 45 patients with impaired LV systolic function, 11 patients did not have clinically overt heart failure. Of the 14 patients with valvular pathology, seven had significant mitral regurgitation, two had abnormal mitral valve leaflet mobility (corresponding to mitral stenosis), and two had abnormal aortic valve morphology and movement (significant aortic valve calcification). In one case, significant aortic regurgitation was accompanied by an ascending aortic aneurysm (6 cm in diameter). Two patients had prosthetic valves (one mitral prosthesis and one both mitral and aortic valve prostheses). In all patients with suspected valve problems (n = 11), the diagnoses were confirmed by standard echocardiographic examinations, after which three patients underwent cardiac surgery. Baseline characteristics of patients with normal and abnormal echocardiographic results are presented in Table 2. Standard echocardiographic examinations had been performed previously in 41 patients (25%), including 25 of 56 patients (45%) with heart failure and 16 of 108 patients (15%) without overt heart failure but with heart failure risk factors.
Table 1 Echocardiographic findings in diagnostic echocardiograms (n = 164) Echocardiographic abnormality
Impaired LV function Enlarged left ventricle Enlarged left atrium LV hypertrophy Valvular pathology Additional findings*
n (%)
45 (27) 21 (13) 31 (19) 47 (29) 14 (8) 1 (0.6)
*A 6-cm ascending aortic aneurysm in a patient with severe aortic regurgitation.
Follow-Up Follow-up data were available for all 164 participants with diagnostic echocardiogram. During 48 6 7 months of follow-up, the combined end point occurred in 41 patients (25%). Twenty-nine (70%) were cardiovascular hospitalizations: 18 for heart failure, five for acute coronary syndromes, and six for cardiac surgery. Twelve patients (7%) died during the follow-up. Clinical outcomes in those with normal versus abnormal echocardiographic results are presented in Table 3. According to receiver operating characteristic analysis, the best cutoff for NT-pro-BNP to predict the combined end point was found to be 206 pg/mL (area under the curve, 0.62; P = .019). Abnormal NT-pro-BNP levels and abnormal hand-carried echocardiographic results were significantly more common among patients with the combined end point in comparison with patients without events (61% vs 39%, P = .006, and 79% vs 41%, P < .0001, respectively). Among 41 patients with the combined end point, two (5%) had abnormal NT-pro-BNP levels and normal hand-carried echocardiographic results, 10 (24%) had abnormal echocardiographic results and normal NT-pro-BNP levels, 24 (58%) had abnormal results on both tests, and five (12%) had normal results on both tests. The sensitivity, specificity, and positive and negative predictive values of abnormal hand-carried echocardiographic results for the prediction of the combined end point were 85%, 52%, 37%, and 91%, respectively. On univariate analysis, heart failure, cerebrovascular disease, atrial fibrillation or flutter, abnormal hand-carried echocardiographic results, and abnormal NT-pro-BNP levels were significant predictors of the occurrence of the combined end point. On multivariate analysis only abnormal hand-carried echocardiographic results remained a significant predictor of outcomes. The clinical characteristics of the patients with versus without events and the univariate and multivariate predictors of clinical outcome are shown in Table 4. Kaplan-Meier event-free survival curves for patients stratified according to normal versus abnormal echocardiographic results, normal versus abnormal NT-pro-BNP levels, and abnormal versus normal results on both tests are presented in Figures 2 to 4.
DISCUSSION The population of patients with heart failure and heart failure risk factors is growing. According to guidelines, it is important to have both diagnostic and prognostic tools to provide proper management in such individuals. Hand-carried echocardiography has an established role in the screening of LV systolic dysfunction, LV hypertrophy, and
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Table 2 Baseline characteristics of the population with diagnostic echocardiograms (n = 164) Clinical characteristic
Normal echocardiographic results (n = 74)
Abnormal echocardiographic results (n = 90)
P
Age (y) Women Smokers Heart failure Hypertension Ischemic heart disease Diabetes Peripheral vascular disease Cerebrovascular disease Atrial fibrillation/flutter Abnormal NT-pro-BNP
64.8 6 6.6 43 (58%) 26 (35%) 0 (0%) 52 (70%) 24 (32%) 26 (35%) 5 (7%) 3 (4%) 3 (4%) 26 (36%)
67.2 6 8.1 52 (58%) 30 (33%) 56 (62%) 81 (90%) 43 (48%) 29 (32%) 11 (12%) 11 (12%) 19 (21%) 49 (57%)
.04 .96 .80 <.0001 .001 .047 .69 .24 .05 .001 .009
Data are expressed as mean 6 SD or as number (percentage).
Table 3 Clinical outcomes in those with normal versus abnormal echocardiographic results Echocardiographic results (n = 164)
Outcome
Death Hospitalization for Acute coronary syndromes Cardiac surgery Heart failure Combined end point
Normal (n = 74)
Abnormal (n = 90)
1
11
1 1 3 6
4 5 15 35
valvular regurgitation.2,3 To our knowledge, our study is the first to demonstrate that simplified hand-carried echocardiographic examinations, performed by an internist with basic training in echocardiography (anyone, anytime, anywhere echocardiography) yield significant prognostic information in a community cohort of patients with heart failure and/or heart failure risk factors. This prognostic value was independent of NT-pro-BNP levels. Abnormal echocardiographic results were the only prognostic factor on multivariate analysis. Neither history nor NT-pro-BNP measurement provided this important clinical information. Abnormal echocardiographic results alone predicted 24% of events, while abnormal NT-pro-BNP predicted only 5%. A combination of abnormal echocardiographic results and abnormal NT-pro-BNP provided the most powerful prognostic information. Lim et al.7 reported very similar results obtained by experienced cardiologists, who used standard echocardiographic machines in patients with suspected heart failure, referred by general practitioners from the community. Our definition of abnormal echocardiographic results was very similar to theirs and included the presence of either LV dysfunction or LV hypertrophy or severe valvular heart disease.7 Recently Goonewardena et al.8 demonstrated that bedside handcarried echocardiographic evaluation of inferior vena cava size can predict readmission after hospitalization for acute decompensated heart failure. This readily measurable parameter might be included in the simplified imaging protocol, supplementing other easily available data.
In our study, the physician performing handheld echocardiographic studies had not had any previous practical experience in echocardiography and underwent basic training in accordance with the standards of the American Society of Echocardiography, widely accepted as a safe and reliable training method.6,9 An effective training period might probably be even shorter, as shown in the study by Vignon et al.,10 in which residents performed examinations after a 3-hour training course and 5 hours of hands-on training. Similarly, a study by DeCara et al.11 reported acceptable diagnostic accuracy obtained by residents after 20 hours of didactic instructions, followed by 20 examinations performed under a sonographer’s supervision. The availability of hand-carried echocardiography raises a debate concerning its diagnostic accuracy, the identification of potential users, a required competence level, and the possibility of missing clinically important diagnoses.12 The high negative predictive value of normal results on hand-carried examinations for the prediction of adverse clinical outcome observed in our study is reassuring in this respect. Moreover, the accuracy of hand-carried echocardiography performed by general practitioners should be compared not only with the accuracy of standard echocardiographic examinations but also with the accuracy of physical examinations. In our study, the hand-carried echocardiographic examinations had an important additional value as a diagnostic tool for asymptomatic LV dysfunction (11 patients) and previously unrecognized severe valvular pathology (three patients). Only 45% of patients with histories of heart failure and 15% of patients with heart failure risk factors had undergone echocardiographic examinations before our study. The figures were significantly smaller than those provided in the Euro-Heart Failure Survey Programme, in which 66% patients had ever undergone echocardiography.13 On the other hand, they were in accordance with the results of the IMPROVEMENT of Heart Failure Programme, in which only 45% of primary care physicians reported that they would routinely consider echocardiography in a patient with suspected heart failure.14 Our data were also almost identical with the results of the European Survey of Primary Care Physicians’ Perceptions on Heart Failure Diagnosis and Management (Euro-HF), in which most patients were diagnosed on symptoms and signs alone, with only 32% having further investigations or referral.15 Nearly the same results were obtained by the most recent Study Group on HF Awareness and
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Table 4 Univariate and multivariate predictors of clinical outcomes
Clinical characteristic
Age (y) Women Smokers Heart failure Hypertension Ischemic heart disease Prior myocardial infarction Diabetes Peripheral vascular disease Cerebrovascular disease Atrial fibrillation/flutter Abnormal echocardiographic results Abnormal NT-pro-BNP
Multivariate
Events (n = 41)
No events (n = 123)
Univariate P
P
HR (95% CI)
66.9 6 6.8 25 (61%) 13 (32%) 22 (54%) 37 (90%) 19 (46%) 12 (29%) 10 (24%) 5 (12%) 8 (19%) 11 (27%) 35 (85%)
65.6 6 7.7 70 (57%) 43 (35%) 34 (28%) 96 (78%) 48 (39%) 35 (28%) 45 (37%) 11 (9%) 6 (5%) 11 (9%) 55 (45%)
.46 .60 .64 .003 .06 .35 .87 .18 .55 .01 .008 <.0001
.72 .26 — .51 — — — — — .20 .38 .0004
1.01 (0.97–1.05) 1.49 (0.73–3.12) — 1.30 (0.35–1.69) — — — — — 1.88 (0.74–5.00) 1.42 (2.04–3.12) 5.55 (2.04–14.28)
26 (67%)
51 (41%)
.006
.07
1.86 (0.93–4.16)
CI, Confidence interval; HR, hazard ratio.
Figure 2 Kaplan-Meier event-free survival curves for patients stratified according to normal versus abnormal hand-carried echocardiographic results.
Perception in Europe (SHAPE) survey, in which 75% of primary care physicians reported that they often or always diagnosed heart failure by signs and symptoms alone, and only 35% would arrange for further investigations. According to the SHAPE investigators, access to echocardiography was poor in nearly all countries; although approximately 60% of primary care physicians considered echocardiography necessary for diagnosis, only 16% could obtain echocardiograms directly and 34% via specialists within 1 month.15 The results
of Euro-HF, SHAPE, and our study demonstrate a great gap between the guidelines and everyday practice. Hand-carried devices operated by primary care physicians appear to provide reliable diagnostic and prognostic information, partially filling this gap. However, careful and methodical studies looking at the reliability and accuracy of diagnoses made by caregivers with basic training have yet to be done. They are especially important as we are facing a heart failure epidemic.
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Figure 3 Kaplan-Meier event-free survival curves for patients stratified according to normal versus elevated NT-pro-BNP levels.
Figure 4 Kaplan-Meier event-free survival curves for patients stratified according to hand-carried echocardiographic results and NT-pro-BNP in combination: both normal, only abnormal NT-pro-BNP, only abnormal hand-carried echocardiographic results, and both abnormal. *Difference statistically significant for both abnormal echocardiographic results and NT-pro-BNP versus others. Limitations of the Study The presence of prosthetic valves was included in the definition of abnormal echocardiographic results, although this information is
available without echocardiography because the presence of valve prosthesis can be considered equivalent to a significant valve abnormality. The latter was included in the definition used by Lim et al.7
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A relatively small sample size is a clear disadvantage, as it limits the statistical power of the study. It should be noted, however, that the sample size corresponds approximately to the population of patients with heart failure and/or heart failure risk factors covered in the system by one or two general practitioners, which further underscores the practical value of the study. The statistical limitation pertains to the combined end point of the study, including ‘‘soft end points’’ and all-cause rather than cardiovascular mortality. However these soft end points would be of vital importance from both patients’ and primary care physicians’ points of view. It is important to underscore that it is unwarranted to extrapolate the results to general outpatients, because specific training, selection criteria, and imaging protocol were applied, aiming primarily at improving the diagnosis of heart failure and LV dysfunction. This specific protocol may not apply to other populations and diagnoses. Hand-carried examinations were not systematically verified by standard echocardiography, although their reliability has been documented previously. Also, in our own experience there was a good agreement between both methods.2 The quantitative measurement set was made as simple as possible, and all measurements were performed from the parasternal long-axis view. This made more sophisticated analyses impossible, but at the same time, it enabled us to simplify the training protocol and make the measurements more reproducible. Although we were not able to provide data addressing the diagnostic accuracy of the noncardiologist’s findings directly in this study, we have previously observed good agreement (k = 0.75) between nonexpert observers (medical students after 6 hours of reading echocardiograms) and experienced cardiologists when visually assessed LV systolic function was categorized as normal, minimally, moderately, and severely impaired and very good agreement (k = 0.83) between nonexpert and expert observers when mitral regurgitation was categorized in a dichotomous manner as significant or nonsignificant.16
10.
CONCLUSIONS
11.
Our study has demonstrated that following short training, simplified echocardiographic examinations performed with hand-carried devices appear to provide important prognostic and additional diagnostic information when used in a community as a screening tool in patients with heart failure risk factors or overt heart failure. A wide application of ‘‘ultrasound stethoscopes’’ might change the standards of care of patients with heart failure and heart failure risk factors.
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ACKNOWLEDGMENTS 14.
We are especially grateful to Professor Catherine M. Otto for the critical review of this report. We also thank doctor Ewa Pasternak and Stanis1aw Kostrzewa, manager at the Outpatient Clinic in I1_za, for their support during the study. REFERENCES 1. Galasko GI, Lahiri A, Senior R. Portable echocardiography: an innovative tool in screening for cardiac abnormalities in the community. Eur J Echocardiogr 2003;4:119-27. 2. Szyma nski P, Lipczy nska M, Klisiewicz A, Kraszewski K, Konka M, Tyczy nski P, et al., Ultrasound stethoscope in the rapid assessment of left
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ventricular systolic function and valvular regurgitation—personal experience [article in Polish]. Przegl Lek 2004;61:572-5. Senior R, Galasko G, Hickman M, Jeetley P, Lahiri A. Community screening for left ventricular hypertrophy in patients with hypertension using hand-held echocardiography. J Am Soc Echocardiogr 2004;17:56-61. Galasko GIW, Barnes SC, Collinson P, Lahiri A, Senior R. What is the most cost-effective strategy to screen for left ventricular systolic dysfunction: natriuretic peptides, the electrocardiogram, hand-held echocardiography, traditional echocardiography, or their combination? Eur Heart J 2006;27: 193-200. Douvall WL, Croft LB, Goldman ME. Can hand-carried ultrasound devices be extended for use by the noncardiology medical community? Echocardiography 2003;20:471-6. Qui~ nones MA, Douglas PS, Foster E, Gorcsan J III, Lewis JF, Pearlman AS, et al., American Society of Echocardiography; Society of Cardiovascular Anesthesiologists; Society of Pediatric Echocardiography. ACC/AHA clinical competence statement on echocardiography: a report of the American College of Cardiology/American Heart Association/American College of Physicians-American Society of Internal Medicine Task Force on clinical competence. J Am Soc Echocardiogr 2003;16:379-402. Lim TK, Hayat SA, Gaze D, Celik E, Collinson P, Senior R. Independent value of echocardiography and N-terminal pro-natriuretic peptide for the prediction of major outcomes in patients with suspected heart failure. Am J Cardiol 2007;100:870-5. Goonewardena SN, Gemignani A, Ronan A, Vasaiwala S, Blair J, Brennan JM, et al., Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure. JACC Cardiovasc Imaging 2008;1:595-601. Seward JB, Douglas PS, Erbel R, Kerber RE, Kronzon I, Rakowski H, et al., Hand-carried cardiac ultrasound (HCU) device: recommendations regarding new technology. A report from the echocardiography task force on new technology of the nomenclature and standards committee of the American Society of Echocardiography. J Am Soc Echocardiogr 2002; 15:369-73. Vignon P, Dugard A, Abraham J, Belcour D, Gondran G, Pepino F, et al., Focused training for goal-oriented hand-held echocardiography performed by noncardiologist residents in the intensive care unit. Intensive Care Med 2007;33:1795-9. DeCara JM, Lang RM, Koch R, Bala R, Penzotti J, Spencer KT. The use of small personal ultrasound devices by internists without formal training in echocardiography. Eur J Echocardiogr 2003;4:141-7. Vourvouri EC, Schinkel AF, Roelandt JR, Boomsma F, Sianos G, Bountioukos M, et al., Screening for left ventricular dysfunction using a hand-carried cardiac ultrasound device. Eur J Heart Fail 2003;5:767-74. Cleland JG, Swedberg K, Follath F, Komajda M, Cohen-Solal A, Aguilar JC, et al., Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. The EuroHeart Failure survey programme—a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. Eur Heart J 2003;24:442-63. Cleland JG, Cohen-Solal A, Aguilar JC, Dietz R, Eastaugh J, Follath F, et al., IMPROVEMENTof Heart Failure Programme Committees and Investigators. Improvement programme in evaluation and management; Study Group on Diagnosis of the Working Group on Heart Failure of the European Society of Cardiology. Management of heart failure in primary care (the IMPROVEMENTof Heart Failure Programme): an international survey. Lancet 2002;360:1631-9. Remme WJ, McMurray JJ, Hobbs FD, Cohen-Solal A, Lopez-Sendon J, Boccanelli A, et al., SHAPE Study Group. Awareness and perception of heart failure among European cardiologists, internists, geriatricians, and primary care physicians. Eur Heart J 2008;29:1739-52. Szyma nski P, Klisiewicz A, Micha1ek P, Lipczy nska M, Langer S, Hoffman P. The feasibility and efficacy of short courses of echocardiography for medical students. Eur J Echocardiogr 2003;4(suppl):S41.
Background: The basic reservation concerning the use of hand-carried echocardiographic devices by general practitioners has been a lack of data demonstrating that they would provide clinically important information on patients’ outcomes. Methods: One hundred seventy-five patients with heart failure and/or heart failure risk factors were selected from a general community outpatient clinic. They underwent simplified hand-carried echocardiography performed by an internist with basic echocardiographic experience and N-terminal pro–B-type natriuretic peptide measurements. Patients were followed for the occurrence of the combined end point, consisting of death or hospitalization for cardiovascular causes. Results: Hand-carried echocardiographic results were abnormal in 90 patients (55%). During 48 6 7 months of follow-up, the combined end point occurred in 41 patients (25%). On multivariate analysis, only abnormal echocardiography (hazard ratio, 5.55; 95% confidence interval, 2.04–14.28; P = .0004) was an independent predictor of outcomes. Conclusions: Hand-carried echocardiographic examinations performed by an internist with basic echocardiographic training can provide important prognostic information, independent of N-terminal pro–B-type natriuretic peptide levels. (J Am Soc Echocardiogr 2011;24:125-31.) Keywords: Hand-carried echocardiography, Internist, Heart failure, Community
In recent years, progress in ultrasound technology has led to the development and dissemination of fully portable and truly handcarried devices, or ‘‘echocardiographic stethoscopes.’’1 The accuracy and reproducibility of hand-carried echocardiography for the detection of left ventricular (LV) systolic dysfunction, LV hypertrophy, and valvular regurgitation by experienced sonographers or cardiologists have been demonstrated both in the hospital setting and in the community.1-4 However, their use by noncardiologists has been debated.5 One of the basic reservations concerning the use of hand-carried devices by general practitioners and internists—so-called anyone, anytime, anywhere echocardiography—has been a lack of data demonstrating that examinations performed by inexperienced physicians would provide reliable and clinically important information on patients’ outcomes. Therefore, we hypothesized that use of an echocardiographic stethoscope by a primary care provider would provide useful prognostic data on clinical outcome in addition to standard clinical measures and serum B-type natriuretic peptide levels in patients with heart failure and heart failure risk factors. We undertook a community-based, From the Echocardiographic Laboratory and Department of Adult Congenital Heart Disease, Institute of Cardiology, Warsaw, Poland. ska, MD, Department of Adult Congenital Reprint requests: Magdalena Lipczyn Heart Disease, Institute of Cardiology, Alpejska 42, 04-628 Warsaw, Poland (E-mail: [email protected]). 0894-7317/$36.00 Copyright 2011 by the American Society of Echocardiography. doi:10.1016/j.echo.2010.10.010
prospective study to evaluate the clinical utility and prognostic value of hand-carried echocardiography, with a simplified imaging protocol, performed by an internist with basic training in echocardiography.
METHODS Study Population The medical records of 5,521 patients, all Caucasians, from a community outpatient clinic, which provides health care services for the population of inhabitants of a small town (I1_za, Poland) were screened. The study selection criteria were age $ 55 years and either a diagnosis of heart failure (n = 56 [32%]) or at least one of the following heart failure risk factors: ischemic heart disease (n = 32 [34%]), hypertension with complications (n = 73 [78%]), or diabetes mellitus (n = 32 [34%]). Two hundred eighteen patients who met the selection criteria were invited to participate in the study. One hundred seventy-five patients (80.3%) responded to a written invitation. During an initial visit, all patients underwent comprehensive physical and simplified echocardiographic examinations with the hand-carried device (OptiGo; Philips Medical Systems, Andover, MA), performed by an internist with basic training in echocardiography. In addition N-terminal pro–B-type natriuretic peptide (NT-pro-BNP) levels were measured. A study flowchart is presented in Figure 1. The study complied with the Declaration of Helsinki, and the research protocol was approved by the ethics committee at our institution. Each patient gave written informed consent to participate in the study. 125
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Doppler showed at least moderate regurgitation or two-dimensional imaging demonstrated visibly abnormal valve morphology and movement or when prosthetic valves were present. A ratio of jet area to left atrial area < 20% and no or minimal flow convergence defined nonsignificant mitral regurgitation. Larger jets were considered significant. Results were defined as abnormal if at least one of the following was present: a visually estimated ejection fraction < 50%, LV enlarge-
Hand-Carried Echocardiography LV = Left ventricular The hand-carried machine was equipped with a 2.5-MHz NT-pro-BNP = N-terminal pro–B-type natriuretic peptide phased-array broadband transducer and weighed 3 kg. The device provided basic two-dimensional imaging, color Doppler, freeze Abbreviations
5521 adult primary care patients screened 5303 excluded (<55 years old and ≥ 55 years old & without HF/HF risk factors: IHD, DM, complicated HTN)
218 patients selected
43 did not respond to invivation 175 patients included physical examination & history, hand-carried ECHO, NT-pro-BNP
11 inadequate hand-carried ECHO quality
164 followed up (48±7 months)
90 abnormal hand-carried ECHO
74 normal hand-carried ECHO
(EF < 50 , LVEDD≥ 56 mm, LVH≥ 12 mm, LA > 40 mm, any valve pathology)
35 events
55 no events
6 events
68 no events
Figure 1 Study flowchart. frame, and linear distance measurement. The machine was equipped neither with spectral Doppler nor image-storing capability. The physician (M.L.), without previous experience in echocardiography, underwent a 4-week training in a busy referral echocardiographic laboratory that performs approximately 1,500 examinations/month. The training covered theory, operating a hand-carried device, and performing 75 complete echocardiographic examinations under the supervision of an experienced cardiologist, which corresponded to basic-level training recommended by the American Society of Echocardiography.6 The trainee focused in particular on a simplified imaging protocol that included (1) three standard measurements in the long-axis parasternal view (LV diastolic diameter, left atrial diameter, and LV posterior wall thickness, according to the recommendations of the American Society of Echocardiography6); (2) assessment of LV function in a binary way, as preserved or impaired (on the basis of a visually estimated LV ejection fraction); and (3) assessment of normal versus abnormal valvular function. Valvular function was defined as abnormal when color
ment (end-diastolic dimension $ 56 mm), LV hypertrophy (posterior wall thickness $ 12 mm), left atrial enlargement > 40 mm, or any valve pathology. In 11 of 175 patients (6%), the quality of the hand-carried echocardiographic images was considered inadequate for the analysis, so the presented data are from the remaining 164 patients. The average duration of the hand-carried echocardiographic studies was 10 6 3 minutes. Serum NT-Pro-BNP Measurement Blood samples for assessment of serum NT-pro-BNP levels were collected during the initial visit. The specimen collection and preparation were performed with kits available commercially, following the manufacturers’ instructions. Plasma was separated and stored at 70 C until analysis. Serum NT-pro-BNP levels were analyzed by an independent laboratory, blinded to the study results, using an Elecsys NT-pro-BNP sandwich-type immunoassay (Roche Diagnostics GmbH, Mannheim,
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Germany). The measuring range was 5 to 35,000 pg/mL, with an analytical sensitivity of 5 pg/mL and a functional sensitivity of 50 pg/mL. Receiver operating characteristic analyses were used to define the best cutoff value of NT-pro-BNP level to predict the occurrence of the combined end point. Clinical Follow-Up Patients were followed up prospectively for 48 6 7 months (range, 5–50 months) by their primary care physicians. Follow-up was complete in all patients. The combined end point of the study was defined as death of any cause, hospital admission for heart failure, acute coronary syndromes, or any cardiac surgery (not planned at the time of baseline evaluation). The events were verified and adjudicated from chart review by an independent researcher, blinded to the results of echocardiographic assessment and NT-pro-BNP levels. Statistical Analysis Results are presented as mean 6 SD for continuous variables and as percentages for categorical data. Categorical data were analyzed using c2 tests and normally distributed continuous data using Student’s t tests (or Mann-Whitney U tests when data were not normally distributed). Cox regression analysis using a multivariate logistic regression model was used to examine the independent prognostic value of abnormal hand-carried echocardiographic examination and NT-pro-BNP levels. Variables statistically significant (P < .05) on univariate analyses and additionally sex and age (as important demographic variables) were included in multivariate analysis. Event-free (combined end point) survival curves for patients with normal versus abnormal echocardiographic results and normal versus abnormal NT-pro-BNP levels were constructed using the Kaplan-Meier method. The comparisons were made using the log-rank test. P values < .05 were considered significant.
RESULTS Hand-Carried Echocardiography Hand-carried echocardiographic results were abnormal in 90 of 164 patients (54%; Table 1). The most frequent abnormalities were LV hypertrophy (n = 47 [29%]) and LV systolic dysfunction (n = 45 [27%]). Of the 45 patients with impaired LV systolic function, 11 patients did not have clinically overt heart failure. Of the 14 patients with valvular pathology, seven had significant mitral regurgitation, two had abnormal mitral valve leaflet mobility (corresponding to mitral stenosis), and two had abnormal aortic valve morphology and movement (significant aortic valve calcification). In one case, significant aortic regurgitation was accompanied by an ascending aortic aneurysm (6 cm in diameter). Two patients had prosthetic valves (one mitral prosthesis and one both mitral and aortic valve prostheses). In all patients with suspected valve problems (n = 11), the diagnoses were confirmed by standard echocardiographic examinations, after which three patients underwent cardiac surgery. Baseline characteristics of patients with normal and abnormal echocardiographic results are presented in Table 2. Standard echocardiographic examinations had been performed previously in 41 patients (25%), including 25 of 56 patients (45%) with heart failure and 16 of 108 patients (15%) without overt heart failure but with heart failure risk factors.
Table 1 Echocardiographic findings in diagnostic echocardiograms (n = 164) Echocardiographic abnormality
Impaired LV function Enlarged left ventricle Enlarged left atrium LV hypertrophy Valvular pathology Additional findings*
n (%)
45 (27) 21 (13) 31 (19) 47 (29) 14 (8) 1 (0.6)
*A 6-cm ascending aortic aneurysm in a patient with severe aortic regurgitation.
Follow-Up Follow-up data were available for all 164 participants with diagnostic echocardiogram. During 48 6 7 months of follow-up, the combined end point occurred in 41 patients (25%). Twenty-nine (70%) were cardiovascular hospitalizations: 18 for heart failure, five for acute coronary syndromes, and six for cardiac surgery. Twelve patients (7%) died during the follow-up. Clinical outcomes in those with normal versus abnormal echocardiographic results are presented in Table 3. According to receiver operating characteristic analysis, the best cutoff for NT-pro-BNP to predict the combined end point was found to be 206 pg/mL (area under the curve, 0.62; P = .019). Abnormal NT-pro-BNP levels and abnormal hand-carried echocardiographic results were significantly more common among patients with the combined end point in comparison with patients without events (61% vs 39%, P = .006, and 79% vs 41%, P < .0001, respectively). Among 41 patients with the combined end point, two (5%) had abnormal NT-pro-BNP levels and normal hand-carried echocardiographic results, 10 (24%) had abnormal echocardiographic results and normal NT-pro-BNP levels, 24 (58%) had abnormal results on both tests, and five (12%) had normal results on both tests. The sensitivity, specificity, and positive and negative predictive values of abnormal hand-carried echocardiographic results for the prediction of the combined end point were 85%, 52%, 37%, and 91%, respectively. On univariate analysis, heart failure, cerebrovascular disease, atrial fibrillation or flutter, abnormal hand-carried echocardiographic results, and abnormal NT-pro-BNP levels were significant predictors of the occurrence of the combined end point. On multivariate analysis only abnormal hand-carried echocardiographic results remained a significant predictor of outcomes. The clinical characteristics of the patients with versus without events and the univariate and multivariate predictors of clinical outcome are shown in Table 4. Kaplan-Meier event-free survival curves for patients stratified according to normal versus abnormal echocardiographic results, normal versus abnormal NT-pro-BNP levels, and abnormal versus normal results on both tests are presented in Figures 2 to 4.
DISCUSSION The population of patients with heart failure and heart failure risk factors is growing. According to guidelines, it is important to have both diagnostic and prognostic tools to provide proper management in such individuals. Hand-carried echocardiography has an established role in the screening of LV systolic dysfunction, LV hypertrophy, and
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Table 2 Baseline characteristics of the population with diagnostic echocardiograms (n = 164) Clinical characteristic
Normal echocardiographic results (n = 74)
Abnormal echocardiographic results (n = 90)
P
Age (y) Women Smokers Heart failure Hypertension Ischemic heart disease Diabetes Peripheral vascular disease Cerebrovascular disease Atrial fibrillation/flutter Abnormal NT-pro-BNP
64.8 6 6.6 43 (58%) 26 (35%) 0 (0%) 52 (70%) 24 (32%) 26 (35%) 5 (7%) 3 (4%) 3 (4%) 26 (36%)
67.2 6 8.1 52 (58%) 30 (33%) 56 (62%) 81 (90%) 43 (48%) 29 (32%) 11 (12%) 11 (12%) 19 (21%) 49 (57%)
.04 .96 .80 <.0001 .001 .047 .69 .24 .05 .001 .009
Data are expressed as mean 6 SD or as number (percentage).
Table 3 Clinical outcomes in those with normal versus abnormal echocardiographic results Echocardiographic results (n = 164)
Outcome
Death Hospitalization for Acute coronary syndromes Cardiac surgery Heart failure Combined end point
Normal (n = 74)
Abnormal (n = 90)
1
11
1 1 3 6
4 5 15 35
valvular regurgitation.2,3 To our knowledge, our study is the first to demonstrate that simplified hand-carried echocardiographic examinations, performed by an internist with basic training in echocardiography (anyone, anytime, anywhere echocardiography) yield significant prognostic information in a community cohort of patients with heart failure and/or heart failure risk factors. This prognostic value was independent of NT-pro-BNP levels. Abnormal echocardiographic results were the only prognostic factor on multivariate analysis. Neither history nor NT-pro-BNP measurement provided this important clinical information. Abnormal echocardiographic results alone predicted 24% of events, while abnormal NT-pro-BNP predicted only 5%. A combination of abnormal echocardiographic results and abnormal NT-pro-BNP provided the most powerful prognostic information. Lim et al.7 reported very similar results obtained by experienced cardiologists, who used standard echocardiographic machines in patients with suspected heart failure, referred by general practitioners from the community. Our definition of abnormal echocardiographic results was very similar to theirs and included the presence of either LV dysfunction or LV hypertrophy or severe valvular heart disease.7 Recently Goonewardena et al.8 demonstrated that bedside handcarried echocardiographic evaluation of inferior vena cava size can predict readmission after hospitalization for acute decompensated heart failure. This readily measurable parameter might be included in the simplified imaging protocol, supplementing other easily available data.
In our study, the physician performing handheld echocardiographic studies had not had any previous practical experience in echocardiography and underwent basic training in accordance with the standards of the American Society of Echocardiography, widely accepted as a safe and reliable training method.6,9 An effective training period might probably be even shorter, as shown in the study by Vignon et al.,10 in which residents performed examinations after a 3-hour training course and 5 hours of hands-on training. Similarly, a study by DeCara et al.11 reported acceptable diagnostic accuracy obtained by residents after 20 hours of didactic instructions, followed by 20 examinations performed under a sonographer’s supervision. The availability of hand-carried echocardiography raises a debate concerning its diagnostic accuracy, the identification of potential users, a required competence level, and the possibility of missing clinically important diagnoses.12 The high negative predictive value of normal results on hand-carried examinations for the prediction of adverse clinical outcome observed in our study is reassuring in this respect. Moreover, the accuracy of hand-carried echocardiography performed by general practitioners should be compared not only with the accuracy of standard echocardiographic examinations but also with the accuracy of physical examinations. In our study, the hand-carried echocardiographic examinations had an important additional value as a diagnostic tool for asymptomatic LV dysfunction (11 patients) and previously unrecognized severe valvular pathology (three patients). Only 45% of patients with histories of heart failure and 15% of patients with heart failure risk factors had undergone echocardiographic examinations before our study. The figures were significantly smaller than those provided in the Euro-Heart Failure Survey Programme, in which 66% patients had ever undergone echocardiography.13 On the other hand, they were in accordance with the results of the IMPROVEMENT of Heart Failure Programme, in which only 45% of primary care physicians reported that they would routinely consider echocardiography in a patient with suspected heart failure.14 Our data were also almost identical with the results of the European Survey of Primary Care Physicians’ Perceptions on Heart Failure Diagnosis and Management (Euro-HF), in which most patients were diagnosed on symptoms and signs alone, with only 32% having further investigations or referral.15 Nearly the same results were obtained by the most recent Study Group on HF Awareness and
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Table 4 Univariate and multivariate predictors of clinical outcomes
Clinical characteristic
Age (y) Women Smokers Heart failure Hypertension Ischemic heart disease Prior myocardial infarction Diabetes Peripheral vascular disease Cerebrovascular disease Atrial fibrillation/flutter Abnormal echocardiographic results Abnormal NT-pro-BNP
Multivariate
Events (n = 41)
No events (n = 123)
Univariate P
P
HR (95% CI)
66.9 6 6.8 25 (61%) 13 (32%) 22 (54%) 37 (90%) 19 (46%) 12 (29%) 10 (24%) 5 (12%) 8 (19%) 11 (27%) 35 (85%)
65.6 6 7.7 70 (57%) 43 (35%) 34 (28%) 96 (78%) 48 (39%) 35 (28%) 45 (37%) 11 (9%) 6 (5%) 11 (9%) 55 (45%)
.46 .60 .64 .003 .06 .35 .87 .18 .55 .01 .008 <.0001
.72 .26 — .51 — — — — — .20 .38 .0004
1.01 (0.97–1.05) 1.49 (0.73–3.12) — 1.30 (0.35–1.69) — — — — — 1.88 (0.74–5.00) 1.42 (2.04–3.12) 5.55 (2.04–14.28)
26 (67%)
51 (41%)
.006
.07
1.86 (0.93–4.16)
CI, Confidence interval; HR, hazard ratio.
Figure 2 Kaplan-Meier event-free survival curves for patients stratified according to normal versus abnormal hand-carried echocardiographic results.
Perception in Europe (SHAPE) survey, in which 75% of primary care physicians reported that they often or always diagnosed heart failure by signs and symptoms alone, and only 35% would arrange for further investigations. According to the SHAPE investigators, access to echocardiography was poor in nearly all countries; although approximately 60% of primary care physicians considered echocardiography necessary for diagnosis, only 16% could obtain echocardiograms directly and 34% via specialists within 1 month.15 The results
of Euro-HF, SHAPE, and our study demonstrate a great gap between the guidelines and everyday practice. Hand-carried devices operated by primary care physicians appear to provide reliable diagnostic and prognostic information, partially filling this gap. However, careful and methodical studies looking at the reliability and accuracy of diagnoses made by caregivers with basic training have yet to be done. They are especially important as we are facing a heart failure epidemic.
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Figure 3 Kaplan-Meier event-free survival curves for patients stratified according to normal versus elevated NT-pro-BNP levels.
Figure 4 Kaplan-Meier event-free survival curves for patients stratified according to hand-carried echocardiographic results and NT-pro-BNP in combination: both normal, only abnormal NT-pro-BNP, only abnormal hand-carried echocardiographic results, and both abnormal. *Difference statistically significant for both abnormal echocardiographic results and NT-pro-BNP versus others. Limitations of the Study The presence of prosthetic valves was included in the definition of abnormal echocardiographic results, although this information is
available without echocardiography because the presence of valve prosthesis can be considered equivalent to a significant valve abnormality. The latter was included in the definition used by Lim et al.7
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A relatively small sample size is a clear disadvantage, as it limits the statistical power of the study. It should be noted, however, that the sample size corresponds approximately to the population of patients with heart failure and/or heart failure risk factors covered in the system by one or two general practitioners, which further underscores the practical value of the study. The statistical limitation pertains to the combined end point of the study, including ‘‘soft end points’’ and all-cause rather than cardiovascular mortality. However these soft end points would be of vital importance from both patients’ and primary care physicians’ points of view. It is important to underscore that it is unwarranted to extrapolate the results to general outpatients, because specific training, selection criteria, and imaging protocol were applied, aiming primarily at improving the diagnosis of heart failure and LV dysfunction. This specific protocol may not apply to other populations and diagnoses. Hand-carried examinations were not systematically verified by standard echocardiography, although their reliability has been documented previously. Also, in our own experience there was a good agreement between both methods.2 The quantitative measurement set was made as simple as possible, and all measurements were performed from the parasternal long-axis view. This made more sophisticated analyses impossible, but at the same time, it enabled us to simplify the training protocol and make the measurements more reproducible. Although we were not able to provide data addressing the diagnostic accuracy of the noncardiologist’s findings directly in this study, we have previously observed good agreement (k = 0.75) between nonexpert observers (medical students after 6 hours of reading echocardiograms) and experienced cardiologists when visually assessed LV systolic function was categorized as normal, minimally, moderately, and severely impaired and very good agreement (k = 0.83) between nonexpert and expert observers when mitral regurgitation was categorized in a dichotomous manner as significant or nonsignificant.16
10.
CONCLUSIONS
11.
Our study has demonstrated that following short training, simplified echocardiographic examinations performed with hand-carried devices appear to provide important prognostic and additional diagnostic information when used in a community as a screening tool in patients with heart failure risk factors or overt heart failure. A wide application of ‘‘ultrasound stethoscopes’’ might change the standards of care of patients with heart failure and heart failure risk factors.
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ACKNOWLEDGMENTS 14.
We are especially grateful to Professor Catherine M. Otto for the critical review of this report. We also thank doctor Ewa Pasternak and Stanis1aw Kostrzewa, manager at the Outpatient Clinic in I1_za, for their support during the study. REFERENCES 1. Galasko GI, Lahiri A, Senior R. Portable echocardiography: an innovative tool in screening for cardiac abnormalities in the community. Eur J Echocardiogr 2003;4:119-27. 2. Szyma nski P, Lipczy nska M, Klisiewicz A, Kraszewski K, Konka M, Tyczy nski P, et al., Ultrasound stethoscope in the rapid assessment of left
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