Ascertaining Death Events in a Pragmatic Clinical Trial: Insights From the TRANSFORM-HF Trial.

BACKGROUND: Death ascertainment can be challenging for pragmatic clinical trials that limit site follow-up activities to usual clinical care. METHODS AND RESULTS: We used blinded aggregate data from the ongoing ToRsemide comparison with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) pragmatic clinical trial in patients with heart failure to evaluate the agreement between centralized call center death event identification and the United States National Death Index (NDI). Of 2284 total patients randomized through April 12, 2021, 1480 were randomized in 2018-2019 and 804 in 2020-2021. The call center identified 416 total death events (177 in 2018-2019 and 239 in 2020-2021). The NDI 2018-2019 final file identified 178 death events, 165 of which were also identified by the call center. The study's inter-rater reliability metric (Cohen's kappa coefficient, 0.920; 95% confidence interval, 0.889-0.951) demonstrates a high level of agreement. The time between a death event and its identification was less for the call center (median, 47 days; interquartile range, 11-103 days) than for the NDI (median, 270 days; interquartile range, 186-391 days). CONCLUSIONS: There is substantial agreement between deaths identified by a centralized call center and the NDI. However, the time between a death event and its identification is significantly less for the call center.

Pragmatic Design of Randomized Clinical Trials for Heart Failure: Rationale and Design of the TRANSFORM-HF Trial.

Randomized clinical trials are the foundation of evidence-based medicine and central to practice guidelines and patient care decisions. Nonetheless, randomized trials in heart failure (HF) populations have become increasingly difficult to conduct and are frequently associated with slow patient enrollment, highly selected populations, extensive data collection, and high costs. The traditional model for HF trials has become particularly difficult to execute in the United States, where challenges to site-based research have frequently led to modest U.S. representation in global trials. In this context, the TRANSFORM-HF (Torsemide Comparison with Furosemide for Management of Heart Failure) trial aims to overcome traditional trial challenges and compare the effects of torsemide versus furosemide among patients with HF in the United States. Loop diuretic agents are regularly used by most patients with HF and practice guidelines recommend optimal use of diuretic agents as key to a successful treatment strategy. Long-time clinical experience has contributed to dominant use of furosemide for loop diuretic therapy, although preclinical and small clinical studies suggest potential advantages of torsemide. However, due to the lack of appropriately powered clinical outcome studies, there is insufficient evidence to conclude that torsemide should be routinely recommended over furosemide. Given this gap in knowledge and the fundamental role of loop diuretic agents in HF care, the TRANSFORM-HF trial was designed as a prospective, randomized, event-driven, pragmatic, comparative-effectiveness study to definitively compare the effect of a treatment strategy of torsemide versus furosemide on long-term mortality, hospitalization, and patient-reported outcomes among patients with HF. (TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure [TRANSFORM-HF]; NCT03296813).

Age, knowledge, preferences, and risk tolerance for invasive cardiac care.

BACKGROUND/OBJECTIVES: The extent to which individual knowledge, preferences, and priorities explain lower use of invasive cardiac care among older vs. younger adults presenting with acute coronary syndrome (ACS) is unknown. We directly surveyed a group of patients to ascertain their preferences and priorities for invasive cardiovascular care. DESIGN: We performed a prospective cohort study of adults hospitalized with ACS. We surveyed participants regarding their knowledge, preferences, goals, and concerns for cardiac care, as well as their risk tolerance for coronary artery bypass grafting (CABG). SETTING: Single academic medical center. PARTICIPANTS: Six hundred twenty-eight participants (373 <75 years old; 255 ≥75 years old). MEASUREMENTS: We compared baseline characteristics, knowledge, priorities, and risk tolerance for care across age strata. We also assessed pairwise differences with 95% confidence intervals (CI) between age groups for key variables of interest. RESULTS: Compared with younger patients, older participants had less knowledge of invasive care; were less willing to consider cardiac catheterization (difference between 75-84 and< 65 years old: -7.8%, 95% CI: -14.4%,-1.3%; for ≥85 vs. <65: -15.7%, 95% CI: -29.8%,-1.6%), percutaneous coronary intervention (difference between 75-84 and< 65 years old: -12.8%, 95% CI: -20.8%,-4.8%; for ≥85 vs. <65: -24.8%, 95% CI: -41.2%,-8.5%), and CABG (difference between 75-84 and< 65 years old: -19.0%, 95% CI: -28.2%,-9.9%; for ≥85 vs. <65: -39.1%, 95% CI: -56.0%,-22.2%); and were more risk averse for CABG surgery (p < .001), albeit with substantial inter-individual variability and individual outliers. Many patients who stated they were not initially willing to undergo an invasive cardiovascular procedure actually ended up undergoing the procedure (49% for cardiac catheterization and 22% for PCI or CABG). CONCLUSION: Age influences treatment goals and willingness to consider invasive cardiac care, as well as risk tolerance for CABG. Individuals' willingness to undergo invasive cardiovascular procedures loosely corresponds with whether that procedure is performed after discussion with the care team.

Death: The Simple Clinical Trial Endpoint.

Death, as a biological phenomenon, is well understood and a commonly employed endpoint for clinical trials. However, death identification and adjudication may be difficult for pragmatic clinical trials (PCT) that rely upon electronic health record and patient reported data. We propose a novel death identification and verification approach that is being used in the ToRsemide compArisoN with furoSemide FOR Management of Heart Failure (TRANSFORM-HF) PCT. We describe our hybrid approach that includes gathering information from clinical trial sites, a centralized call center, and National Death Index searches. Our methods detail how a possible death is triggered from each of these components and the types of information we require to verify a triggered death. Our different trigger/verification elements collectively define the TRANSFORM-HF PCT's definition of a death event.

Acute management of stroke patients taking non-vitamin K antagonist oral anticoagulants Addressing Real-world Anticoagulant Management Issues in Stroke (ARAMIS) Registry: Design and rationale.

BACKGROUND: Non-vitamin K antagonist oral anticoagulants (NOACs, dabigatran, rivaroxaban, apixaban, and edoxaban) have been increasingly used as alternatives to warfarin for stroke prophylaxis in patients with atrial fibrillation. Yet there is substantial lack of information on how patients on NOACs are currently treated when they have an acute ischemic stroke and the best strategies for treating intracerebral hemorrhage for those on chronic anticoagulation with warfarin or a NOAC. These are critical unmet needs for real world clinical decision making in these emergent patients. METHODS: The ARAMIS Registry is a multicenter cohort study of acute stroke patients who were taking chronic anticoagulation therapy prior to admission and are admitted with either an acute ischemic stroke or intracerebral hemorrhage. Built upon the existing infrastructure of American Heart Association/American Stroke Association Get With the Guidelines Stroke, the ARAMIS Registry will enroll a total of approximately 10,000 patients (5000 with acute ischemic stroke who are taking a NOAC and 5000 with anticoagulation-related intracerebral hemorrhage who are on warfarin or a NOAC). The primary goals of the ARAMIS Registry are to provide a comprehensive picture of current treatment patterns and outcomes of acute ischemic stroke patients on NOACs, as well as anticoagulation-related intracerebral hemorrhage in patients on either warfarin or NOACs. Beyond characterizing the index hospitalization, up to 2500 patients (1250 ischemic stroke and 1250 intracerebral hemorrhage) who survive to discharge will be enrolled in an optional follow-up sub-study and interviewed at 3 and 6 months after discharge to assess longitudinal medication use, downstream care, functional status, and patient-reported outcomes. CONCLUSION: The ARAMIS Registry will document the current state of management of NOAC treated patients with acute ischemic stroke as well as contemporary care and outcome of anticoagulation-related intracerebral hemorrhage. These data will be used to better understand optimal strategies to care for these complex but increasingly common emergent real world clinical challenges.

Quality-of-life outcomes with coronary artery bypass graft surgery in ischemic left ventricular dysfunction: a randomized trial.

BACKGROUND: The STICH (Surgical Treatment for Ischemic Heart Failure) trial compared a strategy of routine coronary artery bypass grafting (CABG) with guideline-based medical therapy for patients with ischemic left ventricular dysfunction. OBJECTIVE: To describe treatment-related quality-of-life (QOL) outcomes, a major prespecified secondary end point in the STICH trial. DESIGN: Randomized trial. (ClinicalTrials.gov: NCT00023595). SETTING: 99 clinical sites in 22 countries. PATIENTS: 1212 patients with a left ventricular ejection fraction of 0.35 or less and coronary artery disease. INTERVENTION: Random assignment to medical therapy alone (602 patients) or medical therapy plus CABG (610 patients). MEASUREMENTS: A battery of QOL instruments at baseline (98.9% complete) and 4, 12, 24, and 36 months after randomization (collection rates were 80% to 89% of those eligible). The principal prespecified QOL measure was the Kansas City Cardiomyopathy Questionnaire, which assesses the effect of heart failure on patients' symptoms, physical function, social limitations, and QOL. RESULTS: The Kansas City Cardiomyopathy Questionnaire overall summary score was consistently higher (more favorable) in the CABG group than in the medical therapy group by 4.4 points (95% CI, 1.8 to 7.0 points) at 4 months, 5.8 points (CI, 3.1 to 8.6 points) at 12 months, 4.1 points (CI, 1.2 to 7.1 points) at 24 months, and 3.2 points (CI, 0.2 to 6.3 points) at 36 months. Sensitivity analyses to account for the effect of mortality on follow-up QOL measurement were consistent with the primary findings. LIMITATION: Therapy was not masked. CONCLUSION: In this cohort of symptomatic high-risk patients with ischemic left ventricular dysfunction and multivessel coronary artery disease, CABG plus medical therapy produced clinically important improvements in quality of life compared with medical therapy alone over 36 months. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

Association between patient beliefs and medication adherence following hospitalization for acute coronary syndrome.

BACKGROUND: Patient adherence to medications is crucial for reducing risks following acute coronary syndrome (ACS). We assessed the degree to which medication beliefs were associated with patient adherence to ß-blockers, angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB), and lipid-lowering medications (LL) 3 months following ACS hospitalization. METHODS: We enrolled eligible ACS patients from 41 hospitals to participate in a telephone survey. The Beliefs in Medication Questionnaire-Specific was administered to assess perceived necessity for and concerns about heart medications. Three cohorts were identified for analysis: ß-blockers, ACEI/ARBs, and LL. Patients discharged on or starting the medication class after discharge were included in the cohort. The primary outcome was self-reported nonadherence to the medication class 3 months following hospitalization. Factors associated with nonadherence to each medication class were determined using logistic regression analysis. RESULTS: Overall, 973 patients were surveyed. Of these, 882 were in the ß-blocker cohort, 702 in the ACEI/ARB cohort, and 873 in the LL cohort. Nonadherence rates at 3 months were 23%, 26%, and 23%, respectively. In adjusted analyses, greater perceived necessity for heart medications was significantly associated with lower likelihood of nonadherence in all cohorts (ß-blocker: odds ratio 0.94, 95% CI 0.91-0.98; ACEI/ARB: OR 0.94, 95% CI 0.90-0.98; LL: OR 0.96, 95% CI 0.92-1.00). A greater perceived concern was significantly associated with a higher likelihood of nonadherence in all cohorts (ß-blocker: OR 1.08, 95% CI 1.04-1.13; ACEI/ARB: OR 1.07, 95% CI 1.02-1.11; LL: OR 1.09, 95% CI 1.05-1.14). CONCLUSIONS: Patients' perceived necessity for and concerns about heart medication were independently associated with adherence to 3 medication classes. Assessment of patient beliefs may be useful in clinical practice to identify those at greatest risk for nonadherence and to stimulate development of individualized interventions to change beliefs and improve adherence.

Frequency and predictors of drug-eluting stent use in saphenous vein bypass graft percutaneous coronary interventions: a report from the American College of Cardiology National Cardiovascular Data CathPCI registry.

OBJECTIVES: We examined a large registry to determine the frequency and factors associated with drug-eluting stents (DES) use in saphenous vein graft (SVG) in contemporary practice. BACKGROUND: Prospective trials comparing DES with bare-metal stents in SVG lesions have provided conflicting conclusions regarding safety and efficacy leading to potential variation in stent choice for these lesions. METHODS: We analyzed the frequency and factors associated with DES use in patients undergoing SVG stenting from January 1, 2004, to March 31, 2009, in the National Cardiovascular Data Registry. Generalized estimating equations logistic regression modeling was used to generate independent variables associated with DES use in SVGs. RESULTS: During the study period, percutaneous coronary intervention (PCI) of a SVG represented 5.7% of the total PCI volume (91,355 of 1,596,966). Of the 84,875 patients who received a SVG stent, a DES was used in 64.5%. From 2005 to 2009, DES use in SVG PCI changed from 80% to 62%. Unfractionated heparin was used in 46%, enoxaparin in 17%, bivalirudin in 42%, and a glycoprotein IIb/IIIa inhibitor in 40% of cases. On multivariable analysis, several parameters (including the period, multivessel PCI, prior PCI, no acute myocardial infarction, and no smoking) were associated with DES use. CONCLUSIONS: Currently, DES are used in nearly two-thirds of SVG interventions. Several clinical parameters (such as the period of implantation and the complexity of coronary artery disease) are associated with the decision to implant a DES in these challenging lesions.

Changes in beliefs about medications during long-term care for ischemic heart disease.

BACKGROUND: Beliefs such as self-reported low necessity for medications and high concerns about medications are associated with nonadherence. Changes in these beliefs during long-term care have not previously been studied and were evaluated for purposes of this analysis. METHODS: From January 2006 through September 2007, patients at 41 hospitals who met entry criteria for the CRUSADE Quality Improvement Initiative were consented for participation in a longitudinal follow-up survey study called MAINTAIN. The patients completed The Beliefs about Medicines Questionnaire at 3 and 12 months postdischarge to assess necessity and concerns related to heart medications. Internal reliability and construct validity of the survey were evaluated at both time points. Changes in necessity and concern scores from 3 to 12 months were determined, and factors associated with negative changes were explored. RESULTS: A total of 812 patients completed both surveys. Internal reliability and construct validity were good. From 3 to 12 months, only 9.2% of patients shifted from a high to low necessity score; however, 20.7% of patients shifted from a low to high concern score. Factors found to be statistically significantly and independently associated with increased concern were the perception that the provider did not listen carefully to the patient (odds ratio [OR] 2.63, 95% CI 1.49-4.76), depression at 12 months (OR 2.95, 95% CI 1.57-5.55), hospital discharge with > or =7 medications (OR 1.71, 95% CI 1.07-2.74), and not receiving a medication list/instructions at hospital discharge (OR 1.69, 95% CI 1.05, 2.78). Factors associated with decreased necessity included not having a cardiologist (OR 2.26, 95% CI 1.34-3.83) and nonpersistence at 12 months with lipid-lowering medication (OR 1.85, 95% CI 1.01-3.45). CONCLUSIONS: One third of the patients reported a negative change in their beliefs about heart medications. Although some changes were observed in perceived necessity, negative changes in concerns occurred in 1 of every 5 patients. Interventions that address these concerns may be useful in improving adherence and clinical outcomes.

Quality of life and economic outcomes with surgical ventricular reconstruction in ischemic heart failure: results from the Surgical Treatment for Ischemic Heart Failure trial.

BACKGROUND: Surgical ventricular reconstruction (SVR) is used in conjunction with coronary artery bypass graft surgery (CABG) to improve left ventricular function and clinical outcomes in selected patients with ischemic heart failure. The impact of SVR on quality of life (QOL) and medical costs is unknown. METHODS: We compared CABG plus SVR with CABG alone in 1,000 patients with ischemic heart failure, an anterior wall scar, and a left ventricular ejection fraction or=92% complete. Cost data were collected on 196 (98%) of 200 patients enrolled in the United States. RESULTS: Heart-failure-related QOL outcomes did not differ between the 2 treatment strategies out to 3 years (median Kansas City Cardiomyopathy Questionnaire scores for CABG alone and CABG plus SVR, respectively: baseline 53 versus 54, P = .53; 3 years 85 versus 84, P = .89). There were no treatment-related differences in other QOL measures. In the US patients, total index hospitalization costs averaged over $14,500 higher for CABG plus SVR (P = .004) due primarily to 4.2 extra postoperative, high-intensity care days in the hospital. CONCLUSIONS: Addition of SVR to CABG in patients with ischemic heart failure did not improve QOL but significantly increased health care costs.

Staphylococcus aureus bacteremia among patients with health care-associated fever.

BACKGROUND: Although Staphylococcus aureus bacteremia is a common, serious infection, accurately identifying febrile patients with this diagnosis at the time of initial evaluation is difficult. The purpose of this investigation was to define clinical characteristics present at the time of the initial recognition of fever that were associated with the presence of any bloodstream infection and, in particular, with S. aureus bacteremia. METHODS: All patients > or =18 years of age with a new episode of health care-associated fever (temperature > or =38 degrees C) and at least one blood culture drawn were eligible for enrollment into this prospective multicenter cohort study. Multivariable analyses were conducted and internally validated scoring systems were developed to categorize the risk of bacteremia. RESULTS: Of 1015 patients enrolled, 181 patients (17.8%) had clinically significant bacteremia, including 77 patients (7.6%) with S. aureus bacteremia. Clinical characteristics associated with S. aureus bacteremia were the presence of a hemodialysis graft or shunt (odds ratio [OR] 3.22; 95% confidence interval [CI], 1.85-5.61), chills (OR 2.38; 95% CI, 1.43-3.98), and a history of S. aureus infection (OR 2.68; 95% CI, 1.38-5.20). Peripheral vascular catheters were inversely associated with S. aureus bacteremia (OR 0.42; 95% CI, 0.26-0.69). Clinical characteristics associated with any bloodstream infection were central venous access, chills, history of S. aureus infection, and hemodialysis access. CONCLUSIONS: Among patients with health care-associated fever, the presence of easily recognizable clinical characteristics at the time of obtaining the initial blood cultures can help to identify patients at increased risk for any bloodstream infection, in particular for S. aureus bacteremia.

The Adherence eValuation After Ischemic Stroke Longitudinal (AVAIL) registry: design, rationale, and baseline patient characteristics.

BACKGROUND: Approximately one third of the 780,000 people in the United States who have a stroke each year have recurrent events. Although efficacious secondary prevention measures are available, levels of adherence to these strategies in patients who have had stroke are largely unknown. Understanding medication-taking behavior in this population is an important step to optimizing the appropriate use of proven secondary preventive therapies and reducing the risk of recurrent stroke. METHODS: The Adherence eValuation After Ischemic Stroke Longitudinal (AVAIL) registry is a prospective study of adherence to stroke prevention medications from hospital discharge to 1 year in patients admitted with stroke or transient ischemic attack. The primary outcomes are medication usage as determined by patient interviews after 3 and 12 months. Potential patient-, provider-, and system-level barriers to persistence of medication use are also collected. Secondary outcomes include the rates of recurrent stroke or transient ischemic attack, vascular events, and rehospitalization and functional status as measured by the modified Rankin score. RESULTS: The AVAIL enrolled about 2,900 subjects from 106 hospitals from July 2006 through July 2008. The 12-month follow-up will be completed in August 2009. CONCLUSIONS: The AVAIL registry will document the current state of adherence and persistence to stroke prevention medications among a nationwide sample of patients. These data will be used to design interventions to improve the quality of care post acute hospitalization and reduce the risks of future stroke and cardiovascular events.

Early surgery in patients with infective endocarditis: a propensity score analysis.

BACKGROUND: An accurate assessment of the predictors of long-term mortality in patients with infective endocarditis is not possible using retrospective data because of inherent treatment biases and predictable imbalances in the distribution of prognostic factors. Largely because of these limitations, the role of surgery in long-term survival has not been adequately studied. METHODS: Data were collected prospectively from 426 patients with infective endocarditis. Variables associated with surgery in patients who did not have intracardiac devices who had left-side-associated valvular infections were determined using multivariable analysis. Propensity scores were then assigned to each patient based on the likelihood of undergoing surgery. Using individual propensity scores, 51 patients who received medical and surgical treatment were matched with 51 patients who received medical treatment only. RESULTS: The following factors were statistically associated with surgical therapy: age, transfer from an outside hospital, evidence of infective endocarditis on physical examination, the presence of infection with staphylococci, congestive heart failure, intracardiac abscess, and undergoing hemodialysis without a chronic catheter. After adjusting for surgical selection bias by propensity score matching, regression analysis of the matched cohorts revealed that surgery was associated with decreased mortality (hazard ratio, 0.27; 95% confidence interval, 0.13-0.55). A history of diabetes mellitus (hazard ratio, 4.81; 95% confidence interval, 2.41-9.62), the presence of chronic intravenous catheters at the beginning of the episode (hazard ratio, 2.65; 95% confidence interval, 1.31-5.33), and paravalvular complications (hazard ratio, 2.16; 95% confidence interval, 1.06-4.44) were independently associated with increased mortality. CONCLUSIONS: Differences between clinical characteristics of patients with infective endocarditis who receive medical therapy versus patients who receive surgical and medical therapy are paramount. After controlling for inherent treatment selection bias and imbalances in prognostic factors using propensity score methodology, risk factors associated with increased long-term mortality included diabetes mellitus, the presence of a chronic catheter at the onset of infection, and paravalvular complications. In contrast, surgical therapy was associated with a significant long-term survival benefit.

Identifying frailty in hospitalized older adults with significant coronary artery disease.

OBJECTIVES: To characterize physiological variation in hospitalized older adults with severe coronary artery disease (CAD) and evaluate the prevalence of frailty in this sample, to determine whether single-item performance measures are good indicators of multidimensional frailty, and to estimate the association between frailty and 6-month mortality. DESIGN: Observational cohort study. SETTING: Inpatient hospital cardiology ward. PARTICIPANTS: Three hundred nine consecutive inpatients aged 70 and older admitted to a cardiology service (n = 309; 70% male, 84% white) with minimum two-vessel CAD determined using cardiac catheterization. MEASUREMENTS: Two standard frailty phenotypes (Composite A and Composite B), usual gait speed, grip strength, chair stands, cardiology clinical variables, and 6-month mortality. RESULTS: Prevalence of frailty was 27% for Composite A versus 63% for Composite B. Utility of single-item measures for identifying frailty was greatest for gait speed (receiver operating characteristic curve c statistic = 0.89 for Composite A, 0.70 for Composite B) followed by chair-stands (c = 0.83, 0.66) and grip strength (c = 0.78, 0.57). After adjustment, composite scores and single-item measures were individually associated with higher mortality at 6 months. Slow gait speed (< or =0.65 m/s) and poor grip strength (< or =25 kg) were stronger predictors of 6-month mortality than either composite score (gait speed odds ratio (OR)=3.8, 95% confidence interval (CI) = 1.1-13.1; grip strength OR = 2.7, 95% CI = 0.7-10.0; Composite A OR = 1.9, 95% CI = 0.60-6.1; chair-stand OR = 1.5, 95% CI = 0.5-5.1; Composite B OR = 1.3, 95% CI = 0.3-5.2). CONCLUSION: Gait speed frailty was the strongest predictor of mortality in a population with CAD and may add to traditional risk assessments when predicting outcomes in this population.

Feasibility of point-of-care echocardiography by internal medicine house staff.

OBJECTIVE: To determine whether internal medicine house staff with limited training in echocardiography can use point-of-care echocardiography to make simple, clinically important diagnoses. BACKGROUND: Availability of small, portable ultrasound devices could make point-of-care echocardiography widely available. The training required to perform point-of-care echocardiography has not been established. METHODS: Medical house staff participated in a 3-hour point-of-care echocardiography training program. Patients scheduled for standard echocardiography as part of clinical care underwent point-of-care echocardiography within 24 hours to assess four common clinically important diagnoses. Each standard echocardiogram was interpreted twice. Agreement (kappa) was calculated between point-of-care and standard echocardiography by using standard echocardiography as the gold standard and between the two interpretations of standard echocardiography. RESULTS: Agreement (kappa) between point-of-care echocardiography and standard echocardiography was 75% (0.51) for left ventricular dysfunction (ejection fraction <55%), 79% (0.31) for moderate or severe mitral regurgitation, 92% (0.32) for aortic valve thickening or immobility, and 98% (0.51) for moderate or large pericardial effusion. Agreement between the two interpretations of standard echocardiography was 83% (0.63) for left ventricular dysfunction, 92% (0.68) for moderate or severe mitral regurgitation, 95% (0.62) for aortic valve thickening or immobility, and 97% (0.53) for moderate or large pericardial effusion. CONCLUSIONS: Medical house staff with limited training in echocardiography can use point-of-care echocardiography to assess left ventricular function and pericardial effusion with moderate accuracy that is lower than that of standard echocardiography. Assessment of valvular disease and other diagnoses likely requires more training and/or experience in echocardiography.