Validation of a hand-held Ultrasound device in the evaluation of Aortic Stenosis

doi:10.21203/rs.3.rs-5153609/v1

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Research Article

Validation of a hand-held Ultrasound device in the evaluation of Aortic Stenosis

https://doi.org/10.21203/rs.3.rs-5153609/v1

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Purpose

Hand-held ultrasound devices (HHUD) are increasingly used in routine clinical practice, though they lacked continuous (CW) Doppler capability until recently. There is limited evidence on the utility of HHUD in assessing aortic stenosis (AS) in real-world settings. Our goal is to validate a new HHUD with CW Doppler assessing AS hemodynamic severity.

Methods

An observational, single-center study was conducted with patients diagnosed with AS. Following a reference echocardiographic study in the cardiac imaging laboratory, a HHUD with CW Doppler (Kosmos, EchoNous™) was used by an operator with intermediate echocardiography experience (American Society of Echocardiography, level II). The focus was on measuring aortic transvalvular Doppler velocities. Agreement between the mean trans-aortic gradient (mAG) was assessed using the intraclass correlation coefficient (ICC) test. A total of 101 patients were included.

Results

The reference test obtained a mAG of 29 mmHg (19.8–42.2), while the HHUD test showed 27.2 mmHg (16.2–43.9). A strong correlation was observed (r = 0.89), with an ICC value of 0.87 and no significant bias (1.61 ± 0.9). The HHUD demonstrated excellent ability to identify severe AS (kappa = 0.81, 95% CI 0.68–0.94; global agreement 92.1%). Agreement was lower in patients with obesity, poor acoustic windows, or atrial fibrillation.

Conclusions

The HHUD showed good agreement with standard echocardiography in assessing AS. While it slightly underestimated mAG, it was accurate enough to reliably quantify AS severity.

Echocardiography

point of care ultrasound

hand-held ultrasound

aortic stenosis

Aortic stenosis (AS) is the most common valve disease requiring either surgical or percutaneous intervention in Europe and North America (1). The progressively increasing age of the population also explains the growing prevalence of this condition (2). Simultaneously, safe and less invasive procedures, such as transcatheter aortic valve replacement (TAVR), are now available and provide effective treatment (3). According to the most recent clinical practice guidelines, the evaluation of the hemodynamic severity of AS should be performed by echocardiography (4–6). Among the recommended parameters to assess are the mean aortic gradient, aortic valve area, peak aortic velocity, dimensionless index, and ventricular ejection fraction, which should guide the decision to intervene, along with consideration of the patient's symptoms and comorbidities.

Recent technological advances have resulted in the development of handheld ultrasound devices (HHUD) with high-quality imaging. One of the main advantages of these devices is that they provide rapid and effective bedside assessments. Additionally, this technology is continuously improving and is currently relatively inexpensive. These features have made the HHUD a valuable tool for use both in the inpatient and outpatient hospital settings. As a result, research interest in this field has increased (7, 8).

Thus, some studies have attempted to assess AS using two-dimensional imaging and a semi-quantitative approach. These studies rely on indirect parameters such as the presence of valve calcium and the mobility of the aortic leaflets. Since these parameters essentially subjective, they are considered only as an option for initial screening (9–11).

However, a complete assessment of AS requires a quantitative approach, specifically the measurement of aortic transvalvular velocity. For this, continuous wave (CW) Doppler is necessary. Until recently, this technology was not available in portable echocardiography devices but the Kosmos® (EchoNous) device, a HHUD with CW Doppler capability, now allows for the quantitative evaluation of AS by measuring aortic transvalvular velocities for the first time.

Recently, Sachpekidis and colleagues studied the Kosmos device for the evaluation of AS in a controlled setting, reporting favorable results (8). In their study, an experienced operator conducted the HHUD examination, but he was not blinded to the previous findings obtained with a conventional device. Therefore, while this study serves as a validation of the device for quantificatifyng transaortic velocities with a CW Doppler-equipped HHUD, it differs from how this technique is typically used in daily clinical practice. In real-life settings, HHUD bedside studies are often performed by clinicians who are not necessarily experts in echocardiography, most of whom have only an intermediate level of experience in echocardiography (as defined by the American Society of Echocardiography (ASE) level II) (12).

The objective of our study is to validate the ability of the Kosmos HHUD to quantify AS in a real-life setting, daily practice setting. To this end, we designed a study comparing the results of an HHUD examination performed by an operator with intermediate experienced (ASE level II), who was blinded to the reference standard echocardiographic assessment conducted by experienced operators (ASE level III) at the Echocardiography Laboratory using high-end equipment.

2.1 Study design

We conducted a prospective, observational, single-center study that included patients diagnosed with AS who had undergone a previous echocardiogram. The study was designed following the 2015 Standards for Reporting Diagnostic Accuracy (STARD) statement (13). Approval for the study was obtained from the Cantabria Institutional Review Board (approval number MTVAL1907).

2.2 Participants

Patients were randomly recruited from the cardiac imaging laboratory at a tertiary referral center in the northern Spain between October 2022 and August 2023. They had been previously diagnosed with AS (any severity grade) via echocardiography, based on the definition of the 2021 European Society of Cardiology (ESC) guidelines (4). All patients were over 18 years of age and provided informed consent prior to participation.

2.3 Methods

Immediately after undergoing a standard echocardiography study, a focused echocardiographic assessment of transaortic velocities using the Kosmos HHUD was performed. These assessments were conducted by two independent cardiologists, blinded to each other´s findings. Additionally, the cardiologist performing the HHUD study was blinded to the patient´s clinical history and previous echocardiograms. The cardiologist conducting the reference echocardiogram had expert-level (level III) training in echocardiography as per the 2019 ASE Advanced Training Statement on Echocardiography (12). To simulate a real-world clinical setting, the cardiologist performing the HHUD had intermediate-level training (ASE level II). Both echocardiographic studies were performed consecutively to ensure no significant clinical or hemodynamic changes occurred between them. Blood pressure and heart rate (HR) were measured before each test.

The reference echocardiography system used was the Philips EPIQ CVx™ (Philips Healthcare, Amsterdam, The Netherlands), while the HHUD device was the Kosmos (EchoNous™) with CW Doppler capability (Fig. 1).

2.4 Clinical definitions

AS was defined according to the 2021 ESC guidelines and the 2021 practical guidelines from the British Society of Echocardiography (4, 5, 14). Severe aortic stenosis (SAS) was defined as a mean aortic gradient (mAG) of ≥ 40 mmHg. Moderate aortic stenosis (MAS) was defined as a mAG between 20 mmHg and 39 mmHg. Mild aortic stenosis (MiAS) was defined as a mAG of < 20 mmHg. Low-flow, low gradient AS was defined as mAG < 40mmHg, aortic valve area (AVA) ≤ 1.0 cm² and stroke volume index < 35ml/m². Left ventricle ejection fraction (LVEF) was estimated using the Simpson biplane method, with impaired LVED defined as ≤ 40%.

Body surface area (SA) was calculated using the DuBois formula. A suboptimal acoustic window was defined by the reference echocardiographer. Obesity was classified as a body mass index (BMI) ≥ 30 kg/m². Information on previous lung disease, neurological disease, and atrial fibrillation (AF) was extracted from the patients' electronic medical records.

We chose mAG as the main variable in our study due to its importance in determining AS severity. We also measured maximum aortic velocity (Vmax), aortic velocity-time integral (VTI), left ventricle outflow tract (LVOT) diameter and LVOT VTI, and estimated the VTI ratio and aortic valve area (AVA). All measurements and estimates were conducted according to international guidelines (4, 14). The primary outcome variable was the value of the intraclass correlation (ICC) between the mAG values obtained from the two echocardiographic studies. We also analyzed the ICC for the other quantitative variables.

2.5 Statistical analysis

Quantitative variables were expressed as median and interquartile range (IQR) (25th – 75th percentiles), while qualitative variables were expressed as frequencies (n, %). Differences between quantitative variables were assessed using the Mann-Whitney U test, and differences between qualitative variables were evaluated with the χ² test for. A p-value of less than 0.05 was considered statistically significant.

We performed an ICC test between the quantitative variables. We performed a kappa test between the qualitative variables. We performed a Bland-Altman and a Passing Bablok analysis to graphically describe the outcomes of our data.

Statistical analyses were carried out using STATA 16 software (StataCorp. 2019. Stata Statistical Software: Release 16. College Station, TX: StataCorp LLC).

2.6 Sample size calculation

We estimated the sample size with the formula provided by Bonett and Walter (15, 16). We selected the most conservative sample size estimate, resulting in a calculated sample size of 101 patients.

3.1 Participants

The enrolment period commenced in October 2022 and concluded in August 2023. In accordance with the estimated sample size calculation, 101 patients were recruited from a pool of 105 eligible patients. Four patients were excluded (One patient received an alternative diagnosis, 3 patients refused to participate) (Supplementary Fig. 1).

The study patients were 78.7-year-old and 35.6% were female. The median BMI was 26.3 kg/m², and the median SA was 1.8m². A total of 22 patients (21.8%) were classified as obese. In 25 patients (23.8%) the acoustic window was considered as suboptimal. Twenty-four patients (23.8%) were in AF, 6 (5.9%) had a neurological disorder, 7 (6.9%) a respiratory disorder and 4 (4%) a chest malformation. Median “mean arterial tension” was 92 mmHg (interquartile range: 84.7–100 mmHg) and HR was 70 bpm (interquartile range: 62–75 bpm) when HHUD test was performed. There were no statistically significant differences in mean arterial tension (p = 0.871) and HR (p = 0.794) between the reference test and the HHUD test. The median left ventricle ejection fraction (LVEF) was 60% and 19 (18.8%) had impaired LVEF. These baseline characteristics are shown in Table 1.

Table 1

Main baseline clinical characteristics.
Variables	N = 101
Age (years)	78.7 (73–84)
Female	36 (35.6%)
Height (cm)	165 (156–171)
Weight (kg)	73 (64–82)
Body surface area by DuBois (m²)	1.8 (1.7–1.9)
Body mass index (kg/m²)	26.3 (24.1–29.3)
Obesity (BMI ≥ 30)	22 (21.8%)
Systolic blood pressure (mmHg)	130 (117–150)
Diastolic blood pressure (mmHg)	71 (65–80)
Mean blood pressure (mmHg)	92 (84.7–100)
Heart rate (beats per minute)	70 (62–75)
Previous lung pathology	7 (6.9%)
Previous neurological pathology	6 (5.9%)
Thoracic malformations	4 (4%)
Suboptimal echocardiographic window	25 (24.8%)
Atrial Fibrillation	24 (23.8%)
LVEF (%)	60 (50–65)
LVEF ≤ 40%	19 (18.81%)
Values are shown as “median (Interquartile range)” or “n (%)”. Abbreviations: BMI: Body mass index; LVEF: Left ventricular ejection fraction.

The HHUD test, focused on the evaluation of aortic valve parameters, took a median time of 9 minutes (interquartile range: 7–11 minutes) to be performed.

3.2 Test results

The reference test yielded a median mAG of 29 mmHg (interquartile range: 19.8–42.2 mmHg), whereas the HHUD test resulted in a median mAG of 27.2 mmHg (interquartile range: 16.2–43.9 mmHg). A strong agreement was observed between the HHUD and reference mAG measurements, as indicated by an ICC of 0.87 (95% CI 0.79–0.94). Linear regression analysis revealed a good correlation between the two methods (r = 0.89; 95% CI 0.85–0.94) (see Table 2).

Table 2

Results of the measurements by the two echocardiographs and the agreement tests.
Variables	Reference	Hand-Held device	Test
Aortic valve			ICC	Spearman	Kappa
Mean Aortic Gradient (mmHg)	29 (19.8–42.2)	27.2 (16.2–43.9)	0.87	0.89
Maximum Aortic Velocity (m/s)	343.5 (282.4–402.6)	309.4 (242.6–375.3)	0.71	0.79
Left ventricular outflow tract diameter (mm)	21.6 (19.9–22.9)	21.0 (18.9–22.4)	0.59	0.59
Aortic VTI (cm)	75.2 (59.3–99.2)	72.1 (54.9–88.8)	0.81	0.86
LVOT VTI (cm)	21 (17.1–24.6)	19.3 (16.4–22.9)	0.28	0.76
Left ventricular outflow tract area (cm²)	3.7 (3.1–4.2)	3.5 (2.8–3.9)	0.58	0.59
Aortic valve area (cm²)	0.9 (0.7–1.2)	0.9 (0.7–1.2)	0.46	0.63
Indexed aortic valve area (cm²/m²)	0.5 (0.4–0.7)	0.5 (0.4–0.7)	0.43	0.59
VTI ratio	0.28 (0.19–0.47)	0.25 (0.21–0.36)	0.43	0.76
Aortic valve opening reduction					0.44
Mild	21 (20.1%)	25 (24.8%)
Moderate	35 (34.6%)	34 (33.7%)
Severe	45 (44.6%)	42 (41.6%)
Aortic Valve Calcification					0.39
Mild	15 (14.9%)	22 (21.8%)
Moderate	36 (35.6%)	26 (25.7%)
Severe	50 (49.5%)	53 (52.5%)
Bicuspid Aortic Valve	5 (4.9%)	3 (3%)			-0.04
Values are shown as “median (Interquartile range)” or “n (%)”. Abbreviations: ICC: Intraclass correlation coefficient; LVOT: Left ventricle outflow tract; VTI: Velocity-time integral.

Table 3

Classification of aortic stenosis severity by the two echocardiographs and agreement tests.
Grade of Aortic Stenosis	Reference	Hand-Held device	Kappa test	Agreement
Mild	29 (28.7%)	35 (34.6%)	0.73	88.1%
Moderate	41 (40.6%)	37 (36.6%)	0.58	80.2%
Severe	31 (30.7%)	29 (28.7%)	0.81	92.1%
Global			0.7	80.2%
LF/LG	22 (21.9%)	30 (29.7%)	0.23	70.3%
LF/LG: Low flow / low gradient.

The Bland & Altman analysis demonstrated that 4 cases (3.9%) exceeded the predefined limit, while 3 cases (2.9%) fell below the limit of agreement (LOA) (± 17.8 mmHg) (Fig. 2). The Passing-Bablok analysis revealed no deviation from linearity, with a constant difference of -3.21 mmHg (95% CI: 0.57–5.46) but no evidence of proportional difference (95% CI: 0.83–1.02) (Fig. 3). According to the severity classification of the AS, the reference test diagnosed 31 (30.7%) as SAS, 41 (40.6%) as MAS and 29 (28.7%) as MiAS. Conversely, the HHUD test diagnosed 29 (28.7%) as SAS, 37 (36.6%) as MAS and 35 (34.6%) as MiAS. Kappa analysis showed good agreement with a value of 0.7. Total agreement within each grade exceeded 80.2% (Table 4). Notably, the HHUD exhibited excellent agreement for classifying AS, particularly in the SAS grade, with a kappa value of 0.81 (95% CI 0.68–0.94) and a global agreement of 92.1%. The positive predictive value was 89.6%, while the negative predictive value was 93.1%. Sensitivity and specificity were reported at 83.8% and 95.7%, respectively.

Table 4

Subgroup analyses of the mean aortic gradient according to different variables.
	Reference	Hand-Held device	Correlation	ICC test
Obesity
Present	20.6 (16.4–28.7)	20.2 (11.5–27.9)	0.63	0.59
Absent	32 (20.7–46.8)	30.7 (16.7–46.9)	0.89	0.88
Suboptimal window
Present	28.7 (22.2–41)	27.4 (16.2–39.9)	0.79	0.77
Absent	30.1 (17.2–42.4)	26.7 (16.4–45.2)	0.89	0.89
AF
Present	31.9 (23.9–41.7)	28.85 (19.2–42.2)	0.75	0.73
Absent	28.9 (15.5–42.2)	26.3 (15.9–46.4)	0.9	0.89
Degree of aortic stenosis
Severe	48.5 (44–59.3)	49.9 (42.8–62.3)	0.73	0.81
Moderate	29 (23.7–33.1)	26.3 (21.8–30.7)	0.52	0.43
Mild	14.2 (12.1–16.4)	11.5 (8.8–16.2)	0.35	0.31
LF/LG	26.6 (23.6–29.6)	25.6 (20.4–30.9)	0.69	0.63
Abbreviations: AF: Atrial fibrillation; ICC: Intraclass correlation coefficient; LF/LG: Low flow / low gradient.
DATA AVAILABILITY STATEMENT
The data underlying this article will be shared on reasonable request to the corresponding author.

However, other measurements of the aortic valve demonstrated poorer agreement. The Vmax and VTI showed good agreement (ICC = 0.71 (95% CI: 0.6–0.81); r = 0.79 & (ICC = 0.81 (95% CI: 0.71–0.91); r = 0.86, respectively). In contrast, LVOT diameter and LVOT VTI had poorer agreement (ICC = 0.59 (95% CI: 0.5–0.7); r = 0.59 & (ICC = 0.28 (95% CI: 0.21–0.36); r = 0.76, respectively). Hence, the calculations derived from these measurements showed lower agreement than expected from mAG values. The result for AVA was an ICC of 0.47 (95% CI: 0.31–0.6) and for VTI ratio an ICC of 0.43 (0.27–0.59). (Table 2). To minimize the error derived from LVOT measurement, we also calculated a modified AVA of the HHUD device using the LVOT diameter measured by the reference test which increased the value of ICC from 0.47 to 0.51. Considering the lower agreement value of AVA, we compared the patients classified as low flow / low gradient AS. The reference device classified 22 patients (21.9%) as LFLG and the HHUD device 30 (29.7%) patients. The kappa value was 0.23 with a global agreement of 70.3%. However, mAG measurement in this group of patients showed good agreement (ICC: 0.63).

3.3 Subgroup analyses

Subgroup analysis revealed a stronger correlation of the mAG value when obesity was absent (ICC: 0.88) compared to when it was present (ICC: 0.59). Similarly, absence of a suboptimal acoustic window (ICC: 0.89) and absence of AF (ICC: 0.89) were associated with higher correlation coefficients compared to their presence (ICC: 0.77 for suboptimal acoustic window; ICC: 0.73 for AF) (Table 4).

To our knowledge, this study is the first to attempt to validate a new HHUD for the assessment of AS in a real-life scenario, encompassing a diverse range of patients with varying degrees of AS severity. The results of our study demonstrated a good correlation between the mAG values measured using this new HHUD, equipped with CW Doppler capability, and those obtained from a standard reference echocardiogram. Although there was a slight tendency for the HHUD to measure lower values, these differences were not clinically significant.

Recently, Sachpekidis et al. published a study comparing this new HHUD to the reference echocardiography for evaluating AS in a controlled environment, with similarly positive results (8). They reported excellent agreement between the HHUD and the reference test for the measurement of the Vmax. However, both assessments in their study were performed by an expert echocardiographer who was not blinded to the results.

In contrast, our study was specifically designed to replicate a typical daily clinical scenario. Our cohort consisted of elderly patients (78.7 years-old) with a high prevalence of obesity (26.3%), AF (23.8%), and 25% had a suboptimal acoustic window. We believe that the characteristics of our sample closely reflect the real-world population of AS patients commonly encountered in clinical practice. Additionally, in most clinical settings, HHUD assessments are performed by operators with varying levels of experience, typically ASE Level I or II. Therefore, we intentinoally designed our study to be conducted by a single operator with intermediate experience (ASE Level II), which we consider representative of most bedside HHUD evaluations. The HHUD results were then compared with gold standard studies performed by experienced echocardiographers (ASE Level III) using high-end ultrasound machines.

Overall, our study demonstrated a lower level of agreement across various parameters when compared to the findings of Sachkepidis et al. This discrepancy can be attributed to several factors, particularly the fact that an experienced operator conducted both the standard and HHUD studies in their research, without being blinded to the results of the other technique. Nevertheless, the level of agreement observed in our study was sufficient for a reliable quantitative estimation of AS severity.

Importantly, we found that the HHUD had an excellent accuracy in identifying patients with SAS by evaluating mAG, with a kappa of 0.81 and predictive values exceeding 90%. This is a notable finding, as it highlights the potential utility of the device, considering that handheld ultrasound devices are not intended to replace conventional evaluations in the cardiac imaging laboratory by expert echocardiographers using high-quality equipment. Instead, their role in daily clinical practice is to provide a rapid, initial assessment at the patient's bedside, as recommended by the European Association of Cardiovascular Imaging for focused cardiac ultrasound (17). While the assessment of AS is not currently included among the applications for focused ultrasound in acute settings, our findings could support the use of HHUDs with CW Doppler capability in this context in future guidelines. When the recommendations for focused cardiac ultrasound were developed, most HHUDs lacked high-quality color Doppler, and few had pulsed-wave (PW) Doppler. Thus, the absence of valvular disease quantification in those recommendations is understandable, primarily due to the technical limitations of the HHUDs available at that time. However, with the advent of new HHUDs featuring enhanced Doppler capabilities, a more comprehensive echocardiographic evaluation could be performed, especially after an initial assessment in emergency situations raises suspicion of AS.

The results of our study, conducted in a setting resembling real clinical practice, suggest that performing an initial assessment with the HHUD is a feasible option. Potential scenarios where the portability of this device may be beneficial include the first evaluation of patients with suspected AS in an emergency setting, during on-call shifts, or for follow-up of AS patients in outpatient clinics. Besides, although a formal cost-effectiveness analysis has not been performed, the relatively lower cost of these devices could have a significant impact in rural or resource-limited settings.

4.1 Study limitations

This is a single-center study with a somewhat limited sample-size. The HHUD examination was conducted by a single operator with moderate experience (Level II) while the reference test was performed by multiple experienced echocardiographers (Level III). This could be seen both as a limitation and a strength. While it makes the results more generalizable, it may have contributed to lower agreement levels. Additionally, the reduced agreement in LVOT and LVOT VTI measurements could lead to an overestimation in certain subgroups of severe AS patients, particularly those with discordant mAG and AVA (e.g., low-flow, low-gradient AS). Another limitation is that the operators were aware that the patients had some degree of AS, meaning the study was not fully blinded. Finally, we did not conduct a comprehensive analysis of interobserver and intraobserver variability between operators.

4.2 Future directions

While we observed promising levels of agreement, these findings should be confirmed in a larger, multicenter, international study. Additionally, a full assessment of all recommended AS parameters is necessary to fully validate this device. Validation studies in specific settings (e.g., rural or low-resource environments) would also help evaluate the device’s portability and cost-effectiveness, particularly in scenarios where practitioners with minimal echocardiography training might benefit from using this technology.

4.3 Conclusion

Based on the results of this study, this HHUD device with continuous Doppler capability appears to be a suitable option for bedside assessment of AS by a moderately experienced operator in a real-life clinical scenario. While the HHUD tended to slightly underestimate mAG values, it was still sufficiently accurate to correctly assess AS severity in the majority of patients.

Central figure.

Graphical abstract summarizing the design and results of the study. Upper figure showing a caption of continuous wave doppler corresponds to the hand-held device. Lower figure corresponds to the reference echocardiography device. Upper right figure corresponds to scatter graph showing the correlation between the mean aortic gradient and lower right figure corresponds to Bland-Altman agreement graph.

Supplementary Fig. 1.

Flow-chart of patient selection.

5. FUNDING

This work was financially supported by a grant from Instituto de Investigación Sanitaria, IDIVAL. EchoNous™ did not contribute with any founding to this study.

Author Contribution

J.Z., A.M., R.P.B., M.L., L.R., G.M., and J.A. VdP. conceived the study's concept and protocol. J.Z. and J.A. VdP. drafted the main manuscript. All authors reviewed and approved the final manuscript.

Data Availability

The data underlying this article will be shared on reasonable request to the corresponding author.

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No competing interests reported.

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Validation of a hand-held Ultrasound device in the evaluation of Aortic Stenosis

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Abstract

Purpose

Methods

Results

Conclusions

Figures

1. INTRODUCTION

2. METHODS

2.1 Study design

2.2 Participants

2.3 Methods

2.4 Clinical definitions

2.5 Statistical analysis

2.6 Sample size calculation

3. RESULTS

3.1 Participants

3.2 Test results

3.3 Subgroup analyses

4. Discussion

4.1 Study limitations

4.2 Future directions

4.3 Conclusion

Declarations

Central figure.

5. FUNDING

Author Contribution

Data Availability

References

Additional Declarations

Supplementary Files

Status:

Version 1