Effect of Breast Sling on transthoracic echocardiographic examination time and image quality in women with large breasts Kesaree

Punlee*, Wandee Rochanasiri*, Vithaya Chaithiraphan M.D.**, Suteera Phrudprisan***, Akarin Nimmannit M.D.**** * Cardiac sonographers, HMCC, Siriraj hospital ** Cardiologist, HMCC, Siriraj hospital *** Nurse, HMCC, Siriraj hospital **** Office for Research and Development, Siriraj hospital Abstract: An echocardiographic examination has been extensively well-known as it portrays significant inputs for better specified treatment. However, undergoing transthoracic echocardiography (TTE) to many female patients with large breasts often result in suboptimal study and prolonged scan time. Chest wall soreness is commonly occurred due to more pressure from transducer, which simultaneously cause sonographers shoulder and wrist pain. The team, thus, decided to come up with an assistance to increase the efficiency of transthoracic echocardiography leading to patients and sonographers satisfactory. The objective of this research is to evaluate the result of Breast Sling from the examination time and image quality. In order to achieve the goal and obtain feedbacks from patients and sonographers, the team have conducted a randomized cross-over clinical trial experimental study to evaluate benefits from using home-made breast sling in 26 patients with C-cup or larger breasts. The result demonstrated a faster apical view scanning time comparing to normal examination. Although there was not a substantial improvement, the result has already proved its advantage (p= 0.053). The difference of scanning time between patient with and without breast sling tends to be increasing depending on the larger breast size. According to the total examination, patients with breast sling spent less scanning time than those without, having a substantial improvement of 0.04 (p=0.04). E-cup patients gained the most benefit from the breast sling. In this regard, the team found no difference of TTE image quality from apical views between patients with and without breast sling (p= 0.692). Moreover, the evaluation result of patients and sonographers portrayed the increasing satisfactory after using breast sling with a consecutive substantial improvement of 0.011 and 0.035 (p = 0.011 and p = 0.035). The study, also, discovered the fact that lipid thickness under patients chest is related to the increasing breast size. Key Words Breast sling, large breast, transthoracic echocardiography, image quality

Introduction Echocardiography applies the ultrasound wave to get a real time imaging in order to see the structure of a heart, look for abnormalities1, check the blood flow, assess the left ventricular end diastolic pressure2, and diastolic function3. Today, transthoracic echocardiography (TTE) is currently one of the most frequently used and most important non-invasive tests in cardiology by using advanced ultrasound technology to evaluate cardiac structures and functions. TTE images are acquired by applying a 2-3.5 Mhz frequency transducer on patients chest wall which record a 20 cm depth below tissue and are able to distinct 1 mm resolution4. Basic examination postures include parasternal view, apical view, subcostal view, and suprasternal notch view. Patients with obesity, thick chest wall or large breasts may be resulted in technical difficulty or suboptimal images, since the ultrasound can hardly pass through air, lipid, and solid5. This is one of the reasons that echocardiography has been considered operator dependent as it relies on the operators experience. These potential problems often result in more pressure applying on patients chest wall and causes discomfort and pain to patient as well as pain in the neck, shoulder and wrist of the operator. According to the teams experience, an estimate of 10% of patients referred for TTE examination had large breasts, while 64% of them had suboptimal images in apical views, which resulted in longer scan time. And to make best out of the TTE examination and increase operation efficiencies, the team has, therefore, come up with the most effective solution. In the United States, disposable breast sling has been available for patients with large breasts to alleviate mentioned discomforts, especially when having an apical two- and four-chamber view examination6. The survey in Thailand demonstrated that there has never been a usage of Breast Sling in TTE examination, the Disposable Breast Sling suits better for European people, and the price is very high. Consequently, the team has invented a breast sling from local materials for patients with large breasts and conducted a randomized cross-over clinical study to evaluate the benefits of breast sling in terms of less scan time, image quality and satisfaction of patient and cardiac sonographer. Objectives The primary outcome is to study and evaluate effects of the homemade breast sling in female patients with large breasts by assessing the difference in TTE scanning time in apical view. The secondary outcome is the comparison of the result between female patients using breast sling and those not doing so in terms of; 1) Total examination time, 2) Image quality 3) Satisfactory of the patients 4) Satisfactory of sonographers. Materials and Methods Study design

This experimental study was randomized and cross-over within the same group of patient. The method of randomized cross-over trial was performed to compare between using standard method and intervention (breast sling). Study population The main target was female patients coming to have routine transthoracic echocardiography (TTE) examination at Cardiovascular special investigation unit, Her Majesty Cardiac center (HMCC), Siriraj hospital whose breast sizes were C cup or larger. (measure 2 chest circumferences at the level of both nipples and just below the breasts paralleling with the ground level and then, calculate the difference between the two figures. The cup size can be determined by comparing the calculated number to the standard bra size assessment table)7 The subcutaneous tissue thickness below the breast was measured with calipers. The study was carried out from 1 October 2010 to 31 August 2011, in which the exclusion criteria included 1) informed consent refusal, 2) inability to remain in left decubitus position for a required period and 3) allergic to nylon. Allocation of study population After consented, patients were randomized by a computer program to have standard TTE or TTE with breast slings in the morning. Then all patients had the repeated TTE exam with breast sling or standard TTE in the afternoon. The paired Students test was used to determine sample sizes from 23 patients, and come up with
n=

(Z

/2

+ Z ) 2
2

Type I error of respectively < 0.05 2-side (Z=1.96) Type II error of respectively < 0.2 (Z = 0.84) The standard deviation of time difference between 2 methods = 8 minutes. From the opinion of cardiologists and cardiac sonographers, Breast sling could help reduce the echocardiographic examination time for an estimate of 5 minutes. Though the result was not explicit, it was more than enough for patients who have to suffer the pressure and for cardiac sonographers. Also, this helped reduce the examination time in apical view. Therefore, = 5 according to the nQuery Advisor.

The calc culation made up 10 perc for patie who miight not be able to have the 2nd trea cent ents a atment or found so troubles with the calculation. T ome c Thus, All 26 patients in this study w separate into 2 were ed groups, w setting code for ea data ana while asier alyzing. Interven ntion Breast slling used in this study was designed and made by cardiac sonographer and nursing team of w d s echocard diography lab boratory. The material off this sling was only two pairs of su e w o upport stock kings. The stockings were modiified and app as a b s plied breast sling fo each patie (as show in figure 1-15). All or ent wn patients in the study were subject to wear brea sling in th sequence according to randomized process. t ast he

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Two sep parate TTE, w and witho sling, werre performed with the sam standard protocol as indicated with out d me by each patients c h condition. Ea patient had an inte ach erval from 1 to 3 hourrs between two TTE examinat tions. Well trained PN was assigned to wear breast sling on the patient and s the postu before s set ure having th examinatio (The patie lies on he left side, lifting the left hand up.) he on. ent er All TTE images were digitally reco orded and sto in a PC workstation using alias na for blinded image ored w u ame analysis. In order to avoid measurement bias during examination, sono ographers mu not know the scan ust time, so that any dev that disp time (e watch, sy vice plays e.g. ystem clock in echo mach was rem hine) moved or turned o A nurse a off. assigned to re ecord the cas record for (CRF) wou be in a s se rm uld separate cont room trol

and monitored the examination via Enconcert system. A cardiologist, then, reviewed and analyzed all digital images of all patients offline. Both nurse and cardiologist were not informed whether the patient was wearing breast sling or not. Data Analysis Statistical analysis was performed by the SPSS software (version 17). The main result was the comparison of transthoracic echocardiography scan times in apical view while wearing and not wearing breast sling. The team used paired Students t-test and non-parametric test, Wilcoxon signed rank test (Mann-Whitney U test). P value of <0.05 to analyze average scan times of the two techniques. Also, the team did a subgroup analysis of the cup size. The second result was 1) From the scanning time comparison of a patient having 2 transthoracic echocardiography, wearing and not wearing breast sling, the team calculated the average figure of each procedure by using paired Students t test and non-parametric test, Wilcoxon signed rank test (Mann-Whitney U test), p value < 0.05. The result was substantial statistic. 2) For image quality analysis, after each patient had the examination, their images would be evaluated, 0, 1 or 2 points. The team chose to analyze only apical 2- and 4-chamber views. Visualization of endocardial border of each segment of left ventricle was categorized with scoring of 0 for not visualized, 1 for systolic phase only and 2 for both systolic and diastolic phase. Image quality by total score from 2- and 4chamber view in every examination was analyzed with paired Students t-test and calculated 95% confidence interval. 3) The team measured and analyzed patients and sonographers satisfaction by using non-parametric test (Mann-Whitney U test).

Results Patients characteristics and general clinical data are demonstrated in table 1. Examination details and outcomes such as scan times, image quality and satisfaction scores are presented in table 2. Data related to an attempt to reuse breast sling and adverse events are presented in table 3. Table 1: Patient Characteristics Characteristics N = 26 Age (years) Min-Max 35-81 Mean S.D. 59.4 11 Breast size (%) C cup 7 (27.0) D cup 11 (42.3) E cup 8 (30.7) Subcutaneous thickness (mm) Min-Max 30.0-55.0 Mean S.D. 42.0 7.8 Body weight (kg) Min-Max 55.0-129.0 Mean S.D. 72.7 14.9 Height (cm) Min-Max 145.0-165.0 Mean S.D. 154.8 5.9 Body mass index (BMI)(kg/m) Min-Max 23.1-48.0 Mean S.D. 30.4 5.8 Diagnosis (%) Coronary Artery Disease 9 (34.6) Valvular Heart Disease (VHD) 5 (19.2) Myocardial Disease 10 (38.5) Congenital Heart Disease (CHD) 1 (3.9) Chronic Lung Disease (CLD) 7 (27.0) Statistic of patient allergic to nylon and/or stocking materials: (%) 0 (0)

Patients average age in this study was 59 years old. Most patients had D-cup breast size (42.3%). Myocardial disease and coronary artery disease are the most common diagnosis, consecutively 38.5% and 34.6%. No patients developed allergic reaction to breast sling. Table 2 Average scan times, image quality and satisfaction from patients and sonographers No breast sling Breast sling P- value Outcomes (Mean S.D.) (Mean S.D.) Apical view scan time (min) Apical scan time by cup size C (N=7) D ( N=11) E( N=8) 21.5 7.5 17.0 3.9 19.6 6.5 27.9 7.4 46.8 12.3 18.6 7.2 17.14 7.6 17.8 3.5 21.0 10.5 40.9 13.2 22.0 4.2 3.65 0.5 3.65 0.8 0.053 0.132b 0.527 0.342 0.093 0.044 0.692c 0.011 0.206

Total scan time * (min) Image quality score in apical 2- and chamber 4- views (total = 28) 21.6 5.2 Patient satisfaction (total = 5) Improved scan time 3.35 0.5 Less chest soreness 3.5 0.7 Sonographer satisfaction (total = 5) Wrist pain Shoulder, back or neck pain

0.035 3.27 0.7 3.54 0.9 0.052 3.42 0.8 3.69 0.9 * Total scan time excluded breast sling preparation time. a Wilcoxon signed rank test, except other tests were indicated, bKruskal-Wallis test and ct-test. Table 3: Patient agreement for future breast sling use and adverse events (N=26) N (%) Patient agreement for future breast sling use Definitely Not sure Definitely not Adverse events from breast sling use 23 (88.46) 3 (11.54) 0 (0) 0 (0)

The scan time in apical view, the primary outcome, decreased with breast sling use but not statistically significant (p= 0.053). However, the total scan time (not including breast sling application time) was significantly lower with breast sling (p= 0.044). Echocardiographic image quality in apical view did not improve significantly with or without breast sling use (p = 0.692). Patient satisfaction assessment demonstrated preferable results in examination time reduction (p= 0.011), while sonographer reported less wrist discomfort from scanning with breast sling use (p= 0.035). There were no adverse events reported from using breast sling and 88.5% of patients were willing to use breast sling for future TTE examination. Discussion Even though the scan time decrease in apical view from using breast sling, the primary outcome, could not reach statistical significance in breast sling group, there was a trend suggesting that breast sling is helpful especially in patients with E-cup breasts whose average scan time difference was 6.9 minutes in apical view and 5.9 minutes (p=0.044) in total scan time. Therefore, inclusion of patients with C-cup breasts in our study may have diluted the beneficial effect of breast sling. Another factor which could be a significant determinant affecting scan time and image quality is the thickness of subcutaneous tissue below the breast. This thickness was found increased with larger breast size8(p=0.004) For secondary outcome regarding image quality, there was a very small difference in image quality score (0.4, p = 0.692) between two groups, which possibly indicated that breast sling may not improve acoustic window in these group of patients which performed by cardiac sonographer with high experience. It is also possible that using breast sling in TTE performing by less experienced personnel such as cardiology fellows may yield better results. In term of satisfaction, patients reported more comfort significantly from using breast sling, which could be explained by less scan time (as discussed earlier) and less soreness on lateral chest wall from transducer. Sonographers also preferred using breast sling, simply by eliminating the weight of patients breast on their hands and alleviating shoulder and wrist discomfort, which commonly occurs in daily practice. Conclusion: Wearing breast sling certainly made the examination more effective by reducing the examination time, and also in the apical view. Our breast sling could not significantly reduce TTE apical scan time in female patients with breast size of C-cup or larger. It potentially improves scan time especially in patients with E cup breasts. Patients with large breasts and sonographers significantly prefer using breast sling, which provides comfort and help prevent some discomfort and injuries during TTE examination. Since breast sling was made of low cost materials, commonly available in regular stores, its usage could be applied in

developing countries with limited budget. Until now, our study is the first to report benefits of using breast sling. Study limitations: 1. Although this was a randomized study, both patients and sonographers were aware of the patient wearing breast sling. This could affect their opinions regarding the breast sling use, no matter how careful protocol was designed and carried out. Patients were informed that the breast sling helped them get through the examination more comfortable, not reduce time and pain. 2. Another limitation is the effectiveness of the breast sling to pull up the breast itself. Future development of more effective breast sling is required.

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