Ambulatory ECG monitoring for syncope and collapse in United States, Europe, and Japan: The patients’ viewpoint

Abstract Background Practice guidelines provide clinicians direction for the selection of ambulatory ECG (AECG) monitors in the evaluation of syncope/collapse. However, whether patients’ understand differences among AECG systems is unknown. Methods and Results A survey was conducted of USA (n = 99), United Kingdom (UK)/Germany (D) (n = 75) and Japan (n = 40) syncope/collapse patients who underwent diagnostic AECG monitoring. Responses were quantitated using a Likert‐like 7‐point scale (mean ± SD) or percent of patients indicating a Top 2 box (T2B) for a particular AECG attribute. Patient ages and diagnosed etiologies of syncope/collapse were similar across geographies. Patients were queried on AECG attributes including the ability to detect arrhythmic/cardiac causes of collapse, instructions received, ease of use, and cost. Patient perception of the diagnostic capabilities and ease of use did not differ significantly among the AECG technologies; however, USA patients had a more favorable overall view of ICM/ILRs (T2B: 42.4%) than did UK/D (T2B: 28%) or Japan (T2B: 17.5%) patients. Similarly, US patient rankings for education received regarding device choice and operation tended to be higher than UK/D or Japan patients; nevertheless, at their best, the Likert scores were low (approximately 4.7‐6.0) suggesting need for education improvement. Finally, both US and UK/D patients were similarly concerned with ICM costs (T2B, 31% vs 20% for Japan). Conclusions Patients across several geographies have a similar but imperfect understanding of AECG technologies. Given more detailed education the patient is likely to be a more effective partner with the clinician in establishing a potential symptom‐arrhythmia correlation.


| INTRODUC TI ON
Establishing the cause of syncope and collapse remains a challenge. 1,2 In this regard, practice guidelines and consensus statements provide practitioners with appropriate diagnostic direction. [3][4][5][6][7] In particular, it is agreed that the first steps should comprise a medical history detailing overall health, past medical history, and current symptoms; thereafter, physical examination and selected laboratory tests based on the clinical history (eg, ECG, echocardiogram) are appropriate. However, if the diagnosis continues to be unclear and an arrhythmic cause remains a concern, practice guidelines provide strategies for appropriate use of shorter-and longer-term ambulatory ECG (AECG) monitoring devices in an attempt to document subsequent symptomatic episodes or potentially causal arrhythmias. [3][4][5][6][7] In brief, while the guidelines cannot specify specific values for sensitivity and specificity of monitoring device types since clinical circumstances vary widely, they do teach that for maximum diagnostic sensitivity, the monitoring duration should be selected based on the expected event frequency; specifically, low event frequencies require longer monitoring technologies. Thus, external wearable AECG monitors (ECM) are recommended for those patients in whom spontaneous symptoms are relatively frequent (eg, daily to monthly); for longer inter-event intervals (eg, >30 days apart), insertable cardiac monitors (ICM) are advocated.
Previous reports indicate that the majority of physicians recommend AECG technology appropriately according to guidelines. 8,9 However, the extent to which patients understand differences among the AECG options selected for their care, and consequently the basis for practitioner recommendations is unclear; greater patient understanding of prescribed technology may be expected to lead to greater acceptance and enhanced compliance with a provider-proposed AECG monitoring strategy. In particular, informed patients may be expected to be more attentive to and more successful with capturing ECG findings during symptomatic events (ie, potential symptom-arrhythmia correlations).
The survey reported here was designed to use 'real world' data, 10

| ME THODS
This report comprises findings obtained from a survey undertaken of patients residing in the USA (n = 100), UK/D (n = 75), and Japan (n = 40) in whom AECG monitoring had been experienced as part of an evaluation into the cause of their syncope/collapse. Patients were selected from those presenting with syncope/collapse to Emergency Departments, Cardiology, or Neurology clinics. Potential candidates were identified with the aid of attending physicians, and patients were subsequently qualified by direct communication by an independent polling agency (see below) as having had syncope/collapse and having experienced ambulatory monitoring. The population size was limited by the complexity of data collection across diverse clinics and geographies. Except for mobile cardiac outpatient telemetry (MCOT) which was not widely applied in Europe at the time, the remaining technologies were widely used. The survey was conducted by an independent polling agency (ZS Associates).
In the absence of prior studies offering an estimated difference in patient responses regarding cardiac monitoring in different geographies, the required size of the patient population to observe statistically significant differences was based on estimates guided by the polling agency experience. We assumed that USA and UK/D might be similar in many respects but that their diversity of the population was greater than that of Japan. Consequently, the patient number of patients surveyed was approximately twice as many in USA and UK/D than in Japan.
Respondents completed a quantitative survey instrument online.
As part of the survey, patients were queried regarding their understanding of the attributes of the various available AECG technologies. Simple descriptive materials were used to refresh the patient recollection of the various AECG modalities and terminology.
Surveyed patients individually provided informed consent for use of their data. Each participant was informed that they would remain anonymous and that all information gathered would be confidential. Investigational approval was obtained from the appropriate ethics committee at each data collection site. Responding patient's each received an honorarium of US$50. Medtronic Inc sponsored the survey and a sponsor co-author representative (RKM) assisted with technical aspects of the survey and reviewed the manuscript.
However, the sponsor was not involved with data collection or the interpretation of the findings provided in this manuscript.
Non-dichotomous responses were graded using a Likert-like

| Statistical analysis
Whether the distribution of discrete variables was normal or not was determined by Kolmogorov-Smirnov test. Levene test was used for the evaluation of homogeneity of variances. The descriptive statistics for discrete and ordinal variables were shown as mean ± SD (min-max). The number of cases and percentages were expressed as categorical data.

| Respondent characteristics
The survey comprised 215 patients from three different geographical regions (USA, n = 100; UK/D, n = 75; and Japan, n = 40) who underwent AECG monitoring for syncope/collapse. Data was incomplete in one USA externally monitored (ECM) patient whose data was excluded, resulting in a total of 99 USA patients. Among subjects who were originally approached for inclusion response rates were similar in USA and UK/D (approx. 14%), and in Japan (approx.12%).
This response rate is consistent with what is expected for comparable Web-based surveys.
Demographic and clinical diagnostic characteristics of the respondents are presented in Table 1. Other than the Japanese population which had a greater male proportion than the other 2 geographies (P < .001 vs USA; P < .05 vs UK/D), the patient population ages (mean ± SD; USA 34.7 ± 12.0 years; UK/Germany, 33.5 ± 11.5 years; Japan, 37.6 ± 13.8 years) and presumed etiologies of syncope were similar across geographies. In some patients, multiple causes of syncope were determined to have more than one cause of syncope (eg, orthostatic hypotension and vasovagal syncope) resulting in diagnostic totals >100% in Table 1. Further, patients in all 3 regions sought initial medical evaluation to ascertain the cause of symptoms after fewer than 2 syncope/collapse events (USA, 1.8 ± 5.2; UK/D, 1.2 ± 2.6; Japan 1.5 ± 0.7: USA vs UK/D, P = NS; UK/D vs Japan P < .046, USA vs Japan, P = NS) indicating the importance that they assigned to their symptoms.

| Respondent understanding of AECG technologies
Based on the type of devices prescribed for and personally experienced by respondents, the various AECG technologies did not differ significantly across the three geographies (

| Respondent assessment of AECG device attributes
Respondents were queried with regard to selected attributes of the various diagnostic AECG technologies (Table 3). Findings reveal that patients did not identify major device attribute differences across technologies although there was a non-significant trend for Holter monitors to rank higher than other devices for most attributes (Table 3). Thus, the ability to detect arrhythmic causes of syncope, convenience, and ease of us, and being discreet ranked comparably (Table 3). On the other hand, within technology categories, there were geographical differences. For instance, USA patients tended to be more confident that Holter monitors were effective for detecting an arrhythmia, and were more convenient to use than did UK/D or Japanese patients. Similarly, despite cost concerns discussed below, both USA and Japan patients gave ICM/ILRs higher scores than did UK/D patients (Table 3)

| Patient education
The survey measured patient satisfaction with the information received from clinicians regarding prescribed AECGs (  (Table 3). Finally, and possibly most importantly, patients across all geographies provided relatively low grades for the education that they received regarding the rationale behind clinician AECG recommendations. The latter low scores were most evident among Japan patients, but even in the USA and UK/D there was room for improvement. Since patient compliance is an important factor for AECG diagnostic success, the latter observation indicates that patients may benefit from more robust discussion by providers of the pros and cons of prescribed AECG technologies and the specific rationale behind the clinicians' recommendations for a given individual's circumstance.

| Factors determining AECG choice
The diagnostic effectiveness of available AECG technologies in the evaluation of syncope/collapse inherently depends on: (a) recording duration relative to the frequency of symptom recurrences as pointed out in both the USA and European practice guidelines, 3

| Cost concerns
In this study, US and UK/D patients did register concern regarding ICM costs to a greater extent than did Japanese patients. While the reasons for cost issues were not addressed, US patient concerns may be due to the potential for more expensive technology to trigger greater out-of-pocket expenses since most patients were too young to qualify for government-supported Medicare.

| Limitations
Interpretation of the observations in this survey is subject to sev- be the costliest to the patient, and did raise cost concerns (Figure 2), this possibility did not seem to exert a negative impact on patient opinions of ICM utility. Fifth, cost burden to patients may have affected which technology was used and some health insurers dictate which AECG technology is acceptable and in which order such technology may be applied. We did not address the latter two issues directly, but it is possible that patient experience may have been impacted by factors unrelated to device utility. Finally, patient responses may have been influenced by the respondents having been offered an honorarium. While the source of the honorarium was concealed, the respondent may have assumed that it was derived from an AECG manufacturer.

| CON CLUS IONS
Findings across several geographies with quite different health insurance systems indicate that patients undergoing evaluation for syncope/collapse often lack understanding of differences among various AECG technologies. Providers are encouraged to offer more detailed patient education, focused on the rationale for AECG device selection. An informed patient is likely to exhibit greater investment in documenting his/her symptoms, and thereby be a more effective partner with the clinician in searching for a potential symptomarrhythmia correlation.

ACK N OWLED G M ENTS
The authors wish to acknowledge the patients who participated in this survey. The survey reported here was funded by Medtronic Inc, Minneapolis, Minnesota. Dr Benditt is supported in part by a grant from the Dr Earl E Bakken Family in support of heart-brain research.
Ms Mears is a Medtronic employee.

F I G U R E 2
Bar graphs comparing across the three geographies patient concerns regarding ICM/ILR (Insertable cardiac monitors/ loop recorders) cost. Likert scores are indicated in the colorcoded boxes under the graph. Based on T2B (Top 2 Box) scores, the cost was a greater concern in the USA and UK/D (United Kingdom/Germany) than in Japan