European Heart Journal Advance Access originally published online on November 4, 2005
European Heart Journal 2006 27(1):7-9; doi:10.1093/eurheartj/ehi626
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Syncope Management Guidelines at work: first steps towards assessing clinical utility
Cardiac Arrhythmia Center, University of Minnesota Medical School, MMC 508, 420 Delaware St SE, Minneapolis, MN, USA
* Corresponding author. Tel: +1 612 625 4401; fax: +1 612 624 4937. E-mail address: bendi001{at}umn.edu
This editorial refers to ‘Hospital admission of patients referred to the Emergency Department for syncope: a single-hospital prospective study based on the application of the European Society of Cardiology Guidelines on syncope’
by A. Bartoletti et al., on page 83 and ‘A new management of syncope. Prospective systematic guideline-based evaluation of patients referred urgently to general hospitals’
by M. Brignole et al., on page 76
Management of patients who present after an apparent transient loss of consciousness (TLOC) and who are suspected of having had true syncope remains a clinical challenge; one that is often first confronted by emergency department (ED) and hospital-based physicians. As a first step in assessment of these patients, it is essential that other conditions associated with real (e.g. seizures and concussion) or apparent (e.g. narcolepsy and certain psychogenic disturbances) TLOC, but that are not syncope, be excluded. Syncope refers specifically to TLOC caused by self-limited inadequacy of cerebral perfusion.1,2 Thereafter, attention must be directed towards establishing the most probable cause for syncope; only then can an appropriate treatment strategy be developed.1,3
In terms of TLOC in general, and ‘true syncope’ in particular, conventional diagnostic strategies have long been fraught with confusing terminology,2 incomplete history taking, and inappropriate reliance on excessive laboratory tests; the outcome has been costly with poor diagnostic yields.1,4,5 Clinical guidelines were clearly needed.
The European Society of Cardiology (ESC) Syncope Task Force published the first set of guidelines on the management (diagnosis and treatment) of syncope in 2001, with the most recent update being issued in 2004.1 In addition, the task force published a succinct handbook designed to facilitate clinical application of the recommendations; the first edition was released in 2002 and a revised version is due in early 2006.6
Despite the fact that the recommendations contained in the ESC Syncope Task Force documents are the most comprehensive and thoroughly researched statements addressing the optimal approach to the syncope patient currently available, an important problem remains. Will they improve care?
This editorial refers to two articles that begin to address the ‘Will they help?’ concern. Bartoletti et al.7 evaluated whether ED physicians within a single institution adhered to the ESC Syncope Task Force recommendations concerning need for hospital admission (Table 1). Specifically, they investigated whether patients coming to the ED for evaluation of syncope either were appropriately triaged to in-hospital assessment or, conversely, were found to be appropriate for later outpatient evaluation of their symptoms. The second article, by Brignole et al.,8 details an ambitious undertaking in which an attempt was made to enforce adherence to the ESC Syncope Guidelines in 11 Italian hospitals, beginning with ED assessment and following patients through to hospital discharge. Together, these two studies provide valuable first-step evidence that may encourage both broader application of syncope guidelines and additional prospective assessment of their utility.
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Which syncope patients require in-hospital evaluation?
Among the most important issues facing physicians responsible for initial care of patients thought to have suffered syncope is ‘Does this individual need in-hospital evaluation?’ The outcome of this decision has many implications, including life-style and economic concerns for the patient, as well as health care management issues (e.g. bed availability, hospital costs, and laboratory utilization). Not surprisingly, the ESC Task Force expended considerable effort on this topic (Table 1).
Bartoletti et al.7 address the frequency with which ED physicians appropriately elected hospitalization or outpatient evaluation in a group of patients presenting with TLOC, and in particular in patients deemed to have suffered true syncope. ED physicians were trained with respect to the ESC Guidelines, and particularly with regard to hospital admission recommendations. During the approximate 2-year enrolment period, 1124 patients were deemed to have had a true syncope and 440 of these (39%) had at least one marker supporting admission for evaluation; 393 of these 440 patients (89%) were admitted. In contrast, 684 patients met no evident admission criterion; 511 of 684 patients (75%) were appropriately discharged from the ED (presumably for out-of-hospital evaluation), but 25% were admitted. These results are encouraging, but not optimal. The 25% admission rate in low-risk patients is probably less than is generally the case in practice; nonetheless, it indicates that, despite being ‘backed-up’ by a guideline statement, ED physicians preferred to ‘err’ on the side of admission and observation.
Can guidelines-directed care enhance syncope management in general hospitals?
The potential for the ESC Guidelines to facilitate management of syncope patients referred to EDs of 11 Italian general hospitals is the subject addressed by Brignole et al.8 representing the Evaluation of Guidelines in Syncope Study-2 (EGSYS-2) group. The application of guidelines to clinical circumstances was facilitated by the use of purpose-designed software in addition to personnel training at test sites. The findings were again encouraging in several respects. First, guidelines-consistent evaluation was achieved in 86% of cases (465 of 541 patients). This is an impressive accomplishment, and one that probably could not have been achieved without extra effort invested into professional education and software development. Secondly, the reported diagnostic yield is outstanding. The authors estimated that a ‘definite’ diagnosis was established in 98% of cases, with the vast majority (not surprisingly) being either neurally mediated reflex or orthostatic faints. Finally, a diagnosis was established in 50% of cases by medical history-taking alone, whereas in instances where further testing was required, fewer than two tests were needed. The latter observations suggest that a motivated, well-trained, medical team can improve diagnostic yield and cost-per-diagnosis when compared with conventional historical experience.
Testing applicability of the guidelines committee's recommendations ‘under fire’ is an essential step towards validating guidelines utility. In this regard, both Bartoletti et al.7 and Brignole et al.8 demonstrate that a guidelines-based educational effort can be undertaken to seemingly good effect even in busy medical centres. This is no minor accomplishment. ED physicians must deal rapidly with a wide range of serious clinical conditions; syncope only accounts for 
1% of these1 and is rarely an immediate threat to life. One cannot expect that the mastering of an extensive set of ‘syncope guidelines’ be the ED physician's highest priority.
So, what is missing?
Both studies would have been more compelling had a control group been included. In the case of Bartoletti et al.,7 this could have incorporated a comparison with a period of time before the investigators undertook guideline education. Alternatively, a contemporaneous evaluation of outcomes in a comparable medical centre could have been offered. Without such measures, we cannot say with certainty that guidelines application actually changed hospitalization habits. Similarly, Brignole et al.8 could have divided the hospital group into two parts, one acting as the ‘untutored’ control. Alternatively, they could have used the investigational model used in the OESIL study;9 in essence, guideline teaching would be provided only after an initial ‘untutored’ control period. Given the importance of the outcomes to our better understanding of the impact of syncope guidelines on public health, controlled designs would have been justified.
Apart from the absence of ‘controls’, the primary endpoint selection in both reports warrants further consideration. The endpoint in the study by Bartoletti et al.7 was clear (i.e. guideline-appropriate hospitalization). However, one could reasonably argue that, absent confirmation of ‘best’ clinical outcome, the chosen endpoint is primarily of interest to health care economists. From a clinical point of view, it will be crucial to show that wherever the syncope evaluation is undertaken, the ultimate diagnosis is correct and treatment effective. There is concern that patients dismissed from the ED (albeit ‘guidelines-appropriate’) may have had their subsequent care left to inexperienced (at least from a syncope evaluation perspective) community-based practitioners. Indeed, one might argue that admitting all patients to hospital-based ‘syncope management units’ (SMU) might in the end be more cost- effective than is the notoriously inefficient out-of-hospital assessment. Mandatory referral to an outpatient SMU would resolve this criticism and should be evaluated as future standard practice.
Brignole et al.8 relied for their endpoint on diagnosis rate, with an apparently impressive outcome. However, this endpoint has problems.3 Specifically, the reliability of a proposed ‘diagnosis’ is often suspect. Indeed, the true validity of a diagnosis can only be estimated if a seemingly ‘diagnosis-appropriate’ treatment results in fewer syncope recurrences than does a conventional management strategy. Admittedly, completing this last step in the management chain is complex. Nevertheless, this last step is important and, in fact, has been accomplished with respect to certain forms of syncope by many of these same investigators in the recently presented ISSUE-2 trial (ESC Scientific Sessions, Stockholm 2005). Outcome data are also apparently being gathered for the EGSYS-2 study patients reported here (M. Brignole, personal communication).
When it comes to assessment of syncope, unnecessary and cost-ineffective testing remains an unfortunate feature of current clinical practice. Guidelines offer physicians the help they need to achieve diagnostic goals in a more efficient manner. Despite certain criticisms noted earlier, the findings of Bartoletti and co-workers7 and Brignole et al.8 are important stepping-stones towards validating the utility of the ESC Syncope Guidelines and encouraging their universal application.
The author would like to thank the members of the ESC Task Force on the Syncope Evaluation for many thought provoking hours of discussion and debate that inevitably lead to ideas expressed in this communication.
Conflict of interest: D.G.B. is a member of the ESC Task Force on Syncope and participated in the guideline development process. He is a consultant to and share-holder of Medtronic Inc. and St Jude Medical Inc.
Footnotes
The opinions expressed in this article are not necessarily those of the Editors of the European Heart Journal or of the European Society of Cardiology.
doi:10.1093/eurheartj/ehi474 
doi:10.1093/eurheartj/ehi647 References
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[Abstract/Free Full Text] - Ammirati F, Colivicchi F, Santini M. Diagnosing syncope in clinical practice. Implementation of a simplified diagnostic algorithm in a multicentre prospective trial- the OESIL 2 study (Observatorio Epidemiologico della Sincope nel Lazio). Eur Heart J 2000;21:935–940.
[Abstract/Free Full Text]
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Related articles in EHJ:
- A new management of syncope: prospective systematic guideline-based evaluation of patients referred urgently to general hospitals
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EHJ 2006 27: 76-82.[Abstract] [Full Text] - Hospital admission of patients referred to the Emergency Department for syncope: a single-hospital prospective study based on the application of the European Society of Cardiology Guidelines on syncope
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