Hrev_master [Emergency Care Journal 2016; 12:6046] [page 25] Management of transient loss of consciousness of suspected syncopal cause, after the initial evaluation in the Emergency Department Ivo Casagranda,1 Michele Brignole,2 Simone Cencetti,3 Gianfranco Cervellin,4 Giorgio Costantino,5 Raffaello Furlan,6 Gianluigi Mossini,4 Filippo Numeroso,4 Massimo Pesenti Campagnoni,7 Paolo Pinna Parpaglia,8 Martina Rafanelli,9 Andrea Ungar9 1Syncope Unit, Emergency Department, Santi Antonio e Biagio e Cesare Arrigo Hospital, Alessandria; 2Syncope Unit, Cardiology Department, Tigullio Hospitals, Lavagna; 3Syncope Unit, Emergency Department, S. Maria Nuova Hospital, Florence; 4Emergency Department, University Hospital of Parma, Parma; 5Allergology and Clinical Immunology Department, Niguarda Ca’ Granda Hospital, Milan; 6Syncope Unit, Internal Medicine Department, Humanitas Institute, Rozzano; 7Syncope Unit, Emergency Department, Regional Hospital Umberto Parini, Aosta; 8Syncope Unit, Emergency Department, SS. Annunziata Hospital, Sassari; 9Syncope Unit, Geriatric Cardiology and Medicine Unit, University Hospital of Careggi, Florence, Italy Abstract The recommendations enclosed in the pres- ent document have been developed by a group of experts appointed by the Gruppo Multidisciplinare per lo Studio della Sincope (Multidisciplinary Group for the Study of Syncope; GIMSI) and Academy of Emergency Medicine and Care (AcEMC). The aim is to define the diagnostic pathway and the man- agement of patients referred to the Emergency Department (ED) for transient loss of con- sciousness of suspected syncopal cause, which is still unexplained after the initial evaluation. The risk stratification enables the physician to admit, discharge or monitor shortly the patient in the intensive short-stay Syncope Observation Unit (SOU). There are three risk levels of life-threatening events or serious complications (low, moderate, high). Low risk patients can be discharged, while high risk ones should be monitored and treated properly in case of worsening. Moderate risk patients should undergo clinical and instrumental mon- itoring in SOU, inside the ED. In all these three cases, patients can be subsequently referred to the Syncope Unit for further diag- nostic investigations. Introduction Aim The aim of this consensus document is to define the diagnostic pathway and the man- agement of patients referred to the Emergency Department (ED) for transient loss of con- sciousness (TLoC) of suspected syncopal cause, which is still unexplained after the ini- tial evaluation. The management of patients with a definite diagnosis of syncope after the initial evaluation in the ED, even at high risk, is not included in this document, as well of those patients in whom syncope is the mani- festation of an acute organic disease which in itself justifies the immediate hospitalization, regardless of the nature of syncope (acute heart failure, acute myocardial infarction, active bleeding, etc.) (Figure 1). According to the guidelines on syncope of the European Society of Cardiology (ESC),1 the initial evaluation in ED comprises clinical his- tory taking, physical examination, 12 leads electrocardiogram, blood pressure measure- ments in the supine position and during active standing. This evaluation allows a definite diagnosis in about 50% of the cases. In the other 50%, in which syncope is still unex- plained, risk stratification of cardiac death and of serious adverse events and more detailed clinical/instrumental investigations are mandatory. The recommendations enclosed in the pres- ent document have been developed by a group of experts appointed by Gruppo Multidisciplinare per lo Studio della Sincope (Multidisciplinary Group for the Study of Syncope; GIMSI) and Academy of Emergency Medicine and Care (AcEMC). They are based on evidences from Italian EDs2-11 and have been approved by GIMSI’s and AcEMC’s steer- ing committee. Syncope Syncope is the cause responsible for ED and hospital admissions in 3 and 1% cases, respec- tively.1 Syncope is a difficult condition to man- age from a diagnostic and therapeutic stand- point. Patients follow different pathways from the ED and in the 50% of cases they are admit- ted to different hospital facilities as Emergency Medicine, Internal Medicine, Cardiology, Geriatric and Neurology Departments. Because the nature of syncope remains often unexplained after the first line evaluation in the ED, the main goal for a physi- cian should be risk stratification, which can be guided by the clinical experience and by a standardized risk score questionnaire, which is based on clinical history and the character- istics of syncope. Nevertheless, there is no evi- dence that any of the known syncope scores is better than the clinical judgment in defining the risk. An alternative approach for the patient with unexplained syncope is to be observed and instrumentally monitored in a proper area of the ED, also called the intensive short-stay Syncope Observation Unit (SOU) with an eventual later referral to the Syncope Unit (SU). Syncope Unit and intensive short- stay Syncope Observation Unit Syncope Unit is a hospital facility aimed at providing a standardized approach to TLoC and related symptoms through the clinical experi- ence of a specialized medical team and the easy access to diagnostic pathways and thera- peutic management. Aim of the SU is also to provide clinical knowledge in the field of syn- cope.12 The Unit is part of the hospital facilities, generally belonging to Cardiology, Geriatric, Internal Medicine or Neurology Departments, but it can also be integrated in the ED. Shen and co-authors13 have firstly described, in a randomized single center study, the utility of SOU as part of the ED of a tertiary-care teach- ing hospital with a control group of patients traditionally managed for syncope. Patients from the intervention group had a higher rate of diagnosis and a lower rate of hospital admis- sions, without a reduction in the length of stay Emergency Care Journal 2016; volume 12:6046 Correspondence: Ivo Casagranda, Syncope Unit, Emergency Department, Santi Antonio e Biagio e Cesare Arrigo Hospital, via Venezia 16, 15100 Alessandria, Italy. Tel./Fax: +39.0131.206224. E-mail: icasagranda@ospedale.al.it Key words: Transient loss of consciousness; Syncope; Emergency Department. Note: this consensus document has been approved by the Gruppo Multidisciplinare per lo Studio della Sincope (Multidisciplinary Group for the Study of Syncope; GIMSI) and the Academy of Emergency Medicine and Care (AcEMC) Task Force on April 17th, 2015. Received for publication: 3 June 2016. Accepted for publication: 6 June 2016. This work is licensed under a Creative Commons Attribution 4.0 License (by-nc 4.0). ©Copyright I. Casagranda et al., 2016 Licensee PAGEPress, Italy Emergency Care Journal 2016; 12:6046 doi:10.4081/ecj.2016.6046 Non co mmerc ial us e o nly [page 26] [Emergency Care Journal 2016; 12:6046] in the ED. This approach proved to reduce syn- copal relapses, without affecting the 2-year mortality. By strictly applying the ESC guide- lines on syncope1 and monitoring patients in a dedicated area of the ED, Rodríguez-Entem and colleagues14 reached a 78% of diagnosis, with a 10% of hospital admissions. More recently, the Emergency Department Observation Syncope Protocol study15 has eval- uated 120 moderate risk patients with unex- plained syncope, who were randomized to 12- 24 hours monitoring and echocardiogram in an Observation Unit vs traditional manage- ment. The study showed a reduction in health care costs, without differences in short-term (30 days) adverse events and quality of life. Opinion Report The Italian scene The reduction of in-hospital bed capacity and the need for a greater appropriateness of hospitalizations have gradually changed the purpose of the ED from admit to work to work to admit, needing new filters for hospital admission and leading to redefine more care- ful criteria for hospitalization of patients with urgent clinical conditions. Moreover, improv- ing the standard of care in ED has become a constant need, despite hospitals’ congestion and pressing external demands. To address these complexities, a cost-effective organiza- tional solution has been advanced in the west- ern world from the United States in the 80’s and developed also in Italy in the same period, by the establishment of intensive short-stay (24 h) Observation Units, located inside or near the ED and managed by ED physicians and nurses. More recently, the high intensity diagnostic model has been further improved thanks to newer imaging technologies (multi-slice com- puted tomography) and biomarkers. Later on these units have become specialized in short- term therapies for quickly solvable pathological conditions, e.g. acute asthma, in order to pro- vide for the discharge of patients, without resorting to hospitalization. In Italy, over the past twenty years there has been a large spread of these units in the EDs, which have been defined as intensive Observation Unit. Recently, the Ministry of Health has felt the need to standardize these units by defining their function, equipment and staff’s standards, clinical and instrumental observation duration, symptoms of presentation or the appropriate Opinion Report Figure 1. Transient loss of consciousness’ pathway (first step eval- uation). Figure 2. Proposal of management of suspected syncopal tran- sient loss of consciousness (TLoC), after the initial evaluation in the Emergency Department. Risk=short-term risk (7-30 days) of life-threatening events or serious complications. Table 1. Consensus recommendations: equipment, tests and characteristics required for the management of unexplained syncope in Syncope Observation Unit. Recommendations Details ECG and BP monitoring ECG and NIBP collection and 24 h storing* Standing test Standing test with intermittent NIBP* Carotid sinus massage Supine and standing carotid sinus massage under ECG and NIBP monitoring, according to the method of symptoms** in patients older than 50 years, when indicated Echocardiogram Echocardiogram, when indicated Blood tests Blood tests, when indicated Syncope expert Syncope expert consult, shared management protocol and fast-track referral to SU Expert consults Neurologist, Cardiologist, Geriatrician, Psychiatrist ECG, electrocardiogram; BP, blood pressure; NIBP, non-invasive blood pressure; SU, Syncope Unit. *Beat-to-beat BP monitoring is not mandatory in the SOU; an intermittent BP monitoring will be sufficient. Tilt testing is not performed in Syncope Observation Unit (SOU). The test will be performed, when indicated, in the SU. **Intermittent manual BP measurements are sufficient to perform the carotid sinus massage in SOU. The test will be performed in the SU under beat-to-beat BP monitoring on Tilt-table, when indicated. Non co mmerc ial us e o nly [Emergency Care Journal 2016; 12:6046] [page 27] conditions for admission. The length of stay should be no less than 6 hours and no greater than 36. In general, the admission to intensive Observation Unit of patients with syncope is considered indicated, but the clinical character- istics of the patients for whom it is appropriate are not yet clearly defined. According to this consensus, SOUs should meet the require- ments showed in Table 1. Management of the patient with syncope inside the Emergency Department and role of the Syncope Observation Unit There are three different risk levels for life- threatening events or serious complications (low, moderate, high) and two temporal levels [short-term (7-30 days) or long-term (1-2 years)]. Short-term risk assessment should guide the decision whether to admit or to choose alternative pathways. A high short- term risk justifies the immediate hospitaliza- tion. Conversely, the patients at high long-term risk can be managed in SOU or in SU, consid- ering the low diagnostic power of urgent hos- pitalization.14 The prevalence of short-term risk for life-threatening events in patients with unexplained syncope after the initial evalua- tion is low (0.7% for death and 4.5% for non- fatal events).14 Syncope is considered at low risk in the absence of acute or chronic cardiovascular dis- ease and when its presentation suggests a reflex cause. High risk includes patients with cardiovascular instability in which syncope could be the manifestation of hidden underly- ing life-threatening arrhythmias. Intermediate risk includes those patients who do not fall in either the first group or the second one, because affected by stable cardiovascular dis- ease or stable/unstable not cardiovascular dis- ease. This consensus differentiates patients with previous unknown clinical condition and those characterized by clinical deterioration of known diseases, which were already present before the onset of syncope. Low risk patients can be discharged, while high risk ones should be monitored and treat- ed properly in case of worsening. Moderate risk patients should undergo clinical and instrumental monitoring in SOU. In all three cases, patients can be subsequently referred to SU for further diagnostic investigations. The pathway of patients referred to the ED for syncope should follow the flow-chart below (Figure 1), which highlights the relationship between ED and SU, SOU and SU. Two aspects have not yet been clarified: i) what kind of patients should be admitted in these observation units; ii) what is the precise role of the SOU in the SU. Given the absence of sufficient scientific evidence, this consen- sus is not able to provide specific guidance in this regard and will only provide general guide- lines (as shown in Figure 2), thus leaving deci- sions on individual cases to the clinical judg- ment of the ED physician. We anticipate that this is the intention of the two Societies, which have ordered this document, to develop in the near future a protocol to be validated through an Italian prospective controlled mul- ticenter study. Conclusions As suggested in the European Heart Rhythm Association position paper,12 the Syncope Unit should promote training for the proper man- agement of syncope. GIMSI and AcEMC have structured training course for doctors, particu- larly those from the ED, who have to manage many patients with this symptom. The first competence course on basic management of syncope was firstly made in 2014: it is a stan- dardized, theoretical and practical course, with final tests aimed at verifying the competence acquired by the individual learner. The goal is to train physicians throughout the national territory, in order to address the management of syncope homogeneously according to the current guidelines, to use properly diagnostic tests, and to help doctors to choose the proper pathway among discharge, hospitalization or admission in SOU. References 1. Moya A, Sutton R, Ammirati F, et al. Guidelines for the diagnosis and manage- ment of syncope (version 2009): task force for the diagnosis and management of syn- cope of the European Society of Cardiology (ESC). Eur Heart J 2009;30:2631-71. 2. Brignole M, Menozzi C, Bartoletti A, et al. A new management of syncope: prospec- tive systematic guideline-based evaluation of patients referred urgently to general hospitals. Eur Heart J 2006;27:76-82. 3. Costantino G, Perego F, Dipaola F, et al. STePS investigators. Short-and long-term prognosis of syncope, risk factors, and role of hospital admission: results from the STePS (Short-Term Prognosis of Syncope) study. J Am Coll Cardiol 2008;51:276-83. 4. Vitale E, Maggi R, De Marchi G, et al. L’approccio al paziente con sincope in pronto soccorso: diagnosi differenziale e stratificazione di rischio. Emerg Care J 2009;5:1-9. 5. Ungar A, Del Rosso A, Giada F, et al. Early and late outcome of treated patients referred for syncope to emergency depart- ment: the EGSYS2 follow-upstudy. Eur Heart J 2010;31:2021-6. 6. Numeroso F, Mossini G, Lippi G, et al. Evaluation of the current prognostic role of cardiogenic syncope. Intern Emerg Med 2013;8:69-73. 7. Sun BC, Costantino G, Barbic F, et al. Priorities for emergency department syn- cope research. Ann Emerg Med 2014;64:649-55. 8. Numeroso F, Mossini G, Lippi G, et al. Evaluation of the current prognostic role of heart diseases in the history of patients with syncope. Europace 2014;16:1379-83. 9. Numeroso F, Mossini G, Giovanelli M, et al. Short term prognosis and actual manage- ment of patients with intermediate-risk syncope. Results from the IRiS (Intermediate-Risk Syncope) Study. Acad Emerg Med 2016;14:13013. 10. Ungar A, Tesi F, Chisciotti VM, et al. Assessment of a novel management path- way for patients referred to the Emergency Department for syncope: results in a Tertiary Hospital. Europace 2015;14:106. 11. Costantino G, Sun B, Barbic F, et al. Syncope clinical management in the Emergency Department: a consensus from the first international workshop on syn- cope risk stratification in the ED. Eur Heart J 2015;4:378. 12. Kenny RA, Brignole M, Dan GA, et al. Syncope Unit: rationale and requirement: the European Heart Rhythm Association position statement endorsed by the Heart Rhythm Society. Europace 2015;17:1325- 40. 13. Shen WK, Decker WW, Smars PA, et al. Syncope Evaluation in the Emergency Department Study (SEEDS): a multidisci- plinary approach to syncope management. Circulation 2004;110:3636-45. 14. Rodríguez-Entem F, González-Enríquez S, Olalla-Antolín JJ, et al. Management of syncope in the emergency department without hospital admission: usefulness of an arrhythmia unit coordinated protocol. Rev Esp Cardiol 2008;61:22-8. 15. Sun BC, Mc Creath H, Liang LJ, et al. Randomized clinical trial of an emergency department observation syncope protocol versus routine in patient admission. Ann Emerg Med 2014;64:167. Opinion Report Non co mmerc ial us e o nly