Syncope evaluation: the role of syncope clinics Michele Brignole Arrhythmologic Centre, Lavagna, Italy

Why should we need a Syncope Management Unit? We are not happy with current strategies: - not standardized - inappropriate use of diagnostic tests - high number of misdiagnosis - high number of still unexplained syncope. Multiple experiences with Syncope Facilities showed: - improvement in diagnostic yield - cost effectiveness (ie, cost per reliable diagnosis)

Diagnostic yield Historical, non-standardized (best clinical practice) Standardized protocols (Syncope facilities) Structured algorithms (interactive web-based, remote tutoring) 42% - 54% 17% - 24% Kapoor. N Engl J Med 1983 Linzer (systematic review). Ann Intern Med 1997 Ammirati. G Ital Cardiol 1999 Getchell. J Gen Intern Med 1999 Del Greco. Ital Heart J 2003 Ammirati. Eur Heart J 2000 Alboni. J Am Coll Cardiol 2001 Sarasin. Am J Med 2001 Blanc. Eur Heart J 2002 Chen. Mayo Clin Proc 2003 Shen. Circulation 2004 Brignole. Europace 2009 2% - 5% Brignole. Eur Heart J 2006 Brignole. Europace 2006 Knowing the mechanism is a pre-requisite for preventing future recurrences and related morbidity

Faint evaluation at University of Utah Hospital, 2009 Diagnostic yield Total 95% CI observed (n=100) Final diagnosis at the end of work-up 45 35-55 Reflex 17 10-26 Orthostatic hypotension 7 3-14 Cardiac, arrhythmia 11 6-19 Cardiac, structural 1 0-5 Non-syncopal faints (epilepsy, functional,etc) 9 4-16 Pending after 45 days (implantable loop recorder) 3 1-9 Unknown diagnosis at the end of work-up 52 42-62 Evaluation of Patients with Faint in an American Teaching Hospital: A Dire Need for a Standardized Approach Brignole,., Hamdan. PACE (In press)

Syncope management facilities: ESC standards Optimal standard for quality service delivery: 1- Cohesive, structured care pathway - either delivered within a single syncope facility or as a more multi-faceted service. 2- Adoption of standardized guidelines-based approach for: diagnostic criteria diagnostic work-up risk stratification treatment ESC Guidelines on Management of Syncope

Syncope management facilities: ESC standards Who must manage syncope patients? The Syncope Expert The syncope expert is a single physician or the team of physicians who lead the process of a comprehensive management of the patient from risk stratification to diagnosis, therapy and follow-up. They usually perform directly the core laboratory tests and have preferential access to hospitalization and any other diagnostic test and eventual therapy. ESC Guidelines on Management of Syncope

Organizing the Management of Syncope Initial evaluation (Emergency dept., In- and out-hospital service, General practitioner) Diagnosis certain Syncope-like condition Diagnosis suspected or unexplained Discharge or Treatment Refer to Neurology/ Psychiatry as appropriate ESC Guidelines on Syncope Syncope facility ( Syncope Unit ) Full access to cardiological and autonomic tests and specialists consultancies

Syncope management facilities: ESC standards Core equipment: surface ECG recording phasic blood pressure monitoring tilt table testing equipment external and implantable ECG loop recorders 24 hour ambulatory blood pressure monitoring 24 hour ambulatory ECG autonomic function testing ESC Guidelines on Management of Syncope

Syncope management facilities: ESC standards Preferential diagnostic access to: echocardiography EP studies stress testing coronary angiography CT and MRI scans electroencephalography ESC Guidelines on Management of Syncope

Syncope management facilities: ESC standards Preferential therapy access to: Pacemaker implantation ICD implantation Catheter ablation of arrhythmias and to any eventual therapy for syncope ESC Guidelines on Management of Syncope

AIAC Associazione Italiana Aritmologia e Cardiostimolazione Syncope Unit Project Syncope Unit Project A prospective systematic guideline-based evaluation and treatment of patients referred to the Syncope Units of general hospitals Brignole et al. Europace 2010; 12: 109 118 An official study of Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC)

Syncope Unit Project (SUP) Methods Observational prospective registry from 9 Italian Syncope Units Consecutive patients from March 15th to September 15ht, 2008

Syncope Unit Project (SUP) Management In-hospital Referral source 16% Protected discharge Emergency room 13% 11% 60% Out-hospital

Syncope Unit Project (SUP) Management Diagnostic flow Eligible 941 Analyzed 891 50 (5%) Not evaluable Diagnosis made at initial evaluation 191 (21%) 1.2±1.5 tests Early diagnosis with investigations 541 (61%) 2.8±1.6 tests No diagnosis (follow-up) 159 (18%) 3.5±1.8 tests

Syncope Unit Project (SUP) Management Case mix Reflex Orthostatic hypotension Cardiac Arrhythmia Structural Cardio- Pulmonary Non-syncopal 1 Vasovagal CSS Situational Atypical Likely reflex 2 Classical OH form Delayed OH form (progressive) 3 Brady Sick sinus AV block PM dysf * Tachy VT SVT High risk of SCD 4 ACS Aortic Stenosis Atrial myxoma Pulmonary embolism Others 5 Metabolic Epilepsy Intoxications Drop-attacks Psychogenic TIA Falls 67% 4% 5% 1% 5% Unknown Cause = 18%

Syncope Unit Project (SUP) Limits of current management Diagnosis at initial evaluation n=191 Early diagnosis with tests n=541 No diagnosis n=159 p value Age, median 52 67 73 0.001 Males (%) 54% 51% 62% 0.05 Number of syncopes, median 3 3 3 0.12 History of syncope, years 5 3 2 0.001 No prodromes (%) 9% 30% 43% 0.001 Structural heart disease (%) 8% 16% 48% 0.001 ECG abnormalities (%) 9% 21% 47% 0.001 OESIL risk score, median 0 1 2 0.001 EGSYS risk score, median -1 0 2 0.001

Survival free from syncope Evaluation of Guidelines in SYncope Study 2 (EGSYS-2) Recurrence of syncope in 398 patients 1,00 0,95 0,90 0,85 0,80 0,75 arrhythmic unexplained structural heart disease neuroreflex orthostatic 0,70 0 100 200 300 400 500 600 700 800 Ungar A et al. Eur Heart J 2010 Days

Improving the management of syncope patient Structured algorithms (interactive, web-based, remote tutoring) Documentation of syncope (e.g. prolonged ECG monitoring/ilr)

Faint evaluation at University of Utah Hospital, 2010 Clinical practice Faint-Algorithm Admitted Discharged Admitted Discharged Patients (total n=254) 118 (46%) 136 (54%) 57 (22%) 197 (78%) Serious Events within 7 days after visit; % 10 (8.5%) 5 (3.7%) 9 (16%) 6 (3.0%) Faint Algorithm: Odds ratio for admissions: -67% Short-term risk in patients presenting to the Emergency Department: implications for admissions (in press)

Faint evaluation at University of Utah Hospital, 2009 Observed Estimated (according to the algorithm) Appropriate Total not done estimated Kappa value Total observed Not appropriate Appropriate Admission 33 36% 64% 9% 23 0.49 Diagnosis at initial evaluation 29 41% 59% 29% 24 0.51 Evaluation of Patients with Faint in an American Teaching Hospital: A Dire Need for a Standardized Approach Brignole,., Hamdan. PACE (In press)

Faint evaluation at University of Utah Hospital, 2009 Tests Observed Estimated (according to the algorithm) Total Not Appropriate Appropriate Total observed appropriate not done estimated Kappa value Echocardiogram 62 65% 35% 15% 26 0.21 CSM 0 0% 0% 100% 26 0.00 Tilt testing 7 43% 57% 91% 44 0.04 Holter 21 62% 38% 11% 9 0.47 ELP 20 50% 50% 44% 18 0.42 ILP 3 0% 100% 62% 8 0.52 Stress test 11 36% 74% 42% 12 0.56 EPS 3 67% 33% 83% 6 0.19 Coronary angio 5 20% 80% 0% 4 0.88 Brain CT/MRI 22 59% 41% 0% 9 0.52 Evaluation of Patients with Faint in an American Teaching Hospital: A Dire Need for a Standardized Approach Brignole,., Hamdan. PACE (In press)

Why should we need Syncope Units? Syncope Facilities adopting the ESC standards are the conditio sine qua non toward an optimal management of syncope patient However, further improvements are still warranted