PICTURE Study Place of Reveal In the Care pathway and Treatment of patients with Unexplained Recurrent SyncopE SYNCOPE – Background • Syncope is common in the general population1 • Syncope accounts for 35% of Emergency Department (ED) visits and 1-3% of all hospital admissions2,3 • Cardiac syncope doubled the risk of death from any cause4 Challenges in Diagnosing Unexplained Syncope • Occurrence of syncope tends to be unpredictable, observers are unlikely to have the opportunity to record ECGs at the time of an event5 • Gold standard of diagnosis: when a correlation between the symptoms and a documented arrhythmia is recorded6 What did PICTURE aim to do? • The PICTURE registry aimed to collect information on the use of the Reveal® ICM in the patient care pathway and to investigate the effectiveness of the Reveal ICM in the diagnosis of unexplained recurrent syncope and presyncope in everyday clinical practice • PICTURE was a prospective, multi-center, observational post-marketing study conducted from November 2006 until October 2009 • Data was gathered after the publication of the 2004 ESC guidelines and before the new 2009 version became available PICTURE: Primary Objective • To evaluate the time to diagnosis in relation to the timing of the Reveal® ICM implant PICTURE Study Plan • 88 participating sites in 11 countries – (Austria, the Czech Republic, Denmark, Finland, France, Germany, Israel, The Netherlands, the Slovak Republic, Sweden and Switzerland). • A total of 71 sites contributed to patient enrolment Sweden Finland Denmark Netherlands Germany Czech Rep. France Austria Slovak Rep. Switzerland Israel Study Methods • Patients were eligible if they had recurrent unexplained syncope or pre-syncope • Patients were followed up until the first recurrence of a syncopal event leading to a diagnosis or for at least 1 year Study Methods • 650 patients enrolled (2006-2008) – 570 patients followed-up • Average Follow-Up time: 10±6 months Patient Characteristics Age 61±17 years Gender 54% females Mean age at first syncope 55±20 years Primary Indication Unexplained syncope 91% Pre-syncope 7% Classification missing 2% Reveal® ICM (DX/XT) 55% Reveal® Plus 45% Physicians Consulted and Diagnostic Tests Performed (before Reveal® ICM implant)5 • Overall, patients had seen an average of 3 different specialists for management of their syncope • Most patients (70%) had been hospitalized at least once for syncope, – one third (36%) of these patients had experienced significant trauma in association with a syncopal episode Diagnostic Tests Performed Before Reveal® ICM implant5 •The median number of tests performed per patient in the total study population was 13 (interquartile range 9 - 20) ”No studies evaluated the use of brain imaging for syncope. CT or MRI in uncomplicated syncope should be avoided.”6 Total recruitment 570 (100%) Standard ECG 556 (98%) Echocardiography 490 (86%) Basic laboratory tests 488 (86%) Ambulatory ECG monitoring 382 (67%) In-hospital ECG monitoring 311 (55%) Exercise testing 297 (52%) Orthostatic blood pressure 275 (48%) MRI / CT scan 267 (47%) Neurological or psychiatric evaluation 270 (47%) EEG 222 (39%) Carotid sinus massage 205 (36%) Tilt test 201 (35%) Electrophysiology testing 144 (25%) Coronary angiography 133 (23%) External loop recording 67 (12%) ATP test 15 (3%) Other tests 52 (9%) No tests performed 1 (0%) Results5 • During follow-up, – 218 patients (38%) had a recurrence of syncope within 12 months (shaded area) Blue Line: time to syncopal episode Red Line: time to syncopal episode where Reveal® ICMs played a role in the diagnosis • Reveal® ICMs guided the diagnosis in 170 (78%) patients with recurrent syncope, 75% of these patients had cardiac causes. * *Patients were followed for a maximum of 720 days Treatment of Patients with Episodes5 Treatment decisions made in relation to syncope after diagnosis. Treatment Statistics5 • • • • • Pacemaker implantations (86) Antiarrhythmic drug therapy ICD implantations Ablation therapy No specific treatment 51% 7% 6% 5% 18% Conclusions • PICTURE is the largest observational study to date to evaluate the usage and diagnostic effectiveness of ICMs in the everyday clinical work-up of patients with unexplained syncope5 • Reveal® ICMs contributed to establishing the mechanism of syncope in the vast majority of patients with a recurrence5 • The PICTURE study found a great diversity and number of physicians consulted, plus a large number of tests performed5 • The findings support the recommendation in the 2009 EXC/HRS Syncope Guidelines that the Reveal® ICMs should be implanted early rather than late in the evaluation of unexplained syncope6 References 1. Amer A, et al. Incidence and Mortality Rates of Syncope in the United States. The American Journal of Medicine (2009) 122, 181-188 2. Day SC. Et al. Evaluation and outcome of emergency room patients with transient loss of consciousness. Am J Med. 1982;73:15-23. 3. Silverstein MD et al. Patients with syncope admitted to medical intensive care units. JAMA. 1982;248:1185-1189.4. 4. Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope. N Engl J Med. 2002;347(12):878-885. [Framingham Study Population] 5. Edvardsson N, Frykman V, van Mechelin R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011; 13(2):262269. 6. Moya A. et al. Guidelines for the diagnosis and management of syncope (version 2009) The Task Force for the Diagnosis and Management of Syncope of the European Society of Cardiology (ESC). European Heart Journal; 2009. Brief Statement Indications 9529 Reveal® XT and 9528 Reveal® DX Insertable Cardiac Monitors The Reveal® XT and Reveal® DX Insertable Cardiac Monitors are implantable patient-activated and automaticallyactivated monitoring systems that record subcutaneous ECG and are indicated in the following cases: -patients with clinical syndromes or situations at increased risk of cardiac arrhythmias -patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia. 9539 Reveal® XT and 9538 Reveal® Patient Assistants The Reveal® XT and Reveal® Patient Assistants are intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal® Insertable Cardiac Monitor: -To verify whether the implanted device has detected a suspected arrhythmia or device related event. (Model 9539 only) -To initiate recording of cardiac event data in the implanted device memory. Contraindications There are no known contraindications for the implant of the Reveal® XT or Reveal® DX Insertable Cardiac Monitors. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions 9529 Reveal® XT and 9528 Reveal® DX Insertable Cardiac Monitors Patients with the Reveal® XT or Reveal® DX Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual. 9539 Reveal® XT and 9538 Reveal® Patient Assistants Operation of the Model 9539 or 9538 Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. Potential Complications Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. www.medtronic.com World Headquarters Medtronic, Inc. 710 Medtronic parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and professionals) © Medtronic, Inc. 2010 Minneapolis, MN All Rights Reserved 02/2011