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
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02/2011