Diagnostics and Monitoring - Syncope and the Reveal Plus

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Syncope, a brief self-limited transient loss of consciousness, is a relatively common occurrence in the general population with a variety of underlying causes. It is associated with:

  • 1% to 6% of hospital medical admissions;1
  • 3% of emergency room visits each year;2
    • 740,000 Emergency Department syncope cases per year in the US;3
    • overall admissions rate of 32%;3 and
  • US$700 million in secondary trauma, including approximately 10% of falls in the elderly.4


While the underlying cause of syncope can often be determined and appropriate treatment chosen, as many as 47% of all cases of syncope episodes are unexplained.5

Findings from the Framingham Heart Study population suggest additional diagnostic testing and evaluation of unexplained syncope may be advised. A review of over 7,800 patients showed that those with unexplained and cardiac syncope were at increased risk of death.6

In fact, those with cardiac syncope had:

  • a six-month mortality rate of greater than 10%;6 and
  • double the risk of death.6

The evaluation of syncope is based on many factors including the patientÔÇÖs account of the syncopal episode, clinical presentation, and history of prior events. Long-term electrocardiogram (ECG) monitoring with an insertable loop recorder (ILR) can provide a symptom-rhythm correlation that may help rule in and rule out cardiac arrhythmias in those with recurrent but infrequent syncope.

Reveal Plus ILR is the first and only implantable patient- and automatically activated cardiac monitoring system. Reveal Plus can record an ECG at the time of a syncopal episode that may rule in or rule out life-threatening arrhythmias.

Who Could Benefit from Reveal Plus?

Patients with clinical syndromes or situations at increased risk for arrhythmias, including patients with:7,8

  • unexplained syncope;
  • near syncope;
  • episodic, recurrent palpitations; and
  • drug-refractory epilepsy, seizure-like events, and convulsions.


Improved Diagnosis

Reveal Plus may diagnose where other tests fail:

  • studies show that rhythm captured during a spontaneous syncopal event may not correlate to the rhythm recorded during tilt-table-induced syncopal events.9-11
  • the American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) and the European Society of Cardiology (ESC)12 advise the use of Reveal Plus in the management of syncope.


Early use of Reveal Plus may reduce syncope diagnosis costs:

  • The cost of a primary ILR strategy is 26% less than that of conventional testing in the diagnosis of recurrent, unexplained syncope.13
  • Reveal Plus-based treatments may lead to fewer hospitalization days when compared with conventional testing-based treatments.14


Reveal Plus is simple to implant and follow up:

  • it can be implanted in a short, minimally invasive out-patient procedure.
  • no restrictions due to external wires or recording pads, it is designed to improve patient compliance.
  • during a syncopal episode, the ECG is captured via the one-touch patient activator or the pre-programmed automatic activation option.
  • data are easily retrieved and analyzed via the Medtronic programmer. Ôûá
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  7. ACC/AHA Class I Indications for Ambulatory ECG.
  8. Zaidi A, Clough P, Cooper P, et al.,"Misdiagnosis of epilepsy: many seizure-like attacks have a cardiovascular cause", J Am Coll Cardiology (July 2000);36(1): pp.181-184.
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  9. Deharo JC, Jego C, Lanteaume A, et al.,"An implantable loop recorder study of highly symptomatic vasovagal patients: the heart rhythm observed during a spontaneous syncope is identical to the recurrent syncope but not correlated with the head-up tilt testor adenosine triphosphate test", J Am Coll Cardiology. (February 7, 2006);47(3): pp.587-593.
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  10. Moya A, Brignole M, Menozzi C, et al. "International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with isolated syncope and in patients with tilt-positive syncope. Circulation.
  11. Brignole M, Sutton R, Menozzi C, et al., "Lack of correlation between the responses to tilt testing and adenosine triphosphate test and the mechanism of spontaneous neurally mediated syncope" Eur Heart J. (September 2006);27(18): pp. 2232-2239.
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  12. Brignole M, Alboni P, Benditt DG, et al., "Guidelines on management (diagnosis and treatment) of syncopeÔÇöupdate 2004" Europace. (November 2004);6(6):pp. 467-537.
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  13. Krahn AD, Klein GJ,Yee R, et al., "Cost implications of testing strategy in patients with syncope: randomized assessment of syncope trial" J Am Coll Cardiol. (August 2003);42(3): pp. 495-501.
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  14. Farwell DJ, Freemantle N, Sulke N, "The clinical impact of implantable loop recorders in patients with syncope" Eur Heart J. (February 2006):27(3):pp. 351-356
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