syncope therapy awareness presentation - medtronic · 13 tests, and 1/3 have significant associated...

SYNCOPETHERAPYAWARENESS PRESENTATION Reveal LINQ™

Insertable Cardiac Monitoring System

• Epidemiology• Diagnosis • Guidelines and Evidence to Support Reveal LINQ™

ICM in Syncope Patients• Syncope Care Pathway

SYNCOPE OVERVIEW

SYNCOPE DEFINITION

A leading cause of undiagnosed syncope is heart-related.2

Arrhythmias are most common cause of cardiac syncope.1

1. Moya A. et al. Guidelines for the diagnosis and management of syncope (version 2009). European Heart Journal; 20092. 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]

TLoC Definition1 A loss of consciousness with complete recover, usually spontaneous in onset

Non - traumatic Traumatic (concussion)

Syncope• Temporary loss of

consciousness with rapid recovery

• Usually related to temporary insufficient blood flow to the brain

Substance abuse• Alcohol or drug

induced loss of consciousness

Epileptic seizure• Neurological disorder

in which nerve cell activity in the brain becomes disrupted

Psychogenic• Often an involuntary

reaction of the brain to pressure or distress

TLoC

Syncope | Therapy Awareness Presentation | December 20174

UNEXPLAINED SYNCOPE + CARDIAC SYNCOPEOVER 50% OF PATIENTS

Syncope remains unexplained in approximately 1/3 of cases1

1. Linzer M, et al. Ann Intern Med. 1997;126:989-996.

NeurologicSeizure, stroke, TIA etc.

10%

Unknown34% Cardiac

abnormal rhythms, structural damage

18%

NeurallyMediatedvasovagal, carotid sinus, situational

24%

Orthostatic/Drug-inducedANS failure, medication

11%


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THE SYNCOPE CHALLENGE

Magnitude

1 Kenny RA, et al. eds. The evaluation and treatment of syncope. Futura. 2003:23-27.2 Mendu M, et al. Arch Intern Med. 2009;169:1299-1305.3 Edvardsson N, et al. Europace. 2011;13:262-9269.4 Soteriades ES, et al. N Engl J Med. 2002;347:878-885.

Inpatient Challenge

Patient’s Frustration

Cardiac Causes

Approximately half of patients admitted to hospital leave without a diagnosis.2

In reaching a diagnosis patients see 3 different specialists, undergo 13 tests, and 1/3 have significant associated trauma.3

Cardiac syncope is common, doubles the risk of death, and is associated with a 6-month mortality rate greater than 10%.4

40% of the population will have at least one syncope event.1


SYNCOPETHE CAUSE MATTERS

Cardiac syncope1: Carries a 6-month mortality

rate of greater than 10%

Doubles the risk of death

1. Soteriades ES, et al. N Engl J Med. 2002;347:878-885.

Overall Survival of Participants with Syncope According to Cause

7 Syncope | Therapy Awareness Presentation | December 20177

1 Weiling W, Ganzeboom K, Saul JP. Heart 2004;90:1094-11002 Campbell A, et al. Age and Ageing. 1981;10:264-270.

50% of patients admitted to hospital for syncope-related events are >75 years of age1

10% of falls by elderly are attributed to syncope1

With an aging population, the prevalence of syncope is likely to increase2

SYNCOPEA GROWING CHALLENGE FOR THE SYSTEM

Prevalence of Syncope based on Age and Sex of Patients


DIAGNOSING SYNCOPE

SYNCOPE DIAGNOSISTESTING OPTIONS AND THEIR DIAGNOSTIC YIELDS

1. Kapoor WN. Diagnostic evaluation of syncope. Am J Med. 1991;90:91-106. 2. Krahn et al. Recurrent syncope. Experience with an implantable loop recorder. Cardiol Clin. 1997;15:313-326. 3. Krahn et al. Cost implications of testing strategy in patients with syncope (RAST). J Am Coll Cardiol. 2003;42:495-501. 4. Kapoor. Evaluation and outcome of patients with syncope. Medicine (Baltimore). May 1990;69:160-175. 5. Kapoor. Evaluation and management of the patient with syncope. JAMA. 1992;268:2553-2560. 6. Linzer et al. Diagnosing syncope. Part 2: unexplained syncope. Clinical efficacy assessment project of the american college of physicians. Ann Intern Med. 1997;127:76-86. 7. Krahn et al. Final results from a pilot study with an implantable loop recorder to determine the etiology of syncope in patients with negative noninvasive and invasive testing. Am J Cardiol. 1998;82: 117-

119. 8. Krahn et al. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation 1999;99:406-410.


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PICTURE STUDY1: OVERVIEW

PICTURE was a prospective, multi-center, observational study conducted from November 2006 to October 2009

PICTURE aimed to:

Collect information on the use of the Reveal™ ICM in the syncope patient care pathway

Investigate Reveal ICM’s effectiveness in the diagnosis of unexplained recurrent syncope in everyday clinical practice

71 sites from 11 European and Middle Eastern countries

1. Edvardsson N, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry Europace 2011;13:262-269


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PICTURE STUDY RESULTS

70% of patients had been hospitalized at least once for syncope

36% of patients had experienced significant trauma in association with a syncopal episode

Overall, patients had seen an average of 3 different specialists for their syncope


PATIENT EXPERIENCE1


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PICTURE STUDY RESULTSDIAGNOSTIC TESTS PERFORMED1

The median number of tests performed per patient was 13 (inter-quartile range 9 - 20)



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PICTURE STUDY RESULTSSYNCOPE RECURRENCE AND DIAGNOSTIC YIELD1


During follow-up, 38% of patients had a recurrence of syncope within 1 year

Reveal™ ICMs guided diagnosis in 78% of patients with recurrence


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PICTURE STUDY RESULTSTREATMENT DECISIONS MADE IN RELATION TO SYNCOPE DIAGNOSIS1

Of the 170 Reveal ICM-guided diagnoses, 75% were cardiac-related



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SUPERIOR DIAGNOSTIC YIELD THAN CONVENTIONAL TESTS

Patients with unexplained syncope and without a pacing indication following basic clinical work-up, tilt-test and 24-h Holter

Randomized to Reveal (n=103) or conventional testing (n=98)

Median follow-up: 17 months

More ICM patients received an ECG diagnosis than by conventional testing (43% vs 6%; HR 6.53 [95% CI 3.73-11.4]; p<0.001)

Time to ECG directed therapy was 6.5x quicker for ILR group (P<0.001)

6.5 x more ICM patients diagnosed

6.5 x more ICM patients treated

1. Farwell DJ, et al. The clinical impact of implantable loop recorders in patients with syncope. Eur Heart Journal 2006;27:351-356

6.5X MORE PATIENTS DIAGNOSED1


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PROLONGED MONITORING IS NEEDEDTHE MORE YOU LOOK, THE MORE YOU FIND1

When a strategy of prolonging monitoring is chosen, monitoring should be maintained even for several years until a diagnosis is established.1

1 Furukawa T, Maggi R, Bertolone C, Fontana D, Brignole M. Additional diagnostic value of very prolonged observation by implantable loop recorder in patients with unexplained syncope. J Cardiovasc Electrophysiol 2012;23:67–71.


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ICMs ARE A COST-EFFECTIVE DIAGNOSTIC TOOLPICTURE: EDVARDSSON, EUROPACE 2011 AND 20151,2

Average spending amount to €2,000(£1,613) for diagnostic tests per patient, without establishing a diagnosis.

Prior to ICM implant, only 12% of patients had tests within current guideline recommendations; up to 10% of patients had tests exceeding £3540

The early use of specialized tests and the repetition of tests can be reduced

ICMs are a cost-effective strategy for patients with infrequent episodes of unexplained syncope


1. Edvardsson N, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry Europace 2011;13:262-2692. Edvardsson N et al. Costs of unstructured investigation of unexplained syncope: insights from a micro-costing analysis of the observational PICTURE registry. Europace 2015; 17:1141-48

RECOMMENDATIONS

SYNCOPE DIAGNOSIS

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1. 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). Eur. Heart J. 30, 2631–2671 (2009).

GOLD STANDARD

“The gold standard for the diagnosis of syncope is when a correlationbetween the symptoms and a documented arrhythmia is recorded.”1


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ESC GUIDELINES ON SYNCOPE

Class I ICM Guidelines• Indicated in early phase of evaluation in patients with recurrent syncope of uncertain origin,

absence of high risk criteria and a high likelihood of recurrence within battery longevity of the device.

• Indicated in high risk individuals in whom comprehensive evaluation did not demonstrate a cause of syncope or lead to a specific treatment.

RECOMMENDATION FOR USE OF ICM

Moya el al. Guidelines for the diagnosis and management of syncope. European Heart Journal 2009; 30:2631-71.


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ESC GUIDELINES ON CARDIAC PACING AND CRTDIAGNOSTIC TESTING ACCORDING TO FREQUENCY OF SYMPTOMS1

1. Brignole et al. ESC Guidelines on cardiac pacing and cardiac resynchronisation therapy. Eur Heart Journal (2013) 34, 2281–2329


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USE OF ICM IN SYNCOPE PATHWAY REMAINS INEFFICIENT

42 European centers evaluated use of ICM in clinical practice

Less than 20% of patients with unexplained syncope received an ICM in accordance with guidelines

There is poor adherence to guidelines regarding use of ICM in unexplained syncope

1. Sciaraffia et al. Use of event recorders and loop recorders in clinical practice: results of the European Heart Rhythm Association Survey. Europace 2014;16:1384-86

EHRA SURVEY, EUROPACE 20141


Patient AssistantInsertion Tools NEW App-based Reveal LINQ Mobile Manager

Solution Enablers

CareLink™ Network & Reports

MyCareLink™ Patient Monitor

Reveal LINQ™ ICM Wireless Cellular

NEW FocusOn™ Monitoring Service

REVEAL LINQ™ SYSTEMAN ADVANCED MONITORING SYSTEM


REVEAL LINQ SYSTEMREVOLUTIONIZING CARDIAC MONITORING

The smallest, most powerful insertable cardiac monitor

One-third the size of a AAA battery (1.2 cc)

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Up to a 3-year longevity for long-term monitoring1

MR Conditional at 1.5 and 3.0 Tesla

Minimally invasive, simplified insertion procedure2


1 Reference the Reveal LINQ ICM Clinician Manual for usage parameters.2 Reveal LINQ Usability Study. Medtronic data on file. 2013.

REVEAL LINQ™ SYSTEMSIMPLE INSERTION PROCEDURE

Best location: 45 degrees to sternum over 4th intercostal space, 2 cm from left edge of sternum

97%Of physicians found the insertion tool simple and intuitive.1


1 Reveal LINQ Usability Study. Medtronic data on file. 2013.

PUTTING IT INTO PRACTICE

Structured Care Pathway To maximize implementation of the guidelines “a cohesive, structured care

pathway is recommended for the global assessment of patients with suspected syncope.”

A Multidisciplinary Approach “Experience and training in key components of cardiology, neurology, emergency

and geriatric medicine are pertinent”

Syncope Unit Implementation “A structured care pathway – either delivered within a single syncope facility or as

a more multi-faceted service – is the optimal for quality service delivery.”

Endorsed by: • European Society of Emergency Medicine European

Federation of Internal Medicine• European Union Geriatric Medicine Society• European Neurological Society• European Federation of Autonomic Societies

COLLABORATIVE RECOMMENDATION


SYNCOPE TESTING PATHWAY


SHD = Structural Heart DiseaseCSM = Carotid Sinus MassageEPS = Electrophysiologic Study*Provides up to 36 months of continuous monitoring.This is a general protocol to assist with the management of patients. This is not designed to replace clinical judgment or individual patients needs.

Flowchart adapted from: 1. Olshansky B. Syncope: Overview and approach to management. In: Grubb B and Olshansky B. eds. Syncope: Mechanisms and Management. 2nd ed.

Malden, MA: Blackwell Futura; 2005:1-46.2. Krahn AD, Klein GJ, Yee R, Skanes AC. The use of monitoring strategies in patients with unexplained syncope – role of the external and ILR. Clin Auton Res.

October 2004;14(Suppl 1):55-613. Raviele A, Alboni P, Sutton D, Kenny RA. Initial evaluation of the syncope patient. In: Benditt D, Blanc J-J, Brignole M, Sutton R, eds. The Evaluation and

Treatment of Syncope. Elmsford, NY: Futura. 2003:38-45.4. Strickberger SA, Benson DW, Biaggioni I, et al. AHA/ACCF Scientific Statement on the evaluation of syncope: from the American Heart Association

Councils on Clinical Cardiology, Cardiovascular Nursing, Cardiovascular Disease in the Young, and Stroke, and the Quality of Care and Outcomes Research Interdisciplinary Working Group; and the American College of Cardiology Foundation: in collaboration with the Heart Rhythm Society: endorsed by the American Autonomic Society. Circulation. January 17, 2006;113(2):316-327.

5. Brignole M, Alboni P, Benditt DG, et al. Guidelines on management (diagnosis and treatment) of syncope – update 2004. Europace. November 2004;6(6):467-537.

6. Kaufmann H, Wieling W. Syncope: a clinically guided diagnostic algorithm. Clin Auton Res. October 2004;14 (Suppl 1):87-90.

No

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CONCLUSIONS

Syncope care pathway remains inefficient, despite guidelines.

ICMs should be implanted earlier in evaluation as supported by guidelines.1-4

In unexplained syncope, ICMs provide superior diagnostic yield compared to conventional tests, increasing rate of guideline directed therapy.5-8

ICMs are cost-effective.5,9-11 Used sooner in a syncope care pathway, an ICM can reduce testing without losing diagnostic yield.

A multidisciplinary approach is needed to improve syncope patient care.1

1 Mendu M, et al. Arch Intern Med. 2009;169:1599-1305.2 Edvardsson N, et al. Europace. 2011;13:262-269.3 Edvardsson N, et al. Europace. 2015;17:1141-1148.4 Sciaraffia E, et al. Europace. 2014;16:1384-1386.5 Krahn AD, et al. J Am Coll Cardiol. 2003;42:495-501.6 Farwell DJ, et al. Eur Heart J.. 2006;27:351-356.


7 Da Costa A, et al. Arch Cardiovasc Dis. 2013;106:146-154.8 Podoloneau C, et al. Arch Cardiovasc Dis. 2014;107:546-552.9 Farwell DJ, et al. Eur Heart J..2004;25:1257-1263.

10 Davis S, et al. Europace. 2012;14:402-409.11 Providência R, et al. BMC Cardiovasc Disord. 2014;14:63.

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Brief statementSee the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and / or consult the Medtronic website at www.medtronic.com.

Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.

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syncope therapy awareness presentation - medtronic · 13 tests, and 1/3 have significant associated...

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