The Risk of No Diagnosis in Cryptogenic Stroke and Syncope

Cryptogenic stroke and syncope patients who leave the hospital without a diagnosis are at a significant risk for secondary strokes and syncopal events (fainting/falls). Only comprehensive, extended ambulatory ECG monitoring (>30 days) can either document an arrythmia or confidently allow the clinician to rule out an arrhythmogenic cause. In both cases, enabling the patient to be on optimal therapies.

Additional Use Cases

Arrhythmia Detection is Vital

Detection leads to differential diagnosis, optimal treatment and protection against recurrent stroke or syncopal events.

Detect

Treat

Protect

What is Cryptogenic Stroke?

An ischemic stroke where the underlying cause cannot be determined despite extensive testing is called a cryptogenic (or unexplained) stroke.

Cryptogenic stroke is devastating for patients and their families

stroke hospitalizations annually1
795 k
guideline-recommended ECG patients1
~ 240 k

2021 AHA/ASA Guidelines for Secondary Stroke Prevention

Guidelines for monitoring in Cryptogenic Stroke

Atrial fibrillation (AF) detection leads to treatment with oral anticoagulants and a signficant decrease in recurrent strokes

Secondary Stroke Risk

1 in 4

cryptogenic stroke patients have a recurrent stroke within 5 years2

of strokes are cryptogenic (unexplained)3
~ 35 %
increase in ischemic stroke with AF4
5 x
increased risk of fatal, AF-related stroke5
2 x
decrease in stroke risk with OACs6
67 %

What is Syncope?

Syncope (pronounced SIN-ko-pee) is a sudden, brief loss of consciousness, also called fainting, which occurs when there is a sudden decrease in blood flow to the brain. 

Unexplained Syncope is dangerous for patients

Woman lying on floor after fainting
syncope ER visits annually7
740 k
guideline-recommended ECG patients7
~ 125 k

2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope

Detecting bradycardia or heart block leads to treatment with a pacemaker and protection against recurrent syncopal events

Faint/Fall Risk

1 in 2

syncope patients leave the hospital without a diagnosis7

increased risk of death8
2 x
mortality rate at 6 months8
> 10 %
increased risk of occupational accidents9
1.4 x
increased risk of loss of employment9
2 x

Guidelines Recommend ECG Monitoring 

Cryptogenic Stroke and Unexplained Syncope

Medical guidelines already support ECG monitoring to detect arrhythmias in cryptogenic stroke and syncope patients to best inform ongoing treatment decisions.

But, the current standard of care options for ambulatory ECG monitoring devices don’t provide adequate options for patients.

ECG image

Current ECG Monitors Limit Successful Protection

Short-Term

Holter Patch and MCT Monitors

Don't monitor long enough

Long-Term

Implantable Loop Recorders

Monitoring so long has real costs

Monitoring for up to 180 Days is Critical

Median time to the next actionable event for cryptogenic stroke and syncope patients

The HeartWatch™ covers patients from Day 0 through Diagnosis with an ECG monitor that can comfortably be worn for months at a time. 

Revolutionizing ECG Monitoring

The HeartWatch 

Pioneering the first medical-grade ambulatory ECG monitor specifically designed for extended wear, to provide a definitive diagnosis and enable patient-specific treatments.

Comfort. Accuracy. Access. 

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References
  1. Tsao CW, Aday AW, Almarzooq ZI, et al. Heart Disease and Stroke Statistics—2022 Update: A Report From the American Heart Association. Circulation. February 22, 2022;145(8):e153–e639.
  2. Mohan KM, Wolfe CD, Rudd AG, Heuschmann PU, Kolominsky-Rabas PL, Grieve AP. Risk and cumulative risk of stroke recurrence: a systematic review  and meta-analysis. Stroke. May 2011;42(5):1489-1494.
  3. Kleindorfer DO, Towfighi A, Chaturvedi S, et al. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. July 2021;52(7):e364-e467.
  4. Wolf PA, Abbott RD, Kannel. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. August 1991;22(8):983-988.
  5. Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation. The Framingham Study. Stroke. October 1996;27(10):1760-1764.
  6. Segal JB, McNamara RL, Miller MR, et al. Prevention of thromboembolism in atrial fibrillation. A meta-analysis of trials of anticoagulants and antiplatelet drugs. J Gen Intern Med. 2000;15:56-67.
  7. Esther M. Mizrachi; Kranthi K. Sitammagari. Cardiac Syncope. National Library for Medicine. https://www.ncbi.nlm.nih.gov/books/NBK526027/
  8. Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope. N Engl J Med. September 19, 2002;347(12):878-885.
  9. Numé AK, Kragholm K, Carlson N, et al. Syncope and Its Impact on Occupational Accidents and Employment. Circ Cardiovasc Qual Outcomes. April 2017;10(4).