Atrial Fibrillation Patient

SUSPECTED ATRIAL FIBRILLATION CARDIAC DIAGNOSTICS & MONITORING

Make the connection between atrial fibrillation and heart palpitations for patients at high risk

Atrial Fibrillation & Stroke:
A Global Health Challenge

Atrial fibrillation (AF or AFib) is the most common sustained heart rhythm disorder and increases the risk for heart disease and stroke, both leading causes of death1

15 million people worldwide experience a stroke each year

AF Detection and Treatment Matters

  

5-fold increase in ischemic stroke risk for AF patients - 2x more likely for AF-related ischemic stroke to be fatal as non-AF stroke - 67% decrease in AF patient stroke risk with oral anticoagulants

DIFFICULTIES IN AF DETECTION

  

~90% of AF episodes may be asymptomatic - ~30% of AF is paroxysmal - Stroke is the first symptom for -20% of patients who have an AF-related stroke

Short-term and intermittent cardiac monitoring may miss many patients with paroxysmal AF7-9

  • Short-term monitoring via 24-hour Holter has low sensitivity and negative predictive value for AF detection.7
  • Intermittent and symptom-based monitoring has a significantly lower sensitivity and negative predictive value for AF detection compared with continuous monitoring.8

Longer, continuous monitoring periods result in higher AF detection.9


Are you monitoring high-risk patients long enough?

Detection rate of patients with AF of ≥ 6 minutes in duration10

AF detection Rate (%) over number of months post-insertion
40% AF detection rate in high-risk patients at 30 months - 123 Days was the median time to AF detection in high-risk patients - 85% of patients with AF would have been missed if only monitored for 30 days

SUPERIOR DIAGNOSTIC YIELD

12 Month Estimated AF Detection Rates for One-time, Repeated, and Continuous Monitoring11-14

Incidence of AF detected (%) over one-time monitoring, repeated monitoring and continuous monitoring
  • The AF incidence rate via ICM at 12 months was 27.1%.
  • This exceeded range of estimated rates from all forms of simulated IM (1.1-13.5%).

95% CI included for ICM and one-time monitoring incidence rates.

Range included for repeated monitoring incidence rates.

AF & STROKE: RISK FACTORS15,16

CHADS2 Score: Evaluates ischemic stroke risk in patients with AF
  • Congestive heart failure
  • Hypertension
  • Age
  • Diabetes
  • Stroke/TIA/ thromboembolism

SOCIETY RECOMMENDATIONS & GUIDELINES

INSERTABLE CARDIAC MONITORING

EHRA Recommendations17

The European Heart Rhythm Association (EHRA) recommends insertable loop recorders (insertable cardiac monitors) like Reveal LINQ™ ICM for palpitations for the following indications:

  • Increasing monthly in frequency
  • Associated with hemodynamic compromise
  • Other listed examinations prove inconclusive
  • Non-compliant patients without hemodynamic compromise when a clinically significant arrhythmic cause is likely or must be ruled out
ERHA recommendations flow chart

ACC/AHA Ambulatory ECG Guidelines 200018

These guidelines represent some of the current common clinical uses of ambulatory ECG.

For Assessment of Symptoms of Cardiac Arrhythmias

Class Recommended Use

I

  1. Patients with unexplained syncope, near syncope, or episodic dizziness without obvious cause.
  2. Patients with unexplained recurrent palpitation.

IIb

  1. Patients with episodic shortness of breath, chest pain, or fatigue that is not otherwise explained.
  2. Patients with neurologic events when transient atrial fibrillation or flutter is suspected.
  3. Patients with symptoms such as syncope, near syncope, episodic dizziness, or palpitation in whom a probable cause other than an arrhythmia has been identified but in whom symptoms persist despite treatment of this other cause.

Indications for AECG to Assess Symptoms Possibly Related to Rhythm Disturbances

Class Recommended Use

I

  1. Patients with unexplained syncope, near syncope, or episodic dizziness without obvious cause.
  2. Patients with unexplained recurrent palpitation.

IIb

  1. Patients with episodic shortness of breath, chest pain, or fatigue that is not otherwise explained.
  2. Patients with neurologic events when transient atrial fibrillation or flutter is suspected.
  3. Patients with symptoms such as syncope, near syncope, episodic dizziness, or palpitation in whom a probable cause other than an arrhythmia has been identified but in whom symptoms persist despite treatment of this other cause.

Evidence for Cardiac monitoring

Reveal ICM: Clinical and Cost Effectiveness19

Higher Diagnostic Yield, Lower Cost for Palpitations Diagnosis

Reveal ICM has been shown to be both clinically effective and cost effective when treating palpitations.

Results of the RUP study show:

  • A 73% diagnostic yield for Reveal ICM, compared to a 21% yield for conventional tests
  • Conventional testing arm was 121% more expensive than ICM arm.
rup study palpitation chart

1

World Heart Federation statistics. http://www.world-heart-federation.org/cardiovascular-health/stroke/.

2

Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart Disease and Stroke Statistics — 2017 Update. A Report From the American Heart Association. Circulation. March 7, 2017;135(10):e146-e603.

3

Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke severity in atrial fibrillation: The Framingham Study. Stroke. October 1996;27(10):1760-1764.

4

Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):527-539.

5

Strickberger SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. February 2005;2(2):125-131.

6

Chiang CE, Naditch-Brûlé L, Murin J, et al. Distribution and risk profile of paroxysmal, persistent, and permanent atrial fibrillation in routine clinical practice: insight from the real-life global survey evaluating patients with atrial fibrillation international registry. Circ Arrhythm Electrophysiol. August 1, 2012;5(4):632-639.

7

Hanke T, Charitos EI, Stierle U, et al. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation. September 15, 2009;120(11 Suppl):S177-S184.

8

Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. December 2006;3(12):1445-1452.

9

Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. July 2004;35(7):1647-1651.

10

Reiffel JA, Verma A, Kowey PR, et al. High Incidence of Previously Unknown (“Silent”) Atrial Fibrillation in Patients at High Risk for Atrial Fibrillation and Stroke: Primary Results from the REVEAL AF Study. Abstract presented at Heart Rhythm Society Annual Scientific Sessions. 2017.

11

Reiffel JA, Verma A, Kowey PR, et al. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. October 1, 2017;2(10):1120-1127.

12

Nasir JM, Pomeroy W, Marler A, et al. Predicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF) Study. Heart Rhythm. July 2017;14(7):955-961.

13

Healey JS, Alings M, Ha A, et al. Subclinical Atrial Fibrillation in Older Patients. Circulation. October 3, 2017;136(14):1276-1283.

14

Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. December 26, 2017;3(13):1557-1564.

15

January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. December 2, 2014;130(23):2071-2104.

16

Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. November 2016;18(11):1609-1678.

17

Raviele A, Giada F, Bergfeldt L, et al. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. July 2011;13(7):920-934.

18

ACC/AHA Guidelines for Ambulatory Electrocardiography: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the Guidelines for Ambulatory Electrocardiography). JACC. 1999.

19

Giada F, Gulizia M, Francese M, et al. Recurrent unexplained palpitations (RUP) study comparison of implantable loop recorder versus conventional diagnostic strategy. J Am Coll Cardiol. May 15, 2007;49(19):1951-1956.