ICM EVIDENCE FOR AF MANAGEMENT

Studies of insertable cardiac monitor use in atrial fibrillation management

DISCERN AF Study

Reveal™ ICM Detects AF Burden Correctly 98% of the Time1

Objective

  • Compare symptomatic AF recurrences in patients both pre-ablation & post-ablation

Methods

  • 50 patients implanted >3 months pre-ablation
  • Followed for >18 months post-ablation
  • Reveal™ XT AF episodes adjudicated and compared against patient symptom diary

Results

  • The ratio of Asymptomatic AF episodes increased 3x after ablation.
  • 12% of patients had ONLY Asymptomatic AF post-ablation.
  • The AF Burden as recorded by XT was correct 98% of the time.
  • Each AF episode was correct 69% of the time.

Episode vs Burden

DISCERN AF Results Chart


Perception of Atrial Fibrillation Before and After Radiofrequency Catheter Ablation

Relevance of Asymptomatic Arrhythmia Recurrence2

Overview

Prospective study of 114 AF-ablation patients followed by 7-day Holter before ablation, right after ablation, and after 3, 6, and 12 months of follow-up.

Conclusion

“Even in patients presenting with highly symptomatic AF, asymptomatic episodes may occur and significantly increase after catheter ablation. A symptom-only-based follow-up would substantially overestimate the success rate.”

Rhythm Outcome and Perception of AF Before and After RF Ablation

Mittal AF Management Results Chart


ABACUS Study

More Patients Properly Detected and More Decisions Made with Reveal ICM3

Methods

  • 44 post-ablation patients
  • 1st 6 months: Observational period using Reveal + two 30-day event monitors + daily pulse checks
  • Next 6 months: Randomized to guide treatment
    • One arm using only Reveal data
    • One arm using only a 3rd event monitor

Results

  • 96% of patients with AF were found by Reveal ICM.
    • “Conventional Monitoring” missed 29% in first 6 mo.
  • Reveal episode specificity: 90% of false-detects were from just 14 patients (all pre-FullView)
  • Rate Control and Anti-Arrhythmic drugs were discontinued more in the Reveal Arm (p=0.02, p=0.04)
  • Asymptomatic AF documented in 70% of pts.
  • 16% of Reveal patients had other actionable brady/tachy events vs. 0% in “Conventional” arm

Differences in AF Detection Chart

Antiarrhythmic Drug Discontinuation Chart

More patients discontinue AADs with Reveal™ insertable cardiac monitoring


New-Onset AF (NOAF) Following AFL Ablation

Majority of Patients Had NOAF; ILR Needed to Detect AF4

Methods

  • Observational study to assess % of patients having new-onset AF after AFL ablation.
  • n=20 with 2-3 CHADS risk factors.
  • Approximately 1 year follow-up.

Results

  • 55% of patients had NOAF at an average of 62 days post-ablation.
  • 4 patients showed false detects (sinus tach with frequent PACs)
  • Approximately 1 year follow-up.
    • But associated with <1% AF burden

    Freedom From AF Chart

    The average time to diagnosis of new-onset AF makes the ICM an important tool in this population.

References

1Verma, Atul, Champagne, Jean, et al. Discerning the Incidence of Symptomatic and Asymptomatic Episodes of Atrial Fibrillation Before and After Catheter Ablation (DISCERN AF). JAMA Intern Med. 2013;173(2):149-156. doi:10.1001/jamainternmed.2013.1561.

2Mittal S, Pokushalov E, et al. Long-Term ECG Monitoring Using an Implantable Loop Recorder for the Detection of Atrial Fibrillation Following Cavotricuspid Isthmus Ablation in Patients with Atrial Flutter. Heart Rhythm. 2013 Jul 30. [Epub ahead of print]

3Hindricks G. et al. Perception of Atrial Fibrillation Before and After Radiofrequency Catheter Ablation - Relevance of Asymptomatic Arrhythmia Recurrence. Circulation. 2005;112:307-313.

4Kapa S, Epstein AE, et al. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. 2013 Aug;24(8):875-81. doi: 10.1111/jce.12141. Epub 2013 Apr 11.