ICM evidence for AF 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

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

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

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

  

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