Mitchell Elkind

and 10 more

Objective: To evaluate the cost-effectiveness of insertable cardiac monitors (ICMs) compared to standard of care (SoC) for detecting atrial fibrillation (AF) in patients at high risk of stroke (CHADS2 >2), in the US. Background: ICMs are a clinically effective means of detecting AF in high-risk patients, prompting the initiation of non-vitamin K oral anticoagulants (NOACs). Their cost-effectiveness from a US clinical payer perspective is not yet known. Methods: Using patient data from the REVEAL AF trial (n= 446, average CHADS2 score= 2.9), a Markov model estimated the lifetime costs and benefits of detecting AF with an ICM or with SoC (namely, intermittent use of electrocardiograms [ECGs] and 24-hour Holter monitors). Ischemic and hemorrhagic strokes, intra- and extra-cranial hemorrhages, and minor bleeds were modelled. Diagnostic and device costs were included, plus costs of treating stroke and bleeding events and of NOACs. Costs and health outcomes, measured as quality-adjusted life years (QALYs), were discounted at 3% per annum. One-way deterministic and probabilistic sensitivity analyses (PSA) were undertaken. Results: Lifetime per-patient cost for ICM was $58,132 vs. $52,019 for SoC. ICMs generated a total 7.75 QALYs vs. 7.59 for SoC, with 34 fewer strokes projected per 1,000 patients. The incremental cost-effectiveness ratio (ICER) was $35,452 per QALY gained. ICMs were cost-effective in 72% of PSA simulations, using a $50,000 per QALY threshold. Conclusions: The use of ICMs to identify AF in a high-risk population is likely to be cost-effective in the US healthcare setting.

Graham Lohrmann

and 4 more

Background: Ablation for atrial fibrillation (AF) has emerged as an effective method of rhythm control. This exploratory analysis aimed to determine how various measures of recurrence would influence the definition of treatment success. Methods: Using an EHR dataset from 01/2007-06/2019 linked with Medtronic cardiac implantable electronic device (CIED) data, patients who underwent a first AF ablation procedure following CIED implantation were identified. Data were analyzed for recurrence of AF stratified by varying definitions of successful ablation. Performance of various simulated external AF monitoring strategies was assessed. Results: A total of 665 patients were analyzed including 248 with paroxysmal AF (mean age 66.2±9.3 years, 73.0% male) and 417 patients with persistent AF (mean age 67.3±9.0 years, 73.6% male). Patients with paroxysmal AF, survival free from recurrence at 1 year ranged from 28.2% to 72.1% (>6 min and >23 hours thresholds, respectively) with an overall median percentage of time in AF reduction of 99.6%. Patients with persistent AF, survival free from recurrence at 1 year ranged from 24.9% to 60.0% (>6 min and 7 consecutive days >23 hours thresholds, respectively) with an overall median percentage of time in AF reduction of 99.3%. A single 7-day monitoring strategy had a sensitivity of < 50% for detecting AF > 6 min in patients with paroxysmal and persistent AF. Conclusion: In this real-world dataset of AF patients with CIEDs undergoing catheter ablation, treatment success varied substantially with different definitions of minimally required AF duration and is significantly impacted by the method of recurrence detection.