Effects of Atrial Fibrillation on Treatment of Mitral Regurgitation in the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) Randomized Trial
Key result
Pre-existing atrial fibrillation was associated with similar 12-month freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ compared to no atrial fibrillation (64% vs 61%, p=0.3).
Why the study?
The authors sought to characterize patients with mitral regurgitation and atrial fibrillation treated percutaneously using the MitraClip device and compare the results with surgery in this population.
Population
264 patients with moderately severe or severe MR
Comparison
Percutaneous MitraClip device vs surgery
Design
Randomized controlled trial
Follow-up
1 year
Authors
Discussion
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Implication
Randomized trial demonstrates consistent MitraClip efficacy regardless of atrial fibrillation status in mitral regurgitation, indicating rhythm abnormalities do not impede procedural success.
Key Points
- To characterize outcomes of patients with mitral regurgitation and atrial fibrillation undergoing percutaneous MitraClip repair compared to conventional surgery.
- Randomized trial evaluating 264 patients with moderately severe or severe mitral regurgitation assessed by an independent echocardiographic core laboratory.
- Compared safety and effectiveness endpoints of percutaneous catheter-based MitraClip repair versus surgery at 30 days and 1 year using intention-to-treat and per-protocol analyses.
- Pre-existing atrial fibrillation was present in 27% of patients, and post-procedure reduction of mitral regurgitation to ≤2+ before discharge was 83% in patients with atrial fibrillation versus 75% in patients without it (p = 0.3).
- Twelve-month freedom from death, mitral valve surgery for dysfunction, and mitral regurgitation >2+ was 64% in the atrial fibrillation group versus 61% in the non-atrial fibrillation group (p = 0.3).
- At 12 months, mitral regurgitation reduction to <2+ was greater with surgery than MitraClip, but there was no interaction between heart rhythm and regurgitation reduction, and no difference in all-cause mortality between rhythm cohorts.
Study Design
Type
RCT (n=264)
PICO
P
Population
264 patients with moderately severe or severe mitral regurgitation were evaluated to assess the impact of pre-existing atrial fibrillation on 1-year outcomes.
E
Exposure / Comparator
Pre-existing atrial fibrillation vs No atrial fibrillation
O
Primary Outcome
Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ at 12 months, p=0.3
Main Result
Absolute Event Rate: 64% vs 61%
p-value: p=0.3
Cite This Study
Herrmann et al. (2012) conducted an RCT in Mitral regurgitation and atrial fibrillation (n=264). Pre-existing atrial fibrillation vs. No atrial fibrillation was evaluated on Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ at 12 months (p=0.3). Pre-existing atrial fibrillation was associated with similar 12-month freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ compared to no atrial fibrillation (64% vs 61%, p=0.3).