Author + information
- Received October 12, 2011
- Revision received November 28, 2011
- Accepted December 15, 2011
- Published online April 3, 2012.
- Howard C. Herrmann, MD⁎,⁎ (, )
- Zachary M. Gertz, MD⁎,
- Frank E. Silvestry, MD⁎,
- Susan E. Wiegers, MD⁎,
- Y. Joseph Woo, MD⁎,
- James Hermiller, MD†,
- Douglas Segar, MD†,
- David Heimansohn, MD†,
- William Gray, MD‡,
- Shunichi Homma, MD‡,
- Michael Argenziano, MD‡,
- Andrew Wang, MD§,
- James Jollis, MD§,
- Mark B. Lampert, MD∥,
- John Alexander, MD∥,
- Laura Mauri, MD¶,
- Elyse Foster, MD#,
- Donald Glower, MD§ and
- Ted Feldman, MD∥
- ↵⁎Reprint requests and correspondence:
Dr. Howard C. Herrmann, Director, Interventional Cardiology and Cardiac Catheterization Labs, Hospital of the University of Pennsylvania, 3400 Spruce Street, 9 Gates West, Philadelphia, Pennsylvania 19104-4283
Objectives The purpose of this study was to characterize patients with mitral regurgitation (MR) and atrial fibrillation (AF) treated percutaneously using the MitraClip device (Abbott Vascular, Abbott Park, Illinois) and compare the results with surgery in this population.
Background The EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) randomized controlled trial compared a less invasive catheter-based treatment for MR with surgery, providing an opportunity to assess the impact of AF on the outcomes of both the MitraClip procedure and surgical repair.
Methods The study population included 264 patients with moderately severe or severe MR assessed by an independent echocardiographic core laboratory. Comparison of safety and effectiveness study endpoints at 30 days and 1 year were made using both intention-to-treat and per-protocol (cohort of patients with MR ≤2+ at discharge) analyses.
Results Pre-existing AF was present in 27% of patients. These patients were older, had more advanced disease, and were more likely to have a functional etiology. Similar reduction of MR to ≤2+ before discharge was achieved in patients with AF (83%) and in patients without AF (75%, p = 0.3). Freedom from death, mitral valve surgery for valve dysfunction, and MR >2+ was similar at 12 months for AF patients (64%) and for no-AF patients (61%, p = 0.3). At 12 months, MR reduction to <2+ was greater with surgery than with MitraClip, but there was no interaction between rhythm and MR reduction, and no difference in all-cause mortality between patients with and patients without AF.
Conclusions Atrial fibrillation is associated with more advanced valvular disease and noncardiac comorbidities. However, acute procedural success, safety, and 1-year efficacy with MitraClip therapy is similar for patients with AF and without AF.
Dr. Herrmann has received research funding from Abbott Vascular; and has equity in Micro Interventional Devices Inc. Dr. Hermiller is a consultant for Abbott Vascular. Dr. Gray has received research support and is a consultant for Abbott Vascular. Dr. Argenziano is a consultant receiving fees from Abbott Vascular. Dr. Wang has received research funding from Abbott Vascular and Gilead Sciences; and is on the clinical events committee for Edwards Lifesciences. Dr. Mauri has received grant support from Abbott Vascular, Boston Scientific, Cordis, Medtronic, Eli Lilly, Bristol-Myers Squibb, Sanofi-Aventis, and Daiichi Sankyo; is a consultant for Abbott Vascular, and Cordis; and is an expert witness for Cordis. Dr. Foster has received grant support from Abbott Vascular. Dr. Glower has received grant support from Abott Laboratories. Dr. Feldman is a consultant and receives research grants from Abbott, Boston Scientific, and Edwards. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 12, 2011.
- Revision received November 28, 2011.
- Accepted December 15, 2011.
- American College of Cardiology Foundation