Author + information
- Received October 1, 2013
- Revision received October 22, 2013
- Accepted October 22, 2013
- Published online July 15, 2014.
- D. Scott Lim, MD∗∗ (, )
- Matthew R. Reynolds, MD, MSc†,‡,
- Ted Feldman, MD§,
- Saibal Kar, MD‖,
- Howard C. Herrmann, MD¶,
- Andrew Wang, MD#,
- Patrick L. Whitlow, MD∗∗,
- William A. Gray, MD††,
- Paul Grayburn, MD‡‡,
- Michael J. Mack, MD‡‡ and
- Donald D. Glower, MD#
- ∗Division of Cardiology, University of Virginia, Charlottesville, Virginia
- †Harvard Clinical Research Institute, Boston, Massachusetts
- ‡Division of Cardiology, Lahey Clinic Medical Center, Burlington, Massachusetts
- §Northshore University Health System, Chicago, Illinois
- ‖Heart Institute, Cedars Sinai Medical Center, Los Angeles, California
- ¶Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania
- #Duke University Medical Center, Durham, North Carolina
- ∗∗Cleveland Clinic Foundation, Cleveland, Ohio
- ††Center for Interventional Vascular Therapy, Columbia University, New York, New York
- ‡‡Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas
- ↵∗Reprint requests and correspondence:
Dr. D. Scott Lim, Division of Cardiology, Department of Medicine, University of Virginia, Hospital Expansion, Room 4033, 1215 Lee Street, Charlottesville, Virginia 22908-0386.
Background Surgical mitral valve repair (SMVR) remains the gold standard for severe degenerative mitral regurgitation (DMR). However, the results with transcatheter mitral valve repair (TMVR) in prohibitive-risk DMR patients have not been previously reported.
Objectives This study aimed to evaluate treatment of mitral regurgitation (MR) in patients with severe DMR at prohibitive surgical risk undergoing TMVR.
Methods A prohibitive-risk DMR cohort was identified by a multidisciplinary heart team that retrospectively evaluated high-risk DMR patients enrolled in the EVEREST (Endovascular Valve Edge-to-Edge Repair Study) II studies.
Results A total of 141 high-risk DMR patients were consecutively enrolled; 127 of these patients were retrospectively identified as meeting the definition of prohibitive risk and had 1-year follow-up (median: 1.47 years) available. Patients were elderly (mean age: 82.4 years), severely symptomatic (87% New York Heart Association class III/IV), and at prohibitive surgical risk (STS score: 13.2 ± 7.3%). TMVR (MitraClip) was successfully performed in 95.3%; hospital stay was 2.9 ± 3.1 days. Major adverse events at 30 days included death in 6.3%, myocardial infarction in 0.8%, and stroke in 2.4%. Through 1 year, there were a total of 30 deaths (23.6%), with no survival difference between patients discharged with MR ≤1+ or MR 2+. At 1 year, the majority of surviving patients (82.9%) remained MR ≤2+ at 1 year, and 86.9% were in New York Heart Association functional class I or II. Left ventricular end-diastolic volume decreased (from 125.1 ± 40.1 ml to 108.5 ± 37.9 ml; p < 0.0001 [n = 69 survivors with paired data]). SF-36 quality-of-life scores improved and hospitalizations for heart failure were reduced in patients whose MR was reduced.
Conclusions TMVR in prohibitive surgical risk patients is associated with safety and good clinical outcomes, including decreases in rehospitalization, functional improvements, and favorable ventricular remodeling, at 1 year. (Real World Expanded Multi-center Study of the MitraClip System [REALISM]; NCT01931956)
Dr. Lim is a consultant for and has received research grants from Abbott. Dr. Reynolds receives research grant support from Edwards Lifesciences; and is a consultant for Medtronic and St. Jude Medical. Dr. Feldman is a consultant for and has received honoraria/institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore. Dr. Kar has received honoraria/institutional research support from Abbott. Dr. Herrmann receives research funding to his institution from Abbott Vascular, Edwards Lifesciences, St. Jude Medical, Medtronic, WL Gore, and Siemens Healthcare; and he has equity in Microinterventional Devices. Dr. Wang has received research grants from Abbott, Edwards Lifesciences, Gilead Sciences, and the American Heart Association (Mid-Atlantic Affiliate). Dr. Whitlow’s institution has received research support for participating in the EVEREST trials from Abbott. Dr. Gray is a consultant for, and has received research grant support from, Abbott Vascular. Dr. Grayburn has received grants from Abbott Vascular, Medtronic, Baxter, ValTech Cardio, and Guided Delivery Systems; and consulting fees/honoraria from Abbott Vascular, Tendyne, and Bracco Diagnostics. All authors have reported that they have no other relationships relevant to the contents of this paper to disclose.
- Received October 1, 2013.
- Revision received October 22, 2013.
- Accepted October 22, 2013.
- American College of Cardiology Foundation