Author + information
- Received September 7, 2013
- Revision received November 18, 2013
- Accepted December 17, 2013
- Published online July 15, 2014.
- Donald D. Glower, MD∗∗ (, )
- Saibal Kar, MD†,
- Alfredo Trento, MD†,
- D. Scott Lim, MD‡,
- Tanvir Bajwa, MD§,‖,
- Ramon Quesada, MD¶,
- Patrick L. Whitlow, MD#,
- Michael J. Rinaldi, MD∗∗,
- Paul Grayburn, MD††,
- Michael J. Mack, MD††,
- Laura Mauri, MD‡‡,§§,
- Patrick M. McCarthy, MD‖‖ and
- Ted Feldman, MD¶¶
- ∗Duke University Medical Center, Durham, North Carolina
- †Heart Institute, Cedars Sinai Medical Center, Los Angeles, California
- ‡Division of Pediatric Cardiology, University of Virginia, Charlottesville, Virginia
- §Aurora Cardiovascular Services, Aurora Sinai/Aurora St. Luke's Medical Centers, Milwaukee, Wisconsin
- ‖University of Wisconsin School of Medicine and Public Health, Milwaukee, Wisconsin
- ¶Baptist Hospital of Miami, Miami, Florida
- #Cleveland Clinic, Cleveland, Ohio
- ∗∗Sanger Heart and Vascular Institute, Carolinas Medical Center, Charlotte, North Carolina
- ††Baylor University Medical Center, Baylor Heart and Vascular Institute, Dallas, Texas
- ‡‡Brigham and Women’s Hospital, Boston, Massachusetts
- §§Harvard Clinical Research Institute, Boston, Massachusetts
- ‖‖Division of Cardiac Surgery, Northwestern University, Chicago, Illinois
- ¶¶Northshore University Health System, Chicago, Illinois
- ↵∗Reprint requests and correspondence:
Dr. Donald Glower, Duke University Medical Center, Box 3851, Durham, North Carolina 27710.
Background The EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) High-Risk registry and REALISM Continued Access Study High-Risk Arm are prospective registries of patients who received the MitraClip device (Abbott Vascular, Santa Clara, California) for mitral regurgitation (MR) in the United States.
Objectives The purpose of this study was to report 12-month outcomes in high-risk patients treated with the percutaneous mitral valve edge-to-edge repair.
Methods Patients with grades 3 to 4+ MR and a surgical mortality risk of ≥12%, based on the Society of Thoracic Surgeons risk calculator or the estimate of a surgeon coinvestigator following pre-specified protocol criteria, were enrolled.
Results In the studies, 327 of 351 patients completed 12 months of follow-up. Patients were elderly (76 ± 11 years of age), with 70% having functional MR and 60% having prior cardiac surgery. The mitral valve device reduced MR to ≤2+ in 86% of patients at discharge (n = 325; p < 0.0001). Major adverse events at 30 days included death in 4.8%, myocardial infarction in 1.1%, and stroke in 2.6%. At 12 months, MR was ≤2+ in 84% of patients (n = 225; p < 0.0001). From baseline to 12 months, left ventricular (LV) end-diastolic volume improved from 161 ± 56 ml to 143 ± 53 ml (n = 203; p < 0.0001) and LV end-systolic volume improved from 87 ± 47 ml to 79 ± 44 ml (n = 202; p < 0.0001). New York Heart Association functional class improved from 82% in class III/IV at baseline to 83% in class I/II at 12 months (n = 234; p < 0.0001). The 36-item Short Form Health Survey physical and mental quality-of-life scores improved from baseline to 12 months (n = 191; p < 0.0001). Annual hospitalization rate for heart failure fell from 0.79% pre-procedure to 0.41% post-procedure (n = 338; p < 0.0001). Kaplan-Meier survival estimate at 12 months was 77.2%.
Conclusions The percutaneous mitral valve device significantly reduced MR, improved clinical symptoms, and decreased LV dimensions at 12 months in this high-surgical-risk cohort. (Endovascular Valve Edge-to-Edge REpair STudy [EVERESTIIRCT]; NCT00209274)
Dr. Kar has received honoraria and institutional research support from Abbott. Dr. Lim is a consultant for and has received research grants from Abbott Vascular. Dr. Whitlow’s institution has received research support for participating in the EVEREST trials from Abbott. Dr. Rinaldi is a consultant for Abbott. Dr. Grayburn has received grants from Abbott, Medtronichttp://dx.doi.org/10.13039/100004374, Baxter, ValTech Cardio, and Guided Delivery Systems; and has received consulting fees and/or honoraria from Abbott, Tendyne, and Bracco Diagnostics. Dr. Mauri’s institution has received research grants from Abbott, Boston Scientific, Cordishttp://dx.doi.org/10.13039/100006479, Medtronic, Eli Lilly, Daiichi-Sankyohttp://dx.doi.org/10.13039/501100002973, Bristol-Myers Squibbhttp://dx.doi.org/10.13039/100002491, and Sanofi-Aventis. Dr. McCarthy is a consultant to Abbott and Edwards Lifesciences; and receives royalties from Edwards Lifesciences. Dr. Feldman is a consultant for and has received honoraria and institutional research support from Abbott, Boston Scientific, Edwards Lifesciences, and WL Gore. All other authors have reported they have no relationships relevant to the contents of this paper to disclose.
- Received September 7, 2013.
- Revision received November 18, 2013.
- Accepted December 17, 2013.
- American College of Cardiology Foundation