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Effectiveness of Percutaneous Reduction of Significant Mitral Regurgitation of Functional Etiology in High Surgical Risk Patients
Alfredo Trento, MD1, Michael Argenziano, MD2, William Gray, MD2, Saibal Kar, MD1, Elyse Foster, MD3, Laura Mauri, MD4, Ted Feldman, MD5, Donald Glower, MD6.
1Cedars-Sinai Medical Center, Los Angeles, CA, USA, 2Columbia University Medical Center, New York City, NY, USA, 3University of California, San Francisco, CA, USA, 4Brigham and Women's Hospital, Boston, MA, USA, 5Evanston Hospital, Evanston, IL, USA, 6Duke University Medical Center, Durham, NC, USA.
OBJECTIVE: Treatment of high surgical risk patients with significant functional mitral regurgitation (FMR) presents an important clinical challenge, as surgical correction of MR is not always indicated. The purpose of this analysis is to assess the clinical and echocardiographic outcomes, including MR reduction, LV function and clinical symptoms, and frequency of hospitalizations for congestive heart failure (CHF), which were observed following treatment with the MitraClip device in high surgical risk patients with FMR.
METHODS: EVEREST II High Surgical Risk Trial patients had significant MR (3+/4+) and were deemed high risk for surgery as predicted by a STS risk calculator operative mortality of ≥12%, or surgeon assessment based on pre-specified objective risk factors. Outcome measures included NYHA Class, quality of life (QOL) measures, rate of hospitalizations for CHF, and echocardiographic measurements by an independent core lab.
RESULTS: 149 high surgical risk FMR patients underwent a MitraClip procedure with a 96% implant rate. A majority had prior cardiac surgery (63%), prior MI (57%) and mean calculated surgical mortality by STS calculator of 11.1 ± 7.0%. Mortality at 30 days and 1 year was 4.7% and 22.5%, respectively. Of remaining patients with data at baseline and 1 year, 100 had matched echocardiograms, of whom 82% achieved MR severity of 2+ or less. The annual rate of hospitalizations for CHF 12 months pre and post the MitraClip procedure was 0.65 and 0.29, respectively (p<0.001). Significant improvements in LV volumes, NYHA Class, and QOL (Table) were also observed at 1 year.
CONCLUSIONS: The MitraClip procedure resulted in significant improvements in MR severity, clinical outcomes, ventricular remodeling, and is an important therapeutic option for select patients with significant functional MR who are at high risk for surgical mortality. 
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