Data from the EVEREST III study, which was presented at the American College of Cardiology annual meeting (ACC; 9–11 March, San Francisco, USA) suggests that the MitraClip system (Abbott Vascular) for mitral regurgitation is associated with a significantly lower rate of 30-day mortality than the rate associated with surgery in patients at high surgical risk.
The EVEREST II (Endovascular valve edge-to-edge repair study) High Surgical Risk cohort included data from patients enrolled in the multicentre EVEREST II High Risk and REALISM continued access studies. Findings from 351 symptomatic US patients deemed too high risk for open mitral valve surgery demonstrated:
• A 30-day mortality rate significantly lower than expected for surgery (4.8% for patients treated with the MitraClip system versus 18.2% predicted surgical mortality, p<0.0001)
• A low rate of adverse events, despite the high surgical risk profile of the patients
• An implant success rate of 96%
• Acute reduction in mitral regurgitation to 2+ or less achieved in 86% of patients treated with the MitraClip device
• Clinically significant improvement in left ventricular size, significant improvements in NYHA Functional Class and SF-36 Quality of Life scores, and significantly reduced rates of hospitalisation for heart failure (48% reduction from one year post-discharge compared to the year prior to treatment, p<0.0001).
“Patients with mitral regurgitation who are not candidates for mitral valve surgery due to risk of mortality have an unmet need for a treatment option that will reduce symptoms and improve the quality of their lives,” said D Scott Lim, associate professor of Cardiovascular Medicine at the University of Virginia Health System in Charlottesville, USA. “The findings of the EVEREST II High Surgical Risk cohort suggest that treatment with the MitraClip device represents a new option that could allow these high-risk patients to return to activities they enjoy, and results in a reduction in hospitalizations for heart failure.”