The trial, called PERMIT-CARE, is an investigator-led study evaluating the safety and efficacy of MitraClip treatment in 51 patients with clinically significant functional mitral regurgitation at seven European centres. All patients had unchanged symptoms and unchanged left ventricular volumes after at least six months of CRT. Nearly all patients enrolled in the study were considered ineligible for mitral valve surgery due to a high estimated mortality risk.
Results of the study demonstrate that functional mitral regurgitation reduction with MitraClip treatment is feasible, safe, and leads to substantial improvement in NYHA functional class and reverse left ventricular remodeling in approximately 70% of patients.
“Results of this study suggest that MitraClip treatment could offer, for the first time, a solution for heart failure patients who have severe mitral regurgitation and are unresponsive to CRT,” said Angelo Auricchio, the study’s lead investigator, of the Division of Cardiology at the Fondazione Cardiocentro Ticino in Lugano, Switzerland. “Surgery is not a good option for these patients because of their advanced left ventricular dysfunction and low ejection fraction. We have shown that they were significantly improved following treatment with the MitraClip device. I look forward to additional prospective studies to confirm our findings and to evaluate appropriate timing of MitraClip treatment in heart failure patients.”
Severe functional mitral regurgitation is common in heart failure patients, including approximately one-third of those indicated for CRT therapy. CRT often reduces mitral regurgitation; however, mitral regurgitation has been reported to persist in about 20–25% of CRT treated patients, and in an additional 10–15% mitral regurgitation may actually worsen after CRT treatment.
Results of the study will be published in an upcoming issue of the Journal of the American College of Cardiology. The MitraClip system is designed to reduce significant mitral regurgitation by clipping together the leaflets of the mitral valve, one of the four valves of the heart. The catheter-based MitraClip device is delivered to the heart through the femoral vein, a blood vessel in the leg. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. After treatment, patients are usually home within two to three days and have been observed to recover quickly. The safety and efficacy of the MitraClip system were evaluated in the EVEREST II randomised clinical trial.