More Data On The MitraClip For Mitral Regurgitation Treatment
By Adam Pick on August 17, 2009
As we have discussed before, most minimally invasive treatments for heart valve disease continue to show encouraging results. Recently, additional results for high-tech devices from Edwards Lifesciences, Medtronic and Evalve have been posted.
Specific to the MitraClip for mitral valve repair, I just saw an announcement which detailed the results of 107 patients for the nonrandomized Everest 1 and 2 studies.
- A full 66% of patients did not require surgery and maintained a mitral regurgitation grade of less than 2 at 12 months, the primary efficacy end point of the study.
- In all, 32 patients needed mitral valve replacement surgery within 3.2 years of receiving the MitraClip. Of these procedures, 84% were successful.
- 9%, had a major adverse event during the follow-up period, including one non-procedure-related death.
- Overall procedural success was 74%, and 64% left hospital with a mitral-regurgitation grade of 1 or less, as opposed to grade 3 or 4 at study entry.
- In all, 32 patients needed mitral-valve surgery within 3.2 years of receiving the MitraClip.
“Surgical options were preserved,” the authors, led by Dr Ted Feldman (Evanston Hospital, IL), write in the August 18, 2009 issue of the Journal of the American College of Cardiology. “The fact that there were no in-cath lab deaths during this procedure in over 100 patients compared with, for example, stent therapy, shows that this is acceptable in terms of safety, all the more so given that this is a brand new intervention,” Feldman told heartwire.
Investigators also highlighted the “steep learning curve” seen in the study, with the first 30 procedures taking over four hours, while the last 30 typically took under three hours.
A randomized trial, comparing percutaneous mitral-valve repair with the MitraClip with surgical valve replacement or repair is ongoing; one-year follow-up will be completed in October, Feldman said. The MitraClip received a CE mark in Europe last year.
Keep on tickin!