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Clamp procedure yields positive results in setting of significant mitral regurgitation
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Coverage from the Transcatheter Cardiovascular Therapeutics (TCT) 2010 meeting
The MitraClip valve, associated with improvements in selected patients with significant mitral regurgitation, was also effective in the improvement of NYHA functional class, results from the EVEREST II suggested.
The EVEREST II trial included 279 patients with mitral regurgitation (grade 3 or 4) who were randomly assigned to either the MitraClip (Abbott Vascular) procedure (n=184) or to surgical repair or replacement (n=95) at their surgeon’s discretion. The results of the per protocol analysis that James Hermiller, MD, of St. Vincent’s Hospital/The Heart Center of Minneapolis presented at the meeting included 134 (72.8%) device and 74 (77.9%) surgical patients and met the trial’s primary efficacy endpoint of freedom from the combined outcome of death, surgery or reoperation at 1 year.
Device patients (who had both grade 1 and 2 mitral regurgitation) also had significant improvements in NYHA functional class, while only control patients with grade 1 mitral regurgitation in the control group demonstrated functional improvement. Hermiller said the control group was small, which could limit the applicability of the findings.
In patients with grade 1 or grade 2 mitral regurgitation, both the device and surgical control groups achieved significant reductions in diastolic volumes, while systolic volumes fell in patients with residual grade 1 mitral regurgitation (n=74). Patients in the device group with residual grade 1 or grade 2 mitral regurgitation at 12 months showed left ventricular remodeling, improved functional status and improvements in quality of life at 12 months.
Other data from the trial indicated that surgery after receiving the MitraClip had safety and clinical success rates similar to those of primary surgery, with an adverse event profile at follow-up close to that observed in the de novo surgery group.
Alfredo Trento, MD, of Cedars-Sinai Medical Center in Los Angeles, reported midterm data collected from 37 EVEREST II patients (20 who underwent mitral valve repair and 17 who underwent mitral valve replacement) suggesting that the MitraClip procedure demonstrated durability with similar safety and clinical success vs. with surgery.
Although EVEREST II surgeons were highly experienced in mitral valve repair, Trento said, surgeon experience and duration of implant did not appear to affect the repair/replacement rate. He added that the repair rate in patients who had valve injury or difficulty removing the device is not different from patients who had no such operative difficulties.
Trento also said that the midterm results indicate mitral valve surgery following the MitraClip procedure is safe and associated with results similar to those of the control group at 30 days and at 12 months.
Disclosures:
- Dr. Hermiller reports receiving research grants from and serving as a consultant for Abbott Vascular.
- Dr. Trento reports receiving research grants from Abbott Vascular.