MitraClip Offers Significant Improvements for Both Functional, Degenerative MR in High-Risk Patients

 

November 10, 2011

November 10, 2011 — The results of an analysis of 149 EVEREST II high surgical risk patients with significant mitral regurgitation (MR) of functional etiology were presented at Transcatheter Cardiovascular Therapeutics (TCT) 2011. Michael Argenizano, M.D., chief of adult cardiac surgery for New York-Presbyterian Hospital/Columbia University Medical Center made the presentation.

Functional MR—often referred to as secondary MR—is a disease of the left ventricle, and occurs when the left ventricle is enlarged. It represents an important clinical challenge, as studies have not demonstrated a survival benefit of surgery for patients with isolated functional MR. In addition, recurrence of significant MR is often observed after mitral valve surgery. 

Results of Argenziano’s analysis showed the MitraClip procedure safely reduces MR, resulting in meaningful clinical benefits including:

- Significantly decreased left ventricular (LV) end diastolic volumes (13 percent at one year over baseline)

- Significant improvement in symptoms, with 78.8 percent of patients exhibiting no symptoms (NYHA Functional Class I) or mild symptoms (NYHA Functional Class II) at one year; whereas at baseline, 86.5 percent of patients had moderate symptoms (NYHA Functional Class III) or severe symptoms (NYHA Functional Class IV)

- Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 quality of life assessment survey (an increase of 4 points in the physical quality of life score and an increase of 7 points in mental quality of life score)

- A 55.4 percent reduction in the rate of hospitalizations for congestive heart failure in the 12 months following the MitraClip procedure compared to the 12 months prior.   


MitraClip for High-Risk DMR: Data and Perspectives

The results of an analysis of 62 EVEREST II high surgical risk patients with significant MR of degenerative etiology were also presented.

Ted Feldman, M.D., FSCAI, director, Cardiac Catheterization Laboratory, and the Mr. and Mrs. Charles R. Walgreen chair in interventional cardiology, NorthShore University HealthSystem, Evanston, Ill., made the presentation. Degenerative MR (DMR), also called primary MR, is a disease of the mitral valve leaflets.

Feldman’s analysis showed the MitraClip procedure safely reduces MR resulting in meaningful clinical benefits including:

- Significantly decreased LV end diastolic volumes, (14 percent at one year over baseline)

- A significant improvement in symptoms, with 84.6 percent of patients exhibiting no symptoms or mild symptoms at one year; whereas at baseline, 79.5 percent of patients had moderate symptoms or severe symptoms

- Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 quality of life assessment survey (an increase of 6 points in the physical quality of life score and an increase of 4 points in mental quality of life score)

- A 77 percent reduction in the rate of hospitalizations for congestive heart failure in the 12 months following the MitraClip procedure compared to the 12 months prior.

Patients with Residual MR One Year Following MitraClip Treatment Demonstrate Clinical Benefits

A third analysis examined 116 EVEREST II high surgical risk patients with residual MR grade of either 2+ or less one year following device treatment. Paul Grayburn, M.D., clinical cardiologist and echocardiographyer at the Baylor Heart and Vascular Institute in Dallas, Texas, made the presentation.

Meaningful clinical benefits were observed, including:

- Significantly decreased LV end diastolic volumes (19 percent reduction compared to baseline for patients with MR of 1+ or less; 11.1 percent reduction for MR of 2+)

- A significant improvement in symptoms (75 percent of 1+ patients exhibiting no symptoms or mild symptoms at one year, whereas at baseline, 95.8 percent of patients had moderate symptoms or severe symptoms; 94.1 percent of 2+ patients exhibited no symptoms or mild symptoms at one year; whereas at baseline, 77.9 percent of patients had moderate symptoms or severe symptoms)

- Meaningful improvements in both physical and mental quality of life compared to baseline as measured by the SF-36 quality of life assessment survey (for 1+ patients, an increase of 4 points in the physical quality of life score and an increase of 4.5 points in mental quality of life data; for 2+ patients, an increase of 5.7 points in the physical quality of life score and increase of 8 points in mental quality of life data)

- Significantly decreased hospitalizations for congestive heart failure (a reduction of 73 percent for 1+ patients, and a reduction of 71 percent for 2+ patients).

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