Effects of Mitral Valve Repair With the Geoform Ring on Cardiomyopathy

Congestive heart failure is a leading cause of hospitalization and mortality with an
estimated 5 million people affected in the United States of America. Ischemic and idiopathic
(dilated) cardiomyopathies are the two most common etiologies. As the left ventricle fails,
changes in ventricular geometry and function occurs that leads to functional mitral
regurgitation. Mitral regurgitation is a complication of end stage cardiomyopathy that
adversely affects survival and patient's functional status. Mitral regurgitation in these
patients is not an intrinsic disease of the mitral valve but rather results from mitral
annular dilatation and ventricular dilatation.

Geoform mitral annuloplasty ring reduces the antero-posterior diameter of the mitral valve
and elevates the posterior mitral annulus. Although it has been very effective on
eliminating mitral regurgitation its effects on ventricular geometry have not been fully
elucidated. Evaluation of ventricular and mitral valve geometry and function and their
interactions has been difficult. The availability of three dimensional echocardiogram with
sophisticated finite volume analysis allows us to evaluate the changes in ventricular
geometry associated with the implantation of the Geoform ring. We have then designed this
study with the purpose of evaluating the changes in left ventricular geometry and function
resulting from mitral valve annuloplasty with the Geoform ring in patients with left
ventricular dysfunction and congestive heart failure.

The two primary endpoints of this study will be:

1. To assess the changes on left ventricular geometry and function as assessed by 3D
echocardiography in patients with cardiomyopathy and severe mitral regurgitation who
undergo mitral valve annuloplasty with a Geoform ring. This assessment will be done
preoperatively, at three months, at six months, at one year, and at two years after the
procedure.

2. To evaluate the effects on mitral valve annuloplasty with a Geoform ring on functional
status.

Secondary endpoints will be:

3. To evaluate the effect of mitral valve annuloplasty with a Geoform ring on mortality.

4. To evaluate its effects on hospitalization for congestive heart failure.

5. To evaluate the effect on the need of further interventions for congestive heart
failure (insertion of ventricular assist device, transplantation, cardiac
resynchronization therapy).

Inclusion Criteria:

- Patients would be at least 18 years old.

- They will have history of congestive heart failure and be in New York Heart
Association Class III or IV.

- Their left ventricular ejection fraction will be less or equal to 30%.

- They will have moderate or severe mitral regurgitation as determined by
echocardiogram. Echocardiogram's criteria for severe mitral regurgitation will be:

- regurgitant volume greater than 50 ml,

- regurgitant fraction greater than 50% and

- effective regurgitant orifice greater than 40 mm2.

If the quantitative criteria are not available, severity of the MR will be graded
qualitative in grades I, II, III, and IV. Patients with mitral regurgitation in grade III
and IV will be eligible to be included in the study.

Exclusion Criteria:

- Cancer - Metastatic or any cancer within five years except patients with non-
melanoma skin cancer.

- Recent stroke (less than six months).

- Severe COPD (patients with an FEV1 less than .8 liters).

- Patients on inotropic infusion preoperatively.

- Patients in atrial fibrillation.

- Pregnant patients.

- Patients with any other valvular disease that required surgical intervention except
tricuspid valve disease.

- Patients that will require surgical ventricular restoration.