Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
Assessment of Sustained Systolic-to-diastolic Flexibility of the Mitral Valve Annulus With the Sorin MEMO 3D Mitral Anuloplasty Ring
Mitral valve reconstruction commonly requires the use of an anuloplasty device to assure
 long-term durability of the repair. Among mitral anuloplasty devices, varying from rigid to
 complete flexible ring substitutes, the most recent ones are aimed to restore the natural
 saddle shape of the mitral annulus, in order to decrease the stress tension on both mitral
 leaflets and chordal attachments. So far, even for flexible ring devices, the sustained
 flexibility of the device remained unproven, probably by cicatricial fibrotic tissue ingrowth
 after implantation.

 Due to specific structural characteristics based on a nitinolstent with carbofilm-coating,
 the MEMO 3D ring device of SORIN claims preservation of the ring flexibility during the
 cardiac cyclus. Consequently, mitral anuloplasty with this device is expected to decrease the
 stress during the systolo-diastolic movements of the valve, and so, improve the late
 durability of the repair.

 Echocardiography is the first-line technique for mitral valve assessment after surgical
 repair, for both intra-operative evaluation and serial follow-up of valve function. Recently,
 three-dimensional echocardiography has been introduced into clinical practice, affording
 qualitative and quantitative measurement of mitral valve function and size during the cardiac
 cycle.This method allows to quantify precisely the excursion of the mitral annulus between
 systole and diastole.

 The aim of this study is to analyse the systolo-diastolic movement of the mitral annulus
 after the use of an anuloplasty with the SORIN MEMO 3D device, after surgical implantation
 and its sustainability, 1 year after implantation.

 This hypothesis is tested in a case-controlled comparison with a standard used rigid ring
 device.

 Therefore, 3-D echocardiography will be performed at the time of surgical repair, and after 1
 year, to define the size and surface change of the mitral anuloplasty device during the
 cardiac cycle.

 Based on a sample size calculation, 10 patients in each comparison group will be included,
 suggesting a study cohort of 20 patients eligible for mitral valve repair.
Inclusion Criteria:

 -  All patients requiring the use of an mitral anuloplasty device to restore the mitral
 competence by surgery are potential candidates for study inclusion, if survival of at
 least more than 1 year is expected