SHA24/062004

Dr Aijaz Shah MBBS, FRCP(Edin.)

Prince Sultan Cardiac Center Riyadh

     

ASD. TAVI. Mitral Clip.

Mitral ring device.

Watchman device.

Prosthetic valve leak closure.

   

MitraClip therapy is based on the surgical edge-toedge repair first described by Alfieri.

The first two cases were done in Catania, Italy in 2008.

Since that time more than 7000 cases have been done world wide.

Data: EVEREST I: Feasibility study (n=55) EVEREST II: Randomized trial (n=279) REALISM: Registry ACCESS Europe: Registry TRAMI: Registry COAPT: Ongoing randomized study to study safety and efficacy ◦ RESHAPE-HF: Randomized study, clip vs. medical therapy ◦ ◦ ◦ ◦ ◦ ◦

Inclusion and Exclusion Criteria

Baseline Demographics and Co-morbidities

30 Day Events

Baldus S et al. Eur J Heart Fail 2012;eurjhf.hfs079

Pre- and post-interventional distributions of mitral regurgitation (MR) severity in the total patient cohort.

New York Heart Association (NYHA) functional class at baseline and follow-up (F/U) in the total patient cohort.

ď ˝

Conclusions Data from the German TRAMI and ACCESS-EUROPE registries suggest that MitraClip therapy is a viable treatment option in daily clinical routine for high surgical risk patients with significant MR.



Better results are seen in centers where there is a team approach to percutaneous interventions



Heart valve team for MitraClip should comprise of :

◦ 2 operators (interventionalist) ◦ Echocardiographer ◦ Cardiac anesthetist ◦ Cardiac surgeon





 

The MitraClip procedure is rapidly evolving as an important option among the current therapies for MR There is growing data on the safety and efficacy of the procedure.

The indications of the procedure are still evolving.

At the present time the best indication for Mitra Clip therapy is for symptomatic patients with clinically significant functional or degenerative MR who are at high or increased risk for open heart surgery.

 



The procedure is effective in patient with suitable anatomy.

Transesophageal echo is essential to assess the suitability for clipping and should be done beforehand.

The current recommendations are based on the EVEREST data: ◦ ◦ ◦ ◦ ◦ ◦ ◦



Functional or degenerative MR Coaptation height > 2mm Coaptation depth < 11 mm Flail gap < 10 mm Flail width<15 mm Orifice area >4 cm2 Absence of significant annular calcification or calcification in the grasping area.

Other anatomic features to consider:

◦ Favorable atrial septal anatomy ◦ Septal puncture height from the mitral annular plane between 3.5-4.5 cm ◦ Good posterior leaflet width >8mm with absence of tethering or restriction.

Flail gap > 10mm

Coaptation length < 2mm Coaptation depth > 11mm

Flail 15mm

width >



   

2-D TEE guidance for MitraClip requires considerable expertise of the echocardiographer and the interventionalist.

Most centers use combined 2-D and 3-D imaging.

3D TEE is of great value in understanding the anatomy.

Live 3-D imaging during the procedure gives confidence to the operators 3D TEE allows good visualization and excellent spatial orientation of the device system within the left atrium.



 





 

3D TEE is valuable to determine that the orientation of the clip arms is perpendicular to the line of MV coaptation and that the clip is positioned between the middle scallops.

3-D imaging obviates the need for transgastic imaging.

X-plane imaging is useful to assess the leaflet insertion in the device.

3D TEE can be used to assess proper leaflet insertion using full volume data set and cropping Can shorten the procedural time especially with experienced operators.

3D TEE is not to be use alone during the procedure.

Does it Effect the Outcome of the Procedure?



Limitations: ◦ Relatively small sample size, retrospective, observational, no randomization. ◦ More experienced operators when 3D protocol was used.  Influence of experience on procedural time cannot be excluded.  Integration of 3D TEE in the beginning resulted in a learning curve related to prolongation of procedural time.

◦ The two groups were not matched according to MV anatomy.



 





Mitral valve clip (MitraClip) is a viable treatment option for patients who have functional or degenerative MR, in whom surgical risk outweighs the benefit.

The patient selection should be meticulous.

Combined 2-D and 3-D TEE should be standard for procedural guidance.

3D TEE procedural guidance gives operators increased confidence and can shorten procedure time.

However 2D+3D does not improve the procedural outcome when compared to 2D guidance alone