1. Percutaneous mitral valve repair using the MitraClip® device (e-valve)
Post-script
Percutaneous mitral valve repair using the MitraClip® device (e-valve)
Angela Hoye, Rajesh Nair, Farqad Alamgir
Castle Hill Hospital, Hull

2. No conflict of interest in relation to this presentation

3. Introduction: MR Mitral regurgitation occurs due to:
valvular degeneration (50%)
rheumatic disease (20%)
ischaemia (17%)
Where possible, surgical mortality is lower following MV repair rather than replacement
However, after MV repair surgery, published data show a rate of recurrence of grade 3 or 4 MR of 17-20% at 5 yrs

4. Anatomy

5. The Alfieri technique
The surgical “edge-to-edge” technique was first described in early 1990`s (Alfieri)
Over 1,500 pts reported in the literature
Safe, effective, durable
No occurrence of mitral stenosis
Facilitates proper leaflet coaptation
Degenerative - anchor flail / prolapsing leaflets
Functional - Coapt tethered leaflets to reduce time and force required to close valve
Creates tissue bridge
Tissue bridge limits annulus dilatation

6. The Alfieri technique
Euro Heart Survey demonstrated that despite presence of severe MR and symptoms, HALF of all patients are not considered for surgery
CE Mark approval in March 2008

7. MitraClip® procedure overview
Independent leaflet capture
Arm on ventricular side; Gripper on atrial side
Reduces potential for embolization
Repositionable and removable
Preserves surgical options in the future
Polyester cover designed to promote tissue healing

8. Anatomic Suitability Leaflet mal-coaptation resulting in MR
>2mm
>11mm
<10mm
<15mm
Sufficient leaflet tissue for mechanical coaptation
Non-rheumatic/endocarditic valve morphology
Anatomic considerations
Flail gap <10mm
Flail width <15mm
Mitral Area > 4.0cm
Coaptation length > 2mm

9. Feasibility (completed)
Studies
Enrollment
Population n
EVEREST I
Feasibility (completed)
Registry patients 55
EVEREST II
Randomized n=279
Roll-in
Randomized Clip
Randomized Surgery 60
187 92
High Risk Registry 78
47 sites

10. Data: EVEREST Age 18 years or older
Moderate to severe (3+) or severe (4+) MR
Symptomatic
Asymptomatic with LVEF < 60% or LVESD > 40mm*
MR originates from A2-P2 mal-coaptation
Candidate for mitral valve surgery
Key exclusions:
EF < 25% or LVESD > 55 mm
Renal insufficiency
Endocarditis, rheumatic heart disease
*ACC/AHA Guidelines, Circ. 114;450,2006

11. One or more Clips implanted in 90% of cases
Results
EVEREST I + roll-in phase of EVEREST II
One or more Clips implanted in 90% of cases

12. Clinical results 99% 97% 96% 96% 96% 92% 89% 85% 86% 84% 82% 75% 67%
Survival
96%
96%
96%
92%
89%
Freedom from surgery
85%
86%
84%
82%
75%
67%
66%
65%
63%
Freedom from death, surgery & MR > 2+

13. Reverse LV remodelling
LV Dysfunction Population (EF < 55% or LVIDs > 4.5cm)

14. Our experience All potential patients were discussed at MDT
Pre-procedural TTE and TOE to determine suitability
Teamwork is vital
Interventional cardiologist
Cardiac anaesthetist
ECHO specialist
Lab staff – specialist training given to nursing staff
All procedures performed with support from physicians from the company

15. Our experience
Successfully treated 3 patients, all with degenerative MR
2 pts with a single clip, 1 with 2 clips
No procedural MACE
At 1 month, all patients report a marked improvement in symptoms / exercise capacity

18. Amplatz
Guide

23. Conclusions
Preliminary results of percutaneous mitral valve repair with the MitraClip® demonstrate that it is safe and feasible
Steep learning curve and it is essential to understand MV anatomy and TOE images
Definite place for this technology in a subset of patients with MR and suitable anatomy
All potential candidates should be evaluated by a multidisciplinary team
Patient selection is paramount