Percutaneous mitral valve repair using the MitraClip® device (e-

valve)

Angela Hoye, Rajesh Nair, Farqad AlamgirCastle Hill Hospital, Hull

Post-script

No conflict of interest in relation to this presentation

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

Anatomy

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

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

MitraClip® procedure overview

Anatomic Suitability Leaflet mal-coaptation resulting

in MR• 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

>2mm>11mm

<10mm

<15mm

Enrollment Population n

EVEREST I

Feasibility (completed)Registry patients 55

EVEREST II

Randomized n=279

Roll-in

Randomized Clip

Randomized Surgery

60

187

92

EVEREST II High Risk Registry 78

• 47 sites

Studies

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

One or more Clips implanted in 90% of cases

Results

•EVEREST I + roll-in phase of EVEREST II

Clinical results

Survival

Freedom from surgery

Freedom from death, surgery & MR > 2+

99% 97% 96% 96% 96%

85%75%

67% 66% 65% 63%

84% 82%92% 89% 86%

Reverse LV remodelling•LV Dysfunction Population (EF <

55% or LVIDs > 4.5cm)

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

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

AmplatzGuide

QuickTime™ and a decompressor

are needed to see this picture.

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