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

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 Tissue bridge limits annulus dilatation

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 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

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

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

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 One or more Clips implanted in 90% of cases

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+

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

Amplatz Guide

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