Percutaneous mitral valve repair using the MitraClip® device (e by wgv13363

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									         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
      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                >2mm
                                                >11mm


•   Anatomic considerations
    •   Flail gap <10mm
    •   Flail width <15mm
    •   Mitral Area > 4.0cm         <10mm



    •   Coaptation length > 2mm             <15mm
                  Studies
     Enrollment               Population         n

      EVEREST I
                           Registry patients    55
Feasibility (completed)

                                Roll-in         60
     EVEREST II
                           Randomized Clip      187
 Randomized n=279
                          Randomized Surgery    92

     EVEREST II            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
              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%   Survival
      92% 89%                       Freedom from
85%               86%   84%   82%
      75%                           surgery
            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
      QuickTime™ an d a
         decompressor
are need ed to see this p icture .
           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

								
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