Esc patient selection for Mitraclip
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Esc patient selection for Mitraclip

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Esc patient selection for Mitraclip Esc patient selection for Mitraclip Presentation Transcript

  • Proposed criteria for patient selection for transcatheter mitral valve repair . Francesco Maisano MD, FESC (Milan, IT) San Raffaele Hospital Cardio-thoracic and Vascular Department
  • Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial Interest /arrangement or affiliation with the organization(s) listed below Affiliation/Financial Relationship Company Grant/ Research Support: Consulting Fees/Honoraria: Abbott, Edwards, Nycomed, Medtronic, St Jude, ValtechCardio Major Stock Shareholder/Equity Interest: Royalty Income: Edwards Ownership/Founder: 4Tech Salary: Intellectual Property Rights: ValtechCardio, 4Tech Other Financial Benefit:
  • Transcatheter Mitral Valve Repair.
    • Opportunity
      • Unmet need
      • Reported clinical benefit in selected patients
    • Challenges
      • Lack of evidence, particularly for FMR
      • Limited clinical experience, concentrated in high volume centers
  • Patient selection – a teamwork effort
    • Confirm severity of MR + evaluate symptoms
    • Analize risk of surgery and evaluate life-expectancy and quality of life
    • Assess feasibility of Mitraclip.
    • DMR vs FMR
    Evidence + Risk scores + Guidelines ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
  • Mitraclip for DMR
    • In experienced centers, DMR is treated with surgical repair at low risk, long term durability of repair is achieved in the majority of patients
      • 50% of Euro Heart Survey patients were not referred to surgery (Mirabel EHJ 2007)
      • Age and comorbidity increase the risk of surgery (STS database, 2010)
      • Surgery is not associated with improved QoL in most elderly patients (Maisano et al EJCTS 2009)
  • Mitraclip for FMR
    • Surgical treatment of FMR is associated with
      • High hospital mortality
      • High recurrence rate
      • Long hospital stay
      • Unproven survival benefit
    • Mitraclip for FMR
      • Procedure more simple than for DMR
      • Improvement of symptoms at low risk
      • HRR suggests survival benefit
      • Failure does not modify the surgical option
  • MitraClip anatomical patient selection considerations
    • Moderate to severe MR (Grade 3 or more out of 4 grades)
    • Pathology in A2-P2 area
    • Coaptation length > 2 mm (depending on leaflet mobility)
    • Coaptation depth < 11 mm
    • Flail gap < 10 mm
    • Flail width < 15 mm
    • Mitral valve orifice area > 4cm 2 (depending on leaflet mobility)
    • Mobile leaflet length > 1 cm
    Recommended criteria 1 1. The current patient considerations are based on EVEREST II and commercial European experience to date. The MitraClip Patient Selection Coniderations document has been endorsed by Expert Opinion (Crossroads institute).
  •  
  • Degenerative MR
  • Degenerative MR Multiple lesions
  • Functional MR
  • Anatomic Measurements P=0.05 P=0.1 San Raffaele Preliminary data
  •  
  • Tenting area and QRS duration p=0.002 P=0.01 San Raffaele Preliminary data
  • Jet extension (%) Jet extension/IC diameter p=0.01
  • Jet extension
  • Rejected for MitraClip
    • Mitral valve stenosis (valve area < 4 cm²) non pliable anterior leaflet
  • Rejected for MitraClip
    • Barlow‘s disease, cleft
  • Surgery vs Mitraclip anatomy for Mitraclip Risk of surgery Low High Bad Good Risk of Mitraclip procedure
    • Risk of Mitraclip procedure
    • Preservation of surgical option
    • Long term results of Mitraclip
  • Concomitant conditions
    • Coronary artery disease
    • Atrial fibrillation
    • Tricuspid disease
    • Aortic stenosis
    • dissinchrony
    • STAGED vs COMBINED approach
    • Priority:
      • Evidence
      • Clinical severity
      • physiopathology
  • Concomitant conditions
    • Coronary artery disease
      • STAGED PCI, VS COMBINED CABG AND MVR/REPAIR
    • Atrial fibrillation
      • CONSIDER ABLATION, APPENDAGE CLOSURE
    • Tricuspid disease
      • STAGED APPROACH, MITRACLIP FIRST
    • Aortic stenosis
      • STAGED APPROACH, TAVI FIRST
    • Dissinchrony
      • CRT FIRST
  • Individualize the therapy waiting for more actual randomized trials
    • Anatomy and function
    • Comorbidities, Life expectancy
    • Compare risk and probability of success
    • Preservation of surgical option
    • Patient informed consent for therapy
    • collaboration