Esc patient selection for Mitraclip


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Esc patient selection for Mitraclip

  1. 1. Proposed criteria for patient selection for transcatheter mitral valve repair . Francesco Maisano MD, FESC (Milan, IT) San Raffaele Hospital Cardio-thoracic and Vascular Department
  2. 2. 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:
  3. 3. Transcatheter Mitral Valve Repair. <ul><li>Opportunity </li></ul><ul><ul><li>Unmet need </li></ul></ul><ul><ul><li>Reported clinical benefit in selected patients </li></ul></ul><ul><li>Challenges </li></ul><ul><ul><li>Lack of evidence, particularly for FMR </li></ul></ul><ul><ul><li>Limited clinical experience, concentrated in high volume centers </li></ul></ul>
  4. 4. Patient selection – a teamwork effort <ul><li>Confirm severity of MR + evaluate symptoms </li></ul><ul><li>Analize risk of surgery and evaluate life-expectancy and quality of life </li></ul><ul><li>Assess feasibility of Mitraclip. </li></ul><ul><li>DMR vs FMR </li></ul>Evidence + Risk scores + Guidelines ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ?
  5. 5. Mitraclip for DMR <ul><li>In experienced centers, DMR is treated with surgical repair at low risk, long term durability of repair is achieved in the majority of patients </li></ul><ul><ul><li>50% of Euro Heart Survey patients were not referred to surgery (Mirabel EHJ 2007) </li></ul></ul><ul><ul><li>Age and comorbidity increase the risk of surgery (STS database, 2010) </li></ul></ul><ul><ul><li>Surgery is not associated with improved QoL in most elderly patients (Maisano et al EJCTS 2009) </li></ul></ul>
  6. 6. Mitraclip for FMR <ul><li>Surgical treatment of FMR is associated with </li></ul><ul><ul><li>High hospital mortality </li></ul></ul><ul><ul><li>High recurrence rate </li></ul></ul><ul><ul><li>Long hospital stay </li></ul></ul><ul><ul><li>Unproven survival benefit </li></ul></ul><ul><li>Mitraclip for FMR </li></ul><ul><ul><li>Procedure more simple than for DMR </li></ul></ul><ul><ul><li>Improvement of symptoms at low risk </li></ul></ul><ul><ul><li>HRR suggests survival benefit </li></ul></ul><ul><ul><li>Failure does not modify the surgical option </li></ul></ul>
  7. 7. MitraClip anatomical patient selection considerations <ul><li>Moderate to severe MR (Grade 3 or more out of 4 grades) </li></ul><ul><li>Pathology in A2-P2 area </li></ul><ul><li>Coaptation length > 2 mm (depending on leaflet mobility) </li></ul><ul><li>Coaptation depth < 11 mm </li></ul><ul><li>Flail gap < 10 mm </li></ul><ul><li>Flail width < 15 mm </li></ul><ul><li>Mitral valve orifice area > 4cm 2 (depending on leaflet mobility) </li></ul><ul><li>Mobile leaflet length > 1 cm </li></ul>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).
  8. 9. Degenerative MR
  9. 10. Degenerative MR Multiple lesions
  10. 11. Functional MR
  11. 12. Anatomic Measurements P=0.05 P=0.1 San Raffaele Preliminary data
  12. 14. Tenting area and QRS duration p=0.002 P=0.01 San Raffaele Preliminary data
  13. 15. Jet extension (%) Jet extension/IC diameter p=0.01
  14. 16. Jet extension
  15. 17. Rejected for MitraClip <ul><li>Mitral valve stenosis (valve area < 4 cm²) non pliable anterior leaflet </li></ul>
  16. 18. Rejected for MitraClip <ul><li>Barlow‘s disease, cleft </li></ul>
  17. 19. Surgery vs Mitraclip anatomy for Mitraclip Risk of surgery Low High Bad Good Risk of Mitraclip procedure <ul><li>Risk of Mitraclip procedure </li></ul><ul><li>Preservation of surgical option </li></ul><ul><li>Long term results of Mitraclip </li></ul>
  18. 20. Concomitant conditions <ul><li>Coronary artery disease </li></ul><ul><li>Atrial fibrillation </li></ul><ul><li>Tricuspid disease </li></ul><ul><li>Aortic stenosis </li></ul><ul><li>dissinchrony </li></ul><ul><li>STAGED vs COMBINED approach </li></ul><ul><li>Priority: </li></ul><ul><ul><li>Evidence </li></ul></ul><ul><ul><li>Clinical severity </li></ul></ul><ul><ul><li>physiopathology </li></ul></ul>
  19. 21. Concomitant conditions <ul><li>Coronary artery disease </li></ul><ul><ul><li>STAGED PCI, VS COMBINED CABG AND MVR/REPAIR </li></ul></ul><ul><li>Atrial fibrillation </li></ul><ul><ul><li>CONSIDER ABLATION, APPENDAGE CLOSURE </li></ul></ul><ul><li>Tricuspid disease </li></ul><ul><ul><li>STAGED APPROACH, MITRACLIP FIRST </li></ul></ul><ul><li>Aortic stenosis </li></ul><ul><ul><li>STAGED APPROACH, TAVI FIRST </li></ul></ul><ul><li>Dissinchrony </li></ul><ul><ul><li>CRT FIRST </li></ul></ul>
  20. 22. Individualize the therapy waiting for more actual randomized trials <ul><li>Anatomy and function </li></ul><ul><li>Comorbidities, Life expectancy </li></ul><ul><li>Compare risk and probability of success </li></ul><ul><li>Preservation of surgical option </li></ul><ul><li>Patient informed consent for therapy </li></ul><ul><li>collaboration </li></ul>