new technologies for Mitral regurgitation

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  • 1. Cosa possiamo fare, nella insufficienza mitralica, oltre la MitraClip. Francesco Maisano MD, FESC Ospedale San RaffaeleDipartimentoCardiotoracovascolare
  • 2. MitraClip in the clinicalpractice Opportunity Challenges– Largeunmetneed – Lackofevidence, parti– Reportedclinical cularlyfor FMR benefit in – Limitedclinicalexperi selectedpatients ence, concentrated in high volume centers – Limitedapplicability
  • 3. MitraClip anatomical patient selection considerationsRecommended criteria1• 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 > 4cm2 (depending on leaflet mobility)• Mobile leaflet length > 1 cm 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).
  • 4. Anatomic MeasurementsP=0.05 P=0.1 San Raffaele Preliminary data
  • 5. Tenting area and QRS duration p=0.002 P=0.01 San Raffaele Preliminary data
  • 6. Jet extension (%) p=0.01Jet extension/IC diameter
  • 7. What to do in patients beyond MitraClip feasibility• Surgery• Synergistic approaches• New technologies – Annuloplasty – Neochordae implantation – Mitral valve replacement
  • 8. The Mitraclip is applicable only in selected patients Surgeons use many different techniques to individualize treatment2008-Hugo Vanermen
  • 9. Current transcatheter technologies to treat MR at the leaflet leveltechnique device statusEdge-to-edge MitraClip CE mark Mobius Earlyclinical Mitraflex preclinicalneochordae Neochord Early clinical Babic preclinical Mobius preclinical Valtech - vchordal preclinicalTissue reduction Thermocool preclinicalSpacer Percupro Early clinical
  • 10. Neochord Inc.
  • 11. FB, 85 yo, high surgical risk
  • 12. Neochord Good Bad• “Anatomical” off • Limited applicability pump correction of • Apical attachment of prolapse the neochorda• Minimally invasive • Need for approach annuloplasty• Beating heart adjustment of chordae
  • 13. Beyond Mitraclip - Annuloplasty• Lackof annuloplasty isassociatedtoacceleratedfailure in the overallsurgicalpopulation Maisano F, et al Eur J CardiothoracSurg. 1999;15:419-25 Gillinov et al J ThoracCardiovascSurg 1998;116:734-43
  • 14. Transcatheter annuloplasty Coronary sinus remodeling SL dimensions cinching RF/Ultrasound remodeling External compression Direct annuloplasty
  • 15. Coronary sinus devices MONARC Two-anchor design EVOLUTION (Edwards with chronic trial Lifesciences reshaping (6weeks) (69 pts LLC) by a foreshortening enrolled) bridge CARILLON Acute reshaping AMADEUS trial (Cardiac device acting in (43 pts Dimensions P2P3, repositionable, enrolled ) Inc) retrievable PTMA Tri-lumen catheter, PTOLEMY (Viacor Inc) reshapable, (24 pts possibility of enrolled) multiple long term adjustment
  • 16. Direct annuloplastythe only approach with a proven surgical backgroundMitralign GDS ValtechBident Accucinch Cardioband• Arterial access • Arterial access • Venous access• Transannular • Subannular • Annular fixation cinchin cinching
  • 17. Valtech Cardio - CARDIOBAND• A surgical ring implanted percutaneously
  • 18. Transcatheter MVR• Larger device• Anchoring• Asymmetric anatomy• Interaction with the aortic valve and LVOT• PVL more problematic
  • 19. Trattamento della valvola tricuspide
  • 20. Treating valve disease in the future today Patient-optimized care Minimally Transcatheter Open heart invasive interventions procedures surgery Tailored approach – the best option for the patient
  • 21. Individualizethe therapy waiting for more evidence• Anatomy and function• Comorbidities, Life expectancy• Compare risk and probability of success• Preservation of surgical option• Patient informed consent for therapy• collaboration