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Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man
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Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man

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Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man Presentation Transcript

  • 1. MiCardia: Dynamic Mitral Annuloplasty Device Design Concepts, Experimental Insights and First-in-Man Maurice Buchbinder, MD Foundation for Cardiovascular Medicine La Jolla, CA Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 2. Why Degradable Stents? Disclosure M.Buchbinder – Scientific Advisory, Board Member Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 3. Ischemic MR • Ischemic Mitral Regurgitation (IMR) is seen in up to 20% of patients following acute myocardial infraction. (Hickey; Circulation 1988;78:151- 159, Lamas; Circulation 1997; 96:827-833) • Treatment of IMR includes medical therapy and in severe cases surgical repair with an undersized annuloplasty ring to reduce the size of the mitral annulus and improve leaflet coaptation. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 4. Ischemic MR • Following isolated annuloplasty surgery recurrent (>2+) MR is seen in 10-30% of patients (McGee; J. Thorac Cardiovasc Surg 2004;128:916-24) • Recurrent MR appears to be commonly seen within the first year following surgery and remains relatively stable thereafter (McGee; J. Thorac Cardiovasc Surg 2004;128:916-24) • Unlike in dilated cardiomyopathy IMR is associated with asymmetric deformation of the annulus (Kwan; Circulation. 2003;107:1135.) Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 5. Current technology does not cope with dynamic ischemic disease • MITRAL •Residual post-op Edwards Physio occurrence of 6- 10% •6m recurrence of 15%-25% Medtronic Duran •3 Yr, recurrence of 30% to 50% • TRICUSPID •“Upon Discharge” recurrence of 25% SJM Tailor to 30% •Directly contributes to the onset of HF ATS Simulus when untreated Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 6. MiCardia Semi-Rigid Dynamic Annuloplasty “C” Ring (Degenerative) Baseline Shape (Implanted) Transparent = Baseline Red = Post Activation Shape Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 7. MiCardia Rigid Dynamic Annuloplasty “D” Ring (Ischemic) Baseline MiCardia Dynamic Ring Transparent = Baseline Red = Activated Shape Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 8. The MiCardia Dynamic Ring • “C” and “D” shapes available sizes 28mm through 36mm • Without activation functions as a “standard” ring • Pre-attached electrodes used for activation make the ring Dynamic Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 9. Intra-Operative Re-shaping • Each RF wire is connected to the propriatary MiCardia RF generator. P1 P3 • Following implantation and pending degree of residual P2 MR ,Wires are activated as to re-shape the ring in vivo • Echocardiography confirms effectiveness of activation during and post re-shaping Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 10. Dynamic Ring - Features • Implants identical to existing technology • Semi-rigid metal core maintains its shape. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 11. Intra-Operative Reshaping Early “In-Vivo” experience • A-P distance shortening by 0.5-3.0mm • Inter-Commissural distance contracted by 1.0-3.5mm • No heat damage to the surrounding Postero-Medial commissure activation tissue Courtesy Dr. Alex Marmureanu Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 12. Degenerative Ring Activation Pre-Activation Intra-Op Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 13. Ultimate Valve Repair Modality Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 14. Percutaneous Reshaping • The implanted ring is accessed via transeptal approach. • Thru a Deflectable guide catheter system for optimal positioning • An Expandable basket with built in RF electrodes is used to activate the ring upon contact in multiple zones. • On line echocardiography confirms effectiveness of activation during and after re- shaping Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 15. Percutaneous Animal Experience • A-P distance shortened by 0.3-2.9mm • Inter-Commissural Distance contracted by 1.2- 3.6mm Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 16. TransQ Device Platform • Single lead, atrial exit • No flow interference • Subcutaneous “pocket“ deployment of lead • Simple outpatient activation 30 Minute Outpatient Adjustment • Activate days, weeks or By Interventional months after the initial Cardiologist procedure to correct recurrence Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 17. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 18. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 19. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 20. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 21. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 22. Transcutaneous Activation • Lead Exits Left Atrium • Completely encapsulated 40 days • Connects to MiCardia RF Generator • Allows for Delayed Activation Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 23. Transcutaneous Activation • Full activation takes place within 60 seconds. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 24. Transcutaneous Activation • No infection • No dehiscence • Full activation 60+ days • 100% in-growth • 40 and 60 day testing Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 25. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 26. Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 27. 26 Human Implants completed (June 09) Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 28. First-in-Man Experience February 2008 • 4+MR with P2 leaflet prolapse • Leaflet resection with implantation of a 28mm D+ ring. • Reduced to trace MR Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 29. First-in-Man Experience P2 prolapse Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 30. First-in-Man Experience 4+MR with eccentric anterior jet Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 31. First-in-Man Experience Post repair no MR acute and at discharge Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 32. First-in-Man Experience Ring shape at discharge Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 33. Future Developments 2004-2008 2009-2010 2009-2011 Mitral Mitral Shape Magnetic Memory Tricuspid Percutaneous External Tricuspid Intra-Operative Trans‐Q Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 34. Magnetic Ring • Magnetic drive: no motor • AP + or AP - models • Infinitely adjustable • Can be titrated • Reversible • Multiple activations • Percutaneous activation via R. Heart Access (16Fr) • External via TEE access Maurice Buchbinder, MD Foundation for Cardiovascular Medicine
  • 35. Conclusion • From this early clinical experience the MiCardia Dynamic Annuloplasty Ring appears to be a promising device for treatment of Mitral regurgitation. • The In-Vivo adjustable feature may be an extremely valuable tool for optimization of surgical results • Further percutaneous adjustments in ring geometry in the healing phase could be a compelling advantage for its use . Maurice Buchbinder, MD Foundation for Cardiovascular Medicine