Dr. Jan Kovac, MUDr., FACC, FESC Cardiology Division, Glenfield Hospital University of Leicester NHS Trust, Leicester UK T...
Interventional Cardiology ‘Credo’ “ Anything a cardiac surgeon can do,  an interventional cardiologist can do  as well or ...
1. Percutaneous aortic valve replacement (AS,AI) PVT, Corevalve, Pananigua, 3F, Corazone…  2. Percutaneous therapy of mitr...
The standard for critical AS RX is Surgical AVR Ross Homograft Mechanical Stentless Tissue
Ikonomidis, J. S. et al.; J Thorac Cardiovasc Surg 2003;126:2022-2031 Actuarial and "actual" freedom from valve-...
Mortality in Aortic Valve Replacement n = 1.984 %mortality Burr et al.: Annals of Thor Surg, 1995, 60, S264-269
Aortic valve replacement Refused for Surgery Euro Heart Survey on Valvular Heart Disease (5001 Patients) Iung B. and al, E...
Diseases desperate grown,  By desperate appliances are reliev’d, Or not at all” (Hamlet Act IV)
Prosthetic Aortic Valve Functions 1. Allow normal LVOT function 2. Restore anulus flexibility 3. Conserve sinus motion and...
First Clinical Percutaneous Aortic Valve Alain Cribier - 16/4/02 <ul><li>Equine pericardial valve </li></ul><ul><li>sewn o...
Percutaneous Aortic Valve Replacement Designs/Trials 1. PVT-Edwards-Cribier 2. COREVALVE 3. Panaguia 4. 3F 5. SORIN 6. COR...
<ul><li>Tricuspid valve, equine pericardium </li></ul><ul><li>Stainless steel stent frame </li></ul><ul><li>22mm Numed bal...
Cribier Edwards AV Implant
Cribier PVT Trials Inclusion Criteria   Patients >70 years of age Aortic valve area < 0.7 cm² Aortic annulus diameter: 19-...
Alan Cribier-Edwards PVT Rouen Experience
Alan Cribier-Edwards PVT RECAST Experience
<ul><li>A pericardium porcine tissue valve </li></ul><ul><li>Fixed to the frame in a surgical manner with PTFE sutures </l...
 
CoreValve Study Results Clinical succes In hospital death Convertion to Surgery Phase 1 Phase 2 Phase 1&2:  July 2004-Dec ...
Phase 2 Clinical Study 7 European Investigative Centers Patient type:  High-risk/non-surgical candidates  Euroscore higher...
3F Transapical Antegrade Aortic Valve Implant
Thin Film Nanotechnology  e Nitinol MembranePercValve™
Aortic Valve Calcification
CORAZON percutaneous aortic valve system flexible multilumen central catheter (navigable) soft tip for placement into left...
CORAZON percutaneous aortic valve system
Percutaneous Mitral Valve Therapies
Percutaneous Transvenous Mitral Reshaping/Annuloplasty through the Coronary Sinus Straightening, Stent based Reshaping/Ann...
Percutaneous Mitral E2E Repair
EVEREST  I Endovascular Valve Edge to edge REpair pair STudy
Freedom from surgery to date 35/47 = 74% • No clip deployed (n=5) for insufficient MR reduction • Operations: 4 repairs, 1...
EVEREST II Study Design EVEREST II Study Design Prospective, randomized, multicenter study Control: surgical mitral valve ...
<ul><li>Step 1 </li></ul>Placement of a percutaneous stitch in the free edge(s) of the mitral leaflets,  Edwards LilfeScie...
Mitral Annuloplasty Therapies
Edwards PTMA   Viking Stent based anchors connected by a tether Anchors at the CS ostium and AIV Time delay contracting te...
CarillonTM, Cardiac Dimensions
<ul><li>Straightens the coronary </li></ul><ul><li>sinus </li></ul><ul><li>Anteriorly displaces P2 </li></ul><ul><li>Begin...
Quantum Cor RF Tip of probe is smaller to conform to  annulus shape 8 electrodes (~1.5x2mm) Delivery of RF energy to elect...
Combined percutaneous MV Treatment   …  a bow tie always need a collar
Is Percutaneous Mitral Replacement Possible?
For Cardiac Surgeons.. &quot; In times of change, the learners inherit the Earth, while the   learned find themselves beau...
UK/ Leicester Perspective <ul><li>Aortic valve COREVALVE 18 F Trial (2006) </li></ul><ul><li>EVEREST III Trial (pending EV...
Very early days 120-130 aortic and mitral implants worldwide Does  not stand up to surgical therapy at the moment New skil...
Will it ultimately work? S.Oesterle….the Beauty of Stardom No R+D  but r+ D no Venture Capitalist able to fund >1000 $/pat...
I don’t skate where the puck is.  I skate, to where the puck is going. Wayne Gretzky NHL All Star 81-99
 
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Interventional Techniques

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Interventional Techniques

  1. 1. Dr. Jan Kovac, MUDr., FACC, FESC Cardiology Division, Glenfield Hospital University of Leicester NHS Trust, Leicester UK The Future of Percutaneous Valve Therapies Presenter Disclosure:None
  2. 2. Interventional Cardiology ‘Credo’ “ Anything a cardiac surgeon can do, an interventional cardiologist can do as well or better percutaneously” AH Gershlick, 2003
  3. 3. 1. Percutaneous aortic valve replacement (AS,AI) PVT, Corevalve, Pananigua, 3F, Corazone… 2. Percutaneous therapy of mitral regurgitation leaflet fixation coronary sinus techniques transventricular techniques 3. Pulmonary valve replacement (P.Bohnhoffer) Percutaneous Valve Therapies in 2006
  4. 4. The standard for critical AS RX is Surgical AVR Ross Homograft Mechanical Stentless Tissue
  5. 5. Ikonomidis, J. S. et al.; J Thorac Cardiovasc Surg 2003;126:2022-2031 Actuarial and &quot;actual&quot; freedom from valve-related morbidity or mortality after AVR and MVR
  6. 6. Mortality in Aortic Valve Replacement n = 1.984 %mortality Burr et al.: Annals of Thor Surg, 1995, 60, S264-269
  7. 7. Aortic valve replacement Refused for Surgery Euro Heart Survey on Valvular Heart Disease (5001 Patients) Iung B. and al, Eur. Heart Journal 2003 : 24, 1231-1243 32 % did not undergo surgery !
  8. 8. Diseases desperate grown, By desperate appliances are reliev’d, Or not at all” (Hamlet Act IV)
  9. 9. Prosthetic Aortic Valve Functions 1. Allow normal LVOT function 2. Restore anulus flexibility 3. Conserve sinus motion and sinus flow dynamics 4. Ensure physiological orientation of trileaflet valve 5. Do better than current valves
  10. 10. First Clinical Percutaneous Aortic Valve Alain Cribier - 16/4/02 <ul><li>Equine pericardial valve </li></ul><ul><li>sewn on 23mm BES; </li></ul><ul><li>PVT acquired by Edwards </li></ul><ul><li>1/04 </li></ul>
  11. 11. Percutaneous Aortic Valve Replacement Designs/Trials 1. PVT-Edwards-Cribier 2. COREVALVE 3. Panaguia 4. 3F 5. SORIN 6. CORAZONE 7. SADRA Medical 8. ValveXchange 9. Direct Flow
  12. 12. <ul><li>Tricuspid valve, equine pericardium </li></ul><ul><li>Stainless steel stent frame </li></ul><ul><li>22mm Numed ballon catheter </li></ul><ul><li>Original crimper device </li></ul><ul><li>Compatible with 24-Fr sheath </li></ul>
  13. 13. Cribier Edwards AV Implant
  14. 14. Cribier PVT Trials Inclusion Criteria Patients >70 years of age Aortic valve area < 0.7 cm² Aortic annulus diameter: 19-23 mm Dyspnoea NYHA class IV At extremely high risk for open heart surgery and formally declined by two cardiac surgeons for surgical valve replacement
  15. 15. Alan Cribier-Edwards PVT Rouen Experience
  16. 16. Alan Cribier-Edwards PVT RECAST Experience
  17. 17. <ul><li>A pericardium porcine tissue valve </li></ul><ul><li>Fixed to the frame in a surgical manner with PTFE sutures </li></ul>CoreValve’s Self-Expanding Prosthesis <ul><ul><ul><li>HIGHER PART : increases quality of fixation and axes the system </li></ul></ul></ul><ul><ul><ul><li>MIDDLE PART : is constrained to avoid coronaries (no rotational positioning) and carries the valve </li></ul></ul></ul><ul><ul><ul><li>LOWER PART: High radial force of the frame pushes aside the calcified leaflets and avoids recoil and para-valvular leaks </li></ul></ul></ul>
  18. 19. CoreValve Study Results Clinical succes In hospital death Convertion to Surgery Phase 1 Phase 2 Phase 1&2: July 2004-Dec 2005 (28 patients )
  19. 20. Phase 2 Clinical Study 7 European Investigative Centers Patient type: High-risk/non-surgical candidates Euroscore higher than 20 Trial initiated: December 2005 Primary endpoints:Acute safety and efficacy Long-term outcomes Leicester 2006
  20. 21. 3F Transapical Antegrade Aortic Valve Implant
  21. 22. Thin Film Nanotechnology e Nitinol MembranePercValve™
  22. 23. Aortic Valve Calcification
  23. 24. CORAZON percutaneous aortic valve system flexible multilumen central catheter (navigable) soft tip for placement into left ventricle and a balloon for occluding the LV outflow tract below the aortic valve expandable central lumen with temporary aortic valve enabling beating heart aortic valve treatment aortic isolation of treatment area using a compliant bell designed to conform to the shape of aortic valve cusps balanced solution inflow and aspiration
  24. 25. CORAZON percutaneous aortic valve system
  25. 26. Percutaneous Mitral Valve Therapies
  26. 27. Percutaneous Transvenous Mitral Reshaping/Annuloplasty through the Coronary Sinus Straightening, Stent based Reshaping/Annuloplasty through the Ventricle Percutaneous/Transatrial edge to edge (E2E or Alfieri) repair Plicating Left Atrial/Ventricular Tissue anchors Percutaneous Mitral Repair Technologies
  27. 28. Percutaneous Mitral E2E Repair
  28. 29. EVEREST I Endovascular Valve Edge to edge REpair pair STudy
  29. 30. Freedom from surgery to date 35/47 = 74% • No clip deployed (n=5) for insufficient MR reduction • Operations: 4 repairs, 1 intended replacement after clip deployment (n=7) • Reasons: • 1 device malfunction • 4 partial detachments • Timing (days): 1, 3, 36, 40, 50, 110, 133 • Surgery: • 5 repairs, 2 replacement (1 intended; 1 failed repair) • Concomitant ASD repair (6), MAZE (1), CABG (1) • 2 progressive MR EVEREST I Endovascular Valve Edge to edge REpair pair STudy
  30. 31. EVEREST II Study Design EVEREST II Study Design Prospective, randomized, multicenter study Control: surgical mitral valve repair/ replacement Patients randomized 2:1 37 centers in US and Canada Primary Effectiveness Endpoint Freedom from surgery, death, and moderate to severe (3+) or severe (4+) mitral regurgitation at 12 months. Primary Safety Endpoint Freedom from MAE at one month
  31. 32. <ul><li>Step 1 </li></ul>Placement of a percutaneous stitch in the free edge(s) of the mitral leaflets, Edwards LilfeSciences Step 3 Step 2
  32. 33. Mitral Annuloplasty Therapies
  33. 34. Edwards PTMA Viking Stent based anchors connected by a tether Anchors at the CS ostium and AIV Time delay contracting tether Cinches the mitral annulus, increases mitral leaflet coaptation
  34. 35. CarillonTM, Cardiac Dimensions
  35. 36. <ul><li>Straightens the coronary </li></ul><ul><li>sinus </li></ul><ul><li>Anteriorly displaces P2 </li></ul><ul><li>Begins with a “diagnostic” </li></ul><ul><li>OTW procedure </li></ul><ul><li>Implant placed OTW </li></ul><ul><li>within a 7 Fr sheath </li></ul><ul><li>Implant tethered to a hub </li></ul><ul><li>in the infraclavicular </li></ul><ul><li>fossa </li></ul>Viacor
  36. 37. Quantum Cor RF Tip of probe is smaller to conform to annulus shape 8 electrodes (~1.5x2mm) Delivery of RF energy to electrodes is computer-controlled by maximum temperatures sensed by adjacent thermocouples
  37. 38. Combined percutaneous MV Treatment … a bow tie always need a collar
  38. 39. Is Percutaneous Mitral Replacement Possible?
  39. 40. For Cardiac Surgeons.. &quot; In times of change, the learners inherit the Earth, while the learned find themselves beautifully equipped to deal with a world that no longer exists. &quot; Eric Hoffer Not quite….for a while
  40. 41. UK/ Leicester Perspective <ul><li>Aortic valve COREVALVE 18 F Trial (2006) </li></ul><ul><li>EVEREST III Trial (pending EVEREST II, end 2006) </li></ul><ul><li>Compassionate Use ?? </li></ul>
  41. 42. Very early days 120-130 aortic and mitral implants worldwide Does not stand up to surgical therapy at the moment New skills needed for interventionist-TOE/ICE Old skills refreshed (transseptal, PTMV, CS) Teamwork (blurring boundaries interventionist/ surgeon)
  42. 43. Will it ultimately work? S.Oesterle….the Beauty of Stardom No R+D but r+ D no Venture Capitalist able to fund >1000 $/patient clinical Trial, quality assurance, manufacturing, regulatory issues, distribution “ Make a better mousetrap and world will beat path to your door ” Waldo Emerson
  43. 44. I don’t skate where the puck is. I skate, to where the puck is going. Wayne Gretzky NHL All Star 81-99

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