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History and Future of Transcatheter Mitral Valve Repair ,[object Object],[object Object],[object Object],[object Object]
TAVI is moving rapidly into a clinical procedure widely available ,[object Object],[object Object],[object Object]
Euro Heart Survey surgery is often denied in the older patients Isolated MR (n=877) Severe MR (n=546) No Severe MR (n=331) No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Intervention (n=203) 51% Mirabel et al, European Heart J 2007;28:1358-1365 2/3 of symptomatic MR patients  >70  are denied surgery
Prevalence of valve disease in the population: MR is epidemic in the elderly Nkomo et al , Lancet 2006
Transcatheter mitral interventions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
AJC 3:653,1959  1959
JAMA 1966
1984
1998-2001, Edwards suction and suture device (MILANO 1)
2002-2006 Edwards suction and suture device (MOBIUS / MILANO 2)
Clip repair in porcine heart (6 mos post repair) Fann JI; St. Goar FG; Komtebedde J; Oz MC; Block PC; Foster E; Feldman T; Burdon TA  Circulation 2003, 108:(Supp IV) 493. 2002-2003 Off-pump Edge-to-Edge Mitral Valve Technique Using a Mechanical Clip in a Chronic Model  –  Initial clinical experience FIM (2003)
Worldwide experience  about 750 patients treated
Transcatheter mitral valve procedures ,[object Object],[object Object],[object Object],[object Object]
 
Devices in clinical trial  MONARC (Edwards Lifesciences LLC) ,[object Object],EVOLUTION trial (69 pts enrolled) CARILLON (Cardiac Dimensions Inc) Acute reshaping device  acting in P2P3, repositionable, retrievable AMADEUS trial (43 pts  enrolled ) PTMA  (Viacor Inc) ,[object Object],PTOLEMY (24 pts enrolled)
Device Positioning and Deployment ,[object Object],[object Object],[object Object]
Percutaneous Mitral Valve Repair Prosthetic Ring Coronary Sinus Annuloplasty Safety at 30 Days Monarch Carillon Viacor n 69 43 26 Success implantation % 80 70 42 Death % 3 2 0 MI % 3 4 0 Tamponade % 3 4 4 Dissection CS % 0 2 8
Percutaneous Mitral Valve Repair Prosthetic Ring Coronary Sinus Annuloplasty Efficacy Monarc  Carillon Viacor Pre 6 Mos Pre Post  (TEE no core lab) n 21 Reduction MR>/=1+ 57% 63% NA ERO Cm² 0.31 0.20 0.33 0.19 NA Rvol  ml 42 27 40 24 NA
Ptolemy Trial  - VIACOR implant is modifying annular geometry  ,[object Object],[object Object]
Improved quality of life / symptoms ,[object Object],[object Object]
Coronary Sinus Devices:  potential anatomical issues associated  with efficacy / safety ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Predicting responders in EVOLUTION I and AMADEUS trials ,[object Object],[object Object],Courtesy of J Harnek, MD
Devices to reduce SL dimension ,[object Object],[object Object],Rogers et al, Circulation 2006;113:2329
Direct annular remodeling ,[object Object],[object Object],[object Object],[object Object]
Other devices ,[object Object],[object Object]
Transcatheter MVR ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evalve MitraClip ®  Device
Mitraclip
Description of Valve Repair System Guide Steerable sleeve Clip delivery handle Stabilizer Atrial Septum
versatility ,[object Object],[object Object]
Anatomic Eligibility Leaflet mal-coaptation resulting in MR ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
EVEREST Preliminary Cohort Enrollment with   30 day Core Lab Follow-Up ,[object Object],[object Object],[object Object]
EVEREST Preliminary Cohort Patients with  30 Day Major Adverse Events  ( N = 107 )
EVEREST Preliminary Cohort Efficacy Results through Discharge N = 107 *  Acute Procedural Success (APS):  Defined as placement of one or more Clips   resulting in  discharge  MR severity of 2+ or less , as determined by Core Lab.   70% of procedures are 1 st , 2 nd  or 3 rd  at Site
CASE EXAMPLE, Functional MR  HSR; October 23 rd   2008 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
 
 
 
 
 
 
 
Final result (2 hrs after, skin to skin) ,[object Object],[object Object],[object Object],[object Object]
HRR FMR: Mitral Regurgitation   (ITT) MitraClip therapy results in sustained MR reduction Mild-Moderate MR (Grade 1+/2+) Moderate-Severe or  Severe MR (Grade 3+/4+) 52% of patients had MR grade 0 or 1+ at 12 months n=34, Matched Data 97% 3% 26% 18% 82% 74%
HRR FMR:  LV Function (ITT) MitraClip therapy results in reverse LV remodeling n=34, Matched Data P=0.001 P=0.0002 LVEDV Baseline LVEDV 12 Months LVESV Baseline LVESV 12 Months 192 153 103 87 Systolic Diastolic
European adoption of Mitraclip ,[object Object],[object Object],[object Object]
Mitraclip vs Surgery a preliminary comparison ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The future of endovascular mitral repair Early treatment Anatomical  reconstruction Neochordae Implantation
Edwards Mobius  di 22
TC orientation and capture
Chordal implant dynamic adjustment and post-mortem
 
The future of mitral valve surgery ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Surgeons should prepare for the FUTURE ,[object Object],[object Object],[object Object]
Treating valve disease in the future today Tailored approach – the best option for the patient

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History and Future of Transcatheter Mitral Valve Interventions

  • 1.
  • 2.
  • 3. Euro Heart Survey surgery is often denied in the older patients Isolated MR (n=877) Severe MR (n=546) No Severe MR (n=331) No Symptoms (n=144) Symptoms (n=396) No Intervention (n=193) 49% Intervention (n=203) 51% Mirabel et al, European Heart J 2007;28:1358-1365 2/3 of symptomatic MR patients >70 are denied surgery
  • 4. Prevalence of valve disease in the population: MR is epidemic in the elderly Nkomo et al , Lancet 2006
  • 5.
  • 9. 1998-2001, Edwards suction and suture device (MILANO 1)
  • 10. 2002-2006 Edwards suction and suture device (MOBIUS / MILANO 2)
  • 11. Clip repair in porcine heart (6 mos post repair) Fann JI; St. Goar FG; Komtebedde J; Oz MC; Block PC; Foster E; Feldman T; Burdon TA Circulation 2003, 108:(Supp IV) 493. 2002-2003 Off-pump Edge-to-Edge Mitral Valve Technique Using a Mechanical Clip in a Chronic Model – Initial clinical experience FIM (2003)
  • 12. Worldwide experience about 750 patients treated
  • 13.
  • 14.  
  • 15.
  • 16.
  • 17. Percutaneous Mitral Valve Repair Prosthetic Ring Coronary Sinus Annuloplasty Safety at 30 Days Monarch Carillon Viacor n 69 43 26 Success implantation % 80 70 42 Death % 3 2 0 MI % 3 4 0 Tamponade % 3 4 4 Dissection CS % 0 2 8
  • 18. Percutaneous Mitral Valve Repair Prosthetic Ring Coronary Sinus Annuloplasty Efficacy Monarc Carillon Viacor Pre 6 Mos Pre Post (TEE no core lab) n 21 Reduction MR>/=1+ 57% 63% NA ERO Cm² 0.31 0.20 0.33 0.19 NA Rvol ml 42 27 40 24 NA
  • 19.
  • 20.
  • 21.
  • 22.
  • 23.
  • 24.
  • 25.
  • 26.
  • 29. Description of Valve Repair System Guide Steerable sleeve Clip delivery handle Stabilizer Atrial Septum
  • 30.
  • 31.
  • 32.
  • 33. EVEREST Preliminary Cohort Patients with 30 Day Major Adverse Events ( N = 107 )
  • 34. EVEREST Preliminary Cohort Efficacy Results through Discharge N = 107 * Acute Procedural Success (APS): Defined as placement of one or more Clips resulting in discharge MR severity of 2+ or less , as determined by Core Lab. 70% of procedures are 1 st , 2 nd or 3 rd at Site
  • 35.
  • 36.  
  • 37.  
  • 38.  
  • 39.  
  • 40.  
  • 41.  
  • 42.  
  • 43.
  • 44. HRR FMR: Mitral Regurgitation (ITT) MitraClip therapy results in sustained MR reduction Mild-Moderate MR (Grade 1+/2+) Moderate-Severe or Severe MR (Grade 3+/4+) 52% of patients had MR grade 0 or 1+ at 12 months n=34, Matched Data 97% 3% 26% 18% 82% 74%
  • 45. HRR FMR: LV Function (ITT) MitraClip therapy results in reverse LV remodeling n=34, Matched Data P=0.001 P=0.0002 LVEDV Baseline LVEDV 12 Months LVESV Baseline LVESV 12 Months 192 153 103 87 Systolic Diastolic
  • 46.
  • 47.
  • 48. The future of endovascular mitral repair Early treatment Anatomical reconstruction Neochordae Implantation
  • 49. Edwards Mobius di 22
  • 51. Chordal implant dynamic adjustment and post-mortem
  • 52.  
  • 53.
  • 54.
  • 55. Treating valve disease in the future today Tailored approach – the best option for the patient

Hinweis der Redaktion

  1. Ross J Jr, Braunwald E, Morrow AG AJC 3:653-655,1959 In 1958, while working at National Institutes of Health, Eugene Braunwald was director of a cath lab, and 1st Yr Fellow was John Ross. Ross was using sizing balloons to measure atrial septal defects in the cath lab. A visiting physician from Argentina observed this procedure and asked whether Ross had considered using a needle to puncture the intact septum. Ross discussed at doiner with EB, then requested time off from the cath lab, and developed a needle device in the dog lab. This was introduced into patients via femoral cutdown. A couple of years later when the Seldinger technique was introduced, a surgical resident working with Breaunwald designed a catheter, the Brockenbrough, through which the Ross needle could be placed. Related by EB March 09, 2004
  2. JAMA 196:991-992, 1966
  3. Here is a schematic movie the progressive shortening of the annulus and the theoretical changes of the geometry of the heart
  4. The third step is the implantation, the distal anchor is first deployed , than the proximal At the end of the procedure a coronary angiography is again performed to insure that there is no immediate coronary artery complication
  5. Removed “Remained Improved by 12 months” and put “improved by 12-months”. Remained improved implies the patients who improved at 30-days that were still improved at 12-months. 85% of the 82% 30-day successes were improved at 12-months. – this is 70% of the 30-day success patients. 79% of the total pop improved at 12months
  6. Paired T-Test