History and Future of Transcatheter Mitral Valve Interventions


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Invited lecture at the Scandinavian Society of Cardiothoracic Surgeons on transcathter mitral valve interventions (2009)

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  • 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
  • JAMA 196:991-992, 1966
  • Here is a schematic movie the progressive shortening of the annulus and the theoretical changes of the geometry of the heart
  • 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
  • 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
  • Paired T-Test
  • History and Future of Transcatheter Mitral Valve Interventions

    1. 1. History and Future of Transcatheter Mitral Valve Repair <ul><li>Francesco Maisano </li></ul><ul><li>San Raffaele Hospital </li></ul><ul><li>Milano </li></ul><ul><li>Italy </li></ul>
    2. 2. TAVI is moving rapidly into a clinical procedure widely available <ul><li>Replacement of the aortic valve is less demanding than MVR or repair </li></ul><ul><li>Aortic stenosis is more prevalent in the elderly </li></ul><ul><li>There is evidence of undertreatment of patients with aortic stenosis </li></ul>
    3. 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. 4. Prevalence of valve disease in the population: MR is epidemic in the elderly Nkomo et al , Lancet 2006
    5. 5. Transcatheter mitral interventions <ul><li>Balloon commissurotomy </li></ul><ul><li>Annular repair </li></ul><ul><ul><li>Sinoplasty (Monarc, Carillon, PTMA) </li></ul></ul><ul><ul><li>Direct reshaping (Mitralign, GDS) </li></ul></ul><ul><li>Leaflet repair </li></ul><ul><ul><li>Edge-to-edge repair (Mitraclip) </li></ul></ul><ul><ul><li>Others (plicating clips, chordal repair) </li></ul></ul><ul><li>Cinching devices </li></ul><ul><ul><li>Internal (PS3) </li></ul></ul><ul><ul><li>External (Coapsys) </li></ul></ul><ul><li>Other </li></ul><ul><ul><li>Hybrid devices (Mitral Solutions, Micardia) </li></ul></ul><ul><ul><li>Occluder (Cardiac Solutions) </li></ul></ul><ul><ul><li>Transcatheter MVR (Endovalve) </li></ul></ul><ul><ul><li>Perivalvular leak closure </li></ul></ul>
    6. 6. AJC 3:653,1959 1959
    7. 7. JAMA 1966
    8. 8. 1984
    9. 9. 1998-2001, Edwards suction and suture device (MILANO 1)
    10. 10. 2002-2006 Edwards suction and suture device (MOBIUS / MILANO 2)
    11. 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. 12. Worldwide experience about 750 patients treated
    13. 13. Transcatheter mitral valve procedures <ul><li>Most devices are evolution of surgical devices </li></ul><ul><li>Image-guided delivery vs surgical direct vision </li></ul><ul><li>Therapy guided by function vs lesion </li></ul><ul><li>On line effect or therapy </li></ul>
    14. 15. Devices in clinical trial MONARC (Edwards Lifesciences LLC) <ul><ul><li>Two-anchor design with chronic reshaping (6weeks) by a foreshortening bridge </li></ul></ul>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) <ul><ul><li>Tri-lumen catheter, reshapable, possibility of multiple long term adjustment </li></ul></ul>PTOLEMY (24 pts enrolled)
    15. 16. Device Positioning and Deployment <ul><ul><li>Device Positioning </li></ul></ul><ul><ul><li>Anchor Deployment </li></ul></ul><ul><ul><li>Final Confirmation </li></ul></ul>
    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
    17. 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
    18. 19. Ptolemy Trial - VIACOR implant is modifying annular geometry <ul><li>3D ECHO annulus tracing end-diastole </li></ul><ul><li>Composite SL diameter reduction for 7 implants= 5.6±2.5mm </li></ul>
    19. 20. Improved quality of life / symptoms <ul><li>Quality of life assessment </li></ul><ul><li>6-min-walking test </li></ul>
    20. 21. Coronary Sinus Devices: potential anatomical issues associated with efficacy / safety <ul><li>Anatomical relations with the mitral annulus </li></ul><ul><ul><li>only posterior </li></ul></ul><ul><ul><li>atrialization </li></ul></ul><ul><li>Relation with the Cx artery </li></ul><ul><ul><li>Potential risk of AMI </li></ul></ul><ul><li>Risk of lesions </li></ul><ul><li>PREDICTABILITY OF RESULT </li></ul>
    21. 22. Predicting responders in EVOLUTION I and AMADEUS trials <ul><li>No differences in CS/GCV location relative to the annulus between patients with or without efficacy </li></ul><ul><li>Neither MR reduction or lack of MR reduction is explained by relative position of vein to annulus </li></ul>Courtesy of J Harnek, MD
    22. 23. Devices to reduce SL dimension <ul><li>Ample- PS3 </li></ul><ul><li>Myocor (Edwards) i-Coapsys </li></ul>Rogers et al, Circulation 2006;113:2329
    23. 24. Direct annular remodeling <ul><li>Mitralign </li></ul><ul><li>GDS </li></ul><ul><li>The closest devices to conventional suture annuloplasty </li></ul><ul><li>Initial clinical trials </li></ul>
    24. 25. Other devices <ul><li>Quantumcor </li></ul><ul><li>Percupro – Cardiacsolutions </li></ul>
    25. 26. Transcatheter MVR <ul><li>Larger device </li></ul><ul><li>Anchoring </li></ul><ul><li>Asymmetric anatomy </li></ul><ul><li>Interaction with the aortic valve </li></ul><ul><li>LVOT obstruction </li></ul><ul><li>PVL more problematic </li></ul><ul><li>At least 10 companies are working on t-MVR </li></ul>
    26. 27. Evalve MitraClip ® Device
    27. 28. Mitraclip
    28. 29. Description of Valve Repair System Guide Steerable sleeve Clip delivery handle Stabilizer Atrial Septum
    29. 30. versatility <ul><li>Functional MR </li></ul><ul><li>Degenerative MR </li></ul>
    30. 31. Anatomic Eligibility Leaflet mal-coaptation resulting in MR <ul><li>Sufficient leaflet tissue for mechanical coaptation </li></ul><ul><li>Non-rheumatic/endocarditic valve morphology </li></ul><ul><li>Protocol anatomic exclusions </li></ul><ul><ul><li>Flail gap >10mm </li></ul></ul><ul><ul><li>Flail width >15mm </li></ul></ul><ul><ul><li>LVIDs > 55mm </li></ul></ul><ul><ul><li>Coaptation depth >11mm </li></ul></ul><ul><ul><li>Coaptation length < 2mm </li></ul></ul>
    31. 32. EVEREST Preliminary Cohort Enrollment with 30 day Core Lab Follow-Up <ul><li>Preliminary Cohort analysis per EVEREST II definitions </li></ul><ul><li>30 North American sites </li></ul><ul><li>70% are 1 st , 2 nd , or 3 rd procedure at a site </li></ul>
    32. 33. EVEREST Preliminary Cohort Patients with 30 Day Major Adverse Events ( N = 107 )
    33. 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
    34. 35. CASE EXAMPLE, Functional MR HSR; October 23 rd 2008 <ul><li>66 yo, male, 64 Kg, 164 cm, BSA 1.7 m2, BMI 24 </li></ul><ul><li>Post-ischemic Cardiomyopathy, CCS II, NYHA III </li></ul><ul><li>Comorbidities </li></ul><ul><ul><li>Infrarenal abdominal aneurysm </li></ul></ul><ul><ul><li>2006 stenting of right common carotid artery and right internal carotid artery </li></ul></ul><ul><ul><li>2005 Bone Marrow Tx for AML </li></ul></ul><ul><li>1994 anterior AMI ; 2001 PCI followed by CABG (LIMA—LAD ), followed by multiple PTCA with DES </li></ul><ul><li>1/2008: AMI for intrastent thrombosis -> POBA on LAD </li></ul><ul><li>4/2008 Acute Pulmonary Edema  CRT with Biventricular Pacing and ICD </li></ul>
    35. 43. Final result (2 hrs after, skin to skin) <ul><li>Before treatment </li></ul><ul><li>After mitraclip </li></ul><ul><li>The patient was transferred from ICU to the general ward in day 1 and discharged home 4 days after the procedure </li></ul><ul><li>At 3 months the MR reduction is stable with mild residual MR, reduction of LV volumes, and the patient is in NYHA class II </li></ul>
    36. 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%
    37. 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
    38. 46. European adoption of Mitraclip <ul><li>Mitraclip obtained CE mark late 2008 </li></ul><ul><li>100 cases performed </li></ul><ul><li>Most patients treated are elderly and high risk prolapse patients and patients with CHF </li></ul>
    39. 47. Mitraclip vs Surgery a preliminary comparison <ul><li>Safety is probably superior compared to surgery </li></ul><ul><li>Efficacy is probably inferior compared to surgery </li></ul><ul><ul><li>High rate of pts with residual MR </li></ul></ul><ul><ul><li>clinical benefit yet to be demonstrated </li></ul></ul><ul><li>Results will be influenced by improvements in: </li></ul><ul><ul><li>Learning curve </li></ul></ul><ul><ul><li>Indications </li></ul></ul><ul><ul><li>imaging </li></ul></ul><ul><ul><li>Addition of annuloplasty </li></ul></ul>
    40. 48. The future of endovascular mitral repair Early treatment Anatomical reconstruction Neochordae Implantation
    41. 49. Edwards Mobius di 22
    42. 50. TC orientation and capture
    43. 51. Chordal implant dynamic adjustment and post-mortem
    44. 53. The future of mitral valve surgery <ul><li>Minimally invasive and transcatheter approach </li></ul><ul><li>Image guidance and computer aided decision making </li></ul><ul><li>Devices will be </li></ul><ul><ul><li>ethiology-specific </li></ul></ul><ul><ul><li>Adjustableoff pump </li></ul></ul><ul><ul><li>Implantable with no or minimal conventional suturing </li></ul></ul><ul><li>Early treatment </li></ul><ul><li>Stepwise and combined strategies </li></ul>
    45. 54. Surgeons should prepare for the FUTURE <ul><li>Because transcatheter procedures are the natural evolution of surgery </li></ul><ul><li>Because patients deserve an unbiased choice of the best approach </li></ul><ul><li>Because surgeons own most of the core skills needed to run the procedures </li></ul>
    46. 55. Treating valve disease in the future today Tailored approach – the best option for the patient