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Percutaneous Mitral Valve Repair or Replacement: What's Taking Sooo Long?

Andrew Wang, MD
Duke University Medical Center

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Percutaneous Mitral Valve Repair or Replacement: What's Taking Sooo Long?

  1. 1. Percutaneous Mitral Valve Repair or Replacement: What’s Taking Sooo Long? Andrew Wang, MD
  2. 2. Disclosure • Research: Abbott Vascular; Medtronic Inc; Edwards Lifesciences; • Investigational devices: – Cardioband – Mitralign – CardiAQ – Tiara – Tendyne
  3. 3. Percutaneous MV repair or replacement Are we there yet?
  4. 4. Very different timeline than TAVR 1/2014 CoreValve FDA approval 10/2012 High risk FDA approval 11/2011 SAPIEN FDA approval 9/2010 PARTNER B results 2007 PARTNER Trial begins (n=1057) 2016 Low risk trials start 4/2016 S3 Intermediate risk trial results 6/2015 S3, Evolut FDA approval 6/2014 XT FDA approval + Lotus, Direct Flow, Portico studies ongoing 10/2013 MitraClip FDA approval 4/2011 EVEREST2 results 9/2005 EVEREST2 RCT begins (n=279)
  5. 5. Why aren’t we there yet? • Why might MR interventions be slower to develop – Disease progression – Anatomy and MR sub-types • Percutaneous possibilities – MitraClip – Annuloplasty – MV replacement
  6. 6. Nkomo et al. Burden of Valvular Heart Diseases: A Population-based Study, Lancet, 2006; 368: 1005-11. > 9.3% for ≥75 year olds (p<.0001) 14 12 10 8 6 4 2 0 Prevalence (%) of moderate to severe valve disease Age (years) <45 45-54 55-64 65-74 >75 Aortic valve disease Mitral valve disease All valve disease MR more prevalent than AS
  7. 7. But MR and AS have different event rates Event Severe Mitral Regurgitation Severe Aortic Stenosis Severe to symptom onset 10% per year 25% per year Symptom onset to mortality 10% per year 25% per year
  8. 8. Aortic surgery twice as common as mitral STS Adult Cardiac Surgery Database Executive Summary 2016. STS 2015 • Any AVR = 47, 032 • Any mitral surgery = 22, 334
  9. 9. Which valve has most favorable anatomy? EHJ CV Imaging, (2012) 13, 541–555.
  10. 10. Multilevel Causes of Mitral Regurgitation Source: American Heart Association. Leaflets Annulus Chordae Papillary muscle LV wall
  11. 11. Classification of MR – 2 Types Incompetent mitral valve closure Systolic retrograde blood flow from the LV into the LA Mayo Clinic (www.mayoclinic.com) Primary: Anatomic abnormality the mitral valve • Leaflets • Subvalvular apparatus • Chordae and papillary muscles Secondary: LV dilation; often secondary to ischemic heart disease • Leads to mitral annular dilation • Incomplete coaptation of the mitral valve
  12. 12. Severe MR in symptomatic patients 5737 pts with ≥3+ MR • ~20% HF symptoms • Primary (degenerative) 26% – Most undergo surgery • Secondary (functional) 74% – Most receive medical therapy J Am Coll Cardiol. 2014;63(2):185-186. doi:10.1016/j.jacc.2013.08.723 ? MitraClip repair
  13. 13. Severe, symptomatic MR: Half of patients do not undergo surgery? European Heart Journal (2007) 28, 1358–1365 Older age Comorbid conditions Lower EF
  14. 14. MitraClip TVT Registry • 564 patients, median age 83 years • 91% primary, degenerative MR • STS PROM – Repair 7.9% – Replacement 10% – Frailty 57% JACC, 2016;67:1129-40.
  15. 15. Limitations of MitraClip • Anatomic – Non central jet – Flail gap, width – MV orifice area • Lack of annular reduction • Benefit in functional MR?
  16. 16. Indications for surgery in secondary MR • Severe secondary MR undergoing CABG or AVR (IIa) • Severely symptomatic patients (NYHA class III to IV) with chronic severe secondary MR (stage D) who have persistent symptoms despite optimal GDMT for HF (IIb) AHA/ACC Valvular Heart Disease Guidelines, 2014.
  17. 17. COAPT TRIAL OVERVIEW NPL 03976 Rev B CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only. ~420 patients enrolled at up to 75 US sites Randomize 1:1 Clinical and TTE follow-up: 1, 6, 12, 18, 24, 36, 48, 60 months Control group Standard of care N=210 High risk for mitral valve surgery Specific valve anatomic criteria MitraClip N=210 Significant FMR (≥3+ by core lab) Trial design Protocol conditionally approved by FDA July 26, 2012
  18. 18. COAPT TRIAL OVERVIEW NPL 03976 Rev B CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only. Primary Endpoints • Primary Effectiveness (min 1-year FU all pts) – Recurrent heart failure hospitalizations • Superiority hypothesis (Andersen-Gill) • Primary Safety (1 year) – Composite of all-cause death, stroke, worsening kidney function, or LVAD or cardiac transplant • Non-inferiority hypothesis Protocol conditionally approved by FDA July 26, 2012
  19. 19. Mitral annuloplasty reduces recurrent MR J Thorac Cardiovasc Surg 2001;122:674-81.J Thorac Cardiovasc Surg. 1998 Nov;116(5):734-43. Primary MR Edge-to-edge repair
  20. 20. Coronary sinus annuloplasty Monarc Carillon
  21. 21. Coronary sinus (CS) anatomy: Limitations for mitral “annuloplasty” • Superior to true mitral annulus by ~10 mm • Does not extend to fibrous trigones • Left circumflex often courses between CS and mitral annulus J Thorac CV Surgery, 2008:376-81 Circulation 2007;115:1426-32.
  22. 22. Cardioband direct annuloplasty (n=31) European Heart Journal (2016) 37, 817–825
  23. 23. Cardioband results European Heart Journal (2016) 37, 817–825
  24. 24. TMVR Challenges Anatomic factor TMVR TAVR Size • Transfemoral vs. transapical • Delivery and positioning 33 Fr 14-16 Fr Anchoring • Stability Non-calcified annulus, leaflets in MR Calcified leaflets in AS Shape • Need for orienting valve before deployment • Imaging requirements D-shaped annulus Circular/ovoid Other structures • Design, delivery, positioning Sub-valvular structures LVOT Left circumflex coronary Coronary ostia
  25. 25. Transcatheter MV Replacements Circ 2014;130;1712-22.
  26. 26. Common elements in TMVR • Nitinol self-expanding frame • 3 bovine or porcine pericardial leaflets • Anchoring mechanism in annulus • Large diameter, mostly transapical • Sealing skirt to reduce PVL • Reposition/recapture
  27. 27. CardiAQ TMVR (Edwards Lifesciences)
  28. 28. Aligning from LA to LV: Not so straightforward EuroIntervention. 2016 Feb 20;11(10):1126-51
  29. 29. Tiara TMVR (NeoVasc)
  30. 30. Tendyne TMVR (Abbott)
  31. 31. Summary • Very different timelines for transcatheter MV and AV interventions • Different natural histories and MR sub- types • Complexity of MV anatomy in MR: annulus (large), leaflets, sub-valve, LV
  32. 32. Almost there…
  33. 33. HighLife TMVR
  34. 34. Secondary MR: Ischemic vs. Non-ischemic Journal of the American College of Cardiology, Volume 65, Issue 12, 2015, 1231–1248

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