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Which Patient Should Get
Transcatheter Repair for
Mitral Regurgitation?
Andrew Wang, MD
Case
82 year old man
• s/p CABG x3 (1994, 2004, 2010)
• ILD (FEV1 39%), home O2
• CKD, stage 3
• PAF
• NYHA 3
TEE
When to consider any intervention?
• Moderate-severe or severe MR
– Symptoms (dyspnea) or
– Left ventricular dilation or r...
Severe, symptomatic MR: Half of
patients do not undergo surgery?
European Heart Journal (2007) 28, 1358–1365
Older age Com...
Mitral valve surgery in US
• 2011-14: 61,201 isolated mitral valve
surgeries at 867 sites
• 57% repair, 43% replacement
• ...
Which patient? Assess operative risk
• Most patients had low operative risk
• Operative mortality only 1.4% for mitral val...
STS predicted operative risk for MV
repair
Transseptal crossing
Clip steered to MR jet
Clip advanced below leaflets
Clip retracted to grasp leaflets
Assess MR reduction before release
Deployment
Heart with Clip
MitraClip depends on TEE
What outcome? 5 Year Results
JACC 2016;66:2844-54.
5-year RCT endpoint MitraClip Surgery
Death 21% 27%
Repeat MV intervent...
Percutaneous mitral repair
• Transcatheter mitral valve repair may be considered
for severely symptomatic patients (NYHA c...
MitraClip 1 year TVT results
• 2952 pts, age 82, primary MR >90%
• 93% had moderate or less MR after clip
• In-hospital mo...
Who to treat with MitraClip?
Severe MR (moderate-severe or severe)
Primary MR (prolapse, flail) or mixed
etiology
Sympt...
Anatomic considerations
• Central MR
• Flail gap
• Width of MR jet
Who not to treat
• Patients with low operative risk
• Small mitral orifice area (<3.0 cm2)
• Severe leaflet calcification
Predicting procedural success
SUCCESS= PROCEDURE NOT ABORTED, MR <3+ AT
DISCHARGE
J Am Coll Cardiol Intv 2014;7:394–402.
Residual MV gradient and outcome
J Am Coll Cardiol Intv
2017;10:931–9.
What about secondary MR?
MR: 2 General Types of Impaired Leaflet
Coaptation
Mayo Clinic (www.mayoclinic.com)
Primary (degenerative):
Anatomic abnor...
Majority of severe MR is SECONDARY
5737 pts with ≥3+ MR
• ~20% HF symptoms
• Primary (degenerative) 26%
– Most undergo sur...
Why does MR mechanism matter?
AHA/ACC Valvular Heart Disease Guidelines, 2014.
Guidelines focus on PRIMARY MR
• Observational outcomes
• Expert consensus
• Even weaker level of evidence
for secondary M...
Treatment based on MR etiology
MR
2°
Functional
1°
Degenerative
Medical
therapy
Intervention
Indications for Surgery in FMR
• Severe secondary MR undergoing CABG
or AVR (IIa)
• Severely symptomatic patients (NYHA
cl...
COAPT TRIAL OVERVIEW NPL 03976 Rev B CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use...
MitraClip for Secondary MR
• 2008 CE Mark approval in EU
• >70% of MitraClip procedures for
secondary MR
• High procedural...
Heart failure re-hospitalization
• ~23% at 30 days1
• 44% at 6 months2
• MitraClip for FMR (meta-analysis, n=875)3
– 1 yea...
Conclusions
• MitraClip repair should be considered in
patients with severe, primary MR, advanced
HF symptoms who are high...
Very different timeline than TAVR
1/2014
CoreValve FDA
approval
10/2012
High risk FDA
approval
11/2011
SAPIEN FDA
approval...
Complexity of mitral valve anatomy
TMVR Challenges
Anatomic factor TMVR TAVR
Size
• Transfemoral vs. transapical
• Delivery and positioning
33 Fr 14-16 Fr
An...
Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?
Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?
Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?
Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?
Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?
Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?
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Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?

Andrew Wang, MD
Duke University Medical Center

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Which Patient Should Get Transcatheter Repair for Mitral Regurgitation?

  1. 1. Which Patient Should Get Transcatheter Repair for Mitral Regurgitation? Andrew Wang, MD
  2. 2. Case 82 year old man • s/p CABG x3 (1994, 2004, 2010) • ILD (FEV1 39%), home O2 • CKD, stage 3 • PAF • NYHA 3
  3. 3. TEE
  4. 4. When to consider any intervention? • Moderate-severe or severe MR – Symptoms (dyspnea) or – Left ventricular dilation or reduced EF (<60%) or – Pulmonary hypertension (PASP >50 mm Hg)
  5. 5. Severe, symptomatic MR: Half of patients do not undergo surgery? European Heart Journal (2007) 28, 1358–1365 Older age Comorbid conditions Lower EF
  6. 6. Mitral valve surgery in US • 2011-14: 61,201 isolated mitral valve surgeries at 867 sites • 57% repair, 43% replacement • 75% repair for MR (57% of indications) • 73% sternotomy, 14% right thoractomy • Overall operative mortality 2.4%, major morbidity 17% Ann Thorac Surg 2016;101:2265–71.
  7. 7. Which patient? Assess operative risk • Most patients had low operative risk • Operative mortality only 1.4% for mitral valve repair Ann Thorac Surg 2013;96:1587–95.
  8. 8. STS predicted operative risk for MV repair
  9. 9. Transseptal crossing
  10. 10. Clip steered to MR jet
  11. 11. Clip advanced below leaflets
  12. 12. Clip retracted to grasp leaflets
  13. 13. Assess MR reduction before release
  14. 14. Deployment
  15. 15. Heart with Clip
  16. 16. MitraClip depends on TEE
  17. 17. What outcome? 5 Year Results JACC 2016;66:2844-54. 5-year RCT endpoint MitraClip Surgery Death 21% 27% Repeat MV intervention* 28% 9% More than moderate MR* 12% 2% • More residual MR after Mitraclip, but similar NYHA if MR mild or moderate • Most repeat MV interventions were in 1st year
  18. 18. Percutaneous mitral repair • Transcatheter mitral valve repair may be considered for severely symptomatic patients (NYHA class III to IV) with chronic severe primary MR (stage D) who have favorable anatomy for the repair procedure and a reasonable life expectancy but who have a prohibitive surgical risk because of severe comorbidities and remain severely symptomatic despite optimal GDMT for HF (IIB) AHA/ACC Valvular Heart Disease Guidelines, 2014.
  19. 19. MitraClip 1 year TVT results • 2952 pts, age 82, primary MR >90% • 93% had moderate or less MR after clip • In-hospital mortality 2.7% • One year mortality 26% (secondary MR 31%) • Residual MR associated with mortality – 0/1+ MR 22%, 2+ 29%, 3/4+ 49% https://www.acc.org/latest-in-cardiology/articles/2017/03/13/17/44/sat-1230pm-clinical- outcomes-at-1-year-after-commercial-transcatheter-mv-repair-in-us-acc-2017
  20. 20. Who to treat with MitraClip? Severe MR (moderate-severe or severe) Primary MR (prolapse, flail) or mixed etiology Symptomatic High operative risk of mortality by CT surgery assessment, including STS score
  21. 21. Anatomic considerations • Central MR • Flail gap • Width of MR jet
  22. 22. Who not to treat • Patients with low operative risk • Small mitral orifice area (<3.0 cm2) • Severe leaflet calcification
  23. 23. Predicting procedural success SUCCESS= PROCEDURE NOT ABORTED, MR <3+ AT DISCHARGE J Am Coll Cardiol Intv 2014;7:394–402.
  24. 24. Residual MV gradient and outcome J Am Coll Cardiol Intv 2017;10:931–9.
  25. 25. What about secondary MR?
  26. 26. MR: 2 General Types of Impaired Leaflet Coaptation Mayo Clinic (www.mayoclinic.com) Primary (degenerative): Anatomic abnormality of the mitral valve • Excessive leaflet mobility (leaflet prolapse, flail) Secondary (functional): LV dilation or regional wall motion abnl • Restricted leaflet mobility (tethering) leads to reduced coaptation
  27. 27. Majority of severe MR is SECONDARY 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
  28. 28. Why does MR mechanism matter? AHA/ACC Valvular Heart Disease Guidelines, 2014.
  29. 29. Guidelines focus on PRIMARY MR • Observational outcomes • Expert consensus • Even weaker level of evidence for secondary MR AHA/ACC Valvular Heart Disease Guidelines, 2014.
  30. 30. Treatment based on MR etiology MR 2° Functional 1° Degenerative Medical therapy Intervention
  31. 31. Indications for Surgery in FMR • 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.
  32. 32. COAPT TRIAL OVERVIEW NPL 03976 Rev B CAUTION: Investigational device. Limited by Federal (U.S.) law to investigational use only. 610 patients enrolled Randomize 1:1 Primary endpoint: HF hospitalization at 1 year Control group Standard of care OPTIMAL HF MEDICAL THERAPY MitraClip Significant FMR (≥3+ by core lab) Protocol conditionally approved by FDA July 26, 2012 LVEF <50%
  33. 33. MitraClip for Secondary MR • 2008 CE Mark approval in EU • >70% of MitraClip procedures for secondary MR • High procedural success, low in-hospital mortality (0-3%) • BUT 1 year rehosp 26% and mortality 15% despite only 6% with severe MR3 1EuroIntervention 2013;9:84-90. 2JACC 2013;62:1052-61. 3JACC 2014;64:875-84.
  34. 34. Heart failure re-hospitalization • ~23% at 30 days1 • 44% at 6 months2 • MitraClip for FMR (meta-analysis, n=875)3 – 1 year mortality 17% – Re-hosp 17% at 6 months, 26% at 1 year 1Circ Heart Fail. 2010 Jan; 3(1): 97–103. 2Arch Intern Med. 1997;157(1):99-104. 3Am J Cardiol. 2015;116:325-331.
  35. 35. Conclusions • MitraClip repair should be considered in patients with severe, primary MR, advanced HF symptoms who are high risk for heart surgery (STS risk ≥6% for repair). • Outcome after MitraClip is related to residual MR and stenosis. • One year mortality remains high after MR reduction due to adverse clinical characteristics. • MitraClip for functional MR…Stay tuned!
  36. 36. 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)
  37. 37. Complexity of mitral valve anatomy
  38. 38. 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

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