Percutaneous therapy of pulmonic and mitral valve disease
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Percutaneous Therapy of Pulmonic and Mitral Valve Disease. Atman P. Shah MD FACC FSCAI Director, Coronary Care Unit Assistant Professor of Medicine The University of Chicago February 4th, 2012. Disclosures. Consultant: St. Jude Medical, Abiomed, Medtronic Cardiovascular, Regenerx

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Percutaneous Therapy of Pulmonic and Mitral Valve Disease

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Percutaneous therapy of pulmonic and mitral valve disease

Percutaneous Therapy of Pulmonic and Mitral Valve Disease

Atman P. Shah MD FACC FSCAI

Director, Coronary Care Unit

Assistant Professor of Medicine

The University of Chicago

February 4th, 2012


Disclosures

Disclosures

  • Consultant: St. Jude Medical, Abiomed, Medtronic Cardiovascular, Regenerx

  • Speakers Bureau: Astra Zeneca, Medtronic, Novartis

  • NHLBI RO1 HL076671

2


Pulmonic stenosis

Pulmonic Stenosis

  • Stenosis

    • Rheumatic inflammation

    • Supravalvular obstruction

    • Treatment if P-P >50mmHg

    • Size the balloon at 1.25 to annulus

  • Regurgitation

    • Treatment of Tetralogy

    • Congential malformation of valve

    • Associated with VSD, carcinoid, rheumatic involvement, trauma


  • Medtronic melody valve

    Medtronic Melody Valve

    • 18, 20, 22 mm (28mm) via a 22 French size sheath


    Perspective

    Perspective

    • >250,000 cases of significant Mitral Regurgitation diagnosed annually in the US

    • Current therapeutic options:

      • Medical management

        • Effective in symptom management

        • Ineffective in treating underlying pathophysiology or disease progression

      • Surgical Repair or Replacement (Standard of Care)

        • Effective yet invasive with associated morbidity

        • Only ~20% of patients with significant MR undergo MV surgery

    • Unmet need for an effective less invasive option

    9

    Investigational Device only in the US; Not available for sale in the US


    Percutaneous therapy of pulmonic and mitral valve disease

    Investigational Device only in the US; Not available for sale in the US

    Feldman et al. ACC.10


    Percutaneous therapy of pulmonic and mitral valve disease

    Investigational Device only in the US; Not available for sale in the US

    Feldman et al. ACC.10


    Percutaneous therapy of pulmonic and mitral valve disease

    Investigational Device only in the US; Not available for sale in the US

    Feldman et al. ACC.10


    Percutaneous therapy of pulmonic and mitral valve disease

    Investigational Device only in the US; Not available for sale in the US

    Feldman et al. ACC.10


    Percutaneous therapy of pulmonic and mitral valve disease

    EVEREST II RCT: Patient FlowPost MitraClip Procedure

    Acute Procedural Success

    Not Achieved

    n=41

    Acute Procedural Success

    Achieved

    n=137

    MV Surgery Post

    MitraClip Procedure

    n=9

    2nd MitraClip Procedure

    n=2

    2nd MitraClip

    Procedure

    n=3

    No Additional Intervention

    n=11

    MV Surgery Post MitraClip Procedure

    n=28

    n=37

    81% Follow-up

    96% MR ≤2+

    at 12 months

    15

    Investigational Device only in the US; Not available for sale in the US


    Percutaneous therapy of pulmonic and mitral valve disease

    Investigational Device only in the US; Not available for sale in the US

    Feldman et al. ACC.10


    Percutaneous therapy of pulmonic and mitral valve disease

    EII RCT: Safety & Effectiveness EndpointsIntention to Treat Cohort

    Safety

    Major Adverse Events

    30 days

    Effectiveness

    Clinical Success Rate*

    12 months

    Device Group, n=180

    Device Group, n=175

    15.0%

    66.9%

    pSUP <0.0001

    pNI =0.0005

    Control Group, n=94

    Control Group, n=89

    47.9%

    74.2%

    • Met non-inferiority hypothesis

    • Pre-specified margin = 25%

    • Observed difference = 7.3%

    • 95% UCB = 17.8%

    • Met superiority hypothesis

    • Pre-specified margin =2%

    • Observed difference = 32.9%

    • 97.5% LCB = 20.7%

    *Freedom from the combined outcome of death, MV surgery or re-operation for MV dysfunction >90 days post Index procedure, MR >2+ at 12 months

    LCB = lower confidence bound

    UCB = upper confidence bound

    17

    Investigational Device only in the US; Not available for sale in the US


    Percutaneous therapy of pulmonic and mitral valve disease

    Investigational Device only in the US; Not available for sale in the US

    Feldman et al. ACC.10


    Everest ii rct summary

    EVEREST II RCT: Summary

    • Safety & effectiveness endpoints met

      • Safety: MAE rate at 30 days

        • MitraClip device patients: 9.6%

        • MV surgery patients: 57%

      • Effectiveness: Clinical Success Rate at 12 months

        • MitraClip device patients: 72%

        • MV Surgery patients: 88%

    • Clinical benefit demonstrated for MitraClip System and MV surgery patients through 12 months

      • Improved LV function

      • Improved NYHA Functional Class

      • Improved Quality of Life

  • Surgery remains an option after the MitraClip procedure

  • 19

    Investigational Device only in the US; Not available for sale in the US


    Conclusions

    Conclusions

    • The treatment of pulmonic stenosis involves valvuloplasty with good long term results

    • Emerging technologies allow treatment of valvular disease previously thought to be only operable


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