Percutaneous Therapy of Pulmonic and Mitral Valve Disease Atman P. Shah MD FACC FSCAI Director, Coronary Care Unit Assistant Professor of Medicine The.

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Presentation transcript:

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

2 Disclosures Consultant: St. Jude Medical, Abiomed, Medtronic Cardiovascular, Regenerx Speakers Bureau: Astra Zeneca, Medtronic, Novartis NHLBI RO1 HL

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

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

Investigational Device only in the US; Not available for sale in the US Feldman et al. ACC.10

Investigational Device only in the US; Not available for sale in the US Feldman et al. ACC.10

Investigational Device only in the US; Not available for sale in the US Feldman et al. ACC.10

Investigational Device only in the US; Not available for sale in the US Feldman et al. ACC.10

15 Investigational Device only in the US; Not available for sale in the US EVEREST II RCT: Patient Flow Post MitraClip Procedure 2 nd MitraClip Procedure n=3 MV Surgery Post MitraClip Procedure n=9 2 nd MitraClip Procedure n=2 No Additional Intervention n=11 MV Surgery Post MitraClip Procedure n=28 Acute Procedural Success Not Achieved n=41 Acute Procedural Success Achieved n=137 n=37 81% Follow-up 96% MR ≤2+ at 12 months

Investigational Device only in the US; Not available for sale in the US Feldman et al. ACC.10

17 Investigational Device only in the US; Not available for sale in the US Safety Major Adverse Events 30 days Effectiveness Clinical Success Rate * 12 months EII RCT: Safety & Effectiveness Endpoints Intention to Treat Cohort Device Group, n=180 Control Group, n=94 Met superiority hypothesis Pre-specified margin =2% Observed difference = 32.9% 97.5% LCB = 20.7% Control Group, n=89 Device Group, n=175 Met non-inferiority hypothesis Pre-specified margin = 25% Observed difference = 7.3% 95% UCB = 17.8% 66.9% 74.2% 15.0% 47.9% LCB = lower confidence bound UCB = upper confidence bound p SUP <0.0001p NI = * 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

Investigational Device only in the US; Not available for sale in the US Feldman et al. ACC.10

19 Investigational Device only in the US; Not available for sale in the US 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 EVEREST II RCT: Summary

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