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Transcatheter Pulmonary Valve

Transcatheter Pulmonary Valve. Clinical Experience. FDA Pre-IDE Meeting January 7, 2005. The Device. Bovine Jugular Venous Valve (Contegra) Platinum Iridium Stent. Outflow Tract. Overview 67 patients, 74 valves. Paris, France Original TPV (09/00 – 01/02) 10 pts London, UK

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Transcatheter Pulmonary Valve

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  1. Transcatheter Pulmonary Valve Clinical Experience FDA Pre-IDE Meeting January 7, 2005

  2. The Device • Bovine Jugular Venous Valve (Contegra) • Platinum Iridium Stent

  3. OutflowTract

  4. Overview67 patients, 74 valves • Paris, France • Original TPV (09/00 – 01/02)10 pts • London, UK • Original TPV (11/02 – 03/03) 7 pts • + 4 who later required revised TPV • Revised TPV, (03/04 - 12/04) 50 pts • including 3 later requiring 2nd revised TPVs

  5. Hammock Effect and Revision of TPV

  6. Demographics(n=50) Gender Male: 54% Female: 46% Age at Implant Median: 18 yrs Range: 9 – 44 yrs

  7. NYHA Functional Class (pre)

  8. Echo Parameters (pre) RVOT Velocity 3.7  0.8 m/s TR Velocity 4.0  0.7m/s RVSP 64.6  21.7 mmHg

  9. Pulmonary Regurgitation P<0.001 P<0.001

  10. PPV Implantation Improves Early Exercise Capacity Peak VO2 p=0.009 AT p=0.016

  11. The Mechanism? 160 140 120 100 RVEDV 80 60 40 20 0 Pre Post P<0.001 120 120 100 100 80 80 LV EDV 60 60 40 40 20 20 0 0 Pre Post Pre Post P=0.002 P=0.002

  12. Procedural complicationsn=3 • Homograft rupture 1 • Small homograft 1 • Valve left in place at operation • Device dislodgement 2 • Underestimated size of RVOT1 • Non circumferential homograft 1 • Surgical homograft placement in both

  13. Freedom from Explant 91.7 % Freedom at 1 Year

  14. When the indications are good the results are good • The vast majority of patients with pulmonary regurgitation still needs the surgeon • The surgeon has the responsibility to create the platform for later interventional work

  15. Structural analyses: virtual implantation

  16. Coronary Sinus Approach (Mitralife)

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