1. PERCUTANEOUS PULMONARY VALVE REPLACEMENT:
A NEW PARADIGM
Michael C. Slack, M.D.

2. RELEVANT DISCLOSURES Michael C. Slack, M.D.
● AGA Medical/St. Jude Medical Corporation:
Teaching Proctor and Consultant (compensated)
● Siemens AX Division, Forchheim, Germany
Pediatric Cardiac Catheterization Laboratories Advisory Board Member (uncompensated)

3. A Pulmonary Valve is contained within the surgical CONDUIT used to treat many forms of structural congenital heart disease…

4. What are RV to PA CONDUITS?
● Conduits are placed surgically between the right ventricle and the branch pulmonary arteries when no main pulmonary trunk is present or when an alternative path to the pulmonary arteries is required during a complex surgical repair.
● Major types of valved surgical conduits:
- human cadaver homografts (pulmonary & aortic)
- synthetic material with xenograft valve

5. Who are the patients that need a CONDUIT that contains a pulmonary valve as part the surgical palliation of their CHD?
Structural Congenital Heart Defects that require a CONDUIT as part of the repair:
● Pulmonary Atresia
● Tetralogy of Fallot (coronary issues; absent pulmonary valve)
● Truncus Arteriosus
● Double Outlet Right Ventricle (“Rastelli” Repair)
● Transpostion of the Great Arteries (some)
Other defects:
● Ross Procedure (pulmonary autograft) for AS/AI
● other (endocarditis; early conduit dysfunction, etc.)

6. All Right Ventricle to Pulmonary Artery CONDUITS Eventually Becomes DYSFUNCTIONAL:
Histo-pathologic degrading process occurs & depends on type of conduit:
● pulmonary homografts  valve dissolution
● aortic Homografts  calcification & valve stenosis
● xenograft conduits combination of valve hardening and internal “rind” formation reducing the lumen diameter of conduit
● variable timeline: 6 mo (early failure) to 8-10 yrs

7. Conduit Dysfunction
● RVOT conduit dysfunction results in abnormal RV function & deterioration:
RVOT obstruction (RV pressure load)
Pulmonary regurgitation (RV volume load)
RV Pressure Overload RV Volume Overload

8. Management of Conduit Dysfunction
Traditional Rx Options:
Conduit Valve Insufficiency
Conduit Valve Stenosis
Transcatheter
Balloon angioplasty
Bare metal stent
Surgical conduit replacement:
● Valved conduits
Homografts
Xenografts
● Bioprostheses (Xenograft leaflet tissue)

9. Surgical Homograft Performance
Freedom from Reoperation
Freedom from Failure: Regurgitation
Progression > 2 grades
Freedom from Failure
Freedom from Failure: Stenosis
PSG ≥ 50 mmHg
Baskett et al. J Thorac Cardiovasc Surgery 2003;126:232-9

10. TREATMENT OF CONDUIT VALVE DYSFUNCTION
PRE 2010 ALL Required Repeat Open-Heart Surgery:
POST- JAN 29, 2010 1st Percutaneous Pulmonary Valve System Approved in U.S.

11. FIRST GENERATION PERCUTANEOUS PULMONARY VALVE
CE Mark,
Health Canada
Approval (2006)
1st US Implant (2007)
1st Implant
Paris, France (2000)
Bonhoeffer Cohort (ous)
( )
2000
2002
2004
2006
2008
2010
U.S. FDA Approval (HDE)
US Cohort ( )
Revised TPV (2003)
World Wide: >950 patients among >75 centers

12. FIRST GENERATION PERCUTANEOUS PULMONARY VALVE
Bovine jugular venous valve segment
Platinum-Iridium Balloon Expandable stent

13. 1st Gen. Pulmonary Valve Indications
TPV is indicated for use ONLY in the following conditions:
Existence of a full (circumferential) RVOT conduit that was > 16 mm in diameter when originally surgically placed and either
Regurgitant RVOT conduits with a clinical indication for invasive or surgical intervention; or
Stenotic RVOT conduits where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

14. 1st Generation Percutaneous Pulmonary Valve: Implant System Components
Bovine Jugular Vein Valve sewn to a Balloon Expandable Stent
Sheathed Valve Delivery System

15. Delivery System 22 Fr crossing profile Retractable sheath
Balloon-in-Balloon (BIB) catheter
3 outer balloon diameters:
18 mm
20 mm
22 mm
The Melody is deployed using a delivery system that is based on a balloon-in-balloon catheter with an integrated retractable sheath that has a 22Fr crossing profile
There is one size valve, but the delivery system comes in 3 sizes, with outer balloon diameters of 18, 20, and 22mm
22 Fr crossing profile
Retractable sheath

16. Percutaneous P.V. Implant Cartoon

17. Valve Delivery
Valve Deployment

18. ◄- Before Valve
After Pulmonary Valve
Implant -►

19. Percutaneous Pulmonary Valve
Early Results:
Source: U.S. Trial Data (HDE); Sponsor Executive Summary-FDA, July 22, 2009

20. Percutaneous Pulmonary Valve
Early Results:
Source: U.S. Trial Data (HDE); Sponsor Executive Summary-FDA, July 22, 2009

21. Percutaneous Pulmonary Valve
Early Results:
Source: U.S. Trial Data (HDE); Sponsor Executive Summary-FDA, July 22, 2009

22. Percutaneous Pulmonary Valve Early Results: Device Related A.E.s

23. Coronary compression with ST Δ
1st Gen. Percutaneous P.V. Contraindications:
Coronary Artery Passage Adjacent to Conduit (compression during balloon test inflation):
No compression
Coronary compression with ST Δ

24. 1st Gen. Percutaneous P.V. Contraindications (cont’d):
Native RVOT without Conduit
Target of Future Second Generation Percutaneous Pulmonary Valve Systems

25. Investigational Use Only
COMPASSION: COngenital Multicenter Trial of Pulmonic VAlve Regurgitation Studying the SAPIEN InterventIONal THV
Study began:
Conduits: 16-24mm

26. Thank You!