Next Generations Native RVOT Valves
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- Gavin Hill
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1 Ziyad M. Hijazi, MD, MPH, MSCAI, FACC Professor Of Pediatrics Weill Cornell Medical College Chair, Department of Pediatrics & Director, Sidra Cardiovascular Center of Excellence Doha-Qatar
2 Disclosure: Consultant to Venus Medtech
3 Surgical Procedures for RVOT Obstruction 1. Transannular Patch Repair 2. Homograft 3. Bioprosthetic Valve 4. Prosthetic Valve
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6 Indications to Replace/Place a PV Symptomatic patients with severe PR-NYHA Class II-III Asymptomatic patients: Regurgitant fraction >40%; RVEDV>150 ml/ m2; RV EF<40%; QRS>180 msec
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8 What Are The Available Valves for Homografts/Bioprosthetic Valves?
9 The Melody valve The Edwards Sapien THV
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11 Similarities/Differences Pre requisites: Similar (Conduits/Bioprosthesis) Access: Similar Assessment: similar Coronary assessment: similar Delivery sheath: different Pre-stenting: similar Size of valves: different
12 Similarities/Differences The two valves are suited only for patients with a conduit or a bioprosthetic valve! Only 15-20% of patients S/P Tetralogy repair are candidates for these two valves! Need: Native Outflow Tract Valve!
13 Venus P- Valve
14 !Structure (stent): Nitinol self-expandable " " multi-level support frame"!integrated, unidirectional tri-leaflet porcine " " pericardial tissue valve"!the entire stent is covered (except the distal " " cells) by porcine pericardium"!the stent valve is a modaretely radiopaque" "!Smaller delivery catheter"
15 VENUS P Valve! PA Bif Bif 10 mm Do Marker 1 MPA(SL) 20 mm 25 mm 30 mm 35 mm D Valve 8 mm Marker 2 Marker 3 RVOT OT 12 mm Di D diameter: 16 mm-32 mm! (in 2mm increments)! Di proximal flare: D+10 mm! Do distal flare: D+10 mm! Length proximal flare (RVOT): 12 mm! Length Straight (MPA): 20 mm, 25 mm!! 30 mm, 35 mm! Length distal flare (PA bifurcation): 10 mm! Marker 1: indicating distal flare! Marker 2: Valve position (8 mm! above proximal flare)! Marker 3: indicating proximal flare!
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19 Delivery Catheter! Fr! Fast release! Marker! Slow/precise release!
20 Crimper!
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24 31 yrs. Female, Tetralogy of Fallot, Wt.43Kg.!! 1 st Surgery: Trans-annular patch repair 1995.! 2 nd Surgery: closure of residual VSD 2007.! Echo: Dilated RA (34x29mm) & RV(62x48mm)! Moderate TR!!RVOT D=27 mm!!pa annulus D=21 mm!!mpa D=24 mm; L=32 mm! Mild PS: MAX PG=27 mmhg;!!! Mean PG=17 mmhg! Severe PR(++++)!! Valve used: 26 mm x 52 mm Venus P Valve!
25 Pre-TTE! RV! RV! LV! LA! LV! RVOT! RV! LV! RA! LA!
26 Pre-TTE! RVOT! MPA! RPA! LPA!
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29 Next Generations Native RVOT Valves F/U Chest X-ray!
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31 20 yrs., Female, Ht.155 cm; Wt.52 Kg. ToF.!! S/P Surgical repair in Closed VSD;! pericardial patch repaired RVOT-PA! Echo: Dilated RA (44x34 mm)&rv(93x52 mm)!! Moderate TR!!RVOT D=40 mm!!pa annulus D=22 mm!!mpa D=22-28 mm; L=32 mm! Moderate PS: MAX PG=49 mmhg;!! Mean PG=26 mmhg! Severe PR(++++)!
32 Pre-TTE! RV! LV! LA! RV! LV! RV! RA! LA! LV!
33 Pre-TTE! RVOT! RPA! MPA! LPA! PR!
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41 F/U Chest X-ray!
42 Other Valves 1. The Medtronic valve 2. Beijing Med-Zenith PT Valve Stent
43 The Medtronic Valve
44 Product Overview Native Outflow Tract TPV Delivery System! Porcine pericardial tissue valve, AOA treated! Tissue valve mounted on self expandable frame! Coil loading catheter! 1 size: 25 Fr! Loading funnel to collapse valve prior to sheathing
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48 !"#! $ %&
49 Beijing Med-Zenith PT Valve Stent
50 Devices for TAP Anatomy: Beijing Med-Zenith PT Valve Stent!Self expanding!nitinol frame lined with porcine pericardium!3 Porcine Pericardial Valve sizes! 20, 23, & 26 mm!5 Frame Dimensions with variable widths & lengths!"#$%&'()*%+,'-.&/#&%0)+'1#)$0'2$./$)*'
51 Devices for TAP Anatomy: Beijing Med-Zenith PT Valve Stent!Unique delivery system (18Fr)!Controlled release handle!"#$%&'()*%+,'-.&/#&%0)+'1#)$0'2$./$)*'
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55 CONCLUSIONS The new Venus P-Valve is self expandable, nitinol valve designed for patients S/P trans-annular patch repair. The new valve is available in sizes ranging from 16-36mm and thus is appropriate for most patients with large RVOT. Clinical trials will commence shortly in Europe, Qatar and Asia. Other valves for native RVOT are also being developed
56 Acknowledgment Dr. Qi-Ling Cao Dr. Zhou & Jumbo Ge from Zhongshan Hospital The entire team from Venus Medtech Dr. John P. Cheatham & Mr. Larry Meng
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