CARDIOLOGIA PEDIATRICA
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1 XVIII CURSO DE CARDIOLOGIA PEDIATRICA Pulmonary valve replacement with BioIntegral injectable valve S. Marianeschi S. Ghiselli N. Uricchio G. Vignati Pediatric Cardiology, and Cardiac Surgery, Azienda Ospedaliera Ospedale Niguarda Ca Granda Dipartimento di Cardiochirurgia Niguarda Hospital, Milan, Italy MARZO 7,8,9 y 10 MADR HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON
2 Pulmonary valve replacement:considerations Pulmonary valve regurgitation is frequent sequela after repair of TOF RV overload is the primary cause of reoperation after 20 years from the repair Negative effects on the late follow up Risks of multiple reoperations
3 Need for pulmonary valve implantation Primary repair of CHD (Truncus, TOF absent pulmonary valve) In patients previous operated for TOF repair with transanular patch or pulmonary valvotomy
4 Injectable pulmonary valve BioIntegral No-React
5 Advantages of an injectable pulmonary valve Low profile No distal and proximal suture lines Large spectrum of sizes No coronary compression Biologic material
6 Disadvantages of a pumonary valve Short follow up Is not a real stent No useful when RVOT is stenotic or irregular
7 Why this valve is Versatile May be implanted without cardio-pulmonary by pass Has the same characteristics of a percutaneous valve May be implanted in hybrid theatre with a minimal surgery impact
8 Injectable pulmonary valve: sizes Annulus diameter
9 Methods of implant Without CPB in secondary repair of pathology with pulmonary regurgitation In CPB in pathology with simultaneous repair of intra-cardiac defects and pulmonary artery replacement In CPB in primary correction of cardiopathy that needed a valved RVOT
10 Surgical approach Trans pulmonar in mini-thoracotomy Annulus diameter Trans ventricular In sternotomy Trans ventricular sub xifoid Trans ventricular toracotomy
11 Surgical technique
12 Multicenter study Period: January 2006 February Different European Centers 32 Implants Niguarda Hospital, Milan, Italy 12 de Octubre University Hospital, Madrid, Spain Royal Children Hospital Bristol, UK Baskent University Hospital, Ankara, Turkey Gazian tep University Medical School, Gaziantep, Turkey Regina Margherita Hospital, Turin, Italy Bambin Gesù Hospital, Rome, Italy Ramon y Cajal University Hospital, Madrid, Spain Gregorio Marañon Hospital, Madrid, Spain Kiel University Hospital, Kiel, Germany Southampton University Hospital, Southampton, UK
13 Multicenter study 19 valves implanted without CPB 9 valves implanted with CPB for associated intra-cardiac repair 4 valves implanted with CPB for better repositioning in RVOT
14 Multicenter study: clinical data n=32 mean ± St.Dev. (range) Mean age (Yrs) 20.8 ± 12.5 ( ) BSA (m 2 ) 1.85 ± 0.5 ( ) TOF 23 Diagnosis DORV, PS 8 PA IVS 1 TAP / infundubular patch 26 Surgery Valvotomy 3 Percutaneus valvuloplasty 2 Primary implant AP plasty 1 Years in between the primary repair 19 ± 9.8 ( ) PR Severe in all the patients RVEDVI (ml/m 2 ) ± 26.7 (95-270) RVESVI (ml/m 2 ) 67.4 ± 8.7 ( ) RVEF (%) 46.5 ± 11.4 (30-56)
15 Multicenter study: results Variables Surgical time(min) Enjectable valve (8 pts) ± 27.5 ( ) Grupo Estudio (8pts) ± 39.8 ( ) < 0,001 Valve size(mm) 27.2 ± 2.3 (25-31) 23.8 ± 1 (23-25) ns. CPB (min) ± 45 (60-176) p Additional procedures MPA reduction 1 (12.5%) 0 VSD closure 0 1 (12.5%) Total bleeding(ml) 495 ± ( ) ± ( ) ICU (days) 0.9 ± 0.2 (0.5-1) 1.4 ± 1.1 (1-4) ns. LOS (days) 6.3 ± 3 (2-12) 11.1 ± 4.4 (7-20) < 0,05 Complications 0 0 Mortality 0 0 ns.
16 Intra-operative echocardiography
17 Follow-up echocardiography
18 7 Months Follow-up
19 Post op angiography
20 Magnetic resonance Gold standard to study RVOT
21 Pre-operative MR
22 Pre-operative MR MR Late enhancement Short axis Without fibrosis With fibrosis
23 Pre-operative MR MR Late enhancement 4 chamber view Without fibrosis With fibrosis
24 Post-operative MR
25 Pre-operative MR Pre operative study Post operative study (7 months) LV RV Diastolic volume/cc Systolic volume/cc Stroke volume/cc Ejection fraction LV RV Diastolic volume/cc Systolic volume/cc Stroke volume/cc Ejection fraction
26 MRN Velocity encoding Pre Post
27 Anticoagulation therapy Warfarin (INR 2-3) for 3 months After 3 months: ASA 100 mg/day
28 Conclusions The pulmonary valve replacement with injectable valve is feasible All sizes off the shelf Possibility of additional procedures If mean AP > 31mm pulmonary reduction plasty and external fixation are mandatory In selected case technique easy to reproduce
29 Conclusions The valve showed no calcification or functional deterioration during the follow up Vantages: Less invasive, may be performed in hybrid room Reduction of the costs (CPB, hospital stay, blood loss, better functional recovery) Long tem follow up is needed Good perspectives for primary implant there is still room for improvement
30
31 Injectable pulmonary valve: primary implant Dr. Suleyman, Istanbul Febbraio 2010 Dr. Piero Abbruzzese, Turin September 2010 MARZO 7,8,9 y 10 MADR HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARANON
32 Primary repair 7 month old TOF pulmonary atresia
33 Primary repair Right ventricle infundibulotomy to close the VSD and enlarge RVOT
34 Primary repair The native pulmonary valve is open
35 Primary repair A transanular patch is placed and measured with an hegar sizer
36 Primary repair A 17 mm BioIntegral valve is ready to placed below the transanular patch
37 Primary repair A delivery trocar is used to place the valve
38 Primary repair The valve is injected. Three stiches are placed to fix the valve in position.
39 Primary repair The transanular path suture is completed
40
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