Native Outflow Tract TranscatheterThe Heart Center Pulmonary Valve Replacement

Transcription

1 Native Outflow Tract Transcatheter Pulmonary Valve Replacement John P. Cheatham, MD, FSCAI George H. Dunlap Endowed Chair in Interventional Cardiology Co-Director,, Nationwide Children s Hospital Professor, Pediatrics & Internal Medicine, Cardiology.... The Ohio State University Columbus, Ohio, USA

2 Disclosures As a faculty member of SCAI, I have the following disclosures: Medtronic Consultant, P.I., Proctor NuMED, Inc Consultant, P.I., Proctor Off label use of FDA approved devices will be discussed

3 Acknowledgements Professor Philipp Bonhoeffer A great friend A creative genius The TPV brains Medtronic TPV Team Tremendous hard work A scientific approach

4 Study Design and Implant Bilateral Melody TPV: CHOP (Matt Gillespie) 10 sheep Surgical trans-annular patch 10 Melody placed distal to RUL 5

5 Challenging Patient 33 y/o p/o TOF R & L BT shunts Total repair with large transannular RVOT patch AF: s/p ablation Severe biventricular dysfunction RVEF 17% & LVEF 21% BiV pacing with AICD Morbid obesity: 142 Kg, BSA 2.5 m2 Severe restrictive lung disease smoker Severe PR and poor surgical candidate for S-PVR Turned down for cardiac transplant severe obesity

6 MPA: 3.1cm by 3.0cm RPA: proximal narrowing to 1.5cm x 1.2cm LPA: proximal narrowing to 1.2cm x 1.3cm Cardiac CT

7 Post RPA Melody TPV After P-5010XL Stent

8 Post LPA Melody TPV After P-3110XL Stent

9 Study Population Anomalies of the RVOT Tetralogy of Fallot With Pulm Stenosis Truncus Arteriosus Transposition Great Arteries With Pulm Stenosis/Atresia Right Ventricle to Pulmonary Artery (RV PA) Conduit RV PA Conduit RV PA Conduit Surgical correction of RVOT (non-conduit) = ~85% of RVOT Patients Others = ~15% of RVOT Patients RV PA Conduit

10 Dilated RVOT: A Problem To Solve

11 Presto!!! Early Work with Kurt A.

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13 What Does The Infundibular Reducer Look Like?

14 Infundibular Reducer Excitement

15 From Infundibular Reducer to Native Outflow Tract TPV

16 Prototype Native Outflow Tract TPV

17 Implant in the Ovine Model

18 Custom Patient Experience Custom Patient Experience Dr. Philipp Bonhoeffer approached Medtronic to create a custom device 42 y/o male RVOT patch-repaired patient with severe pulmonary regurgitation Mechanical MVR Multiple complicated surgeries Very stormy post op course High surgical risk Ethics committee & Medtronic agreed on custom-made device Implanted January, 2009

19 Pre Implant CT Evaluation

20 First in Man: Philipp Bonhoeffer Jan 2009, GOSH....

21 Immediate Post Implant Moderate Paravalve & Valve PR

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23 The Native Outflow Tract TPV Team GOSH January, 2009

24 Follow up: September 25, 2012

25 September 25, 2012 Well seated device, No PS, Mild PR, Trivial Paraprosthetic PR

26 September 25, 2012 No frame fractures

27 Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV) Research Clinical Study Early Feasibility Trial

28 Background and Study Rationale Patient Population Patients with Tetralogy of Fallot and surgically repaired RVOTs Population estimated at approximately 85% Patient with surgically placed conduits excluded Purpose To assess in vivo loading conditions of the device for product development specifications Summarize clinical outcomes over five years of clinical follow-up

29 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 Distal End of Delivery System

30 Deployment

31 NCH Team In The Animal Lab

32 Inclusion Criteria Severe pulmonary regurgitation Echo Doppler parameters (similar to Melody TPV) OR CMR with pulmonary regurgitant fx at least 30% Clinical indication for surgical RV-PA conduit or bioprosthetic PVR Symptomatic, i.e. NYHA Class II or greater, RV failure, etc OR RVEDVi at least 150 ml by CMR Subject willing to consent to participate in the study and commit to completion of all follow-up requirements

33 Exclusion Criteria Anatomy unable to accommodate 25 Fr delivery system Obstruction of central veins Active IE or signs of infection Indication for Rx of PBS (no concomitant procedures) + pregnancy baseline or before implant RV-PA conduit in place Non-cardiac disease with < 1 year survival Planned implant of NOT TPV in left heart RVOT unfavorable for anchoring device Known allergy to ASA, heparin, Ni Intracardiac mass, thrombus, vegetation by echo Pre-existing prosthetic heart valve/ring in any position Patient enrolled in another IDE/IND that could influence outcome of trial No concomitant interventional PA procedures

34 Patient Selection & Follow-up 20 Patients in 3 Sites Worldwide Pre-Screening -Echo -CMR No Standard of Care Yes Informed Consent (if not already) -Verify inclusion/exclusion criteria Yes Screening -CT angiography -SLA created to assess device fit No No Excluded Exited from study Yes -Screening Committee recommendation; Investigator has final decision Implant -Angiography to confirm device function 80% Hospital Discharge -Clinical Assessment -CT -Echo In vivo loading condition analysis (every 5 subjects) 1 Month -Clinical Assessment -Echo -Fluoroscopy 3 Month -Clinical Assessment -Echo 6 Month -Clinical Assessment -Echo -Fluoroscopy 2-5 Years: Clinical Assessment, Echo 1 Year -Clinical Assessment -Echo -CMR

35 Imaging of the RVOT in TOF Approach to analyzing the RVOT Kan Hor, MD & Team 3D RVOT to 3D RVOT segmented images

36 Imaging of the RVOT in TOF Many faces of TOF: Various RVOT anatomy Goal: Improve our ability to determine if this single device fits into the various RVOT

37 Imaging of the RVOT in TOF Dynamic 3D Imaging WIP: 3D (dynamic) imaging (x-sectional images)? Color coded segmentation helps improve our ability to visualize the dynamic nature of the RVOT in TOF

38 Dual Source Flash CT

39 Screening Process: Engineering Assessment 3D right-heart models from multiphase CT, perimeter and length measurements Virtual device implant Device in SLA model

40 We take pictures & HD movies of the virtual SLA implant in systole & diastole

41 Perimeter Plots Acceptable fit Unacceptable fit Possible Fit?

42 Simulating Implant in the SLA Model

43 PA Angiogram Pre Implant

44 PA Angiogram Post Implant

45 May ICE th 30, PRE 2013 FIM Implant: POST

46 Investigative Sites Nationwide Children s Hospital P.I. John P. Cheatham, MD 9 implants, 1 pending Toronto Sick Kids Hospital P.I. Lee Benson, MD 1 implant, 1 pending Boston Children s Hospital P.I. James E. Lock, MD & Lisa Bergersen, MD 3 implants, 5 pending

47 Conclusions TPV replacement will become/is the standard of care for RV-PA conduit failure TPV replacement can be performed in selective patients with suitable anatomy of the RVOT without a conduit in place Native Outflow Tract TPV is a heavy computational modeling trial at present, but will become a reality for more patients over the next decade

48 Just Remember. There are no new ideas!!! Pavcnik 1991

49 FIM NCH Native Outflow Tract TPV Team Thanks You