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
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
Acknowledgements Professor Philipp Bonhoeffer A great friend A creative genius The TPV brains Medtronic TPV Team Tremendous hard work A scientific approach
Study Design and Implant Bilateral Melody TPV: CHOP (Matt Gillespie) 10 sheep Surgical trans-annular patch 10 Melody placed distal to RUL 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
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
Post RPA Melody TPV After P-5010XL Stent
Post LPA Melody TPV After P-3110XL Stent
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
Dilated RVOT: A Problem To Solve
Presto!!! Early Work with Kurt A.
What Does The Infundibular Reducer Look Like?
Infundibular Reducer Excitement
From Infundibular Reducer to Native Outflow Tract TPV
Prototype Native Outflow Tract TPV
Implant in the Ovine Model
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
Pre Implant CT Evaluation
First in Man: Philipp Bonhoeffer Jan 2009, GOSH....
Immediate Post Implant Moderate Paravalve & Valve PR
The Native Outflow Tract TPV Team GOSH January, 2009
Follow up: September 25, 2012
September 25, 2012 Well seated device, No PS, Mild PR, Trivial Paraprosthetic PR
September 25, 2012 No frame fractures
Medtronic Native Outflow Tract Transcatheter Pulmonary Valve (TPV) Research Clinical Study Early Feasibility Trial
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
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
Deployment
NCH Team In The Animal Lab
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
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 test @ 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
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
Imaging of the RVOT in TOF Approach to analyzing the RVOT Kan Hor, MD & Team 3D RVOT to 3D RVOT segmented images
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
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
Dual Source Flash CT
Screening Process: Engineering Assessment 3D right-heart models from multiphase CT, perimeter and length measurements Virtual device implant Device in SLA model
We take pictures & HD movies of the virtual SLA implant in systole & diastole
Perimeter Plots Acceptable fit Unacceptable fit Possible Fit?
Simulating Implant in the SLA Model
PA Angiogram Pre Implant
PA Angiogram Post Implant
May ICE th 30, PRE 2013 FIM Implant: POST
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
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
Just Remember. There are no new ideas!!! Pavcnik 1991
FIM NCH Native Outflow Tract TPV Team Thanks You