• Best Techniques for Valve Positioning and Deployment

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    Dr Hasan Jilaihawi Cedars-Sinai Heart Institute, Los Angeles Consulting- Edwards Lifesciences, LLC, St. Jude Medical, Inc., Venus Medtech Off-Label- Discussion pertaining to transcatheter valve therapies Pre-TAVI Iliofemoral evaluation Aortic arch Annular sizing AV morphological assessment Annular/LVOT calcium During TAVI- 2D/3D TEE Angle of intra-procedural fluoroscopic projection Fluoroscopic calcium tracking CT integration Post-TAVI Coronary assessment Long term evaluation- migration/stent fracture Assessment of complications- PV leak/stroke To understand the definitions and clinical implications of optimal and suboptimal TAVR positioning and deployment To appreciate the techniques and imaging modalities that may be used to help TAVR device positioning and deployment To know how these modalities can be used effectively to minimize TAVI complications Low Optimal High Ventricular embolization ˜1% ˜3% Aortic embolization/dislocation 14 – 17mm CAUTION- The Edwards transcatheter valves are investigational devices. Limited by Federal law to investigational use only. These products have not been approved for marketing in the United States, and are not available for commercial sale in the United States. LOWER PART- High radial force pushes aside the calcified leaflets Covered skirt- ?para-valvular leaks CoreValve-Medtronic Self-Expanding Bioprosthesis (18 Fr CRS) A – inflow; LVOT portion MIDDLE PART - concave-convex constrained to avoid coronaries carries the valve HIGHER PART - fixation Low radial force 12 mm 8-10 mm 53-55 mm MCV optimal (measurement)- Lowest portion of stent-frame 5-10 mm below native annulus (NCC) Jilaihawi et al, AHA 2010 Sapien optimal (visual) Middle third “High” “Low” “Optimal” Commoner with MCV Commoner with Sapien Kappetein et al, JACC 2012 High implant with late progression of AR TV in TV with 26 mm valve AR progressed with symptoms Severe PV AR LV 122/2 LVEDP 17 AO 121/52 AR index 28 Trace AR MCV malpositioning and AR CASE 1 Low Malpositioned Corevalve- TV-in-TV c/o J. Kovac 2007 c/o R. Bonan 2009 c/o R. Bonan 2009 Jilaihawi et al, Eur Heart J. 2010 Based on a 5-10 mm optimal depth of implantation Minimal AI despite high valve implantation due to commissural seal High Implantation Masson et al, JACC Intv 2009 Masson et al, JACC Intv 2009 Urena et al, JACC 2012 Piazza et al, JACC Intv 2010 Munoz-Garcia et al., JACC Intv 2012 MCV- depth implantation mean of 10.3±2.7 mm in LBBB (range 6.7 to 14.6 mm vs 5.5 ±3.4 mm (range 0.7 to 12.2 mm) if no LBBB (p=0.005); n=40. MCV- Depth of implantation- MV HR 1.20 (1.08–1.34) <0.001 (n=195) Rate of embolization (%) Rodes-Cabau JACC 2009 Smith et al, NEJM 2010 Leon et al, NEJM 2010 Thomas et al, Circulation 2010 Tay et al, JACC Intv 2010 Figure out the pacing rate you will be using during deployment. Defib pads on, ready to defibrillate Tay et al, JACC Intv 2011 Hing Ong et al, CCI 2010 Second sequential CoreValve implanted successfully with no adverse sequelae Geisbüsch S et al. Circ Cardiovasc Interv 2010 Tamburino et al, Circulation 2011 Ussia et al, Eurointervention 2012 (P=0.024) Earlier data Dislocation 10% 30 day mortality 9.9% Stroke rate=14% vs 7% (p=0.20) Later experience Tamburino et al 4/663 (0.6%) Complication rate not separately reported Ussia et al Dislocation 7/176 (3.9%) 30 day mortality 14.3% 0% stroke Both devices Increased PV AR (if high or low) Increased LBBB (if low) Edwards Sapien Increased leaflet malfunction (if low) Increased mortality (if low with ventricular embolization) Corevalve Increased pacemaker (if low) Increased prosthesis-patient mismatch (if low) Trend to increased stroke (if high with dislocation) Increased mortality in some series (if high with dislocation) Tchetche et al, EuroIntervention 2012;8-556-562 Device iterations and malpositioning- MCV Accutrak Pacemaker 10.6% PV AR grade 2- 12.7% PV AR > grade 2- 0% N=134 A final position between 0 and 6 mm was achieved in 85.8% of patients. Munoz-Garcia et al., JACC Intv 2012 Retroflex 1 Retroflex 3 Novaflex Webb and Wood JACC 2012 Dvir et al, JACC Intv 2012 More pronounced in- Heavy calcification Small sinuses Not more pronounced in- TF vs TA Septal hypertrophy Novaflex vs RF3 Kahlert, AHA 2010 Bagur et al, JACC Imaging 2011 Kurra et al, JACC Intv 2010 Gurvitch et al, JACC Intv 2011 Gurvitch et al, JACC Intv 2011 Excellent Satisfactory Poor even using non contrast CT LAO 15 CAU 18 Tzikas et al, CCI 2010 Intra-procedural Dyna-CT to obtain an exact perpendicular C-arm angulation Rotational angiography performed under rapid pacing with diluted contrast (25cc) In 84% (n=42) of patients the guiding-tool led to an exactly perpendicular C-arm angulation Kempfert et al, AHA 2010 MDCT vs Dyna-CT comparison Once patient on the table, two registration runs are done with 10-15 ml of contrast per run. Overlay is aligned to patient. Live Guidance for valve deployment. CT integration- Philips Heart Navigator Placing multiple markers to define soft tissue planar targets for device placement Using markers to define echo and x-ray optimal views for device implantation Markers appear on live fluoro images during device deployment The future? 3D TEE integration c/o Dr John Carroll The red dot in all four real time images marks the remaining paravalvular leak c/o Dr John Carroll c/o Dr John Carroll Kahlert et al, J Cardiovasc Magn Reson. 2012 Swine model (n=8) rtCMR-guided transarterial aortic valve implatation (TAVI) using the nitinol-based Medtronic CoreValve bioprosthesis. Suboptimal TAVR positioning and deployment have serious clinical implications There has been a rapid growth in the advanced imaging field as well as ongoing TAVR device iterations that are designed to help improve positioning There is a need for ongoing objective data to establish how these technologies can impact and further refine our TAVR practice

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