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TAVR Pearls Addressing the Shortcomings of the Current TAVR Generation. Moderator Ted E. Feldman, MD Director Cardiac Catheterization Laboratory Evanston Hospital Evanston , Illinois. Panelists Ian T. Meredith, MBBS, PhD Professor of Cardiology and Medicine Monash University
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TAVR PearlsAddressing the Shortcomings of the Current TAVR Generation Moderator Ted E. Feldman, MD Director Cardiac Catheterization Laboratory Evanston Hospital Evanston, Illinois
Panelists Ian T. Meredith, MBBS, PhD Professor of Cardiology and Medicine Monash University Director, MonashHeart MonashMedical Centre Southern Health Melbourne, Australia Michael J. Reardon, MD Professor of Cardiothoracic Surgery The Methodist DeBakey Heart Center Houston, Texas Nicolo Piazza, MD, PhD Assistant Professor and Co-Director Structural Heart Disease Program McGill University Health Centre Interventional Cardiology German Heart Center Munich Munich, Germany
TAVR Development • Originally large delivery profiles: up to 25 French • High rate of vascular complications (15%-25%) • Mortality rates at 30 days (10%-15%) were then considered acceptable • Now complication rates much lower • Evolution of devices and careful patient selection
Importance of Imaging • Originally used 2-dimensional imaging • 3-dimensional imaging has become key in selecting valve size and placement • Retrospective analyses comparing valve size in patients based on echo vs estimation using CT, approximately 50% of patients received the incorrect size valvea • Number of paravalvularleaks was tremendously high • Limited number of valve sizes available Piazza N. JACC CardiovascInterv. In press.[2]
CTA Assessment of Aortic Valve Annulus Image courtesy of Ted E. Feldman, MD.
The Ice Cream Cone Analogy .. .. Images courtesy of Ian T. Meredith, MBBS, PhD.
CTA Prediction of TAVR Working Angle Image courtesy of Ted E. Feldman, MD.
Repositioning and Retrievability • A variety of second-generation devices are repositionable and fully retrievable. • A one-to-one connection is needed between the handle outside the body and the movement of the valve in situ.
REPRISE II Aortic Regurgitation Over Time Combined Paravalvular 100 15.2% 80 60 Evaluable Echocardiograms, % 40 20 0 n = 112 n = 110 n = 103 n = 103 Meredith IT. TCT 2013.[3]
Paravalvular Leak Irregular annulus + concentric valve = paravalvular leak Adaptive seal Images courtesy of Ian T. Meredith, MBBS, PhD.
REPRISE II Conclusions • Successful valve implantation and positioning in all 120 patients • Primary device performance end point met • Low mortality (4.2%) and disabling stroke (1.7%) at 30 days • No embolization, ectopic valve deployment, or TAV-in-TAV • Negligible aortic regurgitation • Clinical event rates consistent with those reported for other valves Meredith IT. TCT 2013.[3]
Abbreviations • 2D = 2-dimensional • 3D = 3-dimensional • CT = computed tomography • CTA = computed tomography angiogram • LV = left ventricular • TAVR = transcatheter aortic valve replacement
References 1. ClinicalTrials.gov. Safety and efficacy study of the Medtronic CoreValve® System in the treatment of severe, symptomatic aortic stenosis in intermediate risk subjects who need aortic valve replacement (SURTAVI). clinicaltrials.gov/show/NCT01586910. Accessed December 1, 2013. 2. Piazza N. Erroneous measurement of the aortic annular diameter using 2-dimensional echocardiography resulting in inappropriate CoreValve size selection: a retrospective comparison with multislice computed tomography. JACC CardiovascInterv. In press. 3. Meredith IT. REPRISE II: A prospective registry study of transcatheter aortic valve replacement with a repositionable transcatheter heart valve in patients with severe aortic stenosis. Presented at: Transcatheter Cardiovascular Therapeutics Meeting; October 27-November 1, 2013; San Francisco, CA. 4. Sponga S, Perron J, Dagenais F, et al. Impact of residual regurgitation after aortic valve replacement. Eur J Cardiothorac Surg. 2012;42:486-492.