Evolut R in bicuspid valve anatomies

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1 Evolut R in bicuspid valve anatomies U. Gerckens MD University of Rostock, Germany

2 Potential conflicts of interest Speaker's name: Ulrich Gerckens I have the following potential conflicts of interest to report: Proctor: Boston Scientific, Medtronic Receipt of honoraria or consultation fees: Boston Scientific, Medtronic

3 BAV morphology & Classification Type 0: 26.7% Type 1: 68.3% Type 2: 5.0% Sievers et al. J Thorac Cardiovasc Surg 2007 Mylotte D., JACC. 2014;64(22):

4 BAV Classification in TAVI Era Jilaihawi et al. JACC imag. 2016;9: Jilaihawi et al. JACC imag. 2016

5 - Frame expansion at different levels Bicuspid valves CT Scan, post implantation Annular level Supra annular level

6 Challenges in bicuspid valves Often heavily calcified Incomplete valve expansion ( calcified raphe ) Paravalvular leak Annulus rupture Angulated aortic root Frequently associated with ascending aortic aneurysm Risk of rupture/dissection Oval shaped valve area and eccentric annulus Risk of paravalvular leak Long-term durability of the TAVI valve?

7 Sizing in bicuspid What to consider for sizing: Virtual basal ring or EOA or Intercommissural distance? Annular sizing or supraannular CT based measurement or balloon sizing to identify effective orifice area ( EOA), - best oversizing range?

8 How Sizing in bicuspid Annulus Measurement with Valve Leaflets analysis Bicuspid Type 1 ( Raphé RCS / LCS) EOA or Functional diameter Analysis of Leaflets Anatomy (Bicuspid, Ca++) should be added to annulus measurement to optimize valve size choice and define optimal valve position before TAVI Functional Annulus Diameter

9 Key discussion points Not just Downsizing ---- but how to measure for optimal / best sizing! Should we use annular or supra-annular sizing? If supra-annular, which level above basal plane? Anchoring zone? Role/impact of Intercommissural distance and of the calcified Raphe ( > 4mm)? Balloon sizing for identify the effective orifice area (EOA) and anchoring level? Risk of under sizing Risk of over sizing o Pop-out o PVL o Valve embolization 9 CoreValve Evolut R 34 mm In-service Medtronic - Confidential o Annular rupture o Pacemaker rate o Valve dislodgement o Excess frame/leaflet strain

10 Case example self-expanding prosthesis in bicuspid anatomy

11 Bicuspid valve clinical example sizing/implantation technique MSCT sizing (core lab) Perimeter = 81,2 / 25,8mm derived Sizing chart 29mm Evolute R Trondheim, J. I. G. 18/2/2016

12 Bicuspid valve clinical example sizing/implantation technique TEE valve anatomy Trondheim, J. I. G. 18/2/2016

13 Bicuspid valve clinical example sizing/implantation technique TEE valve anatomy Trondheim, Dr. Bjørnar Grenne, J. I. G. 18/2/2016

14 Bicuspid valve clinical example sizing/implantation technique Angio pre Trondheim, J. I. G. 18/2/2016

15 Bicuspid valve clinical example sizing/implantation technique Angio balloon sizing 22mm TRUE Trondheim, J. I. G. 18/2/2016

16 Bicuspid valve clinical example sizing/implantation technique TEE balloon sizing 22mm TRUE Trondheim, J. I. G. 18/2/2016

17 Bicuspid valve clinical example sizing/implantation technique Angio 26mm Evolut R implantation Trondheim, J. I. G. 18/2/2016

18 Bicuspid valve clinical example sizing/implantation technique TEE: 26mm Evolut R Trondheim, J. I. G. 18/2/2016

19 Bicuspid valve clinical example sizing/implantation technique 26mm Evolut R post dilatation same 22mm balloon Trondheim, J. I. G. 18/2/2016

20 Bicuspid valve clinical example sizing/implantation technique TEE: 26mm Evolut R: postdil. 22mm TRUE Trondheim, J. I. G. 18/2/2016

21 Bicuspid valve clinical example sizing/implantation technique Angio 26mm Evolut R final result Trondheim, J. I. G. 18/2/2016

22 Bicuspid valve clinical example sizing/implantation technique TEE: 26mm Evolut R final result Trondheim, J. I. G. 18/2/2016

23 Final Peak-to-peak: 4 mmhg Pmean: 12,7 mmhg

24 Evolut R in bicuspid valve anatomies Bicuspid aortic valve for TAVI requires valve frame implantation accordingly to leaflet level to ensure suprannular functioning of the self expandable THV Possibility of resheathing, repositioning and supraanular functioning are relevant advantages Self expanding nitinol valvular frame can expand even in the post implant period to conform to the anatomy THV in BAV required often post-dilatation (no balloon upsizing) for optimal THV expansion (TEE or multiplanar view is helpful)

25 Take home message Identify a bicuspid valve morphology and criterias! Sizing concept in bicuspid still under evaluation (value of balloon sizing, CT based supra-annular sizing, intercommissural distance, raphe length) Not only Downsizing best and correct sizing (EOA) needed Implant depth in relation to the anchoring zone (different from annular plane to maintain suprannular functioning! Balloon sizing can be useful for identify the effective orifice area (EOA),for sizing and to identify the anchoring level

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