Hemodynamics Benefit of Supra-Annular Design in Failed Bio-Prosthetic Valves

Hemodynamics Benefit of Supra-Annular Design in Failed Bio-Prosthetic Valves

Speaker's name: I have the following potential conflicts of interest to report: Proctorship for Medtronic

Agenda Failure modes of bio-prosthetic valves Patient prosthetic mismatch (PPM) Considerations for TAVI in failed bioprosthetic valves Why supra annular conclusions

Bio-Prosthetic failure types WHAT THE SURGEON SEES

Bioprosthetic Valves world Carpentier-Edwards Medtronic Magna Theon CE SAV Perimount Sorin Hancock II Mosaic Shelhigh Freestyle Stentless Pericarbon Mitroflow Solo Soprano St Jude Medical Vascutek NR 2000 Semistente d NR 900 A Tricuspid valve Ionescu Shiley Toronto SPV Stentless Biocor Labcor laboratories Epic Trifecta Aspire stented Elan stentless Dokimos Maxime Imperiii stentless Cryolife 0 Brien stentless TLPB-A-Supra Kiros

Components of stented Stent posts bioprosthesis + Base ring = Prosthesis Elgiloy wireform stent Elgiloy and Polyester ring and stent posts Edwards PERIMOUNT Magna

Components of stented Stent posts bioprosthesis + Base ring = Prosthesis Acetyl stent Silicone base ring Polyester covered stent and base ring with outer single layer of pericardium Sorin Mitroflow

Surgical bioprosthetic valves Stentless Bovine pericardial Porcine aortic valve Homograft Sorin Freedom Edwards Prima Plus Medtronic Freestyle St. Jude Toronto SPV

Why Valve-in-Valve? Growing need for treatment options for patients with failed bioprosthetic valve as population ages, life expectancy improves, and use of bioprosthetic valves increases Operative mortality for elective redo aortic valve surgery is generally low (2% to 7%), but it can increase to more than 30% in high-risk and non-elective patients Because transcatheter aortic valve (TAV)-in-surgical aortic valve (SAV) implantation represents a minimally invasive alternative to conventional redo surgery, it may prove to be safer and just as effective as redo surgery 1. Piazza, N, et al. JACC Cardio Interventions. 2011;4:721-32.

Surgical Valves are different Medtronic Hancock II CE Porcine Markers located in crown Markers located in sewing ring Sorin Mitroflow St. Jude Biocor Supra Markers located below sewing ring

Fluroscopic images of bioprosthetic valves Sorin Soprano Mitroflow

Use the available valve identification guide?

Dimensions of surgical stented bioprosthesis D B A C A Stent outer diameter B Stent inner diameter C Sewing ring outer diameter D Stent height

Size 21 mm Dimensions in (mm) Medtronic Mosaic Medtronic Hancock II Medtronic Hancock Modified Orifice Edward s Porcine St. Jude Biocor/Epic Labeled Valve Size Stent Outer Diameter (1) Porcine Aortic Valves Stent Inner Diameter (2) Suture Ring Outer Diameter (3) Valve Height (4) 21 21 18.5 26 15 21 21 18.5 26 16 21 21 18.0 26 15 21 21 19 16 21 21 19 14 Pericardial Aortic Valves Edward Perimount Edward Perimount Magna Sorin Mitroflow 21 21 20 28 15 21 21 20 28 15 21 20.6 N/A 24 13

VIV Procedure: Pre-case Planning Careful pre-case planning is essential to Valve-in-Valve procedural success Patient Selection Avoid patients: Concomitant PVL Is not securely fixed in the native annulus Has a partially detached leaflet (embolization risky ) Valve Identification through patients charts & flouroscopic imaging CT is highly recommended bioprosthesis Determine valve size and differents diameters Valve Sizing Select appropriate appropriate TAVI to implant

Key performance indicators for VIV Flow to the coronary arteries PVL Hemodynamics Effective Orifice Area (EOA) Pressure gradient

Patient Prosthesis Mismatch Patient prosthesis mismatch (PPM) occurs when the effective orifice area (EOA) of a normally functioning prosthesis is too small in relation to the patient s body size... 1 It has been well documented in surgical literature that PPM exists in 20-70% of surgical implants and has negative impacts on the regression of LV hypertrophy, as well as on long-term survival. 2 The relative risk of mortality is significantly higher in patients with a compromised ventricle, so avoidance of PPM is the key to improved survival. 2 1 7 1. Dahou A., et al., Prosthesis-Patient Mismatch After Aortic Valve ReplacementCurr Treat Options Cardio Med (2016) 18:67 2. Pibarot, P. Dumesnil, J.G. Hemodynamic and Clinical Impact of Prosthesis Patient Mismatch in the Aortic Valve Position and Its Prevention. J Am CollCardiol 2000;36:1131 41. *Blais C., et al., Impact of Valve Prosthesis-Patient Mismatch on Short-Term Mortality After Aortic Valve Replacement. Circulation. 2003;108:983-988..

Avoiding PPM With diligent case planning, PPM can be not only be predicted, it can be avoided. 1 Avoidance of PPM at the time of implant may provide the following acute and long-term benefits: A larger EOA allows for less workload on the ventricle, improving LV mass regression and survival. 1 A larger EOA with lower gradients provides immediate relief from AS symptoms. Almost all bioprosthetic valves will show signs of calcification with time, therefore, a larger EOA may provide a longer time until the patient becomes symptomatic from stenosis. 2 A larger EOA provides improved flow, less resistance, and better long-term durability. 3 1 8 1. Dahou A., et al., Prosthesis-Patient Mismatch After Aortic Valve ReplacementCurr Treat Options Cardio Med (2016) 18:67 2. P Pibarot and J G Dumesnil. Prosthesis-patient mismatch: definition, clinical impact, and prevention. Heart 2006:92;1002-1029. 3. Fleming, W, et. Al. Prosthesis-Patient Mismatch Predicts Structural Valve Degeneration in Bioprosthetic Heart Valves. Circulation. 2010; 121:2123-2129..

Supra-annular valve maximizes EOA 19

Supra-annular valve maximizes EOA The lines indicate the level of the working portion of the bioprosthesis. 20

Supra-annular valve maximizes eoa 21

Supra-annular valve maximizes eoa Supra-Annular TAVI Intra-Annular TAVI A supra-annular valve keeps the working portion of the valve above and unconstrained by the annulus while an intra-annular valve is completely housed within the native annulus. 22

Results of the VIVA study

Results of the VIVA study

Global Valve-in-Valve Registry Overview: Retrospective collection of data; 38 centers from Europe, North America, Australia, New Zealand and the Middle East. The CoreValve 26mm & 29mm and Sapien 23mm & 26mm devices were used in this study. Purpose: To evaluate the efficacy and safety of ViV procedures Objectives: Examine clinical outcomes Evaluate results of ViV procedures performed inside bioprostheses types Give correlates for high post-procedural gradients Supply data on possible rare complications Compare procedural characteristics and clinical results of performing Valve in Valve between SAPIEN and CoreValve Dvir et al., CirculationAHA. Oct 2012 32

Global Valve-in-Valve Registry Results Improvements in AV area, mean gradients, and regurgitation in Valve in Valve procedures Stenosis (n=182) Regurgitation (n=139) Combination (n=139) AV Area (cm 2 ) Baseline Post- Procedure AV Mean Gradients (mmhg) Baseline Post- Procedure 0.70 ± 0.20 1.37 ± 0.33 46.4 ± 16.1 18.4 ± 9.8 1.48 ± 0.60 1.56 ± 0.49 18.0 ± 10.1 12.0 ± 6.7 0.91± 0.30 1.56 ± 0.65 37.6 ± 14.9 16.0 ± 8.3 p value <0.001 0.01 <0.001 <0.001 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 97% AR 2 11% 10% 2% 4% Stenosis (n=182) Regurgitat ion (n=139) Note: the chart and graph reflect results including both CoreValve and Sapien. Dvir et al., TCT. Miami, Fl. Oct 2012 33

Global Valve-in-Valve Registry Hemodynamic Results Dvir et al., TCT. Miami, Fl. Oct 2012

Conclusions Hemodynamics (EOA and Pressure gradient) are one of the most important parameters when considering TAVI in failed bio-prosthetic valves Supra annular design decouples the TAVI leaflets from the failed bio-prosthesis and thus presents with lower pressure gradients specifically for small bio-prosthetic valves Possible impact of elevated gradients on valve durability should be examined in long-term.

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