I will not discuss off label use or investigational use in my presentation.

Transcription

1 I will not discuss off label use or investigational use in my presentation.

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5 Surgical valves Design and Durability Testing Potential Concerns Real Practice

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7 The First Successful Valve Replacement: September 21, 1960 Albert Starr

8 1965 First Xenograft Valve Mercurial salt preservation of a porcine xenograft J.P. Binet et A. Carpentier, CR Acad Sci Paris 1965;261:

9 First commercially available Xenograft Valve (1969) Preserved with mercurial salt Warren Hancock Hancock porcine

10 1969: Carpentier advocates the use of glutaraldehyde 1975 Carpentier-Edwards standard porcine bioprosthesis

11 Early durability was limited Late tears in leaflets of porcine bioprostheses in adults JL Pomar, et al. The Annals of Thoracic Surgery, 1984 Vol 37, Butany J, Collins M J J Clin Pathol 2005;58:

12 What can we learn from past surgical valve experience? The Ionescu Pericardial Valve Announced Improvements Durability Better hemodynamics 5 years later, cuspal tears... Product withdrawn

13 Surgical valves Design and Durability Testing Potential Concerns Real Practice

14 Delivery catheter system Bioprosthetic heart valve Material selection and characterization Design - Geometry Loading system Material manufacturing and processing

15 Valve housing, shaft Ergonomics Profile Delivery catheter system Reposition retrieve Working handle Recapture

16 Support structure Sutures Leaflets Bioprosthetic heart valve Anchoring / function Sealing skirt Attachment posts

17 Withstand torsion Withstand compression Appropriate radial force over range of sizes and shapes Frame Withstand multiple cycle loading Frame capable of withstanding crimp profile Maintain integrity over range of sizes and shapes

18 Structural Integrity Analysis Piazza et al. 1 developed a fluoroscopic protocol to identify experimentally induced frame fractures No frame fractures in the 58 patients with a mean follow-up time of 22 months (range 12 to 36 months) Piazza N, Grube E, Gerckens U, et al. A clinical protocol for analysis of the structural integrity of the Medtronic CoreValve System frame and its application in patients with 1-year minimum follow-up. EuroIntervention. 2010;5:

19 Durability Testing Valve Design Leaflet Geometry Annulus positioning Material Selection Thickness Tensile Strength Pliability Performance Clinical Data Bench Testing

20 Simulate in-vivo conditions Durability Fatigue Mechanical loading radial torsional bending Prosthesis geometry Out-of-round configurations Alignment of prosthesis Patient characteristics blood pressure compliance of aorta Biological response over time

21 The 3 components to in-vitro testing Pulse duplicator Gradient Regurgitant volume Effective orifice area Durability Accelerated wear tester 200 standard million cycles ~ 5 years Fatigue Transcatheter aortic valves are tested against a Fatigue tester 600 million cycles ~ 15 years surgical bioprosthetic valve as the gold Assess the wear characteristics of the leaflets Assess structural integrity of the support structure

22 Surgical valves Design and Durability Testing Potential Concerns Real Practice

23 Potential issues One Noncircular configuration of a transcatheter

24 Noncircular configuration of a transcatheter valve removed from the heart at autopsy J Am Coll Cardiol Intv. 2012;5(5): doi: /j.jcin

25 Potential issues One Two Noncircular configuration of a transcatheter Under-deployment of Transcatheter Valves

26 Non-circularity and Under-deployment of Transcatheter Valves Schultz et al. J Am CollCardiol, (10): p

27 Accelerated Wear Testing Elliptical Configuration

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29 Potential issues One Two Noncircular configuration of a transcatheter Under-deployment of Transcatheter Valves Three Four Five Post-dilatation Crimping Valve-in-valve

30 Will SEQUENTIAL VALVE IMPLANTATION influence valve durability? Sequential valves

31 Surgical valves Design and Durability Testing Potential Concerns Real Practice

32 Studies reporting no valve failures at 1,2 and 3 years Gurvitch et al. Circulation 2010;122: Thielmann et al. Ann Thorac Surg 2009;88: Webb et al. Circulation 2007;116: Buellesfeld et al. JACC 2011;57: Ussia et al. Eur Heart J 2012;33: Ussia et al. EuroIntervetion 2012;7: Kodali et al. NEJM 2012;366: Nietlispach et al. JACC Cardiovasc Interv 2012;5: (autopsy 20 pts)

33 All-Cause Mortality All-Cause Mortality (ITT) TAVR AVR HR [95% CI] = 0.88 [0.70, 1.12] p (log rank) = % 26.8% 33.9% 24.3% Months Numbers at Risk TAVR AVR

34 Freedom from SVD Freedom Structural Valve Deterioration 100% 90% 80% 85 y 75 y 65 y 70% 60% 50% 40% 30% 20% 10% 0% Years post-implantation Puvimanasinghe Heart, 2004

35 Take Home Message Frame fractures not reported Only few structural valve failures reported Durability no issue so far More patients with Longer follow-up needed