Sutureless Mitral and Tricuspid Clamp Valves

Transcription

1 Sutureless Mitral and Tricuspid Clamp Valves Simple non-stent annular attachment Dr. Eric Berreklouw, MD PhD Daidalos Solutions B.V. Eindhoven/Son, The Netherlands

2 Disclosures and acknowledgements Author is cardiac surgeon and inventor of Clamp Valves Biological valves provided by Edwards Lifesciences and Vascutek Mechanical valves provided by St Jude Medical Movies by Mediaventures

3 Aortic valved-stents (TAVI) Edwards Sapien 3 Medtronic Evolut

4 Aortic vs Mitral valve Cylindric stent Aortic cylinder Additional or alternative attachment technology required Failing concept of simple stent Frank H. Netter, The CIBA Collection of Medical Illustrations 1969

5 Mitral valved-stents in development Edwards Fortis Edwards CardiAQ Medtronic Medtronic Twelve Intrepid Neovasc Tiara Abbott Tendyne Highlife

6 Mitral valved-stents in development Attachment mechanisms Leaflet attachment: Edwards: Fortis/CardiAQ valve Medtronic: TMVI/Twelve valve Neovasc: Tiara valve Fixation to LV apex: Abbott: Tendyne valve Stent in separate subannular ring: Highlife valve

7 Mitral Valved-stents in development Leaflet attachment DISADVANTAGES LVOTO due to immobilization AML and high profile device Stasis of blood between leaflets and prosthesis Chronic anticoagulation Difficult in large flail and thickened leaflets (MS), or tricuspid leaflets Can not be used when leaflets are removed

8 ANNULAR CLAMP VALVE TECHNOLOGY 1 Nitinol ring with flexible lower flange Lower flange stretched in temporary cold shape

9 ANNULAR CLAMP VALVE TECHNOLOGY 2 Nitinol ring with flexible lower flange Lower flange expanded in final warm shape

10 ANNULAR CLAMP VALVE TECHNOLOGY 3 Nitinol ring with flexible upper and lower flanges Upper and lower fingers stretched in temporary cold state (constrained within tube)

11 ANNULAR CLAMP VALVE TECHNOLOGY 4 Nitinol ring with flexible upper and lower flanges Upper and lower fingers expanded in final warm state

12 Aortic Clamp Valve in Action Video 1

13 Simplified applicator with stretching sutures

14 Mechanical Aortic Clamp Valves Long-term (90 days) swine studies Prof. Van Nooten University Hospital Ghent (UZG) Belgium

15 Mechanical Aortic Clamp Valves chronic (90 days) swine studies Angio after 90 days Video 2

16 Mechanical Aortic Clamp Valves long-term (90 days) swine studies Clamp valve Clamp valve Hand-sewn control Hand-sewn control J Thorac Cardiovasc Surg 2011;141:1231-7

17 Mechanical Aortic Clamp Valves long-term (90 days) swine studies AUTOPSY IN DEVICE SURVIVORS (N=10) SOLIDLY FIXED AT ANNULUS 10/10 NOT MIGRATED 10/10 NO PVL 10/10 COVERED WITH ENDOTHELIA 10/10 NORMAL VALVE FUNCTION (*) 10/10 NO DAMAGE TO CORONARY ARTERIES 10/10 NO DAMAGE TO MITRAL VALVE 10/10 NO DAMAGE TO INTERVENTRICULAR SEPTUM 10/10 (*) excluding tissue overgrowth, broken stretching sutures J Thorac Cardiovasc Surg 2011;141: (*) excluding tissue overgrowth, broken stretching sutures

18 J Thorac Cardiovasc Surg 2011;141:1231-7

19 Biological Aortic Clamp Valves Fixed Upper Flange Edwards Perimount valves J Thorac Cardiovasc Surg 2011;141:1231-7

20 Mitral Clamp Valves acute swine studies Prof. F. Mohr Dr. S. Leontyev Herzzentrum Leipzig

21 Mitral Clamp Valves acute swine studies Ring with fixed upper flange J Thorac Cardiovasc Surg 2011:142:390-5

22 Mitral Clamp Valves acute swine studies Low profile

23 Mitral Clamp Valves acute swine studies Simple Holder with stretching sutures J Thorac Cardiovasc Surg 2011:142:390-5

24 Mitral Clamp Valves acute swine studies Video 3 J Thorac Cardiovasc Surg 2011:142:390-5

25 Mitral Clamp Valves acute swine studies Cardioplegia versus VF J Thorac Cardiovasc Surg 2011:142:390-5

26 Mitral Clamp Valves acute swine studies Results J Thorac Cardiovasc Surg 2011:142:390-5

27 Mitral Clamp Valves acute swine studies

28 J Thorac Cardiovasc Surg 2011:142:390-5

29 Edwards Perimount valve Edwards Magna Ease valve Fixed Upper Flange Valve V1 Both Flanges Flexible Valve V2

30 Mitral Clamp Valve V2 and Constraining Applicator Video 4

31 Mitral Clamp Valve V2 ex-vivo implant in empty cold pig heart Video 5

32 Mitral Clamp Valve V2 ex-vivo implant in warm fluid filled pig heart Video 6

33 Compressible Mitral Clamp Valve At expanded warm state

34 Compressible Mitral Clamp Valve In cold compressed state

35 Compressible Mitral Clamp Valve Ex-vivo implant in empty cold pig heart Video 7

36 Clamp Valve V1 in tricuspid position ex-vivo pig heart from above

37 Pulmonary valve Clamp Valve V1 in tricuspid position ex-vivo pig heart from below

38 Clamp Valves Conclusions I Simple annular attachment is feasible with Aortic Clampvalves in pigs with 90 days FU and with Mitral Clampvalves in acute pig experiments

39 Clamp Valves Conclusions II Can attach all types of valve prostheses in all anatomical positions with a very low profile

40 Clamp Valves Conclusions III Mechanical constraining applicators make use in beating or fibrillating hearts feasible

41 Clamp Valves Conclusions IV Compressible (Catheter) Mitral and Tricuspid Clamp Valves seem feasible with further adaptation of valve, flanges, and delivery system

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