Late failure of transcatheter heart valves: An open question
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1 Late failure of transcatheter heart valves: An open question A comparison with surgically implanted bioprosthetic heart valves. A. Rashid The Cardiothoracic Centre Liverpool, UK.
2 Conflict of Interest Statement I do not have any financial interest or affiliation to any company that I mention their products or name in this presentation.
3 Alexis Carrell in: Carrell A: Results of transplantations of blood vessels, organs & limbs. A. Carpentier in: JAMA 1908; 51:1662 Biological factors affecting long term results of valvular hetrografts. A. Cribier in: J. Thoracic Cardiovasc Surgery 1969:59:457 Percutaneous transcatheter implantations of an aortic valve prosthesis for calcific aortic stenosis, 1 st human case description. Circulation 2002 Dec 10; 106:3006-8
4 Surgery of the Aortic Valve & Root
5 Surgery of the Aortic Valve & Root
6 Surgery of the Aortic Valve & Root
7 Surgery of the Aortic Valve & Root
8 Surgery of the Aortic Valve & Root
9 Surgery of the Aortic Valve & Root
10 Surgery of the Aortic Valve & Root
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13 Valve Evolution Untreated Equine Tissue Treated Bovine Tissue Andersen Hand-made Percutaneous Aortic Valve Cribier-Edwards THV 23mm Edwards SAPIEN THV 23mm, 26mm
14 Edwards SAPIEN THV A single valve with 2 delivery options, offers the versatility to treat the widest range of high risk AS patients. Transfemoral approach using the RetroFlex Delivery System Transapical approach using the Ascendra Delivery System
15 Key develop ment mileston es The pioneers (1) Henning Andersen (May 1st 1989) First successful pig implant Granted with 2 patents Alain Cribier (April 16, 2002) Parallel research and proof of concept Implanted first percutaneous aortic valve on a patient via an antegrade approach John Webb (2004 ) Early work with Edwards transapical Patriot program in late 1990 s Contribute to develop and promote the retrograde approach
16 Edwards Transcatheter Heart Valve Key development milestones The pioneers (1) Henning Andersen (May 1st 1989) First successful pig implant Granted with 2 patents Alain Cribier (April 16, 2002) Parallel research and proof of concept Implanted first percutaneous aortic valve on a patient via an antegrade approach John Webb (2004 ) Early work with Edwards transapical Patriot program in late 1990 s Contribute to develop and promote the retrograde approach
17 Modes of failure of tissue heart valves Endocarditis Tissue overgrowth Degeneration Thrombosis
18 Pathology Thrombus formation (Hancock standard)
19 Pathology Calcification, commissures. (Hancock standard)
20 Pathology, fibrous tissue overgrowth Pathology, fibrous tissue overgrowth with calcification (Hancock Standard)
21 Pathology Endocarditis (Hancock standard)
22 Pathology Calcification, general. (Hancock standard).
23 Calcification Is one of the main factors influencing long term durability Progressive Time related phenomenons Involving all bioprostheses in place for more than 6 years
24 Pathogenesis of calcium deposits. 1. Metabolic factors Pre-implantation treatment 2. Tissue related factors Use of phosphates in the preparation solutions. Loss of proteoglycans during this preparation. Presence of calcium binding ng aminoacids in the tissues. 3. Calcium binding proteins derived from plasma and penetrate into biomaterial.
25 Isihara types of anatomic degeneration of bioprosthetic valves (1982) Type I Tears involving the free edge of the cusps. Type II Linear perforation at the base of the cusps parallel to securing the ring. Type III Large perforation occupying the centre of the cusp. Type IV Small pin hole perforations in the central region of the cusp.
26 Hancock II at 15 Years Freedom from SVD - Aortic Position >65 Years 100,0% 99,6% All ages 81,0% 90,0% <65 Years 76,0% 72,0% Actual Actuarial 0% 20% 40% 60% 80% 100% David et al. Late Results of Heart Valve Replacement with the Hancock II Bioprosthesis. J Thorac Cardiovasc Surg 2001;121;... Cohen et al. Late Results of Heart Valve Replacement with the Hancock II Bioprosthesis. 80th Annual Meeting
27 ACTUARIAL FREEDOM SVD MVR 5YR 15YR ALL PTS100% 70.8% >60YRS100% 72% >65YRS100% 75.6% JOURNAL OF HEART VALVE DISEASE 2006 ; 15 :49-56 GUILIO RIZZOLI PADUA TREVISO AND VENIZIA
28 Structural valve deterioration (by age ranges overall) Freedom from primary tissue failure (overall-age groups) (University of British Columbia, Carpentier-Edwards standard).
29 Modes of failure in tissue heart valves. Long term results of successful valve replacement are determined by three factors: 1. Irreversible structural alterations in the heart and lungs secondary to valvular disease. 2. Occlusive coronary artery disease. 3. The mechanical reliability of the prosthesis and host tissue interactions.
30 Conclusion 1. Transcatheter bioprosthetic heart valves may become ideal valves for the treatment of aortic valvular disease. 2. However because of similarity (of pre- implantation treatment, valve design, haemodynamic stress and prosthesis host tissue interaction and calcification) with surgically implanted bioprosthetic heart valves, similar late outcomes should be expected.
31
32 Bioprosthetic Valves Introduction of gluteraldehyde for the fixation of biological tissue by Carpentier in 1969 facilitated the use of bioprosthesis (porcine and bovine pericardium) as a satisfactory alternative to mechanical valves.
33 Clinical performance assessment usually considers: Patient survival Haemodynamics Thromboembolism Anticoagulant related haemorrhage. Valve endocarditis Re-operation Valve related mortality structural valve deterioration.
34 Design & Flow Characteristics a. Porcine bioprosthesis b. Pericardial bioprosthesis
35 Cribier-Edwards Edwards / Edwards SAPIEN THV* Aortic Implants - Transfemoral/Transapical n = 685 Transfemoral: n = Transapical: n = Feasibility REVIVE REVIVE II II = = REVIVAL REVIVAL II II = = CANADIAN CANADIAN SPECIAL SPECIAL ACCESS ACCESS = = TRAVERCE TRAVERCE = = REVIVAL REVIVAL II II = = CANADIAN CANADIAN SPECIAL SPECIAL ACCESS ACCESS = = Pivotal EU EU Registry Registry = = 88 PARTNER PARTNER EU EU = = * The Edwards SAPIEN THV valve incorporates bovine pericardial tissue and TFX treatment PARTNER PARTNER EU EU = = PARTNER PARTNER US US ~50 ~50
36 Stentless Valve
37 Freedom from primary tissue failure (overall) (University of British Columbia, Carpentier-Edwards standard).
38 Re-operation Freedom from valve-related re-operation (University of Padova, Hancock standard).
39 Freedom from valve-related (re-operation (University of British Columbia, Carpentier Edwards standard).
40 Structural valve deterioration (by age ranges AVR) Freedom from primary tissue failure (aortic valve replacement age groups) (University of British Columbia,Carpentier-Edwards standard).
41 AVR Freedom from primary tissue failure (aortic valve replacement age groups) University of Padova, Hancock standard).
42 Structural valve deterioration (by age ranges MVR) Freedom from primary tissue failure (mitral valve replacement age groups) (University of British Columbia, Carpentier-Edwards standard)
43 Freedom from primary tissue failure (mitral valve replacement-age groups) University of Padova, Hancock standard)
44 Freedom from primary tissue failure (overall-age groups) University of British Columbia, Carpentier-Edwards standard)
45 Valve Related Complications and Survival Summary (% per patient per Patient Year) AVR MVR Multiple CE H CE H CE H Late mortality Thromboembolism fatal Primary tissue failure Re-operation Complications (total)
46 Replacement of Cardiac Valves Freedom from Valve-Related Complications Mitral Valve Replacement (Carpentier-Edwards vs. Hancock). Complications CE H 10 years (%) 10 years (%) 15 years (%) Thromboembolism 77.8 ± ± ± 3.4 Primary tissue failure 71.8 ± ± ± 5.5 Re-operation 67.6 ± ± ± 5.4 Mortality ± ± ± 4.1 Complications (total) 44.8 ± ± ± 4.1
47 Freedom from Valve-Related Complications Multiple Valve Replacements (Carpentier-Edwards vs Hancock) CE H Complications 10 years 10 years (%) 12 years (%) Thromboembolism 96.3 ± ± ± 5.0 Primary tissue failure 65.8 ± ± ± 13.0 Re-operation (VR) 55.3 ± ± ± 11.7 Mortality (VR) 87.8 ± ± ± 6.7 Complications (total) 55.9 ± ± ± 8.5
48 ACTUARIAL FREEDOM SVD AORTIC 5YR 15YR ALL PTS 100% 84.7% >60YRS 100% 93.3% >65YRS 100% 94.2% JOURNAL OF HEART VALVE DISEASE 2006 ; 15 :49-56 GUILIO RIZZOLI PADUA TREVISO AND VENIZIA
49 Pathology of biological valve degeneration. Degeneration of biological valves is related to: 1. Leaflet rupture. 2. Leaflet calcification. - Mechanical stress plays an important role. - Calcification starts at the commissures. - Calcification has three characteristic features: 1. Early intrinsic starts at the commissures. 2.. Intrinsic calcification involving the annulus of the three cusps. 3. Extrinsic calcification (large calcium nodules) in the centre of leaflets.
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