The Role Of Decellularized Valve Prostheses In The Young Patient

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1 The Role Of Decellularized Valve Prostheses In The Young Patient Francisco Diniz Affonso da Costa Human Tissue Bank PUCPR - Brazil

2 Disclosures Ownership and patent license of the SDS decellularization technique (d-cell Allograft) Consultant and Member of the Advisory Board Tissue Regenix Ltd England

3 Decellularized Heart Valve Allografts SDS Decellularization Technique Fresh Allografts, no cryopreservation Storage at 4º C for up to 3 months

4 Fresh Aortic Cusp PRM 100x Descellularized Aortic Cusp PRM 100x

5 Decellularized Heart Valves Brazilian Experience ( ] Number of Implants = 1432 cases

6 Decellularized Heart Valve Allografts Pulmonary Allografts for RVOT Reconstruction during the Ross Operation Aortic Valve Allografts for AVR as Root Replacement Decellularized Allografts for Pediatric Patients under 12 Years of Age with Complex Congenital Heart Disease (ongoing study)

7 Fresh Decellularized versus Santandard Cryopreserved Pulmonary Allografts for RVOT Reconstruction during the Ross 10 YEARS OF FOLLOW-UP - Francisco Diniz Affonso da Costa Human Tissue Bank PUCPR - Brazil

8 This study - n = 363 (includes all consecutive patients operated at the author s official institution who received either a cryopreserved or a fresh dcell allograft for RVOT reconstruction) Group I - Cryopreserved Allografts Group II Fresh Decellularized Allografts

9 Ross Operation Fresh Decellularized Vs Cryopreserved Allografts DECEL (I) CRYO (II) P value No of Patients Age (y) Mean ± SD 31.7± ± Median Range (3-60) (6-54) <21 years (%) 30.3% 23.6% 0.08 Gender (% male) 78.1% 70.7% Valve Diameter (mm) Mean ±SD 24.3 ± ± 2.6 Range (18-30) (17-31) Allograft z score < (23.9%) 35 (18.4%) to (59.3%) 110 (57.9%) > (17.8%) 45 (23.7%) Etiology Rheumatic 21 (13.5%) 92 (45.1%) Congenital 111 (71.6%) 87 (43.1%) Degenerative 9 (5.8%) 12 (5.9%) Endocarditis 8((5.2%) 7 (3.4%) Others 6(3.9%) 5 (2.5%) < Follow-up Time (mean ±SD) (months) 53± ± 51 Echo data (%) 138 (90%) 185 (89%) Time (mean ±SD) (months) 40= ± 60

10 Postoperative Evaluation Clinical Examination Echocardiography Before hospital discharge 6/12 months PO, annualy thereafter Echocardiography Evaluation Primary structural failure of RVOT allograft Peak gradient >40mmHg Valvar insuficiency: moderate or severe CT Scan Evaluation Diameter measurement and Ca scores (On going study]

11 P max (mmhg) Ross Operation RVOT reconstrution Decellularized versus Cryopreserved Allografts Late Gradients Cryopreserved Decellularized Follow-up (months)

12 Ross Operation Fresh Decell x Cryopreserved Allografts Freedom from Gradient > 40 mmhg % Decell 82% Cryo Events free At 10 Years Dcell = 2 cases Cryopreserved = 16 cases P= 0,014 (122) (78) (40) (5) (2) (193) (191) (188) (170) (135) (97) (59) (31) (4) Time (months)

13 Ross Operation Fresh Decell x Cryopreserved Allografts Freedom from PI % Decell 98% Cryo Events free At 10 Years Dcell = 2 cases Cryopreserved = 2 cases P = NS (122) (78) (40) (5) (2) (193) (191) (188) (170) (135) (97) (59) (31) (4) Time (months)

14 Ross Operation Fresh Decell x Cryopreserved Allografts Freedom from SVD % Decell 82% Cryo Events free P=0,02 (122) (78) (40) (5) (2) (193) (191) (188) (170) (135) (97) (59) (31) (4) Time (months)

15 Ross Operation Fresh Decell x Cryopreserved Allografts Freedom from Reoperation % Decell 95% Cryo Events free (122) (78) (40) (5) (2) (193) (191) (188) (170) (135) (97) (59) (31) (4) Time (months)

16 Ross Operation Fresh Decell x Cryopreserved Allografts Freedom from Reoperation % Decell 95% Cryo Events free Up to 10 Years, No Reoperations due to SVD in the Decell Group!! (122) (78) (40) (5) (2) (193) (191) (188) (170) (135) (97) (59) (31) (4) Time (months)

17 Cryopreserved Pulmonary Valve Allografts Mechanisms of Allograft Stenosis Early (2 years) Proximal Anastomosis Conduit Retraction Distal Anastomosis Late (> 5 years) Calcification Degeneration

18 Pulmonary Dcell Allograft CT scan 10 years of follow-up Absence of Calcification No signs of retraction

19 Decellularized Pulmonary Valve Allografts Ross Operation at the age of 7 years Late CT control at 8 years of follow-up

20 Ca Score (Agatston units) Decellularized Pulmonary Valve Allografts 600 Ca Scores < 20 years years > 40 years Follow up (years)

21 PAC1D PAC2D DECELLULARIZED PAC3D PAC4D PAC5D PAC6D Evaluation of humoral immune response to donor HLA after implantation of cellularized versus decellularized human heart valve allografts C. Kneib1, C. Q. C. von Glehn1, F. D. A. Costa2, M. T. B. A. Costa3 & M. F. Susin1,4 CRYOPRESERVED PAC6C PAC5C PAC4C PAC3C PAC2C PAC1C CLASS II Recipient HLA Donor HLA Donor HLA Recipient HLA DRB1*0301 DRB1*0301 DRB1*0407 DRB1*0301 DRB1*1101 DRB1*0701 DRB1*1301 DRB1*1602 DRB3*0202 DRB3*0202 DRB4*0101 DRB5*0101 DRB3*0101 DRB4*0101 DRB3*0202 DRB3*0202 DQB1*0201 DQB1*0201 DQB1*0302 DQB1*0201 DQB1*0301 DQB1*0303 DQB1*0603 DQB1*0502 DQA1*0501 DQA1*0501 DQA1*0301 DQA1*0501 DQA1*0102 DQA1*0201 HLA COMPATIBILITY DQA1*0103 DQA1*0102 DRB1*0701 DRB1*0801 DRB1*0301 DRB1*0301 DRB1*1101 DRB1*1501 DRB1*1101 DRB1*0404 DRB4*0101 x DRB3*0202 DRB3*0202 DRB3*0202 DRB5*0101 DRB3*0101 DRB4*0101 DQB1*0303 DQB1*0402 DQB1*0201 DQB1*0201 DQB1*0301 DQB1*0602 DQB1*0301 DQB1*0302 DQA1*0201 DQA1*0102 DQA1*0102 DQA1*0102 DQA1*0501 DQA1*0401 DONOR SPECIFIC ANTIBODIES DQA1*0501 DQA1*0301 DRB1*1302 DRB1*0401 DRB1*0301 DRB1*1101 DRB1*1401 DRB1*1301 DRB1*1502 DRB1*1301 DRB3*0301 DRB3*0101 DRB3*0202 DRB3*0202 DRB3*0202 DRB4*0101 DRB5*0101 x DQB1*0501 DQB1*0301 DQB1*0201 DQB1*0301 DQB1*0503 DQB1*0603 DQB1*0601 DQB1*0603 DQA1*0102 DQA1*0103 DQA1*0102 DQA1*0501 DQA1*0104 DQA1*0302 DQA1*0103 DQA1*0103 DRB1*0101 DRB1*1101 DRB1*0701 DRB1*0701 DRB1*1501 DRB1*1301 DRB1*1401 DRB1*1104 DRB5*0101 DRB3*0101 DRB3*0101 DRB3*0202 DRB3*0202 DRB4*0101 DRB4*0101 DQB1*0501 DQB1*0301 DQB1*0202 DQB1*0202 DQB1*0602 DQB1*0602 DQB1*0503 DQB1*0301 DQA1*0102 DQA1*0102 DQA1*0104 DQA1*0501 DQA1*0101 DQA1*0501 DQA1*0201 DQA1*0201 DRB1*0403 DRB1*1101 DRB1*0404 DRB1*0401 DRB1*0701 DRB1*1401 DRB1*1501 DRB1*1101 DRB4*0101 DRB3*0201 DRB4*0101 DRB4*0101 DRB3*0202 DRB5*0101 DRB3*0202 DQB1*0202 DQB1*0501 DQB1*0302 DQB1*0301 DQB1*0302 DQB1*0602 DQB1*0602 DQB1*0602 DQA1*0301 DQA1*0301 DQA1*0103 DQA1*0102 DQA1*0201 DQA1*0102 DQA1*0301 DQA1*0302 DRB1*0408 DRB1*0411 DRB1*0404 DRB1*0701 DRB1*1104 DRB1*0901 DRB1*1501 DRB1*0801 DRB4*0101 DRB4*0101 DRB4*0101 DRB4*0101 DRB3*0202 x DRB5*0101 x DQB1*0301 DQB1*0302 DQB1*0302 DQB1*0402 X DQB1*0402 DQB1*0602 DQB1*0201 DQA1*0302 DQA1*0302 DQA1*0102 DQA1*0201 DQA1*0501 x DQA1*0301 DQA1*

22 Evaluation of humoral immune response to donor HLA after implantation of cellularized versus decellularized human heart valve allografts C. Kneib1, C. Q. C. von Glehn1, F. D. A. Costa2, M. T. B. A. Costa3 & M. F. Susin1,4 p= p= p=

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26 Decellularized Aortic Valve Allografts 10 Years Experience Francisco Diniz Affonso da Costa Human Tissue Bank PUCPR - Brazil

27 Clinical Data Decellularized Ao Valve Allografts Study Period: Nov 2005 Aug 2015 Patients: n= 103 (High Risk Profile] Age: 46± 17 (min=0,1 max=81) Sex: Males = 72, Females =31 26 Concomitant Mitral Valve Disease ( Multiple Reoperations] 18 Ascending Aorta / Hemiarch Aneurysm 23 Bacterial Endocarditis 6 Coronary Artery Disease Hospital INC Cardio Santa Casa De Curitiba - PUCPR

28 Data n % Valvular Lesion Aortic Stenosis 30 29,1 Aortic Insufficiency 46 44,6 Mixed Lesion 25 24,2 Unknown 3 2,9 Etiology Rheumatic 15 14,5 Congenital 30 29,1 Degenerative 15 14,8 Prosthetic Valve Dysfunction 18 17,7 Endocarditis 23 22,26 Acute Aortic Dissection 1 1 Unknown 1 1 NYHA Classe Funcional I 7 6,7 II 25 24,2 III 44 42,7 IV 20 19,4 Unknown 8 7,8 Operation Primary 62 60,1 Reoperation 41 39,9

29 Decellularized Ao Valve Allografts Operative Data Surgical Technique Aortic Root Replacement in all patients Allograft Diameter 22 ±1,6 mm (min=6, max=28) Cross-Clamp Time 90±32min (min=50, max=166) Extracorporeal Circulation Time 136±58min (min=71, max=279) Hospital INC Cardio Santa Casa De Curitiba - PUCPR

30 Surgical Technique Root Replacement Decellularized Ao Valve Allografts

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32 Postoperative Evaluation Clinical Examination Echocardiography Before hospital discharge 6/12 months PO, annualy thereafter CT Scan MRI Follow-up Decellularized Aortic Valve Allografts Clinical Follow-up 89 patients (92% complete) Mean clinical follow-up time = 4.2 years (0,1 10)

33 Decellularized Aortic Valve Allografts Results Early Mortality = 5.8% ( 6/103) Low Cardiac Output...2 Sepsis and Multiorgan Failure.. 2 Cardiogenic Shock...2

34 Decellularized Aortic Valve Allografts Late Survival % Survival % early deaths 9 late deaths 20 (70) (62) (52) (43) (31) (17) (3) (1) Time (Years)

35 Decellularized Aortic Valve Allografts Causes of Late Death (n=9) Sudden Death 2 Bilateral Ostial Lesion. 1 Acute Myocardial Infarction 1 Reoperation for CABG. 1 DVP Pulmonary Embolism... 1 Cirrosys...1 Cancer..1 Unknown..1

36 Clinical Follow-up Late Functional Status NYHA I - 75 patients NYHA II - 8 patients NYHA III - 1 patient NYHA IV 0 patient No case of Thromboembolism No case of Bleeding 1 case of Bacterial Endocarditis- Department of Cardiovascular Surgery Santa Casa de Curitiba- PUCPR

37 Max Gradient (mmhg Decellularized Ao Valve Allografts Late Gradients Time (months)

38 Decellularized Aortic Valve Allografts Aortic Regurgitation None Trivial Mild Moderate Severe Time (months)

39 Decellularized Aortic Valve Allografts Freedom from Moderate AR Freedom from disfunction Events 1 due to healed bacterial endocarditis 1 due to cusp prolapse (96) (30) (17) (17) (13) (14) (15) (4) Time (Years) 94%

40 Decellularized Aortic Valve Allografts Reoperations(n=3) AR due to Healed Bacterial Endocarditis 1 Primary Cusp Prolapse *..1 Patient Outgrowth...1 * Patient reoperated elsewhere no echo available surgeon report only

41 Decellularized Aortic Valve Allografts Freedom From Reoperation On The Allograft Freedom from Reoperation (70) (62) (52) (43) (31) (17) (3) (1) 89% Time (Years)

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45 Explanted Aortic Allograft 8 years of Follow-up Aortic Wall Íntima Well preserved aortic wall Elastic fibers intact in vivo repopulation Endothelization Minimal Intimal Hyperplasia

46 Cusp B Ventricularis Free Margin Cusp Insertion A A Fibrosa B

47 Escore de Cálcio (A) 1000 Decellularized Ao Allografts -Calcium Scores Tempo (meses)

48 Decellularized Ao Valve Allografts CT Scan Evaluation Calcium Scores Absent or Minimal Calcification on cusps and conduits up to 10 years of follow-up!!!!!

49 Decellularized Ao Valve Allografts CT Scan Evaluation Calcium Scores Dcell Ao Allograft 8 years of follow-up

50 Pulmonary + Ao Dcell Allografts CT scan at 9 years of follow-up Dcell Ao Allograft Dcell Pulmonary Allograft

51 Decellularized Allografts for Pediatric Patients under 12 Years of Age with Complex Congenital Heart Disease On going study (140 patients) Multi-Institutional (Curitiba, São Paulo and Recife) Preliminary Results have shown excellent hemodynamics, no calcification and no reoperations up to 9 years in the Curitiba group!!!!

52 Decellularized Pulmonary Allograft for correction of Tetralogy of Fallot. Patient operated at the age of 10 years. Control CT scan at 6 years of follow-up. Decellularized Allografts for Pediatric Patients under 12 Years of Age with Complex Congenital Heart Disease Preliminary Results

53 Decellularized Allografts for Pediatric Patients under 12 Years of Age with Complex Congenital Heart Disease Preliminary Results Patient received a decellularized allograft with the age of 1 year. Control CT scan at 8 years of follow-up. No retraction, no calcification.

54 Decellularized Allografts for Pediatric Patients under 12 Years of Age with Complex Congenital Heart Disease Preliminary Results Dcell Allograft Surgical correction of Single Ventricle at the age of 2 years. Control CT scan at 6 years of follow-up.gore-tex intra-atrial baffle with signs of calcification. Dcell Allograft used for Cavo-Pulmonary connection with minimal calcification.

55 Conclusions Decellularized Allografts have shown very promising results up to 10 years of follow-up. They are well incorporated to the host, with minimal inflammation and negligible immune reaction. They do not retract in the pulmonary circulation and do not dilate in the systemic side. Occasional biopsies have demonstrated partial repopulation of these grafts and minimal or absent calcification, even in children under the age of 12 years. These data demonstrate that decellularized allografts have, at least up to 10 years, better performance than conventional cryopreserved allografts and they are currently our graft of choice for patients at any age.

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