-The Living Aortic Valve- Repair or Else? Ismail El-Hamamsy, MD PhD

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1 -The Living Aortic Valve- Repair or Else? Ismail El-Hamamsy, MD PhD Associate Professor Director, Aortic Surgery Division of Cardiac Surgery Montreal Heart Institute Université de Montreal

2 PhD Thesis Imperial College London (2010)

3 -1- THE AORTIC ROOT IS A LIVING STRUCTURE

4 Dagum et al. Circulation 1999 AORTIC ROOT PHYSIOLOGY

5 AORTIC VALVE Endothelial Cells Aortic Side Collagen Interstitial Cells -Smooth muscle cells -Fibroblasts -Myofibroblasts GAGs Elastin Smooth muscle actin Ventricular Side El-Hamamsy et al. J Adv Res 2009

6 AORTIC VALVE Neurofilament El-Hamamsy et al. Curr Vasc Pharmacol 2009

7 El-Hamamsy et al. JACC 2009 AORTIC VALVE

8 THE AORTIC ROOT LIVING STRUCTURE = COMPLEX FUNCTIONS Laminar flow Excellent hemodynamics Resistance to infections Low thrombogenicity

9 OUTCOMES FOLLOWING AVR Laminar Flow Thrombogenicity Survival Valve-related complications Quality of life Hemodynamics (gradients) Resistance to infections

10 Rationale A LIVING AORTIC VALVE SUBSTITUTE IMPROVED CLINICALLY-RELEVANT OUTCOMES

11 NON-ELDERLY ADULTS High level of physical activity Quality of life Prolonged anticipated life expectancy = Exposure to valve-related complications Degeneration + Reoperation (tissue valves) Bleeding + Thromboembolisms (mechanical valves)

12 -2- CONVENTIONAL AVR IN THE YOUNG = EXCESS MORTALITY

13 CONVENTIONAL AVR SEVERAL ADVANTAGES Standardized Easily reproducible Short operative times Long-term data

14 AVR IN THE YOUNG Excess Mortality Kvidal et al. JACC 2000

15 AVR IN THE YOUNG The younger the patients are, The higher excess mortality is Kvidal et al. JACC 2000

16 MECHANICAL AVR IN THE YOUNG Bouhout et al Acquir ed Car diovascular Disea L ong-ter m outcomes after elective isolated mechanical aor tic valve r eplacement in young adults Ismail Bouhout, MSc, a Louis-Mathieu Stevens, MD, PhD, b Amine Mazine, MSc, a Nancy Poirier, MD, a Raymond Cartier, MD, a Philippe Demers, MD, a and Ismail El-Hamamsy, MD, PhD a : 469 isolated mechanical AVR <65 years Obj ectives: The aim of this study was to determine long-term survival and clinical outcomes after elective isolated mechanical aortic valve replacement in young adults. M ethods: A clinical observational study was conducted in a cohort of 450 consecutive adults less than 65 years of agewho had undergone electiveisolated mechanical aortic valvereplacement (AVR) between 1997 and Patients who had undergone previous cardiac surgery, and those undergoing concomitant procedures or urgent surgerymean were excluded. follow-up: 9.1 ± 3.5 Follow-up was 93.3% completewith a mean follow-up of years. The primary end point was survival. Life table analyses were used to determine age- and gender-matched general population survival. Secondary end points were reoperation and valve-related complications. Exclusion: concomittant procedures, coronary disease, reoperations, emergencies (dissection), Follow-up 95% active complete endocarditis (4099 patient-years) Results: Overall actuarial survival at 1, 5, and 10 years was 98% 1%, 95% 1%, and 87% 1%, respectively, which was lower than expected in the age- and gender-matched general population in Quebec. Actuarial freedom from prosthetic valve dysfunction was 99% 0.4%, 95% 1%, and 91% 1% at 1, 5, and 10 years, respectively. Actuarial freedom from valve reintervention was 98% 1%, 96% 1%, and 94% 1% at 1, 5 and 10 years, respectively. Actuarial survival free from reoperation at 10 years was 82% 2%. Actuarial freedom from major hemorrhage was 98% 1%, 96% 1%, and 90% 2% at 1, 5, and 10 years, respectively. Mean age: 53.2 ± 9.2 Conclusions: In young adults undergoing elective isolated mechanical AVR, survival remains suboptimal Bouhout compared et al. JTCVS with an2014 age- and gender-matched general population. Furthermore, there is a low but constant hazard of prosthetic valve reintervention after mechanical AVR. (J Thorac Cardiovasc Surg 2013;- :1-6)

17 SURVIVAL MECHANICAL AVR 87% 78% Bouhout et al. JTCVS 2014

18 SURVIVAL FREE FROM REOPERATION 82% A 10 years, 1 in 5 patients is dead or reoperated Bouhout et al. JTCVS 2014

19 Valve-Related Complications

20 Puskas et al. JTCVS 2014 PROACT Trial (n=375 pts)

21 TISSUE AVR IN THE YOUNG 3,049 Perimount patients; younger patients had worse than expected survival that was further diminished with insertion of a small prosthesis. Mihajlevic et al. JTCVS 2008

22 TISSUE AVR IN THE YOUNG 2,659 Perimount patients; Bourguignon et al. Ann Thorac Surg 2015

23 Excess Mortality in Young Adults -20 yrs -8 yrs Bourguignon et al. Ann Thorac Surg 2015

24 SVD and Death = Competing Risks SVD Survival Bourguignon et al. Eur J Cardiothorac Surg 2016

25 AVR IN THE YOUNG 9,942 isolated AVR <65 years; Goldstone et al. NEJM 2017

26 AVR IN THE YOUNG 15-Year Mortality: 26-30% 15-Year Mortality: 32-36% Goldstone et al. NEJM 2017

27 CONVENTIONAL AVR IN THE YOUNG CURATIVE PALLIATIVE

28 EXCESS MORTALITY IS OBSERVED UP TO 60 YEARS OF AGE AT THE TIME OF SURGERY

29 A LIVING AORTIC VALVE = IMPROVED OUTCOMES?

30 -3- ROSS PROCEDURE = IMPROVED CLINICAL OUTCOMES

31 Historical Perspective

32 Surgical Forum 1965 Historical Perspective

33 ROSS PROCEDURE THE ONLY REPLACEMENT OPERATION THAT GUARANTEES LONG-TERM VIABILITY OF THE AORTIC VALVE/ROOT

34 Negative Biases Transforms single valve disease into double valve disease High operative morbidity and mortality High rate of reoperations

35 SURVIVAL

36 El-Hamamsy et al. Lancet 2010 SURVIVAL - ROSS

37 SURVIVAL - ROSS ROSS GENERAL POPULATION El-Hamamsy et al. Lancet 2010

38 SURVIVAL - ROSS pts 34 +/- 9 years Mean Fup: 10.1 yrs David et al. JTCVS 2010

39 SURVIVAL - ROSS pts 34 +/- 9 years Median Fup: 13.8 years David et al. JTCVS 2014

40 SURVIVAL pts (8 centers) 45+/- 11 years Mean Fup: 8.3 years (662 pts >10 years) Sievers et al. Eur J Cardiothor Surg 2015

41 SURVIVAL pts 42+/- 9 years Median Fup: 10.6 years Mastrobuoni, EJCTS 2015

42 Survival Free from Reoperation UK National Registry patients Survival free from reoperation ROSS MECH TISSUE Sharabiani et al. JACC 2016

43 Ross vs. Mechanical AVR Ross Mechanical Mazine et al. Circulation 2016

44 Ross vs. Mechanical AVR Ross cases Propensity-matched: 275 pairs 43 +/- 11 years Burratto et al. JACC 2018

45 LATE SURVIVAL - ROSS >3600 pts

46 Survival - Ross 5,031 adults, children; Late mortality rates are low and resemble the adult series age-matched population mortality. Takkenberg et al. Circulation 2009

47 Mazine et al. JAMA Cardiol 2018 SURVIVAL

48 THE ROSS PROCEDURE THE ONLY REPLACEMENT OPERATION THAT RESTORES LONG-TERM SURVIVAL FOLLOWING AORTIC VALVE REPLACEMENT

49 WHAT ABOUT THE ROSS IN PATIENTS WITH Ao REGURGITATION AND A DILATED ANNULUS?

50 ACHILLE S HEEL? Reoperation Operative Risk

51 Klieverik et al. Eur Heart J 2007 Autograft Reoperation

52 Ross and AI

53 Ross and AI

54 Ross and AI

55 ROSS PROCEDURE

56 David TE. Circulation 2009

57

58 PARADIGM CHANGE ANTICOAGULATION VS. REOPERATION SURVIVAL + QUALITY OF LIFE

59 LATE SURVIVAL - ROSS

60 Autograft Reoperation

61 Autograft Reoperation TECHNIQUE MATTERS

62 Ross Technique Ann Thorac Surg 2018 MMCTS 2014

63 Tailored Approaches to AI Mazine, El-Hamamsy et al. JACC 2018 (in press)

64 Tailored Ross Technique Trimming of infudibular muscle below the valve Scalloping of the autograft

65 Pulmonary Autograft Trimming

66 Tailored Ross Technique Proximal suture line Place the autograft in an infra-annular position (inside the LVOT) Interrupted sutures Commissural Symmetry

67 Aortic vs Pulmonary Anatomy Wall Annulus Aortic Root Pulmonary Root

68 Tailored Ross Technique

69 Extra-Aortic Annuloplasty Extra-aortic ring annuloplasty is used if: AI or mixed AS/AI (with predominant AI) is the indication Annulus mismatch >2mm (Aortic > Pulmonary)

70 Basal Ring Extra-Aortic Annuloplasty

71 JTCVS 2017 EJCTS 2018

72 Annular reduction and Stabilization Basmadjian et al. JTCVS 2017 Lenoir et al. EJCTS 2018 (in press)

73 Aortic Annuloplasty

74 Aortic Annuloplasty

75 Aortic Annuloplasty

76 Aortic Annuloplasty

77 Aortic Annuloplasty

78 Aortic Annuloplasty

79 Aortic Annuloplasty

80 Tailored Ross Technique Distal Suture Line Short autograft above STJ (or coronary anastomosis) (max 2-3mm) Short interposition graft if ascending aorta 40mm Careful attention to commissural symmetry

81 Tailored Ross Technique Postoperative Management Strict BP control in the perioperative period (max sbp mmHg) Home BP monitoring 6 months (max sbp mmHg)

82 BP Remote Monitoring

83 Ross Procedure June 2017

84 Montreal Ross Program (N=356 patients) Jan-July

85 Montreal Aortic Program (N=611 patients) Ross Procedure N= 356 patients Valve-Sparing/Repair N= 255 patients

86 MONTREAL HEART INSTITUTE (N=356) patients: Mean age 42 yrs (16-67 yrs) 15% redos (N=53) 60% concomittant procedures (N=208) 5% active endocarditis (N=17) Operative mortality: 0.6% (n=2)

87 MONTREAL HEART INSTITUTE (N=356) The first 100 patients Temporary dialysis (n=5) Reexploration for bleeding (n=4) Mortality (n=2) The last 256 patients Temporary dialysis (n=3): 1.2% Reexploration for bleeding (n=2): <1% Mortality (n=0): 0%

88 Montreal Ross Program : 281 consecutive Ross procedures with 1 year of follow-up (Mean age : 46 ± 7 years) 241 Ross procedures Exclusions: - Endocarditis (n=18) - Previous AVR (n=22) AR group (n=73) AS group (n=168) Mean Follow-up: 29 ± 11 months 100% complete for yearly clinical and echo follow-up Bouhout,,El-Hamamsy. EACTS 2018

89 Ross Procedure with Ring Annuloplasty Bouhout,,El-Hamamsy. EACTS 2018

90 El-Hamamsy et al. Lancet 2010 ANY Reoperation

91 Ross Reoperation (aortic/pulmonary) Mazine et al. Circulation 2016

92 Ross Reoperation N= 1779 adult patients ( ) 8 centers Mean follow-up 8.3 years Sievers et al. EJCTS 2015

93 Freedom from Reoperation 1%/patient-year reoperation range

94 Ann Transl Med, August 2017 JTCVS, September 2017 JACC, March 2018 JTCVS, September 2018

95 PARADIGM CHANGE ANTICOAGULATION VS. REOPERATION SURVIVAL + QUALITY OF LIFE

96 ICM SIMILAR OPERATIVE RISK RESTORED LATE SURVIVAL EXCELLENT QUALITY OF LIFE BETTER HEMODYNAMICS BETTER FREEDOM FROM VALVE-RELATED COMPLICATIONS

97 CONCLUSION YOUNG ADULTS = The choice of prosthesis has a direct impact on long-term prognosis CONVENTIONAL AVR IN THE YOUNG = Excess longterm mortality versus general population ROSS PROCEDURE = Improved long-term survival and quality of life in selected patients IN PATIENTS WITH NON-REPAIRABLE AI, a tailored Ross procedure = Improved durability

98

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