TAVI Versus Suturless Valve In Intermediate Risk Patients

Transcription

1 TAVI Versus Suturless Valve In Intermediate Risk Patients Walid Abukhudair FRCSc President of Saudi Society for Cardiac Surgeons Head of Cardiac Surgery in KFAFH

2 Background AS is the most frequent cardiac valve pathology in the western world, with a prevalence of 3% for individuals over the age of 75 years

3 Advances in AVR

4 Background TAVI started as a new therapy for patients with severe aortic stenosis who are not candidates for surgery or who are at high risk for complications due to surgery.3

5 What about intermediate risk patients

6 First Who is Considered an intermediate risk patients

7 Risk scores

8 EUROSCORE In Europe, based on all cardiac operations 12 covariates for mortality Additive Logistic LES

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10 EuroSCORE II Core risk factors are the same Definitions more precise Low risk <4%; Intermediate 4-9%; High risk >9%

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12 STS SCORE Started in 1986 in response to public reporting of outcomes of cardiac surgery 24 covariates for mortality Low is < 4, Intermediate is 4-8, High > 8% Specific of AVR

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14 Ratio of observed/expected mortality Wendt et al Comparison Between Different Risk Scoring Algorithms on Isolated Conventional or Transcatheter Aortic Valve Replacement Ann Thorac Surg 2014

15 Wendt et al Comparison Between Different Risk Scoring Algorithms on Isolated Conventional or Transcatheter Aortic Valve Replacement Ann Thorac Surg 2014

16 Relationship between predicted mortality (PROM) and observed mortality VASSILEVA et al Evaluation of The Society of Thoracic Surgeons Online Risk Calculator for Assessment of Risk in Patients Presenting for Aortic Valve Replacement After Prior Ann Thorac Surg 2015

17 Is the intermediate Risk score patients are truly intermediate risk looking at the mean predicted risk in the surgical arm of SURTVI 4.5 % and the actual mortality is 1.7 %!! observed 30 days mortality 1.7 = = 0.3 expected 30 days mortality 4.5 Surgery wasn't as risky as we thought

18 Who is not Considered in the Risk Assessment Frailty Chest deformities Malnutrition Porcelain aorta Liver Disease Radiotherapy

19 Risk score Is there an alternative Heart Team

20 Evidence for TAVI In Intermediate Risk

21 2017 ESC/EACTS Guidelines for the management of valvular heart disease

22 2017 ESC/EACTS Guidelines for the management of valvular heart disease Clinical characteristic SAVR TAVR STS /euroscore < 4 % + STS /euroscore =/>4 % + presence of severe comorbidity + Age <75 + Age =/>75 + prior cardiac surgery + Frailty + Restricted mobility + suspicion of Endocarditis +

23 2017 ESC/EACTS Guidelines for the management of valvular heart disease Anatomical and technical aspects SAVR TAVR Favourable access for transferral TAVR + Unfavourable access for TAVR + Sequel of chest radiation + Porcelain aorta + Presence of intact grafts + expected PPM + Severe Chest deformity + Short distance between coronary ostia and annulus Size of annulus out of range of TAVI + Aortic root morphology unfavourable for TAVI Unsuitable Valve morphology for TAVI + LV or Aorta thrombi + + +

24 2017 ESC/EACTS Guidelines for the management of valvular heart disease Cardiac condition in addition to AS SAVR TAVR Severe CAD Require revascularization + Severe surgical Mitral disease + Severe tricuspid valve disease + Aneurysm of the ascending aorta + Septal hypertrophy requiring myoctomy +

25 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease

26 Suturless Aortic valve Sutureless and rapid deployment aortic valves are biological, pericardial prostheses that anchor within the aortic annulus with no more than three sutures

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28 Suturless Aortic valve Intuity (Edwards Lifesciences, Irvine, USA Based on a balloon-expandable stainless steel and cloth-covered frame. Three sutures are required in the case of the Edwards Intuity valve. Eusanio et al Sutureless aortic valve replacement Annals of cardiothoracic surgery, 2015

29 Suturless Aortic valve Perceval S (Sorin, Saluggia, Italy) It utilizes the memory of the nitinol metal frame, which deploys and positions the valve with No sutures required Eusanio et al Sutureless aortic valve replacement Annals of cardiothoracic surgery, 2015

30 Differences Between SUAVR and TAVI Require surgical incisions full median sternotomy incision or alternatively minimally invasive incisions Need for CPB Aortic cross-clamping. Diseased valve is excised. Do not require extensive placement and tying of sutures. Eusanio et al Sutureless aortic valve replacement Annals of cardiothoracic surgery, 2015

31 Conventional AVR Procedure Analysis Langhammer et al Swiss Med Wkly. 2017

32 Advantages of SUAVR Over TAVI It does not require crimping of the pericardial leaflet. Direct visualization of the implantation and target orifice location Excision of the diseased calcified aortic valve Eusanio et al Sutureless aortic valve replacement Annals of cardiothoracic surgery, 2015

33 Bourget et al Correlation between structural changes and acute thrombogenicity in transcatheter pericardium valves after crimping and balloon deployment. Morphologie 2017 Alavi et al The Effects of Transcatheter Valve Crimping on Pericardial Leaflets Ann Thorac Surg 2014

34 Conclusion Significant tissue damage was observed at the surface layers of the leaflets. In the deeper tissue layers, damage was substantial for 14F crimping, it became less significant but still visible for larger collapse profiles. Crimping may induce substantial structural damage to pericardial leaflets that does not improve with time. Bourget et al Correlation between structural changes and acute thrombogenicity in transcatheter pericardium valves after crimping and balloon deployment. Morphologie 2017 Alavi et al The Effects of Transcatheter Valve Crimping on Pericardial Leaflets Ann Thorac Surg 2014

35 Athappan et al.incidence, Predictors, and Outcomes of Aortic regurgitation After Transcatheter Aortic Valve Replacement JACC Vol. 61, No. 15, 2013

36 The overall 1-year mortality Athappan et al.incidence, Predictors, and Outcomes of Aortic regurgitation After Transcatheter Aortic Valve Replacement JACC Vol. 61, No. 15, 2013

37 Conclusion Moderate or severe aortic regurgitation is common after TAVR and an adverse prognostic indicator of short- and long-term survival. Athappan et al.incidence, Predictors, and Outcomes of Aortic regurgitation After Transcatheter Aortic Valve Replacement JACC Vol. 61, No. 15, 2013

38 Retrospective Multicenter analysis propensity score-matched analysis resulted in 144 pairs Biancari et al Immediate outcome after sutureless versus transcatheter aortic valve replacement Heart vessel 2015

39 Biancari et al Immediate outcome after sutureless versus transcatheter aortic valve replacement Heart vessel 2015

40 Immediate Results Biancari et al Immediate outcome after sutureless versus transcatheter aortic valve replacement Heart vessel 2015

41 Conclusion The use of sutureless bioprosthesis is associated with a rather low incidence of significant PVL and excellent immediate postoperative survival. SU-AVR is a valid alternative to TAVI in intermediate- risk patients. Biancari et al Immediate outcome after sutureless versus transcatheter aortic valve replacement Heart vessel 2015

42 all comers,7 centres, retrospective 991 Pt isolated severe AS STS >4 and log Euroscore >10 propensity score analysis SAVR (n 204), SUVAR (n 204), and TAVI(n 204). Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

43 1ry end points were 30-day mortality and overall survival at 24-month 2ry end point was survival free from a composite end point MACCE and periprosthetic regurgitation greater than 2. Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

44 Study Population Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

45 Duration of CPB time and aortic cross-clamp time was significantly shorter in SUAVR compared with SAVR. Intensive care unit stay and paravalvular leak also was significantly higher in TAVI Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

46 Comparing between SUVAR & TAVI no difference in mortality, bleeding and stroke. RF, need for dialysis and peripheral complication was significantly higher in TAVI gp. Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

47 Kaplan Meier analysis at 12- and 24-month follow-ups demonstrated that overall survival was significantly better in SAVR & SUVR compared with the TAVR group Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

48 Conclusion In intermediate- risk profile patients the use of TAVR significantly increased early and late morbidity and mortality when compared with standard or sutureless AVR; moreover, the use of TAVR was identified as an independent predictor for all-cause mortality. Muneretto et al A comparison of conventional surgery, transcatheter aortic valve replacement, and sutureless valves in real-world patients wit

49 6 comparative studies using propensity score. 731 patients(suavr) and 731 patients underwent a (TAVI). Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

50 Patients Characteristics Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

51 Results Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

52 Postoperative mortality Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

53 Postoperative stroke Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

54 Postoperative aortic regurgitation Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

55 1 year mortality and 2 years mortality Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

56 Conclusion Surgical aortic valve replacement using sutureless valves is associated with better early and mid-term outcomes com- pared with TAVI in high or intermediate-risk patients. Sutureless aortic valve replacement versus transcatheter aortic valve implantation: a meta-analysis of comparative matched studies using propensity score matching Interactive CardioVascular and Thoracic Surgery (2017) 1 8

57 Retrospective Heart team (TAVI 364 vs SUR-AVR 262) Propensity matched 102 pairs Santarpino et aclinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis

58 Patient characteristics after matching Santarpino et aclinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis

59 Results Paravalvular leakage occurred more frequently in patients from the TAVI group p <0.001 with an impact on follow-up survival rate. Santarpino et aclinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis

60 Results Although OR and hospital stay costs were significantly higher in SU-AVR the total costs in TAVI gp was significantly higher Santarpino et aclinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis

61 Conclusion Patients in the gray zone record a satisfying clinical outcome after sutureless surgery and TAVI. On the costs aspects, TAVI technologies are more expensive, and it reflects on higher overall hospital costs. Santarpino et aclinical Outcome and Cost Analysis of Sutureless Versus Transcatheter Aortic Valve Implantation With Propensity Score Matching Analysis

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64 Our Team has an experience of 15 cases RDAVR

65 RDAVR via MICS Via Upper sternotomy

66 Patients can fall in three category if we assumed its a true intermediate risk patient Intermediate surgical risk High TAVI risk Intermediate TAVI risk Low TAVI risk Surgery surgery/ta VI TAVI

67 Conclusion A randomised trial should be done to compare both technique we should be able to define the population that will benefit from each approach A heart team approach is the mainstay at the time being

68 Thanks

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