TAVI Versus Suturless Valve In Intermediate Risk Patients

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

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

Advances in AVR

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

What about intermediate risk patients

First Who is Considered an intermediate risk patients

Risk scores

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

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

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

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

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

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

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

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

Risk score Is there an alternative Heart Team

Evidence for TAVI In Intermediate Risk

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

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 +

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 + + +

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 +

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Our Team has an experience of 15 cases RDAVR

RDAVR via MICS Via Upper sternotomy

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

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

Thanks wabukhudair@hotmail.com