Trans- catheter aortic valve replacement vs Trans- catheter aortic valve replacement vs. surgical aortic valve replacement in patients at intermediate-high risk: A meta- analysis M. Carnero Alcázar, M. Gª Bouza, B. Ramchandani, J. Cobiella, A. Alswies, F.Reguillo, L. Maroto. Madrid, Spain. www.cirugiadelcorazon.es

No Conflicts Of Interest

Background J Am Coll Cardiol. 2014;63:2438-88 Eur J Cardiothorac Surg. 2012 Oct;42(4):S1-44.

Background

Objectives To perform a meta-analysis to compare major adverse outcomes after TAVR or SAVR Primary events Secondary events Death * Major Stroke * Pacemaker Implantation * Acute Kidney Injury * Major or Life- Threatening Bleeding * Vascular Complications * Moderate or Severe Residual Aortic Regurgitation* Mean Trans-prosthetic Gradients *

Methods 2009- June 2016 Propensity score matched studies or clinical trials comparing TAVR and SAVR STS score above 4% or logistic EuroSCORE above  10% in both arms of treatment At least, 20 patients per arm Differences of STS score <1% score or EuroSCORE <5% between arms One of the following events Early events (30 days post procedure or in-hospital): mortality, major stroke, major or life-threatening bleeding, vascular complications, acute kidney injury or pacemaker implantation Late events (follow-up > 12 months): mortality or major stroke Haemodynamic findings: mean transprosthetic gradients or more than mild residual aortic regurgitation (RAR).

Methods Inverse variance-weighted averages of logarithmic ORs and RRs and mean of the gradients differences in random-effects models Heterogeneity was analysed by means of I2 (25% was mild, 50% moderate and 75% high) and Q test (p<0.10 was consistent with significant heterogeneity). Sensitivity analyses were performed Forest plots were used to illustrate the pooled estimates. Terms: ("sutureless" or "SAVR" or "surgical aortic valve replacement" or “SuAVR”) and (“TAVI” or “TAVR” or "transcatheter aortic valve replacement" or “transcatheter aortic valve implantation” or "trans- catheter aortic valve replacement" or “trans- catheter aortic valve implantation” or "transfemoral aortic valve replacement" or "transfemoral aortic valve implantation" or “trans- femoral aortic valve replacement” or “trans- femoral aortic valve implantation” or "transapical aortic valve implantation” or "transapical aortic valve replacement” or “trans- apical aortic valve implantation“ or “trans- apical aortic valve replacement” or “trans- aortic valve implantation” or “transaortic valve implantation” or “trans- aortic valve replacement” or “transaortic valve replacement” or “trans- subclavian aortic valve replacement” or “trans- subclavian aortic valve implantation” or “transsubclavian aortic valve replacement” or “transsubclavian aortic valve implantation”)

Results n= 20 224

Results OR 1.11 (0.89-1.39) Early Mortality RCT OR 0.8 (0.58-1.11) PSM n= 5 (3838), I2 = 0% OR 0.8 (0.58-1.11) Early Mortality PSM n= 35 (15766), I2 = 0% OR 1.19 (0.93-1.53) OVERALL n= 40 (19 694), I2 = 0% OR 1.11 (0.89-1.39)

Results OR 0.91 (0.78-1.05) Late Mortality RCT OR 0.93 (0.84-1.04) PSM n= 4 (3757), I2 = 0% OR 0.93 (0.84-1.04) Late Mortality PSM n= 13 (6368), I2 = 0% OR 0.91 (0.7-1.19) OVERALL n= 17 (10 125), I2 = 0% OR 0.91 (0.78-1.05)

Results OR 0.97 (0.75-1.25) Early Stroke RCT OR 1.01 (0.65-1.56) PSM n= 5 (3828), I2 = 0% OR 1.01 (0.65-1.56) PSM Early Stroke n= 26 (13352), I2 = 0% OR 0.96 (0.69-1.33) OVERALL n= 31 (17180), I2 = 0% OR 0.97 (0.75-1.25)

Results OR 0.78 (0.56-1.07) Late Stroke RCT OR 1.01 (0.65-1.56) PSM n= 4 (3827), I2 = 0% OR 1.01 (0.65-1.56) PSM Late Stroke n= 6 (4469), I2 = 0% OR 0.66 (0.36-1.21) OVERALL n= 10 (8226), I2 = 0% OR 0.78 (0.56-1.07)

Vascular Complications Mean Difference Mean Gradient (mmHg) Major or LT Bleeding n=21 (11 073) OR 0.42 (0.25-0.69) Results n=19 (9 643) OR 0.51 (0.35-0.74) AKI n=28 (14 655) OR 2.31 (1.73-3.08) Pacemaker Vascular Complications n=17 (12 570) OR 4.88 (2.84-8.39) Moderate or Severe RAR n=22 (9 290) OR 6.83 (4.87-9.6) Mean Difference Mean Gradient (mmHg) n=17 (8 630) MD -2.4 (-3.27—-1.5)

Results x OR RR OR RR OR OR OR OR OR MD Favors TAVR Favors SAVR Subgroup Early Mortality Late Mortality Early Stroke Late Stroke Major Bleeding AKI PM Vas Compl. RAR Mean Difference RCT PSM studies Inter Risk High Risk SuAVR Antegrade Retrograde Balloon Expandable Expandable x OR (95% CI) RR (95% CI) OR (95% CI) RR (95% CI) OR (95% CI) OR (95% CI) OR (95% CI) OR (95% CI) OR (95% CI) MD (95% CI) Favors TAVR Favors SAVR

Conclusions Among patients with moderate or high surgical risk… TAVR and SAVR have similar short and long-term all-cause mortality and risk of stroke. TAVR is superior to SAVR for major bleeding, acute kidney injury and hemodynamic performance. SAVR reduces the risk of vascular complications, need for pacemaker and residual aortic regurgitation. These conclusions remain mostly unchanged in subgroup analysis. Limitations Some major events were not analyzed (AFib, endocarditis…) Limited data on durability of prostheses… 3. Comparison of RAR might be inaccurate as the assessment of RAR is highly dependent on the observer.

HEART TEAM

Results

Background

Results Early Mortality Early Stroke Late Mortality Late Stroke n= 40 (19 694) Early Mortality Early Stroke RR 0.91 (0.78-1.05) n= 17 (8 093) OR 0.97 (0.75-1.25) n= 31 (15 375) Late Mortality Late Stroke n= 10 (8 093) RR 0.78 (0.56-1.07)