Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis
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1 Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III On Behalf of the CoreValve US Clinical Investigators
2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Proctor/consultant Proctor/consultant Company Medtronic Edwards Under direction from Dr. Zorn, Medtronic performed all statistical analyses and assisted in the graphical display of the data. 2
3 Background Severe prosthesis-patient mismatch (PPM) after surgical aortic valve replacement (SAVR) is associated with higher mortality but the association of PPM with transcatheter aortic valve replacement (TAVR) outcomes is unclear PPM has been associated with less LV mass regression at 1 year in SAVR and TAVR patients TAVR may provide an option to reduce PPM and associated clinical events in patients undergoing aortic valve replacement Pibarot P, et al. J Am Coll Cardiol
4 Study Device and Access Routes 4 Valve Sizes (23, 26, 29, 31 mm) (18-29 mm Annular Range) 18F Delivery System Transfemoral Subclavian Direct Aortic 4
5 Objective To compare the incidence of PPM between TAVR using a self-expanding prosthesis and SAVR in the CoreValve US High Risk Pivotal Trial To determine the impact of PPM after aortic valve replacement on clinical outcomes 5
6 Methods Patients with symptomatic severe aortic stenosis at increased risk for surgery were randomized 1:1 to TAVR or SAVR in the CoreValve US High Risk Trial Postoperative PPM was defined by the effective orifice area index (EOAi) Severe PPM was defined as EOAi 0.65 cm 2 /m 2 Moderate PPM was 0.65 < EOAi 0.85 cm 2 /m 2 No PPM was EOAi > 0.85 cm 2 /m 2 This subgroup analysis compares outcomes at 1 year between severe PPM and no severe PPM (EOAi > 0.65 cm 2 /m 2 ) in patients receiving TAVR or SAVR treatment 6
7 Clinical Demographics Characteristic Severe PPM (N=24) TAVR No severe PPM (N=343) P value Severe PPM (N=75) SAVR No severe PPM (N=259) P value Age 81.5 (8.4) 83.1 (7.0) (7.0) 83.7 (6.1) Male 11 (45.8) 186 (54.2) (45.3) 140 (54.1) BMI 31.9 (7.5) 27.8 (6.0) (7.9) 28.0 (5.8) NYHA Class III/IV 22 (91.7) 292 (85.1) (89.3) 223 (86.1) STS Score (Risk of Mortality, %) 7.3 (2.9) 7.2 (2.9) (2.9) 7.5 (3.4) Diabetes mellitus 11 (45.8) 121 (35.3) (57.3) 111 (42.9) Coronary artery disease 17 (70.8) 262 (76.4) (77.3) 195 (75.3) Prior stroke 2 (8.3) 43 (12.5) (13.3) 39 (15.1) Prior CABG 6 (25.0) 105 (30.6) (34.7) 76 (29.3) Prior PCI 6 (25.0) 118 (34.4) (42.7) 97 (37.5) Home oxygen 7 (29.2) 40 (11.7) (12.0) 28 (10.8)
8 Baseline Echocardiographic Findings Characteristic Severe PPM (N=24) TAVR No severe PPM (N=343) P value Severe PPM (N=75) SAVR No severe PPM (N=259) P value EOAI, cm 2 /m (0.07) 0.40 (0.12) ) 0.41 (0.12) Aortic Annulus Diameter, cm 2.07 (0.16) 2.23 (0.21) (0.22) 2.19 (0.21) Doppler Stroke Volume, ml (16.92) (23.93) (18.06) (20.39) LV Mass, gm (60.41) (71.69) (67.42) (63.52) LV Mass Index (gm/m 2 ) (30.64) (35.50) (33.99) (33.43) Ejection Fraction, % (12.25) (11.25) (13.04) (11.44) Moderate MR (%) 5 (20.8) 31 (9.2) (13.5) 26 (10.4)
9 Prosthesis-Patient Mismatch Severe PPM occurs significantly more after SAVR than TAVR 9
10 EOA index: Change from Baseline to 1 Year TAVR SAVR AATS 2015 P-value for change from baseline to 1-Year < for all 10
11 Change in Echocardiographic Findings from Baseline to 1 Year Characteristic Severe PPM TAVR SAVR No severe PPM P value Severe PPM No severe PPM P value AV Peak Velocity (m/s) n=19 n = 270 n = 47 n = 174 Baseline 4.64 (0.63) 4.38 (0.56) (0.55) 4.34 (0.58) Year 2.25 (0.38) 2.01 (0.38) (0.60) 2.22 (0.55) < Mean Gradient, mmhg n=19 n = 270 n = 47 n = 174 Baseline (15.84) (13.50) (16.41) (13.69) Year (3.92) 8.92 (3.41) (7.74) (6.93) < Severe PPM patients had a higher peak velocity and mean gradient than no severe PPM patients in both TAVR and SAVR groups 11
12 LV Mass Regression % at 1 Year 12
13 Moderate/Severe AR does not impact LV mass regression P= P= TAVR LV Mass Index (gm/m 2 13
14 Clinical Outcomes to 1 Year Characteristic All-Cause Mortality or Major Stroke Severe PPM (N=24) TAVR SAVR Overall No severe PPM (N=343) P value Severe PPM (N=75) No severe PPM (N=259) P value Severe PPM (N=99) No severe PPM (N=602) P value 16.9% 12.3% % 17.6% % 14.6% * All-Cause Mortality 16.9% 10.0% % 14.5% % 12.0% * Cardiovascular 9.1% 7.4% % 9.2% % 8.2% All Stroke 0.0% 8.3% % 12.6% % 10.1% Major stroke 0.0% 5.3% % 6.1% % 5.7% MI 0.0% 1.8% % 1.6% % 1.7% Reintervention 0.0% 1.5% % 0.0% NA 0.0% 0.9% Life Threatening or Disabling bleeding Major Vascular Complication 26.5% 13.5% % 38.5% % 24.3% % 6.1% % 1.5% % 4.2% Valve Thrombosis 0.0% 0.0% NA 0.0% 0.0% NA 0.0% 0.0% NA Acute Kidney Injury 12.5% 5.5% % 12.4% % 8.5% * PPM was defined as severe PPM when the EOAi is 0.65 cm2/m2; No Severe PPM was defined as EOAi >0.65 cm2/m2. *adjusted P= for all-cause mortality or major stroke ; adjusted P= for all-cause mortality; adjusted P= for acute kidney injury 14
15 All-Cause Mortality, % 1-Year All-Cause Mortality: SAVR Log-rank P= No. at Risk Months Post Procedure Severe PPM No severe PPM
16 All-Cause Mortality, % 1-Year All-Cause Mortality: TAVR Log-rank P= No. at Risk Months Post Procedure Severe PPM No severe PPM
17 All-Cause Mortality, % All-Cause Mortality: TAVR+SAVR Log-rank P= No. at Risk Months Post Procedure Severe PPM No severe PPM
18 Conclusions In this randomized controlled trial of TAVR vs SAVR in the treatment of aortic stenosis in a high risk population: PPM is more common with SAVR than TAVR PPM did not appear to influence LV mass regression within each treatment group but LV mass regression was notably less in the TAVR vs the SAVR group Patients with severe PPM have a higher rate of all-cause mortality and acute kidney injury than patients without severe PPM 18
19 Limitations Follow-up is only to 12 months and longer-term followup will provide further value There were too few patients with severe PPM in the TAVR treatment group to allow meaningful comparisons of some clinical and echo outcomes. 19
20 THANK YOU to all the CoreValve Investigators!
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