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Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III.

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Presentation on theme: "Prosthesis-Patient Mismatch in High Risk Patients with Severe Aortic Stenosis in a Randomized Trial of a Self-Expanding Prosthesis George L. Zorn, III."— Presentation transcript:

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 Under direction from Dr. Zorn, Medtronic performed all statistical analyses and assisted in the graphical display of the data. 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 RelationshipCompany 2 AATS 2015 Proctor/consultantMedtronic Proctor/consultant Edwards

3 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 Background Pibarot P, et al. J Am Coll Cardiol. 2014 3 AATS 2015

4 18F Delivery System 4 Valve Sizes (23, 26, 29, 31 mm) (18-29 mm Annular Range) Transfemoral Subclavian Direct Aortic Study Device and Access Routes 4 AATS 2015

5 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 Objective 5 AATS 2015

6 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 Methods 6 AATS 2015

7 TAVRSAVR Characteristic Severe PPM (N=24) No severe PPM (N=343)P value Severe PPM (N=75) No severe PPM (N=259)P value Age81.5 (8.4)83.1 (7.0)0.275682.1 (7.0)83.7 (6.1)0.0531 Male11 (45.8)186 (54.2)0.425334 (45.3)140 (54.1)0.1831 BMI31.9 (7.5)27.8 (6.0)0.001630.4 (7.9)28.0 (5.8)0.0134 NYHA Class III/IV22 (91.7)292 (85.1)0.551767 (89.3)223 (86.1)0.4660 STS Score (Risk of Mortality, %) 7.3 (2.9)7.2 (2.9)0.83687.6 (2.9)7.5 (3.4)0.7779 Diabetes mellitus11 (45.8)121 (35.3)0.297543 (57.3)111 (42.9)0.0268 Coronary artery disease 17 (70.8)262 (76.4)0.538058 (77.3)195 (75.3)0.7161 Prior stroke 2 (8.3)43 (12.5)0.752410 (13.3)39 (15.1)0.7012 Prior CABG6 (25.0)105 (30.6)0.562826 (34.7)76 (29.3)0.3781 Prior PCI6 (25.0)118 (34.4)0.346532 (42.7)97 (37.5)0.4140 Home oxygen7 (29.2)40 (11.7)0.01349 (12.0)28 (10.8)0.7726 Clinical Demographics 7 AATS 2015

8 TAVRSAVR Characteristic Severe PPM (N=24) No severe PPM (N=343)P value Severe PPM (N=75) No severe PPM (N=259)P value EOAI, cm 2 /m 2 0.32 (0.07)0.40 (0.12)0.00050.36 0.14)0.41 (0.12)0.0109 Aortic Annulus Diameter, cm 2.07 (0.16)2.23 (0.21)0.00062.14 (0.22)2.19 (0.21) 0.0676 Doppler Stroke Volume, mL69.60 (16.92)76.50 (23.93)0.205069.16 (18.06)77.45 (20.39)0.0025 LV Mass, gm226.45 (60.41)225.95 (71.69)0.9781243.18 (67.42)224.68 (63.52)0.0434 LV Mass Index (gm/m 2 )119.70 (30.64)122.29 (35.50)0.7744127.29 (33.99)123.10 (33.43)0.3790 Ejection Fraction, %56.04 (12.25)58.17 (11.25)0.373755.07 (13.04)58.30 (11.44)0.0380 ≥ Moderate MR (%)5 (20.8)31 (9.2)0.066110 (13.5)26 (10.4)0.4541 Baseline Echocardiographic Findings 8 AATS 2015

9 Prosthesis-Patient Mismatch Severe PPM occurs significantly more after SAVR than TAVR 9 AATS 2015

10 EOA index: Change from Baseline to 1 Year 10 AATS 2015 TAVRSAVR P-value for change from baseline to 1-Year < 0.001 for all

11 Change in Echocardiographic Findings from Baseline to 1 Year TAVRSAVR CharacteristicSevere PPM No severe PPMP valueSevere PPMNo severe PPMP value AV Peak Velocity (m/s)n=19n = 270 n = 47 n = 174 Baseline4.64 (0.63)4.38 (0.56)0.05324.47 (0.55)4.34 (0.58)0.1787 1 Year2.25 (0.38)2.01 (0.38)0.00822.68 (0.60)2.22 (0.55)< 0.0001 Mean Gradient, mmHgn=19n = 270 n = 47 n = 174 Baseline52.63 (15.84)47.74 (13.50)0.133250.13 (16.41)47.19 (13.69)0.2119 1 Year11.18 (3.92)8.92 (3.41)0.006016.41 (7.74)11.32 (6.93)< 0.0001 Severe PPM patients had a higher peak velocity and mean gradient than no severe PPM patients in both TAVR and SAVR groups 11 AATS 2015

12 LV Mass Regression % at 1 Year AATS 2015 12

13 Moderate/Severe AR does not impact LV mass regression TAVR LV Mass Index (gm/m 2 P=0.0048 P=0.1269 AATS 2015 13

14 Clinical Outcomes to 1 Year TAVRSAVROverall Characteristic Severe PPM (N=24) 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 All-Cause Mortality or Major Stroke 16.9%12.3%0.492725.9%17.6%0.109923.7%14.6%0.0188* All-Cause Mortality16.9%10.0%0.243621.8%14.5%0.135820.6%12.0%0.0145* Cardiovascular9.1%7.4%0.769612.5%9.2%0.388211.7%8.2%0.2326 All Stroke0.0%8.3%0.162311.1%12.6%0.81848.4%10.1%0.6756 Major stroke0.0%5.3%0.26636.9%6.1%0.73675.2%5.7%0.9284 MI0.0%1.8%0.52370.0%1.6%0.28490.0%1.7%0.2068 Reintervention0.0%1.5%0.57060.0% NA0.0%0.9%0.3863 Life Threatening or Disabling bleeding 26.5%13.5%0.112835.8%38.5%0.681733.6%24.3%0.0521 Major Vascular Complication 4.2%6.1%0.69932.7%1.5%0.51843.0%4.2%0.6004 Valve Thrombosis0.0% NA0.0% NA0.0% NA Acute Kidney Injury12.5%5.5%0.163321.3%12.4%0.047619.2%8.5%0.0008* 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=0.0860 for all-cause mortality or major stroke ; adjusted P=0.0666 for all-cause mortality; adjusted P=0.0230 for acute kidney injury AATS 2015 14

15 All-Cause Mortality, % Months Post Procedure No. at Risk Severe PPM 75 72 6356 No severe PPM 259 252 227212 Log-rank P=0.14 21.8 10.1 13.5 15 1-Year All-Cause Mortality: SAVR AATS 2015 14.5

16 All-Cause Mortality, % Months Post Procedure No. at Risk Severe PPM24232119 No severe PPM 343342326304 Log-rank P=0.24 16.9 4.4 12.5 1-Year All-Cause Mortality: TAVR 10.0 AATS 2015 16

17 All-Cause Mortality, % Months Post Procedure No. at Risk Severe PPM99958475 No severe PPM 602594553516 Log-rank P=0.01 20.6 6.9 13.3 All-Cause Mortality: TAVR+SAVR 12.0 AATS 2015 17

18 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 Conclusions AATS 2015 18

19 Follow-up is only to 12 months and longer-term follow- up 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. Limitations AATS 2015 19

20 THANK YOU to all the CoreValve Investigators!

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