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STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic.

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Presentation on theme: "STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic."— Presentation transcript:

1 STS 2015 John V. Conte, MD Professor of Surgery Johns Hopkins University School of Medicine On Behalf of the CoreValve US Investigators Transcatheter Aortic Valve Replacement or Surgical Aortic Valve Replacement in Patients With Prior Coronary Artery Bypass Grafting CoreValve US Pivotal Trial

2 STS 2015 Transcatheter aortic valve replacement (TAVR) has had a major impact on how high risk patients with AS are treated TAVR has demonstrated morbidity and mortality advantages over SAVR in many patient cohorts In patients with prior CABG there is no consensus in the literature whether TAVR or SAVR offers a benefit Background Adams DJ, Popma JJ, Reardon MJ, et al. N Engl J Med 2014;370:1790-8. Greason KL, Verghese M, Suri RM, et al. Ann Thorac Surg 2014;98:1-7. Stortecky S, Brinks H, Wenaweser P, et al. Ann Thorac Surg 2011;92:1324-31 2

3 STS 2015 Subgroup analysis of patients in High Risk Arm of Corevalve Clinical Trial who had a prior CABG Analysis Goal: –To identify if there existed any morbidity or mortality benefits with TAVR vs. SAVR therapy Plan of Investigation 3

4 STS 2015 * Randomization stratified by intended access site Pivotal Trial Design 4

5 STS 2015 18Fr delivery system 4 valve sizes (18-29 mm annular range) Transfemoral Subclavian Direct Aortic Study Device and Access Routes 5

6 STS 2015 Subgroup Disposition Patients with Prior CABG 6

7 STS 2015 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Age, years 82.0 ± 5.881.0 ± 5.90.20 Men, % 79.178.40.89 STS Predicted Risk of Mortality, % 7.3 ± 2.78.0 ± 3.50.11 NYHA Class III/IV83.588.3 0.30 Body surface area, m 2 1.9 ± 0.2 0.54 History of hypertension 94.896.40.75 Peripheral vascular disease 41.651.80.13 Cerebrovascular disease 32.728.80.53 Diabetes mellitus 42.652.30.15 Insulin requiring diabetes 14.816.20.77 Prior stroke 17.416.20.81 Chronic lung disease/ COPD 41.738.70.65 STS severe chronic lung disease 4.36.30.51 Baseline Demographics 7

8 STS 2015 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Age, years 82.0 ± 5.881.0 ± 5.90.20 Men, % 79.178.40.89 STS Predicted Risk of Mortality, % 7.3 ± 2.78.0 ± 3.50.11 NYHA Class III/IV83.588.3 0.30 Body surface area, m 2 1.9 ± 0.2 0.54 History of hypertension 94.896.40.75 Peripheral vascular disease 41.651.80.13 Cerebrovascular disease 32.728.80.53 Diabetes mellitus 42.652.30.15 Insulin requiring diabetes 14.816.20.77 Prior stroke 17.416.20.81 Chronic lung disease/ COPD 41.738.70.65 STS severe chronic lung disease 4.36.30.51 Baseline Demographics 8

9 STS 2015 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Age, years 82.0 ± 5.881.0 ± 5.90.20 Men, % 79.178.40.89 STS Predicted Risk of Mortality, % 7.3 ± 2.78.0 ± 3.50.11 NYHA Class III/IV83.588.3 0.30 Body surface area, m 2 1.9 ± 0.2 0.54 History of hypertension 94.896.40.75 Peripheral vascular disease 41.651.80.13 Cerebrovascular disease 32.728.80.53 Diabetes mellitus 42.652.30.15 Insulin requiring diabetes 14.816.20.77 Prior stroke 17.416.20.81 Chronic lung disease/ COPD 41.738.70.65 STS severe chronic lung disease 4.36.30.51 9 Baseline Demographics

10 STS 2015 Cardiac History 10 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Years since CABG 12.6 ± 6.212.5 ± 6.00.93 Patients with LIMA grafts 87.080.20.17 Previous PCI 42.645.00.71 173.371.7 0.86 222.217.4 0.56 3 or more4.410.9 0.43 Total Previous Heart Surgeries 190.491.00.89 29.69.00.89 Mitral valve surgery 2.60.90.62 Balloon valvuloplasty 4.36.30.51 Pre-existing IPG/ICD 26.125.20.88

11 STS 2015 11 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Years since CABG 12.6 ± 6.212.5 ± 6.00.93 Patients with LIMA grafts 87.080.20.17 Previous PCI 42.645.00.71 173.371.7 0.86 222.217.4 0.56 3 or more4.410.9 0.43 Total Previous Heart Surgeries 190.491.00.89 29.69.00.89 Mitral valve surgery 2.60.90.62 Balloon valvuloplasty 4.36.30.51 Pre-existing IPG/ICD 26.125.20.88 Cardiac History

12 STS 2015 12 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Years since CABG 12.6 ± 6.212.5 ± 6.00.93 Patients with LIMA grafts 87.080.20.17 Previous PCI 42.645.00.71 173.371.7 0.86 222.217.4 0.56 3 or more4.410.9 0.43 Total Previous Heart Surgeries 190.491.00.89 29.69.00.89 Mitral valve surgery 2.60.90.62 Balloon valvuloplasty 4.36.30.51 Pre-existing IPG/ICD 26.125.20.88 Cardiac History

13 STS 2015 13 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Years since CABG 12.6 ± 6.212.5 ± 6.00.93 Patients with LIMA grafts 87.080.20.17 Previous PCI 42.645.00.71 173.371.7 0.86 222.217.4 0.56 3 or more4.410.9 0.43 Total Previous Heart Surgeries 190.491.00.89 29.69.00.89 Mitral valve surgery 2.60.90.62 Balloon valvuloplasty 4.36.30.51 Pre-existing IPG/ICD 26.125.20.88 Cardiac History

14 STS 2015 14 Characteristic, % or mean ± SD TAVR N=115 SAVR N=111P Value Years since CABG 12.6 ± 6.212.5 ± 6.00.93 Patients with LIMA grafts 87.080.20.17 Previous PCI 42.645.00.71 173.371.7 0.86 222.217.4 0.56 3 or more4.410.9 0.43 Total Previous Heart Surgeries 190.491.00.89 29.69.00.89 Mitral valve surgery 2.60.90.62 Balloon valvuloplasty 4.36.30.51 Pre-existing IPG/ICD 26.125.20.88 Cardiac History

15 STS 2015 Results

16 1-Year All-Cause Mortality Patients with Prior CABG 16

17 STS 2015 Outcomes with both therapies were excellent –SAVR O/E ratio 0.79 vs. STS PROM –TAVR O/E ratio 0.48 vs. STS PROM Prior to the beginning of the CoreValve US Pivotal Trial Heart Teams had no TAVR experience Clinical Results 17

18 STS 2015 Cox Multivariate Model created using baseline demographic, cardiac and procedural characteristics No single characteristic predictive of mortality Combinations of characteristics were tested Combination of Age >80 and STS PROM Score >7% was predictive of lower 1 year mortality (p=0.03) in TAVR pts Predictors of Mortality

19 STS 2015 Major Stroke Patients with Prior CABG 19

20 STS 2015 All-Cause Mortality or Major Stroke Patients with Prior CABG 20

21 STS 2015 MACCE Patients with Prior CABG 21

22 STS 2015 Index Procedural Events Procedural Events a TAVR N=115 SAVR N=111P Value Blood units transfused b 0.4 ± 1.12.8 ± 3.1 <0.001 ≥ 1 unit b 19.1%73.9% <0.001 ≥ 2 units b 11.3%63.1% <0.001 Procedure time, min 66.9 ± 43.2279.0 ± 95.5 <0.001 Time in ICU, hours 73.9 ± 70.7124.2 ± 174.4 0.006 Index LOS, days 7.3 ± 5.711.8 ± 12.7 <0.001 a Data presented as mean ± SD or percentages and log-rank P values. 22 b Within the first 24 hours post-procedure.

23 STS 2015 Other Outcomes 23 Events a 1 Month1 Year TAVRSAVRP ValueTAVRSAVRP Value Major vascular complications6.12.70.227.02.70.14 Pacemaker implant19.34.6<0.00122.110.80.01 Life threatening or disabling bleeding 11.341.5<0.00114.043.5<0.001 Acute kidney injury5.316.30.0075.316.30.007 a Data presented as Kaplan-Meier estimates and log-rank P values.

24 STS 2015 Paravalvular Regurgitation Patients with Prior CABG 24

25 STS 2015 NYHA Class Patients with Prior CABG 25

26 STS 2015 KCCQ Overall Summary Patients with Prior CABG 26

27 STS 2015 This is the first review to demonstrate an advantage of TAVR over SAVR in patients with prior CABG using prospective randomized data. –Trend towards improvement in the primary endpoint of mortality at 1 year –Significant differences in the composite endpoint of mortality or major stroke –Significant differences in MACCE Conclusions 27

28 STS 2015 No independent predictors of 1 yr mortality Combination of Age >80yrs and STS >7% demonstrated a survival advantage for TAVR at 1 year TAVR demonstrated several procedural advantages with significant reductions in healthcare utilization Conclusions

29 STS 2015 Technological evolutions which reduce : PVL Vascular access problems Pacemakers implantation will encourage a shift of re-operative pts to TAVR Previous CABG patients who may benefit from SAVR include: Young patients who might need more than 1 AVR Patients who need concomitant revascularization and a LIMA available Patients with poor access who require alternative access via sternotomy Implications

30 STS 2015 Thank You On Behalf of the CoreValve US Investigators

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