Aortic Valve Controversies Beyond risk assessment: TAVI for Everybody

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1 Aortic Valve Controversies Beyond risk assessment: TAVI for Everybody Anna Sonia Petronio, MD, FESC Head of Cardiac Catheteriza8on Lab Cardiothoracic and Vascular Department University of Pisa, Italy

2 1. Actually Guidelines 2. Change in treated pa7ents 3. Change in guidelines

3 In your Center, are there regularly scheduled heart team mee4ngs to discuss TAVI pa4ent selec4on? (EAPCI survey in press)

4 STS 11,2% STS 11,8%

5 1. Actually Guidelines 2. Change in treated pa7ents 3. Change in guidelines

6

7

8 STS Partner 2010 Corevalve US 2014 No8on trial 2015 Partner II 2016 FRANCE 2 registry 2012 ADVANCE 2014 Gary Registry 2015 ADVANCE II 2015

9 EAPCI SURVEY Inoperable pa1ents 89% High surgical risk pa1ents (STS >8 %) 95% Intermediate surgica risk pa1ents (4 < STS <8) 45% Low surgicl risk pa1ents (STS <4 %) 10% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Petronio et all, in press Eurointerven7on

10 Average age

11 Neil Ruparelia Am J Cardiol 2016

12 Holmes et al. ; JAAC 2015

13 N= 1327 P<0.001

14

15 Low: STS <3 Intermediate: 3 x 8 High>8 Wenaweser et al; Eur Heart Journal 2013

16 Wenaweser et al; Eur Heart Journal 2013

17 Intermediate risk pa7ents Leon et al; NEJ 2016

18 A Intention-to-Treat Population Death from Any Cause or Disabling Stroke (%) No. at Risk TAVR 1011 Surgery Hazard ratio, 0.89 (95% CI, ) P= Surgery TAVR Months since Procedure B As-Treated Population Death from Any Cause or Disabling Stroke (%) 100 No. at Risk TAVR Surgery Hazard ratio, 0.87 (95% CI, ) P= Surgery TAVR Months since Procedure Intermediate risk pa7ents C Transfemoral-Access Cohort, Intention-to-Treat Analysis Death from Any Cause or Disabling Stroke (%) 100 No. at Risk TAVR Surgery Hazard ratio, 0.79 (95% CI, ) P= Surgery TAVR Months since Procedure D Transfemoral-Access Cohort, As-Treated Analysis Death from Any Cause or Disabling Stroke (%) 100 No. at Risk TAVR Surgery Hazard ratio, 0.78 (95% CI, ) P= Surgery TAVR Months since Procedure Leon et al; NEJ 2016

19 Thourani et al; Lancet 2016

20 Thourani et al; Lancet 2016

21 Low risk pa7ents Hans Gustav H. Thyregod et al; JAAC 2015

22 Hans Gustav H. Thyregod et al; JAAC 2015

23 Hans Gustav H. Thyregod et al; JAAC 2015

24 TAVI in very elderly pa8ents??? Yamamoto et al Am J Cardiol 2014

25 This study revealed acceptable clinical results of transcatheter aor7c valve implanta7on even in very elderly popula7ons Yamamoto et al Am J Cardiol 2014

26 TAVI in very elderly pa8ents??? Many nonagenarians have good outcomes azer TAVR, with prolonged survival and improved QOL, making TAVR in select nonagenarians with severe AS. Mani Arsalan et al; JAAC 2016

27 1. Actually Guidelines 2. Change in treated pa7ents 3. Change in guidelines

28 The ideal guidelines in 2016? Recommenda4ons TAVI SAVR High- risk pa4ents I - B IIb - B Intermediate risk pa4ents I - A I - B Low- risk pa4ents IIa B I - B Partner 1 A- Corevalve US Corevalve US Partner II No8on trial

29 Thank you

30 TAVI in very elderly pa8ents??? Mani Arsalan et al; JAAC 2016

31 P<0.001 P=0.014 P=0.087 Mani Arsalan et al; JAAC 2016

32 The ideal guidelines in 2016? Recommenda4ons TAVI SAVR High- risk pa4ents I - B IIb - B Intermediate risk pa4ents I - A I - B Low- risk pa4ents IIa B I - B Partner 1 A Corevalve US Partner II No8on trial

33 Thank you

34

35 1. Actually Guidelines 2. Change in treated pa7ents 3. Change in device and rate of complica7ons 4. Change in guidelines

36 C Death from Any Cause, According to Severity of Paravalvular Aortic Regurgitation Overall P=0.001 by log-rank test Hazard ratio for mild vs. none or trace, 0.95 (95% CI, ); P=0.82 Hazard ratio for moderate or severe vs. none or trace, 2.85 (95% CI, ); P<0.001 Patients (%) Moderate or severe None or trace Mild Months since Procedure No. at Risk None or trace Mild Moderate or severe New devices, with low profile (22/18F 14 F) Retriveal and reposi7oning device (reduce % PVL)

37 Circula4on 2015

38 Vascular injury Partner 2010 Corevalve US 2014 Partner II 2016 FRANCE 2 registry ADVANCE 2014 Gary registry 2015 OBSERVANT 2015

39 Poten1al conflicts of interest Speaker's name: Anna Sonia Petronio þ I have the following poten1al conflicts of interest to report: Consultant: ABBOTT VASCULAR, BOSTON SCIENTIFIC, MEDTRONIC

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