TAVR-Update Andrzej Boguszewski MD, FACC, FSCAI Vice Chairman, Cardiology Mid-Michigan Health Associate Professor Michigan State University, Central

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1 TAVR-Update Andrzej Boguszewski MD, FACC, FSCAI Vice Chairman, Cardiology Mid-Michigan Health Associate Professor Michigan State University, Central Michigan University 1

2 Disclosure Chiesi Pharma- Consultant 2

3 Objectives Review where TAVR is now Current Challenges TAVR Updates 3

4 Background Aortic valve stenosis 15,000 deaths per year in North America 85,000 valve procedures AVR is indicated for severe AS and either symptoms or LV dysfunction Over 500 TAVR programs open 4

5 th Anniversary of PCI September th Anniversary of TAVR April

6

7 Two TAVR Options Edwards Sapien Valve Cobalt Chromium frameballoon expandable (bovine) More Aortic Regurg, less AV block/ppm Better for severe bulky calcification. Medtronic CoreValve Nitinol Frame-self expanding Less Aortic Regurg, More heart block/ppm

8 PARTNER Study Design Symptomatic Severe Aortic Stenosis Cohort A N = 699 High Risk ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients 2 Parallel Trials: Individually Powered Inoperable Cohort B N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

9 Cohort B Survival 9

10 PARTNER Study Design Symptomatic Severe Aortic Stenosis Cohort A N = 699 High Risk ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients 2 Parallel Trials: Individually Powered Inoperable Cohort B N = 358 Yes ASSESSMENT: Transfemoral Access No ASSESSMENT: Transfemoral Access Transfemoral (TF) Transapical (TA) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 TF TAVR VS AVR TA TAVR VS AVR TF TAVR VS Standard Therapy Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

11 Cohort A: All-Cause Mortality HR [95% CI] = 0.93 [0.74, 1.15] p (log rank) = % 44.8% 44.2% 26.8% 33.7% 24.3% No. at Risk TAVR AVR

12 N Engl J Med 2016; 374:

13 Core Valve 13

14 N Engl J Med 2016; 374:

15 Recurrent Theme: TAVR More vascular complications More pacemakers More PVL Lower gradients and better EOA SAVR More Bleeding More atrial fibrillation Acute kidney injury Equipoise Mortality, Stroke, MI, Aortic reinterventions?, durability (5 years) 16

16 Is TAVR now for everyone? Evidence base: Inoperable patients Extreme Risk patients High Risk patients Intermediate Risk patients On going Trials: Low Risk Patient Uncertain Benefit Cohort C Futility

17 TAVR JACC.2017;70(2):

18 STS database (141,905 pts) 6.2% 13.9% 79.9% High risk (STS > 8%) Intermediate risk (STS 4-8%) Low risk (STS <4%) Courtesy of N. Piazza

19 What about Low Risk Patient? Notion Trial I and II Partner 3 CoreValve Low Risk Trial Sub-studies 20

20 JACC 2015(65)20:

21 JACC 2015(65)20:

22 NOTION Trial (low Risk) Mortality Stroke JACC 2015(65)20:

23 NOTION Trial NYHA Classification PVL JACC 2015(65)20:

24 JACC 2015(65)20:

25 Clinical Outcomes 26

26 27

27 PCRonline.com 28

28 Potential Pitfalls in a low risk patient Need for PPM Potential for TR regurgitation and RV dysfunction Stroke and embolic protection Future CAD and need for PCI Won t usually present to TAVI centers Durability question Bicuspid AV and aortopathy 29

29 The PARTNER 3 Trial Study Design Symptomatic Severe Calcific Aortic Stenosis Low Risk ASSESSMENT by Heart Team (STS < 4%, TF only) TF - TAVR (SAPIEN 3) 1:1 Randomization (n=1228) Surgery (Bioprosthetic Valve) PARTNER 3 Registries Alternative Access (n=100) (TA/TAo/Subclavian) CT Imaging Sub-Study (n=200) Actigraphy/QoL Sub-Study (n=200) CT Imaging Sub-Study (n=200) Actigraphy/QoL Sub-Study (n=200) Bicuspid Valves (n=100) PRIMARY ENDPOINT: Composite of all-cause mortality, all strokes, or re-hospitalization at 1 year post-procedure ViV (AV and MV) (n=100) Follow-up: 30 days, 6 mos, 1 year and annually through 10 years

30 1200 low-risk patients randomized to TAVR vs SAVR Primary end point of mortality and stroke at 2 years 400 patient sub-study on leaflet mobility 31

31 Strokes and Embolic protection 32

32 Strokes post AVR Likely underestimated Diffusion Weight MRI showed up 80% new ischemic lesion post AVR Silent infarct 2-4 fold increase in future strokes >3 fold increase in mortality >2-fold increase in dementia Cognitive decline 33

33 Tay et al. JACC 2011;4(12):

34 Van Mieghem et al. JACC 2015;8(5):

35 Embolic protection Devices 36

36 42% reduction in median new lesion volume 37

37 CLARET Device 38

38 39

39 Durability 40

40 Durability Bio-prosthetic aortic valve degeneration <1% at 1 year 10-30% at 10 years 20-50% at 15 years Trans-catheter Valve --? Dvir et al. EuroPCR? 50% TAVI degenerate at 8 years (2/3 AI) Interact Cardiovasc Thorac Surg 2014;19: Pibarot P et al. Circulation 2009;119:

41 TAVR degeneration Moderate AI and/or mean gradient >20 mmhg not present at 30 days post procedure (not comparable to definition of surgical valve degeneration) Sub-clinical leaflet immobility 42

42 Patient prosthesis mismatch (PPM) Dvir et al. JAMA 2014;312920:

43 RESOLVE and SAVORY Registries Assess prevalence of subclinical leaflet thrombosis 931 patients had 4D CT, ECHO 13% vs 4% thrombosis on TAVR vs SAVR (p=0.001) Resolution on anticoagulation (warfarin or NOAC) No stroke difference but more TIA Aortic gradients >20 mmhg or increase gradient >10 mmhg were seen more frequently in pts with leaflet thrombosis then not. 14% vs 1% p=<0.0001) 44

44 45

45 46

46 Ring fracturing Circ Cardiovasc Inter. 2015;8:e

47 48

48 49

49 Asymptomatic aortic stenosis True asymptomatic Under reported (Sx attributed to normal aging) Risk of SCD 1-2% vs surgery 1-5% mortality No EQUIPOISE if considering SAVR Stress stress testing is indicated ~5-6% doctors give stress tests (fear?) 50

50 51

51 JACC 2012:59(3):

52 SAPIEN 3 Trial Kodali et al. European Heart J

53 Taniguchi et al. JACC 2015;66:

54 55

55 EARLY TAVR Trial Test the hypothesis that early TAVR will be superior to watchful waiting in patients with asymptomatic severe aortic stenosis 56

56 Early intervention with moderate AS and reduced EF? 57

57 Duke echo database identified 1634 pts with LV systolic dysfunction (EF 50%) and AS; 1090 (67%) with moderate AS (mean AV gradient mmhg, mean AVA 1.08 cm2) and 544 (33%) with severe AS (mean AVA 0.72 cm2) Mean age 75yo and major co-morbidities included CAD 61%, DM 33%, and cerebrovascular disease 20% Pts followed at least 5 years after the index echo 58

58 TAVR UNLOAD 600 pts, 1:1 randomization 59

59 Futile TAVR Categories (risk is a continuum) Operable AS patients Surgery (AVR) ~65% Low Risk Evaluation in progress ~25% Moderate Risk TAVR in 2018 Safe for TAVR But surgery also a good option TAVR or AVR Current TAVR TAVR Clinical Use ~10% High Risk OK Extr Risk* preferred Too Sick No * Extreme (prohibitive) risk = inoperable

60 TAVR Over 500 TAVR programs in the US JACC.2017;70(2):

61 Aortic Replacement Guidelines Valvular heart disease Focused Updated. JACC.2017;70(2):

62 Questions: 64

63 Intervention for asymptomatic aortic valve replacement is indicated: a. When mean valvular gradient falls by 20% with exercise b. Resting peak velocity of >5 m/sec c. Prior to moderate risk surgery d. New onset atrial fibrillation 65

64 Intervention for asymptomatic aortic valve replacement is indicated: a. When mean valvular gradient falls by 20% with exercise b. Resting peak velocity of >5 m/sec c. Prior to moderate risk surgery d. New onset atrial fibrillation 66

65 Sentinel Trial: The CLARET Device has shown to: a. Reduce mortality b. Statistically reduce major strokes c. Reduced major lesion volume by MRI d. Increase in vascular complication 67

66 In the intermediate risk TAVR clinical trial SURTAVI: TAVR patients experienced more.. a. life threatening or disabling bleeding b. atrial fibrillation c. more acute kidney injury d. vascular complications 68

67 References: Leon et al. Transcatheter or surgical aortic valve replacement in Intermediate risk patiens. N Engl J Med 2016; 374: AHA/ACC Focused Update of the 2014 AHA/ACC Guidelines for Management of Patients with Valvular Heart Disease. JACC.2017;70(2): Kapadia et al. Protection against embolism during transcatheter aortic valve replacement. JACC 2017;69:

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