1. Structural Heart Live Cases
Supported by:
Medtronic inc
Bard Inc
Terumo Medical Corp

2. Disclosures
Samin K. Sharma, MD, FACC Speaker’s Bureau – Boston Scientific Corp., Abbott Vascular Inc, ABIOMED, CSI Annapoorna S. Kini, MD, FACC Nothing to disclose George Dangas, MD, FACC Nothing to disclose for today’s presentation Gilbert Tang, MD Physician proctor for Medtronic Inc

3. March 14th 2017 Structural Heart Live #16: CS, 88 yr. F
Presentation: Worsening dyspnea on exertion NYHA class III
PMH: Hypertension, Hyperlipidemia, HFpEF, DM, AF on Coumadin, PPM, CABG, Colorectal Carcinoma, PUD, Anemia, Hypothyroidism and OSA
Medications: Aspirin, Warfarin, Torsemide, Atorvastatin, Telmisartan, Omeprazole, Levothyroxine
TTE (1/31/17): Severe AS; PG/MG= 68/42mmHg, Doppler valve area = 0.64 cm2, Ao peak velocity = 4.13 m/s, LVEF 62%
EKG (03/13/17): Paced (Previous AV node ablation and PPM)
Cath (1/30/17): III V CAD, patent LIMA and SVG to D2, RPDA, RPL1 and RI. Moderate PHTn

4. March 14th 2017 Structural Heart Live #16
Contd….
CT Angiography: The bilateral lower extremity peripheral arterial accesses have minimal diameters 6.5 mm
STS risk mortality: %
EuroScore II risk: %
Logistic Euroscore mortality: %
Course: Patient is determined to be extreme risk for surgical AVR due to age and co-morbidities.
Plan Today: Patient is planned for Medtronic Evolut-R TAVR (29 mm) via percutaneous femoral access and GA.
SLIDE TO BE EDITED BY JK

5. Transthoracic Echo
Severe aortic stenosis; peak gradient = 68 mmHg, mean gradient = 42 mmHg, Doppler valve area = 0.64 sq cm, Ao peak CW velocity = 4.13m/sec, LVEF 62%

6. CTA: Aortic Annulus Annulus Min: 21 mm Max: 26 mm Mean: 23.5 mm
Perimeter = 75.4 mm
Area = 442 mm2
Annular angle = 51°
Annulus diameter: 21 x 26mm
Annulus perimeter:75.4mm
Annulus angle: 51°°

7. CTA: SOV, STJ, Coronary Ostia
Sinus of Valsalva
Mean Diameter = 32.7 mm
Sino-tubular junction height (above annulus) = 22.0 mm
Ascending aorta = 33 mm
31.5 mm
33.7mm
32.9 mm
RCA: 15mm LM: 16 mm

8. CTA: Access – 3D

9. Access: Iliac and common femoral arteries
Rt CIA: 7.9 mm Lt CIA: 8.6 mm
Rt CFA: 6.9mm
Lt CFA: 6.5mm

10. EVOLUT R 29 MM Patient Selection Matrix
Criteria
CoreValve Evolut R TAV
Valve Size Selection
Size
23 mm
26 mm
29 mm
34 mm
Annulus Diameter
18 – 20 mm
20 – 23 mm
23 – 26 mm mm
Annulus Perimeter (π x Diam)
56.5 – 62.8 mm
62.8 – 72.3 mm
72.3 – 81.7 mm
81.7 – 94.2 mm
Sinus of Valsalva Diameter (Mean)
≥ 25 mm
≥ 27 mm
≥ 29 mm
≥ 31 mm
Sinus of Valsalva Height (Mean)
≥ 15 mm
≥ 16 mm
Our
patient
23.5
75.4
32.7
22.0

11. Summary of Case - 88 year old male - NYHA Class III
- TTE: AS – mean gradient 42 mmHg
- STS mortality: %
- EuroScore II mortality: %
- Logistic Euroscore mortality: %
- Patient is determined to be extreme risk for
surgical AVR due to age and co-morbidities
- For 29 mm Medtronic Evolut-R CoreValve via
percutaneous femoral approach under GA

12. Issues Related To The Case
Oral anticoagulation and adverse
impact of AFib Post-TAVR

13. TAVR Valve Degeneration: Progression and Predictors

14. Clinical Outcomes (Stroke/TIA) at F/u
Impact of Anticoagulation & Reduced Leaflet Motion % %
(n=0/13)
(n=10/35)
(n=1/115)
(n=3/17)
Makkar et al., N Engl J Med 2015;373:2015

15. Mechanisms of Embolic Complications During and After TAVR: Acute Risk Highest and Likely Embolic
Stortecky and Windecker, Circulation 2012; 126:2921

16. Warfarin and Antiplatelet Therapy Versus Warfarin Alone for Treating Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement
JACC Card. Intervention 2016; 9: 1706

19. Study Flowchart Seeger et al., J Am Coll Cardiol Intv 2017;10:66
Stop VKA 7days/non-VKA 2 days prior to TAVR
Continuous aspirin 100 mg/d or loading dose 500 mg
Transfemoral TAVR
(n=617)
Atrial fibrillation/
new-onset AF (n=272)
Antiplatelet therapy for 4 weeks
Restart oral anticoag
48 hrs post TAVR
VKA
(n=131)
Apixaban
(n=141)
30 days follow-up
12 months follow-up
Sinus rhythm (n=345)
Antiplatelet therapy
Pre-procedure
48 hours
30 days
12 months
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

20. 30-Day Clinical Outcomes Atrial Fibrillation (n=272)
Sinus Rhythm (n=345)
Atrial Fibrillation (n=272)
P Value
Early safety endpoint (%) 33 59
<0.01
Secondary outcome measure (%) 14 27
0.02
All-cause mortality (%) 8 7
0.84
Disabling and non-disabling stroke (%) 10
0.82
Intracerebral bleeding (%) 1
0.26
Acute kidney injury stages 2 and 3 (%) 5
0.01
Life-threatening bleeding (%) 3 12
Major vascular complications (%) 13 15
0.32
Valve dysfunction requiring a repeat procedure (%) -
Endocarditis (%)
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

21. Late Follow-up at 12 Months Atrial Fibrillation (n=131)
Sinus Rhythm (n=154)
Atrial Fibrillation (n=131)
P Value
Secondary outcomes measure
(All-cause mortality and All-stroke) (%) 14 27
0.02
MACE (%) 18 31
All-cause mortality (%) 12 25
0.01
Disabling and non-disabling stroke (%) 2
0.87
Major bleeding (%) 1
0.35
Myocardial infarction (%)
0.19
Rehospitalization (%) 22
0.28
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

22. Landmark Analysis of Mortality
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

23. Patients with Atrial Fibrillation:
30 Day Clinical Outcome
Apixaban
(n=141)
Vitamin K Antagonist
(n=131)
P Value
Early safety endpoint (%) 19 40
<0.01
All-cause mortality (%) 2 5
0.22
Disabling and non-disabling stroke (%) 3 7
0.17
Intracerebral bleeding (%) 1
0.34
Acute kidney injury stages 2 and 3 (%) 11
Life-threatening bleeding (%)
Major vascular complications (%) 10
0.09
Valve dysfunction requiring a repeat procedure (%) -
Endocarditis (%)
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

24. Patients with Atrial Fibrillation:
12-Month Follow-Up
Apixaban
(n=81)
Vitamin K Antagonist
(n=50)
P Value
MACE (%) 22 9
0.34
All-cause mortality (%) 19 6
0.18
Disabling and non-disabling stroke (%) 1
0.73
Rehospitalization (%) 14 8
0.87
Secondary outcome measure
(All-cause mortality and All stroke) (%) 20 7
0.23
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

25. Outcomes in Patients with AF: Apixaban vs VKA
Short-Term Follow-Up until 30 Days Post-Procedure
Landmark Analysis of All Stroke
Apixaban (n141)
Vit K antagonist (n131)
Apixaban (n141)
Vit K antagonist (n131)
Event-free survival from stroke, %
Hazard ratio 1.04 (95% CI )
Log-rank p=0.98
p=0.42
p=0.60 %
p=0.52
All-cause Disabling/ Secondary outcome
mortality nondisabling stroke measure
Seeger et al., J Am Coll Cardiol Intv 2017;10:66

26. The ARTE trial
(Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation)
~300 patients undergoing TAVR
Receive drugs 24 hrs in advance*
Aspirin
(atleast 6 months)
Aspirin (atleast 6 mths) + clopidogrel (atleast 3 months)
12 Months F/U
The ACCOAST will test preloading with a reduced dose of prasugrel
 Death, MI, ischemic stroke/Transient ischemic attack (TIA)
or life threatening/major bleeding
* For trans-apical start clopidogrel within 24 hrs after TAVR
Rhodes-Cabau J. clinicaltrials.gov/show/NCT ‎

28. Ongoing TAVI Pharmacology Trial

29. - 2017: The ENVISAGE Trial - Successful TAVR n=2200
Patients With an Indication to Chronic Oral Anticoagulation
RANDOMIZE 1:1
1-5 Days after the procedure
Background Tx: Single Antiplatelet Therapy as per treating MD discretion (Stratification Variable)
Warfarin (target INR 2-3) n = 1100
Edoxaban 60mg n= 1100
Minimum duration of randomized therapy 12 months
CLINICAL FOLLOW-UP: 1, 6, 12 Months
Primary Safety Endpoint: Major Bleeding
Primary Endpoint - NACE
[Composite of Death, MI, Stroke, TIA, systemic thromboembolism or VARC-2 Life-threatening (LT) or Major bleeding]
Ancillary Imaging Study
MRI substudy
4D CT substudy
Cost-Effectiveness
Neurocognitive function, frailty & QoL substudy
Secondary Endpoints
All-cause Death, MI, Stroke or TIA, VARC-2 Life-threatening (LT) bleeding and Major bleeding

30. Take Home Message: Oral Anti-coagulation and Impact of AFib post-TAVR
Pts undergoing TAVR who had or develops Afib have worse prognosis compared to pts with sinus rhythm. This higher MACE in Afib TAVR pts is the result of higher mortality (not stroke) at F/u
Comparative efficacy of VKA vs NOACs in Afib pts post TAVR has shown NOACs to be better at short term but VKA pts have trend towards better outcomes at one year. This question is being investigated in a planned RCT of VKA vs NOAC in pts with Afib post TAVR

31. Correct answer: C Question # 1
Following are the true statement regarding outcomes of Afib vs NSR in TAVR pts except:
Stroke incidence is similar between 2 groups
Mortality is higher in the Afib group vs NSR
Mortality is similar between 2 groups
Vascular complications and bleeding is numerically higher in the Afib gp vs NSR gp
Correct answer: C

32. Correct answer: C Question # 2
Following are the true statements regarding outcomes of Afib pts on NOAC vs VKA except:
NOAC pts has better short term outcomes vs VKA
NOAC pts have lower bleeding vs VKA
NOAC pts have lower MACE rates at 1 year vs VKA pts
RCT are ongoing to assess the efficacy of NOAC vs VKA
Correct answer: C

33. Correct answer: A Question # 3
Following are the RCT of antithrombotic post TAVR except:
A. SENTINEL
B. ATLANTIS
C. GALILEO
D. ENVISAGE
Correct answer: A