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

2. Disclosures
Samin K. Sharma, MD, FACC None for today’s case Speaker’s Bureau – Boston Scientific Corporation, Abbott Vascular Inc, ABIOMED, CSI, Trireme Inc Annapoorna S. Kini, MD, FACC Nothing to disclose Allan Stewart, MD Nothing to disclose regarding today’s presentation Mathew R Williams, MD Nothing to disclose for today’s case

3. December 13th 2016 Structural Heart Live Case #13: BC, 85 yr M
Presentation: Worsening dyspnea and fatigue on exertion for last few weeks, NYHA class III
PMH: Severe AS, HPL, Idiopathic pulmonary fibrosis on chronic steroid use, Raynaud’s disease, OSA, BPH and hypothyroidism
Medications: Aspirin, Atorvaststin, Flomax, Synthroid, Prednisolone
TTE (11/14/16): Severe valvular AS; PG/MG=65/41mmHg, Doppler valve area = 0.8 cm2, Ao peak velocity = 4.03m/s, LVEF 57%
EKG: Sinus rhythm with narrow QRS, PR prolongation
Cath (11/29/16): 1V CAD, 60% mLAD disease, FFR negative

4. December 13th 2016 Structural Heart Live Case # 13
Contd….
CT Angiography: The bilateral lower extremity peripheral arterial accesses have minimal diameters 8.7mm
STS risk mortality: %
EuroScore II risk: %
Logistic Euroscore mortality: 12.4%
Course: Patient is determined to be high risk for surgical AVR due to history of age, lung disease and chronic steroid use
Plan Today: Patient is planned for Medtronic EVOLUT R CoreValve TAVR (34 mm) via percutaneous femoral access and conscious sedation.
SLIDE TO BE EDITED BY JK

5. Transthoracic Echo
Severe valvular aortic stenosis; peak gradient = 65 mmHg, mean gradient = 41 mmHg, Doppler valve area = 0.79 sq cm, Ao peak CW velocity = 4.03 m/sec, LVEF 57%

6. CTA: Aortic Annulus Annulus Max: 27.3 mm Min: 26.8 mm Mean: 27.1 mm
Perimeter = 89 mm
Area = 6.1 cm2
Annular angle = 56°
Annulus diameter: 27.3 x 26.8mm
Annulus circumference : 89mm
Annulus angle: 56°

7. CTA: SOV and STJ Sinus of Valsalva Mean Diameter = 38.4 mm
Sino-tubular junction height (above annulus)
= mm
Ascending aorta = 36 mm
39.7 mm
39.3mm
37.2 mm
RCA: 19.9 mm LM: 17.1 mm

8. CTA: Access – 3D

9. Access: Iliac and common femoral arteries
Rt CFA: 9.7mm Lt CFA: 9.8mm
Rt CIA: 11.4mm Lt CIA: 10.5mm
Calcific Left CFA

10. EVOLUT R 34 MM Patient Selection Matrix
Aortic Root 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
27.1
89.0
38.4
20.1

11. CoreValve™ Evolut™ R 34 mm

12. 34 mm Delivery Catheter System 16Fr Equivalent DCS Design
Same EnVeo R Delivery System technology with a 16Fr equivalent Capsule and InLine Sheath
Indicated to treat vessels ≥ 5.5 mm
16Fr Equivalent (20FR OD) Capsule
12Fr Inner Shaft
15Fr Stability Layer
16Fr Equivalent (20Fr OD) InLine Sheath

13. Consistent Evolut R design for accurate deliverability & performance
Evolut R 34 mm TAV
Design Fundamentals
Consistent Evolut R design for accurate deliverability & performance
Wider inflow for greater oversizing (34 mm at target implant depth of 3 mm)
Shorter length and outflow width for improved alignment to native annulus
More gradual inflow angle to maintain target oversizing in case of deeper implant depth
Evolut R 34 mm
CoreValve 31 mm
23 mm
31 mm
34 mm
24 mm
38 mm
44 mm
36 mm

14. Evolut R Family cell Dimensions & Target Implant Depth
Consistent inflow frame cell design with a target implant depth is mm for all valve sizes
3 – 5 mm = midway between nodes 0 and 1 to just below node 1
6 mm
4 mm
13mm Skirt
14mm Skirt
23 mm TAV
26 mm TAV
29 mm TAV
34 mm TAV

15. Evolut-R 34 Study: Valve Performance
Effective orifice area
Mean gradient
N=15
Effective Orifice Area, cm2
Mean Gradient, mm Hg
CoreValve™
Evolut™ R 34 mm
Up to 30mm aortic
annulus size
J Popma, TCT 2016

16. Summary of Case - 85 year old male - NYHA Class III
- TTE: AS – mean gradient 41 mmHg
STS mortality: 5.6%
EuroScore II mortality: 1.96%
Logistic Euroscore mortality: 12.4%
Course: Patient is determined to be high risk for surgical AVR due to age, lung disease and chronic steroid use
For 34 mm Medtronic EVOLUT R CoreValve via percutaneous femoral approach under conscious sedation.

17. Issues Related To The Case
Outcomes of Valve-in-Valve TAVR

18. Valve in Valve TAVI
Eggebrecht et al., JACC 2011;4:1218 18

19. Adverse Events Reported with Aortic
Valve-in-Valve Procedures for Failed Bioprosthesis

22. Procedural Characteristics and Early Results
Total (n=202)
CoreVavle (n=124)
Edwards SAPIEN (n=78)
p=<0.0001
p=0.45
p=0.31
p=0.16 %
p=0.11
p=0.32
p=0.64
Dvir et al., Circulation 2012;126:2335

23. Analysis of High Post-procedural Gradients
After Valve-in-Valve Procedure
Mean gradients after Edwards SAPIEN procedures – bioprosthesis size
(r = 0.35, p = 0.28)
Mean gradients after CoreValve procedures – bioprosthesis size
(r = 0.08, p = 0.40)
Dvir et al., Circulation 2012;126:2335

25. Clinical Outcomes at 30 Days
Dvir et al., JAMA 2014;312:162

26. Clinical Outcomes at 1 Year
Dvir et al., JAMA 2014;312:162

27. Time-to-Event Curves in Patients Undergoing Valve-in-Valve Procedures
Mechanism of Surgical Valve Failure
Dvir et al., JAMA 2014;312:162

28. Time-to-Event Curves in Patients Undergoing Valve-in-Valve Procedures
Surgical Valve Label Size
Device Used During VIV Implantation
Dvir et al., JAMA 2014;312:162

29. Results of Valve-in-Valve Measurements Within
the Edwards Perimount
Sedaghat et al., Ann Thorac Surg 2016;101:118

30. CoreValve US Clinical Trial: TAVR for Failed Aortic
Bio-prosthesis: All-Cause Mortality or Major Stroke
N=107
Internal stent diameter (ID) of SAV using valve in valve application developed by Dr. Vinayak Bapat & UBQO Technology
GM Deeb – on Behalf of CoreValve US Investigators, TCT 2015

31. CoreValve US Clinical Trial: TAVR for Failed Aortic
Bio-prosthesis- All-Cause Mortality or Major Stroke
N=107
All-Cause Mortality by Discharge Gradient
Hemodynamic Outcomes
What is driving higher gradient at discharge?
-Surgical valve size
-Modality of failure (> in stenosis)
-Patient prosthesis mismatch
What is the impact of a higher mean valve gradient?
GM Deeb – on Behalf of CoreValve US Investigators, TCT 2015

32. Take Home Message: Outcomes of Valve-in-Valve (ViV) TAVR
TAVR for failed surgical aortic bio-prosthetic valve (ViV) is feasible and is associated with acceptable death and stroke rates at 1-2 years of follow-up. Hence Valve-in-Valve TAVR is an acceptable (recommended) option in appropriate AS pts.
Valve-in-Valve TAVR outcomes are strongly associated with the residual aortic gradient post procedure and mechanism of valve failure. Hence every effort should be made to decrease the residual aortic gradient to < 20mmHg.

33. Correct answer: C Question # 1
Following is the false statement regarding TAVR procedure in aortic bio-prosthetic failure vs native aortic valve :
Higher residual aortic gradient
Lower annulus rupture
Lower coronary obstruction
Less para-valvular regurgitation
Correct answer: C

34. Correct answer: B Question # 2
Following statements are true about the outcomes of balloon expandable vs self expanding TAVR valve except:
Lower need for PPM
Lower residual aortic gradient
Lower para-valvular regurgitation
Similar long-term death and stroke at follow-up
Correct answer: B

35. Correct answer: D Question # 3
Following are the usual factors responsible for higher residual aortic gradient post CoreValve ViV TAVR except:
A. Modality of bio-prosthetic valve failure
B. Baseline surgical valve size
C. Predicted patient prosthetic mismatch
D. Need for permanent pacemaker
Correct answer: D