1. 6-Month Outcomes Following Transcatheter Aortic Valve Implantation With a Novel Repositionable Self-Expanding Bioprosthesis
Ian T. Meredith, MBBS, PhD, MonashHeart and University, Melbourne, Australia
Antony S. Walton, MBBS, Epworth Hospital, Melbourne, Australia
Stephen J. Brecker, MBBS, MD, St. Georges Hospital, London, United Kingdom
Sanjeevan Pasupati, MBChB, Waikato Hospital, Hamilton, New Zealand
Daniel J. Blackman, MD, Leeds General Infirmary, Leeds, United Kingdom
Ganesh Manoharan, MBBCh, MD, Royal Victoria Hospital, Belfast, United Kingdom

2. Potential Conflicts of Interest
Speaker's name: Ian T. Meredith
 I have the following potential conflicts of interest to report:
Consultant: Medtronic and Boston Scientific
Medtronic is the sponsor of the CoreValve Evolut R CE Study; and performed all statistical analyses and assisted in the graphical display of the data.

3. Background
Transcatheter aortic valve implantation (TAVI) is a viable option for the treatment of symptomatic severe aortic stenosis for patients who are at extreme- or high-risk for open heart surgery.
Recent technological advancements have aimed at reducing implant profile and improving valve implantability to ensure optimal valve positioning.
Optimal positioning may be associated with less paravalvular leak and lower new pacemaker rates.
We evaluated outcomes following TAVI with a new and fully repositionable CoreValve Evolut R 14F-equivalent self-expanding TAV through 6 months.
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4. Transcatheter Valve (26, 29 mm) Catheter Delivery System
Evolut R System
Transcatheter Valve (26, 29 mm)
Supra-annular design, optimized sealing
Catheter Delivery System
14Fr-equivalent profile
Loading System
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5. Evolut R Valve Details Redesigned Outflow Enhanced Sealing
Reduced height (~10mm), reshaped for improved fit, especially in angulated anatomy
45 mm
Enhanced Sealing
Optimized Oversizing
Consistent Radial Force
Extended Sealing Skirt*
13 mm
4 mm
6 mm
*Measurements provided are approximate and do not include paddles/frame loops. Images may not be to scale and are for illustration purposes only.
CoreValve Evolut R CE Study 5

6. Study Overview
Objective
To evaluate the safety and clinical performance of the CoreValve Evolut R System (26 mm, 29 mm) in symptomatic extreme- or high-risk patients (Heart Team assessment) with symptomatic aortic stenosis
Design
Prospective, non-randomized, multicentre, observational study
Follow-up at early post-procedure (24h–7 days), 30 days, 6 months, 1 and 2 years post TAVI
Multislice CT of the peripheral vascular and aortic annulus
100% source data monitored
Endpoints
Safety: All-cause mortality and the rate of any stroke at 30 days
Clinical Performance: Device success per Valve Academic Research Consortium (VARC-2) and the % of patients with > mild aortic regurgitation at early post procedure (24h–7d)
Core Labs
Echocardiography (Mayo Clinic, Rochester, MN)
Adjudication
Clinical endpoints reported per VARC-2*
Compliance
98.3% of patients completed 30-day follow-up and 100% completed 6- month follow-up
*Kappetein AP, et al. Eur Heart J 2012; 33:
CoreValve Evolut R CE Study 6

7. Investigational Sites
Belfast
Leeds
Melbourne (2)
London
Hamilton

8. Patients Characteristic, % or mean± SD N = 60 Age (years) 82.8 ± 6.1
Women
66.7
Body surface area (m2)
1.7 ± 0.2
Society of Thoracic Surgeons Predicted Risk of Mortality (%)
7.0 ± 3.7
Logistic EuroSCORE I (%)
20.5 ± 12.5
New York Heart Association class III or IV
68.3
Previous CABG
28.3
Any chronic lung disease
43.3
Diabetes
26.7
Peripheral vascular disease
16.7
Atrial fibrillation / atrial flutter
36.7
Frailty
Pre-existing permanent pacemaker
11.7

9. Procedure Variable, % N = 60 General anaesthesia 63.3 Access Approach
Iliofemoral
98.3
Direct aortic
1.7
Pre TAVI balloon aortic valvuloplasty performed
96.7
Valve Size Implanted
26 mm
31.7
29 mm
68.3
Post TAVI balloon dilatation performed
21.7
Permanent pacemaker implantation
11.7

10. Clinical Performance Variable, % (no./total no.) N = 60
Absence of procedural mortality
100.0 (60/60)
Correct positioning of 1 valve in proper location
98.3 (59/60)
Mean gradient < 20 mm Hg or peak velocity < 3 m/sec
Absence of moderate or severe regurgitation
93.3 (56/60)
Absence of patient prosthesis mismatch*
83.6 (46/55)
VARC-2 device success
78.6 (44/56)
*Effective orifice area could not be determined in 5 patients to calculate patient prosthesis mismatch.

11. Repositioning Successfully used 22 times in 15 patients (25%):
10 Resheaths among 7 patients
12 Full recaptures among 10 patients
No full retrievals
Valve Too Deep
Recapture Begins
Partially Recaptured
Valve Fully Captured

12. Effective Orifice Area, cm2
Haemodynamics
Effective Orifice Area, cm2
Mean Gradient, mm Hg
Gradient 60 57 52
EOA 56 55 54 50
CoreValve Evolut R CE Study 12

13. NYHA Class
Compared with Baseline, 74.9% Improved at 30 Days and 84.9% at 6 Months
Percent of Patients
CoreValve Evolut R CE Study 13

14. Safety Event, K-M rates (no. of patients) 30 Days N=60 6 Months N=60
All-cause mortality
0.0 (0)
5.0 (3)
Cardiovascular
3.3 (2)
All stroke
1.7 (1)
Disabling
Non-disabling
Major vascular complications
8.3 (5)
Life-threatening or disabling bleeding
8.4 (5)
Embolization or migration
Endocarditis
Coronary obstruction
Valve thrombosis
Pacemaker*
11.7 (7)
13.4 (8)
*Patients with a prior pacemaker included in the denominator.
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15. Paravalvular Regurgitation
Percent of Evaluable Echocardiograms
CoreValve Evolut R CE Study 15

16. Implant Depth by Pacemaker Implantation
Mean Implant Depth
Patients with a pacemaker
8.1 ± 3.5 mm (non-coronary cusp)
Patients with NO pacemaker
3.3 ± 2.5 mm (non-coronary cusp)
Difference (P<0.001)
= non-coronary cusp (NCC) = left coronary cusp (LCC)
= annular plane
Patients with Pacemaker (8)
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17. Summary & Conclusions
The ability to reposition the Evolut R TAV resulted in a low pacemaker rate and low incidence of PVL
Forward flow haemodynamics were excellent with single-digit mean gradients
No evidence of valve dysfunction
Improved and sustained symptom reduction
CoreValve Evolut R CE Study 17