6-Month Outcomes Following Transcatheter Aortic Valve Implantation With a Novel Repositionable Self-Expanding Bioprosthesis Ian T. Meredith, MBBS, PhD,

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

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.

3CoreValve Evolut R CE Study

Background

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• 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.

4CoreValve Evolut R CE StudyMDT Confidential

Evolut R System

Transcatheter Valve (26, 29 mm)Supra-annular design, optimized sealing

Catheter Delivery System14Fr-equivalent profile

Loading System

Redesigned Outflow• Reduced height (~10mm),

reshaped for improved fit, especially in angulated anatomy

*Measurements provided are approximate and do not include paddles/frame loops. Images may not be to scale and are for illustration purposes only.

45 mm

6 mm

13 mm 4 mm

Enhanced Sealing• Optimized Oversizing• Consistent Radial Force• Extended Sealing Skirt*

Evolut R Valve Details

5CoreValve Evolut R CE Study

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

6CoreValve Evolut R CE Study*Kappetein AP, et al. Eur Heart J 2012; 33: 2403-18.

7CoreValve Evolut R CE Study

Investigational Sites

Melbourne (2)

Belfast

Hamilton

Leeds

London

8CoreValve Evolut R CE Study

Characteristic, % or mean± SD N = 60

Age (years) 82.8 ± 6.1Women 66.7 Body surface area (m2) 1.7 ± 0.2Society of Thoracic Surgeons Predicted Risk of Mortality (%) 7.0 ± 3.7Logistic EuroSCORE I (%) 20.5 ± 12.5New York Heart Association class III or IV 68.3Previous CABG 28.3 Any chronic lung disease 43.3Diabetes 26.7

Peripheral vascular disease 16.7 Atrial fibrillation / atrial flutter 36.7 Frailty 68.3

Pre-existing permanent pacemaker 11.7

Patients

9CoreValve Evolut R CE Study

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

Procedure

10CoreValve Evolut R CE Study

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 98.3 (59/60)

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)

Clinical Performance

*Effective orifice area could not be determined in 5 patients to calculate patient prosthesis mismatch.

11CoreValve Evolut R CE Study

Valve Too Deep Recapture Begins Partially Recaptured Valve Fully Captured

Repositioning

Successfully used 22 times in 15 patients (25%):

• 10 Resheaths among 7 patients

• 12 Full recaptures among 10 patients

• No full retrievals

Baseline 24 Hrs to 7 Days 30 Days 6 Months0.0

0.5

1.0

1.5

2.0

2.5

0

10

20

30

40

50

60

0.6

1.9 1.9 1.9

49.1

9.2 8.1 7.6

Effective orifice areaMean gradient

Effec

tive

Orifi

ce A

rea,

cm

2 Mean G

radient, mm

Hg

Haemodynamics

12CoreValve Evolut R CE Study

Gradient 60 60 57 52

EOA 56 55 54 50

BaselineN=60

30 DaysN=59

6 MonthsN=53

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

31.7%

37.3%20.8%

60.0%

11.9% 11.3%8.3%

50.8%67.9%

NYHA I NYHA II NYHA III NYHA IV

Perc

ent o

f Pati

ents

NYHA Class

13CoreValve Evolut R CE Study

Compared with Baseline, 74.9% Improved at 30 Days and 84.9% at 6 Months

14CoreValve Evolut R CE Study

Event, K-M rates (no. of patients) 30 DaysN=60

6 MonthsN=60

All-cause mortality 0.0 (0) 5.0 (3)Cardiovascular 0.0 (0) 3.3 (2)

All stroke 0.0 (0) 1.7 (1)Disabling 0.0 (0) 1.7 (1)Non-disabling 0.0 (0) 0.0 (0)

Major vascular complications 8.3 (5) 8.3 (5)Life-threatening or disabling bleeding 5.0 (3) 8.4 (5)Embolization or migration 0.0 (0) 0.0 (0)Endocarditis 0.0 (0) 0.0 (0)Coronary obstruction 0.0 (0) 0.0 (0)Valve thrombosis 0.0 (0) 0.0 (0)Pacemaker* 11.7 (7) 13.4 (8)

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Safety

*Patients with a prior pacemaker included in the denominator.

24 H/ 7 DaysN=59

30 DaysN=58

6 MonthsN=54

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

35.6% 32.8%

57.4%

57.6% 63.8%

35.2%

6.8% 3.4% 7.4%

None/Trace Mild Moderate Severe

Perc

ent o

f Eva

luab

le E

choc

ardi

ogra

ms

Paravalvular Regurgitation

15CoreValve Evolut R CE Study

16CoreValve Evolut R CE StudyMDT Confidential

Implant Depth by Pacemaker Implantation

Patients with Pacemaker (8)= annular plane

= non-coronary cusp (NCC)= left coronary cusp (LCC)

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)

• 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

17CoreValve Evolut R CE Study

Summary & Conclusions