Transcript 6-Month Outcomes Following Transcatheter Aortic Valve Implantation With a Novel Repositionable Self-Expanding Bioprosthesis Ian T.

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.
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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Evolut R System
Catheter Delivery System
14Fr-equivalent profile
Loading System
Transcatheter Valve (26, 29 mm)
Supra-annular design, optimized sealing
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Evolut R Valve Details
Redesigned Outflow
• Reduced height (~10mm),
reshaped for improved fit,
especially in angulated anatomy
45 mm
Enhanced Sealing
13 mm
4 mm
6 mm
• Optimized Oversizing
• Consistent Radial Force
• Extended Sealing Skirt*
*Measurements provided are approximate and do not include paddles/frame loops. Images may not be to scale and are for illustration purposes only.
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Study Overview
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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
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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
Objective
Design
•
•
•
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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*
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98.3% of patients completed 30-day follow-up and 100% completed 6month follow-up
Endpoints
Compliance
*Kappetein AP, et al. Eur Heart J 2012; 33: 2403-18.
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Investigational Sites
Belfast
Leeds
Melbourne (2)
Hamilton
London
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Patients
Characteristic, % or mean± SD
Age (years)
Women
N = 60
82.8 ± 6.1
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
Atrial fibrillation / atrial flutter
Frailty
16.7
36.7
68.3
Pre-existing permanent pacemaker
11.7
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Procedure
Variable, %
General anaesthesia
N = 60
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
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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
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)
*Effective orifice area could not be determined in 5 patients to calculate patient prosthesis mismatch.
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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
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Haemodynamics
2.5
Effective orifice area
Mean gradient
2.0
1.9
1.9
1.9
50
40
1.5
30
1.0
20
0.5
0.0
9.2
0.6
8.1
7.6
Baseline
24 Hrs to 7 Days
30 Days
6 Months
Gradient
60
60
57
52
EOA
56
55
54
50
Mean Gradient, mm Hg
Effective Orifice Area, cm2
49.1
60
10
0
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NYHA Class
Compared with Baseline, 74.9% Improved at 30 Days and 84.9% at 6 Months
100%
90%
8.3%
11.3%
11.9%
Percent of Patients
80%
20.8%
70%
60%
37.3%
60.0%
50%
40%
67.9%
30%
20%
10%
0%
50.8%
31.7%
Baseline
N=60
NYHA I
30 Days
N=59
NYHA II
6 Months
N=53
NYHA III
NYHA IV
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Safety
30 Days
N=60
0.0 (0)
0.0 (0)
0.0 (0)
0.0 (0)
0.0 (0)
8.3 (5)
5.0 (3)
0.0 (0)
0.0 (0)
0.0 (0)
0.0 (0)
11.7 (7)
Event, K-M rates (no. of patients)
All-cause mortality
Cardiovascular
All stroke
Disabling
Non-disabling
Major vascular complications
Life-threatening or disabling bleeding
Embolization or migration
Endocarditis
Coronary obstruction
Valve thrombosis
Pacemaker*
6 Months
N=60
5.0 (3)
3.3 (2)
1.7 (1)
1.7 (1)
0.0 (0)
8.3 (5)
8.4 (5)
0.0 (0)
0.0 (0)
0.0 (0)
0.0 (0)
13.4 (8)
*Patients with a prior pacemaker included in the denominator.
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Paravalvular Regurgitation
Percent of Evaluable Echocardiograms
100%
3.4%
6.8%
7.4%
90%
80%
35.2%
70%
60%
63.8%
57.6%
50%
40%
30%
20%
57.4%
35.6%
32.8%
24 H/ 7 Days
N=59
30 Days
N=58
10%
0%
None/Trace
Mild
6 Months
N=54
Moderate
Severe
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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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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
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