A Patient Level Pooled Analysis of
NeuroProtection with the
TriGuard Embolic DEFLECTion Device
Compared to Unprotected Transcatheter Aortic Valve Replacement
Alexandra Lansky, MD
Yale University School of Medicine
New Haven, CT
John Forrest, Adam Brickman, Didier Tchetche, Pieter Stella, Thomas Cuisset, Joachim
Schofer, Kevin Abrams, Michael Haude, and Andreas Baumbach
• 1.5-6% at 30 days in recent RCTs
• Confer 3- to 9-fold increased risk of
mortality
• Neurologist identified deficits with
+ Brain MRI lesions
• Stroke range is 15-28%
30%
30-Day Stroke Rates In Recent RCTs
7
6
5
5
4.6
4
4
2.6
3
2
5.9
5.8
1.6
4
3
2.6
2
Stroke
Is Underreported
In Trialst
25%
20%
15%
10%
1
5%
0
0%
*AP Kappetein et al. EHJ (2012) 33, 2403–2418;
**Sacco et al. Stroke. 2013;44:2064-2089
28%
17%
15%
15%
v Single-wire nitinol frame and
mesh filter with pore size of
130μm designed to deflect
cerebral emboli during TAVI while
allowing maximal blood flow
v Positioned across all 3 cerebral
vessels and maintained by a
stabilizer in the innominate
v Delivered via 9 Fr sheath from the
femoral artery
Objectives: To evaluate the safety and efficacy of the TriGuard device
as an adjunct to TAVI compared to no protection in an expanded patient
level pooled analysis of 3 prospective clinical trials
Methods: A total of 142 patients (TriGuard N=59 vs Controls N=83).
This per-treatment analysis includes all TG patients with adjudicated
complete cerebral coverage. Trials included:
~ DEFLECT I: A registry of 23 patients with TriGuard
~ DEFLECT III: A randomized trial of 36 patients with TriGuard and 44 Controls
~ NeuroTAVR: A registry of 44 control patients
Endpoints:
•
MACCE: all death, stroke, bleeding, AKI, Vasc Complications
•
Stroke: VARC2 defined * and AHA/ASA defined:**
•
CNS infarction: Number an Volume New MRI lesions
•
Worsening NIHSS and cognitive function (MoCA)
*AP Kappetein et al. EHJ (2012) 33, 2403–2418;
**Sacco et al. Stroke. 2013;44:2064-2089
All 3 Trials Used Same Methodology, Definitions,
MRI Core Lab & CEC
Screening
Procedure
Post-Procedure
4±2 days
NIHSS
mRS
Neurocog*
TAVR
±
TriGuard
30 Days
+30 days
DW-MRI
NIHSS
mRS
Neurocog*
NIHSS
mRS
Neurocog*
*Neurocognitive test battery includes the Montreal Cognitive Assessment (MoCA) and
computerized CogState Research Test. Baseline and 30-day evaluations include supplemental Digit
Symbol Substitution, Trailmaking, and Word Fluency Tests.
BASELINE DEMOGRAPHICS
ITT Population
TriGuard N=59
Controls N=83
P Value
Age (y) ± SD
82.6 ± 6.7
82.8 ± 6.4
0.94
Male
34%
58%
0.005
STS Score
4.7
7.4
0.48
EuroSCORE II
5.3
6.8
0.78
III or IV (%)
41.1%
61.0%
0.13
LVEF %
56 ± 12
55 ± 13
0.72
A Fib on admission
22.0%
36%
0.36
CKD
20.3%
21.7%
0.85
COPD
23.7%
32.9%
0.24
O2 Dependent
5.6%
2.5%
0.4
Previous stroke/TIA
8.5%
16.9%
0.15
Frailty
11.9%
18.4%
0.42
Porcelain Aorta
5.6%
2.5%
0.41
BAV
73%
82%
0.21
NYHA Class
DW-MRI Findings
TriGuard N=59
Controls N=83
P Value
Incidence of CNS
Infarction
72%
92%
0.008
Number of Lesions
3 [0-8]
4.5 [2-10]
0.07
Total DWI volume
mm3 [IQR]
101.4 [0-337]
174 [67-575]
0.04
Average DWI volume
mm3 IQR]
25 [0-8]
43 [18-67]
0.07
27.9%
14%
8.3%
10%
0.008
0.54
Medium (>50150mm3)
14%
28%
0.08
Large (>150mm3)
44%
53%
0.36
Total Volume
None
Small (1-50mm3)
TriGuard Pooled Analysis:
In Hospital Results
MACCE: 18.2% TG vs 24.1% Control, p=0.44
100
90
80
70
60
50
40
30
20
10
0
P=0.008 92
P=0.03
59
P=0.38
P=0.001
35.0
P=0.4
0
VARC 2
Disabling
stroke
37
28
P=0.05
1.2
72
19
0
6
VARC 2 Stroke
0
NIHSS
TG
MOCA
Control
NIHSS or
MoCA
DW-MRI
Lesion
C
O
N
C
L
U
S
I
O
N
S
Neuroprotection with TriGuard

Is safe

Significantly reduced in hospital VARC2 defined
stroke (0% vs. 6.0%, p=0.05)

Significantly reduced stroke rate defined by
worsening NIHSS (National Institutes of Health
Stroke Scale) with DW-MRI lesions (0% vs. 19%,
p=0.002)

TriGuard protected patients showed higher
absence of CNS infarction (28% vs. 8%, p=0.008)

Total lesion volume was reduced significantly
with TriGuard vs. no protection (101.4mm3 vs.
174.0mm3, p=0.04)

None of the TriGuard protected patients had worsened NIHS score, while
17.1% of the patients without protection had worsened NIHS score
(p=0.001)
These clinically meaningful outcomes, clearly demonstrate the importance of using TriGuard, and
the potential consequences of unprotected procedures.
The pivotal REFLECT RCT is designed to confirm our results.
Clinical Outcomes
of the Keystone Heart
rd
3 Generation
deflection Device
Prof J Schofer, MD, PhD
PCR 2016; Euro16A-OP0098 - Stella P., Abawi M., Voskuil M., Bijuklic K., Riess F., Hansen L., Schofer J.
Aims
The TriGuard cerebral embolic protection
System is a nitinol frame and mesh
that is positioned in the aortic arch
to prevent cerebral embolization.
We evaluated the Clinical
performance of the third
Generation TriGuard device
in 2 European centers.
Methods and Results
The device was used in 31 patients (78.8± 8.7 yrs, 45.2% male) with
symptomatic aortic valve stenosis, who underwent transfemoral TAVI
because of high risk for open heart surgery (EuroSCORE II 7.6±6.3,
STS Score 2.4±0.9).
All patient were assessed by trained physicians for neurologic evaluation
pre TAVR and pre discharge.
The TriGuard covered all 3 vessels with no device interference in all
patients.
Pre-TAVI balloon dilatation was performed in 67.7%, post-dilatation in
22.6%, valve in valve implantation in 9.7% of patients.
In 29%, the Medtronic Core Valve/Evolute R, in 67.7%, the Edwards
SAPIEN and in 3.2%, the Boston Scientific Lotus valve was used.
Safety (VARC 2)
Results show
~ MACCE 9.7% (3/31).
~ Mortality, 0.0% (0/31)
~ All stroke, 0.0% (0/31)
disabling stroke, 0.0% (0/31); non-disabling stroke, 0.0% (0/31).
~ Life-threatening or disabling bleeding, 9.7% (3/31) and device
related bleeding, 0.0% (0/31). TriGuard related, 0.0% (0/31).
~ AKI Stage 2/3, 0.0% (0/31).
~ Major Vascular Complication, 0.0% (0/31).
This study is currently ongoing and we are looking forward to further
updates in upcoming meetings.
Conclusions
The third generation TriGuard device
is safe with improved performance
and ease of use, 100% of the cases
had 3 vessel coverage and no
strokes.