Conflit d’intérêt :
Consultant : Edwards, Medtronic, SJM, Thoratec
Brevet : Landanger, Delacroix-Chevalier
Mitraclip : Actual data and perspectives
Jean-François OBADIA Hôpital Louis Pradel
- LYON -
Worldwide Clinical Experience *Data as of 21/3/2012.
Source: Abbott Vascular
Study Population N*
EVEREST I (Feasibility) Feasibility patients 55
EVEREST II (Pivotal) Pre-randomized patients 60
EVEREST II (Pivotal) Non-randomized patients
(High Risk Study)
78
EVEREST II (Pivotal) Randomized patients
(2:1 Clip to Surgery)
279
184 Clip
95 Surgery
REALISM (Continued Access) Non-randomized patients 650
Compassionate/Emergency Use Non-randomized patients 35
ACCESS Europe Phase I Non-randomized patients 566
ACCESS Europe Phase II Non-randomized patients 90
Commercial Use Commercial patients 3,284
Total 5,002
Worldwide Clinical Experience *Data as of 21/3/2012.
Source: Abbott Vascular
Study Population N*
EVEREST I (Feasibility) Feasibility patients 55
EVEREST II (Pivotal) Pre-randomized patients 60
EVEREST II (Pivotal) Non-randomized patients
(High Risk Study)
78
EVEREST II (Pivotal) Randomized patients
(2:1 Clip to Surgery)
279
184 Clip
95 Surgery
REALISM (Continued Access) Non-randomized patients 650
Compassionate/Emergency Use Non-randomized patients 35
ACCESS Europe Phase I Non-randomized patients 566
ACCESS Europe Phase II Non-randomized patients 90
Commercial Use Commercial patients 3,284
Total 5,002
2011
2011
2003
2002
Randomized
Classical
Indicatios
Counter
Indication
Per-cutaneous Valve treatment
Cohort B
Cohort A All indications MR
HR Pts, Funct.MR
MitraClip > Surgery “Safety”
30 Day Modified * MAE Intent to Treat, Hierarchical Events
Safety endpoint met with a wide margin
0
10
20
30
40
50
Device Control
30 D
ay
Modifie
d M
AE (
%)
Major Bleeding Complication*
GI Complication
New Onset Atrial Fibrillation
Ventilation >48hrs
Urgent CV Surgery
Stroke
Death8.3%
42.6%
*Major bleeding requiring transfusion ≥ 2U, or surgical intervention.
p<0.0001
(MitraClip)Devicen=180
(Surgery)Controln=94
Surgery > Mitraclip “Residual MR at 1 year”
MR Severity, Preliminary 24 Month Results
Per Protocol Cohort, Matched Baseline and 12 Months
0
20
40
60
80
100
Baseline 12 Months 24 Months
Pe
rcen
t P
atie
nts
1+
1+ - 2+
2+
4+
(n=119) (n=119) (n=75)
Device Control
p<0.0001
3+
2+
4+
3+
1+
1+ - 2+
2+
4+
3+
0
20
40
60
80
100
Baseline 12 Months 24 Months
Pe
rcen
t P
atie
nts
1+
1+ - 2+
2+
4+
(n=69) (n=69) (n=39)
p<0.0001
3+
2+
3+
0+
1+
1+ - 2+
2+
4+
0+ 1+ - 2+
p - value compares the distribution of MR grade in device with the distribution of MR grade in control at 12 months
(Fishers ’ Exact test)
Regurg.
LV NYHA
2 Years Follow-up
Surgery > Mitraclip “Residual MR at 2 years”
0 grade > 2
2 Re-op.
23 % grade III/IV
15 repair / 13 Replac
4
10 912
7
1614
19
26 25
3028
35 35
47
53 54
70
7880
87
112
97
112
0
20
40
60
80
100
120
Sep
08
Oct Nov Dec Jan
09
Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan
10
Feb Mar Apr May Jun Jul Aug
Co
un
t
# of Patients Treated
# of Sites
# of Sites Treating Patients
* Mitraclip is a safe technique (less blood transfusion)
* Surgery provides better Valve repair
- 96% versus 78 % at 2 years (free from reop.)
* Both Mitraclip and surgery
- Reduce Regurgitation
- Improve LV volumes and NYHA class
• This encouraging but sub-optimal results :
• Cannot deal with dystrophic surgical results
• Could be an elegant option for FMR
Everest II Conclusions Safer - Transfusion
Equivalent to Surgery ???
Everest Conclusions Safer - Transfusion
Equivalent to Surgery ???
See Disclaimer on Slide 2
At Risk
High Risk (n) 78 72 65 53
Control (n) 36 34 27 22
76.4%
55.3%
Impl 30d 6m 12m
1.0
0.8
0.6
0.4
0.2
0.0
Fre
ed
om
fro
m D
eath
HRR: Freedom from Death
P=0.037
HRR
HRR Control30 day mortality in HRR
MitraClip patients is similar
to patients managed with
standard of care treatment
MitraClip Therapy vs. High Risk Control
Everest II HRR (from everest) Access Europ
Demographics and Co-morbidities EVEREST II RCT Device Patients
N=178
High Surgical Risk Cohort
N=211
ACCESS EU – MitraClip Patients
N=566
Age (mean ± SD), years 67 ± 13 76 ± 10 74 ± 10
Logistic EuroSCORE, (%)
Mean ± SD NA NA 23 ± 18
Logistic EuroSCORE ≥ 20%, (%) NA NA 45
Mitral Regurgitation Grade ≥ 3+, (%) 96 86 98
NYHA Functional Class III or IV, (%) 50 86 85
Ejection Fraction < 40%, (%) 6 28 53
Functional MR, (%) 27 71 77
Ischemic NA NA 42
Non-ischemic NA NA 58
Degenerative MR, (%) 73 29 23
“Access Eu” Registry
99.6% Implant Rate N=566
2,7%
37%
60%
0,4%
0%
20%
40%
60%
80%
100%
Perc
ent
0 MitraClips (N=2)
1 MitraClip (N=340)
2 MitraClips(N=208)3 MitraClips (N=15)
4 MitraClips (N=1)
0.2%
Procedural and Post-procedural Results ACCESS EU – MitraClip Patients
N=566
Procedural, (mean ± SD)
Procedure time, (min) 117 ± 69
Contrast volume, (ml) 17 ± 40
Fluoroscopy duration, (min) 29 ± 20
Post-procedural, (mean ± SD)
ICU/CCU duration, (days) 2.5 ± 6.5
Length of hospital stay, (days) 7.7 ± 8.2
Discharge to, (%)
Home 80% (447/561)
Skilled nursing home/nursing facility 18% (103/561)
Died prior to discharge 2% (11/561)
“Access Eu” Registry
30 Day Events*
Patients Experiencing Event, # (%)
All Patients N=566
Logistic EuroSCORE ≥20%
N=252
Logistic EuroSCORE <20%
N=314
Death 19 (3.4%) 11 (4.4%) 8 (2.5%)
Stroke 4 (0.7%) 3 (1.2%) 1 (0.3%)
Myocardial Infarction 4 (0.7%) 2 (0.8%) 2 (0.6%)
Renal Failure 24 (4.2%) 16 (6.3%) 8 (2.5%)
Respiratory Failure 4 (0.7%) 3 (1.2%) 1 (0.3%)
Need for Resuscitation 10 (1.8%) 7 (2.8%) 3 (1.0%)
Cardiac Tamponade 6 (1.1%) 3 (1.2%) 3 (1.0%)
Bleeding Complications 21 (3.7%) 12 (4.8%) 9 (2.9%)
* As reported by sites as of January 12, 2012
“Access Eu” Registry
At Risk 0 Day 30 Days 180 Days
N 566 540 486
88.8%
at 6 Months
96.6%
at 30 Days
“Access Eu” Registry
Reported by Site* ACCESS EU – MitraClip Patients
N=566
MitraClip Device Embolization 0% (0/566)
Single Leaflet Device Attachment (SLDA) 4.6% (26/566)
Mitral Valve Surgery Within 6 Months Post-Index Implant Procedure
4.6% (26/566)
Second Intervention to Place an Additional MitraClip Device 3.4% (19/566)
* As of January 12, 2012
“Access Eu” Registry
N = 392 Matched Cases
80% MR ≤ 2+ at 6 Months
0
20
40
60
80
100
Baseline 6 months
Perc
ent
Patients
3+
4+
3+
2+
1+
0
p<0.0001
2+
4+
* As assessed by the sites
“Access Eu” Residual MR
Access EU NYHA Functional Class
71% NYHA Class I or II at 6 Months
0
20
40
60
80
100
Baseline 6 months
Perc
ent
Patients
II
III
IV
II
III
IV
I
N = 378 Matched Cases
p<0.0001
I
Access EU Quality of Life Score (MLWHF)
0
15
30
45
60
Mean Q
oL S
core
(M
LWH
F)
p<0.0001
Baseline 6 Months
N = 306 Matched Cases
41.4
28.9
Mean improvement
-12.5 points
95% CI: (-14.9, -10.1)
Access EU 6-Minute Walk Distance
0
100
200
300
400
Mean M
ete
rs W
alk
ed
Baseline 6 Months
N = 254 Matched Cases
p=0.0007 Mean improvement
58 meters 95% CI: (44.0, 72.1)
265
323
Conclusions > 5000 procedures
EVEREST II
178 Pts
RCT
ACCESS EU 566 Pts
REALISM 650 Pts
EVEREST II HR 211 Pts
Registries
Franzen, Schillinger, Sven,
Treede, Auricchio
Large cohorts*
Less Transfusion
Surgery Better
Safety Confirmed Functional MR
Reimbursement STIC 2011 rejected
in France PHRC 2012 ?
Bichat 12
Lyon CHU 11
Massy 7
Nantes J.Cartier 5
Toulouse CHU 2
--------------------------
Total 37
37 Patients : 10 females, 27 Males 75 ans
Etiology :
26 Functional, 8 Dystrophic, 6 Mixed
Procedure :
2 Failures
2 Clips in 5 pts
Morbi-Mortality :
1 Clip Detachment Surgery
1 pericardial effusion
1 Esophagus Perf. DCD at 1 month
Results
MR Grade Patients
-1 1
-1,5 2
-2 4
-2,5 13
-3 6
-3,5 4
Country comparison (patients / million inhabitants)
Source : Abbott Vascular Data on file – Sept 2011
0
5
10
15
20
25
30
35
40
Spa
in
Cze
ch R
epubl
ic
Finland
Turke
y
Polan
d
Belgium
Franc
e
Denm
ark
Aus
tria
Swed
en
Neth
erland
s
Switz
erland
Unite
d Kingd
om Italy
Ger
man
y
Nb
er
of
mo
nth
s o
n t
he m
ark
et
0
5
10
15
20
25
Nb
er
of
PM
VR
per
1000 0
00 o
f In
hab
.
“ Wu, Bolling et al JACC 2005 “
ESC 2007 Guidelines
MV Repair Indications for FMR and Results
Mitraclip Candidates and Results
ISSN: 1524-4539 Copyright © 2005 American Heart Association. All rights reserved. Print ISSN: 0009-7322. Online
72514Circulation is published by the American Heart Association. 7272 Greenville Avenue, Dallas, TX
DOI: 10.1161/CIRCULATIONAHA.104.525188 2005;112;I-402-I-408 Circulation
Pagliaro, Lucia Torracca, Francesco Maisano and Ottavio Alfieri Michele De Bonis, Elisabetta Lapenna, Giovanni La Canna, Eleonora Ficarra, Marco
Cardiomyopathy: Role of the "Edge-to-Edge" TechniqueMitral Valve Repair for Functional Mitral Regurgitation in End-Stage Dilated
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MV Repair Indications for FMR and Results
Mitraclip Candidates and Results