(PMVR): Percutaneous Mitral Valve Repair

Percutaneous Mitral Valve Repair
((PMVR):
)
From Science to Practice
T d Feldman,
Ted
F ld
M.D.,
M D FSCAI FACC FESC
Evanston Hospital
18th ANGIOPLASTY SUMMIT
TCTAP 2013
April 23rd-26th, 2013
Seoul, Korea
Ted Feldman MD, FACC, FESC, FSCAI
Disclosure Information
The following relationships exist:
Grant support: Abbott, BSC, Edwards, WL Gore
Consultant: Abbott, BSC, Coherex, Edwards, Intervalve,
Diiachi
h Sankyo-Lilly,
S k
ll WL Gore
G
Off label use of products and investigational devices
willll be
b discussed
d
d in this
h presentation
Congenital
g
Double Orifice Mitral Valve
Cathet Cardiovas Intervent 49:200–203 (2000)
Surgical isolated edge-to-edge mitral repair
without annuloplasty
clinical proof of principle for an endovascular approach
Freedom from re-operation and 2+ MR
Maisano F, Vigano G, Blasio A, Columbo A, Calabrese C, Alfieri O
Eurointervention 2:181-186, 2006
From Science to Practice: Prototype
Catheter-Based Mitral Valve Repair
MitraClip® System
Investigational Device only in the US; Not available for sale in the US
Anesthesiologist
Operators
Echocardiographer
Evalve
Guide & CDS
Anatomic Eligibility
g
y
Leaflet mal-coaptation resulting in MR
Non-rheumatic/endocarditic valve morphology; LVIDs ≤55mm; MVA ≥4cm2
F ld
Feldman
T,
T Kar
K S,
S Rinaldi
Ri ldi M,
M Fail
F il P,
P Hermiller
H
ill J,
J Smalling
S lli R,
R Whitlow
Whitl
PL,
PL Gray
G
W,
W Low
L
R,
R Herrmann
H
HC,
HC Lim
Li S,
S Foster
F t E,
E Glower
Gl
D
Percutaneous Mitral Repair with the MitraClip System: Safety and Midterm Durability in the Initial EVEREST Cohort
J Am Coll Cardiol 54:686-694, 2009
CONCLUSIONS
Although percutaneous repair was less effective at
reducing mitral regurgitation than conventional surgery,
the
h procedure
d
was associated
d with
h superior safety
f
and
d
similar improvements in clinical outcomes.
Mi l Regurgitation
Mitral
R
i i Severity
S
i
MitraClip (N
(N=178)
178)
All
T
Treated
t d
84% MR ≤ 2+ at 3 Years
Surgery (N=80)
(N 80)
P
Patients
ti t (N
(N=258)
258) 96% MR ≤ 2+ at 3 Years
100%
80%
% Patie
ents
0+
1+
60%
2+
3+
4+
40%
20%
0%
BL 1Y
Matched N = 149
13
BL 2Y
126
BL 3Y
119
BL 1Y
66
BL 2Y
57
BL
3Y
50
C-14
Effectiveness:
Reduction in LV Size at 1 Year
Paired Analysis
LVEDV
All ((N = 203))
LVIDd
All ((N = 221))
LVESV
All (N = 202)
‐35
LVIDs
All (N = 210)
‐25
‐15
‐5
5
Mean Difference (mL)
‐0.4
‐0.2
0
0.2
Mean Difference (cm)
Kaplan-Meier Freedom from MV Surgery in
MitraClip group or Re-operation
Re operation in Surgery group
All Treated Patients (N = 258)
Surgery (N = 80)
MitraClip (N = 178)
98.7%
97.1%
1 year
97.2%
96.3%
2 years
95.6%
95.5%
3 years
Surgery Non-High Risk (N = 80)
RCT MitraClip Non-High Risk (N = 178)
MitraClip Non-High Risk (N = 178)
RCT Surgery Non-High Risk (N = 80)
0
15
180
360
540
720
Days Post Index Procedure
900
1080
TCT 2012
Endovascular Valve Edge-to-Edge REpair STudy
Subgroup
g
Analyses for the Primary End Point at 12 Months
Feldman T et al. N Engl J Med 2011;364:1395-1406
Device Implant Rate
EVEREST Trials
100%
98.3%
98%
Impla
ant Rate (%
%)
96%
93.2%
94%
91.2%
92%
90%
91.9%
89 8%
89.8%
88%
86%
84%
2003-2006
2007
2008
2009
2010
Year
N=710
July 2003- Nov 2010
Gary G, Feldman T: The basic technique for the Evalve MitraClip procedure
in Feldman T, St. Goar F: Percutaneous mitral leaflet repair. Informa, London, 2012
Single
g Leaflet Device Attachment
EVEREST Trials
9%
8.2%
Patientts with SLD
DA (%)
8%
7%
6%
5 1%
5.1%
5%
4.0%
4%
2 7%
2.7%
3%
2%
0.9%
1%
0%
2003-2006
2007
2008
2009
2010
Year
Loss of insertion of a single ongoing insertion of the opposing leaflet
N=710
July 2003- Nov 2010
European Use
D i Time
Device
Ti
Reduction of 32
29 minutes in the mean Device Time (p<0.0001)
Ti
Time
0 = 118 mins
i
Time 49 months = 86.1 mins
Source: 5,099 MitraClip device procedures performed at 158 European sites
Maisano TCT 2012
J Am Coll Cardiol 2012;59:130–9
Hospitalizations
p
for CHF
EVEREST II High Surgical Risk Cohort
Overall EF 40-45%
40 45% with no regional wall motion abnormalities
abnormalities.
There is 4+ MR.
Left Anterior Descending:
60-70% stenosis proximal to the 1st diagonal and 50-60%
stenosis 2-3cm distal to the 1st diagonal
- Adenosine
Ad
i negative
ti
6/4/2004
4 Chamb
ber
Long Axis
Pre
5 Years Post
1 Day Post
PASP already down
from 79mm to 55mm
5 Years Post
CRT in Patients With Moderate-Severe Functional MR
and High Operative Risk
Circulation. 2011;124:912-919
Correction of MR in Non-responders to CRT
Mit Cli Improves
MitraClip
I
Symptoms
S
t
and
d Promotes
P
t Reverse
R
Remodeling
R
d li
LV Volume
LVEF
Auricchio A- J. Am. Coll. Cardiol. 2011;58;2183-2189
Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk
~420 patients enrolled at up to 75 US sites
Significant FMR ≥3+ core lab
High risk for mitral valve surgery
Specific valve anatomic criteria
Randomize 1:1
MitraClip
Control group
St d d off care
Standard
Safety: Composite death, stroke, worsening renal
function, LVAD implant, heart transplant at 12 months
Effectiveness: Recurrent heart failure hospitalizations
Protocol conditionally approved by FDA July 26, 2012