1
Jeffrey J. Popma, MDDirector, Interventional Cardiology
Clinical ServicesBeth Israel Deaconess Medical Center
Associate Professor of MedicineHarvard Medical School
Boston, MA
Percutaneous Mitral Valve Therapies
2
Conflict of Interest StatementConflict of Interest Statement
Within the past 12 months, I have had a financial Within the past 12 months, I have had a financial interest/arrangement or affiliation with the interest/arrangement or affiliation with the organization(s) listed below.organization(s) listed below.
Physician NamePhysician Name Company/RelationshipCompany/Relationship
Jeffrey J. Popma, MD Research Grants: Cordis, Boston ScienJeffrey J. Popma, MD Research Grants: Cordis, Boston Scientific,tific,Medtronic, AbbottMedtronic, Abbott--Guidant, eV3, LabCoatGuidant, eV3, LabCoatMedical Advisory Board: Cordis, Boston Medical Advisory Board: Cordis, Boston Scientific, Abbot VascularScientific, Abbot Vascular
3
Transcatheter Mitral ValveTranscatheter Mitral Valve
Mitral Valve PathologyMitral Valve Therapies
Edge-edge repairChordal ShorteningCoronary Sinus AnnuloplastyDirect AnnuloplastyMV Replacement
4
Device Landscape 2011 Device Landscape 2011 Percutaneous MV RepairPercutaneous MV Repair
EdgeEdge--toto--edgeedge•• Evalve MitraClip*Evalve MitraClip*
DirectDirectAnnuloplastyAnnuloplasty
•• Mitralign Bident*Mitralign Bident*•• GDS Accucinch*GDS Accucinch*•• ReCor (US)*ReCor (US)*•• Quantum Cor (RF)Quantum Cor (RF)•• Valtech CardiobandValtech Cardioband•• Micardia enCorMicardia enCor
ChordalChordalShorteningShortening
•• CardiosolutionsCardiosolutions••MitraMitra--Spacer*Spacer*•• NeoChordNeoChord••Valtech VChordalValtech VChordal
Coronary sinusCoronary sinusAnnuloplastyAnnuloplasty
•• Cardiac Dimensions Carillon*Cardiac Dimensions Carillon*•• Edwards Monarch*Edwards Monarch*•• Viacor PTMA*Viacor PTMA*•• Cerclage annuloplastyCerclage annuloplasty
MV replacementMV replacement•• EndoValveEndoValve•• CardiAQCardiAQ•• Valtech CardiovalveValtech Cardiovalve•• ValveXchangeValveXchange
*In patients*In patients
5Adams et al. Eur Heart J 2010;31:1958-1967
+ ++ +++ ++++
FED FED+ Forme Fruste Barlow’s
Leaflet Tissue
First Question: Degenerative or Functional?First Question: Degenerative or Functional?
6
Second Question: What is the Surgical Second Question: What is the Surgical Risk (STS PROM)?Risk (STS PROM)?
FED FED+ Forme Fruste Barlow’s
Increasing Repair Difficulty
Adams et al. Eur Heart J 2010;31:1958-1967
7
Leaflet CoaptationLeaflet Coaptation–– EdgeEdge--toto--Edge RepairEdge Repair–– Alfieri StitchAlfieri Stitch
Annular ReshapingAnnular Reshaping–– CinchingCinching–– AnnuloplastyAnnuloplasty
Percutaneous Methods for Mitral Percutaneous Methods for Mitral Valve Repair Valve Repair Functional MRFunctional MR
8
Percutaneous Mitral Valve RepairMitraClip® System
9
~3,135 patients at ~80 hospitals in EU
and 40 clinical trial sites in the U.S. have been treated with the MitraClip device
The MitraClip: Global ExperienceThe MitraClip: Global Experience(through 4/20/2011)(through 4/20/2011)
Finland
Austria
Italy
Spain
Morocco AlgeriaTunisia
LibyaEgypt
Turkey
Georgia
SyriaIraq
Iran
Kazakhstan
AzerbaijanArmenia
Saudi Arabia
Jordan
Lebanon
Israel
Cyprus
Sweden
Norway
Germany
France
Portugal
HungaryRomania
Bulgaria
Denmark
Poland
Belarus
UkraineCzech Rep.
Slovakia
Greece
Malta
Netherlands
Liechtenstein
SanMarino
Belgium
Ireland
SerbiaMontenegro
Albania
Moldova
Lithuania
Latvia
Estonia
Luxembourg
Andorra
Bosnia&
Herzegovina
CroatiaSlovenia
Switzerland
Macedonia
Iceland
Russia
RussiaUnited
Kingdom
0
0
500 Miles
500 KM
Study n
EVEREST I 55
EVEREST II Roll-in 60
EVEREST II HRR 78
EVEREST II Randomized 184
REALISM (Continued Access) 571
Commercial use (EU) 2187Source: Abbott VascularSource: Abbott Vascular
EVEREST II Randomized Clinical Trial279 Patients enrolled at 37 sites
Randomized 2:1
Echocardiography Core Lab and Clinical Follow-Up Baseline, 30 days, 6 months, 1 year, 18 months, and
annually through 5 years
Control GroupSurgical Repair or Replacement
N=95
Significant MR (3+-4+)73% DMR, 27% FMR
Specific anatomical criteria
Device GroupMitraClip System
N=184
Feldman T et al. NEJM 2011;364:1395Feldman T et al. NEJM 2011;364:1395--406406
11
EVEREST II RCT: Patient FlowEVEREST II RCT: Patient Flow
Acute Procedural Success (APS) = MR ≤2+ at discharge
12 monthsn=134
98.5% Clinical Follow-up98% Echo Follow-up
12 months n=74
94% Clinical Follow-up92% Echo Follow-up
30 daysn=136
99% Clinical Follow-up
30 daysn=79
99% Clinical Follow-up
Acute Procedural SuccessAchieved
n=137 (77.0%)
Randomized, not treatedDevice, n=6
Control, n=15
Treatedn=178
Treatedn=80
(86% MV repair)
Device Groupn=184
Acute Procedural SuccessNot Achieved
n=41 (23.0%)**20 of 41 no implant
Surgical Groupn=95
Randomized Cohort n=279
Feldman T et al. NEJM 2011;364:1395Feldman T et al. NEJM 2011;364:1395--406406
28 had MV surgery28 had MV surgery
9 had MV surgery9 had MV surgery
37/178 total (20.8%)37/178 total (20.8%)
Per Protocol
121
0 0 Myocardial Infarction
2 (2.5%)0 Major Stroke
0 1 (0.7%)GI Complication Requiring Surgery
57.0%9.6%TOTAL % of Patients with MAEp<0.0001*
(95% CI 34.4%, 60.4%)
# Patients experiencing event
42 (53.2%)12 (8.8%)All Transfusions ≥2 units*
0 0 Septicemia
4 (5.1%)0 Ventilation >48 hrs
0 0 Renal Failure0 0 Deep Wound Infection
1 (1.3%)0Re-operation of Mitral Valve4 (5.1%)0 Urgent / Emergent CV Surgery
New Onset Permanent Atrial Fib
Death
Control Group(n=79)
Device Group(n=136)
2 (2.5%)0
0 0
30 Day MAE, non-hierarchical
*p<0.0001 if include Major Bleeding only
EVEREST II RCT: Primary Safety EndpointPer Protocol Cohort
Feldman T et al. NEJM 2011;364:1395Feldman T et al. NEJM 2011;364:1395--406406
13Ted Feldman, ACC 2011 Late Breaking Trial
EVEREST II: Mitral Regurgitation Grade Baseline, 1 and 2 Years (matched)
Intention to Treat
* Within group difference (p<0.05); † Between group difference at 1 year (p<0.05); ‡ Between group difference at 2 year (p<0.05)
0
20
40
60
80
100
Baseline 1 Year 2 Years
Perc
ent Pa
tient
s (%
) 1+
2+
4+
(N=122) (N=122) (N=122)
Percutaneous Surgery
3+
2+
4+3+
1+
2+
4+3+
0
20
40
60
80
100
Baseline 1 Year 2 Years
Perc
ent Pa
tient
s (%
)
1+
2+
4+
(N=56) (N=56) (N=56)
3+
2+3+
0+
1+
2+
0+0+
**
**
‡†‡†
14Ted Feldman, ACC 2011 Late Breaking Trial
EVEREST II: LV Volumes Baseline, 1 and 2 Years (matched)
Intention to Treat
62 57 55 60 55 50
0
20
40
60
80
100
120
140
160
180
LVES
V (m
L)
Percutaneous N=117
157
133124
158
119110
0
20
40
60
80
100
120
140
160
180
LVED
V (m
L)
BL 1 Yr 2 Yrs BL 1 Yr 2 Yrs Surgery N=55
BL 1 Yr 2 Yrs BL 1 Yr 2 Yrs Percutaneous
N=117 Surgery N=55
LV End Systolic Volume
* * *
* * *
* *
* * *
LV End Diastolic Volume
* Within group difference (p<0.05) † Between group difference at 1 year (p<0.05) ‡ Between group difference at 2 year (p<0.05)
† ‡ † ‡
15Ted Feldman, ACC 2011 Late Breaking Trial
EVEREST II: Kaplan-Meier Freedom from DeathIntention to Treat
163 133 52At Risk:
Surgery184 1530 Days 1yr
1666m 1.5yr 2yr 3yr
Percutaneous95 74 63 257178
0.0
0.2
0.4
0.6
0.8
1.0
0 180 360 540 720 900 1080
Days from Index Procedure
Free
dom
fro
m D
eath
PercutaneousSurgery
Surgery = 91.1%Percutaneous = 89.8%
p=0.78
Surgery = 95.0%Percutaneous = 94.9%
p=0.95
16Ted Feldman, ACC 2011 Late Breaking Trial
EVEREST II: Landmark Analysis of Kaplan-Meier Freedom from MV Surgery (Percutaneous)/Re-operation (Surgery)
Intention to Treat
131 109 44At Risk:
Surgery124
1yr1386m 1.5yr 2yr 3yr
Percutaneous72 616977
1840 Days
95
0.0
0.2
0.4
0.6
0.8
1.0
0 180 360 540 720 900 1080
Days from Index Procedure
Free
dom
Fro
m S
urge
ry (
Dev
ice)
or
Reop
erat
ion
(Sur
gery
)
Surgery = 97.3%Percutaneous = 95.6%
p=0.52
Surgery = 98.7%Percutaneous = 96.3%
p=0.32
Percutaneous Surgery
2424
17Ted Feldman, ACC 2011 Late Breaking Trial
EVEREST II: NYHA Functional Class
At Baseline, 1 and 2 Years (matched) Intention to Treat
* *
Percutaneous Surgery
* †
* ‡ †
0
20
40
60
80
100
Baseline 1 Year 2 Years0
20
40
60
80
100
Baseline 1 Year 2 Years
I
II
I
II
I
II
III
IV
I I I
II
II II
III III IV
(N=127) (N=127) (N=127) (N=56) (N=56) (N=56)
III
‡
Perc
ent
(%)
* Within group difference (p<0.05) † Between group difference at 1 year (p<0.05) ‡ Between group difference at 2 year (p<0.05)
18Ted Feldman, TCT 2010
EVEREST II RCT MitraClip ArmEVEREST II RCT MitraClip ArmMR Reduction by EtiologyMR Reduction by Etiology
0%
20%
40%
60%
80%
100%
Baseline 12 Months Baseline 12 Monthsn=135 n=87 n=49 n=32
3+/4+
1+
3+/4+
2+ 2+
2+
1+ 34.5%
11.5%
36.8%
17.2%
40.6%
12.5%
25.0%
21.9%3+/4+
DMR Cohort FMR Cohort
1+-2+
2+
1+-2+
3+/4+
19Ted Feldman, TCT 2010
0
40
80
120
160
Vol
um
e (m
l)
0
40
80
120
160
Vol
um
e (m
l)EVEREST II RCT MitraClip ArmEVEREST II RCT MitraClip ArmLeft Ventricular Function by EtiologyLeft Ventricular Function by Etiology
LV End Diastolic and End Systolic VolumesLV End Diastolic and End Systolic Volumes
LVEDVLVEDV LVESVLVESV
FMR CohortFMR Cohortn=30, matched datan=30, matched data
LVEDVLVEDV LVESVLVESV
BaselineBaseline 12 Months12 Months
p<0.0001p<0.0001
DMR Cohort DMR Cohort n=88, matched datan=88, matched data
p=0.002p=0.002
P=0.0002P=0.0002
p=0.04p=0.04
20Ted Feldman, TCT 2010
0
20
40
60
80
100
Perc
ent
Pati
ents
EVEREST II RCT MitraClip ArmEVEREST II RCT MitraClip ArmNYHA Functional Class by EtiologyNYHA Functional Class by Etiology
97.8%NYHA
Class I/II
96.7%NYHA
Class I/II
I
II
II
III
IVIV
III
II
I
II
I
BaselineBaseline BaselineBaseline12 months12 months 12 months12 months
p<0.0001p<0.0001 p<0.0001p<0.0001
DMR Cohort DMR Cohort n=93, matched datan=93, matched data
FMR CohortFMR Cohortn=31, matched datan=31, matched data
21
EVEREST II High Surgical Risk CohortEnrollment
1 YearN = 133
1 YearN = 78
REALISM High Surgical Risk Trial^N = 294 Enrolled
EVEREST II High Surgical Risk CohortN = 372
EVEREST II High Surgical Risk CohortWith 1 Year Follow-Up
N = 211
EVEREST II High Surgical Risk Trial*N = 78 Enrolled
Ted Feldman. EuroPCR 2011
* EVEREST HR * EVEREST HR defined by predicted defined by predicted
surgical mortality surgical mortality ≥≥12% using STS risk 12% using STS risk calculator or surgeon calculator or surgeon
estimate from coestimate from co--morbuiditiesmorbuidities
^ ACCESS EU high ^ ACCESS EU high risk defined by risk defined by
EuroSCORE EuroSCORE ≥≥20% 20%
22Ted Feldman. EuroPCR 2011
EVEREST II High Surgical Risk Cohort Mitral Regurgitation Grade
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