Transcript 24 th Washington, DC. Ted Feldman, MD, MSCAI

Mitral Valve Repair:
State of the Field - Where Are We Going from Here?
Ted Feldman, M.D., MSCAI FACC FESC
Evanston Hospital
Cardiovascular Research Technologies 2015
February 21st-24th
Washington, DC.
Ted Feldman MD, MSCAI FACC FESC
Disclosure Information
The following relationships exist:
Grant support: Abbott, BSC, Edwards, WL Gore
Consultant: Abbott, BSC, Coherex, Edwards, JenaValve,
Diiachi Sankyo-Lilly, WL Gore
Off label use of products and investigational devices
will be discussed in this presentation
Treated Patients
>19,000
Carillon
>300
>60
MitraClip
>40
>25
TRAMI MitraClip Experience n=828
German TRAnscatheter Mitral valve Interventions Registry
Age
76.0 (71.0-81.0)
STS
6.0 (3.5-11.0)
Functional MR
515/734 (70%)
Procedure time (minutes)
103.2 ± 54.1
Fluoroscopy time (minutes)
29.1± 57.1
Fully successful procedure
682/818 (83.4%)
Death
18/825 (2.2%)
Intraprocedural death
1/825 (0.1%)
Stroke
7/784 (0.9%)
Clip embolisation
0
Early partial leaflet detachment
16/784 (2%)
Severe complications in-hospital
106/828 (12.8%)
-major bleeding requiring transfusion
58/783 (7.4%)
-pericardial tamponade
15/783(1.9%)
-injury of inter-atrial septum
1/828 (0.1%)
Catheter Cardiovasc Interv. 2015 Jan 19. doi: 10.1002/ccd.25838. [Epub ahead of print]
TMVR in prohibitive surgical risk patients is associated with safety and good clinical
outcomes, including decreases in rehospitalization, functional improvements, and favorable
ventricular remodeling, at 1 year.
J Am Coll Cardiol 2014;64:182–92
Left Ventricular Volumes
Left Ventricular End Diastolic
Volume
180
Mean = -17.9 ml
97.5% UCB = -13.5 ml
p<0.0001
Mean Volume (ml)
160
Left Ventricular End Systolic
Volume
85
140
80
120
75
160.5
142.6
100
65
60
60
1 Year
Paired data (N=203)
87.0
70
80
Baseline
Mean = -8.1 ml
97.5% UCB = -4.8 ml
p<0.0001
90
78.9
Baseline
1 Year
Paired data (N=202)
Hospitalizations For Heart Failure
1.00
0.80
0.67
73% Reduction
p < 0.0001
0.60
0.40
0.18
0.20
0.00
1 Year Prior
to MitraClip
N = 127
1 Year Post
Discharge
N = 120
MitraClip Clip Delivery System
Approved October 24, 2013
Indication for Use:
The MitraClip Clip Delivery System is indicated for the
percutaneous reduction of significant symptomatic mitral
regurgitation (MR ≥ 3+) due to primary abnormality of the mitral
apparatus [degenerative MR] in patients who have been
determined to be at prohibitive risk for mitral valve surgery by a
heart team, which includes a cardiac surgeon experienced in
mitral valve surgery and a cardiologist experienced in mitral valve
disease, and in whom existing comorbidities would not preclude
the expected benefit from reduction of the mitral regurgitation.
DMR Case Example
•
•
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87M
Multiple hospitalizations for CHF
EF 70-75%
NYHA Class III
PASP 50mmHg
STS
– Repair 7.5%
– Replace 11%
Pre vs Post 2 Clips
The EVEREST II Randomized Clinical Trial:
5 Year Outcomes By MR Etiology
CONCLUSIONS
Although percutaneous repair was less effective at reducing
mitral regurgitation than conventional surgery, the
procedure was associated with superior safety and similar
improvements in clinical outcomes.
Septal Lateral Annular Dimensions
EVEREST II RCT All Treated Patients - MitraClip Group (N=178)
Diastolic SLAD
5
5
4
4
3.4
3.3
3
2
1
0
Baseline
5 Years
Mean SLADdiast (cm)
Mean SLADsyst (cm)
Systolic SLAD
3.9
3.9
Baseline
5 Years
3
2
1
0
Freedom From Mortality & Reintervention
DMR MitraClip
DMR Surgery
DMR Clip:
DMR Surg:
FMR Clip:
FMR Surg:
FMR Surgery
Baseline
12
Months
24
Months
36
Months
48
Months
60
Months
RCT Device FMR
48
39
33
31
26
9
RCT Device DMR
130
119
110
102
93
49
RCT Surgery FMR
18
15
13
11
9
8
RCT Surgery DMR
62
55
52
46
43
16
# At Risk
Kaplan-Meier estimate
FMR MitraClip
97.7% [92.7%, 99.3%]
91.8% [81.3%, 96.5%]
83.2% [69.1%, 91.3%]
93.8% [63.2%, 99.1%]
At 1 year
DMR Clip:
DMR Surg:
FMR Clip:
FMR Surg:
89.4% [77.7%, 95.2%]
85.9% [60.1%, 95.6%]
59.7% [31.6%, 79.4%]
55.0% [27.2%, 76.0%]
At 5 years
EVEREST II RCT
Therapy for MR
Degenerative
Functional
Low Surgical
Risk
Surgical Mitral
Repair
?
High Surgical
Risk
Commercial
MitraClip
COAPT
Clinical Outcomes Assessment of the MitraClip
Percutaneous Therapy for High Surgical Risk
~430 patients enrolled at up to 75 US sites
Significant FMR ≥3+ core lab; EF<50%; CHF hospitalization or BNP>300
High risk for mitral valve surgery- Local Heart Team
Specific valve anatomic criteria
Randomize 1:1
MitraClip
Control group
Standard of care
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
Outcomes of Unoperated Patients With Severe
Symptomatic MR and Heart Failure
Unoperated patients had lower EF(27 ±15% vs. 42±17%, p < 0.0001) and
higher STS score compared with operated patients (median [interquartile range]: 5.8 [2.8
to 11.5] vs. 4.0 [2.1 to 7.4], p < 0.001.
JACC 63:185-186, 2014
COAPT Inclusion
• Symptomatic functional MR (≥3+)
– Cardiomyopathy ischemic or non-ischemic
• LVEF ≥20% and ≤50%
• HF hospitalization ≤12 months and/or a
corrected BNP ≥300 pg/ml or NT-proBNP
≥1500 pg/ml ≤90 days
• TTE on optimal therapy ≥30 days after:
– any change in GDMT
– revascularization and/or implant of CRT
Version 5.1 November 11, 2013
STS
18.2±8.4%
J Am Coll Cardiol 2014;64:172–81
MitraClip Status
•
•
•
•
•
19,148 total implants
420 global sites in 35 countries
1200 US commercial implants
110 commercial US sites
73 active COAPT sites
– 170 patients randomized
Abbott Vascular updated Dec 31st 2014
Percutaneous Mitral Repair Devices
Already gone
Still developing
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PTMA
Monarc
Mobuis leaflet repair
Recor RF annular
remodeling
• Coapsys
Leaflet repair
CS annuloplasty
Direct annuloplasty
Cerclage
Mitral spacer
Midle Peak
Chordal replacement
Valve replacement
Coronary Sinus- Indirect Annuloplasty
CARILLON Mitral Contour System
Trans Femoral Cardioband
DIRECT ANNULOPLASTY
Mitralign Procedure Steps
Wire Delivery
Pledget Delivery
Plication & Lock
Suture bicuspidization of the tricuspid valve vs ring annuloplasty for
functional tricuspid regurgitation
Midterm results of 237 consecutive patients
Suture bicuspidization is performed by placement of a 2-0 pledget-supported mattress suture from the
antero-posterior to the posteroseptal commissures along the posterior annulus.
J Thorac Cardiovasc Surg 2007;133:117-126
Mitral Replacement Technologies
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CardiaAQ
Neovasc TIARA
Tendyne
Edwards FORTIS
Endovalve
M-Valve
Medtronic
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Valtech
Lutter
MitrAssist
Caisson
MitraSeal
Twelve
HighLife
Others….
Mitral Repair vs Replacement for Severe Ischemic MR
The composite end point included death, stroke, subsequent mitral-valve (MV) surgery, hospitalization
for heart failure, and an increase in the New York Heart Association class of 1 or more.
Acker M et al NEJM 370:23, 2014
The MITRAL Trial
Mitral Implantation of TRAnscatheter vaLves in native mitral stenosis
Principal Investigator Mayra Guerrero, MD
The safety and feasibility of the SAPIEN XT TM Transcatheter Heart
Valve with NovaFlex and Ascendra delivery systems in patients with
symptomatic severe calcific mitral stenosis who are not candidates for
mitral valve Surgery
– Cedars-Sinai Medical Center (Co- Principal Investigators: Saibal Kar,
MD; Rajendra Makkar, MD)
– Columbia University (Co-Principal investigators: Susheel Kodali, MD;
Martin Leon, MD)
– Evanston Hospital (Co- Principal Investigators: Mayra Guerrero, MD;
Ted Feldman, MD)
– Henry Ford Hospital (Principal investigator: William O’Neill, MD)
– Massachusetts General Hospital (Principal Investigator: Igor Palacios,
MD)
– Mayo Clinic (Principal Investigator: Charanjit RIhal, MD)