ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2
.pdf
Mitral Regurgitation Grade
Baseline, 1 and 2 Years (matched)
Intention to Treat
* Within group difference (p<0.05)
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* |
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* |
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100 |
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2+ |
0+ |
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(%) |
80 |
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1+ |
1+ |
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Patients |
60 |
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3+ |
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Percent |
40 |
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2+ |
2+ |
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20 |
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4+ |
3+ |
3+ |
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0 |
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4+ |
4+ |
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Baseline |
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1 Year |
2 Years |
(N=122) (N=122) (N=122)
Percutaneous
Percent Patients (%)
100
80
60
40
20
0
*
*
2+ |
0+ |
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0+ |
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3+ |
1+ |
1+ |
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4+ |
2+ |
2+ |
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3+ |
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Baseline |
1 Year |
2 Years |
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(N=56) |
(N=56) |
(N=56) |
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Surgery |
111 |
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LV Volumes
Baseline, 1 and 2 Years (matched)
Intention to Treat
* Within group difference (p<0.05)
LV End Diastolic Volume
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180 |
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* |
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* |
* |
* |
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* |
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160 |
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140 |
157 |
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158 |
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(mL) |
120 |
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133 |
124 |
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100 |
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119 |
110 |
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LVEDV |
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80 |
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60 |
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40
20
0
BL 1 Yr 2 Yrs |
BL 1 Yr 2 Yrs |
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Percutaneous |
Surgery |
N=117 |
N=55 |
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LVESV (mL)
180
160
140
120
100
80
60
40
20
0
LV End Systolic Volume
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* |
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* |
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* |
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* |
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* |
62 |
57 |
55 |
60 |
55 |
50 |
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BL 1 Yr 2 Yrs BL |
1 Yr 2 Yrs |
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Percutaneous |
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Surgery |
N=117 |
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N=55 |
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112
NYHA Functional Class
At Baseline, 1 and 2 Years (matched)
Intention to Treat
* Within group difference (p<0.05)
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* |
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* |
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100 |
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I |
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I |
I |
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(%) |
80 |
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II |
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60 |
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Percent |
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40 |
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III |
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20 |
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II |
II |
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IV |
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0 |
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Baseline |
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1 Year |
2 Years |
(N=127) (N=127) (N=127)
Percutaneous
100
80
60
40
20
0
*
*
I I I
II
III |
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II |
II |
IV |
III |
III |
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Baseline |
1 Year |
2 Years |
(N=56) |
(N=56) |
(N=56) |
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Surgery |
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113
EVEREST II Pivotal Clinical Trial
Program
EVEREST II
Surgical |
High Surgical Risk |
Population |
Population |
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RCT |
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RCT Surgery |
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MitraClip |
RCT MitraClip |
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High Risk |
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Control |
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Study |
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REALISM |
Continued |
REALISM |
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Access |
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Surgical |
High Surgical |
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Population |
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Risk Population |
114
EVEREST II High Risk and Concurrent Control Baseline Demographics and Co-morbidities
Demographics and |
High Risk |
Concurre |
Cohort |
nt Control |
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Co-Morbidities |
N=211 |
N=36 |
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Age (years) |
76 ±10 |
77 ±13 |
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≥ 75 years, (%) |
57% |
64% |
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Predicted Mortality*, (%) |
15.0% |
16.4% |
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Prior Cardiac Surgery, (%) |
58% |
50% |
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History Myocardial Infarction, (%) |
49% |
36% |
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Prior Stroke, (%) |
14% |
14% |
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COPD / Chronic Lung Disease, (%) |
30% |
31% |
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Moderate to Severe Renal Failure, (%) |
31% |
31% |
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History Atrial Fibrillation, (%) |
64% |
53% |
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Diabetes Mellitus, (%) |
40% |
42% |
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Ejection Fraction < 30%, (%) |
9% |
9% |
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LV ESD (mm) |
4.2 |
3.8 |
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NYHA Class III or IV, (%) |
86% |
84% |
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Etiology – Functional MR, (%) |
71% |
64% |
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* Based on STS ≥ 12% or an assigned mortality 12% for pre-specified comorbidities
EVEREST II High Risk and Non-High Risk Cohorts Predicted vs Observed 30 day Mortality
% Mortality
18
16
14
12
10
8
6
4
2
0
p < 0.001 |
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Predicted |
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16.4% |
Observed |
15.0% |
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8.3%
5.2%
EVEREST II |
Concurrent |
Cohort* |
Control* |
N = 211 |
N = 36 |
High Risk Cohorts
* Predicted mortality based on STS ≥ 12% or an assigned mortality 12% for pre-specified comorbidities
EVEREST II High Surgical Risk and
Concurrent Control
Kaplan-Meier Freedom From All-Cause Mortality
Freedom from All-Cause Mortality
1.0
0.8
0.6
0.4
0.2
0.0
0
At 2 Years
High Risk Cohort
At 1 Year = 66%
High Risk Cohort= 75.9%
Concurrent Control = 55.3%
p=0.048
EVEREST II High Risk Cohort (n=211)
High Risk Concurrent Control (n=36)
120 |
240 |
360 |
480 |
600 |
720 |
Days from Index Procedure
At Risk: |
0 Days |
6m |
1yr |
1.5yrs |
2yrs |
High Risk N |
211 |
179 |
155 |
102 |
53 |
High Risk CC N |
36 |
26 |
18 |
n/a |
n/a |
EVEREST II High Surgical Risk Cohort
NYHA Functional Class
All Patient Data
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100 |
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II |
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80 |
I |
I |
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Patients |
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60 |
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Percent |
III |
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40 |
II |
II |
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20 |
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IV |
III |
III |
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0 |
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Baseline |
1 Year |
2 Year |
1 Year Matched Data
p<0.0001
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100 |
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II |
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80 |
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I |
Patients |
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60 |
III |
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Percent |
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40 |
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II |
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20 |
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IV |
III |
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0 |
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Baseline |
1 Year |
2 Year Matched Data
p<0.0001 p<0.0001 p=NS
II
I I
III
II II
IV III III
Baseline 1 Year 2 Year
N=211 |
N=143 |
N=44 |
N=143 |
N=143 |
N=43 |
N=43 |
N=43 |
EVEREST II High Surgical Risk Cohort
Hospitalization for CHF
Annual Number
200
160
120
80
40
0
12 Months Prior to MitraClip, N=211
12 Months Following MitraClip, N=203
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1 |
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166 |
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Rate |
0.8 |
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p<0.0001 |
0.6 |
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Annual |
0.4 |
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90 |
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71 |
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0.2
36
0
p<0.0001
0.79
47%
Reduction
0.42
CHF Hospitalizations |
Patients |
CHF Hospitalization Rate |
Summary
Mitraclip
•The Everest RCT showed:
Percutaneous repair provides increased safety
Surgery provides more complete MR reduction
•78% of Mitraclip patients were free from surgery at 2 yrs
•Both percutaneous and surgical treatment reduced MR and demonstrated meaningful clinical benefits through 2 years
Significantly improved LV volumes and NYHA Functional Class
•In high risk patients, Mitraclip provided meaningful benefits:
66% survival at 2 years
Reduced LV volumes and improved NYHA functional class at 2 years
120