Federico M. Asch, MD - Cardiolintranet.cardiol.br/coberturaonline/slides/... · Background (i)...
Transcript of Federico M. Asch, MD - Cardiolintranet.cardiol.br/coberturaonline/slides/... · Background (i)...
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Heart Failure and Secondary Mitral Regurgitation:
Echocardiographic Outcomes
from the COAPT trial
Federico M. Asch, MD
Director, Echocardiographic Core Lab
MedStar Health Research Institute
On behalf of Gregg W. Stone, Michael Mack, Neil J Weissman and the
COAPT Investigators
COAPT (NCT01626079)
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Federico M Asch, MD
No personal COI
Institutional conflict
MedStar Health has Institutional contracts for my work as
Director of an Academic Core Lab:
Abbott, Boston Scientific, Edwards, Medtronic, Neovasc,
Livanova, GDS, Mitralign.
Disclosure Statement
COAPT (NCT01626079) is funded by Abbott
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Background (i)
• Secondary or functional mitral regurgitation (SMR) is
present in >50% of patients with heart failure (HF), and is
severe in ~10-15%.
• Prognosis is poor when SMR is severe.
• COAPT: Randomized, open-label, multicenter trial in
patients with HF and moderate-to-severe (3+) or severe
(4+) SMR who remained symptomatic despite maximally-
tolerated GDMT.
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Death or HF Hospitalization
MitraClip + GDMT
GDMT alone
All-
ca
use
Mo
rta
lity o
r
HF
Ho
sp
ita
liza
tio
n (
%)
0%
20%
40%
60%
80%
100%
Time After Randomization (Months)
0 3 6 9 12 15 18 21 24
67.9%
45.7%
MitraClip + GDMT
GDMT alone
302 264 238 215 194 154 145 126 97
312 244 205 174 153 117 90 75 55
No. at Risk:
HR [95% CI] =
0.57 [0.45-0.71]
P<0.001
NNT (24 mo) =
4.5 [95% CI 3.3, 7.2]
Stone GW et al. NEJM 2018;379:2307-18
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Background (ii)
• SMR is a consequence of leaflet tethering and incomplete
leaflet coaptation.
• Evaluation of SMR is challenging, due to asymmetric
leaflet anatomy and regurgitant orifice, eccentric jets and
enlarged left cardiac chambers.
• Expert panels have disagreed on how to define the
severity of SMR, resulting in conflicting European and
American guidelines.
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ObjectivesCOAPT Echo Sub-study
1. To describe the echocardiographic MR grading criteria
utilized in COAPT for screening and post-MitraClip
2. To describe the echocardiographic characteristics of the
COAPT population
3. To evaluate the serial echocardiographic outcomes
4. To identify baseline echocardiographic predictors of
clinical outcomes (responders and non-responders to
MitraClip)
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Methods
• 614 patients with HF and moderate to severe (3+) or
severe (4+) secondary MR
• Randomized 1:1 to maximally-tolerated GDMT + MitraClip
or GDMT alone.
• Transthoracic echocardiograms (TTE) at baseline, 1, 6,
12, 18, 24 months (to continue to year 5)
• All echo analysis by an independent echo core lab,
adapted from American guidelines (ASE, ACC)
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Key Echo Inclusion Criteria
1. LVEF 20% - 50% and LVESD ≤70 mm (ischemic or non-
ischemic)
2. SMR amenable for MitraClip treatment
3. Moderate-to-severe (3+) or severe (4+) SMR confirmed
by an independent echo core laboratory prior to
enrollment
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Inclusion Flowchart (i)
Patients with HF and MR evaluated for enrollment in COAPT
N=1,576
Secondary MR,
Severity 3+ or 4+
(graded by 1 of 3 criteria)
Roll-in
subjects
N=51
Randomized
subjects
N=614
Subjects with screening TTEs and
meeting all eligibility requirements
for enrollment in COAPT
N=665
Ineligible N=911Inadequate MR or DMR (n=244)
Echo criteria not met (n=255)
Not treated with GDMT (n=79)
All inclusion criteria not met (n=85)
Exclusion criteria present (n=34)
Incomplete screening/other (n=419)
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Inclusion Flowchart (ii)
Secondary MR, Severity 3+ or 4+
(graded by 1 of 3 criteria)
EROA ≥ 0.3 cm2
or
PV systolic flow reversal
N=570 (85.7%)
Tier 1
EROA not measured or <0.2 cm2
With at least 2 of the following:
• RV ≥ 45 ml/beat
• RF ≥ 40%
• VC width ≥ 0.5 cm
• PISA radius > 0.9 cm,
but CW of MR jet not done
• Large (≥ 6.0 cm)
holosystolic jet wrapping
around LA
• Peak E velocity ≥ 150 cm/s
N=25 (3.8%)
Tier 3
EROA 0.2 cm2 - <0.3 cm2
With any 1 of the following:
• RV ≥ 45 ml/beat
• RF ≥ 40%
• VC width ≥ 0.5 cm
N=70 (10.5%)
Tier 2
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Baseline Echo Characteristics (i)
Device Group
(N=302)
Control Group
(N=312) P-value
LVEF, % 31.3 ± 9.1 (281) 31.3 ± 9.6 (295) 0.96
LVEDV, ml 194.4 ± 69.2 (281) 191.4 ± 73.0 (295) 0.61
LVESV, ml 135.5 ± 56.1 (281) 134.6 ± 60.4 (295) 0.85
Stroke volume, ml 50.5 ± 16.5 (283) 50.7 ± 16.9 (292) 0.85
LA volume, ml 91.7 ± 36.3 (292) 91.0 ± 44.8 (303) 0.84
RVSP, mmHg 44.0 ± 13.4 (253) 44.6 ± 14.0 (275) 0.60
TR severity 0.16
- Mild (1+) 82.6% (247/299) 80.7% (242/300)
- Moderate (2+) 14.0% (42/299) 16.7% (50/300)
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Device Group
(N=302)
Control Group
(N=312) P-value
MR severity, n (%) 0.13
- Moderate to severe (3+) 49.0% (148/302) 55.1% (172/312)
- Severe (4+) 51.0% (154/302) 44.9% (140/312)
PISA radius, cm 0.89 ± 0.17 (293) 0.88 ± 0.18 (308) 0.62
EROA, PISA cm2 0.41 ± 0.15 (289) 0.40 ± 0.15 (303) 0.41
Reg. volume, PISA ml 59.7 ± 21.0 (288) 59.9 ± 23.5 (302) 0.91
Vena contracta, cm 0.58 ± 0.12 (277) 0.58 ± 0.12 (293) 0.88
Peak E, cm/sec 110.6 ± 28.7 (280) 109.4 ± 24.9 (286) 0.60
Baseline Echo Characteristics (ii)
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Device Group
(N=302)
Control Group
(N=312) P-value
Pulmonary Vein Flow 0.02
- None (0) 0.0% (0/240) 0.0% (0/234)
- Mild (1+) 0.4% (1/240) 0.9% (2/234)
- Moderate (2+) 12.9% (31/240) 12.4% (29/234)
- Moderate to severe (3+) 30.0% (72/240) 42.7% (100/234)
- Severe (4+) 56.7% (136/240) 44.0% (103/234)
MR Color Flow Jet 0.18
- None (0) 0.0% (0/302) 0.0% (0/312)
- Mild (1+) 0.0% (0/302) 0.0% (0/312)
- Moderate (2+) 6.0% (18/302) 6.7% (21/312)
- Moderate to severe (3+) 43.0% (130/302) 47.8% (149/312)
- Severe (4+) 51.0% (154/302) 45.5% (142/312)
Baseline Echo Characteristics (iii)
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Change in LV Volumes Over Time
Ad
juste
d C
ha
ng
e in
LV
ED
V (
mL
) fr
om
Ba
se
line
-25
0
25
50
75
y (Device)
y (Control)
1 6 12 18 24
Months Post Procedure
Device
Control
*p<0.05 (ANCOVA)
*
*
*
*
*
*
Left Ventricular End Diastolic Volume (LVEDV)Paired measures, follow-up minus baseline
Mean ± SE
Subjects with HF death prior to a follow-up visit were assigned the worst observed change from baseline at that visit.
For all other subjects who had missing echo values, multiple imputation was used.
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Change in LV Volumes Over Time
Ad
juste
d C
ha
ng
e in
LV
ES
V (
mL
) fr
om
Ba
se
line
Device
Control
-25
0
25
50
75
100
125
y (Device)
y (Control)
Left Ventricular End Systolic Volume (LVESV)Paired measures, follow-up minus baseline
Mean ± SE
Device
Control
*
*
*
*
*
*
**
1 6 12 18 24
Months Post Procedure*p<0.05 (ANCOVA)
Subjects with HF death prior to a follow-up visit were assigned the worst observed change from baseline at that visit.
For all other subjects who had missing echo values, multiple imputation was used.
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Change in Ejection Fraction Over Time
-15
-10
-5
0
5
y (Device)
y (Control)
Ad
juste
d C
ha
ng
e in
LV
EF
(%
) fr
om
Ba
se
line
Left Ventricular Ejection Fraction (LVEF)Paired measures, follow-up minus baseline
Mean ± SE
Device
Control
*
**
*
**
*
**
Subjects with HF death prior to a follow-up visit were assigned the worst observed change from baseline at that visit.
For all other subjects who had missing echo values, multiple imputation was used.
1 6 12 18 24
Months Post Procedure*p<0.05 (ANCOVA)
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Overall MR Severity
72.9%
8.2%
66.7%
9.2%
69.0%
11.4%
75.2%
12.3%
77.2%
15.8%
19.8%
26.1%
27.1%
28.9%
25.7%
35.4%
19.9%
28.1%
21.9%
27.6%
49.0%55.3%
5.9%
37.4%
4.6%
42.2%
4.3%
34.3%
4.3%
41.2%40.8%
51.0%44.7%
1.5%
28.4%
1.7%
19.7%
0.1%
18.9%
0.7%
18.4% 15.8%
0%
20%
40%
60%
80%
100%
≤1+
2+
3+
4+
0.9%
Perc
enta
ge o
f P
atients
Device
0.0%
Control
0.0%
N=302
D=0
N=311
D=0
N=273
D=10
N=257
D=10
N=240
D=32
N=218
D=40
Device
92.7%
Control
34.2%
Device
93.8%
Control
38.1%
Device
94.8%
Control
46.9%
Device
95.0%
Control
40.4%
Device
99.1%
Control
43.4% MR ≤2+
Baseline 30 Days 6 Months 12 Months 18 Months 24 Months
N=210
D=59
N=175
D=75
N=141
D=69
N=114
D=99
N=114
D=78
N=76
D=115
N denotes number of subjects with MR severity data available;
D denotes subject deaths which occurred by the upper end of the visit window, whether or not the TTE was performed
All P<0.001
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MR Changes From Baseline to 12 MonthsDevice Group
(N=302)
Control Group
(N=312) P-value
MR Severity, n (%) <0.0001
- Improved by ≥2 grades 84.1% (243/289) 15.9% (44/277)
- Improved by 1 grade 11.1% (32/289) 40.4% (112/277)
- No change 4.8% (14/289) 36.8% (102/277)
- Worsened by 1 grade 0.0% (0/289) 6.9% (19/277)
Pulmonary vein flow, n (%) <0.0001
- Improved 83.6% (107/128) 39.6% (53/134)
- No change 14.8% (19/128) 40.3% (54/134)
- Worsened 1.6% (2/128) 20.1% (27/134)
Vena contracta, cm -0.14 ± 0.17 (110) -0.03 ± 0.16 (186) <0.0001
MR color flow jet <0.0001
- Improved 94.1% (272/289) 54.9% (152/277)
- No change 4.8% (14/289) 34.3% (95/277)
- Worsened 1.0% (3/289) 10.8% (30/277)
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Changes From Baseline to 12 Months
Device Group
(N=302)
Control Group
(N=312) P-value
TR severity, n (%) 0.34
- Improved 10.6% (30/282) 13.4% (35/261)
- No change 71.6% (202/282) 70.5% (184/261)
- Worsened 17.7% (50/282) 16.1% (42/261)
RVSP, mmHg -3.5 ± 14.3 (202) -2.1 ± 14.7 (211) 0.13
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24-Month All-cause Mortality
or First HF Hospitalization (i)
0.2 0.5 1 1.5 2.5
Favors MitraClip + GDMT Favors GDMT alone
Subgroup MitraClip + GDMT GDMT Alone HR [95% CI] HR [95% CI] P [Int]
All patients 45.4% (128) 67.4% (189) 0.57 [0.45, 0.71]
Baseline LVEF
≥ 30% (median: n=301) 44.1% (62) 60.5% (84) 0.61 [0.44, 0.85]0.29
< 30% (median: n=274) 45.8% (55) 77.6% (98) 0.46 [0.33, 0.64]
> 40% (n=103) 49.7% (22) 53.5% (26) 0.70 [0.39, 1.23]0.26
≤ 40% (n=472) 43.8% (95) 71.8% (156) 0.50 [0.39, 0.65]
LVEDV (median)
≥ 181 mL (n=288) 48.3% (63) 68.0% (92) 0.57 [0.41, 0.79]0.52
< 181 mL (n=287) 41.5% (54) 68.5% (90) 0.49 [0.35, 0.69]
LVESV (median)
≥ 124 mL (n=288) 46.8% (60) 71.1% (97) 0.51 [0.37, 0.71]0.83
< 124 mL (n=287) 43.1% (57) 65.7% (85) 0.55 [0.39, 0.77]
LV Stroke Volume (median)
≥ 49 mL (n=286) 46.0% (60) 65.0% (88) 0.64 [0.46, 0.89]0.30
< 49 mL (n=289) 44.3% (59) 69.5% (89) 0.49 [0.35, 0.69]
LVEDD (median)
≥ 6.1 cm (n=340) 48.4% (76) 71.2% (110) 0.56 [0.41, 0.75]0.94
< 6.1 cm (n=268) 41.9% (52) 64.3% (79) 0.56 [0.39, 0.79]
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0.2 0.5 1 1.5 2.5
Subgroup MitraClip + GDMT GDMT Alone HR [95% CI] HR [95% CI] P [Int]
All patients 45.4% (128) 67.4% (189) 0.57 [0.45, 0.71]
MR Severity
3+ (n=320) 36.9% (50) 64.4% (98) 0.48 [0.34, 0.68]0.30
4+ (n=293) 53.4% (78) 71.4% (91) 0.62 [0.45, 0.83]
PISA Radius (median)
≥ 0.87 cm (n=306) 48.2% (72) 66.5% (92) 0.57 [0.42, 0.78]0.86
< 0.87 cm (n=294) 42.0% (52) 67.1% (94) 0.54 [0.39, 0.76]
EROA, PISA (median)
≥ 0.37 cm2 (n=309) 49.8% (75) 73.7% (102) 0.52 [0.38, 0.70]0.91
< 0.37 cm2 (n=282) 37.9% (45) 60.4% (81) 0.54 [0.37, 0.78]
Reg Vol, PISA (median)
≥ 23 mL (n=138) 45.1% (30) 62.2% (38) 0.50 [0.31, 0.81]0.71
< 23 mL (n=122) 40.1% (19) 73.5% (47) 0.43 [0.25, 0.74]
Reg Fraction (median)
≥ 36% (n=135) 45.7% (28) 70.5% (43) 0.44 [0.27, 0.71]0.75
< 36% (n=124) 40.9% (21 67.1% (42) 0.50 [0.29, 0.85]
Favors MitraClip + GDMT Favors GDMT alone
24-Month All-cause Mortality
or First HF Hospitalization (ii)
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0.2 0.5 1 1.5 2.5
Favors MitraClip + GDMT Favors GDMT alone
24-Month All-cause Mortality
or First HF Hospitalization (iii)Subgroup MitraClip + GDMT GDMT Alone HR [95% CI] HR [95% CI] P [Int]
Vena Contracta (median)
≥ 0.57 cm (n=294) 46.8% (65) 69.3% (93) 0.53 [0.38, 0.73]0.62
< 0.57 cm (n=275) 44.4% (54) 66.4% (86) 0.59 [0.42, 0.83]
Pulmonary Vein Flow
0 / 1+ / 2+ (n=63) 34.8% (10) 62.7% (19) 0.41 [0.19, 0.89]
0.283+ (n=172) 42.1% (28) 72.5% (64) 0.43 [0.28, 0.68]
4+ (n=238) 49.5% (63) 66.5% (61) 0.65 [0.46, 0.92]
TR severity
≤ 1+ (n=501) 44.7% (107) 64.5% (143) 0.61 [0.47, 0.78]0.21
≥ 2+ (n=98) 49.9% (20) 81.0% (40) 0.43 [0.25, 0.74]
Peak E (median)
≥ 109 cm/sec (n=292) 49.7% (68) 73.7% (98) 0.52 [0.38, 0.72]0.25
< 109 cm/sec (n=274) 41.8% (52) 58.5% (73) 0.69 [0.48, 0.99]
RVSP (median)
≥ 43 mmHg (n=276) 55.8% (69) 76.8% (103) 0.62 [0.45, 0.84]0.79
< 43 mmHg (n=252) 36.1% (40) 53.9% (61) 0.58 [0.39, 0.86]
Tier of Echo Eligibility
Tier 1 (n=530) 47.2% (117) 67.0% (161) 0.58 [0.46, 0.74]
0.21Tier 2 (n=61) 17.4% (4) 67.9% (23) 0.23 [0.08, 0.68]
Tier 3 (n=23) 50.0% (7) 70.0% (5) 0.80 [0.25, 2.54]
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Predictors of 24-Month Mortality or First HF Hospitalization
Multivariable Cox regression
Hazard Ratio [95% CI]
P-Value
RVSP (mmHg) 1.02 [1.01, 1.04] 0.005
STS Repl Score 1.12 [1.02, 1.23] 0.020
LVEDV (mL) 1.00 [1.00, 1.01] 0.07
Sex (Female vs Male) 0.64 [0.37, 1.08] 0.09
EROA, PISA (cm2) 2.56 [0.79, 8.26] 0.12
Isch vs Non-Isch CM 0.70 [0.43, 1.13] 0.15
STS Repair Score 0.95 [0.88, 1.04] 0.26
LVEF (%) 1.01 [0.98, 1.03] 0.56
Age (years) 1.01 [0.98, 1.03] 0.57
TR Grade (≥2+ vs ≤1+) 0.90 [0.51, 1.61] 0.73
Hazard Ratio
[95% CI]P-Value
TR Grade (≥ 2+ vs ≤ 1+) 1.60 [1.07, 2.39] 0.022
LVEF (%) 0.98 [0.96, 1.00] 0.027
RVSP (mmHg) 1.01 [1.00, 1.02] 0.032
EROA, PISA (cm2) 3.15 [1.08, 9.21] 0.036
STS Repl Score 1.07 [0.98, 1.18] 0.14
Age (years) 0.99 [0.97, 1.01] 0.24
STS Repair Score 0.96 [0.87, 1.07] 0.47
Isch vs Non-Isch CM 0.92 [0.62, 1.36] 0.66
LVEDV (mL) 1.00 [1.00, 1.00] 0.84
Sex (Female vs Male) 0.97 [0.64, 1.46] 0.87
GDMT AloneMitraClip + GDMT
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Limitations
• Echo analysis was blinded to clinical condition, but not to
intervention.
• PISA and hemodynamics after MitraClip have major
limitations. Color Doppler, PV flow and vena contracta are
the most available and reliable methods.
• Subgroup predictive analysis was only done based on pre-
specified plans.
• To overcome survivorship bias, worst case scenario and
multiple imputation methods were used to account for missing
follow-up data (pre-specified).
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Conclusions (i)COAPT Echo Sub-study
• To duplicate the COAPT results, specific COAPT
screening echo criteria and expert echo analysis should
be applied to identify proper candidates for MitraClip.
• In patients with HF and 3+ or 4+ secondary MR, TMVr
with MitraClip provided substantial death and HFH
benefits in all echocardiographic subgroups, regardless
of degree of LV dysfunction, LV dimensions, pulmonary
hypertension, severity of TR or individual MR
parameters (all responders).
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Conclusions (ii)COAPT Echo Sub-study
• Baseline LVEF, TR and MR severity predicted poor
outcomes in patients with HF treated with GDMT alone,
but not after MR was corrected by MitraClip.
• RVSP was the only independent echocardiographic
predictor of poor outcomes after MitraClip and GDMT
treatments.
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Acknowledgments
• COAPT Principal Investigators and Co-authors Gregg W. Stone, Michael J. Mack, William T. Abraham,
JoAnn Lindenfeld, Paul A. Grayburn, Robert J. Siegel, Saibal Kar,
D. Scott Lim, Jonathan G. Zaroff, Jacob M. Mishell, Brian Whisenant
and Neil J. Weissman
• Abbott Structural Heart Global Clinical Affairs Jeffrey Ellis, Kartik Sundareswaran
• Abbott Global Biometrics Yu Shu, Juanjuan Li, Deepika Morishetti, Hong Nie
• All COAPT Sites, Research Coordinators, Heart Teams and Patients
• MedStar Echo Core lab Staff Vladimir Masati, Valiere Morgan, Ma Therese Tupas-Habib, et al.