1. 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 (NCT )

2. Institutional conflict COAPT (NCT01626079) is funded by Abbott
Disclosure Statement
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.
COAPT (NCT ) is funded by Abbott

3. 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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4. Death or HF Hospitalization
MitraClip + GDMT
GDMT alone
All-cause Mortality or
HF Hospitalization (%) 0%
20%
40%
60%
80%
100%
Time After Randomization (Months) 3 6 9 12 15 18 21 24
67.9%
45.7%
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 [ ]
P<0.001
NNT (24 mo) =
4.5 [95% CI 3.3, 7.2]
Stone GW et al. NEJM 2018;379:
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5. 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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6. Objectives COAPT Echo Sub-study
To describe the echocardiographic MR grading criteria utilized in COAPT for screening and post-MitraClip
To describe the echocardiographic characteristics of the COAPT population
To evaluate the serial echocardiographic outcomes
To identify baseline echocardiographic predictors of clinical outcomes (responders and non-responders to MitraClip)
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7. 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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8. Key Echo Inclusion Criteria
LVEF 20% - 50% and LVESD ≤70 mm (ischemic or non- ischemic)
SMR amenable for MitraClip treatment
Moderate-to-severe (3+) or severe (4+) SMR confirmed by an independent echo core laboratory prior to enrollment
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9. Inclusion Flowchart (i)
Patients with HF and MR evaluated for enrollment in COAPT
N=1,576
Ineligible N=911
Inadequate 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)
Subjects with screening TTEs and meeting all eligibility requirements for enrollment in COAPT
N=665
Secondary MR, Severity 3+ or 4+
(graded by 1 of 3 criteria)
Roll-in
subjects
N=51
Randomized
subjects
N=614
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10. Inclusion Flowchart (ii)
Secondary MR, Severity 3+ or 4+
(graded by 1 of 3 criteria)
Tier 1
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
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 ≥ 0.3 cm2 or
PV systolic flow reversal
N=570 (85.7%)
MULTIPARAMETRIC ALGORITHM
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11. 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)
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)

12. Baseline Echo Characteristics (ii)
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

13. Baseline Echo Characteristics (iii)
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
0.0% (0/302)
0.0% (0/312)
6.0% (18/302)
6.7% (21/312)
43.0% (130/302)
47.8% (149/312)
51.0% (154/302)
45.5% (142/312)

14. Change in LV Volumes Over Time
Left Ventricular End Diastolic Volume (LVEDV)
Paired measures, follow-up minus baseline
Mean ± SE * *
Adjusted Change in LVEDV (mL) from Baseline
Device
Control * * * * 1 6 12 18 24
Months Post Procedure
*p<0.05 (ANCOVA)
VOLUMES INCREASED IN BOTH GROUPS BUT SIGNIFICANTLY LESS IN THE MC GROUP.
ASTERISKS DENOTE SIGNIFICANT CHANGE FROM BASELINE IN EACH GROUP, NOT A COMPARISON AMONG GROUPS.
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.

15. Change in LV Volumes Over Time
Left Ventricular End Systolic Volume (LVESV)
Paired measures, follow-up minus baseline
Mean ± SE * *
Adjusted Change in LVESV (mL) from Baseline
Device
Control
Device
Control * * * * * * 1 6 12 18 24
Months Post Procedure
*p<0.05 (ANCOVA)
MC DOES NOT CAUSE REVERSE REMODELING BUT SEMI-STABILIZE THE PROGRESSION OF THE NATURAL HISTORY IN ADVANCED CARDIOMYOPATHY
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.

16. Change in Ejection Fraction Over Time
Left Ventricular Ejection Fraction (LVEF)
Paired measures, follow-up minus baseline
Mean ± SE * * *
Adjusted Change in LVEF (%) from Baseline *
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.

17. N denotes number of subjects with MR severity data available;
Overall MR Severity
Baseline
30 Days
6 Months
12 Months
18 Months
24 Months
All P<0.001
MR ≤2+
Device
0.0%
Control
0.0%
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%
0.9%
≤1+ 2+ 3+ 4+
Percentage of Patients
N=302
D=0
N=311
D=0
N=273
D=10
N=257
D=10
N=240
D=32
N=218
D=40
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

18. MR Changes From Baseline to 12 Months
Device 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 (%)
  - Improved
83.6% (107/128)
39.6% (53/134)
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)
MR color flow jet
94.1% (272/289)
54.9% (152/277)
34.3% (95/277)
1.0% (3/289)
10.8% (30/277)

19. 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

20. 24-Month All-cause Mortality or First HF Hospitalization (i)
Subgroup
MitraClip + GDMT
GDMT Alone
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)
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]
0.2
0.5 1
1.5
2.5
Favors MitraClip + GDMT Favors GDMT alone

21. 24-Month All-cause Mortality or First HF Hospitalization (ii)
Subgroup
MitraClip + GDMT
GDMT Alone
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]
0.2
0.5 1
1.5
2.5
Favors MitraClip + GDMT Favors GDMT alone

22. 24-Month All-cause Mortality or First HF Hospitalization (iii)
Subgroup
MitraClip + GDMT
GDMT Alone
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]
0.28
3+ (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]
Tier 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]
0.2
0.5 1
1.5
2.5
Favors MitraClip + GDMT Favors GDMT alone

23. Predictors of 24-Month Mortality or First HF Hospitalization Multivariable Cox regression
MitraClip + GDMT
GDMT Alone
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)
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

24. 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).

25. 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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26. 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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27. 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.
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