coap

5-Year Follow-Up After Transcatheter
Repair of Secondary Mitral Regurgitation
The COAPT™ Trial
Gregg W. Stone, MD
On behalf of Michael J. Mack, William T. Abraham, JoAnn Lindenfeld
and the COAPT investigators
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
The COAPT™ Trial
Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy
for Heart Failure Patients with Functional Mitral Regurgitation
A parallel-controlled, open-label, multicenter trial in 614 patients with
heart failure and moderate-to-severe (3+) or severe (4+) secondary MR
who remained symptomatic despite maximally-tolerated GDMT
Randomize 1:1*
MitraClip + GDMT
N=302
GDMT alone
N=312
*Stratified by cardiomyopathy etiology (ischemic vs. non-ischemic) and site
Stone GW et al. N Engl J Med. 2018;379:2307-18
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Background
• In the COAPT trial, treatment of symptomatic patients
with heart failure (HF) and severe secondary MR with
the MitraClip safely improved survival through 24 months,
reduced HF hospitalizations (HFH), and improved qualityof-life compared with maximally-tolerated guidelinedirected medical therapy (GDMT) alone
• Per protocol, subjects randomized to GDMT were
not allowed to “crossover” to the MitraClip prior to
24 months, but were permitted to do so after 24 months
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Objectives
The present study sought to:
1) Describe the final 5-year clinical outcomes
of patients enrolled in the COAPT trial
2) Analyze the impact of MitraClip treatment
in patients assigned to GDMT alone
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Key Inclusion Criteria
1. Moderate-to-severe (3+) or severe (4+) secondary MR
confirmed by an echo core laboratory (US ASE criteria)
2. LVEF 20%-50% and LVESD ≤70 mm
3. NYHA class II-IVa despite a stable maximally-tolerated
GDMT regimen and CRT (if appropriate) per societal
guidelines
4. HFH within 12 months and/or weight-adjusted BNP ≥300
pg/ml* or NT-proBNP ≥1500 pg/ml*
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Key Exclusion Criteria
1. ACC/AHA stage D HF, hemodynamic instability or shock
2. CAD requiring revascularization
3. COPD requiring continuous home O2 or chronic oral steroid use
4. Severe PHTN or mod/sev RV dysfunction
5. AV or TV disease requiring surgery or transcatheter intervention
6. MV orifice area <4.0 cm2 by site-assessed TTE
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
N=614 at 78 sites
in the US and Canada
MitraClip + GDMT
N=302
N=293
N=9
Randomized
Initial treatment
MitraClip
GDMT alone
Withdrew 4 1 Lost to follow-up
N=297/302 (98.3%)
30-day follow-up
1-year follow-up
2-year follow-up
3-year follow-up
N=269/312 (86.2%)
Withdrew 3 1 Lost to follow-up
4-year follow-up
Withdrew 4 1 Lost to follow-up
N=270/302 (89.4%)
N=277/312 (88.8%)
Withdrew 7 1 Lost to follow-up
Withdrew 6 1 Lost to follow-up
N=275/302 (91.1%)
N=291/312 (93.3%)
Withdrew 11 3 Lost to follow-up
Withdrew 3 1 Lost to follow-up
N=282/302 (93.4%)
N=307/312 (98.4%)
Withdrew 16 0 Lost to follow-up
Withdrew 5 3 Lost to follow-up
N=286/302 (94.7%)
N=1
N=311
Withdrew 5 0 Lost to follow-up
Withdrew 3 0 Lost to follow-up
N=294/302 (97.4%)
GDMT alone
N=312
N=265/312 (84.9%)
Withdrew 1 0 Lost to follow-up
5-year follow-up
N=264/312 (84.6%)
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Baseline Characteristics (i)
MitraClip +
GDMT (N=302)
GDMT alone
(N=312)
MitraClip +
GDMT (N=302)
GDMT alone
(N=312)
71.7 ± 11.8
72.8 ± 10.5
BMI (kg/m2)
27.0 ± 5.8
27.1 ± 5.9
Male
66.6%
61.5%
CrCl (ml/min)
50.9 ± 28.5
47.8 ± 25.0
Diabetes
35.1%
39.4%
- ≤60 ml/min
71.6%
75.2%
Hypertension
80.5%
80.4%
Anemia (WHO)
59.8%
62.7%
Hyperchol.
55.0%
52.2%
BNP (pg/mL)
1015 ± 1086
1017 ± 1219
Prior MI
51.7%
51.3%
NT-proBNP (pg/mL)
5174 ± 6567
5944 ± 8438
Prior PCI
43.0%
49.0%
STS replacement sc
7.8 ± 5.5
8.5 ± 6.2
Prior CABG
40.1%
40.4%
41.7%
43.6%
Prior stroke or TIA
18.5%
15.7%
PVD
17.2%
18.3%
- High*
68.6%
69.9%
COPD
23.5%
23.1%
- Not-high
31.4%
30.1%
H/o atrial fibr
57.3%
53.2%
Age (years)
- ≥8
Surgical risk (central eligibility committee)
* STS repl score ≥8% or one or more factors present predicting extremely high surgical risk
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Baseline Characteristics (ii)
HF parameters
MitraClip +
GDMT (N=302)
GDMT alone
(N=312)
Etiology of HF
Echo core lab
MitraClip +
GDMT (N=302)
GDMT alone
(N=312)
MR severity
- Ischemic
60.9%
60.6%
- Mod-to-sev (3+)
49.0%
55.3%
- Non-ischemic
39.1%
39.4%
- Severe (4+)
51.0%
44.7%
EROA, cm2
0.41 ± 0.15
0.40 ± 0.15
NYHA class
-I
0.3%
0%
LVESD, cm
5.3 ± 0.9
5.3 ± 0.9
- II
42.7%
35.4%
LVEDD, cm
6.2 ± 0.7
6.2 ± 0.8
- III
51.0%
54.0%
LVESV, mL
135.5 ± 56.1
134.3 ± 60.3
- IV
6.0%
10.6%
LVEDV, mL
194.4 ± 69.2
191.0 ± 72.9
HF hosp w/i 1 year
58.3%
56.1%
LVEF, %
31.3 ± 9.1
31.3 ± 9.6
Prior CRT
38.1%
34.9%
- ≤40%
82.2%
82.0%
Prior defibrillator
30.1%
32.4%
44.0 ± 13.4
44.6 ± 14.0
RVSP, mmHg
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Primary Effectiveness: All Heart Failure
Hospitalizations Through 5-Year Follow-up
Cumulative
HF Hospitalizations (n)
500
MitraClip + GDMT
GDMT alone
450
400
350
300
HR [95% CI] =
0.51 [0.39, 0.66]
250
200
150
100
50
0
0
6
18
24
30
36
42
48
54
60
124
79
Time After Randomization (Months)
No. at Risk:
MitraClip
12
302
269
238
219
205
186
167
151
138
GDMT
312
272
224
188
156
120
94
84
59
133
106
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Analyzed using a joint frailty
model to account for
correlated events and the
competing risk of death
Primary Effectiveness: All Heart Failure
Hospitalizations Through 5-Year Follow-up
Cumulative
HF Hospitalizations (n)
500
MitraClip + GDMT
GDMT alone
450
400
447
in 208 pts
350
314
300
in 151 pts
250
200
33.1%/yr in the device group vs.
57.2%/yr in the control group
HR [95% CI] = 0.53 [0.41-0.68]
150
100
50
0
0
6
18
24
30
36
42
48
54
60
124
79
Time After Randomization (Months)
No. at Risk:
MitraClip
12
302
269
238
219
205
186
167
151
138
GDMT
312
272
224
188
156
120
94
84
59
133
106
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Analyzed using a joint frailty
model to account for
correlated events and the
competing risk of death
Primary Safety: Outcomes Through 5 Years
MitraClip implant attempts (n=293)
30
Days
12
Months
All safety events
4 (1.4)
9 (3.3)
Device-specific events
4 (1.4)
4 (1.4)
- SLDA
2 (0.7)
2 (0.7)
- Device embolization
1 (0.3)
1 (0.3)
- Endocarditis requiring surgery
0 (0.0)
0 (0.0)
- Mitral stenosis* requiring surgery
0 (0.0)
0 (0.0)
- Any device-related complication
requiring non-elective CV surgery
1 (0.3)
1 (0.3)
0 (0.0)
5 (2.0)
- LVAD
0 (0.0)
3 (1.2)
- Heart transplantation
0 (0.0)
2 (0.8)
Progressive HF unrelated to device
complications
24
Months
36
Months
48
Months
60
Months
Primary safety endpoint
SLDA = single leaflet device attachment. LVAD = left ventricular assist device. *Mitral valve area <1.5 cm2 by echo core laboratory measurement.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Primary Safety: Outcomes Through 5 Years
MitraClip implant attempts (n=293)
30
Days
12
Months
24
Months
36
Months
48
Months
60
Months
All safety events
4 (1.4)
9 (3.3)
13 (5.2)
20 (8.8)
22 (10.1)
23 (10.8)
Device-specific events
4 (1.4)
4 (1.4)
4 (1.4)
4 (1.4)
4 (1.4)
4 (1.4)
- SLDA
2 (0.7)
2 (0.7)
2 (0.7)
2 (0.7)
2 (0.7)
2 (0.7)
- Device embolization
1 (0.3)
1 (0.3)
1 (0.3)
1 (0.3)
1 (0.3)
1 (0.3)
- Endocarditis requiring surgery
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
- Mitral stenosis* requiring surgery
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
0 (0.0)
- Any device-related complication
requiring non-elective CV surgery
1 (0.3)
1 (0.3)
1 (0.3)
1 (0.3)
1 (0.3)
1 (0.3)
0 (0.0)
5 (2.0)
9 (3.8)
16 (7.5)
18 (8.8)
19 (9.5)
- LVAD
0 (0.0)
3 (1.2)
6 (2.6)
11 (5.1)
12 (5.8)
13 (6.5)
- Heart transplantation
0 (0.0)
2 (0.8)
3 (1.3)
7 (3.4)
9 (4.7)
9 (4.7)
Progressive HF unrelated to device
complications
SLDA = single leaflet device attachment. LVAD = left ventricular assist device. *Mitral valve area <1.5 cm2 by echo core laboratory measurement.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Death or HF Hospitalization
Death or HFH (%)
100%
MitraClip + GDMT
GDMT alone
80%
91.5%
73.6%
60%
40%
HR [95% CI] =
0.53 [0.44-0.64]
20%
0%
0
6
12
18
24
30
36
42
48
54
60
Time After Randomization (Months)
No. at Risk:
MitraClip
302
236
194
174
158
141
118
105
93
81
52
GDMT
312
206
157
122
95
58
43
37
33
26
17
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
5-Year
Death
or HFH
Subgroup
analysis
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
First Heart Failure Hospitalization
First Heart Failure
Hospitalization (%)
100%
MitraClip + GDMT
GDMT alone
80%
83.0%
61.0%
60%
40%
HR [95% CI] =
0.49 [0.40-0.61]
20%
0%
0
6
12
18
24
30
36
42
48
54
60
Time After Randomization (Months)
No. at Risk:
MitraClip
302
236
194
174
158
141
118
105
93
81
52
GDMT
312
206
157
122
95
58
43
37
33
26
17
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
First Heart Failure Hospitalization
First Heart Failure
Hospitalization (%)
100%
MitraClip + GDMT
GDMT alone
80%
76.4%
60%
46.8%
40%
34.3%
30.7%
HR [95% CI] =
0.46 [0.36–0.57]
20%
0%
HR [95% CI] =
0.85 [0.55–1.33]
0
6
12
18
24
30
36
42
48
54
60
Time After Randomization (Months)
No. at Risk:
MitraClip
302
194
158
167
119
63
GDMT
312
157
95
119
82
43
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
All-cause Mortality
All-cause Mortality (%)
100%
MitraClip + GDMT
GDMT alone
80%
67.2%
60%
57.3%
40%
HR [95% CI] =
0.72 [0.58-0.89]
20%
0%
0
6
12
18
24
30
36
42
48
54
60
Time After Randomization (Months)
No. at Risk:
MitraClip
302
269
238
219
205
186
167
151
138
124
79
GDMT
312
272
224
189
157
135
122
107
94
84
59
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
All-cause Mortality
All-cause Mortality (%)
100%
MitraClip + GDMT
GDMT alone
80%
HR [95% CI] =
0.62 [0.47–0.82]
60%
HR [95% CI] =
0.88 [0.64–1.23]
42.8%
40.6%
42.7%
40%
28.1%
20%
0%
0
6
12
18
24
30
36
42
48
54
60
Time After Randomization (Months)
No. at Risk:
MitraClip
302
238
205
167
138
79
GDMT
312
224
157
122
94
59
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Crossover Treatment in the Control Arm
Randomized to GDMT alone
(N = 312)
Not eligible for
crossover at
2 years (N = 169)
Death:
124
LVAD:
16
Transplant:
9
Withdrawals:
26
Lost to follow-up: 3
Other:
2
No MitraClip
treatment
(N = 76)
No MitraClip treatment
before 2 years
(N = 138)
MitraClip treatment
before 2 years
(N = 5)
MitraClip treatment
after 2 years*
(N = 62 of 138; 44.9%)
Total crossovers
(N = 67 of 312; 21.5%)
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Death or HFH After Crossovers
Death or HFH (%)
100%
MitraClip + GDMT
GDMT alone without MitraClip
GDMT alone after MitraClip
80%
60%
40%
Multivariable analysis in GDMT alone group
Adjusted HR [95% CI] after MitraClip
= 0.53 [0.36, 0.78]
20%
0%
0
6
12
18
24
30
36
42
48
54
60
Time After Randomization (Months)
No. at Risk:
MitraClip
302
236
194
158
118
93
52
GDMT without MitraClip
312
205
156
93
40
32
16
GDMT after MitraClip
67
56
42
30
9
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
For crossover patients,
follow-up duration is from the
crossover procedure date
NYHA Class Throughout Follow-up
I
II
III
IV
Died
100%
NYHA class (%)
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Device Control Device Control Device Control Device Control Device Control Device Control Device Control Device Control Device Control
(n=302) (n=311) (n=291) (n=288) (n=286) (n=278) (n=278) (n=266) (n=270) (n=258) (n=260) (n=263) (n=263) (n=255) (n=266) (n=247) (n=257) (n=249)
Baseline
Class I or II
Diff (95% CI)
43.0%
35.4%
7.7% [-0.1, 15.3]
30 days
74.2%
46.5%
6 months
66.4%
47.1%
1 year
61.5%
43.2%
27.7% [19.9, 35.1] 19.3% [11.2, 27.1] 18.3% [9.9, 26.3]
18 months
56.7%
39.5%
17.1% [8.6, 25.3]
2 years
47.3%
37.8%
16.5% [8.2, 24.5]
3 years
42.2%
25.1%
17.1% [9.0, 24.9]
4 years
34.2%
18.6%
15.6% [8.0, 22.9]
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
5 years
24.1%
15.7%
8.5% [1.5, 15.3]
MR Severity (Core Lab)
None
1+
2+
3+
4+
100%
90%
MR grade (%)
80%
70%
60%
50%
40%
30%
20%
10%
0%
Device Control Device Control Device Control Device Control Device Control Device Control Device
(n=302) (n=311) (n=273) (n=257) (n=240) (n=218) (n=210) (n=175) (n=177) (n=141) (n=167) (n=126) (n=120)
Baseline
MR ≤2+
Diff (95% CI)
0%
0%
-
30 days
92.7%
34.2%
6 months
93.8%
38.1%
1 year
94.8%
46.9%
18 months
94.9%
45.4%
2 years
99.4%
46.8%
Control
(n=74)
3 years
98.3%
85.1%
Device
(n=80)
Control
(n=49)
4 years
97.5%
79.6%
58.4% [51.4, 64.5] 55.7% [48.1, 62.3] 47.9% [39.6, 55.5] 49.5% [40.2, 57.9] 52.6% [43.5, 61.1] 13.2% [5.9, 23.1] 17.9% [7.1, 31.3]
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Device
(n=57)
Control
(n=46)
5 years
94.7%
91.3%
3.4% [-7.1, 15.6]
Limitations
• Device treatment was unblinded, and withdrawals during follow-up were more
frequent in the control group.

All-cause death, the endpoint least prone to bias, was reduced, and the results
were consistent after multiple imputation to account for missing data.
• The present results reflect treatment with the first generation MitraClip.

MitraClip NTR/XTR and G4 may be more effective at reducing MR to ≤1+,
and outcomes with other mitral TEER and non-TEER systems are unknown.
• Angiotensin receptor-neprilysin inhibitors were used in < one-third of pts, and only
3 pts were treated with SGLT2 inhibitors (all during the last year of FU).

More frequent use of these agents may have decreased the pool of pts eligible
for enrollment but would likely not have decreased the effects of TEER.
• Whether correction of MR would safely improve outcomes in more or less critically
ill pts or in those with moderate MR is unknown.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Conclusions and Implications (1)
• In pts with heart failure and severe secondary MR who
remained symptomatic despite optimal medical therapy,
TEER with the MitraClip was safe, reduced the rate of
HFHs and improved survival during 5-year follow-up.
• These outcomes were consistent across all pre-specified
subgroups, regardless of patient age, sex, MR severity, left
ventricular function and volume, cardiomyopathy etiology,
and surgical risk.
• Symptomatic status (NYHA class) was also improved
throughout 5-year follow-up, and MitraClip treatment
provided durable repair of mitral regurgitation.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Conclusions and Implications (2)
• Treatment effects were reduced after 2-3 years, in large part
due to MitraClip treatment in 44.9% of control group pts
surviving to 2 years.
• The prognosis of control group pts so treated was substantially
improved, similar to that of pts originally assigned to MitraClip
treatment.
• However, nearly half of control group pts had died before
becoming eligible for crossover at 2 years.
• Heart failure patients appropriate for TEER with the MitraClip
should therefore be identified and considered for treatment
as early as possible.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Conclusions and Implications (3)
• Finally, despite the favorable risk:benefit profile of the
MitraClip in this setting, adverse outcomes continued to
accrue in both groups such that 91.5% of control group pts
and 73.6% of device group pts had either died or been
hospitalized for heart failure within 5 years.
• These findings emphasize the need for further therapies to
address the underlying left ventricular dysfunction in this
high-risk population.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
See Important Safety Information referenced within. ©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.
Rx Only
Important Safety Information
MITRACLIP™ CLIP DELIVERY SYSTEM
Indications for Use
•
The MitraClipTM G4 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.
•
The MitraClipTM G4 System, when used with maximally tolerated guideline-directed medical therapy (GDMT), is indicated for the treatment of symptomatic, moderate-to-severe or
severe secondary (or functional) mitral regurgitation (MR; MR ≥ Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) ≥
20% and ≤ 50%, and a left ventricular end systolic dimension (LVESD) ≤ 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a
multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
Label
Contraindications
The MitraClip G4 System is contraindicated in patients with the following conditions: Patients who cannot tolerate, including allergy or hypersensitivity to, procedural anticoagulation or post
procedural anti-platelet regime; Patients with known hypersensitivity to clip components (nickel / titanium, cobalt, chromium, polyester), or with contrast sensitivity; Active endocarditis of
the mitral valve; Rheumatic mitral valve disease; Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus
Potential Complications and Adverse Events
The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip G4 procedure: Allergic reactions or hypersensitivity to latex, contrast agent, anaesthesia,
device materials (nickel / titanium, cobalt, chromium, polyester), and drug reactions to anticoagulation, or antiplatelet drugs, Vascular access complications which may require transfusion or
vessel repair including: wound dehiscence, catheter site reactions, Bleeding (including ecchymosis, oozing, hematoma, hemorrhage, retroperitoneal hemorrhage), Arteriovenous fistula,
pseudoaneurysm, aneurysm, dissection, perforation / rupture, vascular occlusion, Emboli (air thrombotic material, implant, device component); Peripheral Nerve Injury; Lymphatic
complications; Pericardial complications which may require additional intervention, including: Pericardial effuse on, Cardiac tamponade, Pericarditis; Cardiac complications which may require
additional interventions or emergency cardiac surgery, including: Cardiac perforation, Atrial septal defect; Mitral valve complications, which may complicate or prevent later surgical repair,
including: Chordal entanglement / rupture, Single Leaflet Device Attachment (SLDA), Thrombosis, Dislodgement of previously implanted devices, Tissue damage, Mitral valve stenosis,
Persistent or residual mitral regurgitation, Endocarditis; Cardiac arrhythmias (including conduction disorders, atrial arrhythmias, ventricular arrhythmias); Cardiac ischemic conditions
(including myocardial infarction, myocardial ischemia, and unstable / stable angina); Venous thromboembolism (including deep vein thrombosis, pulmonary embolism, post procedure
pulmonary embolism); Stroke / Cerebrovascular accident (CVA) and Transient Ischemic Attack (TIA); System organ failure: Cardio-respiratory arrest, Worsening heart failure, Pulmonary
congestion, Respiratory dysfunction / failure / atelectasis, Renal insufficiency or failure, Shock (including cardiogenic and anaphylactic); Blood cell disorders (including coagulopathy,
hemolysis, and Heparin Induced Thrombocytopenia (HIT)); Hypotension / hypertension; Infection including: Urinary Tract Infection (UTI), Pneumonia, Septicemia; Nausea / vomiting; Chest
pain; Dyspnea; Edema; Fever or hyperthermia; Pain; Death; Fluoroscopy, Transesophageal echocardiogram (TEE) and Transthoracic echocardiogram (TTE) -related complications: Skin injury
or tissue changes due to exposure to ionizing radiation, Esophageal irritation; Esophageal perforation, Gastrointestinal bleeding
Source: ACC 2023
See Important Safety Information referenced within.
CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at
eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events. Illustrations are artist’s
representations only and should not be considered as engineering drawings or photographs.
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©2023 Abbott. All rights reserved. MAT-2301485 v1.0 | Item approved for U.S. use only.