Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://cr.elmerpub.com

Original Article

Volume 16, Number 1, February 2025, pages 15-21

Transcatheter Edge-to-Edge Repair Versus Annuloplasty in Functional Mitral Valve Regurgitation: A Comparison of Cardiovascular Outcomes

**Table 1.** Patient Characteristics for Those Receiving MitraClip G4 Versus Annuloplasty and Previous Clip Versions
	MitraClip G4 (N = 7,270)	Annuloplasty (N = 12,230)	P-value	Earlier MitraClip (N = 12,205)	P-value
^aValue censored due to low cell size (< 10). Numbers and comparisons incorporate the discharge weights provided in the NIS. Data are from 2016 to 2020. To avoid overlap between G4 and prior iterations, MitraClip data from 2019 were excluded. P-values are comparisons to MitraClip G4. CKD: chronic kidney disease; COPD: chronic obstructive pulmonary disease; SD: standard deviation.
Age, years, mean (SD)	76.4 (10.7)	57.4 (19.8)	< 0.001	78.3 (10.1)	< 0.001
Female, n (%)	3,470 (47.8)	4,545 (37.2)	< 0.001	6,190 (50.7)	0.07
Race, n (%)			< 0.001		0.01
White	5,485 (75.4)	9,195 (75.2)		9,320 (76.4)
Black	770 (10.6)	875 (7.2)		940 (7.7)
Hispanic	410 (5.6)	730 (6.0)		760 (6.2)
Others	605 (8.3)	1,430 (11.7)		1,185 (9.7)
Hospital region, n (%)			< 0.001		0.35
Northeast	1,240 (17.1)	2,315 (18.9)		1,980 (16.2)
Midwest	1,285 (17.7)	3,295 (26.9)		2,415 (19.8)
South	2,810 (38.7)	3,830 (31.3)		4,510 (37.0)
West	1,935 (26.6)	2,790 (22.8)		3,300 (27.0)
Primary payer, n (%)			< 0.001		0.89
Medicare	6,105 (84.0)	4,955 (40.6)		10,645 (87.3)
Medicaid	265 (3.6)	1,220 (9.9)		255 (2.1)
Private insurance	705 (9.7)	5,470 (44.8)		1,115 (9.1)
Others/self-pay	190 (2.6)	575 (4.7)		175 (1.4)
Median household income (quartile), n (%)			< 0.001		0.20
0 - 25th percentile	1,665 (23.3)	2,465 (20.5)		2,705 (22.6)
25 - 50th percentile	1,895 (26.5)	2,720 (22.6)		2,880 (24.0)
50 - 75th percentile	1,865 (26.1)	3,205 (26.7)		3,240 (27.0)
75 - 100th percentile	1,725 (24.1)	3,625 (30.2)		3,170 (26.4)
Comorbidities, n (%)
Cerebrovascular disease I6X	405 (5.6)	670 (5.5)	0.90	680 (5.6)	1.00
Coronary artery disease I25	3,985 (54.8)	4,360 (35.7)	< 0.001	6,705 (54.9)	0.94
Peripheral artery disease I73.9	280 (3.9)	255 (2.1)	0.001	785 (6.4)	0.001
Obstructive sleep apnea G47.33	1,015 (15.4)	1,295 (10.6)	0.002	1,425 (11.7)	0.04
Atrial fibrillation I48	4,430 (60.9)	6,100 (49.9)	< 0.001	7,560 (61.9)	0.53
Obesity E66	915 (12.6)	1,740 (14.2)	0.15	1,225 (10.0)	0.01
Hypertension I10	640 (8.8)	4,305 (35.2)	< 0.001	2,535 (20.8)	< 0.001
Type 2 diabetes mellitus E11.9	675 (9.3)	770 (6.3)	0.001	1,470 (12.0)	0.008
Chronic kidney disease, any stage N18.9	1,880 (25.9)	905 (7.4)	< 0.001	2,940 (24.1)	0.33
CKD stage 1 N18.1	15 (0.2)	15 (0.1)	0.52	15 (0.1)	0.52
CKD stage 2 N18.2	140 (1.9)	250 (2.0)	0.80	155 (1.3)	0.11
CKD stage 3 N18.3	1,290 (17.7)	560 (4.6)	< 0.001	2,000 (16.4)	0.27
CKD stage 4 N18.4	435 (6.0)	80 (0.7)	< 0.001	720 (5.9)	0.91
CKD stage 5 N18.5	-^a	0 (0)	0.07	50 (0.4)	0.14
Tobacco use F17	435 (6.0)	1,160 (9.5)	< 0.001	555 (4.5)	0.05
COPD J44.9	1,330 (18.3)	860 (7.0)	< 0.001	2,520 (20.6)	0.07
Hospital bed-size, n (%)			0.01		0.14
Small	570 (7.8)	1,265 (10.3)		820 (6.7)
Medium	1,440 (19.8)	2,590 (21.2)		2,210 (18.1)
Large	5,260 (72.3)	8,375 (68.5)		9,175 (75.2)
Hospital location and teaching status, n (%)			0.84		0.002
Rural	40 (1.2)	130 (1.1)		90 (0.3)
Urban non-teaching	565 (7.8)	985 (8.1)		1,060 (8.7)
Urban teaching	6,615 (91.0)	11,115 (90.9)		11,105 (91.0)

Table 1. Patient Characteristics for Those Receiving MitraClip G4 Versus Annuloplasty and Previous Clip Versions

MitraClip G4 (N = 7,270)

Annuloplasty (N = 12,230)

P-value

Earlier MitraClip (N = 12,205)

P-value

^aValue censored due to low cell size (< 10). Numbers and comparisons incorporate the discharge weights provided in the NIS. Data are from 2016 to 2020. To avoid overlap between G4 and prior iterations, MitraClip data from 2019 were excluded. P-values are comparisons to MitraClip G4. CKD: chronic kidney disease; COPD: chronic obstructive pulmonary disease; SD: standard deviation.

Age, years, mean (SD)

76.4 (10.7)

57.4 (19.8)

< 0.001

78.3 (10.1)

< 0.001

Female, n (%)

3,470 (47.8)

4,545 (37.2)

< 0.001

6,190 (50.7)

0.07

Race, n (%)

< 0.001

0.01

White

5,485 (75.4)

9,195 (75.2)

9,320 (76.4)

Black

770 (10.6)

875 (7.2)

940 (7.7)

Hispanic

410 (5.6)

730 (6.0)

760 (6.2)

Others

605 (8.3)

1,430 (11.7)

1,185 (9.7)

Hospital region, n (%)

< 0.001

0.35

Northeast

1,240 (17.1)

2,315 (18.9)

1,980 (16.2)

Midwest

1,285 (17.7)

3,295 (26.9)

2,415 (19.8)

South

2,810 (38.7)

3,830 (31.3)

4,510 (37.0)

West

1,935 (26.6)

2,790 (22.8)

3,300 (27.0)

Primary payer, n (%)

< 0.001

0.89

Medicare

6,105 (84.0)

4,955 (40.6)

10,645 (87.3)

Medicaid

265 (3.6)

1,220 (9.9)

255 (2.1)

Private insurance

705 (9.7)

5,470 (44.8)

1,115 (9.1)

Others/self-pay

190 (2.6)

575 (4.7)

175 (1.4)

Median household income (quartile), n (%)

< 0.001

0.20

0 - 25th percentile

1,665 (23.3)

2,465 (20.5)

2,705 (22.6)

25 - 50th percentile

1,895 (26.5)

2,720 (22.6)

2,880 (24.0)

50 - 75th percentile

1,865 (26.1)

3,205 (26.7)

3,240 (27.0)

75 - 100th percentile

1,725 (24.1)

3,625 (30.2)

3,170 (26.4)

Comorbidities, n (%)

Cerebrovascular disease I6X

405 (5.6)

670 (5.5)

0.90

680 (5.6)

1.00

Coronary artery disease I25

3,985 (54.8)

4,360 (35.7)

< 0.001

6,705 (54.9)

0.94

Peripheral artery disease I73.9

280 (3.9)

255 (2.1)

0.001

785 (6.4)

0.001

Obstructive sleep apnea G47.33

1,015 (15.4)

1,295 (10.6)

0.002

1,425 (11.7)

0.04

Atrial fibrillation I48

4,430 (60.9)

6,100 (49.9)

< 0.001

7,560 (61.9)

0.53

Obesity E66

915 (12.6)

1,740 (14.2)

0.15

1,225 (10.0)

0.01

Hypertension I10

640 (8.8)

4,305 (35.2)

< 0.001

2,535 (20.8)

< 0.001

Type 2 diabetes mellitus E11.9

675 (9.3)

770 (6.3)

0.001

1,470 (12.0)

0.008

Chronic kidney disease, any stage N18.9

1,880 (25.9)

905 (7.4)

< 0.001

2,940 (24.1)

0.33

CKD stage 1 N18.1

15 (0.2)

15 (0.1)

0.52

15 (0.1)

0.52

CKD stage 2 N18.2

140 (1.9)

250 (2.0)

0.80

155 (1.3)

0.11

CKD stage 3 N18.3

1,290 (17.7)

560 (4.6)

< 0.001

2,000 (16.4)

0.27

CKD stage 4 N18.4

435 (6.0)

80 (0.7)

< 0.001

720 (5.9)

0.91

CKD stage 5 N18.5

-^a

0 (0)

0.07

50 (0.4)

0.14

Tobacco use F17

435 (6.0)

1,160 (9.5)

< 0.001

555 (4.5)

0.05

COPD J44.9

1,330 (18.3)

860 (7.0)

< 0.001

2,520 (20.6)

0.07

Hospital bed-size, n (%)

0.01

0.14

Small

570 (7.8)

1,265 (10.3)

820 (6.7)

Medium

1,440 (19.8)

2,590 (21.2)

2,210 (18.1)

Large

5,260 (72.3)

8,375 (68.5)

9,175 (75.2)

Hospital location and teaching status, n (%)

0.84

0.002

Rural

40 (1.2)

130 (1.1)

90 (0.3)

Urban non-teaching

565 (7.8)

985 (8.1)

1,060 (8.7)

Urban teaching

6,615 (91.0)

11,115 (90.9)

11,105 (91.0)

**Table 2.** Unadjusted Outcomes of the MitraClip G4 vs. Annuloplasty and Previous Iterations of MitraClip
Outcomes	MitraClip G4 (N = 7,270)	Annuloplasty (N = 12,230)	P-value	Earlier MitraClip (N = 12,205)	P-value
^aValue censored due to low cell size (< 10). Numbers, odds ratios, and comparisons account for discharge weights only. P-values are for comparisons to MitraClip G4. IQR: interquartile range.
In-hospital mortality R99, n (%)	90 (1.2)	195 (1.6)	0.37	165 (1.4)	0.76
Length of stay, days, median (IQR)	1 (1, 3)	6 (5, 9)	< 0.001	2 (1 - 4)	< 0.001
Cost of stay, thousands of dollars, median (IQR)	173.8 (128.5 - 261.0)	167.3 (119.6 - 262.2)	0.06	174.6 (121.2 - 254.5)	0.05
Pulmonary embolism I26, n (%)	40 (0.6)	60 (0.5)	0.80	25 (0.2)	0.07
Acute ischemic stroke I63, n (%)	50 (0.7)	220 (1.8)	0.004	105 (0.9)	0.56
Myocardial infarction I21, n (%)	95 (1.3)	515 (4.2)	< 0.001	125 (1.0)	0.42
Gastrointestinal bleed K92.2, n (%)	40 (0.6)	55 (0.4)	0.66	35 (0.3)	0.20
Non-traumatic intracerebral hemorrhage I61.9, n (%)	0 (0)	0 (0)	-	0 (0)	-
Postprocedural hemorrhage of skin and subcutaneous tissue L76.2, n (%)	0 (0)	-^a	0.44	20 (0.2)	0.12
Pericardial effusion I31.3, n (%)	25 (0.3)	75 (0.6)	0.25	50 (0.4)	0.75
Tamponade I31.4, n (%)	230 (3.2)	320 (2.6)	0.32	270 (2.2)	0.07

Table 2. Unadjusted Outcomes of the MitraClip G4 vs. Annuloplasty and Previous Iterations of MitraClip

Outcomes

MitraClip G4 (N = 7,270)

Annuloplasty (N = 12,230)

P-value

Earlier MitraClip (N = 12,205)

P-value

^aValue censored due to low cell size (< 10). Numbers, odds ratios, and comparisons account for discharge weights only. P-values are for comparisons to MitraClip G4. IQR: interquartile range.

In-hospital mortality R99, n (%)

90 (1.2)

195 (1.6)

0.37

165 (1.4)

0.76

Length of stay, days, median (IQR)

1 (1, 3)

6 (5, 9)

< 0.001

2 (1 - 4)

< 0.001

Cost of stay, thousands of dollars, median (IQR)

173.8 (128.5 - 261.0)

167.3 (119.6 - 262.2)

0.06

174.6 (121.2 - 254.5)

0.05

Pulmonary embolism I26, n (%)

40 (0.6)

60 (0.5)

0.80

25 (0.2)

0.07

Acute ischemic stroke I63, n (%)

50 (0.7)

220 (1.8)

0.004

105 (0.9)

0.56

Myocardial infarction I21, n (%)

95 (1.3)

515 (4.2)

< 0.001

125 (1.0)

0.42

Gastrointestinal bleed K92.2, n (%)

40 (0.6)

55 (0.4)

0.66

35 (0.3)

0.20

Non-traumatic intracerebral hemorrhage I61.9, n (%)

0 (0)

Postprocedural hemorrhage of skin and subcutaneous tissue L76.2, n (%)

0 (0)

-^a

0.44

20 (0.2)

0.12

Pericardial effusion I31.3, n (%)

25 (0.3)

75 (0.6)

0.25

50 (0.4)

0.75

Tamponade I31.4, n (%)

230 (3.2)

320 (2.6)

0.32

270 (2.2)

0.07

**Table 3.** Adjusted Outcomes of Patients Receiving the MitraClip G4 vs. Annuloplasty and Earlier Clip Versions
Outcomes	MitraClip G4 vs. annuloplasty	MitraClip G4 vs. earlier versions
Because treatments are non-randomly assigned, survey regressions (linear or logistic) account for discharge weights and discharge characteristics found to be significantly different between groups. Non-traumatic intracerebral hemorrhage and postprocedural hemorrhage of skin and subcutaneous tissue were not considered due to an insufficient number of events. CI: confidence interval; OR: odds ratio.
In-hospital mortality	0.38 (0.18 - 0.77)	0.007	0.86 (0.48 - 1.54)	0.62
Length of stay, days	-5.51 (-6.32 to -4.70)	< 0.001	-1.23 (-1.75 to -0.71)	< 0.001
Cost of stay, thousands	-17.00 (-35.09 to 1.09)	0.07	5.00 (-5.12 to 15.14)	0.33
Pulmonary embolism	1.61 (0.51 - 5.03)	0.42	3.00 (0.95 - 9.47)	0.06
Acute ischemic stroke	0.29 (0.13 - 0.61)	0.001	0.74 (0.36 - 1.53)	0.42
Myocardial infarction	0.15 (0.08 - 0.28)	< 0.001	1.15 (0.63 - 2.11)	0.65
Gastrointestinal bleed	0.54 (0.17 - 1.70)	0.29	1.81 (0.66 - 4.94)	0.25
Pericardial effusion	0.49 (0.16 - 1.55)	0.23	0.84 (0.30 - 2.38)	0.75
Tamponade	1.73 (1.08 - 2.78)	0.02	1.35 (0.90 - 2.01)	0.15

Table 3. Adjusted Outcomes of Patients Receiving the MitraClip G4 vs. Annuloplasty and Earlier Clip Versions

Outcomes

MitraClip G4 vs. annuloplasty

MitraClip G4 vs. earlier versions

OR/mean difference (95% CI)

P-value

OR/mean difference (95% CI)

P-value

Because treatments are non-randomly assigned, survey regressions (linear or logistic) account for discharge weights and discharge characteristics found to be significantly different between groups. Non-traumatic intracerebral hemorrhage and postprocedural hemorrhage of skin and subcutaneous tissue were not considered due to an insufficient number of events. CI: confidence interval; OR: odds ratio.

In-hospital mortality

0.38 (0.18 - 0.77)

0.007

0.86 (0.48 - 1.54)

0.62

Length of stay, days

-5.51 (-6.32 to -4.70)

< 0.001

-1.23 (-1.75 to -0.71)

< 0.001

Cost of stay, thousands

-17.00 (-35.09 to 1.09)

0.07

5.00 (-5.12 to 15.14)

0.33

Pulmonary embolism

1.61 (0.51 - 5.03)

0.42

3.00 (0.95 - 9.47)

0.06

Acute ischemic stroke

0.29 (0.13 - 0.61)

0.001

0.74 (0.36 - 1.53)

0.42

Myocardial infarction

0.15 (0.08 - 0.28)

< 0.001

1.15 (0.63 - 2.11)

0.65

Gastrointestinal bleed

0.54 (0.17 - 1.70)

0.29

1.81 (0.66 - 4.94)

0.25

Pericardial effusion

0.49 (0.16 - 1.55)

0.23

0.84 (0.30 - 2.38)

0.75

Tamponade

1.73 (1.08 - 2.78)

0.02

1.35 (0.90 - 2.01)

0.15