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Table 2 Adverse events

From: Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure –1 year results from the Ce mark trial

Event

Days 0–180 (n = 50)

Days 181–365 (n = 44)

Total-1-year (nn = 50)

No. Pts

% Pts

No. Events

No. Pts

% Pts

No. Events

No. Pts

% Pts

No. Events

Bleeding

19

38

35

8

18

9

22

44

43

 Requiring surgery

7

14

8

3

7

3

8

16

11

 Gastrointestinal

4

8

6

2

5

3

6

12

9

Any infection

18

36

28

9

20

10

24

48

38

 Sepsis

8

16

8

2

5

2

10

20

10

 Driveline

5

10

5

3

7

3

8

16

8

Stroke

6

12

6

3

7

3

9

18

9

 Ischemic

4

8

4

1

2

1

5

10

5

 Hemorrhagic

2

4

2

2

5

2

4

8

4

Neurologic dysfunctiona

4

8

4

0

0

0

4

8

4

Right heart failure

5

10

5

0

0

0

5

10

5

Requiring RVAD

2

4

2

0

0

0

2

4

2

Pump malfunctions

0

0

0

0

0

0

0

0

0

Pump thrombosis

0

0

0

0

0

0

0

0

0

Ouflow graft thrombosis

0

0

0

1

2

1

1

2

1

Hemolysis

0

0

0

0

0

0

0

0

0

  1. aTransient ischemic attack (n = 2, 4%), seizure (n = 2, 4%)
  2. RVAD right ventricular assist device