Table 3:
Open in new tab

Kaplan–Meier rates of death and valve-related safety events at 30 days and 1, 5 and 7 years of follow-upa

Event rate, %Kaplan–Meier event rate, % (95% CI)b
Event30 days1 year5 years7 years
All death

  • 0.9

  • n = 10

  • 3.0 (2.2–4.2)

  • n = 34

  • 11.6 (9.8–13.7)

  • n = 124

  • 17.4 (15.0–20.2)

  • n = 160

 Cardiac death

  • 0.5

  • n = 6

  • 1.6 (1.0–2.6)

  • n = 18

  • 5.5 (4.3–7.1)

  • n = 57

  • 8.6 (6.8–10.7)

  • n = 75

  Valve-related death

  • 0.0

  • n = 0

  • 0.3 (0.1–0.9)

  • n = 3

  • 1.6 (1.0–2.5)

  • n = 16

  • 2.6 (1.7–4.1)

  • n = 22

Thromboembolism

  • 1.4

  • n = 15

  • 2.7 (1.9–3.8)

  • n = 30

  • 5.6 (4.4–7.2)

  • n = 59

  • 6.3 (4.9–8.1)

  • n = 63

Valve thrombosis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.4 (0.1–1.1)

  • n = 4

  • 0.4 (0.1–1.1)

  • n = 4

All haemorrhagec

  • 1.6

  • n = 17

  • 5.1 (4.0–6.6)

  • n = 57

  • 9.7 (8.1–11.6)

  • n = 103

  • 9.7 (8.1–11.6)

  • n = 103

  Major haemorrhagec

  • 1.0

  • n = 11

  • 3.4 (2.5–4.7)

  • n = 38

  • 5.8 (4.5–7.4)

  • n = 62

  • 5.8 (4.5–7.4)

  • n = 62

All paravalvular leak

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.0 (0.5–1.8)

  • n = 10

  • 1.0 (0.5–1.8)

  • n = 10

  Major paravalvular leak

  • 0.1

  • n = 1

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

Endocarditis

  • 0.2

  • n = 2

  • 1.2 (0.7–2.0)

  • n = 13

  • 4.4 (3.3–5.8)

  • n = 45

  • 6.3 (4.9–8.3)

  • n = 56

Hemolysis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 1.1 (0.6–2.0)

  • n = 10

  • 1.3 (0.7–2.3)

  • n = 11

Non-structural valve dysfunction

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.3 (0.7–2.2)

  • n = 13

  • 1.3 (0.7–2.2)

  • n = 13

SVD/SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SVD requiring reinterventiond

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

Reintervention

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 3.3 (2.4–4.6)

  • n = 34

  • 5.7 (4.3–7.7)

  • n = 47

 Explant

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 2.9 (2.1–4.2)

  • n = 30

  • 4.4 (3.1–6.0)

  • n = 38

Event rate, %Kaplan–Meier event rate, % (95% CI)b
Event30 days1 year5 years7 years
All death

  • 0.9

  • n = 10

  • 3.0 (2.2–4.2)

  • n = 34

  • 11.6 (9.8–13.7)

  • n = 124

  • 17.4 (15.0–20.2)

  • n = 160

 Cardiac death

  • 0.5

  • n = 6

  • 1.6 (1.0–2.6)

  • n = 18

  • 5.5 (4.3–7.1)

  • n = 57

  • 8.6 (6.8–10.7)

  • n = 75

  Valve-related death

  • 0.0

  • n = 0

  • 0.3 (0.1–0.9)

  • n = 3

  • 1.6 (1.0–2.5)

  • n = 16

  • 2.6 (1.7–4.1)

  • n = 22

Thromboembolism

  • 1.4

  • n = 15

  • 2.7 (1.9–3.8)

  • n = 30

  • 5.6 (4.4–7.2)

  • n = 59

  • 6.3 (4.9–8.1)

  • n = 63

Valve thrombosis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.4 (0.1–1.1)

  • n = 4

  • 0.4 (0.1–1.1)

  • n = 4

All haemorrhagec

  • 1.6

  • n = 17

  • 5.1 (4.0–6.6)

  • n = 57

  • 9.7 (8.1–11.6)

  • n = 103

  • 9.7 (8.1–11.6)

  • n = 103

  Major haemorrhagec

  • 1.0

  • n = 11

  • 3.4 (2.5–4.7)

  • n = 38

  • 5.8 (4.5–7.4)

  • n = 62

  • 5.8 (4.5–7.4)

  • n = 62

All paravalvular leak

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.0 (0.5–1.8)

  • n = 10

  • 1.0 (0.5–1.8)

  • n = 10

  Major paravalvular leak

  • 0.1

  • n = 1

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

Endocarditis

  • 0.2

  • n = 2

  • 1.2 (0.7–2.0)

  • n = 13

  • 4.4 (3.3–5.8)

  • n = 45

  • 6.3 (4.9–8.3)

  • n = 56

Hemolysis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 1.1 (0.6–2.0)

  • n = 10

  • 1.3 (0.7–2.3)

  • n = 11

Non-structural valve dysfunction

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.3 (0.7–2.2)

  • n = 13

  • 1.3 (0.7–2.2)

  • n = 13

SVD/SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SVD requiring reinterventiond

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

Reintervention

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 3.3 (2.4–4.6)

  • n = 34

  • 5.7 (4.3–7.7)

  • n = 47

 Explant

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 2.9 (2.1–4.2)

  • n = 30

  • 4.4 (3.1–6.0)

  • n = 38

a

Analysis cohort is all implanted patients (N = 1132).

b

Patients may have had >1 event.

c

Anticoagulant-related haemorrhage only.

d

There were no adjudicated cases of SVD requiring or not requiring reintervention.

SHD: severe hemodynamic dysfunction; SVD: structural valve deterioration.

Table 3:
Open in new tab

Kaplan–Meier rates of death and valve-related safety events at 30 days and 1, 5 and 7 years of follow-upa

Event rate, %Kaplan–Meier event rate, % (95% CI)b
Event30 days1 year5 years7 years
All death

  • 0.9

  • n = 10

  • 3.0 (2.2–4.2)

  • n = 34

  • 11.6 (9.8–13.7)

  • n = 124

  • 17.4 (15.0–20.2)

  • n = 160

 Cardiac death

  • 0.5

  • n = 6

  • 1.6 (1.0–2.6)

  • n = 18

  • 5.5 (4.3–7.1)

  • n = 57

  • 8.6 (6.8–10.7)

  • n = 75

  Valve-related death

  • 0.0

  • n = 0

  • 0.3 (0.1–0.9)

  • n = 3

  • 1.6 (1.0–2.5)

  • n = 16

  • 2.6 (1.7–4.1)

  • n = 22

Thromboembolism

  • 1.4

  • n = 15

  • 2.7 (1.9–3.8)

  • n = 30

  • 5.6 (4.4–7.2)

  • n = 59

  • 6.3 (4.9–8.1)

  • n = 63

Valve thrombosis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.4 (0.1–1.1)

  • n = 4

  • 0.4 (0.1–1.1)

  • n = 4

All haemorrhagec

  • 1.6

  • n = 17

  • 5.1 (4.0–6.6)

  • n = 57

  • 9.7 (8.1–11.6)

  • n = 103

  • 9.7 (8.1–11.6)

  • n = 103

  Major haemorrhagec

  • 1.0

  • n = 11

  • 3.4 (2.5–4.7)

  • n = 38

  • 5.8 (4.5–7.4)

  • n = 62

  • 5.8 (4.5–7.4)

  • n = 62

All paravalvular leak

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.0 (0.5–1.8)

  • n = 10

  • 1.0 (0.5–1.8)

  • n = 10

  Major paravalvular leak

  • 0.1

  • n = 1

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

Endocarditis

  • 0.2

  • n = 2

  • 1.2 (0.7–2.0)

  • n = 13

  • 4.4 (3.3–5.8)

  • n = 45

  • 6.3 (4.9–8.3)

  • n = 56

Hemolysis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 1.1 (0.6–2.0)

  • n = 10

  • 1.3 (0.7–2.3)

  • n = 11

Non-structural valve dysfunction

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.3 (0.7–2.2)

  • n = 13

  • 1.3 (0.7–2.2)

  • n = 13

SVD/SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SVD requiring reinterventiond

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

Reintervention

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 3.3 (2.4–4.6)

  • n = 34

  • 5.7 (4.3–7.7)

  • n = 47

 Explant

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 2.9 (2.1–4.2)

  • n = 30

  • 4.4 (3.1–6.0)

  • n = 38

Event rate, %Kaplan–Meier event rate, % (95% CI)b
Event30 days1 year5 years7 years
All death

  • 0.9

  • n = 10

  • 3.0 (2.2–4.2)

  • n = 34

  • 11.6 (9.8–13.7)

  • n = 124

  • 17.4 (15.0–20.2)

  • n = 160

 Cardiac death

  • 0.5

  • n = 6

  • 1.6 (1.0–2.6)

  • n = 18

  • 5.5 (4.3–7.1)

  • n = 57

  • 8.6 (6.8–10.7)

  • n = 75

  Valve-related death

  • 0.0

  • n = 0

  • 0.3 (0.1–0.9)

  • n = 3

  • 1.6 (1.0–2.5)

  • n = 16

  • 2.6 (1.7–4.1)

  • n = 22

Thromboembolism

  • 1.4

  • n = 15

  • 2.7 (1.9–3.8)

  • n = 30

  • 5.6 (4.4–7.2)

  • n = 59

  • 6.3 (4.9–8.1)

  • n = 63

Valve thrombosis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.4 (0.1–1.1)

  • n = 4

  • 0.4 (0.1–1.1)

  • n = 4

All haemorrhagec

  • 1.6

  • n = 17

  • 5.1 (4.0–6.6)

  • n = 57

  • 9.7 (8.1–11.6)

  • n = 103

  • 9.7 (8.1–11.6)

  • n = 103

  Major haemorrhagec

  • 1.0

  • n = 11

  • 3.4 (2.5–4.7)

  • n = 38

  • 5.8 (4.5–7.4)

  • n = 62

  • 5.8 (4.5–7.4)

  • n = 62

All paravalvular leak

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.0 (0.5–1.8)

  • n = 10

  • 1.0 (0.5–1.8)

  • n = 10

  Major paravalvular leak

  • 0.1

  • n = 1

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

  • 0.2 (0.0–0.7)

  • n = 2

Endocarditis

  • 0.2

  • n = 2

  • 1.2 (0.7–2.0)

  • n = 13

  • 4.4 (3.3–5.8)

  • n = 45

  • 6.3 (4.9–8.3)

  • n = 56

Hemolysis

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 1.1 (0.6–2.0)

  • n = 10

  • 1.3 (0.7–2.3)

  • n = 11

Non-structural valve dysfunction

  • 0.2

  • n = 2

  • 0.5 (0.2–1.2)

  • n = 6

  • 1.3 (0.7–2.2)

  • n = 13

  • 1.3 (0.7–2.2)

  • n = 13

SVD/SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SHD requiring reintervention

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.2 (0.1–0.8)

  • n = 2

  • 1.2 (0.5–2.5)

  • n = 7

 SVD requiring reinterventiond

  • 0.0

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

  • 0.0 (0.0–0.0)

  • n = 0

Reintervention

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 3.3 (2.4–4.6)

  • n = 34

  • 5.7 (4.3–7.7)

  • n = 47

 Explant

  • 0.4

  • n = 4

  • 0.9 (0.5–1.7)

  • n = 10

  • 2.9 (2.1–4.2)

  • n = 30

  • 4.4 (3.1–6.0)

  • n = 38

a

Analysis cohort is all implanted patients (N = 1132).

b

Patients may have had >1 event.

c

Anticoagulant-related haemorrhage only.

d

There were no adjudicated cases of SVD requiring or not requiring reintervention.

SHD: severe hemodynamic dysfunction; SVD: structural valve deterioration.

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