Table 2

Prognostic associations based on peri-device leak size

PDL size categoriesRisk of thromboembolismNumber of studies; observed heterogeneity
PDL > 5 mm
PDL = 0–5 mm
no PDL
OR = 4.37, 95% CI: 1.74–10.97, P = .002
OR = 1.38, 95% CI: 1.11–1.71, P = .003
Reference group
10 studies; I2 = 35%
15 studies; I2 = 5%
Reference group
PDL 0–5 mm
PDL > 5 mm
OR = 1.16, 95% CI: 0.67–2.06, P = .603
Reference group
9 studies; I2 = 2%
PDL > 3 mm
PDL = 1–3 mm
PDL < 1 mm or no PDL
OR = 3.27, 95% CI: 1.27–8.43, P = .014
OR = 1.78, 95% CI: 0.97–3.27, P = .061
Reference group
9 studies; I2 = 13%
8 studies; I2 = 0%
Reference group
PDL 1–3 mm
PDL > 3 mm
OR = 1.73, 95% CI: 0.38–7.91, P = .482
Reference group
5 studies; I2 = 39%
PDL > 5 mm
PDL = 3–5 mm
PDL < 3 mm or no PDL
OR = 5.03, 95% CI: 1.09–24.78, P = .047
OR = 3.31, 95% CI: 1.03–10.61, P = .040
Reference group
6 studies; I2 = 44%
7 studies; I2 = 45%
Reference group
PDL 3–5 mm
PDL > 5 mm
OR = 1.05, 95% CI: 0.24–19.35, P = .932
Reference group
4 studies; I2 = 48%
PDL size categoriesRisk of thromboembolismNumber of studies; observed heterogeneity
PDL > 5 mm
PDL = 0–5 mm
no PDL
OR = 4.37, 95% CI: 1.74–10.97, P = .002
OR = 1.38, 95% CI: 1.11–1.71, P = .003
Reference group
10 studies; I2 = 35%
15 studies; I2 = 5%
Reference group
PDL 0–5 mm
PDL > 5 mm
OR = 1.16, 95% CI: 0.67–2.06, P = .603
Reference group
9 studies; I2 = 2%
PDL > 3 mm
PDL = 1–3 mm
PDL < 1 mm or no PDL
OR = 3.27, 95% CI: 1.27–8.43, P = .014
OR = 1.78, 95% CI: 0.97–3.27, P = .061
Reference group
9 studies; I2 = 13%
8 studies; I2 = 0%
Reference group
PDL 1–3 mm
PDL > 3 mm
OR = 1.73, 95% CI: 0.38–7.91, P = .482
Reference group
5 studies; I2 = 39%
PDL > 5 mm
PDL = 3–5 mm
PDL < 3 mm or no PDL
OR = 5.03, 95% CI: 1.09–24.78, P = .047
OR = 3.31, 95% CI: 1.03–10.61, P = .040
Reference group
6 studies; I2 = 44%
7 studies; I2 = 45%
Reference group
PDL 3–5 mm
PDL > 5 mm
OR = 1.05, 95% CI: 0.24–19.35, P = .932
Reference group
4 studies; I2 = 48%

Using one category as reference, the comparative prognostic difference of the remaining categories, in terms of thromboembolic risk, was calculated. For example, compared with patients with no PDL or PDL of 0–1 mm, those with PDL of 1–3 mm are 1.78 times more likely to have a thromboembolic event, while those with PDL of >3 mm are 3.27 times more likely to have a thromboembolic event.

CI, confidence interval; I2, heterogeneity statistic; OR, odds ratio; PDL, peri-device leak.

Table 2

Prognostic associations based on peri-device leak size

PDL size categoriesRisk of thromboembolismNumber of studies; observed heterogeneity
PDL > 5 mm
PDL = 0–5 mm
no PDL
OR = 4.37, 95% CI: 1.74–10.97, P = .002
OR = 1.38, 95% CI: 1.11–1.71, P = .003
Reference group
10 studies; I2 = 35%
15 studies; I2 = 5%
Reference group
PDL 0–5 mm
PDL > 5 mm
OR = 1.16, 95% CI: 0.67–2.06, P = .603
Reference group
9 studies; I2 = 2%
PDL > 3 mm
PDL = 1–3 mm
PDL < 1 mm or no PDL
OR = 3.27, 95% CI: 1.27–8.43, P = .014
OR = 1.78, 95% CI: 0.97–3.27, P = .061
Reference group
9 studies; I2 = 13%
8 studies; I2 = 0%
Reference group
PDL 1–3 mm
PDL > 3 mm
OR = 1.73, 95% CI: 0.38–7.91, P = .482
Reference group
5 studies; I2 = 39%
PDL > 5 mm
PDL = 3–5 mm
PDL < 3 mm or no PDL
OR = 5.03, 95% CI: 1.09–24.78, P = .047
OR = 3.31, 95% CI: 1.03–10.61, P = .040
Reference group
6 studies; I2 = 44%
7 studies; I2 = 45%
Reference group
PDL 3–5 mm
PDL > 5 mm
OR = 1.05, 95% CI: 0.24–19.35, P = .932
Reference group
4 studies; I2 = 48%
PDL size categoriesRisk of thromboembolismNumber of studies; observed heterogeneity
PDL > 5 mm
PDL = 0–5 mm
no PDL
OR = 4.37, 95% CI: 1.74–10.97, P = .002
OR = 1.38, 95% CI: 1.11–1.71, P = .003
Reference group
10 studies; I2 = 35%
15 studies; I2 = 5%
Reference group
PDL 0–5 mm
PDL > 5 mm
OR = 1.16, 95% CI: 0.67–2.06, P = .603
Reference group
9 studies; I2 = 2%
PDL > 3 mm
PDL = 1–3 mm
PDL < 1 mm or no PDL
OR = 3.27, 95% CI: 1.27–8.43, P = .014
OR = 1.78, 95% CI: 0.97–3.27, P = .061
Reference group
9 studies; I2 = 13%
8 studies; I2 = 0%
Reference group
PDL 1–3 mm
PDL > 3 mm
OR = 1.73, 95% CI: 0.38–7.91, P = .482
Reference group
5 studies; I2 = 39%
PDL > 5 mm
PDL = 3–5 mm
PDL < 3 mm or no PDL
OR = 5.03, 95% CI: 1.09–24.78, P = .047
OR = 3.31, 95% CI: 1.03–10.61, P = .040
Reference group
6 studies; I2 = 44%
7 studies; I2 = 45%
Reference group
PDL 3–5 mm
PDL > 5 mm
OR = 1.05, 95% CI: 0.24–19.35, P = .932
Reference group
4 studies; I2 = 48%

Using one category as reference, the comparative prognostic difference of the remaining categories, in terms of thromboembolic risk, was calculated. For example, compared with patients with no PDL or PDL of 0–1 mm, those with PDL of 1–3 mm are 1.78 times more likely to have a thromboembolic event, while those with PDL of >3 mm are 3.27 times more likely to have a thromboembolic event.

CI, confidence interval; I2, heterogeneity statistic; OR, odds ratio; PDL, peri-device leak.

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