Table 1.
Ref.
|
Study population
|
Type of study
|
Type of LAA closure
|
Incidence of PDL
|
Findings
|
Holmes et al[8] | 485 | Randomized controlled study | Watchman | 14%: ≥ 5 mm | No difference between patients with any PDL in terms of primary effectiveness |
Dukkipati et al[12] | 1205 | Randomized controlled study | Watchman | 0.7%: > 5 mm; 27.7%: 1-5 mm; and 71.6%: no PDL | PDL ≤ 5 mm was associated with an increased risk of stroke, systemic embolism, cardiovascular, unexplained death, or all-cause mortality |
Korsholm et al[13] | 153 | Retrospective study | Amplatzer Amulet, Amplatzer Cardiac Plug | 61% | PDL did not increase the incidence of events related to thromboembolism. |
Wang et al[14] | 152 | Retrospective study | LAmbre | 15.7%: > 3 mm | PDL was not associated with an increased risk for thromboembolic events |
Alkhouli et al[15] | 51333 | Retrospective studies | Watchman, ACP | 73.4%: no PDL; 25.8%: moderate; and 0.7%: severe | Patients with PDL at 1 yr had a 2-fold increase in ischemic stroke/SE at 5 yr compared with patients without PDL |
Miller et al[17] | 43 | Retrospective study | Watchman FLX | More than 40% | 3 TIAs (6.98%) and 3 strokes (6.98%) were documented each within the 6-mo to 1-yr period |
TIA: Transient ischemic attack; PDL: Peri-device leak; SE: Systemic embolization; LAA: Left atrial appendage.