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. Author manuscript; available in PMC: 2022 Jun 25.
Published in final edited form as: JACC Clin Electrophysiol. 2022 Apr 3;8(6):766–778. doi: 10.1016/j.jacep.2022.03.001

Table-4.

Incidence Rates of Adverse Events Stratified by Leak Size

Clinical Outcomes Leak= 0 mm (N=37,696) Leak= 0–5 mm (N=13,258) Leak >5 mm (N= 379)
Ischemic Stroke 1.39% (1.27%–1.52%) 1.61% (1.39%–1.84%) 1.42% (0.18%–2.66%)
Stroke, TIA, or SE 2.98% (2.80%–3.17%) 3.49% (3.16%–3.81%) 3.13% (1.31%–4.94%)
Major Bleeding 7.58% (7.3%–7.86%) 8.57% (8.07%–9.07%) 6.82% (4.19%–9.45%)
Death 5.97% (5.72%–6.23%) 6.41% (5.97%–6.85%) 7.96% (5.13%–10.78%)
Any MAE 17.43% (17.02%–17.83%) 19.44% (18.73%–20.15%) 19.61% (15.46%–23.76%)

TIA; transient ischemic attack, SE; systemic embolization, MASE: major adverse serious event which included death, cardiac arrest, ischemic, hemorrhagic, or undetermined stroke, TIA, SE, major bleeding, major vascular complication (fistula or pseudoaneurysm requiring fibrin injection, angioplasty, or surgical repair), myocardial infarction, pericardial effusion requiring intervention, or device embolization.