Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention.

All-cause deaths (cardiovascular or non-cardiovascular) were assessed.

Major Bleeding

• Type 3a:

  • Any transfusion with overt bleeding
  • Overt bleeding+Hb drop of ≥ 3 to < 5 g/dL (provided Hb drop is related to bleed)

• Type 3b:

  • Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed)
  • Cardiac tamponade
  • Bleeding requiring surgical intervention for (Watchman)
  • Bleeding requiring intravenous vasoactive drugs

• Type 3c:

  • Intracranial hemorrhage including subdural hemorrhages
  • Subcategories confirmed by autopsy/imaging/lumbar puncture
  • Intraocular bleed compromising vision

• Type 5a: Probably fatal bleeding

• Type 5b: Definite fatal bleeding

The number of participants analyzed includes subjects who were available at that time of analysis

Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.

Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

The number of participants analyzed includes subjects who were available at that time of analysis

Device closure (defined as residual jet around the device ≤ 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow was assessed.

The number of participants analyzed includes subjects who were available at that time of analysis

Stroke: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

Systemic Embolism: Acute vascular insufficiency/occlusion of the extremities/any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (trauma/atherosclerosis/instrumentation). When there is presence of prior peripheral artery disease, angiographic/surgical/autopsy evidence is required to show abrupt arterial occlusion.

Cardiovascular/unexplained death includes:

• Death due to proximate cardiac cause
• Death caused by non-coronary/non-CNS vascular conditions
• Death from vascular CNS causes
• All procedure-related deaths
• Sudden/unwitnessed death
• Death of unknown cause

The number of participants analyzed includes subjects who were available at that time of analysis

Major bleeding rate defined as Type 3 or greater based on the Bleeding Academic Research Consortium (BARC) definition was assessed

• Type 3a:

  • Any transfusion with overt bleeding
  • Overt bleeding+Hb drop of ≥ 3 to < 5 g/dL (provided Hb drop is related to bleed)

• Type 3b:

  • Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed)
  • Cardiac tamponade
  • Bleeding requiring surgical intervention for (Watchman)
  • Bleeding requiring intravenous vasoactive drugs

• Type 3c:

  • Intracranial hemorrhage including subdural hemorrhages
  • Subcategories confirmed by autopsy/imaging/lumbar puncture
  • Intraocular bleed compromising vision

• Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging

• Type 5b: Definite fatal bleeding: bleeding that is directly observed or confirmed on autopsy

The number of participants analyzed includes subjects who were available at that time of analysis

Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention.

All-cause deaths (cardiovascular or non-cardiovascular) were assessed.

Major Bleeding

• Type 3a:

  • Any transfusion with overt bleeding
  • Overt bleeding+Hb drop of ≥ 3 to < 5 g/dL (provided Hb drop is related to bleed)

• Type 3b:

  • Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to bleed)
  • Cardiac tamponade
  • Bleeding requiring surgical intervention for (Watchman)
  • Bleeding requiring intravenous vasoactive drugs

• Type 3c:

  • Intracranial hemorrhage including subdural hemorrhages
  • Subcategories confirmed by autopsy/imaging/lumbar puncture
  • Intraocular bleed compromising vision

• Type 5a: Probably fatal bleeding

• Type 5b: Definite fatal bleeding

The number of participants analyzed includes subjects who were available at that time of analysis

Ischemic Stroke: An acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue.

Systemic Embolism: Acute vascular insufficiency or occlusion of the extremities or any non-central nervous system (non-CNS) organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

The number of participants analyzed includes subjects who were available at that time of analysis

Device closure (defined as residual jet around the device ≤ 5 mm) at the 45-day visit documented by transesophageal echocardiogram (TEE/TOE) defined by Doppler flow was assessed.

The number of participants analyzed includes subjects who were available at that time of analysis

Ischemic Stroke is defined as an acute symptomatic episode of focal cerebral, spinal, or retinal dysfunction caused by an infarction of central nervous system tissue and Systemic Embolism is define as Acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g. trauma, atherosclerosis, or instrumentation). When there is presence of prior peripheral artery disease, angiographic or surgical or autopsy evidence is required to show abrupt arterial occlusion.

Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.

Stroke: An acute episode of focal or global neurological dysfunction caused by the brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.

Systemic Embolism: Acute vascular insufficiency/occlusion of the extremities/any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (trauma/atherosclerosis/instrumentation). When there is presence of prior peripheral artery disease, angiographic/surgical/autopsy evidence is required to show abrupt arterial occlusion.

Cardiovascular/unexplained death includes:

Death due to proximate cardiac cause Death caused by non-coronary/non-CNS vascular conditions Death from vascular CNS causes All procedure-related deaths Sudden/unwitnessed death Death of unknown cause

Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.

Major bleeding:

Type 3a: Any transfusion with overt bleeding. Overt bleeding plus a hemoglobin drop of ≥ 3 to < 5 g/dL.

Type 3b: Overt bleeding plus hemoglobin drop ≥ 5 g/dL. Cardiac tamponade. Bleeding requiring surgical intervention for Watchman (excluding dental/nasal/skin/ hemorrhoid). Bleeding requiring intravenous vasoactive drugs.

Type 3c:Intracranial hemorrhage including subdural hemorrhages (does not include microbleeds or hemorrhagic transformation, does include intraspinal). Subcategories confirmed by autopsy or imaging or lumbar puncture. Intraocular bleed compromising vision.

Type 5a: Probably fatal bleeding: bleeding that is clinically suspicious as the cause of death, but the bleeding is not directly observed and there is no autopsy or confirmatory imaging.

Type 5b: Definite fatal bleeding: bleeding that is directly observed (by either clinical specimen) or confirmed on autopsy.

Analysis included subjects who underwent an implant attempt regardless of the device attempted or implanted.