19
Stroke or transient
ischemic attack
(TIA) postablation
Stroke diagnostic criteria:
• Rapid onset of a focal or global neurological deficit with at
least one of the following : change in level of consciousness,
hemiplegia, hemiparesis, numbness or sensory loss affecting
one side of the body, dysphasia or aphasia, hemianopia,
amaurosis fugax, or other neurological signs or symptoms
consistent with stroke.
• Duration of a focal or global neurological deficit ≥24 h;
OR <24 h if therapeutic intervention(s) were performed
(e.g., thrombolytic therapy or intracranial angioplasty); OR
available neuroimaging documents a new hemorrhage or
infarct; OR the neurological deficit results in death.
• No other readily identifiable nonstroke cause for the
clinical presentation (e.g., brain tumor, trauma, infection,
hypoglycemia, peripheral lesion, pharmacological influences).
a
• Confirmation of the diagnosis by at least one of the following :
neurolog y or neurosurgical specialist; neuroimaging
procedure (MR or CT scan or cerebral angiography); lumbar
puncture (i.e., spinal fluid analysis diagnostic of intracranial
hemorrhage)
Stroke definitions
• Transient ischemic attack: new focal neurological deficit with
rapid symptom resolution (usually 1–2 h), always within 24 h;
neuroimaging without tissue injury
• Stroke: (diagnosis as above, preferably with positive
neuroimaging study):
Minor—Modified Rankin score <2 at 30 and 90 days
b
Major—Modified Rankin score ≥2 at 30 and 90 days
a
Patients with nonfocal global encephalopathy will not be reported
as a stroke without unequivocal evidence based upon neuroimaging
studies.
b
Modified Rankin score assessments should be made by qualified
individuals according to a certification process. If there is
discordance between the 30- and 90-day Modified Rankin scores, a
final determination of major versus minor stroke will be adjudicated
by the neurolog y members of the clinical events committee.
Unanticipated
adverse device effect
Unanticipated adverse device effect is defined as complication of
an ablation procedure that has not been previously known to be
associated with catheter or surgical ablation procedures.
Table 7. Definitions of Complications Associated with AF
Ablation (cont'd)
Term Definition