TY - JOUR
T1 - Causes of Recurrent Focal Neurologic Events After Transcatheter Closure of Patent Foramen Ovale With the CardioSEAL Septal Occluder
AU - Kutty, Shelby
AU - Brown, Kimberly
AU - Asnes, Jeremy D.
AU - Rhodes, John F.
AU - Latson, Larry A.
PY - 2008/5/15
Y1 - 2008/5/15
N2 - Transcatheter patent foramen ovale (PFO) closure has been undertaken to eliminate paradoxical emboli as a cause for recurrent strokes/transient ischemic attacks (TIAs). We report the results of investigations to determine causes of all significant focal neurologic events (FNEs) after PFO closure reported to our center. Records of 216 consecutive patients who underwent PFO closure were reviewed. Patients had to have had ≥1 preceding clinical event consistent with stroke/TIA considered by a neurologist to be consistent with an embolic episode. Follow-up was recommended at 24 hours, 1 month, 6 months, 1 year, and every 1 to 2 years thereafter. All patients were requested to report any new FNE possibly suggestive of stroke/TIA to our center. Reports of evaluations were reviewed in detail. Twenty patients had an FNE 0.1 month to 40.2 months after PFO closure over 438 person-years of follow-up (mean 2.1 years, range 1 month to 7.1 years). There were 4 recurrent strokes, 2 likely directly device related. Ten patients had TIA and 6 patients had clear evidence of pathology unrelated to the device. Event rate for recurrent strokes was 0.9% per year (95% confidence interval for difference 0.3 to 2.4) and combined event rate for stroke/TIA was 3.4% per year (95% confidence interval for difference 2 to 5.6). In conclusion, transcatheter PFO occlusion can be accomplished as an outpatient procedure with minimal immediate morbidity. Patients may have multiple possible causes of recurrent FNE. Recurrence rate of cryptogenic FNE compares favorably with reports of medical management. Analysis of results from ongoing randomized trials of transcatheter PFO closure versus medical management may improve our ability to select the best treatment for individual patients.
AB - Transcatheter patent foramen ovale (PFO) closure has been undertaken to eliminate paradoxical emboli as a cause for recurrent strokes/transient ischemic attacks (TIAs). We report the results of investigations to determine causes of all significant focal neurologic events (FNEs) after PFO closure reported to our center. Records of 216 consecutive patients who underwent PFO closure were reviewed. Patients had to have had ≥1 preceding clinical event consistent with stroke/TIA considered by a neurologist to be consistent with an embolic episode. Follow-up was recommended at 24 hours, 1 month, 6 months, 1 year, and every 1 to 2 years thereafter. All patients were requested to report any new FNE possibly suggestive of stroke/TIA to our center. Reports of evaluations were reviewed in detail. Twenty patients had an FNE 0.1 month to 40.2 months after PFO closure over 438 person-years of follow-up (mean 2.1 years, range 1 month to 7.1 years). There were 4 recurrent strokes, 2 likely directly device related. Ten patients had TIA and 6 patients had clear evidence of pathology unrelated to the device. Event rate for recurrent strokes was 0.9% per year (95% confidence interval for difference 0.3 to 2.4) and combined event rate for stroke/TIA was 3.4% per year (95% confidence interval for difference 2 to 5.6). In conclusion, transcatheter PFO occlusion can be accomplished as an outpatient procedure with minimal immediate morbidity. Patients may have multiple possible causes of recurrent FNE. Recurrence rate of cryptogenic FNE compares favorably with reports of medical management. Analysis of results from ongoing randomized trials of transcatheter PFO closure versus medical management may improve our ability to select the best treatment for individual patients.
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U2 - 10.1016/j.amjcard.2008.01.028
DO - 10.1016/j.amjcard.2008.01.028
M3 - Article
C2 - 18471463
AN - SCOPUS:42749096945
SN - 0002-9149
VL - 101
SP - 1487
EP - 1492
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 10
ER -