Abstract Details

Title Late Adverse Events of Patent Foramen Ovale Closure: A Systematic Review

Topic Cerebrovascular Disease and Interventional Neurology

Presentation(s) P05 - (-)

Poster/Presentation
Number 221

Objective

Background BACKGROUND: Optimal secondary stroke prevention for patients with cryptogenic stroke (CS) or transient ischemic attack (TIA) and PFO is not established. Observational studies imply a benefit for PFO closure over medical management. Randomized trials are equivocal or pending. Most studies report short term follow-up that will miss late AEs.

Design/Methods DESIGN/METHODS: A systematic review was conducted of the Manufacturer and User Facility Device Experience (MAUDE) database for all septal closure device reports of late (>30 days) AEs between 1/1/00-9/10/11. Search terms were brand names of PFO closure devices. Cases were those for whom 1) the narrative described PFO as the target lesion, or 2) the device was designed only for PFO closure. Data extracted were device type, time from implantation to AE, and explantation. We collected clinical (e.g. stroke) and device-related (e.g. thrombus on device) AEs.

Results RESULTS: We reviewed 1250 reports - 50 (4%) met inclusion criteria. Devices were CardioSEAL (n=28), Gore Helex (n=11) and Amplatzer (n=11). Clinical AEs were stroke/TIA or systemic embolism (n=20), arrhythmia/palpitations (n=6), pericardial effusion (n=3), visual symptoms (n=3), chest pain (n=2), asymptomatic (n=7), and unknown/other (n=18). Device AEs were thrombus (n=24), residual shunt (n=8), embolization (n=7), erosion (n=3), infection (n=2), fracture (n=1), and unknown/other (n=8). AEs led to device explantation in 28 patients. Time between device placement and AE was 30 days to 6 years; 23 reports (46%) were >1 year.

Conclusions CONCLUSIONS: For device PFO closure, the most common late clinical and device AEs were embolus and thrombus, respectively. Nearly half of reported devices were explanted. These data cannot produce AE incidence rates because the number of implanted devices is unknown. We also cannot determine the comparative safety of devices. However, the data emphasize that late AEs should be included when calculating benefits and risks of PFO closure.

Authors/Disclosures
Sarah E. Nelson, MD, MPH, FAAN (Tufts Medical Center) PRESENTER	Dr. Nelson has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology Journal. Dr. Nelson has received publishing royalties from a publication relating to health care. Dr. Nelson has a non-compensated relationship as a Women Leading in Neurology Program with ��ɫ�� that is relevant to AAN interests or activities.
	No disclosure on file
	No disclosure on file
David E. Thaler, MD, PhD, FAAN (Tufts Medical Center)	Dr. Thaler has nothing to disclose.
Randy Robinson, PhD	No disclosure on file

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