Abstract 14567: Non-Coronary Thromboembolic Events: During and Following Percutaneous Patent Foramen Ovale Device Closure in Patients with Hypercoagulable Disorders
Background: There are conflicting data regarding hypercoagulable disorders (HCD) as a risk factor for recurrence of non-coronary thromboembolic events (NCTE) following device closure of a patent foramen ovale (PFO). We investigated the role of HCD as a risk factor for NCTE in a large patient (pt) cohort during and following PFO closure.
Methods: Between 12/2001 and 9/2010, 766 pts had successful PFO device closure at Mayo Clinic. Indications were cryptogenic stroke, transient ischemic attack (TIA), or paradoxical peripheral embolus. Of the 659 pts with known HCD status, we retrospectively identified 79 with (53% male, average age 52 ± 13 years) and 580 without HCD (59% male, average age 52 ± 14 years). Types of HCD included protein C (24) or S (16) deficiency, heterozygous factor V Leiden (38) or prothrombin gene mutation (4), anticardiolipin antibodies (18), and lupus anticoagulant (8). 27 pts had ≥ 1 HCD. NCTE was defined as stroke, TIA, or other systemic embolic event.
Results: There were no significant differences in age, sex, race, oral contraceptive use, prevalence of coronary artery disease (CAD), CAD risk factors, congestive heart failure, cardiomyopathy, or atrial fibrillation between groups. There was no peri-procedural NCTE or mortality. HCD pts (20% vs 10%, p= 0.01) were more often treated with warfarin than those without HCD, but use of aspirin (69.6% vs. 75%) and clopidogrel (6.3% vs 7.1%) was similar. During similar follow-up intervals (4.4 ± 2.4 vs. 4.7 ± 2.5 yrs), there was a trend towards a higher recurrence risk of NCTE in HCD pts compared to those without HCD (6/75, 8.0% vs. 24/544, 4.4%, HR 1.9, 95% CI 0.7-4.8, p= 0.3), especially in pts with a heterozygous factor V Leiden mutation (4/38, HR 2.5, 95% CI 0.8-7.7, p= 0.2). There were no significant differences with respect to mean age at NCTE (57 ± 18 vs. 62 ± 17 yrs) or time interval between PFO closure and NCTE (2.1 ± 2.0 vs. 2.5 ± 1.9 yrs). Among the 6 HCD pts with recurrent NCTE, only 2 (33.3%) were on warfarin.
Conclusion: In this large device closure PFO cohort, there was a trend towards a higher recurrence risk of NCTE in HCD pts. Heterozygous factor V Leiden mutation positive pts could be particularly at a higher risk. The role of anti-coagulation in reducing NCTE recurrence in such patients warrants further scrutiny.
- © 2011 by American Heart Association, Inc.