Page 12 - Journal of Structural Heart Disease Volume 3, Issue 5

Original Scienti c Article
138
unsuccessful secondary to bilateral femoral venous obstruction. Twenty- ve patients in the reversible thrombophilic group underwent closure (36.2%), whereas 44 patients in the irreversible thrombophil- ia group underwent closure (63.8%). Only 1 patient (1.4%) in the irreversible thrombophilia group had a recurrent stroke after PFO closure. Table 3 presents the patient groups, closure indications, and closure devices used.
One patient in the PFO group (0.7%) with anti-car- diolipin antibody and beta-2 glycoprotein antibody experienced pericarditis post-procedure with a small pericardial e usion from suspected nickel allergy (con rmed via patch testing) 1 month after Am- platzer device deployment. One patient (1.4%) out of the total 34 patients with Amplatzer implants (49%) developed a small left atrial thrombus on the device 1-month post-implant. This patient had thrombophil- ia from beta-2 glycoprotein antibody and was treated post-closure with aspirin and plavix. None of the 33 patients with a Gore Helex device developed throm- bus formation. Of the 69 patients who underwent clo- sure, 50 patients (72.5%) received antiplatelet medica- tion post-procedure (aspirin only, aspirin and plavix, or plavix only), 10 (14.5%) received an anticoagulant only (warfarin), and 8 (11.6%) received a combination of antiplatelets and an anticoagulant. One patient’s post-closure medical regimen was unknown.
One patient developed transient tongue and right lower extremity paresthesia post-closure, and anoth- er patient experienced a transient neurologic de cit 1 month post-closure; both of these episodes were believed to be complex migraines without headache.
Of the 117 women (80.0%), 70 (59.8%) were receiv- ing HRT or OCP at the time of their event (HRT: n = 24, 20.5%; OCP: n = 46, 39.3%), of which 52 (74%) devel- oped stroke, TIA, or peripheral arterial embolism. Of the 104 patients who had a stroke, TIA, or peripher- al arterial embolus, 79 were females (76%), of which 52 (66%) were taking OCP (n = 34, 43%) or HRT (n = 18, 23%). Of the 70 women on OCP or HRT, 68 (97%) stopped pre- or post-closure based on the treating physician’s suggestion (only 2 patients wanted to continue OCP or HRT post-closure). None of the 70 patients who had been on hormone therapy prior to PFO closure developed recurrent thrombotic events, endocarditis, or device erosion.
Three deaths (2.0%) occurred, but none were relat- ed to the device or implantation. One patient died sec- ondary to myocardial infarction, and 2 deaths were non-cardiac. Of the 2 non-cardiac deaths, 1 patient did not undergo device closure, and the other died from septic shock.
Discussion
The purpose of this study was to assess whether patients with thrombophilia have an increased risk for stroke or thrombus formation on closure devices fol- lowing implantation of this foreign body, which has constant contact with circulating blood, in the atrial septum [1]. Due to this hypothetical concern, throm- bophilic patients are usually excluded from clinical trials of percutaneous PFO or ASD closure. Neverthe- less, clinical indications for closure of ASD or PFO may arise in subjects with thrombophilic conditions. This study included patients with a variety of thrombo- philic disorders and prothrombotic states, which has not been reported previously in the literature.
A prospective case-controlled study by Pezzini et al. [1] showed that thrombophilia in PFO patients may pose a risk for stroke. A study by Chaturvedi [3] reported that patients with a PFO and cryptogenic stroke in the presence of thrombophilia had an in- creased risk of recurrent stroke. They proposed that PFO closure in such patients prevents recurrences.
A case report of a patient with Factor V Leiden and PFO describes a paradoxical coronary embolism that caused myocardial infarction [4]. Factor V Leiden has been associated with increased risk of arterial and ve- nous thrombosis [5]. A second case report described a patient with Factor V Leiden and PFO with subse- quent multiple embolic events [6]. A study by Giardi- ni et al. [7] of PFO closure in 72 patients, of whom 20 had thrombophilia, suggests that such patients have enhanced risk of recurrent stroke after a cryptogenic stroke, which is mitigated by PFO closure.
Autoimmune disease may promote a prothrom- botic state that could lead to thrombotic events [5]. The prevalence rates of anti-cardiolipin antibodies in patients with ischemic strokes is reported to be 17-21% [8]. A retrospective case series of 40 patients showed that anti-phospholipid antibodies and hyper- coagulability are common in patients with PFO who
Journal of Structural Heart Disease, October 2017
Volume 3, Issue 5:135-140