Page 10 - Journal of Structural Heart Disease Volume 3, Issue 5

Original Scienti c Article
136
patients with thrombophilia was performed to deter- mine whether atrial septal device implantation could be performed safely without a high risk of device thrombosis or recurrent thrombotic events.
Materials and Methods
A retrospective observational study was conduct- ed in a tertiary care center that performs a moderate volume of percutaneous septal closure procedures. A chart review and analysis of the database was per- formed to determine if any patients who underwent PFO or ASD closure had thrombophilic disorders or prothrombotic states such as gravid state, treatment at the time of presentation with hormone replace- ment therapy (HRT) or oral contraceptive pills (OCP), or cancer. Hypercoagulability and genetic laboratory testing was performed at our institution or the out- side institution that referred the patient for closure. The presence of anticardiolipin antibody, beta-2 gly- coprotein antibody, Dilute Russell viper venom time, prothrombin gene 20210A mutation (deoxy-ribo- nucleic acid test), Factor V Leiden, protein C activity, protein S free antigen assay, antithrombin activity assay, and Factor VIII activity was assessed. The pres- ence of an ASD or PFO was documented by transe- sophageal echocardiography, transthoracic echocar- diography, or transcranial Doppler evaluation and con rmed by crossing the atrial septum at the time of cardiac catheterization.
Risk factors for atherosclerosis, vascular disease, or thrombosis were identi ed such as hypertension, hy- perlipidemia, diabetes, smoking, history of deep ve- nous thrombosis or pulmonary embolism, history of atrial brillation or atrial utter, or history of stroke or TIA (Table 1). Thrombophilic abnormalities consisted of protein C or S de ciency, hyperhomocysteinemia, elevated Factor VIII activity, antiphospholipid anti- body, vasculitis, gravid state, OCP, HRT, prothrombin gene mutation, beta-2 glycoprotein antibody, Factor V Leiden mutation, antithrombin III de ciency, beta thalassemia minor, or cancer (Table 2).
Pre-device closure treatment consisted of warfarin only, aspirin only, aspirin and plavix, or a combination of warfarin, aspirin, and plavix. Post-closure treat- ment consisted of aspirin and plavix (n = 46, 66.7%), a combination of aspirin, plavix, and warfarin (n = 1,
Table 1. Patient characteristics (total = 147 patients)
Patient Characteristics
n (%)
1. Age (46 ± 13 years old) 2. Females
3. Diabetes
4. Hyperlipidemia
5. Hypertension
6. Smoker (past/current)
7. History of deep venous thrombosis or pulmonary embolism
8. history of atrial brillation or atrial utter
9. history of stroke or transient ischemic attack
147
117 (79.6%)
0
2 (1.4%)
5 (3.4%)
14 (9.5%)
14 (9.5%)
[10 irreversible (71.4%); 4 reversible group (28.9%)]
4 (2.7%)
104 (70.7%)
[55 (52.9%) reversible;
49 irreversible group (47.1%)
1.4%), warfarin followed by aspirin and plavix (n = 1, 1.4%), aspirin and warfarin (n = 6, 8.7%), aspirin only in plavix-allergic patients (n = 3, 4.3%), plavix only (n = 1, 1.4%), or warfarin only (n = 10, 14.5%). One pa- tient’s medical regimen post-closure was unknown. The duration of medical treatment was usually 6 months; occasionally, lifelong treatment at the discre- tion of the consulting hematologist was implement- ed for thrombophilia.
Patients were informed of the investigational and non-FDA-approved indication for PFO closure and desired closure for prevention of future strokes, com- plex migraine with transient visual neurologic de cit, or migraine without aura. Informed and written con- sent was obtained from all patients.
Based upon operator preference, all patients re- ceived peri-procedural or post-procedural antibiotics (cefazolin or vancomycin) up to 24 h after closure. Pa- tient outcomes were assessed via 3-6 month clinical follow-up, chart review, or telephone call (mean, 43.5 ± 34.7 months). Mortality status was veri ed by chart review and the Social Security Death Index.
Results
From the total population of 933 patients with PFO or ASD, 861 had a PFO (92.3%), and 72 had an
Journal of Structural Heart Disease, October 2017
Volume 3, Issue 5:135-140