Comparison of Devices for Atrial Septal Defects Closure: A Pilot Study

Exclusion Criteria

• •TEE/CCT/CMR defect diameter \>30mm,
• •rim sizes of \< 5 mm to the coronary sinus, inferior vena cava rim, an atrioventricular valve, or the right upper pulmonary vein,
• •multiple defects,
• •complex congenital heart disease requiring surgical repair within 3 years of device placement,
• •Eisenmenger-syndrome,
• •recent myocardial infarction PCI/CABG \< 6 weeks,
• •demonstrated intra cardiac thrombi on echocardiography (especially LA or LAA thrombi), or atrial tumor
• •known occluded bilateral femoral veins/IVC,
• •pulmonary artery systolic pressure more than half the systemic systolic arterial pressure
• •recent pelvic venous thrombosis
• •serious comorbidity with life expectancy \<3 years (e.g., non-skin cancers not in remission, advanced renal failure serum creatinine \>160 umol/L)
• •patients whose size or condition would cause the patient to be a poor candidate choice for cardiac catheterization (e.g., too small for echocardiographic imaging probe, catheter size, vascular size, active infection, body weight \< 8 kg)
• •serious infection in \< 6 weeks producing bacteremia (e.g. sepsis), active endocarditis, or any other infection that cannot be treated successfully prior to device implantation (patient must have negative blood cultures off antibiotics for 1 week prior to procedure),
• •active GI bleed \< 6 weeks,
• •bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months
• •previous stroke in the past 12 months,
• •documented chronic atrial fibrillation or \>2 episodes of documented paroxysmal atrial fibrillation in the last 12 months,
• •pregnancy or breastfeeding, plan to become pregnant within the next 6 months, not using an effective method of birth control in premenopausal women,
• •documented nickel/titanium allergy, or intolerance to contrast agents.