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An animal study to evaluate the safety and efficacy of a novel superelastic sizing deviceVedat Ozturk, Onur Yolay, Ismihan Selen Onan, Oznur Inan, Yalim Yalcin, Mehmet Hakan Akpinar, Ayhan Olcay. Abstract | | | | Aim: Atrial septal defect measurement can be performed by stretching balloon diameter, two- and 3-dimensional transesophageal echocardiography (TEE). We evaluated a new superelastic sizing device (SSD) for deliniation of atrial septal defect margins and exact measurement without changing anatomy of the defect.
Material and Methods: An artificial ASD was created in 8 swines and defect sizing was done by TEE and SSSD in fluoroscopy and autopsy. Correlation analysis was done between 3 methods in defect size measurement. Any adverse events, such as mortality or heart perforation were assessed.
Results: There was a cardiac tamponade case in one animal because of the limited animal experience of the operator. Thrombus formation was observed in some animals due to prolongation of procedure time and low heparin dosage. SSD and TEE correlation (r=0.97, p
Key words: Atrial septal defect measurement, two- and three-dimensional transesophageal echocardiography, superelastic sizing device
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