Relato Preliminar sobre a Concentração Sanguínea de Níquel Após Oclusão Percutânea de Comunicação Interatrial com a Prótese Cocoon®

Abstract

Background: The possibility of nickel release to the bloodstream after implantation of latest generation atrial septal defect occlusion devices (Cocoon Septal Occluder TM), whose main component is nitinol (55% nickel and 45% titanium), remains controversial, especially in certain groups of patients such as children and women of childbearing age. Thus, the aim of this study was to evaluate the correlation between the device implantation and serum levels of nickel. Methods: This was a prospective longitudinal observational study conducted at a public hospital. Patients undergoing percutaneous atrial septal defect occlusion were clinically evaluated using transthoracic echocardiography and peripheral vein blood sampling for serum nickel before and after (1 day, 1 and 3 months) implantation. Results: The procedure and subsequent examinations were successfully performed in ten patients, with mean age of 34.4 years (range 5 to 60 years). Serial echocardiography confirmed the maintenance of adequate results of the procedure. Patients did not show manifestations that might suggest a reaction to metal, such as skin rash, dyspnea, thoracic discomfort, palpitations or migraine. Serum nickel levels did not show any significant changes and remained within the normal range for the population, according to the dosing methods within 3 months of the procedure. Conclusions: Preliminary results of this investigation with the Cocoon device have shown that during the initial period of endothelization after the procedure there was no significant nickel release into the bloodstream.

Cocoon devices for transcatheter closure of atrial septal defect and patent ductus arteriosus in children

“…We started this program using the Cocoon devices (the providing company won the auction based on the cheapest product compared to similar products like Amplatzer and Occlutech occluders), which are known to be safe, certified in the European Economic Area, and to have a good reputation. [ 9 , 10 ] This is the initial experience of a single center, “Marie Curie” Emergency Children's Hospital, Bucharest, Romania, on the interventional closure of the ostium secundum ASD and PDA with Cocoon devices (Vascular Innovations Co., Nonthaburi, Thailand).…”