Basic And Clinical Research Of Minimal Invasive Transthoracic Off-Pump Closure Of Atrial Septal Defect

Objectives The minimal invasive transthoracic off-pump closure of the atrial septal defect (ASD) is a new treatment for the ASD, which was applied to the clinic in 2000. To systematically investigate the safety and effectiveness of this new surgical treatment, the study on the biocompatibility of the occluder and clinical results of this transthoracic ASD closure is carried out. A variety of standard national biocompatibility evaluation is taken to testify the safety and risk of the implantation of occluder in vivo for a long term; Clinical results and complications of this new method versus surgical and transcatheter treatment of ASD are compared. To decide the indications and contraindications of the transthoracic off-pump closure of ASD, we summarize the previous clinical cases and raise a new method to classify the ASD for this transthoracic treatment. Methods1. Biocompatibility Study According to the national standard GB/T and international standard ISO 10993, experiments including acute toxicity, subacute toxicity test, intracutaneous irritation test, delayed allergic test, cell culture cytotoxicity,pyrogen test, haemolytic test, gene mutation, implantation test were carried out.2. Clinical Study Clinical results (including length of hospital stay, procedure time, post-operative ICU time) and complications (including supraventricular tachycardia, residual shunt, ratio of second thoracotomy) of the minimal invasive transthoracic off-pump closure of ASD versus extracorporeal circulation surgical and transcatheter treatment of ASD were compared.Results1. By the study of experiments including acute toxicity, subacute toxicity test, intracutaneous irritation test, delayed allergic test, cell culture cytotoxicity, pyrogen test, haemolytic test, gene mutation, implantation test, the occluder of ASD was proved to be well tolerated in vivo and fit the international and national standard.2. Compared with the extracorporeal circulation surgical ASD closure, the procedure time, post-operative ICU time, and length of hospital stay in patients underwent the minimal invasive transthoracic off-pump closure of ASD were significantly shortened, whereas the percentage of the aponia patients 48 hours after operation was increased, which indicating the injury to the patients induced by the minimal invasive transthoracic off-pump closure of ASD was much less than the conventional surgical treatment. Compared with the transcatheter ASD closure, the maximum diameter of ASD is significant larger and the...