| Background:In recent years,more and more scholars believe that Patent Foramen Ovale（PFO）is the main cause of migraine,cryptogenic stroke and other diseases,which seriously affects people’s quality of life and has the potential risk of hemiplegia.Therefore,the disease of PFO has been paid more and more attention by clinicians,and its treatment methods have been developed by leaps and bounds.From traditional thoracotomy to minimally invasive interventional closure,interventional closure has become the preferred method for the treatment of PFO due to its advantages of less trauma and complications.The material of the previous sealing device is non-degradable titanium-nickel alloy material.Once implanted,it will be permanently preserved in the body.Complications such as nickel poisoning,wear and perforation of aortic wall,valve regurgitation,thrombosis,hemolysis and so on have been reported continuously.Therefore,the development of biodegradable occluder has become a new hot field,and will become the urgent expectation of the majority of congenital heart disease patients,with broad clinical application prospects.At present,the clinical efficacy and safety of novel fully degradable PFO occluders are rarely reported at home and abroad.Objective:To study the safety and efficacy of biodegradable PFO occluder in the treatment of PFO Methods:A total of 70 patients with PFO admitted to the Department of Cardiac Surgery of the First Hospital of Jilin University from May 21,2020 to September 4,2021 were selected,including 35 patients who were randomly selected to receive PFO with degradable blockers（degradable group）and 35 patients who received Amplatzer blockers（non-degradable group）.The symptoms and past history of migraine,dizziness,nausea and vomiting of all patients were recorded in detail before surgery.Improve preoperative test indicators including blood routine,urine routine,coagulation routine,indicators of liver and kidney function,ECG,TTE,c-TTE/c-TCD and other preoperative examinations.Operative duration,immediate occlusion rate,operative success rate and intraoperative TTE results were collected.The above laboratory indicators,ECG,TTE and c-TTE/c-TCD results of the degradable group were collected at 1,3,6 and 12 months after surgery,as well as at 6 and 12 months after surgery.The ECG,TTE and c-TTE/c-TCD results of the non-degradable group were collected at 1,3,6 and 12 months postoperatively,respectively.Headache relief was assessed by HIT-6 scores in the biodegradable group before and 12 months after surgery.Through the comparison between degradable and non-degradable groups,as well as the preoperative and postoperative comparison of degradable group,the effectiveness and safety of degradable occluder were further analyzed.Results:35 patients（biodegradable group）were enrolled in a prospective single-center clinical trial,with an average age of 36.11±12.61 years,including11 males and 24 females.All patients were successfully implanted,with an average operative time of 26.03±9.1min,and no complications occurred during hospitalization or 12 months after surgery.Six months after the operation,patients underwent Valsalva motion and c-TCD or C-TTE examination found that 3 patients had a large number of microvesicles,3 patients had a medium number of microvesicles,and 12 patients had microvesicles.Re-examination of c-TTE/c-TCD 12 months after surgery showed that 1 case had a large number of microvesicles,2 cases had a medium number of microvesicles,and 10 cases had microvesicles.The average age of 35 patients in the non-degradable group was36.80±13.2 years,including 9 males and 26 females.All patients were also successfully implanted,and the average operation time was 16.57±7.48 min.No complications were found during the 12-month follow-up.c-TTE/c-TCD examination of patients undergoing Valsalva action showed that 1 patient had a large number of microvesicles,2 patients had a medium amount of microvesicles,and 13 patients had microvesicles.Re-examination of c-TTE/c-TCD at 12 months postoperatively showed that 1 case had medium and 10 cases had micro microbubbles.Statistical analysis of c-TTE/c-TCD tests at 6 and 12 months after surgery showed that the P value of the two groups was0.717 and 0.701,respectively.There was no significant difference in effectiveness between the two groups.No complications were found in postoperative TTE examination of patients in the two groups,and there was no significant difference in safety between the two groups.Conclusions:Biodegradable Patent foramen ovale occluder to cure PFO is safe and effective... |
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