【作者】 王旭；

【导师】 高永生；

【作者基本信息】 吉林大学 ， 临床医学硕士（外科学）（专业学位）， 2022， 硕士

【摘要】 研究背景:近些年来,越来越多的学者认为卵圆孔未闭(patent foramen ovale,PFO)是偏头痛、隐源性脑卒中等疾病的主要病因,严重影响人们的生活质量,并存在导致偏瘫的潜在风险。因此,PFO这一疾病越来越受到临床医生的重视,其治疗手段也得到突飞猛进的发展。从传统的开胸手术发展到微创介入封堵手术,介入封堵手术因其创伤小、并发症少等优点成为当前治疗PFO的首选方法。既往封堵装置材料均为不可降解的钛镍合金材料,一旦植入将永久保存于体内,由此引起的镍中毒、主动脉壁磨损穿孔、瓣膜返流、血栓形成、溶血等并发症也被不断报道。因此,可降解封堵器的研制成为一个新的热门领域,将成为广大先天性心脏病患者的迫切期待,具有广阔的临床应用前景。目前新型完全可降解PFO封堵器在临床上的疗效和安全性在国内外更鲜有报道。研究目的:研究可降解PFO封堵器治疗PFO的安全性和有效性。资料与方法:选取从2020年5月21日至2021年9月4日期间就诊于吉林大学第一医院心脏外科的PFO患者70例,其中随机选择接受可降解封堵器(可降解组)治疗PFO的患者35例和接受Amplatzer封堵器(不可降解组)治疗PFO的患者35例。术前详细记录所有患者偏头痛、头晕及恶心呕吐等症状和既往史。完善血常规、尿常规、凝血常规、肝肾功能术前化验指标和心电图、超声心动图(TTE)、声学造影或经颅多普勒超声声学造影(c-TTE/c-TCD)等术前检查。术中收集手术时长、即刻封堵率、手术成功率以及术中TTE结果。收集可降解组分别在术后1个月、3个月、6个月、12个月上述化验指标、心电图和TTE以及术后6个月、12个月的c-TTE/c-TCD结果;收集不可降解组分别在术后1个月、3个月、6个月、12个月的心电图、TTE和术后6个月、12个月的c-TTE/c-TCD结果。同时可降解组在术前和术后12个月进行HIT-6评分,评估头痛缓解情况。通过可降解及不可降解两组之间比较,以及可降解组术前、术后比较,进一步分析可降解封堵器的有效性和安全性。研究结果:35例患者(可降解组)被纳入了前瞻性单中心临床试验,平均年龄36.11±12.61岁,其中男性11例,女性24例,所有患者均植入成功,平均手术时间26.03±9.1min,住院期间及术后12个月期间无并发症发生。术后6个月随访中,患者做瓦氏(Valsalva)动作经c-TCD或c-TTE检查发现:3例存在大量微泡、3例存在中等量微泡、12例存在微量微泡;术后12个月再次复查c-TCD/c-TTE发现:1例存在大量微泡、2例存在中等量微泡、10例存在微量微泡。不可降解组的35例患者平均年龄36.80±13.2岁,其中男性9例,女性26例,所有患者也均植入成功,平均手术时间16.57±7.48 min,随访12个月期间均未发现任何并发症,术后6个月随访中,患者做Valsalva动作经c-TCD或c-TTE检查发现:1例存在大量微泡、2例存在中等量微泡、13例存在微量微泡;术后12月再次复查c-TCD/c-TTE发现:1例存在中等量微泡、10例存在微量微泡。术后6月和术后12月时,两组c-TCD/c-TTE检查统计分析结果显示P值分别为0.717和0.701,两组之间有效性无显著差异。两组患者术后TTE检查均未发现并发症发生,两组之间安全性无显著差异。结论:可降解PFO封堵器治疗PFO是有效和安全的更多还原

【Abstract】 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更多还原