Safety and Efficacy of Biodegradable Patent Foramen Ovale Occluder in Patients with Migraine:A Clinical Trial

Background:Transcatheter closure of patent foramen ovale(PFO)has been widely accepted as a highly effective way to treat high-risk PFO-related diseases.However,traditional non-degradable occluders made of metal alloys will permanently exist in the body,resulting in thrombosis,valve damage,hemolysis,arrhythmia,or other complications.The biodegradable PFO occluder developed by Shanghai Mallow Medical Instrument Co.,Ltd.,China can be fully absorbed and degrade into nontoxic ingredients,reducing postoperative complications.Objectives:To study the safety and efficacy of biodegradable PFO occluders in treating PFO.Methods:This single-center clinical trial collected 30 patients treated with a biodegradable PFO occluder.The follow-up period lasted 12 months to analyze the echocardiographic characteristics and headache relief through HIT-6 scores.Results:The immediate success rate was 100%,with no intraoperative severe occlusion-related complications.The contrast transcranial Doppler(cTCD)at 12 months showed that all patients’right-to-left shunts(RLS)were grade I or 0 with no serious postoperative complications,indicating the overall success rate was 100%.The biodegradable PFO occluder mostly degraded six months after the occlusion.Conclusion:PFO closure with a Mallow biodegradable occluder is safe and effective and has no severe complications.

Percutaneous closure of patent foramen ovale: “Closed” door after the last randomized trials?

Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.

Percutaneous Patent Foramen Ovale Closure versus Medical Therapy in Cryptogenic Stroke: An Update Meta-Analysis of Randomized Controlled Trials

Objectives: Concerns regarding the real efficacy of transcatheter patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke remained unresolved. We performed a meta-analysis using the randomized controlled trials on the efficacy and safety of transcatheter PFO closure in patients with cryptogenic stroke. Methods: Web of Science, EMBASE, PubMed, and the Cochrane Library were searched for relevant randomized controlled trials (RCTs). The primary outcome was recurrent stroke and transient-ischemic attack (TIA). Original data, hazard ratio (HR) with 95% confidence interval (95% CI) were abstracted to calculate a pooled effect size. Results: Our meta-analysis showed benefit with device closure when compared with medical therapy with an HR of 0.54 (95% CI: 0.39 - 0.74, P = 0.108) in the intention-to-treat cohort, 0.44 (95% CI: 0.24 - 0.82, P = 0.103) in the per-protocol populations, and 0.43 (95% CI: 0.31 - 0.60, P = 0.019) in the as-treated populations. There was a significantly higher incidence of new-onset atrial fibrillation in PFO closure patients (OR = 4.53, 95% CI: 2.58 - 7.97, P = 0.094). PFO Patients with an atrial septal aneurysm benefit from device closure (OR = 0.39, 95% CI: 0.22 - 0.69, P = 0.053). Patients with a substantial PFO shunt benefit the greatest with device closure with a pooled OR of 0.27 (95% CI: 0.14 - 0.56, P = 0.525). Conclusions: The meta-analysis concluded that PFO closure was associated with significantly lower risk of recurrent stroke in PFO patients with cryptogenic stroke than with medical therapy alone. The benefit of PFO closure was greater in patients with a substantial shunt and atrial septal aneurysm. PFO closure was associated with higher rates of new-onset atrial fibrillation.

Novel way of patent foramen ovale detection and percutaneous closure by intracardiac echocardiography:A case report

BACKGROUND Patent foramen ovale(PFO)is the most common congenital heart disease and is associated with several diseases,including stroke and migraine.PFO diagnosis involves transoesophageal echocardiography,transthoracic echocardiography,and transcranial Doppler.Recent studies have shown that intracardiac echocardiography(ICE)can be used to diagnose and guide percutaneous transcatheter closure.CASE SUMMARY A 70-year-old male presented with paroxysmal dizziness and limb weakness for the past 3 mo.Magnetic resonance imaging revealed a history of stroke,and a bubble test revealed the presence of PFO.The patient was then transferred to our hospital for PFO closure.Under ICE guidance,the separation of the septum primum and septum secundum was unclear;we then used a Swartz catheter to confirm PFO by applying physical pressure on the right part of the atrial septum without using any contrast.The ICE continuously and clearly guided the procedure.CONCLUSION ICE can guide PFO closure in patients with a history of stroke.When PFO is not evident under ICE,a Swartz catheter can be used.

Patent foramen ovale closure in non-lacunar cryptogenic ischemic stroke:where are we now?

Patent foram ovale(PFO)is the most common anatomical cause of an interarterial shunt.It is usually asymptomatic but may cause paradoxical embolism and is a risk factor for non-lacunar cryptogenic cerebral ischemia in young adults.Although the first clinical trials did not show a significant superiority of PFO closure in the secondary prevention of cerebral ischemia as compared with standard antithrombotic treatment,six subsequent randomized clinical trials(CLOSURE I,PC Trial,RESPECT,CLOSE,REDUCE,and DEFENSE-PFO)performed in a sample of cryptogenic stroke in patients aged 60 years or younger provided evidence of a significant reduction of recurrent cerebral ischemia after percutaneous PFO closure.However,the use of percutaneous PFO closure cannot be generalized to the entire population of patients with cerebral ischemia and PFO,but it is indicated in highly selected patients with non-lacunar cryptogenic cerebral infarction with a large right-to-left shunt,an atrial septal aneurysm and no evidence of atrial fibrillation,as well as in association with antithrombotic treatment for an optimal secondary prevention of cerebral ischemia.

Patent foramen ovale closure in over-60-years old patients with diastolic dysfunction

Background Patent foramen ovale (PFO)-related stroke is a possible and not easily manageable occurrence in ≤60-years-old patients due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure.The grade of diastolic dysfunction for which PFO closure is contraindicated and whether there are changes in diastolic dysfunction class after closure have not been investigated in deep yet.Methods We prospectively enrolled patients who were referred to our centre over a 12 months period for PFO transcatheter closure having echocardiographic demonstration of diastolic dysfunction (≤Ⅲ class diastolic dysfunction).Echocardiography was scheduled at 1,6 and 12 months in order to assess changes in haemodynamic parameters of left ventricle function.Results Thirteen out of 80 patients referred to our centre (16.2%,mean age 65 + 6.4 years) over a 24-month period were enrolled in the study (Table 1).Eighteen Amplatzer PFO Occluder 25 mm and one 35 mm,two Amplatzer 25/25 mm Cribriform Occluder and two 25 nun Premere Occlusion System were successfully implanted with no intraoperative complications.As collateral findings on ICE 8/12 patients (66.7 %) had hypertrophy of the interatrial septum (thickness of the rims ＞ 1.2 mm) probably imputable to hypertensive cardiomyopathy.Four patients developed atrial fibrillation during the first month post-implantation,all successfully treated with antiarrhythmic drugs.After a mean follow-up of 40±4.3 months left ventricle performance indices (ejection fraction and end-diastolic volume) and diastolic dysfunction parameters (E/A,deceleration time,diastolic dysfunction class) did not change significantly.Conclusion The present study suggests that PFO transcatheter closure may be safely performed in aged patients with diastolic dysfunction class 1-2.(J Geriatr Cardio12008;5:3-6.)

Transcatheter closure for decompression sickness with a patent foramen ovale:A case report

A patent foramen ovale is one of the predisposing factors of neurotic decompression sickness.Transcatheter closure of a patent foramen ovale is effective in the secondary prevention of decompression sickness associated with intracardiac shunt.The size of the umbrella should not be limited to the diagnosis of a patent foramen ovale or an atrial septal defect but should be determined by the supporting force of the soft margin of the atrial septum.The surgical method of patent foramen ovale closure is the same as that of the closure of an atrial septal defect,but the closure umbrella of a patent foramen ovale is different from that of the closure umbrella of an atrial septal defect.The size of the umbrella of the right atrium is larger than that of the left atrium,and it is better to close the atrial septum.

Hypoxemia without persistent right-to-left pressure gradient across a patent foramen ovale:A clinical challenge

Patent foramen ovale (PFO) closure for systemic hypoxemia is controversial. The first systematic, albeit retrospective, study was recently presented which showed good procedural and clinical success for PFO closure for this indication. We present a case of acute right to left intra-cardiac shunt across PFO where the shunting is not persistent. Hence making a decision on PFO closure based on the aforementioned promising trial may not have been the right decision for the patient. This case highlights that the decision on PFO closure for such indication needs to be individualized. We also review the sparse literature on PFO closure for this indication and discuss how the decision making for such indication needs to be individualized.

Patent foramen ovale in the elderly:what to do?

The increase in life expectance makes the diagnosis of PFO a possible and not easily manageable event in patients > 60-years-old due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure. The literature review suggests that aged patients with PFO cannot be excluded"a priori"from PFO closure that should evaluated as therapeutic options in presence of anatomical and functional indications. Moreover in the elderly many other syndromes than paradoxical stroke mediated by PFO required full assessment and, if needed, transcather PFO closure:deoxygenating in obstructive sleeping apnoea, unexplained increased dyspnoea associated with hypoxemia after lung surgery, paralysis of the hemidiaphragm, and platypnea orthodeoxia. Differently from in the young and middle age, the management of PFO in aged patients should obligatory include the careful evaluation of potential comorbidities and eventual contraindications, such as severe diastolic dysfunction due to for example to hypertensive cardiomyopathy and coronary heart disease, the main causes of diastolic dysfunction.(J Geriatr Cardiol 2007;4:254-256.)

Platypnea-orthodeoxia syndrome in a patient with a pre-existing patent foramen ovale successfully treated with an atrial septal occluder

Platypnea orthodeoxia syndrome is associated with dyspnea and arterial oxygen desamration accentuated by an upright posture. It can be secondary to an intracardiac shunt. We report a case of platypnea-orthodeoxia syndrome （POS） in a 58-year old male patient who had a pre-existing patent foramen ovale （PFO） and substantial pulmonary pathologies. He was successfully treated by percutaneous transcatheter closure of the PFO. Our case highlights the importance of recognition of this rare syndrome in patients who present with unexplained hy- poxia for whom transcatheter closure of the interatrial shunt can be safely carded out.

卵圆孔未闭相关疾病研究2023 年度进展

卵圆孔未闭(PFO)是一种在人群中患病率较高的先天性心脏病,既往研究已明确其与脑卒中之间的关联,并认可封堵治疗对于PFO相关脑卒中的意义。近年来,关于PFO相关疾病的研究逐渐增多,认识进一步加深,同时国内PFO封堵治疗的例数也增长明显。本文盘点了2023年度PFO领域最新研究进展,主要包括PFO相关疾病谱的扩展(癫痫、不明原因晕厥等),发病机制的探究以及风险评估的手段;针对PFO封堵治疗,本文介绍了关于封堵效果与预后的最新研究结果,以及封堵治疗与心房颤动之间关系。国内在PFO封堵新器械的研发上一直处于领先地位,本文也对该方面的最新成果进行了介绍。

经胸超声心动图监测引导在经皮卵圆孔未闭封堵术中的应用效果

目的 观察经胸超声心动图(TTE)监测引导在经皮卵圆孔未闭(PFO)封堵术中的应用效果。方法 回顾性分析98例PFO患者的资料,患者均行介入封堵术。依据术中引导方式的不同分成X线组(n=50)和TTE组(n=48)。比较2组封堵情况、并发症发生情况、手术指标、右向左分流(RLS)分级情况以及合并偏头痛者的头痛改善情况。结果 98例PFO均成功完成封堵,其中TTE组有2例因术中声窗欠佳,加用经食道超声引导。TTE组手术时间长于X线组,差异有统计学意义(P<0.05)。术后,2组RLS分级及偏头痛者头痛影响测验-6(HIT-6)评分低于术前,差异有统计学意义(P<0.05)。结论 单纯TTE引导的经皮PFO封堵术对PFO患者RLS、偏头痛的改善效果较好,且能规避X线对医患所造成的辐射损伤。

影像学在卵圆孔未闭临床诊断和介入封堵中的应用

卵圆孔未闭(PFO)近年来已经逐渐成为临床热点之一,其引起的反常栓塞、不明原因头痛、头晕等神经系统症状逐渐受到广泛的重视,特别是PFO的诊断和介入封堵治疗涉及神经科、影像科、介入科等多学科医生团队的配合,国内近年来也有多项相关的指南发布。文章就近年来包括超声、心脏计算机断层扫描、数字减影血管造影等多种影像技术在PFO诊断和介入封堵中的应用进行述评。

卵圆孔未闭行封堵术患者偏头痛体验的质性研究

目的探求卵圆孔未闭行封堵术患者的偏头痛体验,为缓解患者偏头痛,提高生活质量制定针对性干预措施。方法采用质性研究法,对2022年10月—2023年4月于复旦大学附属中山医院心内科就诊的11名卵圆孔未闭合并偏头痛行封堵术患者进行一对一、半结构式深入访谈,采用传统内容分析法分析资料。结果卵圆孔未闭行封堵术患者偏头痛体验可归为5大主题:偏头痛发作情形各异;偏头痛带来严重身心影响;不断尝试缓解偏头痛的方式;对封堵术抱有期望;渴望专业支持。结论卵圆孔未闭行封堵术患者偏头痛病程较长,发作情形各异,应对效果不理想,对身心造成较大影响。医院可尝试开设疼痛多学科门诊,医护人员应为患者提供专业而个性化的疼痛管理,重视偏头痛的伴随症状和由此带来的不良情绪,并提高患者对偏头痛的认识和自身管理水平。

单纯输送鞘法经胸超声引导封堵卵圆孔未闭的临床疗效

目的探讨单纯输送鞘法行经胸超声引导下经皮卵圆孔封堵手术的临床治疗效果。方法回顾性分析2020年1月至2022年12月于我院行介入封堵手术或单纯输送鞘法经胸超声引导经皮卵圆孔封堵手术的卵圆孔未闭患者临床资料,分别设为介入封堵组(40例)和单纯输送鞘组(39例)。比较2组患者的手术时间、手术并发症发生率及手术成功率;术后超声评价封堵效果;术后随访6个月,评估患者临床症状缓解情况。结果单纯输送鞘组手术成功率(100%)高于介入封堵组(90.0%),差异有统计学意义(P<0.05)。单纯输送鞘组手术时间长于介入封堵组,差异有统计学意义(P<0.05)。介入封堵组1例患者术中出现少量心包积液;单纯输送鞘组2例患者术中出现血压降低、心率减慢,对症处理后症状消失。2组并发症发生率比较,差异无统计学意义(P>0.05)。术后6个月随访,封堵伞位置良好,无残余漏;介入封堵组28例患者头痛、头晕症状消失,8例患者症状明显缓解;单纯输送鞘组30例患者头痛、头晕症状消失,9例患者症状明显缓解。结论单纯输送鞘法经胸超声引导经皮卵圆孔封堵手术安全可行,疗效满意,手术成功率高,无辐射危害,值得临床推广。

精细化护理在青年卵圆孔未闭封堵术患者围手术期的应用效果

目的探讨精细化护理在青年卵圆孔未闭(PFO)封堵术患者围手术期的应用效果。方法选取2020年9月至2022年9月赣州市人民医院收治的60例青年PFO封堵术患者,依据随机数字表法分为对照组与观察组,每组各30例。对照组予以常规护理,观察组在对照组方法的基础上予以精细化护理。于护理前、后,比较两组患者的心理状况[焦虑自评量表(SAS)、抑郁自评量表(SDS)];于术前、手术当日,比较两组患者的心率(HR)、收缩压(SBP)、舒张压(DBP)变化情况;比较两组患者的手术用时、穿刺置入导管时间、术后24 h呼叫护士次数;比较两组患者的护理满意度。结果护理1周后,两组患者的SAS、SDS评分均低于本组护理前,且观察组低于对照组,差异有统计学意义(P<0.05)。手术当日,两组患者的HR均快于本组术前,SBP、DBP均高于本组术前,差异有统计学意义(P<0.05);但观察组手术当日的HR慢于对照组,SBP、DBP均低于对照组,差异有统计学意义(P<0.05)。观察组的手术用时、穿刺置入导管时间均短于对照组,术后24 h呼叫护士平均次数少于对照组,护理总满意度高于对照组,差异有统计学意义(P<0.05)。结论精细化护理应用于PFO封堵术患者中,可改善患者不良心理状况,稳定生命体征,缩短手术时间,提高患者满意度。

经食管超声心动图、右心声学造影对卵圆孔未闭患者封堵术后左心房功能的评估

目的:分析经食管超声心动图(TEE)、右心声学造影(ASCE)对卵圆孔未闭(PFO)患者封堵术后左心房功能的评估价值。方法:选取本院68例行PFO介入封堵术治疗的患者,均于手术前后接受TEE与ASCE检查,评估右向左分流(RLS)情况,按术后3个月有无RLS分为术后RLS组与术后无RLS组,记录TEE相关参数[左房整体纵向应变、左心耳最小容积(LAA-Vmin)与最大容积(LAA-Vmax)、左心耳射血分数(LAA-EF)、左心耳血流最大排空流速(LAA-PEV)]。结果:ASCE与TEE检查显示,术后3个月RLS检出率明显低于术前(P<0.05);术后3 d,左房储器期、管道期以及泵期整体纵向应变较术前明显降低(P<0.05),但上述指标在术后3个月与术前比较无显著差异(P>0.05);术后3个月,LAA-Vmin、LAA-Vmax、LAA-PEV、LAA-EF与术前比较无显著差异(P>0.05);术后RLS组与无RLS组间LAA-EF、LAA-Vmin、LAA-Vmax、LAA-PEV、左房整体纵向应变比较无显著差异(P>0.05)。结论:ASCE可准确评估PFO患者封堵术后RLS情况,结合TEE,可发现封堵术不会对患者左心房功能造成较大影响。

卵圆孔未闭相关非卒中性疾病防治中国专家共识

随着近年来对卵圆孔未闭(PFO)研究的不断深入,PFO相关卒中的循证医学证据充分,其处理策略已得到国内外的一致认可,相继制定了PFO相关共识或指南。目前,临床上除对PFO相关卒中患者进行介入封堵PFO外,PFO合并其他疾病患者接受PFO封堵的数量也快速增长,但PFO相关非卒中性疾病的循证医学证据尚不充分,国内外尚缺乏指导性文件。为了规范PFO介入治疗,结合国内外PFO临床应用和临床研究领域的最新进展,中国人体健康科技促进会结构性心脏病专委会和中国医师协会神经内科分会组织国内相关领域专家,经多次讨论形成了《卵圆孔未闭相关非卒中性疾病防治中国专家共识》。

卵圆孔未闭封堵术后血清标志物水平变化及其临床意义

目的探讨卵圆孔未闭(PFO)封堵术后血清标志物水平的变化并探讨其临床意义。方法回顾性纳入2019年12月到2022年10月在中国医学科学院阜外医院行PFO封堵术的患者210例。比较患者封堵术前后的血清标志物水平,包括中性粒细胞与淋巴细胞比值(NLR)、血小板与淋巴细胞比值(PLR)、平均血小板体积(MPV)、同型半胱氨酸(Hcy)、白蛋白、总胆固醇以及高密度脂蛋白胆固醇。选取所有患者中PFO并发脑卒中者为观察组(151例),本院同时期入住的149例房间隔缺损患者作为对照组。比较观察组封堵术前后和对照组Hcy水平。结果PFO患者封堵术后NLR、PLR、MPV水平均高于封堵术前,Hcy、白蛋白、总胆固醇、高密度脂蛋白胆固醇水平均低于封堵术前,差异均有统计学意义(均P<0.05)。PFO封堵术前观察组的Hcy水平明显高于对照组[(13.11±10.15)μmol/L比(10.38±3.44)μmol/L],差异有统计学意义(P<0.01),封堵术后观察组的Hcy水平[(11.12±9.68)μmol/L]与对照组比较差异无统计学意义(P>0.05)。结论PFO封堵术后患者Hcy水平显著降低,高Hcy水平可能与PFO并发隐源性脑卒中密切相关。综合来看,对于PFO患者,监测其Hcy水平是有临床意义的。

偏头痛患者合并中量右向左分流卵圆孔未闭行介入封堵术的疗效分析

目的:通过对比介入封堵治疗偏头痛合并中、大量右向左分流(right⁃to⁃left shunt,RLS)卵圆孔未闭(patent foramen ovale,PFO)患者的手术难度与近期疗效,评价偏头痛伴中量RLS⁃PFO患者行介入封堵的可行性。方法:入选偏头痛合并中量或大量RLS⁃PFO并行介入封堵的患者95例,分析两组患者的偏头痛症状、封堵成功率、封堵难度、术后RLS量及术后头痛缓解水平的差异。结果:两组术前头痛影响测试⁃6(headache impact test⁃6,HIT⁃6)、偏头痛残疾评估量表(migraine disability as⁃sessment questionnaire,MIDAS)评分无统计学差异(P>0.05);两组封堵成功率无统计学差异(92.00%vs.98.57%,P=0.137),但中量RLS⁃PFO组术中第2根导丝使用率、心腔内超声利用率及X线曝光时间明显高于大量RLS⁃PFO组(P<0.01);中量RLS⁃PFO组术后3 d有效封堵率高于大量RLS⁃PFO组(86.96%vs.56.52%,P=0.008),两组间术后1个月、3个月、6个月RLS量及有效封堵率无统计学差异(P>0.05);两组患者术后6个月HIT⁃6和MIDAS评分较术前改善(P<0.001),但中量RLS⁃PFO组术后6个月HIT⁃6评分较大量RLS⁃PFO组下降(P=0.012),而MIDAS评分无统计学差异。结论:偏头痛合并中量RLS⁃PFO患者行介入封堵的手术难度较大量RLS⁃PFO高,但介入封堵后头痛缓解疗效两组相似。