卵圆孔未闭相关卒中预防中国专家指南

卵圆孔未闭（PFO）发生率高，约1/4的成年人均存在PFO。随着4项经导管封堵PFO和药物治疗相对比的随机对照研究结果的相继发表，各国相继更新了PFO相关指南或共识。我国关于PFO治疗的推荐仍停留在2017年的“卵圆孔未闭预防性封堵术中国专家共识”上，鉴于PFO人群基数庞大，为规范PFO封堵术的临床应用，在借鉴国内外最新研究的基础上，结合我国具体情况，国内本领域专家形成了卵圆孔未闭相关卒中预防中国专家指南，以供参考。     

房间隔缺损或卵圆孔未闭患者封堵术后封堵器血栓形成的发生率和临床过程

自开展经导管房间隔缺损(ASD)及卵圆孔 未闭(PFO)封堵术以来,先后有多种类型的封堵 器应用于临床。封堵器的血栓形成及其临床过程的有关研究尚不多。该研究观察并分析了1000例 ASD或PFO封堵术后封堵器血栓形成     

新型卵圆孔未闭封堵器的研制及临床应用进展

卵圆孔是房间隔上一个先天性的薄弱区域,约75%的人群在婴幼儿期均会自行关闭,少数人成年后仍未能自行关闭称之为卵圆孔未闭(PFO)。近几年,经导管PFO封堵术在PFO相关卒中或偏头痛的循证证据逐年增加。目前美国食品和药物管理局批准应用于临床的PFO封堵器械有Amplatzer PFO封堵器和Gore Cardioform PFO封堵器,其他封堵器也在临床上广泛应用。但现有器械仍存在术后新发心房颤动、封堵器相关血栓、房间隔周围组织磨蚀等封堵器相关并发症,新型PFO封堵器械的研发一直是行业热点,现对这一领域的研究进展做一综述。     

经导管卵圆孔未闭介入封堵术预防卒中的研究进展

目前临床研究证实卵圆孔未闭（PFO）与隐源性卒中密切相关。迄今为止国际上已开展了多个大规模临床研究评估经皮卵圆孔介入封堵在预防卒中方面是否有效,与卵圆孔未闭相关隐源性卒中的诊治策略也有了长足进展,但依旧有一些问题亟待解决。本文将回顾近年来国内外经导管卵圆孔未闭介入封堵预防卒中再发的研究历程,以加强临床医生对PFO的认识。     

房间隔缺损或卵圆孔未闭患者封堵术后封堵器血栓形成的发生率和临床过程[英]／Krumsdorf U…／／J Am Coll Cardiol．

自开展经导管房间隔缺损(ASD)及卵圆孔未闭(PFO)封堵术以来，先后有多种类型的封堵器应用于临床。封堵器的血栓形成及其临床过程的有关研究尚不多。该研究观察并分析了1000例ASD或PFO封堵术后封堵器血栓形成的发生率、形态学、可能的预测指标及血栓形成的临床处理。     

卵圆孔未闭与偏头痛的研究进展

卵圆孔未闭(PFO)是一种常见的先天结构异常。近期研究发现PFO可能与偏头痛有关。本文对PFO与偏头痛的相关性及经皮PFO封堵术的疗效作一综述。     

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》。     

卵圆孔未闭合并偏头痛患者行经股静脉介入封堵术的临床疗效和安全性分析

目的 探讨卵圆孔未闭(patent foramen ovale,PFO)合并偏头痛患者行经股静脉介入封堵术的临床疗效和安全性.方法 回顾性研究乐山市人民医院心脏外科2018年5月至2019年2月收治的PFO合并偏头痛并行经股静脉介入封堵术患者163例,比较所有患者术前、术后1、6个月经胸心脏超声心动图右心声学造影结果;...     

心房颤动左心耳联合卵圆孔未闭封堵：过犹不及？

心房颤动（房颤）患病率高,左心耳封堵预防缺血性卒中近年来有较大进展。成年人卵圆孔未闭（PFO）的发生率较高,PFO与偏头痛及不明原因卒中可能相关,目前指南/专家共识指出,血栓栓塞性脑梗死伴PFO患者,未发现其他卒中发病机制,结合PFO的解剖和分流情况,可考虑PFO封堵术,但对于老年患者并不积极地建议PFO封堵术。对于房...     

卵圆孔未闭超声诊断中国专家共识

随着对卵圆孔未闭（PFO）相关疾病认识的深入及经导管封堵术等治疗的广泛开展，PFO的精准诊断和评估（包括有无PFO、分流量、相关解剖）成为临床迫切需求。《卵圆孔未闭超声诊断中国专家共识》专家组参考国内外相关研究、共识及指南，达成超声技术（包括经胸/经食管超声心动图联合右心声学造影、对比增强经颅多普勒超声、心腔内超声）诊断PFO的临床应用专家共识，以指导临床实践。     

Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke

OBJECTIVES: The purpose of this study was to compare the efficacy of medical treatment with percutaneous closure of patent foramen ovale (PFO). BACKGROUND: Patients with cryptogenic stroke and PFO are at risk for recurrent cerebrovascular events. METHODS: We compared the risk of recurrence in 308 patients with cryptogenic stroke and PFO, who were treated either medically (158 patients) or underwent percutaneous PFO closure (150 patients) between 1994 and 2000. RESULTS: Patients undergoing percutaneous PFO closure had a larger right-to-left shunt (p < 0.001; 95% confidence interval [CI] 1.38 to 3.07) and were more likely to have suffered more than one cerebrovascular event (p = 0.03; 95% CI 1.04 to 2.71). At four years of follow-up, percutaneous PFO closure resulted in a non-significant trend toward risk reduction of death, stroke, or transient ischemic attack (TIA) combined (8.5% vs. 24.3%; p = 0.05; 95% CI 0.23 to 1.01), and of recurrent stroke or TIA (7.8% vs. 22.2%; p = 0.08; 95% CI 0.23 to 1.11) compared with medical treatment. Patients with more than one cerebrovascular event at baseline and those with complete occlusion of PFO were at lower risk for recurrent stroke or TIA after percutaneous PFO closure compared with medically treated patients (7.3% vs. 33.2%; p = 0.01; 95% CI 0.08 to 0.81, and 6.5% vs. 22.2%; p = 0.04; 95% CI 0.14 to 0.99, respectively). CONCLUSIONS: Percutaneous PFO closure appears at least as effective as medical treatment for prevention of recurrent cerebrovascular events in cryptogenic stroke patients with PFO. It might be more effective than medical treatment in patients with complete closure and more than one cerebrovascular event.     

Secondary prevention of cryptogenic stroke in patients with patent foramen ovale: a systematic review and meta-analysis

The aim of our study is to compare patent foramen ovale (PFO) closure versus medical treatment and antiplatelet versus anticoagulant therapy in patients with cryptogenic stroke (CS) and PFO. We conducted a systematic review and meta-analysis with trial sequential analysis (TSA) of randomized trials. Primary outcomes are stroke or transient ischemic attack (TIA) and all-cause mortality. Secondary outcomes are peripheral embolism, bleeding, serious adverse events, myocardial infarction and atrial dysrhythmias. We performed an intention to treat meta-analysis with a random-effects model. We include six trials (3677 patients, mean age 47.3 years, 55.8% men). PFO closure is associated with a lower recurrence of stroke or TIA at a mean follow-up of 3.88 years compared to medical therapy [risk ratio (RR) 0.55, 95% CI 0.38–0.81; I²?=?40%]. The TSA confirms this result. No difference is found in mortality (RR 0.74, 95% CI 0.35–1.60; I²?=?0%), while PFO closure is associated with a higher incidence of atrial dysrhythmias (RR 4.55, 95% CI 2.16–9.60; I²?=?25%). The rate of the other outcomes is not different among the two groups. The comparison between anticoagulant and antiplatelet therapy shows no difference in terms of stroke recurrence, mortality and bleeding. There is conclusive evidence that PFO closure reduces the recurrence of stroke or TIA in patients younger than 60 years of age with CS. More data are warranted to assess the consequences of the increase in atrial dysrhythmias and the advantage of PFO closure over anticoagulants.     

The role of device closure of patent foramen ovale in patients with cryptogenic stroke

One of the most frequent causes of cardiac embolism in cryptogenic stroke is a paradoxical embolus, which originate from systemic venous source though an unidentified patent foramen ovale (PFO). PFO is a common finding in the general population with a prevalence of 25% to 30%. Transcatheter PFO device closure is known to be feasible and safety treatment for such patients. In recent years, several randomized controlled trials (RCTs) have been conducted to address the superiority of PFO closure over medical therapy alone in the prevention of stroke recurrence in patients with PFO. In contrast to findings from early 3 RCTs, recent 4 RCTs could successfully show the benefits of PFO device closure compared with medical therapy, with less peri‐ and postprocedural complication. Based on these data, PFO device closure is recommended to carefully select cryptogenic stroke patients aged from 18 to 65 years, with a high probability of a causal role of the PFO in stroke events. However, it is still uncertain whether PFO closure is superior to oral anticoagulants therapy in these patients. Therefore, further prospective randomized trials are needed to address the efficacy of PFO device closure to oral anticoagulants therapy.     

Transcatheter closure versus medical therapy of patent foramen ovale and cryptogenic stroke.

OBJECTIVES: The purpose of this study was to evaluate the efficacy and safety of device closure of patent foramen ovale (PFO) versus antiplatelet therapy in patients with cryptogenic stroke (CS). BACKGROUND: There are no controlled data to support the therapeutic value of PFO closure with a device compared to medical treatment in patients with CS. METHODS: We performed a nonrandomized, prospective, patient preference case series comparing the recurrence rate in 92 patients with PFO and CS who were treated either with antiplatelet agents (44 patients) or underwent catheter closure (48 patients) using the Amplatzer PFO occluder (APFOO). All patients completed a 2-year follow-up. RESULTS: PFO closure group. Immediate complete closure (CC) was observed in 44/48 (91%) patients. Four (9%) patients had a minimal residual shunt immediately after the procedure. One patient developed hemopericardium that was successfully managed by pericardiocentesis. No other complication was observed. Follow-up. PFO closure group. Contrast bubble study at 6-month follow-up confirmed CC in all 48 patients. No complications were observed. Antiplatelet therapy group. Three (6%) and 6 (13%) patients had a major and minor hemorrhagic event, respectively. The average incidence of embolic events/year was 0 and 14.75% for the PFO closure group and the antiplatelet therapy group, respectively (P < 0.001). CONCLUSIONS: PFO closure using the APFOO is a rational alternative to medical treatment in patients with CS. Larger randomized clinical trials are required to support the use of this device over the other PFO occluders and medical therapy.     

Percutaneous closure of the patent foramen ovale

A patent foramen ovale (PFO) is a common finding present in 25% of the population. A relationship between PFO and several clinical conditions such as stroke, migraine, platypnea-orthodeoxia syndrome, neurological decompression illness in divers, high altitude pulmonary edema, sleep apnea, and economy class syndrome have been documented. Observational non-randomized studies have shown percutaneous PFO closure more effective than medical treatment for stroke prevention, in particular in patients with complete closure as well as in patients with more than one cerebrovascular event at baseline. In the case of migraine, PFO closure has been shown to result in a marked reduction in migraine burden or migraine days. PFO anatomy, epidemiological data on associated clinical conditions, comparison between percutaneous closure and medical treatment, as well as the technical aspect of the procedure are described in this review.     

The association of different right atrium anatomical-functional characteristics correlates with the risk of paradoxical stroke: an intracardiac echocardiographic study

Background: The contribution of different right atrium anatomical-functional characteristics to the risk of paradoxical stroke has not been extensively investigated, probably in part because of the limits of standard echocardiography.
Objective: We sought to assess, using intracardiac echocardiography (ICE), the right atrium anatomical-functional characteristics and their role in the pathophysiology of paradoxical embolism in a sample of patent foramen ovale (PFO) patients undergoing transcatheter PFO closure.
Methods: Over a 36-month period, we prospectively enrolled 114 consecutive patients (mean age 38+/− 10.5 years, 67 female) referred to our center for PFO catheter-based closure. On ICE study, all sensible characteristics other than PFO and mild ASA were recorded, including prominent EV or large CN, basal shunt without Valsalva maneuver, moderate to severe ASA, and multiperforated fossa ovalis.
Results: After TEE and ICE study and measurements, a prominent EV or CN was diagnosed on ICE in 73%, a basal shunt was present in 48%, a moderate to severe ASA in 47%, and a multiperforated FO in 24% of patients. A tight correlation between number of concurrent factors and proportion of patients with curtain pattern on TC Doppler, larger right-to-left shunt, recurrent cerebral paradoxical embolism before closure, and migraine with aura was clearly evident (r ≥= 0.97). Basal shunt and concurrent ≥= 3 anatomical functional right atrium characteristics resulted as independent predictors of recurrent paradoxical embolisms.
Conclusions: Our data suggest that right atrium anatomical-functional characteristics other than PFO and mild ASA as assessed by ICE deeply affect the pathophysiology of paradoxical stroke.     

卵圆孔未闭与原因不明性卒中

流行病学研究显示,原因不明性卒中患者中的卵圆孔未闭(patent foramen ovale,PFO)患病率显著高于普通人群,二者之间的密切联系支持反常性栓塞为卒中病因的假说.然而,在原因不明性卒中患者中,单纯检测到PFO并不能确立反常性栓塞的诊断.当PFO与其他一些因素共存时,会显著增高缺血性卒中风险.一些研究显示,伴有PFO的原因不明性卒中患者的MRI病灶模式与无PFO者并无显著差异,特别是多发性缺血灶,因此不支持反常性栓塞作为PFO患者卒中病因的理论.PFO的检测方法包括经胸壁超声心动图、经食管超声心动图(transesophageal echocardiography,TEE)和经颅多普勒(transcranial Doppler,TCD).TCD与TEE具有良好的一致性,因此应被推荐为一种简单、无创和可靠的技术,而TEE仅应在经过选择的患者中进行.PFO的治疗选择包括抗血小板药、抗凝药、经皮血管内封堵术和开胸手术.在几项重要的大样本随机对照试验完成之前,对于伴有PFO的原因不明性卒中患者,经皮封堵术仅应考虑用于治疗在接受内科治疗过程中仍然出现复发性事件、对内科治疗存在禁忌证以及某些高危解剖学风险的PFO.     

Percutaneous Closure of Patent Foramen Ovale in Patients with Cryptogenic Stroke — An Updated Comprehensive Meta-Analysis

BackgroundThe ideal treatment strategy for patients with cryptogenic stroke and patent foramen ovale (PFO) is not yet clear. Previous randomized controlled trials (RCTs) comparing transcatheter PFO closure with medical therapy in patients with cryptogenic stroke to prevent recurrent ischemic stroke showed mixed results. This meta-analysis aims to compare rates of recurrent stroke, transient ischemic attack (TIA) and all-cause mortality with PFO closure and medical therapy vs. medical therapy alone.MethodsPubMed and the Cochrane Center Register of Controlled Trials were searched for studies published through June 2018, comparing PFO closure plus medical therapy versus medical therapy alone. Six RCTs (n = 3750) comparing PFO closure with medical therapy were included in the analysis. End points were recurrent stroke, TIA and all-cause mortality. The odds ratios (OR) with 95% confidence interval (CI) were computed and p < 0.05 was considered as a level of significance.ResultsA total of 1889 patients were assigned to PFO closure plus medical therapy and 1861 patients were assigned to medical therapy only. Risk of recurrent stroke was significantly lower in the PFO closure plus medical therapy group compared to medical therapy alone. (OR 0.47, 95% CI 0.33–0.67, p < 0.0001). Rate of TIA was similar between the two groups (OR 0.76, 95% CI 0.52–1.14), p = 0.18). There was no difference in all-cause mortality between two groups (OR 0.73, CI 0.33–1.58, p = 0.42). Patients undergoing PFO closure were more likely to develop transient atrial fibrillation than medical therapy alone (OR: 5.85; CI: 3.06–11.18, p ≤0.0001) whereas the risk of bleeding was similar between the groups (OR: 0.93; CI: 0.55–1.57, p = 0.78).ConclusionsThe results of this meta-analysis suggest that transcatheter closure of PFO plus medical therapy is superior to medical therapy alone for the prevention of recurrent cryptogenic stroke. However, PFO closure in these patients has not been shown to reduce the risk of recurrent TIA or all-cause mortality. There is a higher rate of transient atrial fibrillation post PFO closure device placement, the long-term effects of which have yet to be studied.     

Patent foramen ovale and stroke

Opinion statement Observational data from prospective and retrospective trials indicate that a patent foramen ovale (PFO) is associated with the risk of ischemic stroke. The mechanism involved is presumed to be paradoxical embolism from a venous thrombus that travels via the PFO to the systemic circulation causing an ischemic stroke. Primary stroke prevention data for patients with a PFO are nonexistent. Given the substantial prevalence of PFO in the total population (≈25% to 30%), a primary prevention study may not be feasible. However, whether targeted primary prevention for patients with PFOs of certain morphologic characteristics (eg, larger size, greater degree of shunt) would be possible remains undefined. Given the large number of asymptomatic subjects, no therapy is currently recommended. The best treatment modality to prevent recurrent stroke in patients with PFO has not been defined. There are four major treatment choices: surgical closure, percutaneous device closure, medical therapy with anticoagulants, and medical therapy with antiplatelet agents. Regarding medical therapy, the Patent Foramen Ovale in Cryptogenic Stroke Study has demonstrated that antiplatelet and anticoagulant therapies are of equal benefit in preventing recurrent adverse events. Although closure of the PFO, either surgical or percutaneous, may further reduce the event rates, this remains to be demonstrated because no randomized trial to date has compared PFO closure with medical therapy.     

卵圆孔未闭与原因不明性卒中

流行病学研究显示,原因不明性卒中患者中的卵圆孔未闭(patent foramen ovale,PFO)患病率显著高于普通人群,二者之间的密切联系支持反常性栓塞为卒中病因的假说.然而,在原因不明性卒中患者中,单纯检测到PFO并不能确立反常性栓塞的诊断.当PFO与其他一些因素共存时,会显著增高缺血性卒中风险.一些研究显示,伴有PFO的原因不明性卒中患者的MRI病灶模式与无PFO者并无显著差异,特别是多发性缺血灶,因此不支持反常性栓塞作为PFO患者卒中病因的理论.PFO的检测方法包括经胸壁超声心动图、经食管超声心动图(transesophageal echocardiography,TEE)和经颅多普勒(transcranial Doppler,TCD).TCD与TEE具有良好的一致性,因此应被推荐为一种简单、无创和可靠的技术,而TEE仅应在经过选择的患者中进行.PFO的治疗选择包括抗血小板药、抗凝药、经皮血管内封堵术和开胸手术.在几项重要的大样本随机对照试验完成之前,对于伴有PFO的原因不明性卒中患者,经皮封堵术仅应考虑用于治疗在接受内科治疗过程中仍然出现复发性事件、对内科治疗存在禁忌证以及某些高危解剖学风险的PFO.