左盘外包膜房间隔封堵器治疗卵圆孔未闭的实验研究

目的 评价国产左盘外包膜房间隔封堵器治疗卵圆孔未闭的疗效和安全性.方法 广西巴马小型猪共12只,穿刺其卵圆窝建立卵圆孔未闭动物模型.在X线透视下以国产左盘外包膜房间隔封堵器进行卵圆孔未闭的封堵.术后1、2、3和6个月行超声心动图检查后处死实验动物,对标本进行病理检查.结果 所有封堵器均未观察到血栓和赘生物,封堵器边缘金属丝无断裂、变色、腐蚀.术后6个月的超声心动图检查未显示心房水平分流.封堵器和周边的房间隔组织紧密连接,封堵器表面的胶原组织和内皮层逐渐增厚,炎症逐渐消退.结论 左盘外包膜房间隔封堵器具有良好的生物相容性,内皮化迅速且完全,可以有效地封堵卵圆孔未闭.     

脑卒中患者经导管封堵卵圆孔临床资料分析

目的:探讨经导管封堵卵圆孔未闭(PFO),预防脑部矛盾栓塞并评价其疗效。方法:本组共6例,年龄16～67岁,均经临床经胸超声心动图或经食道超声心动图检查,证实为PFO合并右向左分流患者。6例术前均有缺血性脑梗死。患者选用PFO封堵器经导管置入,进行介入治疗。结果:本组封堵成功率为100%。所有患者均能成功置入并释放封堵器。术后1个月、3个月及6个月行经胸超声心动图检查,未见封堵器移位。术后未有脑卒中事件。结论:经导管封堵PFO是一种较有效的介入治疗方法,可用于预防由于DFO导的致脑部矛盾栓塞。     

103例卵圆孔未闭介入封堵治疗及近期疗效分析

目的评价卵圆孔未闭(PFO)封堵治疗的有效性、安全性及预后转归。方法纳入2018年7月至2020年9月在襄阳市中心医院心内三科行介入封堵治疗的103例PFO患者。在术前完善经胸超声心动图检查、经颅多普勒超声发泡试验(c-TCD)检查,在术后1、3、6和12个月行经胸超声心动图检查,必要时复查c-TCD。偏头痛患者在术前及术后1、3、6和12个月时记录患者头痛症状和头痛影响测试问卷6评分。结果 103例患者中,男性30例(29.1%),平均年龄(44±22)岁,93例封堵成功,手术成功率为90.3%。其中88例用常规方法通过卵圆孔,5例经由SWARTZ鞘通过卵圆孔。10例未成功病例原因均为导丝或导管不能通过卵圆孔。2例术中发生心脏穿孔,1例行急性心包穿刺,1例少量心包积液未处理。术后1例咳血,1 d后自愈。术后平均随访(7.6±2.9)个月,随访中77例达到治愈标准,10例明显缓解,6例无效,总有效率为93.5%。其中2例偏头痛患者治疗无效,2例晕厥患者治疗无效,2例非特异性症状患者治疗无效。围术期及1年期随访过程中无封堵器脱落、严重心律失常、股动静脉瘘等并发症。结论 PFO患者行封堵治疗安全、有效,并发症少。     

经导管封堵术治疗卵圆孔未闭合并隐匿性卒中或短暂性缺血发作的近中期疗效观察

目的:探讨经导管封堵术治疗卵圆孔未闭(PFO)合并隐匿性卒中或短暂性缺血发作的近中期疗效。方法:随访2009-05至2015-12期间在阜外医院成功实施经导管PFO封堵术的PFO合并隐匿性卒中、短暂性缺血发作56例,并于术后24h、1个月、3个月、6个月复查经胸超声心动图、心电图、X线胸片,随后每隔6个月行电话随访。结果:56例患者中合并隐匿性卒中54例,合并短暂性缺血发作2例,53例(94.6%)使用北京华医圣杰公司PFO封堵器,术后应用阿司匹林6个月,平均随访(34.67±23.24)个月,所有患者术后均无卒中、短暂性缺血发作病史,术后均未见残余分流。结论:经导管PFO封堵术治疗PFO合并隐匿性卒中或短暂性脑缺血发作近中期疗效满意,仍需要进一步长期大规模随访。     

卵圆孔未闭封堵器在儿童多孔型房间隔缺损封堵治疗中的研究

目的:总结卵圆孔未闭(PFO)封堵器介入治疗儿童多孔型房间隔缺损(ASD)的疗效和经验。方法:对2017年1月至2018年11月,我院采用PFO封堵器进行介入封堵治疗儿童多孔型ASD的患儿共40例进行总结,术前经临床及经胸超声心动图诊断,术中心导管结合经胸超声心动图及术后随访,观察术后右心房前后径,左右径,右心室内径变化,观察封堵器位置,有无残余分流情况及并发症。结果:所有患儿均成功置入PFO封堵器,所有患儿术后未发现明显心律失常。术后封堵器位置良好,未出现移位,未出现心脏穿孔、封堵器脱落以及栓塞等不良反应。术后1、3、6个月行经胸超声心动图检查测量患儿右心房前后径,左右径,右心室内径,较术前均明显缩小,差异有统计学意义(P0.05)。术后即刻封堵行经胸超声心动图显示39例完全闭合,1例术后6个月仍有少量残余分流,但对血流动力学无影响。结论:PFO封堵器对于封堵儿童多孔型ASD,具有封堵器效率较高,短期疗效可靠的特点,在把握适应证的前提下具有较好的封堵效果。     

单纯超声心动图引导下行动脉导管未闭封堵术的安全性和有效性

目的 探讨超声心动图作为唯一影像学工具引导动脉导管未闭封堵术的安全性和有效性.方法 2013年6月至2014年6月,连续入选单纯动脉导管未闭患者30例,年龄(6.3±2.5)岁,体质量(22.5±7.3)kg,动脉导管直径(3.8 ±0.9)mm.患者均在经胸超声心动图引导下经股动脉行动脉导管未闭封堵术,封堵后以超声心动图评价治疗效果.术后1个月在门诊随访.结果 30例患者均成功在超声心动图引导下完成动脉导管未闭封堵术,手术操作时间为(32.8±5.7) min,Amplatzer ADOⅡ封堵器直径(4.9 ±1.0)mm.6例患者术后早期有微量残余分流,无外周血管损伤及心脏穿孔等并发症.所有患者均康复出院,住院时间为(3.4±0.7)d.术后1个月随访,患者均无残余分流、心包积液等并发症.结论 单纯超声心动图引导下经股动脉行动脉导管未闭封堵术安全、有效,能避免使用X线和对比剂.     

经导管封堵卵圆孔未闭预防脑的矛盾栓塞

目的:经导管封堵卵圆孔未闭(PFO)预防脑的矛盾栓塞并评价其疗效。 方法:本组共32例,年龄15-68(50.2±8.1)岁,体重40-72(53.7±4.3)kg。均经临床及经胸超声心动图(TTE)或经食道超声心动图(TEE)检查证实为PFO合并右向左分流伴脑缺血事件、单纯PFO、PFO合并房间隔瘤或房间隔瘤合并多孔房间隔缺损(房缺)。32例术前均有不同程度的偏头痛,不明原因的晕厥22例,用力性晕厥3例,短暂性语言障碍3例,缺血性脑梗塞4例。20例声学造影显示微泡从右心房进入左心房。PFO合并房间隔瘤、房间隔瘤合并多孔房缺的患者在TTE或TEE下测量房间隔的伸展径,选用房缺封堵器进行介入治疗;对单纯PFO的患者选用PFO封堵器经9-12F的鞘管置入,进行介入治疗。 结果:本组技术成功率为100％。所有患者均能成功置放封堵器。术后24 h,1个月,3个月,6个月,12个月行TTE检查未见封堵器移位。术后1个月复发偏头痛患者1例,1例房间隔瘤患者术后3个月用力时发生头晕症状。 结论:经导管封堵PFO是一种较有效的非手术方法,可用于预防脑的矛盾栓塞。     

卵圆孔未闭介入封堵术后三度房室传导阻滞1例

本文报道1例卵圆孔未闭患者在外院选择34 mm房间隔缺损封堵器行卵圆孔未闭介入封堵后发生三度房室传导阻滞,经药物治疗无效,选择胸腔镜取出封堵器,同时行卵圆孔未闭修补治疗。术中患者即恢复窦性心律,卵圆孔未闭修补正常。     

卵圆孔未闭合并冠心病患者“一站式”手术的单中心回顾性分析

目的 探讨对卵圆孔未闭合并冠状动脉粥样硬化性心脏病（冠心病）的患者,同期进行经皮卵圆孔封堵术联合经皮冠状动脉（冠脉）介入治疗（PCI）一站式治疗的可行性、安全性及疗效。方法 回顾性分析十堰市人民医院于2018年1月至2020年12月收治的228例卵圆孔未闭合并冠心病的患者的临床资料。按手术方式分为一站式联合手术组（n=98,34.03%）和单纯卵圆孔未闭（PFO）封堵组（n=190,65.97%）。术前完善经食道心脏彩超评估PFO各项参数;所有患者术后规律抗血小板治疗。并于术后随访24个月,记录卵圆孔封堵器的位置、血栓形成以及残余分流情况及患者临床表现,包括心源性反常栓塞事件再发、卒中、出血、心律失常、猝死等。Cox回归方法对所有封堵合并冠脉介入患者进行生存分析。结果 一站式联合手术组97例患者置入卵圆孔封堵器及冠脉支架,1例因股动脉及股静脉解剖骑跨放弃手术。单纯行PFO封堵组190例成功置入卵圆孔封堵器,术后即刻封堵效果及PCI疗效满意,术中无器械表面血栓,无心包压塞及血管并发症：随访显示两组患者出血、卒中、封堵器残余分流、血栓、心肌梗死事件未见明显增多,两组器械成功率和手术相关并发...     

动脉导管未闭封堵器在室间隔缺损介入治疗中的应用研究

目的探讨应用动脉导管未闭封堵器治疗室间隔缺损的疗效和安全性。方法分析我院2006年2月—2009年2月应用动脉导管未闭封堵器对27例室间隔缺损患者进行介入治疗的临床资料。结果 27例患者全部封堵成功;术后24h复查,经胸超声心动图显示11例存在少量残余分流,术后1个月复查显示11例残余分流消失;术后心电图显示3例有偶发房性期前收缩,27例均未发生室性心律失常、束支传导阻滞及房室传导阻滞。术后随访3、6、12个月结果显示,右心室流出道流速降低,未发生右室流出道梗阻,左心室舒张末内径下降。结论在管状室间隔缺损介入治疗中应用动脉导管未闭封堵器是安全、有效和可行的。     

Device-less patent foramen ovale closure by radiofrequency thermal energy

The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). METHODS: Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. RESULTS: There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. CONCLUSIONS: The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.     

Percutaneous closure of patent foramen ovale

AIM: To review the safety and efficacy of percutaneous closure of patent foramen ovale (PFO) in symptomatic patients without the use of general anaesthesia or echocardiographic guidance. METHOD: All patients accepted for percutaneous PFO closure by our service from August 2002 to August 2004 were included. Patient demographics and clinical information were obtained from clinical records and by telephone interview. Follow-up outcomes recorded were recurrence of systemic thromboembolism, residual shunt, and change in pattern of migraines. RESULTS: Forty consecutive adult patients, of whom 19 (48%) had an atrial septal aneurysm (ASA), underwent PFO closure using the Amplatzer occluder device with fluoroscopic guidance alone. Their mean age was 45 +/- 10 years (range 23-63 years) and 24 (60%) were male. The indications for closure were ischaemic stroke (n = 26), transient ischaemic attack (TIA) (n = 8), both stroke and TIA (n = 2), refractory hypoxia (n = 2), platypnoea-orthodeoxia (n = 1) and severe migraine with seizures (n = 1). Twenty patients suffered a single neurological event and 16 suffered >1 event, including six with only radiographic evidence of >1 event. Mean procedure time was 17.7 +/- 9.6 min and fluoroscopy time was 6.7 +/- 7.3 min. Implanted device sizes were 18 mm (n = 1), 25 mm (n = 37) and 35 mm (n = 2). In 33 patients, the procedure was performed as a day-case. No complications were encountered. No further neurological events occurred in 39 patients at a mean follow-up time of 11 +/- 7 months (3-25 months) nor was a significant shunt detected in the 34 who underwent follow-up echocardiography. CONCLUSIONS: Percutaneous closure of PFO with or without ASA, under local anaesthesia and without echocardiographic guidance, is a safe and effective procedure which can be performed as a day-case. This has now become our standard clinical practice.     

Percutaneous closure of patent foramen ovale in symptomatic patients

BACKGROUND: Patent foramen ovale (PFO) and atrial septal aneurysm (ASA) have been associated with stroke in young adults. Patients with PFO suffering from paradoxical embolism are at increased risk for recurrent events. Percutaneous PFO closure is a new treatment modality aimed at secondary prevention. METHODS AND RESULTS: Since April 1994, 132 consecutive patients, aged 51 +/- 12 years with PFO and with at least one paradoxical embolic event, underwent percutaneous PFO closure using six different device types. The embolic index event was an ischemic stroke in 62% of patients, a transient ischemic attack (TIA) in 33% of patients, and a peripheral embolism in 5% of patients. Thirty-six (27%) patients had PFO associated with ASA, whereas 96 (73%) patients had PFO only. The implantation procedure was successful in 130 (98%) patients. During and up to 6 years of follow-up (mean 1.8 +/- 1.6 years, 231 patient years), a total of eight recurrent embolic events were observed, with six TIAs, two peripheral emboli, and no ischemic stroke. The actuarial freedom from recurrence of the combined end point of TIA, ischemic stroke, and peripheral embolism was 95.3% (95% confidence interval [CI], 91.0%-96.4%) at 1 year and 90.5% (95% CI, 83.6%-97.2%) at 6 years. CONCLUSIONS: Percutaneous PFO closure can be performed with a high success rate. The procedure appears a promising therapeutic modality for secondary prevention of recurrent embolism in patients with PFO. Randomized trials must define its therapeutic value.     

Percutaneous closure of patent foramen ovale for migraine headaches refractory to medical treatment

Background : Patent foramen ovale (PFO) has been linked to migraine, and several retrospective studies reported an improvement in migraine prevalence or frequency after PFO closure for other reasons, mostly for secondary prevention of paradoxical embolism or following diving accidents. We investigated the outcome of patients undergoing PFO closure solely for migraine headaches refractory to medical treatment. Methods : Seventeen patients (age 44 ± 12 years; 76% female; one atrial septal aneurysm) underwent percutaneous PFO closure using the Amplatzer PFO Occluder (AGA Medical Corporation, Golden Valley, MN). An 18‐mm device was used in two patients, a 25‐mm device in 13, and a 35‐mm device in two. The interventions were solely guided by fluoroscopy, without intraprocedural echocardiography. Results : All implantation procedures were successful. There were no peri‐procedural complications. Contrast transesophageal echocardiography after Valsalva maneuver at 6 months showed complete PFO closure in 16 patients (94%), whereas a minimal residual shunt persisted in one (6%). During 2.7 ± 1.5 years of follow‐up, no deaths and no embolic events occurred. After PFO closure, migraine headaches disappeared in four patients (24%), and improved in eight additional patients (47%). Three patients (18%) reported a decrease of their headaches by 75%, three patients (18%) a decrease of 50%, and two patients (12%) a decrease of 25%, while headaches remained unchanged in five patients (29%). No patient experienced worsening headaches. Moreover, the prevalence of migraine with aura decreased from 82 to 24% (P = 0.002). Conclusions : These results suggest that percutaneous PFO closure durably alters the spontaneous course of shunt associated migraine. © 2009 Wiley‐Liss, Inc.     

Interventional closure with Amplatzer PFO occluder of patent foramen ovale in patients with paradoxical cerebral embolism

Percutaneous transcatheter closure has been proposed as an alternative to surgical closure or long-term anticoagulation in patients with presumed paradoxical embolism and patent foramen ovale (PFO). We report our mid-term results of 55 consecutive symptomatic patients (mean age: 47 years, range: 20-79) who underwent percutaneous transcatheter closure of PFO after at least one event of cerebral ischemia; 16 (29%) patients had at least one transient ischemic attack and 39 (71%) patients at least one embolic stroke. Multiple embolic events had occurred in 6 (11%) patients. Percutaneous transcatheter closure was technically successful in all 55 patients (100%). For the majority of patients, an Amplatzer PFO occluder measuring 25 mm in diameter (n=49) or an Amplatzer PFO occluder measuring 35 mm in diameter (n=6) was used. Complete occlusion by color Doppler and transesophageal contrast echocardiography investigation was achieved in 96% at follow-up 3-6 months after implantation; only 2 patients had a trivial residual shunt at follow-up. Mean fluoroscopy time was 6.7 minutes (range: 1.7-47.1), and in-hospital follow-up was uneventful except for 1 patient who developed a cardiac tamponade requiring uneventful and successful needle pericardiocentesis. At a mean follow-up of 19 months (range: 3-32) no recurrent embolic neurological events was observed. Transcatheter closure of PFO with Amplatzer PFO occluder devices is a safe and effective therapy for patients with previous paradoxical embolism and aneurysmatic or nonaneurysmatic PFO. Percutaneous closure is associated with a high success rate, low incidence of hospital complications, and freedom of cerebral ischemia events.     

Transcatheter closure of patent foramen ovale (PFO) in patients with paradoxical embolism. Periprocedural safety and mid-term follow-up results of three different device occluder systems.

AIMS: Interventional PFO closure has previously been reported to reduce the risk for recurrent thromboembolic events. The aim of the present study was to evaluate three different occluder systems in respect to (a) the safety and practicability and (b) the mid-term risk of recurrent thromboembolic events. METHODS AND RESULTS: Since 08/98 until 12/02, 307 consecutive patients (138 women, 169 men, mean age 43 years) with a symptomatic PFO underwent PFO closure using the PFO-Star ( n=177), Amplatzer PFO occluder ( n=69) and CardioSeal/Starflex ( n=61 ). Implantation was successful in all patients. Periinterventional complications occurred in 9 patients (5x ST-segment elevations, 1x arteriovenous fistula, 2x TIA, 1x device dislodgement). All of them were reversible and not associated with a specific type of device. During the median follow-up of 24 months (25/75th percentiles: 14/37 months), the annual risk of recurrence was 0.6% for TIA, 0% for stroke and 0.2% for peripheral embolism (PFO-Star: 0.8%, Amplatzer PFO occluder: 0.7% and CardioSeal/Starflex: 1.0%). CONCLUSION: Interventional PFO closure appears to be safe and a promising technique in symptomatic PFO patients with a low incidence of periinterventional complications and recurrent thromboembolic events using three different devices (PFO-Star, Amplatzer PFO occluder or the CardioSeal/Starflex).     

Implantation of a second closure device in patients with residual shunt after percutaneous closure of patent foramen ovale.

Percutaneous closure of patent foramen ovale (PFO) in patients with presumed paradoxical embolism yields complete occlusion in > 90% of patients using contemporary closure devices. Patients with a residual shunt after percutaneous PFO closure have been found at increased risk for recurrent paradoxical events. Treatment options for such patients include medical treatment using antiplatelet drugs or oral anticoagulation, surgical device removal and patch closure, and percutaneous implantation of a second closure device. We report our experience with implantation of a second closure device in 10 patients with more than a minimal residual shunt < or = 6 months after percutaneous PFO closure. Procedure and fluoroscopy times were similar for the initial and repeat intervention (32 vs. 30 min and 5 vs. 6 min, respectively; P = NS). There were no procedural complications during implantation of the second closure device. Follow-up transesophageal echocardiography 6 months after the second percutaneous intervention revealed complete PFO closure in nine (90%) patients. Therefore, implantation of a second closure device in patients with persistence of more than a residual shunt after percutaneous PFO closure appears safe and effective.     

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.     

New onset atrial fibrillation after patent foramen ovale closure

Objectives : In this study, we evaluated the incidence of new onset atrial fibrillation (symptomatic or detected by routine ECG) after patent foramen ovale (PFO‐) closure. Background : Although atrial fibrillation is known to occur in some patients following patent foramen ovale closure, the incidence and the risk associated with each device is not well known. Methods : We evaluated 1,349 consecutive patients who underwent PFO closure with an approved device and examined the incidence and risk factors associated with the development of atrial fibrillation. The patients had a mean age of 50 years and underwent PFO closure for cerebrovascular accident in 696 (51.6%), transient ischemic attack in 610 (45.2%), paradoxical embolism in 22 (1.6%), decompression sickness in 13 (0.9%), and other reasons including migraine headaches in 6 (0.4%) of cases. Results : Over a mean follow‐up period of 38.1 ± 28 months, 53 (3.9%) patients developed new onset atrial fibrillation, which is higher compared with an age‐matched population. Of these, 33 (62.3%) patients developed atrial fibrillation within 4 weeks and 8 (15%) within 6 months following PFO closure (totally 77% from 0 to 6 months). The event consisted of a single paroxysm lasting less than 48 hr in 23 patients, resolving either spontaneously or with cardioversion. 40 (75.5%) patients were symptomatic at the time of diagnosis. Thirty (56.6%) patients developed chronic atrial fibrillation. On multivariate analysis, advanced age and use of the STARFlex device predicted atrial fibrillation. Conclusions : The number of patients in whom atrial fibrillation was detected was relatively low. It is often a self‐limited complication of PFO closure that may occur more frequently in elderly patients and those treated with the STARFlex device. © 2009 Wiley‐Liss, Inc.     

Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices

BACKGROUND: Atrial septal aneurysm is frequently associated with patent foramen ovale (PFO) and atrial septal defects (ASD). Moreover, a relationship between atrial septal aneurysm and embolic cerebrovascular events has been suggested. The aims of this study were to analyze morphological and functional characteristics of atrial septal aneurysm in PFO and ASD patients and to assess the feasibility and efficacy of different devices for transcatheter closure and the influence of atrial septal aneurysm. METHODS: Between March 1997 and May 2000 transcatheter ASD or PFO closure was attempted in 63 patients (mean age 47 +/- 13 years) with an atrial septal aneurysm using one of the following devices: Angelwings (n = 3), Cardioseal (n = 5), Cardioseal-Starflex (n = 7), Amplatzer (n = 11), Amplatzer-PFO (n = 5), PFO-Star (n = 25), or Helex (n = 7). RESULTS: Implantation was primarily successful (after the first or second attempt) in all patients. One PFO-Star device embolized 12 hours after the procedure. During follow-up (0.6-37 months, mean 10.4 +/- 9.2) a residual shunt could be detected by transesophageal echocardiography after 2 weeks in four patients and after 6 months in one patient. Three PFO patients had cerebrovascular events after implantation. Two patients had a transient ischemic attack (TIA) and one patient a stroke. A thrombus formation on the device detected in three patients disappeared after antithrombotic therapy. CONCLUSION: We conclude that ASDs and PFOs with an associated atrial septal aneurysm can be closed with different available devices. There seem to be no additional risks compared with patients without atrial septal aneurysm.