septal occluder

间隔封堵器
  • 文章类型: Case Reports
    获得性气管食管瘘(TEF)是食管癌过程中罕见且具有挑战性的并发症。虽然手术是TEF的唯一治愈性治疗选择,但许多患者不符合手术条件。内镜治疗方法,如气管和/或食管支架置入术。但与并发症有关,例如新瘘管的发展和粘液保留。在少数病例报告中报道了在标签外使用心脏amplatzer封堵器来关闭TEF,但短期结果不一致。我们报告了一例使用两个部分重叠的心脏amplatzer封堵器成功闭合两个相邻TEF的案例。插入12毫米和9毫米的装置是成功的,没有并发症。患者对心脏amplatzer装置的耐受性良好,并且可以在2个月后恢复口服食物摄取。关闭两年后,该患者没有症状,提示瘘管完全密封。
    Acquired tracheo-oesophageal fistulas (TEFs) are rare and challenging complications in the course of oesophageal cancer. While surgery is the only curative treatment option for TEFs many patients are not eligible for surgery. Endoscopic treatment approaches such as tracheal- and/or oesophageal- stenting are available, but associated with complications like the development of new fistulas and mucus retention. Off- label-use of cardiac amplatzer occluder devices to close TEFs has been reported in few case-reports with inconsistent short-term outcomes. We report a case of successful closure of two adjacent TEFs with two partially overlapping cardiac amplatzer occluder devices. The insertion of a 12 mm and a 9 mm device was successful and without complications. The patient tolerated the cardiac amplatzer-devices well and could resume oral food uptake after 2 months. Two years after closure, the patient remained free of symptoms suggesting complete sealing of the fistulas.
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  • 文章类型: Journal Article
    背景:房间隔缺损(ASD)闭合伴显著的左向右分流和并发合并症对介入治疗提出了挑战。对于由于血液动力学和医学原因而无法完全闭塞的患者,开窗式房间隔缺损(FASD)装置是可行的选择。这项研究探讨了FASD封堵器在难以完全封堵的继发性ASD和相关合并症患者中的使用。方法本回顾性研究收集了2015年7月至2023年7月在印度东部三级心脏中心诊断为严重继发性ASD并有其他合并症的患者的详细信息。在这个群体中,我们对接受FASD装置置入的患者进行了综合分析.结果总计,16例诊断为继发性ASD,以显著的左向右分流和并发合并症为特征,在研究期间考虑FASD关闭。最终,13例患者(第一组)接受了开窗式房间隔封堵器植入。平均年龄45.07岁,大多数是女性(n=9)。该队列中的合并症包括实质性左心室舒张功能障碍(n=7),左心室舒张功能不全合并中度肺动脉高压(n=1),重度肺动脉高压(n=1),重度肺动脉瓣狭窄伴右心室舒张功能不全(n=2),和系统性红斑狼疮(SLE)(n=2)。从这个队列中,3例患者未接受干预.第二组包括一名患有严重左心室舒张功能障碍的老年患者,有左房性心律失常病史的年轻人,和一个患有杜氏肌营养不良症(DMD)的孩子。接受干预的患者的平均ASD大小为26.38mm,与厚到厚的尺寸测量31.15毫米。手术在所有13名患者中都是成功的,最常用的装置是34毫米封堵器(范围=28-40毫米)。所有设备,不包括最初的,是定制的房间隔封堵器(LifetechScientific)。在患者中,12显示从左到右开窗流,当一名患者经历开窗收缩时,可能是由于封堵器过度拥挤。第一位患者在40毫米Amplatzer间隔封堵器中进行了手工制作的5毫米开窗,在一年的随访中被关闭了。该手术在所有患者中的血流动力学耐受性良好,围手术期无重大并发症。短期随访显示患者进展良好。结论FASD封堵术是涉及并发并发合并症的复杂情况的关键替代方案。提供个性化的定制解决方案。除了传统的相关合并症,如左心室舒张功能不全和肺动脉高压,FASD设备具有将其益处扩展到与其他复杂性作斗争的患者的潜力,包括严重的肺动脉瓣狭窄,SLE,左房性心律失常的易感性,和像DMD这样的条件。确保对患者的适用性进行细致的评估并提供持续的警惕护理对于实现最佳结果至关重要。这些发现的验证和对这种方法的理解的扩大需要进一步的全面调查。
    Background Atrial septal defect (ASD) closure with significant left-to-right shunt and concurrent comorbidities poses challenges for intervention. A fenestrated atrial septal defect (FASD) device is a viable option for patients who cannot undergo complete occlusion due to hemodynamic and medical reasons. This study explores the use of FASD occluders in patients with secundum ASD and associated comorbidities where complete occlusion is difficult. Methodology This retrospective study collected the details of patients recommended for FASD closure diagnosed with significant secundum ASD and who had additional comorbidities between July 2015 and July 2023 in a tertiary cardiac center in eastern India. Among this cohort, patients who underwent FASD device placement were subjected to a comprehensive analysis. Results In total, 16 patients diagnosed with secundum ASD, characterized by significant left-to-right shunt and concurrent comorbidities, were considered for FASD closure during the study period. Ultimately, 13 patients (first group) underwent fenestrated atrial septal occluder implantation. The average age was 45.07 years, with the majority being females (n = 9). Comorbidities among this cohort included substantial left ventricular diastolic dysfunction (n = 7), left ventricular diastolic dysfunction coupled with moderate pulmonary hypertension (n = 1), severe pulmonary hypertension (n = 1), severe pulmonary valvular stenosis with right ventricular diastolic dysfunction (n = 2), and systemic lupus erythematosus (SLE) (n = 2). From this cohort, three patients did not undergo the intervention. The second group consisted of an elderly patient with severe left ventricular diastolic dysfunction, a young adult with a history of left atrial arrhythmia, and a child with Duchenne muscular dystrophy (DMD). The average ASD size among patients who underwent the intervention was 26.38 mm, with a thick-to-thick dimension measuring 31.15 mm. The procedure was successful in all 13 patients, with the most frequently used device being a 34 mm occluder (range = 28-40 mm). All devices, excluding the initial one, were custom-made atrial septal occluders (Lifetech Scientific). Among the patients, 12 exhibited left-to-right fenestration flow, while one patient experienced fenestration constriction, likely due to occluder overcrowding. The first patient had a handmade 5 mm fenestration in a 40 mm Amplatzer septal occluder, which got closed off at the one-year follow-up. The procedure was well-tolerated hemodynamically in all patients, with no major complications during the peri-procedural period. Short-term follow-up indicated favorable patient progress. Conclusions FASD closure emerges as a pivotal alternative for intricate scenarios involving secundum ASD coupled with concurrent comorbidities, offering individualized tailored solutions. Alongside the conventional associated comorbidities, such as left ventricular diastolic dysfunction and pulmonary hypertension, FASD devices hold the potential to extend their benefits to patients grappling with other complexities, including severe pulmonary valvular stenosis, SLE, predisposition to left atrial arrhythmia, and conditions like DMD. Ensuring meticulous evaluation of patient suitability and providing ongoing vigilant care becomes paramount for achieving optimal outcomes. The validation of these findings and the broadening of the comprehension of this approach necessitate further comprehensive investigations.
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  • 文章类型: Journal Article
    卵圆窝房间隔缺损(FOASD)的经皮导管封堵术是一种既定的手术。当股静脉入路由于下腔静脉(IVC)中断或股静脉闭塞而不可行时,其他经颈静脉介入方法,经肝途径,或者可以进行手术闭合。我们报告了2例与IVC中断相关的FOASD经肝闭合装置成功进行,没有任何并发症。
    Percutaneous transcatheter closure of fossa ovalis atrial septal defect (FOASD) is an established procedure. When femoral venous approach is unfeasible due to interrupted inferior vena cava (IVC) or occluded femoral veins, other interventional methods through transjugular, transhepatic approach, or surgical closure can be performed. We report two cases of transhepatic device closure of FOASD associated with IVC interruption successfully performed without any complications.
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  • 文章类型: Journal Article
    UNASSIGNED:最近几十年在继发孔型房间隔缺损(ASD)封堵术的治疗策略和封堵器改良方面取得了显着改善。批准,ASD封堵装置的有效性和安全性已得到证实.这项研究调查了LifeTechCeraFlexTMASD封堵器的临床疗效和安全性,并进行了6个月的随访(FU)。
    UNASSIGNED:收集了2016年4月至2019年12月在德国三个中心考虑使用CeraFlexTM封堵器进行ASD封堵的患者的具体程序数据。封堵器后评估疗效和安全性,在放电时,在6个月的FU。
    UNASSIGNED:102/103名患者(99%)达到了主要终点(成功的ASD闭合,无严重并发症)。2例患者发生装置栓塞(1例早期栓塞,1例晚期栓塞)。在早期圈套恢复栓塞装置后,该ASD通过手术闭合,在另一例晚期器械栓塞患者中,缺损用较大的CeraFlexTM封堵器闭合。94/98名患者达到次要终点(6个月后的临床疗效),因为四名患者发生了新的心律失常。三名患者退出了他们的研究参与,一名患者有中度残余分流,但与封堵器无关。在31例患者中观察到不完整的右束支传导阻滞(iRBBB)。最后,FU只有17例患者剩余iRBBB记录了右心室的有效容量卸载。
    UNASSIGNED:使用CeraFlexTMASD封堵器对继发性ASD进行导管介入封堵是可行的,本研究安全有效。
    UNASSIGNED: The last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlexTM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU).
    UNASSIGNED: Procedure specific data was collected on patients considered for ASD closure with the CeraFlexTM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU.
    UNASSIGNED: The primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlexTM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle.
    UNASSIGNED: Catheter interventional closure of secundum ASDs with the CeraFlexTM ASD occluder was feasible, safe and effective in this study.
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  • 文章类型: Journal Article
    患有扩大的慢性主动脉夹层和近端开放的患者有时是开放手术或TEVAR的不良候选人。先前已建议在选定的患者中使用血管内栓塞封闭近端入口。但随着时间的推移,临床结果是未知的。这项研究分析了近端进入闭塞后的主动脉重塑和临床结果。
    在2007年至2016年之间,有14名患者,随着慢性主动脉夹层的扩大,被认为是标准治疗的不良候选人,在位于弓(n=6)或降主动脉(n=8)的近端入口使用血管内栓塞治疗。Amplatzer™VascularPlugII用于≤4mm的条目,Amplatzer™间隔封堵器或Amplatzer™MuscularVSD封堵器用于5-16mm的条目。患者随访0.5-13年(中位数7.3),临床就诊和计算机断层扫描。测量沿主动脉的直径和横截面积。
    10/14患者(71%)实现了近端入口的阻塞,包括4例需要进行辅助再干预以完全密封的患者。在所有10例成功闭塞的患者中,观察到最大胸主动脉直径不变或减小。在4名患者中,未实现近端闭塞,早期转换为FET(n=1),进行FET/TEVAR(n=2)或TEVAR(n=1)。随访期间发生2例主动脉相关死亡,早期转换后。
    扩张性慢性主动脉夹层近端夹层入口的血管内闭塞可诱导有利的主动脉重塑,可在选择性扩张性慢性主动脉夹层患者中考虑,这些患者不适合进行开放手术或支架移植物修复。
    Patients with expanding chronic aortic dissection and patent proximal entries are sometimes poor candidates for open surgery or TEVAR. Occlusion of proximal entries with endovascular plugs has previously been suggested in selected patients, but clinical results over time are unknown. This study analyses aortic remodelling and clinical outcome after proximal entry occlusion.
    Between 2007 and 2016, 14 patients, with expanding chronic aortic dissection, considered poor candidates for standard treatment, were treated with endovascular plugs in proximal entries located in the arch (n = 6) or descending aorta (n = 8). The Amplatzer™ Vascular Plug II was used for entries ≤4 mm and the Amplatzer™ Septal Occluder or Amplatzer™ Muscular VSD Occluder for entries 5-16 mm. Patients were followed for 0.5-13 years (median 7.3) with clinical visits and computed tomography. Diameters and cross-sectional areas along the aorta were measured.
    Occlusion of proximal entries was achieved in 10/14 patients (71%), including 4 patients with an adjunctive reintervention needed for complete seal in the segment. Unchanged or reduced maximum thoracic aortic diameter was observed in all 10 patients with successful occlusion. In 4 patients, proximal occlusion was not achieved and early conversion to FET (n = 1), FET/TEVAR (n = 2) or TEVAR (n = 1) was performed. Two aorta-related deaths occurred during follow-up, both after early conversion.
    Endovascular occlusion of proximal dissection entries of expanding chronic aortic dissections can induce favourable aortic remodelling and may be considered in selected patients with expanding chronic aortic dissection who are poor candidates for open surgery or stent graft repair.
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  • 文章类型: Case Reports
    背景:新的治疗选择,比如血管内主动脉修复术,降低了急性A型主动脉夹层修复术后并发症患者的死亡率。然而,主动脉夹层的初始成功治疗并不能完全消除晚期主动脉不良事件如吻合口假性动脉瘤的风险.上行和弓形移植物之间吻合的假性动脉瘤可引发并发症,如周围栓塞,吞咽困难或纵隔器官受压。通过再胸骨切开术再次手术对这些患者具有巨大的发病率和死亡率。对于治疗假性动脉瘤的经皮治疗选择存在高度未满足的需求。
    方法:一名59岁男子15年前因A型主动脉夹层接受治疗,因间歇性腹痛住院。详细检查显示2个假性动脉瘤:1个在重新植入的腹腔干水平有症状,1个在头臂干和主动脉弓移植物之间的吻合处无症状。由于多种合并症和以前的操作,手术的风险被认为过高.两种假性动脉瘤均经皮治疗,有症状的1使用覆膜支架,而Amplatzer™间隔封堵器无症状。
    结论:我们提出了一种使用间隔封堵器治疗假性动脉瘤的替代经皮治疗方法。3个月后的随访计算机断层扫描显示成功排除了假性动脉瘤。
    BACKGROUND: New treatment options, like endovascular aortic repair, reduced the mortality rate of patients suffering from complications after an acute type A aortic dissection repair. Nevertheless, initial successful treatment of an aortic dissection does not fully eliminate the risk of later adverse aortic events like anastomotic pseudoaneurysm. Pseudoaneurysm of the anastomosis between the ascending and the arch graft could initiate complications like peripheral embolization, dysphagia or compression of mediastinum organs. Re-operation via re-sternotomy bears enormous morbidity and mortality for these patients. There is a high unmet need for percutaneous therapeutic options to treat pseudoaneurysms.
    METHODS: A 59-year-old-man treated 15 years ago for type A aortic dissection, was hospitalized due to intermittent abdominal pain. A detailed examination revealed 2 pseudoaneurysms: 1 symptomatic at the level of the reimplanted celiac trunk and 1 asymptomatic at the anastomosis between the brachiocephalic trunk and the aortic arch graft. Due to multiple co-morbidities and previous operations, the risk for surgery was considered too high. Both pseudoaneurysm were treated percutaneously, the symptomatic 1 with covered stent and the asymptomatic with Amplatzer™ septal-occluder.
    CONCLUSIONS: We present an alternative percutaneous therapy approach for treatment of pseudoaneurysm using a septal-occluder. A follow-up computed tomography 3 months later showed successfully excluded pseudoaneurysm.
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  • 文章类型: Journal Article
    虽然不常见,不完全左心耳封堵(LAAC)可能是由于残余漏气所致.尽管数据有限,但已描述了经皮闭合。
    我们编制了来自四个中心的患者的注册表,这些患者通过手术手段或使用Watchman设备在LAAC后经皮闭合残余泄漏。泄漏严重程度分类为无(无泄漏),轻度(1-2毫米),中等(3-4毫米),或严重(≥5mm)。手术和临床成功定义为在手术结束或随访时消除渗漏或轻度残余渗漏。分别。
    72名患者(年龄72.2±9.2岁;67%为男性),53名患者使用Watchman设备接受了LAAC,19名患者接受了LAAC手术。平均CHADS2-VA2Sc评分为4.0±1.8。中值泄漏尺寸为5毫米,范围:2-13)。共有13人接受了Amplatzer血管塞-II,18名患者接受了Amplatzer导管封堵器II,40名患者接受了线圈。一个人使用21mm-Watchman进行了闭合。手术成功率为94%。零手术和9名Watchman患者(13%)在手术结束时出现残留泄漏(5名轻度,三个温和,和一名严重)-只有一名患者的泄漏量没有减少。总体泄漏尺寸减少94%。2例(3%)术中出现心包积液。没有装置栓塞,装置相关血栓,或程序性死亡。临床成功率保持在94%。两个人在术后2天(短暂性脑缺血发作)和术后10个月发生了脑血管意外。两人在围手术期30天窗口外大出血。
    左心耳封堵术后残余渗漏的经皮封堵是可行的,且预后良好。程序风险似乎令人满意。
    Though infrequent, incomplete left atrial appendage closure (LAAC) may result from residual leaks. Percutaneous closure has been described though data is limited.
    We compiled a registry from four centers of patients undergoing percutaneous closure of residual leaks following LAAC via surgical means or with the Watchman device. Leak severity was classified as none (no leak), mild (1-2 mm), moderate (3-4 mm), or severe (≥5 mm). Procedural and clinical success was defined as the elimination of leak or mild residual leak at the conclusion of the procedure or follow-up, respectively.
    Of 72 (age 72.2 ± 9.2 years; 67% male) patients, 53 had undergone prior LAAC using the Watchman device and 19 patients surgical LAAC. Mean CHADS2 -VA2 Sc score was 4.0 ± 1.8. The median leak size was 5 mm, range: 2-13). A total of 13 received Amplatzer Vascular Plug-II, 18 received Amplatzer Duct Occluder-II and 40 patients received coils. One underwent closure using a 21 mm-Watchman. Procedural success was 94%. Zero surgical and nine Watchman patients (13%) had a residual leak at procedural-end (five mild, three moderate, and one severe)-only one patient had no reduction in leak size. Overall leak size reduction was 94%. Two (3%) had intraoperative pericardial effusion. There were no device embolizations, device-related thrombi, or procedural deaths. Clinical success was maintained at 94%. Two had cerebrovascular accidents-at 2 days (transient ischemic attack) and 10 months postprocedure. Two had major bleeding outside the 30-day periprocedural window.
    Percutaneous closure of residual leaks following left atrial appendage closure is feasible and associated with good outcomes. The procedural risk appears to be satisfactory.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    评估Amplatzer间隔封堵器在封堵继发孔型房间隔缺损中的安全性和有效性。
    Amplatzer中隔封堵器(ASO;雅培,圣保罗,MN)是FDA批准的经皮封堵继发孔型房间隔缺损(ASD)的装置。以前的小型队列试验显示了良好的安全性和技术疗效。
    我们对评估ASO安全性和植入疗效的所有前瞻性病例系列和对照试验进行了系统回顾和荟萃分析。主要终点是植入的技术成功率。次要结果包括心律失常和栓塞特异性不良事件的比例。
    我们共纳入12项研究,共2972名患者。装置植入的比例按性别为2:1[女性:男性]。综合技术成功率为98%(95%CI:0.968~0.990,P<0.01)。累计不良事件发生率为5.1%(95%CI:0.035-0.068,P<0.01),其中心律失常和栓塞特异性不良事件发生率为1.8%(95%CI:0.007-0.032,P<0.01)和0.7%(95%CI:0.002-0.013,P<0.01),分别。敏感性分析对成功率和不良事件的汇总结果没有显着影响;森林地块和Begg's和Egger's回归测试均支持对称性。
    当将ASO植入secundum型ASD时,可以预期技术成功的可能性很高。预计每20名患者中就有1名患者出现不良事件,因此,我们的结果支持ASO在secondum型ASDs闭合中的安全使用。
    AMPLATZER间隔封堵器是FDA批准的经皮封堵装置,用于继发孔型房间隔缺损(ASD)。我们对评估ASO安全性和植入疗效的所有前瞻性病例系列和对照试验进行了系统回顾和荟萃分析。我们共纳入12项研究,共2972名患者。综合技术成功率为98%(P<0.01)。累计不良事件发生率为5.1%(P<0.01),心律失常发生率1.8%(P<0.01),栓塞率0.7%(P<0.01)。在不良事件发生率低的情况下,技术成功的可能性很高。
    To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects.
    The Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile.
    We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO\'s safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events.
    We included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg\'s and Egger\'s regression tests supported symmetricity.
    A high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure.
    The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO\'s safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.
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