Transcatheter closure of perimembranous ventricular septal defects

Although effective, transcatheter closure of perimembranous ventricular septal defects (pmVSD) with the Amplatzer Membranous VSD Occluder (AGA Medical Corporation, MN) carries a substantial risk of complete heart block, prompting many to abandon this intervention. A newly designed Amplatzer device for pmVSD was modified, in part, to minimize this risk. After rigorous preclinical testing, we report the first human experience with the Amplatzer Membranous VSD Occluder 2 (AGA Medical Corporation) in two patients (a 5‐year old with a 12‐mm pmVSD and a 26‐year‐old male with a 8‐mm defect). Both procedures were successful, with no adverse events at 7 and 4 weeks of follow‐up, respectively. Herein, we discuss characteristics of the new device, potential advantages compared to the prior version, and main technical aspects related to the procedure. © 2013 Wiley Periodicals, Inc.     

Transcatheter closure of perimembranous ventricular septal defects using umbrella devices.

There is only limited experience of interventional closure of perimembranous ventricular septal defects (pmVSDs), particularly on the long-term follow-up. This is a report on our long-term results after transcatheter closure of pmVSDs using the Cardioseal, Starflex, or Rashkind devices. PATIENTS: Between 1993 and 2005, we performed interventional occlusions of pmVSDs in 18 patients. The size of the defect ranged between 4 and 8.5 mm, Q(p)/Q(s) was calculated between 1.3 and 2.2. Except for two, the patients had no other structural heart defect. In the early days, we used the Rashkind PDA occluder (17 mm) in seven, followed by the Cardioseal device (17 mm) in nine, and the 23 mm Starflex device in two patients. RESULTS: Interventional closure of the defects was performed successfully in all patients without any complication during the procedure. Fluoroscopy times were 11.8-53.7 min (median 28.65 min). We achieved a complete closure in 13 patients, three patients with recently implanted devices still show minimal shunting. In two patients the occluder had to be removed surgically because of embolization into the pulmonary artery and significant residual shunting resulting in severe hemolysis in the second patient. In long- (mean 10.7 years) and short-term (mean 0.85 years) follow-up we have not observed any hemolysis, arrhythmias, device dislocations, or device-related aortic or tricuspid regurgitation. CONCLUSION: Transcatheter closure of small pmVSDs using non-selfcentering devices can be performed successfully. Long-term follow-up investigations show encouraging results. Complications like device-embolization and significant residual shunting occur in the presence of large defects and/or concomitant malformations.     

Initial clinical experience with intracardiac echocardiography in guiding transcatheter closure of perimembranous ventricular septal defects: feasibility and comparison with transesophageal echocardiography.

Over the last several years, intracardiac echocardiography (ICE) has been employed successfully in guiding transcatheter device closure of a secundum atrial septal defect (ASD) or patent foramen ovale (PFO). Nothing is known regarding the use of ICE to guide catheter device closure of a perimembranous ventricular septal defect (PMVSD). Twelve patients (seven female/five male) who had a PMVSD (among them, three patients with associated atrial communications: two with an ASD and one with a PFO) underwent attempts at transcatheter device closure using the Amplatzer membranous VSD device of their defects, using sequential transesophageal echocardiography (TEE) and ICE guidance with general endotracheal anesthesia (five patients) and using ICE alone with conscious sedation (seven patients). The mean age of patients was 16.9 +/- 3.7, and their mean weight was 42.4 +/- 6.6. Their mean left ventricular end-diastolic dimension preclosure was 45.7 +/- 2.5. The Qp/Qs ratio ranged from 1.0 to 1.8:1. During the procedure, the ICE catheter was positioned in the right atrium (RA) in all 12 patients and the ICE catheter was advanced to the left atrium to obtain a view of the ventricular septum in 3. Both TEE and ICE provided similar anatomical views of the position of the PMVSD. Furthermore, the relationship of the defect to the aortic valve and tricuspid valves, the measured size of defect, and the guidance of various stages of device deployment were comparable by TEE and ICE. There were no complications encountered during or after closure. We conclude that ICE provides unique images of the PMVSD and measurements similar to those obtained by TEE. ICE potentially could replace TEE in most patients as a guiding imaging tool for PMVSD device closure, thus eliminating the need for general endotracheal anesthesia.     

Transcatheter closure of perimembranous ventricular septal defects using the amplatzer membranous VSD occluder: immediate and midterm results of an international registry.

OBJECTIVE: To report the immediate and midterm results of transcatheter closure of perimembranous ventricular septal defect (PmVSD) using the Amplatzer membranous VSD occluder (AMVSD). METHODS: Between April 2002 and August 2004, 100 patients underwent an attempt of percutaneous device closure of PmVSD using the AMVSD in 24 international centers. The median age was 9.0 years (0.7-58 years) and the median weight was 27.5 kg (7-121 kg). RESULTS: A device was successfully deployed in 93/100 (93%) patients. Reasons for procedural failure were an increased gradient across the left ventricle outflow tract in one patient, aortic regurgitation in 2 patients, and inability to securely position the device in 4 patients. The median VSD size by TEE was 7.0 mm (1.5-13 mm), median device size 10 mm (4-16 mm) and median fluoroscopy time 22.1 min (8.9-96.0 min). Weight below 10 kg (P = 0.0392), inlet extension of the VSD (P = 0.0139) and aortic cusp prolapse into the VSD (P = 0.0084) were significantly associated with a lower procedural success. Patients have been followed up for a median of 182 days (1-763 days). There were no procedure-related deaths. Complications were encountered in 29/100 (29%) patients, including rhythm or conduction anomalies in 13 patients (two with complete heart block requiring permanent pacemaker implantation), new or increased aortic (9 patients) or tricuspid (9 patients) regurgitation, most of which were classified as trivial or mild. Patients with a weight below 10 kg had a significantly higher incidence of adverse events than patients with a weight above 10 kg (58.3% versus 25.0%, P = 0.0285). Immediately after device release complete closure of the defect was present in 54/93 (58.1%) patients, increasing to 46/55 (83.6%) patients at 6-months follow-up (P = 0.0012). Left ventricle end-diastolic diameter decreased from a median of 44 mm prior to device closure to a median of 39 mm at 6-months postprocedure (P = 0.0015). CONCLUSION: Closure of PmVSDs using the AMVSD occluder is safe and effective. However, longer follow-up period is warranted prior to the wide spread use of this device.     

Transcatheter closure of perimembranous ventricular septal defects with Amplatzer occluder assessed by real-time three-dimensional echocardiography.

We report our initial experience in two patients using real-time three-dimensional echocardiography to assess perimembranous ventricular septal defect and device morphology and their relation with contiguous cardiac structure. Defect size and rims as well as device position and profile were displayed from the three-dimensional "en face" views. We think that real-time three-dimensional echocardiography could be a complementary approach to angiography and transesophageal echocardiography in performing transcatheter closure of perimembranous ventricular septal defect.     

Transcatheter closure of a residual postmyocardial infarction ventricular septal defect with the Amplatzer septal occluder

Acute ventricular septal rupture following myocardial infarction carries a high mortality. Early surgery improves survival but long term outcome depends on residual shunting and left ventricular function. Residual shunting is common despite apparently successful closure and may require reoperation. Transcatheter closure is an established method of treating selected congenital defects but clinical experience of transcatheter closure in postinfarction ventricular septal rupture is minimal. Transcatheter closure of a residual ventricular septal defect was successfully done using a new device, the Amplatzer septal occluder, in a 50 year old Indian man who had previously undergone emergency surgical repair for postinfarction acute ventricular septal rupture. The technique is described and its potential as a treatment in postinfarction ventricular septal rupture, its possible complications, and the important aspects of case selection and device design are discussed.

Keywords: ventricular septal defect; transcatheter closure; Amplazter septal occluder     

Evolution of transcatheter closure of perimembranous ventricular septal defects in a single centre

Objectives : To describe the evolution of transcatheter closure of perimembranous ventricular septal defects (PMVSD) using either the Amplatzer membranous or muscular occluders in a single centre. Methods : Retrospective analysis of all patients referred for transcatheter PMVSD closure from December 2003 to December 2007. All patients met unit criteria for surgical closure. Results : There were 27 procedures on 25 patients (11 male) with a preprocedure diagnosis of a PMVSD. Median age was 9.6 years (1.8–32.8). Median weight was 28 kg (10.2–86). Defect size on TOE ranged from 5 to 12 mm. Median Qp:Qs was 1.6:1. A muscular occluder was used in six patients. Median procedure time was 93.5 min (51–214). Implantation was ultimately successful in 23 patients (92%). Acute aortic incompetence resulting in occluder removal occurred in two cases, one requiring surgical removal. Another patient had an aborted attempt but had subsequent successful closure in another unit. Median follow‐up is 19.5 months (1–42). Five patients (22%) have trivial/mild residual leak across the occluder at their latest assessment, the majority of which had an aneurysmal perimembranous septum (n = 4). Two patients (8%) developed new trivial to mild aortic incompetence. To date, none of the patients in our group have developed complete heart block. Conclusions : Transcatheter closure of PMVSD is evolving and should be considered an acceptable alternative to surgery in selected subgroups. Avoidance of oversized occluders and use of muscular occluders in those with aneurysmal defects may help to avoid heart block and aortic regurgitation. Muscular occluders may however interfere with tricuspid valve function. © 2009 Wiley‐Liss, Inc.     

导管介入性关闭膜部室间隔缺损术后并发症(附二例报告)

１９９５年在Ｓｉｄｅｒｉｓ指导下完成经导管Ｓｉｄｅｒｉｓ钮扣式补片关闭膜部室间隔缺损２例。术后患者分别于第４、１５天出现心律不齐、主动脉瓣关闭不全、补片移位致使介入治疗失败而行手术修复。根据手术所见，虽然２例室间隔缺损介入治疗失败，但是介入治疗关闭室间隔缺损仍有重要临床价值，但在器材及操作方法上均有待进一步完善。     

室间隔缺损介入封堵326例经验总结及随访分析

目的 总结经皮导管室间隔缺损介入封堵术的临床经验,并对326例患者的中期随访结果进行回顾性分析.方法 326例室间隔缺损患者均经临床和经胸超声心动图（TTE）确诊,排除干下型室间隔缺损,采取经皮导管室间隔缺损介入封堵术,术后即刻左心室造影和经胸超声心动图检查观察疗效,术后1d、1个月、3个月、6个月、1年、2年、3年、4年、5年行经胸超声心动图、X线胸片和超声心动图检查随访观察.结果 经皮导管室间隔缺损介入封堵成功率为98.3％（320/326）,失败原因为室间隔缺损过大或过小、位置特殊、合并主动脉瓣脱垂及反流、损伤三尖瓣或主动脉瓣、房室传导阻滞等.术后并发症：1例术后1d封堵器移位,急诊心脏外科手术处理;2例8 kg患儿术后股动脉血栓形成,尿激酶溶栓后治愈;12例新出现三尖瓣轻度反流或原有三尖瓣反流增多;1例损伤主动脉瓣致中度反流,急诊外科手术处理;56例出现非阵发性交界性心动过速,经激素、人体白蛋白、营养心肌等治疗后恢复窦性心律;17例不完全性束支传导阻滞;5例完全性左束支传导阻滞.1例术后10个月出现二度Ⅱ型房室传导阻滞,治疗后恢复至二度Ⅰ型房室传导阻滞.1例术后8d出现脑出血,开颅发现脑血管畸形,外科处理后治愈.术后患者左心室舒张末内径、心胸比例较术前改善.结论 经皮导管室间隔缺损介入封堵术具有创伤小、并发症少、无需体外循环、成功率高等特点,值得推广,但应规范选择患者和长期随访.     

对称型室间隔封堵器在先天性膜周部室间隔缺损介入治疗的应用

目的探讨对称型封堵器(SVSO)介入治疗膜周部室间隔缺损(PMVSD)的临床疗效。方法应用SVSO介入治疗63例PMVSD患者。结果手术技术成功率93.0%(58/63)。PMVSD直径5.1±1.9mm,PMVSD距主动脉瓣2.7±1.0mm,SVSO直径7.2±2.1mm。即刻封闭率94.8%。心律失常发生率23.8%(15/63例),心肌损伤2例,封堵器脱落1例,术后新发生的主动脉瓣关闭不全1例,右心室流出道梗阻1例。平均随访7.4±2.7个月,无残余分流、封堵器移位或破损及感染性心内膜炎等发生。结论应用SVSO介入治疗PMVSD疗效好、安全性高,但要高度重视其可能发生的并发症,尤其是要做好心律失常的防治。     

经导管应用Amplatzer封堵器关闭膜周部室间隔缺损

目的 :经导管应用Amplatzer封堵器关闭膜周部室间隔缺损 (perimembranousventricularseptaldefect,PMVSD) ,并对其疗效进行初步分析。方法 :18例室间隔缺损 (VSD)中男性 8例 ,女性 10例 ,平均年龄 7 6岁 ,平均体重 2 6 9kg。局麻下行右心导管检查 ,左室造影测量室缺大小 ,经VSD建立股动脉 股静脉轨道 ,封堵器沿传送装置送至左室 ,打开左侧伞并确认铂金标记 (MARK)位于 6点位 ,指向心尖 ,在室间隔右室侧打开右侧伞 ,经超声心动图和左室造影确认封堵器位置良好 ,无残余分流 ,无三尖瓣及主动脉瓣关闭不全后释放封堵器。结果 :18例VSD患者封堵手术均获成功。VSD平均大小 3 9mm ,所选封堵器平均大小 7 1mm ,放射线观察MARK均在 6点位置。封堵效果良好 ,术后 2 4h左室舒张末径明显缩小 ;术后 2 4h仅 2例有微量残余分流 ,无 1例出现主动脉瓣关闭不全 ,无其它严重并发症 ,平均住院3 5d。结论 :经导管应用Amplatzer封堵器关闭膜周部VSD封堵效果好 ,恢复快 ,免除开胸创伤及体外循环等高风险 ,值得进一步推广。     

Transcatheter closure of perimembranous ventricular septal defect in children: Safety and efficiency with symmetric and asymmetric occluders

Objectives : This study was designed to determine the safety and efficiency of asymmetric and symmetric ventricular septal occluders (AVSDOs and SVSDOs, respectively) for closure perimembranous ventricular septal defect (PMVSD) in children. Methods : Between January 2003 and December 2007, 142 children with PMVSD were treated with occluders (64 with AVSDOs and 78 with SVSDOs). Results : The defect diameter was 5.3 ± 1.1 mm in the AVSDO group and 5.4 ± 1.3 mm in the SVSDO group (P > 0.05). The success rates were similar between two groups [93.8% (AVSDO) vs. 94.9% (SVSDO), P > 0.05]. Two patients in the AVSDO group were switched to the SVSDO group due to residual shunts, and one patient in the SVSDO group was switched due to aortic regurgitation after deployment of the occluder. After procedure, 17 patients [seven with AVSDOs and nine with SVSDOs (P > 0.05)] developed various types of heart block (HB). Among them, 13 patients converted to the normal sinus rhythm. The remaining four cases had not recovered at the end of the study. Conclusions : Transcatheter closure of PMVSD using both AVSDO and SVSDO was safe and effective. Development of HB was the main complication for both devices. © 2010 Wiley‐Liss, Inc.     

Transcatheter coil occlusion of perimembranous ventricular septal defects

Objectives: Our purpose was to determine the feasibility and safety of transcatheter coil occlusion of a perimembranous VSD. Background: Transcatheter coil occlusion of a perimembranous ventricular septal defect (VSD) may be a useful treatment; however, there are few reports on its technical aspects and outcome. Methods: We attempted coil closure of a perimembranous VSD in 41 patients. We approached the VSD via the right ventricle (RV) in 16, via the left ventricle (LV) in 16, simultaneously deployed two coils from the RV (RV/RV) in three, and simultaneously deployed two, three, or four coils from the RV and LV (RV/LV) in six. Coils (0.038″ flipper, 0.052″ Gianturco, or 0.035″ platinum coil) were placed into the defect through the delivery catheter until any flow through the VSD disappeared or became trivial on angiography. Results: We achieved 100% complete closure in all patients in whom coils were deployed, although some patients required a second session. A flipper coil used alone was insufficient to completely occlude VSDs larger than 2.5 mm. Conclusions: Transcatheter coil occlusion of a VSD can be performed reliably and safely by selecting appropriate embolic coils. Small defects (<2.5 mm) can be closed with a flipper coil, but defects ≥2.5 mm require a 0.052″ coil. © 2008 Wiley‐Liss, Inc.     

国产室间隔缺损封堵器与Amplatzer封堵器的疗效比较

目的比较国产室间隔缺损封堵器与Amplatzer封堵器在经导管室间隔缺损封堵术中的疗效。方法41例患儿采用Amplatzer封堵器,76例患儿采用国产封堵器进行室间隔缺损封堵术,对比两组的疗效、并发症和费用等情况。结果国产组75例封堵成功（成功率99%）,进口组40例封堵成功（成功率98%）。两组患儿术前各项临床指标、手术和X线曝光时间、封堵成功率及住院天数,术后各项并发症发生率比较差异无统计学意义,两组患儿治疗前后左室舒张末径、收缩末径及C/T值减少程度无明显差异,治疗总费用进口组明显高于国产组。结论国产室间隔缺损封堵器与Amplatzer封堵器相比较其疗效、并发症发生率无显著差异,治疗费用低,临床应用前景广泛。     

经导管治疗假性室间隔膜部瘤226例临床分析

目的:评价经导管介入治疗假性室间隔膜部瘤的可行性及安全性,并总结其技术难点与临床策略。方法:226例先天性室间隔缺损伴膜部瘤形成患者,超声测量室间隔缺损直径3~15(4.25±2.71)mm,左心室造影测量室间隔缺损直径2~16(4.37±2.84)mm。应用7~10F输送鞘管从右心系统送入相应封堵器。封堵器直径为4~18(6.24±2.48)mm,封堵后15min重复左心室造影和经胸心脏超声波检查,观察封堵的即刻效果。术后连续心电监护5d。术后1、3个月定期心电图、心脏超声检查。结果:226例中220例患者封堵成功,成功率97.3%。未成功的6例中,4例因多出口囊袋状膜部瘤不能完全封堵而建议外科手术,1例因封堵器放置后影响主动脉瓣关闭,1例因严重心律失常而放弃封堵治疗。206例术后15min左心室造影、经胸心脏超声检查显示完全封堵,14例术后造影示少量分流,1~3个月后超声复查无异常分流。术中并发左、右束支传导阻滞分别为8例和12例,均为一过性,1周内恢复。X线透视时间10~65(15.2±8.8)min,操作时间35~120(42.5±16.2)min。结论:经导管采用封堵器治疗假性室间隔膜部瘤疗效好,安全性高,并发症少,临床应用前景好。技术关键在于对膜部瘤形态的判断以及封堵器的选择。     

Catheter closure of perimembranous ventricular septal defects using the new Amplatzer membranous VSD occluder: initial clinical experience.

The surgical closure of membranous ventricular septal defects (VSDs) is associated with morbidity and low mortality. Six patients with VSDs located in the membranous part of the ventricular septum underwent an attempt of catheter closure using a new device specifically designed for the membranous septum. Patients ranged in age from 3.5 to 19 years (median, 10.5 years) and in weight from 15 to 45 kg (median, 29 kg). One patient with associated pulmonary valve stenosis had shortness of breath. The median Qp/Qs ratio was 1.6 (range, 1.1-3) and the median left ventricle end-diastolic dimension (LVEDD) was 44 mm (range, 38-52 mm). The devices were deployed via the femoral vein using 7-8 Fr sheaths. There was immediate complete closure in all patients. One patient developed trivial aortic regurgitation. There were no other complications. The median fluoroscopy time was 15.5 min (range, 10.3-53.4 min). At 24 hr, all patients were doing well. The median LVEDD decreased to 38 mm (range, 34-47 mm). One patient continued to have trace aortic regurgitation. All patients were discharged home after 24 hr. Transcatheter occlusion of membranous VSDs is safe and effective. Further clinical trials are underway to assess the long-term safety and results.     

应用Amplatzer封堵器治疗房间隔缺损

目的 :应用 Amplatzer封堵器治疗继发孔型房间隔缺损并对其疗效进行初步评价。方法 :全组共 6例 ,年龄38± 13岁 （2 0～ 5 5岁 ）。在透视及食管超声心动图监视下经导管置入 Am platzer封堵器封堵房间隔缺损。术后即时行食管超声心动图 ,术后 2 4h、1月、3月分别行经胸超声心动图评价治疗效果。结果 :全组疗效均佳 ,未见残余分流。结论 :应用 Am platzer封堵器治疗继发孔型房间隔缺损是有效的非手术方法 ,操作简便 ,成功率高 ,近期疗效可靠