Transcatheter Ventricular Septal Defect Closure with Nit-Occlud LêVSD Device—Five Years’Experience and Literature Review

Introduction:Transcatheter closure is an alternative to ventricular septal defect(VSD)occlusion surgery.Nit-Occlud LêVSD coil is a new device yet to be evaluated.The study aimed to evaluate immediate and midterm results after transcatheter closure with the Nit-Occlud LêVSD device.Methods:The retrospective analysis included 30 patients with VSD referred for closure during the period from October 2015 to December 2020.Results:At the time of intervention,the patients’mean age and body weights were 7.5±5.6 years and 29.3±19.1 kg.The majority of the defects had perimembranous location(24/30),four defects had muscular and two outlet subaortic position.The mean effective right-side diameter of the VSDs was 3.6±1.3 mm.Single ventricular fibrillation,device embolization,and hemolysis developed in different patients and were successfully treated.None of the patients had a complete atrioventricular block.The coil was successfully placed in 25/30(83.3%)patients.The majority of the devices were 10 mm×6 mm(11/25)and 12 mm×8 mm(8/25)in size.Two patients required the implantation of a second device.The follow-up period was 2.1±1.4 years.Complete VSD closure was achieved in 48%of cases immediately after the intervention,74%during 2.1±1.6 months after the procedure,and 81%over follow-up.The remaining patients had a trivial residual defect.During the follow-up,approximately one-third of patients developed trivial aortic and mitral valve regurgitation,and half of the patients acquired trace/mild tricuspid regurgitation.Standardized(z-score)left ventricular end-diastolic diameter(0.15±0.37 vs.0.92±0.82,p=0.005)and left atrium dimension(0.47±0.58 vs.1.89±1.11,p=0.005),as well as the left atrium to aortic root ratio(1.2±0.1 vs.1.4±0.2,p=0.005)showed a significant decrease over follow-up related to the period before intervention.Conclusion:Intervention with Nit-Occlud
LêVSD coil showed appropriate results regarding VSD closure rate,complications,and chamber remodeling.The introduction of this device into clinical practice is a significant step forward in transcatheter perimembranous VSD occlusion.

Outcomes of Transcatheter Closure in Outlet-Type Ventricular Septal Defect after 1 Year

Background:Ventricular septal defect(VSD)is the most common congenital heart disease.Transcatheter VSD closure is an effective treatment for patients with muscular and perimembranous VSD.However,there is a limit data for outlet VSD,especially impact to the aortic valve leaflet after transcatheter closure.This study aims to assess the outcomes of transcatheter closure of the outlet-type ventricular septal defect(OVSD)after 1 postoperative year.Methods:A retrospective study was performed including 50 patients who underwent transcatheter(n=25)and surgical(n=25)OVSD closure during the exact time frame at two medical centres.Results:The median age and body weight of patients in the transcatheter group were significantly higher than those of patients in the surgical group(7.0 vs.2.8 years;27.0 vs.11.4 kg;p<0.01).The defect size in the surgical group was significantly larger than that in the transcatheter group(5.0 vs.3.0 mm;p<0.01).All OVSD patients have successful transcatheter closure(100%)as effective as surgical closure.Less than small residual shunt was present 20%and 8%immediately after the procedure in the transcatheter and surgical groups(p=0.50),which decreased to 12%and 4%at the 1-year follow-up(p=0.61),respectively.No incidence of complete atrioventricular block and other complications was observed in both groups,and no significant differences were noted in the new onset or worsening of the aortic regurgitation in both groups(p=1.0).Conclusions:Transcatheter treatment could be effectively and safely achieved for OVSD closure at 1-year follow-up.

Effectiveness and Safety of Transcatheter Closure of Various Ventricular Septal Defects Using Second-Generation Amplatzer Duct Occluders

Objective:This study was designed to determine the long-term safety and efficacy of using the Amplatzer Duct Occluder II(ADO II)for the closure of various ventricular septal defects(VSDs).Methods:From January 2011 to December 2019,selected VSD patients were treated through transcatheter intervention using ADO II occluders.The closure results and complications from 188 patients,involving 167 perimembranous ventricular septal defects(pmVSDs),9 intracristal VSDs,11 post surgery residual shunts and 1 post closure residual shunt with the mean outlet diameter3.1±0.8 mm under angiography,were enrolled in this study.Results:The success rate was 98.9%for all procedures.During the median 77-month follow-up period,no cases of complete atrioventricular block(cAVB),infective endocarditis or death occurred.One major adverse event(0.5%)was recorded:cerebrovascular accident occurred 1 day after the procedure in one patient who was transferred to the neurology department.The residual shunt rate was 44.6%,which was the most common minor adverse event.The cardiac conduction block rate was 4.3%.Specifically,one pmVSD patient developed intermittent LBBB during the 28-month follow-up.There were 3 patients(1.6%)with new-onset mild tricuspid insufficiency,and the insufficiency degree was stable during follow-up.There was no new-onset aortic insufficiency that occurred.Conclusions:Transcatheter closure of pmVSDs,some intracristal VSDs,some postsurgery or postclosure residual shunts using ADO II occluders were both safe and effective and yielded excellent long-term results in selected patients.

Transcatheter closure of ventricular septal defect in patients with aortic valve prolapse and mild aortic regurgitation:feasibility and preliminary outcome

Objective:To evaluate the feasibility,safety and efficacy of transcathcter closure of ventricular septal defect(VSD)in patients with aortic valve prolapse(AVP)and mild aortic regurgitation(AR).Methods:Between January 2008 and July 2014,transcatheter closure of VSD was attempted in 65 patients.Results:The total intermediate closure successful rate in all subjects was 96.9%.During the perioperative period,no death,major bleeding,pericardial tamponade,occluder dislodgement,residual shunt or hemolysis occurred.Two procedures had been forced to suspend due to significant aggregation of device related aortic regurgitation,three cases of transient complete left bundle branch block occurred but did not sustain.At 1-year followup,no patients had residual shunts and complications.Furthermore,grade of residual AR were relieved in 61.9%(39/63)cases and degree of AVP were ameliorated in 36.5%(23/63)patients;Conclusions:Transcatheter closure VSD in selected patients with AVP and mild AR is technically feasible and highly effective.Long term safety and efficacy needs to be assessed.

Safety of an improved patent ductus arteriosus occluder for transcatheter closure of perimembranous ventricular septal defects with abnormally attached tricuspid chordae tendineae

BACKGROUND The off-label use of various devices has been reported for the transcatheter closure of perimembranous ventricular septal defects(PmVSD) because of serious complications, such as heart block and tricuspid regurgitation(TR),associated with conventional ventricular septal defect devices. However, whether certain defects such as PmVSD with abnormally attached tricuspid are fit for interventional treatment is still disputable.AIM To explore the feasibility and safety of transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae using an improved patent ductus arteriosus(PDA) occluder.METHODS We retrospectively analyzed 20 patients diagnosed with PmVSD with abnormally attached tricuspid chordae tendineae who underwent interventional treatment using an improved PDA occluder at our center from January 2012 to January 2016. Baseline characteristics and procedural and follow-up data were analyzed.RESULTS All 20 patients achieved procedure success. No heart block occurred during the operation. One patient had a transient complete right bundle branch block within48 h post-procedure and reverted to normal rhythm after intravenous injections of dexamethasone for 3 d. For all 20 patients, no residual shunt was observed by transthoracic echocardiography post-procedure. During the average follow-up period of 2.4 years, no severe TR was observed.CONCLUSION Using of the improved PDA occluder for the transcatheter closure of PmVSD with abnormally attached tricuspid chordae tendineae is a safe and promising treatment option. However, long-term follow-up in a large group of patients is still warranted.

Transcatheter Closure of Perimembranous Ventricular Septal Defect Using the Amplatzer Duct Occluder II

Objective:To evaluate the efficacy of Amplatzer duct occluder II(ADO II)in the treatment of perimembranous ventricular septal defect(pmVSD)in children.Methods:Between June 2017 and June 2020,13 patients with pmVSD had attempted transcatheter closure using ADO II,seven of patients were used antegrade approach and six of them were used retrograde approach.Results:There were 8 males and 5 females,age from 1 to 7 years,weight from 10.5 to 31.0 kg,and VSD size from 2.0 to 4.0 mm.Procedure was successful in all cases with the outer diameter of the occluders ranging from 4 to 6 mm.No aortic,tricuspid regurgitation or residual shunt was found in the immediate ultrasound assessment.No arrhythmia was observed in the Holter monitoring 3 days after the intervention.Discharge echocardiography indicated complete shunt closure.No evidence of occluder prolapse,malignant arrhythmia,or intensed valve regurgitation was seen on a median follow-up of 18 months(range,6 to 36 months).Conclusions:Based on our experience,ADO II showed good efficacy in the early and middle stages of pediatric pmVSD closures.

Transcatheter Closure of a Right Pulmonary Artery to Left Atrium Fistula Using a Ventricular Septal Defect Occluder

Background:Communication between the right pulmonary artery(RPA)and left atrium(LA)is a rare cause of central cyanosis in pediatric patients.Case presentation:We describe a 3-year-old female patient with an oxygen saturation of 70%at admission.The echocardiogram indicated an abnormal color flow Doppler in the LA and she underwent standard cardiac catheterization.The angiography of pulmonary artery revealed a 7.4 mm×7.6 mm fistula between the RPA and LA and achieved successful closure using ventricular septal defect occlusion.Conclusion:The fistula between pulmonary artery and left atrium is an extremely rare but treatable congenital defect.It should be considered in differential diagnosis of cyanosis in children.

Multi-Modality Imaging in a Hybrid Setting Facilitates Transcatheter Closure of a Traumatic Ventricular Septal Defect

We present a case of transcatheter closure of a traumatic ventricular septal defect (VSD), in which simultaneous 3-dimensional (3D) transesophageal echocardiography (TEE) and angiography played a critical role in defect sizing, device selection, and procedural guidance.

Clinical study of transcatheter occlusion in treating ventricular septal defect combined with right coronary cusp bulge

Background: Perimembranous ventricular septal defect combined with right coronary cusp bulge generally should be treated with surgical thoracotomy, owing to the potential aortic regurgitation. However, the minimally invasive method of transcatheter closure has always attracted the attention of cardiologists and patients. The present study aimed to apply transcatheter occlusion in treating ventricular septal defect with right coronary cusp bulge and further evaluate the clinical effect through follow-up. Materials and methods: A total of 40 children diagnosed as having a ventricular septal defect with right coronary cusp bulge, examined using transthoracic echocardiography and cardiovascular angiography, were enrolled in this study. The ventricular septal defects were closed by placing occluders through transcatheter occlusion treatment. During the operation process, the children underwent angiography and transthoracic echocardiography examinations to check the position of the occlude and the extent of aortic regurgitation. The influence of occlusion on the conduction system was evaluated using a surface electrocardiogram. The children were followed up after their procedures. Results: All 40 patients were immediately and successfully occluded. Three patients with filament residual shunts were observed during the operations. No major surgical complications occurred during the perioperative period. During the follow-up period, the positions of all the occluders were good, the residual shunts in the three patients disappeared, and no new or aggravated aortic regurgitation occurred. Electrocardiogram did not reveal any atrioventricular blocks. Only one patient suffered from an incomplete right bundle branch block. Conclusions: Children diagnosed with ventricular septal defect combined with right coronary cusp bulge could be considered for transcatheter occlusion. With appropriate indications and methods, the effect may be favorable.

Nursing Care of Patients With Transcatheter Closure of Atrial Septal Defect via Femoral Vein

Objective:To explore the operative nursing coordination method for the treatment of congenital atrial septal defect(ASD)by transcatheter closure of atrial septal defect via femoral vein.It provides useful experience for the treatment of congenital heart disease.Methods a total of 12 patients undergoing minimally invasive atrial septal defect closure via femoral vein from January 2017 to November 2017 in our department of cardiac surgery were selected as the subjects.All patients received transesophageal ultrasound guided ASD occlusion by femoral vein.The operation and nursing contents include preoperative care,the cooperation of the itinerant nurses,the coordination of the instrument nurses and the postoperative nursing.Results the operation of 12 patients in this group was successful.The diameter of the occluder was 17.1+4.5 mm during the operation.The time of tracheal intubation was 2.4+0.7 h,from the femoral vein to the sheath tube time was 38.7+9.4 min,the occupancy of ICU was 12.5+2.6 h after the operation.The average time of hospitalization was 4.5+1.8 D.There were 2 cases of shunt 1mm immediately after operation.After 24h reexamination,the shunt disappeared,the heart murmur disappeared in the rest of the patients.No residual shunt and other complications occurred.

TRANSCATHETER CLOSURE OF LARGE SECUNDUM ATRIAL SEPTAL DEFECTS WITH AMPLATZER~ SEPTAL OCCLUDER

Objective To evaluate the safety and feasibility of transcatheter closure of large secundum atrial septal defects(ASDs)with Amplatzer~ septal occluder(ASO).Methods A total of 26 patients(age 16 to 67 years,median 43 years;body weight 52 to 102 kg,median 67 kg)with large ASDs underwent an attempted transcatheter closure using ASO.Large ASD was defined as those with a balloon-stretched diameter of ≥30 mm.Another 81 patients with small-to-moderate ASD during same period who underwent closure served as controls.Results In patients with large ASDs,the ASD dimension means were(22.1±3.2)mm(range from 16 to 30 mm)and(23.8±2.6)mm(range from 18 to 31mm)assessed by transesophageal echocardiography(TEE)and transthoracic echocardiography(TTE),respectively.The mean balloon-stretched diameter of the ASD was(31.9±2.1)mm(range from 30 to 37mm).The size of device was(32.0±1.9)mm(range from 30 to 36mm).The transcatheter procedure was successful in all patients(100%).Seventeen deployments were performed using the conventional left atrium approach,and remaining 9 patients required the right upper pulmonary vein approach.Immediately after deployment,TEE revealed that complete closure rate was 73%.Procedure-related complications were recorded in 3 patients(12%),including device embolization in one patient,pericardial effusion in one patient,and large hematoma at puncture site in one patient.During follow-up,the complete closure rate increased to 88% at 24h after procedure and 100% at 6 months.The procedural success rates,immediate TEE results and TTE results at 24h and 6 months after procedure,were not significantly different between patients with large ASDs and those with small-to-moderate ASDs.Conclusion Transcatheter closure of large ASDs using ASO is technical feasible and relatively safe.Proper care selection and specific technique modification such as the right upper pulmonary vein approach is vital for the implantation success.

Ventricular Septal Defect Spontaneous Close Induced by Transcatheter: A Case Report

Congenital ventricular septal defect （VSD） spontaneous close induced by transcatheter treatment is rare and has not yet been reported. We report on one case of VSD spontaneous close induced by transcatheter treatment in a 10 years old girl.

The role of echocardiography in mini-invasive surgical device closure of ventricular septal defect

Objective To assess the application of echocardiography in mini-invasive surgical device closure of ventricular septal defect (VSD) . Methods 73 VSD patients including 35 with aneurysm formation and among them 21 with multi-defects in the aneurysm were treated by mini-invasive device closure. A closure device was positioned to the defect through parasternal mini-incision in all patients. TEE was used to monitor the whole procedure。

Transcatheter versus surgical closure of secundum atrial septal defects:a systematic review and meta-analysis

Background Transcatheter closure and surgical closure of secundum atrial septal defects(SASDs)are common treatment methods.It is not clear which method has a more obvious technical advantage.Objective To summarise data from studies comparing transcatheter closure versus surgical closure of SASDs.Methods Databases including Pub Med,EMbase,Web of science,Cochrane Library,CBM,CNKI and Wanfang databases were searched to enroll randomized controlled trials and cohort study trials comparing the two treatment methods(transcatheter closure versus surgical closure).The literature was screened according to the inclusive and exclusive criteria by two reviewers independently.The quality of the trials was evaluated.The data were extracted and meta-analysis was performed using Rev Man 5.3 software.Results 29 original studies(14,941 patients)were included.All studies were non-random.Transcatheter closure was found to be superior to surgical closure in the following outcomes:all-cause mortality(OR 0.36,95%CI 0.21~0.59,P<0.0001),total complications(OR 0.37,95%CI 0.25~0.55,P<0.00001),and hospital stay length(WMD-3.77,95%CI-4.36~-3.18,P<0.00001).Residual shunts incidence and retreatment incidence were more common in the transcatheter closure group than those in the surgical closure group[(OR 3.55,95%CI 1.79~7.05,P=0.0003)and(OR 2.19,95%CI 1.31~3.65,P=0.003),respectively].Conclusions Both approaches are effective for closure SASDs.Transcatheter is associated with lower mortality,complications and hospital stay length,while surgical closure has incidence of residual shunting and retreatment.

Clinical analysis of transcatheter closure of perimembranous ventricular septal defects with occluders made in China

Background Results of perimembranous ventricular septal defects （pmVSD） transcatheter closure have been reported in the literature mostly using a Amplatzer VSD device. However, the data of percutaneous closure of pmVSD with VSD occluder （VSD-O） made in China are still limited. We sought to analyze safety, efficacy, and follow-up results of percutaneous closure of pmVSD with VSD-O made in China.Methods Between February 2005 and June 2009, 78 patients underwent percutaneous closure of pmVSD at our institution. A VSD device made in China was used for all subjects. The safety and the efficacy of the VSD-O were investigated.Results The average age at closure was 11 years （range 2.5 to 44 years）. The attempt to place device was successful in 74 patients （94.9%）. The average device size used was 8 mm （range 5 to 16 mm）. No deaths occurred. Total occlusion rate was 62.8% at completion of the procedure, rising up to 87.2% at discharge and 99.0% during follow-up. A total of eight early complications occurred （10.3%）, but in all subjects these were transient. The average follow-up period was 40.5 months. The most significant complication was complete atrioventricular block （cAVB） in the early phase （five subjects, 6.4%） and during the follow-up （1 subject, 1.3%）, which saw no need for pacemaker implantation in six subjects.Cox proportional hazards regression analysis showed that the age was only the variable significantly associated with the occurrence of this complication during the procedure （P=0.025; relative risk 0.22）. The subjects who experienced this complication were less than five years old.Conclusions Percutaneous pmVSD closure used VSD-O made in China is associated with excellent success and closure rates, no mortality, and low morbidity. Longer follow-up data and improvements in device characteristics are needed to reduce the risk of cAVB.

Postprocedural Outcomes and Risk Factors for Arrhythmias Following Transcatheter Closure of Congenital Perimembranous Ventricular Septal Defect： A Single-center Retrospective Study

Background： Currently, transcatheter closure of perimembranous ventricular septal defect （pmVSD） is a widely accepted therapeutic modality. However, arrhythmias, especially postprocedural heart blocks, are a concern and outcomes are not very clear. This study explored the outcomes and risk factors of arrhythmias associated with transcatheter device closure ofpmVSD. Methods： A total of 395 patients diagnosed with pmVSD who successfully underwent transcatheter intervention between January 2010 and December 2015 in our center were retrospectively reviewed. Electrocardiographic data before and after the procedure were collected and analyzed. We first evaluated the potential risk factors including gender, age, weight, inlet and outlet diameters of defect, subaortic rim length, occluder size, corrected occluder size into body surface area, fluoroscopy time, presence of aneurysm, and deployment position. We compared the potential risk factors between arrhythmia and nonarrhythmia groups using univariate analysis, followed by logistic analysis for independent risk factors. Results： Various arrhythmias were detected in 95 cases （24.1%） following transcatheter closure procedure. Logistic regression analysis revealed that eccentric （odds ratio [OR] 2.9, 95% confidence interval [（CI]： 1.2-7.2） and large occluders （OR 2.0, 95% （.7： 1.6-2.5）, as well as long fluoroscopy time （OR 1.1, 95% CI： 1.1-1.2）, were correlated with postprocedural arrhythmia. During 35.5 months （range： 9-80 months） of follow-up, most of the patients （74 out of 95） reverted to normal heart rhythm. Conclusions： The mid-term outcome of patients with arrhythmias after transcatheter closure of pmVSD was satisfactory as most of the patients recovered normal rhythm. Eccentric, large device and long fluoroscopy time increase the risk of arrhythmias after transcatheter closure of pmVSD.

Transcatheter Closure of Multiple Membranous Ventricular Septal Defects with Giant Aneurysms Using Double Occluders in Four Patients

The transcatheter closure of perimembranous ventricular septal defect （pmVSD） has become a promising treatment modality. However, transcatheter closure of multiple pmVSDs with giant aneurysm is still very challenging. We present our preliminary experiences.

Transcatheter closure of perimembranous ventricular septal defects by a new Amplatzer membranous ventricular septal defect occluder： a single center study in Beijing

Transcatheter closure of congenital perimembranous ventricular septal defect （VSD） has always been a problem for cardiologists in the past decade because of the risks for interference with the valves and conduction system. Some devices designed for other lesions have been used for closure of perimembranous VSD,^1-3 but the result is unsatisfactory because they are difficult to use and have a high incidence of complications. Until 2002,

完全生物可降解室间隔缺损封堵器植入的中期随访结果

目的:室间隔缺损(ventricular septal defect,VSD)是一种常见的先天性心脏畸形,改良封堵器、选择更优的路径等方法拓展了VSD封堵术的适应证并降低了相关并发症发生率,其中完全生物可降解封堵器的使用有望彻底解决VSD封堵造成的传导阻滞的问题。本研究旨在比较完全生物可降解封堵器与金属封堵器在经食道超声心动图引导下胸骨下段小切口VSD封堵术的中期随访结果,并分析术后发生心电图及瓣膜异常的危险因素。方法:回顾2019年1月1日至11月7日在中南大学湘雅二医院进行VSD封堵术的27例患者术后3年内的随访资料,通过心电图及超声心动图结果评估手术的安全性及有效性,并通过Logistic回归分析探讨术后发生心电图及瓣膜异常的危险因素。结果:分别有12例和15例患者采用金属封堵器和完全生物可降解封堵器进行VSD封堵,患者随访期间均存活,未发生房室传导阻滞、较大残余分流、封堵器过快吸收、明显瓣膜反流等严重并发症。金属封堵器组与完全生物可降解封堵器组术后1、2、3年的心电图和彩色多普勒超声检查结果比较,差异无统计学意义(均P>0.05)。VSD封堵器大小是影响术后2、3年三尖瓣反流的危险因素,封堵器大小与缺损大小的差值是影响术后2年三尖瓣反流的危险因素(P<0.05)。结论:完全生物可降解封堵器在小型VSD封堵中的中期安全性和有效性较高,并具有与传统镍钛合金封堵器相同的术后效果。