Right Axillary Thoracotomy Should Be the Standard of Care for Repair of Non-Complex Congenital Heart Defects in Infants and Children

Minimally invasive approaches for cardiac surgery in children have been lagging in comparison to the adult world.A wide range of the most common congenital heart defects in infants and children can be repaired suc-cessfully through a variety of non-sternotomy incisions.This has been shown to be associated with superior cos-metic results,shorter hospital stays,and rapid return to full activity compared to sternotomy.These approaches have been around for decades,but they have not been widely adopted for a variety of reasons.Right axillary thor-acotomy is one of these approaches that we believe should be the new standard for the repair of a wide variety of heart defects in children and will be the focus of our current review.

Impact of Atrial Septal Defect Closure on Mortality in Older Patients

Background:Atrial septal defect(ASD)is a common form of adult congenital heart disease that can lead to long-term adverse outcomes if left untreated.Early closure of ASD has been associated with excellent outcomes and lower complication rates.However,there is limited evidence regarding the prognosis of ASD closure in older adults.This study aims to evaluate the mortality rates in older ASD patients with and without closure.Methods:A retrospective cohort study was conducted on patients aged 40 years or older with ASD between 2001 and 2017.Patients were followed up to assess all-cause mortality.Univariable and multivariable analyses were performed to identify the predictors of mortality.A p-value of<0.05 was considered statistically significant.Results:The cohort consisted of 450 patients(mean age 56.6±10.4 years,77.3%female),with 66%aged between 40 and 60 years,and 34%over 60 years.Within the cohort,299 underwent ASD closure(201 with transcatheter and 98 with surgical closure).During the median follow-up duration of 7.9 years,51 patients died.The unadjusted cumulative 10-year rate of mortality was 3%in patients with ASD closure,and 28%in patients without ASD closure(log-rank p<0.001).Multivariable analysis revealed that age(hazard ratio[HR]1.04,95%confidence interval[CI]1.006–1.06,p=0.01),NYHA class(HR 2.75,95%CI 1.63–4.62,p<0.001),blood urea nitrogen(BUN)(HR 1.07,95%CI 1.03–1.12,p<0.001),right ventricular systolic pressure(RVSP)(HR 1.07,95%CI 1.003–1.04,p=0.01),and lack of ASD closure(HR 15.12,95%CI 5.63–40.59,p<0.001)were independently associated with mortality.Conclusion:ASD closure demonstrated favorable outcomes in older patients.Age,NYHA class,BUN,RVSP,and lack of ASD closure were identified as independent factors linked to mortality in this population.

Genetic Analysis of Variants of the MYH6 Gene Promoter in Congenital Atrial Septal Defects

Background:Atrial septal defect(ASD)is one of the common congenital heart diseases.The MYH6 gene has a critical role in cardiac development but the role of MYH6 promoter variants in patients with ASD has not been explored.Methods:In 613 subjects including 320 ASD patients,we investigated the MYH6 gene promoter variants and verified the effect on gene expression by using cellular functional experiments and bioinformatics analysis.Results:Eleven variants were identified in the MYH6 gene promoter,of which four variants were found only in ASD patients,and two variants(g.3434G>C and g.4524C>T)were identified for the first time.Cellular functional experiments indicated that all four variants reduced the transcriptional activity of the MYH6 gene promoter(p<0.05).Subsequent analysis through the JASPAR(A database of transcription factor binding profiles)suggests that these variants may alter transcription factor binding sites,which may in turn lead to changes in myocardin subunit expression and ASD formation.Conclusions:Our study for the first time focuses on variants in the promoter region of the MYH6 gene in Chinese patients with ASD and the discovered variants have functional significance.The study provides new insights in the role of the MYH6 gene promoter region to better understand the genetic basis of ASD formation and facilitates clinical diagnosis.

Misdiagnosis of unroofed coronary sinus syndrome as an ostium primum atrial septal defect by echocardiography:A case report

BACKGROUND Unroofed coronary sinus syndrome(UCSS)is a rare congenital heart disease,which has variable morphologic features and is strongly associated with persistent left superior vena cava(PLSVC).However,it is often difficult to visualize the left-to-right shunt pathway through the CS by transthoracic echocardiography(TTE).CASE SUMMARY A 37-year-old female was admitted to the hepatological surgery department of a hospital with complaint of subxiphoid pain that had started 1 wk prior.Physical examination revealed a grade 3/6 systolic murmur at the left margin of the sternum,between the 2nd and 3rd intercostal cartilage.The patient underwent echocardiography and was diagnosed with ostium primum atrial septal defect(ASD);thus,she was subsequently transferred to the cardiovascular surgery department.A second TTE evaluation before surgery showed type IV UCSS with secundum ASD.Right-heart contrast echocardiography(RHCE)showed that the right atrium and right ventricle were immediately filled with microbubbles,but no microbubble was observed in the CS.Meanwhile,negative filling was observed at the right atrium orifice of the CS and right atrium side of the secundum atrial septal.RHCE identified UCSS combined with secundum ASD but without PLSVC in this patient.CONCLUSION This rare case of UCSS highlights the value of TTE combined with RHCE in confirming UCSS with ASD or PLSVC.

Usefulness of myocardial performance index for assessing right ventricular function after percutaneous closure of atrial septal defect

Objective Assessment of right ventricular function in patients with atrial septal defect(ASD)is difficult.The Doppler myocardial performance index(MPI)may provide a method of assessing function in these patients.The purposes of this study were to evaluate the right ventricular function and its changes in patients with ASD after transcatheter closure of ASD.Methods MPI,defined as the sum of isovolumic relaxation time and isovolumic contraction time derived by ejection time,was measured from tricuspid inflow and right ventricular outflow;Doppler velocity profiles recorded during routine echocardiography.Twenty nine patients(13 men,16 women;mean age 25.28±12.69,range 6 to 57 years)were diagnosed to secundum ASD[the stretched diameters of ASD were from 9 To 36(24.91±7.98)mm],and had a successfully placed Amplatzer septal occluder(ASO)(the sizes of ASO were from 11 to 40 mm);there were 81 sex-matched,age-matched healthy people(control group 41men,40 women;mean age 29.02±14.22,range 4 to 45 years).MPI was measured again on 3 days and 1 month after closure of ASD.Change in the study group was assessed and compared to the control subjects with structurally normal hearts.A complete 2-dimensional and Doppler echocardiographic examination was performed in all study groups.Results 1)The isovolumic relaxation and isovolumic contraction times[respectively(77.59±14.39)ms vs(60.93±12.94)ms,P<0.0001;(28.28±10.88)ms vs(23.64±9.01)ms,P=0.027]were prolonged,and ejection time[(260.65±21.86)ms vs(271.85±21.92)ms,P=0.033]was shortened in patients with ASD compared with that in control subjects,resulting in a marked increase in the MPI(0.40±0.07 vs 0.31±0.05,P<0.0001)from normal values;2)by Pearson's correlations,the MPI had no correlation with heart rate and blood pressure in control subjects and patients with ASD,but it correlated positively with age in patients with ASD;3)by Pearson's correlations,the MPI correlated positively with the diameter of ASD and pulmonary artery pressure;4)after transcatheter closure of ASD,the MPI decreased markedly.Conclusions 1)MPI is a conceptually new,simple,and reproducible Doppler index in patients with ASD;2)MPI is free from the effect of age,heart rate and blood pressure;(3)MPI appears to be relatively dependent on changes in the diameter of ASD and pulmonary artery pressure;4)the right ventricular function was improved after transcatheter closure of ASD.

Identification of Two Mutations in PCDHGA4 and SLFN14 Genes in an Atrial Septal Defect Family

Atrial septal defect (ASD)is a common acyanotic congenital cardiac disorder associated with genetic mutations.The objective of this study was to identify the genetic factors in a Chinese family with ASD patients by a whole exome sequencing approach.Causative ASD gene mutations were examined in 16 members from a three-generation family,among which 6 individuals were diagnosed as having ASD.One hundred and eighty-three unrelated healthy Chinese were recruited as a normal control group.Peripheral venous blood was collected from every subject for genetic analysis.Exome sequencing was performed in the ASD patients.Potential causal mutations were detected in non-ASD family members and normal controls by polymerase chain reaction and sequencing analysis.The results showed that all affected family members carried two novel compound mutations,c.1187delT of PCDHGA4 and c.2557insC of SLFN14,and these two mutations were considered to have synergetic function on ASD.In conclusion,the mutations of c.1187delT of PCDHGA4 and c.2557insC of SLFN14 may be pathogenic factors contributing to the development of ASD.

“Treat-Repair-Treat”:Management of Left Main Coronary Compression by a Pulmonary Artery Aneurysm in a Patient with Atrial Septal Defect and Significant Pulmonary Hypertension

Left main coronary compression syndrome(LMCS)may complicate pulmonary artery aneurysms(PAA),usually developed in the context of pulmonary arterial hypertension(PAH).We report the case of a 51-year-old female patient with an atrial septal defect(unsuitable for device closure)complicated by a PAA generating a 90%left main stenosis.The significant PAH held us back from immediate surgery.After specific dual PAH-targeted therapy(sildenafil and bosentan),the atrial septal defect could be closed with a unidirectional valved patch;the PAAinduced LMCS was treated by reductive arterioplasty.The postoperative course was uneventful.Follow-up showed clinical improvement,but PAH treatment was still needed.After three months,coronary angiography showed only an insignificant residual left main stenosis,proving that reductive pulmonary arterioplasty was effective in treating LMCS.Any PAA requires further evaluation for LMCS,a dangerous but treatable complication.The“treat-repair-treat”strategy and shunt-closure with a unidirectional valved patch can both improve surgical prospects of LMCS with shunt-related PAH.

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.

Improvement of the Technique for Transcatheter Closure of Atrial Septal Defect in Children

Objectives To improve experience of procedure and success rate of interventional treatment of atrial septal defect （ASD） in children, applying the technique of controlling release of devices in the pulmonary vein （controlling two disc of device opening for subsequence） in children cases with ASD who can not be occluded by regularly interventional treatment. Methods Since 2000 year 182 child cases （male 70 and 112 female） underwent the procedure of controlling release of devices in the pulmonary vein. The patients＇ age was from 2 to 14 years old （average 3.77±1.55）. The body weight was from 9 to 48 Kg （average 21.53±10.63）. When the devices were placed on the right position with difficulty and failure in some cases with short and soft rims of the defect and large defect and the angle between the device and the interval atrial septal （IAS）, It could be helpful to put the device into the left upper pulmonary vein, and to make right atrium （proximal） disc opened before the left atrium （distal） disc naturally fall down. At the end the double disc of the device clamped and stood up at the right position of the IAS. After closure of ASD, patients were followed up regularly by echocardiography, X-ray and ECG in the 1,3,6,12 month and 3,5 years. Results The successful rate of device implantation in the improving group （98.4%） was obviously higher than that in the regularly group （68%）. The techniques improved in this group with the smaller age, the lighter weight, the larger defect and the larger device comparing with the regularly group. The velocity of the pulmonary vein before occlusion procedure was （0.54±0.15）m/s; after procedure was （0.56±0.16）m/s, P 〉 0.05,there were no significant difference. All cases couldn＇t found pulmonary congestion by follow up. Conclusions The method of controlling release of device in the pulmonary vein has been used more than 5 years in the occlusion of ASD with double disc device. It is feasible and safety. The aim of the improvement is for overcoming the problem with larger ASD and the rim deficiency in the interventional procedure in children with ASD. In summary： 1. The performance of the procedure must be careful; 2. To avoid complication when put the sheath into the pulmonary vein; 3. To avoid to put the left disc into pulmonary vein too long and pull the device too much; 4. When the procedure have to operate repeatedly, the device can not be released before the position satisfactory. The improvement of the technique is needed to carry on long-term follow-up in the clinical trials.

Complications Related to Transcatheter Occlusion of Atrial Septal Defect with Amplatzer Septal Occluder in Children

Objectives To investigate the causes, theraputic and preventive methods of com- plications associated with transcatheter occlusion of at- rial septal defect ( ASD) using the Amplatzer septal oc- cluder (ASO) in children. Methods 289 cases un- derwent transcatheter closure of ASD with ASO. Com- plications occurred in 9 cases. The complications in procedure included systemic circulatory systemic air embolism in 2, pulmonary air embolism in 1, pericar- dial tamponade in 1, ASO malposition requiring emer- gency surgical removal in 1, transient atrial extrasysto- les in 1 and sizing balloon rupture in 1 case. 2 cases with postoperative complications were found in the fol- low-up studies. These included perforation of mitral valve and ASO partially dislodged. In this study, 5 children with intraoperative complication received e- mergency therapy including surgical intervention, and others needed only follow-up, as the complications were transient or asymptomatic. Results There were no children death in this study. The 5 cases who re- ceived treatment were completely healing, and the oth- ers with intra - procedure complications were also had no sequela existed. Cases with mitral valve and ASO partially dislodged were still in follow-up studies, as the 2 patients having no symptoms. Conclutions Air embolism were occurred easily in atrial septal defect cases who received ASO therapy. Complications mainly caused by inappropriate operative procedure and some complications needed emergency treatments. Follow-up studies were important to cases with transcatheter oc- clusion therapy.

Reliability of transthoracic echocardiography in estimating the size of Amplatzer septal occluder and guiding percutaneous closure of atrial septal defects

Background In China, transthoracic echocardiography （TTE） is popularly used for pre-intervention examination for atrial septal defect （ASD） and for guiding ASD closure. However, the ability to determine ASD size and the safety and efficacy of l-rE for guiding ASD closure still has not been widely accepted. This study aimed to evaluate the efficacy and safety of l-rE used before, during and after transcatheter ASD closure with Amplatzer septal occluders （ASO）. Methods Sixty-eight subjects （15 men and 53 women; mean age （33.7±17.3） years） were enrolled. TTE was used to measure the diameters and guide transcatheter closure of ASD. The ASD was examined by long-axis view, basal short-axis view, apical four-chamber view and the subcostal view to observe position, diameter and relation with neighbouring structures. The largest diameter was selected as the reference diameter. Patients were divided into 3 groups according to the ASD reference diameter： 22 subjects with ASD diameter 4-14 mm （group A）; 21 subjects with ASD diameter 15-20 mm （group B）; and 25 subjects with ASD diameter 21-33 mm （group C）. Results ASD was occluded successfully in groups A and B. In group C, occlusion failed in 2 cases; 1 case remained with a 3-mm residual shunt sustained until 6-month follow-up. However, at 6-month follow-up, no case of thromboembolism, ASO dislocation or death occurred in the three groups. The diameter of ASD measured by l-rE could accurately predict the ASO size that could successfully occlude the ASD, especially in patients with ASD 〈20 mm. The ASD diameter measured by l-rE correlated well with ASO size （r= 0.925, P〈0.001 ; r=0.976, P〈0.001 ; r=0.929, P〈0.001 respectively）. Conclusions ASD diameter measured by l-rE can accurately estimate the size of the ASO needed for successful closure of ASD. The larger the ASD, the much larger the ASO needed. l-rE is a satisfactory guiding imaging tool for ASD closure.

Transcatheter Closure of Atrial Septal Defects Improves Cardiac Remodeling and Function of Adult Patients with Permanent Atrial Fibrillation

Background:Permanent atrial fibrillation (AF) is the most common form of dysrhythmia associated with atrial septal defects (ASDs) in patients older than 40 years.However,little is known about cardiac remodeling after transcatheter closure in patients with permanent AF.This study was designed to compare cardiac events and remodeling effects after transcatheter closure in such patients.Methods:Clinical data of 289 adult patients older than 40 years who underwent ASD closure at our center were analyzed retrospectively.Of them,63 patients with permanent AF were assigned to the case group,and the other 226 patients without permanent AF were assigned to the control group.Cardiac events and changes in left and right cardiac cavity dimensions before the procedure and 6 months after the procedure were compared between the two groups.Results:Patients in the case group were significantly older than those in the control group.The right ventricular (RV) volume and right atrial (RA) volume were decreased significantly in both the groups during a median follow-up period of 6 months after closure (P ＜ 0.001).The left atrial dimensions,left ventricular end-systolic dimensions,left ventricular end-diastolic dimensions and left ventricular ejection fraction showed no significant change before and after the procedure in both the groups.Changes of the RV volume and RA volume in the case group were significantly smaller than those in the control group (P =0.005 and P ＜ 0.001).The New York Heart Association cardiac function was improved in both the groups during the 6 months follow-up period.Conclusions:The transcatheter closure of ASD can improve the cardiac remodeling and cardiac function in patients with or without AF.

A novel variant in TBX20 （p.DI76N） identified by whole-exome sequencing in combination with a congenital heart disease related gene filter is associated with familial atrial septal defect

Congenital heart disease （CHD） is the leading cause of birth defects, and its etiology is not completely understood. Atrial septal defect （ASD） is one of the most common defects of CHD. Previous studies have demonstrated that mutations in the transcription factor T-box 20 （TBX20） contribute to congenital ASD. Whole-exome sequencing in combination with a CHD-related gene filter was used to detect a family of three generations with ASD. A novel TBX20 mutation, c.526G〉A （p.D176N）, was identified and co-segregated in all affected members in this family. This mutation was predicted to be deleterious by bioinformatics programs （SIFT, Polyphen2, and MutationTaster）. This mutation was also not presented in the current Single Nucleotide Polymorphism Database （dbSNP） or National Heart, Lung, and Blood Institute （NHLBI） Exome Sequencing Project （ESP）. In conclusion, our finding expands the spectrum of TBX20 mutations and provides additional support that TBX20 plays important roles in cardiac development. Our study also provided a new and cost-effective analysis strategy for the genetic study in small CHD pedigree.

Adult Congenital Heart Disease in the Veteran Population:A Case-Based Report

Simple forms of congenital heart disease can allow patients to go undiagnosed until they reach adulthood.Furthermore,improvements in care of patients with complex congenital heart disease are now allowing most patients to reach adulthood.As some patients with adult congenital heart disease can remain asymptomatic until later in life,it is possible for them to serve in the military and eventually fall under the care of Veterans Administration(VA)providers.Therefore it is important for providers,especially cardiologists at VA centers,to have fundamental understanding of the management of adult congenital heart disease.This article provides multiple cases of adult congenital heart disease experienced at a single VA medical center and reviews the anatomy,physiology,and surgical management of each condition.

单纯超声引导下经皮成人房间隔缺损封堵术的临床研究

目的探讨单纯超声引导经股静脉路径封堵成人房间隔缺损手术的临床效果。方法回顾性分析2021年8月至2023年11月在新疆医科大学第一附属医院心脏外科进行经皮介入治疗的房间隔缺损成人患者116例,其中男17例,女99例;年龄18~73(39.7±11.5)岁,诊断中央型房间隔缺损110例,卵圆孔未闭型房间隔缺损6例。患者心功能正常,无合并其他心内畸形。患者均在气管插管全身麻醉下经股静脉路径,在经食管超声心动图和经胸超声心动图的引导下,进行房间隔缺损封堵术。结果114例患者房间隔缺损封堵成功。失败2例,1例大筛孔型房间隔缺损患者术中封堵器释放后,仍存在大量分流,遂撤回封堵器;另1例为大房间隔缺损(34 mm),左心房小,尝试肺静脉释放法失败;2例患者均中转胸腔镜辅助下房间隔缺损修补术。封堵成功患者平均手术时间(17.4±5.6)min,使用房间隔缺损封堵器平均直径(27.3±6.5)mm。术中未发生外周血管损伤、封堵器移位/脱落、严重残余分流等严重并发症。所有封堵成功患者拔除气管插管后直接转回普通病房,术后住院(2.1±0.9)d。结论单纯超声引导下经皮封堵成人房间隔缺损手术创伤小,安全有效,并能够避免X线损伤。

经胸超声心动图诊断封堵房间隔缺损过程中冠状动脉空气栓塞1例

患者女,55岁,间断头痛20年、加重伴心前区疼痛3个月,期间血压最高达160/110 mmHg;20年前于外院接受子宫切除术;无家族病及遗传病史。心电图未见明显异常。经胸超声心动图(transthoracic echocardiography,TTE):Ⅱ孔中央型房间隔缺损,最大直径8 mm;心房水平左向右分流,左心饱满;三尖瓣少量反流,肺动脉收缩压36 mmHg;经食管超声心动图见10 mm×4 mm椭圆形房间隔缺损,右心房内见冗长下腔静脉瓣回声飘动。

妊娠合并房间隔缺损并发醒后卒中1例报道

妊娠期缺血性卒中发病率低、致死率高。本文通过回顾1例妊娠合并有房间隔缺损并发醒后卒中患者的临床及影像学检查资料,探讨妊娠相关卒中的影像学表现、发病机制和治疗策略,旨在提高临床医师对合并有房间隔缺损的孕妇并发急性脑卒中的认识,为临床诊疗提供参考。

心房颤动介入术后医源性房间隔缺损右向左分流发生情况及其临床影响的研究

目的探讨心房颤动(房颤)患者介入治疗中行房间隔穿刺术后造成医源性房间隔缺损(iASD)的右向左分流(RLS)发生情况及影响因素,并分析其与新发偏头痛之间的相关性,为相关临床事件的预防和治疗提供依据。方法选取2022年11月至2023年3月阜阳市人民医院心血管内科收治的行房颤介入手术[包括导管射频消融术(RFCA)、经皮左心耳封堵术(LAAC)、“一站式”(RFCA+LAAC)手术]的患者54例,根据术后48 h内iASD是否存在RLS分为RLS组24例与非RLS组30例,收集2组一般临床资料及超声指标,分析RLS的发生情况和影响因素,以及术后3个月内新发偏头痛情况。结果所有患者术后iASD均出现左向右分流,24例(44.44%)患者出现RLS,iASD为(5.12±0.80)mm。随访3个月,2组新发偏头痛比较,差异无统计学意义(P>0.05)。RLS组年龄、持续性房颤比例、iASD尺寸大于非RLS组,差异有统计学意义(P<0.05,P<0.01)。多因素logistic回归分析显示,iASD尺寸是发生RLS的危险因素(OR=2.245,95%CI:1.040~4.846,P=0.040)。结论房颤介入治疗术后iASD出现RLS较为常见,与患者早期出现新发偏头痛无相关性,iASD尺寸是发生RLS的危险因素。同时,iASD在血流动力学及临床事件方面的影响应予以关注。

Long-term follow up of interventional therapy of secundum atrial septal defect

Background The percutaneous transcatheter closure of secundum atrial septal defect （ASD） is increasingly a widespread alternative to surgical closure.The aim of this study was to assess long-term results of percutaneous closure of secundum-type atrial septal defect （ASD Ⅱ）.Methods Between January 2001 and December 2005,61 patients underwent a successful percutaneous closure of ASD Ⅱ; including 25 male and 36 female.All were included in the patient study and were followed up to monitor by electrocardiogram and echocardiography,at intervals of 3 days,3 months,6 months,1 year,2 years,and 5 years after operation.Results Three days after percutaneous transcatheter septal closure （PTSC）,the right atrium diameter,right ventricular end-diastolic left-right diameter and right ventricutar end-diastolic volume （RVEDV） decreased significantly （P 〈0.05）.Right ventricular end-diastolic anteroposterior diameter （RVEDD）,right ventricular end-systolic volume （RVESV） and right ventricular ejection fraction （RVEF） also decreased （P〈0.01）.During the period from 3 to 6 months,the size of the right atrium and right ventricle returned to normal range.Three days after PTSC,the left ventricular end-diastolic diameter （LVEDD）,left ventricular end-diastolic volume （LVEDV）,left ventricular end-systolic volume （LVESV）,left ventricular-systolic volume （LVSV） and left ventricular ejection fraction （LVEF） were significantly increased （P 〈0.05）.At 1 year,the size of the left atrium,left ventricle and left cardiac function returned to normal range （P 〈0.01）.There were no deaths or significant complications during the study.At five year follow-up,all defects were completely closed and remained closed thereafter.Conclusion Transcatheter closure of ASD Ⅱ effectively eliminated the abnormal shunt and,subsequently improved the dimensions of each chamber and cardiac function.

Efficacy and safety of a parylene-coated occluder for atrial septal defect:a prospective,multi-center,randomized controlled clinical trial

Background:Nitinol-containing devices are widely used in clinical practice.However,there are concerns about nickel release after nitinol-containing device implantation.This study aimed to compare the efficacy and safety of a parylene-coated occluder vs.a traditional nitinol-containing device for atrial septal defect(ASD).Methods:One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder(n=54)or the control group to receive a traditional occluder(n=54).The plugging success rate at 6 months after device implantation and the pre-and post-implantation serum nickel levels were compared between the two groups.A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device.The Cochran–Mantel–Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.Results:At 6 months after implantation,successful ASD closure was achieved in 52 of 53 patients(98.11%)in both the trial and control groups(95%confidence interval(CI):[4.90,5.16])based on per-protocol set analysis.The absolute value of the lower limit of the 95%CI was 4.90%,which was less than the specified non-inferiority margin of 8%.No deaths or severe complications occurred during 6 months of follow-up.The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group(P<0.05 vs.baseline).In the trial group,there was no significant difference in the serum nickel level before vs.after device implantation(P>0.05).Conclusions:The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder.The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD,especially in patients with a nickel allergy.