| BackgroundAtrial septal defect is one of the most common congenital heart disease,accounting for about 10%of all congenital heart disease.Since King and his colleagues reported the first cases of atrial septal defect intervention in 1976,a growing number of cardiac center began to dealing secondary atrial septal defect with percutameous cardiac catheterization techniques.From that day on,the intervention techniques are evolving and new devices are developling day after day.we observed that there were less complications,more reliable outcomes and nice following-up results when we chosen percutaneous atrial septal defect closure other than opening heart surgury.the American College of Cardiology(ACC)and the American Heart Association(AHA)recommends that regardless of whether there were clinical symptoms or not,atrial septal defect required clinical interventions or surgical repair when caused right atrium and right ventricle enlargement(Class ?).For less than 5 mm of atrial septal defect,without causing the right atrium and right ventricle enlargement were the evidences can not be closed,but if associated with paradoxical embolism it can be closed by catheterization(Class ?).The only absolute contraindications exist is irreversible pulmonary hypertension(pulmonary vascular resistance greater than 8 wood)that no evidence of left-to-right shunt was found(Class ?).Patients underwent interventional treatment of atrial septal defect with no scars,and it does not affect the appearance and it has a rapid recovery and a shorter hospital stay,not mention the fewer complications and the same outcomes in follow-up with thoracotomy surgical repair of atrial septal defect.With the experience accumulation and technique promotion,some cardiac centers have been able to challenge some complicated morphology of atrial septal defect,such as the deficiency the right pulmonary vein rim,or the superior vena cave rim,even the inferior vena cava rim.Because atrial septal defect structure is relatively simple,it is less concerned that what are those serious complications after atrial septal defect catheterization,such as cardiac erosion,cardiac perforation,occluder embolism,complete atrioventricular block,thromboembolism,intracardiac meningitis,etc.In recent years,a growing number of scholars shows their interests to long-term complications concerned to percutaneous atrial septal defect closure,that various studies from several abroad centers showed there were no significant difference between atrial septal defect with deficiency rims and those without deficiency rims in success rate,the incidence of residual shunt,the incidence of arrhythmia,the complications and clinical outcomes from both short term and long term.ObjectiveThis study is about to have a retrospectively observention about residual shunt,arrhythmias,heart erosion,occluder shift embolism concurrent disease,and other complications after percutaneous atrial septal defect closure with or without deficiency rims in short and medium term follow-up.And what we expecting is that the catheterization closure of atrial septal defect with deficiency rims is safety and effectiveness,it can be a nice choice for patients with deficiency rims.Materials and MethodsCriteria for inclusion and exclusion.From January 2011 to april 2014,patient that measured by clinical examination,X-ray,echocardiography and diagnosed as congenital heart disease,the secondary artial septal defect.The existence of atrial septal defect has a hemodynamic meaning.Or though the septal defect is quite small,but it has the risk of thromboembolic.And of course,atrial septal occluder diameter is larger than left atrial diameter of the selected patients.In all cases,patient or his/her guardian signed informed consent which informed risks and possible complications of interventional surgery,and agreed with the left and right heart catheterization and percutaneous atrial septal defect occlusion.Criteria for exclusion.Exclude patients with endocarditis and bleeding disorders,ulcers healed or have contraindications of aspirin therapy(besides those who can take other antiplatelet agents for 6 months).Patients contain severe pulmonary hypertension leading to right to left shunt or need others surgical treatment of cardiac malformations.And those with severe cardiac disease or valvular disease,intracardiac thrombus presence(especially the left atrium or left atrial appendage thrombus)or deep vein thrombosis resulting in venous occlusion.Systemic factors,like severe infectious diseases in recent month,other type of malignant diseases,or life expectancy less than 3 years should also excluded.Block methods.According to whether there has/have a dificiency rim of atrial septal defect or not,regardless of the specific rim of ASD,like pright pulmonary vein rim,superior vena cava rim,atrioventricular valve rim.We have assigned the istance between the edge of defect and Coronary sinus/Atrioventricular valve/Right superior pulmonary vein is less than 5mm as experimental group,and those more than 5mm as control group.152 cases were included in the experimental group,and 355 cases were included in the control group.Occluder selecting.The occluders used in research were chosed from three different companies,one is from Shenzhen technology company,china,one is from Beijing technology material company,china,and one fromAGA Medical Corp.,Golden Valley MNUSA.The occluder model in this study rang from 6 mm to 42 mm,whether it had implanted into patients heart or not.Procedure methods.Intravenous anesthesia or local anesthesia puncture is been used in procedure.Transthoracic echocardiography was applied to assess size of defect bedside,measuring the distance between the edge of defect and Coronary sinus/Atrioventricular valve/Right superior pulmonary vein/the Aorta and to determine the appropriate occluder type.Preoperative intravenous antibiotics is used to prevent infection and intraoperative heparin(100 u/kg)too to hrombosis prophylaxis.Puncturing femoral vein,placed end-hole 6F catheter for routine right heart catheterization,measuring right atrial pressure,right ventricular pressure,pulmonary artery pressure,left atrial pressure respectively,in the superior vena cava,inferior vena cava,the pulmonary artery and the left atrium(pulmonary venous)blood oxygen saturation was tested,those pressure and oxygen saturation data would contribute to calculate circulation and pulmonary flow resistance.Put 6F catheter into the right upper pulmonary vein(or the left pulmonary vein)through the end of 0.035 inches and hard-exchange guidewire,build a vein conveying track.from the femoral vein to inferior vena cava,and to left atrium,right upper pulmonary vein.Choosing the appropriate type of transportation along with the guidewire exchanging the long sheath to the pulmonary vein openings,having a good occluder assembly on supporting transport cable,along the venous access before opening the proximal disc in the left atrium or pulmonary vein and retreat the whole system to the atrial septum at the plate,then opening the right disc in the right atrium after.Transthoracic echocardiography was applied to assess the results like whether there is the residual shunt or not,and whether the device in the right place or not.After that,a "pulling test" will be done to make sure we have done right things putting a device in a man's atrial septem using X-ray.Than release the occluder completely.Follow-up Methods.All subjects underwent routine clinical examination,transthoracic echocardiography,electrocardiogram at 24 hours,3 months,6 months,1 year,3 years after the procedure respectively.1.Transthoracic echocardiography evaluation:before and after the measurement of left atrial diameter,left ventricular end-diastolic diameter,front right atrial diameter,right ventricular end-diastolic diameter,left ventricular ejection fraction,evaluation occluder position,with or without residual shunt and width,with or without left ventricular channel right atrium,left pulmonary artery stenosis,mitral,tricuspid,aortic regurgitation and so on.2.ECG evaluation:?° atrioventricular block,? °AVB,? ° atrioventricular block,left bundle branch block,left branch block,and other arrhythmia(including incomplete atrioventricular dissociation,nodal rhythm walk,heart block,premature ventricular contractions,atrial premature beats,atrial fibrillation,etc.).3.Complications follow-up:During the postoperative follow-up cardiac tamponade,occluder displacement and loss,complete atrioventricular block,embolism,severe arrhythmia emerging into material related adverse reactions(including local inflammation,stimulate reactions,allergic reactions,tissue proliferation,cytotoxicity,coagulation changes,complement activation,carcinogenic performance,immune response,etc.).Statistical MethodsApplication of statistical analysis software SPSS 19.0,P<0.05 were considered statistically significant.measurement data were shown mean ± standard median difference,or that the count information to the absolute number and percentage.Selected population were randomized to experimental group and control group,the basic conditions tabulated,were compared between groups and within groups,descriptive statistics:the normal distribution with mean ± standard deviation,does not meet the normal distribution with median and quartile.Test Methods:Comparison data between group with two independent samples t test,Wilcoxon rank sum test;Comparison different follow-up time,spherically symmetric hypothesis testing used to judge Whether Sphericity Assumed method or Greenhouse-Geisser method to be select,comparisons the results of two multiple echocardiography data with LSD-t test;Comparison Discrete data with chi-square test and Fisher exact probabilities.All the hypothesis test adopt two-side test.The resultsThe study included 507 cases,29 cases(45.2%)were male and 278 cases(54.8%)were female,with a median age of 4 years,range 7 months to 49 years,median weight 15.0 kg,range 7.5 kg to 81.0 kg.One patient had atrial premature beats,right ventricular enlargement were found in 497 cases,there were 4 cases defined as huge atrial septal defect(?35 mm),3 cases combine with ventricular septal defect and 3 with pulmonary valve stenosis.1 case combined with patent ductus arteriosus,1 case combined with atrioventricular node dual-path.And another case found it has combined the uper right pulmonary venous drainage in the process.Basic information.The experimental group has 152 cases 72 male and 80 female.While the control group has 355 cases contain 198 male and 157 female,with chi-square test,the sex ratio of children between the two groups was not statistically significant.The median age of experimental group is 47 months(31,86)months,while the control group is 48 months(32,59)months.The mean weight of experimental group is 15.0 kg(11.1,20.0)kg,while the control group is 15.0 kg(12.0,22.5)kg,the age and body weight between the two groups was not statistically significant.Operation time was:groups:the experimental group,45 min(40,52)min,the control group:40 min(35,50)min,the difference between the two groups regard the operation time was statistically significant(P<0.05);Exposure time was:the experimental group:6.0 min(5.0,8.0)min,the control group:6.0 min(5.0,8.2)min,differences in terms of exposure time was not statistically significant between the two groups(P>0.05);Pulmonary blood circulation ratio was:the experimental group,1.98(1.54,2,64)min,the control group,1.78min(1.42,2.40)min;Maximum diameter of atrial septal defect was:the experimental group,16.0mm(12.0,20.0)mm,the control group,12.0 mm(9.0,17.2)mm;Pulmonary artery pressure was:the experimental group,27 mmHg(24,32)mmHg,the control group,27 mmHg(23,31)mmHg.Between the two groups of pulmonary circulation perfusion ratio,maximum diameter of atrial septal defect and pulmonary artery pressures,the differ was no statistically significant(P>0.05).24 hours observation index.Immediate surgical success rate was 96.4%,18 cases of occlusion failure,which the experimental group contains 8 patients(44.4%),the e control group contains 10 cases(55.6%),surgical success rate between the two groups was no statistically significant(P>0.05).Residual shunt:the experimental group contain 10 patients of residual shunt,the control group contain 18 patients of residual shunt,there is no significant difference(P>0.05)between the two groups in the incidence of residual shunt.The differ of incidence of arrhythmias between the experimental group and the control group was statistically significant(P<0.05).The experimental group suffers 3 cases of arrhythmias.One case in each of the two groups appear occluder off,and end up atrial septal defect repair.No aortic atrium fistula,no hemolysis,no headaches and other thromboembolic complication was found in 24 hours after the procedure.Residual shunt.There were 28 cases residual shunt in 24 hours of observation,the difference of incidence of residual shunt between the experimental group and the control group was no statistically significant(10/142 vs 18/337,P>0.05),and the difference of incidence of residual shunt between the experimental group and the control group 1 month after the procedure was no statistically significant too(3/149 vs 1/345,P>0.05).There were no residual shunt cases found after 3 months of the procedure,and 6 months,and 1 year too.However,the difference of incidence of residual shunt between porous atrial septal defects and non-porous atrial septal defects was statistically significant(10/32 vs 18/447,P<0.05).The residual shunt gradually reduced over time at each obsevation point after the procedure,and about 3 months later the residual shunt is totally disappear in both experimental group and the control group.Arrhythmias.There were 14 cases of arrhythmias after 24 hours,the difference of incidence of arrhythmias between the experimental group and the control group was statistically significant(11/141 vs 3/352,P<0.05).While the difference of incidence of arrhythmias between the two groups 1 month after the preocedure(6/146 vs 5/350),3 months after the preocedure(4/148 vs4/351),6 months after the preocedure(4/148 vs 2/353),and 1 year after the preocedure(4/148 vs 2/353)was on statistically significant(P>0.05).Postoperative arrhythmias have to undergo cardiac nutrition or antiarrhythmic therapy,but the outcomes are always satisfactory.Other complications.Two occluder off to the right ventricular outflow occured within half an hour after the procedure.One case is a 10-month-year-old male,atrial septal defect size is 16 mm,try plugging into an ASD occluder for 24 mm intraoperatively,the superior vena cava rim is about 3.7 mm with soft edges.Another case is a 24-year-old woman,atrial septal defect size is 37 mm,try plugging into an ASD occluder for 42 mm intraoperatively.One patient,a 24-year-old young woman,atrial septal defect size is 28 mm,intraoperative placement occluder model 38 mm,had a headache 1 month after the proocedure,the echocardiography showed no thrombosis,magnetic head resonance examination found no abnormalities,currently with unknown cause until now.Occluder selection and catheter technique There is no significant difference between groups(P>0.05)in the occluder model selection and catheter technique whether using pulmonary vein release or not(P = 0.06),to expand the sample sizes may have a significant difference considering the trend.Pulmonary vein release in experimental group is much higher than control group(57.2 vs 13.5,P<0.05).We assume it is more likely have good influence to atrial septal defect intervention with sufficient rims.ConclusionThe experimental group has satisfied treatment success,low complication rate,reliable short/medium term follow-up,with appropriate cases selection and skilled catheter technique,percutaneous atrial septal defect of deficient rims could considered feasibility and safety.The incidence of residual shunt after interventional treatment of atrial septal defect decreased with extended follow-up period.For the two-hole-type atrial septal defect in children,were commend implanting only an occluder by considering the stretched diameter limitations placed by the septem.Postoperative small amount of residual shunt can be discharged.The incidence of arrhythmias in the experimental group seems a little bit higher than the control group at 24 hours observation spot,but arrhythmias's medium-term follow-up between the two groups had no statistically significant.Atrioventricular block may related to the ratio of the occluder placement model/left atrial diameter.Using pulmonary vein release technique while percutaneous atrial septal defect closure could improve the success rate. |
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