| BackgroundVentricular septal defects(VSD)are the most common type of congenital heart disease(CHD),accounting for about 20%-50%of all CHDs.Perimembranous VSD accounts for about 80%of all VSDs.VSD may cause various complications such as growth retardation,recurrent respiratory tract infection,heart failure,pulmonary hypertension,infective endocarditis etc.which poses a great threat to children’s health.Open surgery with cardiopulmonary bypass is the well-established standard therapy,but it is more invasive and still bears certain complications.Percutaneous device closure of perimembraneous VSD has been introduced since 2002,which was widely applied and already became an alternative therapy for open surgery in selected patients nowadays.Perventricular device closure of perimembraneous VSD has been introduced since 2006 at the basis of percutaneous technique.Currently,both percutaneous and perventricular device closure has been widely applied for more than 10 years.Although these two less invasive techniques have shown promising prospect,certain rate of failure still exist and some associated complications can’t be avoided completely.Currently,percutaneous and perventricular device closure still can’t replace traditional open surgery completely.The accurate indications for each modalities are still not completely clear,large scale study with long period of follow-up data are still very limited.Large scale control study between percutaneous and perventricular device closure of VSD is scarce.Objective:This study aimed to evaluate the short,medium and long-term outcomes of percutaneous device closure of VSD.This study also investigated the failure reasons,postoperative complications.This study explored the interventional indications of special type of VSDs.This study also concluded advantages and disadvantages of each technique by comparing percutaneous with perventricular device closure.This study also aimed to increase success rate of interventional procedure and reduce procedure associated complications as well as provide reference for future clinical work.Method:Part 1The perioperative and follow-up data of all the patients who had underwent transcatheter device closure between June,2002 and May,2017 were retrogradely analysed.The success rate and main complications were described,the risk factors associated with procedure failure and main complications as well as the long term outcomes were analysed.Part 2Feasibility and efficacy of interventional therapy for some special types of VSD were evaluated.We focused on indication,closure strategy and device selection criteria.Firstly,we evaluated feasibility and efficacy of transcatheter closure of VSD with deficient subaortic rim.Secondly,we discussed the feasibility and efficacy of transcatheter closure of multi-holes perimembranous ventricular septal defect with aneurysm.We also presented our preliminary experience of transcatheter closure of multi-holes pmVSD with aneurysm using double occluders.Thirdly,we evaluated the feasibility and efficacy of transcatheter closure of small type VSD with Amplatzer duct occlude 2.Part 3We compared two different closure techniques conducted in recent 5 years at our center,percutaneous versus perventricular device closure.The advantages and disadvantages of each method were compared and the indications of each method was concluded.Outcome:Part 1A total of 748 patients with ventricular septal defect underwent transcatheter closure in our center during the period between June,2002 and May,2017.The number of male and female patients was 368(49.2%)versus 380(50.8%).The mean age was 6.9±7.5(range:1.9-59)years old and the mean weight was 23.3±15.0(range:10-100)kg.According to transthoracic echocardiography,662(86.3%)patients were diagnosed as pmVSD and 379(50.7%)patients complicated with aneurysm.The diameter of maximum outlets was 3.3± 1.2mm(range:1.0-9.0mm),the length of sub-aortic rim was 2.2±1.3mm(range:0-6.0mm).Transcatheter closure procedure succeeded in 685(91.6%)cases and failed in 63(8.4%)cases.A total of 376(50.3%)patients developed various complications post procedure.Main postoperative complications include arrhythmia in 186(24.9%)cases,residual shunt in 106(14.2%)cases,aortic regurgitation in 52(7.0%)cases and hemolysis in 12(1.3%)cases.Minor complications occurred in 348(41.1%)patients and severe complications occurred in 28(3.7%)cases.Logistic regression analysis was conducted to identify the risk factors of main complications.Large occluder(OR 2.3,95%CI:1.2-5.4),eccentric occluder(OR 8.0,95%CI:1.6-13.1)and long exposure time(OR 1.5,95%CI:1.2-3.5)are independent risk factors of postoperative arrhythmia.VSD size(OR 2.3,95%CI:1.6-4.5),septal aneurysm(OR 1.3,95%CI:1.0-1.5)and outlet occlusion(OR2.0,95%CI:1.5-4.0)are risk factors of postoperative residual shunt.Sub-aortic rim less than 2mm(OR 5.3,95%CI:2.2-12.7),inlet occlusion(OR 4.6,95%CI:1.4-14.6)and long exposure time(OR 2.0,95%CI:1.4-5.0)are independent risk factors of postoperative aortic regurgitation.Part 2① Percutaneous closure of VSD with deficient sub-aortic rim(<2mm)According to the length of sub-aortic rim,qualified patients were divided into short-rim group(<2mm)and long-rim group(≥2mm).108 patients were enrolled in short-rim group and 190 in long-rim group.The success rate of short-rim group and long-rim group was 81.5%versus 96.3%.53 patients of short-rim group were implanted eccentric occluders and 35 patients were implanted concentric occluders.30 patients in long-rim group were implanted eccentric occluders.Concentric occluders,small-waist-large-disc occluders and Amplatzer duct occluder 2 were implanted in 124,3 and 26 patients of long-rim group,respectively.Aortic regurgitation developed in 8(9.1%)cases of short-rim group versus 4(2.2%)cases of long-rim group,which was statistically significant.Various arrhythmias developed in 31(35.2%)patients of short-rim group versus 41(22.4%)of long-rim group,which had significant statistical difference.Minor residual shunt developed in 12(13.6%)patients of short-rim group versus 18(9.8%)of long-rim group,which had no significant statistical difference.2 patients of long-rim group while none of short-rim group developed minor mechanical hemolysis,which resolved a few days later.Logistic regression analysis revealed short-rim VSD with large defects(≥5mm)(OR 11.6,95%CI:2.37-57.11)and preoperative aortic valve prolapse(OR 8.8,95%CI:1.4-54.9)were independent risk factors of failure.② Percutaneous closure of large septal aneurysm with multi-holes119 cases with large aneurysm and multi-holes were enrolled in this study,which was expressed as LA group.The patients without aneurysm and patients with ordinary aneurysm acted as control groups,which were expressed as NA and OA group.The success rate of LA,NA and OA group was 95.8%,93.6%and 89.8%,respectively.The incidence of complications post operation of 3 groups was as follows.The incidence of residual shunt of each group was 13.0%,13.1%and 29.2%,respectively.The incidence of arrhythmias of each group was 22.6%,22.2%and 28.3%,respectively.The incidence of aortic regurgitation of each group was 5.2%,5.7%and 2.8%,respectively.The small-waist-large-disk occluders used in each group were 0.4%,4.0%and 37.7%,respectively.Five patients with large aneurysm and multi-holes were implanted double occluders successfully.③ Percutaneous closure of small type VSD using AD02Between February 2012 and December 2015,we attempted to percutaneously close small type of VSD using new generation of Amplatzer duct occlude(AD02)in 51 patients.25 of them were male and 26 were female.The mean age was 5.0±3.7(1.5-25.0)years old and the weight was 19.3±8.1(11.0-52.0)kg.The procedure of transcatheter closure succeeded in 50 patients while failed in 1 patient who was implanted a conventional device subsequently.One patient developed device dislodgement due to incorrect deploy position during operation.The device was successfully retrieved and redeployed into right position subsequently.Retrograde access without arterial-venous loop creation was applied in 40 patients while antegrade access with arterial-venous loop creation applied in 10 patients.Compared with conventional devices,AD02 poses advantages in short hospital stay and medical costs.Part 3During the period of January,2010 and December,2015,a total of 392 patients with VSD underwent percutaneous closure while 316 patients underwent perventricular closure.The success rate of percutaneous access was 92.9%versus 97.5%of perventricular access.The patients whose weight under 10kg accounted for 0.8%in percutaneous group versus 16.8%in perventricular group.The supracristal or subarterial ventricular septal defect accounted for 0.5%in percutaneous group versus 7.0%in perventricular group.VSD with zero sub-aortic rim accounted for 22.2%in percutaneous group versus 41.5%in perventricular group.3 patients in percutaneous group versus 9 patients in perventricular group were implanted double occluders.The mean medical costs of percutaneous group and perventricular group was$36566.1±6818.2 versus $8172.4±9294.4.The hospital stay of percutaneous group was 8.6±1.7 days versus 9.4±3.9 days of perventricular group.There are 2 patients of perventricular group who received blood transfusion during operation while none in percutaneous group.One patient of percutaneous group died of intracerebral hemorrhage following procedure while no death in perventricular group.Other main complications include residual shunt,arrhythmias and aortic regurgitation which had no significant differences between two groups.The constitution of post-procedure arrhythmias differs significantly between two groups.The most common type of arrhythmias in perventricular group was right bundle branch block while left bundle branch block was very rare.Left bundle branch block and junctional arrhythmia were more commonly observed in percutaneous group than perventricular group.Neither group had severe atrioventricular block which need transient or permanent pacemaker implantation developed.New onset minor aortic regurgitation developed in 15 cases of percutaneous group versus 10 in perventricular group.The incidence of residual shunt of percutaneous group and perventricular group was similar,15.8%versus 17.7%.The diameter of residual shunt was between 0.5mm and 2.3mm.Four patients of percutaneous group developed minor mechanical hemolysis which all resolved after conservative therapy.No mechanical hemolysis occurred in perventricular group.ConclusionsPart 11 · Percutaneous closure of perimembranous ventricular septal defect has fairly high success rate,rare severe complications.Medium and long period of follow-up outcome demonstrated percutaneous closure to be safe and efficacious with rare late complications.2.VSD with deficient sub-aortic rim and VSD larger than 10mm were independent risk factors of failure.3.Occluder larger than 8mm,eccentric occluder and long fluorescent time were independent risk factors of postoperative arrhythmias.4.VSD larger than 8mm,septal aneurysm formation,multi-exits were risk factors of residual shunt.Part 21.Preoperative aortic prolapse and defect larger than 5mm were the risk factors of failure for VSD with deficient sub-aortic rim.2.Percutaneous closure of VSD with aneurysm and multi-holes was generally safe and efficacious,but the postoperative residual shunt was higher than common type of VSD.It is technically feasible to close large aneurysm with multi-holes using two occluders,but the indications should be strictly controlled.3.Transcatheter closure of small type VSD using AD02 was safe and efficacious,it has advantages of short procedure time,simple manipulation and less complications.Part 31.Perventricular device closure of VSD had higher success rate than percutaneous closure method,especially in low-weight infant and patients with deficient sub-aortic rim.2.Perventricular device closure of VSD had similar postoperative complications as percutaneous closure technique.3.Percutaneous closure of VSD had superiority over perventricualr access in hospital stay and medical cost.Innovation and significance1.This study made a systemic evaluation of efficacy,complications as well as medium and long term outcomes of percutaneous closure of congenital perimembraneous ventricular septal defect.2.This study explored some risk factors for failure of transcatheter closure of pmVSD,also identified several risk factors associated with main complication following operation.These findings may help to increase success rate and reduce complications.3.This study made an evaluation for transcatheter closure of some special type of VSD which include aneurysmal VSD with multi-exits,VSD with deficient sub-aortic rim etc..This findings help to guide indications of interventional therapy for VSD.4.This study made a detailed evaluation for feasibility and efficacy of new type occluder,Amplatzer duct occluder 2,also put forward the indications of AD02.5.This study made a conclusion of advantages and disadvantages for percutaneous and perventricular closure technique through large scale sample,made a contribution to guidance of future work. |
PDF Full Text Request