| Background:Congenital ventricular septal defect(VSD)can account for 30-40% of all congenital heart diseases,and is the most common congenital heart malformation.VSD may occur alone or in combination with other complex cardiac malformations.Because small defects can be closed automatically as children grow up,the incidence of neonatal disease is higher.Large VSDs are often found in prenatal examinations or in infants and young children,often leading to congestive heart failure and stagnation of development,requiring early intervention.Some relatively small VSD patients do not develop symptoms until adults.At present,the treatment of VSD mainly includes surgery and transcatheter closure.With the improvement of occluder design,the accumulation of operator's experience,and strict screening of indications,transcatheter occlusion can achieve the same clinical effect as surgery.The incidence of complications such as atrioventricular block,residual shunt,aortic regurgitation,occluder embolism has been rarely reported.But at present,the main approach for VSD interventional therapy is femoral artery combined with femoral vein.Femoral artery puncture is prone to puncture-related complications(hemorrhage,arteriovenous fistula,pseudoaneurysm,hematoma,femoral artery thrombosis,nerve injury,vasovagal reflex),even leading to death in severe cases.And after the operation,patients should be strict in bed braking.Therefore,it is worth discussing how to make patients more comfortable and further reduce complications related to vascular puncture.In this respect,the radial artery is undoubtedly more advantageous than the femoral artery.But at present,the radial artery is mainly used for coronary interventional therapy,lacking experience in the treatment of structural heart disease,with only a small range of cases reported.Therefore,this study will explore the feasibility and safety of VSD interventional therapy through radial artery combined with femoral vein.In the first step,we summarized the clinical experience of VSD interventional therapy through radial artery combined with femoral vein approach,and preliminarily discussed the feasibility of its application.Then a randomized controlled trial was designed to further verify the safety and effectiveness of VSD occlusion via radial artery combined with femoral vein approach by comparing the success rate of VSD occlusion,the length of bed rest,hospitalization costs and the incidence of adverse events.Part ?: Preliminary clinical application of transcatheter closure of ventricular septal defectObjectives: To explore the preliminary clinical application of VSD interventional therapy via radial artery combined with femoral vein,and to prove its feasibility and effectiveness.Methods: From June 2017 to November 2017,11 patients with VSD were enrolled,including 3 cases of intracristal type and 8 cases of perimembranous type,and of which 3 cases were complicated with aneurysm.All patients underwent VSD occlusion via radial artery combined with femoral vein.The average age and weight of the patients were 37.82(+12.44)years and 62.79(+14.95)kg.The average diameter of VSD was 5.00 mm and 4.50-7.00 mm by transthoracic echocardiography(TTE).The occlusion effect was evaluated by TTE and left ventricular angiography.ECG and TTE were performed 24 hours,1,3 and 6 months after operation.Results: The occluder was successfully completed in 10 patients,and one patient failed to undergo surgical treatment because the guide wire failed to pass VSD.The average diameter of the occluders was(6.50,4.75-9.25)mm,the average operating time was(47.20(+5.45)min,and the average fluoroscopy time was(13.00(+3.65)min.The average time of lying in bed after operation was(95.00,90.00-105.00)min.Two patients suffered from radial artery spasm during operation.All patients recovered and discharged from hospital.With an average follow-up of(3.00,2.50-6.00)months,no complications such as residual shunt,aortic regurgitation,atrioventricular block,and radial artery occlusion occurred in all patients.Conclusions: There is certain feasibility and safety for VSD occlusion via radial artery combined with femoral vein,and the time of bed rest after operation is short,which is worthy of further clinical research and promotion.Part ?: Clinical study on transcatheter closure of ventricular septal defect through radial artery combined with femoral vein approachObjectives: Preliminarily compare clinical effects of transcatheter VSD closure via radial artery combined with femoral vein and femoral artery combined with femoral vein,to prove the feasibility and safety of radial artery combined with femoral vein approach.Methods: This study was an exploratory study,using a prospective randomized controlled trial with non-inferior design.The experimental group was operated through radial artery combined with femoral vein,while the control group was operated through femoral artery combined with femoral vein.Patients who met the inclusion criteria of this study were randomly assigned to the experimental group or the control group at 1:1 and were treated with transcatheter VSD occlusion.The patients were followed up and adverse events were recorded.The primary end point was success rate of occluder implantation,and the secondary end points were bed rest time,hospitalization expenses and incidence of adverse events,etc.An ?-level of 0.025 was chosen for primary comparison.Results: There was no difference in age,weight,size and type of VSD and diameter of the occluder between the two groups.The success rate of occluder implantation in radial artery combined with femoral vein group(96.67%)was not inferior to that in femoral artery combined with femoral vein group(100%)(non-inferior P value < 0.001),but the time of bed rest in radial artery group was shorter(120(90,120)min vs.300(270,360)min.The average hospitalization cost was lower(28876.96±4560.36 vs.31070.83±3421.34 yuan,P=0.003).At the same time,the comfort of the radial artery group did not change significantly(P=0.892)compared with that of the preoperative group,and the comfort of the femoral artery group was significantly lower than that of the preoperative group(P<0.001).There was no significant difference in operation time,fluoroscopy time and incidence of adverse events between the two groups(P > 0.05).Conclusions: For adult patients,VSD occlusion via radial artery combined with femoral vein is also feasible,safe and effective,avoiding almost all complications of puncture bleeding,and can significantly shorten the bedtime of patients after operation and increase the comfort of patients after operation.However,the transradial approach may lead to failure of the procedure,then puncturing the femoral artery instead.It is not possible to retain the guide wire for left ventricular angiography.But this study is an exploratory study with a small sample size.A prospective multi-center large-scale randomized controlled study will be designed for further verification. |
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