Effectiveness And Safety Of Transcatheter Closure Of Perimembranous Ventricular Septal Defect In Adults

As the advance development of interventional technology, transcatheter closure of ventricular septal defects(VSDs) therapy has become an alternative method to surgical VSD repair because of less pain and faster recovery in selected patients. With accumulation of experience and development of transcatheter closure of VSD devices, percutaneous intervention are extremely attractive to both adult patients and physicians. Due to previous transcatheter closure of perimembranous VSD(pm VSD) with Amplatzer occluder was confined to small clinical studies, and postoperative complete atrioventricular block(c AVB) occurrence rate was high, up to date it had not yet been approved by FDA. Transcatheter closure of a pm VSD with either an Amplatzer pm VSD occluder or a modified double-disk pm VSD occluder is a relatively new technique that has yielded promising results in children. However, there are few studies that focus on the results and outcomes of transcatheter closures of pm VSDs in adults, especially no mid or long-term follow-up study was reported. For the transcatheter pm VSD occlusion technique, the outcomes from different centers were not the same, prospective randomized controlled study was less, and there was no systematic review outcomes to provide powerful evidence-based medical therapy options. In view of our center to carry out the transcatheter closure of VSD earlier in China and promising short and medium term follow-up study results in children, we designed and completed this retrospective study to evaluate the long-term safety and effectiveness of transcatheter closures of congenital pm VSDs in adults and provide technical optimization strategy. According to the current related literatures, we carried on the meta-analysis to demonstrate the safety and effectiveness of transcatheter closure technique for further clinical application.1. Effectiveness and safety of transcatheter closure of pm VSDs in adultsObjective This study was designed to determine the long-term safety and effectiveness of modified double-disk occluders for pm VSD closure in adults. Method Between January 2004 and December 2014, 343 adults with pm VSDs were treated via transcatheter intervention using 2 types of double-disk occluders. All patients were followed until June 2015 via electrocardiogram and transthoracic echocardiography. Results Transcatheter intervention was successfully performed in 337 patients; 302 patients received symmetric concentric pm VSD occluders(S-pm VSO), and 35 patients received asymmetric concentric pm VSD occluders(AS-pm VSO), so the overall success rate was 98.3%. During the median 71-month follow-up period, no cases of infective endocarditis, no cerebrovascular accidents, and no cases of either heart failure or death occurred. Two major adverse events(0.6%) were reported: a complete atrioventricular block(c AVB) requiring surgical treatment in one patient and a severe tricuspid valvular regurgitation requiring surgical repair in another patient. Cardiac conduction block was the most common minor adverse event. The mean left ventricular end diastolic volume decreased from 96.6±23.2 ml to 86.0±22.0 ml(p<0.05) at the 6-month follow-up visit. Previously enlarged left ventricular chambers decreased to normal sizes during the follow-up period.2. A systematic review on the effectiveness and safety of transcatheter device closure of pm VSDs.Background: Advances in interventional techniques now allow for transcatheter treatment of some ventricular septal defects(VSD), although there remain concerns about adverse events. We performed a systematic review to look at outcomes and complications associated with transcatheter closure of pm VSDs. Method: A Pub Med search for series in English on device closure of pm VSD from 2002.01.01 to June 2014.12.31 was performed. We excluded small series that were included in multicenter studies and patients who had acquired VSD following myocardial infarction. The random or fix effects model was used to obtain pooled estimates of success and complications. Results: A total of 56 publications comprising 6670 patients with pm VSD were included in this analysis. The mean age of patients ranged from 1.6 years to 37.4 years. The pooled estimate of successful device implantation was 96.8%(95% CI: 96.4-97.3). The pooled estimate of immediate complete closure rate was 76.2%(95%CI:71.2-81.1). The pooled estimate of the major complication was 0.6%(95% CI: 0.4-0.8). The most common minor complication was arrhythmias(pooled estimate 14.6%; 95% CI: 11.8–17.5). Others included valvular defects(pooled estimate 4.7%; 95% CI: 2.8–5.9) and end of follow-up residual shunts(pooled estimate 3.1%; 95% CI: 2.0–4.1).Conclusion1. In conclusion, transcatheter closure of pm VSDs using modified double-disk occluders is both safe and effective and yielded excellent long-term results in adults, with potential benefits including the remodeling of the heart, reduced incidences of infective endocarditis, and the prevention of left ventricular volume overload.2. Our analysis suggests that transcatheter device closure of VSD is safe and yields good results, and the most common complication is none c AVB arrhythmias, which achieves or superior to surgical results. Further stratification by age of patients, and prevention of complications is needed before this can be recommended for routine treatment.3. This study verified the effectiveness and safety of transcatheter closure of pm VSD in adults, and established the transcatheter closure pm VSD importance therapy status by meta-analysis.