Transcatheter Closure Of pmVSD Research Articles

Risk Factors of Long-Term Sequelae After Transcatheter Closure of Perimembranous Ventricular Septal Defect in Young Children.

Complications arising from transcatheter closure of perimembranous ventricular septal defects (pmVSD) in children, such as residual shunts and aortic regurgitation (AR), have been observed. However, the associated risk factors remain unclear. This study identified risk factors linked with residual shunts and AR following transcatheter closure of pmVSD in children aged 2-12 years. The medical records of 63 children with pmVSD and a pulmonary-to-systemic blood flow ratio <2.0 who underwent transcatheter closure between 2011 and 2018 were analyzed with a minimum 3-year follow-up. The success rate of transcatheter closure was 98.4%, with no emergency surgery, permanent high-degree atrioventricular block, or mortality. Defects ≥4.5 mm had significantly higher odds of persistent residual shunt (odds ratio [OR] 6.85; P=0.03). The use of an oversize device (≥1.5 mm) showed a trend towards reducing residual shunts (OR 0.23; P=0.06). Age <4 years (OR 27.38; 95% confidence interval [CI] 2.33-321.68) and perimembranous outlet-type VSD (OR 11.94, 95% CI 1.10-129.81) were independent risk factors for AR progression after closure. Careful attention is crucial for pmVSDs ≥4.5 mm to prevent persistent residual shunts in transcatheter closure. Assessing AR risk, particularly in children aged <4 years, is essential while considering the benefits of pmVSD closure.

Transcatheter Closure of Perimembranous Ventricular Septal Defect Using the Lifetech Konar-Multi Functional Occluder: Early to Midterm Results of the Indonesian Multicenter Study.

Background:The alternative device to close perimembranous ventricular septal defect (pmVSD) has been searched for better result, less complications and applicable for infants. However, the ideal device is still unavailable. We aimed to evaluate the effectiveness and outcome of transcatheter pmVSD closure using the KONAR-multi functional occluder (MFO).Methods:Clinical, procedural, follow-up data of pmVSD patients with symptom of heart failure or evidence of significant left to right shunt, growth failure, recurrent respiratory tract infection, and history of endocarditis who underwent transcatheter closure using the MFO were prospectively evaluated.Results:Between January 2016 and December 2017, there were complete records of 132 pmVSD children closed using MFO from eleven centers in Indonesia. The median of age was 4.5 (0.3–17.4) years; weight 14.8 (3.5–57) kg, defect size at the smallest part 3.4 (1.0–8.1) mm, flow ratio 1.6 (1.3–4.9), mean pulmonary artery pressure 18 (7–79) mmHg, fluoroscopy time 18 (3.8–91) and procedural time 75 (26–290) minutes. A retrograde approach was done in 41 (31%) patients. Procedures succeeded in first attempt in 126 (95.4%), failed in three and migration in three patients. Six of eight infants with congestive heart failure were closed successfully. Of 126 patients with successful VSD closure, 12 months follow-up were completed in all patients. The rate of complete occlusion at 1 month, 3 months, 6 months and 12 months after intervention were 95.2%, 97.6%, 99.2%, and 99.2%, respectively. New-onset aortic regurgitation and moderate tricuspid regurgitation developed only in five and three patients. Neither complete atrioventricular block, nor other complications occurred.Conclusion:Transcatheter closure of pmVSD using the MFO is safe, effective, and feasible in infants and children.

C37. Device Closure of Perimembranous Ventricle Septal Defect with Zero Fluoroscopy : The First case in Eastern region of Indonesia

Abstract Background Ventricular septal defects (VSDs) are the most common Congenital Heart Defects (CHD) lesion in children. Transcatheter closure is considered as an alternative to surgery, for past few decades transcatheter closure were performed under fluoroscopy, recently guidance under Transesophageal Echocardiography (TEE) is increased. Transcatheter closure under TEE Guidance remains challenging but an alternative to overcome the radiation effect. Case Summary We reported 3-year-old female patient admitted to RSUP Dr. Wahidin Sudirohusodo with chief complaint was easily fatigue, Physical finding revealed regular heart sound with a grade 4/6 pansystolic murmur at the left lower sternal border, Transthoracal Echocardiography (TTE) has shown perimembranous VSD (pm-VSD) 6-7 mm L-R shunt with VSD Gradient 58 mmHg and aortic rim 4,5 mm. The patient was diagnosed with pm-VSD without Pulmonary hypertension and suitable for device closure under TEE Guidance. TEE Procedure was performed under general anesthesia and we found pm-VSD 3-4 mm, we decided to close the defect with Amplatzer Duct Occluder II (AGA) no 4/4 with delivery sheath amplatzer Torqvue LP 4F via retrograde approach with zero fluoroscopy, the device was well fixated with small central residual shunt 1,6 mm with hemodynamically unsignificant, The device was released and the procedure was finished without any significant problem. Conclusion We reported first case of VSD closure under TEE guidance in Eastern region of Indonesia, Transcatheter closure of pm-VSD under TEE Guidance are feasible and safe and can be an alternative to surgery and conventional technique under fluoroscopy to prevent radiation effect.

C37. Device Closure of Perimembranous Ventricle Septal Defect with Zero Fluoroscopy : The First case in Eastern region of Indonesia

Abstract Background Ventricular septal defects (VSDs) are the most common Congenital Heart Defects (CHD) lesion in children. Transcatheter closure is considered as an alternative to surgery, for past few decades transcatheter closure were performed under fluoroscopy, recently guidance under Transesophageal Echocardiography (TEE) is increased. Transcatheter closure under TEE Guidance remains challenging but an alternative to overcome the radiation effect. Case Summary We reported 3-year-old female patient admitted to RSUP Dr. Wahidin Sudirohusodo with chief complaint was easily fatigue, Physical finding revealed regular heart sound with a grade 4/6 pansystolic murmur at the left lower sternal border, Transthoracal Echocardiography (TTE) has shown perimembranous VSD (pm-VSD) 6-7 mm L-R shunt with VSD Gradient 58 mmHg and aortic rim 4,5 mm. The patient was diagnosed with pm-VSD without Pulmonary hypertension and suitable for device closure under TEE Guidance. TEE Procedure was performed under general anesthesia and we found pm-VSD 3-4 mm, we decided to close the defect with Amplatzer Duct Occluder II (AGA) no 4/4 with delivery sheath amplatzer Torqvue LP 4F via retrograde approach with zero fluoroscopy, the device was well fixated with small central residual shunt 1,6 mm with hemodynamically unsignificant, The device was released and the procedure was finished without any significant problem. Conclusion We reported first case of VSD closure under TEE guidance in Eastern region of Indonesia, Transcatheter closure of pm-VSD under TEE Guidance are feasible and safe and can be an alternative to surgery and conventional technique under fluoroscopy to prevent radiation effect.

Management of Late-Onset Complete Atrioventricular Block Post Transcatheter Closure of Perimembranous Ventricular Septal Defects

Long-term late-onset complete atrioventricular block (CAVB) is one of the most serious complications of transcatheter closure of perimembranous ventricular septal defect (pmVSD); it can cause an Adams-Stoke attack or even sudden death. Transcatheter closure of pmVSD is not approved by the FDA, yet the procedure has proved to be a successful alternative to a surgical strategy in China. Although transcatheter closure of pmVSD is widely and successfully performed, especially in China, late-onset CAVB is still difficult to avoid. Here, we report a case with late-onset CAVB post transcatheter closure that was successfully treated. By doing so, we reassess the safety of pmVSD occluder closure and highlight that use of this procedure should adhere to more stringent indications.

Device Closure of Perimembranous Ventricular Septal Defect: Choosing Between Amplatzer Occluders.

Background: Off-label device closure of perimembranous ventricular septal defect (pmVSD) is well reported in the literature with encouraging results. However, technical challenges may be encountered.Objectives: To evaluate and compare feasibility, technical aspects, procedural outcomes, and mid-term follow-up of pmVSD closure using Amplatzer™ occluders.Patients and Methods: From July 2015 to July 2018, patients in whom pmVSD closure was attempted using an Amplatzer occluder were retrospectively identified from our institution's database. Device selection was made according to the defect anatomy that was obtained via ventriculography and trans-esophageal echocardiography. Follow-up evaluations were done at discharge, then at 1, 3, 6, and 12 months and yearly thereafter with transthoracic echocardiography and electrocardiogram.Results: In total, 8 Amplatzer Duct Occluder (ADO), 27 ADO II, and 17 Amplatzer Muscular VSD Occluder (AMO) were used in 51 patients with a mean age of 7.4 ± 6.9 years and a mean weight of 25.4 ± 19.8 kg. Implantation was successful in 50/51 patients (98.0%). There was no procedure related mortality. One ADO accidentally embolized to the aorta after release and was surgically recaptured from the iliac artery. All ADO II were delivered retrogradely with the least amount of time (p = 0.002) and the lowest radiation exposure (p < 0.001). Minor valvular disturbances occurred in 8/49 patients (16.3%), including five tricuspid regurgitation (three with ADOII and two with AMO) and three trivial aortic regurgitations (two with ADO and one with ADOII). On a median follow-up of 194 days (range, 60–895 days), no surgical device removal was necessary. At 6 months of follow-up, trivial residual shunt was present in 5/49 patients (10.2%), among which none occurred with ADO. One complete atrioventricular block was detected 18 months after ADO implantation and required permanent pacing.Conclusions: Transcatheter closure of PmVSD using Amplatzer occluders is feasible, safe and efficacious in properly selected patients. The major key factor behind high procedural success rate is proper device selection. ADOII is remarkably superior in terms of device softness, flexibility and faster implantation process. Yet, its use is limited to small defects with particular anatomy.

Postprocedural Outcomes and Risk Factors for Arrhythmias Following Transcatheter Closure of Congenital Perimembranous Ventricular Septal Defect: A Single-center Retrospective Study.

Background:Currently, transcatheter closure of perimembranous ventricular septal defect (pmVSD) is a widely accepted therapeutic modality. However, arrhythmias, especially postprocedural heart blocks, are a concern and outcomes are not very clear. This study explored the outcomes and risk factors of arrhythmias associated with transcatheter device closure of pmVSD.Methods:A total of 395 patients diagnosed with pmVSD who successfully underwent transcatheter intervention between January 2010 and December 2015 in our center were retrospectively reviewed. Electrocardiographic data before and after the procedure were collected and analyzed. We first evaluated the potential risk factors including gender, age, weight, inlet and outlet diameters of defect, subaortic rim length, occluder size, corrected occluder size into body surface area, fluoroscopy time, presence of aneurysm, and deployment position. We compared the potential risk factors between arrhythmia and nonarrhythmia groups using univariate analysis, followed by logistic analysis for independent risk factors.Results:Various arrhythmias were detected in 95 cases (24.1%) following transcatheter closure procedure. Logistic regression analysis revealed that eccentric (odds ratio [OR] 2.9, 95% confidence interval [CI]: 1.2–7.2) and large occluders (OR 2.0, 95% CI: 1.6–2.5), as well as long fluoroscopy time (OR 1.1, 95% CI: 1.1–1.2), were correlated with postprocedural arrhythmia. During 35.5 months (range: 9–80 months) of follow-up, most of the patients (74 out of 95) reverted to normal heart rhythm.Conclusions:The mid-term outcome of patients with arrhythmias after transcatheter closure of pmVSD was satisfactory as most of the patients recovered normal rhythm. Eccentric, large device and long fluoroscopy time increase the risk of arrhythmias after transcatheter closure of pmVSD.

Whether heart blocks post perimembranous ventricular septal defect device closure remain threatening: how could Chinese experiences impact the world?

Transcatheter closure has become one of the alternations of surgical treatment since 1988. However, cAVB occurred as a threatening incidence of 6.8% after Amplatzer VSD Occluder closure, which was quite higher than the incidence of 1% to 2% post-surgical closure, which leaded this kind of technique, was not approved by FDA. In this commentary, we reviewed the publications of cAVB following the device closure, and summarized current data of Modified Amplatzer-type Occluder during long-term follow-up, especially introduced the experiences from China, where this kind of treatment became a routine procedure for VSD children. Moreover, we carried our visualized analysis based on scientific literatures using CiteSpace to draw knowledge burst mapping, which revealed the development procedure on this interested topics, and demonstrated the role of China's works to make contributions in the field, and figured out the limitation of our researches, which supplied a basic understanding on why we could not impact the world. Finally, it concluded that transcatheter closure of pmVSD with Modified Amplatzer-type Occluder would be safe and efficient with low incidence of well controlled complications, but it failed to spread our experiences in a more scientific way. And, we hope this kind of therapy could be accepted in a wider region of the world with the increasing evidence from China.

Cardiac rhythm abnormalities after transcatheter device closure of perimembraneous ventricular septal defects in pediatric patients at intermediate term follow up

Background: Transcatheter closure of perimembranous ventricular septal defects in pediatric patients poses special challenges owing to anatomical relationship between conduction system and perimembraneous ventricular septal defect. Aims: The study aims to assess and evaluate the conduction disturbances after transcatheter device closure of perimembranous ventricular septal defect using different occluders at mid-term follow-up. Methods: We studied 297 patients having PMVSD with clinical and/or echocardiographic evidence of a significant left-to-right shunt. All subjects underwent clinical examination, electrocardiogram (ECG), chest X-rays and transthoracic echocardiography before discharge and at 1, 6 and 12-months after the procedure and yearly thereafter. Platelet anti-aggregation therapy with aspirin 5 mg/kg/day orally and endocarditis prophylaxis was prescribed for six months. Results: The mean age of the patients was 8.64±3.14 years (range 3-17.2 years). Majority (86.2%) had no residual shunt at follow-up. Total rhythm disturbances were seen in about 6% (18/297) of patients with transient complete atrioventricular block (CAVB) occurring in 3 patients. There was no mortality in our study which compares well with the surgical results in which it is between 0-3 percent. Conclusions: This study showed that transcatheter closure of PMVSD using symmetric PMVSD occluders and duct occluders is a safe and effective alternative to surgery. Oversizing of devices should be minimized and low profile devices appropriate to specific morphology of VSD should be used. It has excellent results in experienced hands with minimum morbidity and almost no mortality.

Succesful transcatheter closure of perimembranous ventricular septal defect with inlet extension using ADOI

Introduction Transcatheter closure of perimembranous ventricular septal defect (PM VSD) is abandoned in many center and in some became restricted to certain age and criteria because of the risk of complete heart block (CHB). The risk of damaging the tricuspid valve (TV) in the presence of inlet extension is another risk. I am presenting successful closure of such defect using Amplatzer occlude device for PDA with reasonable follow up period in Prince Sultan Cardiac Center PSCC. Method Through 2011 4 patients underwent transcatheter closure of PM VSD with inlet extension , all patients were consented and procedure were done under general anesthesia , Transesophageal echocardiography was done in all, one has 3D assessment Hemodynamics were assessed pre procedural, A-V loop was applied in 2 patients, ADOI were used in all, heparin and antibiotics were giving during and 24 hr post procedure, 3 patients were extubated same day and one the following day, all patients were kept on aspirin for 6 months. Result Median age 17 kg , 3 female and 1 male , median age 7 year, Median ventilatory duration is one day, Median hospital stay is 2 days, Median Follow up is 10 months, No immediate or early complication or deaths, normal ECG immediately and during follow up period , normal Echocardiography with no residual leak during follow up period. Conclusion In selected patients with PM VSD and inlet extension ADOI device can be used safely and effectively to close the defect with no immediate or early complications.

Transcatheter closure of perimembranous ventricular septal defect with a new occluder: one-year follow-up

Purpose: Transcatheter closure of peri-membranous ventricular septal defects (pmVSDs) has been associated with a significant risk of complete heart block, leading most groups to abandon the technique. We describe the initial world experience of pmVSD closure with a newly designed occluder. Methods: Patients with pmVSD underwent catheter closure using the Amplatzer® Membranous VSD Occluder 2 (St. Jude Medical, MN, USA). Results: Nineteen patients from the 4 centers initially involved worldwide were prospectively included and followed for a 12±3 months. Patients ranged in age from 1.4 to 62 years (median 6 years) and in weight from 9.3 to 96 kg (median26 kg). The Qp/Qs ratio was (mean ± SD) 1.9±1.6. The size of the defect on left ventricular side was (mean ± SD) 9.9±3.5 mm (range 4.6 – 16 mm) and the orifice on right ventricularside was 8.1±2.8 mm (range 3.9 – 14 mm) by echocardiography. Mean device size was 9.4±2.4 mm (range 5 – 14 mm). An eccentric device was used in 9 patients (47%) and a concentric device in 10 (53%). A device was successfully implanted in 18 patients (95%). Procedural time was 122±39 min (range 60 – 207 min). There were no significant procedural complications. Mild (0-2 mm) residual shunt was initially observed in 14 patients (78%). At last follow-up, mild residual shunt was still observed in only 3 patients (17%). There was no significant increase of aortic or tricuspid regurgitation, compared to pre-catheterization levels. No patient showed conduction abnormalities on the ECG, and 17 out of 18 had a Holter evaluation, which was normal in all. Conclusions: Transcatheter closure of pmVSD with the Amplatzer pmVSD Occluder 2 is safe and effective. No conduction abnormalities or any other complications were observed on short and one-year follow of this initial human series.

Successful transcatheter closure of perimembranous ventricular septal defect with inlet extension using Amplatzer occlude device (ADOI)

Introduction Transcatheter closure of perimembranous ventricular septal defect (PM VSD) is abandoned in many center and in some became restricted to certain age and criteria because of the risk of complete heart block (CHB). The risk of damaging the tricuspid valve (TV) in the presence of inlet extension is another risk. I am presenting successful closure of such defect using Amplatzer occluder device for PDA with reasonable follow up period in Prince Sultan Cardiac Center PSCC. Method Through 2011 4 patients underwent transcatheter closure of PM VSD with inlet extension, all patients were consented and procedure were done under general anesthesia, Transesophageal echocardiography was done in all, one has 3D assessment Hemodynamics were assessed pre procedural, A–V loop was applied in 2 patients, ADOI were used in all,heparin and antibiotics were giving during and 24 h post procedure, 3 patients were extubated same day and one the following day, all patients were kept on aspirin for 6 months. Result Median age 17 kg, 3 female and 1 male, median age 7 year, Median ventilatory duration is one day, Median hospital stay is 2 days, Median Follow up is 16 months, No immediate or early complication or deaths, normal ECG immediately and during follow up period, normal Echocardiography with no residual leak during follow up period. Conclusion In selected patients with PM VSD and inlet extension ADOI device can be used safely and effectively to close the defect with no immediate or early complications.

Transcatheter closure of perimembranous and intracristal ventricular septal defects with the shsma occluder

The objective of this study was to evaluate the safety and efficacy of transcatheter closure of perimembranous ventricular septal defect (pmVSD) and intracristal VSD (icVSD) using the Shanghai Shape Memory Alloy (SHSMA) pmVSD occluder. There is still limited experience with transcatheter closure of pmVSD and icVSD. Between January 2003 and September 2010, 348 patients with pmVSD and 47 patients with icVSD underwent transcatheter closure using a SHSMA pmVSD occluder. The total successful closure rate in pmVSD and icVSD subjects was 97.4 and 78.7%, respectively. During the perioperative period, no death, major bleeding or hemolysis occurred in both groups. In pmVSD group, one case of occluder dislodgement, one case of pericardial tamponade, and two cases of thromboembolism occurred. None in icVSD group had these complications. During a median of 3.2 years of follow-up, there was no evidence of significant residual shunt and device-related valve regurgitation. None in icVSD group and 10 patients (2.9%) in pmVSD group had a persistent arrhythmia. Overall, only one patient (0.3%) with pmVSD acquired complete atrioventricular block requiring implantation of a permanent pacemaker. The rim from the tricuspid valve to the defect < 4 mm was the only predictor of arrhythmic complications after procedure (OR = 4.24; P = 0.021). Transcatheter closure of pmVSD in selected patients using the SHSMA occluder is effective and safe. Transcatheter closure of icVSD in experienced hands using this device is also feasible and safe.

Arrhythmias after transcatheter closure of perimembranous ventricular septal defects with a modified double-disk occluder: early and long-term results

With the development of interventional techniques and devices, transcatheter closure of perimembranous ventricular septal defect has been widely performed. However, there has been a lack of long-term follow-up results about postoperative ECG changes of PmVSD patients. We report our experience of early and late arrhythmias after transcatheter closure of PmVSD with a modified double-disk occluder (MDVO). We performed a retrospective review of 79 patients (47 males, 32 females) between September 2002 and May 2007 who underwent transcatheter closure of perimembranous ventricular septal defect. Symmetric and asymmetric PmVSD occluders were used. The diameter of the evaluated defects ranged from 3 to 12mm, as measured by TTE and 3 to 15mm by left ventriculography. Most cases of PmVSD were treated successfully with a single procedure, resulting in a successful closure rate of 97% (77/79 patients). There was no death in any of the patients. After the operation, 79 patients were followed-up for a range of 10-76months (35.3±17.4months). In this series, 11 cases of incomplete right bundle branch block and five cases of complete right bundle branch block occurred during the early period after operation. During long-term follow-up, these issues declined in prevalence to five and four cases, respectively. Moreover, reversible third-degree AVB occurred during closure or after the procedure, and two of the three patients with reversible AVB received a temporary heart pacemaker implantation. These patients recovered 1h, 6days, and 9days later, respectively. During 10-76months of follow-up, no complications occurred in any of the patients, including residual shunt, severe aortic valve, or tricuspid valve regurgitation. Device closure of perimembranous ventricular septal defects with a modified double-disk occluder (MDVO) resulted in excellent closure rates and acceptably low arrhythmia rates.

Transcatheter device closure of perimembranous ventricular septal defects: mid-term outcomes

AimsThe aim of this study was to evaluate the safety and efficacy of transcatheter closure for perimembranous ventricular septal defect (pmVSD) and its long-term results. The most common congenital heart condition is pmVSD. Transcatheter closure of pmVSD is a recently described technique with limited results for mid- to long-term follow-up.Methods and resultsBetween June 2002 and June 2008, 848 patients with pmVSD were enrolled in our study and treated percutaneously with pmVSD occluders. All patients were followed up until December 2008, an average of 37 months. According to colour Doppler transthoracic echocardiography before the intervention and ventriculography, the average end-diastolic pmVSD size was 5.1 and 5.4 mm, respectively. Placement of the device was successful in 832 patients (98.1%) and the median device size was 8.6 mm. During follow-up, 103 adverse events (12.4%) were reported. Most adverse events were categorized as minor and there were nine major adverse events (8.7%), including two complete atrioventricular block requiring pacemaker implantation. Kaplan–Meier estimates showed >85% freedom from major or minor adverse events during a maximal follow-up of 79 months.ConclusionsIn experienced hands, transcatheter pmVSD closure can be performed safely and successfully with low morbidity and mortality. Long-term prognostic results are favourable, and the transcatheter approach provides a less-invasive alternative that may become the first choice in selected pmVSD patients.This trial is registered with ClinicalTrials.gov, number NCT00890799.