Comparison of perventricular and percutaneous ultrasound-guided device closure of perimembranous ventricular septal defects.

Background: Ultrasound-guided percutaneous device closure of perimembranous ventricular septal defects (PmVSD) is a minimally invasive recent treatment approach. Perventricular PmVSD device closure is an emerging radiation-free intervention, yet it comes with certain limitations. No studies compared both of these treatment approaches. Methods: We performed a retrospective institutional data comparison of percutaneous (PCP Group, n = 138) and perventricular (PVP Group, n = 67) ultrasound-guided device closure procedures in 205 patients with PmVSD between March 2017 and December 2022. Results: Patients of the PCP and PVP groups had a median age of 4.9 years (IQR, 3.1-14.0) and 5.3 years (IQR, 3.4-13.1) respectively. The median PmVSD diameter in the PCP Group was 4.0 mm (IQR, 3.3-5.3) and 5.2 mm (IQR, 4.0-7.0) in the PVP Group (p = 0.001). There was no significant difference in success rates between the PCP and PVP Groups (intention-to-treat population, 88.4% vs. 92.5%, p = 0.36; as-treated population, 88.4% vs. 89.3%, p = 0.84). 5/8 failed percutaneous cases that were shifted to the perventricular approach were successful. Compared to the PVP Group, patients of the PCP group experienced a significant decrease in ventilation time, drainage volume, and postoperative hospital stay (p < 0.001). The median follow-up period was 24 months (IQR, 6-42) for the PCP group and 61 months (IQR, 53-65) for the PVP group. The overall severe adverse event rate was 0% in the PCP group and 3.0% in the PVP group. Conclusions: Perventricular and percutaneous ultrasound-guided device closure of PmVSD are both effective and safe treatment options. The percutaneous approach offers less trauma and faster recovery and may be the preferred approach in selected patients.

Comparisons of perventricular device closure, conventional surgical repair, and transcatheter device closure in patients with perimembranous ventricular septal defects: a network meta-analysis.

BACKGROUND: Treatments for perimembranous ventricular septal defects (pmVSD) mainly include conventional surgical repair (CSR), transcatheter device closure (TDC), and perventricular device closure (PDC). We aimed to perform a network meta-analysis to compare the three approaches in patients with pmVSD. METHODS: We searched for comparative studies on device closure and conventional repair for pmVSD to April 2020. A network meta-analysis was performed under the frequentist frame with risk ratio and 95% confidence interval. The main outcome was the procedural success rate. Additional outcomes were postoperative complications, including residual shunt, intra-cardiac conduction block, valvular insufficiency, incision infection, and pericardial effusion. RESULTS: Twenty-four studies of 8113 patients were included in the comparisons. The pooled estimates of success rate favored the CSR compared with the PDC. No significant differences of success rate were found in the TDC versus CSR and the PDC versus TDC. The pooled estimates of incidences of the residual shunt, new tricuspid regurgitation, incision infection, and pericardial effusion favored the PDC compared with the CSR. There were no significant differences between the PDC and TDC approaches in all outcomes except new aortic regurgitation. CONCLUSION: The PDC technique not only reduces the risk of significant complications compared with the CSR, but also produces not inferior results compared with the TDC in selected pmVSD patients. PROSPERO REGISTRATION NUMBER: CRD42019125257.

A meta-analysis of perventricular device closure of doubly committed subarterial ventricular septal defects.

BACKGROUND: To investigate the safety and efficacy of perventricular device closure of doubly committed subarterial ventricular septal defects (dcsVSDs). METHODS: PubMed and Scopus were searched for studies in English that focused on perventricular device closure of dcsVSDs and were published up to the end of September 2019. We used a random-effects model to obtain pooled estimates of the success and complication rates. RESULTS: A total of 9 publications including 459 patients with dcsVSDs were included. The median follow-up duration ranged from 2 months to 5 years, with the mean age of patients ranging from 6.1 months to 4.5 years. The pooled estimate of the overall success rate of device closure in the 9 studies was 0.89 (95% CI: 0.86-0.93, I2 = 26.5%, P = 0.208). Further meta-regression analysis indicated no significant correlation between the success rate and the following factors: publication year, sample size, study type, mean age, mean weight, mean VSD size, and ratio of device size/weight. The pooled rate of postoperative aortic regurgitation was 0.045 (95% CI: 0.018-0.071, I2 = 50.96%, P = 0.000). The pooled rate of follow-up aortic regurgitation (AR) was 0.001 (95% CI, - 0.003-0.004, I2 = 63.00%, P = 0.009.) The pooled estimated rate of severe intraoperative complications was 0.106 (0.073-0.140, I2 = 70.7%, P = 0.208). Postoperative and follow-up complications were rare. No occurrence of a complete atrioventricular block was reported up to the last follow-up visit. CONCLUSIONS: Perventricular device closure may be an alternative to conventional surgical repair in selected patients with dcsVSDs. The success rate was stable regarding the publication year and sample size, suggesting a relatively short learning curve and the technique's potential for application.

A meta-analysis of perventricular device closure of perimembranous ventricular septal defect.

BACKGROUND: To investigate the safety and efficacy of perventricular device closure of perimembranous VSD (pmVSD). METHODS: PubMed and Scopus were searched for studies in English focusing on perventricular device closure of pmVSD published up to the end of March 2019. We used a random-effects model to obtain pooled estimates of the success and complication rates. RESULTS: A total of 15 publications comprising 1368 patients with pmVSD were included. The median follow-up duration was 2 months to 5 years, with a mean patient age ranging from 2 months to 56 years. The pooled success rate was 0.95 (I2 = 86.2%, P = 0.000). The pooled rate of postoperative residual shunting was 0.02 (95% CI: 0.01-0.03, I2 = 87.3%, P < 0.001). The pooled rate of residual shunting in the follow-up period was 0.001 (95% CI:-0.001-0.002, I2 = 30.5%, P = 0.126). The pooled estimated rate of severe complications was 0.074 (95% CI: 0.046-0.102, I2 = 30.5%, P = 0.126). The pooled incidence of complete atrioventricular block (cAVB) was 0.002 (95% CI: 0.000-0.005, I2 = 0.0%, P = 0.577). CONCLUSIONS: Perventricular device closure may be an alternative to conventional surgical repair in selected patients with pmVSD. The success rate was stable regarding the publication year and sample size and suggested both the short learning curve of this technology and its potential for wide application. The incidence of severe arrhythmia, especially cAVB, was low. These good results may be limited by the number of enrolled patients, and a more detailed and larger sample is required for further analysis.

Effectiveness and safety of perventricular device closure in congenital perimembranous ventricular septal defects: A systematic review and meta-analysis / 中国胸心血管外科临床杂志

@#Objective To investigate the safety and effectiveness of perventricular device closure (PDC) for congenital ventricular septal defects (VSD) by a meta-analysis. Methods PubMed, The Cochrane Library, EMbase and China Biology Medicine (CBM) databases were searched for studies on PDC of VSD up to October 2018 by computer. We included studies only with more than 80% patients diagnosed with perimembranous VSD. A meta-analysis was performed to obtain pooled estimates of success rate and incidences of complications with 95% confidence interval (CI). Subgroup analysis stratified by percentage of perimembranous VSD was performed. Risk difference (RD) was used in the comparison of perioperative data with follow-up data. Results Fifteen studies (2 randomized controlled trials, 3 retrospective cohorts, and other 10 retrospective single-arm studies) involving 4 164 patients (3 848 patients with perimembranous VSD) were included in this meta-analysis. The pooled success rate was 95.4%. Incidences of residual shunt, aortic insufficiency, tricuspid insufficiency, and third-degree atrioventricular block were 5%, 0.1%, 3%, and less than 0.001% respectively. Improvements of residual shunt and aortic insufficiency were confirmed in follow-up patients. Conclusion PDC of congenital perimembranous VSDs is safe and yields good results. Because some limitations can not be overcomed, multicenter randomized controlled trials are needed to confirm our results.

Perventricular device closure of doubly committed sub-arterial ventricular septal defects via a left infra-axillary approach.

BACKGROUND: This study sought to evaluate the feasibility, safety, and efficacy of perventricular device closure of a doubly committed sub-arterial ventricular septal defect (dcVSD) through a left infra-axillary approach. METHOD: Forty-five patients, with a dcVSD of less than 8 mm in diameter, were enrolled in this study. The pericardium was exposed and opened through a left infra-axillary mini-incision. Two parallel purse-string sutures were placed on the right ventricle outflow tract and under transesophageal echocardiography guidance, a delivery sheath loaded with the device was inserted into the right ventricle and advanced through the defect into the left ventricle. The device, connected to a delivery cable, was then deployed. RESULTS: Forty-one patients achieved successful device closure. In four patients, the device failed to occlude the VSD due to device dislodgement, device-related aortic regurgitation, and residual shunts, and open surgical repair was required. The mean dcVSD diameter was 4.5 ± 1.0 mm (range, 3.0-8.0 mm). The implanted device size was 6.0 ± 1.5 mm (range, 4-10 mm). All patients were implanted with an eccentric device. The mean intracardiac manipulation time was 20.9 ± 7.1 min (range, 9-45 min). The procedure time was 62.5 ± 19.5 min (range 34-105 min). There were no severe adverse events. CONCLUSIONS: Perventricular device closure of a dcVSD through a left infra-axillary approach is feasible, safe, and efficacious in selected patients with dcVSD.

Outcomes of perventricular off-pump versus conventional closure of ventricular septal defects: a prospective randomized study.

OBJECTIVES: Perventricular device closure (PVDC) of ventricular septal defects (VSDs) has demonstrated excellent clinical results. However, no prospective studies have compared PVDC with the conventional approach (CA). METHODS: Between June 2012 and August 2014, 640 consecutive patients with isolated VSD were enrolled in the study, and randomized into the PVDC group ( n = 320) and the CA group ( n = 320). The mean ages were 36.2 (10; 36) months and 36.2 (10; 36) months, respectively. The average weights were 13.9 (8.1; 15.0) kg and 14.5 (6.9; 13.8) kg, respectively. The mean follow-up was 24.9 (standard deviation 1.8) months. RESULTS: No early or late deaths occurred in either group. The procedural success rate reached 96.6% in the PVDC group, with a 3.4% conversion rate to CA. Mean procedure time was 56.9 (30; 70) min in the PVDC group and 162 (120; 180) min in the CA group ( P = 0.000). Thirteen (3.9%) patients in the CA group and only 4 (1.3%) in the PVDC group required postoperative blood transfusion in the intensive care unit ( P = 0.040). At the final follow-up, significantly more residual shunts were found in the CA group. No rhythm or conduction disorders occurred in any patient of either group. CONCLUSIONS: According to the mid-term follow-up results, PVDC has similar efficacy to CA for VSD closure. The off-pump PVDC technique reduces blood product transfusion and the procedural time and minimizes surgical trauma while providing excellent cosmetic results.

Hybrid perventricular device closure of doubly committed subarterial ventricular septal defects: mid-term results.

BACKGROUND: Doubly committed Subarterial ventricular septal defect (VSD) is a specific anatomic type of VSD located just beneath the aortic valve. The purpose of this study was to evaluate the safety and feasibility of using minimal invasive perventricular device closure in managing this type of VSD. METHODS: During Dec 2008 and Aug 2010, 34 Pediatric patients with doubly committed subarterial VSD who met the inclusion criteria for device closure were enrolled in this study. Perventricular closure was attempted using a unique design eccentric device under the guidance of real-time transesophageal echocardiography. Complications such as residual shunt, valve regurgitation, arrhythmias were all recorded in postoperative period and during follow-up. RESULT: Perventricular device closure was successfully done in 28 patients (82%). 6 patients converted to open surgical repair due to residual shunt >3mm (1 patient), more than mild degree aortic regurgitation (3 patients) and device mal-position (2 patients). Complete closure rate was achieved in 93% at discharge and 100% during 20 months follow-up. No severe complications such as device embolism, significant arrhythmias and noticeable valve regurgitation were noted during follow-up. Procedure induced trivial grade aortic valve regurgitation was noted in five (18%) patients after procedure while only one (4%) persisted during midterm follow-up. CONCLUSION: Perventricular closure of doubly committed subarterial VSDs appears to be a safe and effective minimally invasive technique with good mid-term outcomes.

Epicardial deployment of right ventricular disk during perventricular device closure in a child with apical muscular ventricular septal defect.

We report a successful perventricular closure of an apical muscular ventricular septal defect (mVSD) by a modified technique. An eight-month-old infant, weighing 6.5 kilograms, presented with refractory heart failure. The transthoracic echocardiogram showed multiple apical mVSDs with the largest one measuring 10 mm. perventricular device closure using a 12 mm Amplatzer mVSD occluder was planned. The left ventricular disk was positioned approximating the interventricular septum; however, the right ventricular (RV) disk was deployed on the free wall of the RV due to an absent apical muscular septum and a small cavity at the apex. The RV disk of the device was covered using an autologous pericardium. His heart failure improved during follow-up.