Nit-Occlud Lê VSD coil versus Duct Occluders for percutaneous perimembranous ventricular septal defect closure

Nguyen, Hieu Lan; Phan, Quang Tan; Dinh, Linh Huynh; Tran, Hieu Ba; Won, Hoyoun; Thottian, Julian Johny; Duc, Dung Doan; Quang, Truong Nguyen; Kim, Sang Wook

doi:10.1111/chd.12613

Cited by 22 publications

(35 citation statements)

References 37 publications

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“…This was the initial study for introducing this device in clinical practice and, therefore, incorporates the learning curve for the operators using this coil. The final closure rates are close to those reported by others [6,9,16,20,21,23,25,29].…”

Section: Discussionsupporting

confidence: 90%

“…Double-umbrella devices are additionally used in VSD without aneurysmal formation and due to the clipping and stenting mechanism, the risk of causing arrhythmias for these types of defects is potentially higher. Nygyen showed that percutaneous pVSD closure using either Nit-Occlud Lê VSD Coil or Amplatzer Duct Occluders is feasible, safe and efficacious in selected patients [21]. The main problems of Duct Occluders are unsuitable defect anatomy and device embolization, while VSD Coil disadvantages are residual shunt and hemolysis.…”

Section: Discussionmentioning

confidence: 99%

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Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

et al. 2020

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Objective This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm. Background The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects. Methods In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD. Results The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2–65) years and a median body weight of 26.7 (10–109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients). Conclusion The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionmentioning

confidence: 99%

Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

et al. 2020

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“…The most feared complication of transcatheter VSD closure is cAVB with a reported incidence of 0-6.4% [7,25,28,30,32] and cAVB after surgical VSD closure has been reported with a prevalence of 1-5% [16,[33][34][35]. More current studies have reported cAVB rates between 1.25 and 1.4% for transcatheter VSD closure as a comparable risk after operation [9,31,[36][37][38][39]. According to our data, we observed only 1/149 (rate 0.7%) patient with cAVB for all different VSD devices investigated during > 6 years of follow-up, which is a lower rate than published data to date for interventional and Fig.…”

Section: Arrhythmiamentioning

confidence: 88%

“…Remarkably, a new small but detectable shunt was again detected in one of our patients with the Nit-Occlud® 3 years after the procedure during pregnancy. This reopening of the shunt might be a result of increased cardiac output and ventricular dilatation during pregnancy [7,9,31,32]. Therefore, residual shunting appears to be related to the device type and location of the VSD.…”

Section: Residual Shuntmentioning

confidence: 99%

“…However, both methods carry a potential risk of complete atrioventricular block (cAVB). Studies show cAVB occurs at a rate of 0.1-6.8% after interventional VSD closure [4][5][6][7][8][9][10][11][12][13] and < 2% after surgical VSD closure [14,15]. Surgical closure can be considered for the majority of patients but disadvantages include the use of general anesthesia, sternotomy, and extracorporeal circulatory support, which results in longer recovery and hospital time [16][17][18].…”

Section: Introductionmentioning

confidence: 99%

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Short- and Long-term Outcome After Interventional VSD Closure: A Single-Center Experience in Pediatric and Adult Patients

et al. 2020

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Interventional closure of congenital ventricular septal defects (VSD) is recording a continuous rise in acceptance. Complete atrioventricular block (cAVB) and residual shunting are major concerns during follow-up, but long-term data for both are still limited. We retrospectively evaluated the outcome of patients with interventional VSD closure and focused on long-term results (> 1 year follow-up). Transcatheter VSD closures were performed between 1993 and 2015, in 149 patients requiring 155 procedures (104 perimembranous, 29 muscular, 19 residual post-surgical VSDs, and 3 with multiple defects). The following devices were used: 65 × Amplatzer™ Membranous VSD Occluder, 33 × Duct Occluder II, 27 × Muscular VSD Occluder, 3 × Duct Occluder I, 24 × PFM-Nit-Occlud®, and 3 × Rashkind-Occluder. The median age at time of implantation was 6.2 (0.01–66.1) years, median height 117 (49–188) cm, and median weight 20.9 (3.2–117) kg. Median follow-up time was 6.2 (1.1–21.3) years and closure rate was 86.2% at last follow-up. Complications resulting in device explantation include one case of cAVB with a Membranous VSD occluder 7 days after implantation and four cases due to residual shunt/malposition. Six (4%) deaths occurred during follow-up with only one procedural related death from a hybrid VSD closure. Overall, our reported results of interventional VSD closure show favorable outcomes with only one (0.7%) episode of cAVB. Interventional closure offers a good alternative to surgical closure and shows improved performance by using softer devices. However, prospective long-term data in the current era with different devices are still mandatory to assess the effectiveness and safety of this procedure.

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Ventricular Septal Defects Closure

Zunzunegui¹,

Solana²

2023

Mastering Structural Heart Disease

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Nit-Occlud Lê VSD coil versus Duct Occluders for percutaneous perimembranous ventricular septal defect closure

Abstract: Percutaneous pmVSD closure using either Nit-Occlud Lê VSD Coil or Duct Occluders is feasible, safe and efficacious in selected patients. The main problems of Duct Occluders are unsuitable defect anatomy and device embolization while VSD Coil disadvantages are residual shunt and hemolysis.

Cited by 22 publications

References 37 publications

Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

Long-term outcome of perimembranous VSD closure using the Nit-Occlud® Lê VSD coil system

Short- and Long-term Outcome After Interventional VSD Closure: A Single-Center Experience in Pediatric and Adult Patients

Ventricular Septal Defects Closure

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