Mid-term results of transcatheter closure of ventricular septal defect using Nit-Occlud Lê ventricular septal defect coil, single-center experience

Shedoudy, Sahar El; El-Doklah, Eman

doi:10.1016/j.jsha.2018.11.002

Cited by 11 publications

(9 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

“…The main reason for failure was inadequate periprocedural sizing of the ventricular septal defect. A similar success rate of VSD closure using the Nit-Occlud® Lê VSD coil has been described in later studies [ 11 , 25 ]. These patients were followed over a 3-year period in 18 European centers.…”

Section: Discussionsupporting

confidence: 76%

“…Recently, it was shown that with new devices, the long-term complication rate is low, however, eccentric, large devices, and long fluoroscopy time increase the risk of early postprocedural arrhythmias after transcatheter closure of VSDs up to 24.1% [ 29 ]. However, a study from Egypt showed that the coil can also cause an AV block and they had to abandon the procedure for this reason in one case [ 25 ]. The pfm occluder has a smooth device design and should be located within the aneurysmal formation of the VSD to make an AV-block III ° unlikely.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

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

et al. 2020

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 76%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

et al. 2020

View full text Add to dashboard Cite

show abstract

“…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: Discussionmentioning

confidence: 99%

“…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 – 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 – 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 surgical approach.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

View full text Add to dashboard Cite

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.

show abstract

Transfemoral Perimembranous Ventricular Septal Defect Device Closure in Infants Weighing ≤ 10 kg

et al. 2023

View full text Add to dashboard Cite

Transcatheter closure of Perimembranous VSDs (PMVSD) remains challenging particularly in infants. The aim of this study is to evaluate the efficacy and safety of transfemoral PMVSD device closure in infants weighing ≤ 10 kg in a single centre. Retrospective review of departmental databases and medical charts to define patient cohort and collect demographic, procedural and follow-up data. Between July 2014 and March 2021, 16 patients underwent attempted transfemoral PMVSD device closure (12 retrograde) at a median age of 11 months (interquartile range [IQR] 9–15.5) and a median weight of 8.3 kg (IQR 7.2–9.5). All patients were either symptomatic, had progressive left heart dilation or had VSD associated valve regurgitation. Median defect size on pre-procedural transoesophageal echocardiography was 6.8 mm (IQR 6–8.5). Median device waist size was 6 mm (IQR 4.5–8). Successful device placement was achieved in 14 patients (88%). One patient developed moderate aortic and tricuspid valve regurgitation upon retrograde and antegrade device deployment, respectively, and subsequently underwent surgical closure. The second patient developed progressive aortic regurgitation (AR) 2 days post procedure, and also underwent surgical removal with no residual AR. There was no cases of device embolization and no femoral arterial compromise. On median follow-up of 40.5 months (IQR 25–64), none of the patients developed complete heart block. Three patients (18.75%) had small residual shunts at latest follow-up which have not required any further intervention. Device closure of PMVSD’s in children weighing ≤ 10 kg is feasible and safe with good procedural success rates. Use of both the antegrade and retrograde approaches may be necessary depending on anatomical variances.

show abstract

Mid-term results of transcatheter closure of ventricular septal defect using Nit-Occlud Lê ventricular septal defect coil, single-center experience

Cited by 11 publications

References 17 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

Transfemoral Perimembranous Ventricular Septal Defect Device Closure in Infants Weighing ≤ 10 kg

Contact Info

Product

Resources

About