Multicenter nit‐occlud® PDA‐R patent. Ductus arteriosus occlusion device trial: Initial and six‐month results

Granja, Miguel; Trentacoste, Luis; Rivarola, Marcelo; Barbosa, Jesús Damsky; Lucini, Victorio; Peirone, Alejandro; Spillman, Ana

doi:10.1002/ccd.24912

Cited by 5 publications

(5 citation statements)

References 12 publications

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“…Consistent with previous reports, we documented minimal minor vascular complications, aligning with findings in the global literature on the use of this device, no patient reported pulseless or acute limb injury, decrease of ejection fraction post-procedure, pericardial effusion or any other 11,13,21,23 . Two patients presented residual shunt of 0.5 mm during follow-up, and one required a new procedure for device closure 10 months later.…”

Section: Discussionsupporting

confidence: 91%

“…In Latin America, the closest study to ours was made in Argentina, evaluating a total of 43 patients treated with Nit-Occlud ® between 2010 and 2011 from three different medical centers 23 . The device was successfully implanted in all patients, achieving full closure of the PDA in all the patients at 3 months.…”

Section: Discussionmentioning

confidence: 99%

“…The device was successfully implanted in all patients, achieving full closure of the PDA in all the patients at 3 months. Only one case of embolization was registered, associated to undersizing, and was treated successfully with a larger device 23 . In our study, two devices caused embolization into the aorta.…”

Section: Discussionmentioning

confidence: 99%

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Experiencia del cierre percutáneo de conducto arterioso persistente de pequeño a grande con el dispositivo Nit-Occlud® en un hospital de referencia terciaria en Colombia

Galvis-Luna,

Guzmán-Serrano,

Olave-Rueda

et al. 2024

ACM

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Background:The decision to close patent ductus arteriosus should always be individualized and taken together with the child's family once the risks and benefits of both choices have been exposed. Objective: This study aims to report the experience and outcomes in patients undergoing endovascular closure of small to medium-size PDA with a Nit-Occlud ® device in a tertiary referral hospital in Colombia. Methods: Longitudinal descriptive study, which included all patients under 18 years of age who underwent percutaneous ductal closure with Nit-Occlud ® device between January 1, 2011, and February 1, 2023. Patients with associated complex congenital heart disease requiring surgical management, pregnant patients, and patients with incomplete data regarding studied variables were excluded from the study. Results: Eighty-seven patients were documented, with a mean age, weight, and height at closure of 51 months, 14 kg, and 95.83 cm, respectively. About 70% of the patients (n = 61) were female, 76% were under 6-years-old and only one patient was over 15. The average size of the ductus at the pulmonary end was 2 mm. Four of the total number of patients did not achieve PDA closure during the procedure. Of the remaining 83, complete immediate closure was achieved in 81 patients. A device exchange for a larger device was required during the same procedure in one of the cases. Two patients presented residual shunt of 0.5 mm during follow-up, and one required a new procedure for device closure 10 months later. Only one device presented repeatedly embolization to the aorta, requiring surgical removal. As a technical difficulty, one device presented repeated passage into the aorta, so it was decided to remove it before releasing it to avoid complications, and given the complex anatomy of the ductus, surgical closure was indicated. Among the complications, one patient presented a hematoma of the subcutaneous tissue in the right thigh, which improved with medical management, and no deaths related to the procedure were registered. Conclusions: Using the Nit-Occlud ® device to close small to moderate-sized ductus remains a safe and effective strategy with successful closure rates at 1-year follow-up irrespective of age, weight, height, or whether it involves a small or medium-sized duct. Despite our limitations, results concerning adverse effects are comparable to those observed in multicentric studies conducted in other regions.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionmentioning

confidence: 99%

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Experiencia del cierre percutáneo de conducto arterioso persistente de pequeño a grande con el dispositivo Nit-Occlud® en un hospital de referencia terciaria en Colombia

Galvis-Luna,

Guzmán-Serrano,

Olave-Rueda

et al. 2024

ACM

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“…Potentially desirable improvements may reduce vascular injury, improve the ease and accuracy of positioning and deployment, or improve ductal closure. Evaluation of efficacy of devices such as Nit-OccludVR PDA in some studies [ 16 , 17 ] was done, and they recommended PDAs ranging from 2 to 6 mm can be effectively and safely closed using the Nit-Occlud PDA device, with good procedural and six-month results [ 18 ].…”

Section: Discussionmentioning

confidence: 99%

Midterm follow up of transcatheter closure of coronary artery fistula with Nit-Occlud® patent ductus arteriosus coil

Amoozgar

Edraki

Naghshzan

et al. 2021

BMC Cardiovasc Disord

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Background Coronary artery fistula (CAF) is a rare congenital anomaly with a challenging scenario in children. This study reports our experience in transcatheter closure of CAF with Nit-Occlude PDA coil and midterm clinical and imaging follow-up. Methods Twelve children with congenital CAF between 2009 and 2019, mean age 2.05 ± 2.05 years (4 days to 7.2 years), mean weight 8.8 ± 4.83 (2.8–17 kg), who underwent transcatheter closure with PFM coil at the Namazi hospital, Shiraz, Iran, were reported. Echocardiography and electrocardiogram were done before and after the procedure (early, 3, and 6 months after), and Multi-slice computerized tomography or conventional coronary angiography was performed at least one year after closure. Results In a median follow-up of 5.5 years (range 13 months to 8 years), retrogradely closed fistula had no residual, and the fistula tract was wholly occluded, but in most anterogradely closed fistula, had a small residual, which made the fistula tract open and need additional coil closure. Conclusions Transcatheter closure of CAF with PFM coil is feasible and effective with low mortality and morbidity, although antegrade closure with this device may be accompanied by residual shunt and need for multiple coil insertion.

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“…This device was especially designed to treat large PDAs and may be utilized in infants with a body weight of less than 10 kg. Previous studies showed that patent arterious duct closure with the Nit‐Occlud PDA‐R® occluder is feasible and safe in large and long ducts located in children more than 10 kg in weight. In these children, initial closure rate was 58% at the end of the procedure, but after 3 month in follow‐up, all 43 duct were completely closed.…”

Section: Discussionmentioning

confidence: 99%

Implantation of the new Nit‐Occlud PDA‐R device in children below 10 kilogram

Moysich

Happel

Laser

et al. 2015

Cathet Cardio Intervent

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Multicenter nit‐occlud^® PDA‐R patent. Ductus arteriosus occlusion device trial: Initial and six‐month results

Abstract: PDAs ranging from 2 to 6 mm can be effectively and safely closed using the Nit-Occlud® PDA-R device, with good procedural and six-month results. The Nit-Occlud® PDA-R emerges as an optimal alternative for closure of small to moderate PDAs.

Cited by 5 publications

References 12 publications

Experiencia del cierre percutáneo de conducto arterioso persistente de pequeño a grande con el dispositivo Nit-Occlud<sup>®</sup> en un hospital de referencia terciaria en Colombia

Experiencia del cierre percutáneo de conducto arterioso persistente de pequeño a grande con el dispositivo Nit-Occlud<sup>®</sup> en un hospital de referencia terciaria en Colombia

Midterm follow up of transcatheter closure of coronary artery fistula with Nit-Occlud® patent ductus arteriosus coil

Implantation of the new Nit‐Occlud PDA‐R device in children below 10 kilogram

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