Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Kobayashi, Daisuke; Salem, Morris; Forbes, Thomas J.; Gordon, Brent M.; Soriano, Brian D.; Dimas, Vasiliki V; Goldstein, Bryan H.; Owada, Carl Y.; Javois, Alexander J.; Bass, John L.; Jones, Thomas K.; Berman, Darren P.; Gillespie, Matthew J.; Moore, John W.; Levi, Daniel S.

doi:10.1002/ccd.27995

Cited by 16 publications

(13 citation statements)

References 5 publications

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“…In addition, most of these studies evaluated device closures performed during infancy with a large percentage of these patients being premature. Reported complications are significantly less in the older patient undergoing PDA device closure [10,[12][13][14][15][16][17]. This is likely due to technical issues based on the size of the patient.…”

Section: Discussionmentioning

confidence: 99%

“…Most of these interventions also appeared to occur within the first few months after PDA device placement [20,21,24]. In patients undergoing PDA device closure at an older age, no reports of subsequent LPA or DAo stenosis requiring intervention have been reported [10][11][12][13][14][15][16][17]. Again, this is likely because the patients are larger and thus the device may be more easily judged as seated well or not in respect to the LPA or DAo.…”

Section: Discussionmentioning

confidence: 99%

“…PDAs discovered later in life may still meet indications for treatment [9]. In these older patients, device closure via catheterization procedure is a reasonable treatment option [10][11][12][13][14][15][16][17].…”

Section: Introductionmentioning

confidence: 99%

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Utility of Follow-Up Echocardiograms in Uncomplicated PDA Device Closures Performed After Infancy

et al. 2022

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Introduction: Guidelines recommend lifelong follow-up with transthoracic echocardiograms (TTE) for patients who had a patent ductus arteriosus (PDA) device closure via catheterization. The goal of this study was to determine the utility of follow-up TTE in patients who underwent an uncomplicated PDA device closure after infancy. Methods: Chart review was performed on patients who had a PDA closure C 1 year of age between 1/1/2002 and 6/1/2020. Patients were excluded if they had other congenital heart disease, did not have a follow-up TTE C 6 months after procedure, had a residual PDA or velocity [ 2.0 m/s in the left pulmonary artery (LPA) or descending aorta (DAo) on the first TTE C 6 months after device placement. Time points included the initial TTE after the procedure, first TTE C 6 months after procedure, and the most recent TTE. Results: A total of 189 patients met the study criteria. The median age and weight at initial procedure were 2.7 (1.0-64.7) years and 12.5 (3.4-69.2) kg. Most recent TTE was performed 2.0 (0.4-17.0) years after PDA closure. There were no significant differences in fractional shortening (36.4 ± 5.0% vs. 36.9 ± 5.6%) or LPA velocity (1.1 ± 0.4 m/s vs. 1.1 ± 0.4 m/s) from initial to most recent TTE, respectively. Left ventricular internal diastolic diameter Zscore significantly decreased (1.4 ± 1.8 vs.-0.01 ± 1.2, p \ 0.01) and DAo peak velocity significantly increased (1.2 ± 0.3 m/s vs. 1.3 ± 0.3 m/s, p = 0.02) from initial to most recent TTE, respectively. No patient died or underwent an intervention on the LPA or DAo for stenosis. Seventy-five patients had a total of 208 repeat TTE [ 1 year after PDA procedure with no change in clinical management. Conclusions: In patients who underwent an uncomplicated PDA closure after infancy, TTE parameters improved or stayed within normal limits on the most recent TTE. Repeat lifetime TTEs after 1-year post-device placement in this population may not necessarily be needed if there are no clinical concerns.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Utility of Follow-Up Echocardiograms in Uncomplicated PDA Device Closures Performed After Infancy

et al. 2022

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“…Several reports on the safety and efficacy of percutaneous PDA closures have been published. [18192021] Most of the reports focused on the pediatric population with limited number of adults included, and the follow-up duration was short or medium term at most.…”

Section: Discussionmentioning

confidence: 99%

Percutaneous device closure of patent ductus arteriosus in adult patients with 10-year follow-up

et al. 2019

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Objectives:We report our 10-year experience with transcatheter closure of patent ductus arteriosus (PDA) in adult using different closure devices.Background:Transcatheter closure of PDA in adults can be challenging because of frequently associated comorbidities. Reports on immediate and intermediate-term results of PDA closure are excellent. This study aimed to provide the outcomes of PDA closure using different devices on long and very long term follow-up in adults.Materials and Methods:Between September 2009 and December 2018, data were retrospectively reviewed from 27 patients who underwent transcatheter closure of PDA. Outcome parameters were procedural success, procedure-related complications, evidence of residual shunt, and improvement in the signs/symptoms for which the procedure was performed. The mean follow-up interval was 72 months.Results:A device was successfully implanted in 27 of 27 patients (15 females). Median age and weight were 24 years (range: 18–57 years) and 69 kg (range: 53–102 kg), respectively. The mean PDA diameter was 4.1 ± 2.1 mm. Devices used were Amplatzer Duct Occluder (19/27), Occlutech Duct Occluder (6/27), and PFM Nit-Occlud (2/27). Doppler transthoracic echocardiography (TTE) demonstrated 92.6% of full occlusion at day 1, rising to 96.3% at 1 month. Three procedure-related complications occurred with no death. Among symptomatic 26 patients (96.3%), there was marked improvement in symptoms. Among 22 patients (81.5%) for whom the procedure was performed to address left ventricular (LV) enlargement, there was reduction or stabilization in LV size on serial TTEs.Conclusions:Transcatheter closure of PDA in the adult patient appears to be safe and effective.

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“…This was done using an Ivalon plug with an 18 F catheter [ 24 ]. Since then, there have been remarkable advances in the technique for transcatheter closure of PDAs [ 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 ], and evolution is continuing with the following aims for the closure device: (1) making the device with material compatible with MRI; (2) conforming it to the full spectrum of PDA sizes and shapes; (3) permitting it to be safely delivered with a sheath of small diameter; (4) allowing free retrievability of the device; (5) crafting a device that will permanently occlude the PDA. Closure by an interventional occluder device is the primary therapeutic choice in infants, children, and adults with a small or moderate size symptomatic PDA [ 1 , 11 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 ].…”

Section: Treatment Of Pda; Surgery Versus Interventionmentioning

confidence: 99%

The Patent Ductus Arteriosus in Adults with Special Focus on Role of CT

et al. 2021

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The primary imaging modality for the diagnosis of patent ductus arteriosus (PDA) is echocardiography. However, CT may be the technique on which an incidental PDA is first recognized because of the increasing number of chest CT scans performed for a variety of causes. Identification of PDA on CT may lead to earlier closure using a PDA occluder device. Immediate identification of incidental PDA is important, but a high rate of missed diagnosis of PDA has been reported due to its small size and anatomic location. In addition, echocardiography may overlook the presence of even a large PDA due to decrease in the amount of shunting through the PDA caused by high pulmonary artery pressures. This review provides the basic CT anatomy and clinical perspective of PDA, and discusses the role of CT in the evaluation of PDA as well as methods to avoid overlooking a small PDA on CT.

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Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus

Cited by 16 publications

References 5 publications

Utility of Follow-Up Echocardiograms in Uncomplicated PDA Device Closures Performed After Infancy

Utility of Follow-Up Echocardiograms in Uncomplicated PDA Device Closures Performed After Infancy

Percutaneous device closure of patent ductus arteriosus in adult patients with 10-year follow-up

The Patent Ductus Arteriosus in Adults with Special Focus on Role of CT

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