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Consensus Guidelines for the Prevention and Management of Periprocedural Complications of Transcatheter Patent Ductus Arteriosus Closure with the Amplatzer Piccolo Occluder in Extremely Low Birth Weight Infants.

ABSTRACT: Transcatheter closure of patent ductus arteriosus (PDA) in premature infants is a feasible, safe, and an effective alternative to surgical ligation and may be performed with an implant success rate of 97%. Major procedural complications related to transcatheter PDA closure in extremely low birth weight (ELBW) infants are relatively infrequent (< 3%) ,but may be associated with a fatality if not optimally managed. Operators performing transcatheter PDA closures should be knowledgeable about these potential complications and management options. Prompt recognition and treatment are often necessary to avoid serious consequences. With strict guidelines on operator training, proctoring requirements, and technical refinements, transcatheter PDA closure in ELBW infants can be performed safely with low complication rates. This article summarizes the consensus guidelines put forward by a panel of physicians for the prevention and management of periprocedural complications of transcatheter PDA closure with the Amplatzer Piccolo Occluder in ELBW infants.

SUBMITTER: Sathanandam S

PROVIDER: S-EPMC8292293 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ?700 grams.

Project description:ObjectivesCharacterize the safety and effectiveness of the Amplatzer Piccolo Occluder for patent ductus arteriosus (PDA) closure.BackgroundThe presence of a hemodynamically significant PDA has been associated with an increased risk of morbidity and mortality in children born premature.MethodsThis was a single arm, prospective, multicenter, non-randomized study to evaluate the Amplatzer Piccolo Occluder to treat PDA in patients ?700?g. From June 2017 to February 2019, 200 patients were enrolled at nine centers, with 100 patients weighing ?2?kg. Primary effectiveness endpoint was the rate of PDA closure at 6-month follow-up. Primary safety endpoint was the rate of major complications through 6 months. Secondary endpoint was rate of significant pulmonary or aortic obstruction through 6?months' follow-up.ResultsThe implant success rate was 95.5% (191/200) overall and 99% in patients ?2 kg (99/100). The primary effectiveness endpoint was achieved in 99.4% of implanted patients. Four patients experienced a primary safety endpoint event (2 transfusions, 1 hemolysis, and 1 aortic obstruction). There were no branch pulmonary artery obstructions. Five patients, all ?2 kg, were noted to have worsening of tricuspid regurgitation (TR) after the procedure. None of the TR incidences manifested clinically. The Amplatzer Piccolo Occluder received FDA approval in January 2019 and became the first device approved for PDA closure in patients ?700?g.ConclusionsThis study supports the safety and effectiveness of the Amplatzer Piccolo Occluder, particularly in patients between 700?g and 2 kg where there is currently a significant unmet need in the United States. ClinicalTrials.gov identifier: NCT03055858.

| S-EPMC7754477 | biostudies-literature

Late Complication After Transcatheter Closure of Patent Ductus Arteriosus.

Project description:We describe the case of a 32-year-old man with history of patent ductus arteriosus (PDA) closed with an Amplatzer device 12 years earlier. Imaging investigations revealed a persistent large PDA and the device migrated in the right pulmonary artery. A new transcatheter PDA occlusion was attempted with optimal post-procedural results. (Level of Difficulty: Advanced.).

| S-EPMC8289132 | biostudies-literature

Transcatheter device closure of patent ductus arteriosus without arterial access--single institution experience.

Project description:ObjectiveRetrospective analysis of feasibility, safety and advantages of device closure of patent ductus arteriosus (PDA) using only venous access.BackgroundArterial access for transcatheter device closure of PDA has been a standard practice, but has inherent complications, especially in infants.MethodRecords of patients who underwent PDA device closure from 2004 to 2012 were reviewed. Echocardiography was used for patient selection and for assessment of procedural outcome.Result151 out of 179 patients underwent PDA device closure with venous access alone, weighing 2.2-58 kg with half <10 kg and follow up of 6 months-8 years. Fluoroscopic time ranged from 2.2 to 16 min. Immediate closure was achieved in 146 patients. Two patients had new-onset left pulmonary artery turbulence and one had residual flow.ConclusionPDA device closure without arterial access can be accomplished safely and effectively in vast majority of patients including infants.

| S-EPMC3860799 | biostudies-literature

Transcatheter Closure of Patent Ductus Arteriosus under Echocardiography Guidance: A Randomized Controlled Noninferiority Trial.

Project description:BackgroundPercutaneous occlusion under fluoroscopy guidance has become the preferred method for the treatment of patent ductus arteriosus (PDA). To avoid radiation exposure and contrast agent use, PDA occlusion under transthoracic echocardiography (TTE) guidance was conducted.ObjectivesWe assessed the hypothesis that the success rate of percutaneous PDA occlusion under TTE was noninferior to that under fluoroscopy guidance.MethodsIn this single-center trial, 100 patients were randomly assigned in a 1 : 1 ratio to the TTE group (n = 50) or to the fluoroscopy group (n = 50). The primary endpoint was the success rate of occlusion, with the noninferiority margin set at 8% for the between-group difference in intention-to-treat analysis. Secondary endpoints were hospitalization duration, cost, procedure time, and rate of adverse events including occluder migration, hemolysis, peripheral vascular complications, and residual shunt at 1-month and 12-month follow-up.ResultsPatient, defect, and device characteristics were similarly distributed between groups. The success rate of occlusion was 98% for the TTE group and 100% for the fluoroscopy group (absolute difference: -2%; 95% confidence interval: -5.9% to 1.9%). Cost and procedure duration were significantly lower in the TTE group, without adverse events in either group at a median of 12.0 months (range, 10.0-15.5 months) of follow-up.ConclusionPercutaneous PDA occlusion can be performed via TTE guidance safely and effectively, and the success rate of the TTE-guided procedure was noninferior to that under fluoroscopy guidance, with reduced cost and procedure time. The trial is registered with http://www.chictr.org.cn (ChiCTR-ICR-15006334).

| S-EPMC7556051 | biostudies-literature

Echocardiographic Prediction of Left Ventricular Dysfunction After Transcatheter Patent Ductus Arteriosus Closure in Children.

Project description:Objectives: To evaluate the change of left ventricular (LV) systolic function after transcatheter patent ductus arteriosus (PDA) closure in children, and to identify whether echocardiography parameters could be the predictors of LV dysfunction post-PDA closure if present. Methods: This study enrolled 191 pediatric PDA patients, and all of them underwent successful transcatheter PDA closure between January 2016 and December 2018. The patent ductus arteriosus diameter (PDAd), aortic root diameter (AOd), left atrial diameter (LAd), right ventricular outflow tract dimension (RVOT), LV end-diastolic dimension (LVEDD), and LV end-systolic dimension (LVESD) were all measured by echocardiography at pre-closure, post-closure (within 24 h after the procedure), and follow-up (3 months after the procedure). The ratio of PDAd to AOd (PDAd/AOd), the ratio of LAd to AOd (LAd/AOd), the left ventricular ejection fraction (LVEF), and the fractional shortening (FS) were calculated. Results: The LAd, LVESD, LVEDD, FS, and LVEF decreased significantly in the 24 h after closure, compared to pre-closure levels. However, all echocardiography parameters recovered to pre-closure levels at 3 months after PDA closure in all patients. Moreover, the pre-closure LAd, LVEF, PDAd/AOd, and LAd/AOd were higher in the patients with post-closure LV systolic dysfunction than in those without post-closure LV systolic dysfunction. Furthermore, the pre-closure LVEF, PDAd/AOd, and LAd/AOd were correlated with the post-closure LVEF, and pre-closure LVEF ≤ 66.5%, PDAd/AOd ≥ 0.28, and LAd/AOd ≥ 1.54 predict the post-closure LV systolic dysfunction. Conclusion: Transcatheter closure of PDA causes a significant deterioration in LV systolic function early after PDA closure, which recovered completely within 3 months of post-closure in children. Pre-closure LVEF, PDAd/AOd, and LAd/AOd can be the predictors of post-closure left ventricular systolic dysfunction.

| S-EPMC6812610 | biostudies-literature

Staged transcatheter closure for atrial septal defect and patent ductus arteriosus: a case report.

Project description:Atrial septal defect (ASD) and patent ductus arteriosus (PDA) are both common congenital heart diseases, but the combination of these two cardiac defects is extremely rare, and the therapeutic strategy is controversial. We treated an adult patient with combined ASD and PDA, and safely attained a successful outcome with two-stage transcatheter closure, which is PDA closure preceding ASD closure, to prevent serious complications. Transcatheter closure of one of the defects is now widely accepted as an alternative to surgical closure. In addition, adults with both ASD and PDA are better suited for transcatheter closure than surgical closure. One of the reasons is the difficulty to ligate the ductus arteriosus of an adult patient due to its friability and calcification. Meanwhile, simultaneous combined transcatheter closure of ASD and PDA can result in serious complications, such as thrombocytopenia and haemolysis, whose mechanism is considered to be the destruction of platelets and red blood cells by the residual shunt through implanted devices. Additionally, antiplatelet therapy that prevents device-related thrombus formation after ASD closure can possibly exacerbate thrombocytopenia and haemolysis. Therefore, the staged strategy is reasonable from the perspectives of antiplatelet therapy and haemodynamic changes.

| S-EPMC6601221 | biostudies-literature

Patent foramen ovale and closure technique with the amplatzer occluder.

Project description:Proof that percutaneous closure of the patent foramen ovale (PFO) is superior to medical treatment is still incomplete. Paradoxical embolism is a rare event occurring over decades rather than years. None of the 4 randomized trials published carried enough patients or was followed up for long enough to reach superiority endpoints. All data, however, point to a benefit of PFO closure. Free wall erosion (exceedingly rare) and triggering of atrial fibrillation (in about 1% of patients) are the only noteworthy complications. They are outweighed by the supposedly prevented events of paradoxical embolisms, such as stroke, transient ischemic attacks, myocardial infarctions, or other systemic embolisms. Medical treatment with perhaps the exception of lifelong oral anticoagulation provides less protection. During a 10-year follow-up of a comparative study the annual mortality was significantly lower in the patients with PFO closure (0.4%) than in those with medical treatment (1.1%, P < 0.03). PFO closure can be accomplished in less than 1 hour with immediate resumption of physical activity. It represents thus a kind of mechanical vaccination.

| S-EPMC4099166 | biostudies-literature

Interventional Closure of a Patent Ductus Arteriosus Using an Amplatz Canine Duct Occluder in an Alpaca Cria.

Project description:A 6-month old female alpaca cria presented to The Ohio State University for evaluation of a cardiac murmur. Echocardiography revealed a left-to-right shunting patent ductus arteriosus, a restrictive left-to-right shunting perimembranous ventricular septal defect, and secondary moderate left atrial and ventricular dilation. Aortic root angiography demonstrated a type IIA patent ductus arteriosus (PDA). Interventional closure of the PDA was successfully performed, without complication, using an Amplatz canine duct occluder. This case report describes the materials and methods used for interventional closure of a PDA in an alpaca cria.

| S-EPMC5508309 | biostudies-literature

Takotsubo syndrome following patent ductus arteriosus device closure.

Project description: Not available

| S-EPMC9373964 | biostudies-literature

Efficacy of pharmacologic closure of patent ductus arteriosus in small-for-gestational-age extremely preterm infants.

Project description:BACKGROUND:Optimal management of the patent ductus arteriosus (PDA) in preterm infants remains controversial. Therefore, studies identifying infants who are most likely to benefit from PDA treatment are needed. AIM:We sought to examine if significant intrauterine growth restriction, defined by birth weight z-score, reduces the efficacy of PDA closure with indomethacin or ibuprofen and thereby increases the need for surgical closure of PDA after pharmacologic treatment. STUDY DESIGN, SUBJECTS, AND OUTCOME MEASURES:We studied infants 23-28weeks' gestation born 2006-2013 at NICHD Neonatal Research Network centers. We examined the responses to PDA treatment with indomethacin and/or ibuprofen and whether the PDA was subsequently closed surgically. Logistic regression generated adjusted odds ratios (ORs) for the associations between the z-score groups (<-2, -2 to -0.5, and >-0.5) and PDA surgery following pharmacologic treatment. RESULTS:5606 infants were diagnosed with PDA; 3587 (64.0%) received indomethacin or ibuprofen or both, and 909 (25.3%) underwent PDA surgery. Mothers of infants with PDA non-closure were less likely to have hypertension (19% vs. 28%). Infants with non-closure were more likely to be female (53% vs. 49%), have lower gestational age and birth weight and to develop sepsis (42% vs. 31%). Compared to infants with z-score>-0.5, PDA surgery was increased among infants with z-score -2 to -0.5 (OR=1.23; 95% CI 1.02-1.47) but not among infants with z-score<-2. CONCLUSION:Infants with birth weight z-score -2 to -0.5 are more likely than normally grown infants to require PDA surgery following pharmacologic treatment.

| S-EPMC5654678 | biostudies-literature

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