*Based on a total of 784 cases reported in 4 states (NSW, Vic, WA, and SA), noting 2 combined years of reporting for Victoria.2
PDA can range from a small haemodynamically insignificant lesion that is not heard on auscultation to one that without intervention is large enough to cause congestive heart failure and pulmonary hypertension.4,5
Small PDAs may cause no symptoms and are sometimes only detected by the presence of a heart murmur.
If left untreated, PDA may lead to complications such as:
· Heart failure
· Renal dysfunction
· Necrotising enterocolitis
· Intraventricular haemorrhage
· Diminished nutrition and growth
· Potentially chronic lung disease
Medical therapies may be appropriate to help close the PDA or manage symptoms. The American College of Cardiology noted that many PDAs are now closed in infancy or childhood with catheter-based or surgical approaches. For those whose ductus remains patent in adulthood, catheter-based or surgical intervention consideration depends on the symptoms and physiological expression of the lesion.
Adults with PDA are better suited for percutaneous closure due to high rates of success and low rates of complications.9
Transcatheter PDA closure—e.g., with an Amplatzer™ Duct Occluder —is the standard of care in most cases.10
Abbreviations:
PDA: patent ductus arteriosus.
References:
1. Data on file at Abbott.
2. Australian Institute of Health and Welfare 2019. Congenital heart disease in Australia. Cat. no. CDK 14. Canberra: AIHW.
3. Krasuki, RA. Patent ductus arteriosus closure. Journal of Interventional Cardiology. 2006;19(5 Suppl):S60-S66.
4. Kim LK. Patent ductus arteriosus. Medscape. emedicine.medscape.com/article/891096-overview. Updated December 31, 2017.
5. Philip, RB. et al. Morphologic characterization of the patent ductus arteriosus in the premature infant and the choice of transcatheter occlusion device. Catheterization and Cardiovascular Interventions. 2016;87(2):310-317.
6. Schneider, DJ & Moore, JW. Patent ductus arteriosus. Circulation. 2006;114(17):1873-1882.
7. Cincinnati Children’s. Congenital Patent Ductus Arteriosus. www.cincinnatichildrens.org/health/heart-encyclopedia/anomalies/pda.htm. Accessed February 2, 2016.
8. Stout KK, et al. 2018 AHA/ACC Guideline for the Management of Adults with Congenital Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2018;000:e000-e000.
9. Warnes CA, et al. ACC/AHA 2008 Guidelines for the Management of Adults with Congenital Heart Disease. J Am Coll Cardiol. 2008;52:e143–e263.
10. Baruteau AE, et al. Transcatheter closure of patent ductus arteriosus: past, present and future. Arch Cardiovasc Dis. 2014;107:122-132.
The Amplatzer™ Family of Duct Occluders offers an extensive line of devices and a simple treatment option for the closure of PDA.
An extensive line of devices that are designed to occlude PDAs of various shapes and sizes.
A minimally invasive catheter-based option that has an easy-to-perform deployment procedure for precise placement.
Achieve complete PDA closure using a pulmonary or aortic approach, with devices that conform to a variety of duct sizes.3
Abbreviations:
PDA: patent ductus arteriosus.
References:
1. Data on file at Abbott.
2. Abbott AmplatzerTM Duct Occluder Instructions for Use.
3. Saliba Z, et al. The Amplatzer Duct Occluder II: a new device for percutaneous ductus arteriosus closure. J Interven Cardiol. 2009;22:496–502.
4. Abbott AmplatzerTM Duct Occluder II Instructions for Use.
5. Amplatzer Piccolo Occluder Instructions for Use.
6. Gruenstein DH, et al. Transcatheter closure of patent ductus arteriosus using the Amplatzer Duct Occluder II (ADO II). Catheter Cardiovasc Interv. 2017;89:1118–1128.
7. Data on File, 302350-001_G Amplatzer Duct Occluder CER.
The Amplatzer™ Duct Occluder was evaluated in a multi-centre, non-randomised, pivotal study evaluating the clinical performance for PDA closure in 435 patients. Patients less than 6 months of age and less than 6 kg were not included in this analysis.2
*Of the number of patients where the device was attempted, those who successfully received a device.
The safety and efficacy of the Amplatzer™ Duct Occluder II were evaluated in a single-arm, multi-centre study in 192 patients aged 6 months to < 18 years. Patients less than 6 kg were excluded from the study.3
The study found that implantation was simple and the ability for retrograde aortic delivery revealed a statistically significant reduction in fluoroscopy time and therefore procedure-related radiation exposure.4
The safety and efficacy of the Amplatzer Piccolo™ Occluder in patients weighing ≥ 700 grams was studied in a 50-patient pivotal trial and in 150 additional patients under a continued access protocol. Patients weighing <700 g and age <3 days at time of the procedure were excluded from the study. When combined, the study enrolled a total of 200 patients. At the time of the procedure, 100 patients weighed ≤ 2 kg and the other 100 patients weighed >2 kg.5
†Assessed by echocardiography and defined as the presence of either a grade 0 (none) or grade 1 (trivial) shunt.
‡Major complications were defined as device or procedure-related adverse events resulting in death, life-threatening adverse event, persistent or significant disability and/or surgical intervention..
Abbreviations:
CAP: community-acquired pneumonia; IDE: investigational device exemption; PDA: patent ductus arteriosus.
References:
1. Data on file at Abbott.
2. Amplatzer Duct Occluder Instructions for Use.
3. Amplatzer Duct Occluder II Instructions for Use.
4. Gruenstein DH, et al. Transcatheter closure of patent ductus arteriosus using the Amplatzer Duct Occluder II (ADO II). Catheter Cardiovasc Interv. 2017;89:1118-1128.
5. Sathanandam SK, et al. Amplatzer Piccolo Occluder clinical trial for percutaneous closure of the patent ductus arteriosus in patients ≥700 grams. Catheter Cardiovasc Interv. 2020;96(6):1266-1276.
6. Zahn, E. The Amplatzer Piccolo™ (ADOIIAS) U.S. Clinical Trial 3-Year Follow-up Report. Presented at: CSI Frankfurt; June 22-25, 2022.
The Amplatzer™ App helps physicians determine which Amplatzer™ Structural Intervention device to use by suggesting applicable devices based on respective Instructions for Use.
Navigate to discover solutions for the following disease areas:
MAT-2208190 V1.0
Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions
MAT-2408064 V1.0