Amplatzer Duct Occluders

The Safety and
Efficacy of Amplatzer
PDA Closure Devices

Amplatzer Duct Occluder

The original Amplatzer Duct Occluder (ADO), CE Marked in 1998, has established track record of efficacy:1

  • 99.2% successful implantation
  • 96.7% composite success rate at 12 months
  • < 6% rate of any adverse events

Amplatzer Duct Occluder II

The original Amplatzer Duct Occluder (ADO) II, CE Marked in 2008, can be introduced via pulmonary or aortic approach. It can be delivered through a low-profile catheter—while also achieving a very high occlusion rate.2    

A prospective study of ADO II found that implantation is simple, and the ability for retrograde aortic delivery revealed a statistically significant reduction in fluoroscopy time and therefore procedure-related radiation exposure.3  

The study furthermore noted a very high rate of complete shunt resolution and a very low rate of complications.3

Amplatzer Duct Occluder II AS2

Fiszer et al. published data on PDA closure using the Amplatzer Duct Occluder II AS (additional sizes). While noting the long-term efficacy data of the ADO and the ADO II, the authors acknowledged that such devices are not typically used in smaller patients due to the possibility of device protrusion into the aorta or the pulmonary artery.

The ADO II AS, however, is designed specifically for small PDA closure and can be delivered with a 4F catheter.

Although there were 170 PDA patients treated during the study timeframe, the authors focused on the patients who received the ADO II AS. Their data suggest that the ADO II AS provides effective closure in small PDA lesions—even in older pediatric patients.
 

PATIENT CHARACTERISTICSOUTCOMES
Procedure success rate98.1%
Mean patient age4.7 ± 4.7 years
Patients ≤ 3 years46.6% (48/103)
Patients > 3 years53.4% (55/103)

During the 6-month follow-up, there was no evidence of obstruction or Doppler flow acceleration in the aortic arch or left pulmonary artery. In addition, the authors noted that 60% of the patients had a tubular, complex, or elongated form of PDA (types C, D, and E). The diversity in the sizes of the ADO II AS allowed implanters to choose an appropriate device for the specific anatomy of each PDA.

Find out more about the 5 types of PDA.

  • Center Observes No Residual Shunt
    Fiszer, et al.4

    In this center the implanters often used “detachable coils. . . . However there are disadvantages such as a relatively high percentage of residual shunt and the lack of implantation control. Notably, we have not observed any residual shunt for the ADO II AS.”
     

     

AP2947053-WBO Rev. A

References
  1. Amplatzer Duct Occluder IFU.
  2. Saliba Z, et al. The Amplatzer Duct Occluder II: a new device for percutaneous ductus arteriosus closure. J Interven Cardiol. 2009;22:496–502.
  3. 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.  doi: 10.1002/ccd.26968.
  4. Fiszer R, et al. Are the Amplatzer Duct Occluder II Additional Sizes devices dedicated only for smaller children? EuroIntervention. 2017;12:2100-2103. doi: 10.4244/EIJ-D-15-00238.

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