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Comparison of the Sideris and Amplatzer septal occlusion devices
K P Walsh1, M Tofeig, D J Kitchiner
1Alder Hey Children's Hospital, Liverpool, United Kingdom. kpwalsh@lynton.u-net.com
Insights
The Amplatzer Septal Occluder demonstrated superior atrial septal defect (ASD) closure rates and reduced fluoroscopy times compared to the Sideris device. This study highlights the Amplatzer device
Area of Science:
- Cardiology
- Medical Devices
- Interventional Procedures
Background:
- Transcatheter atrial septal defect (ASD) occlusion is a common procedure.
- Comparing different occluding devices is crucial for optimizing patient outcomes.
Purpose of the Study:
- To compare the efficacy and safety of the Sideris adjustable buttoned device versus the Amplatzer Septal Occluder for transcatheter ASD occlusion.
Main Methods:
- A comparative study of two consecutive patient series undergoing transcatheter ASD occlusion.
- Outcomes assessed included device implantation success, complications, fluoroscopy time, and residual shunting via transthoracic echocardiography.
Main Results:
- The Amplatzer Septal Occluder had a higher implantation rate (37/39) than the Sideris device (28/33).
- Amplatzer implants required significantly shorter fluoroscopy times (13.4 min) compared to Sideris (23.7 min).
- Complete occlusion rates at 1 year were substantially higher for Amplatzer (93%) versus Sideris (44%).
Conclusions:
- The Amplatzer Septal Occluder is more effective for ASD occlusion than the Sideris device.
- The Amplatzer device offers reduced fluoroscopy exposure for patients and operators.
- Higher occlusion rates and shorter procedure times favor the Amplatzer device in clinical practice.
Abstract:
The results of transcatheter atrial septal defect (ASD) occlusion with 2 different devices (Sideris adjustable buttoned device vs Amplatzer Septal Occluder) were compared in 2 consecutive series of patients. Comparative outcomes were assessed by whether a device was implanted or not, by complications and fluoroscopy time of implantation, and by the incidence of residual shunting on transthoracic echocardiography at follow-up. The patient and defect characteristics were similar in both groups. Twenty-eight of 33 Sideris devices and 37 of 39 Amplatzer devices were implanted. The fluoroscopy time for the Amplatzer implants was 13.4 minutes (range 8 to 41) compared with 23.7 minutes (range 11 to 60.6) for the Sideris implants (p <0.001). The complete occlusion rate for the Amplatzer device was 93% compared with 44% for the Sideris device at 1 year (p <0.001). In conclusion, the Amplatzer device produces higher occlusion rates of ASDs with shorter fluoroscopy times.