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Initial human experience with the Amplatzer perimembranous ventricular septal occluder device
John L Bass1, G S Kalra, Ramesh Arora
1Department of Pediatric Cardiology, University of Minnesota, Minneapolis, Minnesota, USA. bassx001@umn.edu
Summary
A new Amplatzer device for perimembranous ventricular septal defects shows high success rates. This transcatheter approach offers effective closure with minimal complications in early follow-up.
Area of Science:
- Cardiology
- Medical Devices
- Interventional Procedures
Background:
- Transcatheter closure of perimembranous ventricular septal defects (pmVSDs) using non-specific devices can lead to complications like embolization and aortic insufficiency.
- A dedicated device is needed to improve safety and efficacy for pmVSD closure.
Purpose of the Study:
- To evaluate the safety and efficacy of a new asymmetric Amplatzer perimembranous ventricular septal occluder for transcatheter closure of pmVSDs.
- To report the initial clinical experience with this specifically designed device.
Main Methods:
- The study involved 27 patients undergoing transcatheter closure of pmVSDs with the new asymmetric Amplatzer device.
- Device implantation success, orientation, and early occlusion rates were assessed.
- Complications such as device-related insufficiency, arrhythmias, and embolization were monitored.
Main Results:
- Successful implantation was achieved in 25 out of 27 patients (93%).
- Complete occlusion was observed in 23 patients (92%) within one week; two had tiny residual shunts.
- No device-related aortic or tricuspid insufficiency, arrhythmias, or embolization were noted in the 25 patients with the device in situ.
Conclusions:
- The new asymmetric Amplatzer occluder demonstrates excellent acute safety and efficacy for transcatheter closure of perimembranous ventricular septal defects.
- Further long-term follow-up is necessary to confirm these promising initial results.