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Transcatheter closure of atrial septal defect and patent foramen ovale with ASDOS device (a multi-institutional
H Sievert1, U U Babic, G Hausdorf
1Cardiovascular Center Bethanien, Frankfurt, Germany.
Insights
This clinical trial assessed an atrial septal defect (ASD) occlusion system for closing secundum ASD and patent foramen ovale (PFO) after cerebral embolism. The system demonstrated a high success rate and acceptable safety for treating these conditions.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Device Technology
Background:
- Transcatheter closure is an alternative to surgical repair for certain cardiac defects.
- Cerebral embolism is a serious complication associated with patent foramen ovale (PFO) and atrial septal defects (ASD).
- Evaluating novel occlusion systems is crucial for improving patient outcomes.
Purpose of the Study:
- To evaluate the feasibility, safety, and efficacy of a novel occlusion system for transcatheter closure of secundum ASD and PFO.
- To assess the procedural success and complication rates associated with the device.
- To determine the long-term outcomes and device performance in patients with a history of cerebral embolism.
Main Methods:
- A prospective clinical trial involving 200 patients (aged 1-74 years) undergoing transcatheter closure of secundum ASD or PFO.
- Device implantation using the investigational occlusion system.
- Follow-up assessments including echocardiography and clinical evaluation for up to 36 months.
Main Results:
- The occlusion procedure was successful in 87% of patients, with device retrieval required in 13% due to procedural failure or complications.
- Complications included device embolization, entrapment, frame fracture, and atrial wall perforation, with 6% requiring surgical removal.
- At long-term follow-up (mean 17 months), 81% had an implanted system, with low rates of residual shunt and transient neurologic events in PFO patients.
Conclusions:
- The transcatheter occlusion system is a feasible and effective option for closing secundum ASD and PFO in patients with cerebral embolism.
- While procedural and late complications can occur, the overall success rate and acceptable morbidity support its use.
- Further monitoring is warranted for device-related issues like thrombus formation and frame integrity.
Abstract:
A clinical trial was conducted to assess the feasibility, safety, and efficacy of the atrial septal defect (ASD) occlusion system for transcatheter closure of secundum ASD and patent foramen ovale (PFO) after episodes of cerebral embolism. Occlusion was attempted in 200 patients aged 1 to 74 years (mean 32). The procedure failed in 26 patients (13%); the device was retrieved through a catheter in 20 and through surgery in 6 patients. Procedure-related complications necessitating surgical removal of the device included device embolization in 2, device entrapment within the Chiari network in 1, frame fracture in 1, and perforation of atrial wall in 2. All 6 patients experienced an uneventful postoperative course. An additional 11 patients (6%) underwent surgical removal of the device during follow-up. There were 163 patients (81%) with an implanted ASD occlusion system at follow-up of from 6 to 36 months (mean 17). Thrombus formation around the device was detected by transesophageal echocardiography in 9 patients 1 to 4 weeks after implantation. One of these patients (who had a coagulation factor XII deficiency) suffered a cerebral thromboembolism. Late atrial wall perforation (5, 6, and 8 months after implantation) occurred in 3 adult patients. Infectious endocarditis developed in 2 adult patients (1%). No late device embolization and no atrioventricular valve injury occurred. An asymptomatic device frame fracture was found in 14% and frame deformity in 4% of all patients during the follow-up period of >230 patient-years. Immediately after closure, a moderate/large residual shunt remained in 8% and a small shunt in 29% of patients. After 1 year, a moderate/large shunt was present in 2% and a small one in 26% of patients. During a total follow-up of 49 patient-years, only 1 of 46 patients with PFO had a transient neurologic event after the closure. The study indicates that patients with centrally situated secundum ASD and those with PFO after cerebral embolism can be treated with this system with a high success rate and an acceptable morbidity.