The Amplatzer Septal Occluder is the most studied transcatheter atrial septal defect (ASD) closure device available today, with over 20 years of demonstrated clinical experience.1,2
The following three studies, together, cover over 1,500 patient years of device experience.2-4
The Amplatzer Septal Occluder is the most studied transcatheter atrial septal defect (ASD) closure device available today, with over 20 years of demonstrated clinical experience.1,2
The following three studies, together, cover over 1,500 patient years of device experience.2-4
While proving the occluder’s safety and effectiveness, the U.S. Pivotal Trial revealed:
| OUTCOMES (AVERAGE 25.6 MONTHS) | AMPLATZER SEPTAL OCCLUDER PATIENTS§ | SURGICAL CONTROL PATIENTS |
|---|---|---|
| 12-month closure rate* | 98.5% | 100% |
| Major adverse events † | 1.6% | 5.2% |
| Minor adverse events‡ | 6.1% | 18.8% |
* A shunt ≤ 2 mm without the need for surgical repair
† Events that are life threatening, prolong hospitalization, or have long-term consequences or need for ongoing therapy
‡ Device embolization with percutaneous retrieval, cardiac arrhythmia with treatment, phrenic nerve injury, hematoma, other procedural adverse events, pericardial effusion requiring medical management, evidence of device associated thrombus formation without embolization (with or without treatment), marker band embolization without known sequelae
§ Mean age of closure for Amplatzer Septal Occluder group ~18; ~6 for surgical closure group
The 2-year follow-up data are as follows:
| OUTCOMES | RATE |
|---|---|
| Procedure success rate* | 96% |
| 24-hour closure rate† | 99.6% |
| Major adverse events‡ | 1.1% |
| Minor adverse events§ | 4.8% |
* Successful occluder implantation
† Defined as no to a small residual shunt
‡ Includes device embolization with surgical removal
§ Includes procedure-related arrhythmias, device embolization with percutaneous retrieval, heparin over-dosage that required reversal, asymptomatic thrombus in the pulmonary artery that resolved with heparin therapy over 24 hours
One retrospective review study evaluated both hospital costs as well as wage loss for parents of pediatric patients between surgical vs transcatheter ASD closure.
| CATHERIZATION AS CLOSURE | SURGICAL ASD CLOSURE | P VALUE | |
|---|---|---|---|
| Length of stay (days) | 1.3 ± 1.3 | 3.6 ± 1.6 | < 0.001 |
| Mortality | 0 | 0 | - |
| Total charges | $64,966 ± 30,275 | $90,000 ± 43,771 | < 0.001 |
| Wage loss | $857 ± 173 | $2,536 ± 222 | < 0.001 |
The authors noted that because technical proficiency with the transcatheter approach continues to improve, procedure times and radiation exposure are decreasing. Some centers perform catheter-based ASD closure with increasing reliance on echocardiographic guidance.
AP2947055-WBO Rev. A
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