Congenital heart diseaseResearch article
Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular Ventricular Septal Defect (VSD) Occluder
- postapproval study
Authors' conclusion
This postapproval study demonstrates that transcatheter muscular VSD closure with the Amplatzer Muscular VSD Occluder is a safe and effective therapy for the treatment of complex congenital muscular VSDs in patients who are at high-risk for surgical closure.
Study context
- Population
- Patients with complex congenital muscular VSDs at high risk for surgical closure, enrolled between May 2008 and February 2020 in the United States and Canadamedian age, 2 years, 50 females
- Participants
- 92 patients
- Outcome
- Primary effectiveness end points: technical implant success, acute procedure shunt-closure success, and 1-year shunt-closure success
Main finding
As reported in the abstract
Technical implant success
93.8%
Acute shunt-closure success
78.0%
Successful shunt closure at 1-year
94.4%
Further findings
Successful shunt closure · between 2 and 5 years
- Successful shunt closure
- >98%
Safety
Primary safety end point: all-cause serious adverse events · within 12 months of the procedure
- All-cause serious adverse events
- 47 of the 90 (52.2%) patients
- Device-related serious adverse events
- 7
- Procedure-related serious adverse events
- 23
Device- and procedure-related serious adverse events · Between 1 and 5 years
- Additional device- and procedure-related serious adverse event
- 1
Original publication
Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular VSD Occluder. Circ Cardiovasc Interv. Published 5 May 2026. doi:10.1161/circinterventions.125.016121
Summarised from the published abstract; every number is checked against it