Postapproval Study Outcomes of Muscular Ventricular Septal Defect Closure With the Amplatzer Muscular Ventricular Septal Defect (VSD) Occluder
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.
Summarised from the published abstract; every number is checked against it