The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).
Patients with perimembranous ventricular septal defects (PmVSD), as defined by 2D transthoracic echocardiography according to previously published classifications.
Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
Left-to-right ventricular shunt.
Age ≥3 months and body weight≥5 kg.
Eisenmenger physiology (pulmonary vascular resistance > 8 Wood units, nonreactive) with an exclusive right-to-left shunt.
Pre-existing complete heart block or high-risk proximity of the conduction system to the defect without prior pacemaker implantation.
Severe aortic or tricuspid valve disease requiring surgical or catheter-based intervention.
Pregnancy or planned pregnancy if the procedure involves X-ray exposure.
Patients, regardless of gender or geographical location, with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and underwent transcatheter closure using commercially available occluder devices, whether specifically designed for this purpose or used off-label, were followed according to local hospital protocols.
Cohort
Retrospective
Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
DeviceTranscatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
Twelve-month composite non-hierarchical clinical success
Defined as meeting the following 3 criteria: 1) technical success (device successfully implanted and retained at hospital discharge), 2) closure success (trivial or no residual shunt through 12 months), 3) safety success (no serious adverse events (SAEs) through 30 days, and no device events (removal or reintervention) through 12 months).
Technical success
Successful device deployment and stable device position confirmed via post-procedure transthoracic echocardiography (TTE).
Closure success
Complete shunt occlusion or trivial shunt on post-procedure TTE
Procedural success
Technical success with complete closure of PmVSD (residual shunt ≤2 mm confirmed on post-procedure TTE), no interference with adjacent structures, including aortic and tricuspid valves.
Short-term complications (≤30 days)
Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).
Long-term outcomes
* Sustained complete closure (no or minimal residual shunt on TTE). * Late-onset device-related complications (new-onset aortic or tricuspid regurgitation, delayed second-degree or complete heart block, or arrhythmias requiring permanent treatment). * Device migration or embolization requiring catheter or surgical removal * Thromboembolism: thrombosis of device or vascular access that requires thrombolytic therapy * Hemolysis requiring prolonged or redo hospitalization and severe acute hemolysis requiring blood transfusion with or without intervention. * Death
Rate of incomplete closure at the 24-month follow-up.
Rate of incomplete closure at the 24-month follow-up: A significant shunt will be defined as ≥ moderate or requiring treatment (surgical or interventional). The residual shunt will be assessed using color Doppler echocardiography, with shunt size categorized according to previously published classifications.
Functional and quality-of-life measures
Improvement in NYHA/ROSS functional class and in pediatric patients, catch-up growth.
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