Early Experience of Percutaneous Closure of Ventricular Septal Defects Using a New CE-Marked VSD Occluder in Pediatric and Adult Patients

Objectives: Percutaneous ventricular septal defect (VSD) closure remains a complex intervention. In the patient population requiring this intervention, small, flexible, and low-profile devices may offer good closure rates with a low rate of complications. Previously, off-label use of patent ductus arteriosus (PDA) devices (e.g., Amplatzer PDA devices; ADO I and II) has been reported in several case series. In May 2018, the KONAR-MF (multifunctional) VSD device (Lifetech, China) has received CE marking approval for VSD closure. We describe our early experience with this new VSD device.

Methods and Results: Patients (5x pediatric and 1x adult) with clinical indication for perimembranous VSD closure and who had hemodynamically relevant but restrictive VSDs were selected for an interventional approach. The KONAR-MF VSD device (Lifetech) was used through a 4- to 7-Fr sheath or guiding catheter. Device implantation was successful in five out of six patients, who had VSD size ranging from 2 to 6.5 mm. The following devices were used: 10/8, 2 × 9/7, 10/8, and 14/12 mm, but in two patients, devices were upsized during the procedure. One out of six implantations was performed retrogradely (from the RV). One device was not released due to too much residual shunting and tricuspid regurgitation; instead an ADO I was used but also unsuccessful. All patients treated underwent standardized follow-up examinations including Holter and Echo at 1 and 3 months. Current but early follow-up period of nearly 3 months showed no adverse events (AV-block, dysfunction, significant residual shunt, or hemolysis).

Conclusion: VSD closure can be successfully performed by antegrade and retrograde implantation in pediatric patients with the CE-marked KONAR-MF VSD device. It has a favorable low profile, but more data are needed for possible device-related long-term complications.