VSD-Closure with the Konar-MF VSD Occluder: Results from the European Multicenter Prospective Clinical Follow-Up Study

Background: Interventional VSD closure is a safe and effective alternative to surgical closure in congenital heart disease patients. The Lifetech KONAR-MFTM VSD occluder is a percutaneous, transcatheter closure device for the interventional treatment of patients with ventricular septal defect (VSD). Its improved flexibility, high conformability to ventricular septal defects and low profile makes it a lower risk of heart block and can be used in patients with different ages including small infants and became CE marked in 2018.

Methods: The purpose of the study is to collect prospective real-world data for the Lifetech KONAR-MF VSD Occluder during 12-month follow-up. Primary endpoints were: Accurate success rate is defined as VSD closure without complication (dislocation, hemolysis, AVB, device related valve dysfunction, thrombosis, infection or endocarditis) and no or only mild residual shunt after 12 months of follow-up. Procedure successful: Optimal position of the VSD with appropriate closure rate at echocardiographic examination. No or only tiny or without residual shunt and absence of device related aortic or atrio ventricular valve reflux.

Results: A total of 40 patients were enrolled, all were successfully implanted of the study device with an implantation success rate of 100%. The median age was 9.0 (1–82) years, patients were female (65.0%, 26/40). The mean weight was 40.0 ± 27.3 (10.3–98) kg and mean height was 133.4 ± 32.5 (79–177) cm. Eight (20.0%) patients had cardiovascular surgical and intervention history. According to the baseline echocardiography, the mean VSD size was 6.0 ± 2.2 (2–10) mm, 14 (35%) patients had a VSD aneurysm. No device deficiency occurred during the follow up, but in one patient the device had to be explanted due to complex anatomy and increasing residual shunting. Two patients were lost to follow up. The closure rate was 90.0% (36/40) at discharge and 94.4% (34/36) at 12 months follow-up. In one patient with VES and AV-dissociation before and after implantation adaptation of medication with β-Blocker was needed. No cAVB or other arrhythmia occurred. No device related valve dysfunction was reported during the follow-up.

Conclusion: In summary, the results of this study confirmed the procedural success and performance of KONAR-MFTM VSD Occluder for patients with ventricular septal defect (VSD) with a high closure rate and low number of SAE and device related clinical problems.

Publication History

Article published online:
13 February 2024