Background: The pfm Nit-Occlud Lê VSD coil (pfm medical, Cologne, Germany) was developed for closure of perimembranous and muscular ventricular septal defects and received a CE-mark in August 2010. Long-term outcome data of the initial approval study are presented including 93 patients with perimembranous and muscular ventricular septal defects (VSD). Patient inclusion and procedures were performed in six tertiary clinical centers in Germany and Israel from October 13th 2006 to July 21st 2011, the last follow-up visit was performed on June 26th 2016. A set of Objective Performance Criteria (OPC) according to the multi-organization Advisory Panel to FDA for Pediatric Cardiovascular Devices for PDAs were established to evaluate efficacy and safety of the device under investigation.
Methods: Intention to treat was in 99 patients (age 1–65 years, median 7 years; 42 males, 57 females). After LV angiography a coil implantation was performed in 93 pts. 86 VSDs were located in the membranous and 7 in the muscular portion of the IVS. Mean RV defect size was 4.5 ± 1.3 mm. Coils with sizes of 8/6, 10/6, 12/6, 14/8, and 16/8 mm (LV/RV diameter) were implanted thru a 7F sheath. In 79 pts the VSD was closed within the first attempt; in 14 pts a different size of coil was successfully implanted after resizing. Follow-up data were obtained in 82 pts over a 5 years period.
Results: The overall technical success rate was 93.9%. In 63% an immediate complete closure of the VSD was observed. This rate increased to 97% after one year and to 99% after five years. There were no major adverse events. Hemolysis occurred in 9 pts (10%) during the first hours after implantation and lasted for one day up to 14 days; it terminated spontaneously in 8 cases; in 1 patient a second device had to be implanted 14 days after the initial procedure. In another case a second device was placed after one year to close a residual shunt. No permanent heart block occurred during the study period.
Conclusion: In all items the study results fit the Objective Performance Criteria (OPC) for implantation and follow up. The long-term closure rate of the perimembranous and muscular VSD by the device is high after one and five years. In case of significant residual shunt, hemolysis may be of concern. The Nit-Occlud Lê VSD coil offers the possibility for an effective and safe approach in VSD closure in patients with perimembranous and selected muscular VSD.
