Kozlik-Feldmann R, Lorber A, Sievert H, Ewert P, Jux C, Müller GC, Dalla Pozza R, Yigitbasi M, Schranz D, Lindinger A, Galal O, Meinertz T.
Clin Res Cardiol. 2020 Oct 31. doi: 10.1007/s00392-020-01750-6. Online ahead of print.
Take Home Points:
- In carefully selected patients the Nit-Occlud Le VSD coil may offer an effective option for closure of aneurysmal perimembranous VSDs.
- There appears to be a low risk of damage to the conduction system but a relatively high risk of other complications (hemolysis, device embolization, and tricuspid valve injury).
Commentary from Dr. Konstantin Averin (Edmonton), catheterization section editor of Pediatric Cardiology Journal Watch: Percutaneous closure of ventricular septal defects (VSD) – especially of the perimembranous type (pmVSD) – fell out of favor in the early 2000s due to a relatively high (6%) incidence of complete atrioventricular block. However, with new devices and techniques this approach is slowly regaining favor. The Nit-Occlud Le VSD coil has a reinforced coil configuration with Dacron fibers (Figure 1) and is designed for closure of aneurysmal pmVSDs up to 8mm in diameter. The authors present data from a prospective, multicenter, non-randomized clinical trial of the VSD coil.
From October 2006 to June 2011 94 patients with VSDs were screened in 6 tertiary centers in Germany and Israel; 6 were excluded as they had muscular VSDs. The median age was 8 (2-65) years, weight 26.7 (10-109) kg. Device implant was technically successful in 85 (96.6%). The immediate closure rate was 67.2% but increased to 96.4% at 12 month and 98.7% at 5 year follow up.
During the procedure there were 5 adverse events (2 device embolizations, 1 episode of severe hemolysis requiring implant of a second device, and arterial access site complications). There were 3 serious adverse events during the follow up period – 2 patients developed hemodynamically significant tricuspid valve regurgitation requiring surgical repair and 1 developed a large vegetation requiring device explant. Minor hemolysis was seen in 8 patients (9.4%) but resolved in all without further intervention. There were no episodes of 2nd or 3rd degree heart block or post-procedure coil embolization.
In carefully selected patients the Nit-Occlud Le VSD coil may offer an effective option for closure of aneurysmal perimembranous VSDs. There appears to be a low risk of damage to the conduction system but a relatively high risk of other complications (hemolysis, device embolization, and tricuspid valve injury) which may improve as operator experience with the device grows. The authors acknowledge that they did not meet their enrollment goals due to a change in the legal environment in the course of the study.
Close-up image of the Nit Occlud® Lê VSD coil. The device
configures as larger left-sided cone with reinforced and Dacron
fibered distal coil loops and a smaller right-side cone that configures
over the left cone.