Fracture of the GORE HELEX septal occluder: Associated factors and clinical outcomes

Objectives: This study examines factors associated with, and clinical effects of, wire frame fractures (WFF) of the GORE HELEX™ Septal Occluder (HELEX). Methods: Investigator-reported data from every HELEX implanted in the United States between 4/2000 and 4/2005 were reviewed. Clinical and procedural data from patients who experienced WFF were compared with data from patients who did not. The echocardiographic and fluoroscopic images for HELEX with WFF were reviewed for predictors of WFF and alterations in HELEX function. Results: With 90% of subjects followed for >12 months, 19/298 (6.4%) HELEX implanted were found to have WFF. Thirty WFFs were observed, with multiple WFFs occurring in 8/19 HELEX. Univariate predictors of WFF were large device size (P = 0.0003) and balloon defect size (P = 0.001); however, large device size (P = 0.0003) was the only significant predictor of WFF by multivariate analysis. WFF of the 30-mm and 35-mm HELEX accounted for 84% (16/19) of all WFFs. Review of HELEX images with WFF revealed all WFF occurred along the circumferential wire, except one (straight portion of locking loop). Seventeen of 29 (59%) circumferential WFFs were on the right disk. Residual defect status remained clinically insignificant (6/19) or became completely occluded (13/19) during follow-up. There were no clinical sequelae due to WFF; however, secondary to right atrial disk mobility, the HELEX with locking loop WFF was percutaneously removed 6 weeks after implantation. Conclusions: WFF occurred in 6.4% of HELEX and were most common in large devices. With the exception of one device removed for theoretical risks, no clinical sequelae were related to WFF. WFF did not alter the function of the HELEX.