BACKGROUND: Ideally, percutaneous, mechanical closure of defects of the atrial septum should completely resolve shunt. To achieve this goal, more information is needed about the factors associated with device failure. METHODS: Consecutive @entity1 with cryptogenic neurological events who had severe baseline Valsalva shunt (Spencer Grade 5-5+) and intracardiac echocardiography (ICE) defined @entity4616 ( @entity4616 ) who underwent percutaneous @entity4616 closure with the GORE(  ) HELEX Septal Occluder device were evaluated for residual 3-month shunt by transcranial Doppler (TCD). RESULTS: We closed 315 @entity4616 @entity1 with the HELEX devices: 15, 20, 25, 30 mm devices in 19, 138, 150, and 8 @entity1 , respectively. Severe residual Valsalva shunt (TCD Grade 5-5+) at 3 months occurred in 23 of 315 (7%) of all @entity1 and in 2 of 108 (2%), 5 of 86(6%), and 16 of 121 (13%) @entity1 with none, Grade 4, and Grade 5-5+ baseline rest shunt, respectively (P = 0.002). At 3 months, rest shunting was essentially abolished by closure. The percent of @entity1 with severe residual Valsalva shunt was also related to device size: 15 mm (0%), 20 mm (4%), 25 mm (10%), and 30 mm (25%) (P = 0.008) and to @entity439 . All of these variables were independent predictors of failure by multivariate logistic regression. CONCLUSIONS: In an ICE-defined @entity4616 population characterized by severe baseline Valsalva shunt and a high incidence of persistent (rest) shunting, the GORE(  ) HELEX Septal Occluder device effectively reduces both provoked and persistent shunt. The causes of device failure are multifactorial. Larger devices perform less reliably suggesting the need for size-specific modifications to improve closure of more severe defects. (J Interven Cardiol 2011;24:366-372).

Transcranial doppler quantification of residual shunt after percutaneous XXXX closure: efficacy of the GORE(  ) HELEX septal occluder.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity4616 :: ('MESH:D054092', 'Disease') :: ['PFO', 'patent foramen ovale'] @entity439 :: ('MESH:D000783', 'Disease') :: ['atrial septal aneurysm']
@entity4616 :: (MESH:D054092,Disease) :: ['patent foramen ovale']
