title: Outcomes after transcatheter closure of patent foramen ovale in patients with paradoxical embolism.
abstract: The purpose of the present study was to assess clinical outcomes and closure status after the transcatheter closure of patent foramen ovale. Two hundred thirty-seven consecutive patients (mean age 53 +/- 15 years; 48% men) who underwent patent foramen ovale closure for the prevention of recurrent stroke were evaluated. Primary end points were death, recurrent stroke, and residual right-to-left shunt (RLS). Closure status was monitored at 1, 6, 12, 24, 36, and 48 months after the index procedure by power M-mode transcranial Doppler and was defined by the number of embolic tracks detected after the release of a sustained, calibrated Valsalva maneuver. During a mean follow-up period of 568 +/- 364 days, the cumulative event rate for recurrent stroke (n = 8) was 3.4%, for an estimated event-free survival of 0.94 (SE 0.03). There was a significant difference in the estimated probability of recurrent stroke for patients grouped by age (< or =55 years 1.4% vs >55 years 6.6%, p = 0.03). There were 7 deaths (3.0%), 1 secondary to and 6 unrelated to recurrent strokes, and 3 surgical explantations (1.3%). Event-free survival, defined as freedom from death, stroke, or explantation, was 0.92 (SE 0.02). The magnitude of RLS was significantly less at late follow-up compared with baseline (grade 4.6 +/- 0.7 vs 1.8 +/- 1.6, p <0.001). Complete closure or minimal residual RLS (grade 0 to II) was achieved in 66% of patients. Device type (CardioSEAL or Amplatzer) did not affect the risk for adverse events or the presence of large residual RLS. In conclusion, transcatheter patent foramen ovale closure is associated with a low recurrent stroke rate in long-term follow-up.
authors.affiliation: Cardiovascular Research, Swedish Medical Center, Seattle, Washington; Seattle University, Seattle, Washington, USA.
authors.forename: Verna
authors.initials: V
authors.lastname: Harms
authors.forename: Mark
authors.initials: M
authors.lastname: Reisman
authors.forename: Cindy J
authors.initials: CJ
authors.lastname: Fuller
authors.forename: Merrill P
authors.initials: MP
authors.lastname: Spencer
authors.forename: John V
authors.initials: JV
authors.lastname: Olsen
authors.forename: Kimberly A
authors.initials: KA
authors.lastname: Krabill
authors.forename: William A
authors.initials: WA
authors.lastname: Gray
authors.forename: Jill T
authors.initials: JT
authors.lastname: Jesurum
mesh_terms: D000328:Adult; D000368:Aged; D021721:Balloon Occlusion; D006328:Cardiac Catheterization; D018572:Disease-Free Survival; D019320:Embolism, Paradoxical / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000150:complications / Q000628:therapy*; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055502:Secondary Prevention; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome