Practice Parameter: Recurrent stroke with patent foramen ovale and atrial septal aneurysm: [RETIRED]

Abstract

Abstract-Objectives: 1) To evaluate the risk of subsequent stroke or death in patients with a cryptogenic stroke and a patent foramen ovale (PFO), atrial septal aneurysm (ASA), or both. 2) To establish the optimal method of stroke prevention in this population of patients. Methods: MEDLINE, the Cochrane database of systematic reviews, key meeting abstracts from 1997 to 2002, and relevant reference lists were searched to select studies that prospectively collected outcome data in cryptogenic stroke patients with and without interatrial septal abnormalities. Studies were also selected that prospectively compared at least two treatment options. The quality of each study was graded (class I to IV) using a standard classification-of-evidence scheme for each question. Risk analyses were performed and data were pooled when appropriate. Results: The literature search generated 129 articles of which only four fulfilled the inclusion and exclusion criteria. Two studies were graded class I, one study was graded class II, and one study was graded class IV for prognosis. Pooled results of the two class I and one class II studies demonstrated no increased risk of subsequent stroke or death in patients with PFO compared to those without (RR ϭ 0.95, 95% CI 0.62 to 1.44). One class I study found increased risk of recurrent stroke in patients with PFO and ASA (annual rate ϭ 3.8% versus 1.05%, RR ϭ 2.98, 95% CI 1.17 to 7.58) but not increased risk of a composite of stroke and death (annual rate ϭ 3.8% versus 1.8%, RR ϭ 2.10, 95% CI 0.86 to 5.06). Regarding therapy, one study was graded class II, one study class III, and two studies class IV. Among patients with cryptogenic stroke and PFO or ASA, there was no significant difference in stroke or death rate in warfarin-treated patients relative to aspirin-treated patients and the confidence intervals were unable to rule out a benefit of one drug over the other (annual rate ϭ 4.7% versus 8.9%, RR ϭ 0.53, 95% CI 0.18 to 1.58). Minor bleeding rates were higher in the cohort of patients who received warfarin (22.9/100 patient-years versus 8.66/100 patient-years, rate ratio ϭ 2.64, p Ͻ 0.001). No studies compared medical therapy with surgical or endovascular closure. Conclusion: PFO is not associated with increased risk of subsequent stroke or death among medically treated patients with cryptogenic stroke. However, both PFO and ASA possibly increase the risk of subsequent stroke (but not death) in medically treated patients younger than 55 years. In patients with a cryptogenic stroke and an atrial septal abnormality the evidence is insufficient to determine if warfarin or aspirin is superior in preventing recurrent stroke or death, but minor bleeding is more frequent with warfarin. There is insufficient evidence to evaluate the efficacy of surgical or endovascular closure. NEUROLOGY 2004;62:1042-1050 Mission statement. The Quality Standards Subcommittee (QSS) develops evidence based, clinically relevant guidelines to aid in the practice of neurology. This practice parameter assesses the r...

Late cardiac tamponade after percutaneous closure of a patent foramen ovale

“…While numerous studies have suggested an association between PFO and cryptogenic stroke, there are limited explanations on how atrial septal abnormalities are implicated in cryptogenic stroke. 2 In spite of this, percutaneous PFO closure in patients with a paradoxical embolism has emerged as an alternative treatment strategy to lifelong anticoagulation, antiplatelet agents or surgical PFO closure. 3 Several peri-procedural and short-term complications have been recognized in PFO device implantation, but their rate is low.…”

Patent foramen ovale: to close or not to close – still the question

“…In particular, the extent of the PFO-related stroke risk in the general population still remains controversial [14]. Furthermore, several studies have consistently found that the presence of a PFO does not inherently increase the risk of recurrent stroke [4,[15][16][17][18][19]. This may be due to the relatively low overall rate of stroke recurrence in patients with cryptogenic stroke and PFO, ranging in studies from 0 to 12% per year, with an average annualized risk across studies of approximately 2% [17,18].…”

Prevention of Cardioembolic Stroke

“…For patients with incident stroke and PFO detected on echocardiogram and no other attributable cause (i.e., lacunar disease mechanism or large vessel atherosclerosis) with a cryptogenic stroke classification, we advise evaluation for ASA on echocardiogram and use of aspirin or antiplatelet initially, along with another risk factor modification. For patients who fail this approach, we recommend enrollment in a clinical trial studying medical management vs endovascular PFO closure [88]. Recently, the CLO-SURE-1 trial preliminary results were released [89].…”