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Abstract
Objective Current guidelines report no benefit for patent foramen ovale (PFO) closure compared to medical treatment in patients with cryptogenic ischemic stroke (IS) or TIA. Two recent randomized controlled clinical trials have challenged these recommendations.
Methods We performed a systematic review and network meta-analysis of randomized controlled trials to estimate the safety and efficacy of closure compared to medical treatment, and to compare available devices. We conducted pairwise meta-analyses for closure vs medical therapy, irrespective of the device used, and for each device vs medical therapy.
Results Our literature search highlighted 6 studies. PFO occlusion was associated with reduced risk of recurrent IS (risk ratio [RR] 0.42, 95% confidence interval [CI] 0.20–0.91) and IS/TIA (RR 0.65, 95% CI 0.48–0.88) but with increased risk of new-onset atrial fibrillation (AF) (RR 4.59, 95% CI 2.01–10.45) compared to medical treatment. In indirect analyses, both Amplatzer (AMP) and GORE devices were found to be associated with a lower risk of new-onset AF compared to STARFlex (SFX) (RR 0.25, 95% CI 0.10–0.65 and RR 0.28, 95% CI 0.08–0.95). Moreover, AMP was found to be associated with a lower risk of recurrent IS/TIA events compared to the SFX device (RR 0.35, 95% CI 0.14–0.91). In the clustered ranking plot on the risk of IS against new-onset AF, GORE was comparable to AMP; however, on the risk of IS/TIA against new-onset AF, AMP appeared to be superior to the GORE device. In both ranking plots, SFX was highlighted as the worst option.
Conclusion PFO closure is associated with reduced risk of recurrent IS or IS/TIA and with increased risk of new-onset AF.
Glossary
- AF=
- atrial fibrillation;
- AMP=
- Amplatzer Patent Foramen Ovale Occluder;
- ASA=
- atrial septal aneurysm;
- CI=
- confidence interval;
- CINeMA=
- Confidence in Network Meta-Analysis;
- GORE=
- GORE HELEX/CARDIOFORM Septal Occluder;
- GRADE=
- Grading of Recommendations Assessment, Development and Evaluation;
- HR=
- hazard ratio;
- IS=
- ischemic stroke;
- NMA=
- network meta-analysis;
- PFO=
- patent foramen ovale;
- PRISMA=
- Preferred Reporting Items of Systematic Reviews and Meta-Analyses;
- RCT=
- randomized controlled trial;
- RR=
- risk ratio;
- SFX=
- STARFlex Septal Occluder;
- SUCRA=
- surface under the cumulative ranking;
- TEE=
- transesophageal echocardiography
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 14
See page e1
- Received November 23, 2017.
- Accepted in final form March 2, 2018.
- © 2018 American Academy of Neurology
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