PFO and ASD Closure in Adulthood: Where Do We Stand?
- 540 Downloads
Ever since the observation was made linking a higher prevalence of a patent foramen ovale (PFO) in younger individuals with cryptogenic stroke (CS), there has been a vigorous debate as to the role the PFO plays and a search for the optimal management strategy to prevent recurrent CS. Data from observational studies from the past two decades have demonstrated the superiority of percutaneous device closure over medical therapy. The recent publication of three randomized controlled trials (RCTs), which failed to demonstrate the superiority of percutaneous closure has reignited the controversy as to how best treat these patients. In this article, we will review the contemporary literature from the past three years including the results from new meta-analyses of medical therapy and device closure. In addition, we will review the three published randomized control trials to date (ie, CLOSURE I, the PC trial, and RESPECT) along with a meta-analysis of their results. While on primary intention-to-treat analysis, the three RCTs failed to demonstrate a superiority of percutaneous PFO closure vs medical therapy, a closer look at the data seems to suggest a trend toward benefit. We come to the conclusion that the issue of optimal treatment of PFO in patients with CS is far from settled and is unlikely to be a “one size fits all” approach due to the heterogeneity of this condition. In our opinion, based on the entirety of available data, both observational and randomized, there is likely a role for percutaneous device closure in select patients with CS in whom a PFO is the likely cause of their first stroke and will remain a significant risk for recurrent neurologic events. The article will go on to review current indications for atrial septal defect (ASD) closure and will highlight safety, efficacy and caveats regarding this technique.
KeywordsPatent foramen ovale (PFO) Atrial septal defect (ASD) Transcatheter closure Percutaneous closure Cryptogenic stroke Amplatzer septal occluder STARFlex septal occluder Gore-Helix septal occluder RESPECT trial CLOSURE I trial PC trial Meta-analysis Randomized controlled trials
Compliance with Ethics Guidelines
Conflict of Interest
Dr. Asad A. Rizvi and Dr. Ronan Margey each declare no potential conflicts of interest relevant to this article.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the authors.
References and Recommended Reading
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
- 1.Sacco RL, Adams R, Albers G, et al. Guidelines for the prevention of stroke in patients with ischemic stroke or transient ischemic attack. A statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: cosponsored by the Council on Cardiovascular Radiology and Intervention. Stroke. 2006;37:577.PubMedCrossRefGoogle Scholar
- 2.O'Gara PT, Messe SR, Tuzcu EM, et al. Percutaneous device closure of patent foramen ovale for secondary stroke prevention. A call for completion of randomized clinical trials. A science advisory from the American Heart Association/American Stroke association and the American College of Cardiology. Circulation. 2009;119:2743–7.PubMedCrossRefGoogle Scholar
- 3.•Kitsios GD, Dahabreh IJ, Abu Dabrh AM, et al. Patent foramen ovale closure and medical treatments for secondary stroke prevention. A systematic review of observational and randomized evidence. Stroke. 2012;42:422–31. Meta-analysis of 59 observational studies of device closure and medical therapy along with CLOSURE I.CrossRefGoogle Scholar
- 5.••Furlan AJ, Reisman M, Massaro J, for the CLOSURE I Investigators, et al. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. N Engl J Med. 2012;366:991–9. RCT of percutaneous closure using the STARFlex device vs medical therapy (aspirin, warfarin or both). First of RCTs to report result.PubMedCrossRefGoogle Scholar
- 6.••Carroll JD, Saver J, Thaler DE, et al. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med. 2013;368:1092–100. RCT comparing medical therapy and Amplatzer PFO closure device. Negative intention to treat but positive secondary analyses.PubMedCrossRefGoogle Scholar
- 8.www.clinicaltrials.gov. Accessed 23 Sept 2013.
- 14.Roman Peirone A, Fontes PS, Augusto CC. Outcomes after transcatheter ASD closure. Interv Cardiol Clin. 2013;2:39–49.Google Scholar
- 21.Gore Helex Septal Occluder. FDA Scientific Advisory Panel. Atrial Septal Defect Occluders Safety and Effectiveness. W.L. Gore & Associates, Inc Panel Pack. April 12, 2012.Available at: www.fda.gov/downloads/advisorycommittees/committemeetingmaterialmedicaldevices/medicaldeviceadvisorycommittee/circulatorysystemdevicepanels/ucm30939.pdf. Accessed 23 Sept 2013.