Meta-Analysis
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. Jun 26, 2018; 10(6): 41-48
Published online Jun 26, 2018. doi: 10.4330/wjc.v10.i6.41
Patent foramen ovale closure reduces recurrent stroke risk in cryptogenic stroke: A systematic review and meta-analysis of randomized controlled trials
Mahesh Anantha-Narayanan, Dixitha Anugula, Gladwin Das
Mahesh Anantha-Narayanan, Gladwin Das, Division of Cardiovascular Disease, Department of Medicine, University of Minnesota, Minneapolis, MN 55455, United States
Dixitha Anugula, Division of Cardiology, CHI Health Creighton University Medical Center, Omaha, NE 68124, United States
Author contributions: All authors contributed to the manuscript.
Conflict-of-interest statement: No potential conflicts of interest relevant to this article were reported.
PRISMA 2009 Checklist statement: The manuscript was prepared and revised according to the PRISMA 2009 Checklist.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Mahesh Anantha-Narayanan, MD, Academic Fellow, Doctor, Division of Cardiovascular Diseases, Department of Medicine, University of Minnesota, Mayo Mail Code 508, 420 Delaware St SE, Minneapolis, MN 55455, United States. manantha@umn.edu
Telephone: +1-612-6262451 Fax: +1-612-6264411
Received: January 31, 2018
Peer-review started: January 31, 2018
First decision: February 27, 2018
Revised: March 1, 2018
Accepted: March 18, 2018
Article in press: March 18, 2018
Published online: June 26, 2018
Processing time: 146 Days and 7 Hours
Abstract
AIM

To investigate if patent foramen ovale (PFO) closure device reduces the risk of recurrent stroke in patients with cryptogenic stroke.

METHODS

We searched five databases - PubMed, EMBASE, Cochrane, CINAHL and Web-of-Science and clinicaltrials.gov from January 2000 to September 2017 for randomized trials comparing PFO closure to medical therapy in cryptogenic stroke. Heterogeneity was determined using Cochrane’s Q statistics. Random effects model was used.

RESULTS

Five randomized controlled trials with 3440 patients were included in the analysis. Mean follow-up was 50 ± 20 mo. PFO closure was associated with a 41% reduction in incidence of recurrent strokes when compared to medical therapy alone in patients with cryptogenic stroke [risk ratio (RR): 0.59, 95%CI: 0.40-0.87, P = 0.008]. Atrial fibrillation was higher with device closure when compared to medical therapy alone (RR: 4.97, 95%CI: 2.22-11.11, P < 0.001). There was no difference between the two groups with respect to all-cause mortality, major bleeding or adverse events.

CONCLUSION

PFO device closure in appropriately selected patients with moderate to severe right-to-left shunt and/or atrial septal aneurysm shows benefit with respect to recurrent strokes, particularly in younger patients. Further studies are essential to evaluate the impact of higher incidence of atrial fibrillation seen with the PFO closure device on long-term mortality and stroke rates.

Keywords: Patent foramen ovale; Cryptogenic stroke; Meta-analysis

Core tip: The American Association of Neurology guidelines focused update recommended against routine patent foramen ovale (PFO) closure in patients with cryptogenic stroke; but two recent randomized trials showed a significant reduction in recurrent stroke events in patients who had a PFO closure device when compared to patients on medical therapy alone. We therefore, performed a systematic review & meta-analysis of five available randomized controlled clinical trials that addressed the efficacy of PFO closure in patients with cryptogenic stroke. Our analysis shows PFO closure device in appropriately selected patient population is associated with reduction in recurrent stroke events but at the cost of increase in incidence of atrial fibrillation.