Salvatore De Rosa, MD, PhD; Horst Sievert, MD; Jolanda Sabatino, MD; Alberto Polimeni, MD; Sabato Sorrentino, MD, PhD; Ciro Indolfi, MD
Grant Support: This work was partly supported by a grant (OPTIMA CARDIOPATHS PON03PE_00009_4) from the Italian Ministry of Education, University and Research (MIUR).
Disclosures: Dr. Sievert reports study honoraria, travel expenses, and consulting fees from 4Tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie, BioVentrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Cibiem, CGuard, Comed B.V., Contego Medical, CVRx, Edwards, Endologix, Hemoteq, InspireMD, Lifetech, Maquet Getinge Group, Medtronic, Occlutech, pfm Medical, ROX Medical, Terumo, Vascular Dynamics, Venus, and Veryan Medical. Dr. Indolfi reports grants from St. Jude Medical. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-3033.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that her spouse has stock options/holdings with Targeted Diagnostics and Therapeutics. Darren B. Taichman, MD, PhD, Executive Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available at PROSPERO (www.crd.york.ac.uk/PROSPERO/display_record.php?ID=CRD42017074686). Statistical code: See Methods; additional information available from Dr. De Rosa (e-mail, email@example.com). Data set: See Appendix Tables and Figures; additional information available from Dr. De Rosa (e-mail, firstname.lastname@example.org).
Requests for Single Reprints: Ciro Indolfi, MD, Department of Medical and Surgical Sciences, Magna Graecia University, Viale Europa s/n, 88100 Catanzaro (CZ), Italy; e-mail, email@example.com.
Current Author Addresses: Drs. De Rosa, Sabatino, Polimeni, Sorrentino, and Indolfi: Division of Cardiology, Department of Medical and Surgical Sciences, Magna Graecia University, Viale Europa s/n, 88100 Catanzaro (CZ), Italy.
Dr. Sievert: Cardiovascular Center Frankfurt CVC, Seckbacher Landstraße, 65 60389 Frankfurt am Main, Germany.
Author Contributions: Conception and design: S. De Rosa.
Analysis and interpretation of the data: S. De Rosa, J. Sabatino, A. Polimeni.
Drafting of the article: S. De Rosa, J. Sabatino, A. Polimeni.
Critical revision for important intellectual content: S. De Rosa, H. Sievert, A. Polimeni, C. Indolfi.
Final approval of the article: S. De Rosa, H. Sievert, J. Sabatino, A. Polimeni, S. Sorrentino, C. Indolfi.
Statistical expertise: S. De Rosa, J. Sabatino, A. Polimeni.
Obtaining of funding: S. De Rosa, C. Indolfi.
Administrative, technical, or logistic support: S. Sorrentino, C. Indolfi.
Collection and assembly of data: S. De Rosa, J. Sabatino, A. Polimeni, S. Sorrentino.
New evidence emerged recently regarding the percutaneous closure of patent foramen ovale (PFO) to prevent recurrent stroke in patients with cryptogenic stroke.
To compare risks for recurrent cerebrovascular events in adults with PFO and cryptogenic stroke who underwent PFO closure versus those who received medical therapy alone.
PubMed, Scopus, and Google Scholar from 1 December 2004 through 14 September 2017; references of eligible studies; relevant scientific session abstracts; and cardiology Web sites.
Randomized controlled trials, published in English, that compared PFO closure using a currently available device with medical treatment alone and that reported, at minimum, the rates of stroke or transient ischemic attack (TIA) or of new-onset atrial fibrillation (AF) or atrial flutter (AFL).
2 investigators independently extracted study data and assessed study quality.
4 of 5 trials comparing PFO closure with medical therapy used commercially available devices. These 4 trials, involving 2531 patients, found that PFO closure reduced the risk for the main outcome of stroke or TIA (risk difference [RD], −0.029 [95% CI, −0.050 to −0.007]) and increased the risk for new-onset AF or AFL (RD, 0.033 [CI, 0.012 to 0.054]). The beneficial effect of PFO closure was associated with larger interatrial shunts (P = 0.034).
Trials were not double-blind, and inclusion criteria were heterogeneous.
Compared with medical treatment, PFO closure prevents recurrent stroke and TIA but increases the incidence of AF or AFL in PFO carriers with cryptogenic stroke.
Italian Ministry of Education, University and Research (MIUR). (PROSPERO: CRD42017074686)
De Rosa S, Sievert H, Sabatino J, Polimeni A, Sorrentino S, Indolfi C. Percutaneous Closure Versus Medical Treatment in Stroke Patients With Patent Foramen Ovale: A Systematic Review and Meta-analysis. Ann Intern Med. ;168:343–350. doi: 10.7326/M17-3033
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Published: Ann Intern Med. 2018;168(5):343-350.
Published at www.annals.org on 9 January 2018
Cardiology, Neurology, Stroke.
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