Conflict of interest: Dr. H. Sievert's institution has ownership interest in or has received consulting fees, travel expenses or study honoraries from the following companies: Access Closure, AGA, Angiomed, Ardian, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, Bridgepoint, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, EndoCross, EndoTex, Epitek, Evalve, ev3, FlowCardia, Gore, Guidant, Lumen Biomedical, HLT, Kensey Nash, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, OAS, Occlutech, Osprey, Ovalis, Pathway, PendraCare, Percardia, pfm Medical, Recor, Rox Medical, Sadra, Sorin, Spectranetics, SquareOne, Trireme, Trivascular, Viacor, Veryan, Velocimed, CoAptus.
Coronary Artery Disease
Recurrent events after percutaneous closure of patent foramen ovale
Article first published online: 27 JUN 2013
Copyright © 2012 Wiley Periodicals, Inc.
Catheterization and Cardiovascular Interventions
Volume 82, Issue 4, pages 541–546, 1 October 2013
How to Cite
Wallenborn, J., Bertog, S. C., Franke, J., Steinberg, D. H., Majunke, N., Wilson, N., Wunderlich, N. and Sievert, H. (2013), Recurrent events after percutaneous closure of patent foramen ovale. Cathet. Cardiovasc. Intervent., 82: 541–546. doi: 10.1002/ccd.24511
- Issue published online: 23 SEP 2013
- Article first published online: 27 JUN 2013
- Accepted manuscript online: 18 JUN 2012 05:02AM EST
- Manuscript Accepted: 4 JUN 2012
- Manuscript Received: 5 SEP 2011
- patent foramen ovale;
- percutaneous closure;
To determine the incidence of symptomatic recurrent embolic events after patent foramen ovale (PFO) closure and potential causes for these events.
It is well-known that cerebral or other embolic events may occur after PFO closure.
This is a retrospective analysis of consecutive patients who underwent PFO closure for secondary prevention of embolic events at a single institution.
1,930 patients (mean age of 50 ± 13.3 years) underwent transcatheter PFO closure. Complete closure occurred in 92%. The annual recurrence rate of embolic events before PFO closure was 22.4% (785 events in 3,497 patient-years). During follow-up (mean 39 months), 63 recurrent events were documented: 25 strokes, 36 transient ischemic attacks (TIAs), and 2 peripheral embolic events. The overall annual recurrence rate after the procedure was 1% per year (63 events in 6,211 patient-years). The majority of events occurred in patients without residual shunts (54/63). There was no significant association between the presence of a residual shunt and recurrent events [hazard ratio (HR) 1.7; 95% confidence interval (CI) 0.8–3.6, P = 0.16]. The most common cause for recurrent events was atherosclerosis. Nine out of 63 events were considered likely or possible paradoxical embolism due to residual shunt [stroke (2), TIA (5), and peripheral embolism (2)]. After PFO closure, the annual rate of events potentially related to paradoxical embolism was 0.14% (9 events in 6,211 patient-years).
The incidence of symptomatic embolic events after PFO closure is low. Most recurrent events are related to coexistent conditions associated with thromboembolic risk rather than residual shunts. © 2012 Wiley Periodicals, Inc.