Author + information
- Received February 7, 2012
- Accepted February 18, 2012
- Published online July 1, 2012.
- Shikhar Agarwal, MD, MPH, CPH⁎,
- Navkaranbir Singh Bajaj, MD†,
- Dharam J. Kumbhani, MD, SM‡,
- E. Murat Tuzcu, MD⁎ and
- Samir R. Kapadia, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence
: Dr. Samir R. Kapadia, Sones Cardiac Catheterization Laboratories, Department of Cardiovascular Medicine, J2–3, Heart and Vascular Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, Ohio 44195
Objectives In this study, a meta-analysis of observational studies was performed to compare the rate of recurrent neurological events (RNE) between transcatheter closure and medical management of patients with cryptogenic stroke/transient ischemic attack (TIA) and concomitant patent foramen ovale (PFO).
Background A significant controversy surrounds the optimal strategy for treatment of cryptogenic stroke/TIA and coexistent PFO.
Methods We conducted a MEDLINE search with standard search terms to determine eligible studies.
Results Adjusted incidence rates of RNE were 0.8 (95% confidence interval [CI]: 0.5 to 1.1) events and 5.0 (95% CI: 3.6 to 6.9) events/100 person-years (PY) in the transcatheter closure and medical management arms, respectively. Meta-analysis of the limited number of comparative studies and meta-regression analysis suggested that the transcatheter closure might be superior to the medical therapy in prevention of RNE after cryptogenic stroke. Comparison of the anticoagulation and antiplatelet therapy subgroups of the medical arm yielded a significantly lower risk of RNE within patients treated with anticoagulants. Device-related complications were encountered at the rate of 4.1 (95% CI: 3.2 to 5.0) events/100 PY, with atrial arrhythmias being the most frequent complication. After transcatheter closure, RNE did not seem to be related to the pre-treatment shunt size or the presence of residual shunting in the follow-up period. Significant benefit of transcatheter PFO closure was apparent in elderly patients, patients with concomitant atrial septal aneurysm, and patients with thrombophilia.
Conclusions Rates of RNE with transcatheter closure and medical therapy in patients presenting with cryptogenic stroke or TIA were estimated at 0.8 and 5.0 events/100 PY. Further randomized controlled trials are needed to conclusively compare these 2 management strategies.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received February 7, 2012.
- Accepted February 18, 2012.
- American College of Cardiology Foundation