|LETTER TO THE EDITOR
|Year : 2019 | Volume
| Issue : 2 | Page : 86-88
Transcatheter closure of patent foramen ovale: an updated meta-analysis of randomized controlled trials
Fahed Darmoch1, Yasser Al-khadra2, Homam Moussa Pacha3, Mohamad Soud3, M Chadi Alraies4
1 Beth Israel Deaconess Medical Center/Harvard, School of Medicine Boston, Massachusetts, USA
2 Cleveland Clinic Foundation, Cleveland, Ohio, USA
3 MedStar Washington Hospital Center, Washington, D.C, USA
4 Wayne State University, Detroit Medical Center, Detroit Heart Hospital, Detroit, Michigan, USA
|Date of Web Publication||8-Apr-2019|
Dr. M Chadi Alraies
Wayne State University, Detroit Medical Center, 311 Mack Ave, Detroit, MI 48201, Phone: +1 (216) 255-0008
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Darmoch F, Al-khadra Y, Moussa Pacha H, Soud M, Alraies M C. Transcatheter closure of patent foramen ovale: an updated meta-analysis of randomized controlled trials. Avicenna J Med 2019;9:86-8
|How to cite this URL:|
Darmoch F, Al-khadra Y, Moussa Pacha H, Soud M, Alraies M C. Transcatheter closure of patent foramen ovale: an updated meta-analysis of randomized controlled trials. Avicenna J Med [serial online] 2019 [cited 2020 Apr 10];9:86-8. Available from: http://www.avicennajmed.com/text.asp?2019/9/2/86/255693
The association between patent foramen ovale (PFO) and unexplained cryptogenic stroke has been well established in multiple studies. Over ensuing years, PFO has been considered as a source of the paradoxical thromboembolic phenomenon that could increase the risk of stroke. Closing the shunt between the right and left atrium via transcatheter closure devices was suggested as a treatment to decrease the risk of stroke recurrence. Numerous randomized control trials (RCTs) and meta-analysis compared medical therapy alone (antiplatelet and/or anticoagulation) with transcatheter closure. The majority of these studies favored closure of PFO over medical therapy.,,,,,,, Initial RCTs such as CLOSURE I, PC, and RESPECT,, did not show significant benefit in reducing stroke recurrence when compared with medical therapy alone. However, the extended follow-up of the RESPECT study, in addition to CLOSE and Gore REDUCE, showed reduction in stroke recurrence with PFO closure combined with antiplatelet therapy compared with medical therapy alone.,, Recently, the DEFENSE-PFO trial was published and we sought to update a recently published meta-analysis  to include all of these RCTs.
Using the electronic databases MEDLINE, Embase, and Cochrane Library, we searched for clinical trials that randomized patients with cryptogenic stroke to percutaneous PFO closure versus medical therapy. Two authors extracted the data on patient characteristics and outcomes at the longest follow-up available. The primary efficacy outcome was recurrent stroke. Random-effects risk ratios (RRs) were estimated using a DerSimonian and Laird method. Heterogeneity was calculated using the I2 test and publication bias using Egger’s test. Statistical analyses were conducted using RevMan 5.3.
Six trials met our inclusion criteria with a total of 3560 patients included in the analysis and a mean follow-up of 3.25 years. From 1889 patients in the PFO closure group, 37 (1.9%) had a recurrent stroke compared with 78 (4.6%) patients in the medical therapy group (n = 1,671). This difference in recurrent stroke rate was statistically significant, favoring PFO closure (pooled RR for recurrent stroke = 0.43, 95% CI: 0.30, 0.63, I2 = 57%, P < 0.0001) [Figure 1]. The occurrence of atrial fibrillation (AF) was reported in all studies. AF occurred in 79 (4.1%) patients in the PFO closure group compared with 12 (0.7%) patients in the medical therapy group (RR = 4.58, 95% CI: 2.47, 8.51, I2 = 0%, p < 0.0001) [Figure 2].
|Figure 1: Recurrence of stroke in the patent foramen ovale (PFO) closure group compared to medical therapy|
Click here to view
The findings of this meta-analysis suggest that PFO closure significantly decreased the risk of recurrent stroke in patients with cryptogenic stroke and PFO compared with medical therapy alone. These results are consistent with previously published reports with higher patient numbers and longer follow-up periods. Despite convincing evidence that supports PFO closure, current US practice guidelines did not endorse this practice as of yet. Regardless, PFO closure should be a team approach that includes neurologists and cardiologists, including interventional and congenital cardiologists. Patient selection based on suitable anatomy for PFO closure is an imperative step prior to referring patients for PFO closure. There are several limitations to the current analysis. The medical treatment in the medical therapy group was inconsistent among studies. Some studies used antiplatelet therapy alone whereas others used anticoagulation. Different medical regimens can alter the PFO closure efficacy in preventing recurrent stroke. Another interesting observation is that the PFO closure group had higher risk of AF after PFO closure compared with the medical therapy group. However, this increase in AF did not translate into higher stroke rates. Higher rate of AF could be explained by the mechanical irritation from the PFO closure device of the left atrial wall, which could be due to sizing or deployment problems.
In summary, PFO closure is associated with lower rates of recurrent stroke in patients presenting with cryptogenic stroke and higher rate of AF following the closure. Further studies are required to scrutinize the appropriate medical therapy after PFO closure.
| Financial support and sponsorship|| |
| Conflicts of interest|| |
There are no conflicts of interest.
| References|| |
Jorge R, Kizer MD, Richard B, Devereux MD. Patent foramen ovale in young adults with unexplained stroke. New Engl J Med 2005;353:2361-72.
Rengifo-Moreno P, Palacios IF, Junpaparp P, Witzke CF, Morris DL, Romero-Corral A. Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: A systematic review and meta-analysis of randomized controlled trials. Eur Heart J 2013;34:3342-52.
Khan AR, Bin Abdulhak AA, Sheikh MA, Khan S, Erwin PJ, Tleyjeh I, et al
. Device closure of patent foramen ovale versus medical therapy in cryptogenic stroke: A systematic review and meta-analysis. JACC Cardiovasc Interv 2013;6:1316-23.
Kwong JS, Lam YY, Yu CM. Percutaneous closure of patent foramen ovale for cryptogenic stroke: A meta-analysis of randomized controlled trials. Int J Cardiol 2013;168:4132-8.
Li J, Liu J, Liu M, Zhang S, Hao Z, Zhang J, et al
. Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack. Cochrane Database Syst Rev 2015:CD009938.
Spencer FA, Lopes LC, Kennedy SA, Guyatt G. Systematic review of percutaneous closure versus medical therapy in patients with cryptogenic stroke and patent foramen ovale. BMJ Open 2014;4:e004282.
Udell JA, Opotowsky AR, Khairy P, Silversides CK, Gladstone DJ, O’Gara PT, et al
. Patent foramen ovale closure vs medical therapy for stroke prevention: Meta-analysis of randomized trials and review of heterogeneity in meta-analyses. Can J Cardiol 2014;30: 1216-24.
Wolfrum M, Froehlich GM, Knapp G, Casaubon LK, DiNicolantonio JJ, Lansky AJ, et al
. Stroke prevention by percutaneous closure of patent foramen ovale: A systematic review and meta-analysis. Heart 2014;100:389-95.
Darmoch F, Al-Khadra Y, Soud M, Fanari Z, Alraies MC. Transcatheter closure of patent foramen ovale versus medical therapy after cryptogenic stroke: A meta-analysis of randomized controlled trials. Cerebrovasc Dis 2018;45:162-9.
Furlan AJ, Reisman M, Massaro J, Mauri L, Adams H, Albers GW, et al
. Closure or medical therapy for cryptogenic stroke with patent foramen ovale. New Engl J Med 2012;366:991-9.
Meier B, Jüni P. Patent foramen ovale and cryptogenic stroke. N Engl J Med 2013;369:91.
Carroll JD, Saver JL, Thaler DE, Smalling RW, Berry S, MacDonald LA, et al
.; RESPECT Investigators. Closure of patent foramen ovale versus medical therapy after cryptogenic stroke. N Engl J Med 2013;368: 1092-100.
Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, et al
.; CLOSE Investigators. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med 2017;377:1011-21.
Søndergaard L, Kasner SE, Rhodes JF, Andersen G, Iversen HK, Nielsen-Kudsk JE, et al
.; Gore REDUCE Clinical Study Investigators. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med 2017;377:1033-42.
Saver JL, Carroll JD, Thaler DE, Smalling RW, MacDonald LA, Marks DS, et al
.; RESPECT Investigators. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med 2017;377:1022-32.
Kernan WN, Ovbiagele B, Black HR, et al
. Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: A guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014:STR. 0000000000000024.
[Figure 1], [Figure 2]