scholarly journals Patent Foramen Ovale and Cryptogenic Stroke or Transient Ischemic Attack: To Close or Not to Close? A Systematic Review and Meta-Analysis

2018 ◽  
Vol 45 (5-6) ◽  
pp. 193-203 ◽  
Author(s):  
Simona Lattanzi ◽  
Francesco Brigo ◽  
Claudia Cagnetti ◽  
Mario Di Napoli ◽  
Mauro Silvestrini

Background: The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. Summary: Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched. The main efficacy outcome was stroke recurrence. Subgroup-analyses were performed according to age, shunt size, and presence of atrial septal aneurysm (ASA). Safety endpoints included any serious adverse event (SAE), atrial fibrillation (AF), and major bleeding complications. Risk ratios (RRs) and hazard ratios (HRs) with 95% CIs were estimated. Five trials were included, involving 3,440 participants (DC = 1,829, MT = 1,611). There was a protective effect of closure in the risk of recurrent stroke (RR 0.43 [0.21–0.90]; p = 0.024; HR = 0.39 [0.19–0.83]; p = 0.014). The benefit of PFO closure was significant in patients with PFO associated with substantial right-to-left shunt or ASA. There were no differences in the risks of SAEs and major bleedings between the groups. The rate of new-onset AF was higher in the DC than in the MT arm (RR 4.46 [2.35–8.41]; p < 0.001). Successful device implantation and effective PFO closure were achieved in 96 and 91% of the patients respectively. Key Messages: In selected adult patients with PFO and history of cryptogenic stroke, the DC plus MT is more effective to prevent stroke recurrence and is associated with an increased risk of new-onset AF compared to the MT alone.

2021 ◽  
Vol 6 (1) ◽  
pp. 2
Author(s):  
Agnete Teivāne ◽  
Kristaps Jurjāns ◽  
Ainārs Rudzītis ◽  
Krista Lazdovska ◽  
Artūrs Balodis ◽  
...  

Background and Objectives: According to guidelines, patent foramen ovale (PFO) closure is recommended for secondary stroke prevention in patients with cryptogenic stroke. Paradoxial embolism from PFO-mediated right to left shunt has been described as the mechanism of stroke in these cases. The aim of the study was to determine whether PFO closure can be associated with improvement of complaints (headaches, fatigue, heart palpitations, dizziness, and visual impairment) and determine its long-term effectiveness on recurrent stroke risk reduction. Materials and Methods: A total of 103 patients were enrolled in a retrospective study and followed-up by phone up to five years after PFO closure. Standardized survey was conducted about their well-being, recurrent cerebrovascular events, and the use of prescribed medication. Patients were also followed up for residual shunts 24 h, 30 days, 1 year, and 2 years after PFO. The pathogenic ischemic stroke subtypes are determined using CCS (Causative Classification System for Ischemic Stroke). Results: Male patients accounted for 43.7% (n = 45). The mean age was—44.4 ± 13 (18–75). The most probable cause for cryptogenic stroke for 53.4% (n = 55) of patients with possible cardio-aortic embolism was PFO. Residual shunts were mostly observed in patients with Amplatzer occluder—87.5% (n = 14). There was correlation between residual shunt and increased risk of transient ischemic attack recurrence (p = 0.067). Five-years after PFO closure recurrent cerebrovascular events were reported in only 5.1% (n = 5) of patients, this difference is statistically relevant (p < 0.001). Out of 51 patients presented with complaints before PFO closure, 25.5% (n = 13) did not present with any complaints after PFO closure. Conclusions: PFO can be considered a possible risk factor for cryptogenic stroke. PFO closure is effective in reducing recurrent cerebrovascular events. Residual shunt after PFO closure increases the risk of transient ischemic attack recurrence. Amplatzer occluder device is associated with a higher risk for residual shunts after PFO closure. PFO closure can be associated with improvement of complaints.


2020 ◽  
Vol 47 (4) ◽  
pp. 244-249
Author(s):  
Lu He ◽  
Gesheng Cheng ◽  
Yajuan Du ◽  
Yushun Zhang

Percutaneous closure of patent foramen ovale (PFO) is widely performed to prevent recurrent stroke or transient ischemic attack in patients with cryptogenic stroke. However, the influence of different degrees of right-to-left shunting (RLS) has rarely been reported. We retrospectively evaluated the cases of 268 patients with cryptogenic stroke who underwent PFO closure at our hospital from April 2012 through April 2015. In accordance with RLS severity, we divided the patients into 2 groups: persistent RLS during normal breathing and the Valsalva maneuver (n=112) and RLS only during the Valsalva maneuver (n=156). Baseline characteristics, morphologic features, and procedural and follow-up data were reviewed. The primary endpoint was stroke or transient ischemic attack. More patients in the persistent group had multiple or bilateral ischemic lesions, as well as a larger median PFO diameter (2.5 mm [range, 1.8–3.9 mm]) than did patients in the Valsalva maneuver group (1.3 mm [range, 0.9–1.9 mm]) (P &lt;0.001). Atrial septal aneurysm was more frequent in the persistent group: 25 patients (22.3%) compared with 18 (11.5%) (P=0.018). Three patients in the persistent group had residual shunting. The annual risk of recurrent ischemic stroke was similar between groups: 0.298% (persistent) and 0.214% (Valsalva maneuver). Our findings suggest that patients with persistent RLS have more numerous severe ischemic lesions, larger PFOs, and a higher incidence of atrial septal aneurysm than do those without. Although our persistent group had a greater risk of residual shunting after PFO closure, recurrence of ischemic events did not differ significantly from that in the Valsalva maneuver group.


Stroke ◽  
2019 ◽  
Vol 50 (11) ◽  
pp. 3135-3140 ◽  
Author(s):  
Dimitrios Sagris ◽  
Georgios Georgiopoulos ◽  
Kalliopi Perlepe ◽  
Konstantinos Pateras ◽  
Eleni Korompoki ◽  
...  

Background and Purpose— It is unclear whether treatment with anticoagulants or antiplatelets is the optimal strategy in patients with stroke or transient ischemic attack of undetermined cause and patent foramen ovale that is not percutaneously closed. We aimed to perform a systematic review and meta-analysis of randomized controlled trials to compare anticoagulant or antiplatelet treatment in this population. Methods— We searched PubMed until July 16, 2019 for trials comparing anticoagulants and antiplatelet treatment in patients with stroke/transient ischemic attack and medically treated patent foramen ovale using the terms: “cryptogenic or embolic stroke of undetermined source” and “stroke or cerebrovascular accident or transient ischemic attack” and “patent foramen ovale or patent foramen ovale or paradoxical embolism” and “trial or study” and “antithrombotic or anticoagulant or antiplatelet.” The outcomes assessed were stroke recurrence, major bleeding, and the composite end point of stroke recurrence or major bleeding. We used 3 random-effects models: (1) a reference model based on the inverse variance method with the Sidik and Jonkman heterogeneity estimator; (2) a strict model, implementing the Hartung and Knapp method; and (3) a commonly used Bayesian model with a prior that assumes moderate to large between-study variance. Results— Among 112 articles identified in the literature search, 5 randomized controlled trials were included in the meta-analysis (1720 patients, mean follow-up 2.3±0.5 years). Stroke recurrence occurred at a rate of 1.73 per 100 patient-years in anticoagulant-assigned patients and 2.39 in antiplatelet-assigned patients (hazard ratio, 0.68; 95% CI, 0.32–1.48 for the Sidik and Jonkman estimator). Major bleeding occurred at a rate of 1.16 per 100 patient-years in anticoagulant-assigned patients and 0.68 in antiplatelet-assigned patients (hazard ratio, 1.61; 95% CI, 0.72–3.59 for the Sidik and Jonkman estimator). The composite outcome occurred in 52 anticoagulant-assigned and 54 antiplatelet-assigned patients (odds ratio, 1.05; 95% CI, 0.65–1.70 for the Sidik and Jonkman estimator). Conclusions— We cannot exclude a large reduction of stroke recurrence in anticoagulant-assigned patients compared with antiplatelet-assigned, without significant differences in major bleeding. An adequately powered randomized controlled trial of a non–vitamin K antagonist versus aspirin is warranted.


2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
M Delgado Ortega ◽  
A M Rodriguez Almodovar ◽  
N Paredes Hurtado ◽  
...  

Abstract Introduction The prevalence of patent foramen ovale (PFO) in the general population is high (25%). In patients with cryptogenic stroke (CS) and PFO, determining whether it is causally related to stroke or is an incidental finding is a controversial issue. The RoPE score was described in 2013 to predict the likelihood that the stroke was related to the PFO. The higher the score, the greater the risk of attributable causality, considering 6 as the cut-off point. This scale includes clinical variables, but does not consider the echocardiographic characteristics of PFO that were used as inclusion criteria in studies that have shown benefit with percutaneous closure, such as the complex anatomy of PFO (extensive passage of microbubbles across the PFO at rest and/or interatrial septum aneurysm). Purpose Our aim was to investigate the association of the RoPE score with recurrence of stroke in a series of patients with CS and percutaneously closed PFO in a period of time prior to the current recommendations, as well as to describe the presence of complex anatomy of PFO and its relationship with the value of that score. Methods A series of 172 consecutive patients with CS and percutaneous closure of PFO, included from January 2001 to November 2014 in a single center was analyzed, and the RoPE score was calculated retrospectively in each patient. The presence of complex anatomy of the PFO was estimated by echocardiography, and the rate of recurrence of stroke and the relationship of both variables with the value of the RoPE score was investigated. Results Of the 172 patients in the series, it was possible to calculate the RoPE score in 150 (87%) of them, which constitute the study sample. The mean age was 46 years (range 17-78), 60% were male, 21% were hypertense, 6% diabetic and 27% smokers. A history of previous stroke was present in 3% of patients and 11% had an imaging study with cortical infarction. RoPE score was ≥6 in 69% of the sample, and 66% of the patients presented complex anatomy of PFO, without significant differences between those with RoPE score ≥6 and &lt;6 (65% versus 70%, p = 0.62). Acute complications (mortality, cardiac tamponade, stroke, device embolism) related to closure of the PFO were not observed. After 17.5 years of maximum follow-up (mean 9.6 ± 3.7 years, no patients lost, with a total of 1441 patients-years of observation), 6 patients presented a stroke. The recurrence rate of stroke was very low in both groups of patients, either with RoPE score ≥6 or &lt;6 (0.4 versus 0.5 per 100 patients/year, p = 0.87). Conclusions In our center, before the current recommendations of PFO closure associated with CS, most of the patients had a RoPE score≥6. The majority of patients presented a complex anatomy of the PFO and the incidence of stroke recurrence was very low, independently of the value of the RoPE score.


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