Abstract 17143: An Updated Meta Analysis Comparingtranscatheterpatent Foramen Ovale Closure versus Medical Therapy to Prevent Recurrent Cryptogenic Stroke

Circulation ◽  
2018 ◽  
Vol 138 (Suppl_1) ◽  
Author(s):  
Krunalkumar Patel ◽  
Nirav Patel ◽  
Rajkumar Doshi ◽  
Jay Shah ◽  
Tapankumar Miyani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Medical Therapy ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Standard Medical Therapy ◽  
Increased Risk ◽  
Pfo Closure ◽  
Overall Mortality

Background: The closure of patent foramen ovale (PFO) by percutaneous transcatheter approach is controversial in a patient with cryptogenic stroke. Here in, we reviewed the literature and analyzed the data on safety and efficacy of standard medical therapy (MT) compared to mechanical closure by the percutaneous trans-catheter approach after recently published DEFENSE-PFO trial. Hypothesis: Transcatheter PFO closure decreases incidence of recurrent stroke compared to standard MT. Methods: We systematically searched PubMed, SCOPUS and EMBASE for the articles that compared overall mortality, efficacy in preventing recurrent stroke, and transient ischemic attack (TIA) after transcatheter PFO closure compared to standard MT. We also evaluated potential complications such as bleeding and development of atrial fibrillation. Results: A total 6 studies with 3,403 patients met pre-defined inclusion criteria. Mean follow-up was 3.75 years. Overall mortality was indifferent between transcatheter closure compared to MT (RR: 0.74, 95% CI 0.35-1.6, P=0.45, I 2= 0%). However, PFO closure reduced the rate of recurrent stroke by at least 60% (RR: 0.39, 95% CI 0.18-0.82, P=0.01, I 2= 56%), while did not reduce the risk of TIA compared to MT (RR: 0.76, 95% CI 0.52-1.12, P= 0.17, I 2 =0%). Higher incidence of atrial fibrillation was evident in mechanical closure (RR: 4.64, 95% CI 2.37-9.09, p<0.00001, I 2 =11%) but no increase in bleeding (RR: 0.88, 95% CI: 0.4-1.93, p=0.74, I 2 =28%). Conclusions: Mechanical PFO closure by transcatheter approach is a viable option in the prevention of recurrent stroke and TIA with an increased risk of development of atrial fibrillation without the risk of bleeding.

scholarly journals Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials

Cardiology ◽  
2019 ◽  
Vol 144 (1-2) ◽  
pp. 40-49 ◽  
Author(s):  
Aakash Garg ◽  
Mohammed Thawabi ◽  
Amit Rout ◽  
Chris Sossou ◽  
Marc Cohen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20–0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32–12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16–0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29–1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.

Network meta-analysis of patent foramen ovale management strategies in cryptogenic stroke

Neurology ◽  
2018 ◽  
Vol 91 (1) ◽  
pp. e1-e7 ◽  
Author(s):  
Hamidreza Saber ◽  
Mohan Palla ◽  
Shaghayegh Kazemlou ◽  
Mahmoud R. Azarpazhooh ◽  
Navid Seraji-Bozorgzad ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Bleeding Complications ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

ObjectiveTo compare the outcomes of patent foramen ovale (PFO) closure vs antiplatelet agent (APA) vs oral anticoagulation therapy (OAT) for secondary prevention of stroke in patients with cryptogenic stroke, using direct and indirect evidence from existing randomized data.MethodsRelevant randomized controlled trials were identified by a systematic review. The efficacy outcome was stroke recurrence, and safety outcomes were atrial fibrillation and bleeding complications at the end of follow-up. Bayesian network meta-analysis was performed to calculate risk estimates and the rank probabilities using APA therapy as the reference.ResultsIn a network meta-analysis of 6 randomized controlled trials consisting of 3,497 patients (1,732 PFO closure, 1,252 APA, 513 OAT), PFO closure and OAT were associated with lower rates of recurrent stroke (odds ratio [OR] 0.30, 95% credibility interval [CrI] 0.17–0.49 and OR 0.42, 95% CrI 0.22–0.78, respectively) with equal efficacy of OR 0.70 (95% CrI 0.37–1.49). PFO closure had the highest top rank probability of atrial fibrillation and OAT had the highest risk of bleeding complications.ConclusionsThese findings suggest that closure and OAT may be equally effective in recurrent stroke prevention in patients with PFO. There is an increased risk of atrial fibrillation and bleeding with closure and OAT therapy, respectively. A randomized trial is needed to identify patients who would benefit most from each strategy.

scholarly journals Atrial Fibrillation Following Patent Foramen Ovale Closure

Stroke ◽  
2021 ◽  
Vol 52 (5) ◽  
pp. 1653-1661
Author(s):  
Jessie Ze-Jun Chen ◽  
Vincent N. Thijs
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Stroke Risk ◽  
Meta Analysis ◽  
Percutaneous Closure ◽  
Foramen Ovale ◽  
Stroke Risk Factor ◽  
Increased Risk ◽  
Pfo Closure

Background and Purpose: Multiple studies evaluated whether patent foramen ovale (PFO) closure reduces the risk of ischemic stroke. One commonly reported complication of PFO closure is the development of atrial fibrillation (AF), which is itself a powerful stroke risk factor that requires specific management. This study aims to evaluate the frequency of AF in patients post-percutaneous closure of PFO and the clinical factors that predict AF detection. Methods: Studies were identified by systematically searching EMBASE and MEDLINE databases on July 11, 2019. Meta-analysis of proportions was performed, assuming a random-effects model. Results: A total of 6 randomized controlled trials and 26 observational studies were included, comprising 3737 and 9126 patients, respectively. After PFO closure, the rate of AF development was 3.7 patients per 100 patient-years of follow-up (95% CI, 2.6–4.9). The risk of AF development is concentrated in the first 45 days post-procedure (27.2 patients per 100 patient-years [95% CI, 20.1–34.81], compared with 1.3 patients per 100 patient-years [95% CI, 0.3–2.7]) after 45 days. Meta-regression by age suggested that studies with older patients reported higher rate of AF ( P =0.001). In medically treated patients, the rate of AF development was 0.1 per 100 patient-years of follow-up (95% CI, 0.0–0.4). Closure of PFO is associated with increased risk of AF compared with medical management (odds ratio, 5.3 [95% CI, 2.5–11.41]; P <0.001). Conclusions: AF is more common in PFO patients who had percutaneous closure compared with those who were medically treated. The risk of AF was higher in the first 45 days post-closure and in studies that included patients with increased age.

scholarly journals Percutaneous Closure versus Medical Therapy Alone for Cryptogenic Stroke Patients with a Patent Foramen Ovale: Meta-Analysis of Randomized Controlled Trials

2014 ◽  
Vol 41 (4) ◽  
pp. 357-367 ◽  
Author(s):  
Christopher A. Pickett ◽  
Todd C. Villines ◽  
Michael A. Ferguson ◽  
Edward A. Hulten
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Number Needed To Treat ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Randomized Controlled ◽  
Pfo Closure

Of cryptogenic stroke patients younger than 55 years of age, up to 61% have had a patent foramen ovale (PFO). Observational studies have revealed reductions in recurrent neurologic events through PFO closure versus medical therapy, and randomized controlled trials have shown nonsignificant trends toward benefit. We systematically searched for randomized controlled trials of percutaneous PFO closure with medical therapy versus medical therapy alone in patients with cryptogenic stroke and performed a meta-analysis of treatment outcomes. The primary endpoint was combined death, stroke, and transient ischemic attack. We included 3 trials. Of 2,303 total patients, 1,150 underwent PFO closure and 1,153 received medical therapy (median follow-up period, 2.6 yr). The pooled incidence of the primary endpoint was 1.2 events per 100 patient-years in the closure group (95% confidence interval [CI], 0.2–2.3) and 1.8 in the therapy group (95% CI, 0.7–2.9) (P=0.32); the number needed to treat was 167 (range, 100–500). The corresponding pooled hazard ratio was 0.67 (95% CI, 0.44–1.01; P=0.054) in favor of closure. Closure was associated with an increased risk of atrial fibrillation: relative risk=3.51 (95% CI, 1.44–8.55; P=0.006). When stratified by device, use of the Amplatzer™ PFO Occluder resulted in significant stroke-prevention benefit over medical therapy alone: hazard ratio=0.44 (95% CI, 0.21–0.95; P=0.037). When compared with medical therapy alone, PFO closure with medical therapy showed a trend toward a decreased hazard of combined events, although the absolute event reduction was small and the number needed to treat was high.

scholarly journals Patent foramen ovale and atrial fibrillation as causes of cryptogenic stroke: is treatment with surgery superior to device closure and anticoagulation? A review of the literature

2018 ◽  
Vol 7 (9) ◽  
pp. 205846011879392 ◽  
Author(s):  
Thomas Kjeld ◽  
Tem S Jørgensen ◽  
Gitte Fornitz ◽  
Jan Roland ◽  
Henrik C Arendrup
Keyword(s):  
Atrial Fibrillation ◽  
Congenital Heart ◽  
Heart Surgery ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Review Of The Literature ◽  
Device Closure ◽  
Persistent Foramen Ovale ◽  
Pfo Closure

Closure of persistent foramen ovale (PFO) to avoid cryptogenic strokes is performed globally with enthusiasm but lacks prove of efficacy. We present a 79-year-old man who had had a PFO device introduced nine years previously because of cryptogenic strokes presenting as syncopes. The patient was referred from his general practitioner with two new syncopes. Transthoracic echocardiography revealed no cardiac causes of embolism. Transesophageal echocardiography (TEE) revealed a misplaced device like an umbrella in a storm, but no septum defects. Holter revealed seconds-long episodes of atrial fibrillation (AF). The patient was successfully treated with anticoagulation. A literature review showed that: (i) the efficacy of PFO closure devices has not been proven in any trial, but was demonstrated in a meta-analysis comparing three different devices; (ii) PFO devices are rarely controlled by TEE during or after insertion; (iii) residual shunts are detected in up to 45% of cases; (iv) there is an increased rate of post-arrhythmic complications; (v) the risk of AF in congenital heart disease increases with increasing age, with a 13% risk of transient ischemic attacks and stroke; and (vi) surgical treatment of PFO was found to have a 4.1% risk of complications including stroke. The question to be asked is whether device closure of PFO should be avoided, considering that PFO is a congenital heart defect with risks of AF and (cryptogenic) stroke? Heart surgery should be a treatment option for symptomatic PFO.

scholarly journals Atrial fibrillation screening on holter monitoring after percutaneous patent foramen ovale closure: a prospective study

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
F Leclercq ◽  
X Odorico ◽  
C Arquizan ◽  
J C Macia ◽  
B Lattuca ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Adverse Outcomes ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Increased Risk ◽  
Pfo Closure ◽  
New Onset

Abstract Background An increased risk of new-onset atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials. However, systematic screening of AF was not performed in these studies. Purpose We aimed to evaluate incidence of AF in patients undergoing percutaneous PFO closure with serial 24-hours ambulatory electrocardiogram (AECG) monitoring during a 6-months follow-up. Methods All consecutive patients undergoing PFO closure for cryptogenic stroke or decompression sickness (DSC) were prospectively included in 2 centers. AF was defined as an irregular rhythm without discernible P waves lasting at least 30 seconds on 24-hours AECG performed at day 0, 1 month and 6-months follow-up. Primary endpoint was incidence of AF within the study period. Secondary endpoints evaluated clinical outcomes (hospitalization for cardiovascular causes, new stroke or bleeding) within 6-months follow-up. Results Between February 2018 and March 2019, a total of 62 patients underwent PFO closure: 59 (95.2%) for cryptogenic stroke and 3 (4.8%) for DSC. In the overall population, 40 were male (64.5%) and the mean age was 48±9.5 years. An atrial septal aneurysm was present in 37 patients (64.9%). The PFO device mean size was 26±5.0 mm. After a mean follow-up of 33.3±12.2 weeks, new-onset AF occurred in 3 patients (4.8%), all within 1-month after closure and paroxysmal. While symptomatic ectopic atrial heart beats occurred in one fourth of patients, all AF episodes asymptomatic. Two patients (3.2%) required oral anticoagulant therapy according to CHA2DS2-VASc score. No adverse outcomes occurred. Age (RR 1.26 [0.98; 1.61] p=0.3), male sex (p=0.6) and device (p=1.0) were not associated with occurrence of AF but all patients with AF were men and received an Amplatzer device. Conclusion Incidence of AF, evaluated with serial systematic 24-hours AECG during a 6-months follow-up after PFO closure, was relatively low (&lt;5%). Always paroxysmal, AF always occurred within one month after the procedure and was not associated with adverse outcomes. FUNDunding Acknowledgement Type of funding sources: None.

scholarly journals A Modified Anatomical-Functional-RoPE (AF-RoPE) Score Improves Patient Selection for Patent Foramen Ovale Closure

2018 ◽  
Vol 12 ◽  
Author(s):  
Gianluca Rigatelli ◽  
Marco Zuin ◽  
Fabio Dell'Avvocata ◽  
Luigi Pedon ◽  
Roberto Zecchel ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Stepwise Logistic Regression ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Stepwise Logistic Regression Analysis ◽  
Grade 5 ◽  
Risk Patients ◽  
Selection For ◽  
Pfo Closure

Background: RoPE score calculator has been proposed to stratify the patients in whom PFO may be considered not a confounding but presumably a causative factor.Objectives To implement the RoPE score calculator.Methods.  We reviewed the medical data of 1040 consecutive patients (mean age 47.3±17.1 years) prospectively enrolled in two centres over a 13 years period for management of PFO in order to select anatomic and functional parameters to be incorporated in a modified RoPE score. A scoring system (AF-RoPE) was build up and applied in a prospective blind fashion to a cohort of  406 consecutive patients (mean age 43.6 ±17. 5 years, 264 females)  with cryptogenic stroke and PFO comparing its performance with the standard RoPE.Results. Multiple stepwise logistic regression analysis demonstrated that right-to-left  (R-L) shunt at rest (OR 5.9), huge ASA (> 20 mm) (OR 3.9), long tunnelized PFO (> 12 mm) (OR 3.5), and massive R-L shunt (grade 5 by TCD) (OR 1.9) conferred the highest risk of recurrent stroke. The AF-RoPE score  resulted in a more precise separation of patients with RoPE score 8-10. Patients with AF-RoPE score > 11 had more stroke recurrences and more diffuse area of stroke on MRI in the medical history than those ranging 10 to 7 or less.Conclusion. The AF-RoPE score discriminates cryptogenic stroke patients who are more likely to develop recurrent stroke compared with a RoPE score between 8-10.  These highest risk patients may be more likely to benefit from PFO closure.

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