Abstract 73: Risk of Paradoxical Embolism (RoPE) Score Stratification of Pooled Pfo Closure Clinical Trial Data: Lack of Evidence for Improvement in Patient Selection for Closure

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
David E Thaler ◽  
Issa J Dahabreh ◽  
Robin Ruthazer ◽  
Anthony J Furlan ◽  
Mark Reisman ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Recurrent Stroke ◽  
Statistical Significance ◽  
Cryptogenic Stroke ◽  
Recurrence Score ◽  
Paradoxical Embolism ◽  
Stroke Recurrence ◽  
P Value ◽  
Atrial Septal Aneurysm ◽  
Pfo Closure

Introduction: The Risk of Paradoxical Embolism (RoPE) Score can disaggregate patients with cryptogenic stroke (CS) and patent foramen ovale (PFO) into those who are more likely to have a pathogenic PFO (high RoPE score) than an incidental PFO (low RoPE score). Those with higher RoPE scores have a lower risk of recurrent stroke and different recurrence predictors compared to those with low RoPE scores. Hypotheses: Patients with high RoPE scores benefit more from PFO closure than patients with low RoPE scores. Patients with high RoPE scores and risk factors for recurrence should benefit even more. Methods: The RoPE score was created from a database of CS patients with known PFO status to estimate stratum-specific PFO-attributable fraction and recurrence rates. Variables that predict stroke recurrence in high RoPE score groups (atrial septal aneurysm, history of stroke/TIA prior to index event) were added – the “RoPE Recurrence Score.” Using pooled individual patient data from all 3 RCTs of PFO closure vs. medical therapy (ITT populations; stroke outcome) we tested the ability of the scores to predict the heterogeneity of response to assigned treatment. Results: The mean RoPE score was significantly higher (6.8 vs. 6.3) with smaller variance (Stdev 1.5 vs. 1.9) in the pooled RCT population than in the original RoPE cohort (p<0.0001). Hazard ratios favoring closure were 0.82 (0.42-1.59, p=0.56) in the low RoPE score (<7) group and 0.31 (0.11-0.85, p=0.02) in the high RoPE score (≥7) group but the interaction p-value was not significant (p=0.12). The RoPE Recurrence score did not improve the prediction of treatment response (low score HR=0.65 (0.31-1.37), p=0.26; high score HR=0.58 (0.26-1.26), p=0.17; interaction p=0.82). Conclusion: As expected, the HR favoring closure trended lower in the high RoPE score group in the RCTs but missed statistical significance. The RoPE Recurrence score did not improve the prediction. This may be due to the narrow distribution of relatively high RoPE scores amongst RCT patients and so a low power to detect heterogeneity of treatment effect. Given that PFO closure can only prevent PFO-related recurrences, the treatment effect may also have been obscured by including recurrent strokes with non-PFO-related mechanisms.

Abstract 198: PFO and Recurrent Stroke: Predictors Differ In Patients With “Probable Pathogenic” Versus Other PFOs

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
David E Thaler ◽  
Robin Ruthazer ◽  
Emanuele Di Angelantonio ◽  
Marco R Di Tullio ◽  
Jennifer S Donovan ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Recurrence Risk ◽  
Paradoxical Embolism ◽  
Attributable Fraction ◽  
Survival Models ◽  
Stroke Recurrence ◽  
Stroke Risk Factors ◽  
Heterogenous Group ◽  
Echo Features

Background The “RoPE Score” is a predictive model created to stratify patients by the likelihood that a patent foramen ovale (PFO) is incidental or pathogenic using clinical variables. We hypothesized that the predictors of recurrent stroke differ between patients with pathogenic and incidental PFOs. Methods Patients in the Risk of Paradoxical Embolism (RoPE) database with cryptogenic stroke (CS) and PFO were classified as having a probable pathogenic PFO (RoPE Score of >6, estimated PFO attributable fraction 72-99%, n=646) and others (RoPE Score of <6 points estimated PFO attributable fraction 0-72%, n=678). We tested 15 clinical, 5 radiological, and 3 echo variables for associations with stroke recurrence using Cox survival models with component database as a stratification factor. An interaction with RoPE score was checked for the variables that were significant. Results Follow-up was available for 91%, 80%, and 58% at 1, 2, and 3 years. Overall, a higher recurrence risk was associated with an index TIA, not being on a statin at baseline, and having a prior radiological stroke. For the low RoPE score group, older age, male sex, high cholesterol and antiplatelet (vs warfarin) treatment predicted recurrence. For those with high RoPE scores, predictors were prior (clinical) stroke/TIA and 2 echo features: septal hypermobility and a small shunt (<10 bubbles). Conclusions Predictors of recurrence differ when PFO relatedness is classified by the RoPE Score. The hypothesis that patients with CS and PFO form a heterogenous group with different stroke mechanisms is supported. Conventional stroke risk factors were strong predictors among patients with lower RoPE scores. Echocardiographic features - including a counterintuitive association between smaller shunts and increased recurrence risk - were uniquely predictive in the high RoPE score group (likely pathogenic PFO).

scholarly journals Importance of Persistent Right-to-Left Shunt After Patent Foramen Ovale Closure in Cryptogenic Stroke Patients

2020 ◽  
Vol 47 (4) ◽  
pp. 244-249
Author(s):  
Lu He ◽  
Gesheng Cheng ◽  
Yajuan Du ◽  
Yushun Zhang
Keyword(s):  
Transient Ischemic Attack ◽  
Patent Foramen Ovale ◽  
Valsalva Maneuver ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Ischemic Attack ◽  
Pfo Closure

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.

scholarly journals Safety and efficacy of endovascular patent foramen ovale closure: the first results of a Russian multicenter study

2020 ◽  
Vol 12 (6) ◽  
pp. 26-32
Author(s):  
D. V. Ognerubov ◽  
A. S. Tereshchenko ◽  
A. N. Samko ◽  
G. К. Arutyunyan ◽  
O. A. Sivakova ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Secondary Prevention ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Young Patients ◽  
Paradoxical Embolism ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
History Of ◽  
Pfo Closure

Patent foramen ovale (PFO) is detectable in more than 25% of the adult population and is generally clinically insignificant. However, it can be a cause of paradoxical embolism in some cases. Randomized trials indicate that endovascular PFO closure in patients with a history of cryptogenic stroke is an effective method for the secondary prevention of catastrophic brain damage.Objective: to study the safety and efficiency of endovascular PFO closure in young patients with a history of cryptogenic stroke.Patients and methods. Sixty-two patients, including (22 males and 40 females) women, underwent percutaneous PFO closure in May 2018 to March 2020. The patients' mean age was 37.4±7.6 years. The inclusion criteria were a prior cryptogenic ischemic stroke lasting less than 12 months and PFO with a high risk for paradoxical embolism (PFO concurrent with atrial septal aneurysm or hypermobility; PFO, ≥2 mm size; the presence of the Chiari network and/or the Eustachian valve).Results and discussion. The technical success of the operation was achieved in all cases. In 50 (80.6%) patients, the right chamber of the heart was completely isolated from the left one in the first 3 months. During the first year, the atria were also completely isolated in 10 (16.1%) patients. A left-to-right shunt persisted in 2 (3.2%) patents 12 months later. Two patients were found to have main procedural complications: one had perioperative atrial fibrillation and the other had pseudoaneurysm formation at the puncture site.Conclusion. Endovascular PFO closure is a safe and effective operation for the secondary prevention of recurrent ischemic stroke. In our study, blood shunting through the PFO was stopped in 96.6% of patients at less than 6 months after surgery, which suggests that there is a rapid and effective reduction in the risk of paradoxical embolism.

scholarly journals Device closure for patent foramen ovale in patients with cryptogenic stroke: which patients should get it?

2020 ◽  
Vol 22 (Supplement_M) ◽  
pp. M43-M50
Author(s):  
Iris Parrini ◽  
Enrico Cecchi ◽  
Davide Forno ◽  
Alexander R Lyon ◽  
Riccardo Asteggiano
Keyword(s):  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Cardiac Complications ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Device Closure ◽  
Meta Analyses ◽  
Pfo Closure

Abstract Patent foramen ovale (PFO) and cryptogenic stroke (CS) both have a high prevalence. The optimal treatment to reduce stroke recurrence after CS remains controversial. Results from clinical trials, meta-analyses, and position papers, support percutaneous PFO device closure and medical therapy compared to medical therapy alone. However, the procedure may be associated with cardiac complications including an increased incidence of new atrial fibrillation. The benefit/risk balance should be determined on a case-by-case basis with the greatest benefit of PFO closure in patients with atrial septal aneurysm and PFO with large shunts. Future studies should address unsolved questions such as the choice of medical therapy in patients not undergoing closure, the duration of antiplatelet therapy, and the role of PFO closure in patients over 60 years old.

scholarly journals Management of Patients with Patent Foramen Ovale and Cryptogenic Stroke: An Update

Cardiology ◽  
2019 ◽  
Vol 143 (1-2) ◽  
pp. 62-72 ◽  
Author(s):  
Mohammad Abdelghani ◽  
Sahar A.O. El-Shedoudy ◽  
Martina Nassif ◽  
Berto J. Bouma ◽  
Robbert J. de Winter
Keyword(s):  
Healthy Subjects ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Paradoxical Embolism ◽  
Atrial Septal Aneurysm ◽  
Evidence Based ◽  
Foramen Ovale ◽  
Device Closure ◽  
Interatrial Shunt

Patent foramen ovale (PFO) is a common benign finding in healthy subjects, but its prevalence is higher in patients with stroke of unclear cause (cryptogenic stroke). PFO is believed to be associated with stroke through paradoxical embolism, and certain clinical and anatomical criteria seem to increase the likelihood of a PFO to be pathological. Recent trials have shown that closure of PFO, especially if associated with an atrial septal aneurysm and/or a large interatrial shunt, may reduce the risk of recurrent stroke as compared to medical treatment. However, it remains challenging to risk stratify patients with suspected PFO-related stroke and to decide if device closure is indicated. We sought to review contemporary evidence and to conclude an evidence-based strategy to prevent recurrence of PFO-related stroke.

Patent foramen ovale

2020 ◽  
Vol 20 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Vafa Alakbarzade ◽  
Tracey Keteepe-Arachi ◽  
Nazia Karsan ◽  
Robin Ray ◽  
Anthony C Pereira
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Paradoxical Embolism ◽  
Current Evidence ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Peripheral Ischaemia ◽  
New Evidence ◽  
Pfo Closure

Patent foramen ovale (PFO) is the most common anatomical cause of an interatrial shunt. It is usually asymptomatic but may cause paradoxical embolism, manifesting as stroke, myocardial infarction or visceral/peripheral ischaemia. PFO is a risk factor for stroke and may be associated with migraine with aura. New evidence suggests PFO closure reduces the risk of recurrent ischaemic stroke in a highly selected population of stroke survivors: those aged 60 years or younger with a cryptogenic stroke syndrome, a large right-to-left shunt, an atrial septal aneurysm and no evidence of atrial fibrillation. They benefit from percutaneous PFO closure in addition to antiplatelet therapy, rather than antiplatelet therapy alone. Current evidence does not support PFO closure in the treatment of migraine.

Abstract P702: How Many Cryptogenic Stroke Patients Should Be Candidates for Patent Foramen Ovale Closure?

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Hidetaka Mitsumura ◽  
Tomomichi Kitagawa ◽  
Maki Tanabe ◽  
Takeo Sato ◽  
Hiroki Takatsu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Atrial Septal Aneurysm ◽  
Large Artery ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Ischemic Lesion ◽  
Pfo Closure

Background and Purpose: Recent several studies demonstrated that percutaneous patent foramen ovale (PFO) closure reduced the risk of stroke recurrence for patients with cryptogenic stroke (CS) and PFO. Our aim of this retrospective study is to survey the frequency of CS, which can be an indication of PFO closure. Methods: Subjects were consecutive stroke patients with symptomatic ischemic lesion detected by magnetic resonance imaging. Of them, CS were extracted according to exclusion of small-vessel collusion, large-artery atherosclerosis, cardioembolism, definite case of aortogenic embolism, and distinctive causeof ischemic stroke such as arterial dissection, hypercoagulable state and so on. After that, we selected patients in accordance with clinical guideline of PFO closure recommended by the Japanese Stroke Association (Figure). We analyzed the prevalence of CS with right-to-left shunt (RLS) as a good and recommended candidates for PFO closure. Results: Among 1,374 ischemic stroke patients from October 2012 to September 2019 , CS were 240 patients (83 females, mean age of 66 years, 17% of subjects). Of them, 100 patients (42%) had RLS (PFO; 65, atrial septal defect; 1, pulmonary arteriovenous fistula; 1, positive on transcranial Doppler (not performed in TEE) including 21 cases of definite of paradoxical embolism. In 65 patients of CS with PFO, 30 patients younger than 60 years (13% of CS) were good candidates for PFO closure. Moreover, 22 of 1,374 (1.6%) patients who were recommended candidates had one or more high risk factors of PFO, for example large shunt, atrial septal aneurysm, and the presence of shunt at rest (Figure). Conclusions: In our preliminary survey, 2% of acute ischemic stroke should be PFO closure candidates.

Offenes Foramen ovale: gute Gründe, es zu verschließen

2018 ◽  
Vol 143 (05) ◽  
pp. 354-356
Author(s):  
Bernhard Meier
Keyword(s):  
Recurrent Stroke ◽  
Absolute Risk ◽  
Paradoxical Embolism ◽  
Good Evidence ◽  
Number Needed To Treat ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Offenes Foramen Ovale ◽  
Peripheral Ischemia ◽  
Pfo Closure

AbstractA patent foramen ovale (PFO) is not to be considered a disease as it is present in about 25 % of people. Yet, it is the prime reason for paradoxical embolism that can cause serious problems, such as death, stroke, myocardial infarction, and peripheral ischemia. The frequency of such events is probably underestimated as other causes tend to be blamed for them. Device PFO closure can be easily accomplished as outpatient procedure with minimal discomfort and risk and it has been referred to as mechanical vaccination. Randomized trials have proved its value for reduction of recurrent stroke. There is also good evidence that PFO closure solves problems like platypnoea orthodeoxia and exercise desaturation, improves migraine, and is helpful in sleep apnoea. In addition, it renders diving and high altitude climbing safer. The absolute risk of a PFO is dependent on its size and its association with an atrial septal aneurysm, a Eustachian valve, or a Chiari network. The number needed to treat to prevent one stroke by PFO closure may be as low as 2 over lifetime in selected patients.

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.

Abstract 72: Procedural and Long Term Safety of PFO Closure in Cryptogenic Stroke: Insights from the RESPECT Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Richard W Smalling ◽  
John Carroll ◽  
Jeffrey Saver ◽  
David Thaler ◽  
Todd Bull ◽  
...  
Keyword(s):  
Medical Management ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Dropout Rate ◽  
Small Subset ◽  
Post Procedure ◽  
Venous Thromboembolic Events ◽  
Pfo Closure

Background: Complications of percutaneous patent foramen ovale (PFO) closure using the Amplatzer TM PFO Occluder were reported in 2012 after a median follow-up of 2.1 years. The FDA requested an analysis of long-term device safety observed in the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial. Methods: We randomized patients with cryptogenic stroke and PFO in a 1:1 ratio between PFO closure and medical management alone (MM). Post procedure medical management in the closure arm was 30 days of aspirin and clopidogrel followed by 5 months of aspirin alone and continued medical therapy as per the site neurologist. Medical treatment in the MM arm was a guideline-directed antiplatelet regimen or warfarin. An independent data and safety monitoring board adjudicated all adverse events as serious (SAE) or non-serious, and as procedure, device or protocol related. Results: We enrolled 980 patients (mean age, 45.9 years) at 69 sites who were followed for a median of 5.9 years (IQR 4.2-8.0). Follow-up was unequal – 3141 patient-years in the closure arm vs. 2669 in the MM arm, due to a higher dropout rate in the MM arm. There was less warfarin use in the closure arm vs. the MM arm (109 vs 578 patient-years). There were no study-related deaths. Two patients had procedure-related ischemic strokes (7 days and 3 months post-procedure). SAEs were equally distributed between the two arms: 13.7 in the closure arm vs. 12.4 per 100 patient-years in the MM arm, p=0.17. There was no device thrombus or erosion. The incidence of post procedure AF was not increased in the closure arm. Venous thromboembolic events (VTE) occurred at a higher rate in the closure arm, 0.87 per 100 patient-years vs. 0.22 in the MM arm, p=0.0008. In univariable logistic regression modeling, a remote history of DVT prior to randomization was a significant predictor of VTEs in the closure arm. No VTEs occurring beyond 6 months were attributed to the procedure or the device. Conclusions: These new long-term data reaffirm that the Amplatzer TM PFO Occluder has a low rate of procedure (2.4%) and device (2%) related SAE’s. A small subset of cryptogenic stroke patients have an underlying proclivity to VTE and may need long-term anticoagulation.

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