scholarly journals Recurrent stroke secondary to late PFO-closure device thrombus: a case report

2021 ◽  
Author(s):  
Lennox Jerzyna ◽  
Abhisheik Prashar ◽  
George Youssef ◽  
Mark Sader
Keyword(s):  
Late Onset ◽  
Thrombus Formation ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Good Evidence ◽  
Closure Device ◽  
Procedural Complications ◽  
Anticoagulated Patients ◽  
Pfo Closure

Abstract Background Percutaneous patent foramen ovale (PFO) closure has been well established in the secondary prevention of cryptogenic stroke with overall low rates of procedural complications. One such complication is PFO closure device thrombus formation which is now rarely reported with newer generation devices. Case Summary We present the unusual case of a 59 year old woman with myelofibrosis who developed late onset recurrent embolic strokes related to Amplatzer PFO closure device thrombus whilst therapeutically anticoagulated on Warfarin. Surgical management was deemed too high risk and our patient was conservatively managed with enoxaparin. Serial trans-thoracic echocardiography demonstrated reduction in thrombus size and the patient had no further neurological events. Discussion Overall the risk of serious complications following percutaneous PFO closure, such as device-associated thrombus, remains low. The risk of thrombus formation in patients with hypercoagulable states is not well characterised. Despite good evidence for the efficacy in preventing recurrent cryptogenic stroke, the role of PFO closure in addition to anticoagulation is unclear. Given this uncertain benefit of PFO closure in anticoagulated patients and the unclear risk profile, patient selection and thorough preprocedural evaluation is vital when assessing the appropriateness of percutaneous PFO closure.

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.

The emerging value of serum D-dimer measurement in the work-up and management of ischemic stroke

2019 ◽  
Vol 15 (2) ◽  
pp. 122-131
Author(s):  
Tomoyuki Ohara ◽  
Mehdi Farhoudi ◽  
Oh Young Bang ◽  
Masatoshi Koga ◽  
Andrew M Demchuk
Keyword(s):  
Ischemic Stroke ◽  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Treatment Decision ◽  
Treatment Decision Making ◽  
Therapy Effectiveness ◽  
Work Up ◽  
D Dimer ◽  
Etiologic Diagnosis

Background Elevated D-dimer levels are a marker of both thrombin formation and fibrinolysis. Currently D-dimer measurement is routinely used for ruling out venous thromboembolism and diagnosis/monitoring of disseminated intravascular coagulation. Recent emerging data suggest that D-dimer may become an important biomarker in ischemic stroke as well as in cardiovascular diseases. Aims To outline the clinical utility of D-dimer in work-up and management of ischemic stroke. Summary D-dimer measurement is most useful in stroke with active cancer as it can confirm etiologic diagnosis, predict recurrent stroke risk, and aid treatment decision in cancer-associated stroke. In cryptogenic stroke, high D-dimer levels can also provide clues for the cause of stroke as occult cancer and undetected cardiac embolic source as occult atrial fibrillation and may be helpful in treatment decision making of secondary stroke prevention. Serial D-dimer measurements should be further studied to monitor antithrombotic therapy effectiveness in both cardiogenic and cryptogenic etiologies. Conclusion Accumulating data suggests the utility of D-dimer test in the management of ischemic stroke, although the evidence is still limited. Future studies would clarify the role of D-dimer measurement in ischemic stroke.

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.

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 EFFECT OF PFO CLOSURE FOR PREVENTION OF RECURRENT STROKE OR TIA IN HIGHLY SELECTED PATIENTS WITH CRYPTOGENIC STROKE

2017 ◽  
Vol 69 (11) ◽  
pp. 1260
Author(s):  
Minsu Kim ◽  
Woong Chol Kang ◽  
Jeonggeun Moon ◽  
Pyung Chun Oh ◽  
Yae Min Park ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Pfo Closure

scholarly journals Recurrent Stroke after Transcatheter PFO Closure in Cryptogenic Stroke or Tia: Long-Term Follow-Up

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Elisabetta Mariucci ◽  
Andrea Donti ◽  
Luisa Salomone ◽  
Marta Marcia ◽  
Marta Guidarini ◽  
...  
Keyword(s):  
Recurrent Stroke ◽  
Cryptogenic Stroke ◽  
Vascular Risk Factor ◽  
Vascular Risk ◽  
Long Term Follow Up ◽  
Recurrent Strokes ◽  
Few Data ◽  
Pfo Closure

Background. There are few data on the mechanism of recurrent neurological events after transcatheter closure of patent foramen ovale (PFO) in cryptogenic stroke or TIA. Methods. We retrospectively reviewed PFO closure procedures for the secondary prevention of cryptogenic stroke/TIA performed between 1999 and 2014 in Bologna, Italy. Results. Written questionnaires were completed by 402 patients. Mean follow-up was 7 ± 3 years. Stroke recurred in 3.2% (0.5/100 patients-year) and TIA in 2.7% (0.4/100 patients-year). Ninety-two percent of recurrent strokes were not cryptogenic. Recurrent stroke was noncardioembolic in 69% of patients, AF related in 15% of patients, device related in 1 patient, and cryptogenic in 1 patient. AF was diagnosed after the procedure in 21 patients (5.2%). Multivariate Cox’s proportion hazard model identified age ≥ 55 years at the time of closure (OR 3.16, p=0.007) and RoPE score < 7 (OR 3.21, p=0.03) as predictors of recurrent neurological events. Conclusion. Recurrent neurological events after PFO closure are rare, usually noncryptogenic and associated with conventional vascular risk factors or AF related. Patients older than 55 years of age and those with a RoPE score < 7 are likely to get less benefit from PFO closure. After transcatheter PFO closure, lifelong strict vascular risk factor control is warranted.

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.

scholarly journals P772 Percutaneous transcatheter patent foramen ovale closure: does size really matter?

2020 ◽  
Vol 21 (Supplement_1) ◽  
Author(s):  
M F Ramis Barcelo ◽  
C Mas Llado ◽  
A Rodriguez ◽  
I Valadron ◽  
M Noris ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Superior Vena ◽  
Cryptogenic Stroke ◽  
Vena Cava ◽  
Closure Device ◽  
Foramen Ovale ◽  
Device Closure ◽  
Residual Shunt ◽  
Device Size ◽  
Pfo Closure

Abstract Introduction Patent foramen ovale (PFO) has been associated with cryptogenic stroke. Percutaneous transcatheter PFO closure has been in development for the last years. In recent studies, it has shown a reduction of recurrent ischemic stroke events. Several manufactures of PFO device closure have developed guidelines for selection of device size based on anatomic measurements obtained through echocardiography. A study showed that according to the guidelines few patients had adequate tissue rim to allow device implantation, and yet almost all the patients had an effective closure. Purpose and methods The aim of this study was to evaluate the characteristics of PFO with transesophageal echocardiogram (TEE) (size, distance between foramen ovale-superior vena cava (FO-SVC) and distance between FO-aortic annulus (FO-AoAn)) and to determinate the correlation between the size of PFO device implanted and the theoretical device size according to the guidelines. We performed a retrospective study among patients who underwent a PFO closure procedure between 2006 and 2018. Results 42 patients were included, 55% male, mean age 56 years and mean BSA 1,83 m². The PFO mean diameter and length were 3 and 13 mm respectively. The majority of PFO were complex: 91% of patients had defects larger than 8mm and 36% had atrial septum aneurism. Characteristic of PFO were measured (Table). In older patients the distance between PFO-SVC and PFO-AoAn was larger and the septum secundum was thicker (p 0.02). The right-to-left shunt was moderated or severe in most cases (75%). The PFO closure device was successfully implanted in all patients. The majority of them received an Amplatzer PFO device (45%) followed by an Hyperion PFO device. The size of the device was 25mm in half of the patients followed by 30mm device. According to the guidelines, in 67% of the cases the wrong size was chosen and the mean size of the device should had been 30mm (SD ±5,2). TEE examination during follow up showed no residual or mild residual shunt in 80% of the patients. Residual shunt was more prevalent with larger devices (p 0.008) Conclusions These results showed that the size of PFO closure device implanted in our population differed from the size recommended by guidelines. Smaller devices have been used. According to our results, larger devices are associated with more residual shunt, which suggests that a different approach may be necessary to establish new protocols for PFO device closure Table Minimal Maximal Mean SD SVC (mm) 10 30 17.55 ±3,7 AoAn (mm) 9 23 14.1 ±3,5 Minimal and maximal distance between PFO-SVC and AoAn

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.

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