Risk Of Paradoxical Embolism Research Articles

Neurologic recurrence after transcatheter PFO closure in patients with cryptogenic stroke

Abstract Background Patent foramen ovale (PFO) is associated with an increased risk of cryptogenic stroke, and interventional closure is recommended for secondary prevention. However, there is limited real-world data on long-term results. Our objective was to evaluate outcomes following successful transcatheter PFO occlusion. Methods Data from patients undergoing PFO closure for cryptogenic stroke between 2010 and 2015 were analysed to determine short- and long-term outcomes and to identify potential predictors of neurological recurrence. Results 330 patients underwent successful PFO closure. The mean age of patients was 49 (standard deviation (SD) ±12) years, and 55.5% were male. Any in-hospital adverse event was observed in eight patients (2.4%). During a median follow-up of 9.85 (SD ±2.5) years, the combined outcome of transient ischemic attack (TIA), stroke, or death from stroke was observed in 3.6% of patients (0.38 events per 100 person-years). After 5, 10, and 12 years the percentage of patients free of the composite outcome was 97.5%, 96.2%, and 96.2% respectively (Figure 1). New onset atrial fibrillation was detected in 10 patients (3.0%). A thorough analysis of the neurologic recurrences revealed a total number of six cryptogenic strokes (1.8%). Our results revealed that the Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.70, 95% confidence interval [CI]: 0.52 to 0.95; p=0.022) and the number of prior neurologic events (adjHR: 9.78, 95% CI: 2.66 to 35.99; p<0.001) were strong independent predictors of future recurrent neurologic events. Kaplan Meier survival analysis stratified by number of previous neurologic events proved to be statistically significant (p<0.001; Figure 2). Conclusion In this real-world cohort of patients with cryptogenic stroke we observed excellent safety and good efficacy of percutaneous PFO closure, similar to randomized controlled trials or other long-term cohort studies. The rate of recurrent neurological events was low, especially cryptogenic strokes. The RoPE score confirmed good predictive power; in particular, the number of previous neurological events should be taken more into account when determining the indication for closure.

Evaluation of efficacy and safety of simplified procedure for the percutaneous closure of patent foramen ovale: the Ile De France Foramen Ovale Permeable(IDFFOP) prospective, multicenter cohort study

Abstract The superiority of device closure over medical therapy for the prevention of recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) was reported in several meta –analyses of randomized controlled trials. The growing number of PFO procedures requires to find alternatives to conventional guidance by transoesophageal echocardiography (TOE) needing general anesthesia. The aim of our study was to assess prospectively the efficacy and safety of a simplified procedure based on trans thoracic echocardiography (TTE) and local anesthesia rather than TOE during PFO closure. Methods Design and study oversight. The IDFFOP study was a French prospective, multicenter cohort study performed in four centers expert in TTE-guided device deployment. All patients had a stroke history, a PFO and a large or moderate right to left shunt defined by the number of microbubbles in the left atrium ( large shunt > 30, moderate : 10 to 30 microbubbles). A(Risk of Paradoxical Embolism) score>5 was required to confirm PFO imputability in stroke history. The primary end point was efficacy of TTE during the transcatheter PFO closure defined as the successful implantation of the device without malposition, without need of TOE, and absence of significant residual shunt at 3-month TTE control. Safety was defined as the absence of any periprocedural complications. Results 280 patients were enrolled from January 2018 to October 2020 ( male sex : 59.5%; Average age 57 years old ). Average ROPE score was 7; Cumulative immediate procedural success with the TTE-guided method was 99%, without any device embolization. However, in 2 patients, TOE was needed to guide device deployment. There was no severe vascular complication, or any ischaemic event during or after the procedure. 6 post-procedure groin hematomas occurred but none needed anyblood transfusion .One patient experienced a transient periprocedural atrial fibrillation. At 3 months there were only 8 (2,8%) residual right to left shunts (3 large, 5 moderate). Conclusion A simplified procedure for percutaneous PFO closure based on TTE and local anesthesia is safe and effective. Randomized controlled trials should be performed to confirm these results.

Stroke recurrence after transcatheter PFO closure in patients with cryptogenic stroke.

Patent foramen ovale (PFO) closure is recommended for secondary prevention of cryptogenic stroke. However, data on long-term results are limited. We aimed to evaluate safety and efficacy of transcatheter PFO closure and predict neurologic recurrence. Data from patients undergoing PFO closure between 2010 and 2015 was collected to assess the combined endpoint of transient ischemic attack (TIA), stroke, or death from stroke at short- and long-term follow-up. 330 patients were included, mean age was 49 (±12) years and 55.5% were male. Before PFO closure, 86% experienced a stroke and 19% multiple neurological events. Procedure-related complications occurred in 2.4% of patients. Over a median follow-up of 10 years, the combined endpoint occurred in 3.6%, with a recurrence rate of 0.38 per 100 patient-years. Freedom from the combined endpoint at 5 and 10 years was 97.5% and 96.2%, respectively. New-onset atrial fibrillation was detected in 3%. The Risk of Paradoxical Embolism (RoPE) score (adjHR: 0.68; p=0.032), the PFO-Associated Stroke Causal Likelihood (PASCAL) classification system (adjHR: 0.37; p=0.042), and a history of prior neurological events (adjHR: 9.94; p<0.001) were independent predictors of future recurrent neurologic events. Age, sex, and cardiovascular risk factors did not influence outcomes. In this real-world cohort, transcatheter PFO closure was associated with low long-term recurrence of neurologic events, especially cryptogenic strokes. The RoPE score, the PASCAL score and history of previous neurological events were predictive of recurrent events. This study supports the safety and efficacy of PFO closure for secondary prevention of cryptogenic strokes, and underscores the importance of patient selection.

Multidisciplinary Approach to Patent Foramen Ovale Closure for Cryptogenic Stroke: Brain-Heart Board Experience.

Patent foramen ovale (PFO) is present in approximately 25% of adult population. The prevalence of PFO is high in patients with cryptogenic stroke suggesting paradoxical embolism. PFO closure in carefully selected patients is an effective secondary preventive strategy in these patients. We report predictors of management recommendations by the multidisciplinary Board and their impact on outcomes. Brain-Heart Board comprises vascular and interventional neurology and cardiology subspecialties (structural, electrophysiology, and cardiac imaging). Adult patients referred to the Board for consideration of PFO closure between October 2017 to March 2021 were included in this retrospective cohort analysis. Demographics, comorbid conditions, risk of paradoxical embolism (RoPE) score, event frequencies (transient ischemic attack [TIA] or stroke, intracranial hemorrhage [ICH], post-PFO closure cardiac arrhythmias), and modified Rankin Scale (mRS) at 1 year were compared between the groups (PFO closure vs medical management). Multivariable logistic regression was used to identify factors associated with management recommendation and chi-square tests to test differences in outcomes for patients according to management. Two hundred seventy patients (229 stroke; 41 TIA) were discussed by the Board for PFO closure. 119 (44.0%) patients were recommended for PFO closure of which 117 (98.3%) had evidence of ischemic infarct on imaging. In univariate analysis, age was similar (50 ± 11.9 vs 52 ± 12.8, p = 0.17), but RoPE score was higher in closure as compared with the medical management group (6 [IQR 5-7] vs 5 [IQR 4-7], p < 0.05). In multivariable analysis, TIA as the index event was an independent predictor of Board recommendation against PFO closure (OR 0.05, 95% CI 0.01-0.19, p < 0.05). Event frequency was low in both cohorts (5.9% vs 4.8%, p > 0.05) and comprised cardiac arrhythmias (6 cases of atrial fibrillation and 1 ICH in closure group; 1 TIA and 1 recurrent stroke in medical management group). Excellent functional outcome (mRS 0-1) was similar in both cohorts (66.3% vs 70.7%, p > 0.05) at 1 year. Multidisciplinary Brain-Heart Board provides a clinical practice model of collaborative care to ensure proper patient selection for PFO closure. TIA as the index event is associated with recommendation of medical management by the multidisciplinary Brain-Heart Board.

Symptomatic carotid webs and patent foramen ovale: RoPE score in competing stroke etiologies

BackgroundPatent foramen ovale (PFO)-associated stroke is diagnosed more frequently in young patients with infrequent vascular risk factors and embolic appearing infarcts. The risk of paradoxical embolism (RoPE) score is used to identify PFO-associated stroke. Patients with symptomatic carotid artery web (CaW) share a very similar risk profile and these lesions are frequently overlooked. In this study, we evaluate the RoPE score profile in patients with suspected symptomatic CaW. MethodsRetrospective analysis of prospectively collected data of patients with symptomatic CaW as the presumed cause of stroke presenting to 2 comprehensive stroke centers from 2014 to 2021. CaW was diagnosed using computed tomography angiography (CTA) of the neck & head. Shunt study was done using a transthoracic, transesophageal, and/or transcranial-Doppler with bubbles. RoPE score ≥7 was considered high. ResultsSeventy-five patients had stroke from a symptomatic ipsilateral CaW. Mean age was 49.7±11.2 years and 74.7 % were females. Median RoPE score was 7 [5–8], and 52.0 % had a high RoPE score. PFO was detected in 13.3 % of the patients and 20.5 % within the high RoPE score group. Ten percent of the cases would have been misclassified as PFO-associated strokes based on RoPE score. ConclusionHigh RoPE scores were observed in the majority of patients with CaW-attributed stroke, and it should not be used to differentiate CaW- versus PFO-associated stroke. Careful extracranial internal carotid artery evaluation for CaW is warranted in cryptogenic strokes, including in PFO positive patients before defining stroke etiology.

The Modified Risk of Paradoxical Embolism Score Is Associated with Patent Foramen Ovale in Patients with Ischemic Stroke: A Nationwide US Analysis.

The Risk of Paradoxical Embolism (RoPE) score was developed to identify stroke-related patent foramen ovale (PFO) in patients with cryptogenic stroke. We conducted a retrospective analysis of the 2016 to 2020 National Inpatient Sample to determine the performance of the modified RoPE score in identifying the presence of a PFO in patients with acute ischemic stroke (AIS). A total of 3,338,805 hospital admissions for AIS were analysed and 3.0% had PFO. Patients with PFO were younger compared to those without a PFO (median 63 years vs. 71 years, p < 0.001) and fewer were female (46.1% vs. 49.7%, p < 0.001). The patients with PFO had greater mean modified RoPE scores (4.0 vs. 3.3, p < 0.001). The area under the curve for the RoPE score in predicting PFOs was 0.625 (95%CI 0.620-0.629). The best diagnostic power of the RoPE score was achieved with a cut-off point of ≥4 where the sensitivity was 55% and the specificity was 64.2%. A cut-off point of ≥5 increased the specificity (83.1%) at the expense of sensitivity (35.8%). The strongest predictor of PFOs was deep vein thrombosis (OR 3.97, 95%CI 3.76-4.20). The modified RoPE score had modest predictive value in identifying patients with PFO among patients admitted with AIS.

Patent Foramen Ovale Closure in Older Patients With Stroke: Patient Selection for Trial Feasibility.

Whether patent foramen ovale (PFO) closure benefits older patients with PFO and cryptogenic stroke is unknown because randomized controlled trials (RCTs) have predominantly enrolled patients younger than 60 years of age. Our objective was to estimate anticipated effects of PFO closure in older patients to predict the numbers needed to plan an RCT. Effectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium). To estimate stroke recurrence risk, observed outcomes were calculated for patients older than 60 years in the age-inclusive observational databases (n = 549). To estimate the reduction in the rate of recurrent stroke associated with PFO closure vs medical therapy based on the RoPE score and the presence of high-risk PFO features, a Cox proportional hazards regression model was developed on the RCT data in the SCOPE database (n = 3,740). These estimates were used to calculate sample sizes required for a future RCT. Five-year risk of stroke recurrence using Kaplan-Meier estimates was 13.7 (95% CI 10.5-17.9) overall, 14.9% (95% CI 10.2-21.6) in those with high-risk PFO features. Predicted relative reduction in the event rate with PFO closure was 12.9% overall, 48.8% in those with a high-risk PFO feature. Using these estimates, enrolling all older patients with cryptogenic stroke and PFO would require much larger samples than those used for prior PFO closure trials, but selectively enrolling patients with high-risk PFO features would require totals of 630 patients for 90% power and 471 patients for 80% power, with an average of 5 years of follow-up. Based on our projections, anticipated effect sizes in older patients with high-risk features make a trial in these subjects feasible. With lengthening life expectancy in almost all regions of the world, the utility of PFO closure in older adults is increasingly important to explore.

Amplatzer or Figulla Flex II Occluder: a comparative study of outcomes after transcatheter patent foramen ovale closure.

Percutaneous closure of a patent foramen ovale (PFO) for the prevention of recurrent paradoxical thromboembolic events has been shown to be safe and effective in randomized controlled trials. However, it remains uncertain if differences in the structure and design of the occluder devices impact the outcomes. The aim of this study was to compare results of percutaneous PFO closure using 2 widely used double-disc occluders. Consecutive patients who underwent percutaneous PFO closure with the Abbott Amplatzer occluder (APO) or the Occlutech Figulla-Flex-II occluder (OPO) at the Heart Center Lucerne between February 2017 and December 2022 were included in a registry. The primary endpoint was effective closure of the PFO, defined as a residual shunt grade 0 or 1, assessed by contrast echocardiogram at 6-month follow-up. Secondary endpoints included procedural efficacy/safety and major adverse cardiovascular events during the hospital stay and at 6-month follow-up. One hundred ninety-three consecutive patients (mean age 51.7 ± 12.5 years; 39% women; Risk of Paradoxical Embolism (RoPE) score = 7, IQR = 6-8) underwent percutaneous PFO closure with the APO (120 patients, 62.2%) or the OPO (73 patients, 37.8%). Main indications for closure were crypotogenic stroke in 168 patients (87.1%) and peripheral embolism in 13 patients (6.7%). At baseline, right-to-left shunt (RLS) greater than or equal to grade 2 was present in 189 patients (97.9%). Immediate procedural success was 99.5%. In 1 patient, an air embolism occurred during positioning of the APO occluder with transient chest pain and electrocardiogram changes, but without further sequelae to the patient. At 6-month follow-up, effective closure was achieved in 185 patients (95.8%; APO: 96.6% vs OPO: 94.5%, P = .30). Rates of atrial fibrillation and recurrent thromboembolic events were 4.2 and 0.5%, respectively. PFO closure is safe and effective when performed with either the self-expanding Abbott Amplatzer or Occlutech Figulla Flex II PFO occluder.

Abstract 92: Impacts of a Multidisciplinary Brain Heart Team on Patent Foramen Ovale Closure in Patients With Cryptogenic Stroke

Background: The AHA/ASA 2021 Secondary Stroke Prevention Guideline recommends a joint decision by neurology and cardiology for patent foramen ovale (PFO) closure. The impact of a Brain Heart Team (BHT) consisting of interventional cardiologists and vascular neurologists to evaluate PFO closure is unclear. We analyzed whether a BHT implementation led to more guideline recommended PFO closures based on Risk of Paradoxical Embolism (RoPE) score and PASCAL categories across a 15-hospital system. Methods: Data were collected retrospectively between 1/2016 - 2/2023. Baseline demographics, risk factors, method of shunt identification, high-risk shunt features, post PFO atrial fibrillation and stroke rates, RoPE score and PASCAL categorization were abstracted. Non-BHT was defined as absence of vascular neurology involvement. Appropriate PFO closure was defined as RoPE score &gt; 7 and/or PASCAL categories of possible/probable. Chi-squared and t-test were used. Results: Of 174 patients, 108 (62%) were identified as BHT and 66 (38%) as non-BHT. There were no differences in baseline risk factors between BHT and non-BHT besides hyperlipidemia (28.7% vs 53% p &lt; .002) and smoking history (12% vs 31.8% p &lt; .003). BHT patients were younger at age of diagnosis and PFO closure (44.8 yrs ±1.7 vs 56 yrs ±1.2 p=0.003 and 44.7 yrs ±1.9 vs. 56 yrs ±1.3 p=0.004 respectively). There were differences in race/ethnicity (Table 1). More BHT patients had possible/probable PASCAL vs non-BHT (101 [93.5%] vs 44 [66.7%], p &lt;0.001). Patients in BHT had higher mean RoPe scores (7.34 ± 1.55 vs 6.06 ± 2.02 p &lt;0.001). More patients in BHT had a RoPE score &gt; 7 (77 [71.3%] vs 26 [39.4%] p &lt;0.001). There were no differences in atrial fibrillation (5 [4.6%] vs 5 [7.6%] p = 0.635) or stroke after PFO closure (2 [1.9%] vs 2 [3%] p = 1). Conclusion: Implementing a multi-disciplinary approach with a Brain Heart Team leads to more guideline based PFO closures in cryptogenic strokes based on PASCAL and RoPE scores.

Timing on patent foramen ovale closure: early versus delayed closure

Abstract Introduction Pivotal randomized clinical trials showed benefit in patent foramen ovale closure (PFOC) up to 9 months after a cryptogenic stroke or transient ischemic attack (TIA) [1-4]. It might be sensible to indicate PFOC also in non-recent cryptogenic strokes, but evidence is lacking. Purpose We aimed to compare the effectiveness of PFOC according to the time elapsed from the patient’s last episode of cryptogenic cerebrovascular event (CVE) or systemic embolism (SE). Methods A retrospective, international, multicentre, cohort study was performed to compare the outcomes of an early closure (EC, &amp;lt;9 months) or delayed closure (DC, ≥9 months) of patent foramen ovale (PFO) as secondary prevention after the index event. The primary end-point was recurrence of CVE or SE after PFOC. Results A total of 325 and 171 patients were classified in the EC and DC groups, with a median time to PFOC of 3.4 (IQR 1.9-5.5) and 17.5 (IQR 12.2-33.4) months, respectively. No significant differences were observed regarding the type of event indicating PFOC (stroke was the most frequent (77.8% in EC group vs 79.0% in DC group), followed by TIA (19.4% vs 18.7%)); neither about neuroanatomic localization of the lesions, nor contrast transcranial Doppler patterns, nor Risk of Paradoxical Embolism (RoPE) score (7 (IQR 5-8) vs 6 (IQR 5-7), p=0.077). Echocardiographic PFO characteristics of both groups were similar, except for a larger defect size (tunnel width) in the DC group (6 (IQR 4-14) vs 12 (IQR 6-16) mm, p=0.005)). PFOC device, procedural success (99.4 in EC vs 98.8% in DC group) and periprocedural complications (2.1 vs 0.8%) were comparable in both groups. Median follow-up was 2.0 (IQR 1.3-3.8) years in the EC group and 2.2 (IQR 1.2-4.9) in the DC group (p=0.721). No significant differences were observed concerning recurrence of stroke, TIA or SE (3.9% vs 2.6%, p=0.443), time from PFOC to recurrence (0.9 (IQR 0-2.1) vs 6.1 (2.5-8.8) years, p=0.090), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment during follow-up (Figure 1). Moreover, a subanalysis considering those patients with a very delayed PFOC (≥24 months) after the index event also showed no differences in recurrence rate during follow-up compared to the earlier procedures (4.2% in the &amp;lt;24-month group vs 3.4% ≥24-month group, p=0.770). Conclusions No differences were observed regarding recurrences of CVE/SE in patients undergoing PFOC before and after 9 months from the index event. Despite the absence of evidence from randomized trials, this study suggests that the preventive benefit of PFOC after a cryptogenic CVE/SE may be extended beyond 9 months after the last event.Figure 1:Incidence of recurre

Propensity-score matched analysis of patent foramen ovale closure in real-world study cohort with cryptogenic ischemic stroke

IntroductionPatent foramen ovale (PFO) occurs in 25% of the general population and in 40% of cryptogenic ischemic stroke patients. Recent trials support PFO closure in selected patients with cryptogenic stroke. We examined the outcomes of transcatheter PFO closure in a real-world study cohort with cryptogenic stroke. MethodsConsecutive ischemic stroke patients who were classified as cryptogenic on the TOAST aetiology and diagnosed with a PFO were included. All patients underwent either transcatheter PFO closure or medical therapy. A 2:1 propensity score matching by sex and Risk-of-Paradoxical-Embolism (RoPE) score was performed. Multivariable regression models adjusted for sex and RoPE score. ResultsOur cohort comprised 232 patients with mean age 44.3 years (SD 10.8) and median follow-up 1486.5 days. 33.2% were female. PFO closure (n=84) and medical therapy (n=148) groups were well-matched with <10% mean-difference in sex and RoPE score. Two patients in the treated group (2.4%) and seven in the control group (4.7%) had a recurrent ischemic stroke event. Multivariable Cox regression demonstrated a hazard-ratio of 0.26 (95%CI 0.03-2.13, P=0.21) for PFO closure compared to control. The incidence of atrial fibrillation (AF) detected post-PFO closure was similar between the treated and control (1.19% vs 1.35%, multivariable logistic regression odds-ratio 0.90, 95%CI 0.04-9.81, P=0.94). There were no major periprocedural complications documented. The difference in restricted mean survival-time free from stroke at two years between treated and control was 26.2 days (95%CI 5.52-46.85, P=0.013). ConclusionsIn this Asian cohort, we report a low incidence of ischemic stroke recurrence and new-onset AF in patients who underwent PFO closure. When compared to the medical therapy group, there was no significant difference in the incidence of stroke recurrence and new-onset AF. Further studies involving larger real-world cohorts are warranted to identify patients who are more likely to benefit from PFO closure.

Predictive value of transesophageal echocardiography combined with contrast transthoracic echocardiography for embolic stroke of undetermined source.

In this study, we aimed to assess the predictive value of transesophageal echocardiography (TEE) combined with contrast transthoracic echocardiography (cTTE) for embolic stroke of undetermined source (ESUS). A total of 52 patients with ESUS were examined by TEE and cTTE. The detection rate of patent foramen ovale (PFO) and right-to-left shunt (RLS) grade were compared in patients with ESUS between cTTE alone and cTTE combined with TEE. The Risk of Paradoxical Embolism (RoPE) score, PFO diameter, and PFO length of patients with PFO-associated ESUS and non-PFO-associated ESUS were compared by cTTE alone and cTTE combined with TEE. The receiver operating characteristic (ROC) curve was utilized to determine the effect of RoPE score and PFO diameter on patients with PFO-associated ESUS. The positive rate of PFO detected by cTTE alone (46.15%) was lower than that detected by cTTE combined with TEE (69.23%). The proportion of patients with RLS grade I + II + III detected by cTTE combined with TEE (69.23%) was higher than that detected by cTTE alone (46.15%). Both the RoPE score and PFO diameter were significantly greater in the patients with PFO-associated ESUS than in the patients with non-PFO-associated ESUS (p < .05). The combination of RoPE score and PFO diameter had the largest area under the ROC curve (AUC = 0.875), which was larger than the AUC alone of RoPE score (AUC = 0.819) and PFO diameter (AUC = 0.783) (p < .05). The combination of cTTE and TEE is helpful to the diagnosis of ESUS patients caused by PFO and to judge the degree of RLS.

Transesophageal echocardiography-guided percutaneous closure of the patent foramen ovale only uses the sheath.

Percutaneous closure of the patent foramen ovale (PFO) is primarily guided by fluoroscopy in the catheter room, during which procedure both the guidewire and sheath need to pass through the PFO. We performed PFO closure using a transesophageal echocardiography (TEE)-guided approach and only the sheath was passed through the PFO during the procedure. This study aimed to evaluate the feasibility and safety of PFO closure using this technique. A retrospective observational study was performed. A total of 117 consecutive adult patients underwent percutaneous PFO closure without fluoroscopy, under the sole guidance of TEE in our hospital between December 2018 and December 2021. The data of each patient consisted of preoperative, operative, and postoperative variables collected. The primary outcome is that the occluder was successfully released. The secondary outcomes included perioperative and follow-up transthoracic echocardiography (TTE), Headache impact test-6 (HIT-6) score and clinical symptoms. Transvenous PFO closure under TEE guidance was successful in all cases. The sample consisted of 93 females and 24 males with an average age of 42.3±7.8 years. There were 28 patients with preoperative cerebral infarction [Risk of Paradoxical Embolism (RoPE) score >6 points] and 89 patients with migraine. All patients underwent a preoperative TEE to confirm the presence of PFO, and contrast-enhanced transcranial Doppler (c-TCD) acoustic contrast suggested grades 3 to 4. The average time of surgery for patients (puncture to removal of the sheath) was 32 minutes. Three cases of vagus nerve reflex manifestations during surgery and two cases of transient ventricular arrhythmia all improved after symptomatic treatment. There were no instances of metal allergy, hemolysis, or other acute vascular procedural complications. For all 89 patients with migraine, significant relief or resolution was achieved during the first six-month follow-up (P<0.001). As a monotherapy, percutaneous closure of PFO guided by TEE where only the sheath passes through the PFO during the operation is an effective procedure with a high success rate and a low complication rate.

Modified Risk of Paradoxical Embolism More Effectively Evaluates the Risk of Stroke Associated with Patent Foramen Ovale.

Through an analysis of the risk factors associated with patent foramen ovale (PFO)-related stroke (PS), we aimed to modify the Risk of Paradoxical Embolism (RoPE) to assess the risk of PS. A retrospective collection of ischemic stroke (IS) patients with PFO admitted to the Department of Neurology at Beijing Chaoyang Hospital was conducted. The patients were classified into PS and non-PS groups. PS risk factors and RoPE scoring were analyzed based on clinical data, laboratory indicators, and imaging data. Independent risk factors were incorporated into the RoPE scoring system for enhancement. Significant differences were observed between the two groups regarding total cholesterol, low-density lipoprotein-cholesterol (LDL-C), and uric acid levels. The transverse diameter of the left atrium was significantly larger in the non-PS group compared to the PS group. Multivariate logistic regression revealed that higher LDL-C levels and a smaller transverse diameter of the left atrium increased the risk of PS. The modified RoPE score was derived by assigning 1 point each for high LDL-C levels and the absence of transverse diameter enlargement in the left atrium. The area under the curve (AUC) of the receiver operating characteristic (ROC) curves for the classical and modified RoPE score distinguishing PS were 0.661 and 0.798, respectively. LDL-C levels and transverse diameter of the left atrium were identified as independent risk factors for PS. The modified RoPE scoring system exhibited superior performance in assessing the risk of PS compared to the original RoPE score.

P466 PREDICTORS OF RECURRENT CEREBRAL ISCHEMIA AFTER PATENT FORAMEN OVALE CLOSURE: A SINGLE CENTER EXPERIENCE WITH A LONG–TERM FOLLOW–UP

Abstract Aims Transcatheter patent foramen ovale (PFO) closure has been shown to lower recurrent stroke in patients with cryptogenic stroke (CS) or transient ischemic attack (TIA) with an indication for closure. However, the incidence of recurrent stroke is not negligible and underlying pathogenic mechanisms remain largely unknown. We sought to evaluate the prevalence of recurrent CS/TIA and to assess its predictors after transcatheter PFO closure. Methods We enrolled consecutive patients who underwent PFO closure for secondary prevention of neurological ischemic events at the University Hospital of Parma between 2006 and 2021. For each subject, CS/TIA index event was diagnosed after exclusion of alternative etiologies, PFO features were characterized by transesophageal echocardiography (TEE), the Risk of Paradoxical Embolism (ROPE) score was retrospectively assessed and the presence of migraine was investigated. Clinical follow–up was scheduled with outpatient visits at 3 – 12 months and yearly thereafter device implantation; the primary outcome was the recurrence of any ischemic neurological event. Results We enrolled a total of 169 patients with mean Risk of Paradoxical Embolism (ROPE) score at hospital admission of 6.4 ± 1.5. The primary indication for PFO closure was previous CS (94 [55.6%] subjects), followed by TIA (75 [44.4%]). Among patients with complete outcome data (n= 154), after a median follow–up of 112 months, recurrent cerebral ischemia occurred in 13 [8.4%], with an annualized rate of 0.92/100 patients. The presence of obesity [OR 5.268, p = 0.018], ROPE score &amp;lt; 7 [OR 5.991, p = 0.035] and migraine [OR = 5.932 p = 0.012] were independent positive predictors of recurrent stroke/TIA after PFO closure. Conclusion In our study, recurrent cerebral events after PFO closure were not negligible, with an annualized rate of 0.92/100 patients, consistent with prior research. Multiple heterogeneous predictors were identified: the presence of obesity, ROPE score &amp;lt; 7 and migraine were independent positive predictors of recurrent stroke/TIA after PFO closure

Multidisciplinary approach to Patent Foramen Ovale (PFO) closure for Cryptogenic Stroke: Brain-Heart Board Experience (P11-5.024)

<h3>Objective:</h3> Our study evaluates the predictors of closure recommendation by multidisciplinary board for PFO closure and its impact on outcomes. <h3>Background:</h3> PFO closure in carefully selected patients is an effective secondary preventive strategy in young cryptogenic stroke patients which requires close collaborative approach. <h3>Design/Methods:</h3> Brain-Heart Board is comprised of vascular neurology and cardiology subspecialities. Adult patients referred to the board for consideration of PFO closure between October 2017 to March 2021 were included in this analysis. Demographics, comorbid conditions, infarct location, Risk of Paradoxical Embolism (RoPE) Score, event frequencies (recurrent TIA or stroke, intracranial hemorrhage (ICH), post-PFO closure cardiac arrythmias) and modified Rankin Scale (mRS at 1 year) were compared between the groups (PFO closure vs. medical management). Multivariable logistic regression was used to identify predictors of closure and chi-square tests to test differences in outcomes for patients according to management. <h3>Results:</h3> 270 patients (229 stroke; 41 TIA) were included in the analysis. 119 (44%) patients were recommended for PFO closure of which 117 (98%) had infarct on neuroimaging. Age and RoPE score were similar in closure and medical management cohorts (age; 50±12 vs. 52±13, p&gt;0.05 RoPE 4±3 vs. 6±2 p&gt;0.05). In multivariable analysis, absence of infarct on neuroimaging was an independent predictor of medical management recommendation by the board (OR 0.05 95% CI 0.01–0.19 p&lt;0.05). Event frequency was low in both cohorts (5.9% vs. 4.8% p&gt;0.05) and were comprised primarily of cardiac arrhythmias (6 atrial fibrillation and 1 ICH in Closure group; 1 TIA and 1 recurrent stroke in medical management group). Excellent functional outcome (mRS 0–1) was similar in both cohorts (66% vs. 71% p&gt;0.05) at 1 year. <h3>Conclusions:</h3> Multidisciplinary approach towards PFO closure results in low frequency of complications (recurrent ischemic stroke, ICH and post-PFO closure cardiac arrythmias) and good outcomes. Infarct on neuroimaging predicts closure recommendation by the multidisciplinary board. <b>Disclosure:</b> The institution of Dr. Khan has received research support from NINDS. The institution of Dr. Khan has received research support from Genentech. The institution of Dr. Khan has received research support from Spectrum Health-MSU alliance. Dr. Khan has received research support from NIH. Dr. McCarthy has nothing to disclose. Dr. Haggerty has nothing to disclose. Dr. Min has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Abbott . Dr. Min has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Medtronic . Dr. Miller has nothing to disclose. Dr. Tsai has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerenovus. Dr. Merhi has nothing to disclose. Dr. Berkompas has received personal compensation in the range of $10,000-$49,999 for serving as a Proctor and consultant with Medtronic. Dr. Wees has nothing to disclose. Dr. Khan has nothing to disclose. Dr. Ahrar has nothing to disclose. Mrs. Evans has nothing to disclose. Dr. Dahu has nothing to disclose. Dr. Gauri has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Medtronic . Dr. Gauri has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Atricure . Mrs. Moelker has nothing to disclose. Dr. Chalfoun has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Chalfoun has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Atricure. Dr. Chalfoun has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Atricure.

Abstract Number ‐ 10: Stroke Patients with Carotid Artery Web Have High RoPE Scores and Low Frequency of PFO

Introduction PFO‐associated stroke is more common in young patients (&lt;60 years) with less vascular risk factors, and with an infarct pattern consistent with embolic phenomena. These features are included in the Risk of Paradoxical Embolization (RoPE) score in which a high score (≥ 7) indicates a high likelihood of a symptomatic PFO. However, carotid artery webs (CaW) have been reported in patients with the same profile in which a PFO might be detected. In this study, we calculated RoPE score for patients with symptomatic CaW related strokes to identify how many of these patients would have been potentially misclassified as having a PFO‐associated stroke. Methods Patients presenting with ESUS and ipsilateral symptomatic CaW were included. Stroke work up was completed including cervicocranial vascular imaging that was reviewed by a neuroradiologist and an interventional neurologist. Shunt study was done with a TTE, TEE, and/or TCD, all with a bubble study. RoPE score of ≥ 7 was considered high. Results A total of 75 patients fulfilled the inclusion criteria of having an ipsilateral symptomatic CaW as the etiology of ESUS with no competing etiologies aside from PFO. The baseline characteristics are described in the table. The rates of vascular risk factors were generally low which is reflected by a high median RoPE score of 7 [IQR 5‐8], with 52% (n = 39) of patients having a score of ≥ 7. Ten patients (13%) had a PFO, of which 3 had high‐risk features. There was no significant difference in median RoPE score between patients with and without PFO (8 [6‐8] vs 6 [5‐8], p = 0.238), nor in the rate of patients with high RoPE score (78% vs 44%, p = 0.06). Recurrence happened in 16% (n = 12) of the patients and was always ipsilateral to the symptomatic CaW. No significant difference was detected in the rates of recurrence between high vs low RoPE scores (20.5% vs 11.1%, p = 0.351). Patients with a PFO had higher rates of recurrence compared to those without a PFO (40%, n = 4 vs 12.3%, n = 8, p = 0.048); however, none of the PFO patients with a recurrent stroke had a high‐risk PFO. A superimposed thrombus was seen on the CaW in 12.2% (n = 9) and was more commonly seen in patients who had recurrence (36%, n = 4 vs 8%, n = 5, p = 0.024). Conclusions Patients with ESUS from a presumably symptomatic CaW‐related stroke have high RoPE scores. The recurrence rates were high in this population and were always ipsilateral to the side of the CaW including in the PFO population. The PFO is likely incidental in this population despite having a high RoPE score. Neurologists should carefully evaluate the cervical vasculature before concluding that a PFO is stroke‐related and committing patients to PFO treatment.

Abstract TP186: Multidisciplinary Approach To Patent Foramen Ovale (pfo) Closure For Cryptogenic Stroke: Brain-heart Board Experience

Background: The prevalence of PFO is up to 40% in patients with cryptogenic stroke and TIA suggesting paradoxical embolism. PFO closure in carefully selected patients is an effective secondary preventive strategy in these patients. We report predictors of closure recommendation by multidisciplinary board for PFO closure and its impact on outcomes. Methods: Brain-Heart Board is comprised of vascular neurology, cardiology subspecialities (structural, electrophysiology and cardiac imaging). Adult patients referred to the board for consideration of PFO closure between October 2017 to March 2021 were included in this analysis. Demographics, comorbid conditions, infarct location, Risk of Paradoxical Embolism (RoPE) Score, event frequencies (recurrent TIA or stroke, intracranial hemorrhage (ICH), post-PFO closure cardiac arrythmias) and modified Rankin Scale (mRS at 1 year) were compared between the groups (PFO closure vs. medical management). Multivariable logistic regression was used to identify predictors of closure and chi-square tests to test differences in outcomes for patients according to management. Results: The board discussed 270 patients (229 stroke; 41 TIA). 119 (44%) patients were recommended for PFO closure of which 117 (98%) had infarct on neuroimaging. Age and RoPE score were similar in closure and medical management cohorts (age; 50±12 vs. 52±13, p&gt;0.05 RoPE 4±3 vs. 6±2 p&gt;0.05). In multivariable analysis, absence of infarct on neuroimaging was an independent predictor of medical management recommendation by the board (OR 0.05 95% CI 0.01-0.19 p&lt;0.05). Event frequency was low in both cohorts (5.9% vs. 4.8% p&gt;0.05) and were comprised primarily of cardiac arrhythmias (6 atrial fibrillation and 1 ICH in Closure group; 1 TIA and 1 recurrent stroke in medical management group). Excellent functional outcome (mRS 0-1) was similar in both cohorts (66% vs. 71% p&gt;0.05) at 1 year. Conclusion: Multidisciplinary approach for selecting patients for PFO closure results in low frequency of complications (recurrent ischemic stroke, ICH and post-PFO closure cardiac arrythmias) and good outcomes. Presence of infarct on neuroimaging predicts closure recommendation by the multidisciplinary brain-heart board.

ADAMTS-13 activity in stroke of known and unknown cause: Relation to vascular risk factor burden.

The identification of the underlying mechanism in ischemic stroke has important implications for secondary prevention. A disintegrin and metalloprotease with a thrombospondin type 1 motif, member 13 (ADAMTS-13) has antithrombotic properties and was repeatedly implicated in the pathophysiology of stroke. In this study, we, therefore, aimed to investigate whether ADAMTS-13 is associated with stroke etiology and the burden of vascular risk factors. We determined ADAMTS-13 activity in two prospectively recruited stroke cohorts in the long-term course after the event. Cohort 1 (n = 88) consisted of patients who suffered a stroke due to embolic stroke of undetermined source (ESUS), cardioembolic stroke due to atrial fibrillation (AF), large-artery atherosclerosis, or small vessel disease. In cohort 2, patients with cryptogenic stroke and patent foramen ovale (PFO) scheduled for PFO closure (n = 38) were enrolled. As measures of vascular risk factor burden, the CHA2DS2VASC score, the Essen Stroke Risk Score (ESRS), and the Risk of Paradoxical Embolism (RoPE) score were calculated, as appropriate. ADAMTS-13 activity was lower in patients with AF-related stroke compared to patients with ESUS (p = 0.0227), which was, however, due to confounding by vascular risk factors. ADAMTS-13 activity inversely correlated with the ESRS (r = -0.452, p < 0.001) and CHA2DS2VASC (r = -0.375, p < 0.001) in cohort 1. In accordance with these findings, we found a positive correlation between ADAMTS-13 activity and the RoPE score in cohort 2 (r = 0.413, p = 0.010). ADAMTS-13 activity is inversely correlated with the number of vascular risk factors across different stroke etiologies. Further study is warranted to establish ADAMTS-13 as a mediator of cerebrovascular risk.

Potential Embolic Sources in Embolic Stroke of Undetermined Source Patients with Patent Foramen Ovale

Introduction: A patent foramen ovale (PFO) may coexist with other potential embolic sources (PESs) in patients with embolic stroke of undetermined source (ESUS), leading to difficulty in attributing the stroke to either the PFO or other PESs. We aimed to investigate the prevalence and predictors of concomitant PESs in ESUS patients with PFOs. Methods: A retrospective cohort study was conducted in a tertiary stroke centre. Consecutive patients with ESUS and a concomitant PFO admitted between 2012 and 2021 were included in the study. Baseline characteristics and investigations as a part of stroke workup including echocardiographic and neuroimaging data were collected. PESs were adjudicated by 2 independent neurologists after reviewing the relevant workup. Results: Out of 1,487 ESUS patients, a total of 309 patients who had a concomitant PFO with mean age of 48.8 ± 13.2 years were identified during the study period. The median Risk of Paradoxical Embolism (RoPE) score for the study cohort was 6 (IQR 5–7.5). Of the 309 patients, 154 (49.8%) only had PFO, 105 (34.0%) patients had 1 other PES, 34 (11.0%) had 2 PES, and 16 (5.2%) had 3 or more PES. The most common PESs were atrial cardiopathy (23.9%), left ventricular dysfunction (22.0%), and cardiac valve disease (12.9%). The presence of additional PESs was associated with age ≥60 years (p < 0.001), RoPE score ≤6 (p ≤0.001), and the presence of comorbidities including diabetes mellitus (p = 0.004), hypertension (p≤ 0.001), and ischaemic heart disease (p = 0.011). Conclusion: A large proportion of ESUS patients with PFOs had concomitant PESs. The presence of concomitant PESs was associated with older age and a lower RoPE score. Further, large cohort studies are warranted to investigate the significance of the PES and their overlap with PFOs in ESUS.