Patients Undergoing Patent Foramen Ovale Closure Research Articles

Determinants of adverse outcomes following patent foramen ovale closure in elderly patients.

Limited data are available on transcatheter patent foramen ovale (PFO) closure outcomes in the elderly. Through this study, we aimed to determine the incidence and predictors of adverse events (recurrent cerebrovascular events [CVE] and atrial fibrillation [AF]) post-PFO closure in older patients with cryptogenic events. This multicentre international study included patients over 60 years undergoing PFO closure for cryptogenic thromboembolic events. A dedicated database compiled baseline, procedural, and follow-up data. Competing risk and adjusted outcome predictor analyses were conducted. A total of 689 patients were included (median age 65 years, 41.2% female, mean Risk of Paradoxical Embolism [RoPE] score 4.5). The procedural success rate was 99.4%. After a median follow-up of 2 (interquartile range 1-5) years, 66 patients (9.6%) had died. CVE and stroke rates were 1.21 and 0.55 per 100 patient-years, respectively. Diabetes (hazard ratio [HR] 3.89, 95% confidence interval [CI]: 1.67-9.07; p=0.002) and atrial septal aneurysm (ASA; HR 5.25, 95% CI: 1.56-17.62; p=0.007) increased the CVE risk. New-onset AF occurred at a rate of 3.30 per 100 patient-years, with 51.3% within one month post-procedure. Older age (HR 1.05 per year, 95% CI: 1.00-1.09; p=0.023) and the absence of hypertension (HR 2.04, 95% CI: 1.19-3.57; p=0.010) were associated with an increased risk of AF. Older patients undergoing PFO closure had a relatively low rate of CVE and new-onset AF after a median follow-up of 2 years. The presence of diabetes, ASA, and a more advanced age determined an increased risk of adverse clinical events. These factors may be considered in the clinical decision-making process regarding PFO closure in this challenging population.

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

Patent Foramen Ovale Occlusion in Elderly Patients: Is It Worth It? A Large, Single-Center Retrospective Analysis.

Background: Patent foramen ovale (PFO) is often diagnosed in patients with cryptogenic stroke, aged > 60-65 years, but few data report the outcomes of PFO closure in elderly patients. Methods: Consecutive patients undergoing PFO closure at a single institution between January 2006 and December 2011 were included. Baseline clinical features and cerebral imaging data were collected, and a RoPE score was calculated for each patient. Procedural data were recorded as well as medical therapy upon discharge. All-cause death, ischemic stroke, TIA and systemic embolism recurrence at long-term follow-up were investigated, as well as new atrial fibrillation onset. Results: Overall, 462 patients were included, of whom 64 (13.8%) were aged ≥ 65 years. Female gender was slightly more prevalent in the younger group while hypertension was more frequent among elderly patients. Previous stroke/TIA was the indication for PFO closure in 95.3% of older patients and 80.4% of younger patients, whereas other indications were more frequent among younger patients. RoPE scores were lower in older patients (median RoPE score of 5 vs. 7), and atrial septal aneurysm was more frequently detected among elderly patients. All procedures were technically successful. Procedural or in-hospital complications equally occurred in 5 (7.8%) older patients (4 AF and 1 device embolization) and 30 (7.5%) young patients (29 AF or other supraventricular arrhythmias and 1 device embolization). The follow-up duration was longer among younger patients. All-cause mortality was higher in older patients (16 deaths vs. 4 at follow-up, log-rank p < 0.001), no recurrent strokes occurred, and 2 TIAs were reported among non-elderly patients. New-onset atrial fibrillation occurred in three elderly and eight young patients. Conclusions: PFO closure is a safe procedure in patients aged ≥ 65 years, associated with favorable long-term follow-up and the prevention of ischemic neurologic recurrences.

Device Closure or Antithrombotic Therapy After Cryptogenic Stroke in Elderly Patients With a High-Risk Patent Foramen Ovale.

In young patients (aged 18-60 years) with patent foramen ovale (PFO)-associated stroke, percutaneous closure has been found to be useful for preventing recurrent ischemic stroke or transient ischemic attack (TIA). However, it remains unknown whether PFO closure is also beneficial in older patients. Patients aged ≥60 years who had a cryptogenic stroke and PFO from ten hospitals in South Korea were included. The effect of PFO closure plus medical therapy over medical therapy alone was assessed by a propensity-score matching method in the overall cohort and in those with a high-risk PFO, characterized by the presence of an atrial septal aneurysm or a large shunt. Out of the 437 patients (mean age, 68.1), 303 (69%) had a high-risk PFO and 161 (37%) patients underwent PFO closure. Over a median follow-up of 3.9 years, recurrent ischemic stroke or TIA developed in 64 (14.6%) patients. In the propensity score-matched cohort of the overall patients (130 pairs), PFO closure was associated with a significantly lower risk of a composite of ischemic stroke or TIA (hazard ratio [HR]: 0.45; 95% confidence interval [CI]: 0.24-0.84; P=0.012), but not for ischemic stroke. In a subgroup analysis of confined to the high-risk PFO patients (116 pairs), PFO closure was associated with significantly lower risks of both the composite of ischemic stroke or TIA (HR: 0.40; 95% CI: 0.21-0.77; P=0.006) and ischemic stroke (HR: 0.47; 95% CI: 0.23-0.95; P=0.035). Elderly patients with cryptogenic stroke and PFO have a high recurrence rate of ischemic stroke or TIA, which may be significantly reduced by device closure.

Temporal alterations in P-wave electrocardiographic metrics post patent foramen ovale closure: a retrospective study

Aims: This study aimed to analyze the electrocardiograms (ECG) of 69 patients before and after patent foramen ovale (PFO) closure, specifically investigating novel ECG parameters, over a 6-month post-procedure period. Methods: ECGs from 69 patients undergoing PFO closure were examined at three time points: before the procedure, and at 1st and 6th months post-procedure. A comprehensive set of ECG parameters, including P-wave (PW) maximum (PWmax), PW minimum (PWmin), PR interval, PW dispersion (PWdis), PW peak time in lead D2 (PWPTD2), PW peak time in lead V1(PWPTV1), P-axis, PW terminal force in the V1 (PWTF) and heart rate, were analyzed using a generalized linear mixed model (GLMM). Results: The GLMM analysis revealed significant changes in novel ECG parameters at 1-month post-procedure compared to baseline values. Parameters including PWmax (OR=8.898, 95% CI 7.521-10.275, p&amp;lt;0.001, PWmin (OR=6.579, 95% CI 5.611-7.548, p&amp;lt;0.001), PR (OR=4.159,95% CI 3.031-5.288, p&amp;lt;0.001), PWdis (OR=2.594, 95% CI 1.607-3.581, p&amp;lt;0.001), PWPTD2 (OR=4.261, 95% CI 2.928-5.593, p&amp;lt;0.001), PWPTV1 (OR=5.261, 95% CI 4.529-5.992, p&amp;lt;0.001), and PWTF (OR= 5.781, 95% CI 2.083-16.044, p&amp;lt;0.001) exhibited notable alterations, indicating a transient impact on cardiac conduction. However, these changes returned to baseline values by the 6-month follow-up. No statistically significant differences were observed in P-axis and heart rate across all time points. Conclusion: The analysis of ECG in patients undergoing PFO closure highlighted dynamic changes in novel ECG parameters in the early post-procedural period, with subsequent normalization by 6 months. Further research is warranted to elucidate the clinical implications of these dynamic electrocardiographic shifts and their potential association with long-term cardiovascular outcomes.

Approval, Evidence, and "Off-Label" Device Utilization: The Patent Foramen Ovale Closure Story.

Following regulatory approval, medical devices may be used "off-label." Patent foramen ovale (PFO) closure is indicated to reduce recurrent stroke but has been proposed for other indications, including migraine, transient ischemic attack, and diving decompression illness. We sought to evaluate PFO closure rates and indications relative to the timing of regulatory approval and publication of key randomized trials. We performed a retrospective cohort study using the OptumLabs Data Warehouse of US commercial insurance enrollees from 2006 to 2019. We quantified PFO closure among individuals with ≥2 years of preprocedure coverage to establish indications, classified hierarchically as stroke/systemic embolism, migraine, transient ischemia attack, or other. We identified 5315 patients undergoing PFO closure (51.8% female, 29.2%≥60 years old), which increased from 4.75 per 100 000 person-years in 2006 to 6.60 per 100 000 person-years in 2019. Patients aged ≥60 years accounted for 29.2% of closures. Procedure volumes corresponded weakly with supportive clinical publications and device approval. Among patients with PFO closure, 58.6% underwent closure for stroke/systemic embolism, 10.2% for transient ischemia attack, 8.8% for migraine, and 22.4% for other indications; 17.6% of patients had atrial fibrillation at baseline; and 11.9% developed atrial fibrillation postprocedure. Those aged ≥60 years and male were less likely to undergo closure for migraine than stroke/systemic embolism. From 2006 to 2019, PFO closure use was consistently low and corresponded weakly with clinical trial publications and regulatory status. Nearly half of patients underwent PFO closure for indications unapproved by the Food and Drug Administration. Regulators and payers should coordinate mechanisms to promote utilization for approved indications to ensure patient safety and should facilitate clinical trials for other possible indications.

Sex Differences in Patients With Cryptogenic Cerebrovascular Events Undergoing Transcatheter Closure of Patent Foramen Ovale.

Background Scarce data exist on sex differences in patients with cryptogenic cerebrovascular events undergoing patent foramen ovale (PFO) closure. This study aimed to determine the sex differences in clinical profile, procedural characteristics, and long-term outcomes of patients with cryptogenic cerebrovascular events undergoing PFO closure. Methods and Results A retrospective cohort was used, including 1076 consecutive patients undergoing PFO closure because of a cryptogenic cerebrovascular event. Patients were divided into 2 groups: 469 (43.6%) women and 607 (56.4%) men. The median follow-up was 3 years (interquartile range, 2-8 years). Women were younger (46±13 versus 50±12 years; P<0.01) and had a higher risk of paradoxical embolism score (6.9±1.7 versus 6.6±1.6; P<0.01). Procedural characteristics and postprocedural antithrombotic therapy were similar. At follow-up, there were no differences in atrial fibrillation (women versus men: 0.47 versus 0.97 per 100 patient-years; incidence rate ratio [IRR], 0.55 [95% CI, 0.27-1.11]; P=0.095; adjusted P=0.901), stroke (0.17 versus 0.07 per 100 patient-years; IRR, 2.58 [95% CI, 0.47-14.1]; P=0.274; adjusted P=0.201), or transient ischemic attack (0.43 versus 0.18 per 100 patient-years; IRR, 2.58 [95% CI, 0.88-7.54]; P=0.084; adjusted P=0.121); nevertheless, women exhibited a higher incidence of combined ischemic cerebrovascular events (0.61 versus 0.26 per 100 patient-years; IRR, 2.58 [95% CI, 1.04-6.39]; P=0.041; adjusted P=0.028) and bleeding events (1.04 versus 0.45 per 100 patient-years; IRR, 2.82 [95% CI, 1.41-5.65]; P=0.003; adjusted P=0.004). Conclusions Compared with men, women with cryptogenic cerebrovascular events undergoing PFO closure were younger and had a higher risk of paradoxical embolism score. After a median follow-up of 3 years, there were no differences in stroke events, but women exhibited a higher rate of combined (stroke and transient ischemic attack) cerebrovascular events and bleeding complications. Additional studies are warranted to clarify sex-related outcomes after PFO closure further.

The Influence of Patent Foramen Ovale on the Clinical Features of Migraine without Aura: A Cross-Sectional Study.

To investigate the influence of patent foramen ovale (PFO) on the clinical features of migraine without aura (MoA). We consecutively enrolled 390 MoA patients and compared the frequency of headache, episode duration, and the Visual Analogue Scale (VAS), Headache Impact Test 6 (HIT-6), and European Health Interview Survey-Quality of Life 8-item index (EUROHIS-QOL8) scores of patients with and without PFO, those with the mild right-to-left shunt (RLS) and moderate to large RLS, and those with permanent RLS and latent RLS using a nonparametric Mann-Whitney U-test. In addition, we analyzed the clinical features of migraine in 39 MoA patients before and after PFO closure treatment using the paired Wilcoxon test. The prevalence of PFO in the 390 MoA patients was 44.4%. Patients with PFO had significantly higher frequency of headaches, VAS scores, HIT-6 scores, and incidence of white matter lesions than those without PFO (all p< 0.05). Patients with moderate to large RLS had significantly higher VAS scores than those with mild RLS (p = 0.002). Additionally, 39 MoA patients underwent PFO closure, which remarkably decreased their frequency of headache, episode duration, VAS scores, and HIT-6 scores, and increased their EUROHIS-QOL8 scores. The migraine features in MoA patients could be influenced by PFO, especially in patients with moderate to large shunt, in whom PFO closure improved the symptoms.

Patent foramen ovale closure with the Occlutech Figulla flex II device: A long-term (up to 10-years) follow-up

BackgroundPercutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany). MethodsConsecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt. ResultsOverall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge. ConclusionsFigulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.

Outcomes of Patent Foramen Ovale Transcatheter Closure: Should a Short Aortic Rim Preclude Closure?

BackgroundThe risk of erosion of an atrial septal closure device, in particular the Amplatzer Septal Occluder, has been described as higher in patients with a short aortic rim. Similar concern has been applied to patent foramen ovale (PFO) closure devices, but there are only rare reported cases of erosion. It may be that smaller devices are chosen due to fear of device erosion in PFO patients when this is not necessarily an issue. ObjectivesThe authors aimed to assess outcomes after PFO closure with the Amplatzer PFO device in patients with a short (<9 mm) aortic rim. MethodsWe performed a retrospective analysis of PFO closure for any indication, between 2006 and 2017 at a quaternary center. Preprocedural transesophageal echocardiographic parameters including the aortic rim were remeasured. Long-term outcomes were obtained by linkage to provincial administrative databases. ResultsOver the study period, 324 patients underwent PFO closure with the Amplatzer PFO device, with a mean age of 49.8 years; 61% had a short aortic rim (<9 mm). The most common indication was cryptogenic stroke (72%); those with longer aortic distance were more likely to have a non-stroke indication for closure, diabetes (15% vs 6.5%, P = 0.04), and heart failure (15.7% vs 4%, P < 0.001). Over a median 7 years of follow-up, there were no cases of device erosion or embolization requiring cardiac surgery. ConclusionsIn a large cohort with long-term administrative follow-up (1,394 patient-years), implantation of an Amplatzer PFO device was performed safely even in patients with a short aortic rim.

1049 PREVALENCE OF ATRIAL FIBRILLATION AND FEASIBILITY OF PULMONARY VEIN ISOLATION AFTER PATENT FORAMEN OVALE CLOSURE

Abstract Background Data about prevalence and the risk of atrial fibrillation, stroke, and need for pulmonary vein isolation (PVI) after device closure of a patent foramen ovale (PFO) are still lacking. We aim to investigate the prevalence and the risk of atrial fibrillation after PFO closure and the feasibility of PVI in a PFO closure cohort compared to contemporary PVI without PFO closure. Methods retrospective observational study of consecutive patients undergoing PFO closure enrolled from February 2013 to September 2020. Patients were divided into 3 groups: i) patients without AF before and after the procedure (n=132), ii) patients with paroxysmal AF prior to the procedure (n=21), iii) patients with documented AF after the procedure (n=13). All patients with AF occurrence were treated with adequate anticoagulation therapy according to the current ESC Guidelines. We compared the procedural data of these patients to a matched contemporary cohort without previous PFO closure undergoing PVI in our center. AF and stroke prevalence and PVI feasibility after PFO closure were assessed at follow up. Results one-hundred and sixty-six consecutive PFO closure patients were enrolled; the mean age was 54 ± 13 years. Median follow-up was 3.5 + 2.5 years. During the study period, 21 patients had AF before or after the PFO closure (group 2) and 13 (7.8%) new onset AF (group 3). Stroke after the PFO closure occurred in 8 patients (4.8%), of which 4 in the group with new onset AF (30% of the group 3). Among the 34 patients with AF, 10 patients (6%) underwent a PVI. Compared to a contemporary matched PVI cohort, total procedural times and fluoroscopy times were significantly higher in the patients with previous PFO closure (108±15 vs 75±29, p=0.002 and 3±1.5 vs 8±7, p&amp;lt;0.001). Similar rate of AF relapses (p=0.198) was observed between the two groups, with a trend for higher rate of complication (pericardial effusion) for the cohort with previous PFO closure (p=0.06). Conclusion This study shows that a more accurate screening and treatment of AF is needed in patients with cryptogenic stroke despite the presence of a PFO, possibly a bystander. In our study, 30% of patients with new onset AF after PFO closure, experienced a further stroke after the procedure. In case of AF, the indication for PVI should be considered prior to the PFO closure since it turns out to be more difficult in terms of procedural and fluoroscopy times and risks of complications after PFO closure.

Prevalence of atrial fibrillation and feasibility of pulmonary vein isolation after patent foramen ovale closure

Abstract Background Data about prevalence and the risk of atrial fibrillation, stroke, and need for pulmonary vein isolation (PVI) after device closure of a patent foramen ovale (PFO) are still lacking. We aim to investigate the prevalence and the risk of atrial fibrillation after PFO closure and the feasibility of PVI in a PFO closure cohort compared to contemporary PVI without PFO closure. Methods Retrospective observational study of consecutive patients undergoing PFO closure enrolled from February 2013 to September 2020. Patients were divided into 3 groups: i) patients without AF before and after the procedure (n=132), ii) patients with paroxysmal AF prior to the procedure (n=21), iii) patients with documented AF after the procedure (n=13). All patients with AF occurrence were treated with adequate anticoagulation therapy according to the current ESC Guidelines. We compared the procedural data of these patients to a matched contemporary cohort without previous PFO closure undergoing PVI in our center. AF and stroke prevalence and PVI feasibility after PFO closure were assessed at follow up. Results One-hundred and sixty-six consecutive PFO closure patients were enrolled; the mean age was 54±13 years. Median follow-up was 3.5±2.5 years. During the study period, 21 patients had AF before or after the PFO closure (group 2) and 13 (7.8%) new onset AF (group 3). Stroke after the PFO closure occurred in 8 patients (4.8%), of which 4 in the group with new onset AF (30% of the group 3). Among the 34 patients with AF, 10 patients (6%) underwent a PVI. Compared to a contemporary matched PVI cohort, total procedural times and fluoroscopy times were significantly higher in the patients with previous PFO closure (108±15 vs 75±29, p=0.002 and 3±1.5 vs 8±7, p&amp;lt;0.001). Similar rate of AF relapses (p=0.198) was observed between the two groups, with a trend for higher rate of complication (pericardial effusion) for the cohort with previous PFO closure (p=0.06). Conclusion This study shows that a more accurate screening and treatment of AF is needed in patients with cryptogenic stroke despite the presence of a PFO, possibly a bystander. In our study, 30% of patients with new onset AF after PFO closure, experienced a further stroke after the procedure. In case of AF, the indication for PVI should be considered prior to the PFO closure since it turns out to be more difficult in terms of procedural and fluoroscopy times and risks of complications after PFO closure. Funding Acknowledgement Type of funding sources: Public Institution(s).

Transcranial Doppler Screening for Patent Foramen Ovale Closure in Cryptogenic Strokes in Young: A Single Center Experience from South India.

Cryptogenic strokes are common in young adults. Patent foramen ovale (PFO) is an important cause of cryptogenic ischemic strokes. Transcranial Doppler (TCD) with bubble contrast is a noninvasive bedside tool in screening for PFO and other right to left shunt (R-L shunt). Percutaneous PFO closure in selected patients with a high risk for paradoxical emboli is beneficial. Data on PFO in young cryptogenic strokes from India are limited. To determine the utility of screening for R-L shunt using TCD in young patients with cryptogenic strokes and to identify clinical predictors of an R-L shunt. This was a hospital-based prospective study conducted between January 2013 and December 2019 in a tertiary hospital in South India. All consecutive patients with ischemic stroke and ages between 18 and 45 years were included. TCD with bubble contrast study was performed on all patients. Those who were TCD bubble contrast study positive and had features of an embolic stroke of undetermined source (ESUS) underwent transesophageal echocardiography (TEE) to confirm a PFO and to look for its high-risk features. Selected ESUS patients with PFO and associated high-risk features as identified on TEE underwent percutaneous PFO device closure. All patients were followed up in the stroke and cardiology clinics. During the study period, 6,197 patients with ischemic strokes were screened for eligibility of which 304 (4.9%) were between the age of 18 and 45 years. Of these, 300 patients with ischemic stroke in young underwent the TCD bubble contrast study. R-L shunt was found in 121 (40.3%) patients. Based on an extensive etiological evaluation, 72 patients were identified to have an ESUS and underwent TEE for confirming PFO. Of these, 65 patients had PFO, four were negative, and three were found to have extracardiac shunts. Based on clinical findings, imaging features, and high-risk features on TEE, 29 patients underwent PFO closure. Activity at the time of stroke onset equivalent to a Valsalva maneuver (p ≤ 0.01), isolated cortical infarction (p = 0.027), and posterior circulation involvement (p = 0.0135) were significantly associated with the presence of an R-L shunt. The patients who had a higher modified anatomical-functional risk of paradoxical embolism (AF-RoPE) score, a high-grade shunt on the TCD bubble contrast study had a longer length of the tunnel and had the presence of an interatrial septal aneurysm (p = 0.012) were referred for PFO device closure. R-L shunt is common in cryptogenic ischemic strokes in young. TCD with bubble contrast study is a noninvasive and feasible bedside tool to detect them. Applying the ESUS criteria in these cryptogenic strokes with a positive TCD bubble contrast study can be then used for selecting patients for more invasive tests like TEE. High-risk PFOs picked up with TEE can be then considered for PFO closure for secondary stroke prevention. The history of Valsalva maneuver-like activity (such as lifting heavy weights or straining) at the time of stroke onset can be a clinical predictor for the presence of an R-L shunt. In addition to isolated cortical infarction, the presence of posterior circulation infarct in ESUS can predict the presence of an R-L shunt.

Migraine in Patients Undergoing PFO Closure: Characterization of a Platelet-Associated Pathophysiological Mechanism: The LEARNER Study

The association between migraine and patent foramen ovale (PFO) has been documented. We aimed to investigate platelet activation, prothrombotic phenotype, and oxidative stress status of migraineurs with PFO on 100mg/day aspirin, before and 6months after PFO closure. Data show that, before PFO closure, expression of the classical platelet activation markers is comparable in patients and aspirin-treated healthy subjects. Conversely, MHA-PFO patients display an increased prothrombotic phenotype (higher tissue factorpos platelets and microvesicles and thrombin-generation potential), sustained by an altered oxidative stress status. This phenotype, which is more controlled by P2Y12-blockade than by aspirin, reverted after PFO closure together with a complete migraine remission. (pLatelEts And MigRaine iN patEnt foRamen Ovale [LEARNER]; NCT03521193).

Atrial fibrillation screening on systematic ambulatory electrocardiogram monitoring after percutaneous patent foramen ovale closure: A prospective study.

Increased risk of new-onset atrial fibrillation (AF) after patent foramen ovale (PFO) closure was observed in randomized trials without however systematic AF screening. We aimed to evaluate the incidence of AF within 6-month following PFO closure with serial 24-hour ambulatory electrocardiogram (AECG) monitoring. All patients undergoing PFO closure were prospectively included in 2 centers. AF was defined as irregular rhythm without discernible P waves>30s on AECG at day 0, 1-month and 6-month follow-up. Primary endpoint was the incidence of AF within the study period. Secondary endpoints evaluated clinical outcomes within 6-month follow-up. Between February 2018 and March 2019, 62 patients underwent PFO closure including 40 male (64.5%) with a mean age of 48±9.5. Atrial septal aneurysm was observed in 37 patients (64.9%), 57 patients (91.9%) received an Amplatzer Occluder device (AbbottVascular) and 5 (8.1%) an Occlutech device (Occlutech). After a mean follow-up of 7.7±2.8months, new-onset AF occurred in 3 patients (4.8%), all within the first month following PFO closure, including one per-procedural, all were asymptomatic and paroxysmal. Two patients with AF (3.2%) required chronic oral anticoagulant therapy. No adverse outcomes occurred at follow-up. No predictive factors of AF were highlighted. A total of 16 patients (25.8%) reported palpitations without AF on the AECGs. In highly selected patients, incidence of AF, evaluated with 3 systematic 24-hour AECG within 6-month following PFO closure, was low (<5%). Always paroxysmal, AF occurred within the first month after the procedure and was not associated with adverse outcomes.

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

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 (&amp;lt;5%). Always paroxysmal, AF always occurred within one month after the procedure and was not associated with adverse outcomes. Funding Acknowledgement Type of funding sources: None.

Day-Case Patent Foramen Ovale Closure Under Transthoracic Echocardiography and Fluoroscopic Guidance: A Safe and Cost-Effective Approach as Compared to Conventional Hospitalization

Background: Transcatheter Patent Foramen Ovale (PFO) is recommended as a therapy in secondary prevention of cryptogenic stroke. The aim of this study was to report one-year French single-center experience in PFO closure under sole Transthoracic Echocardiography (TTE) and fluoroscopy guidance performed as a day-case procedure versus a 3-day hospitalization. Methods: In 2018, all consecutive patients undergoing PFO closure for stroke were retrospectively included: 108 patients as a day-case procedure (group 1) versus 20 patients performed under a 3-day hospitalization (group 2). A comparison was performed between Occlutech and Amplatzer PFO devices and the impact on hospitalization costs was studied. Results: Occluders included Occlutech (n=81), Amplatzer (n=43), Lifetech (n=2) and PFM (n=2) PFO devices. Implantation succeeded in all. In-group 1, hospital discharge was delayed in only 3 cases. At one-month, 5 patients had Atrial Fibrillation (AF) and 91 patients (84%) had no residual shunt. In-group 2, hospital discharge was delayed in 4 patients. At one month, 1 patient had AF and no shunt was observed in 80%. In the comparative study, no significant statistical difference could be observed between Amplatzer and Occlutech devices. The one-day strategy leaded to a positive balance of 1825 euros per procedure in 2018, with a difference of 3785 euros with group 2. Conclusion: Our experience suggests that day-case PFO closure under fluoroscopy and TTE guidance is safe and effective in the majority of patients leading to a cost reduction and no increased risk of embolization.

Abstract P299: Heart Brain Clinic: Integrated Management of Ischemic Stroke

Background: About 25% of acute ischemic strokes (IS) are categorized into stroke of undetermined etiology and many ultimately have a cardiac source for stroke. Neurologists and cardiologists can improve decision making, as has been shown with other multidisciplinary clinics. We report our experience in creating our Heart Brain Clinic (HBC) with a focus on patients with patent foramen ovale (PFO). Methods: Demographic and clinical data were collected retrospectively for patients with PFO evaluated for IS in the inpatient or outpatient setting. Patients were divided into routine care and HBC groups. We compared time from stroke to PFO closure and number of clinic visits prior to decision about closure. Nonparametric analysis was used to calculate difference between medians, while chi square test was used for categorical values. Results: HBC began in 12/2018 with coordination of administrative and staffing efforts between neurology and cardiology departments. From 2/17 to 7/20, 73 patients were evaluated for PFO (42 routine care, 31 HBC; Table 1). At the time of data analysis, 67 patients had received recommendations about PFO closure and 52 patients underwent PFO closure. More than 50% of all patients traveled from outside Houston. HBC patients required fewer clinic visits (p=0.023) prior to decision about closure; however, in patients who underwent PFO closure, there was no difference in weeks from stroke to closure. Patients seen in HBC were recommended to not undergo closure more often than routine care (p= 0.007) Conclusions: Our data demonstrates that a multidisciplinary, patient-centered approach to management of IS patients with PFO is feasible and may improve the quality of care in this younger patient population. The difference in recommendation to not pursue PFO closure between groups may reflect selection and referral bias. Additional work is needed to determine whether this approach improves other aspects of healthcare.

Incidence and delay of atrial tachycardia after patent foramen ovale closure

Abstract Background In the large randomized trials evaluating patent foramen ovale (PFO) closure vs. medical treatment in secondary prevention of stroke, the incidence of atrial fibrillation has been reported more frequently with PFO closure (2.9–6.6%) than with medical treatment (0.4–1.9%). These episodes were clinically reported and may not reflect the real incidence detected by prolonged ECG recording. Purpose To evaluate the incidence and timing of supraventricular tachycardia (SVT) after percutaneous PFO closure. Methods Prolonged cardiac monitoring was proposed to patients undergoing PFO closure at the tertiary center of Pitié Salpétrière Hospital, Paris. According to the estimated risk of SVT, two different approaches were used to monitor cardiac rhythm. A 3-year permanent recording using REVEAL™ XT or LINQ was proposed to high risk patients (age &amp;gt;45 years, multiple CV risk factors, prior palpitations or supraventricular ectopic activity during Holter monitoring prior to the intervention). A 4-week, 15-lead ECG continuous recording using the patch-free, wire-free, wearable Cardioskin™ system was proposed to lower risk patients. Endpoints of interest were the occurrence of SVT episodes (&amp;gt;30 seconds) and unplanned medical consultation or hospitalization for this reason Results From October 2018 to January 2020, a total of 64 patients underwent prolonged ECG monitoring including 32 (50.0%) and 32 (50.0%) patients with Cardioskin™ and REVEAL™ systems, respectively. A SVT was recorded in 11 (17.4%) patients, including atrial fibrillation (AF) in 6 (9.5%) patients. The median delay of SVT occurrence was 33.0 (14.0–39) days after the procedure (Figure 1) and 18 (10.8–34.8) days for the 6 patients with AF. Unplanned hospitalization or emergency medical visit for symptomatic SVT occurred in 5 (45.5%) patients. Antiarrhythmic medication and oral anticoagulation were initiated in 10 (90.1%) and 7 (63.6%) of the 11 patients, respectively, and SVT recurrences were recorded in 5 (45.5%) patients. No stroke was reported in any of the 11 patients during follow-up. There were no significant differences with respect to baseline and procedural characteristics among patients with or without SVT during follow-up. Conclusion Atrial tachycardia is frequent (17.4%) after PFO closure and long-term continuous ECG recording suggests that the incidence is higher than the clinical episodes reported in the randomized trials. This arrhythmic complication of PFO closure seems limited to the first 4 months following the procedure. Larger studies need now to confirm our findings. Figure 1 Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): ACTION coeur

Residual Shunt After Patent Foramen Ovale Closure and Long-Term Stroke Recurrence: A Prospective Cohort Study.

Residual shunt is observed in up to 25% of patients after patent foramen ovale (PFO) closure, but its long-term influence on stroke recurrence currently is unknown. To investigate the association of residual shunt after PFO closure with the incidence of recurrent stroke and transient ischemic attack (TIA). Prospective cohort study comparing stroke or TIA recurrence in patients with and without residual shunt after PFO closure. Single hospital center. 1078 consecutive patients (mean age, 49.3 years) with PFO-attributable cryptogenic stroke who were undergoing percutaneous PFO closure were followed for up to 11 years. Residual shunt was evaluated by transthoracic echocardiography with saline contrast. Primary outcome was a composite of the first recurrent ischemic stroke or TIA after PFO closure. Compared with complete closure, the presence of residual shunt after PFO closure was associated with an increased incidence of recurrent stroke or TIA: 2.32 versus 0.75 events per 100 patient-years (hazard ratio [HR], 3.05 [95% CI, 1.65 to 5.62]; P < 0.001). This result remained robust after adjustment for important covariates, namely age; study period; device; presence of atrial septal aneurysm, hypertension, hyperlipidemia, diabetes, hypercoagulability, or hypermobile septum; and medication use (HR, 3.01 [CI, 1.59 to 5.69]; P < 0.001). Further stratification based on shunt size revealed that moderate or large residual shunts were associated with a higher risk for stroke or TIA recurrence (HR, 4.50 [CI, 2.20 to 9.20]; P < 0.001); the result for small residual shunts was indeterminate (HR, 2.02 [CI, 0.87 to 4.69]; P= 0.102). Nonrandomized study with potential unmeasured confounding. Among patients undergoing PFO closure to prevent future stroke, the presence of residual shunt, particularly a moderate or large residual shunt, was associated with an increased risk for stroke or TIA recurrence. National Institutes of Health.