Underwent Patent Foramen Ovale Closure Research Articles

Short-term health-related quality of life in patients with ischaemic stroke after PFO closure

Abstract Funding Acknowledgements Type of funding sources: None. Introduction/Purpose: Patent foramen ovale (PFO) is common in asymptomatic adults and is associated with cryptogenic stroke (CS). We sought to evaluate the impact of PFO closure in health-related quality of life (HRQoL) in PFO patients with CS. Method In this pilot study, 19 patients (mean age 47 ± 7.7; 13 male) who underwent PFO closure at our center were invited to a short-term clinical follow up (mean follow-up period 6-10 months). All patients had suffered an ischaemic stroke and their disability level was assessed using the Modified Rankin Scale (MRS, no significant disability 63%). HRQoL was assessed using the 36-Item Short Form Survey (SF-36) and the European Quality of Life-5 Dimensions Questionnaire (EQ-5D) preoperatively and at follow-up. Results Both SF36 and EQ-5D scores improved after the operation as shown by the self-rating scores (20,67% and 40,52% higher scores, respectively). Patients with major mobility problems were more likely to be current smokers (r = 0.481) and those who had lower scores on the MRS scale (r=-0.571) rated higher their scale diagram. The categories of energy/fatigue (r = 0.459; p = 0.048), social functioning (r = 0.547; p = 0.015) and pain (r = 0.550; p = 0.015) were positively correlated with physical function. Finally, there was a positive correlation between role limitations due to emotional problems and energy/fatigue (r = 0,519; p = 0.023), and between energy/fatigue and emotional well-being (r = 0.519; p = 0,023). Conclusions The results of our study indicate that shortly after PFO, subjects perceive improvements in their QoL. However, it seems that poorly rated physical function was more common in active smokers, and affects patients" social life and their emotional state. Health care professionals should encourage these patients to participate in rehabilitation and psychological support programs postoperatively.

Percutaneous suture-mediated patent foramen ovale closure: two-year clinical follow-up.

Percutaneous suture-mediated patent foramen ovale (PFO) closure has been recently introduced in clinical practice showing a favorable efficacy and safety profile in most PFO cases. The aim of this study was to assess the long-term outcomes of PFO closure by direct suture in a large consecutive series of patients. We extracted all consecutive patients who underwent percutaneous closure of the PFO by suture technique (HeartStitch, Fountain Valley, CA, USA) from June 2016 with a follow-up of at least 2 years. After PFO closure, patients were followed-up clinically at 1, 6 and up to 12 months and microbubble transthoracic echocardiography (TTE) scheduled between 3 and 6 months, and at 12-month follow-up. After 12 months, patients were clinically checked every 6 months. As of September 1, 2020, 187 patients had undergone PFO closure with suture for at least two years and, of these, 181 (121 women and 60 men, mean age 45±13 years, range 15-75 years) had complete clinical and instrumental follow-up (97%). There were no peri-procedural complications. Mean follow-up was 1076±251 days (range 727-1574). At 12-month TTE, a significant residual atrial shunt was found in 39 patients (21%). At follow-up no recurrent thromboembolic or cerebral event occurred, no instrumental evidence of suture dehiscence detected and, 18 months after the procedure, one patient had an episode of transient atrial fibrillation lasting less than 24 hours and resolved spontaneously. Long-term follow-up data indicate that PFO closure by direct suturing is safe and effective. Two years after the procedure, there were no significant complications, no permanent arrhythmic complications and evidence of suture dehiscence.

The evolving role of echocardiography in the assessment of patent foramen ovale in patients with left-side thromboembolism.

Patent foramen ovale (PFO) is the most common congenital cardiac abnormality found approximately in 25% of the adult population The pathophysiological role of paradoxical embolization through the PFO in ischemic stroke is well established. "Self-expanding double disk" and, more recently, suture-based "deviceless" systems are used for PFO closure in the setting of secondary prevention after ischemic stroke likely related to paradoxical embolization. Ultrasound plays a significant role in PFO assessment, indication to treatment, intra-procedural guidance, and follow-up for those undergoing PFO closure. Three different techniques are frequently used for these purposes: transesophageal echocardiography, transthoracic echocardiogram, and transcranial Doppler. In this review, advantages and limits of these techniques are discussed in detail to improve our skills in detection and treatment of this important condition by using ultrasound.

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.

Safety and efficiency of multimodal imaging approach of patent foramen ovale closure in patients with cryptogenic stroke

Recent studies have shown a significant superiority of patent foramen ovale (PFO) closure over antithrombotic therapy in stroke recurrence prevention. However, uncertainty about the guidance technique remains. Most centers perform percutaneous closure of PFO using simultaneously fluoroscopic and intra-procedural echocardiography to select the optimal device. While transoesophageal echocardiography (TEE) requires general anaesthesia, intracardiac echocardiography (ICE) is costly and has inherent risks. We report the safety and efficiency data of a simplified technique: local anaesthesia, PFO closure under fluoroscopic guidance, with only pulmonary vein opacification using contrast angiography and transthoracic echocardiography control before releasing the device. Single center retrospective registry enrolling 134 consecutive patients who underwent PFO closure between May 2016 and December 2019 to cryptogenic stroke. The closure decision was taken by multidisciplinary team. All the patients underwent a preprocedure TEE for morphological evaluation of PFO. An echocardiography control was done at 1 month. At 6 and 12 months a bubble test was done. All procedures were successful, regardless PFO complexity (ASA 62.7%), without major procedural complications. Total fluoroscopic time was 5.1 minutes, the dose-area product was 5047.8 mGy/m 2 and the application of contrast medium was 7.2 mL. During a mean follow-up period of 17.2 months, one transient ischemic attack, one deep vein thrombosis and one thrombus on the occluder was reported. Contrast echocardiography at 6 months showed complete closure in 92% of patients, whereas a minimal or moderate residual shunt persisted in 4.6%, 1.8% respectively. At 12 months only 2 patients presented a residual shunt. Percutaneous PFO closure with multimodal imaging approach is a safe and effective procedure and allows a lower radiological exposure and contrast administration.

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 >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 (>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

Comparison of Intracardiac Echocardiography and Transesophageal Echocardiography for Image Guidance in Percutaneous Patent Foramen Ovale Closure.

Background and Objectives: Transesophageal echocardiography (TEE) guidance is the current gold standard for catheter-based procedures in the treatment of structural heart diseases. Intracardiac echocardiography (ICE), which can be performed under local anesthesia, has been recently introduced and is becoming more widely used. We aimed to compare the efficacy and safety of ICE and TEE in patent foramen ovale (PFO) device closure. Materials and Methods: All 74 patients with a history of cryptogenic stroke undergoing PFO closure for secondary prophylaxis were selected from our registry. Intraprocedural TEE was performed by echocardiographer-cardiologists with the patient under general anesthesia. Conversely, ICE was performed with the patient under local anesthesia. Baseline characteristics, procedural details, and immediate outcomes were compared between the TEE and ICE groups (n = 49 and n = 25, respectively). Results: Although patients in the ICE group were older (47 ± 10 vs. 57 ± 7 years, p < 0.001), sex and comorbidity variables were similar between the two groups. The degree of inducible right-to-left shunt via the PFO, assessed using preprocedural TEE, was also comparable. Notably, fluoroscopy time (22 ± 18 vs. 16 ± 7 min, p = 0.030), radiation dose (498 ± 880 vs. 196 ± 111 mGy, p = 0.022), and total procedural time in the catheter laboratory (99 ± 30 vs. 67 ± 12 min, p < 0.001) were significantly lower in the ICE group than those in the TEE group. The entire hospital stay was similar between groups (3.8 ± 2.2 vs. 3.4 ± 1.3 days, p = 0.433). No procedural complications, such as device embolization, pericardial hemorrhage, major bleeding, mortality, or access-related vascular injury were reported in either group. Conclusions: ICE-guided PFO device closure is quicker and less hazardous in terms of radiation exposure than the TEE-guided procedure, with similar procedural outcomes and duration of hospital stay.

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.

Recurrent cerebrovascular events in patients after percutaneous closure of patent foramen ovale

BackgroundRecent published trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) for preventing recurrent cryptogenic cerebrovascular events. However, the risk of recurrent cerebrovascular events (rCVEs) is up to 5.7%, and the etiology is unclear. ObjectiveThis study aimed to investigate the risk factors for rCVEs after closure of PFO during long-term follow-up. MethodsIn our center, 282 consecutive patients underwent PFO closure because of a cryptogenic cerebrovascular event between 2006 and 2014. Their Risk of Paradoxical Embolism (RoPE) score was calculated retrospectively. We followed up with the patients by telephone, using hospital records to identify those who suffered from rCVEs. Patients with rCVEs were matched with two control patients of the same sex and RoPE score without rCVEs who underwent PFO closure at approximately the same time. The patients with rCVEs and controls participated in a clinical examination, including contrast transthoracic echocardiography (TTE) and Holter electrocardiography, to investigate the possible cause of rCVEs compared with controls. ResultsFourteen (5%) out of the 282 consecutive patients who underwent PFO closure suffered from rCVEs during a mean follow-up of 8.4 years (1.7 rCVEs per 100 patient-years). The median RoPE score of the patients was 7. Recurrent CVE occurred in 3.2 patients per 100 patient-years in patients with residual shunting compared with 0.8 patients per 100 patient-years in those without residual shunt. These patients were on antiplatelet treatment or without any effective anticoagulant treatment at the time rCVE occurred. The risk ratio of rCVEs in patients with residual shunting was 2.9-times higher than in patients without residual shunting (95% CI: 1.4–6.1) at follow-up visit. Four patients who had the BioSTAR device implanted suffered from an rCVE despite lack of residual shunting. ConclusionsThis study indicates that residual shunting and choice of the device may be the major reasons for rCVEs.

Effect of Residual Interatrial Shunt on Migraine Burden After Transcatheter Closure of Patent Foramen Ovale

ObjectivesThis study sought to evaluate the long-term effect of transcatheter patent foramen ovale (PFO) closure on migraineurs with and without aura and examine the effect of residual right-to-left shunt. BackgroundMany studies reported improvement in migraine symptoms after PFO closure, yet randomized trials failed to reach its clinical endpoints. MethodsThe study retrospectively analyzed data from 474 patients who underwent transcatheter PFO closure at Massachusetts General Hospital. Patients completed a migraine burden questionnaire at baseline and at follow-up. Migraine severity is reported as migraine frequency (days/month), average duration (min), and migraine burden (days × min/month). Improvement following closure was defined as complete abolishment of symptoms or >50% reduction in migraine burden. ResultsA total of 110 migraineurs who underwent PFO closure were included; 77.0% had aura and 23.0% were without aura, and 91.0% had a cryptogenic stroke. During long-term median follow-up of 3.2 (interquartile range: 2.1 to 4.9) years, there was a significant improvement in migraine symptoms in migraineurs with or without aura. Migraine burden was reduced by >50% in 87.0% of patients, and symptoms were completely abolished in 48%. Presence of aura was associated with abolishment of migraine (odds ratio: 4.30; 95% confidence interval: 1.50 to 12.30; p = 0.006). At 6 months after PFO closure, residual right-to-left shunt was present in 26% of patients. Absence of right-to-left shunt was associated with improvement in migraine burden by >50% (odds ratio: 4.60; 95% confidence interval: 1.30 to 16.10; p = 0.017). ConclusionsLong-term follow-up after transcatheter PFO closure was associated with significant improvement in migraine burden. Aura was a predictor of abolishing symptoms. Absence of residual right-to-left shunt was a predictor of significant reduction in migraine burden.

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

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 <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.

Periprocedural Outcomes of Fluoroscopy-Guided Patent Foramen Ovale Closure With Selective Use of Intracardiac Echocardiography

BackgroundRecent randomized trials have confirmed the role of patent foramen ovale (PFO) closure in the secondary prevention of cryptogenic stroke. Guidelines have suggested a central role for intraprocedural imaging using intracardiac echocardiography (ICE). However, this modality may not be required to achieve safe and effective closure. We aimed to examine the periprocedural outcomes of PFO closure retrospectively, using fluoroscopic guidance in patients with cryptogenic stroke, with provisional ICE guidance driven by anatomic and procedural factors. MethodsA retrospective chart review of consecutive patients who underwent PFO closure in a single centre using the Amplatzer PFO occluder (AGA Medical Corporation, Plymouth, Minnesota) for cryptogenic stroke was conducted. Outcomes analyzed included procedural data, periprocedural complications, length of stay, and factors contributing to the use of intraprocedural imaging. ResultsBetween 2006 and 2017, 467 patients underwent PFO closure for cryptogenic stroke with the Amplatzer PFO occluder; 381 patients underwent closure with fluoroscopy alone, and 86 with ICE and fluoroscopic guidance. Periprocedural arrhythmic complications occurred in 1.3% in the fluoroscopy group and 1.2% in the ICE group (P = 1.000). Vascular complications occurred in 0.5% in the fluoroscopy group and 2.3% (P = 0.323) in the ICE group. One device embolized requiring surgical intervention. There was no in-hospital mortality or stroke. Same-day discharge occurred in 97.6% of patients. ConclusionOur single-centre experience suggests that PFO closure can be safely conducted under fluoroscopic guidance alone with provisional adjunctive ICE use limited to specific anatomic situations.

Patent foramen ovale closure by using transesophageal echocardiography for cryptogenic stroke: single center experience in 132 consecutive patients

BackgroundPercutaneous closure of patent foramen ovale (PFO) is routinely performed using plain fluoroscopy in the catheter room. This method results in inevitable radiation damage, adverse effects of contrast agents on kidneys, and high cost. We performed PFO closure with a simplified and economical transesophageal echocardiography (TEE)-only guided approach in the operating room. This study aimed to investigate the feasibility, safety, and effectiveness of the percutaneous closure of PFO by only using TEE.MethodsWe reviewed the medical records of patients who underwent percutaneous PFO closure at our center from December 2013 to December 2017. A total of 132 patients with PFO and cryptogenic strokes underwent PFO closure by using cardi-O-fix PFO device under TEE guidance. The participants comprised 64 and 68 male and female patients, respectively. The mean age and body weight of the patients were 39.40 ± 13.22 years old (12–68 years old) and 65.42 ± 9.70 kg (40–95 kg), respectively. All patients only received aspirin (3–5 mg/kg body weight, oral administration) for 6 months. Contrast-enhanced transthoracic echocardiography (c-TTE) with Valsalva maneuver was performed during follow-up, and questionnaire surveys were obtained at 3, 6, and 12 months after the procedure.ResultsAll (100%) patients were successfully closed. Follow-ups were conducted for 13 months to 48 months, with an average of 27 months. No severe complications were found during the follow-up period. Paroxysmal atrial fibrillation occurred in 4 patients within 3 months after the procedure. No recurrent stroke or death occurred in all patients during the follow-up period. Transient ischemic attack occurred in one patient 6 months after the procedure. Ten (7.6%) patients had a right-to-left shunt, as demonstrated by c-TTE at 12 months of follow-up. Among the 57 patients suffering from migraine, significant relief or resolution was reported by 42 (73.7%) patients.ConclusionTEE-only guided PFO closure was a safe, feasible, and effective method that did not require the use of X-rays and contrast agents.

547 Same Day Discharge Following Percutaneous Closure of Structural Heart Conditions: A Novel and Safe Approach for Patient Management

Percutaneous closure of patent foramen ovale (PFO) and atrial septal defects (ASD) has become more commonly performed due to recent changes in international guidelines supporting its use. The safety and effectiveness of same day discharge (SDD) home for outpatients who present electively for such procedures has not been examined. We sought to retrospectively investigate the rates of SDD at our institution and review its safety by examining clinical outcomes following elective percutaneous PFO or ASD closure. We also performed an economic analysis evaluating our hospital’s cost data for SDD following these procedures. Patients undergoing elective percutaneous PFO, ASD or PDA closure at St George Hospital, Australia, from January 2011 to January 2020 were evaluated. Primary outcomes included 7-day major adverse cardiovascular endpoints (MACE) and readmission to hospital within 30 days. 24 patients were included in the primary analysis. 10 (41.7%) patients underwent elective ASD closure while 14 (58.3%) underwent PFO closure. Among 24 patients who underwent elective percutaneous closure of structural heart disease, 23 patients (95.8%) were managed with SDD. There were no MACE outcomes at 30 days. No patients were re-admitted to hospital at 30 days following these procedures. When compared to overnight admission to hospital post elective percutaneous structural heart condition closure, SDD yielded a cost saving of $4,817 per case. SDD following elective percutaneous structural heart condition closure was demonstrated to be a safe and effective strategy for managing patients that was also associated with significant cost savings to hospitals.

Long-term efficacy after closure of patent foramen ovale for ischemic neurological events in young adults: A systematic review and meta-analysis.

Background:The efficacy of patent foramen ovale (PFO) closure remains controversial, and it is unclear which patient groups are best benefited. We performed this meta-analysis to clarify the efficacy of PFO closure of younger patients for prevention of recurrent ischemic neurological events.Methods:We systematically searched for studies of PFO closure for younger patients under the age of 55, and pooled available data on PFO closure of younger vs older patients and on PFO closure of younger patients vs medical therapy. The primary endpoints were the composite outcome of recurrent ischemic neurological events [stroke and/or transient ischemic attack (TIA)]. The secondary endpoints included recurrent stroke, TIA, atrial fibrillation (AF) and bleeding events. We calculated the odds ratios (OR) and 95% confidence interval (CI) using fixed-effect and random-effect models.Results:Three randomized controlled trials (RCT) and 13 observational studies were eligible. Compared with older patients undergoing PFO closure, younger patients undergoing closure had a lower risk of composite outcome (OR: 0.40, 95% CI: 0.28 to .56; P < .001) and AF (OR: 0.25, 95% CI: 0.10–0.61; P = .003). Compared with medical therapy, PFO closure of younger patients reduced the risk of composite outcome (OR: 0.50, 95% CI: 0.33–0.75; P<.001); there was no statistical difference in total complications of AF and bleeding events (OR: 2.15, 95% CI: 0.15–30.37; P = .57). Separate analysis of stroke and TIA showed that PFO closure in younger patients was more effective in preventing stroke (OR: 0.45, 95% CI: 0.28–0.72; P < .001) and TIA (OR: 0.35, 95% CI: 0.21–0.58); P < .001) compared with older patients. Compared with medical therapy, PFO closure of younger patients reduced the risk of stroke (OR: 0.26, 95% CI: 0.13–0.51; P < .001); but there was no difference in the risk of TIA (OR: 1.07, 95% CI: 0.16–7.01; P = .94).Conclusions:Compared with PFO closure of older patients and medical therapy, PFO closure of younger patients can benefit more for the prevention of recurrent ischemic neurological events. Our results indicate that PFO closure is the best treatment strategy for younger patients under the age of 55.

Transcatheter Patent Foramen Ovale Closure Is Effective in Alleviating Migraine in a 5-Year Follow-Up.

Background: The association between patent foramen ovale (PFO) and migraine has been reported. However, whether transcatheter PFO closure is effective in alleviating migraine remains controversial. The objective of this study was to investigate the efficacy of PFO closure in alleviating migraine in a 5-year follow-up.Methods: Migraineurs with PFO from 2013 to 2015 were included and divided into PFO closure group and non-PFO closure group according to their therapy. Contrast-enhanced transcranial Doppler (c-TCD) was performed to evaluate the degree of the right-to-left shunt (RLS), and headache impact test (HIT-6) questionnaire was administered to assess the disability of migraine at 1- and 5-year follow-up.Results: Of 192 patients, 91 patients underwent PFO closure, and 101 patients refused. The HIT-6 scores of patients in the PFO closure group were significantly lower than those of the non-PFO closure group at both 1- and 5-year follow-up. These results were more pronounced in patients younger than 45 years. Furthermore, in patients with large RLS, the HIT-6 scores of patients in the PFO closure group were significantly lower at both 1- and 5-year follow-up compared with those of the non-PFO closure group. However, in patients with moderate RLS, this difference was significant only at 5-year follow-up.Conclusions: PFO closure is effective in alleviating migraine in the long term. This effect is more obvious when patients are younger than 45 years and RLS is large.

Cierre percutáneo del foramen oval permeable en pacientes mayores de 60 años con ictus criptogénico

Introduction and objectivesRandomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. MethodsOf 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66±5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44±10 years). ResultsOlder patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). ConclusionsIn older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF.

Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism.

Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years. Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66±5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44±10 years). Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269). In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF.

Impact of Discontinuation of Antithrombotic Therapy Following Closure of Patent Foramen Ovale in Patients With Cryptogenic Embolism

No data exist on the optimal duration of antithrombotic therapy (AT) following patent foramen ovale (PFO) closure. We sought to assess the safety of AT discontinuation following PFO closure in patients with a cryptogenic ischemic event. A total of 453 consecutive patients (mean age: 48 ± 13years, men: 51%) who underwent PFO closure due to a cryptogenic ischemic event were included. All patients were on AT following PFO closure (antiplatelet therapy: 92.7%, anticoagulation: 7.3%). Ischemic and bleeding events, and AT were assessed at a median follow-up of 8 (IQR: 4 to 11) years, and follow-up was complete in 96% of patients. Stroke and transient ischemic attack occurred in 4 (0.9%) and 12 (2.6%) patients, respectively, and 27 (6.0%) patients had bleeding events (major in 6 [1.3%] patients, including 4 episodes of intracranial hemorrhage). All major bleeding events occurred under aspirin therapy. A total of 82 patients (18%) stopped the AT at a median of 7 (IQR: 5 to 34) months post-PFO closure (due to a bleeding event or gastrointestinal symptoms: 13 patients, no specific reason: 69 patients), and none of them had any ischemic event after a median time of 7 (IQR 3 to 10) years without any AT. A propensity score matched analysis including 46 patients who discontinued the AT within 1-year post-PFO closure and 120 patients with an ongoing AT showed the lack of differences in ischemic events between groups (0 vs 0.2 stroke/transient ischemic attack per 100 patient-years in the no-AT and AT groups, respectively). In conclusion, in young patients who underwent PFO closure, bleeding events occurred in ∼6% of patients after a median follow-up of 8years. AT was discontinued in about one fifth of patients (most of them within the year following PFO closure), and this was not associated with any increase in ischemic events at long-term follow-up. These results suggest that, in patients without other co-morbidities increasing the risk of stroke, temporary AT following PFO closure may be a reasonable strategy.

Abstract TP49: Trends of Patent Foramen Ovale (pfo) Closure From 2008 to 2014 at National Level: Us Experience

Introduction: Evidence for patent foramen ovale (PFO) closure has been controversial, as was reflected in the guidelines published by AHA/ASA in 2014. Prior to 2014, three randomized controlled trials compared PFO closure and medical management. Evidence of PFO closure was lacking however PFO closure was being performed in both trial settings and non-trial settings. Methods: We analyzed the Nationwide Inpatient sample (NIS) from 2008 to 2014. Ischemic stroke (IS) patients with primary diagnosis using ICD 9 codes were selected along with secondary diagnosis of PFO/ ASD (ICD 9 code: 745.5). Further we selected the patients who underwent the PFO closure procedure using ICD 9 procedure codes: 35.51 and 35.52. We evaluated the rate of PFO closure, characteristics of patients receiving closure and evolution of trend during that time period at the national level. Results: Total number of patients admitted over 7 years in US with Ischemic stroke associated with PFO was 77964. Only a minority of patients [n=1487 (1.9%)] received PFO closure and about half were females (50.2%). Majority of treatments (70%) were performed in teaching hospital setting. Patients who underwent PFO closure were younger, mean age 55.3 years (± SD 16.6) years versus 61.4 years (± SD 16.7) (p&lt; 0.001) in patent who did not receive closure. Medical comorbidities were significantly lower in group receiving treatment (Congestive heart failure 0.9% vs. 7.6%, hypertension 55% vs. 64.6%, atrial fibrillation 6.9% vs. 11.6%) but no difference was noted in deep venous thrombosis, pulmonary embolism and diabetes mellitus. We noted a significant downward trend of PFO closure at the national level and at teaching hospitals over 7 years (see graph 1) Conclusion: National database demonstrated that only a minority of patients received PFO closure in setting of ischemic stroke and overall a downward trend was noted over the years in setting of negative randomized trials.