Benefit Of Patent Foramen Ovale Closure Research Articles

Unrecognized Patent Foramen Ovale in Patient With Sinus Venosus-Type Atrial Septal Defect With Partial Anomalous Pulmonary Venous Return.

Unrecognized Patent Foramen Ovale in Patient With Sinus Venosus-Type Atrial Septal Defect With Partial Anomalous Pulmonary Venous Return.

A Systematic Review and Meta-Analysis of the Association between Residual Shunts after Patent Foramen Ovale Closure and Long-Term Cerebrovascular Events

Background: The association between a patent foramen ovale (PFO) and cryptogenic stroke (CS) is well established, and the benefits of PFO closure are clearly recognized. This study aimed to investigate the presence of a residual shunt in patients who have experienced cryptogenic cerebrovascular events following a PFO closure. Methods: Two researchers systematically searched the PubMed and Embase online database for pertinent clinical studies published between January 2000 and July 2021 concerning the recurrence of cerebrovascular events after PFO closures. Results: Upon screening an initial list of 2,342 articles, six studies were identified, involving 2,083 patients. Overall, the analysis indicated a marked difference in the recurrence of cerebrovascular events in 8.89% of residual shunt (RS) cases compared to only 2.90% of non-RS cases. The summary odds ratio was 3.484 (95% confidence interval, 2.169–5.596), which suggested that RS may be a risk factor for recurrent cerebrovascular events in patients that experienced PFO-related cerebrovascular events within 6 months after PFO closure surgery. Conclusions: The presence of RS significantly increases the risk of recurrent cerebrovascular events in patients with clinical PFO closure.

Patent foramen ovale and stroke: current evidence and treatment options.

Recent data have changed the landscape of patent foramen ovale (PFO) closure for secondary stroke prevention. This review synthesizes the data and provides a framework for optimal management of stroke patients with PFO. The cumulative evidence indicates that PFO closure reduces the risk of recurrent stroke in carefully selected young cryptogenic stroke patients, with an annualized risk reduction of ∼0.6%. The benefit of PFO closure is particularly evident in patients with embolic appearing strokes, large right-to-left shunt, or an associated atrial septal aneurysm. There may be little or no benefit in patients with small deep infarcts, a small PFO, or an indication for long-term anticoagulation. Closure is accompanied by a small risk of major procedural complication and atrial fibrillation. The annual risk of stroke from PFO is low relative to other stroke mechanisms, but the life-time cumulative risk in young patients who have experienced a prior stroke may be substantial, in which case the absolute benefit of closure is likely impactful. PFO is highly prevalent in the general population, present in about one in four adults, and should not be considered to be the cause of the stroke until a thorough workup has excluded alternative mechanisms.

STEMI and CVA in Hypercoagulable State with Ostium Secundum Defect.

Atrial septal defect (ASD) is a risk factor for multiple vascular thrombotic events, which can occur either sequentially or simultaneously. In this report we present a case of ST-elevation myocardial infarction (STEMI) and cerebrovascular accident (CVA). The severity of adverse cardiovascular or cerebrovascular events can be increased by the presence of specific type of ASD, such as a patent foramen ovale (PFO) or osteum secundum defect. This case report discusses a unique presentation of a 48-year old male on warfarin therapy for a history of cerebral venous thrombosis (CVT) who subsequently presented with simultaneous STEMI with CVA, and who was incidentally found to have an ostium secundum defect on echocardiography. He was emergently taken for cardiac catheterization, which revealed significant proximal LAD occlusion. There has been a long standing debate within the international scientific communities regarding the therapeutic benefit of PFO closure for long-term secondary prevention of recurrence CVA. We discuss the different points of view regarding PFO closure for secondary prevention of CVA with a review of the literature on this rather controversial topic.

Closing the gap on patent foramen ovale and cryptogenic stroke

ABSTRACTIntroduction: The treatment options for prevention of recurrent of cryptogenic stroke in patients with patent foramen ovale (PFO) have been intensely debated in the recent decades. The suggested options were percutaneous closure of PFO versus medical therapy. However, up to these date there is a controversy regarding the indication of percutaneous closure. Multiple meta-analysis and recent randomized control trials showed the benefit of PFO closure when compared with medical therapy alone.Areas covered: The article reviews the prevalence, physiology, diagnosis and treatment options of PFO after cryptogenic stroke. Furthermore, it will discuss the results of randomized control trials that compared the PFO closure to medical therapy.Expert opinion: The association between PFO and unexplained cryptogenic stroke has been well established in the multiple studies. The diagnosis and management of PFO might be challenging in some cases. Although multiple studies showed that PFO closure is associated with lower rates of recurrent stroke in patients presenting with cryptogenic stroke, the indication and patient selection for this intervention are not well established yet in the guidelines.

Patent foramen ovale and stroke.

A patent foramen ovale (PFO) is a highly prevalent finding in cryptogenic ischaemic stroke, particularly in young adults. A common challenge in clinical practice is to distinguish between incidental and pathogenic PFO. Some clinical features and tools such as the Risk of Paradoxical Embolism score may help determining the probability of a stroke-related PFO. Nonetheless, the best therapeutic option to reduce stroke recurrence after a cryptogenic stroke with PFO has been a matter of debate for a long time. We review the mechanisms of stroke-related PFO, together with its clinical features and diagnostic criteria. In addition, we focus on the methodological details and results from new studies in the field of secondary prevention. In contrast to prior evidence, the data from three recent clinical trials and an updated meta-analysis favour PFO closure over medical treatment after cryptogenic stroke/TIA for the prevention of stroke recurrence. The PFO closure device procedure is not associated with higher mortality or cardiovascular events, except for a small increase in the occurrence of transient atrial fibrillation. Furthermore, the benefit of PFO closure was higher among those with atrial septal aneurysm and PFO with large right-to-left shunt. Future studies should address pending issues such as the option for anticoagulants or antiplatelet in patients not undergoing closure, the duration of antiplatelet treatment after PFO closure and the role of PFO closure in patients older than 60.

Patent Foramen Ovale and Cryptogenic Stroke or Transient Ischemic Attack: To Close or Not to Close? A Systematic Review and Meta-Analysis

Background: The optimal strategy of secondary stroke prevention in patients with patent foramen ovale (PFO) is controversial. This study was performed to evaluate the efficacy and safety of the device closure (DC) versus the medical therapy (MT) in patients with cryptogenic stroke or transient ischemic attack (TIA) and PFO. Summary: Randomized controlled trials with active and control groups receiving the DC plus MT and MT alone in patients with history of cryptogenic stroke/TIA and diagnosis of PFO were systematically searched. The main efficacy outcome was stroke recurrence. Subgroup-analyses were performed according to age, shunt size, and presence of atrial septal aneurysm (ASA). Safety endpoints included any serious adverse event (SAE), atrial fibrillation (AF), and major bleeding complications. Risk ratios (RRs) and hazard ratios (HRs) with 95% CIs were estimated. Five trials were included, involving 3,440 participants (DC = 1,829, MT = 1,611). There was a protective effect of closure in the risk of recurrent stroke (RR 0.43 [0.21–0.90]; p = 0.024; HR = 0.39 [0.19–0.83]; p = 0.014). The benefit of PFO closure was significant in patients with PFO associated with substantial right-to-left shunt or ASA. There were no differences in the risks of SAEs and major bleedings between the groups. The rate of new-onset AF was higher in the DC than in the MT arm (RR 4.46 [2.35–8.41]; p < 0.001). Successful device implantation and effective PFO closure were achieved in 96 and 91% of the patients respectively. Key Messages: In selected adult patients with PFO and history of cryptogenic stroke, the DC plus MT is more effective to prevent stroke recurrence and is associated with an increased risk of new-onset AF compared to the MT alone.

Cryptogenic Stroke and High-Risk Patent Foramen Ovale: The DEFENSE-PFO Trial

BackgroundRecent reports showing the favorable role of patent foramen ovale (PFO) closure in patients with cryptogenic stroke have raised the issue of selecting optimal candidates. ObjectivesThis study, DEFENSE-PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale), evaluated whether the benefits of PFO closure can be determined on the basis of the morphologic characteristics of the PFO, as evaluated by transesophageal echocardiography. MethodsPatients with cryptogenic stroke and high-risk PFO were divided between a transcatheter PFO closure and a medication-only group. High-risk PFO included PFO with atrial septal aneurysm, hypermobility (phasic septal excursion into either atrium ≥10 mm), or PFO size (maximum separation of the septum primum from the secundum) ≥2 mm. The primary endpoint was a composite of stroke, vascular death, or Thrombolysis In Myocardial Infarction–defined major bleeding during 2 years of follow-up. ResultsFrom September 2011 until October 2017, 120 patients (mean age: 51.8 years) underwent randomization. PFO size, frequency of septal aneurysm (13.3% vs. 8.3%; p = 0.56), and hypermobility (45.0% vs. 46.7%; p > 0.99) were similar between the groups. All PFO closures were successful. The primary endpoint occurred exclusively in the medication-only group (6 of 60 patients; 2-year event rate: 12.9% [log-rank p = 0.013]; 2-year rate of ischemic stroke: 10.5% [p = 0.023]). The events in the medication-only group included ischemic stroke (n = 5), cerebral hemorrhage (n = 1), Thrombolysis In Myocardial Infarction–defined major bleeding (n = 2), and transient ischemic attack (n = 1). Nonfatal procedural complications included development of atrial fibrillation (n = 2), pericardial effusion (n = 1), and pseudoaneurysm (n = 1). ConclusionsPFO closure in patients with high-risk PFO characteristics resulted in a lower rate of the primary endpoint as well as stroke recurrence. (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High-Risk Patent Foramen Ovale [DEFENSE-PFO]; NCT01550588)

Abstract WP401: Residual Shunting Post PFO Closure is Associated With Increased Long-term Risk of Recurrent Stroke

Background: Patent foramen ovale (PFO) is an independent risk factor for ischemic stroke, and recent clinical trials have shown long-term benefit of PFO closure. We previously found PFO may increase the risk of stroke due to right-to-left shunting, resulting in venous contamination of arterial circulation, with elevated neurovascular mediators such as homocysteine. However, in clinical practice, residual blood shunting can be observed in ~10% of patients post PFO closure, with unclear significance. Here we prospectively investigated the long-term influence of residual shunting on patient outcome. Method: 1018 PFO stroke patients s/p PFO closure from several medical centers were prospectively recruited in accordance with IRB protocol and followed up to 7 years. Result: While closure rate at our center is much lower (&lt;5%), overall closure rate of patients from all major referral centers range between 5-14%. Patients with compete PFO closure (86%) developed higher event-free probability from recurrent TIA/stroke compared to those with residual shunting (14%) (Figure1A, p = 0.001). The risk of recurrent stroke depended on residual shunt size with lower event-free probability in larger shunting (Figure 1B, p = 0.002). Conclusion: Consistent with clinical trials, our prospective observational study suggests complete PFO closure results in lower risk of stroke recurrence. Patients with residual shunting (incomplete PFO closure) may face continued risk, though the overall risk of stroke recurrence is very low. PFO-related shunting appears to be critical in the pathophysiology of recurrent stroke.

Percutaneous Patent Foramen Ovale Closure versus Medical Therapy in Cryptogenic Stroke: An Update Meta-Analysis of Randomized Controlled Trials

Objectives: Concerns regarding the real efficacy of transcatheter patent foramen ovale (PFO) closure versus medical therapy in patients with cryptogenic stroke remained unresolved. We performed a meta-analysis using the randomized controlled trials on the efficacy and safety of transcatheter PFO closure in patients with cryptogenic stroke. Methods: Web of Science, EMBASE, PubMed, and the Cochrane Library were searched for relevant randomized controlled trials (RCTs). The primary outcome was recurrent stroke and transient-ischemic attack (TIA). Original data, hazard ratio (HR) with 95% confidence interval (95% CI) were abstracted to calculate a pooled effect size. Results: Our meta-analysis showed benefit with device closure when compared with medical therapy with an HR of 0.54 (95% CI: 0.39 - 0.74, P = 0.108) in the intention-to-treat cohort, 0.44 (95% CI: 0.24 - 0.82, P = 0.103) in the per-protocol populations, and 0.43 (95% CI: 0.31 - 0.60, P = 0.019) in the as-treated populations. There was a significantly higher incidence of new-onset atrial fibrillation in PFO closure patients (OR = 4.53, 95% CI: 2.58 - 7.97, P = 0.094). PFO Patients with an atrial septal aneurysm benefit from device closure (OR = 0.39, 95% CI: 0.22 - 0.69, P = 0.053). Patients with a substantial PFO shunt benefit the greatest with device closure with a pooled OR of 0.27 (95% CI: 0.14 - 0.56, P = 0.525). Conclusions: The meta-analysis concluded that PFO closure was associated with significantly lower risk of recurrent stroke in PFO patients with cryptogenic stroke than with medical therapy alone. The benefit of PFO closure was greater in patients with a substantial shunt and atrial septal aneurysm. PFO closure was associated with higher rates of new-onset atrial fibrillation.

Migraine and percutaneous patent foramen ovale closure: a systematic review and meta-analysis

BackgroundThe association between patent foramen ovale (PFO) and migraine with aura (MA) is well established. However, the benefits of PFO closure are less certain in patients with migraine without aura (MwoA).MethodsWe systematically searched Pubmed for pertinent clinical studies published from January 2000 to July 2015. The primary end-point was the elimination or significant improvement of migraine symptoms after PFO closure.ResultsUpon screening an initial list of 315 publications, we identified eight studies that included 546 patients. Overall, our analysis indicated a significant improvement of migraine in 81% of MA cases compared to only 63% of MwoA cases. The summary odds ratio was 2.5 (95% confidence interval 1.09–5.73), and the benefits of PFO closure were significantly greater for patients with MA compared to patients with MwoA (P = 0.03).ConclusionsThe presence of aura provides a reference standard for the clinical selection of patients with migraine for PFO closure intervention.

Abstract 168: Differences in Description of Patent Foramen Ovale Influence Choice of Treatment

Background: Clinical trials of patent foramen ovale (PFO) closure for stroke prevention have produced controversial results. We investigated differences in presenting the net benefits of PFO closure or description of the PFO in a randomized vignette-based internet survey. Methods: Adults aged 18 to 60 inclusive were recruited via Amazon’s Mechanical Turk. Participants read a vignette asking them to imagine that they had a minor stroke. The vignettes included three randomized factors in a 2 x 2 x 3 factorial design: a) benefit of PFO closure (no proven benefit versus ~3% absolute risk reduction, analogous to difference in individual trials versus subsequent meta-analysis); b) normalization intervention (PFO described as very common and benign for most individuals versus no such description); and c) labeling of the PFO (?PFO? versus ?hole in the heart? versus ?difference in heart structure?). Participants were then asked their choice of treatment (PFO closure or aspirin). Secondary outcomes included self-perceived stroke risk and level of anxiety about the PFO diagnosis. Regression analysis was used to assess predictors of treatment choice (logistic) and secondary outcomes (linear). Results: 2157 participants completed the survey (54.6% female, 76.2% non-Hispanic white, median age 32 with IQR 27 – 41). Participants shown data suggesting 3% absolute risk reduction for PFO closure were more likely to choose PFO closure (30.9% vs. 7.5%, p &lt; 0.001). The normalization intervention decreased anxiety about the PFO. The labeling intervention increased self-perceived stroke risk and had differential effects on patient anxiety (see Table for details). Conclusion: Differences in how information is presented can influence choice of treatment, perceived stroke risk, and level of anxiety surrounding PFO-associated stroke. Future work should address the impact of information presentation on potential variability in use of PFO closure and patient psychological outcomes.

Abstract WMP103: Late Adverse Events of Patent Foramen Ovale Closure: A Systematic Review

Background: Optimal secondary stroke prevention for patients with cryptogenic stroke (CS) or transient ischemic attack (TIA) and patent foramen ovale (PFO) is not established. Observational studies imply a benefit for PFO closure over conventional medical management. Data from randomized trials are more equivocal or pending. Most studies report short term follow-up that will miss late adverse events (AEs). Methods: A systematic review was conducted of the Manufacturer and User Facility Device Experience (MAUDE) database for all septal closure device reports of late (&gt;30 days) AEs between 1/1/00-9/10/11. Search terms were brand names of closure devices used in PFOs. To exclude patients not treated for a PFO, cases were those for whom 1) the narrative clearly described PFO as the target lesion, or 2) the device was designed only for PFO closure. Data extracted were device type, indication for closure, time from implantation to AE, and explantation. We collected clinical (e.g. stroke) and device-related (e.g. thrombus on device) AEs. Results: We reviewed 1250 reports - 50 (4%) met inclusion criteria. Devices were CardioSEAL (n=28), Gore Helex (n=11) and Amplatzer PFO or ASD Occluders (n=11). Clinical AEs were stroke/TIA or systemic embolism (n=20), arrhythmia/palpitations (n=6), pericardial effusion (n=3), visual symptoms (n=3), chest pain (n=2), asymptomatic (n=7), and unknown/other (n=18). Device AEs were thrombus (n=24), residual shunt (n=8), embolization (n=7), erosion (n=3), infection (n=2), fracture (n=1), and unknown/other (n=8). AEs led to device explantation in 28 patients. The range of time between device placement and AE was 30 days to 6 years; 23 reports (46%) were &gt;1 year. Conclusion: The most common late clinical AE for device PFO closure was embolization and most common device event was thrombus. Nearly half of reported devices were explanted. These data cannot produce AE incidence rates because the number of implanted devices is unknown. We are also unable to determine the comparative safety of devices. However, the data emphasize that late AEs should be included when calculating the overall risk with the possible benefits of PFO closure.

Benefit of PFO Closure in Cryptogenic Stroke Remains Elusive

Approximately 30% to 40% of ischemic strokes are classified as cryptogenic because a recognized cause is not identified [Sacco RL et al. Ann Neurol 1989]. Paradoxical embolism due to patent foramen ovale (PFO) is a possible cause of ischemic stroke, particularly in young cryptogenic stroke patients. Several presentations at TCT 2012 added important data to the growing literature about PFO closure and highlighted how elusive secondary stroke prevention with device therapy remains.

Is Patent Foramen Ovale a Modifiable Risk Factor for Stroke Recurrence?

Although the prevalence of a patent foramen ovale (PFO) in the general population is ≈25%, it is approximately doubled among cryptogenic stroke (CS) patients. This has generally been attributed to paradoxical embolism, and many physicians recommend PFO closure to prevent recurrence. However, the benefit of PFO closure in patients with stroke has not been demonstrated. Furthermore, the epidemiology of stroke recurrence in patients with CS with PFO versus without PFO and in those with large right-to-left shunts versus small right-to-left shunts has yielded results that appear difficult to reconcile with the hypothesis that paradoxical embolism is an important cause of stroke recurrence. The purpose of this review is to critically examine the epidemiologic evidence that PFO is a potentially modifiable risk factor for stroke recurrence in patients with CS. The evidence suggests that many patients with CS and PFO have strokes that are PFO attributable, but many have strokes that are unrelated to their PFO. We introduce the concept of "PFO propensity," defined as the patient-specific probability of finding a PFO in a patient with CS on the basis of age and other risk factors. We show that this value is directly related to the probability that CS is PFO attributable. Because there is substantial heterogeneity in both PFO propensity and recurrence risk among patients with PFO and CS, stratification for PFO closure by these joint probabilities will likely prove crucial for appropriate patient selection.

Patent Foramen Ovale and Stroke: Should PFOs Be Closed in Otherwise Cryptogenic Stroke?

Since initial reports of its association with ischemic stroke appeared in 1988, there has been continued controversy regarding the existence and strength of the association between patent foramen ovale (PFO) and ischemic stroke. Many case-control studies have reported an association between incident cryptogenic ischemic stroke and PFO, yet population-based studies have failed to confirm this association. Studies of the risk of recurrent stroke in patients with cryptogenic stroke with or without PFO have not shown an increased risk of recurrent stroke in patients with PFO. Meanwhile, use of devices to close PFOs and atrial septal defects percutaneously has increased dramatically since their introduction. Completion of the randomized clinical trials of PFO closure currently in progress is vital to determine if the benefits of PFO closure in cryptogenic stroke outweigh its risks.

Patent Foramen Ovale Closure for Migraine Relief: A Persistent Headache

Data from small observational studies suggest that migraine headaches improve or resolve in selected patients who undergo closure of patent foramen ovale (PFO), usually for indications other than migraine. However, the only randomized trial to test this potential benefit of PFO closure did not confirm it (JW Cardiol Mar 26 2008 …

Patent foramen ovale closure: A new therapy for migraine

Migraine is a recurrent disabling disorder predominantly affecting middle-aged women. Migraine occurs with or without aura symptoms. Several studies have shown an increased prevalence of right-to-left shunts (RLSs) in migraine with aura. The overwhelming majority of these shunts were due to a patent foramen ovale (PFO). Furthermore, migraine with aura is more prevalent in clinical entities associated with a RLS, e.g. cryptogenic stroke, decompression illness in divers, or in patients with hereditary hemorrhagic teleangiectasia and pulmonary arteriovenous fistulas. Retrospective studies have consistently shown that shunt closure was associated with a significant reduction in migraine frequency. Its beneficial effect seemed to exceed the efficacy of conventional migraine therapy. Several randomized clinical trials to prospectively assess the benefit of shunt closure in migraine patients have been initiated. The only one completed, the MIST trial (Migraine Intervention with STARFLEX Technology), showed a significant reduction of migraine with aura after device implantation, compared with controls. However, the benefit of PFO closure was more modest than expected. This review recapitulates the current data regarding PFO closure and migraine with aura and summarizes in brief the current knowledge regarding migraine pathophysiology and the link to a RLS.