BACKGROUND The Food and Drug Administration has approved percutaneous atrial septal defect(ASD)and patent foramen ovale(PFO)closure devices for hemodynamically significant interatrial shunts,paradoxical emboli includi...BACKGROUND The Food and Drug Administration has approved percutaneous atrial septal defect(ASD)and patent foramen ovale(PFO)closure devices for hemodynamically significant interatrial shunts,paradoxical emboli including stroke,and decompression sickness.We aimed to study the trends in utilization and reimbursements of transcatheter ASD/PFO closure devices.AIM To analyze trends in utilization and Medicare reimbursements for transcatheter ASD/PFO closure procedures from 2013 to 2022.METHODS A query of administrative data on United States Medicare beneficiaries undergoing transcatheter ASD/PFO was conducted from 2013 to 2022 using the Centers for Medicare and Medicaid Services Part B National Summary Data File.Inflation adjustments were made using the 2023 Consumer Price Index.Trend analysis was quantified using growth rate and simple linear regression calculations.All analyses were performed using Microsoft Excel 16.77.1(2023).RESULTS The annual number of transcatheter ASD/PFO closure procedures increased by 81%since 2013,with an average yearly growth rate of 44%cases per year(P<0.001).Annual Medicare reimbursements for transcatheter ASD/PFO therapies mirrored the annual procedure trends.The per-case reimbursements decreased by 18%,i.e.,$1128.80 in 2013 and$770.21 in 2022(P<0.001).There was a significant drop in the number of procedures in the year 2020,which correlates to the onset of the coronavirus disease 2019 pandemic,followed by a sharp uptick in the number of cases in 2021 and 2022.CONCLUSION Medicare utilization of transcatheter ASD/PFO closure therapies has grown significantly in procedural volume from 2013 to 2022.However,this has been accompanied by a decrease in per-case reimbursements.展开更多
Patent foramen ovale(PFO)is a common congenital heart disorder associated with stroke,decompression sickness and migraine.Combining synchronized contrast transcranial Doppler with contrast transthoracic echocardiograp...Patent foramen ovale(PFO)is a common congenital heart disorder associated with stroke,decompression sickness and migraine.Combining synchronized contrast transcranial Doppler with contrast transthoracic echocardiography has important clinical significance and can improve the accuracy of detecting right-left shunts(RLSs)in patients with PFO.In this letter,regarding an original study presented by Yao et al,we present our insights and discuss how to better help clinicians evaluate changes in PFO-related RLS.展开更多
Compared with traditional nickel-titanium alloy patent foramen ovale occluders,which are widely used in clinical practice,biodegradable patent foramen ovale occluders have obvious differences in material characteristi...Compared with traditional nickel-titanium alloy patent foramen ovale occluders,which are widely used in clinical practice,biodegradable patent foramen ovale occluders have obvious differences in material characteristics,interventional operation mode and postoperative management strategy.This article gives expert consensus on the selection of clinical indications and standardized operating procedures,so as to standardize the clinical application of biodegradable patent foramen ovale occluders.展开更多
This study aimed to evaluate the feasibility,safety,and efficacy of a noveltranscatheter suture closure system(HaloStitch^(®))for patent foramen ovale(PFO)closure in a swine model.Methods:Thirteen swine underwent...This study aimed to evaluate the feasibility,safety,and efficacy of a noveltranscatheter suture closure system(HaloStitch^(®))for patent foramen ovale(PFO)closure in a swine model.Methods:Thirteen swine underwentexperimental PF0 model creation.All animals received implantationof the transcatheter suture closure system to evaluate procedural success.Comprehensive follow-up over sixmonths included serial ultrasound imaging,histopathological analysis,and gross anatomical exaninationof cardiac specimens.Results:Successful HaloStitch^(®)device implantation was adhieved in 11 of 13 swine.Gross anatomical examination confirrned secure positioning of all sutures in the atrial septum,with noredundancy or thrombus formation.Postoperative ultrasound demonstrated stable suture and staplepositions throughout follow-up,with no evidence of suture breakage,displacement,or thrombus.Stapleswere clearly visualized under ultrasound imaging,Both the atrial septal defect orifice diameter and residualseptal shunt flow velocity decreased significantly during the observation period.Histopathological analysisrevealed partially organized thrombi at the implant head and fibrous connective tissue encapsulation withlocalized inflammatory cell infiltration surrounding the polymer material.Conclsions:The transcathetersuture closure system(HaloStitch^(®))demonstrated feasibility,safety,and biocompatib ility for PFO closure ina swine model,supporting its potential for clinical translation.展开更多
BACKGROUND Patent foramen ovale(PFO)is the most common congenital heart disease and is associated with several diseases,including stroke and migraine.PFO diagnosis involves transoesophageal echocardiography,transthora...BACKGROUND Patent foramen ovale(PFO)is the most common congenital heart disease and is associated with several diseases,including stroke and migraine.PFO diagnosis involves transoesophageal echocardiography,transthoracic echocardiography,and transcranial Doppler.Recent studies have shown that intracardiac echocardiography(ICE)can be used to diagnose and guide percutaneous transcatheter closure.CASE SUMMARY A 70-year-old male presented with paroxysmal dizziness and limb weakness for the past 3 mo.Magnetic resonance imaging revealed a history of stroke,and a bubble test revealed the presence of PFO.The patient was then transferred to our hospital for PFO closure.Under ICE guidance,the separation of the septum primum and septum secundum was unclear;we then used a Swartz catheter to confirm PFO by applying physical pressure on the right part of the atrial septum without using any contrast.The ICE continuously and clearly guided the procedure.CONCLUSION ICE can guide PFO closure in patients with a history of stroke.When PFO is not evident under ICE,a Swartz catheter can be used.展开更多
AIM To test the potential association between atrial septal aneurysm(ASA) and migraine in patent foramen ovale(PFO) closure patients through an observational, singlecenter, case-controlled study.METHODS We studied a t...AIM To test the potential association between atrial septal aneurysm(ASA) and migraine in patent foramen ovale(PFO) closure patients through an observational, singlecenter, case-controlled study.METHODS We studied a total of 450 migraineurs who had rightto-left shunts and underwent PFO closure in a retrospective single-center non-randomized registry from February 2012 to October 2016 on the condition that they were aged 18-45 years old. Migraine was diagnosed according to the International Classification of Headache Disorders, 3^(rd) edition and evaluated using the Headache Impact Test-6(HIT-6). All patients underwent preoperative transesophageal echocardiography, contrast transthoracic echocardiography, and computed tomography or magnetic resonance imaging examinations, with subsequent fluoroscopy-guided PFO closure. Based on whether they have ASA or not, the patients were divided into two groups: A(PFO with ASA, n = 80) and B(PFO without ASA, n = 370). Baseline characteristics and procedural and follow-up data were reviewed. RESULTS Compared to group B, group A had an increased frequency of ischemic lesions(11.3% vs 6.2%, P = 0.038) and migraine with aura(32.5% vs 21.1%, P = 0.040). The PFO size was significantly larger in group A(P = 0.007). There was no significant difference in HIT-6 scores between the two groups before and at the oneyear follow-up after the PFO closure [61(9) vs 63(9), P = 0.227; 36(13) vs 36(10), P = 0.706].CONCLUSION Despite its small sample size, our study suggests that the prevalence of ASA in PFO with migraine patients is associated with ischemic stroke, larger PFO size, and migraine with aura.展开更多
AIM To investigate if patent foramen ovale(PFO) closure device reduces the risk of recurrent stroke in patients with cryptogenic stroke.METHODS We searched five databases-Pub Med,EMBASE,Cochrane,CINAHL and Web-of-Scie...AIM To investigate if patent foramen ovale(PFO) closure device reduces the risk of recurrent stroke in patients with cryptogenic stroke.METHODS We searched five databases-Pub Med,EMBASE,Cochrane,CINAHL and Web-of-Science and clinicaltrials.gov from January 2000 to September 2017 for randomized trials comparing PFO closure to medical therapy in cryptogenic stroke.Heterogeneity was determined using Cochrane's Q statistics.Random effects model was used.RESULTS Five randomized controlled trials with 3440 patients were included in the analysis.Mean follow-up was 50 ± 20 mo.PFO closure was associated with a 41% reduction in incidence of recurrent strokes when compared to medical therapy alone in patients with cryptogenic stroke [risk ratio(RR): 0.59,95%CI: 0.40-0.87,P = 0.008].Atrial fibrillation was higher with device closure when compared to medical therapy alone(RR: 4.97,95%CI: 2.22-11.11,P < 0.001).There was no difference between the two groups with respect to all-cause mortality,major bleeding or adverse events.CONCLUSION PFO device closure in appropriately selected patients with moderate to severe right-to-left shunt and/or atrial septal aneurysm shows benefit with respect to recurrent strokes,particularly in younger patients.Further studies are essential to evaluate the impact of higher incidence of atrial fibrillation seen with the PFO closure device on long-term mortality and stroke rates.展开更多
BACKGROUND Cardiogenic embolism caused by patent foramen ovale(PFO)is a common etiology of cryptogenic stroke(CS),particularly in young and middle-aged patients.Studies about right-to-left shunt(RLS)detection using co...BACKGROUND Cardiogenic embolism caused by patent foramen ovale(PFO)is a common etiology of cryptogenic stroke(CS),particularly in young and middle-aged patients.Studies about right-to-left shunt(RLS)detection using contrast-enhanced transcranial Doppler(c-TCD)are numerous.According to the time phase and number of microbubbles detected on c-TCD,RLS can be classified and graded.We hypothesized that the characteristics of an infarction lesion on diffusion-weighted imaging differs when combining the type and grade of RLS on c-TCD in patients with PFO-related CS.AIM To explore the characteristics of infarction lesions on diffusion-weighted imaging when combining the RLS type and grade determined by c-TCD.METHODS We retrospectively evaluated CS patients from August 2015 to December 2019 at a tertiary hospital.In total,111 PFO-related CS patients were divided according to whether RLS was permanent(microbubbles detected both at resting state and after the Valsalva maneuver)or latent(microbubbles detected only after the Valsalva maneuver)on c-TCD.Each group was subdivided into small,mild and large RLS according to the grade of shunt on c-TCD.A normal control group was composed of 33 patients who suffered from simple dizziness.Intragroup and intergroup differences were analyzed in terms of clinical,laboratory and diffusion-weighted imaging lesion characteristics.The correlation between RLS grade evaluated by c-TCD and size of PFO determined by transesophageal echocardiography were also analyzed.RESULTS In 111 patients with PFO-related CS,68 had permanent RLS and 43 had latent RLS.Clinical characteristics and laboratory tests were not significantly different among the permanent RLS,latent RLS and normal control groups.The proportion of patients with multiple territory lesions in the permanent RLS group(50%)was larger than that in the latent RLS group(27.91%;P=0.021).Posterior circulation was more likely to be affected in the latent RLS group than in the permanent RLS group(30.23%vs 8.82%,P=0.004).Permanent-large and latent-large RLS were both more likely to be related to multiple(P_(trend)=0.017 and 0.009,respectively),small(P_(trend)=0.035 and 0.006,respectively)and cortical(P_(trend)=0.031 and 0.033,respectively)lesions.The grade of RLS evaluated by c-TCD was correlated to the size of PFO determined by transesophageal echocardiography(r=0.758,P<0.001).CONCLUSION Distribution of the infarct suggested the possible type of RLS.Multiple,small and cortical infarcts suggest large RLS induced by a large PFO.展开更多
BACKGROUND A few randomized clinical trials(RCT)and their meta-analyses have found patent foramen ovale closure(PFOC)to be beneficial in prevention of stroke compared to medical therapy.Whether the benefit is extended...BACKGROUND A few randomized clinical trials(RCT)and their meta-analyses have found patent foramen ovale closure(PFOC)to be beneficial in prevention of stroke compared to medical therapy.Whether the benefit is extended across all groups of patients remains unclear.AIM To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke,we performed this meta-analysis of RCTs.METHODS Electronic search of PubMed,EMBASE,Cochrane Central,CINAHL and ProQuest Central and manual search were performed from inception through September 2018 for RCTs.Ischemic stroke(IS),transient ischemic attack(TIA),a composite of IS,TIA and systemic embolism(SE),mortality,major bleeding,atrial fibrillation(AF)and procedural complications were the major outcomes.Random-effects model was used to perform analyses.RESULTS Meta-analysis of 6 RCTs including 3560 patients showed that the PFOC,compared to medical therapy reduced the risk of IS[odds ratio:0.34;95%confidence interval:0.15-0.78;P=0.01]and the composite of IS,TIA and SE[0.55(0.32-0.93);P=0.02]and increased the AF risk[4.79(2.35-9.77);P<0.0001].No statistical difference was observed in the risk of TIA[0.86(0.54-1.38);P=0.54],mortality[0.74(0.28-1.93);P=0.53]and major bleeding[0.81(0.42-1.56);P=0.53]between two strategies.Subgroup analyses showed that compared to medical therapy,PFOC reduced the risk of stroke in persons who were males,≤45 years of age and had large shunt or atrial septal aneurysm.CONCLUSION In certain groups of patients presenting with stroke,PFOC is beneficial in preventing future stroke compared to medical therapy.展开更多
Recent trials and metanalysis even not fully conclusive and still debated,at least suggested that mechanical device-based closure of patent foramen ovale(PFO)is more effective than medical therapy in prevent recurrenc...Recent trials and metanalysis even not fully conclusive and still debated,at least suggested that mechanical device-based closure of patent foramen ovale(PFO)is more effective than medical therapy in prevent recurrence of stroke. In a proportion ranging from 20% to nearly 40% of patients in literature,PFO is associated to atrial septal aneurysm(ASA):ASA is a well-known entity often associated with additional fenestration. Additionally small atrial septal defects("Flat ASD") can present with signs of paradoxical embolism and cannot be easily detected by transthoracic echocardiography or even by transesophageal echocardiography and are usually discovered by intracardiac echocardiography at the moment of transcatheter closure. This evidence might change potentially the anatomical diagnosis from PFO to fenestrated ASA or as we called it to "hybrid defect",being a bidirectional flow through a small ASD or/and an additional fenestration,often present. Despite the differences in anatomy,pathophysiology and haemodynamic paradoxical embolism may occur in both entities and also may be the first appearance of fenestrated ASA. Because some overlapping do really exist between PFO and hybrid defects,which are often not clearly differentiable by standard diagnostic tools,it is likely that a proportion of patients evaluated for potential transcatheter closure of PFO had actually a different anatomical substrate. These different anatomical and pathophysiologic entities have not been address in any of the previous trials,potentially having an impact on overall results despite the similar mechanical treatment. Neurologists and general cardiologists in charge of clinical management of PFOrelated cryptogenic stroke should be aware of the role of hybrid defects in the pathophysiology of paradoxical embolism- mediated cerebral ischemic events in order to apply the correct decision- making process and avoid downgrading of patients with paradoxical embolism-related interatrial shunt variants different from PFO.展开更多
Objective Recently it has been suggested that, in patients with large patent foramen ovale （PFO） and atrial septal aneurysms （ASA）, a certain amount of left atrial （LA） dysfunction may be active as an alternate ...Objective Recently it has been suggested that, in patients with large patent foramen ovale （PFO） and atrial septal aneurysms （ASA）, a certain amount of left atrial （LA） dysfunction may be active as an alternate mechanism promoting arterial embolism. Following this hypothesis, elderly patients, being more susceptible to atrial chambers stiffness, should present a more severe LA dysfunction profile. We sought to evaluate the grade of LA dysfunction in elderly patients submitted to transcatheter PFO closure. Methods We retrospectively enrolled 28 consecutive patients with previous stroke （mean age 674-12.5 years, 18 females） referred to our centre for catheter-based PFO closure after recurrent stroke. Baseline values of LA passive and active emptying, LA conduit function, LA ejection fraction, and spontaneous echocontrast （SEC） in the LA and LA appendage were compared with those of 50 atrial fibrillation patients, as well as a sex/age/cardiac risk matched population of 70 healthy controls. Results Pre-closure elderly subjects demonstrated significantly greater reservoir function as well as passive and active emptying, with reduced conduit function and LA ejection fraction, when compared to healthy and younger patients. After closure in elderly patients, LAparameters did not return completely to the levels of healthy patients, whereas LA dysfunction in younger subjects returned normal. Conclusions This study suggests that elderly patients have more severe LA dysfunction than younger patients, which affects the LA remodelling after closure.展开更多
An elderly gentleman presented to the emergency department with a recent history of dyspnoea, collapse and transient neurological symptoms. He was noted to be hypoxic with a significantly elevated D Dimer. A computer ...An elderly gentleman presented to the emergency department with a recent history of dyspnoea, collapse and transient neurological symptoms. He was noted to be hypoxic with a significantly elevated D Dimer. A computer tomography pulmonary angiogram demonstrated a large embolus with a further filling defects within the left and the right atria, abutting the interatrial septum. Suspicion of a paradoxical pulmonary embolus was raised and the patient subsequently underwent echocardiography which confirmed a patent foramen ovale(PFO). He was commenced on warfarin therapy. In patients with elevated right heart pressure, a PFO can be unmasked and give rise to cerebral emboli. Clinical suspicion should be raised in patients with pulmonary emboli or deep venous thrombosis if there is a concomitant history of focal neurological symptoms.展开更多
BACKGROUND Venous thromboembolism is a common vascular syndrome presenting as deep vein thrombosis and/or pulmonary embolism.Thrombus has the possibility of migrating into the left circulation via patent foramen ovale...BACKGROUND Venous thromboembolism is a common vascular syndrome presenting as deep vein thrombosis and/or pulmonary embolism.Thrombus has the possibility of migrating into the left circulation via patent foramen ovale in certain extreme circumstances.Thrombus straddling a patent foramen ovale is a direct evidence of this scenario.However,the confirmed cases of thrombus in transit are still rare.CASE SUMMARY A 32-year-old man suffered from recurrent syncope and intermittent dyspnea for 1 wk.Transthoracic echocardiography confirmed a thrombus straddling the patent foramen ovale,and thrombi were also found in the bilateral pulmonary artery by computed tomography.The man underwent inferior vena cava filter placement and thrombolysis with alteplase.Echocardiography showed the absence of thrombi in both the right atrium and left atrium 2 d after hospitalization.The man was discharged to home on warfarin without any complications 2 wk later.CONCLUSION Scrutinizing intracardiac thrombi provides measurable value in pulmonary embolism as closure of patent foramen ovale may be considered in certain patients.Early intervention plays a critical role in thrombus straddling a patent foramen ovale.A sedentary lifestyle may predispose young adults to thromboembolism,even if there are no other risk factors.展开更多
In this study, we investigated the changes in the right-to-left shunt (RLS) of the patent foramen ovale (PFO) at different phases of the Valsalva maneuver and analyzed the possible mechanisms. The study population con...In this study, we investigated the changes in the right-to-left shunt (RLS) of the patent foramen ovale (PFO) at different phases of the Valsalva maneuver and analyzed the possible mechanisms. The study population consisted of 57 patients with symptoms highly suggestive of a PFO. These patients had been diagnosed with apsychia, migraine with aura, cerebral infarction, transient ischemic attack (TIA), and cerebral ischemia with unknown cause. Routine echocardiography was performed in all patients to rule out a cardiac malformation. Contrast-transcranial Doppler (c-TCD) and contrast-enhanced transthoracic echocardiography (c-TTE) were used to visualize and quantify the RLS. The standard apical four chamber view was used to observe the changes of E peak, A peak, and velocity-time integral (VTI) ratio of tricuspid blood flow during the strain phase and release phase of the Valsalva maneuver. Paired t-test was used to compare E peak, A peak, and VTI ratio of tricuspid blood flow during the different phases. The right-to-left shunt across the PFO (PFO-RLS) was graded in the two phases and compared by Kruskal-Wallis test. Compared with the strain phase of the Valsalva maneuver, the parameters of E, A, and VTI in diastolic period in patients with PFO-RLS at the release phase were significantly increased [54.30 ± 13.65 cm/s vs 100.35 ± 21.11 cm/s, 42.21 ± 12.32 cm/s vs 57.30 ± 18.88 cm/s, 10.34 ± 3.27 cm/s vs 19.58 ± 4.56 cm/s, respectively], and the difference was statistically significant. The positive consequence of PFO-RLS, as diagnosed by c-TTE with the Valsalva maneuver at the release phase of the Valsalva maneuver, was significantly higher than that at the strain phase of the Valsalva maneuver. At the beginning of release phase of the Valsalva maneuver, decreased intrathoracic pressure led to increased venous backflow into the right atrium. Thus, high-velocity blood flow rapidly pushed the PFO open, which resulted in a significant increase in the PFO-RLS. Therefore, the increase of the PFO-RLS during the Valsalva maneuver is caused by the impact of high-velocity blood flow the PFO.展开更多
Patent foramen ovale (PFO) closure for systemic hypoxemia is controversial. The first systematic, albeit retrospective, study was recently presented which showed good procedural and clinical success for PFO closure fo...Patent foramen ovale (PFO) closure for systemic hypoxemia is controversial. The first systematic, albeit retrospective, study was recently presented which showed good procedural and clinical success for PFO closure for this indication. We present a case of acute right to left intra-cardiac shunt across PFO where the shunting is not persistent. Hence making a decision on PFO closure based on the aforementioned promising trial may not have been the right decision for the patient. This case highlights that the decision on PFO closure for such indication needs to be individualized. We also review the sparse literature on PFO closure for this indication and discuss how the decision making for such indication needs to be individualized.展开更多
Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have bee...Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.展开更多
Patent foram ovale(PFO)is the most common anatomical cause of an interarterial shunt.It is usually asymptomatic but may cause paradoxical embolism and is a risk factor for non-lacunar cryptogenic cerebral ischemia in ...Patent foram ovale(PFO)is the most common anatomical cause of an interarterial shunt.It is usually asymptomatic but may cause paradoxical embolism and is a risk factor for non-lacunar cryptogenic cerebral ischemia in young adults.Although the first clinical trials did not show a significant superiority of PFO closure in the secondary prevention of cerebral ischemia as compared with standard antithrombotic treatment,six subsequent randomized clinical trials(CLOSURE I,PC Trial,RESPECT,CLOSE,REDUCE,and DEFENSE-PFO)performed in a sample of cryptogenic stroke in patients aged 60 years or younger provided evidence of a significant reduction of recurrent cerebral ischemia after percutaneous PFO closure.However,the use of percutaneous PFO closure cannot be generalized to the entire population of patients with cerebral ischemia and PFO,but it is indicated in highly selected patients with non-lacunar cryptogenic cerebral infarction with a large right-to-left shunt,an atrial septal aneurysm and no evidence of atrial fibrillation,as well as in association with antithrombotic treatment for an optimal secondary prevention of cerebral ischemia.展开更多
1 Introduction Isolated atrial septal defects （ASD） represent 7% of all cardiac anomalies and can present at any age. Adolescents and adults with simple congenital heart disease such as isolated atrial septal defec...1 Introduction Isolated atrial septal defects （ASD） represent 7% of all cardiac anomalies and can present at any age. Adolescents and adults with simple congenital heart disease such as isolated atrial septal defects are more likely to reach adult age without being diagnosed. Secundum ASD （sASD） is by far the most common type, occurring in 1/1500 live births, with 65% to 75% involving females, On the other hand, patent foramen ovale （PFO） represents an endemic variant in the normal population with a prevalence of 25%-27%. These two entities appear so different that is difficult to fred a conjunction ring： nevertheless we use the same philosophy for the treatment, Indeed, device-based closure has been proved to be effective in both settings.展开更多
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 t...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.展开更多
文摘BACKGROUND The Food and Drug Administration has approved percutaneous atrial septal defect(ASD)and patent foramen ovale(PFO)closure devices for hemodynamically significant interatrial shunts,paradoxical emboli including stroke,and decompression sickness.We aimed to study the trends in utilization and reimbursements of transcatheter ASD/PFO closure devices.AIM To analyze trends in utilization and Medicare reimbursements for transcatheter ASD/PFO closure procedures from 2013 to 2022.METHODS A query of administrative data on United States Medicare beneficiaries undergoing transcatheter ASD/PFO was conducted from 2013 to 2022 using the Centers for Medicare and Medicaid Services Part B National Summary Data File.Inflation adjustments were made using the 2023 Consumer Price Index.Trend analysis was quantified using growth rate and simple linear regression calculations.All analyses were performed using Microsoft Excel 16.77.1(2023).RESULTS The annual number of transcatheter ASD/PFO closure procedures increased by 81%since 2013,with an average yearly growth rate of 44%cases per year(P<0.001).Annual Medicare reimbursements for transcatheter ASD/PFO therapies mirrored the annual procedure trends.The per-case reimbursements decreased by 18%,i.e.,$1128.80 in 2013 and$770.21 in 2022(P<0.001).There was a significant drop in the number of procedures in the year 2020,which correlates to the onset of the coronavirus disease 2019 pandemic,followed by a sharp uptick in the number of cases in 2021 and 2022.CONCLUSION Medicare utilization of transcatheter ASD/PFO closure therapies has grown significantly in procedural volume from 2013 to 2022.However,this has been accompanied by a decrease in per-case reimbursements.
文摘Patent foramen ovale(PFO)is a common congenital heart disorder associated with stroke,decompression sickness and migraine.Combining synchronized contrast transcranial Doppler with contrast transthoracic echocardiography has important clinical significance and can improve the accuracy of detecting right-left shunts(RLSs)in patients with PFO.In this letter,regarding an original study presented by Yao et al,we present our insights and discuss how to better help clinicians evaluate changes in PFO-related RLS.
基金Chinese Academy of Medical Sciences Fuwai Hospital High Level Hospital clinical research fund(2022-GSPGG-18).
文摘Compared with traditional nickel-titanium alloy patent foramen ovale occluders,which are widely used in clinical practice,biodegradable patent foramen ovale occluders have obvious differences in material characteristics,interventional operation mode and postoperative management strategy.This article gives expert consensus on the selection of clinical indications and standardized operating procedures,so as to standardize the clinical application of biodegradable patent foramen ovale occluders.
基金supported by grants from National High-Level Hospital Clinical Research Funding(2023-GSP-RC-04).
文摘This study aimed to evaluate the feasibility,safety,and efficacy of a noveltranscatheter suture closure system(HaloStitch^(®))for patent foramen ovale(PFO)closure in a swine model.Methods:Thirteen swine underwentexperimental PF0 model creation.All animals received implantationof the transcatheter suture closure system to evaluate procedural success.Comprehensive follow-up over sixmonths included serial ultrasound imaging,histopathological analysis,and gross anatomical exaninationof cardiac specimens.Results:Successful HaloStitch^(®)device implantation was adhieved in 11 of 13 swine.Gross anatomical examination confirrned secure positioning of all sutures in the atrial septum,with noredundancy or thrombus formation.Postoperative ultrasound demonstrated stable suture and staplepositions throughout follow-up,with no evidence of suture breakage,displacement,or thrombus.Stapleswere clearly visualized under ultrasound imaging,Both the atrial septal defect orifice diameter and residualseptal shunt flow velocity decreased significantly during the observation period.Histopathological analysisrevealed partially organized thrombi at the implant head and fibrous connective tissue encapsulation withlocalized inflammatory cell infiltration surrounding the polymer material.Conclsions:The transcathetersuture closure system(HaloStitch^(®))demonstrated feasibility,safety,and biocompatib ility for PFO closure ina swine model,supporting its potential for clinical translation.
基金Supported by the National Key Research and Development Program of China,No.2017YFC0908800。
文摘BACKGROUND Patent foramen ovale(PFO)is the most common congenital heart disease and is associated with several diseases,including stroke and migraine.PFO diagnosis involves transoesophageal echocardiography,transthoracic echocardiography,and transcranial Doppler.Recent studies have shown that intracardiac echocardiography(ICE)can be used to diagnose and guide percutaneous transcatheter closure.CASE SUMMARY A 70-year-old male presented with paroxysmal dizziness and limb weakness for the past 3 mo.Magnetic resonance imaging revealed a history of stroke,and a bubble test revealed the presence of PFO.The patient was then transferred to our hospital for PFO closure.Under ICE guidance,the separation of the septum primum and septum secundum was unclear;we then used a Swartz catheter to confirm PFO by applying physical pressure on the right part of the atrial septum without using any contrast.The ICE continuously and clearly guided the procedure.CONCLUSION ICE can guide PFO closure in patients with a history of stroke.When PFO is not evident under ICE,a Swartz catheter can be used.
文摘AIM To test the potential association between atrial septal aneurysm(ASA) and migraine in patent foramen ovale(PFO) closure patients through an observational, singlecenter, case-controlled study.METHODS We studied a total of 450 migraineurs who had rightto-left shunts and underwent PFO closure in a retrospective single-center non-randomized registry from February 2012 to October 2016 on the condition that they were aged 18-45 years old. Migraine was diagnosed according to the International Classification of Headache Disorders, 3^(rd) edition and evaluated using the Headache Impact Test-6(HIT-6). All patients underwent preoperative transesophageal echocardiography, contrast transthoracic echocardiography, and computed tomography or magnetic resonance imaging examinations, with subsequent fluoroscopy-guided PFO closure. Based on whether they have ASA or not, the patients were divided into two groups: A(PFO with ASA, n = 80) and B(PFO without ASA, n = 370). Baseline characteristics and procedural and follow-up data were reviewed. RESULTS Compared to group B, group A had an increased frequency of ischemic lesions(11.3% vs 6.2%, P = 0.038) and migraine with aura(32.5% vs 21.1%, P = 0.040). The PFO size was significantly larger in group A(P = 0.007). There was no significant difference in HIT-6 scores between the two groups before and at the oneyear follow-up after the PFO closure [61(9) vs 63(9), P = 0.227; 36(13) vs 36(10), P = 0.706].CONCLUSION Despite its small sample size, our study suggests that the prevalence of ASA in PFO with migraine patients is associated with ischemic stroke, larger PFO size, and migraine with aura.
文摘AIM To investigate if patent foramen ovale(PFO) closure device reduces the risk of recurrent stroke in patients with cryptogenic stroke.METHODS We searched five databases-Pub Med,EMBASE,Cochrane,CINAHL and Web-of-Science and clinicaltrials.gov from January 2000 to September 2017 for randomized trials comparing PFO closure to medical therapy in cryptogenic stroke.Heterogeneity was determined using Cochrane's Q statistics.Random effects model was used.RESULTS Five randomized controlled trials with 3440 patients were included in the analysis.Mean follow-up was 50 ± 20 mo.PFO closure was associated with a 41% reduction in incidence of recurrent strokes when compared to medical therapy alone in patients with cryptogenic stroke [risk ratio(RR): 0.59,95%CI: 0.40-0.87,P = 0.008].Atrial fibrillation was higher with device closure when compared to medical therapy alone(RR: 4.97,95%CI: 2.22-11.11,P < 0.001).There was no difference between the two groups with respect to all-cause mortality,major bleeding or adverse events.CONCLUSION PFO device closure in appropriately selected patients with moderate to severe right-to-left shunt and/or atrial septal aneurysm shows benefit with respect to recurrent strokes,particularly in younger patients.Further studies are essential to evaluate the impact of higher incidence of atrial fibrillation seen with the PFO closure device on long-term mortality and stroke rates.
基金People’s Livelihood Science and Technology Project(Research on Application of Key Technologies)of Suzhou(No.SS202061)Technical Cooperation Project of Soochow University(No.H211064).
文摘BACKGROUND Cardiogenic embolism caused by patent foramen ovale(PFO)is a common etiology of cryptogenic stroke(CS),particularly in young and middle-aged patients.Studies about right-to-left shunt(RLS)detection using contrast-enhanced transcranial Doppler(c-TCD)are numerous.According to the time phase and number of microbubbles detected on c-TCD,RLS can be classified and graded.We hypothesized that the characteristics of an infarction lesion on diffusion-weighted imaging differs when combining the type and grade of RLS on c-TCD in patients with PFO-related CS.AIM To explore the characteristics of infarction lesions on diffusion-weighted imaging when combining the RLS type and grade determined by c-TCD.METHODS We retrospectively evaluated CS patients from August 2015 to December 2019 at a tertiary hospital.In total,111 PFO-related CS patients were divided according to whether RLS was permanent(microbubbles detected both at resting state and after the Valsalva maneuver)or latent(microbubbles detected only after the Valsalva maneuver)on c-TCD.Each group was subdivided into small,mild and large RLS according to the grade of shunt on c-TCD.A normal control group was composed of 33 patients who suffered from simple dizziness.Intragroup and intergroup differences were analyzed in terms of clinical,laboratory and diffusion-weighted imaging lesion characteristics.The correlation between RLS grade evaluated by c-TCD and size of PFO determined by transesophageal echocardiography were also analyzed.RESULTS In 111 patients with PFO-related CS,68 had permanent RLS and 43 had latent RLS.Clinical characteristics and laboratory tests were not significantly different among the permanent RLS,latent RLS and normal control groups.The proportion of patients with multiple territory lesions in the permanent RLS group(50%)was larger than that in the latent RLS group(27.91%;P=0.021).Posterior circulation was more likely to be affected in the latent RLS group than in the permanent RLS group(30.23%vs 8.82%,P=0.004).Permanent-large and latent-large RLS were both more likely to be related to multiple(P_(trend)=0.017 and 0.009,respectively),small(P_(trend)=0.035 and 0.006,respectively)and cortical(P_(trend)=0.031 and 0.033,respectively)lesions.The grade of RLS evaluated by c-TCD was correlated to the size of PFO determined by transesophageal echocardiography(r=0.758,P<0.001).CONCLUSION Distribution of the infarct suggested the possible type of RLS.Multiple,small and cortical infarcts suggest large RLS induced by a large PFO.
文摘BACKGROUND A few randomized clinical trials(RCT)and their meta-analyses have found patent foramen ovale closure(PFOC)to be beneficial in prevention of stroke compared to medical therapy.Whether the benefit is extended across all groups of patients remains unclear.AIM To evaluate the efficacy and safety of PFOC vs medical therapy in different groups of patients presenting with stroke,we performed this meta-analysis of RCTs.METHODS Electronic search of PubMed,EMBASE,Cochrane Central,CINAHL and ProQuest Central and manual search were performed from inception through September 2018 for RCTs.Ischemic stroke(IS),transient ischemic attack(TIA),a composite of IS,TIA and systemic embolism(SE),mortality,major bleeding,atrial fibrillation(AF)and procedural complications were the major outcomes.Random-effects model was used to perform analyses.RESULTS Meta-analysis of 6 RCTs including 3560 patients showed that the PFOC,compared to medical therapy reduced the risk of IS[odds ratio:0.34;95%confidence interval:0.15-0.78;P=0.01]and the composite of IS,TIA and SE[0.55(0.32-0.93);P=0.02]and increased the AF risk[4.79(2.35-9.77);P<0.0001].No statistical difference was observed in the risk of TIA[0.86(0.54-1.38);P=0.54],mortality[0.74(0.28-1.93);P=0.53]and major bleeding[0.81(0.42-1.56);P=0.53]between two strategies.Subgroup analyses showed that compared to medical therapy,PFOC reduced the risk of stroke in persons who were males,≤45 years of age and had large shunt or atrial septal aneurysm.CONCLUSION In certain groups of patients presenting with stroke,PFOC is beneficial in preventing future stroke compared to medical therapy.
文摘Recent trials and metanalysis even not fully conclusive and still debated,at least suggested that mechanical device-based closure of patent foramen ovale(PFO)is more effective than medical therapy in prevent recurrence of stroke. In a proportion ranging from 20% to nearly 40% of patients in literature,PFO is associated to atrial septal aneurysm(ASA):ASA is a well-known entity often associated with additional fenestration. Additionally small atrial septal defects("Flat ASD") can present with signs of paradoxical embolism and cannot be easily detected by transthoracic echocardiography or even by transesophageal echocardiography and are usually discovered by intracardiac echocardiography at the moment of transcatheter closure. This evidence might change potentially the anatomical diagnosis from PFO to fenestrated ASA or as we called it to "hybrid defect",being a bidirectional flow through a small ASD or/and an additional fenestration,often present. Despite the differences in anatomy,pathophysiology and haemodynamic paradoxical embolism may occur in both entities and also may be the first appearance of fenestrated ASA. Because some overlapping do really exist between PFO and hybrid defects,which are often not clearly differentiable by standard diagnostic tools,it is likely that a proportion of patients evaluated for potential transcatheter closure of PFO had actually a different anatomical substrate. These different anatomical and pathophysiologic entities have not been address in any of the previous trials,potentially having an impact on overall results despite the similar mechanical treatment. Neurologists and general cardiologists in charge of clinical management of PFOrelated cryptogenic stroke should be aware of the role of hybrid defects in the pathophysiology of paradoxical embolism- mediated cerebral ischemic events in order to apply the correct decision- making process and avoid downgrading of patients with paradoxical embolism-related interatrial shunt variants different from PFO.
文摘Objective Recently it has been suggested that, in patients with large patent foramen ovale （PFO） and atrial septal aneurysms （ASA）, a certain amount of left atrial （LA） dysfunction may be active as an alternate mechanism promoting arterial embolism. Following this hypothesis, elderly patients, being more susceptible to atrial chambers stiffness, should present a more severe LA dysfunction profile. We sought to evaluate the grade of LA dysfunction in elderly patients submitted to transcatheter PFO closure. Methods We retrospectively enrolled 28 consecutive patients with previous stroke （mean age 674-12.5 years, 18 females） referred to our centre for catheter-based PFO closure after recurrent stroke. Baseline values of LA passive and active emptying, LA conduit function, LA ejection fraction, and spontaneous echocontrast （SEC） in the LA and LA appendage were compared with those of 50 atrial fibrillation patients, as well as a sex/age/cardiac risk matched population of 70 healthy controls. Results Pre-closure elderly subjects demonstrated significantly greater reservoir function as well as passive and active emptying, with reduced conduit function and LA ejection fraction, when compared to healthy and younger patients. After closure in elderly patients, LAparameters did not return completely to the levels of healthy patients, whereas LA dysfunction in younger subjects returned normal. Conclusions This study suggests that elderly patients have more severe LA dysfunction than younger patients, which affects the LA remodelling after closure.
文摘An elderly gentleman presented to the emergency department with a recent history of dyspnoea, collapse and transient neurological symptoms. He was noted to be hypoxic with a significantly elevated D Dimer. A computer tomography pulmonary angiogram demonstrated a large embolus with a further filling defects within the left and the right atria, abutting the interatrial septum. Suspicion of a paradoxical pulmonary embolus was raised and the patient subsequently underwent echocardiography which confirmed a patent foramen ovale(PFO). He was commenced on warfarin therapy. In patients with elevated right heart pressure, a PFO can be unmasked and give rise to cerebral emboli. Clinical suspicion should be raised in patients with pulmonary emboli or deep venous thrombosis if there is a concomitant history of focal neurological symptoms.
基金The Application of Clinical Features of Capital City of Science and Technology Commission China Beijing Special SubjectNo.Z151100004015205。
文摘BACKGROUND Venous thromboembolism is a common vascular syndrome presenting as deep vein thrombosis and/or pulmonary embolism.Thrombus has the possibility of migrating into the left circulation via patent foramen ovale in certain extreme circumstances.Thrombus straddling a patent foramen ovale is a direct evidence of this scenario.However,the confirmed cases of thrombus in transit are still rare.CASE SUMMARY A 32-year-old man suffered from recurrent syncope and intermittent dyspnea for 1 wk.Transthoracic echocardiography confirmed a thrombus straddling the patent foramen ovale,and thrombi were also found in the bilateral pulmonary artery by computed tomography.The man underwent inferior vena cava filter placement and thrombolysis with alteplase.Echocardiography showed the absence of thrombi in both the right atrium and left atrium 2 d after hospitalization.The man was discharged to home on warfarin without any complications 2 wk later.CONCLUSION Scrutinizing intracardiac thrombi provides measurable value in pulmonary embolism as closure of patent foramen ovale may be considered in certain patients.Early intervention plays a critical role in thrombus straddling a patent foramen ovale.A sedentary lifestyle may predispose young adults to thromboembolism,even if there are no other risk factors.
文摘In this study, we investigated the changes in the right-to-left shunt (RLS) of the patent foramen ovale (PFO) at different phases of the Valsalva maneuver and analyzed the possible mechanisms. The study population consisted of 57 patients with symptoms highly suggestive of a PFO. These patients had been diagnosed with apsychia, migraine with aura, cerebral infarction, transient ischemic attack (TIA), and cerebral ischemia with unknown cause. Routine echocardiography was performed in all patients to rule out a cardiac malformation. Contrast-transcranial Doppler (c-TCD) and contrast-enhanced transthoracic echocardiography (c-TTE) were used to visualize and quantify the RLS. The standard apical four chamber view was used to observe the changes of E peak, A peak, and velocity-time integral (VTI) ratio of tricuspid blood flow during the strain phase and release phase of the Valsalva maneuver. Paired t-test was used to compare E peak, A peak, and VTI ratio of tricuspid blood flow during the different phases. The right-to-left shunt across the PFO (PFO-RLS) was graded in the two phases and compared by Kruskal-Wallis test. Compared with the strain phase of the Valsalva maneuver, the parameters of E, A, and VTI in diastolic period in patients with PFO-RLS at the release phase were significantly increased [54.30 ± 13.65 cm/s vs 100.35 ± 21.11 cm/s, 42.21 ± 12.32 cm/s vs 57.30 ± 18.88 cm/s, 10.34 ± 3.27 cm/s vs 19.58 ± 4.56 cm/s, respectively], and the difference was statistically significant. The positive consequence of PFO-RLS, as diagnosed by c-TTE with the Valsalva maneuver at the release phase of the Valsalva maneuver, was significantly higher than that at the strain phase of the Valsalva maneuver. At the beginning of release phase of the Valsalva maneuver, decreased intrathoracic pressure led to increased venous backflow into the right atrium. Thus, high-velocity blood flow rapidly pushed the PFO open, which resulted in a significant increase in the PFO-RLS. Therefore, the increase of the PFO-RLS during the Valsalva maneuver is caused by the impact of high-velocity blood flow the PFO.
文摘Patent foramen ovale (PFO) closure for systemic hypoxemia is controversial. The first systematic, albeit retrospective, study was recently presented which showed good procedural and clinical success for PFO closure for this indication. We present a case of acute right to left intra-cardiac shunt across PFO where the shunting is not persistent. Hence making a decision on PFO closure based on the aforementioned promising trial may not have been the right decision for the patient. This case highlights that the decision on PFO closure for such indication needs to be individualized. We also review the sparse literature on PFO closure for this indication and discuss how the decision making for such indication needs to be individualized.
文摘Patent foramen ovale(PFO) percutaneous closure has previously been an accepted intervention for the prevention of recurrent cryptogenic stroke on the basis of observational studies. However, randomized trials have been lacking until now. Three recently published randomized trials(CLOSURE I, PC and RESPECT) do not demonstrate the superiority of this intervention versus optimal medical therapy, therefore making this practice questionable. Nonetheless, these trials have had certain pitfalls, mainly a lower than initially estimated number of patients recruited, therefore lacking sufficient statistical power. On the other hand, different closure devices were used in the three trials. In two of them(PC and RESPECT), the Amplatzer PFO Occluder was used and the STARflex device was used in the other one(CLOSURE I). Taken altogether, a meta-analysis of these three trials does not demonstrate a statistically significant benefit of percutaneous PFO closure(1.9% vs 2.9%; P = 0.11). However, if we analyze only the PC and RESPECT trials together, in which the Amplatzer PFO Occluder was used, a statistically significant benefit of percutaneous PFO closure is observed(1.4% vs 3.0%, P = 0.04). In conclusion, our interpretation of these trials is that the use of a dedicated, specifically designed Amplatzer PFO device could possibly reducethe risk of stroke in patients with PFO and cryptogenic stroke. This consideration equally applies to patients who have no contraindications for anticoagulant or antithrombotic therapy.
文摘Patent foram ovale(PFO)is the most common anatomical cause of an interarterial shunt.It is usually asymptomatic but may cause paradoxical embolism and is a risk factor for non-lacunar cryptogenic cerebral ischemia in young adults.Although the first clinical trials did not show a significant superiority of PFO closure in the secondary prevention of cerebral ischemia as compared with standard antithrombotic treatment,six subsequent randomized clinical trials(CLOSURE I,PC Trial,RESPECT,CLOSE,REDUCE,and DEFENSE-PFO)performed in a sample of cryptogenic stroke in patients aged 60 years or younger provided evidence of a significant reduction of recurrent cerebral ischemia after percutaneous PFO closure.However,the use of percutaneous PFO closure cannot be generalized to the entire population of patients with cerebral ischemia and PFO,but it is indicated in highly selected patients with non-lacunar cryptogenic cerebral infarction with a large right-to-left shunt,an atrial septal aneurysm and no evidence of atrial fibrillation,as well as in association with antithrombotic treatment for an optimal secondary prevention of cerebral ischemia.
文摘1 Introduction Isolated atrial septal defects （ASD） represent 7% of all cardiac anomalies and can present at any age. Adolescents and adults with simple congenital heart disease such as isolated atrial septal defects are more likely to reach adult age without being diagnosed. Secundum ASD （sASD） is by far the most common type, occurring in 1/1500 live births, with 65% to 75% involving females, On the other hand, patent foramen ovale （PFO） represents an endemic variant in the normal population with a prevalence of 25%-27%. These two entities appear so different that is difficult to fred a conjunction ring： nevertheless we use the same philosophy for the treatment, Indeed, device-based closure has been proved to be effective in both settings.
文摘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.
