Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials

Rengifo‐Moreno, Pablo; Palacios, Igor F.; Junpaparp, Parichart; Witzke, Christian; Morris, D. Lynn; Romero‐Corral, Abel

doi:10.1093/eurheartj/eht285

Cited by 125 publications

(82 citation statements)

References 17 publications

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“…Addressing this, the multiple meta-analyses using published aggregate data have been conflicting ( Table 2). [78][79][80][81][82][83][84] Recently, a meta-analysis was performed using individual patient-level data that enabled standardization across all 3 studies, as well as more detailed statistical assessment. 85 The primary endpoint was the composite of stroke, TIA or death and the secondary endpoint was recurrent stroke.…”

Section: Discussionmentioning

confidence: 99%

Patent Foramen Ovale and Stroke

Sun

Homma

2016

Circ J

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Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp coalesce into a single orifice that becomes the foramen secundum. The septum secundum then forms via involution of the ventrocranial wall and overlaps with the foramen secundum. The septum secundum does not close fully and an oval-shaped opening remains, which becomes the foramen ovale. 17 Prior to birth, the fetus is dependent on the maternal circulation for oxygenation, as the immature fetal lungs do not yet participate in oxygen exchange. As such, the foramen ovale (as well as the ductus arteriosus), enables shunting of blood away from the pulmonary circulation. At birth, when the neonate's lungs begin to participate in oxygen exchange, there is a precipitous drop in the pulmonary vascular resistance and there is reversal of flow through both the foramen ovale and ductus arteriosus. 18 In approximately 75% of individuals, the foramen ovale closes within a few years while in the remaining others, it stays open permanently as a PFO. EpidemiologyThe prevalence of PFO in the healthy adult population ranges from 15% to 25% on echocardiography and 15-35% on autopsy studies. 1,2,19,20 Observational and autopsy studies have showed that the prevalence of detected PFOs is lower in older patients and that detected PFOs in older individuals tend to be larger. 1,19,20 Those studies, however, may be confounded by selection and detection bias because none of the longitudinal studies have demonstrated that individual PFOs change in size. The prevalence of PFOs is equal among men and women, though there may be race-ethnic differences. 1,19,21 he foramen ovale is an important fetal structure that closes after birth in most individuals and remains open as a patent foramen ovale (PFO) in approximately 25% of the healthy population. 1-3 In these individuals, bypass of the pulmonary circulation via shunting from the right-sided venous circulation to the left-sided arterial circulation is possible. Although most patients with PFOs are completely asymptomatic, reports from the late 1800 s by Cohnheim and Litten described cases of patients who were found to have the triad of deep venous thrombosis (DVT), PFO and systemic embolization. They hypothesized that the PFO enabled bypass of a venous thrombosis to the systemic arterial circulation, a process now termed paradoxical embolization. 4,5 Since those initial observations, additional studies have demonstrated a strong association between the presence of PFO and cryptogenic stroke in young patients. 6-11 In addition to its association with stroke, PFO has also been implicated in platypneaorthodeoxia, 12 decompression illness, 13 myocardial infarction, 14 obstructive sleep apnea, 15 and migraine headaches. 16 This review will focus on the relationship between PFO and stroke, discussing the embryology, epidemiology, association, mechanisms, diagnostic methods, associated anatomic factors and management strategies. EmbryologyThe right and left atria begin as a single chamber and separation b...

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Section: Discussionmentioning

confidence: 99%

Patent Foramen Ovale and Stroke

Sun

Homma

2016

Circ J

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“…Closure devices have changed over time, and different attitudes across centers might theoretically have had an impact on the results as well. 12 This is an unavoidable feature of a multicenter, long-term, longitudinal study with a stringent age cutoff for patient inclusion like ours, whose potential implications are noteworthy. However, although we were unable to perform separate subgroup analyses for each device category because of the low number of patients, we did not detect outcome differences according to the type of device used.…”

Section: Discussionmentioning

confidence: 78%

“…11 The effectiveness of percutaneous closure of PFO was also greater in patients with a substantial shunt size according to a further stratified analysis. 12 These findings implicate that, perhaps, subgroups of patients can be identified in whom device closure is safe and superior to medical therapy and that additional patient data are needed to better define optimal treatment in individual cases. To further investigate these issues, we tested the effectiveness of percutaneous PFO closure compared with medical treatment in the setting of the IPSYS registry (Italian Project on Stroke in Young Adults).…”

Section: What the Study Addsmentioning

confidence: 97%

Propensity Score–Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients With Cryptogenic Stroke and Patent Foramen Ovale

Pezzini

Grassi

Lodigiani

et al. 2016

Circ: Cardiovascular Interventions

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Background— We sought to compare the benefit of percutaneous closure to that of medical therapy alone for the secondary prevention of embolism in patients with patent foramen ovale (PFO) and otherwise unexplained ischemic stroke, in a propensity scored study. Methods and Results— Between 2000 and 2012, we selected consecutive first-ever ischemic stroke patients aged 18 to 45 years with PFO and no other cause of brain ischemia, as part of the IPSYS registry (Italian Project on Stroke in Young Adults), who underwent either percutaneous PFO closure or medical therapy for comparative analysis. Primary end point was a composite of ischemic stroke, transient ischemic attack, or peripheral embolism. Secondary end point was brain ischemia. Five hundred and twenty-one patients qualified for the analysis. The primary end point occurred in 15 patients treated with percutaneous PFO closure (7.3%) versus 33 patients medically treated (10.5%; hazard ratio, 0.72; 95% confidence interval, 0.39–1.32; P =0.285). The rates of the secondary end point brain ischemia were also similar in the 2 treatment groups (6.3% in the PFO closure group versus 10.2% in the medically treated group; hazard ratio, 0.64; 95% confidence interval, 0.33–1.21; P =0.168). Closure provided a benefit in patients aged 18 to 36 years (hazard ratio, 0.19; 95% confidence interval, 0.04–0.81; P =0.026) and in those with a substantial right-to-left shunt size (hazard ratio, 0.19; 95% confidence interval, 0.05–0.68; P =0.011). Conclusions— PFO closure seems as effective as medical therapy for secondary prevention of cryptogenic ischemic stroke. Whether device treatment might be more effective in selected cases, such as in patients younger than 37 years and in those with a substantial right-to-left shunt size, deserves further investigation.

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“…Data from observational studies conducted before 2012 strongly favour percutaneous PFO closure [9]. However, the results of three randomised control studies (RCT) do not confirm the superiority of invasive procedures compared to medical treatment, including antiplatelets or oral anticoagulants [3][4][5], and numerous meta-analyses of RCTs are also inconclusive [10][11][12].…”

Section: Discussionmentioning

confidence: 99%

Efficiency of transcatheter patent foramen ovale closure in children after paradoxical embolism events

et al. 2016

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A b s t r a c tBackground and aim: Patent foramen ovale (PFO) may result in a cerebrovascular event -a presumed paradoxical embolism (PE). However, the presence of this phenomenon among paediatric patients was rarely evaluated. Transcatheter PFO closure was considered to be a method of treatment in such patients. Methods:For evaluation clinical data and long-term outcome, we reviewed records of patients below 18 years of age, with history of cerebrovascular event related to PE, who underwent procedure of percutaneous PFO closure in years 1999-2014 in our department.Results: Among 230 patients with cerebrovascular events who had PFO closed percutaneously, seven children (aged 12--16 years, five male) were selected. Indications for closure were cryptogenic stroke in two patients and transient ischaemic attack (TIA) in five patients. Diagnosis of PFO was established by transthoracic echocardiography, with right-to-left shunt (RLS) through PFO confirmed by transoesophageal echocardiography. Contrast transcranial Doppler (c-TCD) was performed preprocedurally in four patients, revealing significant RLS. For percutaneous closure of PFO different occluders (Starflex, Amplatzer PFO devices, Cardio-O-Fix) were used. Closure was successfully completed in all patients and no procedure-related complications were observed. Postprocedural c-TCD six months after closure revealed no significant RLS. During follow-up (3 to 10 years) one patient had an episode of recurrent TIA; however, in this patient paroxysmal atrial fibrillation was found during the follow-up period. Conclusions:Cerebral embolism due to PFO is uncommon in children. Transcatheter PFO closure in this group of patients is a safe and effective procedure. C-TCD is plausible technique for detection RLS and monitoring PFO closure efficacy in this group of patients.

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Patent foramen ovale transcatheter closure vs. medical therapy on recurrent vascular events: a systematic review and meta-analysis of randomized controlled trials

Abstract: These results suggest that in patients with cryptogenic stroke, TC PFO closure may be beneficial in reducing the risk of recurrent vascular events when compared to medical treatment. The benefit of TC PFO closure may be greater in patients with a substantial shunt.

Cited by 125 publications

References 17 publications

Patent Foramen Ovale and Stroke

Patent Foramen Ovale and Stroke

Propensity Score–Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients With Cryptogenic Stroke and Patent Foramen Ovale

Efficiency of transcatheter patent foramen ovale closure in children after paradoxical embolism events

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