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
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
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
A patent foramen ovale is one of the predisposing factors of neurotic decompression sickness.Transcatheter closure of a patent foramen ovale is effective in the secondary prevention of decompression sickness associate...A patent foramen ovale is one of the predisposing factors of neurotic decompression sickness.Transcatheter closure of a patent foramen ovale is effective in the secondary prevention of decompression sickness associated with intracardiac shunt.The size of the umbrella should not be limited to the diagnosis of a patent foramen ovale or an atrial septal defect but should be determined by the supporting force of the soft margin of the atrial septum.The surgical method of patent foramen ovale closure is the same as that of the closure of an atrial septal defect,but the closure umbrella of a patent foramen ovale is different from that of the closure umbrella of an atrial septal defect.The size of the umbrella of the right atrium is larger than that of the left atrium,and it is better to close the atrial septum.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
Background Patent foramen ovale (PFO)-related stroke is a possible and not easily manageable occurrence in ≤60-years-old patients due to the presence of different comorbidities and in particular of diastolic dysfunct...Background Patent foramen ovale (PFO)-related stroke is a possible and not easily manageable occurrence in ≤60-years-old patients due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure.The grade of diastolic dysfunction for which PFO closure is contraindicated and whether there are changes in diastolic dysfunction class after closure have not been investigated in deep yet.Methods We prospectively enrolled patients who were referred to our centre over a 12 months period for PFO transcatheter closure having echocardiographic demonstration of diastolic dysfunction (≤Ⅲ class diastolic dysfunction).Echocardiography was scheduled at 1,6 and 12 months in order to assess changes in haemodynamic parameters of left ventricle function.Results Thirteen out of 80 patients referred to our centre (16.2%,mean age 65 + 6.4 years) over a 24-month period were enrolled in the study (Table 1).Eighteen Amplatzer PFO Occluder 25 mm and one 35 mm,two Amplatzer 25/25 mm Cribriform Occluder and two 25 nun Premere Occlusion System were successfully implanted with no intraoperative complications.As collateral findings on ICE 8/12 patients (66.7 %) had hypertrophy of the interatrial septum (thickness of the rims ＞ 1.2 mm) probably imputable to hypertensive cardiomyopathy.Four patients developed atrial fibrillation during the first month post-implantation,all successfully treated with antiarrhythmic drugs.After a mean follow-up of 40±4.3 months left ventricle performance indices (ejection fraction and end-diastolic volume) and diastolic dysfunction parameters (E/A,deceleration time,diastolic dysfunction class) did not change significantly.Conclusion The present study suggests that PFO transcatheter closure may be safely performed in aged patients with diastolic dysfunction class 1-2.(J Geriatr Cardio12008;5:3-6.)展开更多
Background:Transcatheter closure of patent foramen ovale(PFO)has been widely accepted as a highly effective way to treat high-risk PFO-related diseases.However,traditional non-degradable occluders made of metal alloys...Background:Transcatheter closure of patent foramen ovale(PFO)has been widely accepted as a highly effective way to treat high-risk PFO-related diseases.However,traditional non-degradable occluders made of metal alloys will permanently exist in the body,resulting in thrombosis,valve damage,hemolysis,arrhythmia,or other complications.The biodegradable PFO occluder developed by Shanghai Mallow Medical Instrument Co.,Ltd.,China can be fully absorbed and degrade into nontoxic ingredients,reducing postoperative complications.Objectives:To study the safety and efficacy of biodegradable PFO occluders in treating PFO.Methods:This single-center clinical trial collected 30 patients treated with a biodegradable PFO occluder.The follow-up period lasted 12 months to analyze the echocardiographic characteristics and headache relief through HIT-6 scores.Results:The immediate success rate was 100%,with no intraoperative severe occlusion-related complications.The contrast transcranial Doppler(cTCD)at 12 months showed that all patients’right-to-left shunts(RLS)were grade I or 0 with no serious postoperative complications,indicating the overall success rate was 100%.The biodegradable PFO occluder mostly degraded six months after the occlusion.Conclusion:PFO closure with a Mallow biodegradable occluder is safe and effective and has no severe complications.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
The increase in life expectance makes the diagnosis of PFO a possible and not easily manageable event in patients > 60-years-old due to the presence of different comorbidities and in particular of diastolic dysfunc...The increase in life expectance makes the diagnosis of PFO a possible and not easily manageable event in patients > 60-years-old due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure. The literature review suggests that aged patients with PFO cannot be excluded"a priori"from PFO closure that should evaluated as therapeutic options in presence of anatomical and functional indications. Moreover in the elderly many other syndromes than paradoxical stroke mediated by PFO required full assessment and, if needed, transcather PFO closure:deoxygenating in obstructive sleeping apnoea, unexplained increased dyspnoea associated with hypoxemia after lung surgery, paralysis of the hemidiaphragm, and platypnea orthodeoxia. Differently from in the young and middle age, the management of PFO in aged patients should obligatory include the careful evaluation of potential comorbidities and eventual contraindications, such as severe diastolic dysfunction due to for example to hypertensive cardiomyopathy and coronary heart disease, the main causes of diastolic dysfunction.(J Geriatr Cardiol 2007;4:254-256.)展开更多
Platypnea orthodeoxia syndrome is associated with dyspnea and arterial oxygen desamration accentuated by an upright posture. It can be secondary to an intracardiac shunt. We report a case of platypnea-orthodeoxia synd...Platypnea orthodeoxia syndrome is associated with dyspnea and arterial oxygen desamration accentuated by an upright posture. It can be secondary to an intracardiac shunt. We report a case of platypnea-orthodeoxia syndrome （POS） in a 58-year old male patient who had a pre-existing patent foramen ovale （PFO） and substantial pulmonary pathologies. He was successfully treated by percutaneous transcatheter closure of the PFO. Our case highlights the importance of recognition of this rare syndrome in patients who present with unexplained hy- poxia for whom transcatheter closure of the interatrial shunt can be safely carded out.展开更多
Background:Randomized controlled trials(RCTs)that directly compare the efficacy and safety of percutaneous patent foramen ovale(PFO)closure devices have not been conducted.Thus,we performed a network meta-analysis to ...Background:Randomized controlled trials(RCTs)that directly compare the efficacy and safety of percutaneous patent foramen ovale(PFO)closure devices have not been conducted.Thus,we performed a network meta-analysis to identify the efficacy and safety of occluder devices.Methods:From 1 st January,2000 to 1 st May,2018,we searched Embase,PubM ed,and Cochrane Library for RCTs about percutaneous closure devices(such as STARFlex,GORE,and Amplatzer)and medical therapy for cryptogenic cerebral ischemic patients with PFO.The occurrence rate of recurrent stroke,atrial fibrillation(AF),major vascular complication(MVC),headache,transient ischemic attack,and bleeding were compared with the frequentist and Bayesian methods using R statistics.Results:We included 3747 patients from six RCTs.The GORE and Amplatzer occluders were found to be significantly associated with a decreased risk of recurrent stroke[relative risk(RR):0.37 and 0.49;95%confidence interval(CI):0.17–0.81,0.29–0.83,respectively].Moreover,STARFlex was correlated to an increased risk of postoperative AF and MVCs(RR:11.66 and 7.63;95%CI:4.87–21.91,2.34–24.88).Conclusions:Among the three devices,the GORE and Amplatzer occluders are found to be the most effective in preventing secondary stroke in patients with PFO.Meanwhile,STARFlex is the least recommended device because it cannot decrease the risk of recurrent stroke and is the most likely to cause adverse events.展开更多
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.
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A patent foramen ovale is one of the predisposing factors of neurotic decompression sickness.Transcatheter closure of a patent foramen ovale is effective in the secondary prevention of decompression sickness associated with intracardiac shunt.The size of the umbrella should not be limited to the diagnosis of a patent foramen ovale or an atrial septal defect but should be determined by the supporting force of the soft margin of the atrial septum.The surgical method of patent foramen ovale closure is the same as that of the closure of an atrial septal defect,but the closure umbrella of a patent foramen ovale is different from that of the closure umbrella of an atrial septal defect.The size of the umbrella of the right atrium is larger than that of the left atrium,and it is better to close the atrial septum.
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Background Patent foramen ovale (PFO)-related stroke is a possible and not easily manageable occurrence in ≤60-years-old patients due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure.The grade of diastolic dysfunction for which PFO closure is contraindicated and whether there are changes in diastolic dysfunction class after closure have not been investigated in deep yet.Methods We prospectively enrolled patients who were referred to our centre over a 12 months period for PFO transcatheter closure having echocardiographic demonstration of diastolic dysfunction (≤Ⅲ class diastolic dysfunction).Echocardiography was scheduled at 1,6 and 12 months in order to assess changes in haemodynamic parameters of left ventricle function.Results Thirteen out of 80 patients referred to our centre (16.2%,mean age 65 + 6.4 years) over a 24-month period were enrolled in the study (Table 1).Eighteen Amplatzer PFO Occluder 25 mm and one 35 mm,two Amplatzer 25/25 mm Cribriform Occluder and two 25 nun Premere Occlusion System were successfully implanted with no intraoperative complications.As collateral findings on ICE 8/12 patients (66.7 %) had hypertrophy of the interatrial septum (thickness of the rims ＞ 1.2 mm) probably imputable to hypertensive cardiomyopathy.Four patients developed atrial fibrillation during the first month post-implantation,all successfully treated with antiarrhythmic drugs.After a mean follow-up of 40±4.3 months left ventricle performance indices (ejection fraction and end-diastolic volume) and diastolic dysfunction parameters (E/A,deceleration time,diastolic dysfunction class) did not change significantly.Conclusion The present study suggests that PFO transcatheter closure may be safely performed in aged patients with diastolic dysfunction class 1-2.(J Geriatr Cardio12008;5:3-6.)
基金supported by the Health and Family Planning Commission of Wuhan Municipality,Grant WX21Z26.
文摘Background:Transcatheter closure of patent foramen ovale(PFO)has been widely accepted as a highly effective way to treat high-risk PFO-related diseases.However,traditional non-degradable occluders made of metal alloys will permanently exist in the body,resulting in thrombosis,valve damage,hemolysis,arrhythmia,or other complications.The biodegradable PFO occluder developed by Shanghai Mallow Medical Instrument Co.,Ltd.,China can be fully absorbed and degrade into nontoxic ingredients,reducing postoperative complications.Objectives:To study the safety and efficacy of biodegradable PFO occluders in treating PFO.Methods:This single-center clinical trial collected 30 patients treated with a biodegradable PFO occluder.The follow-up period lasted 12 months to analyze the echocardiographic characteristics and headache relief through HIT-6 scores.Results:The immediate success rate was 100%,with no intraoperative severe occlusion-related complications.The contrast transcranial Doppler(cTCD)at 12 months showed that all patients’right-to-left shunts(RLS)were grade I or 0 with no serious postoperative complications,indicating the overall success rate was 100%.The biodegradable PFO occluder mostly degraded six months after the occlusion.Conclusion:PFO closure with a Mallow biodegradable occluder is safe and effective and has no severe complications.
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The increase in life expectance makes the diagnosis of PFO a possible and not easily manageable event in patients > 60-years-old due to the presence of different comorbidities and in particular of diastolic dysfunction which is considered as a contraindication to PFO closure. The literature review suggests that aged patients with PFO cannot be excluded"a priori"from PFO closure that should evaluated as therapeutic options in presence of anatomical and functional indications. Moreover in the elderly many other syndromes than paradoxical stroke mediated by PFO required full assessment and, if needed, transcather PFO closure:deoxygenating in obstructive sleeping apnoea, unexplained increased dyspnoea associated with hypoxemia after lung surgery, paralysis of the hemidiaphragm, and platypnea orthodeoxia. Differently from in the young and middle age, the management of PFO in aged patients should obligatory include the careful evaluation of potential comorbidities and eventual contraindications, such as severe diastolic dysfunction due to for example to hypertensive cardiomyopathy and coronary heart disease, the main causes of diastolic dysfunction.(J Geriatr Cardiol 2007;4:254-256.)
文摘Platypnea orthodeoxia syndrome is associated with dyspnea and arterial oxygen desamration accentuated by an upright posture. It can be secondary to an intracardiac shunt. We report a case of platypnea-orthodeoxia syndrome （POS） in a 58-year old male patient who had a pre-existing patent foramen ovale （PFO） and substantial pulmonary pathologies. He was successfully treated by percutaneous transcatheter closure of the PFO. Our case highlights the importance of recognition of this rare syndrome in patients who present with unexplained hy- poxia for whom transcatheter closure of the interatrial shunt can be safely carded out.
基金supported by grants from the National Natural Science Foundation of China(No.81471201,No.81873750).
文摘Background:Randomized controlled trials(RCTs)that directly compare the efficacy and safety of percutaneous patent foramen ovale(PFO)closure devices have not been conducted.Thus,we performed a network meta-analysis to identify the efficacy and safety of occluder devices.Methods:From 1 st January,2000 to 1 st May,2018,we searched Embase,PubM ed,and Cochrane Library for RCTs about percutaneous closure devices(such as STARFlex,GORE,and Amplatzer)and medical therapy for cryptogenic cerebral ischemic patients with PFO.The occurrence rate of recurrent stroke,atrial fibrillation(AF),major vascular complication(MVC),headache,transient ischemic attack,and bleeding were compared with the frequentist and Bayesian methods using R statistics.Results:We included 3747 patients from six RCTs.The GORE and Amplatzer occluders were found to be significantly associated with a decreased risk of recurrent stroke[relative risk(RR):0.37 and 0.49;95%confidence interval(CI):0.17–0.81,0.29–0.83,respectively].Moreover,STARFlex was correlated to an increased risk of postoperative AF and MVCs(RR:11.66 and 7.63;95%CI:4.87–21.91,2.34–24.88).Conclusions:Among the three devices,the GORE and Amplatzer occluders are found to be the most effective in preventing secondary stroke in patients with PFO.Meanwhile,STARFlex is the least recommended device because it cannot decrease the risk of recurrent stroke and is the most likely to cause adverse events.
