scholarly journals Patent foramen ovale closure, antiplatelet therapy or anticoagulation in patients with patent foramen ovale and cryptogenic stroke: a systematic review and network meta-analysis incorporating complementary external evidence

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e023761 ◽  
Author(s):  
Hassan Mir ◽  
Reed Alexander C Siemieniuk ◽  
Long Cruz Ge ◽  
Farid Foroutan ◽  
Michael Fralick ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Persistent Atrial Fibrillation ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
External Evidence ◽  
Pfo Closure

ObjectiveTo examine the relative impact of three management options in patients aged <60 years with cryptogenic stroke and a patent foramen ovale (PFO): PFO closure plus antiplatelet therapy, antiplatelet therapy alone and anticoagulation alone.DesignSystematic review and network meta-analysis (NMA) supported by complementary external evidence.Data sourcesMedline, EMBASE and Cochrane CENTRAL.Study selectionRandomised controlled trials (RCTs) addressing PFO closure and/or medical therapies in patients with PFO and cryptogenic stroke.Review methodsWe conducted an NMA complemented with external evidence and rated certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system.ResultsTen RCTs in eight studies proved eligible (n=4416). Seven RCTs (n=3913) addressed PFO closure versus medical therapy. Of these, three (n=1257) addressed PFO closure versus antiplatelet therapy, three (n=2303) addressed PFO closure versus mixed antiplatelet and anticoagulation therapies and one (n=353) addressed PFO closure versus anticoagulation. The remaining three RCTs (n=503) addressed anticoagulant versus antiplatelet therapy. PFO closure versus antiplatelet therapy probably results in substantial reduction in ischaemic stroke recurrence (risk difference per 1000 patients over 5 years (RD): −87, 95% credible interval (CrI) −100 to −33; moderate certainty). Compared with anticoagulation, PFO closure may confer little or no difference in ischaemic stroke recurrence (low certainty) but probably has a lower risk of major bleeding (RD −20, 95% CrI −27 to −2, moderate certainty). Relative to either medical therapy, PFO closure probably increases the risk of persistent atrial fibrillation (RD 18, 95% CI +5 to +56, moderate certainty) and device-related adverse events (RD +36, 95% CI +23 to +50, high certainty). Anticoagulation, compared with antiplatelet therapy, may reduce the risk of ischaemic stroke recurrence (RD −71, 95% CrI −100 to +17, low certainty), but probably increases the risk of major bleeding (RD +12, 95% CrI −5 to +65, moderate certainty).ConclusionsIn patients aged <60 years, PFO closure probably confers an important reduction in ischaemic stroke recurrence compared with antiplatelet therapy alone but may make no difference compared with anticoagulation. PFO closure incurs a risk of persistent atrial fibrillation and device-related adverse events. Compared with alternatives, anticoagulation probably increases major bleeding.PROSPERO registration numberCRD42017081567.

Closure of patent foramen ovale in “cryptogenic” stroke: Has the story come to an end?

2018 ◽  
Vol 13 (3) ◽  
pp. 240-242 ◽  
Author(s):  
Jean-Louis Mas ◽  
Gilles Chatellier
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
Permanent Disability ◽  
Increased Risk ◽  
Procedural Complications

Contrasting with three randomized trials that failed to show any superiority of patent foramen ovale closure over antithrombotic therapy, two trials recently reported lower rates of stroke recurrence among patients assigned to patent foramen ovale closure than among those assigned to antiplatelet therapy. In addition, one of the initially negative trials concluded in favor of patent foramen ovale closure after an extended follow-up period. A better selection of patients, the use of reference treatment groups that included patients who received antiplatelet therapy alone (rather than antiplatelet drugs or oral anticoagulants, according to physician preference), and a longer follow-up of patients, may explain the divergent findings across studies. Procedural complications were reported in 1.5% to 5.9% of the patients, none of which led to permanent disability or death. Patent foramen ovale closure was associated with an increased risk of new-onset atrial fibrillation in several studies and of venous thromboembolism in one study.

PP122 A Quick Cost-Effectiveness Analysis Of Patent Foramen Ovale Closure In Korean Patients With Cryptogenic Stroke

2018 ◽  
Vol 34 (S1) ◽  
pp. 112-113
Author(s):  
Jeonghoon Ahn ◽  
Eung Ju Kim ◽  
Kyungmi Oh ◽  
Justin Seung-Ho Yoo ◽  
Maria Koullick
Keyword(s):  
Cost Effectiveness ◽  
Prospective Study ◽  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Oral Anticoagulants ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Effectiveness Analysis ◽  
The Cost ◽  
Pfo Closure

Introduction:Patent foramen ovale (PFO) is an open hole between the right and left upper chambers of the heart. It may increase the risk of stroke, so closure of the hole is considered a secondary prevention in patients who have experienced cryptogenic stroke. Recent evidence has been published on the effectiveness of PFO closure, including a publicly funded prospective study on the effectiveness of PFO closure for preventing recurrent stroke or transient ischemic attack in selected Korean patients who have experienced cryptogenic stroke. The objective of this study was to examine the cost-effectiveness of PFO closure using this recent evidence.Methods:Available clinical data from the aforementioned Korean prospective study and other recent multicenter trials funded by public bodies were used. The cost data were obtained from the current Korean National Health Insurance fee schedule. Utility data were extracted from local research on stroke patients. A cost-effectiveness analysis, based on a 20-year Markov model, was conducted using these data to compare PFO closure plus antiplatelet therapy with oral anticoagulants alone.Results:The initial analysis showed that PFO plus antiplatelet therapy costs KRW 7.13 million (USD 6,547) more than oral anticoagulants alone but has a higher utility of 1.3 quality-adjusted life-years (QALYs) per patient, which corresponds to an incremental cost-effectiveness ratio (ICER) of KRW 5.6 million (USD 5,142) per QALY. The implicit Korean ICER threshold is KRW 25 million (USD 22,955) for non-cancer drugs, so it seems that PFO plus antiplatelet therapy is cost effective in the Korean setting.Conclusions:Since this study used some transition probabilities from foreign sources, the results may not be completely transferable to the Korean setting. However, this is the best available evidence so far in Korea for the economic evaluation of the PFO closure procedure. Therefore, use of PFO closure in carefully selected patients with a history of cryptogenic stroke may benefit the public payer in Korea.

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

2018 ◽  
Vol 45 (5-6) ◽  
pp. 193-203 ◽  
Author(s):  
Simona Lattanzi ◽  
Francesco Brigo ◽  
Claudia Cagnetti ◽  
Mario Di Napoli ◽  
Mauro Silvestrini
Keyword(s):  
Transient Ischemic Attack ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Bleeding Complications ◽  
Stroke Recurrence ◽  
Foramen Ovale ◽  
History Of ◽  
Ischemic Attack ◽  
Pfo Closure ◽  
New Onset

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

Hole in My Heart

2016 ◽  
Author(s):  
Ji Y. Chong ◽  
Michael P. Lerario
Keyword(s):  
Antiplatelet Therapy ◽  
Medical Therapy ◽  
Stroke Prevention ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Young Patients ◽  
Foramen Ovale ◽  
Pfo Closure

The presence of a patent foramen ovale (PFO) is associated with cryptogenic stroke, especially in young patients. Medical therapy for patients with stroke and PFO includes antiplatelet therapy or anticoagulation. PFO closure is not routinely recommended for stroke prevention.

scholarly journals Cryptogenic Stroke: A Challenge in Diagnosis and Management

2021 ◽  
Vol 42 (3) ◽  
Author(s):  
Sidhi Laksono Purwowiyoto ◽  
Budhi Setianto ◽  
Gea Panindhita ◽  
Reynaldo Halomoan ◽  
I Nyoman Wiryawan
Keyword(s):  
Risk Factors ◽  
Ischemic Stroke ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Clinical Settings ◽  
Cardiac Structure ◽  
Foramen Ovale ◽  
Advanced Knowledge ◽  
Pfo Closure

Ischemic stroke is responsible for 85% of all stroke globally. However, the etiology of around a quarter of ischemic stroke are undetermined, this is called cryptogenic stroke. This kind of stroke affects younger population. Several mechanism are associated with the incidence of cryptogenic stroke such as paroxysmal atrial fibrillation, patent foramen ovale, atherosclerosis, and atrial cardiopathy. Despite many advanced knowledge on stroke generally, cryptogenic stroke is still a challenge in clinical settings. To understand more about cryptogenic stroke, a new term of embolic strokes of undetermined source (ESUS) is proposed and may need a specific workup. Specific workup aims to detect any silent risk factors and also to evaluate the cardiac structure. The term of ESUS also leads to the understanding that cryptogenic stroke is highly related to embolic mechanism and anticoagulation administration might benefit the patients. However, the result of several recent studies showed that anticoagulant was not superior to antiplatelet, and antiplatelet is still the preferred treatment. Studies on PFO closure also shows different result, but the majority of the trials showed benefit of PFO closure in reducing the risk of stroke recurrence.

scholarly journals Device closure for patent foramen ovale in patients with cryptogenic stroke: which patients should get it?

2020 ◽  
Vol 22 (Supplement_M) ◽  
pp. M43-M50
Author(s):  
Iris Parrini ◽  
Enrico Cecchi ◽  
Davide Forno ◽  
Alexander R Lyon ◽  
Riccardo Asteggiano
Keyword(s):  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Cardiac Complications ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Device Closure ◽  
Meta Analyses ◽  
Pfo Closure

Abstract Patent foramen ovale (PFO) and cryptogenic stroke (CS) both have a high prevalence. The optimal treatment to reduce stroke recurrence after CS remains controversial. Results from clinical trials, meta-analyses, and position papers, support percutaneous PFO device closure and medical therapy compared to medical therapy alone. However, the procedure may be associated with cardiac complications including an increased incidence of new atrial fibrillation. The benefit/risk balance should be determined on a case-by-case basis with the greatest benefit of PFO closure in patients with atrial septal aneurysm and PFO with large shunts. Future studies should address unsolved questions such as the choice of medical therapy in patients not undergoing closure, the duration of antiplatelet therapy, and the role of PFO closure in patients over 60 years old.

Patent foramen ovale

2020 ◽  
Vol 20 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Vafa Alakbarzade ◽  
Tracey Keteepe-Arachi ◽  
Nazia Karsan ◽  
Robin Ray ◽  
Anthony C Pereira
Keyword(s):  
Antiplatelet Therapy ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Paradoxical Embolism ◽  
Current Evidence ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Peripheral Ischaemia ◽  
New Evidence ◽  
Pfo Closure

Patent foramen ovale (PFO) is the most common anatomical cause of an interatrial shunt. It is usually asymptomatic but may cause paradoxical embolism, manifesting as stroke, myocardial infarction or visceral/peripheral ischaemia. PFO is a risk factor for stroke and may be associated with migraine with aura. New evidence suggests PFO closure reduces the risk of recurrent ischaemic stroke in a highly selected population of stroke survivors: those aged 60 years or younger with a cryptogenic stroke syndrome, a large right-to-left shunt, an atrial septal aneurysm and no evidence of atrial fibrillation. They benefit from percutaneous PFO closure in addition to antiplatelet therapy, rather than antiplatelet therapy alone. Current evidence does not support PFO closure in the treatment of migraine.

Abstract P702: How Many Cryptogenic Stroke Patients Should Be Candidates for Patent Foramen Ovale Closure?

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Hidetaka Mitsumura ◽  
Tomomichi Kitagawa ◽  
Maki Tanabe ◽  
Takeo Sato ◽  
Hiroki Takatsu ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Stroke Recurrence ◽  
Atrial Septal Aneurysm ◽  
Large Artery ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Ischemic Lesion ◽  
Pfo Closure

Background and Purpose: Recent several studies demonstrated that percutaneous patent foramen ovale (PFO) closure reduced the risk of stroke recurrence for patients with cryptogenic stroke (CS) and PFO. Our aim of this retrospective study is to survey the frequency of CS, which can be an indication of PFO closure. Methods: Subjects were consecutive stroke patients with symptomatic ischemic lesion detected by magnetic resonance imaging. Of them, CS were extracted according to exclusion of small-vessel collusion, large-artery atherosclerosis, cardioembolism, definite case of aortogenic embolism, and distinctive causeof ischemic stroke such as arterial dissection, hypercoagulable state and so on. After that, we selected patients in accordance with clinical guideline of PFO closure recommended by the Japanese Stroke Association (Figure). We analyzed the prevalence of CS with right-to-left shunt (RLS) as a good and recommended candidates for PFO closure. Results: Among 1,374 ischemic stroke patients from October 2012 to September 2019 , CS were 240 patients (83 females, mean age of 66 years, 17% of subjects). Of them, 100 patients (42%) had RLS (PFO; 65, atrial septal defect; 1, pulmonary arteriovenous fistula; 1, positive on transcranial Doppler (not performed in TEE) including 21 cases of definite of paradoxical embolism. In 65 patients of CS with PFO, 30 patients younger than 60 years (13% of CS) were good candidates for PFO closure. Moreover, 22 of 1,374 (1.6%) patients who were recommended candidates had one or more high risk factors of PFO, for example large shunt, atrial septal aneurysm, and the presence of shunt at rest (Figure). Conclusions: In our preliminary survey, 2% of acute ischemic stroke should be PFO closure candidates.

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