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.

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: diagnosis and updates in secondary stroke prevention

2018 ◽  
Vol 3 (2) ◽  
pp. 84-91 ◽  
Author(s):  
Kristy Yuan ◽  
Scott Eric Kasner
Keyword(s):  
Patient Selection ◽  
Stroke Prevention ◽  
Patent Foramen Ovale ◽  
Clinical Decision Making ◽  
Cryptogenic Stroke ◽  
Clinical Decision ◽  
Current Evidence ◽  
Secondary Stroke Prevention ◽  
Foramen Ovale ◽  
Pfo Closure

The patent foramen ovale (PFO), given its high prevalence in the general population and especially in patients with cryptogenic stroke, has long generated investigation and debate on its propensity for stroke by paradoxical embolism and its management for stroke prevention. The pendulum has swung for percutaneous PFO closure for secondary stroke prevention in cryptogenic stroke. Based on a review of current evidence, the benefit from PFO closure relies on careful patient selection: those under the age of 60 years with few to no vascular risk factors and embolic-appearing stroke deemed cryptogenic after thorough evaluation. As these data look towards influencing guideline statements and device approvals in the future, patient selection remains the crucial ingredient for clinical decision making and future trials.

A model of multi-disciplinary approach to the diagnosis and treatment of young patients with cryptogenic stroke and patent foramen ovale

2012 ◽  
Vol 22 (3) ◽  
pp. 327-334 ◽  
Author(s):  
Sara Mazzucco ◽  
Paolo Bovi ◽  
Monica Carletti ◽  
Giampaolo Tomelleri ◽  
Giorgio Golia ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Events ◽  
Scientific Evidence ◽  
Cryptogenic Stroke ◽  
Young Patients ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Therapeutic Decisions

AbstractBackgroundTreatment of patent foramen ovale in young patients with stroke is not supported by robust scientific evidence. In clinical practice, a pragmatic approach is needed to guide such therapeutic decisions. This study aims at standardising the diagnostic pathway for stroke patients younger than 55 years of age with a patent foramen ovale; elaborating a therapeutic algorithm; discussing every case in regular interdisciplinary counselling meeting; and setting up a follow-up schedule to assess clinical outcomes.MethodsThis is a cohort study on the effect of a standardised treatment of stroke patients with a patent foramen ovale. The primary endpoints include occurrence of recurrent ischaemic events, major bleeding, and device-related complications. The secondary endpoints include drug- or procedure-related side effects, persistence of right-to-left shunt, and persistent cardiac arrhythmia of new onset.ResultsA total of 103 patients have been enrolled. In all, 51 patients underwent percutaneous atrial septal repair; of these, one had minor post-procedural bleeding. At 12 months, 25% of this group of patients showed a latent I grade shunt, one patient a latent II degree shunt, and none had a persistent shunt. The remaining 52 patients were addressed to medical therapy; one of them experienced stroke recurrences while on medical therapy.ConclusionsThis model of implementation of available evidence to clinical practice via a group-based, multi-disciplinary counselling provides a shared and coherent decision pathway and yielded a very low rate of recurrent events and therapy-related complications. This approach could be replicated in specific protocols for other complex or neglected clinical problems.

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.

scholarly journals Safety and efficacy of endovascular patent foramen ovale closure: the first results of a Russian multicenter study

2020 ◽  
Vol 12 (6) ◽  
pp. 26-32
Author(s):  
D. V. Ognerubov ◽  
A. S. Tereshchenko ◽  
A. N. Samko ◽  
G. К. Arutyunyan ◽  
O. A. Sivakova ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Secondary Prevention ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Young Patients ◽  
Paradoxical Embolism ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
History Of ◽  
Pfo Closure

Patent foramen ovale (PFO) is detectable in more than 25% of the adult population and is generally clinically insignificant. However, it can be a cause of paradoxical embolism in some cases. Randomized trials indicate that endovascular PFO closure in patients with a history of cryptogenic stroke is an effective method for the secondary prevention of catastrophic brain damage.Objective: to study the safety and efficiency of endovascular PFO closure in young patients with a history of cryptogenic stroke.Patients and methods. Sixty-two patients, including (22 males and 40 females) women, underwent percutaneous PFO closure in May 2018 to March 2020. The patients' mean age was 37.4±7.6 years. The inclusion criteria were a prior cryptogenic ischemic stroke lasting less than 12 months and PFO with a high risk for paradoxical embolism (PFO concurrent with atrial septal aneurysm or hypermobility; PFO, ≥2 mm size; the presence of the Chiari network and/or the Eustachian valve).Results and discussion. The technical success of the operation was achieved in all cases. In 50 (80.6%) patients, the right chamber of the heart was completely isolated from the left one in the first 3 months. During the first year, the atria were also completely isolated in 10 (16.1%) patients. A left-to-right shunt persisted in 2 (3.2%) patents 12 months later. Two patients were found to have main procedural complications: one had perioperative atrial fibrillation and the other had pseudoaneurysm formation at the puncture site.Conclusion. Endovascular PFO closure is a safe and effective operation for the secondary prevention of recurrent ischemic stroke. In our study, blood shunting through the PFO was stopped in 96.6% of patients at less than 6 months after surgery, which suggests that there is a rapid and effective reduction in the risk of paradoxical embolism.

scholarly journals Recurrent Stroke Reduction with Patent Foramen Ovale Closure versus Medical Therapy Based on Patent Foramen Ovale Characteristics: A Meta-Analysis of Randomized Controlled Trials

Cardiology ◽  
2019 ◽  
Vol 144 (1-2) ◽  
pp. 40-49 ◽  
Author(s):  
Aakash Garg ◽  
Mohammed Thawabi ◽  
Amit Rout ◽  
Chris Sossou ◽  
Marc Cohen ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Recurrent Stroke ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Controlled Trials ◽  
Foramen Ovale ◽  
Randomized Controlled ◽  
Pfo Closure

Efficacy of patent foramen ovale (PFO) closure in patients with cryptogenic stroke remains a matter of debate. We performed a comprehensive meta-analysis of available randomized controlled trials (RCTs) to evaluate the efficacy and safety of PFO closure versus medical therapy (MT) based on PFO characteristics. Random-effects meta-analysis was conducted to estimate risk ratio (RR) with 95% confidence intervals (CI) for the primary end points of stroke. After systematic search, six RCTs (3,747 patients) with 1,889 patients randomized to PFO closure and 1,858 patients randomized to the MT group were included in the meta-analysis. Overall, PFO closure was associated with a significant reduction in recurrent stroke compared to MT [RR 0.41; 95% CI 0.20–0.83]. While there were no differences in mortality or major bleeding between the two groups, risk of newly diagnosed atrial fibrillation was higher in the PFO closure group compared to MT [RR 5.29; 95% CI 2.32–12.06]. Further, risk reduction in stroke with PFO closure was significant in patients with high-risk PFO characteristics [RR 0.37; 95% CI 0.16–0.87] but not in low-risk patients [RR 0.73; 95% CI 0.29–1.84]. In conclusion, among patients with cryptogenic stroke, PFO closure is associated with a significantly reduced risk of recurrent stroke compared to MT. Additionally, the benefit of PFO closure might be dependent on certain PFO characteristics.

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.

Patent foramen ovale closure for secondary stroke prevention

2019 ◽  
Vol 40 (28) ◽  
pp. 2339-2350 ◽  
Author(s):  
Mohamad Alkhouli ◽  
Horst Sievert ◽  
David R Holmes
Keyword(s):  
Stroke Prevention ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Cryptogenic Stroke ◽  
Current Data ◽  
Diagnostic Tools ◽  
Foramen Ovale ◽  
Future Landscape ◽  
Pfo Closure ◽  
Open Issues

Abstract Transcatheter closure of patent foramen ovale (PFO) in patients with cryptogenic stroke is gaining momentum after the recent publication of four randomized clinical trials suggesting its benefit. This article provides a contemporary overview of the anatomy and pathophysiology of PFO, the available diagnostic tools for the assessment and risk stratification of PFO, and the current and future landscape of PFO closure devices and their optimal utilization. It also summarizes the current data on PFO closure for stroke prevention, and discusses the remaining open issues in the field of PFO closure.

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