On horse sense and horse feathers: An argument against insistence on enrolling cryptogenic stroke patients with patent foramen ovale in randomized clinical trials

2006 ◽  
Vol 69 (1) ◽  
pp. 1-3 ◽  
Author(s):  
Paul Kramer
Keyword(s):  
Clinical Trials ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Stroke Patients

scholarly journals Update on the Management of Patent Foramen Ovale in 2017: Indication for Closure and Literature Review

2017 ◽  
Vol 11 (2) ◽  
pp. 75 ◽  
Author(s):  
Kimberly Atianzar ◽  
Peter Casterella ◽  
Ming Zhang ◽  
Rahul Sharma ◽  
Sameer Gafoor ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Decompression Sickness ◽  
Cryptogenic Stroke ◽  
Closure Device ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Consensus Statements ◽  
Pfo Closure

Patent foramen ovale (PFO) is a common congenital abnormality with a high prevalence of approximately 25 % in the general population and an even higher incidence of about 40 % in the cryptogenic stroke population. PFO closure in cryptogenic stroke patients as a treatment modality for the secondary prevention of recurrent stroke has been much debated and studied. Several completed randomized clinical trials sought to answer the question of whether PFO closure is beneficial for cryptogenic stroke patients. Until the most recent of these trials, no significant benefit had been demonstrated. Based on newer evidence, in October 2016 the US Food and Drug Administration approved the first dedicated closure device for PFO. This review article describes the association between PFO and cryptogenic stroke, reviews current diagnostic modalities of PFO assessment, discusses management approaches, and reviews randomized clinical trials, practice guidelines, and consensus statements. Associations between PFO and other conditions such as migraine headaches, platypnea-orthodeoxia syndrome, and decompression sickness in divers are also briefly reviewed.

scholarly journals Patent Foramen Ovale Closure for Secondary Prevention of Cryptogenic Stroke: Updated Meta-Analysis of Randomized Clinical Trials

2018 ◽  
Vol 131 (5) ◽  
pp. 575-577 ◽  
Author(s):  
Muthiah Vaduganathan ◽  
Arman Qamar ◽  
Ankur Gupta ◽  
Navkaranbir Bajaj ◽  
Harsh B. Golwala ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Secondary Prevention ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Foramen Ovale

scholarly journals Patent foramen ovale closure versus medical therapy after cryptogenic stroke: An updated meta-analysis of all randomized clinical trials

2019 ◽  
Vol 26 (1) ◽  
pp. 47-55 ◽  
Author(s):  
Babikir Kheiri ◽  
Ahmed Abdalla ◽  
Mohammed Osman ◽  
Sahar Ahmed ◽  
Mustafa Hassan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Medical Therapy ◽  
Patent Foramen Ovale ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Cryptogenic Stroke ◽  
Foramen Ovale

scholarly journals Impact on actual clinical practice of the latest evidence for percutaneous closure of patent foramen ovale associated with stroke. A single center experience

2021 ◽  
Vol 22 (Supplement_1) ◽  
Author(s):  
L Carnero Montoro ◽  
M Ruiz Ortiz ◽  
N Paredes Hurtado ◽  
M Delgado Ortega ◽  
A Rodriguez Almodovar ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Percutaneous Closure ◽  
Publication Date ◽  
Foramen Ovale ◽  
Complex Anatomy ◽  
The Mean ◽  
The Impact

Abstract Funding Acknowledgements Type of funding sources: None. Background and aims Since september 14th, 2017. Three large clinical trials demonstrated that, in selected patients, percutaneous closure of patent foramen ovale (PFO) was associated with lower recurrence in patients with cryptogenic stroke (CS). Our aim was to determine the impact of these findings on routine  clinical practice in a tertiary hospital. Methods Patients with percutaneous closure of PFO due to CS (January 2001-January 2020) were included. The clinical characteristics were analyzed individually and grouped in the RoPE score, before and after the publication date. Complex anatomy (CA) defined as interatrial septum aneurysm or basal wide bubble passage was evaluated in both periods. Results 293 patients were included. The mean age was 49 ± 11 years, 15% were older than 60 years, 60% men, 26% hypertensive, 28% smokers and 7%diabetics. The median RoPEscore was 6 [p25-75, 5-7] and 75% met CA criteria. Since september 14th, 2017, the frequency of CA and the mean age of the patients were significantly higher (89% vs. 69% p <0.0005 and 51 ± 11 vs. 48 ± 11 years, p = 0.02, respectively), and RoPEscore, significantly lower (5 [5-7] vs. 6 [5-7], p = 0.02). Conclusion The publication of clinical trials wich demonstrated the benefit of percutaneous closure of PFO in CS had a significant impact on the daily clinical practice of our institution, with an increase in indications for CA, despite a clinical profile suggestive of lower causal probability of PFO.

Differential Lesion Patterns on T2WI and FLAIR Sequences in Cryptogenic Stroke Patients With Patent Foramen Ovale

2015 ◽  
Vol 20 (5) ◽  
pp. 75-79 ◽  
Author(s):  
Yang-Yang Huang ◽  
Bei Shao ◽  
Xian-Da Ni ◽  
Jian-Ce Li ◽  
Xiao-Ting Niu ◽  
...  
Keyword(s):  
Patent Foramen Ovale ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Stroke Patients

Abstract 2922: Patent Foramen Ovale Is A Cause Of Ischemic Stroke In Patients With Antiphospholipid Syndrome

Stroke ◽  
2012 ◽  
Vol 43 (suppl_1) ◽  
Author(s):  
Yoshiaki Shimada
Keyword(s):  
Ischemic Stroke ◽  
Antiphospholipid Syndrome ◽  
Patent Foramen Ovale ◽  
Multiple Logistic Regression Analysis ◽  
Cryptogenic Stroke ◽  
Control Group ◽  
Atrial Septal Aneurysm ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Significant Difference

Background: The antiphospholipid syndrome (APS) is a systemic autoimmune disorder characterized by a combination of arterial and/or venous thrombosis and recurrent fetal loss, and can be an independent risk factor for a first-ever ischemic stroke especially in young female patients. Patent foramen ovale (PFO) has been established as a cause of cryptogenic stroke. Atrial septal aneurysm (ASA) is associated with PFO. Until recently, the precise pathophysiology of APS as causing ischemic stroke has been essentially unknown. In the present study, we investigated the relationship between APS and potential embolic sources including PFO and ASA using transesophageal echocardiography (TEE). Methods: This study was a retrospective case series design. From July 2006 to June 2008, 120 patients with ischemic stroke who admitted to Juntendo University Hospital underwent TEE. In this study period, consecutive ischemic stoke patients diagnosed as APS based on the modified Sapporo criteria were enrolled and classified into APS group. Controls were selected among age- and gender-matched stroke patients without APS who also underwent TEE. We assessed clinical characteristics and presence of embolic sources including PFO and atrial septal aneurysm (ASA) between APS and Control groups. Results: Nine of ischemic stroke patients with APS and 41 controls were included. Primary APS was present in one patient (11.1%) of the APS group, and APS with SLE were found in eight patients (88.9%). There is no significant difference in age, risk factors for ischemic stroke, and MRI findings between two groups. The prevalence of PFO and ASA were significantly higher in APS group compared to Control group (89% vs 41%, P=0.027; 67% vs 20%, P=0.015, respectively). C reactive protein was relatively higher in APS group. Multiple logistic regression analysis showed that PFO (OR: 13.71; 95% CI: 1.01 to 185.62; P=0.049) and ASA (OR: 8.06; 95% CI: 1.17 to 55.59; P=0.034) were independently associated with the APS group. Conclusion: Atrial septal abnormalities including PFO and ASA are strongly associated with APS group, and could be potential embolic sources in ischemic stroke patients with APS.

D-dimer for prediction of long-term outcome in cryptogenic stroke patients with patent foramen ovale

2015 ◽  
Vol 114 (09) ◽  
pp. 614-622 ◽  
Author(s):  
Young Dae Kim ◽  
Dongbeom Song ◽  
Hyo Suk Nam ◽  
Kijeong Lee ◽  
Joonsang Yoo ◽  
...  
Keyword(s):  
Ischaemic Stroke ◽  
Patent Foramen Ovale ◽  
Pulmonary Thromboembolism ◽  
Cryptogenic Stroke ◽  
Foramen Ovale ◽  
Stroke Patients ◽  
Term Outcome ◽  
Long Term Outcome ◽  
D Dimer

SummaryPatent foramen ovale (PFO) is a potential cause of cryptogenic stroke, given the possibility of paradoxical embolism from venous to systemic circulation. D-dimer level is used to screen venous thrombosis. We investigated the risk of embolism and mortality according to the presence of PFO and D-dimer levels in cryptogenic stroke patients. A total of 570 first-ever cryptogenic stroke patients who underwent transesophageal echocardiography were included in this study. D-dimer was assessed using latex agglutination assay during admission. The association of long-term outcomes with the presence of PFO and D-dimer levels was investigated. PFO was detected in 241 patients (42.3 %). During a mean 34.0 ± 22.8 months of follow-up, all-cause death occurred in 58 (10.2 %) patients, ischaemic stroke in 33 (5.8 %), and pulmonary thromboembolism in 6 (1.1 %). Multivariate Cox regression analysis showed that a D-dimer level of > 1,000 ng/ml was an independent predictor for recurrent ischaemic stroke in patients with PFO (hazard ratio 5.341, 95 % confidence interval 1.648–17.309, p=0.005), but not in those without PFO. However, in patients without PFO, a D-dimer level of > 1,000 ng/ml was independently related with all-cause mortality. The risk of pulmonary thromboembolism tended to be high in patients with high D-dimer levels, regardless of PFO. Elevated D-dimer levels in cryptogenic stroke were predictive of the long-term outcome, which differed according to the presence of PFO. The coexistence of PFO and a high D-dimer level increased the risk of recurrent ischaemic stroke. The D-dimer test in cryptogenic stroke patients may be useful for predicting outcomes and deciding treatment strategy.

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