Closure of persistent foramen ovale with the BioSTAR biodegradable PFO closure device: Feasibility and long-term outcome

Background: The presence of a patent foramen ovale (PFO) is associated with higher rates of cryptogenic stroke. In patients with hypercoagulable states, the incidence of recurrent cerebral ischemic events may be greatly increased if a PFO is present. Percutaneous PFO closure is an alternative therapeutic approach for patients with both conditions who are not candidates for long-term anticoagulation, or have developed recurrent neurological events despite medical therapy. Methods: Between January 1995 to February 2007, 424 consecutive patients with PFO and cryptogenic stroke underwent percutaneous PFO closure. Of these, we identified 112 (26%) patients with a hypercoagulable disorder. We compared the safety and long-term outcome of percutaneous PFO closure in these two groups of patients. Results: Patients with thrombophilia were older (51.7±13 vs 48.3±14 years, p = 0.025), yet no different regarding baseline demographics or echocardiographic characteristics. Percutaneous PFO closure was successful in all the patients. There were no differences in the type of device used (Amplatzer: 53.6 vs 50%, Cardioseal 39.3 vs 41.7%, Sideris 7.1 vs 8.3%; p= 0.78). At median follow-up of 14.3 months (interquartile range: 6.1–31.4 months) there rate of stroke/TIA was similar for both groups (1.7 vs 1.6%, log rank test p = 0.35). At follow-up echocardiography, the rate of complete PFO closure was greater in the thrombophilic patients (97.3 vs 91.7%, p=0.04). Conclusions: Percutaneous PFO closure is safe and effective in preventing recurrent ischemic cerebral events in patients with thrombophilia.

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Long Term Outcome after Application of the Angio-Seal Vascular Closure Device in Minipigs

PLoS ONE ◽

10.1371/journal.pone.0163878 ◽

2016 ◽

Vol 11 (9) ◽

pp. e0163878 ◽

Cited By ~ 2

Author(s):

Lisa Kabelitz ◽

Andrea Nonn ◽

Kay W. Nolte ◽

Omid Nikoubashman ◽

Ahmed Othman ◽

...

Keyword(s):

Closure Device ◽

Vascular Closure Device ◽

Term Outcome ◽

Long Term Outcome

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

Thrombosis and Haemostasis ◽

10.1160/th14-12-1040 ◽

2015 ◽

Vol 114 (09) ◽

pp. 614-622 ◽

Cited By ~ 5

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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