A registry of patients from the Asia-Pacific region with PFO and ischemic stroke, designed to study the characteristics, investigations, treatment and outcomes using real-world data.
Subject has experienced acute ischemic stroke or transient ischemic attack
Subject is screened with presence of PFO (right-to-left shunt) on appropriate cardiac imaging (transthoracic echocardiography and/or transesophageal echocardiography) or transcranial Doppler bubble study
Age ≥18 years
Stroke mimics, haemorrhagic stroke or cerebral venous thrombosis
Subjects with less than 3 months of follow up
Patients with ischemic stroke or TIA and PFO identified would be screened for inclusion into the PACIFIC-PFO registry. Consecutive patients should be identified for inclusion by the local research team in each participating centers. Reason for exclusion after screening should be clearly stated and documented on a Screening and Enrollment Log, in order to minimize bias.
Cohort
Other
PFO closure using approved PFO closure devices, Surgical PFO closure
Procedure/SurgeryPFO closure using approved PFO closure devices, Surgical PFO closure
Medical management
DrugAntiplatelet therapy * ASA, also called acetylsalicylic acid (Aspirin, Asaphen, Entrophen, Novasen) * clopidogrel (Plavix) * ticagrelor (Brilinta) * dipyridamole (Persantine) * cilostazol Anticoagulation therapy * apixaban (Eliquis) * dabigatran (Pradaxa) * edoxaban (Lixiana) * rivaroxaban (Xarelto) * warfarin (Coumadin)
Recurrent ischemic stroke or transient ischemic attack event within 1 year
Ischemic stroke is defined as: Acute focal neurological dysfunction caused by focal infarction at single or multiple sites of the brain or retina. Evidence of acute infarction may come either from A) Symptom duration lasting more than 24 hours B) Neuroimaging or other technique in the clinically relevant area of the brain TIA is defined as: A transient episode of focal neurological dysfunction caused by focal brain or retinal ischemia without acute infarction in the clinically relevant area of the brain or retina. Symptoms should resolve completely within 24 hours.
Modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.
Short term and long term neurological and cardiovascular outcomes
1. Recurrent stroke or TIA 2. Systemic embolism 3. Acute myocardial infarction 4. Cardiovascular mortality 5. All-cause mortality 6. Major and minor bleeding defined according to the ISTH criteria 7. Intracranial hemorrhage
To validate PFO risk stratification scores in an Asia-Pacific cohort - RoPE score
PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding. ROPE score The RoPE score ranges from 0 to 10, with scores of 0 to 3 indicating a negligible likelihood that the stroke is attributable to the PFO and a score of 10 indicating an approximately 90% probability that the stroke is attributable to the PFO.
To validate PFO risk stratification scores in an Asia-Pacific cohort - PASCAL score
PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding. PASCAL score PASCAL combines the RoPE score with the presence or absence of high-risk PFO features to determine the likelihood that the PFO was causally related to the index stroke
To validate PFO risk stratification scores in an Asia-Pacific cohort - Spencer Grading
PFO risk stratification scores are widely used to determine the likelihood that PFO discovered in the setting of an otherwise-cryptogenic stroke was pathogenically related to the stroke rather than an incidental finding. Spencer algorithm grading scale with transcranial Doppler bubble study methodology
To evaluate the impact of access to PFO closure and availability of heart-brain teams on patient outcomes
The outcomes of the patients will be compared between centres with PFO closures services and heart-brain teams with those without. Patients treated by a heart-brain multi-disciplinary team were compared to those who were not.
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