Neuro Advances

Testing the Efficacy of a
PFO Closure Device



•    Director's Letter
•    NOVA
•    Schwannoma Case
•    Chiari Malformations
•    Neuroscience at UCSB
•    Neurogenic Thoracic Outlet Syndrome
  PFO Closure Device

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Joseph Aragon, MD

At Santa Barbara Cottage Hospital, Santa Barbara Neuroscience Institute physicians recently participated in a multi-center clinical trial to investigate the connection between stroke and patent foramen ovale (PFO ).


The CLOSURE I trial evaluated the safety and efficacy of the STARFlex® Septal Closure System versus best medical therapy in patients with a stroke or transient ischemic attack (TIA)

due to presumed paradoxical embolism through a PFO. Results of the study, which involved 900 patients, are expected to be available this fall. Over the final two years of the study, Cottage was one of the top enrolling sites in the country, with medical personnel such as Phil Delio, MD , stroke neurologist and medical director of the stroke program at Cottage, and Zarith Alvarado, stroke nurse coordinator at Cottage, screening approximately 16 patients.


“We pride ourselves in pushing to explore the limits of the fields of stroke and neurology,” Dr. Delio says. “This research is important for determining how we manage and care for patients with complex stroke.”


Study Specifics


Participants in the study were between 18 and 60 years old, had a PFO and, during the six months prior to the study’s start, had experienced a stroke or TIA not due to another cardiac or vascular condition. Individuals were randomized to Coumadin® or aspirin or to closure with the STARFlex device. Follow-up occurred at intervals over two years, with participants in the medical therapy arm observed for recurrent stroke or TIA.


“A large percentage of patients who suffer cryptogenic stroke have a PFO,” says Joseph Aragon, MD , FACC, FS CAI, cardiologist and director of the structural heart disease program at Cottage and division director of the department of cardiology at the Sansum Clinic. “We lack concrete evidence that closing these PF Os reduces the risk of a second event in comparison to medical therapy.


If this trial clearly demonstrates that closing PFOs works better than medical


Parameters for PFO Screening


“PFO [patent foramen ovale] is usually found in people younger than 60 who have had a first stroke or TIA [transient ischemic attack], in those with unexplained recurrent neurological events or in a migraine patient with a diffuse white matter injury and an abnormal MRI [magnetic resonance imaging] test,” says Joseph Aragon, MD, FACC, FSCAI, cardiologist and director of the structural heart disease program at Santa Barbara Cottage Hospital and division director of the department of cardiology at the Sansum Clinic. “Those patients really should be screened for PFO.”


Testing should include a transesophageal echocardiogram (TEE) and Valsalva maneuver. A diagnosis, however, does not necessarily mean the PFO should be closed. In very young patients, especially those who have not had recurrent stroke, Dr. Aragon often does not recommend PFO closure, as this may prevent a patient from undergoing valve treatments involving the atrial septum if required in the future.



therapy, the closure procedure will become much more prevalent, especially among young patients who dislike the prospect of taking medication for an indefinite period.”


For more information about stroke care or research at Santa Barbara Neuroscience Institute, please e-mail