Dr. Harsimran S. Singh

The relevance of patent foramen ovale as an antecedent to cryptogenic stroke, particularly in young, otherwise healthy, individuals has long been the subject of debate and continues to garner significant attention. According to Harsimran S. Singh, MD, Director of Adult Congenital Heart Disease and a specialist in interventional cardiology at NewYork-Presbyterian/Weill Cornell Medical Center, several retrospective and randomized control trials have investigated the association of PFOs with cryptogenic stroke and the efficacy of PFO closure in the prevention of recurrent stroke.

These studies culminated in October 2016 with the FDA approval of the first device dedicated to PFO closure — the AMPLATZER™ PFO Occluder — for patients with cryptogenic stroke predominantly between the ages of 18 and 60 years. The PFO occluder reduces the risk of stroke in patients who previously had a stroke believed to be caused by a blood clot that was able to reach the brain through a portal created by the patent foramen ovale. The device, studied in the multicenter RESPECT trial, compared outcomes after PFO closure to medical therapy in patients with cryptogenic stroke and evidence of a PFO.

Placement of AMPLATZER™ PFO Occluder
(Courtesy of Abbott)

“This trial provided evidence supporting the observational data and physiologic hypothesis that PFO closure can help prevent recurrent stroke in appropriately selected patients with an approved device specifically designed for this purpose,” notes Dr. Singh in an article recently published in Cardiology in Review. Upon approving the device, the FDA stressed the importance of collaborative decision making between neurologists and cardiologists before consideration of PFO closure.

In an editorial published in the December 26, 2017, issue of JAMA Neurology, stroke expert Hooman Kamel, MD, a neurologist with the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine, seconded the argument for consideration of PFO in certain stroke patients. “Clinicians can now make recommendations with much more certainty about the risks and benefits, and eligible patients have an additional proven treatment option for preventing stroke,” says Dr. Kamel, citing the research data that shows that PFO closure should be considered only in patients younger than 60 who have had an ischemic stroke that has no other apparent cause. He also cautions that PFO closure should not be offered to patients with other types of stroke that are not caused by PFO, or to those with transient ischemic attack.

Dr. Hooman Kamel

“It is also important to note that PFO should not automatically be considered the cause of an ischemic stroke,” adds Dr. Kamel. “Before agreeing to PFO closure, patients should ask whether their profile fits the profile of patients in the clinical trials. If it does not, there is no way to know whether PFO closure will lead to more benefit than harm.”

At NewYork-Presbyterian/Weill Cornell, the decision to close a PFO is made in consultation with a multidisciplinary team of neurologists and interventional cardiologists. “A good relationship between the two services is crucial,” says Dr. Singh, who performs the PFO closure procedure. “Presence of a PFO alone is not enough reason to close. We work together with our colleagues in neurology to evaluate every patient to determine if a closure procedure is warranted. I think patients appreciate the collaborative approach — they know they are getting our best advice.”

“Even when indicated, PFO closure does not provide lifelong protection against stroke because patients can develop other risk factors as they age. This is another crucial reason for multidisciplinary care,” says Dr. Kamel. “When a decision is made to perform PFO closure, our interventional cardiologists have the experience and skill to perform these procedures safely, and our stroke neurologists then provide expert follow-up care. Patients should receive lifelong monitoring and intensive management of common stroke risk factors.”