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Consensus statement endorses multidisciplinary teams for PFO closure
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The Society for Cardiovascular Angiography and Interventions announced it has developed an expert consensus statement on best practices for closure of patent foramen ovale to prevent recurrent stroke, including use of multidisciplinary teams.
The statement, affirmed by the American Academy of Neurology (AAN), includes recommendations on optimal institutional infrastructure and essential individual skills necessary to maintain a PFO closure program.
As Cardiology Today’s Intervention previously reported, three randomized trials published in 2017 showed PFO closure plus antiplatelet therapy bettered antiplatelet therapy alone in patients with PFO and cryptogenic stroke. The FDA has granted indications to two devices for PFO closure to prevent recurrent stroke; the practice used to be off-label.
“Completion of the randomized trials demonstrating the superiority of PFO closure and medical therapy over medical therapy alone for appropriately selected patients with cryptogenic stroke and a PFO was a landmark achievement that has resolved decades of uncertainty,” Eric Horlick, MD, FSCAI, assistant professor of medicine at the University of Toronto, interventional cardiologist at the Peter Munk Cardiac Centre and chair of the paper’s writing group, said in a press release. “The appropriate use of PFO closure has the potential to change the natural history of a potentially devastating disease process. SCAI and AAN representatives collaborated to help cardiologists and neurologists provide the highest standard of care.”
Skill requirements
Technical skill sets an operator must have include ability to use various imaging modalities; to manipulate cardiac catheters, wires and sheaths; to manage vascular access; to use all forms of endovascular retrieval devices; and to recognize and treat complications, according to the document.
The panel wrote that institutional requirements should include at least 100 structural/congenital catheter interventions in the 2 years before program initiation and at least 50 in each year after initiation, including at least 12 involving PFO closure; continuous availability of qualified echocardiography personnel; a multidisciplinary team with necessary staff and experience to evaluate patients, perform the procedures and follow the patients after the procedure; ready access to a cardiothoracic surgery program; and access to a cath lab.
Multidisciplinary teams
The committee noted that multidisciplinary teams have been successfully used in structural heart disciplines such as transcatheter aortic valve replacement and left atrial appendage closure, and suggested that “an analogous concept be extended to programs engaged in PFO closure for prevention of recurrent ischemic stroke and that it be embedded in centers which have stroke and structural/congenital heart disease programs.”
The team should include a stroke neurologist, a structural and/or adult congenital interventional cardiologist, a hematologist, noninvasive imaging physicians, an anesthesiologist, a cardiac surgeon and auxiliary personnel, the authors wrote.
The document also makes recommendations regarding training and quality assessment.
“SCAI can now confidently offer evidence-based recommendations for the treatment of these patients, who are seeking answers to guide their therapeutic decision-making after a potentially catastrophic event,” Horlick said in the release. “I am very proud of the work produced by our dedicated and highly experienced SCAI writing group, including representatives from the AAN. The resulting document is pragmatic and aims to inform and assist clinicians and institutions in maintaining an evidence-based, patient-centered approach to the care of this patient population with a focus on quality and safety.” – by Erik Swain
Disclosure: Horlick reports he is a consultant for, has conducted clinical trials for and has received fellowship support from Abbott, Edwards Lifesciences and Medtronic; and has received an unrestricted educational grant from Abbott.
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