Questions definition of 'routine'Patent foramen ovale (PFO) closure is not recommended as a routine therapy for patients with cryptogenic ischemic stroke, according to the American Academy of Neurology (AAN).
A systemic review of the literature for the Academy's stroke care guideline update published in Neurology turned up no stroke prevention benefit with the STARFlex PFO occluder compared with medical therapy alone (risk difference [RD] 0.13%, 95% CI -2.2% to 2.0%).
With the Amplatzer, however, there was a decreased risk of recurrent stroke (RD -1.68%, 95% CI -3.18% to -0.19%) at the cost of more new-onset atrial fibrillation (RD 1.64%, 95% CI 0.07% to 3.2%) and a procedural complication risk of 3.4% (95% CI 2.3% to 5%).
Thus, "in rare circumstances, such as recurrent strokes despite adequate medical therapy with no other mechanism identified, clinicians may offer the Amplatzer PFO Occluder if it is available (Level C)," the guideline development subcommittee of the AAN wrote.
Yet "this practice advisory is out of date," warned John Carroll, MD, of University of Colorado Hospital in Aurora, because the AAN did not have access to the latest 5-year data from the RESPECT trial. "The composition of the AAN group did not include one interventional cardiologist," he added. "In 2016 it is odd to have a proclamation about the value of a procedure without anyone on the group ever having performed the procedure."
The new numbers from RESPECT were taken into account during an FDA advisory meeting in May 2016 wherein the majority of panelists voted that the evidence tilted towards safety and efficacy with the Amplatzer compared to medical therapy alone. "Clinicians and patients should have the option of PFO closure with an approved device," said Carroll, who was not involved with the guidelines.
Even David E. Thaler, MD, PhD, of Boston's Tufts Medical Center -- and member of the dissemination committee for the AAN guideline -- seemed to agree. "I think the recommendations are cautious and already a little dated," Thaler told MedPage Today.
When asked if the guideline updates regarding routine PFO closure were appropriate, Thaler said it "depends on the definition of 'routine.'"
"If 'routine' is what currently happens in some practices – i.e., an episode of dizziness, interpreted by primary care provider as transient ischemic attack, not seen by neurology, echo shows PFO, referred to cardiology for closure – then yes, indeed, I agree with the recommendation."
"However, if 'routine' is as it should be – i.e., a stroke patient, evaluated by a vascular neurologist with 'complete investigations' (which is a changing landscape), a high RoPE score, a well-educated patient with regard to the current state of PFO science, realistic expectations of treatments, adherence to long-term secondary stroke prevention measures even after possible closure – then no, I think the recommendation is too cautious and dismissive of the totality of the evidence that shows that closure is probably better and no evidence to indicate that it's worse than medical management," he said.
Thaler's allusion to the uncertainty around PFO was echoed by Patrick D. Lyden, MD, of Cedars-Sinai Medical Center in Los Angeles.
"I have found a tendency for clinicians to stop looking for stroke causes once they find a PFO. It's important to complete a full evaluation on every patient, and not jump too quickly to conclude the PFO is the cause of the stroke," he told MedPage Today.
"Here is how I explain it to patients: we have two studies in favor and two studies against PFO closure. Let's wait for the 'tie breaker' study to finish before we decide to close your PFO," Lyden said. So let the patient bear all the risk? It is not the doctors brain that is in danger, so what the hell.