PFO Closure Still Attracts Controversy

Didactic session explores current indications, reimbursement issues related to the procedure

The frequency of patent foramen ovale (PFO) closure procedures has decreased in the past several years, but there is still a need for specific patients, according to a presentation at TCT 2015.

Mark Reisman, MD, of the University of Washington Medical Center/Regional Heart Center, Seattle, Wash., said his institution used to perform PFO closure in up to 100 patients annually. “Over the last 2 years, as someone who gets a few referrals, I’ve closed two PFOs,” he said. “I don’t even, quite frankly, at this point consider PFO closure as part of my clinical practice.”

“My store is still open,” Reisman continued, but the “dramatic change… has been remarkable to watch.”

The justifiable circumstances to close a PFO are “provocative and very complicated,” he said. “We really need resolution for both patients and you very dedicated physicians who have had many birthdays and anniversaries over the course of this story.”

Although the indications for PFO closure have lessened, identifying and closing these structures has become even more important, Reisman said, “I want to go on the record to say that I believe that there is a PFO stroke and a PFO headache. There are times that closing a PFO is the better approach.”

Awaiting RESPECT

The “big three” studies on PFO closure – CLOSURE I, RESPECT and PC – have helped in defining patients who are most likely to benefit from the procedure, he said. However, each of these trials was limited by loss to follow-up and an intent-to-treat approach, Reisman explained, adding that “all of a sudden A-fib and shunt size [are also important].”

Long-term results of the RESPECT trial are being presented in the Late-Breaking Clinical Trial session today. “I just want to know if there’s something we can do for these patients,” he said.

Reimbursement concerns

When an informal poll was taken of attendees, almost all raised their hands to say they had previously been unable to perform PFO closure due to insurance reimbursement issues.

Panelist Nina C. Wunderlich, MD, of Cardiovascular Center Darmstadt, Germany, said reimbursement is “usually not a problem” for her. Specifically, she said, her institution follows neurologist-guided standards that stroke/TIA patients should receive PFO closure after a second event, “but you’re still getting paid if a patient [only has] one event.”

Panelist Patrick A. Calvert, BMBCh, MA, PhD, of Queen Elizabeth Hospital, Birmingham, England, said that in the United Kingdom PFO closures were not funded for a period of 18 months, but that reimbursement started again about 6 months ago as long as the indication for the procedure followed that outlined by the RESPECT study.

Beyond reimbursement, physicians need to be more attuned to patient anxiety, according to an audience member. “From the patient perspective, they are terrified and will do whatever they’re led to do,” he said, adding that he had seen patients who were practicing neurosurgeons and neurologists who had never considered PFO closure as an option.

In response to an audience member who asked the panelelists what they would do if they personally had a PFO and a hard embolic event, all said they would undergo closure, with the exception of John D. Carroll, MD, of the University of Colorado Denver, Aurora, Colo., who is presenting the long-term RESPECT data. “My answer is embargoed until tomorrow,” he said.

Disclosures:

• Calvert reports receiving consultant/honoraria fees from AstraZeneca, serving as a proctor for St. Jude Medical and receiving travel and accommodations from Biosensors International and St. Jude Medical.
• Carroll reports receiving grant/research support and consultant fees/honoraria/speakers fees from Philips Healthcare and St. Jude Medical and holding intellectual property rights in Philips Healthcare.
• Reisman and Wunderlich report no relevant conflicts of interest.