PFO Research Foundation Responds to Clinical Trial Data
Posted Mar 14 2012 9:32pm
“…patients are more than a P-value and in the case of PFO the quality of life can be very different between a patient who is tolerating medical therapy well and one who is not. ” -Bray Patrick-Lake | President and CEO of the PFO Research Foundation
For David Dansereau, an avid ice hockey player and marathoner, being on blood thinners for the rest of his life after his second cryptogenic stroke wasn’t a treatment he was willing to settle for so he chose to have his patent foramen ovale (PFO) closed with a device in 2007. PFO is commonly referred to as a “hole in the heart” condition, describing a tunnel-like remnant of fetal circulation between the atrial chambers of the heart. PFO may be found in 20-25% of the population and has been linked to conditions such as cryptogenic stroke (stroke of unknown origin), migraine, decompression illness and hypoxemia (low blood oxygen), although not everyone with a PFO will have complications with the condition.
For the unlucky patients like Dansereau, suffering a stroke can be a life altering experience with lifelong consequences. Standard medical therapy typically involves taking daily oral anti-coagulants that thin the patients’ blood to prevent clotting. Dansereau said he felt punched in the gut when he learned about the medical therapy for his condition. He noted that blood thinners carry a number of risks like hemorrhages, often require patients to get frequent blood tests, radically modify their diets, and abstain from beloved activities. The 44 year-old father of 3 with a busy physical therapy practice said he carefully considered the risks of being on blood thinners versus having a device placed in his heart and opted for the PFO closure procedure. He was home from the hospital 24 hours later and when he finished a brief course of blood thinning medications following the procedure he resumed his normal activities, ever grateful to rejoin his kids on the ice. The data being published from the CLOSURE 1 clinical trial may show no statistical difference between the effectiveness of the two therapies, but Dansereau said in his case one therapy clearly offered him a much higher quality of life when he considered all of the risks and benefits.
Dansereau is not alone in his experience. After suffering a stroke at the age of 42 and discovering she had a PFO, Peggy Mahrt was initially prescribed aspirin therapy. Two months later she suffered a transient ischemic attack (TIA), or loss of blood flow to the brain, and was switched to a stronger blood thinner before enrolling in the RESPECT Trial at UCLA, which was investigating the effect of PFO closure on recurrent cryptogenic stroke. Mahrt was randomized to the medical therapy arm of the trial, meaning she stayed on blood thinners instead of receiving device closure, so researchers could compare the number of strokes and TIA’s between the two groups. Yet what they studied seemed to leave a huge gap in knowledge of interest to patients who are making treatment decisions, said Mahrt. She is frustrated that the quality of life issues between the two therapies weren’t emphasized when she was being treated.
Mahrt remained on warfarin for over a year while in the study. During that time she says she had difficulty tolerating the drug. She had no energy, her hair fell out, her skin changed for the worse and black circles that she’d never before had appeared under her eyes. She experienced episodes of dizziness that caused her to fall and split her head open twice, and left her bleeding profusely in front of her children. Both incidents required trips to the ER and were upsetting to her family members. Her injuries also required multiple MRI and CT scans to make sure that no hemorrhages happened for the two weeks after her injuries. Mahrt says, “my life became limited and filled with fear of another injury. The daily diet restrictions of not eating too many greens, broccoli or cranberry juice and weekly blood draws became draining and depressing. This was not something I looked forward to doing for the rest of my life … I was only in my early 40’s! I did not have the freedom to do the things I used to do; water skiing, hiking, white water rafting/kayaking, and running, all in fear of that I would fall or hit my head. This was also extremely stressful on my children and husband. It was a daily source of concern and anxiety in our lives.”
Mahrt sought out PFO experts and held open discussions with her family. She came to the decision that this was not the way she wanted to live for the rest of her life and her family agreed. She then researched device closure, traditional open heart surgery and robotic closure for PFO. In September 2010, she chose to close her PFO with a device percutaneously in hopes of reclaiming her life. The effects were overwhelmingly positive and Mahrt says she has been amazed with the improvement in her life. She says she didn’t realize how limited her life had been due to PFO. She was unsure of device closure at first and the thought of having a device in her heart was overwhelming at times. But after being on warfarin and seeing her lifestyle change for the worse, she is grateful for the improved quality of life device closure offered her. To Mahrt the fact there is no statistical difference between the two therapies means researchers left the most important part of the equation out: the patient.
Bray Patrick-Lake serves as the President and CEO of the PFO Research Foundation, an organization founded by patients with PFO for patients with PFO with the goals of providing patients with unbiased scientific information and improving patient care. She has long been concerned with the issues raised by Mahrt and Dansereau. She co-authored a commentary with PFO expert, Dr. John Carroll of the University of Colorado Hospital, entitled “Design of patent foramen ovale trials: the importance of patient reported outcomes,” which appeared in the September 2011 issue of Clinical Investigation. Patrick-Lake does not doubt the data from CLOSURE 1. However, she emphasizes that patients are more than a P-value and in the case of PFO the quality of life can be very different between a patient who is tolerating medical therapy well and one who is not.
According to Patrick-Lake, the announcement of the CLOSURE 1 trial results at the American Heart Association meeting has affected the informed consent process and increased insurance denials for PFO patients seeking device closure. She said the foundation has seen a sizeable increase in correspondence from concerned patients who felt their doctors or insurers forced them into a treatment that is not right for them, as well as a rise in increased concern from young women in their childbearing years for whom some medical therapy may not be appropriate. “The knee jerk reaction to the CLOSURE 1 data can prove to be dangerous to patients like Peggy who aren’t doing well on blood thinners by denying them access to device closure through reimbursement restriction and failing to inform them of other treatment options,” said Patrick-Lake. She went on to say that in order for true shared decision making to take place patients must be able to evaluate the risks and benefits of each therapy in combination with their values and preferences through unbiased dialogue with their physicians, and to accurately do that quality of life measures have to be made available to patients. “Unfortunately the conversation about PFO has become one of cost containment for now rather than patient quality of life, which is ironic in light of what was spent mopping up Peggy’s blood thinner complications. For the patients who do well on medical therapy it is a non-issue and the foundation supports the standard medical therapy protocol, but we also believe patients like Peggy deserve to have options that give patients a decent quality of life,” said Patrick-Lake.