Follow-up: PFO and Migraines
For those having PFO in combination with migraine, the treatment decision making process is complex and patients should remember there is no cure for migraine. The current research on PFO and migraine addresses their relationship in terms of the threshold theory, where vasoactive chemicals and micro-emboli thought to pass through the PFO might tip the balance, so to speak, and act as triggers that make patients more susceptible to migraine. No large-scale studies researching the effect of PFO closure on migraine burden have reached their conclusion so this treatment is still considered to be investigational. Smaller observational studies of different subpopulations (types) of PFO-migraine patients have so far been unable to produce a statistically significant answer as to which migraine patients benefit – chronic or episodic; although it is generally believed that migraine patients with aura benefit more than those without. Anecdotal reports from patients in online patient communities vary. While some patients report cessation of migraine upon PFO closure, others report increased or new migraine with aura, which is possibly due to tiny clots forming on the device before the body grows tissue over it and then entering circulation on the left side of the heart.
There are many considerations when navigating the treatment decision making process and it is recommended that patients consult both their migraine specialist and a cardiologist experienced in treating PFO. Getting unbiased opinions is key. Firstly, the thought process is a delicate balance of risk, benefit and quality of life. PFO’s may be closed through open heart surgery or by placing a device in the heart through a small catheter that is threaded through the femoral vein by making a small incision in the patient’s groin. The risks of open heart surgery include bleeding, infection, scarring and complications from being on a heart-lung machine during the surgery. The recovery time and time away from work are longer than that of transcatheter PFO closure, but the defects are closed with sutures so patients will not have the long-term concerns of having a device implanted in their hearts.
Many patients consider open heart surgery to be extreme and instead seek transcatheter device closure of the PFO. It is important to remember that device closure is a low-risk procedure, but there is no such thing as a no-risk procedure; thus migraineurs doing well with medical therapy are not encouraged to close their PFO’s simply as a preventive measure. The conversation changes, however, when patients have not found a medication or therapy that controls their migraine after working earnestly with a migraine specialist, they find their quality of life is poor due to treatment side effects (therapeutic burden), or the PFO is the last unmitigated potential trigger for their migraine. Vascular complications, infection or abnormal heart rhythms occur in a small percentage of cases when a device is placed into the heart so these risks must be carefully weighed against migraine treatment side effects and the burden of living with uncontrolled migraine. Additionally, patients receive anti-coagulant medications during the procedure and anti-platelet medications for a period of time afterward that carry their own risks and side effects. Nickel allergy is also a consideration and there have been anecdotal reports in online communities made by patients with chronic inflammatory diseases who posted about flares in inflammation following the PFO closure procedure. Lastly, although the procedure is typically done with conscious sedation on an outpatient basis that could have patients leaving the hospital as little as four-hours later, patients should understand there is a very small chance of having open heart surgery or an additional procedure should something go wrong with the placement of the device.
In addition, once a device is placed in the heart and tissue begins to grow over it the only way to remove it is through open heart surgery, and long-term evidence on device performance is lacking. In 2012, the FDA reviewed an approved device commonly used to close PFO’s off-label after learning of erosion of nearby heart structures that was catastrophic in at least two cases and reported as late as eight years after implantation in at least one case. After a thorough review of existing data, the device was still deemed to be safe overall, but migraineurs should consider all potential risks when deciding whether PFO closure is right for them.
Secondly, there are insurance reimbursement issues regarding device closure of PFO since it is still considered investigational. No PFO closure devices are approved in the U.S. at this time. This means the current devices are atrial septal defect (ASD) closure devices being used “off-label.” Because of this, a patient and his or her medical team might decide it is best for the patient to close the PFO and then discover the insurance company will not pay for the procedure. It is becoming increasingly rare that insurers agree to cover PFO closure with no questions asked. Current insurance practices tend to cover transcatheter PFO closure for patients who have experienced two cryptogenic strokes since research is still ongoing. In some cases, patients have been successful in obtaining reimbursement after one cryptogenic stroke. In general, migraine patients and their care teams should be prepared to provide a high level of documentation about why the procedure is medically necessary with the tenacity to see the request for coverage through the appeals process.
Clinical trials remain a potential option for PFO closure. There is still one ongoing clinical trial researching PFO and migraine in the U.S. and Canada, the PREMIUM trial by St. Jude Medical, which might allow patients access to PFO occluders while covering the costs of associated medical care if they meet inclusion criteria and are willing to complete the related study requirements. The trial was reportedly close to meeting its enrollment goals in late 2012, but appeared to still be actively enrolling as late as June 2013. Patients can learn more at www.clinicaltrials.gov.
Since the majority of transcatheter cardiac devices are tested and reach the market in Europe many years before being available in the U.S., an alternative pathway for PFO closure exists. Some desperate patients give up fighting with insurance companies or national health care systems and participate in medical tourism, thus having their PFO’s closed in Switzerland or Germany by highly skilled interventional cardiologists for approximately 25 – 33% of what the “cash price” would be in the U.S. If a patient decides to pursue this option then a high level of research is needed regarding the reputation of facilities and physicians, as well as devices. The same holds true regardless of procedure location – different devices have different procedural outcomes and physician experience with each device is important. Often, the cases involving adverse events from device closure presented at scientific conferences were performed by inexperienced physicians so be prepared to ask the interventional cardiologist how many cases of PFO closure he or she has performed and with which devices; and be highly suspicious if anyone states there are no complications associated with device closure.
Finally, patients should communicate with their physicians prior to the procedure about how their post-procedural care will be managed and what type of follow-up testing will be performed regardless of where they undergo closure. Anyone leaving the country for a procedure should give extra attention to post-procedural care coordination and have an established relationship with a cardiologist and care team prepared to support the patient upon return. It is extremely important to understand coverage policies when undergoing a procedure an insurance company or health care system has refused to cover previously. In some cases, any related expense may not be covered if the patient experiences adverse events that require care so patients should be certain to do their homework related to health care benefits before undergoing a procedure.
In sum, the decision to pursue PFO closure for migraine is a delicate balance between risk/benefit, quality of life, and reimbursement. Patients should beware that professional opinions on the matter are highly varied between specialties and it would be wise to get unbiased opinions from the migraine, cardiology and patient communities. The science is still evolving and there are currently no guarantees regarding outcomes. Patient preference will play heavily into the decision making process so patients and/or their caregivers need to be ready to take a leadership role in navigating the process and advocating for their needs. Most importantly, there is no cure for migraine. Closing a PFO could bring relief if PFO proves to be an aggravating factor in a patient’s migraine disease, but patients should be prepared to continue managing other factors in their disease whether they undergo PFO closure or not.
Ms. Patrick-Lake supports efforts to actively engage patient advocacy organizations and other stakeholders in Clinical Trials Transformation Initiative efforts to improve clinical trials. She also implements strategies to enhance awareness of CTTI’s work, particularly with patient advocates, and to extend the impact of CTTI results and recommendations. During the past 15 years, Ms. Patrick-Lake has founded and led several non-profit organizations including the PFO Research Foundation, which she started in response to the lack of definitive scientific information regarding the condition of patent foramen ovale (PFO). Ms. Patrick-Lake has served as a patient representative at the FDA on a variety of advisory committees and panels, in workgroups for EMA and NIH/NINDS, as a guest lecturer and an external reviewer for IOM, and as a key stakeholder for AHRQ and PCORI grants. She is a member of the ACC Foundation Patient-centered Care (PC3) Shared Decision Making Workgroup, the DIA Patient Fellowship Selection Committee, the TVT Registry Stakeholder Advisory Committee, and is a board member for the Alliance for Headache Disorders Advocacy. She is a frequent guest lecturer on patient issues and clinical trials, both nationally and internationally.