What is the evidence for percutaneous PFO closure?
This is a huge topic in itself. The following information is restricted to Cryptogenic CVA/TIA and Migraine with Aura.
CVA/TIA (and other arterial embolic events)
There are ways to determine if the PFO in a young cryptogenic embolic victim is simply an innocent bystander, or if it has a high probability of being the conduit for paradoxical embolic event. The details in this regard are beyond the scope of this introductory document.
The RESPECT trial showed if a patient received a PFO closure after a cerebral event they had less chance of a secondary event compared with medical therapy. This avoids the need for lifelong warfarin/ NOAC therapy.
Migraine with Aura
The classical migraine is now known to be a risk factor for an early cardiovascular event as evidenced by the recently released US Nurses study.
It is present in 10-15% of the population. In fact, MRI studies have shown a significant number of young females with migraine have had an asymptomatic brain ischaemic event.
Studies have also shown a significant number of severely debilitated migraineurs will have a large PFO.
To date, randomised studies have not given us a clear answer as to whether closure is better than medical therapy.
This has been largely due to poor patient selection techniques and difficulty in conducting the trials as many randomised patients have proceeded to closure outside the study protocol.
Also closure rates have been low due to first generational devices and even today some operators have non-closure rates as bad as 20% long term.
Cardio Remedy follows a specific assessment and closure protocol and follows up all patients with the gold standard cTCD to note non-closure rates as little as 1% in over 400 cases.
Some of our work was presented at a major international cardiovascular conference in Europe and showed a complete cure rate of 85% and a total response rate of 98% (defined as complete cure or, little or no disability) at two years.
These patients were carefully selected, severely disabled patients following a strict assessment process. Many of our patients, after years of non-participation have returned to the work force or study within months of closure.
Patients usually withdraw migraine prophylactic drugs in the months following their procedure.