Should divers consider surgical PFO
closure to avoid DCS?A March 2012 New England Journal of Medicine study finds that in patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure with a device did not offer a greater benefit than medical therapy alone for the prevention of recurrent stroke or TIA. Dr. Richard Moon of Duke Dive Medicine discusses the implications for divers at risk for decompression sickness.
The prevalence of patent foramen ovale among patients with cryptogenic stroke is
higher than that in the general population. Closure with a percutaneous device is
often recommended in such patients, but it is not known whether this intervention
reduces the risk of recurrent stroke.
We conducted a multicenter, randomized, open-label trial of closure with a percutaneous
device, as compared with medical therapy alone, in patients between 18 and
60 years of age who presented with a cryptogenic stroke or transient ischemic attack
(TIA) and had a patent foramen ovale. The primary end point was a composite of
stroke or transient ischemic attack during 2 years of follow-up, death from any
cause during the first 30 days, or death from neurologic causes between 31 days
and 2 years.
A total of 909 patients were enrolled in the trial. The cumulative incidence (Kaplan–
Meier estimate) of the primary end point was 5.5% in the closure group (447 patients)
as compared with 6.8% in the medical-therapy group (462 patients) (adjusted hazard
ratio, 0.78; 95% confidence interval, 0.45 to 1.35; P = 0.37). The respective rates were
2.9% and 3.1% for stroke (P = 0.79) and 3.1% and 4.1% for TIA (P = 0.44). No deaths
occurred by 30 days in either group, and there were no deaths from neurologic
causes during the 2-year follow-up period. A cause other than paradoxical embolism
was usually apparent in patients with recurrent neurologic events.
In patients with cryptogenic stroke or TIA who had a patent foramen ovale, closure
with a device did not offer a greater benefit than medical therapy alone for the
prevention of recurrent stroke or TIA. (Funded by NMT Medical; ClinicalTrials.gov