Transcatheter closure of patent foramen ovale in patients older than 60 years of age with cryptogenic embolism.

INTRODUCTION AND

OBJECTIVES

Randomized trials have shown the efficacy of transcatheter closure of patent foramen ovale (PFO) in patients aged ≤ 60 years with cryptogenic embolism. We aimed to assess the long-term safety and efficacy of PFO closure in patients aged> 60 years.

METHODS

Of 475 consecutive patients with cryptogenic embolism who underwent PFO closure, 90 older patients aged> 60 years (mean, 66±5 years) were compared with 385 younger patients aged ≤ 60 years (mean, 44±10 years).

RESULTS

Older patients had a higher prevalence of cardiovascular risk factors (CVRF) (hypertension, dyslipidemia, diabetes; P <.01 for all vs younger patients). There were no differences in periprocedural complications between the 2 groups. During a median follow-up of 8 (4-12) years, there were a total of 17 deaths, all from noncardiovascular causes (7.8% and 2.6% in the older and younger patient groups, respectively; HR, 4.12; 95%CI, 1.56-10.89). Four patients had a recurrent stroke (2.2% and 0.5% in the older and younger patient groups, respectively; HR, 5.08; 95%CI, 0.71-36.2), and 12 patients had a transient ischemic attack (TIA) (3.3% and 2.3% in the older and younger patient groups, respectively; HR, 1.71; 95%CI, 0.46-6.39). There was a trend toward a higher rate of the composite of stroke/TIA in older patients (5.5% vs 2.6%; HR, 2.62; 95%CI, 0.89-7.75; P=.081), which did not persist after adjustment for CVRF (HR, 1.97; 95%CI, 0.59-6.56; P=.269).

CONCLUSIONS

In older patients with cryptogenic embolism, PFO closure was safe and associated with a low rate of ischemic events at long-term. However, older patients exhibited a tendency toward a higher incidence of recurrent stroke/TIA compared with younger patients, likely related to a higher burden of CVRF.