Abstract 8807: Efficacy and Effectiveness Evaluation of Secondary Prevention of Cryptogenic Stroke or TIA in Patients with PFO Successfully Treated by Percutaneous Approach: Six Years Follow-Up.
Background: Cryptogenic stroke remains the final diagnosis in 40% of ischemic acute cerebrovascular events. The aim of this study was to evaluate the recurrence in patients successfully treated by percutaneous closure of PFO.
Methods: From February 2004 to May 2010, 88 symptomatic (70 stroke and 18 TIA) patients, (37 females and 51 males; average age 41 yrs, range 14–69) underwent percutaneous closure of PFO. Thirty-one (35%) of the 88 patients had a concomitant history of migraine, 22 (71%) of whom with aura. Five different occluder devices were used and selected on the basis of PFO anatomy by ICE, with a total amount of 90 implants. All pts were studied during the follow-up by: Clinical evaluation (Rankin modified scale), HRQL (SF36), TCD,TTE, MR.
Results: Successful device deployment was achieved in 100%. All patients were discharged within 3 days in good overall conditions. The follow-up was complete in 100% of the cases (median 32, range 1–75 months). In 86 patients (97.7%) the Rankin scale (after 6 months) significantly (p<0.0001) reduced to 0 whereas only in 2 patients score 1 was reached. In 22 (71%) of the 31 patients with concomitant migraine, the intensity and the frequency of the attacks significantly (P<0.0001) decreased over time. The SF36 (after 3 months) showed for the PCS a significantly (P<0.0001) improvement with a cut-off fixed at 33.52, whereas for the MCS the improvement was less significant (P<0.03) with a cut-off at 44.78. At the TCD (after 6 months), 6 (7%) patients resulted positive for microembolic signals (MES) with an overall significant reduction (18.5±7.0 vs 3.8±8.3; P<0.0001) after the procedure. Moreover, only 2 (2.3%) patients underwent a secondary successfully treatment for an associate defect. The TTE (after 1, 3, 6 and 12 months and once a year for 5 years) showed however an optimal sealing of all devices without signs of erosion, incomplete closure and thrombus formation. There were no new cerebral lesions detected at MR volume (mm3) evaluation (after 2 years) by ITK-SNAP software: 3798±3297 vs 3353±3622; P=0.72.
Conclusions: Our experience suggests that percutaneous treatment of PFO is safe and beneficial at medium term follow-up for secondary prevention of recurrence of acute cerebrovascular events irrespective of the device used.
- © 2010 by American Heart Association, Inc.