ABSTRACT
BACKGROUND: Clinically silent lesions on cerebral magnet resonance imaging have been found in larger numbers after pulmonary vein isolation (PVI) especially with phased radio frequency (pRF) using all ten electrodes. However, the neuropsychological effects of cerebral microembolism during the procedure remain unclear and data regarding this issue so far are inconsistent. METHODS: Between August 2011 and June 2012, 76 patients undergoing their first PVI were randomized to ablation with either phased (40) or irrigated (36) radio frequency (iRF). A comprehensive neuropsychological test battery was performed the day before and after PVI as well as 6 months after ablation. The occurrence of cerebral microemboli during the procedure was performed via a transcranial Doppler ultrasound device. RESULTS: PVI using pRF was associated with increased number of microembolic signals (MES) compared to iRF (1530.0 ± 979.8 vs. 645.7 ± 448.7; p < 0.001). Neuropsychological assessment did not reveal any changes in correlation with the used ablation technique. Besides an age-related effect there was a diffuse, sub-clinical impairment of neurologic function depending on age and the number of MES. CONCLUSIONS: There was no clinical overt cognitive deficit and no significant difference in cognitive function correlating with the used ablation technique. The number of MES correlated with a subtle, diffuse post-procedural impairment of neuropsychological function highlighting the need to reduce microemboli during ablation.
Subject(s)
Atrial Fibrillation/surgery , Catheter Ablation/adverse effects , Cognition Disorders/psychology , Cognition , Intracranial Embolism/psychology , Aged , Atrial Fibrillation/diagnosis , Catheter Ablation/methods , Cognition Disorders/diagnosis , Cognition Disorders/etiology , Female , Germany , Humans , Intracranial Embolism/diagnosis , Intracranial Embolism/etiology , Male , Middle Aged , Neuropsychological Tests , Predictive Value of Tests , Prospective Studies , Risk Factors , Therapeutic Irrigation/adverse effects , Time Factors , Treatment Outcome , Ultrasonography, Doppler, TranscranialABSTRACT
Anirolac, a new nonsteroidal anti-inflammatory drug, was evaluated for relative efficacy, safety, and time course of analgesia. In a stratified, randomized, parallel, double-blind trial, 120 hospitalized women with moderate or severe postpartum uterine pain were treated with single oral doses of anirolac, 50 or 100 mg, naproxen sodium, 550 mg, or placebo. Using verbal scales, patients rated pain intensity, pain relief, and side effects at regular intervals for 6 hours. Highest summed analgesic ratings over placebo were induced by anirolac, 100 mg (P less than or equal to 0.001), and naproxen (P less than or equal to 0.001), followed by anirolac, 50 mg (P less than or equal to 0.005). At each assessment after the first hour, anirolac, 50 and 100 mg, and naproxen induced significantly stronger analgesia than did placebo. Statistically significantly more drowsiness was reported with all three active agents than with placebo. Our results suggest that, for postpartum uterine pain, analgesia with anirolac, 50 or 100 mg, is equivalent to that with naproxen, 550 mg.