Nimodipine for the treatment of otolaryngic indications.

PURPOSE: The uses of nimodipine for otolaryngic indications are reviewed, and recommendations for its use in clinical practice are provided. SUMMARY: Nimodipine is currently indicated for the improvement of neurologic outcomes in adult patients with aneurysmal subarachnoid hemorrhage (aSAH). However, other oral and i.v. calcium channel blockers have not exhibited the same beneficial effects in patients with aSAH, leading clinicians to believe that nimodipine possesses unique neuroprotective effects in addition to its calcium channel-blocking and vasodilatory properties. Consequently, clinical investigations of nimodipine have been conducted for cochlear and facial nerve preservation after vestibular schwannoma (VS) surgery, symptomatic management of Ménière's disease and peripheral vertigo, and recovery of vocal cord paralysis after laryngeal nerve injury. Three prospective randomized studies have investigated nimodipine for hearing and/or nerve preservation in patients undergoing VS resection, the results of which have suggested a potential benefit of initiating nimodipine during the perioperative period. Several studies of Ménière's disease and/or peripheral vertigo have reported improved symptom control with nimodipine. For vocal fold paralysis associated with recurrent laryngeal nerve (RLN) injury, nimodipine may increase the recovery rate based on the results of 1 nonrandomized prospective study that used nimodipine in a protocolized manner. One small pilot study found that nimodipine improved facial nerve function after maxillofacial surgery. CONCLUSION: Due to its proposed vasoactive and neuroprotective effects, nimodipine may play a role in the treatment of a number of otolaryngic pathologies including VS, Ménière's disease, peripheral vertigo, RLN injury, and facial weakness after maxillofacial surgery. Small studies have shown improved symptom control and recovery after surgery. Since all of the aforementioned indications are still considered off label, clinicians and patients should collaboratively assess the risks and benefits before initiating treatment.

Four-factor prothrombin complex concentrate for life-threatening bleeds or emergent surgery: A retrospective evaluation.

PURPOSE: Previous trials investigating usage of four-factor prothrombin complex concentrate (4F-PCC) excluded patients with various thrombotic risk factors. The objective of this study was to evaluate the safety and effectiveness of 4F-PCC in a real-world setting based on an institutional protocol that does not have strict exclusion criteria. METHODS: This was a retrospective study of adult patients who received 4F-PCC. The primary outcome was a confirmed thromboembolism within 14 days after 4F-PCC administration. Secondary outcomes included international normalized ratio (INR) correction to <1.5 at first draw and incidence of INR rebound for patients undergoing reversal of warfarin and hemostatic effectiveness for patients experiencing a bleed. RESULTS: Ninety-three patients received 4F-PCC. Sixty-three (67.7%) were reversed for bleeding and 30 (32.3%) for surgery. Eleven patients (11.8%) developed a thromboembolism within 14 days. The median (interquartile range) time to event was 5 (2-7) days. Significant risk factors were heparin-induced thrombocytopenia (P= .01) and major surgery within 14 days (P= .02), as well as the presence of >6 thrombotic risk factors (P= .01). For patients post-warfarin reversal, 45/63 (71.4%) achieved INR correction at first draw, 55/63 (87.3%) achieved INR correction within 24 hours, and 14/55 (25.5%) experienced INR rebound. Of these 14 patients, 8 (57.1%) did not receive concomitant vitamin K. CONCLUSIONS: 4F-PCC was associated with a notable thromboembolic risk. All patient-specific risk factors should be considered prior to administration. 4F-PCC remains a useful agent for warfarin reversal. Lack of concomitant vitamin K may contribute to INR rebound.