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CLINICAL TRIAL
JOURNAL ARTICLE
MULTICENTER STUDY
[Vernakalant in hospital emergency practice: safety and effectiveness].
OBJECTIVES: To study the effectiveness and safety of vernakalant for restoration of sinus rhythm in patients with atrial fibrillation (AF) in routine hospital emergency department care, and to evaluate factors associated with a more effective response.
MATERIAL AND METHODS: Prospective multicenter cohort study enrolling consecutive patients who were administered vernakalant for medical cardioversion of AF between September 2014 through March 2016 in 5 hospitals in the Spanish autonomous community of Valencia.
RESULTS: We studied 165 cases. The median (interquartile range) was 68 years (56-77) years. Cardioversion with vernakalant was effective in 77.6% (95% CI, 71.1%-84%). The median time to conversion was 8 ( 6-12) minutes after a first dose and 34 (22-62) minutes after a second dose. A prior history of cardiac insufficiency was nonsignificantly less common in patients who converted with vernakalant (6.3%) than in those who did not (18.9%) (adjusted odds ratio [OR], 0.45 [95% CI, 0.13-1.56]; P=.208). Having no prior history of AF was nonsignificantly related to greater effectiveness (in 54.7% vs in 35.1% with prior AF). Duration less than 12 hours was significantly associated with greater effectiveness (83.6% vs 59.5%; adjusted OR, 2.76 [95% CI, 1.12-6.80]; P=.028). Adverse events were reported for 30 patients. None of the events had clinically important consequences, and in only 2 cases (1.2%) was it necessary to suspend treatment.
CONCLUSION: Vernakalant is effective and safe for restoring sinus rhythm in the hospital emergency department.
MATERIAL AND METHODS: Prospective multicenter cohort study enrolling consecutive patients who were administered vernakalant for medical cardioversion of AF between September 2014 through March 2016 in 5 hospitals in the Spanish autonomous community of Valencia.
RESULTS: We studied 165 cases. The median (interquartile range) was 68 years (56-77) years. Cardioversion with vernakalant was effective in 77.6% (95% CI, 71.1%-84%). The median time to conversion was 8 ( 6-12) minutes after a first dose and 34 (22-62) minutes after a second dose. A prior history of cardiac insufficiency was nonsignificantly less common in patients who converted with vernakalant (6.3%) than in those who did not (18.9%) (adjusted odds ratio [OR], 0.45 [95% CI, 0.13-1.56]; P=.208). Having no prior history of AF was nonsignificantly related to greater effectiveness (in 54.7% vs in 35.1% with prior AF). Duration less than 12 hours was significantly associated with greater effectiveness (83.6% vs 59.5%; adjusted OR, 2.76 [95% CI, 1.12-6.80]; P=.028). Adverse events were reported for 30 patients. None of the events had clinically important consequences, and in only 2 cases (1.2%) was it necessary to suspend treatment.
CONCLUSION: Vernakalant is effective and safe for restoring sinus rhythm in the hospital emergency department.
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