Accepted for/Published in: JMIR Formative Research
Date Submitted: Jul 21, 2024
Date Accepted: Nov 26, 2024
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Impact of preventive intravenous amiodarone on reperfusion ventricular fibrillation in patients with left ventricular hypertrophy undergoing open-heart surgery: a randomized controlled clinical trial.
ABSTRACT
Background:
Ventricular fibrillation (VF) is a vicious arrhythmia usually generated after removal of the aortic cross-clamp (ACC) in patients undergoing open heart surgery, which could damage cardiomyocytes, especially in patients with left ventricular hypertrophy (LVH). Amiodarone has the prominent properties of converting VF and restoring sinus rhythm. However, few studies concentrated on the effect of amiodarone before ACC release on reducing VF in patients with LVH.
Objective:
The study was designed to explore the effectiveness of prophylactic intravenous amiodarone in reducing VF after the release of ACC in patients with LVH.
Methods:
Fifty-four patients with LVH scheduled for open-heart surgery were enrolled and randomly divided (1:1) into two groups: group A (amiodarone group) and group P (placebo-controlled group). Thirty minutes before removal of the ACC, the trial drugs were administered intravenously. In group A, 150 mg of amiodarone was pumped in 15 minutes. In group P, the same volume of normal saline was pumped in 15 minutes. The primary outcome was the incidence of VF 10 minutes after removal of the ACC.
Results:
The incidence of VF was lower in group A than in group P (29.6% vs 70.4%, P = 0.003). The duration of VF, the number of defibrillations, and the defibrillation energy were also lower in group A than in group P (P < 0.05). After the end of cardiopulmonary bypass, the heart rate and mean arterial pressure were lower in group A, the mean pulmonary arterial pressure and the dose of vasoactive drugs was higher than those in group P (P < 0.05). However, there were no significant differences in the use of vasoactive-inotropic agents and hemodynamic status between the two groups before the end of surgery (P > 0.05).
Conclusions:
In patients with LVH who undergo open-heart surgery, amiodarone can be safely used and reduce the incidence of VF, the duration of VF, the frequency of defibrillation and the energy of defibrillation after ACC removal. Clinical Trial: Chinese Clinical Trial Registry, ChiCTR2000035057; https://www.chictr.org.cn/showprojEN.html?proj=57145
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