Background: In this prospective randomized controlled trial, we compared the standard del Nido cardioplegia solution (SDN) with the modified del Nido cardioplegia solution (MDN) in which the base solution was the plain Ringer solution.
Methods: A total of 80 patients aged < 12 years undergoing intracardiac repair of Tetralogy of Fallot were randomized into SDN (n = 39) or MDN (n = 41) groups. The primary outcome was a change in cardiac index (CI). Secondary outcomes were ventricular arrhythmias after the release of aortic-cross clamp, postoperative inotropic score (IS), time to peripheral rewarming, duration of mechanical ventilation, intensive care unit (ICU) length of stay, and hospital length of stay, and electron microscopic differences between the 2 groups. Cardiac Troponin-I, inflammatory markers tumor necrosis factor-α (TNF-α), and interleukin-L (IL-6) were measured.
Results: Applying the noninferiority confidence interval approach, the difference between the changes in CI between the 2 groups was −0.093 L/min/m2 (95% CI: −0.46-0.27 L/min/m2) which was within the noninferiority threshold of −0.5 indicating that CI was similar in both SDN and MDN. Ventricular arrhythmias postclamp release (P = .91), IS (P = .09), duration of mechanical ventilation (P = .27), ICU length of stay (P = .50), hospital length of stay (P= .57), IL-6 (P = .19), TNF-α (P = .17), Troponin-I (P = .15), electron microscopy changes (P > .05) were not different between groups.
Conclusion: MDN was shown to be noninferior to the SDN cardioplegia in terms of preservation of cardiac index. In addition, other metrics indicative of myocardial protection were similar between groups. In developing nations where SDN is not available or is expensive, MDN cardioplegia is an acceptable alternative.