IV Sotalol Use in Pediatric and Congenital Heart Patients: A Multicenter Registry Study

Malloy-Walton, Lindsey; Bergen, Nicholas H. Von; Balaji, Seshadri; Fischbach, Peter S.; Garnreiter, Jason M.; Asaki, S. Yukiko; Moak, Jeffrey P.; Ochoa, Luis; Chang, Philip M.; Nguyen, Hoang H.; Patel, Akash R.; Kirk, Christa C. Jefferis; Sherman, Ashley; Silva, Jennifer N. Avari; Saul, J. Philip

doi:10.1161/jaha.121.024375

Cited by 10 publications

(8 citation statements)

References 18 publications

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“…While an age-factor nomogram developed for patients < 2 years of age exists, reports of using higher dose strategies without a slow up titration for terminating and improving tachyarrhythmias have been reported, using both enteral and IV formulations. [17][18][19][20][21] This present study found that our institutional dose regimen is significantly higher than the age-factor nomogram dosing recommendation (p < .001) and does not utilize a slow up titration (Figure 1). The use of a higher-dose regimen as initial therapy would theoretically allow for a shorter time to control of the arrhythmia, and decreased hospital stay.…”

Section: Discussionmentioning

confidence: 51%

“…However, concerns of QTc prolongation, pro‐arrhythmic effects, variable renal clearance, and limited pharmacologic data in neonates has resulted in variable dosing strategies. While an age‐factor nomogram developed for patients < 2 years of age exists, reports of using higher dose strategies without a slow up titration for terminating and improving tachyarrhythmias have been reported, using both enteral and IV formulations 17–21 …”

Section: Discussionmentioning

confidence: 99%

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Sotalol in neonates for arrhythmias: Dosing, safety, and efficacy

Kiskaddon

Decker

2023

Cardiovasc electrophysiol

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Introduction Various agents may be utilized to manage supraventricular tachycardia (SVT) in neonates and infants. Recently, sotalol has piqued interest given its reported success in managing neonates and infants with SVTs, especially with the intravenous formulation. While the manufacturer recommends using an age‐related nomogram in neonates and young infants to guide doses, clinical reports describe various dosing based on weight (mg/kg) or on body surface area (BSA) in mg/m2. Given the reported variation in clinical practice with regard to dosing in neonates, there is a gap in the literature and translation into clinical practice regarding applicability of the nomogram into clinical practice. The purpose of this study was to describe sotalol doses based on body weight and BSA in neonates for SVT. Methods This is a single center retrospective study evaluating effective sotalol dosing from January 2011 and June 2021 (inclusive). Neonates who received intravenous (IV) or oral (PO) sotalol for SVT were eligible for inclusion. The primary outcome was to describe sotalol doses based on body weight and BSA. Secondary outcomes include comparison of doses to the manufacturer nomogram, description of dose titrations, reported adverse outcomes, and change in therapy. Two‐sided Wilcoxon signed‐rank tests were used to determine statistically significant differences. Results Thirty‐one eligible patients were included in this study. The median (range) age and weight were 16.5 (1−28) days and 3.2 (1.8−4.9) kg, respectively. The median initial dose was 7.3 (1.9−10.8) mg/kg or 114.3 (30.9−166.7) mg/m2/day. Fourteen (45.2%) of patients required a dose increase for SVT control. The median dose required for rhythm control was 8.5 (2−14.8) mg/kg/day or 120.7 (30.9−225) mg/m2/day. Of note, the median recommended dose per manufacturer nomogram for our patients would have been 51.3 (16.2−73.8) mg/m2/day, which is significantly lower than both the initial dose (p < .001) and final doses (p < .001) utilized in our study. A total of 7 (22.9%) patients were uncontrolled on sotalol monotherapy using our dosing regimen. Two patients (6.5%) had reports of hypotension and one patient (3.3%) had a report of bradycardia requiring discontinuation of therapy. The average change in baseline QTC following sotalol initiation was 6.8%. Twenty‐seven (87.1%), 3 (9.7%), 1 (3.3%) experienced prolongation, no change, or a decrease in QTc, respectively. Conclusions This study demonstrates that a sotalol strategy significantly higher than the manufacture dose recommendations are required for rhythm control in neonates with SVT. There were few adverse events reported with this dosing. Further prospective studies would be advantageous to confirm these findings.

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Section: Discussionmentioning

confidence: 51%

Section: Discussionmentioning

confidence: 99%

Sotalol in neonates for arrhythmias: Dosing, safety, and efficacy

Kiskaddon

Decker

2023

Cardiovasc electrophysiol

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“…Recent studies have shown that intrave-nous sotalol is effective for refractory SVT. 50,51 An initial treatment dose of 30 mg/m 2 (without age nomogram adjustment) given over 15 minutes provides effective chemical cardioversion in most patients. 51 Emerging data show that ivabradine, a novel selective inhibitor of hyperpolarization-activated cyclic nucleotide-gated channels, appears to be a safe and well-tolerated medication that can induce suppression of SVT and restoration of sinus rhythm in children with refractory SVT.…”

Section: Initial Svt Treatmentsmentioning

confidence: 99%

Pharmacological Management of Cardiac Arrhythmias in the Fetal and Neonatal Periods: A Scientific Statement From the American Heart Association

Batra,

Silka,

Borquez

et al. 2024

Circulation

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Disorders of the cardiac rhythm may occur in both the fetus and neonate. Because of the immature myocardium, the hemodynamic consequences of either bradyarrhythmias or tachyarrhythmias may be far more significant than in mature physiological states. Treatment options are limited in the fetus and neonate because of limited vascular access, patient size, and the significant risk/benefit ratio of any intervention. In addition, exposure of the fetus or neonate to either persistent arrhythmias or antiarrhythmic medications may have yet-to-be-determined long-term developmental consequences. This scientific statement discusses the mechanism of arrhythmias, pharmacological treatment options, and distinct aspects of pharmacokinetics for the fetus and neonate. From the available current data, subjects of apparent consistency/consensus are presented, as well as future directions for research in terms of aspects of care for which evidence has not been established.

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“…Additional adverse effects of sotalol may include hypotension, bradycardia and AV block [7,8] . Nevertheless, since its approval, IV sotalol has been successfully and safely used in both adult and pediatric patient populations for the management of arrhythmias in acute and chronic settings [9,10,11,12] . Initiation of sotalol therapy with PO loading requires 5 successive oral doses over a 3-day hospital stay for monitoring, at an estimated cost of $2931.55 per day [13] .…”

mentioning

confidence: 99%