Heart rate changes following the administration of sugammadex in children: a prospective, observational study.

INTRODUCTION: Sugammadex is a novel agent to reverse steroidal neuromuscular blocking agents (NMBA) with potential clinical advantages over acetylcholinesterase inhibitors such as neostigmine. However, rare instances of bradycardia were reported during its initial clinical trials. To better define this issue, its incidence and mitigating factors, we prospectively evaluated heart rate changes after sugammadex administration in pediatric-aged patients. METHODS: Patients less than 18 years of age who were to receive sugammadex were included. After sugammadex administration, heart rate (HR) was recorded every minute for 15 min and then every 5 min for the next 15 min or until the patient was transferred from the operating room. Bradycardia was defined as HR below the 5th percentile for age. RESULTS: The study cohort included 221 children. Bradycardia was noted in 18 cases (8%; 95% confidence interval 5%, 13%), occurring at a median of 2 min (IQR: 1, 6) after sugammadex administration. Among patients developing bradycardia, 7 of 18 (38%) had comorbid cardiac conditions (congenital heart disease). No patient required treatment for bradycardia and no clinically significant blood pressure (BP) changes were noted. On bivariate analysis, initial sugammadex dose was not associated with bradycardia onset. In multivariable analysis, cardiac comorbid conditions and male gender were associated with an increased incidence of bradycardia. CONCLUSIONS: The incidence of bradycardia following the administration of sugammadex is low, is not associated with BP changes or other clinically significant effects, and did not require treatment. A higher incidence of bradycardia was noted in patients with cardiac comorbid conditions.

Decrease in heart rate following the administration of sugammadex in adults.

BACKGROUND AND AIMS: Sugammadex is a novel agent for reversal of steroidal neuromuscular blocking agents (NMBAs) with potential advantages over acetylcholinesterase inhibitors. In preclinical trials, there have been rare instances of bradycardia with progression to cardiac arrest. To better define this issue, its incidence and mitigating factors, we prospectively evaluated the incidence of bradycardia after sugammadex administration in adults. MATERIAL AND METHODS: Patients ≥ 18 years of age who received sugammadex were included in this prospective, open label trial. After administration, heart rate (HR) was continuously monitored. HR was recorded every minute for 15 minutes and then every five minutes for the next 15 minutes or until patient was transferred out of the operating room. Bradycardia was defined as HR less than 60 beats/minute (bpm) or decrease in HR by ≥ 10 beats per minute (bpm) if the baseline HR was <70 bpm. RESULTS: The study cohort included 200 patients. Bradycardia was observed in 13 cases (7%; 95% confidence interval: 4, 11), occurring a median of 4 minutes after sugammadex administration (IQR: 4, 9, range: 2-25). Among patients developing bradycardia, two (15%) had cardiac comorbid conditions. One patient received treatment for bradycardia with ephedrine. No clinically significant blood pressure changes were noted. On bivariate analysis, patients receiving a higher initial sugammadex dose were more likely to develop bradycardia. On multivariable logistic regression, initial sugammadex dose was not associated with the risk of bradycardia. CONCLUSION: The incidence of bradycardia after administration of sugammadex in our study was low and not associated with significant hemodynamic changes.

Age-Dependent Impact of Pre-Transplant Intensive Care Unit Stay on Mortality in Heart Transplant Recipients.

BACKGROUND: Heart transplantation (HTx) is a treatment option for refractory end-stage heart failure. Severe illness requiring pre-transplant intensive care unit (ICU) stay may be a risk factor for diminished post-transplant survival, but this association is surprisingly inconsistent in recent studies. To clarify the significance of ICU stay as a risk factor for heart transplant outcomes, we aimed to define if patient age was a factor in which ICU stay was predictive of survival after HTx. METHODS: De-identified data were obtained on isolated first-time HTx performed during the years 2006 - 2015 from the UNOS Registry. Nine age groups were defined. The primary outcome was 1-year post-transplant mortality. Cox proportional hazard regression estimated unadjusted and adjusted hazard ratio (HR) associated with pre-transplant ICU stay in each age group. RESULTS: The analysis included 19,508 patients (9% deceased within 1 year). In the overall cohort, pre-transplant ICU stay was associated with increased hazard of 1-year mortality (HR = 1.3; 95% confidence interval (CI): 1.2 - 1.4; P < 0.001); but further univariate analysis showed a greater hazard of 1-year mortality associated with ICU stay in infants (HR = 2.2; 95% CI: 1.5 - 3.2; P < 0.001). However, the adjusted analysis found that adults ages 40 - 49 had the highest statistically significant hazard of 1-year mortality (HR = 1.5; 95% CI: 1.1 - 2.1; P = 0.011). CONCLUSIONS: Our study established age variation in the association between ICU stay and survival after HTx, with this association being strongest among adults, 40 to 49 years of age, undergoing HTx. Previous data suggesting decreased survival in infants may be related to the increased use of extracorporeal membrane oxygenation as a mechanical cardiac assist rather than ventricular assist devices.