RESUMEN
Background: Post cardiac arrest left ventricular ejection fraction (LVEF) is routinely assessed, but the implications of this are unknown. This study aimed to assess the association between post cardiac arrest LVEF and survival to hospital discharge. Methods: In this retrospective cohort study, all in-hospital and out of hospital cardiac arrests at our tertiary care center between January 2012 and September 2015 were included. Baseline demographics, clinical data, characteristics of the arrest, and interventions performed were collected. Earliest post cardiac arrest echocardiograms were reviewed with LVEF documented. The primary outcome was survival to discharge. Results: A total of 736 patients were included in the analysis (mean age 58 years, 44% female). 15% were out of hospital cardiac arrest (24% shockable rhythm). After adjusting for covariates, patients with LVEF < 30% had 36% lower odds of surviving to hospital discharge than those with LVEF ≥ 52% (p = 0.014). Shockable initial rhythm and targeted temperature management were associated with improved survival. Conclusion: After a cardiac arrest, an initial LVEF < 30% is associated with significantly lower odds of survival to hospital discharge.
RESUMEN
The evaluation of stability with respect to particles in prefilled syringes is complicated by the presence of silicone oil. The mobility, colloidal characteristics, and kinetic instability of silicone oil in contact with a protein formulation may be influenced in unpredictable ways by pharmaceutical variables, storage, and handling conditions. To provide insight into the impact of these variables on silicone oil originating specifically from the siliconized prefillable syringe (PFS), a series of studies were conducted at incremental syringe barrel siliconization levels. Size-exclusion chromatography and particle counting methods were used to quantitate soluble aggregates and submicron and subvisible particles in peginterferon beta-1a in a PFS siliconized with a fixed nozzle spray-on siliconization process. The effect of silicone oil on the peginterferon beta-1a molecule was examined under pharmaceutically relevant conditions, accelerated degradation, and under denaturing conditions. Resonant mass measurement was used to discriminate silicone oil from protein particles establishing that silicone oil does not mask adverse trends in non-silicone oil particles. The peginterferon beta-1a molecule was shown to be stable in the presence of silicone oil and robust with respect to the formation of soluble aggregates and submicron and subvisible particles in its PFS siliconized over the range of 0-1.2 mg silicone oil per syringe barrel.
