Objective: To compare intranasal midazolam, using a Mucosal Atomization Device (IN-MMAD), with rectal diazepam (RD) for the home treatment of seizures in children with epilepsy.Design: Prospective randomized study.Setting: Patients' homes and a freestanding children's hospital that serves as a referral center for 5 states.Patients: A total of 358 pediatric patients who visited a pediatric neurology clinic from July 2006 through September 2008 and were prescribed a home rescue medication for their next seizure.Intervention: Caretakers were randomized to use either 0.2 mg/kg of IN-MMAD (maximum, 10 mg) or 0.3 to 0.5 mg/kg of RD (maximum, 20 mg) at home for their child's next seizure if it lasted more than 5 minutes.Outcome Measures: The primary outcome measure was total seizure time after medication administration. Our secondary outcome measures were total seizure time, time to medication administration, respiratory complications, emergency medical service support, emergency department visits, hospitalizations, and caretakers' ease of administration and satisfaction with the medication.Results: A total of 92 caretakers gave the study medication during a child's seizure (50 IN-MMAD, 42 RD). The median time from medication administration to seizure cessation for IN-MMAD was 1.3 minutes less than for RD (95% confidence interval, 0.0-3.5 minutes; P=.09). The median time to medication administration was 5.0 minutes for each group. No differences in complications were found between treatment groups. Caretakers were more satisfied with IN-MMAD and report that it was easier to give than RD.
Conclusions:There was no detectable difference in efficacy between IN-MMAD and RD as a rescue medication for terminating seizures at home in pediatric patients with epilepsy. Ease of administration and overall satisfaction was higher with IN-MMAD compared with RD.
This analysis provides evidence that long-term destination therapy can be improved well beyond the pioneering experience of the Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure trial. With continued evolution of devices, management, and patient selection, outcomes approaching those of heart transplantation may be possible.
Ventricular assist devices have become standard therapy for patients with advanced heart failure either as a bridge to transplantation or destination therapy. Despite the functional and biologic evidence of reverse cardiac remodeling, few patients actually proceed to myocardial recovery, and even fewer to the point of having their device explanted. An enhanced understanding of the biology and care of the mechanically supported patient has redirected focus on the possibility of using ventricular assist devices as a bridge to myocardial recovery and removal. Herein, we review the current issues and approaches to transforming myocardial recovery to a practical reality.
Background
Continuous-flow (CF) left ventricular assist devices (LVADs) are standard of care for bridging patients to cardiac transplantation. However, existing data about preoperative factors influencing early post-transplant survival in this population are limited. We sought to determine risk factors for mortality using a large international database.
Methods
All patients in the International Society for Heart and Lung Transplantation Transplant Registry who were bridged to transplantation with CF LVADs between June 2008 and June 2012 were included. Risk factors for mortality within 30 days of transplant were identified. Statistical approach included multivariable analysis and Kaplan-Meier survival analysis.
Results
During the study period, 2,152 CF LVAD patients underwent heart transplantation. Post-transplant survival was 95.5% at 30 days. Risk factors for mortality during this window included ventilator support at transplant (HR 5.00, 95% CI 1.51–16.58), female recipient/male donor (compared to male recipient/male donor, HR 3.29, 95% CI 1.90–5.72), history of hemodialysis (HR 2.51, 95% CI 1.14–5.51), and history of coronary bypass grafting (HR 1.89, 95% CI 1.19–3.00). Increasing recipient age (p=0.002), body mass index (p=0.002), creatinine (p=0.004), and total bilirubin (p<0.001) were also associated with an increase in mortality.
Conclusions
In patients supported with CF LVADs, risk factors for early mortality can be identified pre-transplant, including ventilator support, female recipient/male donor, and increasing recipient age and body mass index. Despite the inherent complexities of reoperative surgery, patients bridged to transplant with CF LVADs have excellent perioperative survival.
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