Search

This article discusses the VenoValve bioprosthetic device, which is designed to improve valvular competence in the deep venous system of the lower extremities and treat deep venous insufficiency.

IMPORTANCE: Both military and civilian clinical practice guidelines include early plasma transfusion to achieve a plasma to red cell ratio approaching 1:1 to 1:2. However, it was not known how early plasma should be given for optimal benefit. Two recent randomized clinical trials were published, with apparently contradictory results. The Prehospital Air Medical Plasma (PAMPer) clinical trial showed a nearly 30% reduction in mortality with plasma transfusion in the prehospital environment, while the Control of Major Bleeding After Trauma (COMBAT) clinical trial showed no survival improvement. OBJECTIVE: To facilitate a post hoc combined analysis of the COMBAT and PAMPer trials to examine questions that could not be answered by either clinical trial alone. We hypothesized that prehospital transport time influenced the effects of prehospital plasma on 28-day mortality. DESIGN, SETTING, AND PARTICIPANTS: A total of 626 patients in the 2 clinical trials were included. Patients with trauma and hemorrhagic shock were randomly assigned to receive either standard care or 2 U of thawed plasma followed by standard care in the prehospital environment. Data analysis was performed between September 2018 and January 2019. INTERVENTIONS: Prehospital transfusion of 2 U of plasma compared with crystalloid-based resuscitation. MAIN OUTCOMES AND MEASURES: The main outcome was 28-day mortality. RESULTS: In this post hoc analysis of 626 patients (467 men [74.6%] and 159 women [25.4%]; median [interquartile range] age, 42 [27-57] years) who had trauma with hemorrhagic shock, a Cox regression analysis showed a significant overall survival benefit for plasma (hazard ratio [HR], 0.65; 95% CI, 0.47-0.90; P = .01) after adjustment for injury severity, age, and clinical trial cohort (COMBAT or PAMPer). A significant association with prehospital transport time was detected (from arrival on scene to arrival at the trauma center). Increased mortality was observed in patients in the standard care group when prehospital transport was longer than 20 minutes (HR, 2.12; 95% CI, 1.05-4.30; P = .04), while increased mortality was not observed in patients in the prehospital plasma group (HR, 0.78; 95% CI, 0.40-1.51; P = .46). No serious adverse events were associated with prehospital plasma transfusion. CONCLUSIONS AND RELEVANCE: These data suggest that prehospital plasma is associated with a survival benefit when transport times are longer than 20 minutes and that the benefit-risk ratio is favorable for use of prehospital plasma. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01838863 (COMBAT) and NCT01818427 (PAMPer)

IMPORTANCE: Nonbattle injury (NBI) among deployed US service members increases the burden on medical systems and results in high rates of attrition, affecting the available force. The possible causes and trends of NBI in the Iraq and Afghanistan wars have, to date, not been comprehensively described. OBJECTIVES: To describe NBI among service members deployed to Iraq and Afghanistan, quantify absolute numbers of NBIs and proportion of NBIs within the Department of Defense Trauma Registry, and document the characteristics of this injury category. DESIGN, SETTING, AND PARTICIPANTS: In this retrospective cohort study, data from the Department of Defense Trauma Registry on 29 958 service members injured in Iraq and Afghanistan from January 1, 2003, through December 31, 2014, were obtained. Injury incidence, patterns, and severity were characterized by battle injury and NBI. Trends in NBI were modeled using time series analysis with autoregressive integrated moving average and the weighted moving average method. Statistical analysis was performed from January 1, 2003, to December 31, 2014. MAIN OUTCOMES AND MEASURES: Primary outcomes were proportion of NBIs and the changes in NBI over time. RESULTS: Among 29 958 casualties (battle injury and NBI) analyzed, 29 003 were in men and 955 were in women; the median age at injury was 24 years (interquartile range, 21-29 years). Nonbattle injury caused 34.1% of total casualties (n = 10 203) and 11.5% of all deaths (206 of 1788). Rates of NBI were higher among women than among men (63.2% [604 of 955] vs 33.1% [9599 of 29 003]; P

Objective To quantify the impact of fibrinogen-containing cryoprecipitate in addition to the antifibrinolytic tranexamic acid on survival in combat injured. Design Retrospective observational study comparing the mortality of 4 groups: tranexamic acid only, cryoprecipitate only, tranexamic acid and cryoprecipitate, and neither tranexamic acid nor cryoprecipitate. To balance comparisons, propensity scores were developed and added as covariates to logistic regression models predicting mortality. Setting A Role 3 Combat Surgical Hospital in southern Afghanistan. Patients A total of 1332 patients were identified from prospectively collected UK and US trauma registries who required 1 U or more of packed red blood cells and composed the following groups: tranexamic acid (n = 148), cryoprecipitate (n = 168), tranexamic acid/cryoprecipitate (n = 258), and no tranexamic acid/cryoprecipitate (n = 758). Main Outcome Measure In-hospital mortality. Results Injury Severity Scores were highest in the cryoprecipitate (mean [SD], 28.3 [15.7]) and tranexamic acid/cryoprecipitate (mean [SD], 26 [14.9]) groups compared with the tranexamic acid (mean [SD], 23.0 [19.2]) and no tranexamic acid/cryoprecipitate (mean [SD], 21.2 [18.5]) (P

Incharacterizing theeffectofa2009mandate to reducemedical evacuation times inAfghanistan, in this issueof JAMASurgery, Kotwal and colleages1 demonstrate the effectiveness of combining advanced trauma care capability with informed policy. Unlike any report before it, this study demonstrates that one without the other—capability without policy or policy without capability—results in compromised success. In this case, the principle applies to success of theUS military’s trauma system that endeavors to save lives and improve recovery of personnel injured in defense of the nation. Acompelling finding fromthis report is thedecrease in the case fatality rate (CFR) even before initiation of the 60minute directive. Figure 1 illustrates that the CFR decreased tobelow15%between2001 and2009, a ratepredicted tohave reached 10%by2013.1 Although several factors contributed to this decrease, an enhanced trauma care capability—one improved by knowledge and materiel solutions coming from a robust trauma research program—undoubtedly played a role. The longitudinal CFR analysis provides evidence that as gaps incasualtycarewerebeingnarrowed,anenhancedtraumacare capability developed. Notably, gaps in care that guide military trauma research were reinvigorated in 2008 through timelyGuidance forDevelopment of theForce issued through the same US Secretary of Defense.2,3 Reduction in thepercentage killed in action following the 2009 policy change provides evidence of the effect of an enhanced capability during the “goldenhour” after injury. Although the notion of a golden hour is not new, this study assembled injurymanagement data from theUSDepartment of DefenseTraumaRegistry, autopsydata fromtheArmedForces Medical Examiner, and previously classified data pertaining to evacuation times to provide insight into what can be accomplished during this acute phase of care. Findings of a reduced percentage killed in action also confirmprevious studies suggesting theeffectivenessofpoint-of-injury care and the care provided by enhanced en route platforms.4,5 Lestwe view this report as a pronouncement that themission is complete, it is vital to consider the study’s limitations. Foremost, the incomplete and inaccessible nature of the data needed forwhat shouldbe amore routineprocess is troubling. Althoughthearticledoesnot lament, it is likely that it tookyears for 9 senior military investigators to assemble the data to provide this analysis by which to enlighten policy. Unless we are willing todismissprehospitalmortalityasunsolvable,wemust do better at recording, coordinating, and analyzing data from this phaseof care.Also chastening is the fact that the advances reported in this studywereachieved inoptimal theatersofwar withunfettered air access andpositioningof surgical facilities. Futurecasualty care scenariosmaybe frighteninglymorecomplexandinvolvedelayedresuscitation,prolongedfieldcare,and longer-distance critical care transport.6 Itwouldbewisenot to bemesmerized by trends reported in this study. Instead, military and civilian planners should learn from the whole of the effort—including its limitations—and develop better ways to build traumacare capability and informpolicy for future,more complex casualty scenarios.