Desirability of Outcome Ranking and Response Adjusted for Antibiotic Risk (DOOR/RADAR) Post Hoc Analysis Supports Equipoise for Antibiotic Initiation Strategies in Intensive Care Unit-Acquired Pneumonia.

Background: Pneumonia is the most common intensive care unit (ICU)-acquired infection and source of potential sepsis in ICU populations but can be difficult to diagnose in real-time. Despite limited data, rapid initiation of antibiotic agents is endorsed by society guidelines. We hypothesized that a post hoc analysis of a recent randomized pilot study would show no difference between two antibiotic initiation strategies. Patients and Methods: The recent Trial of Antibiotic Restraint in Presumed Pneumonia (TARPP) was a pragmatic cluster-randomized pilot of antibiotic initiation strategies for patients with suspected ICU-acquired pneumonia. Participating ICUs were cluster-randomized to either an immediate initiation protocol or a specimen-initiated protocol where a gram stain was required for initiation of antibiotics. Patients in the study were divided into one of seven mutually exclusive outcome rankings (desirability of outcome ranking; DOOR): (1) Survival, No Pneumonia, No adverse events; (2) Survival, Pneumonia, No adverse events; (3) Survival, No Pneumonia, ventilator-free-alive days ≤14; (4) Survival, Pneumonia, ventilator-free-alive days ≤14; (5) Survival, No Pneumonia, Subsequent episode of suspected pneumonia; (6) Survival, Pneumonia, Subsequent episode of suspected pneumonia; and (7) Death. These rankings were further refined using the duration of antibiotics prescribed for pneumonia (response adjusted for antibiotic risk; RADAR). Results: There were 186 patients enrolled in the study. After applying the DOOR analysis, a randomly selected patient was equally likely to have a better outcome in specimen-initiated arm as in the immediate initiation arm (DOOR probability: 50.8%; 95% confidence interval [CI], 42.7%-58.9%). Outcome probabilities were similar after applying the RADAR analysis (52.5%; 95% CI, 44.2%-60.6%; p = 0.31). Conclusions: We found that patients for whom antibiotic agents were withheld until there was objective evidence (specimen-initiated group) had similar outcome rankings to patients for whom antibiotic agents were started immediately. This supports the findings of the TARPP pilot trial and provides further evidence for equipoise between these two treatment strategies.

Provider Perceptions of Antibiotic Initiation Strategies for Hospital-Acquired Pneumonia.

Background: The practice of rapidly initiating antibiotic therapy for patients with suspected infection has recently been criticized yet remains commonplace. Provider comfort level has been an understudied aspect of this practice. Hypothesis: We hypothesized that there would be no significant differences in provider comfort level between the two treatment groups. Methods: We prospectively surveyed critical care intensivists who provided care for patients enrolled in the Trial of Antibiotic Restraint in Presumed Pneumonia (TARPP), which was a multicenter cluster-randomized crossover trial that evaluated an immediate antibiotic initiation protocol compared with a protocol of specimen-initiated antibiotic initiation in ventilated patients with suspected new-onset pneumonia. At the end of each enrollment arm, physicians at each center were surveyed regarding their overall comfort level with the recently completed treatment arm, and perception of adherence. Both a paired and unpaired analysis was performed. Results: We collected 51 survey responses from 31 unique participants. Providers perceived a higher rate of adherence to the immediate initiation arm than the specimen-initiated arm (Always Adherent: 37.5% vs. 11.1%; p = 0.045). Providers were less comfortable waiting for objective evidence of infection in the specimen-initiated arm than with starting antibiotic agents immediately (Very Comfortable: 83.3% vs. 40.7%; p = 0.004). For the smaller paired analysis, there was no longer a difference in comfort level. Conclusions: There may be differences in provider comfort levels and perceptions of adherence when considering two different antibiotic initiation strategies for suspected pneumonia in ventilated patients. These findings should be considered when planning future studies.

Trial of antibiotic restraint in presumed pneumonia: A Surgical Infection Society multicenter pilot.

BACKGROUND: Pneumonia is the most common intensive care unit-acquired infection in the trauma and emergency general surgery population. Despite guidelines urging rapid antibiotic use, data supporting immediate antibiotic initiation in cases of suspected infection are limited. Our hypothesis was that a protocol of specimen-initiated antibiotic initiation would have similar compliance and outcomes to an immediate initiation protocol. METHODS: We devised a pragmatic cluster-randomized crossover pilot trial. Four surgical and trauma intensive care units were randomized to either an immediate initiation or specimen-initiated antibiotic protocol for intubated patients with suspected pneumonia and bronchoscopically obtained cultures who did not require vasopressors. In the immediate initiation arm, antibiotics were started immediately after the culture regardless of patient status. In the specimen-initiated arm, antibiotics were delayed until objective Gram stain or culture results suggested infection. Each site participated in both arms after a washout period and crossover. Outcomes were protocol compliance, all-cause 30-day mortality, and ventilator-free alive days at 30 days. Standard statistical techniques were applied. RESULTS: A total of 186 patients had 244 total cultures, of which only the first was analyzed. Ninety-three patients (50%) were enrolled in each arm, and 94.6% were trauma patients (84.4% blunt trauma). The median age was 50.5 years, and 21% of the cohort was female. There were no differences in demographics, comorbidities, sequential organ failure assessment, Acute Physiology and Chronic Health Evaluation II, or Injury Severity Scores. Antibiotics were started significantly later in the specimen-initiated arm (0 vs. 9.3 hours; p < 0.0001) with 19.4% avoiding antibiotics completely for that episode. There were no differences in the rate of protocol adherence, 30-day mortality, or ventilator-free alive days at 30 days. CONCLUSION: In this cluster-randomized crossover trial, we found similar compliance rates between immediate and specimen-initiated antibiotic strategies. Specimen-initiated antibiotic protocol in patients with a suspected hospital-acquired pneumonia did not result in worse clinical outcomes compared with immediate initiation. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Efficacy and safety of bariatric revisions in patients older than 65 years old.

BACKGROUND: Bariatric surgery in advanced age patients (>65-years-old) has been proven safe and effective. Revisional bariatric surgery is infrequently required for cases of refractory obesity. However, there is a paucity of data regarding revisional surgery for the elderly. We hypothesize that revisional bariatric surgery is viable and safe in elderly patients. METHODS: Retrospective chart review of all bariatric revisions performed at two high-volume bariatric centers of excellence between 2011 and 2018. Perioperative and long-term outcomes were compared between patients >65 and those <65-years-old. RESULTS: 145 bariatric revisions were performed for weight loss. 10% (N = 15) were >65 years old. There were no differences in mortality between the two groups There was a longer median length of stay in the younger cohort (2 vs 1 day, p = 0.001). Percent excess weight loss was similar at 12-months, as was resolution of comorbidities. CONCLUSIONS: Bariatric revisions in elderly patients appears to be safe and effective. Revisional surgery in this population was not shown to have increased morbidity or mortality with similar excess body weight loss when compared to a younger cohort.

Mobile Smartphone Thermal Imaging Characterization and Identification of Microvascular Flow Insufficiencies in Deep Inferior Epigastric Artery Perforator Free Flaps.

BACKGROUND: Mobile smartphone thermal imaging (MTI) devices correlate with blood flow, which makes them appealing adjuncts during reconstructive surgery. MTI was assessed in the setting of deep inferior epigastric artery perforator (DIEAP) free flaps. We hypothesized that MTI can be a surrogate for blood flow to identify microvascular flow insufficiencies. METHODS: Nineteen patients underwent 30 DIEAP flaps for breast reconstruction. Images were obtained preoperatively, intraoperatively, and at instances of concern for flap viability. Three groups were evaluated: normal DIEAP flaps (NDFs), flaps with arterial insufficiency (AI), and flaps with venous congestion (VC). RESULTS: All flaps were successful. There were significant temperature increases from max ischemia (24.5 ± 2.1°C) to 1 min after anastomosis (27.2 ± 1.6°C, P < 0.001). NDFs continued to warm until the final MTI was taken when leaving the operating room. There were no differences between MTI flap temperatures before transfer to the chest and after completion of microanastomosis. With questionable flap viability, VC and AI temperatures were found to be significantly colder than the NDF group (28.3 ± 1.9°C versus 32.2 ± 1.8°C, P = 0.003) in the VC group and (27.2 ± 0.7°C versus 32.2 ± 1.8°C, P = 0.001) in the AI group. After correction of the identified flow insufficiency, VC and AI rewarmed and temperatures were no different compared with NDF. CONCLUSIONS: MTI recognizes microanastomotic failure and is a practical adjunct in the evaluation of free flap perfusion.

Variations in Courtesy Authorship Perceptions and Practices Among Modern Surgical Journals: The Generation Gap.

BACKGROUND: Academic journals have adopted strict authorship guidelines to eliminate the addition of authors who have not met criteria, also known as "courtesy authors." We sought to analyze current perceptions, practices, and academic rank-related variations in courtesy authorship use among modern surgical journals. METHODS: Authors who published original research articles in 2014-2015 in eight surgical journals were surveyed and categorized as junior (JF) or senior faculty (SF) by years in practice. Responses regarding courtesy authorship perceptions and practices were analyzed. Subanalyses were performed based on journal impact factor. RESULTS: A total of 455 authors responded (34% JF versus 66% SF). SF were older (52 versus 39 y) and more predominantly male (80% versus 61%) versus JF. JF more frequently added a courtesy author to the index publication versus SF (23% versus 13%, P = 0.02), but had similar historical rates of adding courtesy authors (58% versus 51%, P = not significant) or being added as a courtesy author (29% versus 37%, P = not significant). JF felt courtesy authorship was more common in their practice and felt more pressure by superiors to add courtesy authors. Perceptions regarding the practice of courtesy authorship differed significantly, with 70% of JF feeling courtesy authorship use has not declined versus 45% of SF (P < 0.05). Both JF and SF cited courtesy authorship positives, including avoiding author conflicts (17% versus 33%, respectively) and increasing morale (25% versus 45%, respectively). CONCLUSIONS: Courtesy authorship use continues to be common among both JF and SF. However, perceptions about the benefits, harms, and pressures vary significantly by academic rank and with journal impact factor.

An Evaluation of a Novel Medical Device Versus Standard Interventions in the Treatment of Tension Pneumothorax in a Swine Model (Sus scrofa).

INTRODUCTION: Tension pneumothorax is a common cause of preventable death in trauma. Needle decompression is the traditional first-line intervention but has high failure rates. We sought to evaluate the effectiveness and expedience of needle thoracostomy, surgical tube thoracostomy, and Reactor™ thoracostomy - a novel spring-loaded trocar insertion device. MATERIALS AND METHODS: Yorkshire swine underwent controlled thoracic insufflation to create tension pneumothorax physiology for device comparison. Additional experiments were performed by increasing insufflation pressures to achieve pulseless electrical activity. Intervention was randomized to needle thoracostomy (14 gauge), tube thoracostomy (32Fr), or Reactor™ thoracostomy (36Fr). Air leak was simulated throughout intervention with 40-80 mL/kg/min insufflation. Intrathoracic pressure monitoring and hemodynamic parameters were obtained at 1 and 5 minutes. RESULTS: Tension physiology and tension-induced pulseless electrical activity were created in all iterations. Needle thoracostomy (n = 28) was faster at 7.04 ± 3.04 seconds than both Reactor thoracostomy (n = 32), 11.63 ± 5.30 (p < 0.05) and tube thoracostomy (n = 32), 27.06 ± 10.73 (p < 0.01); however, Reactor™ thoracostomy was faster than tube thoracostomy (p < 0.001). Physiological decompression was achieved in all patients treated with Reactor™ and tube thoracostomy, but only 14% of needle thoracostomy. Cardiac recovery to complete physiologic baseline occurred in only 21% (6/28) of those treated with needle thoracostomy whereas Reactor™ or tube thoracostomy demonstrated 88% (28/32) and 94% (30/32) response rates. When combined, needle thoracostomy successfully treated tension pneumothorax in only 4% (1/28) of subjects as compared to 88% (28/32) with Reactor™ thoracostomy and 94% (30/32) with tube thoracostomy (p < 0.01). CONCLUSIONS: Needle thoracostomy provides a rapid intervention for tension pneumothorax, but is associated with unacceptably high failure rates. Reactor™ thoracostomy was effective, expedient, and may provide a useful and technically simpler first-line treatment for tension pneumothorax or tension-induced pulseless electrical activity.

Courtesy Authorship in Academic Surgery Publications.

Importance: Courtesy authorship is defined as including an individual who has not met authorship criteria as an author. Although most journals follow strict authorship criteria, the current incidence of courtesy authorship is unknown. Objective: To assess the practices related to courtesy authorship in surgical journals and academia. Design, Setting, and Participants: A survey was conducted from July 15 to October 27, 2017, of the first authors and senior authors of original articles, reviews, and clinical trials published between 2014 and 2015 in 8 surgical journals categorized as having a high or low impact factor. Main Outcomes and Measures: The prevalence of courtesy authorship overall and among subgroups of authors in high impact factor journals and low impact factor journals and among first authors and senior authors, as well as author opinions regarding courtesy authorship. Results: A total of 203 first authors and 254 senior authors responded (of 369 respondents who provided data on sex, 271 were men and 98 were women), with most being in academic programs (first authors, 116 of 168 [69.0%]; senior authors, 173 of 202 [85.6%]). A total of 17.2% of respondents (42 of 244) reported adding courtesy authors for the surveyed publications: 20.4% by first authors (32 of 157) and 11.5% by senior authors (10 of 87), but 53.7% (131 of 244) reported adding courtesy authorship on prior publications and 33.2% (81 of 244) had been added as a courtesy author in the past. Although 45 of 85 senior authors (52.9%) thought that courtesy authorship has decreased, 93 of 144 first authors (64.6%) thought that courtesy authorship has not changed or had increased (P = .03). There was no difference in the incidence of courtesy authorship for low vs high impact factor journals. Both first authors (29 of 149 [19.5%]) and senior authors (19 of 85 [22.4%]) reported pressures to add courtesy authorship, but external pressure was greater for low impact factor journals than for high impact factor journals (77 of 166 [46.4%] vs 60 of 167 [35.9%]; P = .04). More authors in low impact factor journals than in high impact factor journals thought that courtesy authorship was less harmful to academia (55 of 114 [48.2%] vs 34 of 117 [29.1%]). Overall, senior authors reported more positive outcomes with courtesy authorship (eg, improved morale and avoided author conflicts) than did first authors. Conclusions and Relevance: Courtesy authorship use is common by both first and senior authors in low impact factor journals and high impact factor journals. There are different perceptions, practices, and pressures to include courtesy authorship for first and senior authors. Understanding these issues will lead to better education to eliminate this practice.

Efficacy of intermittent versus standard resuscitative endovascular balloon occlusion of the aorta in a lethal solid organ injury model.

BACKGROUND: High-grade solid organ injury is a major cause of mortality in trauma. Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) can be effective but is limited by ischemia-reperfusion injury. Intermittent balloon inflation/deflation has been proposed as an alternative, but the safety and efficacy prior to operative hemorrhage control is unknown. METHODS: Twenty male swine underwent standardized high-grade liver injury, then randomization to controls (N = 5), 60-min continuous REBOA (cR, n = 5), and either a time-based (10-minute inflation/3-minute deflation, iRT = 5) or pressure-based (mean arterial pressure<40 during deflation, iRP = 5) intermittent schedule. Experiments were concluded after 120 minutes or death. RESULTS: Improved overall survival was seen in the iRT group when compared to cR (p < 0.01). Bleeding rate in iRT (5.9 mL/min) was significantly lower versus cR and iRP (p = 0.02). Both iR groups had higher final hematocrit (26% vs. 21%) compared to cR (p = 0.03). Although overall survival was lower in the iRP group, animals surviving to 120 minutes with iRP had decreased end organ injury (Alanine aminotransferase [ALT] 33 vs. 40 in the iRT group, p = 0.03) and lower lactate levels (13 vs. 17) compared with the iRT group (p = 0.03). No differences were seen between groups in terms of coagulopathy based on rotational thromboelastometry. CONCLUSION: Intermittent REBOA is a potential viable adjunct to improve survival in lethal solid organ injury while minimizing the ischemia-reperfusion seen with full REBOA. The time-based intermittent schedule had the best survival and prolonged duration of tolerable zone 1 placement. Although the pressure-based schedule was less reliable in terms of survival, when effective, it was associated with decreased acidosis and end-organ injury.

Lifesaving interventions in blackout conditions using night vision technology: Come to the dark side.

BACKGROUND: During military combat operations and civilian night-time aeromedical transport, medical providers are frequently required to perform lifesaving interventions (LSIs) in low-light environments. Because definitive surgical care is often delayed until a white light environment is permissible, we sought to determine if night optical device (NOD) technology could enable surgical capabilities in blackout conditions. METHODS: Using a crossover design, six surgeons performed 11 different procedures on six swine, three in normal light conditions (LC) and 3 in blackout conditions (BC) using two-chamber NODs after familiarization with the procedures in both conditions on manikins. Successful completion and procedural times were compared between groups. RESULTS: Blackout conditions were confirmed with ambient light reading of 0.2 lux during BC versus 3962.9 lux for LC (p < 0.001). There were no significant differences in success rates for any procedure. There were no differences in operative times between BC and LC for extremity tourniquet placement, femoral artery cut-down and clamping, resuscitative thoracotomy, or percutaneous resuscitative endovascular balloon occlusion of the aorta placement. The following procedures took significantly longer in BC vs. LC: Focused Assessment with Sonography for Trauma examination (98 seconds vs. 62 seconds), peripheral IV placement (140 seconds vs. 35 seconds), intraosseous access (51 seconds vs. 26 seconds), jugular vein cut-down and access (237 seconds vs. 104 seconds), laparotomy and packing (71 seconds vs. 51 seconds), stapled splenectomy (137 seconds vs. 74 seconds), resuscitative endovascular balloon occlusion of the aorta placement via cutdown (1,008 seconds vs. 338 seconds), and cricothyroidotomy (177 seconds vs. 109 seconds) (all p < 0.05). CONCLUSION: Lifesaving interventions can be safely and effectively performed in blackout conditions using NODs, although increased difficulty with select procedure types was identified. Focused training and technological improvements to currently available devices are needed. LEVEL OF EVIDENCE: Basic science.

Sleeve Gastrectomy for Obesity in Polycystic Ovarian Syndrome: a Pilot Study Evaluating Weight Loss and Fertility Outcomes.

PURPOSE: Polycystic ovarian syndrome (PCOS) is a common endocrine disorder associated with obesity and infertility. Gastric bypass has been shown to be effective in treating these symptoms. However, the efficacy of vertical sleeve gastrectomy (VSG) has not been studied in the PCOS population. This study analyzed weight loss and fertility outcomes of VSG in this population. METHODS: A retrospective review of patients with PCOS and without PCOS (CON) undergoing VSG from 2008 to 2016 was performed at two bariatric centers. BMI and percent excess weight loss (%EWL) were collected at 3, 6, and 12 months postoperatively. Patient characteristics and postoperative pregnancy status were compared between the two cohorts. RESULTS: One hundred nineteen PCOS patients were compared to 119 CON patients. Similar attrition rates were seen between cohorts at 3-month (5 vs 8%), 6-month (13 vs. 14%), and 12-month (18 vs. 13%) evaluation. PCOS patients had greater ΔBMI at 3 months (- 7.64 vs. - 6.82; p = 0.05), 6 months (- 10.56 vs. - 9.49; p = 0.02), and 12 months (- 12.43 vs. - 11.49; p = 0.04). PCOS patients also had greater %EWL at 12 months compared to CON (66 vs 60%; p = 0.05). Twenty-two percent of PCOS patients became pregnant within 12 months, 69% of which were previously nulliparous. CONCLUSION: Compared to non-PCOS patients, PCOS patients had greater postoperative ΔBMI and %EWL at 1 year. The majority of patients becoming pregnant after VSG were previously nulliparous. This study shows that VSG is effective for weight loss in PCOS patients with obesity and may positively augment effect fertility rates.

Extending the golden hour for Zone 1 resuscitative endovascular balloon occlusion of the aorta: Improved survival and reperfusion injury with intermittent versus continuous resuscitative endovascular balloon occlusion of the aorta of the aorta in a porcine severe truncal hemorrhage model.

BACKGROUND: Noncompressible hemorrhage can be controlled using resuscitative endovascular balloon occlusion of the aorta (REBOA). Prolonged ischemia limits REBOA application during Zone 1 deployment. Intermittent inflation/deflation may effectively mitigate this problem. METHODS: A lethal abdominal vascular injury was created in 28 swines. Animals were randomized to controls (n = 7), 60 minutes full REBOA (FR, n = 5), time-based intermittent REBOA (iRT, n = 7), and pressure-based REBOA (iRP, n = 9). Intermittent groups had an initial inflation for 15 minutes, followed by 10-minute inflation: 3-minute deflation cycles (iRT), or an inflate/deflate schedule based on mean arterial pressure (MAP) less than 40 mm Hg (iRP). Experiments were concluded after 120 minutes or death (MAP < 20 mm Hg). RESULTS: Intermittent REBOA animals all survived to 120 minutes versus 15 minutes for controls and 63 minutes for FR (p < 0.001). After 60 minutes, FR animals were more hypotensive (MAP 20 mm Hg vs. 80 mm Hg [iRP] and 100 mm Hg [iRT]; p < 0.001), had lower cardiac output (1.06 mL/min vs. 5.1 L/min [iRP] and 8.2 L/min [iRT]; p < 0.001), higher lactate (12.5 mg/dL vs. 8.5 mg/dL [iRP], p = 0.02), and decreased clot firmness on rotational thromboelastometry than iRP/T (64 mm vs. 69 mm [iRP] and 69 mm [iRT], p = 0.04). Acidosis was worse in iRT versus iRP at 120 minutes (pH 7.28 vs. pH 7.12; p = 0.02), improved lactate (11.9 mg/dL vs. 16.3 mg/dL; p = 0.04), and decreased whole blood resuscitation (452 mL vs. 646 mL, p = 0.05). Blood loss (clot weight) was higher in controls (2.0 kg) versus iRT and iRP (1.16 kg and 1.23 kg; p < 0.01) and not different from FR (0.87 kg; p = 0.10). CONCLUSION: Intermittent REBOA can maintain supraceliac hemorrhage control while decreasing distal ischemia in a swine model. Prolonged survival times, decreased acidosis, and lower resuscitation requirements indicate that this technique could potentially extend Zone 1 REBOA deployment times. Schedules based on MAP may be superior to time-based regimens.

Mobile forward-looking infrared technology allows rapid assessment of resuscitative endovascular balloon occlusion of the aorta in hemorrhage and blackout conditions.

INTRODUCTION: Objective assessment of final resuscitative endovascular balloon occlusion of the aorta (REBOA) position and adequate distal aortic occlusion is critical in patients with hemorrhagic shock, especially as feasibility is being increasingly investigated in the prehospital setting. We propose that mobile forward-looking infrared (FLIR) thermal imaging is a fast, reliable, and noninvasive method to assess REBOA position and efficacy in scenarios applicable to battlefield and prehospital care. METHODS: Ten swine were randomized to a 40% hemorrhage group (H, n = 5) or nonhemorrhage group (NH, n = 5). Three experiments were completed after Zone I placement of a REBOA catheter. Resuscitative endovascular balloon occlusion of the aorta was deployed for 30 minutes in all animals followed by randomized continued deployment versus sham in both light and blackout conditions. Forward-looking infrared images and hemodynamic data were obtained. Images were presented to 62 blinded observers for assessment of REBOA inflation status. RESULTS: There was no difference in hemodynamic or laboratory values at baseline. The H group was significantly more hypotensive (mean arterial pressure 44 vs. 60 mm Hg, p < 0.01), vasodilated (systemic vascular resistance 634 vs. 938dyn·s/cm, p = 0.02), and anemic (hematocrit 12 vs. 23.2%, p < 0.01). Hemorrhage group animals remained more hypotensive, anemic, and acidotic throughout all three experiments. There was a significant difference in the temperature change (ΔTemp) measured by FLIR between animals with REBOA inflated versus not inflated (5.7°C vs. 0.7°C, p < 0.01). The H and NH animals exhibited equal magnitudes of ΔTemp in both inflated and deflated states. Blinded observer analysis of FLIR images correctly identified adequate REBOA inflation and aortic occlusion 95.4% at 5 minutes and 98.8% at 10 minutes (positive predictive value at 5 minutes = 99% and positive predictive value at 10 minutes = 100%). CONCLUSIONS: Mobile thermal imaging is an easy, rapid, and reliable method for assessing distal perfusion after occlusion by REBOA. Smartphone-based FLIR technology allows for confirmation of adequate REBOA placement at the point of care, and performance was not degraded in the setting of major hemorrhage or blackout conditions.

The effects of hemorrhage on the pharmacokinetics of tranexamic acid in a swine model.

BACKGROUND: The early use of tranexamic acid (TXA) is strongly advocated in patients who are likely to require massive transfusion to decrease mortality. This study determines the influence of hemorrhage on the pharmacokinetics of TXA in a porcine model. METHODS: The investigation was a prospective experimental study in Yucatan minipigs. First, in vitro plasma-cell partitioning of TXA was evaluated by inoculating whole blood with known aliquots, centrifuging, and measuring the supernatant with high-performance liquid chromatography with mass spectrometry (HPLC-MS). Then, using in vivo modeling, normovolemic and hypovolemic (35% reduction in blood volume) swine (n = 4 per group) received 1 g of intravenous TXA and had blood sampled at 14 time points over 4 hours to determine baseline clearance via HPLC-MS. Additional swine (n = 4) were hemorrhaged 35% of their blood volume, and TXA was administered as a 15 mg/kg infusion over 10 minutes followed by infusion of 1.875 mg/kg per hour to simulate massive hemorrhage scenario. During the first hour of TXA administration, one total blood volume was hemorrhaged and simultaneously replaced with TXA free blood. Serial blood samples and the hemorrhaged blood were analyzed by HPLC-MS to determine the percentage of dose lost via hemorrhage. RESULTS: Clearance of TXA was diminished in the hypovolemic group compared with the normovolemic group (115 ± 4 vs 70 ± 7 mL/min). Percentage of dose lost via hemorrhage averaged 25%. The lowest measured plasma level during the exchange transfusion was 34 µg/mL. CONCLUSION: Mean 25% of the present 2017 Joint Trauma System Clinical Practice Guideline dosing of TXA can be lost to hemorrhage if a blood volume is transfused within an hour of initiating therapy. In the case of TXA, which has limited distribution and is administered during active hemorrhage and massive blood transfusions, replacement strategies should be developed and tested to find simple methods of adjusting the current dosing guidelines to maintain therapeutic plasma concentrations. LEVEL OF EVIDENCE: Therapeutic, level II.

Esophageal Magnetic Sphincter Augmentation as a Novel Approach to Post-bariatric Surgery Gastroesophageal Reflux Disease.

BACKGROUND: We sought to evaluate the safety and effectiveness of magnetic sphincter augmentation (MSA) in patients with GERD after bariatric surgery. METHODS: Pre- and post-operative GERD quality of life (G-QOL) surveys were conducted. Standard indications (SI) group or the post-bariatric group (PB) created. Outcomes were compared between groups. RESULTS: Twenty-eight patients analyzed with no losses to follow-up. All patients had preoperative testing confirming normal motility and presence of GERD. No patients were lost to follow-up. The PB group (N = 10) were mostly prior sleeve gastrectomies (N = 8) with two previous gastric bypasses. PB patients required larger MSA device size (16 beads) compared to the SI group (14 beads, p < 0.001). Outcomes were no different with percent improvement between pre- and post-operative G-QOL survey scores with 70% improvement for PB and 84% for SI (p = 0.13). Medication cessation was possible in 90% for PB versus 94% for SI (p = 0.99). Rates of post-operative dysphagia were similar between the two groups. CONCLUSIONS: Although larger prospective randomized studies are needed, there is an exciting potential for the role of MSA, providing surgeons a new and much needed tool in their armamentarium against refractory or de novo GERD after bariatric procedures.

Panniculectomy after bariatric surgical weight loss: Analysis of complications and modifiable risk factors.

INTRODUCTION: Bariatric surgery results in massive weight loss, leaving many patients with redundant skin that can cause significant physical and psychosocial limitations. We sought to identify variables associated with postoperative complications and adjuncts associated with the mitigation of postoperative complications. METHODS: A retrospective review was performed of all post-bariatric surgery patients who underwent panniculectomy over a 10-year period. RESULTS: Total 706 patients included. Overall complication rate was 56%: dehiscence (24%), surgical site infection (22%), seroma (18%), and post-operative bleeding (5%). Return to operating room rate was 12%. Significant factors were: BMI >26 (p < 0.01), fleur-de-lis panniculectomy (p < 0.01), concomitant hernia repair (p < 0.01). Multivariate regression analysis demonstrated ASA class >2 (OR 1.97, p < 0.05) and incision type (OR 1.64, p < 0.05) to be independent predictors of morbidity. CONCLUSION: High morbidity for post-bariatric panniculectomy is primarily local wound complications. Potentially modifiable factors that increase the complication risk profile include higher BMI, higher ASA class, and the use of fleur-de-lis incision.

Smartphone-based mobile thermal imaging technology to assess limb perfusion and tourniquet effectiveness under normal and blackout conditions.

BACKGROUND: Over the past decade, there has been a resurgence of tourniquet use in civilian and military settings. Several key challenges include assessment of limb perfusion and adequacy of tourniquet placement, particularly in the austere or prehospital environments. We investigated the utility of thermal imaging to assess adequacy of tourniquet placement. METHODS: The FLIR ONE smartphone-based thermal imager was utilized. Ten swine underwent tourniquet placement with no associated hemorrhage (n = 5) or with 40% hemorrhage (n = 5). Experiment 1 simulated proper tourniquet application, experiment 2 had one of two tourniquets inadequately tightened, and experiment 3 had one of two tourniquets inadequately tightened while simulating blackout-combat conditions. Static images were taken at multiple time points up to 30 minutes. Thermal images were then presented to blinded evaluators who assessed adequacy of tourniquet placement. RESULTS: The mean core temperature was 38.3 °C in non-hemorrhaged animals versus 38.2 °C in hemorrhaged animals. Hemorrhaged animals were more hypotensive (p = 0.001), anemic (p < 0.001), vasodilated (p = 0.008), and had a lower cardiac output (p = 0.007) compared to non-hemorrhaged animals. The thermal imaging temperature reading decreased significantly after proper tourniquet placement in all animals, with no difference between hemorrhaged and non-hemorrhaged groups at 30 minutes (p = 0.23). Qualitative thermal image analysis showed clearly visible perfusion differences in all animals between baseline, adequate tourniquet, and inadequate tourniquet in both hemorrhaged and non-hemorrhaged groups. Ninety-eight percent of blinded evaluators (n = 62) correctly identified adequate and inadequate tourniquet placement at 5 minutes. Images in blackout conditions showed no adverse impact on thermal measurements or in the ability to accurately characterize perfusion and tourniquet adequacy. CONCLUSIONS: A simple handheld smartphone-based forward looking infrared radiometry device demonstrated a high degree of accuracy, reliability, and ease of use for assessing limb perfusion. Forward looking infrared radiometry also allowed for rapid and reliable identification of adequate tourniquet placement that was not affected by major hemorrhage or blackout conditions.