Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

Penetrating Abdominal Aortic Injury: Comparison of ACS-Verified Level-I and II Trauma Centers.

OBJECTIVES: Penetrating abdominal aortic injury (PAAI) is a highly acute injury requiring prompt surgical management. When compared to surgeons at level-II trauma centers, surgeons at level-I trauma centers are more likely to take in-house call, and may more often be available within 15 minutes of patient arrival. Thus, we hypothesized that level-I trauma centers would have a lower mortality rate than level-II trauma centers in patients with PAAI. METHODS: We queried the Trauma Quality Improvement Program database for patients with PAAI, and compared patients treated at American College of Surgeons (ACS)-verified level-I centers to those treated at ACS level-II centers. RESULTS: PAAI was identified in 292 patients treated at level-I centers and 86 patients treated at level-II centers. Patients treated at the 2 center types had similar median age, injury severity scores and prevalence of diabetes, hypertension, and smoking (p > 0.05). There was no difference in the frequency of additional intra-abdominal vascular injuries (p > 0.05). Median time to hemorrhage control (level-I: 40.8 vs level-II: 49.2 minutes, p = 0.21) was similar between hospitals at the 2 trauma center levels. We found no difference in the total hospital length of stay or post-operative complications (p > 0.05). When controlling for covariates, we found no difference in the risk of mortality between ACS verified level-I and level-II trauma centers (OR:1.01, CI:0.28-2.64, p = 0.99). CONCLUSION: Though the majority of PAAIs are treated at level-I trauma centers, we found no difference in the time to hemorrhage control, or the risk of mortality in those treated at level-I centers when compared to those treated at level-II trauma centers. This finding reinforces the ACS-verification process, which strives to achieve similar outcomes between level-I and level-II centers.

Risk Factors for Closure Failure following Percutaneous Transfemoral Transcatheter Aortic Valve Implantation.

BACKGROUND: The percutaneous access site of transfemoral transcatheter aortic valve implantation (TAVI) procedures is commonly closed using a preclosure technique with suture-type closure devices. We sought to evaluate the predictors and outcomes of percutaneous closure device (PCD) failure during transfemoral TAVI. METHODS AND RESULTS: This single-center retrospective analysis included 184 patients who underwent transfemoral TAVI using 2 ProGlide sutures for severe aortic stenosis between July 2011 and September 2018. PCD failure was observed in 11.4%. The causes of PCD failure included 5 cases of insufficient hemostasis, 13 cases of arterial stenosis or occlusion, and 3 cases of dissection. Closure failures were managed by surgical repair in 10 patients and endovascular treatment in 11 patients. In a multivariate binary logistic model, a minimum lumen diameter of the common femoral artery (CFA) (odds ratio [OR] 0.35, 95% confidence interval [CI] 0.15-0.83, P = 0.017) and left femoral access (OR 2.89, 95% CI 1.01-8.30, P = 0.048) was identified as a predictor of PCD failure. PCD failure was not associated with increased mortality (0% vs. 2.5%, P = 1.000) or a major adverse cardiovascular event (MACE; 4.8% vs. 4.3%, P = 1.000) at 30 days. CONCLUSIONS: PCD failures were not uncommon in patients undergoing percutaneous transfemoral TAVI. Small CFA diameter and left femoral access are predictors of PCD failure. However, PCD failures were not associated with increased mortality or MACE.

Management and Outcomes of Isolated Axillary Artery Injury: A Five-Year National Trauma Data Bank Analysis.

BACKGROUND: The aim of this study is to evaluate recent national trends in the clinical characteristics, management, and outcomes of patients with isolated axillary artery injuries. METHODS: The National Trauma Data Bank was queried to identify records submitted from 2011 to 2015 that contained an ICD-9-CM diagnosis code for an injury to axillary artery (903.01) and an external cause of injury code indicating blunt or penetrating trauma. Records that contained a diagnosis code for an injury to an additional blood vessel (900.00-903.00, 903.2-904.9), an injury to a nonupper extremity or unclassifiable body region, or whose operative management could not be discerned were excluded. The final study sample included 221 patients with isolated axillary artery injury. The patient's clinical management was the primary outcome of interest. The study sample was stratified by trauma type, and descriptive statistics were performed on all variables. RESULTS: Seventy-one percent of patients received operative management. Patients with penetrating injury were 24% more likely to be managed operatively than bluntly injured patients (76.9% vs. 62.1%, P = 0.0178). In operatively managed patients, the open repair rate was 82.8% and endovascular repair rate was 10.2%. Graft repair was performed most often (28.0%), followed by placement of a temporary intravenous shunt (17.8%) and surgical occlusion (10.2%). Surgical vessel occlusion was significantly more likely to be performed on patients with penetrating injury than with blunt injury (14.6% vs. 1.9%, P = 0.0124). Patients with penetrating injury had significantly shorter median emergency department length of stay (87.0 min vs. 152.0 min, P < 0.0001), intensive care unit length of stay (2.0 days vs. 3.0 days, P < 0.0388), hospital length of stay (4.0 days vs. 5.0 days, P = 0.0026), and time-to-operative management (1.6 hr vs. 3.9 hr, P < 0.001) compared to bluntly injured patients. Patients with blunt injury had a higher reportable in-hospital complication rate (13.8% vs. 6.0%, P = 0.0477). The overall mortality rate was 3.1% for isolated axillary artery injuries and did not significantly differ by trauma type. CONCLUSIONS: Axillary artery injury is more often caused by penetrating trauma. Despite introduction of novel endovascular techniques, the majority of patients with isolated axillary artery injury are managed using open repair. Penetrating axillary artery injury is significantly more likely to be managed using open repair and by surgical occlusion. Patients with blunt injury have higher complication rates and longer hospital length of stays. The mortality rate is lower than previously published.

Outcomes of patients who undergo percutaneous coronary intervention with covered stents for coronary perforation: A systematic review and pooled analysis of data.

OBJECTIVES: This review aims to evaluate the adverse outcomes for patients after treatment with covered stents. BACKGROUND: Coronary perforation is a potentially fatal complication of percutaneous coronary revascularization which may be treated using covered stents. Studies have evaluated long-term outcomes among patients who received these devices, but hitherto no literature review has taken place. METHODS: We conducted a systematic review of adverse outcomes for patients after treatment with covered stents. Data from studies were pooled and outcomes were compared according to stent type. RESULTS: A total of 29 studies were analyzed with data from 725 patients who received covered stents. The proportion of patients with chronic total occlusions, vein graft percutaneous coronary intervention (PCI), intracoronary imaging and rotational atherectomy were 16.9, 11.5, 9.2, and 6.6%, respectively. The stents used were primarily polytetrafluoroethylene (PTFE) (70%) and Papyrus (20.6%). Mortality, major adverse cardiovascular events, pericardiocentesis/tamponade and emergency surgery were 17.2, 35.3, 27.1, and 5.3%, respectively. Stratified analysis by use of PTFE, Papyrus and pericardial stents, suggested no difference in mortality (p = .323), or target lesion revascularization (p = .484). Stent thrombosis, pericardiocentesis/tamponade and emergency coronary artery bypass surgery (CABG) occurred more frequently in patients with PTFE stent use (p = .011, p = .005, p = .012, respectively). In-stent restenosis was more common with pericardial stent use (<.001, pooled analysis for first- and second-generation pericardial stents). CONCLUSIONS: Cases of coronary perforation which require implantation of a covered stent are associated with a high rate of adverse outcomes. The use of PTFE covered stents appears to be associated with more stent thrombosis, pericardiocentesis/tamponade, and emergency CABG when compared to Papyrus or pericardial stents.

Red Blood Cell Product Transfusion Thresholds and Clinical Outcomes.

OBJECTIVE: To determine whether patients transfused red blood cell (RBC) products according to guideline-specified pretransfusion hemoglobin (Hb) concentrations or for other reasons were more likely to survive their intensive care unit (ICU) stay. DESIGN: An observational study of 375 478 episodes of ICU care, over 5 years, was performed with ICU survival as the primary outcome. Outcomes were analyzed as a function of pretransfusion Hb concentration for groups with distinct transfusion indications while adjusting for potential confounders. SETTING AND PATIENTS: This study included all adult patients discharged from 1 of 203 adult ICUs from 32 US health-care systems. The patients were from community hospitals, tertiary, and academic medical centers. INTERVENTION: Transfusion of allogenic packed RBCs or whole blood was prescribed at the discretion of the treating clinicians. MEASUREMENTS AND MAIN RESULTS: We found that 15% of adult ICU patients are transfused RBC products, and most transfusions for hemodynamically stable patients are administered above the guideline-specified pretransfusion Hb threshold of 7 g/dL. Hemodynamically stable patients transfused below this threshold were significantly more likely to survive their ICU stay than those not transfused (odds ratio [OR] 0.59, 95% confidence interval [CI], 0.43-0.81; P = .001), and patients transfused at thresholds above 9 g/dL were less likely to survive their ICU stay than those not transfused. Patients of the acute blood loss group who were transfused appeared to benefit or were not harmed by transfusion. CONCLUSION: Conservative RBC product transfusion practices for groups that are targeted by guidelines are justified by outcomes observed in clinical practice. This study provides evidence for the liberal administration of RBC products to critically ill adults with acute blood loss based on association with lower risk of mortality.

Prevention and treatment of dilator injuries during central venous catheter placement.

BACKROUND: Misuse of vascular dilators during the placement of central venous catheters has been infrequently reported and can lead to devastating intrathoracic hemorrhage and death. These injuries should be preventable in most cases. If a major intrathoracic vascular injury is recognized intraoperatively, less invasive treatment options are available to minimize the consequences. METHODS: The records of 20 patients who suffered 21 major vascular injuries during insertion of central venous catheters, ports, or dialysis catheters and resulted in malpractice claims over the course of 8 years were analyzed to determine the mechanism of injury, the timing of diagnosis, and how these injuries were treated. How the injury could have been prevented, why earlier diagnosis was not made, and what treatment options were possible were also examined. RESULTS: Twelve women and eight men were documented to have sustained intrathoracic major venous injuries during catheter insertions. There were five injuries to the superior vena cava, six to the right innominate vein, and 10 to the left innominate vein. All procedures were done using fluoroscopic guidance, and resistance to passage of the dilators was documented in eight cases. In most cases, the operator reported inserting the dilators to their maximum length. In four cases, the catheter could be seen intraoperatively in the thoracic cavity. Bleeding was diagnosed in the operating room in 11 cases, in the postanesthesia care unit in seven cases, and on postoperative days 2 and 5 after misplaced catheters were removed. Ten patients underwent thoracotomies and one patient each underwent thoracoscopy and placement of a covered stent in an attempt to stop the hemorrhage. Eight patients died before the diagnosis was made. Seventeen patients died. CONCLUSIONS: In spite of U.S. Food and Drug Administration warnings, dilators are still inserted too far in patients, resulting in devastating hemorrhage. These complications are preventable if proper technique is used. When a catheter is noted to be misplaced, it must not be removed before either a covered stent or thoracoscopy is available; otherwise, uncontrolled hemorrhage into the chest may occur. If a patient becomes unstable in the operating room or immediate postoperative period injury to a major vein must be considered and corrected quickly.

Earlier time to hemostasis is associated with decreased mortality and rate of complications: Results from the Pragmatic Randomized Optimal Platelet and Plasma Ratio trial.

BACKDROP: Clinicians intuitively recognize that faster time to hemostasis is important in bleeding trauma patients, but these times are rarely reported. METHODS: Prospectively collected data from the Pragmatic Randomized Optimal Platelet and Plasma Ratios trial were analyzed. Hemostasis was predefined as no intraoperative bleeding requiring intervention in the surgical field or resolution of contrast blush on interventional radiology (IR). Patients who underwent an emergent (within 90 minutes) operating room (OR) or IR procedure were included. Mixed-effects Poisson regression with robust error variance (controlling for age, Injury Severity Score, treatment arm, injury mechanism, base excess on admission [missing values estimated by multiple imputation], and time to OR/IR as fixed effects and study site as a random effect) with modified Bonferroni corrections tested the hypothesis that decreased time to hemostasis was associated with decreased mortality and decreased incidence of acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), multiple-organ failure (MOF), sepsis, and venous thromboembolism. RESULTS: Of 680 enrolled patients, 468 (69%) underwent an emergent procedure. Patients with decreased time to hemostasis were less severely injured, had less deranged base excess on admission, and lower incidence of blunt trauma (all p < 0.05). In 408 (87%) patients in whom hemostasis was achieved, every 15-minute decrease in time to hemostasis was associated with decreased 30-day mortality (RR, 0.97; 95% confidence interval [CI], 0.94-0.99), AKI (RR, 0.97; 95% CI, 0.96-0.98), ARDS (RR, 0.98; 95% CI, 0.97-0.99), MOF (RR, 0.94; 95% CI, 0.91-0.97), and sepsis (RR, 0.98; 95% CI, 0.96-0.99), but not venous thromboembolism (RR, 0.99; 95% CI, 0.96-1.03). CONCLUSION: Earlier time to hemostasis was independently associated with decreased incidence of 30-day mortality, AKI, ARDS, MOF, and sepsis in bleeding trauma patients. Time to hemostasis should be considered as an endpoint in trauma studies and as a potential quality indicator. LEVEL OF EVIDENCE: Therapeutic/care management, level III.

Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.

BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear. METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death. CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.

Machine Learning to Predict Outcomes in Patients with Acute Gastrointestinal Bleeding: A Systematic Review.

Risk stratification of patients with gastrointestinal bleeding (GIB) is recommended, but current risk assessment tools have variable performance. Machine learning (ML) has promise to improve risk assessment. We performed a systematic review to evaluate studies utilizing ML techniques for GIB. Bibliographic databases and conference abstracts were searched for studies with a population of overt GIB that used an ML algorithm with outcomes of mortality, rebleeding, hemostatic intervention, and/or hospital stay. Two independent reviewers screened titles and abstracts, reviewed full-text studies, and extracted data from included studies. Risk of bias was assessed with an adapted Quality in Prognosis Studies tool. Area under receiver operating characteristic curves (AUCs) were the primary assessment of performance with AUC ≥ 0.80 predefined as an acceptable threshold of good performance. Fourteen studies with 30 assessments of ML models met inclusion criteria. No study had low risk of bias. Median AUC reported in validation datasets for predefined outcomes of mortality, intervention, or rebleeding was 0.84 (range 0.40-0.98). AUCs were higher with artificial neural networks (median 0.93, range 0.78-0.98) than other ML models (0.81, range 0.40-0.92). ML performed better than clinical risk scores (Glasgow-Blatchford, Rockall, Child-Pugh, MELD) for mortality in upper GIB. Limitations include heterogeneity of ML models, inconsistent comparisons of ML models with clinical risk scores, and high risk of bias. ML generally provided good-excellent prognostic performance in patients with GIB, and artificial neural networks tended to outperform other ML models. ML was better than clinical risk scores for mortality in upper GIB.

Effect of hospital-admission volume on outcomes following acute non-variceal upper gastrointestinal bleeding.

INTRODUCTION: Treatment-requiring acute non-variceal upper gastrointestinal bleeding (NVUGIB) is a common, potentially life-threatening emergency. This study investigated whether hospital admittance volume of patients with NVUGIB was associated with reduced mortality, reduced lasting failure of haemostatic procedures defined as rate of re-endoscopy with repeated haemostasis intervention (ReWHI), transfusion requirements and conversion to surgery. METHODS: Data on Danish nationwide admissions of patients with acute NVUGIB from 2011-2013 were analysed to estimate 30-day mortality, re-bleeding (ReWHI), transfusion rates and rates of conversion to surgery. Data were analysed by regression modelling while controlling for confounders including age, admission haemoglobin, the American College of Anesthesiologists score, comorbidities and the Forrest classification. RESULTS: A total of 3,537 patients with acute non-variceal upper gastrointestinal bleeding were included in the study. The hospital admission volume of patients with NVUGIB was positively associated with a significant increase in ReWHI with an odds ratio of 1.27; p = 1.91 × 10-6. There was no significant association between admission volume and conversion to surgery, 30-day mortality or transfusion rates. CONCLUSIONS: A positive association between admission volumes of patients with NVUGIB and ReWHI was identified. No association between admission volumes and 30-day mortality or other failure of haemostasis events could be identified. FUNDING: none. TRIAL REGISTRATION: not applicable.

Is a covered stent justifiable in the treatment of coronary artery perforation? An observational analysis of long-term results of two different covered stent types.

OBJECTIVES: In this retrospective observational study, we investigate outcome of patients treated with or without covered stent (CS) implantation in the management of coronary artery perforation (CAP) during coronary intervention. BACKGROUND: CSs have shown to be effective devices to achieve acute hemostasis in large CAP. However, doubts have been raised regarding their long-term outcome. METHODS: Data of 19 061 PCI procedures during a 10-year period were reviewed. Fifty-five cases of large CAP were withheld (Ellis type 2, 3 or cavity spilling). All medical and procedural records of these cases were retrospectively reviewed. RESULTS: Twenty-four (43.6%) patients were treated with CS implantation (15 polytetrafluoroethylene and 9 pericardium CSs). Twenty-six (47.3%) patients were managed without CS implantation, of whom five had unsuccessful delivery of a CS (stent delivery failure 17.2%). Although significantly more Ellis type-3 perforations were present in the CS group compared to the Non-CS group (75.0% vs 45.2%; P = 0.03), in-hospital mortality was not significantly different (8.3% vs 6.4%; [P = 0.79]). We observed a high rate of CS restenosis (29.2%) but a lower rate of CS thrombosis (4.2%). Despite these observations, 5-year MACE and all-cause mortality were not significantly different between CS and Non-CS group (respectively, 58.8% vs 50.0% (P = 0.26) and 26.7% vs 13.3% (P = 0.36)). CONCLUSION: Although deliverability of CSs was not flawless and a high rate of CS restenosis appeared, short- and long-term outcome were comparable between patients treated with or without CS. Therefore, CSs are justifiable in the treatment of CAP.

Outcome measures in clinical trials of treatments for acute severe haemorrhage.

BACKGROUND: Acute severe haemorrhage is a common complication of injury, childbirth, surgery, gastrointestinal pathologies and other medical conditions. Bleeding is a major cause of death, but patients also die from non-bleeding causes, the frequency of which varies by the site of haemorrhage and between populations. Because patients can bleed to death within hours, established interventions inevitably take priority over randomisation into a trial. These circumstances raise challenges in selecting appropriate outcome measures for clinical trials of haemostatic interventions. MAIN BODY: We use data from three large randomised controlled trials in acute severe haemorrhage (CRASH-2, WOMAN and HALT-IT) to explore the strengths and limitations of outcome measures commonly used in trials of haemostatic treatments, including all-cause and cause-specific mortality, blood transfusion and surgical interventions. Many deaths following acute severe haemorrhage are due to patient comorbidities or complications rather than bleeding. If non-bleeding deaths are unaffected by a haemostatic intervention, even large trials will have low power to detect an effect on all-cause mortality. Due to the dilution from deaths unaffected or reduced by the trial treatment, all-cause mortality can also obscure important harmful effects. Additionally, because the relative contributions of different causes of death vary within and between patient populations, all-cause mortality is not generalisable. Different causes of death occur at different time intervals from bleeding onset, with bleeding deaths generally occurring early. Time-specific mortality can therefore be used as a proxy for cause in un-blinded trials where bias is a concern or in situations where cause of death cannot be assessed. Urgent treatment is critical, and so post-randomisation blood transfusion and surgery are often planned before or at the time of randomisation and therefore cannot be influenced by the trial treatment. CONCLUSIONS: All-cause mortality has low power, lacks generalisability and can obscure harmful effects. Cause-specific mortality, such as death due to bleeding or thrombosis, avoids these drawbacks. In certain scenarios, time-specific mortality can be used as a proxy for cause-specific mortality. Blood transfusion and surgical procedures have limited utility as outcome measures in trials of haemostatic treatments.

Impact of percutaneous femoral arteriotomy closure using the MANTATM device on vascular and bleeding complications after transcatheter aortic valve replacement.

OBJECTIVES: To evaluate the feasibility of fully percutaneous closure using a novel collagen-based vascular closure device after transfemoral aortic valve replacement (TAVR). BACKGROUND: TAVR is utilized increasingly for the treatment of severe symptomatic aortic stenosis. Vascular complications related to access and closure dominate the adverse event profile of the procedure despite progressively reducing arteriotomy caliber. The advent of a novel collagen-based device (MANTATM ) and preliminary data suggest this could be used as a routine percutaneous closure device. METHODS: A prospective observational study of unselected consecutive patients undergoing TAVR in a single center. Data were collected via hospital electronic records and the SWEDEHEART registry. The primary clinical outcome was closure success and time to hemostasis. Secondary outcomes included VARC-2 defined major and minor vascular and bleeding complications within 30 days using suture-based closure with Prostar-XL within the same center. RESULTS: A consecutive cohort of 346 patients underwent TAVR via the transfemoral approach. Vascular closure with MANTATM was successful in all with a mean time to hemostasis of 42 sec (SD 115.5, range 0-600). The composite of all-cause mortality and major complications related to the main access site was similar between the groups (1.1% vs 1.9%, P = .61). Major bleeding occurred less frequently with MANTA TM (1.1% vs 7.8%, P = .02). CONCLUSION: The novel use of a collagen-based vascular closure device for large caliber arteriotomy is feasible in an unselected population undergoing transfemoral TAVR and appears efficacious compared to percutaneous suture-based closure. These data should prompt larger studies to evaluate efficacy and safety.

Vascular complications after balloon aortic valvuloplasty in recent years: Incidence and comparison of two hemostatic devices.

OBJECTIVES: To define the incidence of vascular complications (VC) after balloon aortic valvuloplasty (BAV) in recent years, and to compare the performance of two vascular closure devices (VCD). BACKGROUND: VC remain the most frequent drawback of BAV and are associated with adverse clinical outcomes. METHODS: All BAV procedures performed at 2 high-volume centers over a 6-year period (n = 930) were collected in prospective registries and investigated to assess the incidence of Valve Academic Research Consortium-2 (VARC-2) defined VC. Incidence of life-threatening, major and minor bleeding was also assessed. In-hospital major adverse cardiac and cerebrovascular events (MACCE) rate (composite of in-hospital death, myocardial infarction, TIA/stroke, and life-threatening bleeding) as well as 30-day survival was compared between a suture-mediated closure system and a collagen plug hemostatic device. RESULTS: A 9 Fr arterial sheath was used in most of the patients (84.1%). Vascular closure was obtained with the Angio-Seal in 643 patients (69.1%) and the ProGlide in 287 (30.9%). The overall incidence of major VC was 2.7%, and minor VC 6.6%, without significant differences between groups. The Angio-Seal group was associated with a higher rate of small hematomas (6.9% vs. 3.5%, P = 0.042), whilst blood transfusions were more frequent in the ProGlide group (6.6% vs. 3.5%, P = 0.034). Rates of in-hospital MACCE and 30-day survival were similar. Use of either VCD was not independently associated with major VC. CONCLUSIONS: VC rate after BAV is fairly low in experienced centers without major differences between the 2 most used VCD.

Acute lower gastrointestinal haemorrhage: outcomes and risk factors for intervention in 949 emergency cases.

PURPOSE: Outcomes of acute lower gastrointestinal haemorrhage (ALGIH) are mostly derived from studies performed in the sub-acute/elective rather than the emergency department (ED) setting. The aims of this study were to determine the incidence and outcomes of patients presenting to a tertiary hospital ED with ALGIH and to identify associated clinicopathological risk factors. METHOD: A retrospective observational cohort study of consecutive patients presenting with ALGIH to a tertiary hospital ED was performed. Primary outcome measures included mortality and hospital (including high dependency [HDU]) admission. Secondary outcome measures included rates of (i) blood transfusion, (ii) radiological/endoscopic investigation(s) and (iii) therapeutic intervention. RESULTS: ALGIH accounted for 949 (512 M, mean age 62.3 years) of 130,262 (0.73%) ED presentations, of which 285 patients (30.1%) were on anti-platelet/coagulant therapy. There were five deaths (0.5%). Hospital admission was required in 498 patients (52.5%), of which 19 (3.8%) required HDU monitoring. Hospital admission was twice as likely in males and four times more likely in patients >75 years old and those taking multiple anti-platelet/coagulant therapy (P < 0.05). Blood product transfusion was required in 172 patients (34.5%), specialist investigations in 230 (46.2%) and therapeutic intervention in 51 (10.2%) (surgery in 24 [4.8%]; endoscopic haemostasis in 20 [4.0%] and angiographic embolisation in 9 [1.8%] patients). CONCLUSION: ALGIH accounts for 1% of all ED presentations, with half requiring hospital admission. Mortality and surgical intervention rates are low and although most patients can be managed supportively, access to interventional radiology/endoscopy is important.

Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial.

BACKGROUND: Haemorrhage is a leading cause of death in severe trauma. Fibrinogen plays a critical role in maintaining haemostasis in traumatic haemorrhage. Early fibrinogen replacement is recommended by several international trauma guidelines using either fibrinogen concentrate (FC) or cryoprecipitate (Cryo). There is limited evidence to support one product over the other with widespread geographic and institutional variation in practice. This pilot trial is the first randomised controlled trial comparing FC to Cryo in traumatic haemorrhage. METHODS/DESIGN: The Fibrinogen Early In Severe Trauma studY (FEISTY) is an exploratory, multicentre, randomised controlled trial comparing FC to Cryo for fibrinogen supplementation in traumatic haemorrhage. This trial will utilise thromboelastometry (ROTEM®) to guide and dose fibrinogen supplementation. The trial will recruit 100 trauma patients at four major trauma centres in Australia. Adult trauma patients with evidence of haemorrhage will be enrolled on arrival in the trauma unit and randomised to receiving fibrinogen supplementation with either FC or Cryo. The primary outcome is the differential time to fibrinogen supplementation. There are a number of predetermined secondary outcomes including: effects of the intervention on plasma fibrinogen levels, feasibility assessments and clinical outcomes including transfusion requirements and mortality. DISCUSSION: The optimal method for replacing fibrinogen in traumatic haemorrhage is fiercely debated. In this trial the feasibility and efficacy of fibrinogen supplementation using FC will be compared to Cryo. The results of this pilot study will facilitate the design of a larger trial with sufficient power to address patient-centred outcomes. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02745041 . Registered 4 May 2016.

Dialysis Access Hemorrhage: Access Rescue from a Surgical Emergency.

BACKGROUND: Hemorrhage from a dialysis access can be a life-threatening condition. This study details our experience using access rescue strategies, including in situ graft replacement, primary repair, or conversion to an autogenous fistula, coupled with treatment of central vein occlusion to maintain access usage in patients presenting with conduit hemorrhage. METHODS: During a 3-year period (2012-2014), 26 patients (14 women, 12 men) on chronic hemodialysis were treated for access conduit bleeding (n = 18) or life-threatening hemorrhage (n = 8), located in the upper extremity (n = 23) or thigh (n = 3). All patients had developed bleeding from a skin eschar/ulcer over a bovine (n = 9) or polytetrafluoroethylene (n = 9) bridge graft, or aneurysmal autogenous fistula (n = 8). A retrospective review of outcome relative to clinical signs, etiology of conduit bleeding (infection, wall erosion), and the type of rescue procedure(s) was performed. Duplex ultrasound testing was used to guide therapy based on the presence of aneurysmal degeneration, perigraft fluid, or access flow pattern indicative of venous outflow obstruction. RESULTS: One-half of the patients were taken emergently to the operating room for hemorrhage control or impending rupture of an infected false aneurysm, the remaining repaired on an urgent basis. In 18 patients, emergency room personnel attempted control of access site bleeding by suturing (n = 14) or tourniquet (n = 4). Dialysis access salvage was achieved in 22 (85%) of 26 patients by in situ conduit replacement using a rifampin-soaked polytetrafluoroethylene conduit (n = 19) or primary repair (n = 3). Two patients with sepsis and ruptured, infected false aneurysm were treated by ligation, and 2 patients with nonsalvable access had conversion to an autogenous fistula. One-third of rescued accesses (n = 7) had staged endovascular treatment of central vein stenosis. One patient died within 30 days. All dialysis access revisions remained patent and used for immediate dialysis (n = 5), within 4-5 weeks (n = 19), or after vein maturation (n = 2). One replaced graft was revised for infection. Positive blood or bleeding site cultures were obtained from 9 (45%) of 20 patients tested. CONCLUSIONS: Salvage of a functional dialysis access is possible in the majority of patients presenting with conduit hemorrhage. Loss of wall integrity, infection, and venous hypertension were etiologic factors. Application of in situ graft replacement strategies known to be effective in the treatment of graft infection should be considered in the management of this surgical emergency.

Does the presence of an emergency physician influence pre-hospital time, pre-hospital interventions and the mortality of severely injured patients? A matched-pair analysis based on the trauma registry of the German Trauma Society (TraumaRegister DGU®).

PURPOSE: The role of emergency physicians in the pre-hospital management of severely injured patients remains controversial. In Germany and Austria, an emergency physician is present at the scene of an emergency situation or is called to such a scene in order to provide pre-hospital care to severely injured patients in approximately 95% of all cases. By contrast, in the United States and the United Kingdom, paramedics, i.e. non-physician teams, usually provide care to an injured person both at the scene of an incident and en route to an appropriate hospital. We investigated whether physician or non-physician care offers more benefits and what type of on-site care improves outcome. MATERIAL AND METHODS: In a matched-pair analysis using data from the trauma registry of the German Trauma Society, we retrospectively (2002-2011) analysed the pre-hospital management of severely injured patients (ISS ≥16) by physician and non-physician teams. Matching criteria were age, overall injury severity, the presence of relevant injuries to the head, chest, abdomen or extremities, the cause of trauma, the level of consciousness, and the presence of shock. RESULTS: Each of the two groups, i.e. patients who were attended by an emergency physician and those who received non-physician care, consisted of 1235 subjects. There was no significant difference between the two groups in pre-hospital time (61.1 [SD 28.9] minutes for the physician group and 61.9 [SD 30.9] minutes for non-physician group). Significant differences were found in the number of pre-hospital procedures such as fluid administration, analgosedation and intubation. There was a highly significant difference (p<0.001) in the number of patients who received no intervention at all applying to 348 patients (28.2%) treated by non-physician teams and to only 31 patients (2.5%) in the physician-treated group. By contrast, there was no significant difference in mortality within the first 24h and in mortality during hospitalisation. CONCLUSION: This retrospective analysis does not allow definitive conclusions to be drawn about the optimal model of pre-hospital care. It shows, however, that there was no significant difference in mortality although patients who were attended by non-physician teams received fewer pre-hospital interventions with similar scene times.

Trends in 1029 trauma deaths at a level 1 trauma center: Impact of a bleeding control bundle of care.

BACKGROUND: Over the last decade the age of trauma patients and injury mortality has increased. At the same time, many centers have implemented multiple interventions focused on improved hemorrhage control, effectively resulting in a bleeding control bundle of care. The objective of our study was to analyze the temporal distribution of trauma-related deaths, the factors that characterize that distribution and how those factors have changed over time at our urban level 1 trauma center. METHODS: Records at an urban Level 1 trauma center were reviewed. Two time periods (2005-2006 and 2012-2013) were included in the analysis. Mortality rates were directly adjusted for age, gender and mechanism of injury. The Mann-Whitney and chi square tests were used to compare variables between periods, with significance set at 0.05. RESULTS: 7080 patients (498 deaths) were examined in 2005-2006, while 8767 patients (531 deaths) were reviewed in 2012-2013. The median age increased 6 years, with a similar increase in those who died. In patients that died, no differences by gender, race or ethnicity were observed. Fall-related deaths are now the leading cause of death. Traumatic brain injury (TBI) and hemorrhage accounted for >91% of all deaths. TBI (61%) and multiple organ failure or sepsis (6.2%) deaths were unchanged, while deaths associated with hemorrhage decreased from 36% to 25% (p<0.01). Across time periods, 26% of all deaths occurred within one hour of hospital arrival, while 59% occurred within 24h. Unadjusted mortality dropped from 7.0% to 6.1 (p=0.01) and in-hospital mortality dropped from 6.0% to 5.0% (p<0.01). Adjusted mortality dropped 24% from 7.6% (95% CI: 6.9-8.2) to 5.8% (95% CI: 5.3-6.3) and in-hospital mortality decreased 30% from 6.6% (95% CI: 6.0-7.2) to 4.7 (95% CI: 4.2-5.1). CONCLUSIONS: Over the same time frame of this study, increases in trauma death across the globe have been reported. This single-site study demonstrated a significant reduction in mortality, attributable to decreased hemorrhagic death. It is possible that efforts focused on hemorrhage control interventions (a bleeding control bundle) resulted in this reduction. These changing factors provide guidance on future prevention and intervention efforts.