Acute pancreatitis is a potentially life-threatening condition with a wide spectrum of clinical presentation and illness severity. An infection of pancreatic necrosis (IPN) results in a more than ...twofold increase in mortality risk as compared with patients with sterile necrosis. We sought to identify prognostic factors for the development of IPN among adult patients with severe or necrotizing pancreatitis.
We conducted this prognostic review in accordance with systematic review methodology guidelines. We searched six databases from inception through March 21, 2021. We included English language studies describing prognostic factors associated with the development of IPN. We pooled unadjusted odds ratio (uOR) and adjusted odds ratios (aOR) for prognostic factors using a random-effects model. We assessed risk of bias using the Quality in Prognosis Studies tool and certainty of evidence using the GRADE approach.
We included 31 observational studies involving 5,210 patients. Factors with moderate or higher certainty of association with increased IPN risk include older age (uOR, 2.19; 95% confidence interval CI, 1.39-3.45, moderate certainty), gallstone etiology (aOR, 2.35; 95% CI, 1.36-4.04, high certainty), greater than 50% necrosis of the pancreas (aOR, 3.61; 95% CI, 2.15-6.04, high certainty), delayed enteral nutrition (aOR, 2.09; 95% CI, 1.26-3.47, moderate certainty), multiple or persistent organ failure (aOR, 11.71; 95% CI, 4.97-27.56, high certainty), and invasive mechanical ventilation (uOR, 12.24; 95% CI, 2.28-65.67, high certainty).
This meta-analysis confirms the association between several clinical early prognostic factors and the risk of IPN development among patients with severe or necrotizing pancreatitis. These findings provide the foundation for the development of an IPN risk stratification tool to guide more targeted clinical trials for prevention or early intervention strategies.
Systematic review and meta-analysis, Level IV.
Blunt abdominal solid organ injury is common and is often managed nonoperatively. Clinicians must balance risk of both hemorrhage and thrombosis. The optimal timing of pharmacologic venous ...thromboembolism prophylaxis (VTEp) initiation in this population is unclear. The objective was to evaluate early (< 48 h) compared to late initiation of VTEp in adult trauma patients with blunt abdominal solid organ injury managed nonoperatively.
Embase, MEDLINE, and the Cochrane Central Register of Controlled Trials were searched from inception to March 2021. Studies comparing timeframes of VTEp initiation were considered. The primary outcome was failure of nonoperative management (NOM) after VTEp initiation. Secondary outcomes included risk of transfusion, other bleeding complications, risk of deep vein thrombosis (DVT) and pulmonary embolism, and mortality.
Ten cohort studies met inclusion criteria, with a total of 4642 patients. Meta-analysis revealed a statistically significant increase in the risk of failure of NOM among patients receiving early VTEp (OR 1.76, 95% CI 1.01-3.05, p = 0.05). There was no significant difference in risk of transfusion. Odds of DVT were significantly lower in the early group (OR 0.36, 95% CI 0.22-0.59, p < 0.0001). There was no difference in mortality (OR 1.50, 95% CI 0.82-2.75, p = 0.19). All studies were at serious risk of bias due to confounding.
Initiation of VTEp earlier than 48 h following hospitalization is associated with an increased risk of failure of NOM but a decreased risk of DVT. Absolute failure rates of NOM are low. Initiation of VTEp at 48 h may balance the risks of bleeding and VTE.
Abstract
Background
Postoperative atrial fibrillation (POAF) is a frequent adverse event after thoracic surgery with associated morbidity, mortality, and healthcare costs. It has been shown to be ...preventable with prophylactic amiodarone, which is only recommended in high-risk individuals due to the potential associated side effects. Risk factors for POAF have been identified and incorporated into a prediction model to identify high-risk patients. Further evaluation in the form of a multicenter clinical trial is required to assess the effectiveness of prophylaxis specifically in this high-risk population. The feasibility of such a trial first needs to be assessed.
Methods
The PREP-AF trial is a double-blind randomized controlled feasibility trial. Individuals undergoing major thoracic surgery who are identified to be high-risk by the POAF prediction model will be randomized 1:1 to receive a short course of amiodarone vs. placebo in the immediate postoperative period. The primary outcome is feasibility, which will be measured by the number of eligible patients identified, consented, and randomized; intervention adherence; and measurement of future outcomes of a full trial.
Discussion
This study will determine the feasibility of a randomized controlled trial to assess the effectiveness of prophylactic amiodarone, in high-risk patients undergoing major thoracic surgery. This will inform the development of a multi-center trial to establish if prophylactic amiodarone is safe and effective at reducing the incidence of POAF. Preventing this adverse event will not only improve outcomes for patients but also reduce the associated health resource utilization and costs.
Trial registration
ClinicalTrials.gov
NCT04392921
. Registered on 19 May 2020.
Blood loss and red blood cell (RBC) transfusion in liver surgery are areas of concern for surgeons, anesthesiologists, and patients alike. While various methods are employed to reduce surgical blood ...loss, the evidence base surrounding each intervention is limited. Hypovolemic phlebotomy, the removal of whole blood from the patient without volume replacement during liver transection, has been strongly associated with decreased bleeding and RBC transfusion in observational studies. This trial aims to investigate whether hypovolemic phlebotomy is superior to usual care in reducing RBC transfusions in liver resection.
This study is a double-blind multicenter randomized controlled trial. Adult patients undergoing major hepatic resections for any indication will be randomly allocated in a 1:1 ratio to either hypovolemic phlebotomy and usual care or usual care alone. Exclusion criteria will be minor resections, preoperative hemoglobin <100g/L, renal insufficiency, and other contraindication to hypovolemic phlebotomy. The primary outcome will be the proportion of patients receiving at least one allogeneic RBC transfusion unit within 30 days of the onset of surgery. Secondary outcomes will include transfusion of other allogeneic blood products, blood loss, morbidity, mortality, and intraoperative physiologic parameters. The surgical team will be blinded to the intervention. Randomization will occur on the morning of surgery. The sample size will comprise 440 patients. Enrolment will occur at four Canadian academic liver surgery centers over a 4-year period. Ethics approval will be obtained at participating sites before enrolment.
The results of this randomized control trial will provide high-quality evidence regarding the use of hypovolemic phlebotomy in major liver resection and its effects on RBC transfusion. If proven to be effective, this intervention could become standard of care in liver operations internationally and become incorporated within perioperative patient blood management programs.
ClinicalTrials.gov NCT03651154 . Registered on August 29 2018.
Background: Guidelines recommend preoperative nutrition optimization in patients with penetrating Crohn disease. However, recommendations on formulation, route of administration, and duration are ...lacking. The purpose of this review was to determine if a superior preoperative nutritional optimization strategy exists for patient undergoing surgery for penetrating Crohn disease. Methods: Electronic databases were searched from January 2000 to February 2021 for studies reporting preoperative nutritional optimization strategies in patients undergoing surgery for septic complications from penetrating Crohn disease. Information pertaining to study design, patient population, preoperative nutritional optimization strategy, and postoperative adverse events were extracted. Qualitative synthesis and meta-analysis using a random-effects model were performed as appropriate. Results: Seven retrospective, 5 prospective cohort, and 1 randomized controlled trial involving 1518 patients were included. Seven studies compared exclusive enteral nutrition (EEN) to standard of care; the remainder compared various other nutritional regimens, including oral nutritional supplementation and parenteral nutrition. In the meta-analysis of studies comparing EEN to standard of care, EEN was associated with reduction in anastomotic leak (odds ratio OR 0.41, 95% confidence interval CI 0.20-0.84, n = 5 studies, 587 patients), wound infection (OR 0.47, 95% CI 0.3-0.75, n = 6 studies, 657 patients), and a trend toward reduction in postoperative adverse events (OR 0.56, 95% CI 0.31-1.01). There was no difference in risk of diverting loop ileostomy at the time of surgery or length of hospital stay. This review had several limitations. First, the majority of included studies were retrospective and observational in nature; this likely introduced significant selection bias into the results, thereby limiting the certainty of conclusions that can be drawn from this meta-analysis. Furthermore, the limited number of studies reporting adjusted data precluded sensitivity analysis of adjusted data. There was also appreciable heterogeneity in baseline characteristics of included patient populations as well as in the formulation and duration of the prescribed nutritional regimens. Finally, the lack of studies evaluating nutritional optimization strategies other than EEN, such as parenteral nutrition, limits our ability to determine and compare the efficacy of these techniques. Conclusion: Nutritional optimization with EEN may be associated with improved postoperative outcomes in patients undergoing bowel resection for penetrating Crohn disease, specifically anastomotic leak and wound infection. The development of a standardized evidence-based preoperative nutritional optimization strategy is warranted for this complex patient population.
To evaluate the effect of intraoperative blood cell salvage and autotransfusion (IBSA) use on red blood cell (RBC) transfusion and postoperative outcomes in liver surgery.
Intraoperative RBC ...transfusions are common in liver surgery and associated with increased morbidity. IBSA can be utilized to minimize allogeneic transfusion. A theoretical risk of cancer dissemination has limited IBSA adoption in oncologic surgery.
Electronic databases were searched from inception until May 2021. All studies comparing IBSA use with control in liver surgery were included. Screening, data extraction, and risk of bias assessment were conducted independently, in duplicate. The primary outcome was intraoperative allogeneic RBC transfusion (proportion of patients and volume of blood transfused). Core secondary outcomes included: overall survival and disease-free survival, transfusion-related complications, length of hospital stay, and hospitalization costs. Data from transplant and resection studies were analyzed separately. Random effects models were used for meta-analysis.
Twenty-one observational studies were included (16 transplant, 5 resection, n=3433 patients). Seventeen studies incorporated oncologic indications. In transplant, IBSA was associated with decreased allogeneic RBC transfusion mean difference -1.81, 95% confidence interval (-3.22, -0.40), P =0.01, I 2 =86%, very-low certainty. Few resection studies reported on transfusion for meta-analysis. No significant difference existed in overall survival or disease-free survival in liver transplant hazard ratio (HR)=1.12 (0.75, 1.68), P =0.59, I 2 =0%; HR=0.93 (0.57, 1.48), P =0.75, I 2 =0% and liver resection HR=0.69 (0.45, 1.05), P =0.08, I 2 =0%; HR=0.93 (0.59, 1.45), P =0.74, I 2 =0%.
IBSA may reduce intraoperative allogeneic RBC transfusion without compromising oncologic outcomes. The current evidence base is limited in size and quality, and high-quality randomized controlled trials are needed.
The objective of this work was to carry out a systematic review of clinical practice guidelines (CPGs) pertaining to intraoperative red blood cell (RBC) transfusions, in terms of indications, ...decision-making, and supporting evidence base.
Red blood cell (RBC) transfusions are common during surgery and there is evidence of wide variability in practice.
Major electronic databases (MEDLINE, EMBASE, and CINAHL), guideline clearinghouses and Google Scholar were systematically searched from inception to January 2019 for CPGs pertaining to indications for intraoperative RBC transfusion. Eligible guidelines were retrieved and their quality assessed using AGREE II. Relevant recommendations were abstracted and synthesized to allow for a comparison between guidelines.
Ten guidelines published between 1992 and 2018 provided indications for intraoperative transfusions. No guideline addressed intraoperative transfusion decision-making as its primary focus. Six guidelines provided criteria for transfusion based on hemoglobin (range 6.0-10.0 g/dL) or hematocrit (<30%) triggers. In the absence of objective transfusion rules, CPGs recommended considering other parameters such as blood loss (n = 7), signs of end organ ischemia (n = 5), and hemodynamics (n = 4). Evidence supporting intraoperative recommendations was extrapolated primarily from the non-operative setting. There was wide variability in the quality of included guidelines based on AGREE II scores.
This review has identified several clinical practice guidelines providing recommendations for intraoperative transfusion. The existing guidelines were noted to be highly variable in their recommendations and to lack a sufficient evidence base from the intraoperative setting. This represents a major knowledge gap in the literature.
Background: Hepatic pedicle clamping (HPC) is frequently used to minimize blood loss during liver parenchymal transection in patients undergoing hepatectomy; this may cause intestinal hypoperfusion ...and is considered a possible risk factor for colonic anastomotic leak. The objective of this study is to determine the effect of HPC on the risk of colonic anastomotic leak in patients undergoing combined hepatectomy and colectomy. Methods: Patients undergoing combined hepatectomy and colectomy between 2014 and 2018 were identified from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database. Organ space infection was used as a surrogate marker for colonic anastomotic leak. We performed 1:1 coarsened exact matching for age, body mass index, American Society of Anesthesiology score, diabetes, smoking, wound class, type of colectomy, type of hepatectomy, and creation of a diverting stoma. Multivariable logistic regression of the unmatched patient cohort was also performed adjusting for the same covariates. Results: We identified 549 patients, of whom 130 (23%) underwent HPC during the study period. Ninety-one patients (17%) had organ space infections. Among 218 patients in the matched cohort, there was no difference in organ space infections among patients with or without HPC (17.4%, 95% confidence interval CI 10.2-24.6 v. 14.7%, 95% CI 7.9-21.4, p = 0.58). Similarly, there was no difference in the odds of organ space infection in patients with and without HPC on multivariable logistic regression (odds ratio 1.1, 95% CI 0.64-1.91, p = 0.72). HPC was not associated with organ space infection, which covaries with colonic anastomotic leak, in patients undergoing combined hepatectomy and colectomy. Conclusion: Prospective studies are needed to determine the safe duration and technique (i.e., intermittent or continuous) of HPC in this patient population.
Background: Point-of-care testing for hemoglobin (POCTHb) is increasingly used in the operating room to guide transfusions. The accuracy of POCT-Hb in surgery is, however, unclear, and inaccurate ...devices could lead to inappropriate transfusions. A systematic review and meta-analysis of method comparison studies assessing the accuracy of POCT-Hb versus central laboratory in patients undergoing surgery was performed. Embase, Ovid MEDLINE, and EBM Reviews were searched from inception to April 2020. Methods: Studies that compared hemoglobin measurements between POCT-Hb devices and central laboratory in patients undergoing any surgery in the operating room were included. The primary outcome was the mean difference (MD) between POCT-Hb and central laboratory (with standard deviation SD). Using a random-effects model, the population limits of agreement (95% LOA) were calculated as a function of the average difference between the 2 tests, the average within-study variation, and variation in bias across studies. Results: The allowable reference standard for hemoglobin measurement defined by the Institute of Quality Management in Healthcare (IQMH) is 4.0 g/L. Of 2377 identified studies, 32 were included (n = 2591 patients, 8476 hemoglobin paired measurements). Several devices were compared with central laboratory (pulse co-oximetry: 24 studies; Hem°Cue: 9 studies; iSTAT: 6 studies; blood gas analyzers: 9 studies; and hematology analyzer: 1 study). The median sample size was 40 paired measurements, 10 of 32 studies had manufacturer funding, and 15 of 32 studies were low risk of bias. The pooled MD (95% LOA) was 2.5 g/L (-28.2 to 33.1) for pulse co-oximeters, -0.6 g/L (-10.6 to 9.3) for Hem°Cue, -0.3 g/L (-8.4 to 7.8) for iSTAT, and -2.0 g/L (-16.5 to 12.5) for blood gas analyzers. The pooled intervals for POCT-Hb devices were all larger than the allowable reference defined by IQMH. Conclusion: Hemoglobin values measured by POCT devices cannot be considered interchangeable with central laboratory, and abundant caution is necessary when using these devices to guide transfusions in the operative setting.
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