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Trends in Cardiovascular Medicine Feb 2020Oral anticoagulants, old and new, are effective therapies for prevention and treatment of venous thromboembolism and reduction of stroke risk in patients with atrial... (Review)
Review
Oral anticoagulants, old and new, are effective therapies for prevention and treatment of venous thromboembolism and reduction of stroke risk in patients with atrial fibrillation. However, blocking elements of the clotting cascade carries an inherent risk of bleeding. Also, anticoagulated patients sometimes require urgent surgery or invasive procedures. This has led to the emergence of a body of scientific literature on the reversal of anticoagulation in these two settings. Traditionally, vitamin K antagonists (VKAs), which indirectly inactivate clotting factors II, VII, IX and X (and natural anticoagulant proteins C and S), had been the mainstay of oral anticoagulation for half a century. Only a few years ago, the US Food and Drug Administration (FDA) approved a specific VKA reversal agent, 4-Factor Prothrombin Complex Concentrate (4F-PCC). The last decade has seen the rise of non-Vitamin K oral anticoagulants (NOACs), which target specific factors, i.e. Factors IIa and Xa. Investigators have rapidly developed reversal agents for these agents as well, idarucizumab for the Factor IIa inhibitor dabigatran (Pradaxa) and andexanet alfa for the entire class of Factor Xa inhibitors (FXaIs), currently four drugs: rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa) and betrixaban (Bevyxxa). Clinicians still use off-label PCC for reversing FXaIs in some settings, and a universal reversal agent, ciraparantag, remains in development. This review summarizes the safety and efficacy of these reversal agents in the setting of anticoagulant-associated major bleeding and the need for urgent surgery.
Topics: Administration, Oral; Anticoagulants; Antidotes; Atrial Fibrillation; Blood Coagulation; Blood Loss, Surgical; Clinical Decision-Making; Coagulants; Drug Administration Schedule; Humans; Perioperative Care; Postoperative Hemorrhage; Risk Assessment; Risk Factors; Stroke; Treatment Outcome; Venous Thromboembolism
PubMed: 30952383
DOI: 10.1016/j.tcm.2019.03.004 -
JAMA Surgery Sep 2022Post-cardiopulmonary bypass (CPB) coagulopathy and bleeding are among the most common reasons for blood product transfusion in surgical practices. Current retrospective... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Post-cardiopulmonary bypass (CPB) coagulopathy and bleeding are among the most common reasons for blood product transfusion in surgical practices. Current retrospective data suggest lower transfusion rates and blood loss in patients receiving prothrombin complex concentrate (PCC) compared with plasma after cardiac surgery.
OBJECTIVE
To analyze perioperative bleeding and transfusion outcomes in patients undergoing cardiac surgery who develop microvascular bleeding and receive treatment with either PCC or plasma.
DESIGN, SETTING, AND PARTICIPANTS
A single-institution, prospective, randomized clinical trial performed at a high-volume cardiac surgical center. Patients were aged 18 years or older and undergoing cardiac surgery with CPB. Patients undergoing complex cardiac surgical procedures (eg, aortic replacement surgery, multiple procedures, or repeated sternotomy) were preferentially targeted for enrollment. During the study period, 756 patients were approached for enrollment, and 553 patients were randomized. Of the 553 randomized patients, 100 patients met criteria for study intervention.
INTERVENTIONS
Patients with excessive microvascular bleeding, a prothombin time (PT) greater than 16.6 seconds, and an international normalized ratio (INR) greater than 1.6 were randomized to receive treatment with either PCC or plasma. The PCC dose was 15 IU/kg or closest standardized dose; the plasma dose was a suggested volume of 10 to 15 mL/kg rounded to the nearest unit.
MAIN OUTCOMES AND MEASURES
The primary outcome was postoperative bleeding (chest tube output) from the initial postsurgical intensive care unit admission through midnight on postoperative day 1. Secondary outcomes were PT/INR, rates of intraoperative red blood cell (RBC) transfusion after treatment, avoidance of allogeneic transfusion from the intraoperative period to the end of postoperative day 1, postoperative bleeding, and adverse events.
RESULTS
One hundred patients (mean [SD] age, 66.8 [13.7] years; 61 [61.0%] male; and 1 [1.0%] Black, 1 [1.0%] Hispanic, and 98 [98.0%] White) received the study intervention (49 plasma and 51 PCC). There was no significant difference in chest tube output between the plasma and PCC groups (median [IQR], 1022 [799-1575] mL vs 937 [708-1443] mL). After treatment, patients in the PCC arm had a greater improvement in PT (effect estimate, -1.37 seconds [95% CI, -1.91 to -0.84]; P < .001) and INR (effect estimate, -0.12 [95% CI, -0.16 to -0.07]; P < .001). Fewer patients in the PCC group required intraoperative RBC transfusion after treatment (7 of 51 patients [13.7%] vs 15 of 49 patients [30.6%]; P = .04); total intraoperative transfusion rates were not significantly different between groups. Seven (13.7%) of 51 patients receiving PCCs avoided allogeneic transfusion from the intraoperative period to the end of postoperative day 1 vs none of those receiving plasma. There were no significant differences in postoperative bleeding, transfusions, or adverse events.
CONCLUSIONS AND RELEVANCE
The results of this study suggest a similar overall safety and efficacy profile for PCCs compared with plasma in this clinical context, with fewer posttreatment intraoperative RBC transfusions, improved PT/INR correction, and higher likelihood of allogeneic transfusion avoidance in patients receiving PCCs.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02557672.
Topics: Aged; Blood Coagulation Disorders; Blood Coagulation Factors; Blood Loss, Surgical; Cardiopulmonary Bypass; Female; Humans; Male; Middle Aged; Postoperative Hemorrhage; Prospective Studies; Retrospective Studies
PubMed: 35767271
DOI: 10.1001/jamasurg.2022.2235 -
CMAJ : Canadian Medical Association... Jul 2019Among adults undergoing contemporary noncardiac surgery, little is known about the frequency and timing of death and the associations between perioperative complications...
BACKGROUND
Among adults undergoing contemporary noncardiac surgery, little is known about the frequency and timing of death and the associations between perioperative complications and mortality. We aimed to establish the frequency and timing of death and its association with perioperative complications.
METHODS
We conducted a prospective cohort study of patients aged 45 years and older who underwent inpatient noncardiac surgery at 28 centres in 14 countries. We monitored patients for complications until 30 days after surgery and determined the relation between these complications and 30-day mortality using a Cox proportional hazards model.
RESULTS
We included 40 004 patients. Of those, 715 patients (1.8%) died within 30 days of surgery. Five deaths (0.7%) occurred in the operating room, 500 deaths (69.9%) occurred after surgery during the index admission to hospital and 210 deaths (29.4%) occurred after discharge from the hospital. Eight complications were independently associated with 30-day mortality. The 3 complications with the largest attributable fractions (AF; i.e., potential proportion of deaths attributable to these complications) were major bleeding (6238 patients, 15.6%; adjusted hazard ratio [HR] 2.6, 95% confidence interval [CI] 2.2-3.1; AF 17.0%); myocardial injury after noncardiac surgery [MINS] (5191 patients, 13.0%; adjusted HR 2.2, 95% CI 1.9-2.6; AF 15.9%); and sepsis (1783 patients, 4.5%; adjusted HR 5.6, 95% CI 4.6-6.8; AF 12.0%).
INTERPRETATION
Among adults undergoing noncardiac surgery, 99.3% of deaths occurred after the procedure and 44.9% of deaths were associated with 3 complications: major bleeding, MINS and sepsis. Given these findings, focusing on the prevention, early identification and management of these 3 complications holds promise for reducing perioperative mortality. ClinicalTrials.gov, no. NCT00512109.
Topics: Aged; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Postoperative Complications; Postoperative Hemorrhage; Prospective Studies; Sepsis; Surgical Procedures, Operative
PubMed: 31358597
DOI: 10.1503/cmaj.190221 -
Journal of the American College of... May 2021It is increasingly recognized that non-opioid analgesia is an important analgesia in the perioperative period. Specifically, NSAIDs (nonsteroidal anti-inflammatory... (Meta-Analysis)
Meta-Analysis
BACKGROUND
It is increasingly recognized that non-opioid analgesia is an important analgesia in the perioperative period. Specifically, NSAIDs (nonsteroidal anti-inflammatory drugs) have been touted as an adjunct, or even replacement, for opioids. However, uptake of NSAIDs has been slow due to concern for side effects, including bleeding. We sought to understand the risk of bleeding caused by NSAIDs in the perioperative period.
STUDY DESIGN
A physician-librarian team performed a search of electronic databases (MEDLINE, EMBASE), using search terms covering the targeted intervention (use of NSAIDs) and outcomes of interest (surgical complications, bleeding), limited to English language articles of any date. We performed a systematic review and meta-analysis of the data.
RESULTS
A total of 2,521 articles were screened, and 229 were selected on the basis of title and abstract for detailed assessment. Including reference searching, 74 manuscripts met inclusion criteria spanning years 1987-2019. These studies included 151,031 patients. Studies included 12 types of NSAIDs, the most common being ketorolac, diclofenac, and ibuprofen, over a wide-range of procedures, from otorhinolaryngology (ENT), breast, abdomen, plastics, and more. More than half were randomized control trials. The meta-analyses for hematoma, return to the operating room for bleeding, and blood transfusions showed no difference in risk in any of 3 categories studied between the NSAID vs non-NSAID groups (p = 0.49, p = 0.79, and p = 0.49, respectively). Quality scoring found a wide range of quality, with scores ranging from lowest quality of 12 to highest quality of 25, out of a total of 27 (average = 16).
CONCLUSIONS
NSAIDs are unlikely to be the cause of postoperative bleeding complications. This literature covers a large number of patients and remains consistent across types of NSAIDs and operations.
Topics: Analgesia; Anti-Inflammatory Agents, Non-Steroidal; Blood Loss, Surgical; Blood Transfusion; Diclofenac; Humans; Ibuprofen; Ketorolac; Pain, Postoperative; Pain, Procedural; Perioperative Period; Postoperative Hemorrhage; Surgical Procedures, Operative; Treatment Outcome
PubMed: 33515678
DOI: 10.1016/j.jamcollsurg.2021.01.005 -
Anesthesiology Aug 2023
Topics: Humans; Factor VIIa; Off-Label Use; Blood Loss, Surgical; Cardiac Surgical Procedures; Recombinant Proteins; Postoperative Hemorrhage; Retrospective Studies
PubMed: 37155359
DOI: 10.1097/ALN.0000000000004569 -
European Archives of... Mar 2022Although haemorrhage is a common and in some cases life-threatening complication after tonsillectomy, surprisingly little is known about the temporal fluctuations of the...
PURPOSE
Although haemorrhage is a common and in some cases life-threatening complication after tonsillectomy, surprisingly little is known about the temporal fluctuations of the onset of bleeding. The purpose of this study was to assess circadian and seasonal rhythms of post-tonsillectomy haemorrhage (PTH) and potential ramifications to educate patients and health care staff.
METHODS
This retrospective study carried out at a tertiary referral hospital included paediatric and adult patients requiring emergency surgery due to severe PTH between 1993 and 2019. Medical records were reviewed and patient demographics, details regarding the initial procedure, postoperative day of haemorrhage, and start time of emergency surgery were extracted. Descriptive statistics, Kruskal-Wallis test, Mann-Whitney U test, and Chi-square goodness of fit tests were used to detect potential differences.
RESULTS
A total of 300 patients with severe PTH and subsequent emergency surgery were identified. The median postoperative duration until PTH was 6 (range: < 1-19) days. 64.7% (n = 194) of all emergency surgeries had to be performed during evening and night hours (6 pm-6 am) (p < 0.0001). Compared to diurnal incidents, the risk of a nocturnal PTH event increased, the longer ago the initial surgery was (p < 0.0001). No seasonal variations were identified. Age, sex, and details of the initial procedure had no significant influence on the start time according to the surgical protocol.
CONCLUSION
The discovered temporal fluctuations of PTH are of relevance for patient awareness and preoperative education. Due to possible life-threatening complications, management of severe PTH requires specific resources and trained medical staff on call.
Topics: Adult; Child; Humans; Postoperative Hemorrhage; Postoperative Period; Retrospective Studies; Tonsillectomy
PubMed: 34557959
DOI: 10.1007/s00405-021-07080-1 -
Acta Ortopedica Mexicana 2021No Abstract available.
No Abstract available.
Topics: Humans; Blood Loss, Surgical; Orthopedic Procedures; Postoperative Hemorrhage
PubMed: 35793247
DOI: No ID Found -
Journal of Otolaryngology - Head & Neck... Sep 2019Despite advances in surgical technique, postoperative hemorrhage remains a common cause of mortality and morbidity for patients following tonsillectomy. Application of... (Review)
Review
Despite advances in surgical technique, postoperative hemorrhage remains a common cause of mortality and morbidity for patients following tonsillectomy. Application of biomaterials at the time of tonsillectomy can potentially accelerate mucosal wound healing and eliminate the risk of post-tonsillectomy hemorrhage (PTH). To understand the current state and identify possible routes for the development of the ideal biomaterials to prevent PTH, topical biomaterials for eliminating the risk of PTH were reviewed. Alternative topical biomaterials that hold the potential to reduce the risk of PTH were also summarized.
Topics: Antifibrinolytic Agents; Biocompatible Materials; Fibrin Tissue Adhesive; Hemostasis, Surgical; Humans; Postoperative Hemorrhage; Tonsillectomy
PubMed: 31492172
DOI: 10.1186/s40463-019-0368-1 -
Anaesthesia Mar 2023
Topics: Humans; Tranexamic Acid; Arthroplasty, Replacement, Knee; Antifibrinolytic Agents; Postoperative Hemorrhage; Blood Loss, Surgical
PubMed: 36599643
DOI: 10.1111/anae.15960 -
Journal of Nippon Medical School =... 2021With advancements in the development of flexible endoscopes and endoscopic devices and the increased demand for minimally invasive treatments, the indications of... (Review)
Review
With advancements in the development of flexible endoscopes and endoscopic devices and the increased demand for minimally invasive treatments, the indications of therapeutic endoscopy have been expanded. Methods of endoscopic treatment used for tissue removal, hemostasis, and dilatation are as follows. Endoscopic submucosal dissection (ESD) is considered the gold standard curative method for removal of gastrointestinal node-negative neoplasms, regardless of their size or the presence of ulcer formation. Laparoscopic endoscopic cooperative surgery (LECS), which incorporates ESD, was introduced for removal of lesions in deeper layers. Another technique is endoscopic full-thickness resection, which is challenging without the assistance of laparoscopy. In terms of hemostasis, management of iatrogenic bleeding after endoscopic treatment is an important issue. Shielding methods and suturing techniques have been introduced for large mucosal defects after ESD, and their efficacy has been investigated clinically. Peroral endoscopic myotomy (POEM) is a new alternative surgical approach for minimally invasive treatment of esophageal achalasia. Furthermore, endoscopic fundoplication after POEM was devised to prevent post-POEM gastroesophageal reflux disease. Many endoscopic treatments, including ESD, LECS, and POEM, have been introduced in Japan. With the aging of the population, more attention will be directed toward therapeutic endoscopy for elderly patients, because it is less invasive. Development of endoscopic treatments with expanded indications is expected.
Topics: Endoscopes, Gastrointestinal; Endoscopy, Gastrointestinal; Esophageal Achalasia; Female; Fundoplication; Gastric Mucosa; Gastroesophageal Reflux; Gastrointestinal Neoplasms; Hemostasis, Endoscopic; Humans; Laparoscopy; Male; Myotomy; Postoperative Complications; Postoperative Hemorrhage
PubMed: 33692281
DOI: 10.1272/jnms.JNMS.2021_88-109