Quality can be defined by processes of care and by the characteristics of the care and its outcomes. In terms of blood loss and transfusion, otolaryngologists should be aware of available guidelines, standards for use of blood products, devices and hemostatic agents, outcomes metrics relevant to patients, and tools for implementing quality improvements. This article reviews the definition of health care quality, and discusses the data regarding anticoagulant medications (particularly new oral anticoagulants) and guidelines for blood product transfusion. A brief outline of quality tools is provided to help otolaryngologists create quality plans for themselves and their institutions/systems.
Key learning points
At the end of this article, the reader will:
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Be able to define quality.
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Understand how new anticoagulant medications can be reversed or managed in the acute setting.
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Know the indications for transfusion of red blood cells.
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Know the indications for transfusion of platelets, fresh frozen plasma, and cryoprecipitate.
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Know the possible metrics and tools for developing a quality plan for hemostasis and transfusion.
Introduction
Quality can be defined by processes of care and by the characteristics of the care and its outcomes. In terms of blood loss and transfusion, otolaryngologists should be aware of available guidelines, standards for use of blood products, devices and hemostatic agents, outcomes metrics relevant to patients, and tools for implementing quality improvements.
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Institute of Medicine (IOM) 2001 “Crossing the Quality Chasm” report:
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“The degree to which Health Services… increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”
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IOM components of quality:
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Safe
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Effective
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Patient centered
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Timely
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Efficient
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Equitable
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Agency for Healthcare Research and Quality
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Doing the right thing (getting the health care services you need) at the right time (when you need them) in the right way (using the appropriate test or procedure) to achieve the best possible results, avoiding underuse, avoiding overuse, and eliminating misuse.
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Best practices in hemostasis have been developed individually and institutionally, but there are no national guidelines for the use of specific techniques, tools, devices, or hemostatic agents. In addition, newer anticoagulant medications have brought challenges in managing acute blood loss situations, creating the opportunity and obligation for otolaryngologists to be involved in developing personal and systems-based plans surrounding these challenges.
Introduction
Quality can be defined by processes of care and by the characteristics of the care and its outcomes. In terms of blood loss and transfusion, otolaryngologists should be aware of available guidelines, standards for use of blood products, devices and hemostatic agents, outcomes metrics relevant to patients, and tools for implementing quality improvements.
- •
Institute of Medicine (IOM) 2001 “Crossing the Quality Chasm” report:
- ○
“The degree to which Health Services… increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”
- ○
IOM components of quality:
- ▪
Safe
- ▪
Effective
- ▪
Patient centered
- ▪
Timely
- ▪
Efficient
- ▪
Equitable
- ▪
- ○
- •
Agency for Healthcare Research and Quality
- ○
Doing the right thing (getting the health care services you need) at the right time (when you need them) in the right way (using the appropriate test or procedure) to achieve the best possible results, avoiding underuse, avoiding overuse, and eliminating misuse.
- ○
Best practices in hemostasis have been developed individually and institutionally, but there are no national guidelines for the use of specific techniques, tools, devices, or hemostatic agents. In addition, newer anticoagulant medications have brought challenges in managing acute blood loss situations, creating the opportunity and obligation for otolaryngologists to be involved in developing personal and systems-based plans surrounding these challenges.
Managing anticoagulants in the acute and perioperative settings
Otolaryngologists manage epistaxis, hemorrhage from the oral cavity and pharynx, maxillofacial trauma in the acute clinical setting, and intraoperative and perioperative bleeding. To better devise institutional plans and guidelines to best manage these problems, an understanding of current practices and medications for anticoagulant therapy is imperative ( Fig. 1 ).
Older Anticoagulant Medications
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Heparin: inactivates IIa (thrombin) and Xa via an antithrombin mechanism, binds to platelets
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Indications: prevention and treatment of venous thromboembolism (VTE) and pulmonary embolus (PE); prevention of mural thrombus formation after myocardial infarction (MI); treatment of patients with unstable angina and MI; perioperative bridge
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No gastrointestinal absorption; must be given intravenously or subcutaneously
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Onset is immediate (intravenous) and 20 to 60 minutes (subcutaneous)
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Half-life 1.5 hours (dose dependent and nonlinear)
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Downsides: variable anticoagulant response, possible heparin resistance, heparin-induced thrombocytopenia (HIT), and osteopenia
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HIT occurs within 2 days (type 1 immune response) or 4 to 10 days (type 2 immune response); suspect if platelet count decreases more than 50% from baseline; characterized by skin lesions at injection site, possible systemic response (fevers, chills, dyspnea, chest pain), and possible venous thromboembolism; 0.2% of all heparin-exposed patients
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Dose is adjusted and therapeutic effect is monitored by activated partial thromboplastin time (aPTT)
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Most institutions have nomograms for dosing
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Main advantages: quick onset, short half-life, easy to monitor therapeutic effectiveness (as well as normalization before operating room)
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Low-molecular-weight heparin (Lovenox; Sanofi, and others): inactivates factor Xa
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Indications: prevention of VTE, treatment of VTE
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Time to peak effect 3 to 5 hours
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Half-life 4.5 hours after subcutaneous administration
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Laboratory monitoring is not generally required; anti–factor Xa level should be checked in patients with renal insufficiency, morbidly obese patients, and pregnant women; platelet count is generally checked throughout therapy if prolonged; platelet aggregation test should be done if patient has had HIT with unfractionated heparin
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Warfarin (Coumadin; Bristol-Myers Squibb)
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Vitamin K antagonist
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Hepatic metabolism, renal elimination
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Narrow therapeutic index
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Multiple drug and diet interactions
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Slow onset of action (peak activity at 72–96 hours)
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Half-life 40 hours
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Antidote is vitamin K
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If severe bleeding or intracranial bleeding and International Normalized Ratio (INR) greater than 1.5, treatment with vitamin K and prothrombin complex concentrate (discussed later) or fresh frozen plasma (FFP) is recommended, followed by repeat INR
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Oral Antiplatelet Agents
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For patients on antiplatelet agents with severe bleeding or intracranial bleeding, reversal protocol may include desmopressin and platelet transfusion.
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Aspirin (acetylsalicylic acid [ASA]): irreversible cyclooxygenase (COX) inhibitor, affects COX-1 more than COX-2
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Broad, well-known indications and variable dosing
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Primary and secondary prevention of stroke and MI
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Recent studies have questioned utility in primary prevention
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Acute coronary syndrome (ACS)
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Percutaneous coronary intervention (PCI)
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Peripheral vascular disease (PVD)
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Half-life 2 to 4.5 hours with small doses (<250 mg), 15 to 30 hours if greater than 4 g
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Recommend holding 7 days before elective major surgery (unless contraindicated in patient with stent)
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Clopidogrel (Plavix; Bristol-Myers Squibb): irreversible inhibition of ADP receptor, preventing ADP binding and activation of platelets
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Indications: ASA intolerance or failure, primary and secondary prevention of stroke and MI, ACS, PCI, PVD
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Often used in addition to ASA
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Peak effect 6 hours
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Half-life 0.5 hours
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Hold 5 to 7 days before elective procedure or surgery
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Ticagrelor (Brilinta; AstraZeneca): reversible inhibition of ADP receptor, preventing ADP binding and activation of platelets
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Indications: treatment of ACS along with ASA
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Peak effect 2 hours
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Half-life 6 to 9 hours
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Hold 5 days before elective procedure or surgery
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Prasugrel (Effient; Eli Lilly): irreversible inhibition of ADP receptor, preventing ADP binding and activation of platelets
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Indications: treatment of ACS along with ASA for patients undergoing PCI
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Contraindicated in advanced age or history of stroke
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Peak effect 4 hours
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Half-life 2 to 15 hours
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Hold 7 days before elective procedure or surgery
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Ticlopidine (Ticlid): discontinued because of higher risk of thrombotic thrombocytopenic purpura and neutropenia
New Oral Anticoagulants: Target Xa and Thrombin
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More rapid onset of action than warfarin ( Table 1 )
Table 1
Summary of new oral anticoagulant medications
NOA
Indication
Dosing Frequency
Peak Activity (h)
Half-life (h)
Dabigatran (Pradaxa; Boehringer Ingelheim)
Nonvalvular afib, prevention of VTE in THA, TKA
Twice daily
2–4
12–17
Rivaroxaban (Xarelto; Bayer and Janssen R&D LLC)
Prevention of VTE in THA, TKA, nonvalvular afib, tx of DVT/PE, risk reduction of recurrent VTE
Once daily
2–4
5–9 (9–13 elderly pts)
Apixaban (Eliquis; Pfizer and Bristol-Myers Squibb)
Nonvalvular afib, prevention of VTE in THA, TKA
Twice daily
3–4
10–14
Abbreviations: afib, atrial fibrillation; DVT, deep venous thrombosis; NOA, new oral anticoagulant; pts, patients; THA, total hip arthroplasty; TKA, total knee arthroplasty; tx, treatment.
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No diet interactions
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All have drug interactions with P-glycoprotein inducers and inhibitors; rivaroxaban and apixaban additionally interact with drugs affecting cytochrome P 3A4
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Hepatic metabolism, renal and fecal elimination to varying degrees
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High cost
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No specific antidotes
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No long-term safety data
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Some institutions have restricted prescribing authority to select physician groups
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No monitoring required; downside is there is no direct ability to assess therapeutic effect
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Dabigatran causes variable prolongation of the aPTT, variable increase of the INR (not sensitive), and increase in thrombin time (determines whether dabigatran is present but does not help with emergency monitoring)
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Rivaroxaban prolongs aPTT in a dose-dependent fashion (but there is no standard calibration) and increases prothrombin time (PT), although INR is variably affected and not adequate
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Apixaban may prolong aPTT (data are limited) and increases the INR
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Dabigatran (Pradaxa; Boehringer Ingelheim): direct thrombin inhibitor
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Indications: nonvalvular atrial fibrillation for stroke prevention, primary prevention of venous thromboembolic events in adults after total hip arthroplasty (THA) or total knee arthroplasty (TKA)
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Patients with unstable INR on warfarin benefit most from dabigatran
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Recommended dosage is 150 mg twice daily
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Peak activity at 2 to 4 hours
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Half-life 12 to 17 hours
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Rates of major bleeding similar to warfarin; lower overall rate of bleeding events with dabigatran
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No specific antidote but is reversible via hemodialysis
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Activated charcoal impairs its absorption if taken within 2 hours of ingestion
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Rivaroxaban (Xarelto; Bayer and Janssen R&D LLC of Johnson & Johnson): inhibits Xa
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Indications: primary prevention of venous thromboembolic events in adults after THA or TKA, nonvalvular atrial fibrillation for stroke prevention, treatment of deep vein thrombosis (DVT) and PE, reduction of risk of recurrent DVT and PE after initial treatment
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Recommended dosage is 10 to 20 mg once daily (depending on indication)
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Peak activity at 2 to 4 hours
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Half-life 5 to 9 hours (9–13 hours in the elderly)
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Bleeding rates similar to warfarin
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No antidote, no reversibility via hemodialysis
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Apixaban (Eliquis; Pfizer and Bristol-Myers Squibb): inhibits Xa
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Indications: nonvalvular atrial fibrillation for stroke prevention and primary prevention of venous thromboembolic events in adults after THA or TKA
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Recommended dosage is 5 mg twice daily (less in elderly, low body weight, increased creatinine level)
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Peak activity at 3 to 4 hours
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Half-life 10 to 14 hours
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Bleeding rates similar to aspirin, lower than warfarin
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No antidote, no reversibility via hemodialysis
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Stopping New Oral Anticoagulants Before Elective Surgery
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If possible, most surgeons request new oral anticoagulants to be stopped 1 week before elective procedures. Otherwise, based on creatinine clearance, medications should be stopped 1 to 4 days before the procedure, depending on risk for bleeding complications ( Table 2 ).
