NEWSLETTER The Official Journal of the Anesthesia Patient Safety Foundation Volume 32, No. 1 ...

28 Pages·2017·1.64 MB·English

NEWSLETTER
The Official Journal of the Anesthesia Patient Safety Foundation
www.apsf.org
Volume 32, No. 1, 1–28 Circulation 122,210 June 2017
Perioperative Management of the New
Anticoagulants: Novel Drugs and Concepts
by Jerrold H. Levy, MD, FAHA, FCCM; Pierre Albaladejo, MD; Charles-Marc Samama MD, PhD; Beverley Hunt, MD; Alex C Spyropoulos, MD; James Douketis, MD, FRCPC
Introduction Direct Oral Anticoagulants
Currently Available
The increasing use of the direct oral anticoag-
ulants (DOACs) has provided clinicians and The currently available non-vitamin K DOACs
patients with alternatives to warfarin for the include the direct thrombin inhibitor dabigatran
treatment of venous thromboembolism (VTE), etexilate (Pradaxa®, Boehringer-Ingelheim
the prevention of cerebrovascular embolic stroke Pharma), and direct factor Xa inhibitors,
in patients with atrial fibrillation, and thrombo- rivaroxaban (Xarelto®, Johnson and Johnson/
prophylaxis in patients undergoing surgery. Four Bayer HealthCare), apixaban (Eliquis®, Bristol
DOACs are currently approved in most countries Myers Squibb/Pfizer), and edoxaban (Savaysa®,
and have added a novel paradigm for anticoagu- Daiichi Sankyo). The advantages of the DOACs
lation management. However, providers should include a rapid onset of action, with a peak effect
be aware of perioperative management strategies two to four hours following oral administration,
regarding patients on these agents for both elec- predictable anticoagulant/pharmacodynamic
tive and emergency surgery. Currently, a specific effects, minimal drug interactions, and no present
reversal agent, idarucizumab, is available for requirement for routine laboratory monitoring.
dabigatran, and clinical trials are currently The particular use of each individual agent
underway for reversing apixaban, rivaroxaban, depends upon multiple factors including current
and edoxaban. In this review, a group of interna- approval, labelling of the drugs, availability, and
tional experts will review perioperative manage- country-specific approved dose regimens. Of note,
ment strategies that include when to stop these there are multiple reviews related to these agents, Reproduced with permission. Levy JH, Key NS, Azran MS. Novel oral
and a growing body of literature.1-3 anticoagulants: implications in the perioperative setting.
drugs for elective surgery or invasive procedures,
Anesthesiology 2010;113:728.
how to assess and monitor their anticoagulant One of the important consistent findings from
Figure 1. The coagulation cascade. TF = tissue factor;
effects, current protocols for temporary discon- multiple publications is that, compared with war-
PL = phospholipids.
tinuations of DOAC therapy, and the utility of farin, DOACs have a lower risk for intracranial
specific DOAC reversal agents. bleeding and as low or a lower risk for other types See “Anticoagulants,” Page 3
Robert C. Morell, MD, Immediate Past APSF Newsletter
Editor-in-Chief, Reflects on Past Accomplishments
by APSF Newsletter Co-Editors Lorri A. Lee, MD, and Steven B. Greenberg, MD
In October of 2016, Dr. Robert C. Morell bid dedication and appointed him associate editor Dr. Morell obtained his undergraduate degree
the APSF farewell as he stepped down as the from 1997 to 2000. from the University of Virginia and his MD from
second editor-in-chief of the APSF Newsletter the Medical College of Virginia. He then attended
Dr. Morell became editor-in-chief in 2001. His
after 23 years of dedicated service to patient numerous accomplishments were driven by his Bowman Gray School of Medicine (currently
safety and the APSF. Dr. Morell joined the edito- incredible enthusiasm for patient safety, his creativ- known as Wake Forest School of Medicine) for his
rial staff of the APSF Newsletter in 1994. Dr. John ity, and a strong desire to keep the anesthesia com- residency in anesthesiology, serving as chief resi-
Eichhorn, the founding editor of the APSF News- munity informed regarding emerging clinical issues dent in 1986, followed by a regional fellowship at
letter, quickly realized Dr. Morell’s talents and that could impact patient safety. See “Morell,” Page 7
TABLE OF CONTENTS, NEXT PAGE
APSF NEWSLETTER June 2017 PAGE 2
Table of ConTenTs
Articles:
Perioperative Management of the New Anticoagulants: Novel Drugs and Concepts ................................Cover
Robert C. Morell, MD, Immediate Past APSF Newsletter Editor-in-Chief,
NEWSLETTER
Reflects on Past Accomplishments .....................................................................................................................Cover
Spotlight on Infection Prevention: Safe Injection Practices .............................................................................Page 8 The Official Journal of the Anesthesia Patient Safety Foundation
APSF Joins NPSF in National Multidisciplinary Effort to Reduce Preventable Health Care Harm ..........Page 9 The Anesthesia Patient Safety Foundation Newsletter
Q&A: Unintended Discharge of an ICD in a Patient Undergoing Total Knee Replacement ....................Page 10 is the official publication of the nonprofit Anesthesia
Patient Safety Foundation and is published three
Article Review: Medication Safety: An Important APSF Initiative Revisited .............................................Page 13
times per year in Wilmington, Delaware. Individual
Congratulations to a True Pioneer in Simulation: David M. Gaba, MD ......................................................Page 14 subscription–$100, Corp ora te–$500. Contrib utions to
the Foundation are tax deduct ible. ©Copy right,
Q&A: Nitrous Oxide For Labor Analgesia: Is It Safe for Everyone? ............................................................Page 19
Anesthesia Patient Safety Foundation, 2017.
Q&A: A Rational Approach to Lymphedema Risk Reduction Practices .....................................................Page 21 The opinions expressed in this Newsletter are not
To Err is Human; To Tolerate, Inhumane .........................................................................................................Page 23 necessarily those of the Anesthesia Patient Safety
Foundation. The APSF neither writes nor promulgates
Letters to the Editor: standards, and the opinions expressed herein should
not be construed to constitute practice standards or
TAVRs under MAC: Debate Continues! ...........................................................................................................Page 24
practice parameters. Validity of opinions presented,
Anesthesia Safety Concerns for CT-Guided Tumor drug dosages, accuracy, and completeness of content
Cryoablation and the Risk of the Frozen Instrument ....................................................................................Page 25 are not guaranteed by the APSF.
Erroneous Placement of Antimicrobial-Impregnated Central APSF Executive Committee:
Venous Catheter in a Patient Susceptible to an Allergic Reaction ................................................................Page 26 Mark A. Warner, President; Jeffrey B. Cooper, PhD,
Executive Vice President; George A. Schapiro,
The Role of Capnography to Prevent Postoperative Respiratory Events ....................................................Page 27
Executive Vice President; Steven R. Sanford, JD, Vice
APSF Announcements: President; Matthew B. Weinger, Secretary; Casey D.
Blitt, MD, Treasurer; Douglas A. Bartlett; David J.
Guide for Authors .................................................................................................................................................Page 2 Birnbach, MD; Robert A. Caplan, MD; Daniel J. Cole,
SAVE THE DATE: APSF Sponsored Conference: Perioperative Handoffs ...................................................Page 4 MD; David M. Gaba, MD; Steven B. Greenberg, MD;
Steven K. Howard, MD; Lorri A. Lee, MD; A. William
APSF Corporate Supporter Page .......................................................................................................................Page 15 Paulsen, PhD, AA-C, Richard C. Prielipp, MD; Maria
APSF Donor Page ................................................................................................................................................Page 16 van Pelt, CRNA, PhD. Consultants to the Executive
Committee: John H. Eichhorn, MD; Bruce P. Hallbert,
Corporate and Anesthesia Practice Management Companies Advisory Council .....................................Page 24
PhD; Marjorie P. Stiegler, MD.
APSF Website Offers Online Educational DVDs ............................................................................................Page 27
Newsletter Editorial Board:
Lorri A. Lee, MD, Co-Editor; Steven B. Greenberg,
MD, Co-Editor; Sorin J. Brull, MD; Joan M. Christie,
APSF Newsletter MD; Jan Ehrenwerth, MD; John H. Eichhorn, MD;
Nikolaus Gravenstein, MD; Tricia Meyer, PharmD;
guide for authors Glenn S. Murphy, MD; Wilson Somerville, PhD;
Jeffrey Vender, MD.
Address all general, contributor, and sub scription
correspondence to:
The APSF Newsletter is the official journal of the to the editors. Commercial products are not advertised Administrator, Janet Henderson
Anesthesia Patient Safety Foundation. It is published or endorsed by the APSF Newsletter; however, upon Anesthesia Patient Safety Foundation
three times per year, in June, October, and February. The occasion, articles about certain novel and important Charlton 1-145
APSF Newsletter is not a peer-reviewed publication, and technological advances may be submitted. In such Mayo Clinic
200 1st Street SW
decisions regarding content and acceptance of instances, the authors should have no commercial ties
Rochester, MN 55905
submissions for publication are the responsibility of the to, or financial interest in, the technology or commercial
E-mail: [email protected]
editors. Individuals and/or entities interested in product. The editors will make decisions regarding
Address Newsletter editorial comments, questions, letters,
submitting material for publication should contact the publication on a case-by-case basis.
and suggestions to:
editors directly at [email protected] and/or greenberg@
If accepted for publication, copyright for the
apsf.org. Full-length original manuscripts such as those Lorri A. Lee, MD
accepted article is transferred to the Anesthesia Patient Co-Editor, APSF Newsletter
that would normally be submitted to peer review
Safety Foundation. Except for copyright, all other rights [email protected]
journals such as Anesthesiology or Anesthesia & Analgesia
such as for patents, procedures, or processes are retained
are generally not appropriate for publication in the Steven B. Greenberg, MD
by the author. Permission to reproduce articles, figures, Co-Editor, APSF Newsletter
Newsletter due to space limitations and the need for a
tables, or content from the APSF Newsletter must be [email protected]
peer-review process. Letters to the editor and occasional
brief case reports are welcome and should be limited to obtained from the APSF. Send contributions to:
1,500 words. Special invited articles, regarding patient All submissions should include author affiliations Anesthesia Patient Safety Foundation
safety issues and newsworthy articles, are often solicited including institution, city, and state, and a statement 1061 American Lane
by the editors. These articles should be limited to 2,000 regarding disclosure of financial interests, particularly in Schaumburg, IL 60167-4973
words. Ideas for such contributions may also be directed relation to the content of the article. Or please donate online at www.apsf.org.
APSF NEWSLETTER June 2017 PAGE 3
International Experts Weigh in on Perioperative DOAC Management
“Anticoagulants,” From Cover Page erative management of patients treated with Preoperative Management of
DOACs.10 The evaluation of DOAC-treated Patients Receiving DOACs
of bleeding.4 Warfarin, a vitamin K antagonist,
patients for procedural interventions should
produces an anticoagulant effect by reducing cir- Specific considerations for the preoperative
include documenting the timing of the last DOAC
culating levels of coagulation factors II, VII, IX, management of DOAC-treated patients include
dose, renal function that influences elimination
and X.5 Although giving vitamin K is a logical pharmacokinetics of the particular drug, renal
time, and the procedure-associated bleeding risk
reversing agent, its effect is not immediate and that affects interruption timing. DOACs require function, and specific considerations regarding
time is required to reverse the INR, and it takes 24 specific coagulation assays to measure anticoagu- whether the surgery requires emergency interven-
tion or is elective, and the particular risk of throm-
to 72 hours to restore adequate levels of functional lation levels accurately (i.e., dilute thrombin time
bosis and bleeding of the individual surgical
coagulation factors. On the other hand, the for dabigatran, anti-Xa levels for oral Xa inhibi-
procedure. Based on the availability of idaruci-
DOACs are reversible direct pharmacologic inhib- tors), although standard coagulation screening
zumab as a specific antidote for dabigatran,
itors of either thrombin or factor Xa, two critical tests (i.e., prothrombin time [PT] for rivaroxaban,
patients can be readily managed if they require
targets of the hemostatic cascade that have a phar- activated partial thromboplastin time [aPTT] for
emergent or urgent surgical or procedural inter-
macologic effect similar to other commonly used dabigatran) may provide a qualitative assessment ventions. Although other reversal strategies for
parenteral anticoagulants such as low-molecular- if there is a residual DOAC anticoagulant effect. oral Xa inhibitors are under investigation, none of
weight heparin (LMWH), heparin, or other direct
Specialty societies have endorsed general rec- them today have been studied in patients requir-
thrombin inhibitors (i.e., bivalirudin, argatroban).3 ing emergent procedural interventions. Other
ommendations for patient management to pro-
Although, in general, DOACs have a lower mote hemostasis in anticoagulated patients potential off-label therapies have been evaluated
risk of bleeding,6-8 managing anticoagulation in requiring surgery or other invasive procedures. and will be considered subsequently.
the perioperative period is problematic because all These include general stopping rules (such as ≥24 Dabigatran etexilate is the only oral direct
anticoagulants can cause bleeding.9 Despite their hours for low bleed-risk procedures and ≥48 hours thrombin inhibitor. Dabigatran is a prodrug that is
apparent safety compared with warfarin, periop- for high bleed-risk surgery in patients with normal encapsulated to allow for absorption in the gut
erative management strategies for patients receiv- renal function) for elective procedures. Switching and its major mechanism of metabolism is via
ing DOACs require specific considerations. In a to LMWH, in general, is not required during peri- renal elimination (~80%). Apixaban, rivaroxaban,
recent international survey, we observed that phy- procedural DOAC interruption because of the and edoxaban are direct factor Xa inhibitors, and
sicians had limited knowledge about the periop- rapid offset and onset of DOACs.2 are primarily hepatically metabolized (~65–70%).
Clinicians should consider the half-life of the
DOACs approximately 12 hours in most patients
unless they have reduced renal function. Dabiga-
tran elimination is the most dependent on renal
function, and preoperative interruption should be
based on creatinine clearance (CrCl) calculated
according to the Cockcroft-Gault formula.11,12
Renal function is less an issue with rivaroxaban,
apixaban, and edoxaban unless there is severe
renal insufficiency.13
Multiple recommendations for perioperative
management of DOAC-treated patients exist but
such recommendations should be considered as
potential therapeutic guidance statements given
that prospective standardized management proto-
cols are still in development, and are also based on
specific drug recommendations as well.2,14,15 These
recommendations are based on an international
group of physicians, many of whom are authors of
the present article. Readers should examine the
American Society for Regional Anesthesia (ASRA)
guidelines for discontinuation of anticoagulants
prior to regional anesthesia. (https://www.asra.
com/advisory-guidelines/article/1/anticoagula-
tion-3rd-edition).
In general, management is based on proce-
Reproduced with permission. Levy JH, Key NS, Azran MS. Novel oral anticoagulants: implications in the perioperative setting. Anesthesiology dure-related bleeding risk. Selected minimal
2010;113:728. bleeding risk procedures are likely to be safely
undertaken without DOAC interruption (e.g.,
Figure 2. The primary mechanism of action of the established anticoagulants (unfractionated heparin [UFH], low-
minor dental procedures, cataract surgery, pace-
molecular-weight heparin [LMWH], and fondaparinux) via antithrombin-dependent binding (A) and the new antico-
maker implantaion, skin biopsies) although pro-
agulants (rivaroxaban, apixaban, and dabigatran etexilate) via antithrombin-independent binding (B). UFH also
spective validation studies are needed. Other
inactivates factors Xa, IXa, XIa, and XII via antithrombin, but to a lesser extent than inactivation of thrombin. LMWH
also inactivates thrombin via antithrombin, but to a lesser extent than inactivation of factor Xa. AT = antithrombin. See “Anticoagulants,” Next Page
APSF NEWSLETTER June 2017 PAGE 4
Normal Coagulation Studies Don’t Exclude Residual DOAC Effects
“Anticoagulants,” From Preceding Page Additional studies to assess standardized peri- consistent with an anticoagulant effect as reported.
operative management protocols in DOAC- (http://www.nejm.org/doi/suppl/10.1056/
procedures can be classified as low bleeding risk
treated patients are ongoing.19,22 The management NEJMoa1502000/suppl_file/nejmoa1502000_
(e.g., laparoscopic cholecystecomy or hernia
of patients who are receiving DOACs and require appendix.pdf). However, a normal aPTT does not
repair), or high bleeding risk (e.g, cardiovascular,
emergency surgery or other procedural interven- exclude residual anticoagulant effect. A normal
intracranial or spine surgery, major cancer surgery,
tion due to trauma or other emergencies continues thrombin time or diluted thrombin time will
any surgery with spinal or epidural anesthesia).
to evolve as we develop additional management exclude an anticoagulant effect of dabigatran. In
The European Society of Anaesthesiology and strategies that will be subsequently discussed. addition, the dilute thrombin time provides a
the French Working Group on Perioperative Hae- more reliable and precise measurement of the anti-
mostasis (GIHP) recommend interruption of Measurement of coagulant effect of dabigatran, an assay not cur-
DOAC therapy ~24 hours (two or three half- Anticoagulation with the rently cleared by FDA but available in specialized
centers.25, 26 In Europe, the calibrated Hemoclot®
lives) before an elective low bleeding risk proce- DOACs
thrombin inhibitor assay (Hyphen BioMed, Neu-
dure (non-regional anesthesia related), and 5
One of the major advantages of the DOACs is ville-sur-Oise, France) is recommended as the
days before a medium or high bleeding risk pro-
that routine anticoagulation monitoring is not method of assessing anticoagulation in dabigatran-
cedure. These recommendations also account for
presently required due to predictable pharmacoki- treated patients.27 In Europe, the ecarin clotting
patient’s renal function.16,17 The European Heart
netic and pharmacodynamic properties. However, time (ECT) assay is also commonly used in spe-
Rhythm Association’s guide to DOAC use for following acute traumatic injury or in patients cialized centers to evaluate anticoagulation in
elective surgery suggests a general stopping rule who require emergency surgical or otherwise pro- dabigatran-treated patients.28
of ≥24 hours for low-risk procedures and ≥48 cedural intervention, anticoagulation monitoring
Monitoring and/or assessing the effects of the
hours for high-risk surgery. However, longer may be helpful.23,24 Other information important
anti-Xa “xaban” agents is more complicated despite
interruption intervals are suggested for patients to obtain for the clinician to guide potential inter-
their growing use as the mainstays of DOAC ther-
with CrCl <80 mL/min on dabigatran and those pretation and management of the results includes
apy. Although the INR is used routinely to monitor
with CrCl 15 to 30 mL/min on oral Xa inhibi- the history of when the last dose of anticoagulant
anticoagulation with vitamin K antagonists, it is not
tors.2,18 Other expert consensus documents rec- was taken, the patient’s renal function, and other a dependable or specific assay for assessing the anti-
ommend a 24- to 48-hour interruption interval potential concomitant medications including coagulant effects of the DOACs.25 Following trau-
based on the specific DOAC, renal function, and potential antiplatelet therapies.23 matic injury or major surgery, patients routinely
procedural bleeding risk.19,20 However, as a In dabigatran-treated patients, standard coag- have a prolonged PT due to multiple causes and,
reminder, caution should be considered for pre- ulation testing can be used to determine potential therefore, it is an insensitive assay of the anticoagu-
operative bridging of any oral anticoagulant effects. The aPTT assay is an effective screening lant effects of Xa inhibitors, especially apixaban.29-31
with LMWH as noted in recent recommenda- assay to determine a potential anticoagulation If levels are required, then specific drug-calibrated
tions and clinical trials.20,21 effect due to dabigatran, and a prolonged aPTT is See “Anticoagulants,” Next Page
Save the Date
Stoelting Conference
Royal Palms Resort and Spa, Phoenix, AZ
Wednesday, September 6, 2017
Perioperative Handoffs:
Achieving Consensus on How to Get it Right
Handoffs in health care are potential patient safety risks, but are also opportunities to identify
missed problems. Perioperative handoffs, including those occurring intraoperatively, from the OR to
PACU or OR to ICU, have both common and unique issues. In this one-day consensus-building
workshop, APSF aims to identify critical elements of handoff processes, including how to conduct
Jeffrey B. Cooper, PhD
handoffs safely and how to implement new handoff processes that work locally.
Jeffrey B. Cooper, PhD, and Meghan B. Lane-Fall, MD, MSHP, will be the co-moderators of this
workshop, which will include expert presentations and panel discussions. The primary focus of this
meeting will be achieving consensus about key issues through closely facilitated working groups. If
you have expertise or an interest in helping to improve handoffs, consider participating.
If you are interested in attending, please contact Janet Henderson,
APSF administrator, at [email protected]. Space is limited. Meghan B. Lane-Fall, MD, MSHP
APSF NEWSLETTER June 2017 PAGE 5
Reversal Agents for DOAC Anticoagulation are Emerging
“Anticoagulants,” From Preceding Page dabigatran-treated patients who had treatment least 24 hours. Idarucizumab was approved in 2015
interruption for an elective procedure, experienced by the United States Food and Drug Administration
factor Xa assays, similar to those used to determine
low molecular weight heparin concentrations are more major bleeding events with bridging therapy for the reversal of dabigatran-related anticoagula-
available in some institutions. These potential quan- than patients who did not receive bridging therapy, tion in cases where emergency surgery and/or
titative measurements of the “xabans” are calibrated with no significant effect on arterial thromboembo- urgent procedures are required, or in cases of life-
in anti-Xa units and have been reported for rivaroxa- lism.40 As a result, bridging therapy is not indicated threatening or uncontrolled bleeding.46 An Ameri-
ban and apixaban,32,33 and edoxaban.34 These assays when anticoagulation needs to be interrupted for can Heart Association report suggested that a 5 g
are not widely available, require specific calibration short intervals of approximately 24 to 48 hours in dose of idarucizumab resulted in immediate and
to each individual agent, and are rarely available on advance of an invasive or surgical procedure.28 complete reversal of dabigatran anticoagulation in
an urgent basis outside of specialized centers.25,31 The Similar guidance and recommendations are also 82–99% of critically ill elderly patients taking dabi-
different coagulation assays currently available for suggested for apixaban.41,42 Treatment with apixa- gatran who presented with life-threatening emer-
each DOAC are listed in Table 1. ban, rivaroxaban, and edoxaban should be stopped gencies, and intraoperative hemostasis was judged
at least 24 hours before an invasive or surgical pro-
by surgeons as “normal” in 93% of the surgical/
Interruption of Oral cedure of low risk, but may require longer discon-
procedural patients. This study included approxi-
Anticoagulation and tinuation intervals for procedures with a moderate mately 200 complex, critically ill patients undergo-
to high risk of bleeding. There is ongoing interest
Bridging/Switching Between ing a multitude of orthopedic, surgical, and other
regarding whether certain procedures, particularly
procedures in a high-risk patient population.47
Anticoagulants pacemaker or defibrillator implantation, can be
done without DOAC interruption. Randomized Andexanet-alfa is in phase III clinical trials as a
Previously reported guidelines for periproce-
controlled trials currently underway, such as specific reversal agent for emergency reversal of
dural and/or preoperative management of patients
BRUISE CONTROL-2, are expected to inform best apixaban, edoxaban, rivaroxaban, fondaparinux,
on warfarin anticoagulation included discontinu-
ing warfarin and proceeding with the use of practices for such patients.43 and the low molecular weight heparins such as
enoxaparin.48,49 It is important to realize that andex-
LWMH or unfractionated heparin to bridge
patients with atrial fibrillation who were at Reversal of DOAC-induced anet-alfa has not been studied for reversal of antico-
increased risk for thromboembolic events.35,36 More Anticoagulation agulation in surgical patients to date. Andexanet-alfa
recent data on anticoagulant bridging to allow for With Specific Agents is a bioengineered human factor Xa decoy protein.
procedural interventions and invasive procedures By binding to circulating factor Xa inhibitors, andex-
to proceed has been called into question.37,38 Guide- When anticoagulated patients present for anet-alfa makes endogenous factor Xa available to
lines from the American Academy of Neurology emergency surgery or following traumatic injury, contribute to the coagulation cascade.49,50 Ciraparan-
report that bridging therapy with heparin is associ- bleeding is an expected and feared risk in DOAC- tag is another drug in early evaluation as a reversal
or warfarin-treated patients among those periop-
ated with increased risk of bleeding compared to agent for factor Xa inhibitors and low molecular
warfarin discontinuation.39 In a large, randomized erative providers caring for them. Therefore, weight heparin, but is not currently available.51,52
specific reversal agents are under development for
study of atrial fibrillation patients reported by
Douketis et al. in 2015 from the BRIDGE investiga- all DOACs. Currently, when DOAC-treated patients present
for emergency surgery or procedural interventions
tors, stopping warfarin without LMWH bridging For patients on dabigatran, idarucizumab, a
receiving one of the anti-Xa agents, management
was non-inferior to bridging therapy for arterial specific reversal agent, is currently approved in
strategies are needed. Growing data from case
thromboembolism when warfarin treatment was many countries for dabigratran reversal in cases of
reports, in vitro studies, and volunteers suggest
interrupted for an elective operation or other elec- serious bleeding or emergency surgery/proce-
some efficacy for the ability of prothrombin com-
tive invasive procedure and was associated with a dures. Idarucizumab is a humanized monoclonal
plex concentrates (PCCs) to reverse DOACs.51-53 At
significant decrease in post-procedural major and antibody that selectively binds dabigatran and
minor bleeding.21 reverses dabigatran-induced anticoagulation. In least one registry trial is underway to assess out-
comes in bleeding patients or those requiring
For patients anticoagulated with DOACs, the the REVERSE-AD study, idarucizumab reversed
urgent care treated with DOACs and reversed with
limited data currently available suggest that peri- the anticoagulant effects of dabigatran in patients
PCCs, and other potential agents. As previously
operative bridging with LMWH during DOAC with a major bleeding event, or in need of an
discussed, in emergency situations where patients
interruption provides no therapeutic benefit and urgent invasive procedure (within the next 8
can lead to increased major bleeding. In a recent hours).44,45 Following intravenous administration, are bleeding and have taken anti-Xa agents, the
sub-analysis of data from the RE-LY trial, where idarucizumab reversal is immediate and lasts for at See “Anticoagulants,” Next Page
Table 1. Assays for Monitoring Direct Oral Anticoagulant Activity1,2
Quantitative Assays Qualitative Assays
Drug (Provides an Estimate of Anticoagulant Drug Levels) (to Indicate Presence or Absence of Drug Effect) Not Recommended
Direct Factor Xa inhibitors Specific, calibrated anti-Factor Xa assays None currently available Prothrombin time (except rivaroxaban where there
(apixaban/rivaroxaban/edoxaban) may be a dose-related prolongation), activated
partial thromboplastin time, dilute thrombin time or
thrombin time assays, or heparin-specific assays
such as the activated clotting time assay
Direct thrombin inhibitor Dilute thrombin time assay (available in some Activated partial thromboplastin time, Chromogenic anti-Factor Xa assays, heparin-
(dabigatran) specialized centers in US, ecarin clotting time thrombin time specific assays such as the activated clotting time
(not available in US) assay
APSF NEWSLETTER June 2017 PAGE 6
Prothrombin Complex Concentrates for DOAC Reversal: Data is Limited!
“Anticoagulants,” From Preceding Page Pierre Albaladejo is Professor in the Department of 3. Levy JH, Spyropoulos AC, Samama CM, Douketis J. Direct oral
anticoagulants: new drugs and new concepts. JACC Cardiovascu-
ability to rapidly measure therapeutic effects or Anesthesiology and Intensive Care Medicine, Grenoble lar Interventions 2014;7:1333–51.
drug levels with the Xa inhibitors is limited. University Hospital, Grenoble, France. 4. Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu
N, Ezekowitz MD, et al. Comparison of the efficacy and safety of
Charles-Marc Samama is Professor in the Department new oral anticoagulants with warfarin in patients with atrial
One particular noteworthy study evaluated a
fibrillation: a meta-analysis of randomised trials. Lancet
of Anesthesiology and Intensive Care Medicine,
5 mm punch biopsy in healthy subjects receiving a 2014;383:955–62.
Assistance Publique-Hôpitaux de Paris, Cochin 5. Gulati G, Hevelow M, George M, Behling E, Siegel J. International
single dose of 60 mg edoxaban. The authors noted
University Hospital, Paris, France. normalized ratio versus plasma levels of coagulation factors in
that four factor-prothrombinanse complex concen- patients on vitamin K antagonist therapy. Arch Pathol Lab Med
2011;135:490–4.
trate (4F-PCC) produced a dose-dependent rever- Beverley Hunt is Professor at the Thrombosis &
6. Beyer-Westendorf J, Forster K, Pannach S, Ebertz F, Gelbricht V,
sal of edoxaban’s effect on bleeding duration, Haemophilia Centre, Guy’s & St Thomas’ NHS Thieme C, et al. Rates, management and outcome of bleeding
complications during rivaroxaban therapy in daily care: results
bleeding volume, and thrombin generation and Foundation Trust, London, England. from the Dresden NOAC registry. Blood 2014; 124:955–962.
normalized values to baseline levels before antico- Alex C Spyropoulos is Professor in the Department of 7. Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang
S, et al. Periprocedural bleeding and thromboembolic events with
agulation using a 50 IU/kg dose of 4F-PCCs.53 Medicine, Northwell Health Systems at Lenox Hill dabigatran compared with warfarin: results from the Random-
However, PT was only partially reversed and this Hospital, New York, NY, US. ized Evaluation of Long-Term Anticoagulation Therapy (RE-LY)
randomized trial. Circulation 2012;126:343–8.
is a consistent finding in all of the PCC reversals of 8. Beyer-Westendorf J, Gelbricht V, Förster K, Ebertz F, Köhler C,
James Douketis is Professor in the Department of
anti-Xa agents.53 In the volunteers who underwent Werth S, et al. Peri-interventional management of novel oral anti-
Medicine, McMaster University, Canada. coagulants in daily care: results from the prospective Dresden
reversal of anticoagulation, there were no safety NOAC registry. Eur Heart J 2014;35:1888–1896.
issues and no thromboembolic events. Notably, 9. Levy JH. Role of coagulation factor concentrates for reversing
Disclosures: dabigatran-related anticoagulation. Anesthesiology 2014;120:
this is the only study to evaluate a specific bleed- 1316–1318.
ing parameter associated with DOAC reversal J Levy: Scientific Advisory Boards: Bayer, Boehringer- 10. Faraoni D, Samama CM, Ranucci M, Dietrich W, Levy JH. Periop-
using a four factor PCC.53 Ingelheim, CSL Behring, Grifols, Instrumentation esurartviveye. mClainniacgs eLmabe Mnte odf 2n0e1w4; o3r4a:6l 3a7n–ti6c5o4a.gulants: an international
Laboratories, Jiangsu Singchn, Janssen, Leading 11. Stangier J, Rathgen K, Stähle H, Mazur D. Influence of renal
Summary: Biosciences, and Pfizer. impairment on the pharmacokinetics and pharmacodynamics of
oral dabigatran etexilate: an open-label, parallel-group, single-
P Abaladejo: Scientific Advisory Boards: Octapharma, centre study. Clinical Pharmacokinetics 2010;49:259–68.
The DOACs have provided important addi- 12. Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW,
CSL Behring, LFB, Bayer, Boehringer-Ingelheim, CSL
tional therapeutic approaches for anticoagulation et al. The effect of dabigatran plasma concentrations and patient
Behring, Sanofi, BMS-Pfizer, Daichii-Sankyo. Research characteristics on the frequency of ischemic stroke and major
in patients. The benefits as previously discussed bleeding in atrial fibrillation patients: the RE-LY Trial (Random-
support Boehringer-Ingelheim and Portola.
ized Evaluation of Long-Term Anticoagulation Therapy). J Am
include predictable pharmacokinetics, no present
CM Samama: Scientific Advisory Boards: AstraZeneca, Coll Cardiol 2014;63:321–8.
requirement for routine monitoring, and overall 13. Kubitza D, Becka M, Mueck W, Halabi A, Maatouk H, Klause N,
Bayer, BMS, Boehringer-Ingelheim, Daichii-Sankyo, et al. Effects of renal impairment on the pharmacokinetics, phar-
the potential for fewer risks of bleeding and
Fresenius-Kabi, GSK, Haemonetics, Lilly, Pfizer, Roche, macodynamics and safety of rivaroxaban, an oral, direct Factor
improved outcomes as noted in the multiple stud- Xa inhibitor. Br J Clin Pharmacol 2010;70:703–12.
Sanofi; Research support: Bayer, BMS, Boehringer- 14. Albaladejo P, Bonhomme F, Blais N, Collet JP, Faraoni D, Fontana
ies that led to approval by the Food and Drug
Ingelheim, LFB, GSK, Haemonetics, Sanofi. P, et al. Management of direct oral anticoagulants in patients
Administration. As with any anticoagulants, the undergoing elective surgeries and invasive procedures: updated
B Hunt: none guidelines from the French Working Group on Perioperative
drug should be stopped for high-risk surgical pro- Hemostasis (GIHP) - September 2015. Anaesth Crit Care Pain Med
cedures in patients at increased risk for bleeding, A Spyropoulos: Scientific Advisory Boards: Bayer, 2017;36:73–6.
Janssen, Pfizer, Daiichi-Sankyo, Boehringer Ingelheim, 15. Faraoni D, Levy JH, Albaladejo P, Samama CM, Groupe d’Interet
and for all the agents, renal function should be en Hemostase P. Updates in the perioperative and emergency
considered. Monitoring can be used in elective Sanofi, Consultant: Boehringer Ingelheim, Bristol Myers management of non-vitamin K antagonist oral anticoagulants.
Squibb, Pfizer, Janssen, and Daiichi Sankyo. Crit Care 2015;19:203.
surgical interventions, but for emergencies, the 16. Gogarten W, Vandermeulen E, Van Aken H, Kozek S, Llau JV,
availability and need for emergent or urgent sur- J Douketis: Scientific Advisory Boards/Education: Astra- Samama CM. Regional anaesthesia and antithrombotic agents:
Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers- recommendations of the European Society of Anaesthesiology.
gery is an important consideration. For dabiga- Eur J Anaesthesiol 2010;27:999–1015.
tran, idarucizumab is a specific reversal agent that Squibb, Leo Pharma, Pfizer, Sanofi. Consultant: Janssen. 17. Sié P, Samama CM, Godier A, Rosencher N, Steib A, Llau JV, et al.
Surgery and invasive procedures in patients on long-term treat-
has been studied in a multiplicity of surgical ment with direct oral anticoagulants: thrombin or Factor-Xa
This article does not reflect the opinion of the editors or the inhibitors. Recommendations of the Working Group on Periop-
patients. For the “xbans,” currently there is no
APSF. The information provided is for safety-related erative Haemostasis and the French Study Group on Thrombosis
approved agent available for specific reversal, and and Haemostasis. Arch Cardiovasc Dis 2011;104:669–76.
educational purposes only, and does not constitute medical
18. Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Old-
andexanet has not been studied as of yet in surgi- or legal advice. Content is provided for purposes of gren J, et al. EHRA practical guide on the use of new oral antico-
cal patients. Therefore, clinicians need an alterna- education or discussion, and comprises neither statements agulants in patients with non-valvular atrial fibrillation: executive
summary. Eur Heart J 2013;34:2094–106.
tive therapeutic approach, and off-label use of of advice nor the opinions of the APSF. It is not the intention
19. Spyropoulos AC, Douketis JD. How I treat anticoagulated
prothrombin complex concentrates has been of the APSF to provide specific medical or legal advice or to patients undergoing an elective procedure or surgery. Blood
reported, but all procoagulants pose prothrom- endorse any specific views or recommendations. In no event 2012;120:2954–62.
20. Spyropoulos AC, Al-Badri A, Sherwood MW, Douketis JD. Peri-
botic risks as well. Nonetheless, clinicians need shall the APSF be responsible or liable, directly or indirectly, procedural management of patients receiving a vitamin K antag-
for any damage or loss caused or alleged to be caused by or in onist or a direct oral anticoagulant requiring an elective
therapeutic approaches when dealing with emer- procedure or surgery. J Thromb Haemost 2016;14:875–85.
connection with the reliance on any such information.
gencies and bleeding in surgical patients. In man- 21. Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA,
Dunn AS, et al. Perioperative bridging anticoagulation in patients
aging patients who are bleeding, standard with atrial fibrillation. N Engl J Med 2015;373:823–33.
References:
approaches should always be considered, includ- 22. Schulman S, Carrier M, Lee AY, Shivakumar S, Blostein M, Spen-
1. Raval AN, Cigarroa JE, Chung MK, Diaz-Sandoval LJ, Diercks D, cer FA, et al. Perioperative management of dabigatran: a prospec-
ing hemostatic and hemodynamic support, and Piccini JP, et al. Management of patients on non-vitamin K antag- tive cohort study. Circulation 2015;132:167–73.
with life-threatening hemorrhage, the use of mas- onist oral anticoagulants in the acute care and periprocedural set- 23. Levy JH, Faraoni D, Spring JL, Douketis JD, Samama CM. Man-
ting: a scientific statement from the American Heart Association. aging new oral anticoagulants in the perioperative and intensive
sive transfusion protocols. Circulation 2017;135: e604–e33. care unit setting. Anesthesiology 2013;118:1466–74.
2. Heidbuchel H, Verhamme P, Alings M, Antz M, Diener HC, 24. Samama MM, Guinet C. Laboratory assessment of new antico-
Jerrold H. Levy is Professor in the Department of Hacke W, et al. Updated European Heart Rhythm Association agulants. Clinical chemistry and laboratory medicine. CCLM/
Anesthesiology and Intensive Care, Duke University Practical Guide on the use of non-vitamin K antagonist anticoag- FESCC 2011;49:761–72.
ulants in patients with non-valvular atrial fibrillation. Europace
School of Medicine, Durham, NC. 2015;17:1467–507. See “Anticoagulants,” Page 14
APSF NEWSLETTER June 2017 PAGE 7
Dr. Morell Establishes High Impact Safety Columns— Dear SIRS and Q&A
“Morell,” From Cover Page private practice experience at the APSF Executive the Dear SIRS column, along with Dr. Michael
Virginia Mason Medical Center. He has over Committee meetings enabled the group to make Olympio, which brought anesthesia professionals
30 years of practice experience in both academic recommendations that could work in both aca- and manufacturers together to solve problems
and private practice institutions, rising to the rank demic and private practice settings. Dr. Morell concerning medications and devices in a collab-
of Associate Professor at Wake Forest University. ensured that the APSF Newsletter maintained orative spirit. During his tenure as editor-in-chief
Dr. Morell is currently in private practice in high-quality content and disseminated the latest from 2001 to 2016, the APSF Newsletter distribu-
Niceville, FL. His experiences in both settings breaking research and development impacting tion list has grown from approximately 34,000 to
allowed him to bridge the gap that sometimes patient safety. Perhaps one of his most important more than 122,000 anesthesia professionals and
exists between these groups. His strong voice for and enduring contributions was the creation of affiliated industries.
Robert C. Morell, MD, Reflects on His Time With the APSF and as Editor of the APSF Newsletter
My first involvement with the APSF occurred in circulation of any anesthesia publication in the world.
1993 when the FDA added a black box warning to the None of this would have been possible without the
package insert for succinylcholine, warning of the continued support of Dr. Bob Stoelting, the Executive
potential for hyperkalemia due to unrecognized myo- Committee, the Board of Directors and most impor-
pathic conditions in children and adolescents. There tantly, the Editorial Board. Jan Ehrenwerth, Joan
was significant push back due to concerns that this Christie, Jeff Vender, Glenn Murphy, and John Eich-
would force anesthesia professionals, particularly horn have inspired and authored many important
those who only occasionally administered pediatric articles. Wilson Somerville, PhD, and Addie Larimore
anesthetics, toward unfamiliar induction techniques have provided incredible editorial support. Bonnie
that might result in greater risk. Being one of those Burkert has been the brains and brawn of production
“occasional pediatric anesthesiologists,” I was also before, during, and after my tenure. In the spirit of
concerned that this black box warning was misdi- my initial mentoring, I was so very fortunate to meet
rected, as it was unlikely that adolescents would have
Robert C. Morell, MD and recruit, first, Dr. Lorri Lee (a world-renowned
undiagnosed muscular dystrophies compared to
expert in many safety areas such as postoperative
younger children. After reading the APSF Newsletter, I on patient safety entitled, Patient Safety in Anes-
visual loss and neuroanesthesia) and subsequently,
felt that an article should be written on the topic and thetic Practice. It was such an honor to have Dr. Jeep
Dr. Steve Greenberg (part of the prestigious North-
that the APSF should send a representative to the Pierce author the forward, and Dr. Leroy Vandam
western and present NorthShore University Health-
pending FDA/Anesthetic Drug and Life Support contribute the first chapter on the historical aspects
System [Evanston, IL] legacy, with great expertise in
Advisory Committee meeting. I phoned Rick Siker, of patient safety. It was very gratifying that
critical care, cardiac anesthesia, and neuromuscular
then APSF executive director, to share my concerns esteemed experts and authors such as Drs. Steve
blockade.) My ability to step down was made possi-
and request APSF involvement. That was my first Hall, Jonathan Benumof, John Butterworth, J.S.
ble by the dedication of Dr. Lee as my co-editor and
interaction with this pioneer of patient safety. Dr. Gravenstein, Steve Howard, Jan Ehrenwerth and
Dr. Greenberg as assistant editor. Their enthusiasm,
Siker quickly agreed with me and suggested that I Richard Prielipp were so excited and willing to
creativity, knowledge base, and editorial expertise
attend the meeting and write the article, giving me contribute to the book.
have allowed, and will continue to allow, the Newslet-
contact information for Dr. John Eichhorn, who was
While taking a long walk along the piers in San ter to remain the fresh, relevant, and critically impor-
the founding and current editor of the Newsletter. Dr.
Francisco at an ASA meeting, Dr. Michael Olympio, tant face of the APSF. I thank all those who put up
Eichhorn served as a mentor to me for that first safety
then chair of the APSF Committee on Technology,
with me, encouraged me, corrected me, and helped
reporting assignment, which resulted in a pro/con and I had the joint inspiration for the Dear SIRS
me over these many years. The opportunity to have
column published in the APSF Newsletter in 1994 (Safety Information Response System) column, as
collaborated with such wonderful people, to be sup-
(http://www.apsf.org/newsletters/html/1994/ well as the Q and A column, both of which have con-
spring/#art 2). Dr. Eichhorn encouraged my involve- tinued as very popular regular columns in the News- ported in my creativity and evolution of the Newslet-
ment in the Newsletter and provided me the opportu- letter. The Dear SIRS column has addressed some ter, to have contributed to important safety initiatives
nity to continue to contribute. We formed a warm and very hot topics in anesthesia including the inaugural and to have facilitated the dissemination of safety
solid relationship. John continued as my mentor for Dear SIRS issue in 2004 regarding a common gas information has been profoundly meaningful to me.
several years, gradually giving me more responsibil- outlet concern that resulted in a corrective action by This has truly been a rewarding journey.
ity, allowing me to attend the editorial board and the manufacturer. Other topics have included an Dr. Morell remains active in private practice in Nicev-
executive committee meetings and introducing me to incorrect network connection simultaneously crash- ille, FL, and is a local champion for patient safety in his insti-
Dr. Ellison C. (Jeep) Pierce. It was a tremendous honor ing multiple anesthesia machines and anesthesia cir- tution, having served as chair of the department of surgery
to be allowed to work alongside such dedicated and cuit obstruction by CO2 absorbent wrappers. For and currently serving as chief of staff at Twin Cities Hospi-
brilliant pioneers in patient safety. Drs. Pierce, Siker, many years Dr. Olympio, followed by Dr. William tal. He has just achieved one of his most important lifetime
and Gravenstein were also incredibly gracious to a Paulsen, as chairs of the Committee on Technology, accomplishments—that of becoming a grandfather to beauti-
newcomer and were always willing to listen to my provided their invaluable expertise on anesthesia
ful baby girl, Brylee, in February of this year!
ideas, some of which were good and some not so equipment for this column.
much. As my experience grew, I moved from editorial
Over my 23 years of involvement with the APSF,
board member to associate editor and eventually edi-
I was fortunate to participate in many important
tor-in-chief of the APSF Newsletter.
APSF initiatives that have greatly improved patient
The opportunities for creativity were simply safety. The Newsletter has always been, and contin-
wonderful. I was supported in taking the Newsletter ues to be, the face of the APSF, the means of com-
from green and black and white to full color. Photo- municating important, and often, critical
graphic opportunities abounded. In 1997, John Eich- information, as well as serving as a wide-reaching
horn and I edited and published the first textbook educational tool. The Newsletter enjoys the largest
APSF NEWSLETTER June 2017 PAGE 8
Spotlight on Infection Prevention: Safe Injection Practices
by Terri Lee Roberts, BSN, RN, CIC, FAPIC
Safe injection practices are part of Standard Drug Diversion is a Patient Safety • Processes to observe and audit use of controlled
Precautions, providing for patient safety and substances
and Infection Prevention Event
health care provider protections. According to the • Immediate attention to suspicious audits
Centers for Disease Control and Prevention According to the U.S. Department of Justice • Collaborative relationships with public health
(CDC), syringe reuse and misuse of medication Drug Enforcement Agency (DEA), the abuse of and regulatory officials
vials over the past decade have resulted in dozens controlled substances is a serious problem, and • Staff education on drug diversion
of infectious outbreaks and the need to alert more health care providers are as likely as anyone else For more information, please visit the DEA
than 100,000 patients to seek testing for infection to abuse drugs. Drug-impaired health care pro- Diversion Control Division website and the CDC’s
with hepatitis B virus, hepatitis C virus, and HIV. viders are a source of controlled-substances Injection Safety website.
This harm is preventable! diversion. Health care providers have easy access Terri Lee Roberts, BSN, RN, CIC, FAPIC, is an
to controlled substances and some will divert and infection prevention analyst with the Pennsylvania
For more information, please visit the CDC’s
abuse these drugs to self-medicate, relieve stress, Patient Safety Authority.
Injection Safety website:
or improve mental alertness and work perfor-
http://www.cdc.gov/injectionsafety
mance. Disclosure: The author has no financial conflicts of
interest to disclose for this article.
If a health care provider tampers with injectable
drugs, they must do so quickly to avoid detection. It Additional Resources
is likely sterile technique is not used and the needle Prevent the occurrence of bloodborne disease transmis-
used to inject the drug is not replaced. If the health sion associated with unsafe injection practices. Pa Patient
Saf Advis [online] 2011 Jun. Retrieved from http://
care provider is infected with hepatitis B virus, hep-
patientsafetyauthority.org/ADVISORIES/AdvisoryLi-
atitis C virus, and/or HIV, the exposed patients are brary/2011/jun8(2)/Pages/70.aspx.
at risk of developing infection.
Bradley S, Perz JF, & McKnight EV. (2014, October 14).
Drug-diversion programs for health care facili- Patient Safety Authority [Webinar]. Injection safety:
ties include what every ambulatory surgery facility physician and
The One & Only Campaign manager/owner needs to know. Retrieved from http://
• Policies to prevent, detect, and report drug patientsafetyauthority.org/EducationalTools/Presenta-
The Centers for Disease Control and Prevention diversion tions/Pages/webinar_20141021.aspx.
and the Safe Injection Practices Coalition lead the
One & Only Campaign, a public health initiative to
increase awareness of safe injection practices. Its
DANGEROUS
goal is to eliminate infections resulting from unsafe
MISPERCEPTIONS
injection practices. Remember “One Needle, One
Syringe, Only One Time” for each and every injec- Here are some examples of dangerous
misperceptions about safe injection practices.
tion! For example, use a new syringe and new
needle when drawing up more propofol for an infu-
Myth Truth
sion. Never re-use tubing for infusions between
patients, even if it is auxiliary tubing inserted
Once they are used, both the needle and syringe are
upstream into the patients main i.v. line. Changing the needle makes contaminated and must be discarded. A new sterile needle
a syringe safe for reuse. and a new sterile syringe should be used for each injection
For more information, please visit the One and and each entry into a medication vial.
Only Campaign website.
http://www.oneandonlycampaign.org Syringes and needles should never be reused. The IV
tubing, syringe, and other components represent a single,
Syringes can be reused as long as
Sharps Disposal Containers an injection is administered through interconnected unit. Distance from the patient, gravity,
or infusion pressure do not ensure that small amounts
IV tubing.
of blood won't contaminate the syringe once it has been
Used sharps need to be disposed of immedi- connected to the unit.
ately into a sharps container approved by the U.S.
Food and Drug Administration (FDA). These con- Germs such as hepatitis C virus and staph or MRSA are
If you don't see blood in the IV
tainers have been evaluated for safety and effec- tubing or syringe, it means that invisible to the naked eye, but can easily infect patients
even when present in microscopic quantities. Do not reuse
those supplies are safe for reuse.
tiveness to help reduce the risk of injury and syringes, needles, or IV tubing.
infections from sharps. FDA-cleared sharps dis-
posal containers are made from puncture-resistant
materials with leak-resistant sides and bottom and It’s okay to use leftover medicine Single-dose or single-use vials should not be used for
from use single-dose or single-use more than one patient regardless of how much medicine
a tight fitting, puncture-resistant lid. These con- vials for more than one patient. is remaining.
tainers are labeled to warn of hazardous waste
and marked with a line to indicate when the con-
Injection Safety is Every Provider’s Responsibility!
tainer is considered full. Close and properly dis-
pose of the container when it is full. The One & Only Campaign is a public health effort to eliminate For the latest news and updates,
unsafe medical injections. To learn more about safe injection follow us on Twitter @injectionsafety
For more information, please visit the CDC’s practices, please visit OneandOnlyCampaign.org. and Facebook/OneandOnlyCampaign.
Stop Sticks Campaign website and the FDA’s This material was developed by CDC. The One & Only Campaign is made possible by a partnership between the CDC Foundation and Lilly USA, LLC.
Medical Devices website. One of the resources available on www.cdc.gov/injectionsafety.
APSF NEWSLETTER June 2017 PAGE 9
APSF Joins NPSF in National Multidisciplinary
Effort to Reduce Preventable Health Care Harm
The Anesthesia Patient Safety Foundation
(APSF) strongly supports the goals and direction
of the National Patient Safety Foundation’s National Patient Safety Foundation®
(NPSF’s) Call to Action and widespread adoption TWENTY YEARS
CALL TO ACTION
of the public health framework described in “Pre-
ventable Health Care Harm Is a Public Health
Crisis and Patient Safety Requires a Coordinated Preventable Health Care Harm Is a Public Health Crisis
Public Health Response.”
and Patient Safety Requires a Coordinated
The APSF serves as the primary safety organi-
Public Health Response
zation for more than 100,000 anesthesia profes-
sionals in the United States and is dedicated to Information and technical review
provided by the Centers for
improving the safety of all patients undergoing Disease Control and Prevention.
Summary
surgical and diagnostic procedures while anes-
Preventable harm in health care is a public health crisis, As outlined below, NPSF believes that a public health
thetized and during their perioperative care. with estimates placing it as a leading cause of death in response — one that draws on the experience and exper-
These anesthesiologists, nurse anesthetists, and the United States.1–4 tise of public health professionals and public health
organizations — will accelerate progress in the prevention
anesthesiologist assistants are involved in the full The National Patient Safety Foundation (NPSF) calls on of harm and establish the critical infrastructure needed
spectrum of perioperative care, ranging from pre- dheinaaltthe dc apreu bleliacd heersa altnhd r pesopliocynmsea5k,6e tros tiom ipnritoiavtee paa ctoieonrt- tcoo nadsidsrteesnst tlyh iasn cdh aslulesntagien aabcrloy.ss the US health care system
operative assessment through intraoperative care safety and drive the collective work needed to ensure
that patients and those who care for them are free from Building on successful efforts to reduce HAIs5,8–13 and
to the provision of critical care services and pain preventable harm (see figure 1). Such an approach has taking advantage of critical lessons learned,7 NPSF pro-
management. Since its inception in 1985, the already contributed to significant reductions in health poses the following public health framework to guide
care–associated infections (HAIs).7 efforts. This evidence-based approach identifies effective,
APSF has provided more than $10 million to sup- replicable interventions for effec-
port perioperative patient safety research. Figure 1. tive propagation across the health
care system.
Through its publications and conferences, the Public Health Framework for the Prevention of Harm in Health Care
NPSF urges greater collaboration
APSF has a worldwide impact and works closely among all stakeholders to address
with health care professional societies to advo- DePfionleic ythmea Pkreorbs laenmd aHneda lSteht C Naartei oLneaald Gerosa ls preventable health care harm and
recommends widespread adoption
cate for practices that improve perioperative of our public health framework to
patient outcomes. StakCeohoorlddienrast eC oAlclatibvoitriaetse to guide collective efforts (figure 1).
Too often, efforts to blame individu-
als and organizations for prevent-
In joining the NPSF in their patient safety
able harm diverts attention and
endeavors, the APSF Newsletter, website (www. resources away from a more effec-
apsf.org), and other social media sources will peri- the CInofmormmu nity anMd eMasounrieto r anIdde Innttiefyr vCeanutsioens s aEnddu Tcraatien treivsep oannsde. sustainable collective
odically disseminate updates from the NPSF for Read more >>>
this coordinated effort among multidisciplinary
groups at reducing patient harm.
The National Patient Safety Foundation’s vision is to create a world where patients and those who care for them are free from harm. A central voice
Sincerely, for patient safety since 1997, NPSF partners with patients and families, the health care community, and key stakeholders to advance patient safety
and health care workforce safety and disseminate strategies to prevent harm. NPSF is an independent, not-for-profit 501(c)(3) organization.
National Patient Safety Foundation • 280 Summer Street, Ninth Floor • Boston, MA 02210
617. 391.9900 • [email protected] • www.npsf.org
Mark A. Warner, MD
President
NPSF Urges Call to Action on poses a public health approach to guide collective
efforts and calls on health care leaders and policy-
Preventable Health Care Harm
The APSF continues to accept makers to initiate a coordinated response to drive
and appreciate contributions. We will all be patients someday, yet evidence the collective work needed to ensure that patients
suggests that preventable harm in health care is a and those who care for them are free from prevent-
Please donate online by clicking the
leading cause of death and morbidity in the US. As able harm. By initiating a public health approach
Donate button below or make checks
a reflection of APSF’s commitment to advancing and working together to implement it, health care
payable to the APSF & mail donations to
safe care and elevating patient and workforce leaders and policymakers can accelerate progress
Anesthesia Patient safety as a core value, we are among the early in patient safety and establish the infrastructure
Safety Foundation (APSF) endorsers of the National Patient Safety Founda- needed to ensure that patients and the health care
1061 American Lane tion’s new Call to Action: Preventable Health Care workforce are free from preventable harm across
Schaumburg, IL 60167-4973 Harm Is a Public Health Crisis and Patient Safety the health care spectrum.
Requires a Coordinated Public Health Response. Read more and download the full NPSF Call to Action
The Call to Action builds on successful efforts to document at http://c.ymcdn.com/sites/www.npsf.org/
reduce health care-associated infections and takes resource/resmgr/pdf/NPSF_CallToAction_PubHealth.
advantage of critical lessons learned. NPSF pro- pdf?hhSearchTerms=%22preventable+and+harm%22.
APSF NEWSLETTER June 2017 PAGE 10
Unintended Discharge of an ICD in a Patient
Undergoing Total Knee Replacement
Dear Q&A,
This brief communication questions the current
recommendations for perioperative management
of cardiovascular implantable electronic devices
(CIED) which include pacemakers, implantable
cardioverter defibrillators (ICDs), and cardiac
resynchronization therapy (CRT) devices. This
case pertains to the ICD.
There are two strategies for patient’s undergoing
surgeries who also have an internal cardiac defi-
brillator (ICD) to prevent inappropriate discharge
of the device in the presence of electromagnetic
interference (EMI). The first is to program the
device to “off” by using a manufacturer’s specific
programmer. The other, simpler strategy is to
place a doughnut magnet directly over the
devices’ generator. This will inhibit the devices’
tachyarrhythmia therapy function, not its brady-
arrhythmic therapy (pacemaker) function.
The 2011 HRS/ASA expert consensus statement Figure 1. Top tracing: Atrial sense lead. Middle tracing: Ventricular sense lead. Bottom tracing: Discrimination
suggested inactivating the ICD for all surgeries (channel) lead. Atrial, ventricular, and discrimination channel leads show similar rapid wave form signals suggest-
above the umbilicus.1 However, the document ing to the ICD that this is ventricular fibrillation. The device senses this and then analyzes the wave form during a
implied that it was unnecessary to do so for sur- programmable duration delay of approximately eight seconds. It determines that this is ventricular fibrillation, and
geries below the umbilicus, as the risk of EMI then charges for approximately 5 seconds—while continuing to analyze the waveforms—and then discharges. The
being detected, and hence of discharge of the point is that the discharge event was set in motion many seconds before the actual discharge.
device, was very low and in fact never docu-
VF *** Device charging Lightning bolt symbol indicates discharge
mented to have occurred.1 We recently cared for a
patient undergoing lower extremity surgery—
total knee replacement—whose ICD discharged
during surgery despite appropriate placement of
the electrocautery grounding pad.
The patient was an 82-yr.-old male (height: 5’ 6”,
weight: 146 lbs.) with a history of coronary artery
disease and an ischemic cardiomyopathy (ejec-
tion fraction=25%). The patient also had a CIED
(St. Jude Medical; Little Canada, MN. Quadra
Assura™ 3365-40Q CRT-D; RV lead: maximum
sensitivity setting, 0.5 mV; autosense mode “on”)
located in the left pectoral region. Neither a
magnet nor reprogramming was used to disable
Figure 2. Table depicts events of interest, including the event leading to device discharge (electrogram shown in
the device’s antitachyarrhythmic therapy func-
Fig. 1), as well as their duration. The “VF” event at 09:47 consists of several short epochs of high frequency wave
tion. He subsequently underwent a right total forms whose total duration is 21 seconds, but with no shock delivered. The device identifies some epochs as ven-
knee replacement under spinal anesthesia. The tricular fibrillation, but correctly identifies most as high frequency “noise” and, therefore, the device does not
See “Q&A,” Next Page discharge (electrogram not shown).
The APSF sometimes receives questions that are not suitable for the Dear SIRS column. This Q and A column allows the APSF to forward these questions to
knowledgeable committee members or designated consultants. The information provided is for safety-related educational purposes only, and does not constitute
medical or legal advice. Individual or group responses are only commentary, provided for purposes of education or discussion, and are neither statements of advice
nor the opinions of the APSF. It is not the intention of the APSF to provide specific medical or legal advice or to endorse any specific views or recommendations in
response to the inquiries posted. In no event shall the APSF be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by
or in connection with the reliance on any such information.