16
NEWSLETTER Volume 19, No. 1, 1-16 Circulation 36,825 Spring 2004 www.apsf.org Inside: Complications Associated With Regional Anesthesia..............................................Pg 5 Burton Dole Becomes Largest APSF Donor ..............................................................Pg 7 Misplaced Valve Poses Potential Hazard (Dear SIRS) ............................................Pg 8 APSF Grant Program ....................................................................................................Pg 10 Safe Use of Epidural Steroids ......................................................................................Pg 14 The Official Journal of the Anesthesia Patient Safety Foundation Can We Alter Long-Term Outcome? The Role of Inflammation and Immunity in the Perioperative Period (Part II) most a few days following surgery. Most anesthesia patient safety initiatives have naturally focused on events that occur while anesthesiologists are actively involved with care—a period that has now become extraordinarily safe. This focus may need to shift as the risk of dying during the first postopera- tive year may be as high as 5% to 14% in certain patient populations. New evidence suggests that this mortality might be influenced by specific anes- thetic interventions at the time of surgery. 2-4 Recent biomedical research has demonstrated the importance of inflammation in the progression of chronic diseases such as atherosclerosis, cancer, and dementia. Anesthesia and surgery are also associated with a dramatically increased inflamma- tory response and concurrent suppression of cell- mediated immunity. 5,6 Since most long-term deaths after surgery are due to cardiovascular events and cancer, it is reasonable to postulate that perioperative immune responses play some role in these outcomes. The first article in this two-part series intro- duced the APSF readership to the concept that medical decisions during the perioperative period may have long-term consequences for patient safety. 1 The potential relationship between anesthe- sia management and long-term outcome is not intu- itively obvious. Anesthesia practice typically functions within a “beat-to-beat” environment where intraoperative complications happen sud- denly, anesthetic drugs wear off quickly, and patient outcomes are measured within hours or at See “Outcome,” Page 3 Editor’s Note: The fall 2003 Issue of this Newsletter contained an article entitled “Can We Alter Long-Term Outcome? The Role of Anesthetic Management and the Inflammatory Response,” by Drs. Meiler, Moond, Mayfield, and Head. The following article is the second in this two-part series and provides a glimpse into evidence linking perioperative inflammation and long term morbidity and mortality. It raises some very interesting and provocative questions. As part of this initiative exploring periopera- tive inflammation, the APSF is organizing a multi-specialty Expert Panel entitled “Anes- thetic Depth, Inflammation, and Surgical Out- comes,” to be held in Washington, DC, in September 2004, under the leadership of David Gaba, MD. A world-class group of investigators will meet to consider the current data, identify gaps in understanding, develop research strate- gies, and discuss the potential impact on periop- erative management. Surgical leaders will participate, including Shukri Khuri, MD (VA), Thomas Russell, MD (ACS), and David Hunt (CMS), as well as anesthesiologists and scientists including Charles Serhan, MD, Simon Gelman, MD, Lee Fleisher, MD, Rober Legasse, MD, Mar- cel Durieux, MD, Steffen Meiler, MD, and Terri Monk, MD. Patient Safety experts will include Robert Stoelting, MD, and Jeffrey Cooper, PhD. This panel will be co-sponsored by the Joint Commission on Accreditation of Healthcare Organizations, represented by Jerold Loeb, PhD, and the National Quality Forum, represented by Kenneth Kizer, MD. by Steffen E. Meiler, MD, Terri G. Monk, MD, James B. Mayfield, MD, and C. Alvin Head, MD Our short-term interventions may have long-term consequences.

NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

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Page 1: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

NEWSLETTERVolume 19, No. 1, 1-16 Circulation 36,825 Spring 2004

www.apsf.org

Inside: Complications Associated With Regional Anesthesia..............................................Pg 5Burton Dole Becomes Largest APSF Donor ..............................................................Pg 7Misplaced Valve Poses Potential Hazard (Dear SIRS) ............................................Pg 8APSF Grant Program ....................................................................................................Pg 10Safe Use of Epidural Steroids......................................................................................Pg 14

The Official Journal of the Anesthesia Patient Safety Foundation

Can We Alter Long-Term Outcome?The Role of Inflammation and Immunity in the Perioperative Period (Part II)

most a few days following surgery. Most anesthesiapatient safety initiatives have naturally focused onevents that occur while anesthesiologists areactively involved with care—a period that has nowbecome extraordinarily safe. This focus may need toshift as the risk of dying during the first postopera-tive year may be as high as 5% to 14% in certainpatient populations. New evidence suggests thatthis mortality might be influenced by specific anes-thetic interventions at the time of surgery.2-4

Recent biomedical research has demonstratedthe importance of inflammation in the progressionof chronic diseases such as atherosclerosis, cancer,and dementia. Anesthesia and surgery are alsoassociated with a dramatically increased inflamma-tory response and concurrent suppression of cell-mediated immunity.5,6 Since most long-term deathsafter surgery are due to cardiovascular events andcancer, it is reasonable to postulate that perioperativeimmune responses play some role in these outcomes.

The first article in this two-part series intro-duced the APSF readership to the concept thatmedical decisions during the perioperative periodmay have long-term consequences for patientsafety.1 The potential relationship between anesthe-sia management and long-term outcome is not intu-itively obvious. Anesthesia practice typicallyfunctions within a “beat-to-beat” environmentwhere intraoperative complications happen sud-denly, anesthetic drugs wear off quickly, andpatient outcomes are measured within hours or at

See “Outcome,” Page 3

Editor’s Note: The fall 2003 Issue of thisNewsletter contained an article entitled “CanWe Alter Long-Term Outcome? The Role ofAnesthetic Management and the InflammatoryResponse,” by Drs. Meiler, Moond, Mayfield,and Head. The following article is the second inthis two-part series and provides a glimpse intoevidence linking perioperative inflammationand long term morbidity and mortality. Itraises some very interesting and provocativequestions.

As part of this initiative exploring periopera-tive inflammation, the APSF is organizing amulti-specialty Expert Panel entitled “Anes-thetic Depth, Inflammation, and Surgical Out-comes,” to be held in Washington, DC, inSeptember 2004, under the leadership of DavidGaba, MD. A world-class group of investigatorswill meet to consider the current data, identifygaps in understanding, develop research strate-gies, and discuss the potential impact on periop-erative management. Surgical leaders willparticipate, including Shukri Khuri, MD (VA),Thomas Russell, MD (ACS), and David Hunt(CMS), as well as anesthesiologists and scientistsincluding Charles Serhan, MD, Simon Gelman,MD, Lee Fleisher, MD, Rober Legasse, MD, Mar-cel Durieux, MD, Steffen Meiler, MD, and TerriMonk, MD. Patient Safety experts will includeRobert Stoelting, MD, and Jeffrey Cooper, PhD.This panel will be co-sponsored by the JointCommission on Accreditation of HealthcareOrganizations, represented by Jerold Loeb, PhD,and the National Quality Forum, represented byKenneth Kizer, MD.

by Steffen E. Meiler, MD, Terri G. Monk, MD, James B.Mayfield, MD, and C. Alvin Head, MD

Our short-term interventions may have long-term consequences.

Page 2: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

APSF NEWSLETTER Spring 2004 PAGE 2

The Anesthesia Patient Safety FoundationNewsletter is the official publication of the nonprofitAnesthesia Patient Safety Foundation andis published quarterly at Wilmington, Delaware.Annual membership: Individual - $25.00, Corporate -$500.00. This and any additional contributions to theFoundation are tax deductible. © Copyright, AnesthesiaPatient Safety Foundation, 2004.

The opinions expressed in this Newsletter are notnecessarily those of the Anesthesia Patient SafetyFoundation or its members or board of directors.Validity of opinions presented, drug dosages,accuracy, and completeness of content are notguaranteed by the APSF.APSF Executive Committee:

Robert K. Stoelting, MD, President; Jeffrey B.Cooper, PhD, Executive Vice President; George A.Schapiro, Executive Vice President; David M. Gaba,MD, Secretary; Casey D. Blitt, MD, Treasurer; Robert A.Caplan, MD; Nassib G. Chamoun; John H. Eichhorn,MD.Newsletter Editorial Board:

Robert C. Morell, MD, Editor; Sorin J. Brull, MD;Joan Christie, MD; Jan Ehrenwerth, MD; John H.Eichhorn, MD; Regina King; Rodney C. Lester, PhD,CRNA; Glenn S. Murphy, MD; Denise O’Brien, BSN,RN; Karen Posner, PhD; Keith Ruskin, MD; WilsonSomerville, PhD; Jeffery Vender, MD.

Address all general, membership, and subscriptioncorrespondence to:AdministratorAnesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922e-mail address: [email protected]

Address Newsletter editorial comments, questions, letters, and suggestions to:Robert C. Morell, MDEditor, APSF Newsletterc/o Addie Larimore, Editorial AssistantDepartment of AnesthesiologyWake Forest University School of Medicine9th Floor CSBMedical Center BoulevardWinston-Salem, NC 27157-1009e-mail: [email protected]

The goals of the Joint Taskforce are to

• Communicate safety priorities, best practices,and related programs conducted by eachassociation.

• Evaluate and implement partneringopportunities for patient safety.

• Provide updates to the leadership of theAmerican Society of Anesthesiologists (ASA)and The Society of Critical Care Medicine(SCCM).

Members of the Joint Taskforce on Safetyinclude APSF appointees, Jeffrey Cooper, PhD;David Gaba, MD; Robert Morell, MD; and RichardPrielipp, MD (co-chair); and CCCE appointees,Yvonne Harter, MBA; Patricia McGaffigan, RN(co-chair); Marcus Schabacker, MD; and MargaretParker, MD.

For additional information on the Safety JointTaskforce please contact by email: Richard Prielippwith the APSF at [email protected], or PatriciaMcGaffigan with Aspect Medical, representing theCCCE, at [email protected].

Safety initiatives continue to be refined through-out the continuum of perioperative and extendedcritical care. Patients commonly travel throughthese areas, and attention to quality care and patientsafety should be universal across all providers andthroughout the organization. Defining commongoals provides opportunity for anesthesia and criti-cal care practitioners to collaborate on best practicesand initiate new approaches to optimize patientsafety.

Therefore, the Anesthesia Patient Safety Foun-dation (APSF), founded in 1986, and the Coalitionfor Critical Care Excellence (CCCE), founded in1991, have appointed a Joint Taskforce on Safety toexplore a shared vision and mission to improvepatient safety throughout the perioperative period.

A Partnership and Common VisionThe Anesthesia Patient Safety Foundation (APSF)and The Coalition for Critical Care Excellence(CCCE) Initiate Joint Taskforce

The APSF continues toaccept and appreciatecontributions for theE.C. Pierce, Jr., MD,

Research Award. Please make checks payable tothe APSF and mail donations

to:

APSFc/o Ellison C. Pierce, Jr., MD,

Research Award4246 Colonial Park Drive

Pittsburgh, PA 15227-2621

The APSF Website

is now undergoing a

redesign—stay tuned

for a new, user-

friendly, exciting, and

informative website!

www.apsf.org

New APSFContact

InformationAnesthesia Patient Safety Foundation

Building One, Suite Two

8007 South Meridian Street

Indianapolis, IN 46217-2922

Telephone: 317-885-6610

Facsimile: 317-888-1482

Executive Assistant:

Deanna M. Walker

E-mail (Executive Assistant):

[email protected]

President: Robert K. Stoelting, MD

E-mail (President): [email protected]

Page 3: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

APSF NEWSLETTER Spring 2004 PAGE 3

heightened inflammatory state, orchestrated by therelease of pro-inflammatory cytokines, reduced lev-els of anti-inflammatory cytokines, and increasedproduction of arachidonic acid metabolites, super-oxide radicals, and other mediators. Interestingly,individual genetic profiles, assessed by gene poly-morphism, may also predispose certain patients toan enhanced inflammation risk.13 To put this con-cept into perspective, we propose a hypotheticalmodel to explain how the perioperative immuneresponse might impact long-term outcomes (Figure1). This model is supported by the following ratio-nale and studies that document the postoperativeprogression of disease known to be influenced byinflammatory processes:

1. The typical pro-inflammatory mediators releasedin surgical patients overlap significantly withthose involved in atherosclerosis and cancer.5-9

2. The beneficial effects of beta-blockers onpostoperative cardiac risk 14 were initiallyattributed to altered hemodynamics; however,more recent studies demonstrated theirsignificant anti-inflammatory properties.15,16

3. Surgical patients demonstrate reducedlymphocyte counts and function, which couldresult in impaired tumor cell surveillance andelimination. Several studies have reported on theassociation of surgery and an increased incidenceof metastatic tumor spread.17-19

Possible Changes inPerioperative Management:

Considering the Immune SystemAt this point, the link between patient outcome

and immune response is circumstantial, but credi-ble. Enough is known to hypothesize a variety ofclinical interventions that might improve or protectimmune homeostasis (see Figure 2).

• The neuroendocrine response to stress is animportant modifier of immune function, andanxiety, fear, and pain have been shown to beassociated with adverse outcomes.20 There is awealth of data on modification of stress hormoneresponses by anesthetic drugs, but very fewstudies relating hormone levels to long-termoutcome. Stress hormones like norepinephrinecan trigger a pronounced and immediateactivation of pro-inflammatory cells andcytokines.21,22 The triggers for stress responsesare both psychological and physical, so it seemsreasonable that postoperative immune functioncould be improved by increased attention toperioperative anxiolysis and analgesia.

• Once adrenergic stress hormones have beenreleased, their pro-inflammatory signals can beeffectively intercepted with the use of beta- oralpha-blockers.22 Despite well-documented

In this article we discuss some of the research onthis topic, and briefly address three broad ques-tions:1. What is the evidence that perioperative inflam-

mation and immunity are determinants of long-term morbidity and mortality?

2. Do we have evidence that anesthesia care islikely to affect this biology? Is it possible thatsome anesthetic approaches accelerate diseaseprocesses while others have protective effects?

3. Will it be possible, by using these insights, toimprove preoperative risk stratification anddevelop strategies that reduce long-term adverseevents?

Inflammation: A Key Element in Disease

“Inflammation is a local, protective response tomicrobial invasion or injury. It must be fine-tunedand regulated precisely, because deficiencies orexcesses of the inflammatory response cause mor-bidity and shorten lifespan.”

— Nature 2002;420:853

There is now a large and growing literature onthe role of inflammation in the pathogenesis of ath-erosclerosis and cancer. Atherosclerosis is generallyheld to be an inflammatory disease of the vascularwall, and it responds to treatment with diverseclasses of anti-inflammatory medications, such asaspirin, beta-blockers, HMG-CoA reductaseinhibitors (statins), ACE-inhibitors, and activators ofPPAR-α (fibrates).7,8 Statins, for example, have beenshown in large trials to reduce mortality, but thisbenefit cannot be completely explained by theireffects on cholesterol. It is likely that some of thebenefit comes from their significant vascular anti-inflammatory effects.9,10 Another body of researchsuggests a link between inflammation and cancer.Many cancers not only arise from areas of chronicinfection and inflammation (e.g., hepatitis/hepato-cellular carcinoma or inflammatory boweldisease/colon cancer), but they often require a pro-inflammatory milieu to support their growth andmetastatic spread.11 The fact that chronic use ofaspirin and NSAIDs is associated with a reducedincidence of certain malignancies further substanti-ates the role of inflammation in the biology of can-cers.12

What about anesthesia and surgery? It is nowwell recognized that surgery frequently producesprofound changes in both the innate and acquiredimmune systems.5,6 The duration and the extent of asurgical procedure as well as preoperative anxietyand postoperative pain can all influence thisresponse. In the perioperative period, there is a

Perioperative Inflammation Model Suggested

See “Outcome,” Next Page

“Outcome,” From Page 1

Inflammation Profile/Disease Risk

Preoperative(baseline)

Surgery TIME

Preoperative Postoperative(long-term — weeks to months)

Increased inflammationand associated risk for disease progression

Threshold foradverse impact on health

Figure 1. Perioperative Inflammation and Long-Term Risk: A Hypothetical Model.

The green curve depicts the perioperative inflammatory response of an otherwise healthy individual, characterized by atransient elevation in various inflammatory mediators and then prompt return to a baseline state. In a high-risk patient(red curve), the amplitude and duration of the inflammatory response are prolonged. This sustained period of inflamma-tion may contribute to new or accelerated disease risk.

Page 4: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

benefits for short- and long-term outcome, theperioperative use of beta-blockers remainsdisconcertingly low (the topic was previouslydiscussed in this newsletter23,24). Given thesuccess of beta-blocker treatment, similaroutcome studies using other anti-inflammatorydrugs (statins, COX-2 inhibitors, ACE-inhibitors,local anesthetics) deserve high priority.

• Perioperative temperature management is nowknown to play an important role in postoperativeinflammatory processes. Maintenance ofintraoperative normothermia improves woundhealing and reduces wound infection,25 whilemild hypothermia is known to be associated withlymphocyte suppression and increased stresshormone levels.26,27

• A small number of studies indicate that certainanesthetic agents exert direct toxic effects andmay contribute to long-term risk. In some clinicalstudies, volatile anesthetics have been associatedwith a greater systemic inflammatory responsecompared to total intravenous anesthetics withadjuvant narcotic therapy.28,29 In vitro studieshave shown that volatile anesthetics havesubstantial immunosuppressive effects byinducing programmed cell death in lymphocytes,diminishing lymphocyte function, and alteringthe distribution of lymphocyte cell subsets.30-33 Ina study of metastatic melanoma in the mouse,volatile anesthetics alone (without surgery)caused a 2- to 3-fold increase in tumor burden.19 Itis too early to link the immune-modulating effectsof volatile anesthetics to an increased risk fortumor growth and spread in humans, but furtherwork in this area is clearly needed.

• The studies of Weldon and Lennmarken showthat deeper levels of anesthetic effect and,presumably, larger average doses of volatileanesthetics are associated with increased risk ofmortality.2,3 This suggests a possible patientbenefit from reducing the overall exposure toinhaled anesthetic agents. The anestheticconcentration needed to prevent consciousness(MAC-awake) is much less than that needed toprevent movement (MAC) or autonomicresponses (MAC-BAR).34 Titrating volatile agentsto suppress movement or to blood pressure andheart rate endpoints, not only results in theadministration of higher doses, but may also beassociated with underutilization of adjuvanttherapy, such as beta-blockers and opioids. Whenanesthetic agents are titrated to hypnoticendpoints using EEG-based monitors, there is asignificant reduction in anesthetic dosing.35-37

Regardless of the interventions we ultimatelychoose to investigate, it will be important to “mea-

sure” inflammation by analysis of appropriateserum markers. Measuring inflammation at preoper-ative baseline may significantly improve the accu-racy with which we stratify patients for operativerisk. The markers of inflammation, C-reactive pro-tein and myeloperoxidase, have a high predictiveutility in determining the clinical course and acuteevent rate of coronary artery disease.38,39 Preopera-tive measurements of these markers may provide a“window” on the inflammatory state or vulnerabil-ity of coronary lesions and improve outcome predic-tions. It is also possible that a postoperative profileof these bio-markers may identify patients whowould benefit from more sustained anti-inflamma-tory treatment strategies. Similarly, these postopera-tive profiles may provide a means for optimizinganesthetic management.

In summary, the available evidence strongly sug-gests that immune system dysfunction in the periop-erative period, with its combined pro-inflammatoryand immuno-suppressive effects, can influence long-term disease progression, morbidity, and mortality.A substantial amount of research — much of it, wehope, by members of the APSF — is needed to estab-lish whether changes in anesthetic practice canmeaningfully reduce this risk. Should anesthesiolo-gists really be looking at events 6 months or a yearfollowing surgery? The demographics are certainlycompelling, since even a small improvement in

1-year outcome could mean thousands of livessaved each year and a significant reduction in eco-nomic burden. Although some of the observationsshared in this article are still at the conceptual stage,we are confident that research on perioperativeinflammation and immunity will yield significantimprovements in long-term patient safety.

Dr. Meiler is an Associate Professor and Vice Chairfor Research in the Department of Anesthesiology andPerioperative Medicine, and Director of the Program forMolecular Perioperative Medicine & Genomics at theMedical College of Georgia. Dr. Monk is a Professor in theDepartment of Anesthesiology at the University of FloridaCollege of Medicine. Dr. Mayfield is an Associate Profes-sor and Vice Chair of Clinical Anesthesia in the Depart-ment of Anesthesiology and Perioperative Medicine at theMedical College of Georgia. Dr. Head is Professor andChair of the Department of Anesthesiology and Periopera-tive Medicine at the Medical College of Georgia.

References

1. Meiler SE, Monk TG, Mayfield JB, Head CA. Can wealter long-term outcome? The role of anesthetic manage-ment and the inflammatory response. APSF Newsletter2003;18:33,35.

2. Weldon C, Mahla ME, Van der Aa MT, Monk TG.Advancing age and deeper intraoperative anesthetic lev-els are associated with higher first year death rates. Anes-thesiology 2002;97(Suppl):A1097.

APSF NEWSLETTER Spring 2004 PAGE 4

Research Needed to Assess Long-Term Outcome “Outcome,” From Preceding Page

STRATEGIES

MINIMIZE DURATION AND INTENSITYOF PERIOPERATIVE INFLAMMATORY RESPONSE

Preoperative• Stratify risk (inflammatory

biomarkers)• Provide anti-inflammatory

prophylaxis (? best agent, ? best duration)

• Provide anxiolysis

Perioperative• Minimize surgical trauma (e.g.,

leparoscopic approach)• Maintain tight hemodynamic control• Maintain normothermia• Prevent infection• Consider regional vs. general

anesthesia• Optimize anesthetic management:

- Administer preemptive analgesia- Consider intravenous vs. volatile

agent- Administer appropriate adjuvants

(e.g., β-blockers)- Minimize anesthetic exposure

(e.g., CNS-based titration)

Postoperative• Provide effective pain

management (epidural, PCA, NSAID)

• Provide anti-inflammatory therapy (? best agent, ? best duration)

• Prevent infection

Figure 2. Conceptual framework of strategies that may minimize the perioperative inflammatory response and long-termadverse outcomes.

See “Outcome,” Page 7

Page 5: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

APSF NEWSLETTER Spring 2004 PAGE 5

The regional anesthesia group contained a sig-nificantly higher proportion of claims associatedwith temporary injury and permanent nerve injurycompared to the other surgical anesthesia group,whereas death or permanent brain damage waspresent in a significantly higher proportion of othersurgical anesthesia claims (Figure 1).

The primary damaging events (mechanism bywhich the injury occurs) were block-related in 48%of regional anesthesia claims (Table 1). Complica-tion of block technique was the most common dam-aging event in these claims.

Regional anesthesia claims with death or braindamage were associated with block-related primarydamaging events in 49% of cases. Of these events,neuraxial cardiac arrest (i.e., the sudden onset ofsevere bradycardia or cardiac arrest during neurax-ial block with relatively stable hemodynamics pre-ceding the event) was the most common (37%),followed by unintentional intravenous injection(6%), and other block/anesthesia-related events(6%). In death or brain damage claims associatedwith regional techniques, the breakdown was asfollows: 51% spinal blockade, 41% epidural, 2%interscalene block, 1% axillary block, and 5% mis-cellaneous blocks.

Eighty-four percent of the neuraxial cardiacarrest claims from the 1980s and 1990s (n = 81) wereassociated with either intentional (70%) or inadver-tent intrathecal blockade (14%). The remainder ofthese claims was associated with lumbar epidural(12%), caudal epidural (2%), and thoracic epidural(2%) anesthesia. Outcome for neuraxial cardiacarrest resulted in death or brain damage in 91% ofcases, and was similar between decades. The use ofpulse oximetry and capnography in the 1990sclaims (n = 31) did not prevent the occurrence of

neuraxial cardiac arrest or improve the outcome ofdeath or brain damage compared to the 1980sclaims when these monitors were not widely avail-able (Table 2). It is unclear if prevention or resusci-tation of neuraxial cardiac arrest has improved overthe last decade because the ASA Closed ClaimsDatabase lacks denominator data and is biasedtoward cases with poorer outcomes. Inadvertentintrathecal blocks and occurrence of cases outsidethe operating room may account for some of thedelays in recognition and resuscitation of neuraxialcardiac arrest. The rapid onset of bradycardia/asys-tole and the intense loss of sympathetic tone causedby spinal blockade (which reduces circulating bloodvolume) may explain why some cases of neuraxialcardiac arrest may be refractory to prompt treat-ment.

A greater proportion of regional anesthesiaclaims were associated with permanent nerveinjury compared to the other surgical anesthesiagroup (Figure 1). Lumbosacral nerve root, paraple-gia, and median nerve damage were significantlymore common in the regional anesthesia groupcompared to the other surgical anesthesia group.Brachial plexus, ulnar nerve, and femoral/sciaticnerve injuries occurred in a greater proportion ofother surgical anesthesia claims compared toregional anesthesia claims. Eighty-four claims ofinjuries to the neuraxis were identified in theregional anesthesia group, and 36 cases (44%) wereassociated with hematoma. Outcomes for neuraxialinjuries, including hematoma, anterior spinal arterysyndrome, spinal cord infarct, and other/unknowncauses, were poor and resulted in permanent neu-rologic damage in the majority of cases. Neuraxialinjury caused by herniated discs and infections such

Review of ASA Closed Claims by Lorri A. Lee, MD

Many anesthesiologists perceive regional anes-thesia to be a safer alternative to general anesthesiabecause it has been associated with reduced postop-erative mortality caused by thromboembolic dis-ease and myocardial infarction, improvedpostoperative analgesia, decreased incidence ofearly postoperative cognitive dysfunction, andshorter recovery times compared to general anes-thesia.1,2 However, significant morbidity maydirectly result from regional anesthesia. The inci-dence of cardiac arrest associated with spinal block-ade has been reported to be as much as 0.06%, andfrequently results in death or brain damage.3-5

Other high severity complications associated withregional anesthesia include epidural hematoma,cauda equina syndrome, and unintentional intra-venous injections of local anesthetic. Less severeinjuries such as postdural puncture headache, inad-equate analgesia, transient paresthesias, and backpain are more frequent sequelae of regional anes-thesia. To determine the differences in liabilityclaims associated with regional anesthesia com-pared to claims associated with other types of sur-gical anesthesia (general anesthesia and monitoredanesthesia care), we utilized the database of theAmerican Society of Anesthesiologists (ASA)Closed Claims Project. Because the database doesnot contain denominator data on all anesthetics per-formed, this analysis does not provide informationcomparing the incidence of injuries betweenregional and general anesthetics, but offers a per-spective on the liability associated with each group.Claims between 1980 to 1999 that were associatedwith regional anesthesia and other surgical anesthe-sia were included in this analysis from a database of5,802. Chronic pain blocks, postoperative painblocks placed outside the operating room, eyeblocks performed by ophthalmologists, and obstet-ric claims that involved no maternal injury wereexcluded. A more detailed analysis of regionalanesthesia claims including eye blocks and periph-eral nerve blocks, as well as a subset comparison ofobstetric and non-obstetric neuraxial claims isreported elsewhere.5

Obstetrics was associated with approximatelyone-third (36%) of the regional anesthesia claims (n= 1005) and significantly influenced the demo-graphics of this group, resulting in significantlymore ASA 1-2, young, female patients compared tothe other surgical anesthesia group (n = 3551).Epidural anesthesia was utilized most commonly inregional anesthesia claims (42%), followed byspinal blockade (34%), axillary blocks (6%), eyeblocks (4%), interscalene blocks (2%), and intra-venous regional anesthesia (IVRA).

Complications Associated With Regional Anesthesia

Percent of Claims in Group

* *

*

Death or BrainDamage

Permanent NerveInjury

Temporary injury

Regional Anesthesia Claims (N = 1005)

Other Claims (N = 3552)

60.00%

50.00%

40.00%

30.00%

20.00%

10.00%

0.00%

*p < 0.05

See “Complications,” Next Page

Figure 1: Outcomes in Regional Anesthesia Vs. Other Surgical Anesthesia Claims 1980-1999.

Page 6: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

APSF NEWSLETTER Spring 2004 PAGE 6

as meningitis and abscess demonstrated full recoveryin the majority of cases. Vascular surgery was themost common operation associated with hematoma(56%), and coagulopathy was associated with 72% (n= 26) of all hematoma claims. Needle trauma above L1occurred in 17% of hematoma claims with neuraxialinjury. The most common presenting symptom wasincreased motor block out of proportion to the localanesthetic used (83%), followed by increased sensoryblock (53%), and back pain (25%). A median delay of 1day from symptom onset to diagnosis was thought tocontribute to the poor neurologic recovery in themajority of hematoma claims. Heightened vigilancefor symptoms and signs of epidural hematoma (e.g.,increased motor block) and prompt diagnostic work-up and treatment may improve neurologic outcome.

Claims associated with regional anesthesia had asignificantly lower percentage of claims with pay-ment to the plaintiff compared to the other surgicalanesthesia group, a lower median payment, a higherpercentage of claims judged to have met appropriatecare standards, and a lower percentage of paymentin cases with appropriate standard of care. Thesedifferences may reflect the greater proportion ofregional anesthesia claims with temporary injurycompared to other surgical anesthesia claims.

In summary, regional anesthesia accounts forapproximately one-fifth of professional liabilityclaims. Most of the injuries from regional anesthesiaclaims are temporary, and approximately one-half ofthe temporary claims are associated with obstetrics.High severity injuries continue to result from neu-raxial cardiac arrest and neuraxial hematomas asso-ciated with coagulopathy. Heightened vigilance andprompt diagnosis and treatment may improve out-come in these cases.

Dr. Lee is an Assistant Professor in the Departmentof Anesthesiology at the University of Washington, Seat-tle, WA.

References1. Rodgers A, Walker N, Schug S, et al. Reduction of post-

operative mortality and morbidity with epidural orspinal anaesthesia: results from overview of randomisedtrials. BMJ 2000;321:1493.

2. Wulf H, Biscoping J, Beland B, et al. Ropivacaineepidural anesthesia and analgesia versus general anes-thesia and intravenous patient-controlled analgesia withmorphine in the perioperative management of hipreplacement. Ropivacaine Hip Replacement MulticenterStudy Group. Anesth Analg 1999;89:111-6.

3. Auroy Y, Narchi P, Messiah A, et al. Serious complica-tions related to regional anesthesia: results of a prospec-tive survey in France. Anesthesiology 1997;87:479-86.

4. Auroy Y, Benhamou D, Bargues L, et al. Major complica-tions of regional anesthesia in France: The SOS RegionalAnesthesia Hotline Service. Anesthesiology 2002;97:1274-80.

5. Lee LA, Posner KL, Domino KB, et al. Injuries associatedwith regional anesthesia in the 1980s and 1990s: AClosed Claims Analysis. Anesthesiology (in press).

Regional Accounts for 20% of Claimsn (%)

Block-related 482 (48%)

Block technique 249 (25%)

Neuraxial cardiac arrest 81 (8%)

Inadequate anesthesia/analgesia 48 (5%)

High spinal/epidural 41 (4%)

Epidural/spinal catheter 35 (3%)

Unintentional IV injection 28 (3%)

Non-Block-related 523 (52%)

Pulse oximetry 74%

Capnography 35%

Sedation 52%

Out of operating room 35%

Recognition delay 26%

Resuscitation delay 61%

George A. Schapiro, Chair

Abe AbramovichDatascope

Richard AtkinSpacelabs

Paul A. BaumgartGEMS IT

Casey D. Blitt, MDAPSF

James E. CarneBaxter

Nassib G. ChamounAspect

Mark CostanzaCerner

Ann CustinDräeger

Sandy EamesMedical Strategic Planning

Robert Evans, MDDocusys

Michael S. FerraraBecton-Dickinson

David Goodale, PhD, DDSAstraZeneca

Walter HuehnPhilips

Kevin KingGEMS IT

Regina KingBaxter

George X. MaliekalAbbott

Charles H. McLeskeyAbbott

Steven C. MendellLMA

Patty ReillyNellcor

Marcus Schabacker, MDB. Braun

D.J. SirotaCook

Robert K. Stoelting, MDAPSF

Robert A. ViragTRIFID

George YarivOridion

A N E S T H E S I A P A T I E N T S A F E T Y F O U N D A T I O NCORPORATE ADVISORY COUNCIL

“Complications,” From Preceding Page Table 1. Block-Related Primary Damaging Events in Regional Anesthesia Claims

Table 2. Associated Factors: 1990s Neuraxial Cardiac Arrest Claims (n=31)

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APSF NEWSLETTER Spring 2004 PAGE 7

Outcome References SupportNeed for More Research

3. Lennmarken C, Lindholm ML, Greenwald SD, Sandin R.Confirmation that low intraoperative BIS levels predictincreased risk of postoperative mortality. Anesthesiology2003;99(Suppl):A303.

4. Mangano DT, Layug EL, Wallace A, Tateo I. Effect ofatenolol on mortality and cardiovascular morbidityafter noncardiac surgery. Multicenter Study of Periop-erative Ischemia Research Group. N Engl J Med1996;335:1713-20.

5. McBride WT, Armstrong MA, McBride SJ. Immunomod-ulation: an important concept in modern anaesthesia.Anaesthesia 1996;51:465-73.

6. Salo M. Effects of anaesthesia and surgery on the immuneresponse. Acta Anaesthesiol Scand 1992;36:201-20.

7. Ross R. Atherosclerosis?an inflammatory disease. N Engl JMed 1999;340:115-26.

8. Libby P. Inflammation in atherosclerosis. Nature2002;420:868-74.

9. Lefer AM, Scalia R, Lefer DJ. Vascular effects of HMGCoA-reductase inhibitors (statins) unrelated to choles-terol lowering: new concepts for cardiovascular disease.Cardiovasc Res 2001;49:281-7.

10. Poldermans D, Bax JJ, Kertai MD, et al. Statins are associ-ated with a reduced incidence of perioperative mortalityin patients undergoing major noncardiac vascularsurgery. Circulation 2003;107:1848-51.

11. Coussens LM, Werb Z. Inflammation and cancer. Nature2002;420:860-7.

12. Baron JA, Sandler RS. Nonsteroidal anti-inflammatorydrugs and cancer prevention. Annu Rev Med 2000;51:511-23.

13. Tomasdottir H, Hjartarson H, Ricksten A, et al. Tumornecrosis factor gene polymorphism is associated withenhanced systemic inflammatory response andincreased cardiopulmonary morbidity after cardiacsurgery. Anesth Analg 2003;97:944-9.

14. Auerbach AD, Goldman L. Beta-blockers and reductionof cardiac events in noncardiac surgery: clinical applica-tions. JAMA 2002;287:435-44.

15. Jenkins NP, Keevil BG, Hutchinson IV, Brooks NH.Beta-blockers are associated with lower C-reactive pro-tein concentrations in patients with coronary artery dis-ease. Am J Med 2002;112:269-74.

16. Anzai T, Yoshikawa T, Takahashi T, et al. Early use ofbeta-blockers is associated with attenuation of serum C-reactive protein elevation and favorable short-termprognosis after acute myocardial infarction. Cardiology2003;99:47-53.

17. Vallejo R, Hord ED, Barna SA, et al. Perioperativeimmunosuppression in cancer patients. J Environ PatholToxicol Oncol 2003;22:139-46.

18. Tsuchiya Y, Sawada S, Yoshioka I, et al. Increased surgi-cal stress promotes tumor metastasis. Surgery2003;133:547-55.

19. Moudgil GC, Singal DP. Halothane and isofluraneenhance melanoma tumor metastasis in mice. Can JAnaesth 1997;44:90-4.

20. Page GG, Ben-Eliyahu S. The immune-suppressivenature of pain. Semin Oncol Nurs 1997;13:10-5.

21. Maes M, Song C, Lin A, et al. The effects of psychologi-cal stress on humans: increased production of pro-inflammatory cytokines and a Th1-like response instress-induced anxiety. Cytokine 1998;10:313-8.

22. Bierhaus A, Wolf J, Andrassy M, et al. A mechanismconverting psychosocial stress into mononuclear cellactivation. Proc Natl Acad Sci U S A 2003;100:1920-5.23.Royster RL. Perioperative beta-blockade can reducemorbidity and mortality. APSF Newsletter 2002;17:21,23.

24. Royster RL. Perioperative beta-blockade II: practicalclinical application APSF Newsletter 2002;17:54.

25. Sessler DI. Mild perioperative hypothermia. N Engl JMed 1997;336:1730-7.

26. Frank SM, Higgins MS, Breslow MJ, et al. The cate-cholamine, cortisol, and hemodynamic responses tomild perioperative hypothermia. A randomized clinicaltrial. Anesthesiology 1995;82:83-93.

27. Beilin B, Shavit Y, Razumovsky J, et al. Effects of mildperioperative hypothermia on cellular immuneresponses. Anesthesiology 1998;89:1133-40.

28. Schneemilch CE, Band U. Release of pro- and anti-inflammatory cytokines during different anesthesia pro-cedures. Anaesthesiol Reanim 2001;26:4-10.

29. Crozier TA, Muller JE, Quittkat D, et al. Effect of anaes-thesia on the cytokine response to abdominal surgery.Br J Anaesth 1994;72:280-5.

30. Matsuoka H, Kurosawa S, Horinouchi T, et al. Inhala-tion anesthetics induce apoptosis in normal peripherallymphocytes in vitro. Anesthesiology 2001;95:1467-72.

31. Karabiyik L, Sardas S, Polat U, et al. Comparison ofgenotoxicity of sevoflurance and isoflurance in humanlymphocytes studied in vivo using the comet assay.Mutat Res 2001;492:99-107.

32. Brand JM, Kirchner H, Poppe C, Schmucker P. Theeffects of general anesthesia on human peripheralimmune cell distribution and cytokine production. ClinImmunol Immunopathol 1997;83:190-4.

33. Corsi M, Mariconti P, Calvillo L, et al. Influence ofinhalational, neuroleptic and local anaesthesia on lym-phocyte subset distribution. Int J Tissue React1995;17:211-7.

34. Stanski DR. Monitoring depth of anesthesia. In: MillerRD, ed. Anesthesia, 5th ed. New York: Churchill Living-stone, 2000: 1087-116.

35. Recart A, Gasanova I, White PF, et al. The effect of cere-bral monitoring on recovery after general anesthesia: acomparison of the auditory evoked potential and bis-pectral index device with standard clinical practice.Anesth Analg 2003;97:1667-74.

36. Luginbuhl M, Wuthrich S, Petersen-Felix S, et al. Differ-ent benefit of bispectal index (BIS) in desflurane andpropofol anesthesia. Acta Anaesthesiol Scand 2003;47:165-73.

37. Guignard B, Coste C, Menigaux C, Chauvin M. Reducedisoflurane consumption with bispectral index monitor-ing. Acta Anaesthesiol Scand 2001;45:308-14.

38. Ridker PM, Morrow DA. C-Reactive Protein, inflamma-tion, and coronary risk. Cardiol Clin 2003;21:315-25.

39. Brennan ML, Penn MS, Van Lente F, et al. Prognosticvalue of myeloperoxidase in patients with chest pain. NEngl J Med 2003;349:1595-604.

Burton Dole BecomesLargest IndividualAPSF Donor

Burton A. Dole, former Vice President of theAnesthesia Patient Safety Foundation, has madeyet another important contribution to the APSF.Mr. Dole has designated the APSF to be therecipient of a $200,000 contribution upon thesettlement of his estate. This tremendously gen-erous example of planned giving is appreciatedby the APSF Executive Committee. Mr. Dolehopes that his gift will serve as an example forothers to follow when contemplating estateplanning.

Burt was a founding member of the APSF.The Puritan-Bennett company, of which Burtwas the CEO at the time, gave the APSF$300,000 in startup funds. The Parker B. FrancisFoundation, the charitable arm of the founder ofPuritan-Bennett, also gave $300,000 as a found-ing grant. Burt has served as APSF Treasurer, aswell as Vice President, and received the firstAPSF award for service to this organization in1997. He retired from the APSF Executive Com-mittee in 2002, but remains on the Board ofDirectors. His career has been a shining exam-ple of a life devoted to helping others and insur-ing patient safety. Thank you, Mr. Dole.

Burton A. Dole, former Vice President of theAnesthesia Patient Safety Foundation.

“Outcome,” From Page 4

ErratumOn page 58 of the Winter 2003-04 issue of this

Newsletter, credit to Dr. C.F. Ward, San Diego, CAwas omitted from his letter entitled “Power Inter-ruption: Still A Major Safety Disruption.” We apol-ogize for this oversight, and appreciate Dr. Ward’sthoughtful contribution to the APSF Newsletter.

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APSF NEWSLETTER Spring 2004 PAGE 8

Misplaced Valve Poses Potential HazardDear SIRS:

We have discovered what we believe to be anerror in the assembly of 9 Datex-Ohmeda Aestivaanesthesia machines recently delivered and installedwhich, if not detected, has the potential to causeinjury to anesthetized patients.

The problem is in the AGSS (active gas scaveng-ing system) option which produces, when the evacu-ation hose becomes occluded, sustained airwaypressures (PEEP) of up to 40 cm. This condition isexacerbated by high fresh gas flows and whenmechanical ventilation is in use.

The AGSS is designed to have an opening in thebottom of a plastic receiver, providing relief of bothpositive and negative excess pressures. In whatappears to be an assembly error, a negative pressurerelief valve (similar to a circle system one-way valve)was installed in this opening (see photos 1 and 2).This provided relief of excess negative pressure (toomuch evacuation suction), but no positive pressurerelief. This valve is used appropriately in the passivesystem, but the passive system also has a positivepressure relief in the upper portion of the receiverunit. Our best explanation is that the receiver assem-bly is composed of a top and a bottom section. Wewere (possibly) delivered units with the top receiverhalf from an active system and the bottom half froma passive system.

No injury hasoccurred in our institu-tion as a result of thisincident, but this discov-ery followed a numberof our anesthesia staffreporting unusual venti-lator behavior which we subsequently traced to lowevacuation flows. The most dramatic incident waswhen, after a bed rolled over a gas scavenging hose,the Aestiva ventilator immediately stopped cycling inmid-exhalation. The evacuation hose (color codedpurple) is equipped with a needle valve which isadjusted to provide moderate flows (as shown by asmall ball indicator on the side of the absorber assem-bly). The presence of the mis-assembled scavengingreceiver may be detected either by a temporary venti-lator failure when the evacuation hose is manuallyoccluded (hand crimped) or by gross fluctuations ofthe ball indicator during normal ventilator cycling.

The Datex-Ohmeda company has been promptand thorough in their response to this incident. Theyare in the process of identifying AGSS equipped unitsthat may have been assembled incorrectly and arecurrently pursuing action to remedy this situation.

James M. Berry, MDProfessor

Steve Blanks, CRNAChief CRNANashville, TN

Photo 1. Bottom view of the active scavenging reservoirwithout valve (correct configuration).

Photo 2. Bottom view of the active scavenging reservoirwith valve in place (incorrect configuration).

The APSF is pleased toannounce an importantnew technology initiativewhich will appear as a regular column inthe APSF Newsletter. This feature is entitled“Dear SIRS” and refers to the Safety Infor-mation Response System. The purpose ofthis column is to expeditiously communi-cate technology-related safety concernsraised by our readers, with input andresponses from manufacturers and industryrepresentatives. This process was developedby Drs. Michael Olympio, Chair of the Com-mittee on Technology, and Robert Morell,Editor of this newsletter. Dr. Olympio isoverseeing the column and coordinating thereaders’ inquiries and the responses fromindustry. “Dear SIRS” makes its debut inthis issue with an important safety concernraised by James M. Berry, MD, and SteveBlanks, CRNA, from Vanderbilt UniversityMedical Center.

Michael Olympio, MD, Chair of the APSF Committee onTechnology and Co-Founder of the SIRS Initiative.

S AFETY

I NFORMATION

R ESPONSE

S YSTEM

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APSF Spotlight

APSF NEWSLETTER Spring 2004 PAGE 9

Manufacturer ProvidesPrompt Response

APSF Executive Vice President

George A. ShapiroGeorge A. Schapiro, Executive Vice President of APSF

since October 2003, also serves on the Executive Committee ofthe Board of Directors. He first served on the Board from 1985to 1991. He has been active in strengthening the APSF Corpo-rate Advisory Council since its inception and served in thelate 1980s as Chairman of the APSF Development Committee.He is a management consultant to or a member of the Boardof Directors of a number of technology companies, most ofwhich concentrate in medical device businesses. From 1992 to2001 he served as Interim CEO for six medical device, indus-trial technology, and biotech companies. From 1976 to 1991,he was President and CEO of Andros Incorporated, supplierof gas analyzers to the patient monitoring industry. From1969 to 1976, he was with the Hewlett-Packard Companywhere from 1974 to 1976, he was responsible for the PatientMonitoring product line (now part of Philips Medical Sys-tems) on a world-wide basis.

(In Reply)

Dear SIRS:Datex-Ohmeda would like to thank the APSF

Newsletter for the opportunity to respond to the let-ter by Berry and Blanks.

The authors have correctly identified the rootcause of the rising airway pressure encountered insome of their Aestiva anesthesia machines. Thereare two options for gas scavenging in the Aestiva.One is passive and the other, the option used by theauthors, is an active system that uses vacuum toremove the scavenged gases from the patient circuitand from the ventilator drive system.

The AGSS units that were assembled incorrectlyhad a valve normally used for the passive systemsinstalled in the base of the AGSS unit. The presenceof this valve prevented excessive gases within theAGSS from escaping when the vacuum outflowwas occluded, as described by the authors.

Datex-Ohmeda has identified the cause of theincorrect assembly and has instituted changes in theassembly process to avoid a repeat of this error. Inaddition, there is now an additional test of theAGSS to verify that all units have the correct valvesin place. Datex-Ohmeda has also identified theentire population of AGSS units that may have beenassembled incorrectly, has identified the location ofthe entire suspect population, and has begun anactive Field Action to check the AGSS units, verify

Letter to the Editor:

Spinal Anesthesiain the 21st Century?To the Editor:

I read with interest the letter by Dr. J. AntonioAldrete in your Winter APSF Newsletter.1 He sum-marized some important aspects of potential prob-lems with drugs and spinal anesthesia. Drugs cancertainly cause damage, but one should not forgetthat unwanted material can also be introducedinadvertently into the subarachnoid space, e.g., ahair follicle.2

John Brock-Utne MD, PhDStanford, CA

References

1. Aldrete JA. Reader questions safety of spinal anesthesia(letter). APSF Newsletter 2003-04;18:60.

2. Brock-Utne JG, Mankowitz E, Kallichurum S, DowningJW. Hair follicle introduced into the subarachnoid spaceduring spinal anesthesia: a case report. Anesth Analg1981;60:694-5.

2005 APSFGrant

ApplicationsDue

June 14, 2004

See the APSF Website

at apsf.orgfor details!

Bottom View of Active Scavenging Reservoir

Drawing of the bottom view of the active scavengingreservoir without the valve (correct configuration).

Reproduced withpermission from Datex-Ohmeda, Madison, WI

their proper manufacture and assure that any occlu-sion of the AGSS exhaust hoses will not produce arise in the system airway pressure in the future.

Michael MittonDirector of Clinical AffairsDatex-Ohmeda, now a part of GE Medical Systems

George A. Schapiro, Executive Vice Presidentand member of the Executive Committee ofthe Board of Directors of APSF.

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60%

50%

40%

30%

20%

10%

0%

% of Application % of Funded Projects

ID Predictors of Ptsat Risk for Mishaps

New Methods toPrevent/Diagnose

Mishaps

Eval. Technology toPrevention/Diagnose

Mishaps

Methods to StudyLow Frequence

Events

InnovativeEducation/Training

Methods

APSF NEWSLETTER Spring 2004 PAGE 10

with 31% indicating that the APSF applicationprocess helped them get started. Most of thoseapplicants still actively conduct anesthesia research.

The survey showed a relatively good matchbetween the stated APSF priority research areas,applications, and grant funding. Survey respondentswere asked to classify their applications according toAPSF research priority areas. The APSF priority

research areas that were most commonly funded areillustrated in Figure 1 and include

• Identification of predictors of patients atincreased risk for mishaps (40% of applications,48% of funded studies)

• New clinical methods for prevention or earlydiagnosis of mishaps (28% of applications, 21%of funded studies)

• Evaluation of new or re-evaluation of oldtechnologies for prevention and diagnosis ofmishaps (28% of applications, 15% of fundedstudies)

• Development of innovative methods for study oflow-frequency events (20% of applications, 30%of funded studies)

• Innovative methods of education and training insafety (11% of applications, 18% of fundedstudies).

Survey responses showed that applications andfunded studies were not restricted to a focus on rel-atively healthy patients. Survey respondentsreported that their applications and funded studieswere nearly evenly split between a focus on rela-tively healthy patients (28% of applications; 30% offunded studies) and special patient populationssuch as pediatrics or the elderly (29% of applica-tions; 30% of funded studies).

by Karen L. Posner, PhD

As part of its objective to enhance anesthesiapatient safety, the APSF has been providing fund-ing for patient safety research since 1987. The grantprogram started at a time when funding for patientsafety research was virtually non-existent. Theobjective of the grant program was (and still is) tostimulate studies leading to prevention of mortalityand morbidity resulting from anesthesia mishaps.Priority is given to studies that address problemsaffecting relatively healthy patients or studies thatare broadly applicable and promise improvedmethods of patient safety with a defined and directpath to implementation into clinical care. Priority isalso given to studies investigating innovative meth-ods of education and training to improve patientsafety.

The APSF Scientific Evaluation Committee con-ducted a comprehensive evaluation of the APSFGrant Program. This evaluation included a surveyof prior grant applicants plus a literature search andgrant applicant survey to create a comprehensivelist of publications stimulated by the APSF GrantProgram.

Between 1987 and 2001, a total of 272researchers applied for funding for 347 patientsafety research projects through the APSF GrantProgram. An average of 23 projects were reviewedby the APSF Scientific Evaluation Committee annu-ally. APSF funding was restricted to 2-3 grants peryear. Over the first 15 years of the APSF Grant Pro-gram, 48 projects received funding from the APSF,for a funding rate of approximately 1 in 7 applica-tions. An anonymous survey was sent to all priorapplicants who could be located (237). Responseswere received from 95 prior applicants (40%),including 33 who received APSF funding (69%response rate), and 84 who did not receive funding(33% response rate).

Evaluation ResultsStimulating Patient Safety Research

The APSF is meeting its goal of stimulatinganesthesia patient safety research. The APSFfunded 48 patient safety projects. Nearly all fundedstudies were completed, with 88% resulting in pub-lications. Two-thirds of grant recipients whoresponded to the survey indicated that they wenton to conduct additional research along the sameline of inquiry as their APSF grant. Half receivedadditional funding, totaling over $11 million. Thereis also evidence that the APSF Grant Program mayhave stimulated research beyond the projectsdirectly funded by APSF. Nearly half of surveyrespondents who did not receive APSF funding fortheir projects went on to complete their projects,

APSF Scientific Grant Program: ImprovingPatient Safety Through Research Funding

“The APSF funding opened the doors for

significant research support. Three PhD students on the project are now designing

medical devices for the anesthesia industry. A fourth student is

developing software for a hospital corporation.”

Figure 1. Most commonly funded research areas.

See “Grant Program,” Next Page

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The APSF Grant Program lists a number ofsafety topics appropriate for APSF funding. Appli-cants classified their projects into multiple cate-gories. The most common topics of projects areshown in Figure 2 and include

• Outcomes or incident measurement (38% ofapplications, 42% of funded studies)

• Monitoring, effectiveness, or injury prevention(36% of applications, 21% of funded studies)

• Risk assessment or risk factors (29% ofapplications, 39% of funded studies)

• Human factors or performance (27% ofapplications, 39% of funded studies)

• Prevention of a specific complication or injury(25% of applications, 30% of funded studies)

• Simulation or computer modeling (15% ofapplications, 30% of funded studies).

Most funded studies involved clinical trials,non-clinical research involving human subjects,database analysis or simulation, or computer mod-eling. Few applications or funded studies involvedlaboratory, bench science, or medical recordsreview.

Improving Patient Safety

Grant recipients reported that the APSF GrantProgram had a positive impact on patient safety inanesthesia and beyond. This impact consisted ofdirect improvements in anesthesia patient safety aswell as enhancement of careers in patient safetyresearch that would contribute toward additionalpatient safety improvements.

APSF NEWSLETTER Spring 2004 PAGE 11

jects legitimized human factors research in clinicalanesthesia, introduced human factors and crisisresource management (CRM) concepts and trainingin anesthesia and medicine, improved risk analysismethodology and the transfer of these methods toother fields such as trauma care and medicaldevices, and raised public policy issues regardingsleep and work schedules for residents. APSF fund-ing has influenced device development includinganesthesia workstations, ICU ventilators, respira-tory monitors, and simulation devices, as well ascontributing toward new ways of processing sig-nals and displaying clinical data on monitors.APSF-funded researchers commented on other spe-cific clinical safety contributions resulting fromtheir APSF funded projects. These researchersreported that the APSF Grant Program:

• Was largely responsible for makingperioperative normothermia a standard of care

• Raised awareness of postoperative cognitivedeficit after non-cardiac surgery and in elderlypatients

• Confirmed safety and cost-effectiveness of fast-track cardiac anesthesia

• Reduced concerns about pediatric URI historyand risk of airway complications during andafter general anesthesia

• Reduced concerns about the need for ambulatorypatients to void before discharge

• Influenced ASA practice parameters andperioperative practices

• Raised awareness of the need to reviewanesthetic emergency protocols.

Publication and Disseminationof Anesthesia Patient Safety

Research ResultsNearly all studies funded through the APSF

Grant Program resulted in publication of theirresults. Only 2 studies funded prior to 1999 did notresult in any publications. In addition to publicationof APSF-funded project results, APSF funding con-tributed to additional publications beyond the ini-tial project reporting. The 48 projects fundedthrough the APSF Grant Program have resulted inpublication of 214 publications that incorporate ordiscuss APSF-funded project results.

Criticisms of the APSF Grant Program

It is not surprising that few prior APSF GrantProgram applicants who did not received APSFfunding for their projects responded to the survey.Among the 84 responses were a number of com-ments indicating areas for improvement in the pro-gram. Most comments addressed feedback on

APSF grant funding was instrumental in devel-opment of successful careers in anesthesia patientsafety research for APSF funded investigators aswell as other research team members. Grant recipi-ents commented that the APSF was the only fund-ing source for patient safety research in the earlyyears of the program. As one respondent aptlystated, “Without the APSF, I would never havebeen able to become a successful patient safetyresearcher since pre-IOM report there were reallyno other sources of funding for anesthesia patientsafety research.” Many respondents commented onthe importance of APSF funding as “seed money”that led to careers and additional funding forpatient safety research. One respondent com-mented, “APSF funding created an active researchteam. One member has developed an innovativeICU ventilator. Another directs a simulation center.A third has developed a respiratory monitor foranesthesia. I have continued in anesthesia researchfor 15 years.” Another respondent commented that,“The APSF funding opened the doors for significantresearch support. Three PhD students on the projectare now designing medical devices for the anesthe-sia industry. A fourth student is developing soft-ware for a hospital corporation.” Anotherrespondent’s comments are representative of manyothers, “Impossible to have done this work withoutAPSF funding . . . (it) made me a permanent patientsafety researcher.”

Many projects funded through the APSF GrantProgram led to direct improvements in anesthesiapatient safety. The APSF Grant Program was instru-mental in development of simulators for anesthesia,ACLS, critical care, hemodynamics, sedation, andbioterrorism management. Funding of APSF pro-

60%

50%

40%

30%

20%

10%

0%

% of Application % of Funded Projects

Outcome/IncidentMeasurement of Ptsat Risk for Mishaps

Monitoring,Effectiveness,

Injury Prevention

Risk Assessment/Risk Factors

Human Factors/Performance

Prevent Spec. Injury Simulation/Computer Model

48 Projects Result in 214 Publications“Grant Program,” From Preceding Page

See “Grant Program,” Next PageFigure 2. Most common research topics.

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APSF NEWSLETTER Spring 2004 PAGE 12

approximately equal absorbing capabilities, andtheir cost is similar. Amsorb, a newer agent whichcontains neither potassium, barium, nor sodium hasbeen proposed as a safer alternative, but it has notyet reached wide market acceptance.

The history of anesthesia is littered with prod-ucts that fell out of practice for reasons of risk topatient safety. We no longer use ether or cyclo-propane due to the risk of explosion. We no longeruse hanging bellows due to the risks of decreasedcircuit leak detection. We no longer use droperidoldue to the risk of QT prolongation. All, however,fell out of practice only when better substituteswere available. Soda lime is an excellent CO2absorbent and is as efficient as barium-containingabsorbers; however, soda lime is less likely to beassociated with these rare but real risks when usedwith the newer volatile anesthetics. It is time toreassess our use of this product, and add it to ourlist of anesthesia museum pieces.

Roy G. Soto, MDTampa, FL

References1. Eger EI, Ion P, Laster M, Weiskopf R. Baralyme dehy-

dration increases and soda lime dehydration decreasesthe concentration of compound A resulting fromsevoflurane degradation in a standard anesthetic circuit.Anesth Analg 1997;85:892-8.

2. Fang Z, Eger E, Laster M, et al. Carbon monoxide pro-duction from degradation of desflurane, enflurane,isoflurane, halothane, and sevoflurane by soda lime andbaralyme. Anesth Analg 1995;80:1187-93.

3. Holak E, Mei D, Dunning M, et al. Carbon monoxideproduction from sevofluration breakdown: modeling ofexposures under clinical conditions. Anesth Analg2003;96:757-64.

Letter to the Editor

Barium …Is It Time to SayGoodbye?To the Editor:

Recent reports of circuit fires following expo-sure of sevoflurane to desiccated carbon dioxideabsorbent has refocused attention on the risks asso-ciated with volatile anesthetics. Volatile anestheticshave been in use for more than 150 years, and it issurprising to many clinicians when “new” compli-cations seem to come to light every few years. In thepast 20 years, carbon dioxide absorbents have beenimplicated in a number of these complications.Although we perform daily machine and circuitchecks, and most of us have a good working knowl-edge of how our machines and ventilators work,the CO2 absorbent rarely gets much attention,unless of course, its color changes, marking exhaus-tion of its CO2 absorbing capability.

One of the job descriptions of an anesthesiolo-gist is that of trend watcher, and a trend involvingbarium-containing CO2 absorbers has slowly cometo light. Exposure of sevoflurane to CO2 absorbentresults in Compound A formation. Desflurane isassociated with carbon monoxide formation whenexposed to desiccated CO2 absorbent, and therecent case reports of extreme heat during sevoflu-rane use have all been associated with the exposureof agent to CO2 absorbent. All of these risks areincreased when barium is the basis of the CO2absorbent:

• Barium-based absorber dehydration increasesthe concentration of Compound A; whereas sodalime dehydration decreases it.1

• Desiccated barium-based absorbers areassociated with a nearly 7-fold increase in carbonmonoxide production (11600 ppm vs. 1800 ppm)versus soda lime when exposed to clinically usedconcentrations of desflurane.2

• All of the 4 reported cases of circuit firesassociated with sevoflurane and dessicated CO2absorbent involved barium, and a recentlaboratory report described how the CO2absorber canister exploded and burst into flameswhen dehydrated barium-based absorber wasexposed to sevoflurane.3

Barium and soda lime neutralize exhaled CO2via an exothermic reaction with a strong base: theformer via barium hydroxide, and soda lime viasodium and potassium hydroxide. Both have

Improved APSF website:

www.apsf.org

APSF ExecutiveCommittee

InvitesCollaboration

From time to time the AnesthesiaPatient Safety Foundation reconfirmsits commitment of working with allwho devote their energies to makinganesthesia as safe as humanlypossible. Thus, the Foundation invitescollaboration from all who administeranesthesia, and all who provide thesettings in which anesthesia ispracticed, all individuals and allorganizations who, through theirwork, affect the safety of patientsreceiving anesthesia. All will find useager to listen to their suggestionsand to work with them toward thecommon goal of safe anesthesia for allpatients.

applications. Other comments addressed clarity (orlack of clarity) regarding funding priorities and dis-agreement with APSF priorities or focus.

The most common criticisms of the programconcerned feedback on unsuccessful applications.Of the 84 applicants not receiving APSF fundingwho responded to the survey, 9 received either nofeedback on their applications or felt the feedbackthey did receive was not useful. Other respondentsfelt the APSF should clarify its research interestsand perhaps broaden them. Some applicants feltmisunderstood, including applicants who receivedfunding for their projects from other sources.

The APSF Scientific Evaluation Committee hasrecently revised its grant guidelines to include moreinformation on application scoring. An attempt hasbeen made to improve the quality of feedback pro-vided to unsuccessful applicants. These changesmay address some of the criticisms expressed bysurvey respondents.

ConclusionsOver its first 15 years, the APSF Grant Program

has stimulated anesthesia patient safety researchdirectly through project funding and indirectly bystimulating careers in anesthesia patient safetyresearch. Projects started with APSF funding haveled to continued research in anesthesia patientsafety by providing the necessary initial results aswell as providing legitimacy to patient safetyresearch. APSF-funded researchers can point outdirect impacts on anesthesia patient safety as well asapplication to patient safety in general.

Dr. Posner is Vice-Chair of the APSF Scientific Eval-uation Committee and is a Research Associate Professorin the Department of Anesthesiology at the University ofWashington in Seattle.

“Grant Program,” From Preceding Page

Your APSF President - Robert K. Stoelting, MD

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APSF NEWSLETTER Spring 2004 PAGE 13

Corporate DonorsFounding Patron ($400,000 And Up)American Society of Anesthesiologists (asahq.org)

Foundation Patron ($100,000 to $399,999)AstraZeneca Pharmaceuticals, LP

(astrazeneca.com)

Benefactor Patron ($50,000 to $99,999)GE Medical Systems

(gemedical.com)

Benefactor Patron ($25,000 to $49,999)

Abbott Laboratories (abbott.com)

Aspect Medical Systems(aspectms.com)

Datex-Ohmeda (us.datex-ohmeda.com)

Grand Patron ($15,000 to $24,999)Baxter Anesthesia & Critical Care (www.baxter.com)Philips Medical Systems (www.medical.philips.com)Preferred Physicians Medical Risk Retention Group, Inc.

(ppmrrg.com)Data Dictionary Task Force Supporters ($20,000-30,000)Cerner Corporation (cerner.com)Deio (deio.net)Dräger Medical (nad.com)eko systems, inc. (ekosystems.com)GE Medical Systems (gemedical.com)Picis, Inc. (picis.com)Philips Medical Systems (medical.philips.com)Siemens Medical Systems (siemensmedical.com)Patrons ($10,000 to $14,999)Becton Dickinson (bd.com)Cerner Corporation (cerner.com)Tyco Healthcare (tycohealthcare.com)Sustaining Members ($5,000 to $9,999)Alaris Medical Systems (alarismed.com)Anesthesiologists' Professional Assurance Management, Inc.

(apac-apam.com)B. Braun Medical (bbraun.co.uk)

Datascope Corporation (datascope.com)LMA North America (lmana.com)Medical Education Technologies, Inc. (meti.com)Organon Pharmaceuticals, Inc. (organon.com)Vance Wall FoundationSponsoring Members ($1,000 to $4,999)Andros Incorporated (andros.com)Arrow International, Inc. (arrowintl.com)DocuSys (docusys.net)King Systems Corporation (kingsystems.com)Masimo Corporation (masimo.com)Medical Gas Management (www.mgmusa.com)Medical Strategic Planning (medsp.com)Oridion (oridion.com)Trifid Medical Group, Inc. (trifidmedical.com)Corporate Level Members (up to $999)Belmont Instrument Corporation (belmontinstrument.com)Boehringer Laboratories, Inc. (autovac.com)Hoana Medical, Inc. (hoana.com)Somnia (somnia.com)Spectrum Medical Group (spectrummedicalgroup.com)Subscribing SocietiesAmerican Society of Anesthesia Technicians & Technologists

(www.asatt.org)

Anesthesia Patient Safety Foundation

Community Donors(Includes Anesthesia Groups, Individuals,Specialty Organizations, and State Societies)

Grand Sponsor ($5,000 And Up)Florida Society of AnesthesiologistsIndiana Society of AnesthesiologistsRobert K. Stoelting, MDSustaining Sponsor ($2,000 to $4,999)Academy of AnesthesiologyAlabama Society of AnesthesiologistsAnaesthesia Associates of MassachusettsAnesthesia ConsultantsAnesthesia Resources ManagementAnesthesia Service Medical GroupArizona Society of AnesthesiologistsGeorgia Society of AnesthesiologistsMichigan Society of AnesthesiologistsNassib G. ChamounOhio Society of AnesthesiologistsOld Pueblo Anesthesia GroupPennsylvania Society of AnesthesiologistsSociety of Cardiovascular AnesthesiologistsWisconsin Society of AnesthesiologistsContributing Sponsor ($750 to $1,999)Affiliated Anesthesiologists, Inc.J. Jeffrey Andrews, MDAnesthesia Associates of ColumbusAnesthesia Service of Eugene, PCArkansas Society of AnesthesiologistsAsheville Anesthesia GroupAssociation of Anesthesia Program DirectorsFred W. Cheney, MDConnecticut Society of Anesthesiologists

Jeffrey B. Cooper, PhDIllinois Society of AnesthesiologistsIowa Society of AnesthesiologistsKentucky Society of AnesthesiologistsEdward R. Molina-Lamas, MDMassachusetts Society of AnesthesiologistsMembers of the Academy of AnesthesiologyMichiana Anesthesia GroupMinnesota Society of AnesthesiologistsMissouri Society of AnesthesiologistsRobert C. Morell, MDNebraska Society of AnesthesiologistsJohn B. Neeld, MDNevada Society of AnesthesiologistsNew Jersey State Society of AnesthesiologistsOklahoma Society of AnesthesiologistsOregon Society of AnesthesiologistsPhysician Anesthesia ServiceEllison C. Pierce, Jr., MDPittsburgh Anesthesia AssociatesSociety of Academic Anesthesia ChairsSociety for Ambulatory Anesthesia Society of Neurosurgical Anesthesia and Critical

Care South Carolina Society of AnesthesiologistsSouth Dakota Society of AnesthesiologistsWashington State Society of AnesthesiologistsWest Jersey Anesthesia AssociatesWisconsin Society of AnesthesiologistsSponsor (Up to $749)American Society of Maxillofacial SurgeonsSusan Bender, CRNACalifornia Society of AnesthesiologistsRobert A. Caplan, MD

Cardiovascular Anesthesia, LLCJohn C. Chatelain, MDMelvin A. Cohen, MDColorado Society of AnesthesiologistsCommonwealth Anesthesia AssociatesPaula A. Craigo, CRNADeborah Dlugose, CRNANorig Ellison, MDBarry L. Friedberg, MDGeorgia Anesthesia AssociatesBarry M. Glazer, MDGriffin Anesthesia AssociatesJonathan Griswold, MDPeter L. Hendricks, MDDr. & Mrs. Glen E. HolleyIdaho Society of AnesthesiologistsIndependence Anesthesia, Inc.Instream, Raleigh, NCJCAHOSharon Rose JohnsonRobert E. Johnstone, MDKansas State Society of AnesthesiologistsScott D. Kelley, MDSusan M. Lawlor, CRNARoger M. Litwiller, MDMaine Society of AnesthesiologistsMedical Anesthesiology Consultants Corp.Roger A. Moore, MDNew Hampshire Society of AnesthesiologistsBeverly K. Nichols, CNRAL. Charles Novak, MDDenise O’Brien, RNJill Oftebro, CRNA

PAR Management LLCPhysician Specialists in AnesthesiaRichard C. Prielipp, MDRhode Island Society of AnesthesiologistsSociety for Technology in AnesthesiaSociety for Pediatric AnesthesiaSouthern Tier Anesthesiologists, PCUniversity of Maryland Anesthesiology Assoc.Vermont Society of AnesthesiologistsVirginia Society of AnesthesiologistsMatthew A. Warner, MDMatthew B. Weinger, MDWest Virginia Society of AnesthesiologistsDr. & Mrs. Bernard Wetchler, MDLawrence Wobbrock, MDWoodland Anesthesia AssociatesIn MemoriumIn memory of Normand Macdonald Bremmer,

MD (Texas Society of Anesthesiologists)In Honor of Doctor’s Day 2004 (Instream,Raleigh, NC)Critical Health Systems of SC, Lexington Practice CenterCritical Health Systems of SC,

Baptist Practice CenterMt. Pleasant Anesthesia, PAAnesthesia Resources of the CarolinasDr. Ann EptingLaurinburg Anesthesia AssociatesDr. Steven Schwam, MD, PAPain Management, LLCCoastal Anesthesia AssociatesCoastal Carolina Cardiothoracic & Vascular

Anesthesia Specialists

Note: Donations are always welcome. Send to APSF; c/o 520 N. Northwest Highway, Park Ridge, IL 60068-2573 (Donor List Current as of 4/12/04)

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APSF NEWSLETTER Spring 2004 PAGE 14

I have reviewed published literature, including thatobtained from a Medline search subsequent to our1996 complications review, information from theClosed Claims Analysis, as well as several cases Ipersonally reviewed as an expert witness that havesince been settled.

Nerve InjuryDirect Spinal Cord Injury

I have reviewed 2 cases in which spinal cordinjury occurred following injection. One caseinvolved a cervical epidural injection performedunder fluoroscopy in a deeply sedated patient. Thepatient suffered a cardiac arrest and was resusci-tated, but had severe brain and spinal cord injuryand expired following removal of life support. MRIshowed injury to the brainstem and cervical spinalcord. The second case involved a lumbar epiduralsteroid injection done without fluoroscopy. Thepatient was deeply sedated because she was “aller-gic” to local anesthetics. Following the procedureshe had severe motor and sensory loss in one leg.MRI showed a lesion in the conus.

Hodges et al.3 reported two cases of nerve injuryfollowing cervical epidural steroid injections, bothperformed in heavily sedated patients using fluo-roscopy. In both cases, dural puncture occurred andthe needles were repositioned prior to injectingsteroids. One patient experienced new persistentpainful paresthesias in the upper extremity. Theother had new persistent painful paresthesias inone arm and one leg. In both patients, injury to thecord was evident on MRI.

Brouwers et al.4 reported a spinal cord infarc-tion following a C-6 nerve root injection withiotrolan, bupivacaine, and triamcinolone hexace-tonide. The cord injury was documented on MRIscan and resulted in the patient’s death. Baker et al.5cited this case and 6 other cases of cord injury aftertransforaminal injections that could not be reportedbecause of pending litigation. They suggested thatthe mechanism of injury was likely the injection ofsteroid suspension into a radicular artery withembolization of the spinal cord. They documentedvisualization of a spinal radicular artery followinginjection of radiographic dye during a C6-7 trans-foraminal injection.

HematomaI could find only 2 reported cases of neurologic

injury associated with hematomas resulting fromepidural steroids. One was a report of a subduralhematoma following a cervical epidural steroidinjection. The patient had been taking Fiorinal®,which was stopped 2 weeks before the procedure.She developed quadriplegia, recovered partiallyfollowing surgical decompression, but developedmeningitis and died.6 The other case also occurred

after cervical epidural steroid injection. The patienthad received 6 previous epidurals over a 2-yearperiod. The patient became quadriplegic, but even-tually recovered following extensive decompres-sion surgery.7 I reviewed the case of a patient whodeveloped upper extremity weakness associatedwith an epidural hematoma following a cervicalepidural steroid injection. Surgical decompressionrelieved his symptoms, but he developed a recur-rent hematoma and experienced permanent upperextremity weakness despite a second operation. Hehad been on no anticoagulant or antiplatelet drugs.I also reviewed the case of a patient who developedmotor and sensory loss after a lumbar epiduralsteroid injection. He had undergone myelographythe day before, which was interpreted as disc her-niation. At surgery, he was found to have anepidural angiofibroma and a significant subarach-noid hemorrhage. His recovery was complete. Thiscase occurred prior to the routine use of MRI.

Horlocker et al.8 prospectively assessed 1035patients undergoing a total of 1214 epidural steroidinjections for the development of neurologic dys-function associated with hematoma formation.Blocks were performed at the cervical level in 107procedures, thoracic in 15, lumbar in 988, and cau-dal in 104. A history of bleeding or bruising waselicited in 176 patients, and 383 patients were tak-ing NSAIDS, with aspirin being the most prevalent.None were taking clopidogrel or ticlopidine. Nopatients experienced neurological dysfunctionrequiring assessment for a hematoma.

The Closed Claims Project reported a total of 14claims of spinal cord injury following epiduralsteroid injection and 1 following cervical facet injec-tion. The report did not specify the mechanism ofspinal cord injury in most cases, although it wasstated that 2 cases involved hematomas in patientsreceiving anticoagulants. An additional 14 patientshad non-spinal cord nerve injury, but the exactnature of these was not reported.

InfectionIn our 1995 literature review, we found only 2

cases of epidural abscess reported followingepidural steroid injection, both in diabetic patients.1One patient recovered uneventfully, the other died.Knight et al.9 subsequently reported an additional 6 cases, most of which were in diabetics. We foundreports of 2 cases of meningitis after epiduralsteroids. In 1 case a dural puncture was docu-mented, and in the other case dural puncture couldnot be ruled out. The Closed Claims Projectreported an additional 12 cases of meningitis and 7 cases of epidural abscess as well as 2 cases ofosteomyelitis. No details were reported for any ofthese cases.

by Stephen E. Abram, MD

Injection of suspensions of corticosteroids intoor adjacent to the spinal canal is performed on aregular basis in the United States. Translaminarepidural steroid injections are performed at thelumbar, thoracic, and cervical levels. Caudal injec-tions are done by a “single shot” needle techniqueas well as by fluoroscopically-guided catheters thatare directed toward a particular nerve root. Trans-foraminal steroid injections (also known as selectivenerve root blocks) are performed at nearly everyspinal level. Facet joint injections of steroid andlocal anesthetic are performed routinely in the lum-bar and cervical regions. It is not uncommon forinjected material to flow into the epidural space,either through rupture of the capsule during injec-tion or via existing capsular tears.

Neuraxial steroid injections are generally con-sidered to be safe by physicians in the U.S. On theother hand, sensationalized reporting of a patient’sclaim of arachnoiditis resulting from a steroidepidural nearly resulted in abandonment ofepidural steroid injections in Australia. As it turnedout, the arachnoiditis had been documented onMRI prior to the procedure.

A thorough review of the literature published in1996 reported a very low incidence of serious com-plications.1 Unfortunately, a literature search maynot be the best method to determine the true inci-dence of complications. A somewhat more realisticsurvey of complications can be found by reviewingthe report on the ASA Closed Claims Project pub-lished by Fitzgibbon et al., who found that 42% ofall claims associated with chronic pain treatmentwere for complications related to epidural steroidinjections (N=114) or facet injections (N=4).2

While closed claims analysis helps to identifythe types of complications associated with neuraxialsteroid injections, it fails to provide a reasonableestimate of the incidence of those complications. Wedo not know how many and what type of complica-tions occurred with no malpractice claim filed, nordo we know the denominator, i.e., the total numberof procedures performed. Another confounding fac-tor is the delay in processing malpractice claims.There is often a delay of months to years in filing aclaim, and it may take several years before a claimis litigated or settled. Therefore, we are unaware ofmost of the complications that have occurred in thepast several years, during which time practice mayhave changed appreciably. For instance, it is likelythat a higher proportion of epidural injections arenow being done under fluoroscopic guidance, andmore patients are treated with a transforaminalapproach.

I will briefly review the types of complicationsthat have been reported following neuraxial steroidinjections and discuss methods for minimizing risk.

The Safe Use of Epidural Steroid Injections

See “Epidural,” Next Page

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APSF NEWSLETTER Spring 2004 PAGE 15

Inflammatory ComplicationsA few case reports of adhesive arachnoiditis

were reported following multiple intrathecal injec-tions of methylprednisolone acetate in patients withmultiple sclerosis.1 This led to warnings in the neu-rology literature about the potential hazards ofepidural steroid injections despite the fact that nocases have been reported after epidural injections.Indeed, I have found no reports of arachnoiditisafter only 1 intrathecal steroid injection. There havebeen several reports of aseptic meningitis afterintrathecal deposteroid injections. Symptomsinclude fever, nausea and vomiting, lower extrem-ity pain, and, in one report, seizures. CSF examina-tion shows elevated leucocytes and protein anddecreased glucose. Cultures are negative. To myknowledge, no cases have gone on to permanentneurologic dysfunction or increased pain. There areno reported cases after epidural steroid injections.

Other Complications and Side Effects

Systemic steroid-induced side effects, includingfluid retention, hypertension, congestive heart fail-ure, facial edema, buffalo hump, supraclavicular fatpads, easy bruising, and scaly skin can occur afterdepo steroid injections. In most cases these changesare dose-related, occurring mainly in patients whoreceive multiple injections. Cushingoid symptomscan be long-lasting, even when injections are dis-continued.10 Hyperglycemia is commonly seen forseveral days after the procedure in diabeticpatients. Exacerbation of radicular symptoms iscommon but rarely prolonged. Exacerbation ofepidural lipomatosis, severe enough to require sur-gical decompression, was reported following aseries of 3 epidural steroid injections.11

Nine cases of death or brain damage werereported in the Closed Claims Project.2 Five werethe result of unintended intrathecal local anestheticinjection, while 3 involved delayed respiratorydepression from the addition of morphine to theepidural. A severe allergic reaction accounted forthe other case.

Safety RecommendationsWhile risks are probably small, catastrophic

complications can occur after steroid epidurals. Fol-lowing are suggestions that may reduce risks topatients and may help protect physicians from neg-ligence claims:

1. Provide detailed informed consent. Informdiabetic patients about increased risk of infectionas well as the probability of hyperglycemia.Discuss post-procedure diabetes care with thepatient and with the primary care physician ifpre-procedure management is difficult.

2. Take a careful history; ask about the use ofantiplatelet drugs and anticoagulants. Includelay terms such as “blood thinners” and “heartmedications.” Avoid epidurals in patients onnewer antiplatelet drugs such as clopidogrel,ticlopidine, and low molecular weight heparin.Ask about recent bacterial infections. Look forcontraindications to corticosteroids.

3. Perform a physical examination. Documentpreexisting neurologic abnormalities. Look forskin bruising.

4. Do not perform the procedure for improperindications. The procedure is most effective forpatients with well-documented radiculopathy. Itis generally ineffective for axial low back or neckpain.

5. Consider the use of fluoroscopy. Check forallergy to contrast materials. Inject radiographicdye “live” to rule out intravascular, andparticularly, intra-arterial injection. This shoulddefinitely be done for transforaminal injections.

6. Rule out intrathecal needle placement with alocal anesthetic test dose. Abandon theprocedure if dural puncture is evident. Do notattempt the procedure at another level at thattime. Allow time for the dural puncture to healbefore reattempting.

7. Minimize the amount of steroid used. There isprobably no reason to use more than 80 mgmethylprednisolone acetate or its equivalent forepidural injection. Lower doses are appropriatefor transforaminal injections. Wait at least 2weeks before considering a repeat injection ofsteroids at any site. Do not routinely perform a“series” of injections, but tailor therapy to thepatient’s response. A single injection may beadequate.

8. Limit the total local anesthetic to an amount thatis safe if delivered intrathecally. Provide closemonitoring initially, which should be continueduntil total recovery if an intrathecal injectionoccurs. Use a short-acting local anesthetic,especially in outpatients.

9. Avoid the addition of epidural opioids,especially morphine.

The performance of epidural and transforaminalsteroid injections is part of the practice of medicine,and should only be performed by those who areactively (not necessarily exclusively) involved inthe practice of pain medicine. Patients who are can-didates for these injections deserve careful assess-ment and attention to technical detail during theprocedure.

Dr. Abram is a Professor in the Department of Anes-thesiology at the Medical College of Wisconsin.

Epidural Suggestions May Reduce Risks“Epidural,” From Preceding Page References

1. Abram SE, O'Connor TC. Complications associatedwith epidural steroid injections: a review. Reg Anesth1996;21:149-62.

2. Fitzgibbon DR, Posner KL, Caplan RA, et al. Chronicpain management: American Society of Anesthesiolo-gists Closed Claims Project. Anesthesiology 2004;100:98-105.

3. Hodges SD, Castleberg RL, Miller T, et al. Cervicalepidural steroid injection with intrinsic spinal corddamage: two case reports. Spine 1998;23:2137-42.

4. Brouwers PJ, Kottink EJ, Simon MA, Prevo RL. A cervi-cal anterior spinal artery syndrome after diagnosticblockade of the right C6-nerve root. Pain 2001;91:397-9.

5. Baker R, Dreyfuss P, Mercer S, Bogduk N. Cervicaltransforaminal injection of corticosteroids into a radicu-lar artery: a possible mechanism for spinal cord injury.Pain 2003;103:211-5.

6. Reitman CA, Watters W. Subdural hematoma after cer-vical epidural steroid injection. Spine 2002;27:E174-6.

7. Williams KN, Jackowski A, Evans PJD. Epiduralhematoma requiring surgical decompression followingrepeated cervical epidural steroid injections for chronicpain. Pain 1990;42:197-9.

8. Horlocker TT, Bajwa Z, Ashraf Z, et al. Risk assessmentof hemorrhagic complications associated with nons-teroidal anti-inflammatory medications in ambulatorypain clinic patients undergoing epidural steroid injec-tions. Anesth Analg 2002;95:1691-7.

9. Knight JW, Cordingley JJ, Palazzo MG. Epidural abscessfollowing epidural steroid and local anesthetic injection.Anaesthesia 1997;52:576-8.

10. Tuel SM, Meythaler JM, Cross LL. Cushing’s syndromefrom methylprednisolone. Pain 1990;40:81-4.

11. Sandberg DI, Lavyne MH. Symptomatic spinal epidurallipomatosis after local epidural corticosteroid injections:case report. Neurosurgery 1999;45:162-5.

APSF GrantApplications Due

June 14, 2004

See Website fordetails!

Page 16: NEWSLETTER - Anesthesia Patient Safety Foundation · may have long-term consequences for patient safety.1 The potential relationship between anesthe-sia management and long-term outcome

Anesthesia Patient Safety FoundationBuilding One, Suite Two8007 South Meridian StreetIndianapolis, IN 46217-2922

NONPROFIT ORG.U.S. POSTAGE

PAIDWILMINGTON, DEPERMIT NO. 1387

APSF NEWSLETTER Spring 2004 PAGE 16

APSF NewsletterNOW in Color NEWSLETTERVolume 18, No. 4, 45-64

Circulation 36,825

Winter 2003-2004

www.apsf.org

Inside: President Reports on State of the APSF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pg 46

ASA Papers Highlight Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pg 49

APSF Awards Three New Grants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pg 50

APSF Grant Program Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pg 53

Bar Coding May Reduce Drug Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pg 54

APSF Workshop Explores HRO Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Pg 55

The Official Journal of the Anesthesia Patient Safety FoundationCanister Fires BecomeA Hot Safety Concern3. Turn off the vaporizers when not in use.

4. Verify the integrity of the packaging of new CO2

absorbents prior to use.5. Periodically monitor the temperature of the CO2

absorbent canisters.6. Monitor the correlation between the sevoflurane

vaporizer setting and the inspired sevoflurane

concentration. An unusually delayed rise orunexpected decline of inspired sevoflurane

concentration compared to the vaporizer setting

may be associated with excessive heating of the

CO2 absorbent canister.Abbott also pointed out that the color indicator

of CO2 absorbents does not necessarily change as a

result of desiccation. If excessive heat is detected

the patient should be disconnected from the anes-

thesia circuit, fresh gas flow to the circuit should be

shut off, and the CO2 absorbent should be replaced.

The patient should also be monitored for carbon

monoxide exposure and the potential for chemical

thermal injury. Clinical findings associated with

these events can include1. Failed inhalation induction or inadequateanesthesia with sevoflurane.2. Clinical signs of airway irritation.3. Oxygen desaturation, increased airway pressure,

and difficulty with ventilation.4. Severe airway edema and erythema.5. Elevated carboxyhemoglobin levels.

Ellison C. (Jeep)Pierce, Jr., MD,Retires From APSFThe APSF and ASA Meetings held this past

October in San Francisco witnessed a landmark

event, the retirement of Ellison C. (Jeep) Pierce, Jr.,

MD, from his position as Executive Director of the

Anesthesia Patient Safety Foundation. Jeep is truly

the father of patient safety, both in the United States

and abroad. His dedication, persistence, enthusiasm,

and hard work led to the formation of the Anesthe-

sia Patient Safety Foundation, which served as the

model for the National Patient Safety Foundation

and numerous similar international organizations.

The celebrations held in Jeep’s honor were bitter-

sweet, sweet with the love and admiration that so

many hold for this amazing man and his accom-

plishments, and sad with the knowledge that he is

now retiring from the APSF. Jeep has served as a

role model and mentor for many anesthesiologists

and leaders in the field of patient safety; his influ-

ence has been and continues to be enormous. Like so

many men of greatness, Jeep’s contributions will

continue to be recognized, recounted, and rediscov-

ered, long after his retirement. Please join with the

Executive Committee and the Board of Directors of

the APSF in wishing Jeep a long and happy retire-

ment, replete with the knowledge of the lives he has

touched and the lives he has saved.

by Michael A. Olympio, MD, and Robert C. Morell, MDReports of fire and/or extreme heat occurring in

the carbon dioxide absorber portion of the anesthe-

sia circle system have come to the attention of the

APSF. An October communication received from an

anesthesiologist described canister overheating and

a burning expiratory valve. Rapid communications

and discussions revealed the existence of other,

extremely rare, but similar occurrences. Input from

the ASA Committee on Equipment and Facilities

and from the FDA Center for Devices and Radio-

logic Health revealed 3-4 other reports. While the

exact etiology of these “canister fires” is not known,

the mechanism appears to be related to chemical

interactions between desiccated CO2 absorbent and

potent inhaled anesthetic agents. The ECRI has also

received reports of this dangerous phenomenon

and has identified some common elements in 4 fires

that were reported to them over the past few years.

These common elements include the use of barium

hydroxide containing CO2 absorbent, desiccation of

the absorbent, and the use of sevoflurane. Abbott Laboratories issued a “Dear Health Care

Professional” letter on November 17, 2003, calling

attention to these rare, isolated reports.1 In their let-

ter a number of suggestions are described that

might limit the risk of canister fires. These include1. If you suspect that the CO2 absorber may be

desiccated because it has not been used for an

extended period of time, it should be replaced.2. Shut off the anesthesia machine (and fresh gas

flow) after any case, when an extended period of

non-use is anticipated.

Dr. Stoelting (left) honors Dr. Pierce with a plaque at the

APSF Board of Directors Meeting.

See “Fires,” Page 47

Inside:◆ Inflammation and

Long-Term Outcome

◆ Complications AssociatedWith Regional Anesthesia

◆ Review of APSF GrantProgram

◆ Safety of Epidural Steroids

◆ Dear SIRS Debut

S AFETY

I NFORMATION

R ESPONSE

S YSTEM

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