Pro: NIRS is “Standard of Care”

for Postoperative Management

James S. Tweddell, Nancy S. Ghanayem, and George M. Hoffman

Successful postoperative management depends on early detection and correction of cir-

culatory insufficiency. Global cardiac output and oxygen delivery must be adequate and
distributed appropriately to meet metabolic demands to prevent the development of multi-
organ dysfunction, morbidity, and death. Decreased cardiac output during the postopera-
tive period is common, but circulatory assessment using standard monitoring provides
inadequate information to reliably detect low cardiac output syndrome or effectively guide
therapy. Goal-directed therapy using invasive estimates of global oxygen supply-demand
balance (SvO2) has been shown to improve survival among patients in shock states. Near
infrared spectroscopy (NIRS) is a noninvasive assessment of regional oxygen supply–
demand balance. Multiple prospective observational studies have shown that NIRS-derived
measures of systemic oxygen balance correlate with global circulatory measures, including
SvO2 and biochemical indicators of shock. Additionally, NIRS has been shown in multiple
prospective observational studies to identify circulatory inadequacy in specific organ
systems, such as the brain, kidney, and gut. NIRS provides continuous, non-invasive
measures that are suitable targets for goal-directed therapy to treat deficiencies in global
and regional perfusion and should be standard of care.
Semin Thorac Cardiovasc Surg Pediatr Card Surg Ann 13:44-50 © 2010 Published by
Elsevier Inc.

The Problem With to intermittent physical examination and laboratory testing,

Our Current Approach
to the Postoperative Patient
T he final common pathway to postoperative mortality and
morbidity following surgery for congenital heart disease
is inadequate oxygen delivery. Low cardiac output syndrome
is common following surgery for congenital heart disease and
occurs in 25% of patients following biventricular repair.1-5 It
is likely that incidence and severity are higher among patients
with univentricular heart disease. Clinical assessment of
the adequacy of oxygen delivery using standard monitor-
ing typically includes: continuous monitoring of the elec-
trocardiogram, arterial blood pressure, left atrial pressure,
central venous pressure, and arterial saturation, in addition
From the Department of Surgery, Division of Cardiothoracic Surgery, The
Department of Pediatrics, Section of Critical Care, and the Department of
Anesthesia, Medical College of Wisconsin, Children’s Research Institute
and the Herma Heart Center, Children’s Hospital of Wisconsin, Milwau-
kee, WI.
Address correspondence to James S. Tweddell, MD, Cardiothoracic Surgery,
Children’s Hospital of Wisconsin, 9000 W. Wisconsin Ave., Milwaukee,
WI 53226; E-mail: jtweddell@chw.org
including arterial blood gases. However, these measures pro-
vide poor inter-rater reliability and diagnostic accuracy for
low cardiac output.6 Tibby and colleagues tested the ability of
clinicians to assess cardiac output in intubated two ventricle
pediatric patients, of which the majority (27 of 36) were
postoperative cardiac surgical patients.6 Twenty-seven clini-
cians performed 112 estimates of cardiac output. The clini-
cians could perform a physical exam and all laboratory data
were available, the estimates were then compared with ther-
modilution cardiac output. The correlation between clinician
estimates and thermodilution cardiac output was poor (r2 ⫽
0.06). Clinicians could not accurately determine cardiac out-
put of intubated pediatric patients with in-series circulation
and it seems likely that clinical assessment of cardiac output
in single ventricle patients with parallel circulation is even
worse (Fig. 1).
Even if the clinician was able to accurately estimate cardiac
output, this might not be the appropriate target for assess-
ment of overall circulatory well-being. Cardiac output is only
one component of the oxygen supply function, and large
variations in oxygen demand occur in the course of critical
illness, particularly in the early postoperative period follow-
ing complex congenital heart surgery.7 Measurement of he-

44 1092-9126/10/$-see front matter © 2010 Published by Elsevier Inc.

doi:10.1053/j.pcsu.2010.02.008
Pro: NIRS is “standard of care” for postoperative management 45

Our own experience using venous saturation monitoring

in patients with hypoplastic left heart syndrome (HLHS) re-
veals a high incidence of low SvO2 in the presence of other-
wise acceptable arterial and atrial pressures, and a clear rela-
tionship between low SvO2 and biochemical shock.13,14 We
found an early postoperative period of vulnerability revealed
by SvO2 monitoring, during which goal-directed interven-
tions that achieved early normalization of SvO2 improved
survival (Fig. 3).15 Thus, in both adults and children, a pa-
rameter that is related to systemic oxygen supply– demand
economy can improve outcome when incorporated as a tar-
get for intervention in critical illness.
Invasive measures of oxygen balance such as venous oxim-
etry, although beneficial, have risks, including thrombosis,
bleeding, and infection. To limit the risk of these complica-
tions, venous oximetry can only be used for a limited time.
The SvO2 is the flow-weighted average of regional venous
Figure 1 Twenty-seven clinicians performed 112 estimates of car-
diac output (CO) on 36 intubated pediatric patients with two-ven-
tricle anatomy. The clinicians could perform a physical exam and all
laboratory data were available. The clinician’s estimates were com-
pared with thermodilution CO. Clinicians could not accurately de-
termine CO of intubated pediatric patients with in-series circula-
tion. (Reprinted with permission.6)

moglobin oxygen saturation of the mixed venous blood

(SvO2) in the pulmonary artery, or alternatively the superior
vena cava (SVC), is a summation of the last blood in contact
with the tissues at the capillary level and provides an index of
the oxygen supply– demand balance that is inclusive of all
components of oxygen supply and demand.

The Case for

Goal-Directed Therapy
Goal-directed therapy using objective assessment of systemic
oxygen delivery such as SvO2 has been shown to improve
outcome of critically ill patients.8,9 In these studies, SvO2-
derived parameters drove hemodynamic interventions that
would not have been initiated based on vital signs and bio-
chemical indicators, and included inodilator therapy in nor-
motensive patients with low SvO2 and inoconstrictor ther-
apy in patients with high SvO2. These interventions reduced
the incidence of multiple organ system dysfunction, and re-
sulted in improved survival that persisted after hospital dis-
charge, suggesting that the course of critical illness could be
altered by aggressive reversal of shock states, but only if ini-
tiated early during a time-limited window before irreversible
ischemic organ injury occurred.10-12
A randomized controlled trial of SVC SvO2 in the outcome
of septic shock in pediatric patients was conducted by de
Figure 2 Children and adolescents with severe sepsis or fluid-refrac-
Oliveira et al.13 They used the American College of Critical
tory septic shock were randomly assigned to American College of
Care Medicine – Pediatric Advanced Life Support resuscita- Critical Care Medicine – Paediatric Advanced Life Support recom-
tion protocol, with randomization of half the patients to re- mended resuscitation with or without ScvO2 goal-directed therapy.
ceive SvO2 monitoring with treatment aimed at achieving an A, Objective measures of systemic oxygen delivery results in im-
SvO2 greater than 70%. They found that the addition of proved survival in pediatric patients with septic shock. B, Treatment
venous saturation monitoring improved survival, with the was most effective in those identified initially with decreased sys-
greatest impact in patients with initially low SvO2 (Fig. 2). temic oxygen delivery. (Reprinted with permission.13)
46
Figure 3 Among 116 patients with hypoplastic left heart syndrome
undergoing stage 1 palliation with a Blalock-Taussig shunt in which
SvO2 was routinely monitored and included in a prospective peri-
operative hemodynamic database, the outcome of the patients with
the lowest 25 percentile of SvO2 upon arrival to the ICU following
the Norwood procedure are shown. Among the 29 patients in the
lowest quartile, the initial SvO2 level on arrival in the intensive care
unit was not different with respect to the three outcome end points
of uncomplicated survival, survival with complications, and early
death. Two thirds of patients with low SvO2 could be successfully
treated and were ultimately survivors. These data suggest that goal-
directed therapy, specifically efforts to increase a low SvO2 in the
postoperative neonate, are successful in a proportion of patients
with the lowest SvO2. (Reprinted with permission.15)
saturations and, as such, provides a global estimation of the
adequacy of systemic oxygen delivery. Significant derangements
in blood flow and oxygen delivery to specific organs at risk
(brain, kidneys, and gut) can occur in the presence of normal
global SvO2 or arterial-venous oxygen content difference.
Near Infrared Spectroscopy
(NIRS) Provides a
Noninvasive Target
for Goal-Directed
Therapy
Several noninvasive methods to assess cardiac output have
been developed. Among these are the use of either transtho-
racic or transesophageal pulse contour analysis, electric ve-
locimetry, and NIRS.16-21 With the exception of NIRS, these
techniques attempt to measure actual cardiac output which,
in the absence of oxygen consumption data, may be limiting
J.S. Tweddell, N.S. Ghanayem, and G.M. Hoffman
in managing the physiologically vulnerable patient. Alterna-
tively, both venous oximetry and NIRS have the potential to
provide information on the adequacy of systemic oxygen de-
livery, potentially more useful information for determining
the state of the tissue oxygen economy in the setting of altered
oxygen utilization and cyanosis that is commonly observed
following complex congenital heart surgery.
NIRS techniques rely on application of the Beer-Lambert law
for measurement of the concentration of a substance according
to its absorption of light, and modified to include photon loss
due to scatter in biologic tissue.22 In the optical window of 700 –
900 nm light can pass easily through skin and bone, and most
photon absorption is from hemoglobin. From the differential
absorption of two wavelengths of light by oxygenated and de-
oxygenated hemoglobin, NIRS devices provide an estimate of
oxyhemoglobin saturation in a volume of tissue beneath the
probe. Unlike pulse oximetry, which uses subtraction compu-
tational algorithms to estimate arterial saturation, NIRS devices
use subtraction algorithms to remove the effects of shallow sig-
nals, and therefore estimate the average hemoglobin saturation
in tissue deep to the probe. Because most of the hemoglobin in
tissue is on the venous side of the circulation, NIRS provides a
venous-weighted oxyhemoglobin saturation index. The most
commonly used devices provide continuous display of regional
oxygen saturation (rSO2) providing real-time assessment of re-
gional oxygen saturation.
NIRS can be used as a non-invasive proxy for SvO2. Sev-
eral studies have looked at the correlation between cerebral
rSO2 and SVC, jugular venous saturation, or mixed venous
saturation in neonates and infants following cardiac surgery.
In a prospective observational study, Ranucci et al18 found
that cerebral rSO2 correlated with SVC saturation in pediatric
cardiac surgical patients, although the venous saturation
tended to be higher than the cerebral rSO2. The correlation
was better in cyanotic patients. NIRS was found to be a reli-
able trend monitor and changes in cerebral rSO2 correlated
with changes in SvO2. In a prospective observational study of
52 neonates and infants following cardiac surgery, Kaufman
et al17 showed a significant correlation between rSO2 mea-
sured from either the flank or abdomen and venous satura-
tion (Fig. 4).
Most commercial NIRS devices, including the most com-
monly used device by Somanetics (Troy, MI), have at least
two recording channels. We and others have used a strategy
of multi-site cerebral and somatic monitoring with NIRS
probes placed both on the head and in a somatic region
measuring renal, mesenteric, or muscle saturation. We have
found that two-site NIRS monitoring provides a better esti-
mate of SvO2 than monitoring in either the cerebral or so-
matic sites alone.23 Further evidence of the utility of two-site
NIRS monitoring in gauging the adequacy of the global oxy-
gen economy comes from a recent prospective observational
study by Chakravarti and colleagues,24 who found a strong
correlation between the averaged cerebral and renal rSO2
and the development of lactic acidosis in children follow-
ing cardiac surgery. An averaged cerebral and renal rSO2
value ⬍65% predicted a lactate level ⬎3.0 mmol/L, with a
sensitivity of 95% and a specificity of 83% (P ⫽ 0.0001).
Pro: NIRS is “standard of care” for postoperative management 47

rized above indicate that NIRS can be used to assess the

global oxygen economy in neonates and infants following
complex congenital heart operations.
NIRS can provide useful information concerning regional
perfusion. In a prospective observational study, Fortune et
al26 used two-site NIRS monitoring to evaluate the risk of
developing necrotizing enterocolitis in neonates using cere-
bral and mesenteric (anterior abdominal) probes. The degree
of somatic flow redistribution was expressed as the somatic/
cerebral rSO2 ratio As this ratio fell to less than 75%, the risk
of developing necrotizing enterocolitis was eight times
greater, with a sensitivity of ⬎90% (Fig. 6). In our own
experience with neonates undergoing the Norwood proce-
dure, rSO2 measured from the renal (lumbar) region in the
first 24 postoperative hours predicted the development of
renal failure on postoperative day 3 (Fig. 7).23 Abdul-Khaliq
and colleagues27 evaluated 30 pediatric patients with congen-
ital heart disease and found that NIRS measured from the side
of the head, in a position corresponding to the middle cere-
bral artery distribution, correlated closely with jugular ve-
nous bulb saturation (Fig. 8). In our own neonatal single
ventricle population, an average 48-hour postoperative cere-
bral rSO2 ⬍55% was associated with impaired neurodevel-
opmental outcome as assessed at school age using the Beery
test of visual motor integration (Fig. 9).28 In total, the pro-
spective observational studies above indicate that NIRS can
detect important aberrations in critical tissue bed perfusion,

Figure 4 In a prospective observational study of 52 neonates and

infants following cardiac surgery, venous saturation was compared
with NIRS measured from probes placed on the abdomen (just
below the umbilicus) and the dorsolateral flank (at the T-10 to L-1
level). Clinically useful correlations were observed between NIRS
measurements and SvO2. (Reprinted with permission.17)

The two-site approach can also detect changes in the dis-

tribution of systemic blood flow that occur with sympathetic
activation, inflammation that occurs following cardiopulmo-
nary bypass, and with vasoactive drug treatment. A near-
universal feature of shock states is the activation of the sym-
pathetic nervous system to redistribute blood flow away from
the renal, mesenteric, and splanchnic regions to preserve
cerebral blood flow. In a prospective observational study,
postoperative cardiac neonates had NIRS probes placed on
the head to assess cerebral circulation and on the flank to
evaluate renal-somatic circulation, which normally exhibits
high blood flow for non-metabolic purposes and low oxygen Figure 5 During shock states, blood is shunted away from less vital
extraction. The degree of systemic somatic to cerebral blood organs beds, such as the splanchnic circulation, to more vital or-
flow redistribution was expressed as the absolute difference gans, such as the brain. To identify circulatory aberrations in a
prospective observational study, postoperative neonates had NIRS
between the somatic rSO2 and the cerebral rSO2, providing
probes placed on the head to assess cerebral circulation and on the
an index of systemic oxygen distribution independent of flank to evaluate somatic circulation. A simple algorithm in which
variation in arterial saturation.25 As this value approaches and the cerebral saturation is subtracted from the somatic saturation was
becomes ⬍0, the risk of biochemical shock, organ dysfunc- developed. As this value approaches and becomes ⬍0, the risk of
tion, and death are increased. This study indicates that NIRS death, biochemical shock, and death are increased. This study in-
can identify altered perfusion observed in shock states (Fig. dicates that NIRS can identify altered perfusion observed in shock
5). The multiple, prospective, observational studies summa- states. (Reprinted with permission.25)
48
Figure 6 A prospective observational study of 40 neonates, 10 with
acute abdomens including 4 with necrotizing enterocolitis. This
study evaluated two-site NIRS monitoring, cerebral and abdominal,
for prediction of splanchnic ischemia. The receiver operator curves
comparing abdominal tissue oxygen index (TOI) alone with a ratio
of cerebral TOI to abdominal TOI are shown. The use of two-site
NIRS monitoring substantially increased the specificity and sensi-
tivity for detection of splanchnic ischemia. This degree of sensitivity
and specificity is clearly of clinical utility and is a suitable target for
goal-directed therapy. This study demonstrates that NIRS can detect
regional malperfusion. (Reprinted with permission.26)
specifically the gut, kidneys, and brain, that result in organ
injury.
The Evidence
Supports the Inclusion
of NIRS as Standard of Care
Standard of care can be defined as the degree of care an
ordinary, reasonable, and prudent physician would exercise
in a given patient care circumstance. Arguably the best efforts
Figure 7 A prospective observational study in postoperative stage I
patients in which the somatic NIRS recorded from the flank upon
return to the intensive care unit was compared with the creatinine
on postoperative day 3. NIRS predicted elevation of creatinine. This
study indicates that NIRS can identify important and clinically rel-
evant deficiencies in renal perfusion. (Reprinted with permission.23)
J.S. Tweddell, N.S. Ghanayem, and G.M. Hoffman
Figure 8 In this observational study of 30 neonates, infants, and
children with congenital heart disease, jugular venous oxygen sat-
uration was compared with cerebral RSO2. The x-ray shows the
position of the NIRS probe and the jugular venous catheter. The
NIRS probe is positioned over the middle cerebral circulation and is
in close proximity to the bed drained by the internal jugular vein.
There is excellent correlation between the RSO2 and the jugular
venous bulb saturation. These data show that NIRS can be used to
determine the adequacy of cerebral circulation. (Reprinted with
permission.27)
to establish standards of care for patients with heart disease
are the consensus statements of the American Heart Associ-
ation (AHA) and the American College of Cardiology (ACC)
Task Force on Practice Guidelines.29 Within these guidelines,
levels of evidence and treatment effects are defined. The high-
est levels of evidence are supported by multiple randomized
controlled trials. While ideally all practice guidelines should
be supported by the ultimate in clinical studies, this is neither
practical nor even possible. Indeed the authors of the practice
guidelines themselves have stated as much: “A recommenda-
tion with Level of Evidence B or C does not imply that the
recommendation is weak. Many important clinical questions
addressed in the guidelines do not lend themselves to clinical
trials. Even though randomized trials are not available, there
may be a very clear clinical consensus that a particular test or
Pro: NIRS is “standard of care” for postoperative management
Figure 9 In this study of patients following stage 1 palliation for
hypoplastic left heart syndrome, the postoperative cerebral NIRS
and all hemodynamic data recorded in the ICU were compared with
visual motor index (VMI) determined at 4 to 5 years of age. Low VMI
was significantly related to low Stage 1 postoperative rSO2C (mean
rSO2C, 55⫾5 vs 66⫾7, P ⬍.05; logistic regression VMI, ⬍85 vs
rSO2C, P ⬍.01; hours with rSO2C, ⬍50 odds ratio 31, P ⬍.01); 13% of
the variance in VMI was attributable to rSO2C, with an apparent cutoff
at rSO2C ⬍55. Although preliminary, these data suggest cerebral RSO2
is a suitable target for postoperative goal-directed therapy with the
potential to minimize neurodevelopmental delay. (Reprinted with per-
mission.28)
therapy is useful or effective.”29 Tricoci and colleagues,30 in a
study of 16 ACC/AHA clinical practice guidelines, found that
only 314 of 2,711 (11%) recommendations were classified as
level of evidence A (evidence based on multiple randomized
trials or meta-analyses), whereas almost half were level of
evidence C. In the most recent ACC/AHA guidelines on man-
agement of patients with valvular heart disease, one of the
areas of heart disease with the longest history of treatment,
among 172 class I recommendations, those with the greatest
treatment effect, only one was based on ‘level A’ data.31 There
are no randomized controlled trials or meta-analyses in pe-
diatric cardiac surgery in which intervention for either global
or regional perfusion inadequacy was based on NIRS and
therefore, admittedly, there is no ‘level A’ data to support the
recommendation of NIRS as standard of care. Such a study
would require a two-fold approach: first, decreased perfusion
would be recognized, and secondly, effective therapy ren-
dered. Although the treatment of decreased perfusion has
been shown to be of survival benefit even today, the exact
nature of treatment, intensity, and duration may be difficult
to define. Indeed, this has been cited as a shortcoming in
studies investigating the use of NIRS in adult patients under-
going cardiac surgery.32 Effective treatment of low cardiac
output syndrome is still a relatively new area, and the first
step is identifying low cardiac output. The use of NIRS is
supported by multiple prospective observational studies and,
although they do not rise to ‘level A’ in total, these studies do
rise to ‘level B’ evidence. As such, the quality of data support-
ing NIRS is well in excess of that supporting most recommen-
dations that rise to the “standard of care.” The level of accu-
mulated evidence has reached a point that the US Food and
49
Drug Administration has permitted marketing of the Soma-
netics NIRS device, recognizing that “in neonates, infants and
children, cerebral and somatic rSO2 provide noninvasive in-
dications of oxygen changes in the cerebral and peripheral
circulatory systems and may provide an early indication of
oxygen deficits associated with impending shock states and
anaerobiosis.”33 We cannot find similar evidence supporting
the use of pulse oximetry, invasive, or non-invasive blood
pressure measurements in the postoperative congenital heart
surgery population, and yet these would all be considered
standard of care.
Conclusion
In summary, conventional postoperative monitoring pro-
vides little information concerning cardiac output or oxygen
delivery. Low cardiac output is a common problem occurring
in 25% of patients undergoing two-ventricle repair and prob-
ably a higher proportion of patients undergoing single ven-
tricle palliation. Goal-directed therapy using objective mea-
sure of systemic oxygen balance such as SvO2 can be used to
treat low cardiac output with increased survival. NIRS corre-
lates with global perfusion indices and is a suitable target for
early goal-directed therapy to improve outcomes, and addi-
tionally is noninvasive, providing a low-risk means of pro-
longed monitoring of critically ill patients. Furthermore,
NIRS can provide non-invasive estimates of specific organ per-
fusion with the potential to limit important morbidity both
short- (renal insufficiency, necrotizing enterocolitis) and long-
term (neurodevelopmental impairment). Thus, NIRS should be
the standard of care.
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