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J Thorac Cardiovasc Surg 2009;137:154-159
© 2009 The American Association for Thoracic Surgery

Congenital Heart Disease

Near-infrared spectroscopy: What we know and what we need to know—A systematic review of the congenital heart disease literature

Jennifer C. Hirsch, MDa,*, John R. Charpie, MD, PhDb, Richard G. Ohye, MDa, James G. Gurney, PhDc

a Department of Surgery, Section of Cardiac Surgery, Division of Pediatric Cardiovascular Surgery, University of Michigan Medical School, Ann Arbor, Mich
b Department of Pediatrics, Section of Pediatric Cardiology, University of Michigan Medical School, Ann Arbor, Mich
c Department of Pediatrics, Child Health Evaluation and Research Unit, University of Michigan Medical School, Ann Arbor, Mich

Received for publication January 9, 2008; revisions received May 5, 2008; accepted for publication August 2, 2008.

* Address for reprints: Jennifer C. Hirsch, MD, 5144 Cardiovascular Center, Ann Arbor, MI 48109-5864. (Email: jhirsch{at}umich.edu).


   Abstract
Top
 Abstract
Introduction
 Methods
 Results
 Conclusions
 Table E1
 Table E2
 Table E3
 References
 E-References
 
Objectives: Neurologic dysfunction is a problem in patients with congenital heart disease. Near-infrared spectroscopy may provide a real-time window into cerebral oxygenation. Enthusiasm for near-infrared spectroscopy has increased hopes of reducing neurologic dysfunction. However, potential gains need to be evaluated relative to cost before routine implementation. Responding to data in ways that seem intuitively beneficial can be risky when the long-term impact is unknown. Thus, we performed a systematic review of the literature on near-infrared spectroscopy in congenital heart disease.

Methods: A literature search from 1950 to April 2007 for near-infrared spectroscopy in congenital heart disease was undertaken. We identified 54 manuscripts and\ 13 reviews.

Results: There were 47 case series, 4 randomized trials, and 3 retrospective studies. Two studies had postdischarge follow-up, one incorporating neurologic testing. Neither of these studies demonstrated a benefit. One retrospective study, which included near-infrared spectroscopy and other intraoperative measures of cerebral perfusion, demonstrated a decrease in neurologic dysfunction using this combination of monitors. Three small studies were able to correlate near-infrared spectroscopy with other clinical and radiologic findings.

Conclusions: Many centers, and even entire countries, have adopted near-infrared spectroscopy as standard of care. The available data suggest that multimodality monitoring, including near-infrared spectroscopy, may be a useful adjunct. The current literature on the use of near-infrared spectroscopy alone, however, does not demonstrate improvement in neurologic outcome. The data correlating near-infrared spectroscopy findings with indirect measures of neurologic outcome or mortality are limited. Although near-infrared spectroscopy has promise for measuring regional tissue oxygen saturation, the lack of data demonstrating improved outcomes limits the support for widespread implementation.

Abbreviations and Acronyms CHD = congenital heart disease; MRI = magnetic resonance imaging; NIRS = near-infrared spectroscopy; rScO 2 = regional cerebral oxygen saturation


   Introduction
Top
 Abstract
 Introduction
Methods
 Results
 Conclusions
 Table E1
 Table E2
 Table E3
 References
 E-References
 
Neurologic dysfunction is a significant problem in congenital heart disease (CHD). Historically, cardiac surgeons and cardiologists have had significant interest in acute clinical neurologic abnormalities such as stroke and seizure. With improved perioperative care, however, the prevalence of major acute neurologic abnormalities has decreased to 1% to 2% of open heart cases.1Go Of growing concern are late neurodevelopmental and behavioral problems associated with pediatric cardiac surgery.2Go These late neurologic impairments are compounded in children who require multiple operations. With increasing overall survival, the understanding of the impact of long-term neurologic sequelae on quality of life is crucial. Significant efforts from physicians and industry have been directed toward developing improved monitoring techniques for early detection of neurologic injury in hopes of averting or ameliorating subsequent complications. Current technologies include transcranial Doppler, electroencephalograms, bispectral index, biomarkers, and jugular bulb oximetry. Physician enthusiasm has increased for the use of near-infrared spectroscopy (NIRS) in the perioperative period in hopes of reducing neurologic dysfunction.

NIRS is based on the differential absorption of varying wavelengths of light by hemoglobin as it associates with oxygen. It provides a regional measurement of oxygen content in a localized tissue bed. The device can be used for both cerebral and somatic regional measurements. The value reported represents the amount of oxygen present within the tissue, including arterioles, capillaries, and venules. The measurement is venous weighted (85% venous, 15% arterial). The purported value of cerebral NIRS is the ability to obtain noninvasive, real-time information on the cerebral oxygen content in the frontal cortex that reflects both oxygen delivery and consumption. This information may help guide interventions by the surgical team or intensive care physicians to maintain theoretically safe cerebral oxygenation levels.

NIRS technology has been described in the adult and pediatric cardiac literature in multiple clinical settings, including the intensive care unit and operating room. As with any new technology, the potential clinical gains (and limitations) need to be critically evaluated before integration into routine patient care. Each additional monitoring device comes with an additional cost and with increasing patient care complexity. In addition, responding to data in ways that seem intuitively beneficial can be risky when the long- or even intermediate-term impact on clinical outcomes is unknown. Within this context, we conducted a systematic review of the scientific literature to examine the available evidence for the use of NIRS in the care of patients with CHD.


   Methods
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 Abstract
 Introduction
 Methods
Results
 Conclusions
 Table E1
 Table E2
 Table E3
 References
 E-References
 
Eligibility Criteria
Inclusion criteria for the literature search were limited to human studies, English language, and pediatric cardiac patients; all such manuscripts using NIRS in any area of pediatric cardiology and pediatric cardiac surgery were included. Editorials, case reports, and duplicates were excluded. We reviewed narrative reviews of the use of NIRS in pediatric cardiac patients to avoid publication bias and to highlight the key difference between systematic and narrative reviews. The content of the narrative reviews was not included, as is customary, in the formal systematic review as it does not represent a primary scientific manuscript. All references were evaluated from the manuscripts to confirm inclusion of all pertinent studies.

Search Strategy
We searched the English language literature about the use of NIRS in the pediatric cardiac population from 1950 to April 2007 with MEDLINE, Pre-MEDLINE, EMBASE, and Cochrane databases. The MEDLINE search was performed combining the key word search: near infrared spectroscopy, NIRS, or infrared spectroscopy. This list was combined with a keyword search including the following: pediatric cardiac surgery, CHD, pediatric, pediatric cardiology, intensive care, ICU, cardiopulmonary bypass, CPB, hypothermic circulatory arrest, or DHCA. The results of the MEDLINE search are outlined in Figure 1 . We identified a total of 224 manuscripts and we reviewed all abstracts. Manuscripts were excluded on adult patients, noncardiac patients, non-English language, editorials, single case reports, and duplicates. After these exclusions, a total of 48 manuscripts remained with an additional 8 manuscripts identified from the references of the narrative reviews. Further, we evaluated all articles classified as narrative review articles involving the patient population of interest along with their references to confirm an exhaustive review of the scientific literature.


Figure 1
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  		Figure 1. Search strategy and study selection for inclusion. *Exclusion criteria: adult patients, non-English, noncardiac patients, editorials, case reports, and duplicates.

 
Data Review and Analysis
We created a standardized data retrieval form. A single reviewer (J.C.H.) extracted data from the manuscripts and assessed clinical study site, study design, patient population, sample size, mode of monitoring, NIRS device, primary and secondary outcomes, intervention if any, and follow-up. We subclassified manuscripts into general clinical sites for review and compilation (Figure 2 ). It was not possible to perform a meaningful meta-analysis with generation of a summary statistic owing to variation in end points, study design, monitoring device, and statistical analyses.


Figure 2
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  		Figure 2. Classification of included manuscripts based on clinical application.

 

   Results
Top
 Abstract
 Introduction
 Methods
 Results
Conclusions
 Table E1
 Table E2
 Table E3
 References
 E-References
 
We identified 56 manuscripts that fit the eligibility criteria (Figure 1). We also identified and reviewed an additional 13 narrative review articles for comparative purposes. For simplicity of evaluation, we sorted the manuscripts by the clinical setting (Figure 2). Of the 13 review articles, 4 narrative reviews specifically focused on NIRS in the care of patients undergoing pediatric cardiac surgery.3-6Go These review articles were not inclusive of all the potential clinical settings. The median number of manuscripts referenced within the review articles on NIRS and CHD patients was 8.5.3-15Go

The primary research manuscripts evaluated 6 different devices: INVOS (Somanetics, Troy, Mich), NIRO (Hamamatsu Photonics, Hamamatsu City, Japan), NIMS (NIMS Inc, Philadelphia, Pa), Radiometer (Copenhagen, Denmark), PSA-3N (Biomedical Science, Kanazawa, Japan), and Inspectra Tissue Spectrometer (Hutchinson Technology, Hutchinson, Minn). Owing to the natural progression of device technology, one can observe multiple models of the INVOS and NIRO devices evaluated in the literature. Various devices use different terminology to refer to cerebral oxygen content (Table 1 ).


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  		Table 1 NIRS devices and monitoring terminology
 
Intraoperative Monitoring
A total of 38 manuscripts involved the use of NIRS in the intraoperative setting. The manuscripts were subdivided into 8 categories for summative purposes (Figure 3 ). Table E1 shows the author, year of publication, study design, monitoring device, patient population, number of patients, primary end point, and results. The manuscripts include 31 case series, 4 randomized trials, and 3 retrospective studies. The median sample size was 20 (range, 9–250). Two of the 38 manuscripts (in fact, the only 2 of the 56 overall manuscripts) had planned follow-up after hospital discharge; these follow-ups occurred at 3 months.16,17Go One retrospective study assessed the role of an interventional algorithm on neurologic outcomes.18Go They found that in patients with postoperative neurologic changes, more had noteworthy intraoperative cerebral perfusion changes (defined as a 50% decrease in cerebral blood flow by transcrianial Doppler, excessive electroencephalographic slowing, or a decrease in regional cerebral oxygen saturation [rScO 2] by NIRS of > 20% for 3 minutes) that were not intervened on with a predetermined algorithm (P = .003).18Go Three manuscripts evaluated the association of NIRS findings with direct clinical outcomes.19-21Go One retrospective study (n = 34) demonstrated that patients who died after a single ventricle first-stage palliation had lower rScO 2 at the end of the operation (P = .01), but with no correlation to clinical neurologic abnormalities.22Go Two case series correlated intraoperative NIRS measurements with postoperative magnetic resonance imaging (MRI) findings.19,21Go One (n = 16)21Go demonstrated that decreased rScO 2 during aortic crossclamping in patients was associated with abnormal postoperative MRIs (P = .08). The other (n = 22)19Go found that prolonged low postoperative rScO 2 less than 45% for more than 180 minutes was associated with either new or worsening lesions on postoperative MRI (P = .029).


Figure 3
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  		Figure 3. Classification of NIRS monitoring in the operating room.

 
Intensive Care Unit Monitoring
Eleven manuscripts were identified that described the use of NIRS in the intensive care unit for patients with CHD. All of these manuscripts were case series, with a median sample size of 15 (range, 5–110). No studies contained neurologic follow-up assessments, nor did they correlate NIRS findings with clinical outcomes. Table E2 shows the author, year of publication, study design, monitoring device, patient population, number of patients, primary end point, and results. Three studies focused on preoperative monitoring to define baseline values23Go and the response to hypoxia24Go and hypercarbia.25Go Seven studies focused on postoperative intensive care monitoring. These studies sought to correlate NIRS measurements with somatic NIRS measurements,26,27Go alterations in ventilator management,28,29Go sildenafil use,30Go and global measurements of systemic oxygenation.31,32Go They identified correlations between rScO 2 and various traditional hemodynamic parameters (mean and systemic arterial pressure, arterial saturation, and mixed venous saturation). One study incorporated NIRS monitoring for single ventricle patients after stage 1 palliation on temporary ventricular assist devices. That study demonstrated a significant decrease in rScO 2 after the discontinuation of cardiopulmonary bypass. The decreased rScO 2 did not normalize for 48 hours despite normalization of other standard measurements such as lactate and mean arterial pressure.33Go The overarching findings in all of the studies were the presence of large interindividual variability and intraindividual temporal variability, which makes direct comparisons or determination of discrete safety measurements difficult.

Cardiac Catheterization Laboratory
Seven manuscripts were identified that described the use of NIRS for patients with CHD in the catheterization laboratory. All of these manuscripts were case series, with a median sample size of 29 (range, 11–98). None of these studies contained neurologic follow-up or correlated NIRS findings with clinical outcomes. Table E3 shows the author, year of publication, study design, monitoring device, patient population, number of patients, primary end point, and results. As with the studies in the intensive care unit, many studies attempted to correlate NIRS findings with standard measurements of global oxygenation.34-38Go One study correlated alterations in regional and global saturation with alterations in ventilation.39Go A second manuscript reported on the effect of balloon inflation during balloon dilation procedures in patients with and without intracardiac shunts. This study found that rScO 2 decreases with balloon inflation in patients with intracardiac shunts and that the recovery time is directly related to inflation time.40Go As with the studies in the intensive care unit, significant interindividual variability existed, making it difficult to compare patients.


   Conclusions
Top
 Abstract
 Introduction
 Methods
 Results
 Conclusions
Table E1
 Table E2
 Table E3
 References
 E-References
 
Systematic reviews allow for a "pause" in the process of conducting research. They demonstrate, based on the available evidence, what we do know about a specific question. This information is then used to direct future research studies to clarify the areas of uncertainty. Systematic reviews follow a prospectively defined protocol to identify and appraise the relevant evidence. This is important in minimizing publication and information bias, which sets this methodology apart from traditional narrative reviews. Systematic reviews are limited by the quality of the original research being reviewed and do not represent primary data. In addition, negative studies often do not reach publication, which can favor the treatment. Meta-analyses represent a type of systematic review that involves formal quantitative analyses of the summarized information. Meta-analyses require similar methodologies and outcomes measures for a summary statistic. With the wide variability in devices, small sample size, and variable end points, this was not possible with the available literature. Owing to the strength of minimizing bias, systematic reviews play an important role in clinical and health care policy decision-making.

Many centers, and even entire countries, have adopted NIRS as a standard of care (forum discussion at 2007 Congenital Heart Surgeons Society Meeting). Yet, no level I evidence-based medical research has been published to indicate that clinical decision-making based on NIRS data is beneficial to the patient. Although the continued desire to mitigate the neurologic complications associated with CHD and its surgical intervention is laudable, the role for NIRS in meeting that goal remains clouded by the lack of reliable scientific evidence.

This study provides a comprehensive review of the scientific literature on NIRS for patients with CHD. The majority of studies reporting on NIRS for this patient population are limited by their case series design, with no appropriate comparison groups, and with small sample sizes. In addition, the NIRS technology has changed significantly since its inception. The literature reflects these changes over time with 6 different NIRS technologies represented in articles we reviewed. Although all of the devices are based on the same theoretical premise of the monitoring of regional oxygenation, they employ various measurement indices, making it difficult to cull the data from multiple studies for comparison. The significant variability in NIRS measurements, temporally and between individual patients, precludes the establishment of absolute threshold values for tissue ischemia. Relative values and individual patient trends have been used rather than absolute values. However, there is only limited evidence to indicate that these correlate with clinical outcomes.18,41Go Furthermore, the wide heterogeneity in anatomy and physiology in CHD patients results in varying baseline levels of oxygenation. In combination with the small sample sizes, the diverse patient populations studied cause extrapolation to the overall CHD population to be challenging, if not impossible.

The available data suggest that multimodality monitoring of cerebral perfusion, including NIRS, may be a useful adjunct to prevent neurologic injury.18Go The current literature on the use of NIRS alone for CHD patients does not demonstrate a clinical improvement in short-term neurologic outcome. There are no prospective data evaluating NIRS findings with direct clinical outcomes. The data correlating NIRS findings with indirect measures of neurologic outcome, such as MRI or mortality, are also limited.19,21,22Go

In assessing the potential role of NIRS monitoring in CHD, it is important to emphasize its unique qualities, including noninvasive, continuous, and real-time measurement of regional tissue oxygen saturation. However, caution must be exercised in extrapolating regional measurements to global findings. For example, alterations in regional oxygen saturation may reflect local changes and not necessarily indicate global hypoperfusion. Conversely, regional changes in oxygenation may be earlier, more sensitive indicators of impending multisystem organ injury. To date, no study has validated the correlation of NIRS measurements with other measurements of low cardiac output states. This is an important distinction when analyzing the literature in that reports of low regional cerebral oxygenation measurements do not necessarily indicate a low cardiac output state or global altered cerebral perfusion.

Future research needs to focus on how the addition of this regional oxygen saturation adds value to the clinical setting, rather than attempts to correlate NIRS with previously established global measurements of perfusion. Most important, before universal implementation of this technology, it is essential that rigorous clinical trials be performed to demonstrate improved clinical outcomes with the addition of NIRS monitoring.


   Table E1
Top
 Abstract
 Introduction
 Methods
 Results
 Conclusions
 Table E1
Table E2
 Table E3
 References
 E-References
 

NIRS monitoring in the operating room
Author Year Study design * Device Patient population Total number Primary end point Results
Anesthesia
 LeBlanc et al16Go 2000 Randomized NIRO Elective ASD or VSD with (n = 11) or without (n = 13) propofol 24 Effect of propofol on the redox status of Cytaa3 and neurologic complications. Propofol has similar effects on Cytaa3 as hypothermia; no gross neurologic complications.
Coarcatation repair
 Berens et alE42Go 2006 Case series INVOS Aortic coarctation repair via left thoracotomy 26 Describe the changes in regional cerebral and somatic rSO 2 with aortic XC. The decrease in somatic rSO 2 with XC is less in children than neonates and infants (P < .01), significant increase in cerebral rScO 2 during XC in children > 1 year.
 Azakie et alE43Go 2005 Case series NIRO Aortic coarctation repair via left thoracotomy 18 Determine whether aortic occlusion impairs left hemispheric cerebral oxygen balance. Significant decrease in oxyHgb–deoxyHgb between the right and left (P = .03), significant decrease in oxyHgb–deoxyHgb with nitroprusside (P < .001).
Deep hypothermia with and without circulatory arrest (CA)
 Kussman et alE44Go 2005 Case series INVOS Infant biventricular repair (no arch reconstruction) 62 Evaluate the differences in bihemispheric measurement of rScO 2 during hypothermic CPB. No difference between right and left rScO 2 measurements irrespective of CA
 du Plessis et alE45Go 1995 Case series NIRO Infant biventricular repair with low flow or CA 63 Relationship between cerebral oxyHgb and Cytaa3 Median time to nadir of oxyHgb during CA was 25 minutes, increased total Hgb and oxyHgb above baseline with rewarming (P < .001) with delayed Cytaa3 recovery, dissociation between intravascular and mitochondrial oxygenation more pronounced in patients > 2 weeks
 Kurth et al41Go 1995 Case series NIMS Repair or palliation using CA 26 Variation in changes of intraop rScO 2 between neonates, infants, children and are these changes associated with postop neurologic dysfunction The half life of rScO 2 during CA is longer for neonate > infants > children (P < .001), patients with neurologic complications had less of an increase in rScO 2 on CPB and a significantly shorter cooling time pre-CA (P < .05), no significant difference in rScO 2 between groups
 Kurth et alE46Go 1992 Case series NIMS Neonates undergoing surgery with CA 17 Kinetics of oxyHgb in neonates during DHCA OxyHgb increases during cooling (P < .05), decreases during CA in a curvilinear distribution until a plateau at 40 minutes (P < .001), and returns to baseline with rewarming
 Greeley et alE47Go 1991 Case series NIRO Deep hypothermia with or without CA in neonates and children 15 The effect of CA on CMRO 2 and oxygenation OxyHgb and Cytaa3 decreased during CA, CMRO 2 and Cytaa3 remained lower than baseline after CPB with CA but returned to normal in non-CA patients (P < .01).
Regional low flow perfusion (RLFP)
 Hofer et alE48Go 2005 Case series INVOS RLFP for Norwood procedure 10 Correlation of bilateral NIRS monitoring during RLFP with variable flow rates. There was a significant decrease in bilateral rScO 2 and jugular SvO 2 with decreasing RLFP rates (P < .001). Wide interindividual variation in rScO 2.
 Andropoulos et alE49Go (same patient sample)+ 2004 Case series INVOS RLFP for Norwood procedure or aortic arch reconstruction 19 Correlation of bilateral NIRS monitoring during RLFP adjusted for CBFV with TCD. During RLFP, correlation between hemispheres was poor and only partially returned to baseline after RLFP with the left side always being the lower value.
 Hoffman et alE50Go 2004 Case series INVOS RLFP for Norwood procedure 9 Relative changes in cerebral and somatic oxygenation during RLFP adjusted for rScO 2 and CBFV. rScO 2 was maintained during RLFP but decreased below baseline after CPB. There was no correlation between cerebral and somatic oxygenation at any time point.
 Kilpack et alE51Go (same patient sample) * 2004 Case series INVOS RLFP for Norwood procedure or aortic arch reconstruction 34 Demonstrate maintenance of adequate rScO 2 with RLFP when CPB flow adjusted for rScO 2 and CBFV. No difference in rScO 2 on full flow CPB, RLFP, and resumption of full flow CPB. However, CPB flow was adjusted to maintain value within 10% of baseline.
Andropoulos et alE52Go (same patient sample) * 2003 Case series INVOS RLFP for Norwood procedure or aortic arch reconstruction 34 Describe the addition of CBFV monitoring by TCD to rScO 2 as a guide to bypass flow during RLFP. Poor correlation between MAP and required CPB flow. 14/34 had rScO 2 > 95% during RLFP increasing the risk of hyperperfusion. No outcomes correlation for the addition of CBFV to rScO 2 to guide CPB flow.
 Andropoulos et alE53Go (same patient sample)+ 2003 Case series INVOS RLFP for Norwood procedure or aortic arch reconstruction 20 Demonstrate the correlation between CBVI based on NIRS and CBFV by TCD. Poor correlation between CBVI and CBFV. Right sided CBFV did not correlate with RLFP flow rate.
 Pigula et alE54Go 2001 Case series INVOS RLFP for Norwood procedure or aortic arch reconstruction 15 Ability of RLFP to provide subdiaphragmatic somatic circulatory support as measured by somatic NIRS. Abdominal aortic blood pressure, quadriceps blood volume, and quadriceps rSO 2 were significantly greater during RLFP than DHCA (P < .05).
 Pigula et alE55Go 2000 Case series INVOS/NIRO Neonatal aortic arch reconstruction with RLFP (n = 6) and neonatal cardiac repair with DHCA (n = 6) 12 Experiential report of using NIRS guided RLFP versus DHCA. RLFP flow rate of 20 mL · kg–1 · min–1 maintained baseline values. rScO 2 and CBVI decrease significantly during DHCA but are maintained during RLFP.
Perfusion techniques
 Han et alE56Go 2004 Randomized INVOS Repair of ASD or VSD with bloodless (n = 18) or blood (n = 18) prime 36 Compare the effect of blood versus bloodless CPB prime on rScO 2. rScO 2 decreases below baseline in both groups at the start of CPB and during rewarming (P < .001) with a greater reduction in the bloodless prime group (P < .01).
 Sakamato et alE57Go 2004 Randomized NIRO CPB in cyanotic patients using alpha-stat (n = 19) versus pH-stat (n = 21) strategy 40 Evaluate the effect of pH strategies on rScO 2 and SPCC. rScO 2 was significantly lower (P = .008) and the deoxyhgb was significantly higher (p<0.0001) with alpha-stat. SPCC was significantly lower with pH-stat (P < .0001).
 Shaaban et alE58Go 2004 Case series NIRO Cold (25°C) (n = 9) versus warm (35°C) (n = 9) CPB for biventricular repair 18 Compare the effect of cold versus warm CPB in terms of extent of cerebral damage (measured by S100β) and oxyHgb. S100β increased significantly in both groups. No correlation between S100β and NIRS measurements except lowest post-CPB Cytaa3 level (P = .016). TOI was significantly impaired during rewarming.
 Wardle et alE59Go 1998 Case series NIRO Deep hypothermia (15°C) (n = 15) versus mild–moderate hypothermia (22°–28°C) (n = 15) CPB 30 Investigate the effect of hypothermia and CA on cerebral FOE. FOE increases with the institution of CPB in cyanotic patients. FOE decreases during cooling and only increases during rewarming in the continuous flow group. No significant difference between groups at any time in Cytaa3.
 Chow et alE60Go 1997 Randomized crossover NIRO CPB using pulsatile and nonpulsatile flow 40 Examine the relationship between pump flow rate and cerebral hemodynamics during pulsatile and nonpulsatile CPB. CBF decreased by 36% per L · m2 · min–1 decrease in pump flow rate regardless of pulsatility.
 Kurth et alE61Go 1997 Randomized NIMS CPB: warm (n = 10), hypothermic (25°C) (n = 10), hypothermic/low flow (n = 9), and hypothermic/low Hct (n = 9) 38 Evaluate the effect of perfusate temperature, pump flow rate, and Hct on cerebral O2 extraction. rScO2 increases during cooling (P < .001), rScO 2 increased after CPB was discontinued in the low flow and low Hct group.
Intraoperative monitoring
 Fenton et al22Go 2007 Retrospective INVOS Single ventricle staged palliation (n = 34) and ductus-dependent complete repair (n = 12) 46 Determine whether rScO 2 is related to the stage of single ventricle palliation. rScO 2 at the end of the operation was significantly lower in patients who died (P = .01), rScO 2 decreases significantly after stage 1 palliation (P = .001) and increases after stage 2 palliation (P = .04). No correlation with neurologic complications.
 Murayama et alE62Go 2006 Case series NIRO Repair of cyanotic (n = 10) and noncyanotic (n = 10) heart defects 20 Differences in rScO 2 at the initiation of CPB for cyanotic and noncyanotic heart defects. Cerebral oxyHgb, deoxyHgb, and total Hgb decrease and then plateau on CPB. DeoxyHgb and total Hbg decreased more markedly in the cyanotic patients (P < .01).
 Fenton et al20Go 2005 Retrospective INVOS Repair of cyanotic and noncyanotic CHD 143 Determine CHD patient groups with abnormally low baseline rScO 2. Preop rScO 2 is lower in cyanotic and noncyanotic infants with left-to-right shunts (P < .01) but not in cyanotic infants without left-to-right shunts. Periop death was associated with a baseline rScO 2 < 50%.
 Hayashida et alE63Go 2004 Case series PSA-3N Noncyanotic CHD repaired with CPB 65 Measure the incidence of cerebral ischemia using bispectral index and NIRS in children having cardiac surgery. Cerebral ischemia (defined as abrupt decrease in both rScO2 and bispectral index with acute hypotension) was more common and frequent in children < 4 years. rScO 2 was more dependent on arterial pressure in children < 4 years. Cerebral ischemia frequency correlated negatively with Hct (P < .0001).
 Morimoto et alE64Go 2003 Case series NIRO Repair of VSD 16 Examined changes in cerebral oxygenation using NIRS during VSD repair. OxyHgb decreases on CPB with no change in deoxyHgb.
 Daubeney et alE65Go 1998 Case series INVOS Biventricular repair 18 Identify periods of cerebral oxygen supply and demand mismatch using NIRS. rScO 2 decreased by > 15% in 10/18 patients before cannulation with cardiac manipulation. rScO 2 increases with the institution of CPB and decays at 0.25%/min at < 20°C and 2%/min at > 20°C. rScO 2 varied inversely with the rate of cooling (P = .04).
 Austin et al18Go 1997 Retrospective INVOS CHD repair with CPB 250 Examine the potential benefit of interventions based on intraop neurophysiologic monitoring (TCD, EEG, NIRS) in decreasing postop neurologic complications and length of hospital stay. Of patients with neurologic changes, significantly more had noteworthy intraop changes that were not intervened on (P = .003) with significantly fewer of these patients discharged from the hospital within 1 week (P < .05).
 Chow et alE66Go 1997 Case series NIRO Noncyanotic CHD repair with CPB 14 Explore the relation between arterial oxygen tension and CBF during CPB. No relation between arterial oxygen tension and CBF. CBF is associated with CPB flow rate (decreases 4.2 fold per l/m2/min).
 Van Bel et alE67Go 1996 Case series Radiometer Neonatal and infant CHD repair with CPB 12 Investigate the changes in cerebral hemodynamics and oxygenation during DHCA. CBV decreased significantly with cooling and increased significantly with rewarming (P < .001). CBV did not change with pump flow rate or MAP.
 Fallon et alE68Go 1994 Case series NIRO Elective CHD repair with CPB 19 Measure the change in CBV associated with changing PaCO 2 (CBVR) under anesthesia and during hypothermic CPB. CBVR is preserved under anesthesia and hypothermic CPB. The relationship between CBV and PaCO 2 is linear.
 Skov and GreisenE69Go 1994 Case series Radiometer Biventricular cyanotic (n = 5) and noncyanotic (n = 9) CHD repair with CPB 14 Examine the changes in cerebral cytaa3 during induction of CPB. In cyanotic patients, the total Hgb decreased rapidly and then reached a plateau, Cytaa3 decreased and oxyHgb index increased. There were no significant changes in the noncyanotic patients. The magnitude of the change in Cytaa3 was associated with the magnitude of change in total Hgb (P < .0001). Signal noise analysis raised concern about the validity of the results.
 Fallon et alE70Go 1993 Case series NIRO Repair of CHD with CPB 13 Use of NIRS to monitor CBF, CBV, and CBVR. CBVR significantly decreased during hypothermic (25°C) bypass.
Intraoperative combined with preoperative/postoperative monitoring
 McQuillen et al21Go 2007 Case series NIRO Patients with CHD, preop/postop MRI and intraop NIRS 16 Define the risk factors for preop and postop brain injuries and association with functional cardiac anatomic groups (intraop NIRS was a secondary analysis). TOI significantly decreased during aortic XC in patients with positive postop MRIs (P = .008).
 Dent et al19Go 2006 Case series INVOS Norwood procedure with RLFP, preop/postop MRI, preop/intraop/postop NIRS 22 Preop and postop MRI findings in neonates undergoing a Norwood procedure with RLFP. Prolonged low postop rScO 2 (<45% for >180 minutes) was associated with new or worsening lesions (P = .029) with a positive predictive value of 90% for positive MRI findings.
 Toet et al17Go 2005 Case series INVOS Transposition of the great arteries repaired with DHCA, preop/intraop/postop NIRS 20 Monitoring NIRS before, during, and after arterial switch operation to evaluate its relation to neurodevelopmental outcomes. Recovery time for the EEG did not correlate with normalization of the rScO 2. Complete recovery of the rScO 2 takes 6–72 hours postop. Preop decrease in rScO 2 tended to correlate with decreased Bayley score but was not significant.
Monitoring technique
 Roberts et alE71Go 1998 Case series NIRO Repair of CHD with CPB 19 Describe a novel method to measure CBF using indocyanine green tracer with NIRS. 11% variation between measurements within individual patients, 73% of the variability was accounted for by pump flow and temperature.
* Evidence Based Medicine Levels of Evidence: Level 1, systematic review of randomized controlled trials (RCTs), individual RCTs; level 2, systematic review of cohort studies, individual cohort studies; level 3, individual case control studies; level 4, case series; level 5, expert opinion.

ASD, Atrial septal defect; CA, circulatory arrest; CBF, cerebral blood flow; CBFV, cerebral blood flow velocity; CBV, cerebral blood volume; CBVI, cerebral blood volume index; CHD, congenital heart disease; CMRO 2, cerebral metabolism; CPB, cardiopulmonary bypass; DHCA, deep hypothermic circulatory arrest; EEG, electroencephalography; FOE, fractional oxygen extraction; Hct, hematocrit; MAP, mean arterial pressure; MRI, magnetic resonance imaging; NIRS, near-infrared spectroscopy; oxyHgb, oxyhemoglobin; RLFP, regional low flow perfusion; rSO 2, regional oxygen saturation; SPCC, systemic–pulmonary collateral circulation; TCD, transcranial Doppler; TOI, tissue oxygenation index; VSD, ventricular septal defect; XC, crossclamp.


   Table E2
Top
 Abstract
 Introduction
 Methods
 Results
 Conclusions
 Table E1
 Table E2
Table E3
 References
 E-References
 

NIRS monitoring in the intensive care unit
Author Year Study design * Device Patient population Total number Primary end point Results
Preoperative ICU monitoring
Takami et al24Go 2005 Preop–postop NIRO CHD patients with increased pulmonary blood flow 8 Evaluate serial changes in oxygenation state in the head and body in patients with increased pulmonary blood flow. With decreased SaO 2 after the initiation of hypoxia, cerebral and brachial oxyHgb decreased with an increase in deoxyHgb
Ramamoorthy et al25Go 2002 Randomized crossover observational NIM-prototype Single ventricle neonates 15 Evaluate changes in rScO 2 with inspired 17% FIO 2 or 3% CO2 Significant increase in rScO 2 and MAP with 3% CO2, no change in rScO 2 or MAP with 17% FIO 2
Kurth et al23Go 2001 Case series NIM-prototype CHD and normal 110: 91 with CHD, 19 normal Correlation of rScO 2 and CEO 2 between CHD patients and normals rScO 2 was significantly decreased in patients with PDA, TOF, HLHS, PA, SV with shunt, and BDG but was the same for VSD, CoA, and Fontan. CEO 2 was significantly increased for PDA and HLHS. SaO 2 was correlated with rScO 2 but was not a good substitute (R 2 =.4)
Postoperative ICU monitoring
McQuillen et al26Go 2007 Case series INVOS Postop CHD patients 70 Relationship between changes in rScO 2 with changes in regional flank SO 2 and central SvO 2. Monitored for 24 hours. Central SvO 2 was correlated with rScO 2 and flank rSO 2 with wide limits of agreement precluding interchangeability. Changes in PaCO 2 and MAP were associated with changes in rScO 2 but not flank rSO 2 or SvO 2. Changes in SaO 2 were associated with SvO 2 but not rScO 2.
Mott et al28Go 2006 Case series INVOS Bidirectional Glenn (BDG) 10 Response of rScO 2 to (1) hyperventilation with increased TV, (2) hyperventilation with increased RR, (3) hypoventilation with decreased RR. Monitoring for 4 hours. (1) Increased pH, decreased PCO 2, and decreased rScO 2; (2) same as 1; (3) no change in pH, increased PCO 2, and increased rScO 2. Hyperventilation should be avoided in patients with BDG due to potential decrease in rScO 2.
Nagdyman et al30Go 2006 Case series NIRO Elevated pulmonary vascular resistance after CPB 13 Examine alterations in cerebral oxygenation in children treated with increasing doses of sildenafil for elevated pulmonary vascular resistance. Monitored for 1 hour. TOI increased significantly after the first two doses but quickly returned to baseline (P = .01), no change with the third dose. There was no correlation between cardiac index and TOI
Li et al27Go 2006 Case series INVOS Postop Norwood pateints 11 Determine if NIRS cerebral and splanchnic monitoring accurately reflects systemic oxygen delivery when compared with direct measurements. Monitored for 72 hours. rScO 2 correlates with SaO 2 and PaO 2 (P < .0001) with large interindividual variation, rScO 2 correlates with SvO 2 (P < .0001) with no interindividual variation. Overall, large interindividual variablity and intraindividual temporal variablity.
Bassan et al29Go 2005 Case series NIRO Postop CHD patients 43 Correlation of NIRS parameters (HbD = deoxyHgb–oxyHgb) with CBFV by TCD; identify pressure-passive cerebral perfusion by simultaneous measurements of HbD and MAP; and associate higher CO2 levels with pressure-passive cerebral perfusion. Measurements at 6 and 20 hours postop. Significant relationship between change in CBFV and change in HbD (P < .0001), also with change in oxyHgb (P < .001). 13% of patients had disturbed cerebral pressure autoregulation at 6 hours that persisted at 18 hours, high end tidal CO2 was correlated with pressure passive rather than autoregulated cerebral perfusion (P < .001)
Tortoriello et al31Go 2005 Case series INVOS Elective postop CHD patients 20 Compare rScO 2 with SvO 2 (oximetry) after pediatric cardiac surgery. Single measurement 6 hours postop. rScO 2 correlated with SvO 2 (P < .001). There was low intrasubject variation with significant intersubject variation; therefore cannot predict absolute values but can follow trends.
Nagdyman et al32Go 2004 Case series NIRO Postop CHD patients 43 Determine the relationship between TOI as a value for regional rScO 2 and global SvO 2 (right atrial saturation via central line). Single measurement 2 to 3 hours postop. TOI correlated with SvO 2 (P < .001). PaO 2 (P = .031), SaO 2 (P = .027), SBP (P = .035), and MAP (P = .042). There was no correlation with PaCO 2, heart rate, and hemoglobin.
Postoperative circulatory assist device monitoring
Giacomuzzi et al33Go 2005 Case series INVOS HLHS with postop circulatory support 5 rScO 2 on circulatory support after SV repair rScO 2 levels dropped significantly after separation from CPB and remained 20% below baseline for 24 hours and did not normalize until 48 hours despite stable SvO 2, MAP, and decreasing lactates.
* Evidence Based Medicine Levels of Evidence: Level 1, systematic review of randomized controlled trials (RCTs), individual RCTs; level 2, systematic review of cohort studies, individual cohort studies; level 3, individual case control studies; level 4, case series; level 5, expert opinion.

BDG, Bidirectional Glenn; CBFV, cerebral blood flow velocity; CEO 2, cerebral O2 extraction; CHD, congenital heart disease; CoA, coarctation of the aorta; CPB, cardiopulmonary bypass; FIO 2, inspired oxygen fraction; ICU, intensive care unit; HLHS, hypoplastic left heart syndrome; MAP, mean arterial pressure; NIRS, near-infrared spectroscopy; PA, pulmonary atresia; PDA, patent ductus arteriosus; RR, respiratory rate; rScO 2, regional cerebral oxygen saturation; SBP, systemic blood pressure; SV, single ventricle; TCD, transcranial Doppler; TOF, tetralogy of Fallot; TOI, tissue oxygenation index; TV, tidal volume; VSD, ventricular septal defect.


   Table E3
Top
 Abstract
 Introduction
 Methods
 Results
 Conclusions
 Table E1
 Table E2
 Table E3
References
 E-References
 

NIRS monitoring in the catheterization laboratory
Author Year Study design * Device Patient population Total number Primary end point Results
Bhutta et al34Go 2007 Case series INVOS OHT annual biopsy 29 Correlation of rScO 2 with IVC, SVC, and PA SaO 2 on RA and 100% rScO 2 correlates with SVC and PA SaO 2 on RA and 100%
Kirshbom et al38Go 2007 Case series INVOS Elective cardiac catheterization in single ventricle patients 20 Determine the best non-invasive predictor of SVC SvO 2 as a marker of adequacy of systemic oxygen delivery. NIRS was a significant independent predictor of SVC SvO 2 (P = .000).
Levy et al35Go 2005 Case series Inspectra Tissue Spectrometer Elective cardiac catheterization 98 (50% with intracardiac mixing) Evaluate tissues saturation (NIRS-deltoid) as a measure of SvO 2 No correlation between tissue saturation and SvO 2
Nagdyman et al36Go 2005 Case series NIRO Elective cardiac catheterization 60 Correlation between tissue oxygenation index (TOI) with jugular SvO 2 (SjO 2) SjO 2 does correlates with TOI with poor sensitivity of spatially resolved spectroscopy
de Vries et al40Go 2000 Case series INVOS Balloon dilation 11 (I: 6 no intracardiac shunt, II: 5 with intracardiac shunt) Changes in cerebral hemodynamics (TCD) and oxygen metabolism (NIRS) during balloon dilation With balloon dilation, significant decrease in velocity in the MCA with no change in rScO 2 group I, significant decrease in rScO 2 with no change in velocity in the MCA group II. Longer inflation time correlated with longer time to recovery
Watzman et al39Go 2000 Case series NIM-prototype Elective cardiac catheterization 20 Correlation of SaO 2, rScO 2, an SjO 2 with normocapnia/FIO 2 21%, normocapnia/FIO 2 100%, hypocapnia/FIO 2 21% rScO 2 correlates with SaO 2 and SjO 2. The arterial to venous ratio for rScO 2 is consistent within patients but varies significantly between patients
Daubeney et al 37Go 1996 Case series INVOS Pediatric CHD patients in the cath lab (29) and during cardiac surgery (11) 40 Determine if rScO 2 reflects jugular bulb venous saturations. Correlation between rScO 2 and jugular bulb SvO 2 was 0.69 (P < .0001) with decreased reliability at extremes.
* Evidence Based Medicine Levels of Evidence: Level 1, systematic review of randomized controlled trials (RCTs), individual RCTs; level 2, systematic review of cohort studies, individual cohort studies; level 3, individual case control studies; level 4, case series; level 5, expert opinion.

CHD, Congenital heart disease; FIO 2, inspired oxygen fraction; IVC, inferior vena cava; MCA, main cerebral artery; NIRS, near-infrared spectroscopy; OHT, orthotopic heart transplantation; PA, pulmonary atresia; RA, radial artery; rScO 2, regional cerebral oxygen saturation; SjO 2, jugular SvO 2; SVC, superior vena cava; TCD, transcranial Doppler; TOI, tissue oxygenation index.


   Footnotes
 
The project was supported by the Michigan Congenital Heart Outcomes Research and Discovery unit (M-CHORD) with intramural funds from the Department of Surgery, University of Michigan.


   References
Top
 Abstract
 Introduction
 Methods
 Results
 Conclusions
 Table E1
 Table E2
 Table E3
 References
E-References
 

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 Table E3
 References
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