Effects of Blood Pressure on Brain Tissue Pulsation Amplitude in a Phantom Model.

OBJECTIVE: The precise mechanism and determinants of brain tissue pulsations (BTPs) are poorly understood, and the impact of blood pressure (BP) on BTPs is relatively unexplored. This study aimed to explore the relationship between BP parameters (mean arterial pressure [MAP] and pulse pressure [PP]) and BTP amplitude, using a transcranial tissue Doppler prototype. METHODS: A phantom brain model generating arterial-induced BTPs was developed to observe BP changes in the absence of confounding variables and cerebral autoregulation feedback processes. A regression model was developed to investigate the relationship between bulk BTP amplitude and BP. The separate effects of PP and MAP were evaluated and quantified. RESULTS: The regression model (R2 = 0.978) revealed that bulk BTP amplitude measured from 27 gates significantly increased with PP but not with MAP. Every 1 mm Hg increase in PP resulted in a bulk BTP amplitude increase of 0.29 µm. CONCLUSION: Increments in BP were significantly associated with increments in bulk BTP amplitude. Further work should aim to confirm the relationship between BP and BTPs in the presence of cerebral autoregulation and explore further physiological factors having an impact on BTP measurements, such as cerebral blood flow volume, tissue distensibility and intracranial pressure.

Improving communications in PPE: a solution for 'landline' telephone communication.

BACKGROUND: Emergency care staff wearing elastomeric respiratory personal protective equipment (PPE) report difficulties in communicating by telephone. We developed and tested an affordable technological solution aimed at improving telephone call intelligibility for staff wearing PPE. METHODS: A novel headset was created to enable a throat microphone and bone conduction headset to be used in combination with a standard hospital 'emergency alert' telephone system. Speech intelligibility of an ED staff member wearing PPE was compared between the proposed headset and current practice by simultaneously recording a version of the Modified Rhyme Test and a Key Sentences Test. Recordings were played back to a group of blinded ED staff listening to pairs of recordings under identical conditions. The proportion of correctly identified words was compared using a paired t-test. RESULTS: Fifteen ED staff correctly identified a mean of 73% (SD 9%) words for speech communicated via the throat microphone system, compared with only 43% (SD 11%) of words for standard practice (paired t-test, p<0.001). CONCLUSIONS: Introduction of a suitable headset could significantly improve speech intelligibility during 'emergency alert' telephone calls.

Are portable ankle brachial pressure index measurement devices suitable for hypertension screening?

OBJECTIVE: In a large-scale population cardiovascular screening programme, peripheral artery disease (PAD) and hypertension would ideally be rapidly assessed using a single device. The ankle-brachial pressure index (ABPI) is calculated by comparing the ankle and brachial blood pressure (BP). However, it is currently unclear whether brachial BP measurements provided by automated PAD screening systems are sufficiently accurate for simultaneous hypertension screening. METHODS: Two portable PAD screening devices, the MESI ABPI MD and Huntleigh's Dopplex ABIlity, were evaluated following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010 using a mercury-free sphygmomanometer as a reference device. RESULTS: On average, the MESI slightly underestimated brachial systolic blood pressure (BP) with a bias and standard deviation (SD) of -3.5 (SD: 3.3) mmHg and diastolic BP with a bias of -1.5 (SD: 2.3) mmHg. For systolic BP estimates, the Dopplex was more accurate than the MESI with a lower bias of -0.5 (SD: 4.2) mmHg but less precise. The MESI successfully fulfilled all the requirements of the ESH-IP for hypertension screening. The Dopplex device failed the ESH-IP due to the absence of DBP measurements. CONCLUSIONS: The MESI device appears to be suitable for simultaneous PAD and hypertension screening as part of a preventative care programme. Huntleigh's Dopplex ABIlity failed to pass the ESH-IP validation test. Further clinical trials are underway to assess the use of the MESI for simultaneous screening for hypertension and PAD in a population screening setting.

Three-dimensional simulations of embolic stroke and an equation for sizing emboli from imaging.

Stroke simulations are needed to run in-silico trials, develop hypotheses for clinical studies and to interpret ultrasound monitoring and radiological imaging. We describe proof-of-concept three-dimensional stroke simulations, carrying out in silico trials to relate lesion volume to embolus diameter and calculate probabilistic lesion overlap maps, building on our previous Monte Carlo method. Simulated emboli were released into an in silico vasculature to simulate 1000 s of strokes. Infarct volume distributions and probabilistic lesion overlap maps were determined. Computer-generated lesions were assessed by clinicians and compared with radiological images. The key result of this study is development of a three-dimensional simulation for embolic stroke and its application to an in silico clinical trial. Probabilistic lesion overlap maps showed that the lesions from small emboli are homogeneously distributed throughout the cerebral vasculature. Mid-sized emboli were preferentially found in posterior cerebral artery (PCA) and posterior region of the middle cerebral artery (MCA) territories. For large emboli, MCA, PCA and anterior cerebral artery (ACA) lesions were comparable to clinical observations, with MCA, PCA then ACA territories identified as the most to least probable regions for lesions to occur. A power law relationship between lesion volume and embolus diameter was found. In conclusion, this article showed proof-of-concept for large in silico trials of embolic stroke including 3D information, identifying that embolus diameter could be determined from infarct volume and that embolus size is critically important to the resting place of emboli. We anticipate this work will form the basis of clinical applications including intraoperative monitoring, determining stroke origins, and in silico trials for complex situations such as multiple embolisation.

Magnetic resonance imaging of the pulsing brain: a systematic review.

OBJECTIVE: To perform a systematic review of the literature exploring magnetic resonance imaging (MRI) methods for measuring natural brain tissue pulsations (BTPs) in humans. METHODS: A prospective systematic search of MEDLINE, SCOPUS and OpenGrey databases was conducted by two independent reviewers using a pre-determined strategy. The search focused on identifying reported measurements of naturally occurring BTP motion in humans. Studies involving non-human participants, MRI in combination with other modalities, MRI during invasive procedures and MRI studies involving externally applied tests were excluded. Data from the retrieved records were combined to create Forest plots comparing brain tissue displacement between Chiari-malformation type 1 (CM-I) patients and healthy controls using an independent samples t-test. RESULTS: The search retrieved 22 eligible articles. Articles described 5 main MRI techniques for visualisation or quantification of intrinsic brain motion. MRI techniques generally agreed that the amplitude of BTPs varies regionally from 0.04 mm to ~ 0.80 mm, with larger tissue displacements occurring closer to the centre and base of the brain compared to peripheral regions. Studies of brain pathology using MRI BTP measurements are currently limited to tumour characterisation, idiopathic intracranial hypertension (IIH), and CM-I. A pooled analysis confirmed that displacement of tissue in the cerebellar tonsillar region of CM-I patients was + 0.31 mm [95% CI 0.23, 0.38, p < 0.0001] higher than in healthy controls. DISCUSSION: MRI techniques used for measurements of brain motion are at an early stage of development with high heterogeneity across the methods used. Further work is required to provide normative data to support systematic BTPs characterisation in health and disease.

Selecting Portable Ankle/Toe Brachial Pressure Index Systems for a Peripheral Arterial Disease Population Screening Programme: a Systematic Review, Clinical Evaluation Exercise, and Consensus Process.

OBJECTIVE: To provide an overview of systems available for peripheral arterial disease (PAD) screening, together with respective accuracies and a clinical evaluation to identify a system suitable for use in a community screening programme. METHODS: A systematic review of the diagnostic accuracy of six ankle brachial pressure index (ABPI) and toe brachial pressure index (TBPI) devices deemed to be portable, which were Conformité Européenne (CE) marked, and were automated or semi-automated was carried out compared with gold standard handheld Doppler and duplex ultrasound. The devices were MESI-ABPI-MD, Huntleigh Dopplex Ability, Huntleigh ABPI and TBPI systems, Systoe TBPI system, and BlueDop. Seven databases (MEDLINE, EMBASE, Scopus, Web of Science, Cochrane Database of Systematic Reviews, Cochrane Register of Controlled Trials (CENTRAL), and Cumulative Index to Nursing and Allied Health Literature (CINAHL)) were searched, and 11 studies were identified as eligible for review. This was followed by hands on clinical evaluation by abdominal aortic aneurysm (AAA) screening staff (n = 39). During this, devices were demonstrated to staff which they then tested on volunteers and gave feedback using pre-designed questionnaires on their suitability for use in a screening programme. Finally, accuracy data and staff preferences were combined during a consensus conference that was held between study and screening staff to determine the most appropriate device to use in a community screening programme. RESULTS: Generally, the evaluated systems have a moderate level of sensitivity and a high level of specificity: Dopplex ability sensitivity 20% - 70%, specificity 86% - 96%; MESI sensitivity 57% - 74%, specificity 85% - 99%; BlueDop sensitivity 95%, specificity 89%; and Systoe sensitivity 71%, specificity 77%. Clinical evaluation by screening staff identified a preference for the MESI system. The consensus conference concluded that the MESI device was a good candidate for use in a community PAD screening programme. CONCLUSION: The MESI system is a good candidate to consider for community PAD screening.

Development of a Flow Phantom for Transcranial Doppler Ultrasound Quality Assurance.

Anecdotal evidence was recently brought to our attention suggesting a potential difference in velocity estimates between transcranial Doppler (TCD) systems when measuring high velocities (∼200 cm/s) close to the threshold for sickle cell disease stroke prevention. As we were unable to identify a suitable commercial TCD phantom, a middle cerebral artery (MCA) flow phantom was developed to evaluate velocity estimates from different devices under controlled conditions. Time-averaged velocity estimates were obtained using two TCD devices: a Spencer Technologies ST3 Doppler system (ST3 PMD150, Spencer Technologies, Seattle, WA, USA) and a DWL Dopplerbox (DWL Compumedics, SN-300947, Singen, Germany). These were compared with velocity estimates obtained using a Zonare duplex scanner (Zonare Medical Systems, Mountain View, CA, USA), with timed collection of fluid as the gold standard. Bland-Altman analysis was performed to compare measurements between devices. Our tests confirmed that velocities measured with the DWL TCD system were +4.1 cm/s (+3.7%; limits of agreement [LoA]: 2%, 5%; p = 0.03) higher than the Spencer system when measuring a velocity 110 cm/s and +12 cm/s higher (+5.7 %; LoA: 4.8%, 6.6%; p = 0.03) when measuring velocities of 210 cm/s, close to the diagnostic threshold for stroke intervention. We found our MCA phantom to be a valuable tool for systematically quantifying differences in TCD velocity estimates between devices, confirming that the DWL system gave consistently higher readings than the Spencer ST3 system. Differences become more pronounced at high velocities, which explains why they were not identified earlier. Our findings have clinical implications for centers using TCD to monitor patients with sickle cell disease, as extra care may be needed to adjust for bias between manufacturers when making treatment decisions about children with sickle cell with velocities close to the diagnostic threshold.

Paediatric brain MRI findings following congenital heart surgery: a systematic review.

OBJECTIVE: This systematic review aimed to establish the relative incidence of new postoperative brain MRI findings following paediatric congenital cardiac surgery. DESIGN: To distinguish perioperative changes from pre-existing MR findings, our systematic search strategy focused on identifying original research studies reporting both presurgery and postsurgery brain MRI scans. Patient demographics, study methods and brain MR findings were extracted. RESULTS: Twenty-one eligible publications, including two case-control and one randomised controlled trial, were identified. Pre-existing brain MRI findings were noted in 43% (513/1205) of neonates prior to surgery, mainly white matter injuries (WMI). Surgery was performed at a median age of 8 days with comparison of preoperative and postoperative MR scans revealing additional new postoperative findings in 51% (550/1075) of patients, mainly WMI. Four studies adopted a brain injury scoring system, but the majority did not indicate the severity or time course of findings. In a subgroup analysis, approximately 32% of patients with pre-existing lesions went on to develop additional new lesions postsurgery. Pre-existing findings were not found to confer a higher risk of acquiring brain lesions postoperatively. No evidence was identified linking new MR findings with later neurodevelopmental delay. CONCLUSION: This systematic review suggests that surgery approximately doubles the number of patients with new brain lesions.

Survey of the publics' preferences for communication of medical radiation risk.

To comply with the Ionising Radiations (Medical Exposures) Regulations 2017, patients need to be adequately informed of medical radiation risks prior to exposure. This study used a survey developed in partnership with patients and members of the public to explore patient preferences for radiation risk communication. It was distributed through social media between 28/4/2020 and 18/7/2020. All respondents (N= 376) wanted to be informed about radiation risk, though the threshold at which they wished to be informed varied. The current practice of displaying posters in waiting areas does not meet the expressed preference of the patients if used in isolation. Only 6% of respondents were satisfied with the commonly used statement that the 'risk is low' if used in isolation. The majority of respondents (73%) said they would not be concerned about an increase in the risk of cancer of less than 1 in 10 000. The level of risk at which patients express a concern and the methodology for risk communication has been evaluated and based on these findings, and pre-existing literature, a graded approach to radiation risk communication based on modality is proposed. Patients must be involved throughout the evolution of this practice.

Ultrasound shear wave elastography imaging of common carotid arteries in patients with Spontaneous Coronary Artery Dissection (SCAD).

BACKGROUND: Shear wave elastography (SWE) is emerging as a valuable clinical tool for a variety of conditions. The aim of this pilot study was to assess the potential of SWE imaging of the common carotid arteries (CCA) in patients with spontaneous coronary artery dissection (SCAD), a rare but potentially life-threatening condition, hypothesized to be linked to changes in vessel wall elasticity. METHODS: Ultrasound shear wave elastography (SWE) estimates of artery wall elasticity were obtained from the left and right CCAs of 89 confirmed SCAD patients and 38 non-dissection controls. SWE images obtained over multiple cardiac cycles were analysed by a blinded observer to estimate elasticity in the form of a Young's Modulus (YM) value, across regions of interest (ROI) located within the anterior and posterior CCA walls. RESULTS: YM estimates ranged from 17 to 133 kPa in SCAD patients compared to 34 to 87 kPa in non-dissection controls. The mean YM of 55 [standard deviation (SD): 21] kPa in SCAD patients was not significantly different to the mean of 57 [SD: 12] kPa in controls, p = 0.32. The difference between groups was 2 kPa [95% Confidence Interval - 11, 4]. CONCLUSIONS: SWE imaging of CCAs in SCAD patients is feasible although the clinical benefit is limited by relatively high variability of YM values which may have contributed to our finding of no significant difference between SCAD patients and non-dissection controls.

Brain tissue motion in acute hemorrhagic stroke using amplified MRI (aMRI).

Brain tissue pulsates with each cardiac cycle, however the effect of disease on this natural motion is still unclear. Current literature mainly focuses on healthy brain tissue, with only limited studies looking at disease states such as Chiari malformation and acute ischemic stroke. This case report advances on recent literature by describing the case of a patient with an acute intracerebral hemorrhage and demonstrating an amplified MRI cine of the brain's motion. A clearer understanding of the effects of disease on brain motion may guide clinical application of pulsation measurement.

Does radiology require informed consent for radiation risk?

Recent trends in medical decision-making have moved from paternalistic doctor-patient relations to shared decision-making. Informed consent is fundamental to this process and to ensuring patients' ongoing trust in the health-care profession. It cannot be assumed that patients consent to the risk associated with medical exposures, unless they have been provided with the information to make that decision. This position is supported by both the legal and ethical framework around Radiation Protection detailed in this commentary.

A Novel Elastography Phantom Prototype for Assessment of Ultrasound Elastography Imaging Performance.

The aims of this study were firstly to manufacture and evaluate a novel elastography test phantom and secondly to assess the performance of an elastography system using this phantom. A novel Leicester-St. Thomas' Elastography Pipe (L-STEP) test phantom consisting of five soft polyvinyl acrylic-cryogel pipes of varying diameters (2-12 mm), embedded at 45° within an agar-based tissue-mimicking material was developed. A shear-wave elastography (SWE) scanner was used by two blinded operators to image and assess longitudinal sections of the pipes. Young's modulus estimates were dependent on the diameter of pipes and at superficial depths were greater than deeper depths (mean 98 kPa vs. 59 kPa) and had lower coefficients of variation (mean 21% vs. 53%). The penetration depth (maximum depth at which a SWE signal was obtained) increased with increasing pipe diameter. Penetration depth measurements had excellent inter- and intra-operator reproducibility (intra-class correlation coefficients >0.8) and coefficient of variation range of 2%-12%. A new metric, called the summative performance index, was defined as the sum of the ratios of the penetration depth/pipe diameter. The L-STEP phantom is suitable for assessing key aspects of elastography imaging performance: resolution, accuracy, reproducibility, depth dependence, sensitivity and our novel summative performance index.

Emerging Detection Techniques for Large Vessel Occlusion Stroke: A Scoping Review.

Background: Large vessel occlusion (LVO) is the obstruction of large, proximal cerebral arteries and can account for up to 46% of acute ischaemic stroke (AIS) when both the A2 and P2 segments are included (from the anterior and posterior cerebral arteries). It is of paramount importance that LVO is promptly recognised to provide timely and effective acute stroke management. This review aims to scope recent literature to identify new emerging detection techniques for LVO. As a good comparator throughout this review, the commonly used National Institutes of Health Stroke Scale (NIHSS), at a cut-off of ≥11, has been reported to have a sensitivity of 86% and a specificity of 60% for LVO. Methods: Four electronic databases (Medline via OVID, CINAHL, Scopus, and Web of Science), and grey literature using OpenGrey, were systematically searched for published literature investigating developments in detection methods for LVO, reported from 2015 to 2021. The protocol for the search was published with the Open Science Framework (10.17605/OSF.IO/A98KN). Two independent researchers screened the titles, abstracts, and full texts of the articles, assessing their eligibility for inclusion. Results: The search identified 5,082 articles, in which 2,265 articles were screened to assess their eligibility. Sixty-two studies remained following full-text screening. LVO detection techniques were categorised into 5 groups: stroke scales (n = 30), imaging and physiological methods (n = 15), algorithmic and machine learning approaches (n = 9), physical symptoms (n = 5), and biomarkers (n = 3). Conclusions: This scoping review has explored literature on novel and advancements in pre-existing detection methods for LVO. The results of this review highlight LVO detection techniques, such as stroke scales and biomarkers, with good sensitivity and specificity performance, whilst also showing advancements to support existing LVO confirmatory methods, such as neuroimaging.

Acute ischemic stroke diagnosis using brain tissue pulsations.

Healthy brain tissue pulsates with the cardiac cycle, but whether brain tissue pulsations (BTPs) are impaired by tissue ischemia due to ischemic stroke is currently unclear. This study is the first to explore the clinical potential of measuring BTPs using ultrasound in acute ischemic stroke patients. BTPs were measured in 24 healthy volunteers (aged 52-82 years) and 14 acute ischemic stroke patients (aged 51-86 years) using a novel Transcranial Tissue Doppler (TCTD) method. Measurements were quick to perform and were well tolerated by all subjects. A mixed-methods approach was used for blinded analysis of recordings. This identified qualitative disruption of BTPs in acute stroke patients, which were used to create an analysis checklist. Blinded BTP analysis by novices using the checklist resulted in high sensitivity but low specificity for stroke detection. Quantitative analysis also identified differences between stroke and healthy participants, including weaker BTPs in stroke patients. This first study reporting BTP characteristics in acute ischemic stroke revealed weaker brain tissue pulsations and waveform disruption in acute stroke patients. However, further clinical evaluation using a larger sample size is required to confirm these findings and to explore whether TCTD monitoring might be beneficial for clinical neuromonitoring.

The Effects of Hypocapnia on Brain Tissue Pulsations.

Hypocapnia is known to affect patients with acute stroke and plays a key role in governing cerebral autoregulation. However, the impact of hypocapnia on brain tissue pulsations (BTPs) is relatively unexplored. As BTPs are hypothesised to result from cerebrovascular resistance to the inflow of pulsatile arterial blood, it has also been hypothesised that cerebral autoregulation changes mediated by hypocapnia will alter BTP amplitude. This healthy volunteer study reports measurements of BTPs obtained using transcranial tissue Doppler (TCTD). Thirty participants underwent hyperventilation to induce mild hypocapnia. BTP amplitude, EtCO2, blood pressure, and heart rate were then analysed to explore the impact of hypocapnia on BTP amplitude. Significant changes in BTP amplitude were noted during recovery from hypocapnia, but not during the hyperventilation manoeuvre itself. However, a significant increase in heart rate and pulse pressure and decrease in mean arterial pressure were also observed to accompany hypocapnia, which may have confounded our findings. Whilst further investigation is required, the results of this study provide a starting point for better understanding of the effects of carbon dioxide levels on BTPs. Further research in this area is needed to identify the major physiological drivers of BTPs and quantify their interactions with other aspects of cerebral haemodynamics.

Brain Tissue Pulsation in Healthy Volunteers.

It is well known that the brain pulses with each cardiac cycle, but interest in measuring cardiac-induced brain tissue pulsations (BTPs) is relatively recent. This study was aimed at generating BTP reference data from healthy patients for future clinical comparisons and modelling. BTPs were measured through the forehead and temporal positions as a function of age, sex, heart rate, mean arterial pressure and pulse pressure. A multivariate regression model was developed based on transcranial tissue Doppler BTP measurements from 107 healthy adults (56 male) aged from 20-81 y. A subset of 5 participants (aged 20-49 y) underwent a brain magnetic resonance imaging scan to relate the position of the ultrasound beam to anatomy. BTP amplitudes were found to vary widely between patients (from ∼4 to ∼150 µm) and were strongly associated with pulse pressure. Comparison with magnetic resonance images confirmed regional variations in BTP with depth and probe position.

Neurological impact of emboli during adult cardiac surgery.

OBJECTIVES: This study draws on advances in Doppler ultrasound bubble sizing to investigate whether high volumes of macro-bubbles entering the brain during cardiac surgery increase the risk of new cerebral microbleeds (CMBs), ischemic MR lesions, or post-operative cognitive decline (POCD). METHODS: Transcranial Doppler (TCD) ultrasound recordings were analysed to estimate numbers of emboli and macrobubbles (>100 µm) entering the brain during cardiac surgery. Logistic regression was used to explore the hypothesis that emboli characteristics affect the incidence of new brain injuries identified through pre- and post-operative MRI and neuropsychological testing. RESULTS: TCD, MRI, and neuropsychological test data were compared between 28 valve and 18 CABG patients. Although valve patients received over twice as many emboli per procedure [median: 1995 vs. 859, p = .004], and seven times as many macro-bubbles [median: 218 vs. 28, p = .001], high volumes of macrobubbles were not found to be significantly associated with new CMBs, new ischaemic lesions, or POCD. The odds of acquiring new CMBs increased by approximately 5% [95% CI: 1 to 10%] for every embolus detected in the first minute after the release of the aortic cross-clamp (AxC). Logistic regression models also confirmed previous findings that cardiopulmonary bypass time and valve surgery were significant predictors for new CMBs (both p = .03). Logistic regression analysis estimated an increase in the odds of acquiring new CMBs of 6% [95% CI: 1 to 12%] for every minute of bypass time over 91 mins. CONCLUSIONS: This small study provides new information about the properties and numbers of bubbles entering the brain during surgery, but found no evidence to substantiate a direct link between large numbers of macrobubbles and adverse cognitive or MR outcome. Clinical Trial Registration URL - http://www.isrctn.com. Unique identifier: 66022965.

Ultrasound measurement of brain tissue movement in humans: A systematic review.

INTRODUCTION: It has long been suggested that ultrasound could be used to measure brain tissue pulsations in humans, but potential clinical applications are relatively unexplored. The aim of this systematic review was to explore and synthesise available literature on ultrasound measurement of brain tissue motion in humans. METHODS: Our systematic review was designed to include predefined study selection criteria, quality evaluation, and a data extraction pro-forma, registered prospectively on PROSPERO (CRD42018114117). The systematic review was conducted by two independent reviewers. RESULTS: Ten studies were eligible for the evidence synthesis and qualitative evaluation. All eligible studies confirmed that brain tissue motion over the cardiac cycle could be measured using ultrasound; however, data acquisition, analysis, and outcomes varied. The majority of studies used tissue pulsatility imaging, with the right temporal window as the acquisition point. Currently available literature is largely exploratory, with measurements of brain tissue displacement over a narrow range of health conditions and ages. Explored health conditions include orthostatic hypotension and depression. CONCLUSION: Further studies are needed to assess variability in brain tissue motion estimates across larger cohorts of healthy subjects and in patients with various medical conditions. This would be important for informing sample size estimates to ensure future studies are appropriately powered. Future research would also benefit from a consistent framework for data analysis and reporting, to facilitate comparative research and meta-analysis. Following standardisation and further healthy participant studies, future work should focus on assessing the clinical utility of brain tissue pulsation measurements in cerebrovascular disease states.

Part II. Comparison of Neurodevelopmental Outcomes Between Normothermic and Hypothermic Pediatric Cardiopulmonary Bypass.

Objectives: In the previous study we demonstrated that normothermic cardiopulmonary bypass (N-CPB, ≥35°C) provided better early clinical outcomes compared to mild/moderate hypothermic cardiopulmonary bypass (H-CPB, 28-34°C) for congenital heart surgery. In this follow-up study we compare early neurodevelopmental outcomes 2-3 years post-surgery. Methods: In this retrospective, non-randomized observational study, the medical notes of children from our previous cohort were reviewed after 2-3 years. Demographic and neurodevelopmental outcomes were tabulated to enable blinded statistical analysis comparing outcomes between N-CPB and H-CPB surgery for congenital heart defects. Multivariate logistic regression models were developed to identify any differences in outcomes after adjustment for confounders. Results: Ninety-five children who underwent H-CPB (n = 50) or N-CPB (n = 45) were included. The proportions of patients with one or more adverse neurodevelopmental outcomes 2-3 years later were 14/50 (28.0%) in the H-CPB group and 11/45 (24.4%) in N-CPB, which was not significantly different between groups (p = 0.47). The two CPB groups were balanced for demographic and surgical risk factors, with the exception of genetic conditions. A higher incidence of H-CPB patients acquired learning difficulties [23.1% compared to 2.56% for N-CPB (p = 0.014)] and neurological deficits [30.8% compared to 7.69% for N-CPB (p = 0.019)], but these differences were not robust to adjustment for genetic syndromes. Conclusions: Our study did not reveal any significant differences in early neurodevelopmental outcomes between H-CPB or N-CPB surgery for congenital heart defects. The most important factor in predicting outcomes was, as expected, the presence of a genetic syndrome. We found no evidence that CPB temperature affects early neurodevelopmental outcomes.