Plastic and Reconstructive Surgery - Global Open, 2018
B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique c... more B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique challenge to repairing B.Y.'s encephalocele was a microcephalic skull and large proportion of likely functional extracranial brain tissue, which would need to be preserved. At Boston Children's Hospital, a simulation-based collaborative presurgical planning and rehearsal process, using both digital and 3D printed models, enabled successful technical completion and outcome of an otherwise inoperable case.
Plastic and Reconstructive Surgery - Global Open, 2018
B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique c... more B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique challenge to repairing B.Y.'s encephalocele was a microcephalic skull and large proportion of likely functional extracranial brain tissue, which would need to be preserved. At Boston Children's Hospital, a simulation-based collaborative presurgical planning and rehearsal process, using both digital and 3D printed models, enabled successful technical completion and outcome of an otherwise inoperable case.
Clinical outcomes are measurable changes in health, function, or quality of life that are importa... more Clinical outcomes are measurable changes in health, function, or quality of life that are important for evaluating the quality of care and comparing the efficacy of interventions. However, clinical outcomes and related measurement tools need to be well-defined, relevant and valid. In adults, Core Outcome Measures in Effectiveness Trials (COMET) methodology has been used to develop core outcome sets for perioperative care. Systematic literature reviews identified Standardized Endpoints (StEP) and valid measurement tools, and consensus across a broader range of relevant stakeholders was achieved via a Delphi process to establish Core Outcome Measures in Perioperative and Anaesthetic Care (COMPAC). Core outcome sets for pediatric perioperative care cannot be directly extrapolated from adult data. The type and weighting of endpoints within particular domains can be influenced by age-dependent differences in the indications for and/or nature of surgery and medical co-morbidities, and the validity and utility of many measurement tools vary significantly with developmental stage and age. Involvement of parents/carers is essential as they frequently act as surrogate responders for preverbal and developmentally delayed children, parental response may influence child outcome, and parental and/or child ranking of outcomes may differ from those of health professionals. Here we describe formation of the international Pediatric Perioperative Outcomes Group, which aims to identify and create validated, broadly applicable, patient-centered outcome measures for infants, children and young people. Methodologies parallel that of the StEP and COMPAC projects, and systematic literature searches have been performed within agreed age-dependent subpopulations to identify reported outcomes and measurement tools. This represents the first steps for developing core outcome sets for pediatric perioperative care. 1 THE NEED FOR CORE OUTCOME SETS FOR PEDIATRIC PERIOPERATIVE CARE 1.1 Rationale for consensus in outcome reporting Clinical outcomes are measurable changes in health, function or quality of life which, in conjunction with the structures (settings, qualifications of providers, administrative systems for care) and processes (components of care) surrounding care delivery, are important in evaluating the quality of health care in adults 1,2 and children. 3,4 However, clinical outcomes and related measurement tools need to be well-defined, relevant and valid to contribute to quality improvement 5 and to enable comparative trials to assess the clinical efficacy of different interventions. 6 A number of worldwide initiatives have been established to improve the relevance and consistency of selection of clinical outcomes and their measurement. The Core Outcome Measures in Effectiveness Trials (COMET) initiative 7,8 supports the development of agreed standardized core outcome sets that can be consistently reported across all trials to: reliably discriminate between beneficial, ineffective or harmful interventions; 9 allow combination of data in high-quality systematic reviews and meta analyses; 10 compare efficacy of different interventions; 6 inform evidence-based practice; and drive improvements in care. 7,8 In addition, standardized and clearly-defined endpoints should be of significance to key stakeholders, relevant to the patient, clinically important, and valid to ensure subsequent impact on health care delivery or policy. 11 COMET resources include details of standardized methodology, 8,12 a database of current and completed projects, 7 and updated reviews. 13 A core outcome set (COS) is defined as a minimum set of outcomes to be measured and reported in clinical trials for a specific condition. However, core outcome sets can also be used for research designs other than randomized controlled trials, and for quality improvement projects. 12 Quality improvement initiatives related to surgical and perioperative care, such as the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) 14 and the Perioperative Quality Improvement Programme in the United Kingdom 15 focus on adult practice, but similar approaches are also relevant for pediatric surgery 3,16 and perioperative care. 4,17-19 1.2 Core outcome sets in adult perioperative care Determining which outcomes should be used to measure success is a research priority for anesthesia and perioperative care. 20 COMET methodology 8,12 is being utilized to develop core outcome sets for perioperative care in adults (age ³ 18 years). 21,22 Systematic reviews have extracted reported outcomes, and expert interpretation and consensus identified Standardized Endpoints (StEP) for Perioperative Medicine, valid measurement tools, and clinically-important times for assessment. In parallel to this 'top-down approach', a 'bottom up' approach to achieve consensus across a broader range of relevant stakeholders that includes patients and carers is achieved via a Delphi process.
Objective To evaluate patient outcomes of minimally invasive endoscopic strip craniectomy (ESC) f... more Objective To evaluate patient outcomes of minimally invasive endoscopic strip craniectomy (ESC) for craniosynostosis. Study design This is a retrospective cohort analysis (2004-2018) of 500 consecutive infants with craniosynostosis treated by ESC with orthotic therapy at a single center. Operative outcomes included transfusions, complications, and reoperations as well as head circumference change based on World Health Organization percentiles. Multivariable logistic regression was used to identify risk factors associated with blood transfusion. Paired t tests were used for within-patient comparisons and Fisher exact test to compare syndromic and nonsyndromic subgroups. Results ESC was associated with low rates of blood transfusion (6.6%), complications (1.4%), and reoperations (3.0%). Risk factors for transfusion included syndromic craniosynostosis (P = .01) and multiple fused sutures (P = .02). Median surgical time was 47 minutes, and hospital length of stay 1 day. Transfusion and reoperation rates were higher among syndromic patients (both P < .001). Head circumference normalized by 12 months of age relative to World Health Organization criteria in infants with sagittal, coronal, and multisuture craniosynostosis (all P < .001). Conclusions ESC is a safe, effective, and durable correction of infantile craniosynostosis. ESC can achieve head growth normalization with low risks of blood transfusion, complications, or reoperation. Early identification of craniosynostosis in the newborn period and prompt referral by pediatricians allows families the option of ESC vs larger and riskier open reconstruction procedures.
This is the author manuscript accepted for publication and has undergone full peer review but has... more This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as
Purpose of review Perioperative bleeding and blood product transfusion are associated with signif... more Purpose of review Perioperative bleeding and blood product transfusion are associated with significant morbidity and mortality. Prevention and optimal management of bleeding decreases risk and lowers costs. Tranexamic acid (TXA) is an antifibrinolytic agent that reduces bleeding and transfusion in a broad number of adult and pediatric surgeries, as well as in trauma and obstetrics. This review highlights the current pediatric indications and contraindications of TXA. The efficacy and safety profile, given current and evolving research, will be covered. Recent findings Based on the published evidence, prophylactic or therapeutic TXA administration is a well-tolerated and effective strategy to reduce bleeding, decrease allogeneic blood product transfusion, and improve pediatric patients’ outcomes. TXA is now recommended in recent guidelines as an important part of pediatric blood management protocols. Summary Based on TXA pharmacokinetics, the authors recommend a dosing regimen of between 10 to 30 mg/kg loading dose followed by 5 to 10 mg/kg/h maintenance infusion rate for pediatric trauma and surgery. Maximal efficacy and minimal side-effects with this dosage regime will have to be determined in larger prospective trials including high-risk groups. Furthermore, future research should focus on determining the ideal TXA plasma therapeutic concentration for maximum efficacy and minimal side-effects.
What is already known: Multimodal patient blood management strategies are recommended by internat... more What is already known: Multimodal patient blood management strategies are recommended by international organizations, including the World Health Organization, as a means to best manage blood loss and limit blood transfusion. What this article adds: This article provides Pediatric Patient Blood Management Standards, per the Society for the Advancement of Blood Management, to guide clinicians, and as a resource for hospitals caring for pediatric patients to implement a comprehensive pediatric PBM program.
Design: Retrospective comparative study. Objective: The purpose of this study is to measure SSI o... more Design: Retrospective comparative study. Objective: The purpose of this study is to measure SSI outcomes before and after implementation of our center's multidisciplinary clinical pathway protocol for high-risk spinal surgery. Background: Surgical site infections (SSIs) after spinal fusion harm patients and are associated with significant health care costs. Given the high rate of SSI in neuromuscular populations, there is a rationale to develop infection prevention strategies. Methods: An institutional clinical pathway was created in 2012 and based on nationally published Best Practice Guidelines as well as hospital practices with a goal of reducing the rate of deep SSI in high-risk patients. Patient and procedure characteristics were compared prior to (2008-2011) and after (2012-2016) implementation of the pathway. Logistic regression using penalized maximum likelihood was used to assess differences in rate of infection before and after implementation. Results: Cohorts of 132 and 115 high-risk patients were analyzed before and after pathway implementation. Rate of deep infections decreased from 8% to 1% of patients (p 5 .005). Preoperative antibiotics were dosed within 1 hour in 90% of the postpathway cohort. Redosing was successful in 94% of patients for first redose and 79% for second redose. Betadine irrigation was used in 76% of cases and vancomycin administered in 86%. Multivariable analysis determined that instances of compliant antibiotics dosing had 63% lower odds of infection compared with instances of noncompliance (p 5 .04). Conclusions: Implementation of a multidisciplinary pathway aimed to reduce infection in patients at high risk for SSI after spinal fusion led to a significant reduction in deep SSI rate. It is impossible to attribute the drop in the deep SSI rate to any one factor. Our results demonstrate that adherence to a protocol using multiple strategies to reduce infection results in a lower SSI rate, lower care costs, and improved patient-related outcomes.
Background: Tranexamic acid (TXA) is an antifibrinolytic drug that reduces surgical blood loss. E... more Background: Tranexamic acid (TXA) is an antifibrinolytic drug that reduces surgical blood loss. Evidence supporting its efficacy in surgery for adolescent idiopathic scoliosis is not robust. This trial was designed to validate the clinical efficacy of TXA in surgery for adolescent idiopathic scoliosis. Methods: This institutional review board-approved prospective double-blinded trial involved 111 patients with adolescent idiopathic scoliosis who were randomized to receive either a placebo or TXA (50-mg/kg loading dose and 10-mg/kg/h infusion). Power analysis indicated that 50 patients per group would provide power to detect a >20% difference in blood loss. Two-way analysis of variance (ANOVA) was applied to compare blood loss rates (slopes) using the group-by-time interaction F test. Results: The risk of clinically relevant blood loss (>20 mL/kg) was more than twice as high in the placebo group than in the TXA group (44% versus 21%, relative risk = 2.1, 95% confidence interval = 1.2 to 3.7). Compared with the placebo group, the TXA group had a 27% reduction in intraoperative blood loss, a significantly lower rate of intraoperative bleeding per hour (mean and standard deviation, 190 ± 73 versus 230 ± 80 mL, p = 0.01; F = 9.77, p < 0.001) and per fused spinal level (82 ± 32 versus 110 ± 40 mL, p < 0.001), less intraoperative blood loss (836 ± 373 versus 1,031 ± 484 mL, p = 0.02), and less postoperative bleeding (in the drain) (498 ± 228 versus 645 ± 318 mL, p = 0.009). Six patients who received a placebo and no patient who received TXA required an allogenic blood transfusion. No perioperative adverse events, including thromboembolic events or seizures, were observed. Three independent factors were predictive of blood loss: TXA administration, duration of surgery, and number of levels fused. Greater intraoperative blood loss was the only independent variable predictive of a longer hospital stay. Conclusions: Use of TXA in patients undergoing surgery for adolescent idiopathic scoliosis significantly reduced blood loss, by 27%, compared with that in the placebo group. The rate of intraoperative blood loss per hour and per level fused and the amount of postoperative blood loss were significantly lower in the TXA group. More placebo-treated patients received allogenic blood. Patients with greater intraoperative blood loss spent a longer time in the hospital. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. S pinal fusion is the fifth most common procedure performed in U.S. hospitals 1. Blood transfusion is the second most common procedure performed during a U.S. hospital stay for the pediatric population 2. During surgery for adolescent-onset idiopathic scoliosis, blood loss ranges from 500 mL to 2 L, and blood transfusion is common even with recent advances in surgical technique 3. Perioperative bleeding and blood transfusion are associated with significant morbidity and mortality 4-7. Bleeding and blood transfusion are independently associated with increased postoperative infection rates,
ASAIO journal (American Society for Artificial Internal Organs : 1992), Jan 26, 2018
Patient sedation and analgesia on extracorporeal membrane oxygenation (ECMO) is vital for safety ... more Patient sedation and analgesia on extracorporeal membrane oxygenation (ECMO) is vital for safety and comfort. However, adsorption to the circuit may alter drug pharmacokinetics and remains poorly characterized. This study characterizes drug adsorption of morphine, fentanyl, midazolam, and dexmedetomidine in an ex vivo infant ECMO circuit utilizing polymethylpentene (PMP) membrane oxygenator (MO) with protein-bounded polyvinylchloride (PVC) tubing. Twelve closed-loop ex vivo ECMO circuits were prepared using P.h.i.s.i.o (phosphorylcholine)-coated PVC tubing (Sorin Group USA, Inc.) and a Quadrox-iD pediatric polymethylpentene MO (Maquet Cardiopulmonary AG). Once the circuits were primed and running, a single medication was injected as a bolus into the circuit with three circuits per drug. Drug samples were drawn following injection, at 2, 5, 15, 30, 60, 120 minutes and at 4, 12, 24, 36, and 48 hours and analyzed using ultra high-performance liquid chromatography with mass spectrometry...
Plastic and Reconstructive Surgery - Global Open, 2018
B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique c... more B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique challenge to repairing B.Y.'s encephalocele was a microcephalic skull and large proportion of likely functional extracranial brain tissue, which would need to be preserved. At Boston Children's Hospital, a simulation-based collaborative presurgical planning and rehearsal process, using both digital and 3D printed models, enabled successful technical completion and outcome of an otherwise inoperable case.
Plastic and Reconstructive Surgery - Global Open, 2018
B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique c... more B.Y. was born full term after a large vertex encephalocele was diagnosed prenatally. The unique challenge to repairing B.Y.'s encephalocele was a microcephalic skull and large proportion of likely functional extracranial brain tissue, which would need to be preserved. At Boston Children's Hospital, a simulation-based collaborative presurgical planning and rehearsal process, using both digital and 3D printed models, enabled successful technical completion and outcome of an otherwise inoperable case.
Clinical outcomes are measurable changes in health, function, or quality of life that are importa... more Clinical outcomes are measurable changes in health, function, or quality of life that are important for evaluating the quality of care and comparing the efficacy of interventions. However, clinical outcomes and related measurement tools need to be well-defined, relevant and valid. In adults, Core Outcome Measures in Effectiveness Trials (COMET) methodology has been used to develop core outcome sets for perioperative care. Systematic literature reviews identified Standardized Endpoints (StEP) and valid measurement tools, and consensus across a broader range of relevant stakeholders was achieved via a Delphi process to establish Core Outcome Measures in Perioperative and Anaesthetic Care (COMPAC). Core outcome sets for pediatric perioperative care cannot be directly extrapolated from adult data. The type and weighting of endpoints within particular domains can be influenced by age-dependent differences in the indications for and/or nature of surgery and medical co-morbidities, and the validity and utility of many measurement tools vary significantly with developmental stage and age. Involvement of parents/carers is essential as they frequently act as surrogate responders for preverbal and developmentally delayed children, parental response may influence child outcome, and parental and/or child ranking of outcomes may differ from those of health professionals. Here we describe formation of the international Pediatric Perioperative Outcomes Group, which aims to identify and create validated, broadly applicable, patient-centered outcome measures for infants, children and young people. Methodologies parallel that of the StEP and COMPAC projects, and systematic literature searches have been performed within agreed age-dependent subpopulations to identify reported outcomes and measurement tools. This represents the first steps for developing core outcome sets for pediatric perioperative care. 1 THE NEED FOR CORE OUTCOME SETS FOR PEDIATRIC PERIOPERATIVE CARE 1.1 Rationale for consensus in outcome reporting Clinical outcomes are measurable changes in health, function or quality of life which, in conjunction with the structures (settings, qualifications of providers, administrative systems for care) and processes (components of care) surrounding care delivery, are important in evaluating the quality of health care in adults 1,2 and children. 3,4 However, clinical outcomes and related measurement tools need to be well-defined, relevant and valid to contribute to quality improvement 5 and to enable comparative trials to assess the clinical efficacy of different interventions. 6 A number of worldwide initiatives have been established to improve the relevance and consistency of selection of clinical outcomes and their measurement. The Core Outcome Measures in Effectiveness Trials (COMET) initiative 7,8 supports the development of agreed standardized core outcome sets that can be consistently reported across all trials to: reliably discriminate between beneficial, ineffective or harmful interventions; 9 allow combination of data in high-quality systematic reviews and meta analyses; 10 compare efficacy of different interventions; 6 inform evidence-based practice; and drive improvements in care. 7,8 In addition, standardized and clearly-defined endpoints should be of significance to key stakeholders, relevant to the patient, clinically important, and valid to ensure subsequent impact on health care delivery or policy. 11 COMET resources include details of standardized methodology, 8,12 a database of current and completed projects, 7 and updated reviews. 13 A core outcome set (COS) is defined as a minimum set of outcomes to be measured and reported in clinical trials for a specific condition. However, core outcome sets can also be used for research designs other than randomized controlled trials, and for quality improvement projects. 12 Quality improvement initiatives related to surgical and perioperative care, such as the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) 14 and the Perioperative Quality Improvement Programme in the United Kingdom 15 focus on adult practice, but similar approaches are also relevant for pediatric surgery 3,16 and perioperative care. 4,17-19 1.2 Core outcome sets in adult perioperative care Determining which outcomes should be used to measure success is a research priority for anesthesia and perioperative care. 20 COMET methodology 8,12 is being utilized to develop core outcome sets for perioperative care in adults (age ³ 18 years). 21,22 Systematic reviews have extracted reported outcomes, and expert interpretation and consensus identified Standardized Endpoints (StEP) for Perioperative Medicine, valid measurement tools, and clinically-important times for assessment. In parallel to this 'top-down approach', a 'bottom up' approach to achieve consensus across a broader range of relevant stakeholders that includes patients and carers is achieved via a Delphi process.
Objective To evaluate patient outcomes of minimally invasive endoscopic strip craniectomy (ESC) f... more Objective To evaluate patient outcomes of minimally invasive endoscopic strip craniectomy (ESC) for craniosynostosis. Study design This is a retrospective cohort analysis (2004-2018) of 500 consecutive infants with craniosynostosis treated by ESC with orthotic therapy at a single center. Operative outcomes included transfusions, complications, and reoperations as well as head circumference change based on World Health Organization percentiles. Multivariable logistic regression was used to identify risk factors associated with blood transfusion. Paired t tests were used for within-patient comparisons and Fisher exact test to compare syndromic and nonsyndromic subgroups. Results ESC was associated with low rates of blood transfusion (6.6%), complications (1.4%), and reoperations (3.0%). Risk factors for transfusion included syndromic craniosynostosis (P = .01) and multiple fused sutures (P = .02). Median surgical time was 47 minutes, and hospital length of stay 1 day. Transfusion and reoperation rates were higher among syndromic patients (both P < .001). Head circumference normalized by 12 months of age relative to World Health Organization criteria in infants with sagittal, coronal, and multisuture craniosynostosis (all P < .001). Conclusions ESC is a safe, effective, and durable correction of infantile craniosynostosis. ESC can achieve head growth normalization with low risks of blood transfusion, complications, or reoperation. Early identification of craniosynostosis in the newborn period and prompt referral by pediatricians allows families the option of ESC vs larger and riskier open reconstruction procedures.
This is the author manuscript accepted for publication and has undergone full peer review but has... more This is the author manuscript accepted for publication and has undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as
Purpose of review Perioperative bleeding and blood product transfusion are associated with signif... more Purpose of review Perioperative bleeding and blood product transfusion are associated with significant morbidity and mortality. Prevention and optimal management of bleeding decreases risk and lowers costs. Tranexamic acid (TXA) is an antifibrinolytic agent that reduces bleeding and transfusion in a broad number of adult and pediatric surgeries, as well as in trauma and obstetrics. This review highlights the current pediatric indications and contraindications of TXA. The efficacy and safety profile, given current and evolving research, will be covered. Recent findings Based on the published evidence, prophylactic or therapeutic TXA administration is a well-tolerated and effective strategy to reduce bleeding, decrease allogeneic blood product transfusion, and improve pediatric patients’ outcomes. TXA is now recommended in recent guidelines as an important part of pediatric blood management protocols. Summary Based on TXA pharmacokinetics, the authors recommend a dosing regimen of between 10 to 30 mg/kg loading dose followed by 5 to 10 mg/kg/h maintenance infusion rate for pediatric trauma and surgery. Maximal efficacy and minimal side-effects with this dosage regime will have to be determined in larger prospective trials including high-risk groups. Furthermore, future research should focus on determining the ideal TXA plasma therapeutic concentration for maximum efficacy and minimal side-effects.
What is already known: Multimodal patient blood management strategies are recommended by internat... more What is already known: Multimodal patient blood management strategies are recommended by international organizations, including the World Health Organization, as a means to best manage blood loss and limit blood transfusion. What this article adds: This article provides Pediatric Patient Blood Management Standards, per the Society for the Advancement of Blood Management, to guide clinicians, and as a resource for hospitals caring for pediatric patients to implement a comprehensive pediatric PBM program.
Design: Retrospective comparative study. Objective: The purpose of this study is to measure SSI o... more Design: Retrospective comparative study. Objective: The purpose of this study is to measure SSI outcomes before and after implementation of our center's multidisciplinary clinical pathway protocol for high-risk spinal surgery. Background: Surgical site infections (SSIs) after spinal fusion harm patients and are associated with significant health care costs. Given the high rate of SSI in neuromuscular populations, there is a rationale to develop infection prevention strategies. Methods: An institutional clinical pathway was created in 2012 and based on nationally published Best Practice Guidelines as well as hospital practices with a goal of reducing the rate of deep SSI in high-risk patients. Patient and procedure characteristics were compared prior to (2008-2011) and after (2012-2016) implementation of the pathway. Logistic regression using penalized maximum likelihood was used to assess differences in rate of infection before and after implementation. Results: Cohorts of 132 and 115 high-risk patients were analyzed before and after pathway implementation. Rate of deep infections decreased from 8% to 1% of patients (p 5 .005). Preoperative antibiotics were dosed within 1 hour in 90% of the postpathway cohort. Redosing was successful in 94% of patients for first redose and 79% for second redose. Betadine irrigation was used in 76% of cases and vancomycin administered in 86%. Multivariable analysis determined that instances of compliant antibiotics dosing had 63% lower odds of infection compared with instances of noncompliance (p 5 .04). Conclusions: Implementation of a multidisciplinary pathway aimed to reduce infection in patients at high risk for SSI after spinal fusion led to a significant reduction in deep SSI rate. It is impossible to attribute the drop in the deep SSI rate to any one factor. Our results demonstrate that adherence to a protocol using multiple strategies to reduce infection results in a lower SSI rate, lower care costs, and improved patient-related outcomes.
Background: Tranexamic acid (TXA) is an antifibrinolytic drug that reduces surgical blood loss. E... more Background: Tranexamic acid (TXA) is an antifibrinolytic drug that reduces surgical blood loss. Evidence supporting its efficacy in surgery for adolescent idiopathic scoliosis is not robust. This trial was designed to validate the clinical efficacy of TXA in surgery for adolescent idiopathic scoliosis. Methods: This institutional review board-approved prospective double-blinded trial involved 111 patients with adolescent idiopathic scoliosis who were randomized to receive either a placebo or TXA (50-mg/kg loading dose and 10-mg/kg/h infusion). Power analysis indicated that 50 patients per group would provide power to detect a >20% difference in blood loss. Two-way analysis of variance (ANOVA) was applied to compare blood loss rates (slopes) using the group-by-time interaction F test. Results: The risk of clinically relevant blood loss (>20 mL/kg) was more than twice as high in the placebo group than in the TXA group (44% versus 21%, relative risk = 2.1, 95% confidence interval = 1.2 to 3.7). Compared with the placebo group, the TXA group had a 27% reduction in intraoperative blood loss, a significantly lower rate of intraoperative bleeding per hour (mean and standard deviation, 190 ± 73 versus 230 ± 80 mL, p = 0.01; F = 9.77, p < 0.001) and per fused spinal level (82 ± 32 versus 110 ± 40 mL, p < 0.001), less intraoperative blood loss (836 ± 373 versus 1,031 ± 484 mL, p = 0.02), and less postoperative bleeding (in the drain) (498 ± 228 versus 645 ± 318 mL, p = 0.009). Six patients who received a placebo and no patient who received TXA required an allogenic blood transfusion. No perioperative adverse events, including thromboembolic events or seizures, were observed. Three independent factors were predictive of blood loss: TXA administration, duration of surgery, and number of levels fused. Greater intraoperative blood loss was the only independent variable predictive of a longer hospital stay. Conclusions: Use of TXA in patients undergoing surgery for adolescent idiopathic scoliosis significantly reduced blood loss, by 27%, compared with that in the placebo group. The rate of intraoperative blood loss per hour and per level fused and the amount of postoperative blood loss were significantly lower in the TXA group. More placebo-treated patients received allogenic blood. Patients with greater intraoperative blood loss spent a longer time in the hospital. Level of Evidence: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. S pinal fusion is the fifth most common procedure performed in U.S. hospitals 1. Blood transfusion is the second most common procedure performed during a U.S. hospital stay for the pediatric population 2. During surgery for adolescent-onset idiopathic scoliosis, blood loss ranges from 500 mL to 2 L, and blood transfusion is common even with recent advances in surgical technique 3. Perioperative bleeding and blood transfusion are associated with significant morbidity and mortality 4-7. Bleeding and blood transfusion are independently associated with increased postoperative infection rates,
ASAIO journal (American Society for Artificial Internal Organs : 1992), Jan 26, 2018
Patient sedation and analgesia on extracorporeal membrane oxygenation (ECMO) is vital for safety ... more Patient sedation and analgesia on extracorporeal membrane oxygenation (ECMO) is vital for safety and comfort. However, adsorption to the circuit may alter drug pharmacokinetics and remains poorly characterized. This study characterizes drug adsorption of morphine, fentanyl, midazolam, and dexmedetomidine in an ex vivo infant ECMO circuit utilizing polymethylpentene (PMP) membrane oxygenator (MO) with protein-bounded polyvinylchloride (PVC) tubing. Twelve closed-loop ex vivo ECMO circuits were prepared using P.h.i.s.i.o (phosphorylcholine)-coated PVC tubing (Sorin Group USA, Inc.) and a Quadrox-iD pediatric polymethylpentene MO (Maquet Cardiopulmonary AG). Once the circuits were primed and running, a single medication was injected as a bolus into the circuit with three circuits per drug. Drug samples were drawn following injection, at 2, 5, 15, 30, 60, 120 minutes and at 4, 12, 24, 36, and 48 hours and analyzed using ultra high-performance liquid chromatography with mass spectrometry...
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