Faculty Bibliography

Purpose: Extended bed rest after catheter ablation plays a major role in postprocedure recovery and ambulation time, length of stay, patient experience, and complication risks. The VASCADE MVP (Cardiva Medical, Santa Clara, CA) venous vascular closure system (VVCS), is an investigational device that delivers an extravascular, resorbable collagen plug and aims to provide ambulatory hemostasis in 2-3 hours compared to the current standard of care of 4-8 hours for manual compression (MC).
Method(s): AMBULATE was an FDA IDE, multicenter, openlabel, randomized controlled trial of VVCS vs. MC for multi-access ablation procedures. Inclusion criteria were 3-4 femoral vein sheaths (6-12F inner diameter; no more than 2 access sites per limb). Primary efficacy outcome was Time to Ambulation (TTA); secondary efficacy outcomes included Total Post Procedure Time (TPPT), Time to Discharge Eligibility (TTDe) and Time to Hemostasis (TTH). Safety endpoints were 30-day major and minor complications, measured by limb, and powered for non-inferiority to MC. A prespecified 30-day ultrasound sub-study (25 subjects per arm) was conducted in addition to collection of pain medication usage during bedrest and a patient reported satisfaction survey at discharge. Database was locked April 2018.
Result(s): 204 eligible patients across 28 operators and 13 sites were randomized to receive VVCS (100 patients; 369 access sites) or MC (104 patients; 382 access sites). Demographic, baseline, and procedural characteristics were similar between groups (Table 1). Anticoagulant or antiplatelet therapy was reported in 84% of patients in the VVCS group and 85% of patients in the MC group. Mean TTA, TPPT, TTDe, and TTH were all substantially lower in the VVCS arm (Table 1). Post-procedural pain medication and opioid use were also substantially lower in the VVCS arm (Table 1). There were no major access-site complications in either group including those within the ultrasound sub-study. Minor complications were non-inferior with 1.0% in the VVCS arm and 2.4% in the MC arm. In the ultrasound sub-study, minor complications were 0.0% in the VVCS arm and 4.0% in the MC arm. Patient satisfaction for length of bed rest and comfort during bed rest were 63% and 36% higher with VVCS vs. MC (P<.0001 for both). Patient reported pain scores during bedrest were 25% lower (P=.001) with VVCS vs. MC and 40% lower (P=.002) for subjects with a previous ablation.
Conclusion(s): Use of the VVCS for multi-access ablation procedures resulted in significant reductions in TTA, TPPT, TTH, TTDe and opioid use, with increased patient satisfaction and no increase in complications

BACKGROUND:Following neonatal resuscitation program (NRP) training, decay in clinical skills can occur. Simulation-based deliberate practice (SBDP) has been shown to maintain NRP skills to a variable extent. Our study objectives were (a) to determine whether a single 30 min simulation-based intervention that incorporates SBDP and mastery learning (ML) can effectively restore skills and prevent skill decay and (b) to compare different timing options. METHODS:Following NRP certification, pediatric residents were randomly assigned to receive a video-recorded baseline assessment plus SBDP-ML refresher education at between 6 and 9 months (early) or between 9 and 12 months (late). One year following initial certification, participants had repeat skill retention videotaped evaluations. Participants were scored by blinded NRP instructors using validated criteria scoring tools and assigned a global performance rating score (GRS). RESULTS:Twenty-seven participants were included. Residents in both early and late groups showed significant skill decay 7 and 10 months after initial NRP. SBDP-ML booster sessions significantly improved participants' immediate NRP performance scores (p<0.001), which persisted for 2 months, but were again lower 4 months later. CONCLUSIONS:NRP skills may be boosted to mastery levels after a short SBDP-ML intervention and do not appear to significantly decline after 2 months. Brief booster training could potentially serve as a useful supplement to traditional NRP training for pediatric residents.

Therapeutic hypothermia (TH) is provided to newborns with moderate to severe hypoxic-ischemic encephalopathy (HIE) to improve survival and long-term neurodevelopmental outcomes. Although the benefits certainly outweigh the risks associated with therapeutic hypothermia, it is important to be mindful of potential rare side effects in the background of asphyxia-related injury to various body organs. One of those side effects includes subcutaneous fat necrosis (SCFN) that can occur in term newborns after perinatal hypoxia-ischemia or other stressing factors such as systemic hypothermia. It is usually a self-limited condition, however, in some cases, it can lead to severe hypercalcemia. We report three such cases of SCFN in newborns with HIE treated with TH. Due to potential long-term complications, such as metastatic calcifications, caregivers should be informed about this potential complication prior to discharge from hospital so that they can help diagnose or continue to monitor cases of severe hypercalcemia.

OBJECTIVE:To assess whether neonatologists show implicit racial and/or socioeconomic biases and whether these are predictive of recommendations at extreme periviability. STUDY DESIGN/METHODS:weeks of gestation asked physicians how likely they were to recommend intensive vs comfort care. Participants were randomized to 1 of 4 versions of the vignette in which racial and socioeconomic stimuli were varied, followed by 2 implicit association tests (IATs). RESULTS:IATs revealed implicit preferences favoring white (mean IAT score = 0.48, P < .001) and greater socioeconomic status (mean IAT score = 0.73, P < .001). Multivariable linear regression analysis showed that physicians with implicit bias toward greater socioeconomic status were more likely than those without bias to recommend comfort care when presented with a patient of high socioeconomic status (P = .037). No significant effect was seen for implicit racial bias. CONCLUSIONS:Building on previous demonstrations of unconscious racial and socioeconomic biases among physicians and their predictive validity, our results suggest that unconscious socioeconomic bias influences recommendations when counseling at the limits of viability. Physicians who display a negative socioeconomic bias are less likely to recommend resuscitation when counseling women of high socioeconomic status. The influence of implicit socioeconomic bias on recommendations at periviability may influence neonatal healthcare disparities and should be explored in future studies.

BACKGROUND:Due to the extremely low incidence of TORCH (toxoplasmosis, rubella, CMV, herpes simplex virus) infections, diagnostic testing of all small for gestational age (SGA) infants aimed at TORCH etiologies may incur unnecessary tests and cost. OBJECTIVE:To determine the frequency of urine CMV PCR and total IgM testing among infants with birth weight <10% and the rate of test positivity. To evaluate the frequency of alternative etiologies of SGA in tested infants. METHODS:Retrospective chart review of SGA infants admitted to the neonatal intensive care unit (NICU) at NYU Langone Medical Center between 2007 and 2012. Subjects were classified as being SGA with or without intrauterine growth restriction (IUGR). The IUGR subjects were then further categorized as having either symmetric or asymmetric IUGR utilizing the Fenton growth chart at birth. Initial testing for TORCH infections, which included serum total IgM, CMV PCR and head ultrasound, were reviewed and analyzed. RESULTS:Three hundred and eighty-six (13%) infants from a total of 2953 NICU admissions had a birth weight ≤10th percentile. Of these, 44% were IUGR; 34% being symmetric IUGR and 10% asymmetric. A total of 32% of SGA infants had urine CMV PCR and total IgM tested with no positive results. As expected, significantly higher percentage of symmetric IUGR infants were tested compared to asymmetric IUGR and non-IUGR SGA infants, (64% vs. 47% vs. 19%) P≤0.01. However, 63% of infants with a known cause for IUGR had same testing done aimed at TORCH infections. We calculated additional charges of $64,065 that were incurred by such testing. CONCLUSIONS:The majority of infants in our study who received testing for urine CMV PCR and total IgM aimed at TORCH infections had one or more other known non-infectious etiologies for IUGR. Because the overall yield of such testing is extremely low, we suggest tests for possible TORCH infections may be limited to symmetric IUGR infants without other known etiologies. Improved guidelines testing for TORCH infections can result in reducing hospital charges and unnecessary studies.

OBJECTIVE: To compare neurally adjusted ventilatory assist and conventional ventilation on patient-ventilator interaction and neural breathing patterns, with a focus on central apnea in preterm infants. DESIGN: Prospective, observational cross-over study of intubated and ventilated newborns. Data were collected while infants were successively ventilated with three different ventilator conditions (30 min each period): 1) synchronized intermittent mandatory ventilation (SIMV) combined with pressure support at the clinically prescribed, SIMV with baseline settings (SIMVBL), 2) neurally adjusted ventilatory assist, 3) same as SIMVBL, but with an adjustment of the inspiratory time of the mandatory breaths (SIMV with adjusted settings [SIMVADJ]) using feedback from the electrical activity of the diaphragm). SETTING: Regional perinatal center neonatal ICU. PATIENTS: Neonates admitted in the neonatal ICU requiring invasive mechanical ventilation. MEASUREMENTS AND MAIN RESULTS: Twenty-three infants were studied, with median (range) gestational age at birth 27 weeks (24-41 wk), birth weight 780 g (490-3,610 g), and 7 days old (1-87 d old). Patient ventilator asynchrony, as quantified by the NeuroSync index, was lower during neurally adjusted ventilatory assist (18.3% +/- 6.3%) compared with SIMVBL (46.5% +/-11.7%; p < 0.05) and SIMVADJ (45.8% +/- 9.4%; p < 0.05). There were no significant differences in neural breathing parameters, or vital signs, except for the end-expiratory electrical activity of the diaphragm, which was lower during neurally adjusted ventilatory assist. Central apnea, defined as a flat electrical activity of the diaphragm more than 5 seconds, was significantly reduced during neurally adjusted ventilatory assist compared with both SIMV periods. These results were comparable for term and preterm infants. CONCLUSIONS: Patient-ventilator interaction appears to be improved with neurally adjusted ventilatory assist. Analysis of the neural breathing pattern revealed a reduction in central apnea during neurally adjusted ventilatory assist use.

OBJECTIVES: Antacid medications are frequently administered to preterm infants. These medications can change gastric pH levels and can affect regular gastrointestinal function and gut micro-bacterial flora. We hypothesized that preterm infants exposed to antacid medications are at a greater risk of necrotizing enterocolitis (NEC) and sepsis, and set out to determine any association, as well as to assess the clinical efficacy of these medications. MATERIALS AND METHODS: Retrospective chart review of preterm infants /=Bell stage 2) or culture proven sepsis. RESULTS: The study comprised 65 eligible neonates, 28 in antacid treatment group and 37 in control. The incidence of NEC (21.4% vs. 2.7%, P=0.04) was significantly higher in the antacid group, but these infants tended to be born more prematurely than control subjects. There was a trend toward more culture proven sepsis cases in the antacid group. We found no difference in signs generally associated with neonatal reflux (apnea, bradycardia, and desaturation events) in subjects treated with antacid medications after treatment began. CONCLUSIONS: Treatment of preterm infants with antacid medications is potentially associated with a higher risk of NEC, and possibly sepsis, while appearing to provide little benefit.

Global tissue perfusion and oxygenation are important indicators of physiologic function in humans. The monitoring of splanchnic oximetry through the use of near-infrared spectroscopy (NIRS) is an emerging method used to assess tissue oxygenation status. Splanchnic tissue oxygenation (SrSO2) is thought to be potentially of high value in critically ill patients because gastrointestinal organs can often be the first to suffer ischemic injury. During conditions of hypovolemia, cardiac dysfunction, or decreased oxygen-carrying capacity, blood flow is diverted toward vital organs, such as the brain and the heart at the expense of the splanchnic circulation. While monitoring SrSO2 has great potential benefit, there are limitations to the technology and techniques. SrSO2 has been found to have a relatively high degree of variability that can potentially make it difficult to interpret. In addition, because splanchnic organs only lie near the skin surface in children and infants, and energy from currently available sensors only penetrates a few centimeters deep, it can be difficult to use clinically in a noninvasive manner in adults. Research thus far is showing that splanchnic oximetry holds great promise in the ability to monitor patient oxygenation status and detect disease states in humans, especially in pediatric populations.

OBJECTIVES: Nasal continuous positive airway pressure (NCPAP) is an accepted form of non-invasive ventilation in preterm infants. Few, if any, studies have shown an advantage of one type of NCPAP over another. It has been theorized that bubble-generated NCPAP may be advantageous for the preterm neonate versus traditionally used ventilator-generated NCPAP. The aim of this study was to examine for any short-term differences in physiologic parameters in preterm subjects receiving these two different methods of NCPAP. METHODS: We conducted a randomized, prospective, cross-over pilot study of preterm infants being treated with NCPAP in the neonatal intensive care unit. Subjects were continuously monitored for several physiologic parameters including heart rate, respiratory rate, oxygen saturation, cerebral tissue oxygen saturation and cerebral fractional oxygen extraction using routine neonatal monitors and near-infrared spectroscopy (NIRS) while on 2 h of bubble NCPAP and 2 h of ventilator NCPAP. Subjects were randomized to be monitored while either starting on bubble NCPAP and then switching to ventilator NCPAP or starting on ventilator NCPAP and switching to bubble NCPAP. RESULTS: Eighteen subjects were included. We found no statistically significant difference in any of the physiologic parameters while subjects were receiving bubble NCPAP versus ventilator NCPAP during the monitoring time periods. While on bubble NCPAP, subjects showed a trend toward decreasing respiratory rate and decreasing cerebral fractional oxygen extraction over time, but this did not reach statistical significance. CONCLUSION: There appears to be no difference in immediate physiologic effects between bubble NCPAP and ventilator NCPAP. This does not preclude the possibility of potential long-term differences, but any differences seen would likely be based on mechanisms that take more time to develop. A larger prospective trial is warranted to confirm our findings.