Machine learning for prediction of ventricular arrhythmia episodes from intracardiac electrograms of automatic implantable cardioverter-defibrillators.

BACKGROUND: Despite effectiveness of the implantable cardioverter-defibrillator (ICD) in saving patients with life-threatening ventricular arrhythmias (VAs), the temporal occurrence of VA after ICD implantation is unpredictable. OBJECTIVE: The study aimed to apply machine learning (ML) to intracardiac electrograms (IEGMs) recorded by ICDs as a unique biomarker for predicting impending VAs. METHODS: The study included 13,516 patients who received Biotronik ICDs and enrolled in the CERTITUDE registry between January 1, 2010, and December 31, 2020. Database extraction included IEGMs from standard quarterly transmissions and VA event episodes. The processed IEGM data were pulled from device transmissions stored in a centralized Home Monitoring Service Center and reformatted into an analyzable format. Long-range (baseline or first scheduled remote recording), mid-range (scheduled remote recording every 90 days), or short-range predictions (IEGM within 5 seconds before the VA onset) were used to determine whether ML-processed IEGMs predicted impending VA events. Convolutional neural network classifiers using ResNet architecture were employed. RESULTS: Of 13,516 patients (male, 72%; age, 67.5 ± 11.9 years), 301,647 IEGM recordings were collected; 27,845 episodes of sustained ventricular tachycardia or ventricular fibrillation were observed in 4467 patients (33.0%). Neural networks based on convolutional neural networks using ResNet-like architectures on far-field IEGMs yielded an area under the curve of 0.83 with a 95% confidence interval of 0.79-0.87 in the short term, whereas the long-range and mid-range analyses had minimal predictive value for VA events. CONCLUSION: In this study, applying ML to ICD-acquired IEGMs predicted impending ventricular tachycardia or ventricular fibrillation events seconds before they occurred, whereas midterm to long-term predictions were not successful. This could have important implications for future device therapies.

Impact of preprocedural left ventricular systolic function on the safety and durability of percutaneous coronary intervention.

BACKGROUND: Percutaneous coronary intervention (PCI) is considered less safe in patients with reduced ejection fraction (EF), an impression based on older data. Whether the safety and durability of contemporary PCI are different in patients with reduced EF compared with normal EF patients is unknown. METHODS: Patients from the BIOFLOW II, IV and V clinical trials were grouped as normal EF (≥50%) and reduced EF (30%-50%). Using multivariable logistic regression and cox proportional hazards regression, we determined relations of EF category with procedural safety (a composite of cardiac death, myocardial infarction, stroke and urgent coronary artery bypass grafting within 30 days of PCI) and target lesion failure (TLF; comprising cardiac death, target vessel myocardial infarction, target vessel revascularization within 1 year of PCI) respectively. In sensitivity analyses, we regrouped patients into EF < 45% and ≥55% and repeated the aforementioned analyses. RESULTS: In 1685 patients with normal EF (mean age 65 years; 27% women; mean EF 61%) and 259 with low EF (mean age 64 years; 17% women; mean EF 41%), 101 safety and 148 TLF events occurred. Compared with patients in the normal EF group, those with reduced EF had neither a statistically significant higher proportion of safety events, nor a higher multivariable-adjusted risk for such events. Similarly, patients with reduced EF and normal EF did not differ in terms of TLF event proportions or multivariable-adjusted risk for TLF. The results were similar in sensitivity analyses with EF groups redefined to create a 10% between-group EF separation. CONCLUSION: PCI safety and durability outcomes are similar in patients with mild-moderately reduced EF and normal EF.

Physical Activity in Cardiac Implantable Electronic Device Recipients During the COVID-19 Pandemic.

OBJECTIVE: To characterize the physical activity (PA) level in patients with a cardiac implantable electronic device (CIED) during the coronavirus disease 2019 (COVID-19) pandemic and compare PA level during the pandemic in 2020 with the year 2019. METHODS: We performed a retrospective analysis of PA activity in individuals implanted with a CIED enrolled in the BIOTRONIK CERTITUDE Registry. Mean daily and weekly PA from January to August 2020 was compared with 2019. RESULTS: A total of 21,660 individuals met eligibility criteria, with mean age of 72.6±11.6 years, and 12,411 (57.3)% were males. A significant decline in daily PA was noted following the pandemic declaration in 2020, with a maximum mean reduction of -24.5±36.3 minutes (P<.0001) observed in April 2020 compared with 2019. PA in 2020 increased from April to May (120.6±67.4 to 129.2±70.9 min/d). PA was lower for all months in 2020 compared with 2019. The decrease in PA was observed in all prespecified groups based on age, sex, type of device, and region of the country. CONCLUSION: After the declaration of the coronavirus disease 2019 pandemic, a significant decline in daily PA was observed in individuals with a CIED. Future investigation to establish the impact of this reduction on short and long-term cardiovascular outcomes is required.

The Safety of High-Dose Intranasal Fentanyl in the Pediatric Emergency Department.

OBJECTIVES: This study aimed to determine if the use of intranasal (IN) fentanyl in the pediatric emergency department of 2 to 5 µg/kg at doses greater than 100 µg is associated with adverse events in pediatric patients. METHODS: We performed a retrospective chart review of patients receiving IN fentanyl at an urban, tertiary care emergency department in Memphis, TN, from January 1, 2011, to December 31, 2017. All adverse events documented through the hospital's voluntary safety reporting system involving IN fentanyl were reviewed to determine patient outcomes. RESULTS: A total of 3205 patients received greater than 100 µg of IN fentanyl during the study period from 2011 to 2017. The average (SD) patient age was 13.7 (2.65) years, ranging from 5 to 18 years. The mean (SD) initial dose was 162 (30) µg ranging from 102 to 265 µg (2 doses were given greater than 200 µg in the study period). Initial average (SD) dose for weight was 2.62 (0.5) µg/kg. A total of 13 adverse events were documented, with only 3 occurring at doses greater than 100 µg. No patients required the reversal agent naloxone or invasive respiratory support. CONCLUSIONS: To our knowledge, this is the first study using doses greater than 100 µg of IN fentanyl in a pediatric population. Our results indicate that fentanyl can be safely administered at doses of greater than 100 µg without any clinically significant adverse outcomes observed for 7 years of use. It is our hope that this information will increase utilization of IN fentanyl for treatment of acute pain in emergency departments and in the prehospital setting.

Utilization and programming of an automatic MRI recognition feature for cardiac rhythm management devices.

BACKGROUND: Cardiac implantable electronic devices (CIED)-ie, pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices-have recently been designed to allow for patients to safely undergo magnetic resonance imaging (MRI) when specific programming is implemented. MRI AutoDetect is a feature that automatically switches CIED's programming into and out of an MR safe mode when exposed to an MRI environment. OBJECTIVE: The purpose was to analyze de-identified daily remote transmission data to characterize the utilization of the MRI AutoDetect feature. METHODS: Home Monitoring transmission data collected from MRI AutoDetect-capable devices were retrospectively analyzed to determine the workflow and usage in patients experiencing an MRI using the MRI AutoDetect feature. RESULTS: Among 48,756 capable systems, 2197 devices underwent an MRI using the MRI AutoDetect feature. In these 2197 devices, the MRI AutoDetect feature was used a total of 2806 times with an average MRI exposure of 40.83 minutes. The majority (88.9%) of MRI exposures occurred on the same day as the MRI AutoDetect programming. A same day post-MRI exposure follow-up device interrogation was performed 8.6% of the time. A device-related complaint occurred within 30 days of the MRI exposure in 0.25% of MRI exposures using MRI AutoDetect but with no adverse clinical outcome. CONCLUSION: As a result of automation in device programming, the MRI AutoDetect feature eliminated post-MRI device reprogramming in 91.4% of MRI exposures and, while less frequent, allowed for pre-MRI interrogations prior to the day of the MRI exposure-reducing resource utilization and creating workflow flexibility.

Determining the impact of body mass index on ultrasound accuracy for diagnosing appendicitis: Is it less useful in obese children?

BACKGROUND: Ultrasonography (US) is the preferred imaging for suspected pediatric appendicitis. We hypothesize that children with elevated Body-Mass-Index-for-age percentile (BMIP) may be more likely to have an inaccurate or equivocal (IE) US. METHODS: After IRB approval, a four-year review was performed on pediatric patients evaluated for appendicitis by US. The CDC BMIP Calculator was used. IE subgroups were analyzed together for comparison against the accurate group. RESULTS: 1059 patients were included: median age 11.3 years (IQR: 8.2, 14.6), 506 (47.8%) males. Median BMIP was 65.9 (IQR: 33.9, 89.6). US accurately diagnosed 857 (80.9%), incorrectly diagnosed 76 (7.2%), 126 (11.9%) were equivocal. Overall sensitivity was 0.85, specificity 0.96, PPV 0.93 and NPV 0.91. Obese children (BMIP ≥95%), had higher odds of IE US (OR: 1.86, 95% CI: 1.28, 2.70; p = 0.001). When analyzed by sex, risk increased in obese males (OR: 2.55, 95% CI:1.53, 4.24; p = 0.0003) but normalized in obese females (OR: 1.30, 95% CI:0.74, 2.28; p = 0.35). CONCLUSIONS: An elevated BMIP may increase difficulty in visualizing the appendix, resulting in inaccurate or equivocal findings. This risk is seen specifically in obese males. If US findings do not correlate with clinical assessment in obese children with abdominal pain, further evaluation may be warranted.

The use of computed tomography versus clinical acumen in diagnosing appendicitis in children: A two-institution international study.

BACKGROUND: Appendicitis in children can be diagnosed utilizing clinical and laboratory findings, with the assistance of ultrasound (US) and/or computed tomography (CT). However, repeated exposure to ionizing radiation increases the lifetime risk of cancer. We compared the work-up of suspected appendicitis between a children's hospital in the United States (USA) and one in Spain to identify differences in imaging use and associated outcomes. METHODS: A two-institution retrospective review was performed for surgical consultations of suspected appendicitis from 2015-2017. We compared imaging use, the utilization of overnight observation, and diagnostic accuracy rates between the two centers. RESULTS: A total of 1,952 children were evaluated. Among the 1,288 in the USA center, 754(58.5%) underwent CT during their evaluation. The most common imaging modality was US only (39.9%), then CT only (39.3%), CT+US (19.3%), and no imaging (i.e. only clinical acumen) (1.6%). In Spain, only 19 (2.9%) of 664 children underwent CT compared to the USA (p < 0.0001). Only clinical acumen was the most common modality employed (48.6%), followed by US only (48.5%), US+CT (2.4%), and CT only (0.5%). In the USA, 16.8% were observed overnight, 2.3% of whom received no imaging. In Spain, 33.4% were observed overnight, 32.4% of whom had no imaging (p < 0.0001). The accuracy rates for diagnosing appendicitis in the USA and Spain centers were 94.7% and 95.1%, respectively. CONCLUSION: Use of clinical acumen and/or US have similar clinical outcomes and similar accuracy rates compared to heavy reliance on CT imaging for diagnosing appendicitis, with associated decrease in radiation exposure. The disparate diagnostic approach of the two centers may reflect that physical examination is a dying art in North America. LEVEL OF EVIDENCE: III.

Outcomes Associated With Early vs Late Initiation of Exclusive Enteral Feeding Regimens Following Laparoscopic Gastrostomy Tube Placement in the Pediatric Patient.

OBJECTIVES: Despite frequent placement of pediatric laparoscopic gastrostomy tubes (GTs), no rigorous evaluation of initial feeding and advancement regimens exists. Therefore, the aim of this study was to determine whether early enteral feeding after GT placement is associated with increased symptoms, procedural complications, or length of stay (LOS). METHODS: In this retrospective cohort study, the records of all patients at a tertiary care pediatric hospital who had gastrostomy placement were reviewed. Only patients fed exclusively via gastrostomy were included. Feeding was monitored starting with the first postoperative feed and subsequently in 24-hour increments. Adverse events were recorded based on clinical documentation. RESULTS: A total of 480 patients met inclusion criteria. Patients who started feeds between 24 and 36 hours had a shorter LOS compared with those who started at 36-48 hours (P = .0072) or >48 hours (P < .0001). Patients requiring ≥60 hours to reach goal feeds had significantly longer LOS than the other groups. There was no difference in the distribution of the LOS based on percentage of goal feeds initiated. Patients who required ≥60 hours to attain goal feeds had the most feeding complications. CONCLUSIONS: More aggressive feeding advancement and earlier initiation of feeds were associated with decreased LOS without an associated increase in adverse clinical events.

Novel two-lead cardiac resynchronization therapy system provides equivalent CRT responses with less complications than a conventional three-lead system: Results from the QP ExCELs lead registry.

INTRODUCTION: The novel two-lead cardiac resynchronization therapy (CRT)-DX system utilizes a floating atrial dipole on the implantable cardioverter-defibrillator lead, and when implanted with a left ventricular (LV) lead, offers a two-lead CRT system with AV synchrony. This study compared complication rates and CRT response among subjects implanted with a two-lead CRT-DX system to those subjects implanted with a standard three-lead CRT-D system. METHODS AND RESULTS: A total of 240 subjects from the Sentus QP-Extended CRT Evaluation with Quadripolar Left Ventricular Leads postapproval study were selected to identify 120 matched pairs based on similar demographic characteristics using a Greedy algorithm. The complication-free rate was evaluated as the primary endpoint. All-cause mortality, heart failure hospitalizations, device diagnostic data, New York Heart Association (NYHA) class improvement, and defibrillator therapy were evaluated from clinical data, in-office interrogations, and remote monitoring throughout the follow-up period. Complication-free survival favored the CRT-DX group with 92.5% without a major complication compared to 85.0% in the CRT-D cohort (P = .0495; 95% confidence interval: 0.1%-14.9%) over a mean follow-up of 1.3 and 1.4 years, respectively. Incidence of all-cause mortality, heart failure hospitalizations, NYHA changes at 6 months postimplant, and percent of LV pacing during CRT therapy were similar in both device cohorts. Inappropriate shocks were more frequent in the CRT-D cohort with 5.8% of subjects receiving an inappropriate shock vs 0.8% in the CRT-DX cohort. CONCLUSION: The results of this subanalysis demonstrate that the CRT-DX system can provide similar CRT responses and significantly fewer complications when compared to a similar cohort with a conventional three-lead CRT-D system.

Factors Associated With Return Visits at 7 Days After Hospital Discharge.

OBJECTIVE: To identify variables associated with return visits to the hospital within 7 days after discharge. METHODS: We performed a retrospective study of 7-day revisits and readmissions between October 2012 and September 2015 using the Pediatric Health Information System database supplemented by electronic medical record data from a tertiary-care children's hospital. We examined factors associated with revisits among the top 10 most frequent indications for hospitalization using generalized estimating equations. RESULTS: There were 736 (4.2%) revisits and 416 (2.3%) readmissions within 7 days. Predictors of 7-day revisits and readmissions included age, length of hospital stay, and presence of a chronic medical condition. In addition, insurance status was associated with risk of revisits and race was associated with risk of readmissions in the bivariate analysis. CONCLUSIONS: In this study, we identified patient characteristics that may be associated with a higher risk of early return to the emergency department and/or readmissions. Early identification of this at-risk group of patients may provide opportunities for intervention and enhanced care coordination at discharge.

Shunt Failure-The First 30 Days.

BACKGROUND: Incontrovertible predictors of shunt malfunction remain elusive. OBJECTIVE: To determine predictors of shunt failure within 30 d of index surgery. METHODS: This was a single-center retrospective cohort study from January 2010 through November 2016. Using a ventricular shunt surgery research database, clinical and procedural variables were procured. An "index surgery" was defined as implantation of a new shunt or revision or augmentation of an existing shunt system. The primary outcome was shunt failure of any kind within the first 30 days of index surgery. Bivariate models were created, followed by a final multivariable logistic regression model using a backward-forward selection procedure. RESULTS: Our dataset contained 655 unique patients with a total of 1206 operations. The median age for the cohort at the time of first shunt surgery was 4.6 yr (range, 0-28; first and third quartile, .37 and 11.8, respectively). The 30-day failure rates were 12.4% when analyzing the first-index operation only (81/655), and 15.7% when analyzing all-index operations (189/1206). Small or slit ventricles at the time of index surgery and prior ventricular shunt operations were found to be significant covariates in both the "first-index" (P < .01 and P = .05, respectively) and "all-index" (P = .02 and P < .01, respectively) multivariable models. Intraventricular hemorrhage at the time of index surgery was an additional predictor in the all-index model (P = .01). CONCLUSION: This study demonstrates that only 3 variables are predictive of 30-day shunt failure when following established variable selection procedures, 2 of which are potentially under direct control of the surgeon.

Concurrent Use of Calcium Chloride and Arginine Vasopressin Infusions in Pediatric Patients with Acute Cardiocirculatory Failure.

Acute heart failure (AHF) can cause low cardiac output and poor end-organ perfusion. Inotropic agents along with vasodilators can improve organ perfusion. Arginine vasopressin (AVP) and calcium chloride (CaCl) infusions are increasingly being used in low cardiac output states in pediatric AHF. We retrospectively reviewed 77 patients (0-18 years) with AHF admitted between January 2014 and May 2017 who received concurrent AVP and CaCl infusions. Surrogates of cardiac output and organ perfusion included hemodynamic vital signs, laboratory parameters, and urine output (UO). Organ dysfunction and vasopressor inotropic scores were also calculated. Median (IQR) age was 0.88 years (0, 3.75), and median weight was 6.62 kg (3.5, 13.7). Congenital heart disease was present in 70% (46/77) patients. Univentricular physiology was present in 25% (25/77) patients. None of the patients were in the immediate postoperative period. Median durations of AVP and CaCl were 2 days (1, 3) and 3 days (2, 6), respectively. Using Wilcoxon-signed rank test and Bonferroni correction, post hoc comparison showed that at 8 h post infusion, all systolic blood pressure (SBP) and diastolic blood pressure (DBP) results, and UO were greater than those 1 h prior to infusion. Median SBP increased from 79 mm Hg (71, 92) 1 h prior to 97 mm Hg (84, 107) 8 h post. Median DBP increased from 44 mm Hg (35, 52) 1 h prior to 54 mm Hg (44, 62) 8 h post. Heart rate showed a decrease between measurements 1 h prior to infusion and 8 h post, with median scores 146 (127, 162) and 136 (114, 150) beats per minute, respectively. Within first 8 h, median UO continuously increased from 6 mL/h. (0, 25) at 1 h post infusion to 20 mL/h. (2, 62) at 8 h post infusion. Median pediatric logarithmic organ dysfunction scores on days 4 through 7 post infusion were lower compared to day 1; median vasopressor inotropic scores on day 2 through 7 post infusion were lower compared to day 1. Serum lactate level, arterial pH, and base excess all showed favorable trend. Concurrent use of AVP and CaCl infusions may improve surrogates of cardiac output, and intensive care outcomes, and prevent organ dysfunction in children with AHF.

Testing for Urinary Tract Infection in the Influenza/Respiratory Syncytial Virus-Positive Febrile Infant Aged 2 to 12 Months.

OBJECTIVE: Infants 12 months or younger with influenza and respiratory syncytial virus (RSV) commonly present to the emergency department (ED) with fever. Previous publications have recommended that these patients have a urinalysis and urine culture performed. We aimed to assess the prevalence of urinary tract infection (UTI) in febrile RSV/influenza positive infants aged 2 to 12 months presenting to the ED. We also examined whether the 2011 American Academy of Pediatrics (AAP) UTI clinical practice guidelines could be used to identify patients at lower risk of UTI. METHODS: This was a retrospective chart review examining all infants aged 2 to 12 months with a documented fever of higher than 38°C who presented to our ED from 2009 to 2013 and tested positive for influenza and/or RSV. RESULTS: One thousand seven hundred twenty-four patients were found to meet our inclusion criteria. Of these, 98 were excluded because of known urinary tract anomaly or systemic antibiotic use in the 24 hours preceding evaluation. Of those patients remaining, 10 (0.62%) of 1626 had positive urine cultures (95% confidence interval, 0.3%-1.1%), and 8 (0.49%) of 1626 (95% confidence interval, 0.2%-0.97%) had positive urine cultures with positive urinalyses as defined in the 2011 AAP UTI clinical practice guidelines. All subjects with positive urine cultures as defined by the AAP had risk factors for UTI that placed their risk for UTI above 1%. CONCLUSIONS: Our population of 2- to 12-month-old febrile infants with positive influenza/RSV testing, who did not have risk factors to make their risk of UTI higher than 1%, may not have required evaluation with urinalysis or urine culture.

Platelet Transfusions in the PICU: Does Disease Severity Matter?

OBJECTIVES: Pediatric intensivists frequently prescribe platelet transfusions to critically ill children, but there are limited data on platelet transfusion practice and platelet transfusion-related outcomes in the PICU. In this study, we evaluated the current platelet transfusion practice and platelet transfusion-related outcomes in the PICU. DESIGN: Institutional review board-approved, retrospective cohort study from January 2010 to March 2016. SETTING: Tertiary-level PICU. PATIENTS: Children less than 19 years old who received platelet transfusions in the PICU. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Thirty-six percent (1,547/4,339) of platelet transfusions in the institution were given to 2.4% of PICU patients (232/9,659). The patients who received a platelet transfusion (platelet transfusions, n = 232) compared with those who did not receive platelets (no platelet transfusions, n = 9,427) were younger, had similar gender distribution, had a higher median Pediatric Risk of Mortality-3 score, and stayed longer in the PICU. Fifty percent of platelet transfusions were prescribed prophylactically for thrombocytopenia to patients without extracorporeal membrane oxygenation support. The mortality was higher for platelet transfusions group (30% vs 2.3%) with an 18 times increased unadjusted odds of mortality when compared with no platelet transfusion group (odds ratio, 18.2; 95% CI, 13.3-24.8; p < 0.0001). In a multiple logistic regression analysis, the predicted probability of dying for platelet transfusion group compared with no platelet transfusion group depended on the median Pediatric Risk of Mortality-3 score. Patients who received platelet transfusion versus no platelet transfusion have increased odds of dying at lower median Pediatric Risk of Mortality-3 scores, but decreased odds of dying at higher median Pediatric Risk of Mortality-3 scores. CONCLUSIONS: This PICU cohort demonstrates that the odds or predicted probability of dying change in patients who received platelet transfusions based on underlying disease severity measured by Pediatric Risk of Mortality-3 score compared with patients who did not receive platelet transfusions. A large, prospective trial is required to confirm this association and determine whether to consider underlying disease severity in estimating risks and benefits of prophylactic platelet transfusions in critically ill children.

Reducing Time to Pain Medication Administration for Pediatric Patients with Long Bone Fractures in the Emergency Department.

INTRODUCTION: Pain management is a critical aspect of effective long bone fracture treatment. Pediatric patients frequently report suboptimal pain management, which is an area of growing public concern. The purpose of this quality improvement project was to develop a protocol with the goal to administer pain medication to children presenting with suspected long bone fractures ≤47 minutes of emergency department arrival. METHODS: A multidisciplinary team developed a standardized protocol for pain management of patients presenting with musculoskeletal pain utilizing acetaminophen as the first-line agent under a nurse-initiated order. Following education and implementation, weekly reports generated using the International Classification of Diseases codes of fractures were reviewed to assess compliance with the protocol. This study evaluates the frequency of a second pain medication administration and reduction in vital signs and pain scores. RESULTS: Implementation of a pain management protocol reduced median time to pain medication administration to 26 minutes. Overall, 63% (n = 638) of patients required a second pain medication. Of these, 66.5% (348/523) who initially received acetaminophen and 59.7% (286/479) who initially received an opioid required a second pain medication. No significant changes in pre and posttreatment vital signs were found between groups. Patients who initially received opioids experienced a greater reduction in posttreatment pain scores. CONCLUSIONS: Using a standardized pain management protocol in combination with comprehensive education effectively reduces median time to pain medication administration in pediatric patients with long bone fractures. Acetaminophen is a rapid and effective first-line agent for managing pain in this population.