Prognostic value of exercise longitudinal right ventricular free wall strain in patients with sickle cell disease.

Longitudinal right ventricular free wall strain (RVFWS) has been identified as an independent prognostic marker in patients with pulmonary hypertension. Little is known however about the prognostic value of RVFWS in patients with sickle cell (SC) disease, particularly during exercise. We therefore examined the prognostic significance of RVFWS both at rest and with exercise in patients with SC disease and normal resting systolic pulmonary artery pressure (SPAP). Consecutive patients with SC disease referred for bicycle ergometer stress echocardiography (SE) were enrolled ftom July 2019 to January 2021. All patients had measurable tricuspid regurgitation velocity (TRV). Conventional echocardiography parameters, left ventricular global longitudinal strain (LVGLS), RVFWS, and ventriculoarterial coupling indices (TAPSE/SPAP and RVFWS/SPAP) were assessed at rest and peak exercise. Repeat SE was performed at a median follow-up of 2 years. The cohort consisted of 87 patients (mean age was 31 ± 11 years, 66% females). All patients had normal resting TRV < 2.8 m/s, RVFWS and LVGLS at baseline. There were 23 (26%) patients who had peak stress RVFWS < 20%. They had higher resting and peak stress TRV and SPAP, but lower resting and peak stress TAPSE/SPAP, RVFWS/SPAP, and LVGLS as well as lower peak stress cardiac output when compared to patients with peak stress RVFWS ≥ 20% (p < 0.05). Patients with baseline peak stress RVFWS < 20% had a significant decrease in exercise performance at follow-up (7.5 ± 2.7 min at baseline vs. 5.5 ± 2.8 min at follow-up, p < 0.001). In the multivariate analysis, baseline peak stress RVFWS was the only independent predictor of poorer exercise performance at follow-up [odds ratio 8.2 (1.2, 56.0), p = 0.033]. Among patients with SC disease who underwent bicycle ergometer SE, a decreased baseline value of RVFWS at peak stress predicted poorer exercise time at follow-up.

Pathophysiology of Myocardial Infarction With Nonobstructive Coronary Artery Disease: A Contemporary Systematic Review.

Background: Myocardial infarction with nonobstructive coronary artery disease (MINOCA) is defined as acute myocardial infarction (AMI) with angiographically nonobstructive coronary artery disease. MINOCA represents 6% of all AMI cases and is associated with increased mortality and morbidity. However, the wide array of pathophysiological factors and causes associated with MINOCA presents a diagnostic conundrum. Therefore, we conducted a contemporary systematic review of the pathophysiology of MINOCA. Methods: A comprehensive systematic review of MINOCA was carried out through the utilization of the PubMed database. All systematic reviews, meta-analyses, randomized controlled trials, and cohort studies available in English or French that reported on the pathophysiology of MINOCA published after January 1, 2013 were retained. Results: Of the 600 identified records, 80 records were retained. Central to the concept of MINOCA is the definition of AMI, characterized by the presence of myocardial damage reflected by elevated cardiac biomarkers in the setting of acute myocardial ischemia. As a result, a structured approach should be adopted to thoroughly assess and address clinically overlooked obstructive coronary artery disease, and cardiac and extracardiac mechanisms of myocyte injury. Once these options have been ruled out, a diagnosis of MINOCA can be established, and the appropriate multimodal assessment can be conducted to determine its specific underlying cause (plaque disruption, epicardial coronary vasospasm, coronary microvascular dysfunction, and coronary embolism and/or spontaneous coronary dissection or supply-demand mismatch). Conclusions: Integrating a suitable definition of AMI and understanding the pathophysiological mechanisms of MINOCA are crucial to ensure an effective multimodal diagnostic evaluation and the provision of adequate tailored therapies.

Contexte: L'infarctus du myocarde sans obstruction des artères coronaires (MINOCA) est défini comme un infarctus aigu du myocarde (IAM) en présence d'une coronaropathie non obstructive confirmée par angiographie. Le MINOCA représente 6 % de tous les cas d'IAM et est associé à une hausse des taux de mortalité et de morbidité. Cependant, le large éventail de facteurs physiopathologiques et de causes associés au MINOCA représente une énigme diagnostique. C'est pourquoi nous avons réalisé une analyse systématique des publications contemporaines sur la physiopathologie du MINOCA. Méthodologie: Une analyse exhaustive des publications sur le MINOCA a été menée au moyen de la base de données PubMed. L'ensemble des analyses systématiques, des méta-analyses, des essais contrôlés randomisés et des études de cohorte publiés en anglais ou en français après le 1er janvier 2013 qui faisaient état de la physiopathologie du MINOCA ont été retenus. Résultats: Parmi les 600 dossiers relevés, 80 ont été retenus. La définition de l'IAM était centrale au concept de MINOCA et était caractérisée par la présence d'une lésion myocardique attestée par des taux élevés de biomarqueurs cardiaques en contexte d'ischémie myocardique aiguë. Par conséquent, une approche structurée devrait être adoptée pour évaluer pleinement et traiter les coronaropathies obstructives qui passent inaperçues en clinique ainsi que les mécanismes cardiaques et extracardiaques des lésions aux myocytes. Une fois ces options exclues, un diagnostic de MINOCA peut être établi et l'évaluation multimodale appropriée peut être menée pour déterminer la cause sous-jacente précise (rupture de plaque, vasospasme d'une artère coronaire épicardique, dysfonction microvasculaire coronarienne et embolie coronarienne et/ou dissection spontanée d'une artère coronaire ou déséquilibre entre apports et besoins). Conclusions: Il est crucial d'intégrer une définition convenable de l'IAM et de comprendre les mécanismes physiopathologiques du MINOCA pour assurer une évaluation diagnostique multimodale efficace et une prestation de traitements adaptés et adéquats.

Prevalence of H. pylori among patients undergoing coronary angiography (The HP-DAPT prevalence study).

Helicobacter pylori (H. pylori) screening and treatment is recommended for patients on chronic aspirin (ASA) therapy to reduce the risk of gastrointestinal bleeding. Coronary artery disease patients requiring combination antithrombotic therapy (dual antiplatelet therapy; DAPT, or dual pathway inhibition; DPI) are at an even higher risk of GI bleeding. Therefore, we aimed to evaluate the prevalence of H. pylori among patients referred for angiography and likely to receive DAPT or DPI. This single-center prospective observational study recruited patients undergoing coronary angiography and with the possibility of requiring DAPT or DPI. All included patients underwent H. pylori serology testing. Multivariable logistic regression was performed to determine predictors of seropositivity. 195 patients were included in the analysis. Mean age was 67 years, 50% had known prior CAD, and 49% underwent coronary intervention. H. pylori serology was positive in 36%. Chronic kidney disease (odds ratio [OR] 2.76; 95% confidence interval [CI] 1.24 to 6.15; p = 0.01) and chronic obstructive pulmonary disease (OR 2.52; 95% CI 1.14 to 5.55; p = 0.02) history were independent predictors of H. pylori seropositivity. Given the clinically significant prevalence of H. pylori seropositivity among patients referred for angiography, systematic screening strategies and eradication of H. pylori could significantly reduce the incidence of GI bleeding in patients requiring DAPT or DPI.

Usability Testing and Technology Acceptance of an mHealth App at the Point of Care During Simulated Pediatric In- and Out-of-Hospital Cardiopulmonary Resuscitations: Study Nested Within 2 Multicenter Randomized Controlled Trials.

BACKGROUND: Mobile apps are increasingly being used in various domains of medicine. Few are evidence-based, and their benefits can only be achieved if end users intend to adopt and use them. To date, only a small fraction of mobile apps have published data on their field usability and end user acceptance results, especially in emergency medicine. OBJECTIVE: This study aims to determine the usability and acceptance of an evidence-based mobile app while safely preparing emergency drugs at the point of care during pediatric in- and out-of-hospital cardiopulmonary resuscitations by frontline caregivers. METHODS: In 2 multicenter randomized controlled parent trials conducted at 6 pediatric emergency departments from March 1 to December 31, 2017, and 14 emergency medical services from September 3, 2019, to January 21, 2020, the usability and technology acceptance of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app were evaluated among skilled pediatric emergency nurses and advanced paramedics when preparing continuous infusions of vasoactive drugs and direct intravenous emergency drugs at pediatric dosages during standardized, simulation-based, pediatric in- and out-of-hospital cardiac arrest scenarios, respectively. Usability was measured using the 10-item System Usability Scale. A 26-item technology acceptance self-administered survey (5-point Likert-type scales), adapted from the Unified Theory of Acceptance and Use of Technology model, was used to measure app acceptance and intention to use. RESULTS: All 100% (128/128) of nurses (crossover trial) and 49.3% (74/150) of paramedics (parallel trial) were assigned to the mobile app. Mean total scores on the System Usability Scale were excellent and reached 89.5 (SD 8.8; 95% CI 88.0-91.1) for nurses and 89.7 (SD 8.7; 95% CI 87.7-91.7) for paramedics. Acceptance of the technology was very good and rated on average >4.5/5 for 5 of the 8 independent constructs evaluated. Only the image construct scored between 3.2 and 3.5 by both participant populations. CONCLUSIONS: The results provide evidence that dedicated mobile apps can be easy to use and highly accepted at the point of care during in- and out-of-hospital cardiopulmonary resuscitations by frontline emergency caregivers. These findings can contribute to the implementation and valorization of studies aimed at evaluating the usability and acceptance of mobile apps in the field by caregivers, even in critical situations. TRIAL REGISTRATION: ClinicalTrials.gov NCT03021122; https://clinicaltrials.gov/ct2/show/NCT03021122. ClinicalTrials.gov NCT03921346; https://clinicaltrials.gov/ct2/show/NCT03921346. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3726-4.

In situ simulation training for parental presence during critical situations in PICU: an observational study.

Family presence during invasive procedures or cardiopulmonary resuscitation (CPR) is a part of the family-centered approach in pediatric intensive care units (PICUs). We established a simulation program aiming at providing communication tools to healthcare professionals. The goal of this study was to evaluate the impact of this program on the stress of PICU professionals and its acceptance. An observational study of a simulation program, with questionnaire, was used to measure pre- and post-simulation stress and the degree of satisfaction of the participants. PICU of Geneva Children's Hospital, Switzerland. Forty simulations with four different simulation scenarios and various types of parental behavior, as imitated by professional actors, were completed during a 1-year period. Primary outcomes were the difference in perceived stress level before and after the simulation and the degree of satisfaction of healthcare professionals (nursing assistants, nurses, physicians). The impact of previous experience with family members during critical situations or CPR was evaluated by variation in perceived stress level. Overall, 201 questionnaires were analyzed. Perceived stress associated with parental presence decreased from a pre-simulation value of 6 (IQR, 4-7) to 4 (IQR, 2-5) post-simulation on a scale of 1-10. However, in 25.7% of cases, the individually perceived post-simulation stress level was higher than the pre-simulation one. Satisfaction of the participants was high with a median of 10 (IQR, 9-10) out of 10. CONCLUSIONS: A simulation program helps reduce PICU team emotional stress associated with the presence of family members during critical situations or CPR, and is welcomed by PICU team members. WHAT IS KNOWN: • Family presence during cardiopulmonary resuscitation (CPR) or critical situations is a part of the family-centered approach in pediatric intensive care. • The benefits for the family have been already demonstrated. However, this policy is still controversy among healthcare professionals. WHAT IS NEW: • A simulation program seeking to provide skills focused on family presence management in the PICU is useful to reduce stress and was well accepted by participants. • It might become an indispensable training intervention for the implementation of a PICU policy to allow family presence during CPR or other critical situations.

Impact of blended learning on manual defibrillator's use: A simulation-based randomized trial.

BACKGROUND: Blended learning, defined as the combination of traditional face-to-face instructor-led learning and e-learning course, has never been validated as a teaching method for the effective use of manual defibrillators in cardiopulmonary resuscitation. AIM: To evaluate whether paediatric emergency and critical care providers exposed to a blended learning session performed better and recalled more defibrillator skills than those exposed to face-to-face learning only. STUDY DESIGN: A two-period prospective, stratified, single-centre, simulation-based, randomized, controlled trial. METHODS: Registered nurses and postgraduate residents from either a paediatric emergency department or an intensive care unit were randomly assigned to a blended learning or face-to-face learning sessions on the recommended use of a manual defibrillator. Participants' adherence to recommendations was assessed by testing defibrillator skills in three consecutive paediatric cardiopulmonary scenarios performed on the day of the training and once again 2 months later. The primary endpoint was the number of errors observed during defibrillation, cardioversion, and transcutaneous pacing at the time of the initial intervention. RESULTS: Fifty participants were randomized to receive the intervention and 51 to the control group. When pooling all three procedures, the median total errors per participant was lower (2 [IQR: 1-4]) in providers exposed to blended learning than in those exposed to face-to-face learning only (3 [IQR: 2-5]; P = .06). The median of total errors per procedure was also lower. However, both training methods appeared insufficient to maintain appropriate skill retention over time as a repetition of procedures 2 months later without any refresher learning session yielded more errors in both groups. CONCLUSIONS: Learners exposed to blended learning showed a reduced number in the total amount of errors compared with those exposed to face-to-face learning alone, with waning of skills over time. RELEVANCE TO CLINICAL PRACTICE: Proficiently teaching the use of a manual defibrillator can be performed through blended learning.

Assessing the Accuracy of a Second-Generation Optical Sensor Pressure Wire in a Wire-to-Wire Comparison (The ACCURACY Study).

BACKGROUND: The phenomenon of "pressure drift" increases uncertainty about the correct FFR value. Redesigned and incorporating an optical pressure sensor, the "OptoWire Deux™" is purported to be less prone to the pressure drift seen with piezoelectric coronary pressure wires. The aim of this first in vivo real-world clinical study is to evaluate the performance of OptoWire Deux™ in terms of measurements agreement and propensity to pressure drift in a wire to wire comparison. METHODS: This is a single center, prospective, non-blinded clinical investigation enrolling 45 consecutive patients with a clinical indication for coronary lesion FFR assessment. Lesions were either simultaneously assessed with two optical sensor pressure wires (OSPW) (Group O-O; 30 patients, 34 lesions) or one OSPW and one piezoelectric pressure wire (PEPW) simultaneously (Group O-P; 15 patients, 15 lesions). Significant drift was defined as a pressure ratio deviation of >0.03. RESULTS: Mean FFR measurements in Group OO were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group OP, however, mean FFR measurement with PEPW (0.85±0.09) was numerically lower than that observed with the OSPW (0.88±0.08; P = 0.09). Level of agreement using the Bland-Altman method was higher when 2 OSPW were used for FFR assessment (-0.002 95% CI [-0.033,0.029] vs. 0.026 95% CI [-0.078, 0.130], respectively). The rate of drift was significantly lower with an OSPW compared to a PEPW (4.8% vs. 26.7% respectively, P = 0.02). CONCLUSION: The optical sensor guidewire showed a high level of readings' agreement after simultaneous usage of 2 optical sensor guidewires. There was also significantly less drift when compared to a piezoelectric guidewire.

Iatrogenic Superior Vena Cava Syndrome: A Rare Cause of Hemodynamic Compromise After Cardiac Surgery.

Given the broad array of potential complications following cardiac surgery, specialized care is critical to ensuring good patient outcomes. Herein, we present a rare case of severe hemodynamic compromise, following cardiac surgery, found to be due to iatrogenic superior vena cava syndrome in the setting of baseline biventricular dysfunction. Hemodynamics improved immediately upon addressing the syndrome, highlighting the importance of multidisciplinary collaboration in the postoperative care of cardiac surgery patients.

Compte tenu du large éventail de complications potentielles après une chirurgie cardiaque, des soins spécialisés sont indispensables afin de garantir de bons résultats pour les patients. Nous présentons ici un cas rare de compromis hémodynamique grave à la suite d'une chirurgie cardiaque, causé par un syndrome iatrogène de compression de la veine cave supérieure dans un contexte de dysfonction biventriculaire existante. Le compromis hémodynamique s'est immédiatement amélioré après la prise en charge du syndrome, ce qui souligne l'importance de la collaboration multidisciplinaire dans les soins postopératoires des patients en chirurgie cardiaque.

Impact of a Mobile App on Paramedics' Perceived and Physiologic Stress Response During Simulated Prehospital Pediatric Cardiopulmonary Resuscitation: Study Nested Within a Multicenter Randomized Controlled Trial.

BACKGROUND: Out-of-hospital cardiac arrests (OHCAs) are stressful, high-stake events that are associated with low survival rates. Acute stress experienced in this situation is associated with lower cardiopulmonary resuscitation performance in calculating drug dosages by emergency medical services. Children are particularly vulnerable to such errors. To date, no app has been validated to specifically support emergency drug preparation by paramedics through reducing the stress level of this procedure and medication errors. OBJECTIVE: This study aims to determine the effectiveness of an evidence-based mobile app compared with that of the conventional preparation methods in reducing acute stress in paramedics at the psychological and physiological levels while safely preparing emergency drugs during simulated pediatric OHCA scenarios. METHODS: In a parent, multicenter, randomized controlled trial of 14 emergency medical services, perceived and physiologic stress of advanced paramedics with drug preparation autonomy was assessed during a 20-minute, standardized, fully video-recorded, and highly realistic pediatric OHCA scenario in an 18-month-old child. The primary outcome was participants' self-reported psychological stress perceived during sequential preparations of 4 intravenous emergency drugs (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate) with the support of the PedAMINES (Pediatric Accurate Medication in Emergency Situations) app designed to help pediatric drug preparation (intervention) or conventional methods (control). The State-Trait Anxiety Inventory and Visual Analog Scale questionnaires were used to measure perceived stress. The secondary outcome was physiologic stress, measured by a single continuous measurement of the participants' heart rate with optical photoplethysmography. RESULTS: From September 3, 2019, to January 21, 2020, 150 advanced paramedics underwent randomization. A total of 74 participants were assigned to the mobile app (intervention group), and 76 did not use the app (control group). A total of 600 drug doses were prepared. Higher State-Trait Anxiety Inventory-perceived stress increase from baseline was observed during the scenario using the conventional methods (mean 35.4, SD 8.2 to mean 49.8, SD 13.2; a 41.3%, 35.0 increase) than when using the app (mean 36.1, SD 8.1 to mean 39.0, SD 8.4; a 12.3%, 29.0 increase). This revealed a 30.1% (95% CI 20.5%-39.8%; P<.001) lower relative change in stress response in participants who used the app. On the Visual Analog Scale questionnaire, participants in the control group reported a higher increase in stress at the peak of the scenario (mean 7.1, SD 1.8 vs mean 6.4, SD 1.9; difference: -0.8, 95% CI -1.3 to -0.2; P=.005). Increase in heart rate during the scenario and over the 4 drugs was not different between the 2 groups. CONCLUSIONS: Compared with the conventional method, dedicated mobile apps can reduce acute perceived stress during the preparation of emergency drugs in the prehospital setting during critical situations. These findings can help advance the development and evaluation of mobile apps for OHCA management and should be encouraged. TRIAL REGISTRATION: ClinicalTrials.gov NCT03921346; https://clinicaltrials.gov/ct2/show/NCT03921346. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-019-3726-4.

Effect of a Mobile App on Prehospital Medication Errors During Simulated Pediatric Resuscitation: A Randomized Clinical Trial.

Importance: Medication errors are a leading cause of injury and avoidable harm, affecting millions of people worldwide each year. Children are particularly susceptible to medication errors, but innovative interventions for the prevention of these errors in prehospital emergency care are lacking. Objective: To assess the efficacy of an evidence-based mobile app in reducing the occurrence of medication errors compared with conventional preparation methods during simulated pediatric out-of-hospital cardiac arrest scenarios. Design, Setting, and Participants: This nationwide, open-label, multicenter, randomized clinical trial was conducted at 14 emergency medical services centers in Switzerland from September 3, 2019, to January 21, 2020. The participants were 150 advanced paramedics with drug preparation autonomy. Each participant was exposed to a 20-minute, standardized, fully video-recorded, realistic pediatric out-of-hospital cardiac arrest cardiopulmonary resuscitation scenario concerning an 18-month-old child. Participants were tested on sequential preparations of 4 intravenous emergency drugs of varying degrees of preparation difficulty (epinephrine, midazolam, 10% dextrose, and sodium bicarbonate). Intervention: Participants were randomized (1:1 ratio) to the support of an app designed to assist with pediatric drug preparation (intervention; n = 74) or to follow conventional drug preparation methods without assistance (control; n = 76). Main Outcomes and Measures: The primary outcome was the rate of medication errors, defined as a failure in drug preparation according to predefined, expert consensus-based criteria. Logistic regression models with mixed effects were used to assess the effect of the app on binary outcomes. Secondary outcomes included times to drug preparation and delivery, assessed with linear regression models with mixed effects. Results: In total, 150 advanced paramedics (mean [SD] age, 35.6 [7.2] years; 101 men [67.3%]; mean [SD] time since paramedic certification, 8.0 [6.2] years) participated in the study and completed 600 drug preparations. Of 304 preparations delivered using the conventional method, 191 (62.8%; 95% CI, 57.1%-68.3%) were associated with medication errors compared with 17 of 296 preparations delivered using the app (5.7%; 95% CI, 3.4%-9.0%). When accounting for repeated measures, with the app, the proportion of medication errors decreased in absolute terms by 66.5% (95% CI, 32.6%-83.8%; P < .001), the mean time to drug preparation decreased by 40 seconds (95% CI, 23-57 seconds; P < .001), and the mean time to drug delivery decreased by 47 seconds (95% CI, 27-66 seconds; P < .001). The risk of medication errors varied across drugs with conventional methods (19.7%-100%) when compared with the app (4.1%-6.8%). Conclusions and Relevance: Compared with conventional methods, the use of a mobile app significantly decreased the rate of medication errors and time to drug delivery for emergency drug preparation in a prehospital setting. Dedicated mobile apps have the potential to improve medication safety and change practices in pediatric emergency medicine. Trial Registration: ClinicalTrials.gov Identifier: NCT03921346.

Implications of COVID-19 on Time-Sensitive STEMI Care: A Report From a North American Epicenter.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has forced dramatic changes to the healthcare systems throughout the world. Time-sensitive management of cardiovascular emergencies such as ST-elevation myocardial infarction (STEMI) has yet to be evaluated in the context of these new policies, particularly in so-called "hot spot" cities. METHODS: We evaluated the early impact of the pandemic on STEMI performance in the Greater Montreal Area. A total of 167 patients from 3 different study periods were included. Patients presenting in the lockdown period from mid-March to mid-May 2020 (Group C, 53 patients) were compared to those from mid-March to mid-May 2019 (Group A, 60 patients) and the 2020 pre-COVID-19 period (Group B, 54 patients). RESULTS: The number of STEMI admissions was unaffected during the lockdown. However, significantly longer delays between symptom onset and first medical contact (FMC) were noted (Group C 189.0 IQR [70.0, 840.0] min vs. Group A 103.0 IQR [42.5, 263.0] min vs. Group B 91.0 IQR [38.0, 235.5 min], P = 0.007). In contrast, additional safety protocols do not appear to have significantly affected delays between FMC and first intracoronary device activation (Group C 102 IQR [73.0, 133.0] min vs. Group A 104 IQR [87.0, 146.0] min vs. Group B 99.5 IQR [80.0, 150.0] min, P = 0.37). Patients that presented during the outbreak were more likely to be unstable with a higher incidence of Killip classes II-IV compared to groups A and B (28.3% vs. 18.3% vs. 5.6% respectively, P = 0.008). Worse in-hospital outcomes were also noted with a significantly higher rate of major adverse cardiac events (Group A 5.0% vs. Group B 11.1% vs. Group C 22.6%, P = 0.007). CONCLUSION: During the lockdown period, many patients appear to have been reluctant to present to hospitals. This was associated with more unstable STEMI presentations and worse in-hospital course. Importantly, the health care system appears able to ensure timely acute cardiac care while ensuring that COVID-19 protocols are respected.

Analysis of the COMPARE-AMI trial: First report of long-term safety of CD133+ cells.

BACKGROUND: Data related to long-term safety of intracoronary (IC) injection of CD133+ bone marrow stem cells (BMSC) following an acute myocardial infarction (MI) are still lacking. METHODS: COMPARE-AMI is a double-blind, placebo-controlled phase II clinical trial evaluating the safety and efficacy of IC injection of CD133+ enriched hematopoietic BMSC in patients with ST-elevation myocardial infarction (STEMI) and persistent left ventricular (LV) dysfunction following successful primary percutaneous coronary intervention (PCI). Herein, we report outcomes up to ten years of follow-up. RESULTS: Between November 2007 and July 2012, we enrolled 38 patients in our study. Males were 89% and the median age was 50.5 years. Baseline left ventricular ejection fraction (LVEF) was 40.0%, and 90% of lesions were located in the left anterior descending (LAD) artery. The median follow-up time was 8.5 years IQR [7.9, 10.0]. Using Kaplan-Meier methods, MACE-free survival up to 10 years was 77.3% overall. IC injection of CD133+ BMSC was associated with a similar event-free survival rate compared to placebo (87.8% vs. 66.3%, p = .37). Two cancer cases in each group were recorded. No malignant arrhythmias were observed. CONCLUSIONS: IC injection of CD133+ BMSC is safe up to 10 years of follow-up. The long-term efficacy needs to be confirmed by a larger randomized trial.

A mobile device app to reduce prehospital medication errors and time to drug preparation and delivery by emergency medical services during simulated pediatric cardiopulmonary resuscitation: study protocol of a multicenter, prospective, randomized controlled trial.

BACKGROUND: Emergency drug preparation and administration in children is both complex and time-consuming and places this population at a higher risk than adults for medication errors. Moreover, survival and a favorable neurological outcome from cardiopulmonary resuscitation are inversely correlated to drug preparation time. We developed a mobile device application (the pediatric Accurate Medication IN Emergency Situations (PedAMINES) app) as a step-by-step guide for the preparation to delivery of drugs requiring intravenous injection. In a previous multicenter randomized trial, we reported the ability of this app to significantly reduce in-hospital continuous infusion medication error rates and drug preparation time compared to conventional preparation methods during simulation-based pediatric resuscitations. This trial aims to evaluate the effectiveness of this app during pediatric out-of-hospital cardiopulmonary resuscitation. METHODS/DESIGN: We will conduct a multicenter, prospective, randomized controlled trial to compare the PedAMINES app with conventional calculation methods for the preparation of direct intravenously administered emergency medications during standardized, simulation-based, pediatric out-of-hospital cardiac arrest scenarios using a high-fidelity manikin. One hundred and twenty paramedics will be randomized (1:1) in several emergency medical services located in different regions of Switzerland. Each paramedic will be asked to prepare, sequentially, four intravenously administered emergency medications using either the app or conventional methods. The primary endpoint is the medication error rates. Enrollment will start in mid-2019 and data analysis in late 2019. We anticipate that the intervention will be completed in early 2020 and study results will be submitted in late 2020 for publication (expected in early 2021). DISCUSSION: This clinical trial will assess the impact of an evidence-based mobile device app to reduce the rate of medication errors, time to drug preparation and time to drug delivery during prehospital pediatric resuscitation. As research in this area is scarce, the results generated from this study will be of great importance and may be sufficient to change and improve prehospital pediatric emergency care practice. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03921346. Registered on 18 April 2019.

Effects of Blindfold on Leadership in Pediatric Resuscitation Simulation: A Randomized Trial.

Background: Pediatric resuscitations are rare events. Simulation-based training improves clinical and non-clinical skills, as well as survival rate. We assessed the effectiveness of using blindfolds to further improve leadership skills in pediatric simulation-based training. Methods: Twelve teams, each composed of 1 pediatric emergency fellow, 1 pediatric resident, and 2 pediatric emergency nurses, were randomly assigned to the blindfold group (BG) or to the control group (CG). All groups participated in one session of five simulation-based resuscitation scenarios. The intervention was using a blindfold for the BG leader for the scenarios B, C, and D. Three evaluators, who were blinded to the allocation, assessed leadership skills on the first and last video-recorded scenarios (A and E). Questionnaires assessed self-reported changes in stress and satisfaction about skills after the first and the last scenarios. Results: Improvement in leadership skills doubled in the BG compared with the CG (11.4 vs. 5.4%, p = 0.04), whereas there was no increase in stress or decrease in satisfaction. Conclusion: Blindfold could be an efficient method for leadership training during pediatric resuscitation simulated scenarios. Future studies should further assess its effect at a follow-up and on clinical outcomes after pediatric resuscitation.

A mobile device application to reduce medication errors and time to drug delivery during simulated paediatric cardiopulmonary resuscitation: a multicentre, randomised, controlled, crossover trial.

BACKGROUND: Vasoactive drug preparation for continuous infusion in children is both complex and time consuming and places the paediatric population at higher risk than adults for medication errors. We developed a mobile device application (app) as a step-by-step guide for the preparation to delivery of drugs requiring continuous infusion. The app has been previously tested during simulation-based resuscitations in a previous single-centre trial. In this trial, our aim was to assess this app in various hospital settings. METHODS: We did a prospective, multicentre, randomised, controlled, crossover trial to compare this app with an internationally used drug-infusion-rates table for the preparation of continuous drug infusion during standardised, simulation-based, paediatric post-cardiac arrest scenarios using a high-fidelity manikin. The scenarios were split into two study periods to assess the two preparation methods consecutively, separated by a washout distraction manoeuvre. Nurses in six paediatric emergency centres in Switzerland were randomly assigned (1:1) to start the scenario with either the app or the infusion-rates table and then complete the scenario using the other preparation method. The primary endpoint was the proportion of participants committing a medication error, which was defined as a deviation from the correct weight dose of more than 10%, miscalculation of the infusion rate, misprogramming of the infusion pump, or the inability to calculate drug dosage without calculation and guidance help from the study team. The medication error proportions observed with both preparation methods were compared by pooling both study periods, with paired data analysed using the unconditional exact McNemar test for dependent groups with a two-sided α level of 0·05. We did sensitivity analyses to investigate the carryover effect. This trial is registered with ClinicalTrials.gov, number NCT03021122. FINDINGS: From March 1 to Dec 31, 2017, we randomly assigned 128 nurses to start the scenario using the app (n=64) or the infusion-rates table (n=64). Among the 128 drug preparations associated with each of the two methods, 96 (75%, 95% CI 67-82) delivered using the infusion-rates table were associated with medication errors compared with nine (7%, 3-13) delivered using the mobile app. Medication errors were reduced by 68% (95% CI 59-76%; p<0·0001) with the app compared with the table, as was the mean time to drug preparation (difference 148·2 s [95% CI 124·2-172·1], a 45% reduction; p<0·0001) and mean time to drug delivery (168·5 s [146·1-190·8], a 40% reduction; p<0·0001). Hospital size and nurses' experience did not modify the intervention effect. We detected no carryover effect. INTERPRETATION: Critically ill children are particularly vulnerable to medication errors. A mobile app designed to help paediatric drug preparation during resuscitation with the aim to significantly reduce the occurrence of medication errors, drug preparation time, and delivery time could have the potential to change paediatric clinical practice in the area of emergency medicine. FUNDING: Swiss National Science Foundation.

Medium- and Large-Sized Autologous Breast Reconstruction using a Fleur-de-lys Profunda Femoris Artery Perforator Flap Design: A Report Comparing Results with the Horizontal Profunda Femoris Artery Perforator Flap.

BACKGROUND: The volume of the profunda femoris artery perforator (PAP) flap limits its indications to small- and medium-sized breast reconstructions after modified radical mastectomy for cancer. We report a modified PAP flap design, including not only a vertical extension that increases its volume but also the skin surface, which suits larger breasts requiring immediate or delayed breast reconstructions and compare the results with our horizontal skin paddle PAP flap experience. PATIENTS AND METHODS: In our center between November 2014 and November 2016, 51 consecutive patients underwent a PAP flap breast reconstruction following breast cancer. A retrospective analysis on the collected data was performed to compare 34 patients with a bra cup smaller than C who underwent 41 horizontal PAP flap procedures, with those (n = 17) of a bra cup greater than or equal to C who underwent 21 fleur-de-lys PAP flap procedures. Demographic, anthropometric, flap and surgical characteristics, postoperative complication rates, and hospital stay were compared between the two groups. RESULTS: The average flap weight was 480 g (range: 340-735 g) for the fleur-de-lys PAP flap group compared with 222 g (range: 187-325 g) for the horizontal PAP flap procedure (p < 0.001). The mean flap dimensions were 25 × 18 cm for the fleur-de-lys PAP flap group compared with 25 × 7 cm in the horizontal PAP flap group. No flap failure was observed in the fleur-de-lys PAP flap group compared with two flap failures secondary to venous thrombosis in the horizontal PAP flap group (NS). Three patients (14%) experienced delayed healing at the donor site compared with four patients (10%) in the horizontal PAP flap group (NS). CONCLUSION: The fleur-de-lys skin paddle design not only allows an increase of the horizontal PAP flap volume, but also increases the skin surface, with an acceptable donor site morbidity. For medium- or large-sized breasts, the fleur-de-lys PAP flap seems to be ideal when a DIEP flap-based reconstruction is contraindicated.

Longer Inflation Duration and Predilation-Sizing-Postdilation Improve Bioresorbable Scaffold Outcomes in a Long-term All-Comers Canadian Registry.

BACKGROUND: Real-world long-term safety and efficacy of the ABSORB (Abbott Vascular, Santa Clara, CA) bioresorbable vascular scaffold has not been well characterized in the literature, particularly in the setting of acute coronary syndromes (ACS). Herein, we report outcomes up to 4 years in such a high-risk cohort, with identification of parameters associated with better outcomes. METHODS: ReABSORB is a Canadian dual-centre, prospective, nonrandomized, all-comers registry consisting of 125 consecutively enrolled nontrial patients between October 2012 and December 2016. Angiographic and clinical follow-up is now available up to 4 years. RESULTS: Average age was 59 ± 11 years and 69% were male. Most (70.4%) presented with ACS and the median available follow-up was 1330 days (interquartile range, 1035-1483). Treated lesions (n = 163) were type A in 23%, type B (1 or 2) in 64%, and type C in 13%. Procedural success and device success were 98.2% and 98.8%, respectively. Using Kaplan-Meier methods, major adverse cardiac event-free survival (EFS) up to 4 years of clinical follow-up was 90.7% overall. However, use of a predilation-sizing-postdilation (PSP) technique was associated with an EFS rate of 95.8% vs 74.0% without PSP (P = 0.001). No significant differences in major adverse cardiac EFS rates were found between patients with or without ACS (92.7% vs 86.0%, respectively, P = 0.239). Use of PSP as well as inflation time ≥ 60 seconds were independent predictors of EFS at 2 years. CONCLUSIONS: In this prospective, real-world registry with mostly ACS patients, use of the recommended PSP implantation technique and longer inflations times were associated with significantly higher EFS.

A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial.

BACKGROUND: During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. OBJECTIVE: The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods. METHODS: This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral prescription by the physician to drug delivery by the nurse in each allocation group. TDD includes TDP. Stress level during the resuscitation scenario will be assessed for each participant by questionnaire and recorded by the heart rate monitor of a fitness watch. The study is formatted according to the Consolidated Standards of Reporting Trials Statement for Randomized Controlled Trials of Electronic and Mobile Health Applications and Online TeleHealth (CONSORT-EHEALTH) and the Reporting Guidelines for Health Care Simulation Research. RESULTS: Enrollment and data analysis started in March 2017. We anticipate the intervention will be completed in late 2017, and study results will be submitted in early 2018 for publication expected in mid-2018. Results will be reported in line with recommendations from CONSORT-EHEALTH and the Reporting Guidelines for Health Care Simulation Research . CONCLUSIONS: This paper describes the protocol used for a clinical trial assessing the impact of a mobile device app to reduce the rate of medication errors, time to drug preparation, and time to drug delivery during pediatric resuscitation. As research in this area is scarce, results generated from this study will be of great importance and might be sufficient to change and improve the pediatric emergency care practice. TRIAL REGISTRATION: ClinicalTrials.gov NCT03021122; https://clinicaltrials.gov/ct2/show/NCT03021122 (Archived by WebCite at http://www.webcitation.org/6nfVJ5b4R).