Mobile health vs. standard care after cardiac surgery: results of The Box 2.0 study.

AIMS: Postoperative atrial fibrillation (POAF) is a common complication of cardiac surgery, yet difficult to detect in ambulatory patients. The primary aim of this study is to investigate the effect of a mobile health (mHealth) intervention on POAF detection after cardiac surgery. METHODS AND RESULTS: We performed an observational cohort study among 730 adult patients who underwent cardiac surgery at a tertiary care hospital in The Netherlands. Of these patients, 365 patients received standard care and were included as a historical control group, undergoing surgery between December 2017 and September 2018, and 365 patients were prospectively included from November 2018 and November 2020, undergoing an mHealth intervention which consisted of blood pressure, temperature, weight, and electrocardiogram (ECG) monitoring. One physical outpatient follow-up moment was replaced by an electronic visit. All patients were requested to fill out a satisfaction and quality of life questionnaire. Mean age in the intervention group was 62 years, 275 (70.4%) patients were males. A total of 4136 12-lead ECGs were registered. In the intervention group, 61 (16.7%) patients were diagnosed with POAF vs. 25 (6.8%) patients in the control group [adjusted risk ratio (RR) of POAF detection: 2.15; 95% confidence interval (CI): 1.55-3.97]. De novo atrial fibrillation was found in 13 patients using mHealth (6.5%) vs. 4 control group patients (1.8%; adjusted RR 3.94, 95% CI: 1.50-11.27). CONCLUSION: Scheduled self-measurements with mHealth devices could increase the probability of detecting POAF within 3 months after cardiac surgery. The effect of an increase in POAF detection on clinical outcomes needs to be addressed in future research.

Design and rationale of DUTCH-AF: a prospective nationwide registry programme and observational study on long-term oral antithrombotic treatment in patients with atrial fibrillation.

INTRODUCTION: Anticoagulation therapy is pivotal in the management of stroke prevention in atrial fibrillation (AF). Prospective registries, containing longitudinal data are lacking with detailed information on anticoagulant therapy, treatment adherence and AF-related adverse events in practice-based patient cohorts, in particular for non-vitamin K oral anticoagulants (NOAC). With the creation of DUTCH-AF, a nationwide longitudinal AF registry, we aim to provide clinical data and answer questions on the (anticoagulant) management over time and of the clinical course of patients with newly diagnosed AF in routine clinical care. Within DUTCH-AF, our current aim is to assess the effect of non-adherence and non-persistence of anticoagulation therapy on clinical adverse events (eg, bleeding and stroke), to determine predictors for such inadequate anticoagulant treatment, and to validate and refine bleeding prediction models. With DUTCH-AF, we provide the basis for a continuing nationwide AF registry, which will facilitate subsequent research, including future registry-based clinical trials. METHODS AND ANALYSIS: The DUTCH-AF registry is a nationwide, prospective registry of patients with newly diagnosed 'non-valvular' AF. Patients will be enrolled from primary, secondary and tertiary care practices across the Netherlands. A target of 6000 patients for this initial cohort will be followed for at least 2 years. Data on thromboembolic and bleeding events, changes in antithrombotic therapy and hospital admissions will be registered. Pharmacy-dispensing data will be obtained to calculate parameters of adherence and persistence to anticoagulant treatment, which will be linked to AF-related outcomes such as ischaemic stroke and major bleeding. In a subset of patients, anticoagulation adherence and beliefs about drugs will be assessed by questionnaire. ETHICS AND DISSEMINATION: This study protocol was approved as exempt for formal review according to Dutch law by the Medical Ethics Committee of the Leiden University Medical Centre, Leiden, the Netherlands. Results will be disseminated by publications in peer-reviewed journals and presentations at scientific congresses. TRIAL REGISTRATION NUMBER: Trial NL7467, NTR7706 (https://www.trialregister.nl/trial/7464).

Use of Smart Technology for the Early Diagnosis of Complications After Cardiac Surgery: The Box 2.0 Study Protocol.

BACKGROUND: Atrial fibrillation (AF), sternal wound infection, and cardiac decompensation are complications that can occur after cardiac surgery. Early detection of these complications is clinically relevant, as early treatment is associated with better clinical outcomes. Remote monitoring with the use of a smartphone (mobile health [mHealth]) might improve the early detection of complications after cardiac surgery. OBJECTIVE: The primary aim of this study is to compare the detection rate of AF diagnosed with an mHealth solution to the detection rate of AF diagnosed with standard care. Secondary objectives include detection of sternal wound infection and cardiac decompensation, as well as assessment of quality of life, patient satisfaction, and cost-effectiveness. METHODS: The Box 2.0 is a study with a prospective intervention group and a historical control group for comparison. Patients undergoing cardiac surgery at Leiden University Medical Center are eligible for enrollment. In this study, 365 historical patients will be used as controls and 365 other participants will be asked to receive either The Box 2.0 intervention consisting of seven home measurement devices along with a video consultation 2 weeks after discharge or standard cardiac care for 3 months. Patient information will be analyzed according to the intention-to-treat principle. The Box 2.0 devices include a blood pressure monitor, thermometer, weight scale, step count watch, single-lead electrocardiogram (ECG) device, 12-lead ECG device, and pulse oximeter. RESULTS: The study started in November 2018. The primary outcome of this study is the detection rate of AF in both groups. Quality of life is measured with the five-level EuroQol five-dimension (EQ-5D-5L) questionnaire. Cost-effectiveness is calculated from a society perspective using prices from Dutch costing guidelines and quality of life data from the study. In the historical cohort, 93.9% (336/358) completed the EQ-5D-5L and patient satisfaction questionnaires 3 months after cardiac surgery. CONCLUSIONS: The rationale and design of a study to investigate mHealth devices in postoperative cardiac surgery patients are presented. The first results are expected in September 2020. TRIAL REGISTRATION: ClinicalTrials.gov NCT03690492; http://clinicaltrials.gov/show/NCT03690492. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16326.

Mobile phones in cryptogenic strOke patients Bringing sIngle Lead ECGs for Atrial Fibrillation detection (MOBILE-AF): study protocol for a randomised controlled trial.

BACKGROUND: Recently published randomised clinical trials indicate that prolonged electrocardiom (ECG) monitoring might enhance the detection of paroxysmal atrial fibrillation (AF) in cryptogenic stroke or transient ischaemic attack (TIA) patients. A device that might be suitable for prolonged ECG monitoring is a smartphone-compatible ECG device (Kardia Mobile, Alivecor, San Francisco, CA, USA) that allows the patient to record a single-lead ECG without the presence of trained health care staff. The MOBILE-AF trial will investigate the effectiveness of the ECG device for AF detection in patients with cryptogenic stroke or TIA. In this paper, the rationale and design of the MOBILE-AF trial is presented. METHODS: For this international, multicentre trial, 200 patients with cryptogenic stroke or TIA will be randomised. One hundred patients will receive the ECG device and will be asked to record their ECG twice daily during a period of 1 year. One hundred patients will receive a 7-day Holter monitor. DISCUSSION: The primary outcome of this study is the percentage of patients in which AF is detected in the first year after the index ischaemic stroke or TIA. Secondary outcomes include markers for AF prediction, orally administered anticoagulation therapy changes, as well as the incidence of recurrent stroke and major bleeds. First results can be expected in mid-2019. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT02507986 . Registered on 15 July 2015.

Delaying a shock after takeover from the automated external defibrillator by paramedics is associated with decreased survival.

INTRODUCTION: The purpose of this study was to investigate whether the takeover by Advanced Life Support [ALS] trained ambulance paramedics from rescuers using an automated external defibrillator [AED] delays shocks and if this delay is associated with decreased survival after out-of-hospital cardiac arrest [OHCA]. METHODS: We analyzed continuous ECG recordings of LIFEPAK AEDs and associated manual defibrillator recordings of OHCA of presumed cardiac cause, prospectively collected from July 2005 to July 2009. The primary outcome measure was survival to discharge. Among 693 patients treated with AEDs, 110 had a shockable initial rhythm and a shockable rhythm during ALS takeover. We measured the time interval between the expected shock if the AED would remain attached to the patient and the first observed shock given by the manual defibrillator [shock timing]. RESULTS: Survival was 62% (13/21) if the shock was given early (<-20s), 52% (11/21; odds ratio [OR]=0.68, ns) if given on time (-20 to 20s), 29% (10/34; OR=0.26, 95% confidence interval [CI]=0.08-0.81; P=0.02) if the shock was 20-150s delayed and 21% (7/34; OR=0.16, 95% CI=0.05-0.54; P=0.003) if the shock was delayed >150s. The OR for trend was 0.41, 95% CI=0.25-0.71; P=0.001. The association between shock timing and survival was significant for patients with more than 150s shock delay (OR=0.19; 95% CI=0.04-0.71; P=0.02) or for trend in shock timing (0.42, 95% CI=0.20-0.84; P=0.02) after multivariable adjustment for prognostic factors age and slope of ventricular fibrillation. CONCLUSIONS: ALS takeover delays the next shock delivery in almost two-third of cases. This delay is associated with decreased survival.

Definition of successful defibrillation.

OBJECTIVES: The definition of defibrillation shock "success" endorsed by the International Liaison Committee on Resuscitation since the publication of Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiac Care has been removal of ventricular fibrillation at 5 secs after shock delivery. Although this success criterion provides a direct assessment of the primary task of a shock, it may not be the only clinically useful measure of shock outcome. We evaluated a different defibrillation success criterion to determine whether it could provide additional insight into the relative performance of different defibrillation shocks. DESIGN: A randomized study comparing monophasic and biphasic waveform shocks is reported with return of organized rhythm as the primary outcome measure of defibrillation success. PATIENTS: A total of 120 patients with out-of-hospital ventricular fibrillation as the first recorded rhythm were treated with defibrillation with automated external defibrillators. MEASUREMENTS AND MAIN RESULTS: Return of organized rhythm (two QRS complexes, <5 secs apart, <60 secs after defibrillation) was achieved in 31 monophasic shock (45%) and 35 biphasic shock (69%) patients (relative risk, 1.53, 95% confidence interval, 1.11-2.10). Logistic regression analysis revealed that shock waveform was the strongest independent predictor of return of organized rhythm (odds ratio, 4.0; 95% confidence interval, 1.67-10.0). Defibrillation success with the conventional International Liaison Committee on Resuscitation criterion was very high (91% and 98%, respectively) and not significantly different between groups. CONCLUSIONS: Return of organized rhythm proved to be a more sensitive measure of relative defibrillation shock performance than the conventional shock success criterion. Inclusion of return of organized rhythm as an end point in future clinical research could help discern more subtle defibrillation shock effects and contribute to further optimization of defibrillation technology.

Trained first-responders with an automated external defibrillator: how do they perform in real resuscitation attempts?

INTRODUCTION: The quality of first-responder performance at the end of automated external defibrillator (AED) training may not predict the performance adequately during a real resuscitation attempt. METHODS: Between January and December 2000, we evaluated 67 resuscitation attempts in Amsterdam and surroundings, where police officers used an AED. We compared their performance with their assessment at the end of their ERC AED training course. One of the main goals of training was to deliver a shock within 90 s after switching the power on in the AED. RESULTS: We analysed 127 police officers working in 67 police-teams. The police officers had a mean age of 35 years (range 23-54 years), 73% was male. The interval between AED training and the first resuscitation attempt was a median of 4 months (range 1-13). 78% percent of the 67 teams consisted of two police officers who both were qualified as "competent" after the initial training. Successful completion of the course correlated well with good performance during a resuscitation attempt (p = 0.009). When measured switching the power on in the AED, 92% of the victims received a shock within 90 s. CONCLUSIONS: Successful training correlates well with successful performance in the field. Competence of a team may be better than competence of two separate individuals.

Cognitive impairment in survivors of out-of-hospital cardiac arrest.

BACKGROUND: The huge importance of rapid provision of care, especially early defibrillation, for survival of out-of-hospital cardiac arrest (OHCA) is well known. This prospective cohort study investigated cognitive functioning of OHCA survivors in relation to the time-related elements of the resuscitation. METHODS: Fifty-seven consecutive survivors, from a cohort of 308 witnessed OHCA patients with ventricular fibrillation as the initial rhythm, underwent extensive neuropsychologic examination, including tests of memory, attention, and executive functioning, 6 months after the resuscitation. Time-related aspects of the resuscitation were collected on scene. Cognitive functioning was studied in relation to the administration of cardiopulmonary resuscitation (CPR) prior to ambulance arrival, and time from collapse to start of CPR, defibrillation, and return of spontaneous circulation (ROSC). RESULTS: Depending of the test, between 11% and 28% of survivors were cognitively impaired, while 58% scored unimpaired for all tests. Daily life activities were limited in 19% of the patients. Patients who received CPR prior to arrival of the ambulance showed a trend towards overall better cognitive functioning and significant better immediate memory and visuomotor tracking (P =.03 and P <.01). We found a weak correlation between the time to CPR, time to defibrillation, or time to ROSC and cognitive functioning. CONCLUSIONS: The majority of survivors of OHCA with ventricular fibrillation as the initial rhythm are cognitively unimpaired. Long delays to ROSC are compatible with good cognitive outcome. Initiation and cessation of resuscitation efforts should not be based on the duration of circulatory arrest.

Training of police officers as first responders with an automated external defibrillator.

UNLABELLED: A short and effective training programme is an essential prerequisite for the use of automated external defibrillators (AED) by EMS providers and first responders. We evaluated a 3-h AED course based on the ERC requirements. METHODS: As part of a study evaluating the effectiveness of AEDs used by first responders (ARREST 4), we trained all police officers in the region of Amsterdam, the Netherlands. By means of a Basic Life Support (BLS) assessment at the beginning of the course and at the end, we evaluated whether BLS can be improved in a 3-h AED course. Through a combined BLS and AED assessment at the end of the course, we evaluated whether AED skills can be acquired sufficiently. BLS skills were measured with the Laerdal SkillMeter in evaluation mode. AED skills were assessed using 13 criteria. By means of logistic regression, we analysed the influence of student characteristics, such as age, gender, previous training, resuscitation experience and motivation for BLS and AED on BLS and AED skills acquisition. RESULTS: Between September 1999 and June 2000, 823 police officers were trained (76% male, mean age 36 (S.D. 9) years). BLS improved significantly (P < 0.001) in all criteria, except for hypoventilation (P < 0.001). After training, 89% of the students were able to use an AED safely and effectively. Self-confidence and motivation improved from 12 and 73% to 99 and 94% over the course (P < 0.001). Independent student characteristics influencing the success of the AED course were: previous BLS training, motivation before the course for an AED, and resuscitation experience that dated back for more than 12 months. CONCLUSION: The majority of police officers can be trained to use an AED safely and effectively within a 3-h AED course. During this course, they also improve on their BLS skills. Successful completion of the course depends in part on the student characteristics.

Health system costs of out-of-hospital cardiac arrest in relation to time to shock.

BACKGROUND: Early defibrillation results in higher admission rates and healthcare costs. This study determined the healthcare resources used and related medical costs after out-of-hospital cardiac arrest (OHCA) in relation to time to shock. We assessed the incremental healthcare costs per life gained from reduction in time to shock of 2, 4, and 6 minutes. METHODS AND RESULTS: Clinical and costs data of patients in witnessed OHCA with ventricular fibrillation as initial rhythm were collected. Each patient's time to shock was estimated and assigned to 1 of 3 categories: < or =7 minutes (early), 7 to 12 minutes (intermediate), and >12 minutes (late). Incremental cost-effectiveness analysis and Monte Carlo simulation compared scenarios of reduction in time to shock of 2, 4, and 6 minutes. Six-month survival was 22%. Mean prehospital, in-hospital, and posthospital costs in the first half-year after OHCA were 559 Euros, 6869 Euros and 666 Euros. Mean costs were 28,636 Euros per survivor and 2384 Euros per nonsurvivor. Among patients shocked early (n=24), 46% survived, with costs averaging 20,253 Euros. Of the intermediate group (n=149), 26% survived, with costs averaging 31,467 Euros. Among patients shocked late (n=135), 13% survived, with costs averaging 27,781 Euros. The point estimates of the incremental cost-effectiveness ratios of reduction of time to shock of 2, 4, and 6 minutes compared with baseline were 17,508 Euros, 14,303 Euros, and 12,708 Euros per life saved, respectively. CONCLUSIONS: Costs per survivor were lowest with the shortest time to shock because of shorter stay in the intensive care unit. Reducing the time to defibrillation increases the healthcare costs by an acceptable amount according to current standards and is economically attractive.

Assessment of quality of life and cognitive function after out-of-hospital cardiac arrest with successful resuscitation.

This prospective cohort study evaluated the impact of the time-related elements of the "chain of survival" on the quality of life of patients, taking their characteristics into account. Between 1995 and 2002, consecutive, out-of-hospital cardiac arrest patients from Amsterdam and the surrounding areas were included in this study. A total of 227 patients (12%) survived to hospital discharge and 174 were definitive survivors who were available for assessment at 6 months. Quality of life was measured with the 136-item Sickness Impact Profile (SIP); cognitive functioning was assessed through the Mini Mental State Examination. SIP profiles were compared with profiles of an open Dutch population of the elderly and patients who experienced a stroke. Time intervals of the chain of survival were calculated from the estimated moment of collapse and related to outcome using regression analysis. The SIP profile of survivors was a little above the reference profile, indicating a slightly poorer quality of life, and below the profile of patients after stroke, indicating a better quality of life. Impaired cognitive function was associated with delay in the start of cardiopulmonary resuscitation (odds ratio 4.3, 95% confidence interval 1.0 to 19). Absence of the need for advanced cardiopulmonary life support was associated with better cognitive functioning (odds ratio 0.3, 95% confidence interval 0.1 to 0.9). Female gender and older age were associated with impaired physical functioning. Trends were found for better outcomes after early access, immediate resuscitation, early defibrillation, and early advanced care.

Use of automated external defibrillator by first responders in out of hospital cardiac arrest: prospective controlled trial.

OBJECTIVE: To test the hypothesis that the use of an automated external defibrillator by police and fire fighters results in higher discharge rates for out of hospital cardiac arrest. DESIGN: Controlled clinical trial with initial random allocation of automated external defibrillators to first responders in four of the eight participating regions; each region switched from control to experimental, and vice versa, every four months. SETTING: Amsterdam and surroundings, the Netherlands. PARTICIPANTS: Patients with witnessed out of hospital cardiac arrests, identified by the emergency medical system between January 2000 and January 2002. MAIN OUTCOMES MEASURES: Survival to hospital discharge; return of spontaneous circulation; admission to hospital. RESULTS: 243 patients (65% in ventricular fibrillation) were included in the experimental area and 226 patients (67% in ventricular fibrillation) in the control area. The median time interval between collapse and first shock was 668 seconds in the experimental area and 769 seconds in the control area (P < 0.001). 44 (18%) patients in the experimental area versus 33 (15%) patients in the control area were discharged (odds ratio 1.3 (95% confidence interval 0.8 to 2.2), P = 0.33), 139 (57%) experimental versus 108 (48%) control patients had return of spontaneous circulation (1.5 (1.0 to 2.2), P = 0.05), and 103 (42%) experimental versus 74 (33%) control patients were admitted (1.5 (1.1 to 1.6), P = 0.02). The median delay from receipt of call to dispatch of the ambulance was 120 seconds, and the delay to dispatch of the first responder was 180 seconds. CONCLUSIONS: Use of automated external defibrillators by first responders did not significantly increase survival to discharge from hospital, although it did improve return of spontaneous circulation and admission to hospital. Improved dispatch procedures should increase the success of programmes of first responders using external defibrillators.

VF recurrence: characteristics and patient outcome in out-of-hospital cardiac arrest.

BACKGROUND: Refibrillation after successful defibrillation in out-of-hospital cardiac arrest is a frequent event. Little is known of factors that predispose to the occurrence of refibrillation. The effect of recurrence of ventricular fibrillation (VF) on survival is not known. METHODS: Data of patients in out-of-hospital cardiac arrest were collected in a combined first responder and paramedic programme in Amsterdam, the Netherlands. Continuous recorded rhythm data of 322 patients covering the entire out-of-hospital resuscitation attempt was included in the analysis. Recurrence of VF was recorded, the patient and process characteristics were analysed in relation to the occurrence of refibrillation. The number of refibrillations was related to survival. RESULTS AND CONCLUSION: Of the studied patients 79% had at least one recurrence of VF, and a median number of two times 25-75%; one to four times). The median time from successful first shock to VF recurrence was 45 s (25-75%: 23-115 s). A significant inverse relation was found between the number of refibrillations and survival of out-of-hospital cardiac arrest. The recurrence of VF was independent of the underlying cardiac disorder, the time to defibrillation, the defibrillation waveform and other characteristics of the patient and the process. Anti-arrhythmics should be considered in all patients found in VF to reduce the number of recurrences.

Interruption of cardiopulmonary resuscitation with the use of the automated external defibrillator in out-of-hospital cardiac arrest.

STUDY OBJECTIVE: The protocol for the use of the automated external defibrillator calls for a period of "hands-off" time, during which no cardiopulmonary resuscitation (CPR) can be performed. We assessed the actual interruption time of CPR during the use of the automated external defibrillator in patients in out-of-hospital cardiac arrest. METHODS: This study included 184 patients experiencing out-of-hospital cardiac arrest in which an automated external defibrillator was applied by first responders. ECG and voice recordings from the automated external defibrillator were downloaded and analyzed. Start and end times of CPR were recorded, as were intervals measured from the recordings concerning the programmed interruption time and the interruption time related to performance. RESULTS: The automated external defibrillators were connected for a median time of 4 minutes 47 seconds (range 31 to 1,404 seconds). CPR was performed during 45%+/-15% (mean+/-SD) of the connected time or until return of spontaneous circulation. During the automated external defibrillator connection time in the 96 patients with a shockable rhythm, CPR was performed 36%+/-20% of the time. Programmed interruption of CPR took 40%+/-15% of the automated external defibrillator connection time, and no CPR was performed related to performance during 23%+/-15% of the time. A palpable pulse was never present immediately after a shock, and return of spontaneous circulation was observed in 3 of 184 patients before arrival of the ambulance. Ultimately, return of spontaneous circulation occurred in 87 of 184 patients. CONCLUSION: First responders using automated external defibrillator voice prompts provide CPR less than half the time that the automated external defibrillator is connected to the patient. Technical improvements in automated external defibrillator rhythm analysis, more efficient resuscitation algorithms, and first-responder education could increase CPR delivery and, perhaps, improve outcome.

A prospective, randomised and blinded comparison of first shock success of monophasic and biphasic waveforms in out-of-hospital cardiac arrest.

BACKGROUND: Evidence suggests that biphasic waveforms are more effective than monophasic waveforms for defibrillation in out-of-hospital cardiac arrest (OHCA), yet their performance has only been compared in un-blinded studies. METHODS AND RESULTS: We compared the success of biphasic truncated exponential (BTE) and monophasic damped sine (MDS) shocks for defibrillation in OHCA in a prospective, randomised, double blind clinical trial. First responders were equipped with MDS and BTE automated external defibrillators (AEDs) in a random fashion. Patients in ventricular fibrillation (VF) received BTE or MDS first shocks of 200 J. The ECG was recorded for subsequent analysis continuously. The success of the first shock as a primary endpoint was removal of VF and required a return of an organized rhythm for at least two QRS complexes, with an interval of <5 s, within 1 min after the first shock. The secondary endpoint was termination of VF at 5 s. VF was the initial recorded rhythm in 120 patients in OHCA, 51 patients received BTE and 69 received MDS shocks. The success rate of 200 J first shocks was significantly higher for BTE than for MDS shocks, 35/51 (69%) and 31/69 (45%), P=0.01. In a logistic regression model the odds ratio of success for a BTE shock was 4.01 (95% CI 1.01-10.0), adjusted for baseline cardiopulmonary resuscitation, VF-amplitude and time between collapse and first shock. No difference was found with respect to the secondary endpoint, termination of VF at 5 s (RR 1.07 95% CI: 0.99-1.11) and with respect to survival to hospital discharge (RR 0.73 95% CI: 0.31-1.70). CONCLUSION: BTE-waveform AEDs provide significantly higher rates of successful defibrillation with return of an organized rhythm in OHCA than MDS waveform AEDs.