Wearable Cardioverter-Defibrillator after Myocardial Infarction.

BACKGROUND: Despite the high rate of sudden death after myocardial infarction among patients with a low ejection fraction, implantable cardioverter-defibrillators are contraindicated until 40 to 90 days after myocardial infarction. Whether a wearable cardioverter-defibrillator would reduce the incidence of sudden death during this high-risk period is unclear. METHODS: We randomly assigned (in a 2:1 ratio) patients with acute myocardial infarction and an ejection fraction of 35% or less to receive a wearable cardioverter-defibrillator plus guideline-directed therapy (the device group) or to receive only guideline-directed therapy (the control group). The primary outcome was the composite of sudden death or death from ventricular tachyarrhythmia at 90 days (arrhythmic death). Secondary outcomes included death from any cause and nonarrhythmic death. RESULTS: Of 2302 participants, 1524 were randomly assigned to the device group and 778 to the control group. Participants in the device group wore the device for a median of 18.0 hours per day (interquartile range, 3.8 to 22.7). Arrhythmic death occurred in 1.6% of the participants in the device group and in 2.4% of those in the control group (relative risk, 0.67; 95% confidence interval [CI], 0.37 to 1.21; P=0.18). Death from any cause occurred in 3.1% of the participants in the device group and in 4.9% of those in the control group (relative risk, 0.64; 95% CI, 0.43 to 0.98; uncorrected P=0.04), and nonarrhythmic death in 1.4% and 2.2%, respectively (relative risk, 0.63; 95% CI, 0.33 to 1.19; uncorrected P=0.15). Of the 48 participants in the device group who died, 12 were wearing the device at the time of death. A total of 20 participants in the device group (1.3%) received an appropriate shock, and 9 (0.6%) received an inappropriate shock. CONCLUSIONS: Among patients with a recent myocardial infarction and an ejection fraction of 35% or less, the wearable cardioverter-defibrillator did not lead to a significantly lower rate of the primary outcome of arrhythmic death than control. (Funded by the National Institutes of Health and Zoll Medical; VEST ClinicalTrials.gov number, NCT01446965 .).

Setting and motivation in the decision to participate: An approach to the engagement of diverse samples in mobile research.

Internet and mobile based research are powerful tools in the creation of large, cohort studies (eCohort). However, recent analysis indicates that an underrepresentation of minority and low income groups in these studies might exceed that found in traditional research [1-5]. In this report, we present findings from an experiment in research engagement using the Eureka Research Platform developed to enroll diverse populations in support of biomedical clinical research. This experiment involved the recruitment of African American and Latino participants in a smartphone based survey at a temporary, charitable, dental event sponsored, in part, by the research team, in order to explore the impact of setting and approach on recruitment outcomes. 211 participants enrolled including a significant representation of African Americans (51%) and Latinos (31%) and those with education levels at high school or less (37%). Interviews conducted after the study confirmed that our recruitment efforts within the context of a service event affected the decision to participate. While further research is necessary, this experiment holds promise for the engagement of underrepresented groups in research.

Smartphone-Based Geofencing to Ascertain Hospitalizations.

BACKGROUND: Ascertainment of hospitalizations is critical to assess quality of care and the effectiveness and adverse effects of various therapies. Smartphones, mobile geolocators that are ubiquitous, have not been leveraged to ascertain hospitalizations. Therefore, we evaluated the use of smartphone-based geofencing to track hospitalizations. METHODS AND RESULTS: Participants aged ≥18 years installed a mobile application programmed to geofence all hospitals using global positioning systems and cell phone tower triangulation and to trigger a smartphone-based questionnaire when located in a hospital for ≥4 hours. An in-person study included consecutive consenting patients scheduled for electrophysiology and cardiac catheterization procedures. A remote arm invited Health eHeart Study participants who consented and engaged with the study via the internet only. The accuracy of application-detected hospitalizations was confirmed by medical record review as the reference standard. Of 22 eligible in-person patients, 17 hospitalizations were detected (sensitivity 77%; 95% confidence interval, 55%-92%). The length of stay according to the application was positively correlated with the length of stay ascertained via the electronic medical record (r=0.53; P=0.03). In the remote arm, the application was downloaded by 3443 participants residing in all 50 US states; 243 hospital visits at 119 different hospitals were detected through the application. The positive predictive value for an application-reported hospitalization was 65% (95% confidence interval, 57%-72%). CONCLUSIONS: Mobile application-based ascertainment of hospitalizations can be achieved with modest accuracy. This first proof of concept may ultimately be applicable to geofencing other types of prespecified locations to facilitate healthcare research and patient care.

Secondhand smoke and atrial fibrillation: Data from the Health eHeart Study.

BACKGROUND: Cigarette smoking is a risk factor for atrial fibrillation (AF), but whether secondhand smoke (SHS) impacts the risk of AF remains unknown. OBJECTIVE: To determine if SHS exposure is associated with an increased risk of AF. METHODS: We performed a cross-sectional analysis of data from participants enrolled in the Health eHeart Study, an internet-based, longitudinal cardiovascular cohort study, who completed baseline SHS exposure and medical conditions questionnaires. SHS was assessed through a validated 22-question survey, and prevalent AF was assessed by self-report, with validation of a subset (n = 42) by review of electronic medical records. RESULTS: Of 4976 participants, 593 (11.9%) reported having AF. In unadjusted analyses, patients with AF were more likely to have been exposed to SHS in utero, as a child, as an adult, at home, and at work. After multivariable adjustment for potential confounders, having had a smoking parent during gestational development (OR 1.37, 95% CI 1.08-1.73, P = .009) and residing with a smoker during childhood (OR 1.40, 95% CI 1.10-1.79, P = .007) were each significantly associated with AF. Both positive associations were more pronounced among patients without risk factors for AF (P values for interaction <.05). CONCLUSIONS: SHS exposure during gestational development and during childhood was associated with having AF later in life. This association was even stronger in the absence of established risk factors for AF. Our findings indicate that SHS in early life may be an important, potentially modifiable risk factor for the development of AF.

Perceptions, Information Sources, and Behavior Regarding Alcohol and Heart Health.

Despite the equipoise regarding alcohol's cardiovascular effects and absence of relevant rigorous controlled trials, the lay press frequently portrays alcohol as "heart healthy." The public perception of alcohol's heart effects, the sources of those perceptions, and how they may affect behavior are unknown. We performed a cross-sectional analysis of data obtained from March 2013 to September 2014 from consecutive participants enrolled in the Health eHeart Study. Of 5,582 participants, 1,707 (30%) viewed alcohol as heart healthy, 2,157 (39%) viewed it as unhealthy, and 1,718 (31%) were unsure. Of those reporting alcohol as heart healthy, 80% cited lay press as a source of their knowledge. After adjustment, older age (odds ratio 1.11), higher education (odds ratio 1.37), higher income (odds ratio 1.07), US residence (odds ratio 1.63), and coronary artery disease (odds ratio 1.51) were associated with perception of alcohol as heart healthy (all p <0.003). Ever smokers (odds ratio 0.76, p = 0.004) and those with heart failure (odds ratio 0.5, p = 0.01) were less likely to cite alcohol as heart healthy. Those perceiving alcohol as heart healthy consumed on average 47% more alcohol on a regular basis (95% confidence interval 27% to 66%, p <0.001). In conclusion, of >5,000 consecutive Health eHeart participants, approximately 1/3 believed alcohol to be heart healthy, and the majority cited the lay press as the origin of that perception. Those with a perception of alcohol as heart healthy drink substantially more alcohol.

Remifentanil plus low-dose midazolam for outpatient sedation in transesophageal echocardiography.

BACKGROUND: The search for optimal sedation for transesophageal echocardiography (TEE) continues. We hypothesized that the ultra-short acting opioid remifentanil combined with very low-dose midazolam would provide a better sedation and recovery profile compared to midazolam alone. METHODS: 41 consecutive outpatients scheduled for TEE received either IV midazolam (group M, 2.5 mg bolus plus 1 mg increments repeated as needed, n=18) or a combination of a low-dose IV bolus of midazolam (0.5 mg) plus an infusion of remifentanil (group RM, 0.1 mcg/kg/min, reduced to 0.08 mcg/kg/min after probe insertion, n=23). All patients received topical pharyngeal anesthesia with 2 puffs of lidocaine 4% spray. We recorded BP, SpO(2), HR, time-to-discharge (modified Aldrete score of 13), duration of procedure, resource utilization, complications, ease of probe introduction, ease and quality of the procedure. Patients' satisfaction with sedation was assessed using the Iowa Satisfaction with Anesthesia Scale (ISAS). RESULTS: Mean dose of midazolam in group M was 3.7+/-1.3 mg. Median time-to-discharge was significantly reduced in the RM group compared with the M group (5 (5-10) vs. 30 (5-240) min, p<0.0001), with 22 of the 23 group RM patients ready for "street discharge" within 5 min of removal of the TEE probe. Ease of probe insertion (p=0.001), resource utilization (p=0.0001), patient satisfaction (p=0.03) and overall ease and quality of the procedure (p=0.0001) were significantly better in the RM group than in the M group. No episodes of desaturation were observed. CONCLUSIONS: This is the first report of the use of an ultra-short acting opioid, remifentanil, combined with a low-dose of midazolam, as a sedative technique for outpatient TEE. In this pilot, non-randomized prospective study, remifentanil plus low-dose midazolam provided better sedation than our current practice of higher bolus doses of midazolam alone. This novel approach is associated with improved procedure tolerance, faster recovery and minimal resource utilization. A randomized, controlled study is under way to verify our preliminary results.