Enhancing mHealth Technology in the Patient-Centered Medical Home Environment to Activate Patients With Type 2 Diabetes: A Multisite Feasibility Study Protocol.

BACKGROUND: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow. OBJECTIVE: We aim to address underlying technology needs and gaps related to the use of mHealth technology and the activation of patients living with type 2 diabetes. Stated differently, we enable supporting technologies while seeking to influence patient activation and self-care activities. METHODS: This is a multisite phased study, conducted within the US Military Health System, that includes a user-centered design phase and a PCMH-based feasibility trial. In phase 1, we will assess both patient and provider preferences regarding the enhancement of the enabling technology capabilities for type 2 diabetes chronic care management. Phase 2 research will be a single-blinded 12-month feasibility study that incorporates randomization principles. Phase 2 research will seek to improve patient activation and self-care activities through the use of the Mobile Health Care Environment with tailored behavioral messaging. The primary outcome measure is the Patient Activation Measure scores. Secondary outcome measures are Summary of Diabetes Self-care Activities Measure scores, clinical measures, comorbid conditions, health services resource consumption, and technology system usage statistics. RESULTS: We have completed phase 1 data collection. Formal analysis of phase 1 data has not been completed. We have obtained institutional review board approval and began phase 1 research in late fall 2016. CONCLUSIONS: The study hypotheses suggest that patients can, and will, improve their activation in chronic care management. Improved activation should translate into improved diabetes self-care. Expected benefits of this research to the scientific community and health care services include improved understanding of how to leverage mHealth technology to activate patients living with type 2 diabetes in self-management behaviors. The research will shed light on implementation strategies in integrating mHealth into the clinical workflow of the PCMH setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT02949037. https://clinicaltrials.gov/ct2/show/NCT02949037. (Archived by WebCite at http://www.webcitation.org/6oRyDzqei).

Assessment of major adverse cardiovascular events and ischemic stroke with coronary computed tomography angiography based upon angiographic diagnosis in a high-volume single center.

BACKGROUND: Patient prognosis has been shown to directly correlate with the severity of coronary artery disease diagnosed by coronary computed tomography angiography (CCTA). Although the presence of coronary artery calcium has been associated with increased incidence of ischemic stroke, there are no data on the incidence of ischemic stroke based upon the severity of coronary artery disease by CCTA. Therefore, we sought to investigate the rate of major adverse cardiovascular events, including ischemic stroke, based upon the severity of coronary artery disease by CCTA over a 6-year period in a high-volume single military center. METHODS: We performed a retrospective chart review of all CCTA studies to evaluate the incidence of all-cause mortality, non-fatal myocardial infarction, ischemic stroke, and late revascularization (>90 days following CCTA) from January 2005 until July 2012. We reviewed 1518 CCTA reports, dividing patients into groups with obstructive (≥50% stenosis), non-obstructive (<50% stenosis), and no coronary artery disease (no angiographic disease). Subsequent major adverse cardiovascular events data (incidence of all-cause mortality, ischemic stroke, non-fatal myocardial infarction, and late revascularization) were obtained. RESULTS: Over a review period of 6 years with a resultant median follow-up period of 22 months (interquartile range = 13-34 months), the major adverse cardiovascular events rate was significantly higher with obstructive coronary artery disease compared to both non-obstructive coronary artery disease and no coronary artery disease (8.9% vs 0.7%, p < 0.001; 8.9% vs 1.6%, p < 0.001). The incidence of ischemic stroke alone was also significantly higher in those with obstructive coronary artery disease compared to those with no coronary artery disease (3.8% vs 0.4%, p < 0.001). CONCLUSION: Being free of disease on CCTA was associated with excellent cardiovascular prognosis. Obstructive coronary artery disease was associated with a significantly increased incidence of ischemic stroke. There was also a direct correlation between the severity of coronary artery disease on CCTA and cardiovascular prognosis over the follow-up period of 24 months.

Thermogenic supplement use does not alter characteristics of sudden death in the young.

BACKGROUND: To evaluate supplement use, most notably ephedra, which has been temporally associated with sudden death. Animal models suggest increased myocardial irritability may predispose to primary arrhythmic death. METHODS: Clinical, pathological, and investigative records from the Office of the Armed Forces Medical Examiner's Cardiovascular Death Registry were reviewed. Forty-eight cases of those with known supplement use were compared to 144 age-, gender-, and socioeconomic-matched controls in a 1:3 case:control manner. RESULTS: Of the 48 sudden deaths temporally associated with supplement use, the mean age was 34.2 ± 10.0 years and predominantly male (n = 44, 91.7%). The underlying cause of death was fatal atherosclerotic coronary disease in 18 (37.5%), sudden unexplained death in 16 (33.3%), and hypertrophic cardiomyopathy in six (12.5%). Compared with controls, there were no statistically significant differences in adjudicated cause of death. On autopsy, there were no differences in cardiac mass, ventricular wall thickness, or presence of atherosclerosis in those known to be taking identified supplements compared to a control population. In the subject ≥35 years, and known to be taking supplements, there was a significant increase in causality of death as due to sudden unexplained death (relative risk = 5.1 [95% confidence interval, 1.4-18.7]). CONCLUSIONS: Active surveillance of mortality in an autopsy-derived series of young adults finds atherosclerotic coronary disease and idiopathic sudden death are common etiologies of death when taking supplements, but no cardiac structural or histologic mechanism to suggest different pathologic process than a matched control population.

Computed tomography coronary angiography versus stress myocardial perfusion imaging for risk stratification in patients with high occupational risk.

PURPOSE: To compare the performance of myocardial perfusion imaging (MPI) versus cardiac computed tomographic angiography (CCTA) in patients with a low pretest likelihood of obstructive coronary artery disease and high-risk occupation. MATERIALS AND METHODS: We performed a retrospective chart review of all MPI and CCTA studies performed at our institution from January 2006 to May 2008. The primary outcome measure was the incidence of referral to invasive coronary angiography (ICA). RESULTS: There were 512 MPS and 170 CCTA studies performed during the study period that met the study criteria. The average age was 35±10 for the CCTA arm and 45±5 for the myocardial perfusion scans (MPS) arm, which was statistically significant (P<0.001), with similar sex distribution between the 2 arms (21% female patients in the MPI arm and 20% female patients in the CCTA arm). The incidence of referral to ICA was 15.8% (81/512) after MPS versus 2.4% (4/170) with CCTA (P<0.001). Among patients referred for ICA, the false-positive rate was 93% (75/81) and 50% (2/4) with MPI and CCTA, respectively (P=0.043). CONCLUSIONS: Compared with MPI, CCTA significantly reduced ICA referral and false-positive noninvasive imaging rates among symptomatic patients with a low probability of coronary artery disease but high occupational risk.

Sudden death in young adults: an autopsy-based series of a population undergoing active surveillance.

OBJECTIVES: The purpose of this study was to define the incidence and characterization of cardiovascular cause of sudden death in the young. BACKGROUND: The epidemiology of sudden cardiac death (SCD) in young adults is based on small studies and uncontrolled observations. Identifying causes of sudden death in this population is important for guiding approaches to prevention. METHODS: We performed a retrospective cohort study using demographic and autopsy data from the Department of Defense Cardiovascular Death Registry over a 10-year period comprising 15.2 million person-years of active surveillance. RESULTS: We reviewed all nontraumatic sudden deaths in persons 18 years of age and over. We identified 902 subjects in whom the adjudicated cause of death was of potential cardiac etiology, with a mean age of 38 ± 11 years. The mortality rate for SCD per 100,000 person-years for the study period was 6.7 for males and 1.4 for females (p < 0.0001). Sudden death was attributed to a cardiac condition in 715 (79.3%) and was unexplained in 187 (20.7%). The incidence of sudden unexplained death (SUD) was 1.2 per 100,000 person-years for persons <35 years of age, and 2.0 per 100,000 person-years for those ≥ 35 years of age (p < 0.001). The incidence of fatal atherosclerotic coronary artery disease was 0.7 per 100,000 person-years for those <35 years of age, and 13.7 per 100,000 person-years for those ≥ 35 years of age (p < 0.001). CONCLUSIONS: Prevention of sudden death in the young adult should focus on evaluation for causes known to be associated with SUD (e.g., primary arrhythmia) among persons <35 years of age, with an emphasis on atherosclerotic coronary disease in those ≥ 35 years of age.

The effect of airway pressure release ventilation on pulmonary catheter readings: specifically pulmonary capillary wedge pressure in a Swine model.

Background. Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that theoretically believed to improve cardiac output by lowering right atrial pressure. However, hemodynamic parameters have never been formally assessed. Methods. Seven healthy swine were intubated and sedated. A baseline assessment of conventional ventilation (assist control) and positive end-expiratory pressure (PEEP) of 5 cm H(2)O was initiated. Ventilator mode was changed to APRV with incremental elevations of CPAP-high from 10 to 35 cm H(2)O. After a 3-to-5-minute stabilization period, measurements of hemodynamic parameters (PCWP, LAP, and CVP) were recorded at each level of APRV pressure settings. Results. Increasing CPAP caused increased PCWP and LAP measurements above their baseline values. Mean PCWP and LAP were linearly related (LAP = 0.66(∗)PCWP + 4.5 cm H(2)O, R(2) = 0.674, and P < .001) over a wide range of high and low CPAP values during APRV. With return to conventional ventilation, PCWP and LAP returned to their baseline values. Conclusion. PCWP is an accurate measurement of LAP during APRV over variable levels of CPAP. However, PCWP and LAP may not be accurate measurements of volume when CPAP is utilized.

Coronary thrombus detected by cardiac CT angiography before cardiac catheterization.

A patient presented with a complaint of pleuritic chest discomfort with elevated cardiac biomarkers. After a cardiac magnetic resonance imaging scan for the suspicion of myopericarditis showed a potential myocardial infarct, a coronary CT scan was performed. This revealed a thrombus of the left anterior descending artery. Cardiac catheterization confirmed the findings, and a small clot was removed. To our knowledge, this is the first reported case of coronary thrombus being detected by CT angiography with cardiac catheterization correlation. Coronary CT angiography has been increasingly used to evaluate acute chest pain with a negative predictive value close to 100%. In a young patient with suspicion of myopericarditis, CT angiography proved to be useful in diagnosing thrombus in the coronary tree.

Differential manifestation of cardiovascular complaints as a function of utilization of ergogenic supplements.

INTRODUCTION: The rate of use of dietary supplements among young adults is significant. While the military makes significant restrictions on the use of certain pharmacologic drugs and actively tests for illegal drugs in a deployed environment, there is a near-unlimited supply of body-enhancing supplements available at military exchanges to deployed personnel. By emphasizing physical performance and providing these for purchase, the military leadership, perhaps unknowingly, endorses the use of these products. Cardiovascular symptoms represent one of the leading nontraumatic causes of aeromedical evacuation from a combat zone. Whether the use of supplements is associated with a differential presentation to cardiovascular complaint is unknown. METHODS: Retrospective review using the US Department of Defense Military Health System data, we identified patients evaluated for cardiovascular complaints of syncope or palpitations while deployed to Iraq and Afghanistan. RESULTS: There were 905 US military personnel who presented with complaint of syncope or palpitations (mean age 31 +/- 10 years, 77% male). There were 83 (9.2%) who self-reported taking an ergogenic supplement. The incidence of reported use of supplements among males was 10.8%, which was significantly higher than its use among females at 3.8% (P = 0.001). In those >30 years, those on supplements had a higher resting pulse (90 +/- 28 vs 79 +/- 24 beats/min, P = 0.032), and the incidence of resting tachycardia was three-fold higher (35.0% vs 11.4%, P = 0.008). Supplement use was seen in 12.3% of those who presented with palpitations, which was significantly higher than those who presented without palpitations (7.8%, P = 0.043). In those taking supplements, symptoms were more likely during exertion (26.5% vs 15.0%, P < 0.001), and immediately postexertional (13.2% vs 4.6%, P < 0.001). An electrocardiogram was suggestive of diagnosis in 103 (16.3%), while head computed tomography, treadmill, and echocardiogram had no diagnostic utility in this patient population. DISCUSSION: In a healthy population serving within a combat zone, there exists a differential expression of disease in those taking supplements. Further study of a prospective nature to determine the impact of supplement use in this environment may allow for a more refined policy toward use and medical evaluation.

The Effects of Extended Release Niacin in Combination with Omega 3 Fatty Acid Supplements in the Treatment of Elevated Lipoprotein (a).

Objective. To assess the effectiveness of niacin/fish oil combination therapy in reducing Lipoprotein (a) [Lp(a)] levels after twelve weeks of therapy. Background. Lipoprotein (a) accumulates in atherosclerotic lesions and promotes smooth muscle cell growth and is both atherogenic and thrombogenic. A clinical trials of combination therapy for the reduction of Lp(a) has not been previously reported. Methods. The study was an observational study following subjects with an elevated Lp(a) (>70 nmol/L) to assess impact of 12 weeks of combination Omega 3FA, niacin, and the Mediterranean diet on Lp(a). Results. Twenty three patients were enrolled with 7 patients lost to follow up and 2 patients stopped due to adverse events. The average Lp(a) reduction in the remaining 14 subjects after 12 weeks of combination therapy was 23% ± 17% [P = .003] with a significant association of the reduction of Lp(a) with increasing baseline levels of Lp(a) [R(2) = 0.633, P = .001]. Conclusions. There was a significant reduction in Lp(a) levels with combination therapy. A more pronounced effect was noted in patients with higher baseline levels of Lp(a).

Transcatheter cardiac fistula repair with the Amplatzer Duct Occluder: a case report and review.

BACKGROUND: Clinically significant cardiac fistulas occur rarely and traditionally are surgically repaired. We describe the first known case of percutaneous closure of a left ventricular outflow tract (LVOT) to left atrium (LA) fistula formed as the result of aortic valve replacement surgery. CASE REPORT: The patient was an 86-year-old woman with a history of aortic valve replacement who began complaining of shortness of breath 7 years later. Initially she was misdiagnosed as having mitral regurgitation. However, a transesophageal echocardiography (TEE) showed the presence of a 7.5 mm fistula between her LVOT and LA, producing a large regurgitant jet. As she was not a good surgical candidate, she underwent percutaneous closure. An Amplatzer Duct Occluder 9-PDA-006 (10 mm x 8 mm) device was successfully deployed in the fistula using TEE guidance. On follow-up, the patient described marked improvement of her symptoms. DISCUSSION: In the rare case of cardiac fistulas that are deemed high risk for surgical intervention, a percutaneous approach with an occlusive device offers promise in treating these patients.