Reproducibility and validity of a novel invasive method of assessing peripheral microvascular vasomotor function.

In healthy arteries, blood flow is regulated by microvascular tone assessed by changes in blood flow volume and vascular resistance to endothelium-dependent and -independent vasodilators. We developed a novel method of using intravascular ultrasound (IVUS) and a Doppler flow wire to measure changes in blood flow volume and vascular resistance of the profunda arterial bed. We assessed the variability over 6 months in measuring microvascular endothelium-dependent dilation to acetylcholine and endothelium-independent dilation to adenosine in 20 subjects who were part of a larger study of Gulf War Illness without obstructive peripheral artery disease. Vasomotor function was assessed by Infusions of control (dextrose), acetylcholine (10-6M), adenosine (50µg), and nitroglycerin (25µg/ml). 400 IVUS and 240 flow velocity images were measured a mean 6 (SD = 2) months apart blind to measurement and infusion stage. The mean (SD) baseline profunda flow was 227 (172) ml/min and vascular resistance 4.6 x 104 (2.4 x 104) dynes-s/cm5. The intraclass correlation coefficients for 6-month variability for vascular function were excellent (range 0.827-0.995). Bland-Altman analyses showed mean differences of less than 2% for microvascular endothelium-dependent function (flow volume and resistance) and less than 1% for macrovascular endothelium-dependent function with acceptable limits of agreement. In 49 subjects assessing concurrent validity of the technique against atherosclerosis risk factors, we observed greater impairment in microvascular endothelium-dependent function per year of age (flow volume = -1.4% (p = 0.018), vascular resistance = 1.5% (p = 0.015)) and current smoking (flow volume = -36.7% (p = .006), vascular resistance = 50.0% (p<0.001)). This novel method of assessing microvascular vasomotor function had acceptable measurement reproducibility and validity.

Impact of patient-centred home telehealth programme on outcomes in heart failure.

BACKGROUND: Telehealth is a promising intervention to reduce readmissions and healthcare-associated costs in patients with heart failure. METHODS: We performed a retrospective analysis of the impact of telehealth on 197 heart failure patients who had successfully completed one year of home telehealth monitoring following a heart failure admission as part of a clinically mandated programme at a Veterans Affairs Medical Center. Outcomes were compared both within the group (one year before and one year after home telehealth monitoring), and to a contemporary control cohort of 870 heart failure patients who were admitted but not enrolled in home telehealth. The following outcomes were analysed: admissions for any cause, heart failure admissions, total hospital days per patient, average length of stay per admission, urgent care and emergency room visits, and primary care visits. RESULTS: Both the home telehealth and control cohorts consisted of older male patients. Total hospital days per patient was significantly reduced by home telehealth monitoring in the home telehealth group (2.4 ± 3.5) in comparison to the previous year without monitoring (4.1 ± 4.6, p < 0.0001) and to the control group (3.8 ± 5.3, p < 0.001). A significantly lower admission rate (1.1 ± 1.6) and length of stay (5.7 ± 11.3 days) were observed during home telehealth monitoring within the home telehealth group compared to the prior year (1.6 ± 1.7, p < 0.05 and 9.5 ± 14 days, p < 0.01 respectively) but not in comparison with the control group (1.4 ± 2.0, p < 0.07). The home telehealth group also had a significantly lower length of stay when compared to the control group (5.7 ± 11.3 vs 9.0 ± 14.9, p < 0.01). The number of urgent care and emergency room visits, or primary care visits, was not significantly different during home telehealth monitoring as compared to the prior year. CONCLUSIONS: Personalised and patient-centred home telehealth monitoring in heart failure patients was successful in reducing outcomes without an increase in outpatient and urgent care visits.

Development of a plain-language library of educational resources for research participants.

There is a paucity of educational resources for potential clinical trial participants, particularly resources in plain language, attentive to health literacy principles and translated into native languages. The New England Research Subject Advocacy Group was formed to explore common issues, interests, and concerns related to the experience of participation in clinical research and research participant safety. Specifically, the group sought to increase community awareness and trust through the development and distribution of publicly accessible informational resources. In support of these aims, the group developed a robust library of high-quality, plain-language educational materials covering topics in health research, research participation, and common research procedures, and translated the majority of the materials into an additional 15 languages. These resources have been downloaded over 130,000 times. After English, the most common languages downloaded are Vietnamese, Spanish, and Korean.

Long-term outcomes in patients with acute coronary syndromes related to prolonging dual antiplatelet therapy more than 12 months after coronary stenting.

OBJECTIVES: To assess the impact of stent type on the risk of death or myocardial infarction (MI) related to dual antiplatelet therapy (DAPT) more than 12 months (prolonged DAPT) versus 12 or less months after PCI for an acute coronary syndrome (ACS). BACKGROUND: The recent DAPT study reported lower recurrent ischemic events from prolonged DAPT in patients treated with PCI for an ACS, but was underpowered to determine the impact of stent type. METHODS: We determined clinical outcomes after PCI for an ACS (median follow-up: DES = 26 months, BMS = 46 months) in 18,484 patients in the Veterans Affairs system treated with first generation drug-eluting stents (DES) or bare-metal stents (BMS). We used landmark analyses starting 1 year after the index PCI to assess the risk of prolonged DAPT on the primary endpoint of death or MI. Multivariable and propensity models adjusted for confounding. RESULTS: There was a significant interaction between stent type and prolonged DAPT for death and MI (P = 0.0036), death (P = 0.054), and major bleeding (P = 0.0013). Patients treated with prolonged DAPT had lower risks of death or MI (HR = 0.71, 95% CI = 0.61, 0.82) and death (HR = 0.74, 95%CI = 0.62, 0.89) with DES, but not BMS, and higher risks of major bleeding, particularly with BMS (HR = 1.67, P < 0.001) than DES (HR = 1.24, p = 0.01). CONCLUSIONS: Prolonging DAPT more than 12 months after PCI for ACS only associated with a lower risk of ischemic events in the 1-4 years after PCI in those receiving first generation DES. Stent type may influence the benefit of prolonged DAPT. © 2016 Wiley Periodicals, Inc.