Remote Therapy to Improve Outcomes in Lung Transplant Recipients: Design of the INSPIRE-III Randomized Clinical Trial.

BACKGROUND: Impaired functional capacity and emotional distress are associated with lower quality of life (QoL) and worse clinical outcomes in post lung transplant patients. Strategies to increase physical activity and reduce distress are needed. METHODS: The Investigational Study of Psychological Interventions in Recipients of Lung Transplant-III study is a single site, parallel group randomized clinical trial in which 150 lung transplant recipients will be randomly assigned to 3 months of telephone-delivered coping skills training combined with aerobic exercise (CSTEX) or to a Standard of Care plus Education control group. The primary endpoints are a global measure of distress and distance walked on the 6-Minute Walk Test. Secondary outcomes include measures of transplant-specific QoL, frailty, health behaviors, and chronic lung allograft dysfunction-free survival. RESULTS: Participants will be evaluated at baseline, at the conclusion of 3 months of weekly treatment, at 1-year follow-up, and followed annually thereafter for clinical events for up to 4 years (median = 2 y). We also will determine whether functional capacity, distress, and health behaviors (eg, physical activity, medication adherence, and volume of air forcefully exhaled in 1 second (FEV1), mediate the effects of the CSTEX intervention on clinical outcomes. CONCLUSIONS: Should the CSTEX intervention result in better outcomes compared with the standard of care plus post-transplant education, the remotely delivered CSTEX intervention can be made available to all lung transplant recipients as a way of enhancing their QoL and improving clinical outcomes.

Neurocognition in treatment-resistant hypertension: profile and associations with cardiovascular biomarkers.

BACKGROUND: Hypertension in midlife has been associated with increased risk of stroke and neurocognitive decline. Few studies, however, have examined neurocognition among individuals with treatment-resistant hypertension or potential mechanisms by which treatment-resistant hypertension may impair neurocognition. METHODS: We examined the pattern of neurocognitive impairment and potential mechanisms in a sample of 96 overweight adults with treatment-resistant hypertension, aged 41-81 years. Neurocognitive function was assessed using a 45-min test battery consisting of executive function and memory. Vascular and metabolic mechanisms examined included cerebrovascular risk factors (CVRFs: Framingham Stroke Risk Profile), insulin sensitivity (homeostatic model assessment of insulin resistance), waist-to-hip ratio, microvascular function (hyperemic response), and peak oxygen consumption from an exercise treadmill test. Simple path analyses were used to assess the association between potential vascular and metabolic mechanisms and neurocognition. RESULTS: Neurocognitive impairments were common, with 70% of the sample exhibiting impaired performance on at least one executive function subtest and 38% on at least one measure of memory. Higher levels of aerobic fitness, greater insulin sensitivity, and better microvascular function, as well as lower CVRFs and waist-to-hip ratio were associated with better neurocognition. In path analyses, aerobic fitness, microvascular function, and CVRFs all were independently associated with neurocognitive performance. Insulin resistance associated with worse executive function but better memory performance among older participants. CONCLUSION: Neurocognitive impairments are common in adults with treatment-resistant hypertension, particularly on tests of executive function. Better neurocognition is independently associated with aerobic fitness, microvascular function, and CVRFs.

Effects of Coping Skills Training on Quality of Life, Disease Biomarkers, and Clinical Outcomes in Patients With Heart Failure: A Randomized Clinical Trial.

BACKGROUND: Heart failure (HF) is a chronic disease that compromises patients' quality of life (QoL). Interventions designed to reduce distress and improve disease self-management are needed. We evaluated the efficacy of a telephone-based coping skills training (CST) intervention. METHODS AND RESULTS: This randomized clinical trial involved 180 HF outpatients with reduced ejection fraction. Participants ranged in age from 29 to 87 years (mean=58 years); 27% were women, and 47% were nonwhite. Participants were randomized to either a CST intervention or heart failure education, both delivered over 16 weeks. The primary outcomes were (1) postintervention effects on QoL and HF disease biomarkers (both with α=0.01), and (2) a composite measure of time to death or first hospitalization (with α=0.03) over a median follow-up period of 3 years. CST resulted in greater improvements in QoL compared with heart failure education (P<0.01), including the Kansas City Cardiomyopathy Questionnaire (P=0.009), depressive symptoms (P=0.027), and the 6-minute walk test (P=0.012). However, it did not differentially improve HF disease biomarkers or reduce risk of all-cause hospitalizations or death (hazard ratio=0.84 [95% confidence interval, 0.59-1.12]). Interestingly, exploratory analyses showed that participants randomized to CST experienced a reduction in the composite end point of worsening HF hospitalization or death during the 3-year follow-up period (hazard ratio=0.65 [95% confidence interval, 0.44-0.98]; P=0.040). CONCLUSIONS: CST improved QoL in patients with HF. Monitoring and improving QoL is emerging as an important aspect of the clinical management of HF that can reduce disease burden and may help improve clinical outcomes in this vulnerable patient population. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00873418.

Utility and safety of axillo-subclavian venous imaging with carbon dioxide (CO) prior to chronic lead system revisions.

BACKGROUND: Prior to attempting placement of one or more electrodes to revise existing rhythm control devices, patency of the central veins should be documented, in view of a high incidence of significant chronic occlusions. Since iodinated contrast venography may be contraindicated in select situations, imaging of the axillo-subclavian venous system with gaseous carbon dioxide (CO(2)) was evaluated prospectively in 23 consecutive individuals who were considered for revision of previously implanted pacemaker or automatic cardioverter defibrillator lead systems. METHODS: Approximately 20 mL of CO(2) were manually infused via CO(2) primed injection tubing into a vein at or above the level of the antecubital fossa ipsilateral to the side of prior lead placements. Digital subtraction imaging over the axillo-subclavian region, lower neck, and mediastinum was performed. Formal interpretation was obtained from one of three interventional radiologists and at least one electrophysiologist. RESULTS: Significant venous occlusions were identified in five (22%) patients. Vascular access utilized for the subsequent 18 revisions performed included the imaged patent ipsilateral vein in 14 patients and the contralateral, right-sided subclavian venous system in three patients. One patient required epicardial left ventricular lead placement. There were no complications from venography. CONCLUSIONS: Axillo-subclavian venography with gaseous CO(2) in patients undergoing pacemaker or implantable cardioverter defibrillator lead revisions is feasible and safe when use of iodinated dye is contraindicated. This technique should be employed in patients with azotemia, dye contrast allergies, or significant inflammation in the vicinity of the intravenous line insertion.

The chain of cross-contamination: link-by-link.

Conscious efforts must be made to break the chain of cross-contamination--link-by-link. Pay attention to detail Avoid being careless Avoid touching objects while wearing soiled gloves Frequently wash hands (15-second hand washing) to remove pathogens--before and after gloving, and before handling food or drink Wear all PPE, and change accordingly.