Efficacy and Adherence Rates of a Novel Community-Informed Virtual World-Based Cardiac Rehabilitation Program: Protocol for the Destination Cardiac Rehab Randomized Controlled Trial.

BACKGROUND: Innovative restructuring of cardiac rehabilitation (CR) delivery remains critical to reduce barriers and improve access to diverse populations. Destination Cardiac Rehab is a novel virtual world technology-based CR program delivered through the virtual world platform, Second Life, which previously demonstrated high acceptability as an extension of traditional center-based CR. This study aims to evaluate efficacy and adherence of the virtual world-based CR program compared with center-based CR within a community-informed, implementation science framework. METHODS: Using a noninferiority, hybrid type 1 effectiveness-implementation, randomized controlled trial, 150 patients with an eligible cardiovascular event will be recruited from 6 geographically diverse CR centers across the United States. Participants will be randomized 1:1 to either the 12-week Destination Cardiac Rehab or the center-based CR control groups. The primary efficacy outcome is a composite cardiovascular health score based on the American Heart Association Life's Essential 8 at 3 and 6 months. Adherence outcomes include CR session attendance and participation in exercise sessions. A diverse patient/caregiver/stakeholder advisory board was assembled to guide recruitment, implementation, and dissemination plans and to contextualize study findings. The institutional review board-approved randomized controlled trial will enroll and randomize patients to the intervention (or control group) in 3 consecutive waves/year over 3 years. The results will be published at data collection and analyses completion. CONCLUSIONS: The Destination Cardiac Rehab randomized controlled trial tests an innovative and potentially scalable model to enhance CR participation and advance health equity. Our findings will inform the use of effective virtual CR programs to expand equitable access to diverse patient populations. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05897710.

Proximal Femur Replacements for an Oncologic Indication Offer a Durable Endoprosthetic Reconstruction Option: A 40-year Experience.

BACKGROUND: Proximal femur replacements (PFRs) are an effective surgical option to treat primary and metastatic tumors causing large bony defects in the proximal femur. Given the relative rarity of these indications, current studies on PFR for oncologic indications are generally limited by patient volume or relatively short-term follow-up. Because recent advances in systemic therapy have improved the prognosis of patients who undergo limb salvage surgery for musculoskeletal tumors, data on the long-term durability of endoprosthetic reconstructions have become increasingly important. QUESTIONS/PURPOSES: (1) How does the long-term survival of cemented bipolar PFRs compare with patient survival in patients who underwent PFR for benign, aggressive, and metastatic tumors? (2) What are common reasons for revisions of primary PFRs? (3) Which factors are associated with survival of primary PFRs? (4) What is the survivorship free from conversion of bipolar PFRs to THA? METHODS: Between January 1, 1980, and December 31, 2020, we treated 812 patients with an endoprosthetic reconstruction for an oncologic indication. All patients who underwent a primary PFR for an oncologic indication were included in this study. The study cohort consisted of 122 patients receiving a primary PFR. Eighteen patients did not reach a censored endpoint such as death, revision, or amputation within 2 years. Thirty-three patients died within 2 years of their surgery. Of the 122 patients with primary PFRs, 39 did not reach a censored endpoint and have not been seen within the past 5 years. However, the mean follow-up time for these patients was longer than 10 years. The Social Security Death Index was queried to identify any patients who may have died but might not have been captured by our database To allow for adequate follow-up, endoprosthetic reconstructions performed after December 31, 2020 were excluded. The mean age at the time of the index surgery was 48 ± 22 years. The mean follow-up time of surviving patients was 7 ± 8 years. All PFRs were performed using a bipolar hemiarthroplasty with a cemented stem, and all implants were considered comparable. Demographic, oncologic, procedural, and outcome data including prosthesis survival, patient survival, complication rates, and rates of conversion to THA were analyzed. Patient, prosthesis, and limb salvage survival rates were generated, with implant revision as the endpoint and death as a competing risk. Statistical significance was defined as p < 0.05. RESULTS: Generally, patients with benign or low-grade (Stage I) disease outlived their implants (100% patient survival through 30 years; p = 0.02), whereas the opposite was true in patients with high-grade, localized Stage II disease (64% patient survival at 5 years [95% CI 49% to 76%]; p = 0.001) or widespread Stage III metastatic disease (6.2% patient survival at 5 years [95% CI 0.5% to 24%]; p < 0.001). Primary PFR implant survival at 5, 10, 20, and 30 years was 97% (95% CI 90% to 99%), 81% (95% CI 67% to 90%), 69% (95% CI 46% to 84%), and 51% (95% CI 24% to 73%), respectively. Eight percent (10 of 122) of primary PFRs were revised for any reason. The most common causes of revision were aseptic loosening (3% [four of 122]), infection (3% [three of 122]), breakage of the implant (2% [two of 122]), and tumor progression (1% [one of 122]). Follow-up time was the only factor that was associated with revision of primary PFRs. Neither segment length nor stem length were associated with revision of primary. Six percent (seven of 122) of PFRs were converted to THA at a mean 15 ± 8 years from the index procedure. Survivorship free from conversion to THA (accounting for death as a competing risk) was 94% (95% CI 85% to 99%), 86% (95% CI 68% to 94%). and 77% (95% CI 51% to 91%) at 10, 20, and 30 years, respectively. CONCLUSION: Cemented bipolar PFRs for an oncologic indication are a relatively durable reconstruction technique. Given the relative longevity and efficacy of PFRs demonstrated in our study, especially in patients with high-grade or metastatic disease where implant survival until all-cause revision was longer than patient survival, surgeons should continue to seriously consider PFRs in appropriate patients. The relative rarity of these reconstructions limits the number of patients in this study as well as in current research; thus, further multi-institutional collaborations are needed to provide the most accurate prognostic data for our patients. LEVEL OF EVIDENCE: Level III, therapeutic study.

Novel Virtual World-Based Cardiac Rehabilitation Program to Broaden Access to Underserved Populations: A Patient Perspective.

This report describes Destination Rehab, a novel virtual world-based cardiac rehabilitation program, which aims to increase cardiac rehabilitation access to underserved populations. We highlight the experience of a cardiac patient whose successful participation in the program allowed her to overcome significant psychosocial and access barriers to cardiac rehabilitation.

Economic evaluation of a pharmacogenomic multi-gene panel test to optimize anti-hypertension therapy: simulation study.

AIMS: Hypertension is the strongest modifiable risk factor for cardiovascular disease, affecting 80 million individuals in the US and responsible for ∼360,000 deaths, at total annual costs of $93.5 billion. Antihypertension therapies guided by single genotypes are clinically more effective and may avert more adverse events than the standard of care of layering anti-hypertensive drug therapies, thus potentially decreasing costs. This study aimed to determine the economic benefits of the implementation of multi-gene panel guided therapies for hypertension from the payer perspective within a 3-year time horizon. MATERIALS AND METHODS: A simulation analysis was conducted for a panel of 10 million insured patients categorized clinically as untreated, treated but uncontrolled, and treated and controlled over a 3-year treatment period. Inputs included research data; empirical data from a 11-gene panel with known functional, heart, blood vessel, and kidney genotypes; and therapy efficacy and safety estimates from literature. Cost estimates were categorized as related to genetic testing, evaluation and management, medication, or adverse events. RESULTS: Multi-gene panel guided therapy yielding savings of $6,256,607,500 for evaluation and management, $908,160,000 for medications, and $37,467,508,716 for adverse events, after accounting for incremental genetic testing costs of $2,355,540,000. This represents total 3-year savings of $42,276,736,216, or a 47% reduction, and 3-year savings of $4,228 and annual savings of $1,409 per covered patient. CONCLUSIONS: A precision medicine approach to genetically guided therapy for hypertension patients using a multi-gene panel reduced total 3-year costs by 47%, yielding savings exceeding $42.3 billion in an insured panel of 10 million patients. Importantly, 89% of these savings are generated by averting specific adverse events and, thus, optimizing choice of therapy in function of both safety and efficacy.

Differences of energy expenditure while sitting versus standing: A systematic review and meta-analysis.

Background Replacing sitting with standing is one of several recommendations to decrease sedentary time and increase the daily energy expenditure, but the difference in energy expenditure between standing versus sitting has been controversial. This systematic review and meta-analysis aimed to determine this difference. Designs and methods We searched Ovid MEDLINE, Ovid Embase Scopus, Web of Science and Google Scholar for observational and experimental studies that compared the energy expenditure of standing versus sitting. We calculated mean differences and 95% confidence intervals using a random effects model. We conducted different predefined subgroup analyses based on characteristics of participants and study design. Results We identified 658 studies and included 46 studies with 1184 participants for the final analysis. The mean difference in energy expenditure between sitting and standing was 0.15 kcal/min (95% confidence interval (CI) 0.12-0.17). The difference among women was 0.1 kcal/min (95% CI 0.0-0.21), and was 0.19 kcal/min (95% CI 0.05-0.33) in men. Observational studies had a lower difference in energy expenditure (0.11 kcal/min, 95% CI 0.08-0.14) compared to randomised trials (0.2 kcal/min, 95% CI 0.12-0.28). By substituting sitting with standing for 6 hours/day, a 65 kg person will expend an additional 54 kcal/day. Assuming no increase in energy intake, this difference in energy expenditure would be translated into the energy content of about 2.5 kg of body fat mass in 1 year. Conclusions The substitution of sitting with standing could be a potential solution for a sedentary lifestyle to prevent weight gain in the long term. Future studies should aim to assess the effectiveness and feasibility of this strategy.

Supervised, Vigorous Intensity Exercise Intervention for Depressed Female Smokers: A Pilot Study.

INTRODUCTION: Few studies have evaluated exercise interventions for smokers with depression or other psychiatric comorbidities. This pilot study evaluated the potential role of supervised vigorous exercise as a smoking cessation intervention for depressed females. METHODS: Thirty adult women with moderate-severe depressive symptoms were enrolled and randomly assigned to 12 weeks of thrice weekly, in person sessions of vigorous intensity supervised exercise at a YMCA setting (EX; n = 15) or health education (HE; n = 15). All participants received behavioral smoking cessation counseling and nicotine patch therapy. Assessments were done in person at baseline, at the end of 12 weeks of treatment, and at 6 months post-target quit date. Primary end points were exercise adherence (proportion of 36 sessions attended) and biochemically confirmed 7-day point prevalence abstinence at Week 12. Biomarkers of inflammation were explored for differences between treatment groups and between women who smoked and those abstinent at Week 12. RESULTS: Treatment adherence was high for both groups (72% for EX and 66% for HE; p = .55). The Week 12 smoking abstinence rate was higher for EX than HE (11/15 [73%] vs. 5/15 [33%]; p = .028), but no significant differences emerged at 6-month follow-up. Interleukin-6 levels increased more for those smoking than women abstinent at Week 12 (p = .040). CONCLUSIONS: Vigorous intensity supervised exercise is feasible and enhances short-term smoking cessation among depressed female smokers. Innovative and cost-effective strategies to bolster long-term exercise adherence and smoking cessation need evaluation in this population. Inflammatory biomarkers could be examined in future research as mediators of treatment efficacy. IMPLICATIONS: This preliminary study found that vigorous intensity supervised exercise is feasible and enhances short-term smoking cessation among depressed female smokers. This research addressed an important gap in the field. Despite decades of research examining exercise interventions for smoking cessation, few studies were done among depressed smokers or those with comorbid psychiatric disorders. A novel finding was increases in levels of a pro-inflammatory biomarker observed among women who smoked at the end of the intervention compared to those who did not.

Noninvasive assessment of cardiac output by brachial occlusion-cuff technique: comparison with the open-circuit acetylene washin method.

Cardiac output (CO) assessment as a basic hemodynamic parameter has been of interest in exercise physiology, cardiology, and anesthesiology. Noninvasive techniques available are technically challenging, and thus difficult to use outside of a clinical or laboratory setting. We propose a novel method of noninvasive CO assessment using a single, upper-arm cuff. The method uses the arterial pressure pulse wave signal acquired from the brachial artery during 20-s intervals of suprasystolic occlusion. This method was evaluated in a cohort of 12 healthy individuals (age, 27.7 ± 5.4 yr, 50% men) and compared with an established method for noninvasive CO assessment, the open-circuit acetylene method (OpCirc) at rest, and during low- to moderate-intensity exercise. CO increased from rest to exercise (rest, 7.4 ± 0.8 vs. 7.2 ± 0.8; low, 9.8 ± 1.8 vs. 9.9 ± 2.0; moderate, 14.1 ± 2.8 vs. 14.8 ± 3.2 l/min) as assessed by the cuff-occlusion and OpCirc techniques, respectively. The average error of experimental technique compared with OpCirc was -0.25 ± 1.02 l/min, Pearson's correlation coefficient of 0.96 (rest + exercise), and 0.21 ± 0.42 l/min with Pearson's correlation coefficient of 0.87 (rest only). Bland-Altman analysis demonstrated good agreement between methods (within 95% boundaries); the reproducibility coefficient (RPC) = 0.84 l/min with R2 = 0.75 at rest and RPC = 2 l/min with R2 = 0.92 at rest and during exercise, respectively. In comparison with an established method to quantify CO, the cuff-occlusion method provides similar measures at rest and with light to moderate exercise. Thus, we believe this method has the potential to be used as a new, noninvasive method for assessing CO during exercise.

Prognostic value of resting pulmonary function in heart failure.

BACKGROUND: The heart and lungs are intimately linked anatomically and physiologically, and, as a result, heart failure (HF) patients often develop changes in pulmonary function. This study examined the prognostic value of resting pulmonary function (PF) in HF. METHODS AND RESULTS: In all, 134 HF patients (enrolled from January 1, 1999 Through December 31, 2005; ejection fraction (EF) = 29% ± 11%; mean age = 55 ± 12 years; 65% male) were followed for 67 ± 34 months with death/transplant confirmed via the Social Security Index and Mayo Clinic registry. PF included forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), diffusing capacity of the lungs for carbon monoxide (DLCO), and alveolar volume (VA). Patients were divided in tertiles according to PF with survival analysis via log-rank Mantel-Cox test with chi-square analysis. Groups for FVC included (1) >96%, (2) 96% to 81%, and (3) <81% predicted (chi-square = 18.9, P < 0.001). Bonferroni correction for multiple comparisons (BC) suggested differences between groups 1 and 3 (P < 0.001) and 2 and 3 (P = 0.008). Groups for FEV1 included (1) >94%, (2) 94% to 77%, and (3) <77% predicted (chi-square = 17.3, P <0.001). BC suggested differences between groups 1 and 3 (P <0.001). Groups for DLCO included (1) >90%, (2) 90% to 75%, and (3) <75% predicted (chi-square = 11.9, P = 0.003). BC suggested differences between groups 1 and 3 (P < 0.001). Groups for VA included (1) >97%, (2) 97% to 87%, and (3) <87% predicted (Chi-square = 8.5, P = 0.01). BC suggested differences between groups 1 and 2 (P = 0.014) and 1 and 3 (P = 0.003). CONCLUSIONS: In a well-defined cohort of HF patients, resting measures of PF are predictive of all-cause mortality.

A health survey of a colonia located on the west Texas, US/Mexico border.

Little is known about how health disparities affect the health status and general health perceptions of Hispanics living in Texas colonias. The purpose of this study was to conduct a health survey of residents (n = 216) of a colonia community on the border between El Paso, Texas and Juarez, Mexico. Instruments used in this study included a researcher developed demographic questionnaire, the Short Acculturation Scale for Hispanics (SASH), Cutting down, Annoyance by criticism, Guilty feeling and Eye-openers (CAGE) for alcohol consumption, and the Short Form version 2 (SF36v2) health survey. Study findings show the average participant was approximately 42 years old, attained an average of 9.6 years of education, earned an average annual household income of $17,575 and had an average SASH score of 25.4. SASH scores range from 12 to 60, with higher scores suggesting higher levels of American acculturation. Findings from this health survey suggest the average resident of the colonia may have health disadvantages when compared to residents from other parts of El Paso and Texas. Binge drinking was self-reported by 13.4% of all participants; with 5.6% having a CAGE score greater than 2 (indicating an increased propensity towards problems with alcohol). The self-report rates of diabetes, depression and anxiety were 15.3%, 20.4% and 16.7% respectively. The SF36v2 composite functional health status scores mirrored the national norms.

Diabetes prevalence and treatment adherence in residents living in a colonia located on the West Texas, USA/Mexico border.

Little is known about how diabetes affects the health status of Hispanic people living in colonias located along the USA/Mexico border. The purpose of this report is to describe the demographic factors, prevalence of diabetes, and the health status of the residents living in a colonia on the border between El Paso, Texas, USA, and Juarez, Mexico, and to report the residents' adherence to the Behavioral Risk Factor Surveillance System (BRFSS) protocols for the management of type 2 diabetes. This study included 188 participants. The instruments used included a demographic questionnaire, the Short Acculturation Scale for Hispanics, "Cutting Down, Annoyance by Criticism, Guilty Feelings, and Eye-openers", BRFSS, and the Short Form-36 (v2). The prevalence of diabetes was 15.4% and 41.3% of the residents had a Body Mass Index score > 30. The rate of hypertension, elevated cholesterol, and depression for those reporting diabetes was significant. The SF-36 v2 physical score for the diabetic residents was 42.9 and it was 52.4 for the non-diabetic residents. The average resident of the colonia who reports diabetes has many health disadvantages when compared to those in other parts of Texas and the USA generally.