Cardiac Rehabilitation During the COVID-19 Pandemic and the Potential for Digital Technology to Support Physical Activity Maintenance: Qualitative Study.

BACKGROUND: Social distancing from the COVID-19 pandemic may have decreased engagement in cardiac rehabilitation (CR) and may have had possible consequences on post-CR exercise maintenance. The increased use of technology as an adaptation may benefit post-CR participants via wearables and social media. Thus, we sought to explore the possible relationships of both the pandemic and technology on post-CR exercise maintenance. OBJECTIVE: This study aimed to (1) understand CR participation during the COVID-19 pandemic, (2) identify perceived barriers and facilitators to physical activity after CR completion, and (3) assess willingness to use technology and social media to support physical activity needs among older adults with cardiovascular disease. METHODS: We recruited participants aged 55 years and older in 3 different CR programs offered at both public and private hospitals in Northern California. We conducted individual interviews on CR experiences, physical activity, and potential for using technology. We used thematic analysis to synthesize the data. RESULTS: In total, 22 participants (n=9, 41% female participants; mean age 73, SD 8 years) completed in-depth interviews. Themes from participants' feedback included the following: (1) anxiety and frustration about the wait for CR caused by COVID-19 conditions, (2) positive and safe participant experience once in CR during the pandemic, (3) greater attention needed to patients after completion of CR, (4) notable demand for technology during the pandemic and after completion of CR, and (5) social media networking during the CR program considered valuable if training is provided. CONCLUSIONS: Individuals who completed CR identified shared concerns about continuing physical activity despite having positive experiences during the CR program. There were significant challenges during the pandemic and heightened concerns for safety and health. The idea of providing support by leveraging digital technology (wearable devices and social media for social support) resonated as a potential solution to help bridge the gap from CR to more independent physical activity. More attention is needed to help individuals experience a tailored and safe transition to home to maintain physical activity among those who complete CR.

Cost Analysis of Remote Cardiac Rehabilitation Compared With Facility-Based Cardiac Rehabilitation for Coronary Artery Disease.

Remote cardiac rehabilitation (RCR) represents a promising, noninferior alternative to facility-based cardiac rehabilitation (FBCR). The comparable cost of RCR in US populations has yet to be extensively studied. The purpose of this prospective, patient-selected study of traditional FBCR versus a third-party asynchronous RCR platform was to assess whether RCR can be administered at a comparable cost and clinical efficacy to FBCR. Adult insured patients were eligible for enrollment after an admission for a coronary heart disease event. Patients selected either FBCR or Movn RCR, a 12-week telehealth intervention using an app-based platform and internet-capable medical devices. Clinical demographics, intervention adherence, cost-effectiveness, and hospitalizations at 1-year after enrollment were assessed from the Highmark claims database after propensity matching between groups. A total of 260 patients were included and 171 of those eligible (65.8%) received at least 1 cardiac rehabilitation session and half of the patients chose Movn RCR. The propensity matching produced a sample of 41 matched pairs. Movn RCR led to a faster enrollment and higher completion rates (80% vs 50%). The total medical costs were similar between Movn RCR and FBCR, although tended toward cost savings with Movn RCR ($10,574/patient). The cost of cardiac rehabilitation was lower in those enrolled in Movn RCR ($1,377/patient, p = 0.002). The all-cause and cardiovascular-related hospitalizations or emergency department visits in the year after enrollment in both groups were similar. In conclusion, this pragmatic study of patients after a coronary heart disease event led to equivalent total medical costs and lower intervention costs for an asynchronous RCR platform than traditional FBCR while maintaining similar clinically important outcomes.

Effects of a patient-centered digital health intervention in patients referred to cardiac rehabilitation: the Smart HEART clinical trial.

BACKGROUND: Cardiac rehabilitation (CR) improves outcomes in heart disease yet remains vastly underutilized. Remote CR enhanced with a digital health intervention (DHI) may offer higher access and improved patient-centered outcomes over non-technology approaches. We sought to pragmatically determine whether offering a DHI improves CR access, cardiac risk profile, and patient-reported outcome measures. METHODS: Adults referred to CR at a tertiary VA medical center between October 2017 and December 2021 were offered enrollment into a DHI alongside other CR modalities using shared decision-making. The DHI consisted of remote CR with a structured, 3-month home exercise program enhanced with multi-component coaching, a commercial smartphone app, and wearable activity tracker. We measured completion rates among DHI participants and evaluated changes in 6-min walk distance, cardiovascular risk factors, and patient-reported outcomes from pre- to post-intervention. RESULTS: Among 1,643 patients referred to CR, 258 (16%) consented to the DHI where the mean age was 60 ± 9 years, 93% were male, and 48% were black. A majority (90%) of the DHI group completed the program. Over 3-months, significant improvements were seen in 6MWT (mean difference [MD] -29 m; 95% CI, 10 to 49; P < 0.01) and low-density lipoprotein cholesterol (MD -11 mg/dL; 95% CI, -17 to -5; P < 0.01), and the absolute proportion of patients who reported smoking decreased (10% vs 15%; MD, -5%; 95% CI, -8% to -2%; P < 0.01) among DHI participants with available data. No adverse events were reported. CONCLUSIONS: The addition of a DHI-enhanced remote CR program was delivered in 16% of referred veterans and associated with improved CR access, markers of cardiovascular risk, and healthy behaviors in this real-world study. These findings support the continued implementation of DHIs for remote CR in real-world clinical settings. TRIAL REGISTRATION: This trial was registered on ClinicalTrials.gov: NCT02791685 (07/06/2016).

Retrospective Analysis and Forecasted Economic Impact of a Virtual Cardiac Rehabilitation Program in a Third-Party Payer Environment.

Background: Participation in cardiac rehabilitation (CR) is recommended for all patients with coronary artery disease (CAD) following hospitalization for acute coronary syndrome or stenting. Yet, few patients participate due to the inconvenience and high cost of attending a facility-based program, factors which have been magnified during the ongoing COVID pandemic. Based on a retrospective analysis of CR utilization and cost in a third-party payer environment, we forecasted the potential clinical and economic benefits of delivering a home-based, virtual CR program, with the goal of guiding future implementation efforts to expand CR access. Methods: We performed a retrospective cohort study using insurance claims data from a large, third-party payer in the state of Pennsylvania. Primary diagnostic and procedural codes were used to identify patients admitted for CAD between October 1, 2016, and September 30, 2018. Rates of enrollment in facility-based CR, as well as all-cause and cardiovascular hospital readmission and associated costs, were calculated during the 12-months following discharge. Results: Only 37% of the 7,264 identified eligible insured patients enrolled in a facility-based CR program within 12 months, incurring a mean delivery cost of $2,922 per participating patient. The 12-month all-cause readmission rate among these patients was 24%, compared to 31% among patients who did not participate in CR. Furthermore, among those readmitted, CR patients were readmitted less frequently than non-CR patients within this time period. The average per-patient cost from hospital readmissions was $30,814 per annum. Based on these trends, we forecasted that adoption of virtual CR among patients who previously declined CR would result in an annual cost savings between $1 and $9 million in the third-party healthcare system from a combination of increased overall CR enrollment and fewer hospital readmissions among new HBCR participants. Conclusions: Among insured patients eligible for CR in a third-party payer environment, implementation of a home-based virtual CR program is forecasted to yield significant cost savings through a combination of increased CR participation and a consequent reduction in downstream healthcare utilization.

Preventive Cardiology in the Digital and COVID-19 Era: A Brave New World within the Veterans Health Administration.

The past year challenged patients, health care providers, and health systems alike to adapt and recalibrate to meet healthcare needs within pandemic constraints. The coronavirus 2019 (COVID-19) pandemic has radically interfered with the accessibility and delivery of cardiovascular care in the United States. With an emphasis on social distancing and stay-at-home orders in effect, many Americans delayed seeking routine medical care and treatment for acute cardiac symptoms due to fear of contracting the coronavirus. The COVID-19 pandemic compelled a rapid shift toward virtual care solutions across cardiovascular domains. The U.S Department of Veterans Affairs (VA) expanded virtual modalities, notably in specialty care and rehabilitation, which offered secure solutions to maintain treatment continuity. Within the VA and other health systems, virtual cardiac rehabilitation (CR) was embraced as an efficacious alternative to on-site cardiac rehabilitation that enabled patients to receive cardiac care remotely. Leveraging the infrastructure and lessons learned from the pandemic-induced expansion of virtual care carries enormous potential to refine virtual CR and revitalize future treatment paradigms for cardiovascular disease patients.

Rationale and design of a smartphone-enabled, home-based exercise program in patients with symptomatic peripheral arterial disease: The smart step randomized trial.

BACKGROUND: Supervised exercise therapy (SET) is recommended in patients with symptomatic peripheral arterial disease (PAD) as first-line therapy, although patient adoption remains low. Home-based exercise therapy (HBET) delivered through smartphones may expand access. The feasibility of such programs, especially in low-resource settings, remains unknown. METHODS: Smart Step is a pilot randomized trial of smartphone-enabled HBET vs walking advice in patients with symptomatic PAD in an inner-city hospital. Participants receive a smartphone app with daily exercise reminders and educational content. A trained coach performs weekly phone-based coaching sessions. All participants receive a Fitbit Charge HR 2 to measure physical activity. The primary outcome changes in 6-minute walking test (6MWT) distance at 12 weeks over baseline. Secondary outcomes are the degree of engagement with the smartphone app and changes in health behaviors and quality of life scores after 12 weeks and 1 year. RESULTS: A total of 15 patients are randomized as of December 15, 2019 with a mean (SD) age of 66.1 (5.8) years. The majority are female (60%) and black (87%). At baseline, the mean (SD) ABI and 6MWT were 0.86 (0.29) and 363.5 m, respectively. Enrollment is expected to continue until December 2020 to achieve a target size of 50 participants. CONCLUSIONS: The potential significance of this trial will be to provide preliminary evidence of a home-based, "mobile-first" approach for delivering a structured exercise rehabilitation program. Smartphone-enabled HBET can be potentially more accessible than center-based programs, and if proven effective, may have a potential widespread public health benefit.

Rationale and design of the granulocyte-macrophage colony stimulating factor in peripheral arterial disease (GPAD-3) study.

BACKGROUND: Lower extremity peripheral arterial disease (PAD) is a public health problem and many patients with PAD experience claudication despite adequate medical and/or surgical management. Mobilization of endogenous progenitor cells using Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) is a novel therapeutic option that has shown promising results in experimental models and phase I/IIA clinical trials. The GPAD-3 trial will study the effect of two successive administrations of GM-CSF at 3-month interval for improving claudication among patients with lower extremity PAD. METHODS: We plan to recruit 176 patients in this ongoing randomized, double-blind, placebo-controlled Phase IIB trial. After screening for inclusion and exclusion criteria, eligible subjects undergo a 4-week screening phase where they perform subcutaneous placebo injections thrice weekly and walk at least three times a day until they develop claudication. After the screening phase, eligible subjects undergo baseline testing and are randomized 2:1 to receive 500 µg/day of GM-CSF subcutaneously thrice weekly for three weeks or placebo injections. After 3 months, follow-up endpoint testing is performed and subjects in the GM-CSF group receive the second administration of the drug for three weeks while subjects in placebo group receive matching placebo injections. All participants undergo endpoint testing at six-month and nine-month follow-up. The primary endpoint is change in 6-min walk distance between baseline and 6-month follow-up. CONCLUSION: GPAD-3 explores a novel approach to address the need for alternative therapies that can alleviate symptoms among patients with lower extremity PAD. If successful, this study will pave the way for a pivotal Phase III trial.

Reconfiguring Cardiac Rehabilitation to Achieve Panvascular Prevention: New Care Models for a New World.

Atherosclerotic cardiovascular disease (ASCVD) and its associated economic burden are increasing globally. Although cardiac rehabilitation is a vital component of secondary prevention with proven benefits, it is underutilized due to numerous barriers, especially in resource-limited settings. New care models for delivery of comprehensive prevention programs such as community-based, home-based, and "hybrid" models implementing m-health, e-health, and telemedicine need to be adopted. Such new care models should be offered to all patients with established ASCVD (coronary, cerebral, and peripheral) and additionally to those at high risk of developing ASCVD with multiple risk factors for panvascular prevention.

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease.

Cardiac rehabilitation (CR) is recommended for patients with coronary heart disease, however, participation among veterans remains poor. Smartphones may facilitate data transfer and communication between patients and providers, among other benefits. We evaluated the feasibility of a smartphone-enabled CR program in a population of veterans. Qualifying veterans were prospectively enrolled in a single-arm, nonrandomized feasibility study of a smartphone-enabled, home-based CR program, featuring an app with daily reminders to exercise, log vitals, and review educational materials. A coach remotely monitored patients through an online dashboard and scheduled telephone visits. Clinical end points were assessed as an exploratory aim. After 21 veterans provided informed consent, 18 were enrolled and successfully completed at least 30days of the program; 13 completed the entire 12-week intervention. Mean (standard deviation) age was 62 (7) years and 96% were male. Program completers logged a mean (standard deviation) of 3.5 (1.4) exercise sessions and 150 (86) exercise minutes per week. The majority (84%) of program completers reported being satisfied overall with the program. Mean functional capacity improved by 1.0 metabolic equivalents (5.3 to 6.3, 95% confidence interval 0.3 to 1.7; p = 0.008) and mean systolic blood pressure at rest improved by 9.6mm Hg (mean difference 9.6, 95% confidence interval -19.0 to -0.7; p = 0.049) among completers. Smartphone-enabled, home-based CR is feasible in veterans with heart disease and is associated with moderate to high levels of engagement and patient satisfaction.

Uric acid, heart failure survival, and the impact of xanthine oxidase inhibition.

Increasing evidence suggests that serum uric acid (UA), a product of xanthine oxidase (XO), may be a useful marker for metabolic, hemodynamic, and functional staging in heart failure (HF) and a valid predictor of survival in HF patients. Recent data support an expanded role for UA and the XO pathway in the pathogenesis of HF, as studies have shown that an elevation in the enzymatic activity of XO can lead to increases in oxidative stress, endothelial dysfunction, and reduced myocardial function. Numerous population studies have previously reported that elevated UA levels are an independent predictor of cardiovascular mortality, and recent evidence suggests that lowering serum levels of UA may lead to improved outcomes in HF patients. The question of whether UA is only a marker rather than a causal factor in the pathogenesis of HF remains. Regardless of whether UA levels are ready for routine clinical use, either as a prognostic factor or novel therapeutic target, further prospective studies are necessary to demonstrate that routine measurement or reduction of UA levels improves outcomes in HF patients.

Uric acid as a predictor of all-cause mortality in heart failure: a meta-analysis.

Serum uric acid (SUA) is a product of xanthine oxidase (XO). Apoptosis and tissue hypoxia lead to increased purine catabolism, which, in turn, increases XO activity and subsequently SUA levels. The purpose of this study was to perform a meta-analysis to evaluate the evidence supporting SUA as a predictor of all-cause mortality in patients with heart failure (HF) and to determine the SUA cut-off for the increase in risk. A search of the MEDLINE database (1966 to March 2009) supplemented by manual searches of bibliographies of key relevant articles was performed. The authors selected all cohort studies in which SUA was measured and mortality was reported in patients with HF. The pooled relative risk (RR) with the corresponding 95% confidence interval (CI) for all-cause mortality using the fixed-effects method was calculated. The effects of SUA on all-cause mortality at different SUA cut-offs using meta-regression was evaluated. The search strategy yielded 358 studies, of which only 6 met our eligibility criteria. The studies, however, comprised 1456 evaluable patients with HF, with a median ejection fraction of 32% (range, 26%-40%). The RR of all-cause mortality was 2.13 (95% CI, 1.78-2.55) for SUA>6.5 mg/dL compared with <6.5 mg/dL SUA level. There was a linear association (P<.01) between SUA and mortality after 7 mg/dL. Uric acid is an important prognostic marker for all-cause mortality in HF. SUA levels >7 mg/dL are associated with higher all-cause mortality.

Oral and extraoral plasmablastic lymphoma: similarities and differences in clinicopathologic characteristics.

Plasmablastic lymphoma (PBL), initially characterized as an aggressive lymphoma arising in the jaw and oral mucosa in HIV-infected patients, was recently reported to occur with extraoral manifestations, heterogeneous histologic findings, and variable association with immunodeficiency states. We reviewed clinical, morphologic, and immunophenotypic features of 13 cases of PBL to determine whether these different subtypes represent distinct morphologic and clinical entities. Two distinct subtypes of PBL were identified and classified as oral and extraoral PBL. The oral PBLs were strongly associated with HIV infection and commonly demonstrated plasmablastic morphologic features without plasmacytic differentiation. Extraoral PBLs tended to occur in patients with underlying non-HIV-related immunosuppression and universally demonstrated plasmacytic differentiation. The patients with oral PBL demonstrated better overall survival compared with patients with extraoral PBL (P = .02). Our findings suggest that PBL with oral and extraoral manifestation represent 2 distinct clinicopathologic entities.