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Impact of telehealth on the current and future practice of lipidology: a scoping review.
Schubert, TJ, Clegg, K, Karalis, D, Desai, NR, Marrs, JC, McNeal, C, Mintz, GL, Romagnoli, KM, Jones, LK
Journal of clinical lipidology. 2023;(1):40-54
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Abstract
Telehealth services have been implemented to deliver care for patients living with many chronic conditions and have expanded greatly during the COVID-19 pandemic. Little is known about the current or future impacts of telehealth on lipid management practices. The PubMed database was searched from inception to June 25, 2021, with the keywords "lipids or cholesterol" and "telehealth," which yielded 376 published articles. Telehealth was defined as a synchronous visit between a patient and clinician that replaced an in-office appointment. Studies that solely used remote monitoring, mobile health technologies, or callbacks of results, were excluded. Articles must have measured lipid values. Review articles and protocol papers were not included. After evaluation, 128 abstracts were included for full text evaluation, with 55 full-text articles eventually included. Of the articles, 29 were randomized clinical trials, 15 were pre-post evaluations, and 11 were other study designs. Telehealth had positive to neutral impacts on lipid management. Reported facilitators include easier implementation of multidisciplinary approaches to care, and utilization of patient-centered programs. Reported barriers to telehealth services include technological barriers, such as various skill levels with technology; systems barriers, such as cost and reimbursement; patient-related barriers, including patient non-adherence; and clinician-related barriers, such as difficulty standardizing care. Clinicians reported improved satisfaction among patients but had mixed feelings regarding their ability to deliver quality care. Telemedicine use to provide care for individuals with lipid conditions has expanded during the COVID-19 pandemic, but more research is needed to determine its potential as a sustainable tool for lipid management.
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Nonadherence to lipid-lowering therapy and strategies to improve adherence in patients with atherosclerotic cardiovascular disease.
Desai, NR, Farbaniec, M, Karalis, DG
Clinical cardiology. 2023;(1):13-21
Abstract
Despite the availability of effective therapies that lower low-density lipoprotein cholesterol (LDL-C) levels in patients with atherosclerotic cardiovascular disease, many eligible patients are inadequately treated and their LDL-C levels remain suboptimal. Patient nonadherence to lipid-lowering therapy (LLT) is a major contributor to the failure of LDL-C goal attainment. Several factors have been identified as contributing to LLT nonadherence, including healthcare disparities due to socioeconomic status, age, race, sex, and cost; limited access to healthcare; perceived side effects associated with LLT; health literacy; and the presence of comorbidities. Suboptimal LLT use has also been associated with clinician factors, including failure to identify patients who require LDL-C reassessment, insufficient LDL-C monitoring, and clinical inertia such as a lack of therapy intensification. Several strategies to enhance LLT adherence have been shown to be effective, including the implementation of educational initiatives and tools for both patients and physicians, the use of clinical protocols and algorithms to identify patients at risk and optimize treatment, and improvements in electronic healthcare records. Pharmacy-based programs designed to help patients with prescription refills, including reminders or the use of prescription delivery by mail, have also proven effective. Drugs requiring frequent administration can represent a barrier to treatment adherence; therefore, newer, more effective LLTs with lower frequency of administration and lower potential for polypharmacy may improve patient adherence to LLT. Implementation of strategies to identify patients at risk for LLT nonadherence and the use of flexible tools such as telemedicine to overcome geographical barriers may improve LLT adherence.
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Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF).
Ghazi, L, Desai, NR, Simonov, M, Yamamoto, Y, O'Connor, KD, Riello, RJ, Huang, J, Olufade, T, McDermott, J, Inzucchi, SE, et al
American heart journal. 2022;:107-115
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Abstract
Heart failure with reduced ejection fraction (HFrEF) is one of the most common chronic illnesses in the United States and carries significant risk of morbidity and mortality. Use of guideline-directed medical therapy (GDMT) for patients with HFrEF has been shown to dramatically improve outcomes, but adoption of these treatments remains generally low. Possible explanations for poor GDMT uptake include lack of knowledge about recommended management strategies and provider reluctance due to uncertainties regarding application of said guidelines to real-world practice. One way to overcome these barriers is by harnessing the electronic health record (EHR) to create patient-centered "best practice alerts" (BPAs) that can guide clinicians to prescribe appropriate medical therapies. If found to be effective, these low-cost interventions can be rapidly applied across large integrated healthcare systems. The PRagmatic Trial Of Messaging to Providers about Treatment of Heart Failure (PROMPT-HF) trial is a pragmatic, cluster randomized controlled trial designed to test the hypothesis that tailored and timely alerting of recommended GDMT in heart failure (HF) will result in greater adherence to guidelines when compared with usual care. PROMPT-HF has completed enrollment of 1,310 ambulatory patients with HFrEF cared for by 100 providers who were randomized to receive a BPA vs usual care. The BPA alerted providers to GDMT recommended for their patients and displayed current left ventricular ejection fraction (LVEF) along with the most recent blood pressure, heart rate, serum potassium and creatinine levels, and estimated glomerular filtration rate. It also linked to an order set customized to the patient that suggests medications within each GDMT class not already prescribed. Our goal is to examine whether tailored EHR-based alerting for outpatients with HFrEF will lead to higher rates of GDMT at 30 days post randomization when compared with usual care. Additionally, we are assessing clinical outcomes such as hospital readmissions and death between the alert versus usual care group. Trial Registration: Clinicaltrials.gov NCT04514458.
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Reducing Cardiovascular Risk in the Medicare Million Hearts Risk Reduction Model: Insights From the National Cardiovascular Data Registry PINNACLE Registry.
Borden, WB, Wang, J, Jones, P, Tang, Y, Contreras, J, Daugherty, SL, Desai, NR, Virani, SS, Wasfy, JH, Maddox, TM
Circulation. Cardiovascular quality and outcomes. 2022;(4):e007908
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Abstract
BACKGROUND The Million Hearts Cardiovascular Disease Risk Reduction Model provides financial incentives for practices to lower 10-year atherosclerotic cardiovascular disease (ASCVD) risk for high-risk (ASCVD ≥30%) Medicare patients. To estimate average practice-level ASCVD risk reduction, we applied optimal trial outcomes to a real-world population with high ASCVD risk. METHODS This study uses observational registry data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence Registry from January 2013 to June 2016. We modeled ASCVD risk reductions using historical clinical trial data (reducing cholesterol by 26.5%, reducing systolic blood pressure by 10.9%, reducing smoking rates by 21.8%) the average reduction in ASCVD risk associated with individual and combined risk factor modifications, and then percentage of practices achieving the various incentive thresholds for the Million Hearts Model. RESULTS The final study population included 135 166 patients, with 16 248 (12.0%) with 10-year ASCVD risk of ≥30%, but without existing ASCVD. The mean 10-year ASCVD risk was 41.9% (±1 SD of 11.6). Using risk factor reductions from clinical trials, lowering cholesterol, blood pressure, and smoking rates reduced 10-year ASCVD risk by 3.3% (±3.1), 6.3% (±1.1) and 0.5% (±1.3), respectively. Combining all 3 reductions resulted in a 9.7% (±3.6) reduction, with 67 (27.0%) of practices achieving a patient-level average 10-year ASCVD risk reduction of ≥10%, 181 (73.0%) achieving a 2 to 10% reduction, and no practice achieving <2% reduction. CONCLUSIONS In cardiology practices, about 1 out of 8 patients have a 10-year ASCVD risk ≥30% and qualify as high risk in the Million Hearts Model. If practices target the three main modifiable risk factors and achieve reductions similar to clinical trial results, ASCVD risk could be substantially lowered and all practices could receive incentive payments. These findings support the potential benefit of the Million Hearts Model and provide guidance to participating practices.
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Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial.
Ghazi, L, Yamamoto, Y, Riello, RJ, Coronel-Moreno, C, Martin, M, O'Connor, KD, Simonov, M, Huang, J, Olufade, T, McDermott, J, et al
Journal of the American College of Cardiology. 2022;(22):2203-2213
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BACKGROUND The use of guideline-directed medical therapy (GDMT) is underprescribed in patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVES This study sought to examine whether targeted and tailored electronic health record (EHR) alerts recommending GDMT in eligible patients with HFrEF improves GDMT use. METHODS PROMPT-HF (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure) was a pragmatic, EHR-based, cluster-randomized comparative effectiveness trial. A total of 100 providers caring for patients with HFrEF were randomized to either an alert or usual care. The alert notified providers of individualized GDMT recommendations along with patient characteristics. The primary outcome was an increase in the number of GDMT classes prescribed at 30 days postrandomization. Providers were surveyed on knowledge of guidelines and user experience. RESULTS The study enrolled 1,310 ambulatory patients with HFrEF from April to October 2021. Median age was 72 years; 31% were female; 18% were Black; and median left ventricular ejection fraction was 32%. At baseline, 84% of participants were receiving β-blockers, 71% received a renin-angiotensin-aldosterone system inhibitor, 29% received a mineralocorticoid receptor antagonist, and 11% received a sodium-glucose cotransporter-2 inhibitor. The primary outcome occurred in 176 of 685 (26%) participants in the alert arm vs 117 of 625 (19%) in the usual care arm, thus increasing GDMT class prescription by >40% after alert exposure (adjusted relative risk: 1.41; 95% CI: 1.03-1.93; P = 0.03). The number of patients needed to alert to result in an increase in addition of GDMT classes was 14. A total of 79% of alerted providers agreed that the alert was effective at enabling improved prescription of medical therapy for HF. CONCLUSIONS A real-time, targeted, and tailored EHR-based alerting system for outpatients with HFrEF led to significantly higher rates of GDMT at 30 days when compared with usual care. This low-cost intervention can be rapidly integrated into clinical care and accelerate adoption of high-value therapies in heart failure. (PRagmatic trial Of Messaging to Providers about Treatment of Heart Failure [PROMPT-HF; NCT04514458]).
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Effect of Inotropes on Patient-Reported Health Status in End-Stage Heart Failure: A Review of Published Clinical Trials.
Clarke, JD, Riello, R, Allen, LA, Psotka, MA, Teerlink, JR, Lindenfeld, J, Desai, NR, Ahmad, T
Circulation. Heart failure. 2021;(2):e007759
Abstract
BACKGROUND A growing population of patients with end-stage heart failure (HF) with reduced ejection fraction has limited treatment options to improve their quality and quantity of life. Although positive inotropes have failed to show survival benefit, these agents may enhance patient-reported health status, that is, symptoms, functional status, and health-related quality of life. We sought to review the available clinical trial data on positive inotrope use in patients with end-stage HF and to summarize evidence supporting the use of these agents to improve health status of patients with end-stage HF. METHODS A literature review of randomized controlled trials examining the use of positive inotropy in HF with reduced ejection fraction was conducted. We searched MEDLINE, SCOPUS, and Web of Science between January 1980 to December 2018 for randomized controlled trials that used as their main outcome measures the effects of inotrope therapy on (1) morbidity/mortality, (2) symptoms, (3) functional status, or (4) health-related quality of life. Inotropes of interest included adrenergic agents, phosphodiesterase inhibitors, calcium sensitizers, myosin activators, and SERCA2a (sarcoplasmic reticulum Ca2+-ATPase) modulators. RESULTS Twenty-two out of 26 inotrope randomized controlled trials measured the effect of inotropes on at least one patient-reported health status domain. Among the 22 studies with patient-related health status outcomes, 11 (50%) gauged symptom response, 15 (68%) reported functional capacity changes, and 12 (54%) reported health-related quality of life measures. Fourteen (64%) of these trials noted positive outcomes in at least one health status domain measured; 11 (79%) of these positive studies used agents that worked through phosphodiesterase inhibition. CONCLUSIONS There has been a lack of standardization surrounding measurement of patient-centered outcomes in studies of inotropes for end-stage HF with reduced ejection fraction. The degree to which positive inotropes can improve patient-reported health status and the adverse risk they pose remains unknown.
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The impact of heart failure on patients and caregivers: A qualitative study.
McHorney, CA, Mansukhani, SG, Anatchkova, M, Taylor, N, Wirtz, HS, Abbasi, S, Battle, L, Desai, NR, Globe, G
PloS one. 2021;(3):e0248240
Abstract
BACKGROUND Heart failure is rising in prevalence but relatively little is known about the experiences and journey of patients and their caregivers. The goal of this paper is to present the symptom and symptom impact experiences of patients with heart failure and their caregivers. METHODS This was a United States-based study wherein in-person focus groups were conducted. Groups were audio recorded, transcribed and a content-analysis approach was used to analyze the data. RESULTS Ninety participants (64 patients and 26 caregivers) were included in the study. Most patients were female (52.0%) with mean age 59.3 ± 8 years; 55.6% were New York Heart Association Class II. The most commonly reported symptoms were shortness of breath (81.3%), fatigue/tiredness (76.6%), swelling of legs and ankles (57.8%), and trouble sleeping (50.0%). Patients reported reductions in social/family interactions (67.2%), dietary changes (64.1%), and difficulty walking and climbing stairs (56.3%) as the most common adverse disease impacts. Mental-health sequelae were noted as depression and sadness (43.8%), fear of dying (32.8%), and anxiety (32.8%). Caregivers (mean age 55.5 ± 11.2 years and 52.0% female) discussed 33 daily heart failure impacts, with the top three being reductions in social/family interactions (50.0%); being stressed, worried, and fearful (46.2%); and having to monitor their "patience" level (42.3%). CONCLUSIONS There are serious unmet needs in HF for both patients and caregivers. More research is needed to better characterize these needs and the impacts of HF along with the development and evaluation of disease management toolkits that can support patients and their caregivers.
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Hyperkalemia treatment modalities: A descriptive observational study focused on medication and healthcare resource utilization.
Desai, NR, Rowan, CG, Alvarez, PJ, Fogli, J, Toto, RD
PloS one. 2020;(1):e0226844
Abstract
Renin-angiotensin-aldosterone system inhibitor (RAASi) therapy has been shown to improve outcomes among patients with congestive heart failure, diabetes, or renal dysfunction. These patients are also at risk for the development of hyperkalemia (HK), often leading to down-titration and/or discontinuation of RAASi therapy. Patiromer is the first sodium-free, non-absorbed potassium (K+) binder approved for the treatment of hyperkalemia (HK) in over 50 years. We described the association between use of K+ binders (Patiromer and sodium polystyrene sulfonate [SPS]) and renin-angiotensin-aldosterone system inhibitor (RAASi), on healthcare resource utilization (HRU). The study population consisted of Medicare Advantage patients with HK (K+ ≥ 5.0 mmol/L) in Optum's Clinformatics® Data Mart between 1/1/2016-12/31/2017. Patiromer and (SPS) initiators, and HK patients not exposed to a K+ binder (NoKb) were included. The index date was the date of the first K+ binder dispensing or HK diagnosis. Outcomes assessed at 6 months post-index were: (1) K+ binder utilization, (2) RAASi continuation, and (3) HRU (pre- vs post-index). HRU change was analyzed using McNemar's statistical test. Study cohorts included 610 (patiromer), 5556 (SPS), and 21,282 (NoKb) patients. Overall baseline patient characteristics were: mean age 75 years; female 49%, low-income subsidy 29%, chronic kidney disease 48% (63% for patiromer cohort), and congestive heart failure 29%. At 6 months post-index, 28% (patiromer) and 2% (SPS) remained continuously exposed to the index K+ binder. RAASi continued for 78% (patiromer), 57% (SPS), and 57% (NoKb). The difference (pre- vs post-index) in hospitalized patients was: -9.4% (patiromer; P<0.05), -7.2% (SPS), and +16.8% (NoKb; P<0.001). Disparate K+ binder utilization patterns were observed. The majority of patiromer patients continued RAASi therapy while the percentage of SPS patients that continued RAASi therapy was lower, overlapping CIs were observed. Following continuous patiromer exposure, statistically significant reductions in hospital admissions and emergency department visits were observed, continuous SPS exposure observed no statistically significant reductions in either hospitalizations or ED visits, while NoKb patients with continuous exposure had statistically significant increases in both. Further research, with a larger sample size using comparative analytic methods, is warranted.
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Association Between Circulating Baseline Proprotein Convertase Subtilisin Kexin Type 9 Levels and Efficacy of Evolocumab.
Desai, NR, Giugliano, RP, Wasserman, SM, Gibbs, JP, Liu, T, Scott, R, Sabatine, MS
JAMA cardiology. 2017;(5):556-560
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IMPORTANCE Levels of proprotein convertase subtilisin kexin type 9 (PCSK9) vary markedly across the population and are influenced by genetic and nongenetic factors. Evolocumab is a fully human, monoclonal antibody against PCSK9 that reduces low-density lipoprotein cholesterol (LDL-C) levels by 55% to 75%. Whether the efficacy of evolocumab varies based on an individual's baseline PCSK9 level remains unknown. OBJECTIVE To characterize variability in PCSK9 levels and determine whether the LDL-C level reduction achieved with evolocumab differs based on PCSK9 levels. DESIGN, SETTING, AND PARTICIPANTS This study included pooled data from 3016 patients from 4 phase 3 randomized clinical trials of evolocumab as part of the Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 in Different Populations. Circulating PCSK9 levels were measured at baseline using quantitative enzyme-linked immunosorbent assays and used to stratify patients into quartiles, and LDL-C level was measured at baseline and weeks 10 and 12. In an additional 138 patients enrolled in a pharmacokinetic and pharmacodynamic substudy from 4 phase 2 trials, circulating PCSK9 levels were measured at baseline and then weekly at weeks 8 through 12. MAIN OUTCOMES AND MEASURES Placebo-controlled percentage change in LDL-C level with evolocumab, 140 mg every 2 weeks and 420 mg once monthly, across quartiles of baseline PCSK9 levels. RESULTS Of the 3016 patients, 1492 (49.5%) were female and 2758 (91.4%) were white. The median baseline circulating PCSK9 level was 323 ng/mL (interquartile range, 258-406 ng/mL). Patients with higher levels of PCSK9 were more likely to be receiving intensive statin therapy (56%, 36%, 25%, and 13% in the fourth through first quartiles; P < .001) and had significantly lower baseline LDL-C level (123 mg/dL, 124 mg/dL, 128 mg/dL, and 137 mg/dL in the fourth through first quartiles; P < .001). After stratifying by statin use, there was no correlation between PCSK9 levels and LDL-C levels (ρ = 0.03 [95% CI, -0.04 to 0.10] for nonstatin users, P = .39, and ρ = 0.03 [95% CI, -0.01 to 0.08] for statin users, P = .12). Across all quartiles of baseline PCSK9 levels, both evolocumab 140 mg every 2 weeks and 420 mg once monthly suppressed circulating PCSK9 levels by 90% to 100% within 1 week of administration. Both evolocumab 140 mg every 2 weeks and 420 mg once monthly were associated with significant reductions in LDL-C levels between 64% and 71% (P < .001), regardless of PCSK9 levels (P for interaction = .76 and .21, respectively). CONCLUSIONS AND RELEVANCE Regardless of baseline PCSK9 levels, the doses of evolocumab being studied in a large cardiovascular outcomes trial suppress PCSK9 levels and consistently and substantially reduce LDL-C levels.
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Lipoprotein(a) for risk assessment in patients with established coronary artery disease.
O'Donoghue, ML, Morrow, DA, Tsimikas, S, Sloan, S, Ren, AF, Hoffman, EB, Desai, NR, Solomon, SD, Domanski, M, Arai, K, et al
Journal of the American College of Cardiology. 2014;(6):520-7
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OBJECTIVES The purpose of this study was to assess the prognostic utility of lipoprotein(a) [Lp(a)] in individuals with coronary artery disease (CAD). BACKGROUND Data regarding an association between Lp(a) and cardiovascular (CV) risk in secondary prevention populations are sparse. METHODS Plasma Lp(a) was measured in 6,708 subjects with CAD from 3 studies; data were then combined with 8 previously published studies for a total of 18,978 subjects. RESULTS Across the 3 studies, increasing levels of Lp(a) were not associated with the risk of CV events when modeled as a continuous variable (odds ratio [OR]: 1.03 per log-transformed SD, 95% confidence interval [CI]: 0.96 to 1.11) or by quintile (Q5:Q1 OR: 1.05, 95% CI: 0.83 to 1.34). When data were combined with previously published studies of Lp(a) in secondary prevention, subjects with Lp(a) levels in the highest quantile were at increased risk of CV events (OR: 1.40, 95% CI: 1.15 to 1.71), but with significant between-study heterogeneity (p = 0.001). When stratified on the basis of low-density lipoprotein (LDL) cholesterol, the association between Lp(a) and CV events was significant in studies in which average LDL cholesterol was ≥130 mg/dl (OR: 1.46, 95% CI: 1.23 to 1.73, p < 0.001), whereas this relationship did not achieve statistical significance for studies with an average LDL cholesterol <130 mg/dl (OR: 1.20, 95% CI: 0.90 to 1.60, p = 0.21). CONCLUSIONS Lp(a) is significantly associated with the risk of CV events in patients with established CAD; however, there exists marked heterogeneity across trials. In particular, the prognostic value of Lp(a) in patients with low cholesterol levels remains unclear.
