Comparative Genitourinary Safety of In-class Sodium-Glucose Cotransporter-2 Inhibitors among Patients with Heart Failure with Preserved Ejection Fraction: A Cohort Study.

PURPOSE: The American Heart Association recommended sodium-glucose cotransporter-2 inhibitors (SGLT2i) for the management of heart failure with preserved ejection fraction (HFpEF). However, little is known about their real-world in-class comparative safety in patients with HFpEF. We aimed to assess the comparative safety of SGLT2i in the risk of urinary tract infection (UTI) or genital infection separately or as a composite outcome among patients with HFpEF. METHODS: This cohort study using MarketScan® Commercial and Medicare supplemental databases (2012-2020) included patients aged ≥ 18 years with a diagnosis of HFpEF who initiated SGLT2i therapy. Three pairwise comparison groups were established: cohort 1, dapagliflozin versus canagliflozin; cohort 2, empagliflozin versus canagliflozin; and cohort 3, dapagliflozin versus empagliflozin. After stabilized inverse probability treatment weighting, Cox proportional hazards regression was used to compare the risk of UTI or genital infection separately or as a composite outcome in each cohort. RESULTS: The risk of the composite outcome did not significantly differ between canagliflozin and dapagliflozin (adjusted hazard ratio [aHR] 0.64; 95% confidence interval [CI] 0.36-1.14) or between empagliflozin and canagliflozin (aHR 1.25; 95% CI 0.77-2.05). Similarly, there was no evidence of difference between dapagliflozin and empagliflozin in this risk (aHR 0.76; 95% CI 0.48-1.21). The results of analyses separately assessing UTI or genital infection were similar. CONCLUSIONS: There was no significant difference in the risk of UTI or genital infection among patients with HFpEF who initiated canagliflozin, dapagliflozin, or empagliflozin.

Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are used for the management of heart failure with preserved ejection fraction (HFpEF). It is important to assess their comparative risk of urinary tract infection (UTI) or genital infection among patients with HFpEF. We compared patients with HFpEF using SGLT2i in three pairwise groups: cohort 1, dapagliflozin versus canagliflozin; cohort 2, empagliflozin versus canagliflozin; and cohort 3, dapagliflozin versus empagliflozin. We found that there was no significant difference in the risk of genitourinary infections including UTI or genital infections among dapagliflozin, empagliflozin, and canagliflozin.

Systematic Review of Literature Citing the ISCHEMIA Trial.

PURPOSE OF REVIEW: Optimal therapy for patients with chronic coronary artery disease (CCD) has long been a topic under investigation and a subject of debate. Seeking to clarify appropriate management, the International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) trial compared medical management versus coronary angiography for patients with stable ischemic heart disease. Its reception in the medical community has been met with both acclaim and criticism. In light of such disparate views of this trial, a systematic review of the literature citing the ISCHEMIA trial was performed. RECENT FINDINGS: All articles citing the ISCHEMIA trial on PubMed as of July 21, 2023, were compiled and underwent qualitative analysis. A total of 430 articles were evaluated; 109 (25.3%) did not offer substantial commentary on ISCHEMIA and cite it as background evidence for further study. Of the commentary articles, the majority (224, 52.1%) gave balanced, honest appraisals of the ISCHEMIA trial. A total of 46 (10.7%) strongly praised the trial while another 39 (9.1%) were strongly critical of the results. Almost three-quarters of the literature citing the ISCHEMIA trial was commentary in nature, with roughly equal distribution across the spectrum of praise and criticism. Despite being one of the largest studies on CCD and coronary revascularization ever conducted, the impact of ISCHEMIA on the cardiology community appears to be mixed.

Comparative effectiveness of sacubitril/valsartan versus angiotensin receptor blockers in patients with heart failure with preserved ejection fraction: A real-world study.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: Sacubitril/valsartan (SAC/VAL) or angiotensin receptor blockers (ARBs) are recommended therapy for heart failure with preserved ejection fraction (HFpEF), but little is known about their real-world comparative effectiveness among patients with HFpEF. The objective of this study was to determine the comparative effectiveness of SAC/VAL vs ARBs in preventing HF-related hospitalization or all-cause hospitalization among patients with HFpEF. METHODS: We conducted a cohort study using IBM MarketScan commercial and Medicare supplemental databases to identify patients aged 18 years or older with a diagnosis of HFpEF and initiation of SAC/VAL (2015-2020) or ARB (2009-2014) therapy. The index date was the date of the first SAC/VAL or ARB prescription fill. After propensity score (PS) matching with a ratio of 1 up to 3, Cox proportional hazards regression was used with robust variance estimators to compare the risks of HF-related hospitalization and all-cause hospitalization between the 2 therapies. Several subgroup and sensitivity analyses were conducted to check the robustness of the main analysis. RESULTS: After PS matching, 2,520 patients (846 receiving SAC/VAL and 1,674 receiving an ARB) were included in the final analyses. After controlling for covariates, there was no difference in the risk of HF-related hospitalization between SAC/VAL and ARB recipients (adjusted hazard ratio [aHR], 1.33; 95% confidence interval [CI], 0.99-1.77). There was also no difference in the risk of all-cause hospitalization between SAC/VAL and ARB recipients (aHR, 1.06; 95% CI, 0.91-1.24). CONCLUSION: Among individuals with private or Medicare Advantage insurance plans, there was no significant difference in the risk of HF-related hospitalization or all-cause hospitalization between adults with HFpEF who received SAC/VAL and those who received ARB therapy.

2023 Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease: A Summary for JASE.

This report provides a descriptive summary of the ACC/AHA/ASE/ASNC/ASPC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2023 Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease with an emphasis on the role of stress echocardiography.

ACC/AHA/ASE/ASNC/ASPC/HFSA/HRS/SCAI/SCCT/SCMR/STS 2023 Multimodality Appropriate Use Criteria for the Detection and Risk Assessment of Chronic Coronary Disease.

The American College of Cardiology (ACC) Foundation, along with key specialty and subspecialty societies, conducted an appropriate use review of stress testing and anatomic diagnostic procedures for risk assessment and evaluation of known or suspected chronic coronary disease (CCD), formerly referred to as stable ischemic heart disease (SIHD). This document reflects an updating of the prior Appropriate Use Criteria (AUC) published for radionuclide imaging, stress echocardiography (echo), calcium scoring, coronary computed tomography angiography (CCTA), stress cardiac magnetic resonance (CMR), and invasive coronary angiography for SIHD. This is in keeping with the commitment to revise and refine the AUC on a frequent basis. As with the prior version of this document, rating of test modalities is provided side-by-side for a given clinical scenario. These ratings are explicitly not considered competitive rankings due to the limited availability of comparative evidence, patient variability, and the range of capabilities available in any given local setting1-4.This version of the AUC for CCD is a focused update of the prior version of the AUC for SIHD4. Key changes beyond the updated ratings based on new evidence include the following: 1. Clinical scenarios related to preoperative testing were removed and will be incorporated into another AUC document under development. 2. Some clinical scenarios and tables were removed in an effort to simplify the selection of clinical scenarios. Additionally, the flowchart of tables has been reorganized, and all clinical scenario tables can now be reached by answering a limited number of clinical questions about the patient, starting with the patient's symptom status. 3. Several clinical scenarios have been revised to incorporate changes in other documents such as pretest probability assessment, atherosclerotic cardiovascular disease (ASCVD) risk assessment, syncope, and others. ASCVD risk factors that are not accounted for in contemporary risk calculators have been added as modifiers to certain clinical scenarios. The 64 clinical scenarios rated in this document are limited to the detection and risk assessment of CCD and were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines.5 These clinical scenarios do not specifically address patients having acute chest pain episodes. They may, however, be applicable in the inpatient setting if the patient is not having an acute coronary syndrome and warrants evaluation for CCD.Using standardized methodology, clinical scenarios were developed to describe common patient encounters in clinical practice focused on common applications and anticipated uses of testing for CCD. Where appropriate, the scenarios were developed on the basis of the most current ACC/American Heart Association guidelines. A separate, independent rating panel scored the clinical scenarios in this document on a scale of 1 to 9, following a modified Delphi process consistent with the recently updated AUC development methodology. Scores of 7 to 9 indicate that a modality is considered appropriate for the clinical scenario presented, midrange scores of 4 to 6 indicate that a modality may be appropriate for the clinical scenario, and scores of 1 to 3 indicate that a modality is rarely appropriate.

The Medicare Appropriate Use Criteria Program: A Review of Recommendations for Testing in Coronary Artery Disease.

BACKGROUND: Congress established the Appropriate Use Criteria (AUC) Program to reduce unnecessary advanced imaging studies. Organizations that wish to develop AUC can apply to the Centers for Medicare & Medicaid Services (CMS) to qualify as provider-led entities (PLEs) under this program. Variable methods, content, and formatting of PLE-generated AUC could lead to clinician uncertainty about whether an advanced imaging test is appropriate or not. PURPOSE: To review AUC published by CMS-qualified PLEs focused on advanced imaging tests for coronary artery disease (CAD), a "priority clinical area" identified by CMS. DATA SOURCES: Publicly available data from the worldwide web searched on 29 August 2022. STUDY SELECTION: Approved AUC with recommendations related to testing for CAD. DATA EXTRACTION: Manual review of published AUC by all authors. DATA SYNTHESIS: Among the 17 CMS-qualified PLEs, only 7 had published AUC related to CAD. Substantial variation in the methods and formatting of these AUCs was observed. The number of clinical scenarios covered ranged from 6 to 210, and the number of advanced imaging methods covered ranged from 1 to 25. When specifically applied to clinical scenarios, many AUC offered no guidance on appropriateness; those that did conflicted with respect to appropriateness. LIMITATION: Other CMS-identified priority clinical areas were not evaluated. CONCLUSION: CMS-qualified AUC for imaging of CAD are heterogeneous and sometimes discrepant, creating substantial potential for uncertainty among clinicians seeking to provide their patients with appropriate imaging tests. PRIMARY FUNDING SOURCE: No funding was received for this study.

Comparative effectiveness of sodium-glucose cotransporter-2 inhibitors among patients with heart failure with preserved ejection fraction.

BACKGROUND: Sodium-glucose cotransporter-2 inhibitors (SGLT2i) are recommended by the American Heart Association for management of heart failure with preserved ejection fraction (HFpEF), but little is known about their in-class comparative effectiveness in real-world settings. OBJECTIVES: To assess the in-class comparative effectiveness of SGLT2i for preventing HF-related and all-cause hospitalizations among patients with HFpEF. METHODS: Using MarketScan® Commercial and Medicare Supplemental research databases (2012-2020), this cohort study included adults with HFpEF treated with SGLT2i. Stabilized inverse probability treatment weighted Cox proportional hazards regression was used to compare HF-related and all-cause hospitalizations in three pairwise comparisons: dapagliflozin versus canagliflozin, empagliflozin versus canagliflozin, and dapagliflozin versus empagliflozin. Subgroup and sensitivity analyses were conducted to assess robustness of the main analysis. RESULTS: In total, 3629 SGLT2i users (881 dapagliflozin, 1120 canagliflozin, and 1628 empagliflozin) were included. Compared with canagliflozin, dapagliflozin was associated with decreased risk of HF-related hospitalization (adjusted hazard ratio [aHR], 0.75; 95% confidence interval [CI], 0.56-1.01) and all-cause hospitalization (aHR, 0.84; 95% CI 0.73-0.97). Compared with canagliflozin, empagliflozin was associated with 55% decreased risk of HF-related hospitalization (aHR, 0.45; 95% CI 0.34-0.59) and 18% decreased risk of all-cause hospitalization (aHR, 0.82; 95% CI 0.73-0.93). Compared with empagliflozin, dapagliflozin was associated with 50% increased risk of HF-related hospitalization (aHR, 1.50; 95% CI 1.09-2.07) and a statistically nonsignificant increase in the risk of all-cause hospitalization (aHR, 1.05; 95% CI 0.92-1.20). CONCLUSIONS: Compared with canagliflozin or dapagliflozin use, empagliflozin use was associated with decreased risk of HF-related and all-cause hospitalizations. Compared with canagliflozin, dapagliflozin was associated with a reduced risk of HF-related and all-cause hospitalizations.

Prognostic Value of Frailty for Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation: A Systematic Review.

Frailty is associated with poor clinical outcomes in heart failure patients. The impact of frailty on outcomes following left ventricular assist device (LVAD) implantation, however, is less clearly defined. We therefore sought to conduct a systematic review to evaluate current frailty assessment strategies and their significance for patients undergoing LVAD implantation. We conducted a comprehensive electronic search of PubMed, Embase, and CINAHL databases from inception until April 2021 for studies examining frailty in patients undergoing LVAD implantation. Study characteristics, patient demographics, type of frailty measurement, and outcomes were extracted. Outcomes were organized into 5 basic categories: implant length of stay (iLOS), 1-year mortality, rehospitalization, adverse events, and quality of life (QOL). Of the 260 records retrieved, 23 studies involving 4935 patients satisfied the inclusion criteria. Approaches to measuring frailty varied, with the 2 most common being sarcopenia determined by computed tomography and Fried's frailty phenotype assessment. Outcomes of interest were also widely variable, with iLOS stay and mortality being the most frequently reported, albeit with differing definitions of both between studies. The heterogeneity among included studies precluded quantitative synthesis. Narrative synthesis showed that frailty by any measure is more likely to be associated with higher mortality, longer iLOS, more adverse events and worse QOL post-LVAD implant. Frailty can be a valuable prognostic indicator in patients undergoing LVAD implantation. Further studies are needed to determine the most sensitive frailty assessment, as well as the ways in which frailty may serve as a modifiable target to improve outcomes following LVAD implantation.

Informing Use of Telehealth for Managing Chronic Conditions: Mixed-Methods Evaluation of Telehealth Use to Manage Heart Failure During COVID-19.

Background The COVID-19 pandemic forced Veterans Health Administration facilities to rapidly adopt and deploy telehealth alternatives to provide continuity of care to veterans while minimizing physical contact. The impact of moving to virtual visits on patients with congestive heart failure (HF) is unknown. The goal of this study was to understand how patients with HF and their providers experienced the shift to telehealth for managing a chronic condition, and to inform best practices for continued telehealth use. Methods and Results We identified Veterans Health Administration Medical Centers with high telehealth use before COVID-19 and sites that were forced to adopt telehealth in response to COVID-19, and interviewed cardiology providers and veterans with HF about their experiences using telehealth. Interviews were recorded, transcribed, and analyzed using team-based rapid content analysis. We identified 3 trajectory patterns for cardiology telehealth use before and during COVID-19. They were the low-use class (low to low), high-use class (relatively high to higher), and increased-use class (low to high). The high-use and increased-use classes fit the criteria for sites that had high telehealth use before COVID-19 and sites that rapidly adopted telehealth in response to COVID-19. There were 12 sites in the high-use class and 4 sites in the increased-use class. To match with the number of sites in the increased-use class, we selected the top 4 sites by looking at the months before COVID-19. We identified 3 themes related to telehealth use among patients with HF and cardiology providers: (1) technology was the primary barrier for both patients and providers; (2) infrastructural support was the primary facilitator for providers; and (3) both patients and providers had largely neutral opinions on how telehealth compares to in-person care but described situations in which telehealth is not appropriate. Conclusions Only 12 sites fit the criteria of high telehealth use in cardiology before COVID-19, and 4 fit the criteria of low use that increased in response to COVID-19. Patients and providers at both site types were largely satisfied using telehealth to manage HF. Understanding best practices for managing ambulatory care-sensitive conditions through virtual visits can help the Veterans Health Administration prepare for long-term impacts of COVID-19 on in-person visits, as well as improve access to care for veterans who live remotely or who have difficulty traveling to in-person appointments.

Assessment of Cardiovascular Risk for Noncardiac and Nonsurgical Activities.

Cardiovascular risk stratification is a frequent evaluation performed by health professionals. Not uncommonly, requests for risk stratification involve activities or procedures that fall outside of the scope of current evidence-based guidelines. Estimating risk and providing guidance for these requests can be challenging due to limited available evidence. This review focuses on some of these unique requests, each of which are real examples encountered in our practice. We offer guidance by synthesizing the available medical literature and formulating recommendations on topics such as the initiation of testosterone and erectile dysfunction therapy, SCUBA and skydiving, polygraphy, and electroconvulsive therapy.

Trends in pharmacotherapy utilization among patients with heart failure with preserved ejection fraction.

Study objective: Half of patients with heart failure have preserved ejection fraction (HFpEF). Over the years, guidelines have recommended or advised against various therapies for HFpEF management. However, there is limited evidence on the trends in utilization of the various medications. The aim of this study was to examine the trends in the use of pharmacotherapies among patients with HFpEF from 2008 through 2020. Design: Retrospective cohort study of patients with HFpEF used MarketScan® Commercial and Medicare Supplemental Databases (2007-2020). Participants: Patients with HFpEF. Outcome measures: Utilization rates for angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), angiotensin receptor-neprilysin inhibitors (ARNIs), aldosterone receptor antagonists (ARAs), diuretics, ß-blockers, calcium channel blockers (CCBs), phosphodiesterase 5 inhibitors (PDE5Is), nitrates, digoxin, and sodium glucose cotransporter-2 inhibitors (SGLT2i) within 90 days of the first HFpEF diagnosis. Results: We identified 156,730 patients with HFpEF (mean [SD] age, 73 [13.4] years; 57 % females). From 2008 to 2020, we found increased utilization rates for ARNIs (0.02 % vs. 0.17 % of all patients, p < 0.01), ARBs (14.3 % vs. 18.6 %, p < 0.01), ARAs (7.0 % vs. 8.4 %, p < 0.01), CCBs (30.6 % vs. 33.4 %, p < 0.01), and SGLT2i (0.001 % vs. 0.021 %, p < 0.01). By contrast, the utilization of ACEIs (30.4 % vs. 20.5 %, p < 0.01), digoxin (9.5 % vs. 2.4 %, p < 0.01), nitrates (10.7 % vs. 4.9 %, p < 0.01), diuretics (54.1 % vs. 50.4 %, p = 0.20), and ß-blockers (52.6 % vs. 51.7 %, p < 0.01) decreased, while utilization rates of PDE5Is remained stable (1.5 % vs. 1.1 %, p = 0.90) . Conclusions: During the 13-year study period, the utilization of ARNIs, ARBs, ARAs, CCBs, and SGLT2i increased while the utilization of digoxin, nitrates, diuretics, and ß-blockers decreased among patients with HFpEF.

The New Role of Telehealth in Contemporary Medicine.

PURPOSE OF REVIEW: Understand the current uses for telehealth as well as future directions as it relates to the COVID-19 pandemic and cardiovascular medicine. RECENT FINDINGS: Telehealth interventions in various forms have proven to be efficacious in the management of obesity, hypertension, glycemic control in diabetes, hyperlipidemia, medication adherence, and ICU length of stay and mortality. The use and study of such interventions have been greatly expanded during the pandemic partly due to the expanded coverage by payers. However, heterogenous interventions and a relative lack of cost analyses are barriers to more widespread adoption. Telehealth has proven efficacy for modifying risk factors for cardiovascular disease. To date, this has not been shown to translate to a reduction in hard cardiovascular endpoints such as mortality. With ongoing research and expanded funding, the role of telehealth is likely to evolve as the COVID pandemic continues.

Implementation effort: Reducing the ordering of inappropriate echocardiograms through a point-of-care decision support tool.

Study objective: Reduce inappropriate transthoracic echocardiograms (TTEs) using a series of Plan-Do-Study-Act (PDSA) quality improvement cycles. Design: Three PDSA cycles were designed with the first integrating a previously published decision support tool (DST) into the electronic TTE order, the second tailoring the DST to reflect the most common inappropriately ordered TTEs at our institution, and the third integrating direct clinician education. Setting: Malcom Randall Veterans Administration Medical Center, Gainesville, Florida, USA. Participants: Consecutive patients were studied using the database of all TTEs performed at our institution without regard for specific patient characteristics. Interventions: Three PDSA Cycles as described above. Main outcome measure: Reduction in inappropriate TTEs at our institution. Results: After implementing our DST during the first cycle, no difference in inappropriate TTEs was observed (relative risk [RR] 0.71, p = 0.12, 95 % confidence interval [CI] 0.46-1.09). After the second cycle, we observed a reduction in the proportion of inappropriate TTEs (RR = 0.69, p = 0.014, 95 % CI 0.5-0.94), however two of the four inappropriate TTEs targeted by the DST increased. Feedback gathered from clinicians in the third cycle showed significant knowledge gaps regarding appropriate use criteria for TTE. Conclusions: At our facility, implementation of a DST failed to substantially reduce inappropriate TTEs, even when adapted to facility-specific ordering patterns. Gaps in clinician knowledge about TTEs may have contributed to the inefficacy of our DST.