Urgent Visits Research Articles

Can Resident Auditory-Perceptual Voice Assessments Predict Medical Urgency of Voice Disorders?

Growing reliance on telemedicine has created new triaging challenges. This study investigated how effectively otolaryngology resident auditory-perceptual voice assessments performed via telemedicine determined the need for urgent in-person clinic visits. Twelve otolaryngology resident physicians (PGY1-PGY5) performed auditory-perceptual assessments on 25 voice samples recorded during initial voice evaluations. Voice samples were balanced in severity and taken in equal numbers from patients with the following diagnoses: benign laryngeal lesions, laryngeal cancer, functional voice disorders, laryngeal edema (associated with LPR), and laryngeal paralysis/paresis. Urgent diagnoses were defined as laryngeal cancer and severe unilateral laryngeal paralysis. For each voice sample, residents were initially blinded to patient medical history. Residents rated severity of voice disorder, predicted patient diagnosis, and determined the urgency of seeing the patient in clinic. Residents then reviewed information from the patient's medical history and again rated urgency of voice disorder. On average, residents identified urgent voice disorders in 56% of cases. After reviewing medical history, this number significantly increased to 77% (P=0.001). Voice severity, smoking history, time since onset, and course of symptoms were considered most influential when determining medical urgency of voice patients. Year in residency program had no effect on rating accuracy. As expected, diagnostic accuracy of auditory-perceptual assessments was low, ranging from 40% for laryngeal paralysis/paresis to 5% for laryngeal edema. Auditory-perceptual voice assessment, combined with medical history, predicted most medically urgent voice disorders. Further work should investigate if task-specific training might improve these results and which medical history items are most critical. Until accuracy of auditory-perceptual assessment of medical urgency is improved, these data underscore the importance of laryngeal examination in identifying medical urgency and etiology of dysphonia.

Eventos adversos e cultura de segurança do paciente na prática odontológica: estudo transversal

Abstract Introduction Adverse events (AE) are injuries or harm not related to the natural progression of the disease but that result in harm to patients. In healthcare institutions, the adoption of a patient safety culture can reduce the occurrence of AE. Objective To identify the frequency of AE reported by dentists in primary dental care and analyze the dimensions of patient safety culture (PSC) associated with this outcome. Material and method This cross-sectional study was conducted in two Brazilian states in 2021. A total of 350 dentists working in primary dental care participated in the study. The outcome (AE) was measured using a semi-structured questionnaire, which was tested through a pilot study. Independent variables were collected through sociodemographic questionnaires and the validated Medical Office Survey on Patient Safety Culture instrument, which measures dimensions of PSC. Poisson regression analysis was used. Result The most reported event was: "The patient required an urgent return visit due to pain, swelling, or other reasons" after a clinical intervention (60.6%). The dimensions of PSC related to AE were "Overall perception of patient safety and quality" (PR: 0.86, 95% CI: 0.76-0.89), "Work processes and standardization" (PR: 0.86, 95% CI: 0.78-0.92), and "Teamwork" (PR: 1.11, 95% CI: 1.03-1.73). Conclusion Adverse events are frequent in primary dental care practice and are associated with dimensions of patient safety culture. This reinforces the need to expand knowledge about this topic and implement barriers to prevent harm to patients during dental care at this level of health care.

Impact of COVID-19 on emergency oral health care in New Jersey

BackgroundThe COVID-19 pandemic led to reduced services of private dental practices. The public emergency clinic of Rutgers School of Dental Medicine (RSDM) (Newark, NJ) faced changing demands during various periods of the pandemic. MethodsRecords of patients visiting the emergency clinic at RSDM during 3 distinct periods (prelockdown, lockdown, teledentistry) from January 10, 2020, through June 30, 2020, were retrospectively reviewed. Qualitative and quantitative attributes pertaining to patient encounters were reviewed and analyzed. ResultsA total of 1,799 records were included in this study. Patient visits increased during the early lockdown but were reduced after the implementation of teledentistry. Trends were noted in patient volume, reasons for visits, treatment needs, symptoms, diagnostic methodology, prescription use, and final disposition of patients. ConclusionsThe lockdown affected emergency dental clinic services at RSDM. Teledentistry visits played a key role in screening patients and in facilitating the delivery of oral health care and timely follow-ups to patients who needed urgent in-person emergency visits. Practical ImplicationsData gathered will lead to a better understanding of patients seen in the emergency clinic and can help with long-term planning for both institutional and smaller outpatient clinics during public health emergencies.

Guideline implementation, drug sequencing, and quality of care in heart failure: design and rationale of TITRATE-HF.

Current heart failure (HF) guidelines recommend to prescribe four drug classes in patients with HF with reduced ejection fraction (HFrEF). A clear challenge exists to adequately implement guideline-directed medical therapy (GDMT) regarding the sequencing of drugs and timely reaching target dose. It is largely unknown how the paradigm shift from a serial and sequential approach for drug therapy to early parallel application of the four drug classes will be executed in daily clinical practice, as well as the reason clinicians may not adhere to new guidelines. We present the design and rationale for the real-world TITRATE-HF study, which aims to assess sequencing strategies for GDMT initiation, dose titration patterns (order and speed), intolerance for GDMT, barriers for implementation, and long-term outcomes in patients with de novo, chronic, and worsening HF. A total of 4000 patients with HFrEF, HF with mildly reduced ejection fraction, and HF with improved ejection fraction will be enrolled in >40 Dutch centres with a follow-up of at least 3years. Data collection will include demographics, physical examination and vital parameters, electrocardiogram, laboratory measurements, echocardiogram, medication, and quality of life. Detailed information on titration steps will be collected for the four GDMT drug classes. Information will include date, primary reason for change, and potential intolerances. The primary clinical endpoints are HF-related hospitalizations, HF-related urgent visits with a need for intravenous diuretics, all-cause mortality, and cardiovascular mortality. TITRATE-HF is a real-world multicentre longitudinal registry that will provide unique information on contemporary GDMT implementation, sequencing strategies (order and speed), and prognosis in de novo, worsening, and chronic HF patients.

The Role of SGLT2 Inhibitors on Heart Failure Outcomes in Nondiabetic Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) improve cardiovascular outcomes in patients with heart failure (HF). However, studies examining their benefits exclusively in nondiabetic patients on various HF outcomes are limited. By conducting a MEDLINE and ClinicalTrials.gov search for randomized controlled trials, we identified 4 studies on SGLT2i with data on HF outcomes in nondiabetic patients and performed a meta-analysis. There were 10.638 nondiabetic patients, with 5316 patients in the SGLT2i group and 5322 in the placebo group included in this meta-analysis. The composite of worsening HF (hospitalization for HF or urgent visit for HF) or cardiovascular death had 726 events (13.66%) in the SGLT2i group and 907 (17.04%) in the placebo group, with a hazard ratio (HR) of 0.78 and 95% confidence interval (CI) of 0.71-0.86 ( P < 0.0001). There were 551 events (10.36%) of hospitalization for HF in the SGLT2i group, compared with 751 (14.11%) in the placebo group with an HR of 0.71 (95% CI, 0.62-0.81; P < 0.0001). Cardiovascular death occurred in 396 patients (7.45%) in the SGLT2i group and 452 (8.49%) in the placebo group, with an HR of 0.88 (95% CI, 0.77-1.00; P = 0.059). All-cause mortality occurred in 552 patients (10.38%) in the SGLT2i group and 586 (11.01%) in the placebo group, with an HR of 0.95 (95% CI, 0.84-1.07; P = 0.37). This study showed that in patients with HF without diabetes mellitus, SGLT2i improve HF outcomes, including a significant decrease in hospitalizations for HF and a favorable response for the outcome of cardiovascular death.

Effect of dapagliflozin on outpatient worsening heart failure in patients with mildly reduced or preserved ejection fraction: the DELIVER trial

Abstract Background Hospitalization is recognized as a sentinel event in the disease trajectory of patients with heart failure (HF), but not all patients experiencing decompensation are hospitalized. Outpatient intensification of diuretics is common in response to worsening symptoms suggestive of HF, yet its prognostic and clinical relevance is less certain. Purpose To evaluate the prognostic importance of outpatient oral diuretic intensification and assess the treatment effect of dapagliflozin across the spectrum of worsening HF events. Methods DELIVER was a global, randomized clinical trial of dapagliflozin vs. placebo in 6,263 participants with HF with mildly reduced or preserved ejection fraction. In this prespecified landmark analysis, we assessed the association between various non-fatal worsening HF events (those requiring hospitalization, urgent outpatient visits requiring intravenous HF therapies, and outpatient oral diuretic intensification) and rates of subsequent mortality. Diuretic intensification was defined as new initiation (among those not on diuretics at baseline) or dose uptitration sustained for at least 30 days (among those on diuretics at baseline). We also examined the treatment effect of dapagliflozin on an expanded composite endpoint of CV death, HF hospitalization, urgent HF visit, or outpatient oral diuretic intensification. Results In DELIVER, 4,532 (72%) patients experienced no worsening HF event, while 789 (13%) had outpatient oral diuretic intensification, 86 (1%) required an urgent HF visit, 585 (9%) had a HF hospitalization, and 271 (4%) died of CV causes as a first manifestation of worsening HF. Patients with a first presentation manifesting as outpatient oral diuretic intensification experienced rates of subsequent mortality that were higher (10 per 100py) than those without a worsening HF event (4 per 100py) but similar to rates of subsequent death following urgent HF visit (10 per 100py). Patients with a HF hospitalization as a first presentation of worsening HF had the highest rates of subsequent death (35 per 100py); Figure 1. The addition of outpatient diuretic intensification to the adjudicated DELIVER primary endpoint (CV death, HF hospitalization, or urgent HF visit) increased the overall number of patients experiencing an event from 1,122 to 1,731. Dapagliflozin reduced the need for outpatient diuretic intensification alone (HR 0.72; 95% CI: 0.64-0.82; P&amp;lt;0.001) and when analyzed as a part of an expanded composite endpoint of worsening HF (HR 0.76; 95% CI: 0.69-0.84; P&amp;lt;0.001); Figure 2. Conclusions Even in patients with HF with mildly reduced or preserved ejection fraction, hospitalization as a first presentation of worsening HF is associated with significant subsequent mortality. Moreover, oral diuretic intensification in ambulatory care was frequent, adversely prognostic, and significantly reduced by dapagliflozin.Figure 1Figure 2

Heart failure early post-discharge appointment: a 1.5-year single-centre experience

Abstract Background According to Heart Failure (HF) guidelines, a follow-up visit should be conducted within 1 to 2 weeks after hospital discharge to monitor signs and symptoms of HF, optimize therapy, and evaluate treatment side effects. Retrospective studies have shown that this approach is associated with lower 30-day readmission rates. Purpose Our aim is to describe the role of early post-discharge appointment in the management of HF patients and to evaluate prognostic factors after HF hospitalization. Methods We conducted a single-centre prospective registry of consecutive patients evaluated in the early post-discharge appointment at our centre, from March 2021 to September 2022. HF symptoms, vital signs, blood test results, treatment decision, and 90-day HF events were recorded. Results Overall, 153 patients were included (mean age 65.7 ± 13.0 years, 63.4% male). The mean time from hospital discharge to post-discharge appointment was 13.4 ± 5.7 days. Left ventricle ejection fraction was reduced in 83.6% (n = 127) of patients. Guideline-directed medical treatment prescribed at discharge, as well as up-titration and withdrawal patterns at the post-discharge appointment, are presented in Table 1. At the post-discharge appointment, 34.3% of patients (n = 35) presented with drug adverse effects, most often including hyperkalemia (17.5%, n = 22), acute kidney injury (9.9%, n = 12), and hypotension (3.9%, n = 6). Of those evaluated at the post-discharge appointment, 11.2% (n = 17) were scheduled to another appointment one week later, for early re-evaluation, 90.1% (n = 137) were followed-up in the standard HF ambulatory program, and 2.6% (n = 4) were hospitalized. The serum creatinine (1.10 [0.87 – 1.36] mg/dL vs 1.40 [1.09 – 1.95] mg/dL, p&amp;lt;0.001), the serum C cystatin (1.50 [1.25 – 1.98] mg/dL vs 1.97 [1.54 – 2.46] mg/dL, p = 0.007) and the NT-proBNP levels (1859 [977 – 4877] mg/dL vs 5928 [2817 – 11957] mg/dL, p = 0.013), measured at the time of the post-discharge appointment, were found to be associated with HF events within 90 days (urgent HF visit or HF hospitalization). An NT-proBNP level above 2400 pg/mL adjusted to C cystatin was found to be a strong predictor of 90-day HF events (OR 9.855, 95% CI 2.657 – 36.550, p = 0.001). This model yielded a good prognostic performance (AUC 0.790, CI 95% 0.689-0.890, p&amp;lt;0.001). Conclusions Early evaluation of HF patients after hospital discharge allows for guideline-directed medical therapy up-titration and early detection of drug adverse effects. The NTproBNP level and kidney function, assessed early after discharge, have been found to be strong predictors of 90-day HF events, indicating which patients would benefit most from a stricter follow-up program. Table 1 – Guideline-directed medical therapy patterns of prescription both at hospital discharge and during the early post-discharge appointment. ACE, angiotensin converting enzyme; ARA, aldosterone receptor antagonist, MRA, mineralocorticoid receptor antagonist.

Self-monitoring using Mobile App to improve symptoms and Reduce rehospitalization and morTality in Heart Failure (SMART-HF trial)i

Abstract Background Considering the uncertainty of the benefits of mobile apps in patients with heart failure (HF), we developed a mobile health platform and aimed to evaluate this intervention in terms of improving symptoms and outcomes in HF. Methods Seven tertiary hospitals in South Korea participated in this prospective, randomized, open-label, nationwide, multicenter, pilot trial (SMART-HF trial). Patients aged ≥20 years hospitalized for acute heart failure who were able to use a smartphone were enrolled before discharge. Eligible participants were then randomized 1:1 to either the intervention group (AIDA/KT-app with devices) or the control group (AIDA/KT-app only). The mobile health platform consists of three parts: 1) smartphone app for patients (2) dashboard system for physicians (3) clinical decision support system. Only in the intervention group, the applications were automatically paired with a Bluetooth blood pressure monitor, weight scale and body water analyzer. The intervention group were able to enter their HF symptom scale into the app and receive feedback or alerts on their input. In the control group, patients could only enter their blood pressure, weight, and HF symptom into the app, and there are no connected devices and no feedback from the app. Results 84 patients were randomized to the intervention group (n=43) and control group (n=41). Overall, 62.8% of the patients were male, and the median age was 63.0 years. At 4 weeks, dyspnea score by questionnaire (range 0-10) was 1.5±2.3, and 2.0±2.4 in the intervention and control groups, respectively, and was not significantly different (P=0.415). The total HF symptom score (range 0-12) including dyspnea, fatigue, edema, and palpitation entered by the participants in the apps was not significantly different between two groups (2.0±2.1, and 1.6±2.1, P=0.454). In the intervention group, the level of body water composition showed trend toward decreasing during study period (initial level 7.46 -&amp;gt; final level 6.71, P=0.10). App adherence during the study period was higher in the intervention group compared with control group (70.6±32.5% vs. 47.8±32.0%, P=0.004). App satisfaction scores tended to be higher in the intervention group (7.1±2.6 vs. 6.2±2.9, P=0.147). Secondary composite endpoints including death, rehospitalization, and urgent HF visit were not significantly different between two groups (4/40 vs. 3/38, P=0.999). Conclusions Our mobile health platform showed feasibility and efficacy for HF patients although clinical outcomes were not significantly different, maybe due to small sample size. Considering that motivating patients to use the mHealth tool more frequently may lead to greater clinical benefit, further large research with a positive user experience is needed for HF patient care.

Diabetes mellitus and response to IL-1 blockade with Anakinra after ST-elevation myocardial infarction: a pooled analysis of the VCU-ART studies

Abstract Background ST segment elevation myocardial infarction (STEMI) elicits an intense inflammatory response which is thought to contribute to subsequent maladaptive myocardial healing and remodeling, ultimately leading to heart failure (HF). The interleukin-1 (IL-1) blocker anakinra administered during the first 14 days after STEMI patients has been shown to effectively dampen the inflammatory response and reduce the incidence of HF events in pilot randomized controlled trials. Diabetes mellitus is a condition of enhanced systemic inflammation. Purpose To assess the role of diabetes mellitus as a modulating factor in respect to the efficacy of anakinra treatment during the first 14 days after STEMI. Methods We conducted a pooled analysis of three previous proof of principle trials on anakinra in STEMI. Diabetes mellitus was defined based on clinical history, use of glucose-lowering medications, or elevated hemoglobin A1c &amp;gt;6.5% at time of enrollment and further characterized as type I or type II based on the available clinical assessment. The area-under-the-curve for C reactive protein (AUC-CRP) at 14 days was used as a measure of the systemic inflammatory response during STEMI. The clinical endpoint was composite of death, hospitalizations for HF and urgent HF visits. Results The study population included 139 patients, of whom 39 (28%) had a diagnosis of diabetes mellitus at time of enrolment, all with type II. Median age was 56 [49-63] and 56 [49-63] years in patients with and without diabetes, respectively (p=0.652). There were 29 (21%) female and 52 (37%) Black-African American patients among those with diabetes compared to 29 (21%) female and 52 (37%) Black-African American patients in those without diabetes (p=0.69 and p=0.16, respectively). Treatment with anakinra (N=84) significantly dampened acute inflammation associated with STEMI in patients with diabetes (AUC-CRP 223 [117-399] vs 76 [42-148] mg•day/L, p&amp;lt;0.001) and in those without diabetes (AUC-CRP 223 [117-399] vs 76 [42-148] mg•day/L, p&amp;lt;0.001 – Figure 1). No statistically significant interaction between diabetes status and treatment with anakinra on outcomes was detected (pint=0.92): treatment with anakinra was associated with a hazard ratio [HR] 0.28 [0.09-0.84](p=0.02) in non-diabetic patients and HR 0.26 [0.11-1.32](p=0.10) in diabetic patients – Figure 2. Conclusion In this pooled analysis of the VCU-ART trials, the presence of type II diabetes mellitus showed no interaction with the efficacy of the treatment with anakinra early after STEMI in reducing the systemic inflammatory response or preventing new onset heart failure, hospitalization for HF or death.Figure 1.Figure 2

Impact of in-hospital initiation of sodium-glucose cotransporter-2 inhibitors in patients with heart failure and reduced ejection fraction

Abstract Introduction Safety and early clinical benefit make sodium-glucose cotransporter-2 inhibitor (SGLT-2i) therapy suitable for in-hospital initiation in patients with heart failure and reduced ejection fraction (HFrEF). Despite randomized controlled trials and guideline recommendations, they are underused and clinical inertia may play a role. Objectives Primary: To assess the impact of initiating SGLT-2i at discharge on 90-day prescription rates in patients with HFrEF during hospitalization for acute heart failure (AHF). Secondary: To evaluate the presence of contraindications at discharge and the independent factors associated with in-hospital prescription, and to assess clinical outcomes at 90 days. Methods Retrospective analysis of a consecutive prospective single-center cohort. Adult patients hospitalized between January 2021 and October 2022 with a primary diagnosis of AHF and left ventricular ejection fraction (LVEF) &amp;lt;40% were included. Patients who underwent heart transplantation during hospitalization, used SGLT2i before admission, died or were referred during the index hospitalization were excluded. Those who started SGLT-2i before or at discharge were compared with those who did not. The primary outcome was SGLT-2i prescription rate at 90 days, and the exploratory secondary endpoints was the composite of hospitalization or urgent visit for AHF or all-cause mortality at 90 days. Independent factors associated with inpatient SGLT-2i prescription were analyzed using a logistic regression model. Results Among 378 patients with documented HFrEF, 240 (64%) met the inclusion criteria. Mean age was 76±11 years, 75.4% were male and the mean LVEF was 25±13%. SGLT-2i was indicated during hospitalization in 31.6% of patients. A total of 86% of the cohort had a 90-day follow-up, and the SGLT2i prescription rate was 94.2% in those with in-hospital initiation and 14.4% in those without (p&amp;lt;0.001). Among those without contraindications at discharge (n=141), the independent factor associated with inpatient prescription was lower age, OR 0.96 (0.93-0.99) for each year. There were no statistically significant differences between the two groups for the combined endpoint of all-cause death, HF rehospitalisation or unplanned HF visit at 90 days (p=0.3). Conclusions In-hospital initiation of SGLT-2-i was associated with significantly higher prescription rates 90 days after discharge, without differences in death from all causes and hospitalization or urgent visit for AHF at 90 days. This study reflects the presence of medical inertia, particularly in older patients. It also highlights the hospitalization period as an optimal time to start SGLT-2i and achieve the proven clinical benefits that accumulate rapidly over weeks, with solid safety and tolerability.

Mediators of the benefit of sotagliflozin in patients with worsening heart failure in SOLOIST-WHF

Abstract Background In SOLOIST-WHF, the dual SGLT1 and SGLT2 inhibitor sotagliflozin (SOTA) reduced primary endpoint events – total occurrences of cardiovascular (CV) death and hospitalizations and urgent visits for heart failure (HF) – by 33% relative to placebo (PBO) among 1222 patients hospitalized for worsening HF. The extent to which treatment group differences in biomarkers assessed during study follow-up contributed to this benefit of SOTA is unknown. Purpose The contributions of 20 biomarkers (identified in published mediation analyses of SGLT2 inhibitors: HbA1c; weight; BMI; systolic and diastolic BP; heart rate; serum creatinine, urate, albumin, sodium, and magnesium; eGFR; hematocrit; hemoglobin; erythrocytes; total cholesterol; LDL-C; HDL-C; non-HDL-C; triglycerides) to the reduction of primary endpoint events by SOTA relative to PBO were quantified via mediation analyses to describe the mechanisms of SOTA. Methods Patients were randomized 1:1 to SOTA 200 mg/day (with possible increase to 400 mg/day) or PBO and followed for a median 9 months. Two conditions must be met for a biomarker to be a mediator: there had to be a treatment group difference on the biomarker and an association between the biomarker and risk of primary endpoint events. For the first condition, treatment group differences in change from baseline in each biomarker were analyzed by mixed effects repeated measures models. For the second condition, time-varying values of each biomarker were related to the risk of primary endpoint events by calculating the time-weighted moving average (TWMA) for each variable, using all values for a given patient. Each was analyzed in a competing risks marginal model for total events (stratified according to left ventricular ejection fraction at baseline and geographic region of enrollment), in which non-CV deaths were treated as competing terminal events and TWMA values were included as a time-varying covariate. The individual and joint mediation of those biomarkers determined to be mediators were assessed in competing risks marginal models that included treatment assignment. If biomarkers that would otherwise be included in multivariable models were strongly correlated (baseline values R2&amp;gt;0.5), the marker with the greatest univariate mediation was included. All analyses were intention-to-treat. Results Among the biomarkers considered, serum urate, hemoglobin, and total cholesterol met the criteria for being mediators. Serum urate was the strongest single mediator, while the joint mediation for these three biomarkers was 22.3% (Figure 1). Conclusion In SOLOIST-WHF, a fraction of the benefit of SOTA was attributable to effects on biomarkers accounting for most of the treatment benefits of other SGLT2 inhibitors on CV death and HF events. Further investigation is therefore needed to identify what unique biomarker treatment effects might account for the majority of SOTA benefit.Figure 1

Abstract 17940: Effects of Continuous Accelerated Pacing on Clinical Outcomes in Patients With Heart Failure With Preserved Ejection Fraction: Three Year Follow Up of the myPACE Randomized Clinical Trial

Background: Heart failure with a preserved ejection fraction (HFpEF) is prevalent and has few evidence-based therapies. In a trial of HFpEF patients with specialized pacemakers, an accelerated personalized pacing rate averaging 75 bpm (myPACE) improved quality of life, NT-proBNP, physical activity, and atrial fibrillation burden compared with the standard lower rate setting of 60bpm (usual care). The one-year myPACE trial was not powered for clinical outcomes, but most patients elected to remain on their assigned treatment. Methods: The myPACE study was a single-center, blinded, randomized controlled trial that enrolled patients from June 2019 to November 2020. In this per-protocol analysis of clinical events over a 3-year follow-up, we included trial participants who remained on their assigned heart rate after study completion. The outcome of this analysis is a composite of the first clinical event (urgent visit or hospitalization for heart failure or atrial fibrillation, unstable angina or myocardial infarction, stroke, and death). Events were obtained by chart review and adjudicated by two blinded investigators. A Kaplan-Meier event-free survival plot and a log-rank test evaluated differences between the two treatment arms. Results: Of the 100 myPACE trial participants, most (40/48 myPACE and 48/52 usual care) remained on their assigned heart rate over a median (IQR) of 3.3 (2.6, 3.7) years after enrollment. The median (IQR) age was 75(69-80), and 45% were female. Accelerated personalized pacing was associated with reduced adverse clinical outcomes by about 60 percent. The Kaplan-Meier event-free survival plot for the composite of clinical events is shown in the Figure. Conclusions: In a per-protocol clinical event analysis of the extended myPACE study, those who continued the myPACE accelerated pacing protocol had fewer adverse clinical events than those with a lower rate setting of 60 bpm.

Abstract 13727: Cost-Effectiveness of Sotagliflozin in Heart Failure Patients With Preserved and Reduced Ejection Fractions—Results From the SOLOIST-WHF

Background: SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) showed patients with diabetes and recent worsening heart failure (HF), sotagliflozin initiated before or shortly after discharge lowered incident cardiovascular deaths, hospitalizations, and HF urgent visits. In this study, we evaluated the cost-effectiveness of sotagliflozin in all patients and those with preserved (HFpEF ≥50%) and reduced (HFrEF &lt;50%) ejection fraction. Methods: We ran a Markov microsimulation model based on treatment effects from SOLOIST-WHF, healthcare costs and utilities from national sources, and estimated net costs for sotagliflozin of $434 (range from $407 to $612) monthly, to calculate projected lifetime healthcare costs, HF and CVD events, survival, and quality-adjusted life-years (QALYs) for sotagliflozin vs placebo in SOLOIST-WHF eligible patients from a payer perspective. Outcome measured as the incremental cost-effectiveness ratio (ICER), incremental costs / QALYs gained. Sensitivity analyses assessed and quantified uncertainties. Results: Over a lifetime, sotagliflozin compared to placebo added 0.39 QALYs (4.43 vs. 4.04 QALYs) and 0.64 life-years (7.12 vs. 6.48) at an incremental cost of $29,449 (95% uncertainty interval (UI): $26,610-$32,528) for an ICER of $75,510 per QALY gained (UI: $55,640-$98,300). In HFpEF patients, sotagliflozin compared to placebo added 0.43 QALYs (4.53 vs. 4.10 QALYs) and 0.68 life-years (7.14 vs. 6.46) at an incremental cost of $26,615 (UI: $23,376-$29,694) for an ICER of $61,488 per QALY gained (UI: $41,618-$84,280). In HRrEF patients, sotagliflozin added 0.37 QALYs (4.33 vs. 3.96 QALYs) and 0.63 life-years (7.09 vs. 6.46) at an incremental cost of $30,012 (UI: $26,773-$33,251) for an ICER of $77,996 per QALY gained (UI: $58,126-$100,780). The benefit of sotagliflozin in QALY mainly results from the decrease in CVD deaths. Findings were sensitive to drug cost and number of readmissions. Conclusions: This study demonstrates that sotagliflozin priced from $407 to $612 per month is a clinically and economically favorable medication in patients with diabetes, recent worsening heart failure, with both preserved and reduced ejection fraction.

Abstract 13696: Sotagliflozin is Associated With Early Clinical Benefit for Heart Failure and Atherosclerotic Events

Background: SGLT inhibitors reduce cardiovascular (CV) death and heart failure (HF)-related outcomes in HF patients, with benefits observed within 1 month. Less data exist for the time to clinical benefit for reducing HF or major cardiovascular events (MACE; CV death, myocardial infarction, and stroke) with SGLT inhibitors in patients with chronic kidney disease at high CV risk. Objective: This analysis evaluates the time to clinical benefit for HF-related events and MACE with sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in SCORED. Methods: SCORED was a randomized, double-blind study of 10,584 patients with type 2 diabetes, chronic kidney disease, and other CV risk factors, where patients were randomized 1:1 to sotagliflozin or placebo. The primary endpoint was total CV death, hospitalization for HF, or urgent visit for HF. A prespecified secondary endpoint was total MACE. The present post hoc analysis calculated the sotagliflozin:placebo hazard ratios (HR) and 95% confidence intervals (CI) for each of these outcomes and determined the day after randomization where the treatment effect reached statistical significance (p&lt;0.05) and remained statistically significant for the duration of follow-up. Results: The overall risk of the primary endpoint was reduced by 26% (HR (95% CI) = 0.74 (0.63, 0.88); p&lt;0.001) with sotagliflozin, with a sustained significant reduction 95 days after randomization (HR (95% CI) = 0.70 (0.50, 0.98) at 95 days; Figure A). For MACE, the overall risk reduction with sotagliflozin was 23% (HR (95% CI) = 0.77 (0.65, 0.91); p&lt;0.001), with a sustained significant reduction 94 days after randomization (HR (95% CI) = 0.69 (0.47, 0.99) at 94 days; Figure B). Conclusion: In this stable, outpatient population at high risk for CV events, the time to clinical benefit with sotagliflozin was very early at approximately three months for both HF- and MACE-related outcomes.

Optimization of telemedicine in advanced practice provider (APP) led oncology/hematology remote-only clinic.

523 Background: To continue quality timely patient care telemedicine usage increased during the COVID-19 pandemic. A systematic review of the literature supports the use of telemedicine beyond the pandemic. The goal of this quality improvement (QI) project sought to identify barriers and promoters to sustain telemedicine visits for adult oncology/hematology patients seen in the Virtual Advanced Practice Provider (VAPP) clinic. A Telemedicine Toolkit (TT) was developed for providers to enhance and improve the provider/patient experience. Methods: Retrospectivedata retrieved from EMR/VAPP included details from 1,985 patient visits for March-August 2022 to investigate how to optimize the specialty care visit. Over a 10-day period, staff completed pre/posttest surveys to assess engagement and satisfaction with TT. Results: The data points from the statewide EMR and VSee platforms showed the patient median age was 62; age range seen 19-95. More females were seen at 65% (1290) than males at 35% (695); predominant race/ethnicity was white at 47.5% (943). The main diagnosis seen was breast at 28.86% (573), then lung at 7% (127), followed by colon at 6.90% (137). Visit type from high to low: the teaching visit at 44.5% (884), standard follow-up visit (toxicity checks and hospital follow-ups) at 32.9% (645), new genetics visits at 11.5% (228) and follow-up genetic visits at 7% (138), Advance care planning visits (ACP) at 3% (58), urgent care follow-up visit at 1% (24) and the high-risk/preventive care at 0.4% (8). Nearly 250 locations were served predominantly in central Texas. Patient devices used included iPhone/IOS at 48%, Windows OS at 27.5%, Android at 20.5%, and Mac OS at 4%. Conclusions: The VAPP clinic with a robust infrastructure, is now serving the entire state of Texas. The staff noted the TT to be intuitive and helpful. Sustainability of the TT through updates and continued staff education is essential. This project did not find a significant problem with Wi-Fi services and the most common reason for an aborted/canceled visit was the patient did not remember their Apple ID/Google password to be able to download the VSee application. Patient education prior to visits regarding Vsee needs would potentially reduce canceled/aborted visits.

Efficacy of Sotagliflozin in Adults With Type 2 Diabetes in Relation to Baseline Hemoglobin A1c

BackgroundThe SCORED (Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk) and SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trials demonstrated that sotagliflozin, an SGLT1 and SGLT2 inhibitor, improves outcomes in individuals with type 2 diabetes who have heart failure (HF) or kidney disease. ObjectivesWe assessed the efficacy of sotagliflozin on HF clinical outcomes in individuals with differing baseline glycosylated hemoglobin (HbA1c) levels. MethodsWe included all adults from SCORED and SOLOIST-WHF. The primary outcome was a composite of cardiovascular death, hospitalizations for HF, and urgent visits for HF. The efficacy of sotagliflozin compared with placebo was evaluated by baseline HbA1c using competing-risk marginal proportional hazards models. ResultsWe identified 11,744 adults. Individuals with HbA1c ≤7.5% experienced the primary outcome at a lower rate in the sotagliflozin group (11.2 per 100 person-years) than the placebo group (15.5 per 100 person-years) (HR: 0.73; 95% CI: 0.57-0.93). Similarly, individuals with HbA1c of 7.6% to 9.0% experienced the primary outcome at a lower rate in the sotagliflozin group (7.3 per 100 person-years) than the placebo group (9.4 per 100 person-years) (HR: 0.77; 95% CI: 0.63-0.96). These findings were also consistent among individuals with HbA1c >9.0%, with a primary outcome rate in the sotagliflozin group (7.8 per 100 person-years) that was lower than the placebo group (11.6 per 100 person-years) (HR: 0.65; 95% CI: 0.50-0.84). The efficacy of sotagliflozin was consistent by baseline HbA1c level (P for interaction = 0.58). ConclusionsIn individuals with type 2 diabetes and either HF or kidney disease, sotagliflozin reduced HF outcomes irrespective of baseline HbA1c.

Use of Win Statistics to Analyze Outcomes in the DAPA-HF and DELIVER Trials

BackgroundThe primary end point in most heart failure (HF) trials is a composite of time to a first worsening HF event or cardiovascular death. Prevention of recurrent events and improvements in symptoms/quality of life are also important for patients but are usually analyzed separately. Win statistics can integrate all these outcomes into a single composite end point, which is analyzed in hierarchical order, reflecting the clinical importance of each component.MethodsThe Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure (DAPA-HF, n=4744) and Dapagliflozin Evaluation to Improve the Lives of Patients with Preserved Ejection Fraction Heart Failure (DELIVER, n=6263) trials enrolled patients with New York Heart Association class II, III, or IV HF, elevated natriuretic peptides, and either an ejection fraction of 40% or less (DAPA-HF) or greater than 40% and left atrial enlargement/left ventricular hypertrophy (DELIVER). We examined the effects of dapagliflozin compared with placebo on a hierarchical composite outcome, including cardiovascular death, total (first and recurrent) HF hospitalizations, total urgent HF visits, and improvement/deterioration in Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS; range from 0 to 100, with a higher score indicating fewer symptoms and physical limitations) at 8 months.ResultsFor this composite outcome, the win ratio was 1.30 (95% confidence interval [CI], 1.23 to 1.36) in the pooled cohort, 1.33 (95% CI, 1.23 to 1.43) in the DAPA-HF trial, and 1.27 (95% CI, 1.18 to 1.36) in the DELIVER trial. Win odds and net benefit in overall patients were 1.19 (95% CI, 1.14 to 1.24) and 8.7% (95% CI, 6.6 to 10.9%), respectively. In the overall pooled cohort, the majority of wins and losses were accounted for by KCCQ-TSS; 52.4% were settled by the KCCQ-TSS tier in the pooled cohort.ConclusionsIn both the DAPA-HF and DELIVER trials, dapagliflozin led to a significant improvement in composite outcomes that incorporated patient-reported outcomes along with total HF events, as well as cardiovascular deaths. These analyses provided a comprehensive presentation of win statistics and illustrated the utility and flexibility of win statistics in describing the effects of dapagliflozin in two recent clinical trials in patients with HF. (Funded by British Heart Foundation Centre of Research Excellence and others; clinical trial registration numbers, NCT03036124 and NCT03619213.)

Soluble ST2, BCN-Bio-HF calculator and MAGGIC-HF score in long-term risk prediction after an urgent visit for heart failure.

Soluble ST2 (sST2) is the expression of a pathogenic process related to adverse remodeling that ultimately leads to increased mortality in heart failure (HF). Risk score models provide a comprehensive approach for mortality prediction, beyond the use of biomarkers alone. The objective was to determine the additional value of sST2 and two well-validated contemporary risk scores, BCN-Bio-HF and MAGGIC-HF, in predicting mortality and readmission in the acute setting. This prospective study included 129 patients (mean age 75 ± 9 years; 52% males) after an urgent HF visit. Baseline sST2 levels were measured and the two risk scores were calculated. The primary endpoint was all-cause mortality, and the secondary endpoint was HF readmissions. The follow-up period was 3.6 ± 1.9 years. Patients who died (46%) had higher sST2 concentrations (80.5 vs. 42.7 ng/ml; p < 0.001). The BCN-Bio-HF calculator with sST2 demonstrated the best discriminative ability for mortality prediction (area under the ROC curve: 0.792; p < 0.001). In multivariate analysis for each risk score, the MAGGIC-HF score retained its predictive value only in the model without sST2 (3-year risk: HR = 1.036; 95% CI 1.019-1.054; p < 0.001). However, the BCN-Bio-HF score maintained its prognostic value with sST2 (HR = 1.032; 95%CI 1.020-1.044; p < 0.001), as well as without sST2 (HR = 1.035; 95% CI 1.021-1.049; p < 0.001). sST2 was not associated with readmission, and only the BCN-Bio-HF risk of HF hospitalization showed independent predictive value (OR = 1.040; 95% CI 1.005-1.076; p = 0.023). For predicting long-term mortality in HF in the emergency department, the BCN-Bio-HF calculator with sST2 demonstrated superior discrimination and allows estimation of the risk of HF hospitalizations.

Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial

Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference,-0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Smartphone App PACOM to Provide Advice Regarding Self-Triage for the Acute Primary Care Needs of Children: Accuracy of Algorithms.

We developed a phone app, PACOM (Parents Application Conseils et Orientation Médicale), to provide medical advice to caregivers based on several algorithms and a series of binary questions related to children's symptoms. We compared the recommendations of the PACOM algorithms and clinicians for children visiting the emergency department (ED). Between January and February 2022, we prospectively recruited French-speaking parents of children without any chronic disease who presented to the pediatric ED with any complaint except for mental health problems or trauma. Isolated head trauma was included. They completed questionnaires and the various PACOM algorithms. The first algorithm, called "Quick Look," was developed to identify children with life-threatening emergencies. The standard reference was the advice of the ED clinicians who were blinded to the parental responses to the PACOM algorithm questions. The recommendations included "call urgent medical support," "visit the ED," "visit your general practitioner within 24 hours," and "visit your general practitioner in the next days." The study included 269 parents. The response rate was 75%. The median age of the children was 3 years with interquartile range: 1 to 7 years. In total, 268 children completed the "Quick Look," 141 "fever," 83 "abdominal pain," 72 "cough," 70 "vomiting," 130 questionnaires relative to other proposed symptoms, and 70 "other symptom" questionnaires. The PACOM recommendations were "call urgent medical assistant" for 98 children, "ED visit" for 131, "visit general practitioner within 24 hours" for 13, and "visit general practitioner during the next days" for 24. The sensitivity and specificity of the PACOM recommendation to "call urgent medical support or visit the ED" were 98.1% (95% confidence interval, 95.5-100.00) and 22.1% (95% confidence interval, 15.3-28.8), respectively. The PACOM algorithms has high sensitivity but low specificity for reducing ED visits and calls for urgent medical support.