Advanced Heart Failure Therapies Research Articles

Bias in team decision-making for advanced heart failure therapies: model application

ABSTRACT Bias in advanced heart failure therapy allocation results in inequitable outcomes for minoritized populations. The purpose of this study was to examine how bias is introduced during group decision-making with an interprofessional team using Breathett’s Model of Heart Failure Decision-Making. This was a secondary qualitative descriptive analysis from a study focused on bias in advanced heart failure therapy allocation. Team meetings were recorded and transcribed from four heart failure centers. Breathett’s Model was applied both deductively and inductively to transcripts (n = 12). Bias was identified during discussions about patient characteristics, clinical fragility, and prior clinical decision-making. Some patients were labeled as “good citizens” or as adherent/non-adherent while others benefited from strong advocacy from interprofessional team members. Social determinants of health also impacted therapy allocation. Interprofessional collaboration with advanced heart failure therapy allocation may be enhanced with the inclusion of patient advocates and limit of clinical decision-making using subjective data.

EXPRESS: Association of suPAR, ST2, and Galectin-3 with eGFR Decline and Mortality in Patients with Advanced Heart Failure with Reduced Ejection Fraction.

Patients with heart failure with reduced ejection fraction (HFrEF) are at risk for chronic kidney disease (CKD). Elevated levels of circulating biomarkers soluble urokinase plasminogen activator receptor (suPAR), galectin-3, soluble suppression of tumorigenicity 2 (ST2), and N-terminal prohormone B-type natriuretic peptide (NT-proBNP) are associated with CKD progression and mortality. The predictive value of these biomarkers in a population with HFrEF and kidney disease is relatively unknown. We sought to determine whether these biomarkers were associated with longitudinal trajectory of eGFR in HFrEF and assess their association with mortality using a joint model to account for competing risks of ventricular assist device (VAD) implantation and heart transplantation. We included participants from the Registry Evaluation of Vital Information for Ventricular Assist Devices in Ambulatory Life with repeated eGFR measures over 2 years. Of 309 participants mean age was 59 years, median eGFR 60 ml/min/1.73m2, 45 participants died, 33 received VAD, and 25 received OHT. Higher baseline serum standardized suPAR [β coefficient =-0.36 √(ml/min/1.73m2), 95% CI (-0.48, -0.24), P<0.001], standardized galectin-3 [-0.14 √(ml/min/1.73m2) (-0.27, -0.02), P=0.02], and log NT-proBNP [-0.23 √(ml/min/1.73m2) (-0.31, -0.15), P<0.001], were associated with eGFR decline. ST2 and log NT-proBNP were associated with mortality. Higher baseline suPAR, galectin-3, and NT-proBNP are associated with eGFR decline in patients with HFrEF. Only ST2 and NT-proBNP are associated with greater mortality after controlling for other factors including change in eGFR. These biomarkers may provide prognostic value for kidney disease progression in HFrEF and inform candidacy for advanced heart failure therapies.

Hopes, expectations, and informational needs in patients undergoing advanced heart failure therapy evaluations

BackgroundPatients undergoing evaluation for advanced heart failure therapies (AHT) are at a critical juncture of their illness. Guidelines recommend shared decision-making with patients and caregivers; however, the approach and content of these discussions is unknown. MethodsPatients referred to a specialty palliative care service during AHT evaluation between October 2018 and September 2022 were identified from electronic healthcare records. Goals of care conversations documented in an advance care planning module were analyzed for participants, content, and timing prior to transplant selection committee meeting. Primary outcomes included prevalence of documented hopes, worries, shared prognostic communication, illness understanding, treatment expectations, and information preferences. Patients were followed for a minimum of six months to evaluate secondary processes and clinical outcomes. Results94 patients (mean age 52.8 years, 76.6% male) met criteria. Most (97.9%, n=92) had illness understanding documented. In initial discussions, 76.3% (n=71) hoped to “live longer” and 67.7% (n=63) to “be independent”; thematic analysis supported these hopes with 91.0% of patients expecting “better functionality”. Most patients preferred multi-modal information and communication. During follow-up, 27.7% (n=26) had treatment decisions deferred at initial committee presentation, and 43.6% (n=41) were reviewed at multiple selection committee meetings. By the end of the study period, 53.2% (n=50) underwent one or more AHT and 24.5% (n=23) had died. ConclusionPatients undergoing the AHT evaluation process face considerable uncertainty. A standardized approach by a specialty palliative care service elicits patients’ illness understanding, hopes, worries, treatment expectations, and information preferences to promote shared decision-making at this critical time.

(1082) - Characteristics and Outcomes of Patients Receiving Advanced Heart Failure Therapies from a Safety-Net Hospital in the United States

(1082) - Characteristics and Outcomes of Patients Receiving Advanced Heart Failure Therapies from a Safety-Net Hospital in the United States

(115) - Availability, Volumes, and Referral Strategies of Advanced Heart Failure Therapies in the Eastern Mediterranean Region: Results from The AHF-EMR Survey

(115) - Availability, Volumes, and Referral Strategies of Advanced Heart Failure Therapies in the Eastern Mediterranean Region: Results from The AHF-EMR Survey

(283) - Sex and Gender Differences in Patients Referred for Advanced Heart Failure Therapies

(283) - Sex and Gender Differences in Patients Referred for Advanced Heart Failure Therapies

The challenge of advanced therapies in the contemporary era: first in Europe ECPELLA long-distance transfer. A case report

Abstract Background The use of mechanical circulatory support (MCS) has markedly increased over the last decade, so have the inter-hospital transfers, with the aim of being able to offer advanced heart failure (AHF) therapies and centralising patients to tertiary centres. Case summary In this article, we present the first in Europe long-distance air transfer of a patient supported by Veno-Arterial Extracorporeal Membrane Oxygenator and Impella (ECPELLA), as a bridge to successful heart transplant. In our case report, a foreign young patient with AHF due to familiar cardiomyopathy required multiple MCS devices to achieve cardiovascular stability. After appropriate planning and multidisciplinary discussion, the patient was transferred on MCS to his country of origin via a fixed-wing airplane, in order to be assessed for heart transplantation. During take-off the Impella flows temporarily dropped and a suction alarm was displayed; however, this rectified without intervention and the rest of the flight was uneventful. One month after transfer, the patient underwent successful heart transplantation and remained clinically stable during the 12-month follow-up. Discussion Our experience links together the current challenges in the evolving AHF strategies and the increased need for inter-facility cooperation. Both these clinical and logistic challenges appear to lead to possible improved outcomes, after appropriate assessment, training and accurate planning. Our experience provides useful information on feasibility of long-distance transport of patients supported by ECPELLA in Europe.

Cardiomyopathies in Women.

Heart failure affects over 2.6 million people in the United States. While women have better overall survival rates, they also suffer from higher morbidity as shown by higher rates of hospitalization and worse quality of life. Several anatomical differences in women's hearts affect both systolic and diastolic cardiac physiology. Despite these findings, women are significantly underrepresented in clinical trials, necessitating extrapolation of data from males. Because women have sex-specific etiologies of heart failure and unique manifestations in genetic-related cardiomyopathies, meaningful sex-related differences affect heart failure outcomes as well as access to and outcomes in advanced heart failure therapies in women. This review explores these gender-specific differences and potential solutions to balance care between women and men.

CMR feature tracking–based left atrial mechanics predicts response to cardiac resynchronization therapy and adverse outcomes

BackgroundCardiac resynchronization therapy (CRT) is an established therapy for advanced heart failure (HF) with prolonged QRS duration. However, 30% of patients have shown no benefit from the treatment. ObjectiveThis study aimed to examine the value of left atrial (LA) mechanics by cardiac magnetic resonance (CMR) to predict response to CRT and clinical outcomes. MethodsA total of 163 CRT recipients with preimplantation CMR examination were retrospectively recruited. CMR feature tracking was used to evaluate LA size and function. The end points include (1) improvement of at least 5% in left ventricular ejection fraction combined with a reduction of at least 1 New York Heart Association functional class at 6-month follow-up and (2) any all-cause death or HF hospitalization during follow-up. ResultsOverall, 82 (50.3%) were CRT responders. CRT nonresponders had larger LA and worse LA reservoir and booster function than did responders (P < .001 for all). LA structural (maximum volume index < 47 mL/m2) and functional (booster strain > 8.5%) criteria were incremental to traditional indicators in detecting CRT response (χ2, 40.83 vs 9.98; P < .001). During follow-up (median 41 months), survival free from death or HF hospitalization increased with the number of positive LA criteria (log-rank, P < .001). After adjustment for clinical confounders, the absence of the 2 criteria remained associated with a considerably increased risk of death or HF hospitalization (adjusted hazard ratio 6.2; 95% confidence interval 2.15–17.88; P = .001). ConclusionThe preprocedure LA mechanics evaluated using CMR may be useful to predict response to CRT and improve risk stratification in CRT recipients.

Using Multiphase Optimization Strategy and Human-Centered Design to Create an Integrated Model of Palliative Care Skills in Home-Based Physical Therapy for Advanced Heart Failure.

Background: Many older adults with advanced heart failure receive home health rehabilitation after hospitalization. Yet, integration of palliative care skills into rehabilitation is limited. Objective: Describe using the Multiphase Optimization Strategy (MOST) framework with human-centered design principles to engage clinical partners in the Preparation phase of palliative physical therapy intervention development. Design: We convened a home-based physical therapy advisory team (four clinicians, three clinical leaders) to identify physical therapist needs and preferences for incorporating palliative care skills in rehabilitation and design an intervention prototype. Results: Between 2022 and 2023, we held five advisory team meetings. Initial feedback on palliative care skill preferences and training needs directly informed refinement of our conceptual model and skills in the intervention prototype. Later feedback focused on reviewing and revising intervention content, delivery strategy, and training considerations. Conclusion: Incorporating human-centered design principles within the MOST provided a useful framework to partner with clinical colleagues in intervention design.

Advanced Heart Failure: Therapeutic Options and Challenges in the Evolving Field of Left Ventricular Assist Devices.

Heart Failure is a chronic and progressively deteriorating syndrome that has reached epidemic proportions worldwide. Improved outcomes have been achieved with novel drugs and devices. However, the number of patients refractory to conventional medical therapy is growing. These advanced heart failure patients suffer from severe symptoms and frequent hospitalizations and have a dismal prognosis, with a significant socioeconomic burden in health care systems. Patients in this group may be eligible for advanced heart failure therapies, including heart transplantation and chronic mechanical circulatory support with left ventricular assist devices (LVADs). Heart transplantation remains the treatment of choice for eligible candidates, but the number of transplants worldwide has reached a plateau and is limited by the shortage of donor organs and prolonged wait times. Therefore, LVADs have emerged as an effective and durable form of therapy, and they are currently being used as a bridge to heart transplant, destination lifetime therapy, and cardiac recovery in selected patients. Although this field is evolving rapidly, LVADs are not free of complications, making appropriate patient selection and management by experienced centers imperative for successful therapy. Here, we review current LVAD technology, indications for durable MCS therapy, and strategies for timely referral to advanced heart failure centers before irreversible end-organ abnormalities.

Enhancing heart failure treatment decisions: interpretable machine learning models for advanced therapy eligibility prediction using EHR data

Timely and accurate referral of end-stage heart failure patients for advanced therapies, including heart transplants and mechanical circulatory support, plays an important role in improving patient outcomes and saving costs. However, the decision-making process is complex, nuanced, and time-consuming, requiring cardiologists with specialized expertise and training in heart failure and transplantation. In this study, we propose two logistic tensor regression-based models to predict patients with heart failure warranting evaluation for advanced heart failure therapies using irregularly spaced sequential electronic health records at the population and individual levels. The clinical features were collected at the previous visit and the predictions were made at the very beginning of the subsequent visit. Patient-wise ten-fold cross-validation experiments were performed. Standard LTR achieved an average F1 score of 0.708, AUC of 0.903, and AUPRC of 0.836. Personalized LTR obtained an F1 score of 0.670, an AUC of 0.869 and an AUPRC of 0.839. The two models not only outperformed all other machine learning models to which they were compared but also improved the performance and robustness of the other models via weight transfer. The AUPRC scores of support vector machine, random forest, and Naive Bayes are improved by 8.87%, 7.24%, and 11.38%, respectively. The two models can evaluate the importance of clinical features associated with advanced therapy referral. The five most important medical codes, including chronic kidney disease, hypotension, pulmonary heart disease, mitral regurgitation, and atherosclerotic heart disease, were reviewed and validated with literature and by heart failure cardiologists. Our proposed models effectively utilize EHRs for potential advanced therapies necessity in heart failure patients while explaining the importance of comorbidities and other clinical events. The information learned from trained model training could offer further insight into risk factors contributing to the progression of heart failure at both the population and individual levels.

Influence of myocardial contractility therapy for advanced heart failure

With more than 5 million patients’ diagnosed with heart failure (HF) and more than 1 million hospitalizations each year, HF continues to have a significant impact on health-care resources. Despite treatment, a significant number of patients continue to have progressive HF symptoms, classified as Class III or IV. The aim of this study was to compare different inotropic therapy for patients of End-Stage Heart Failure. When persistent intravenous access was used and acute hemodynamic improvement was established, the durable medical equipment (DME) benefit category reimbursed 80% of outpatient inotropic medication and supplies for HF. Acute hemodynamic improvement was defined as a 20% reduction in pulmonary capillary wedge pressure and/or a 20% increase in cardiac index, both of which were related to a decrease in dyspnea. The Centers for Medicaid and Medicare Services contracted with regional carriers to run the program. The amounts reimbursed per beneficiary for inotrope and supplies (not adjusted for differential follow-up) were essentially representative of the inotrope cost. Dobutamine, milrinone, and supplies had mean (and median) amounts of 5025 (1168), 87781 (31440), and 7284 (3131), respectively. We found that patients who received this medication had a relatively high death rate, however not as high as people who received chemotherapy. Milrinone-treated patients were compensated more for hospitalizations both before and after starting the inotrope. In addition, the milrinone group had a higher level of digoxin use in the background. Nonetheless, there is an early decrease in overall expenditures following inotrope initiation, which can be attributed to a decrease in hospitalization. Considering the lack of double-blind trials comparing inotropes to placebo or dobutamine to milrinone, decisions regarding the use of inotropes, the type of inotrope used, and the duration of treatment should take into account the impact on resources.

Cardiac Rehabilitation Use After Heart Failure Hospitalization Associated With Advanced Heart Failure Center Status.

Cardiac rehabilitation (CR) is an evidence-based, guideline-endorsed therapy for patients with heart failure with reduced ejection fraction (HFrEF) but is broadly underutilized. Identifying structural factors contributing to increased CR use may inform quality improvement efforts. The objective here was to associate hospitalization at a center providing advanced heart failure (HF) therapies and subsequent CR participation among patients with HFrEF. A retrospective analysis was performed on a 20% sample of Medicare beneficiaries primarily hospitalized with an HFrEF diagnosis between January 2008 and December 2018. Outpatient claims were used to identify CR use (no/yes), days to first session, number of attended sessions, and completion of 36 sessions. The association between advanced HF status (hospitals performing heart transplantation or ventricular assist device implantations) and CR participation was evaluated with logistic regression, accounting for patient, hospital, and regional factors. Among 143 392 Medicare beneficiaries, 29 487 (20.6%) were admitted to advanced HF centers (HFC) and 5317 (3.7%) attended a single CR session within 1 yr of discharge. In multivariable analysis, advanced HFC status was associated with significantly greater relative odds of participating in CR (OR = 2.20: 95% CI, 2.08-2.33; P < .001) and earlier initiation of CR participation (-8.5 d; 95% CI, -12.6 to 4.4; P < .001). Advanced HFC status had little to no association with the intensity of CR participation (number of visits or 36 visit completion). Medicare beneficiaries hospitalized for HF were more likely to attend CR after discharge if admitted to an advanced HFC than a nonadvanced HFC.

Influence of socioeconomic status on rates of advanced heart failure therapies

BackgroundSocioeconomic deprivation is associated with a lower likelihood of referral for advanced heart failure (HF) evaluation, but it is not known whether it influences rates of advanced HF therapies independently of key hemodynamic measures and comorbidity following advanced HF evaluation in a universal healthcare system. Materials and MethodsWe linked data from a single-center Danish clinical registry of consecutive patients evaluated for advanced HF with patient-level information on socioeconomic status. Patients were divided into groups based on the level of education (low, medium, and high), combined degree of socioeconomic deprivation (low, medium, and high), and household income quartiles. Rates of the combined outcome of left ventricular assist device implantation or heart transplantation (advanced HF therapy) with death as a competing risk were estimated with cumulative incidence functions, and Cox proportional hazards models adjusted for age, sex, central venous pressure, cardiac index, and comorbidities. ResultsWe included 629 patients, median age 53 years, of whom 77% were men. During a median follow-up of 5 years, 179 (28%) underwent advanced HF therapy. The highest level of education was associated with higher rates (high vs. low, adjusted HR 1.81 95% CI 1.14-2.89, p = 0.01), whereas household income quartile groups (Q4 vs. Q1, adjusted HR 1.37 95% CI 0.76-2.47, p=0.30) or groups of combined socioeconomic deprivation (high vs. low degree of deprivation, adjusted HR 0.86 95% CI 0.50-1.46, p = 0.56) were not significantly associated with rates of advanced HF therapy. ConclusionsPatients with a lower level of education might be disfavored for advanced HF therapies and could require specific attention in the advanced HF care center.

Left ventricular assist device and transcatheter edge-to-edge mitral valve repair in advanced heart failure: allies or enemies?

The implantation of left ventricular assist devices (LVADs) has been increasing, with good long-term results, in parallel with a growing population with advanced heart failure (HF). However, in some European countries, LVADs are still underused, with one of the main issues being the patient's late referral. On the contrary, the use of transcatheter edge-to-edge mitral valve repair (TEER) has exponentially increased over the past decade, expanding its potential use even in patients on the heart transplantation waiting list. Even though the study populations of the main trials that investigated the prognostic impact of LVAD and TEER are different, in clinical practice a clear distinction might not be so clear. Therefore, patients with refractory HF symptoms and significant mitral regurgitation should be thoroughly evaluated through a multidisciplinary Heart Team meeting with both an advanced HF specialist and interventional cardiologist, to avoid futile procedures and to define the optimal timing for advanced HF therapies, when they are indicated. We analyzed the main available studies and registries on both TEERs and LVADs and we compared their populations and outcomes, to provide the current evidence on the use of LVAD and TEER in the HF population, especially in the light of the recently released 5-year follow-up results, giving some insights on the Italian situation, and finally to stress the importance of a solid HF network between hospitals, aiming for advanced HF patients' timely referral for LVAD or heart transplants.

Uptake of Sodium-Glucose Cotransporter-2 Inhibitors in Hospitalized Patients With Heart Failure: Insights From the Veterans Affairs Healthcare System

BackgroundThe use of sodium-glucose cotransporter-2 inhibitor (SGLT2i) in Veteran Affairs (VA) patients hospitalized with heart failure (HF) has not been previously reported. MethodsVA electronic health record data were used to identify patients hospitalized for HF (primary or secondary diagnosis) from 01/2019-11/2022. Patients with SGLT2i allergy, advanced/end-stage chronic kidney disease (CKD), or advanced HF therapies were excluded. We identified factors associated with discharge SGLT2i prescription among hospitalizations in 2022. We also compared SGLT2i and angiotensin receptor-neprilysin inhibitor (ARNI) prescription rates. Hospital-level variation in SGLT2i prescription was assessed via the median odds ratio. ResultsA total of 69,680 patients were hospitalized for HF; 10.3% were prescribed SGLT2i at discharge (4.4% newly prescribed, 5.9% continued pre-admission therapy). SGLT2i prescription increased over time and was higher in patients with HFrEF and primary HF. Among 15,762 patients hospitalized in 2022, SGLT2i prescription was more likely in patients with diabetes (adjusted odds ratio [aOR] 2.27; 95% confidence interval [CI]: 2.09-2.47) and ischemic heart disease (aOR 1.14; 95% CI: 1.03-1.26). Patients with increased age (aOR 0.77 per 10 years; 95% CI: 0.73-0.80) and lower systolic blood pressure (aOR 0.94 per 10mmHg; 95% CI: 0.92-0.96) were less likely to be prescribed SGLT2i, and SGLT2i prescription was not more likely in patients with CKD (aOR 1.07; 95% CI 0.98-1.16). The adjusted median odds ratio suggested a 1.8-fold variation in the likelihood that similar patients at 2 random VA sites were prescribed SGLT2i (range 0%-21.0%). In patients with EF ≤40%, 30.9% were prescribed SGLT2i while 26.9% were prescribed ARNI (p<0.01). ConclusionOne-tenth of VA patients hospitalized for HF were prescribed SGLT2i at discharge. Opportunities exist to reduce variation in SGLT2i prescription across hospitals and promote use in patients with CKD and older age.

A Single-Center Analysis of Palliative-Care Clinician Contact Following Declination of Advanced Heart Failure Therapy

A Single-Center Analysis of Palliative-Care Clinician Contact Following Declination of Advanced Heart Failure Therapy

Pulmonary Artery Catheter Usage and Impact on Mortality in Patients With Cardiogenic Shock: Results From a Canadian Single-Centre Registry

BackgroundHemodynamic assessment for cardiogenic shock (CS) phenotyping in patients has led to renewed interest in the use of pulmonary artery catheters (PACs). MethodsWe included patients admitted with CS from January 2014 to December 2020 and compared clinical outcomes among patients who received PACs and those who did not. The primary outcome was the rate of in-hospital mortality. Secondary outcomes included use of advanced heart failure therapies and coronary intensive care unit (CICU) and hospital lengths of stay. ResultsA total of 1043 patients were analysed and 47% received PACs. Patients selected for PAC-guided management were younger and had lower left ventricular function. They also had higher use of vasopressor and inotropes, and 15.2% of them were already supported with temporary mechanical circulatory support (MCS). In-hospital mortality was lower in patients who received PACs (29.3% vs 36.2%; P = 0.02), mainly driven by a reduction in mortality among those in Society for Cardiovascular Angiography and Interventions (SCAI) stages D and E CS. Patients who received PACs were more likely to receive temporary MCS with Impella, durable ventricular assist devices (VADs), or orthotopic heart transplantation (OHT) (P < 0.001 for all analyses). CICU and hospital lengths of stay were longer in patients who used PACs. ConclusionsAmong patients with CS, the use of PACs was associated with lower in-hospital mortality, especially among those in SCAI stages D and E. Patients who received PACs were also more frequently rescued with temporary MCS or received advanced heart failure therapies, such as durable VADs or OHT.

Non-Medical Characteristics Affect Referral for Advanced Heart Failure Services: a Retrospective Review.

Patients with advanced heart failure (AHF) are extensively evaluated before heart transplantation or left ventricular assist device (LVAD) eligibility. Patients are assessed for medical need and psychosocial or economic factors that may affect success post-treatment. For patients to be evaluated, however, they first must be referred. This study investigated social and economic factors affecting AHF referral, specialist visits, or treatment. Patients with heart failure (n = 24,258) were reviewed at one large hospital system over 4years. Independent variables age, sex, marital status, race/ethnicity, preferred language, smoking, and insurance status were assessed for the outcomes of referral, clinic visit, and treatment by Chi-square and ANOVA. In-house and 1-year mortality were evaluated by logistic regression, and time-to-event was assessed by the Cox proportional hazards model. Younger (HR 0.934, 95% CI 0.925-0.943), male (HR 2.216, 95% CI 1.544-3.181), and publicly insured (HR 1.298 [95% CI 1.038, 1.623]) patients were more likely to be referred, while unmarried (HR 0.665, 95% CI 0.488-0.905) and smoking (HR 0.549, 95% CI 0.389-0.776) patients had fewer referrals. Younger, married, and nonsmoking patients were more likely to have a clinic visit. Younger age, White race, and Hispanic/Latino ethnicity were associated with receiving a heart transplant, and LVAD recipients were more likely Hispanic/Latino ethnicity. Advanced age, Hispanic/Latino ethnicity, and smoking were associated with 1-year mortality after heart failure diagnosis. Disparities in access exist before evaluation for AHF therapies. Improving access at the levels of referral and evaluation is a necessary step toward achieving equity in organ allocation.