Trajectories of Sacubitril/Valsartan Adherence Among Medicare Beneficiaries With Heart Failure.

Background: Sacubitril/valsartan, an angiotensin receptor/neprilysin inhibitor (ARNi), improves heart failure (HF) outcomes, yet real-world adherence patterns are not well understood. Objectives: The purpose of this study was to analyze longitudinal patterns of adherence to ARNis in patients with HF and to identify factors associated with adherence patterns. Methods: Using Medicare beneficiaries from 2015 to 2018, we included patients diagnosed with HF who initiated an ARNi. A group-based trajectory model was constructed to identify adherence patterns during follow-up. We used multivariable logistic regression to investigate factors associated with membership in each adherence trajectory group. Results: Among 9,475 eligible beneficiaries (age 77 ± 7 years, 34% female), we identified 5 distinct ARNi adherence trajectories, characterized as: immediate discontinuers, who discontinued treatment within the first 3 months (12%); early discontinuers, who discontinued treatment in months 4 to 7 (10%); late discontinuers, who discontinued treatment in months 7 to 10 (12%); intermittently adherent patients (12%); and consistently adherent patients (54%). The first 4 groups were collectively categorized as nonconsistent adherents. Living in a socioeconomically disadvantaged area, ie, a county with the top 20% of Area Deprivation Index (adjusted OR [aOR]: 1.12 [95% CI: 1.00-1.24]) and Black race (aOR: 1.36, [95% CI: 1.18-1.56]) were associated with a higher likelihood of being nonconsistently adherent. Receiving prescriptions from a cardiologist (aOR: 0.64 [95% CI: 0.57-0.73]) was associated with a lower likelihood of suboptimal ARNi adherence. Conclusions: Half of ARNi users were not consistently adherent to the drug in the first year after treatment initiation. There exist significant racial and socioeconomic inequities in longitudinal adherence to ARNi.

Left ventricular assist device implantation outcomes in patients with subcutaneous implantable cardioverter-defibrillators: A case series.

Background: Left ventricular assist devices (LVADs) may induce electromagnetic interference (EMI) affecting implanted cardiac devices, including more novel subcutaneous implantable cardiac defibrillators (S-ICDs). Methods: In this case series, the authors retrospectively reviewed courses of 6 patients with S-ICDs who underwent LVAD implantation at a single center. Results: Of the 6 patients reviewed, 4 experienced inappropriate ICD shocks, of which 3 resulted from EMI. Five of the 6 patients ultimately had S-ICD therapies disabled. Conclusions: Due to EMI resulting in inappropriate shocks and improved tolerability of malignant arrhythmias, deactivation or removal of S-ICDs should be considered in patients undergoing LVAD implantation.

Temporary mechanical support in the peripartum patient as a bridge to postpartum recovery: A report of three cases.

Cardiogenic shock (CS) is a severe complication of peripartum cardiomyopathy (PPCM). Patients with deteriorating CS often require temporary mechanical circulatory support. In PPCM, this can be used as a bridge to postpartum recovery or bridge to decision. The outcomes are unclear, especially if prolonged utilization is required. We present a case series of three patients with PPCM in deteriorating CS who were successfully supported with a ventricular assist device or veno-arterial extracorporeal membrane oxygenation as a bridge to postpartum recovery.

An ISHLT consensus statement on strategies to prevent and manage hemocompatibility related adverse events in patients with a durable, continuous-flow ventricular assist device.

Life expectancy of patients with a durable, continuous-flow left ventricular assist device (CF-LVAD) continues to increase. Despite significant improvements in the delivery of care for patients with these devices, hemocompatability-related adverse events (HRAEs) are still a concern and contribute to significant morbility and mortality when they occur. As such, dissemination of current best evidence and practices is of critical importance. This ISHLT Consensus Statement is a summative assessment of the current literature on prevention and management of HRAEs through optimal management of oral anticoagulant and antiplatelet medications, parenteral anticoagulant medications, management of patients at high risk for HRAEs and those experiencing thrombotic or bleeding events, and device management outside of antithrombotic medications. This document is intended to assist clinicians caring for patients with a CF-LVAD provide the best care possible with respect to prevention and management of these events.

A new opportunity for patient selection and optimization: Systematic review of cognitive frailty in patients undergoing left ventricular assist device implantation.

The prognostic implication of cognitive frailty assessment in patients undergoing left ventricular assist device (LVAD) implantation remains unclear. We conducted a systematic review to evaluate assessment strategies and their significance for patients undergoing LVAD implantation. A comprehensive search of PubMed, Embase, and the Cumulative Index to Nursing and Allied Health Literature from inception until September 2022 and a review of meeting proceedings were performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies that investigated the prognostic value of cognitive frailty or any related cognition-based assessment in patients undergoing LVAD implantation were included. Study characteristics, patient demographics, and type of cognitive assessment were extracted. Primary outcomes included length of stay, readmissions, and all-cause mortality. Of 664 records retrieved, 12 (4 prospective, 8 retrospective) involving 16 737 subjects (mean age, 56.9 years; 78.3% men) met inclusion criteria; 67% of studies used the Montreal Cognitive Assessment to assess cognitive frailty. Outcomes reported were highly variable, with 42% reporting readmission, 33% reporting LOS, and 83% reporting mortality data; only two studies provided data on all three. Cognitive frailty was associated with prolonged length of stay in 75% of studies reporting this outcome. Only 40% and 60% of studies that reported readmissions and mortality outcomes, respectively, suggested a predictive association. Pre-LVAD cognitive frailty is likely associated with worse outcomes postimplant. However, the heterogenous reporting of outcomes data and lack of consistent definitions in the literature limit its prognostic value. Additional research on markers for cognitive frailty and improved standards of reporting may allow for future analyses and enhance preoperative risk assessment and patient care. Geriatr Gerontol Int 2024; 24: 204-210.

Left Ventricular Assist Device Use in Minorities: An Analysis of the National Inpatient Sample.

Minorities are less likely to receive a left ventricular assist device (LVAD). This, however, is based on total implant data. By examining rates of LVAD implant among patients admitted with heart failure complicated by cardiogenic shock, we sought to further elucidate LVAD utilization rates and racial disparities. Utilizing the National Inpatient Sample from 2013 to 2019, all patients admitted with a primary diagnosis of heart failure complicated by cardiogenic shock were included for analysis. Those who then received an LVAD during that hospitalization defined the LVAD utilization which was examined for any racial disparities. Left ventricular assist device utilization was low across all racial groups with no significant difference noted in univariate analysis. Non-Hispanic Blacks had the highest length of stay (LOS), the highest proportion of discharge to home (71.52%), and the lowest inpatient mortality (6.33%). Multivariable modeling confirmed the relationship between race and LOS; however, no differences were noted in mortality. Non-Hispanic Blacks were found to be less likely to receive an LVAD; however, when controlling for payer, median household income, and comorbidities, this relationship was no longer seen. Left ventricular assist devices remain an underutilized therapy in cardiogenic shock. When using a multivariable model, race does not appear to affect LVAD utilization.

Reconsidering FDA Guidelines: A Single-Center Experience of Prolonged Impella 5.5 Support.

OBJECTIVE: Impella 5.5 (Abiomed, Danvers, MA, USA) is approved by the US Food and Drug Administration (FDA) for mechanical circulatory support for ≤14 days. It is unknown whether prolonged support is associated with worse outcomes. We sought to review our single-center experience with Impella 5.5 and compare outcomes based on support duration. METHODS: We retrospectively reviewed adult patients (≥18 years old) supported with Impella 5.5 at our institution (May 2020 to April 2023). Patients on prolonged support (>14 days) were compared with those supported for ≤14 days. RESULTS: There were 31 patients supported with Impella 5.5 including 14 (45.2%) supported >14 days. Median support duration for those on prolonged support was 43.5 (interquartile range [IQR] 25 to 63.5) days versus 8 (IQR 6, 13) days for those who were not (P < 0.001). Overall, the device-related complication rate was 9.7% and did not differ between groups (P = 0.08). Overall, 30-day postimplant survival was 71% and did not differ by support duration (P = 0.2). In-hospital mortality was 32% and did not differ between cohorts (P > 0.99). Among those surviving to explant (n = 22), long-term strategy included bridge to durable ventricular assist device (18%, n = 4), cardiac transplant (55%, n = 12), and cardiac recovery (27%, n = 6). CONCLUSIONS: High-risk patients with cardiogenic shock may be supported with Impella 5.5 beyond the FDA-approved duration without increased risk of complications or mortality.

Transthyretin Cardiac Amyloidosis Disguised as Light Chain Amyloidosis or Multiple Myeloma?

We describe 2 challenging cases of cardiac transthyretin amyloidosis initially treated as cardiac amyloidosis light chain in the setting of active myeloma. Endomyocardial biopsy with mass spectrometry was essential to confirm the appropriate diagnosis to direct the treatment.

A study of generative large language model for medical research and healthcare.

There are enormous enthusiasm and concerns in applying large language models (LLMs) to healthcare. Yet current assumptions are based on general-purpose LLMs such as ChatGPT, which are not developed for medical use. This study develops a generative clinical LLM, GatorTronGPT, using 277 billion words of text including (1) 82 billion words of clinical text from 126 clinical departments and approximately 2 million patients at the University of Florida Health and (2) 195 billion words of diverse general English text. We train GatorTronGPT using a GPT-3 architecture with up to 20 billion parameters and evaluate its utility for biomedical natural language processing (NLP) and healthcare text generation. GatorTronGPT improves biomedical natural language processing. We apply GatorTronGPT to generate 20 billion words of synthetic text. Synthetic NLP models trained using synthetic text generated by GatorTronGPT outperform models trained using real-world clinical text. Physicians' Turing test using 1 (worst) to 9 (best) scale shows that there are no significant differences in linguistic readability (p = 0.22; 6.57 of GatorTronGPT compared with 6.93 of human) and clinical relevance (p = 0.91; 7.0 of GatorTronGPT compared with 6.97 of human) and that physicians cannot differentiate them (p < 0.001). This study provides insights into the opportunities and challenges of LLMs for medical research and healthcare.

Recurrent Cardiac Sarcoidosis and Giant Cell Myocarditis After Heart Transplant: A Case Report and Systematic Literature Review.

Recurrence of cardiac sarcoidosis (CS) and giant cell myocarditis (GCM) after heart transplant is rare, with rates of 5% in CS and 8% in GCM. We aim to identify all reported cases of recurrence in the literature and to assess clinical course, treatments, and outcomes to improve understanding of the conditions. A systematic review, utilizing Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines, was conducted by searching MEDLINE/PubMed and Embase of all available literature describing post-transplant recurrent granulomatous myocarditis, CS, or GCM. Data on demographics, transplant, recurrence, management, and outcomes data were collected from each publication. Comparison between the 2 groups were made using standard statistical approaches. Post-transplant GM recurrence was identified in 39 patients in 33 total publications. Reported cases included 24 GCM, 12 CS, and 3 suspected cases. Case reports were the most frequent form of publication. Mean age of patients experiencing recurrence was 42 years for GCM and 48 years for CS and favored males (62%). Time to recurrence ranged from 2 weeks to 9 years post-transplant, occurring earlier in GCM (mean 1.8 vs 3.0 years). Endomyocardial biopsies (89%) were the most utilized diagnostic method over cardiac magnetic resonance and positron emission tomography. Recurrence treatment regimens involved only steroids in 40% of CS, whereas other immunomodulatory regimens were utilized in 70% of GCM. In conclusion, GCM and CS recurrence after cardiac transplantation holds associated risks including concurrent acute cellular rejection, a higher therapeutic demand for GCM recurrence compared with CS, and mortality. New noninvasive screening techniques may help modify post-transplant monitoring regimens to increase both early detection and treatment of recurrence.

Utility of Fiberoptic Endoscopic Evaluation of Swallowing After Left Ventricular Assist Device Implantation.

Objective Dysphagia following cardiac surgery is common and associated with adverse outcomes. Among patients receiving left ventricular assist devices (LVAD), we evaluated the impact of fiberoptic endoscopic evaluation of swallowing (FEES) on outcomes. Methods A single-center pilot study was conducted in adults (≥18 years of age) undergoing durable LVAD (February 2019 - January 2020). Six patients were prospectively enrolled, evaluated, and underwent FEES within 72 hours of extubation-they were compared to 12 control patients. Demographic, surgical, and postoperative outcomes were collected. Unpaired two-sided t-tests and Fisher's exact tests were performed. Results Baseline characteristics were similar between groups. Intraoperative criteria including duration of transesophageal echo (314 ± 86 min) and surgery (301 ± 74 min) did not differ. The mean time of intubation was comparable (57.3 vs. 68.7 hours, p=0.77). In the entire cohort, 30-day, one-year, two-year, and three-year mortality were 0%, 5.6%, 5.6%, and 16.7%, respectively. Sixty-seven percent of the patients that underwent FEES had inefficient swallowing function. The FEES group trended to a shorter hospital length of stay (LOS) (29.1 vs. 46.6 days, p=0.098), post-implantation LOS (25.3 vs 30.7 days, p=0.46), and lower incidence of postoperative pneumonia (16.7% vs. 50%, p=0.32) and sepsis (0% vs. 33.3%, p=0.25). Conclusion FEES did not impact 30-day, one-year, two-year, or three-year mortality. Though not statistically significant, patients who underwent FEES trended toward shorter LOS and lower postoperative pneumonia and sepsis rates. Additionally, we report a higher incidence of dysphagia among patients undergoing FEES despite comparable baseline risk factors with controls.

Durable biventricular assist device support for 1212 days as a bridge to heart transplantation.

Experience with durable biventricular assist devices (BiVADs) as a bridge to heart transplantation (HTx) is limited, particularly in women. A 41-year-old woman with biventricular failure complicated by cardiogenic shock underwent durable concurrent BiVAD implantation and was supported for 1212 days as a bridge to HTx. During BiVAD support, she experienced bacteremia (day 1030 of support), appropriately managed with intravenous antibiotics. She is alive and well, 1479 days from BiVAD implantation and 267 days from orthotopic HTx. Strategies contributing to successful prolonged support include concurrent BiVAD implantation, aggressive cardiac rehabilitation, diet management for weight loss and frequent interval surveillance.

Successful extended use of Impella 5.5 as a bridge to heart transplantation.

We present the case of a 60-year-old gentleman who was admitted with acute-on-chronic cardiogenic shock and was supported with axillary Impella 5.5® for 123 days prior to heart transplantation. Total length of temporary mechanical circulatory support (MCS) was 132 days, which included 9 days with an intra-aortic balloon pump prior to Impella. During support, the patient remained extubated, participated in regular ambulation and rehabilitation with physical therapy and had continuous monitoring of device positioning. He did not experience any vascular or septic events while on temporary MCS and had improved hemodynamics and renal function after Impella initiation. Post-transplantation course was uncomplicated, and he is doing well without evidence for allograft dysfunction over 581 days post-transplantation. To our knowledge, this is the longest Impella 5.5®-supported patient during the new United Network for Organ Sharing Heart Allocation era who was successfully bridged to heart transplantation with over 1-year follow-up.

Utilization of the percutaneous left ventricular support as bridge to heart transplantation across the United States: In-depth UNOS database analysis.

BACKGROUND: Intra-aortic balloon pump (IABP) and Impella device utilization as a bridge to heart transplantation (HTx) have risen exponentially. We aimed to explore the influence of device selection on HTx outcomes, considering regional practice variation. METHODS: A retrospective longitudinal study was performed on a United Network for Organ Sharing (UNOS) registry dataset. We included adult patients listed for HTx between October 2018 and April 2022 as status 2, as justified by requiring IABP or Impella support. The primary end-point was successful bridging to HTx as status 2. RESULTS: Of 32,806 HTx during the study period, 4178 met inclusion criteria (Impella n = 650, IABP n = 3528). Waitlist mortality increased from a nadir of 16 (in 2019) to a peak of 36 (in 2022) per thousand status 2 listed patients. Impella annual use increased from 8% in 2019 to 19% in 2021. Compared to IABP, Impella patients demonstrated higher medical acuity and lower success rate of transplantation as status 2 (92.1% vs 88.9%, p < 0.001). The IABP:Impella utilization ratio varied widely between regions, ranging from 1.77 to 21.31, with high Impella use in Southern and Western states. However, this difference was not justified by medical acuity, regional transplant volume, or waitlist time and did not correlate with waitlist mortality. CONCLUSIONS: The shift in utilizing Impella as opposed to IABP did not improve waitlist outcomes. Our results suggest that clinical practice patterns beyond mere device selection determine successful bridging to HTx. There is a critical need for objective evidence to guide tMCS utilization and a paradigm shift in the UNOS allocation system to achieve equitable HTx practice across the United States.

Severe cardiogenic shock and cardiac arrest due to fulminant cardiac sarcoidosis: a case report.

BACKGROUND: Cardiac sarcoidosis is found to occur in approximately 5% of patients with sarcoidosis. Its presentation can typically range from complete heart block to ventricular arrhythmias. This condition can rarely present with severe heart failure and cardiogenic shock requiring aggressive and timely management strategies. Advanced imaging techniques are usually required to assist with its diagnosis. CASE PRESENTATION: A 70-year-old woman with a history of pulmonary sarcoidosis presented with non-ST elevation myocardial infarction, congestive hepatopathy, and acute renal failure. Left heart catheterization showed evidence of non-obstructive coronary artery disease, and right heart catheterization revealed severely elevated filling pressures and depressed cardiac index. She underwent aggressive diuresis and placement of an intra-aortic balloon pump in addition to initiation of inotropic and vasopressor support. While in the cardiac intensive care unit, she experienced frequent episodes of ventricular tachycardia and went into cardiac arrest requiring cardiopulmonary resuscitation. High clinical suspicion for cardiac sarcoidosis was confirmed by cardiac magnetic resonance imaging findings. After starting immunosuppressive therapy for cardiac sarcoidosis, she demonstrated clinical improvement. CONCLUSION: Patients with cardiac sarcoidosis may remain asymptomatic or present with conduction abnormalities and arrhythmias. They rarely present with severe biventricular heart failure and cardiogenic shock, and in such cases, they require timely initiation of pharmacologic and device therapies, along with implementation of mechanical circulatory support.

Pharmacological Therapy Optimization for Heart Failure: A Practical Guide for the Internist.

Heart failure carries significant morbidity and mortality and affects a large population of patients cared for predominantly by primary care physicians. The complexity of managing heart failure patients is increasing as new therapies continue to emerge. This review outlines important clinical pearls and proposes strategies for optimization of medical therapy.

Artificial intelligence guidance of advanced heart failure therapies: A systematic scoping review.

Introduction: Artificial intelligence can recognize complex patterns in large datasets. It is a promising technology to advance heart failure practice, as many decisions rely on expert opinions in the absence of high-quality data-driven evidence. Methods: We searched Embase, Web of Science, and PubMed databases for articles containing "artificial intelligence," "machine learning," or "deep learning" and any of the phrases "heart transplantation," "ventricular assist device," or "cardiogenic shock" from inception until August 2022. We only included original research addressing post heart transplantation (HTx) or mechanical circulatory support (MCS) clinical care. Review and data extraction were performed in accordance with PRISMA-Scr guidelines. Results: Of 584 unique publications detected, 31 met the inclusion criteria. The majority focused on outcome prediction post HTx (n = 13) and post durable MCS (n = 7), as well as post HTx and MCS management (n = 7, n = 3, respectively). One study addressed temporary mechanical circulatory support. Most studies advocated for rapid integration of AI into clinical practice, acknowledging potential improvements in management guidance and reliability of outcomes prediction. There was a notable paucity of external data validation and integration of multiple data modalities. Conclusion: Our review showed mounting innovation in AI application in management of MCS and HTx, with the largest evidence showing improved mortality outcome prediction.

Timing and Outcomes of Concurrent and Sequential Biventricular Assist Device Implantation: A Society of Thoracic Surgeons Intermacs Analysis.

BACKGROUND: Biventricular heart failure remains a clinically challenging condition to manage. Available literature describing the use of durable biventricular assist device (BiVAD) support has numerous limitations hindering the development of useful treatment algorithms. Analysis of BiVAD use within a large multicenter data set is needed to clarify outcomes associated with this therapy. METHODS: The Society of Thoracic Surgeons Intermacs database was queried to identify adults aged ≥18 years who received durable circulatory support from January 1, 2010, to December 31, 2220. The data set was divided into the following cohorts: (1) left ventricular assist device (LVAD) only (n = 27,325), (2) LVAD and concurrent right ventricular assist device (RVAD) (n = 1090), and (3) LVAD and sequential RVAD (n = 556). Propensity score matching was used to compare 1-year mortality and adverse events between concurrent (n = 565) and sequential BiVADs (n = 565). RESULTS: Overall survival within 1 year was significantly worse for the BiVAD cohort compared with the LVAD-only cohort (12-month survival: 50.8% vs 82.6%; log-rank P < .001). In a propensity-matched cohort, patients implanted with a BiVAD concurrently had an improved survival compared with those implanted an LVAD and an RVAD sequentially (12-month survival: 55.8% vs 41.8%; log-rank P < .001). Early (<3 months) adverse event rates were higher among patients receiving sequential BiVADs for bleeding, infection, neurologic dysfunction, and renal dysfunction (P < .01). CONCLUSIONS: After matching for patient and disease characteristics, patients with sequential BiVAD implantation have worse outcomes than patients with concurrent BiVAD implantation.

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.