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Long-term predictors of morbidity and mortality in patients following LVAD replacement

Jimenez Contreras, Fabian; Rames, Jess David; Schroder, Jacob; Russell, Stuart D; Katz, Jason; Omer, Tariq; Barac, Yaron D; Milano, Carmelo
BACKGROUND:As heart transplant guidelines evolve, the clinical indication for 73% of durable left ventricular assist device (LVAD) implants is now destination therapy. Although completely magnetically levitated LVAD devices have demonstrated improved durability relative to previous models, LVAD replacement procedures are still required for a variety of indications. Thus, the population of patients with a replaced LVAD is growing. There is a paucity of data regarding the outcomes and risk factors for those patients receiving first-time LVAD replacements. METHODS:The study cohort consisted of all consecutive patients between 2006 and 2020 that received a first-time LVAD replacement at a single institution. Preoperative clinical and laboratory variables were collected retrospectively. The primary endpoint was death or need for an additional LVAD replacement. Data were subjected to Kaplan-Meier, univariate, and multivariate Cox hazard ratio analyses. RESULTS:In total, 152 patients were included in the study, of which 101 experienced the primary endpoint. On multivariate analysis, patients receiving HeartMate 3 (HM3) LVADs as the replacement device showed superior outcomes (HR 0.15, 95% CI 0.065-0.35, p < 0.0001). Independent risk factors for death or need for additional replacement included preoperative extracorporeal membrane oxygenation (ECMO) (HR 4.44, 95% CI 1.87-14.45, and p = 0.00042), increased number of sternotomies (HR 5.20, 95% CI 1.87-14.45, and p = 0.0016), and preoperative mechanical ventilation (HR 1.98, 95% CI 1.01-3.86, and p = 0.045). CONCLUSIONS:Replacement with HM3 showed superior outcomes compared to all other pump types when controlling for both initial pump type and other independent predictors of death or LVAD replacement. Preoperative ECMO, mechanical ventilation, and multiple sternotomies also increased the odds for death or the need for subsequent replacement.
PMID: 37814840
ISSN: 1525-1594
CID: 5783162

Defining the Time-limited Trial for Patients with Critical Illness: An Official American Thoracic Society Workshop Report

Kruser, Jacqueline M; Ashana, Deepshikha C; Courtright, Katherine R; Kross, Erin K; Neville, Thanh H; Rubin, Eileen; Schenker, Yael; Sullivan, Donald R; Thornton, J Daryl; Viglianti, Elizabeth M; Costa, Deena Kelly; Creutzfeldt, Claire J; Detsky, Michael E; Engel, Heidi J; Grover, Neera; Hope, Aluko A; Katz, Jason N; Kohn, Rachel; Miller, Andrew G; Nabozny, Michael J; Nelson, Judith E; Shanawani, Hasan; Stevens, Jennifer P; Turnbull, Alison E; Weiss, Curtis H; Wirpsa, M Jeanne; Cox, Christopher E
In critical care, the specific, structured approach to patient care known as a "time-limited trial" has been promoted in the literature to help patients, surrogate decision makers, and clinicians navigate consequential decisions about life-sustaining therapy in the face of uncertainty. Despite promotion of the time-limited trial approach, a lack of consensus about its definition and essential elements prevents optimal clinical use and rigorous evaluation of its impact. The objectives of this American Thoracic Society Workshop Committee were to establish a consensus definition of a time-limited trial in critical care, identify the essential elements for conducting a time-limited trial, and prioritize directions for future work. We achieved these objectives through a structured search of the literature, a modified Delphi process with 100 interdisciplinary and interprofessional stakeholders, and iterative committee discussions. We conclude that a time-limited trial for patients with critical illness is a collaborative plan among clinicians and a patient and/or their surrogate decision makers to use life-sustaining therapy for a defined duration, after which the patient's response to therapy informs the decision to continue care directed toward recovery, transition to care focused exclusively on comfort, or extend the trial's duration. The plan's 16 essential elements follow four sequential phases: consider, plan, support, and reassess. We acknowledge considerable gaps in evidence about the impact of time-limited trials and highlight a concern that if inadequately implemented, time-limited trials may perpetuate unintended harm. Future work is needed to better implement this defined, specific approach to care in practice through a person-centered equity lens and to evaluate its impact on patients, surrogates, and clinicians.
PMCID:10848901
PMID: 38063572
ISSN: 2325-6621
CID: 5788402

The HFSA Advanced Heart Failure and Transplant Cardiology Fellowship Consensus Conference

Drazner, Mark H; Ambardekar, Amrut V; Berlacher, Kathryn; Blumer, Vanessa; Chatur, Safia; Cheng, Richard; Cheng, Richard K; Grandin, E Wilson; Gorodeski, Eiran Z; Kataria, Rachna; Katz, Jason N; Kittleson, Michelle M; Krishnamoorthy, Arun; Lala, Anuradha; Lenneman, Andrew J; Lohr, Nicole L; Margulies, Kenneth B; Mentz, Robert J; Reza, Nosheen; Wilcox, Jane; Youmans, Quentin R; Zieroth, Shelley; Teerlink, John R
There is waning interest among cardiology trainees in pursuing an Advanced Heart Failure/Transplant Cardiology (AHFTC) fellowship as evidenced by fewer applicants in the National Resident Matching Program match to this specialty. This trend has generated considerable attention across the heart failure community. In response, the Heart Failure Society of America convened the AHFTC Fellowship Task Force with a charge to develop strategies to increase the value proposition of an AHFTC fellowship. Subsequently, the HFSA sponsored the AHFTC Fellowship Consensus Conference April 26-27, 2023. Before the conference, interviews of 44 expert stakeholders diverse across geography, site of practice (traditional academic medical center or other centers), specialty/area of expertise, sex, and stage of career were conducted virtually. Based on these interviews, potential solutions to address the declining interest in AHFTC fellowship were categorized into five themes: (1) alternative training pathways, (2) regulatory and compensation, (3) educational improvements, (4) exposure and marketing for pipeline development, and (5) quality of life and mental health. These themes provided structure to the deliberations of the AHFTC Fellowship Consensus Conference. The recommendations from the Consensus Conference were subsequently presented to the HFSA Board of Directors to inform strategic plans and interventions. The HFSA Board of Directors later reviewed and approved submission of this document. The purpose of this communication is to provide the HF community with an update summarizing the processes used and concepts that emerged from the work of the HFSA AHFTC Fellowship Task Force and Consensus Conference.
PMCID:11540483
PMID: 37806488
ISSN: 1532-8414
CID: 5788362

Mobile Application-Based Communication Facilitation Platform for Family Members of Critically Ill Patients: A Randomized Clinical Trial

Cox, Christopher E; Ashana, Deepshikha C; Riley, Isaretta L; Olsen, Maren K; Casarett, David; Haines, Krista L; O'Keefe, Yasmin Ali; Al-Hegelan, Mashael; Harrison, Robert W; Naglee, Colleen; Katz, Jason N; Yang, Hongqiu; Pratt, Elias H; Gu, Jessie; Dempsey, Katelyn; Docherty, Sharron L; Johnson, Kimberly S
IMPORTANCE:Unmet and racially disparate palliative care needs are common in intensive care unit (ICU) settings. OBJECTIVE:To test the effect of a primary palliative care intervention vs usual care control both overall and by family member race. DESIGN, SETTING, AND PARTICIPANTS:This cluster randomized clinical trial was conducted at 6 adult medical and surgical ICUs in 2 academic and community hospitals in North Carolina between April 2019 and May 2022 with physician-level randomization and sequential clusters of 2 Black patient-family member dyads and 2 White patient-family member dyads enrolled under each physician. Eligible participants included consecutive patients receiving mechanical ventilation, their family members, and their attending ICU physicians. Data analysis was conducted from June 2022 to May 2023. INTERVENTION:A mobile application (ICUconnect) that displayed family-reported needs over time and provided ICU attending physicians with automated timeline-driven communication advice on how to address individual needs. MAIN OUTCOMES AND MEASURES:The primary outcome was change in the family-reported Needs at the End-of-Life Screening Tool (NEST; range 0-130, with higher scores reflecting greater need) score between study days 1 and 3. Secondary outcomes included family-reported quality of communication and symptoms of depression, anxiety, and posttraumatic stress disorder at 3 months. RESULTS:A total of 111 (51% of those approached) family members (mean [SD] age, 51 [15] years; 96 women [86%]; 15 men [14%]; 47 Black family members [42%]; 64 White family members [58%]) and 111 patients (mean [SD] age, 55 [16] years; 66 male patients [59%]; 45 Black patients [41%]; 65 White patients [59%]; 1 American Indian or Alaska Native patient [1%]) were enrolled under 37 physicians randomized to intervention (19 physicians and 55 patient-family member dyads) or control (18 physicians and 56 patient-family member dyads). Compared with control, there was greater improvement in NEST scores among intervention recipients between baseline and both day 3 (estimated mean difference, -6.6 points; 95% CI, -11.9 to -1.3 points; P = .01) and day 7 (estimated mean difference, -5.4 points; 95% CI, -10.7 to 0.0 points; P = .05). There were no treatment group differences at 3 months in psychological distress symptoms. White family members experienced a greater reduction in NEST scores compared with Black family members at day 3 (estimated mean difference, -12.5 points; 95% CI, -18.9 to -6.1 points; P < .001 vs estimated mean difference, -0.3 points; 95% CI, -9.3 to 8.8 points; P = .96) and day 7 (estimated mean difference, -9.5 points; 95% CI, -16.1 to -3.0 points; P = .005 vs estimated mean difference, -1.4 points; 95% CI, -10.7 to 7.8; P = .76). CONCLUSIONS AND RELEVANCE:In this study of ICU patients and family members, a primary palliative care intervention using a mobile application reduced unmet palliative care needs compared with usual care without an effect on psychological distress symptoms at 3 months; there was a greater intervention effect among White family members compared with Black family members. These findings suggest that a mobile application-based intervention is a promising primary palliative care intervention for ICU clinicians that directly addresses the limited supply of palliative care specialists. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03506438.
PMCID:10767607
PMID: 38175648
ISSN: 2574-3805
CID: 5788432

Shared Decision-making in Palliative and End-of-life Care in the Cardiac Intensive Care Unit

Godfrey, Sarah; Barnes, Alexis; Gao, Jing; Sulistio, Melanie S.; Katz, Jason N.; Chuzi, Sarah
Patients and clinicians in the cardiac intensive care unit (CICU) are often tasked with making high-stakes decisions about aggressive or life-sustaining therapies. Shared decision-making (SDM), a collaborative process where patients and clinicians work together to make medical decisions that are aligned with a patient"™s goals and values, is therefore highly relevant in the CICU, especially in the context of palliative or end-of-life decisions. Despite its importance, there are barriers to optimal integration and implementation of SDM. This review describes the fundamentals and models of SDM, the role of SDM in the CICU, and evidence-based strategies to promote SDM in the CICU.
SCOPUS:85203597216
ISSN: 1758-3896
CID: 5716572

Interhospital Variation in Admissions Managed With Critical Care Therapies or Invasive Hemodynamic Monitoring in Tertiary Cardiac Intensive Care Units: An Analysis From the Critical Care Cardiology Trials Network Registry

Donnelly, Sarah; Barnett, Christopher F; Bohula, Erin A; Chaudhry, Sunit-Preet; Chonde, Meshe D; Cooper, Howard A; Daniels, Lori B; Dodson, Mark W; Gerber, Daniel; Goldfarb, Michael J; Guo, Jianping; Kontos, Michael C; Liu, Shuangbo; Luk, Adriana C; Menon, Venu; O'Brien, Connor G; Papolos, Alexander I; Pisani, Barbara A; Potter, Brian J; Prasad, Rajnish; Schnell, Gregory; Shah, Kevin S; Sridharan, Lakshmi; So, Derek Y F; Teuteberg, Jeffrey J; Tymchak, Wayne J; Zakaria, Sammy; Katz, Jason N; Morrow, David A; van Diepen, Sean
BACKGROUND:Wide interhospital variations exist in cardiovascular intensive care unit (CICU) admission practices and the use of critical care restricted therapies (CCRx), but little is known about the differences in patient acuity, CCRx utilization, and the associated outcomes within tertiary centers. METHODS:The Critical Care Cardiology Trials Network is a multicenter registry of tertiary and academic CICUs in the United States and Canada that captured consecutive admissions in 2-month periods between 2017 and 2022. This analysis included 17 843 admissions across 34 sites and compared interhospital tertiles of CCRx (eg, mechanical ventilation, mechanical circulatory support, continuous renal replacement therapy) utilization and its adjusted association with in-hospital survival using logistic regression. The Pratt index was used to quantify patient-related and institutional factors associated with CCRx variability. RESULTS:The median age of the study population was 66 (56-77) years and 37% were female. CCRx was provided to 62.2% (interhospital range of 21.3%-87.1%) of CICU patients. Admissions to CICUs with the highest tertile of CCRx utilization had a greater burden of comorbidities, had more diagnoses of ST-elevation myocardial infarction, cardiac arrest, or cardiogenic shock, and had higher Sequential Organ Failure Assessment scores. The unadjusted in-hospital mortality (median, 12.7%) was 9.6%, 11.1%, and 18.7% in low, intermediate, and high CCRx tertiles, respectively. No clinically meaningful differences in adjusted mortality were observed across tertiles when admissions were stratified by the provision of CCRx. Baseline patient-level variables and institutional differences accounted for 80% and 5.3% of the observed CCRx variability, respectively. CONCLUSIONS:In a large registry of tertiary and academic CICUs, there was a >4-fold interhospital variation in the provision of CCRx that was primarily driven by differences in patient acuity compared with institutional differences. No differences were observed in adjusted mortality between low, intermediate, and high CCRx utilization sites.
PMID: 38179787
ISSN: 1941-7705
CID: 5788442

Droxidopa or Atomoxetine for Refractory Hypotension in Critically Ill Cardiothoracic Surgery Patients

Lessing, Julia K; Kram, Shawn J; Levy, Jerrold H; Grecu, Loreta M; Katz, Jason N
OBJECTIVE:To evaluate the effects of droxidopa or atomoxetine on intravenous (IV) vasoactive agent discontinuation in cardiothoracic intensive care unit (ICU) patients with hypotension refractory to midodrine. DESIGN/METHODS:Single-center, retrospective cohort study. SETTING/METHODS:Tertiary- and quaternary-care university teaching hospital. PARTICIPANTS/METHODS:Included patients who received at least 4 consecutive doses of droxidopa or atomoxetine and remained on concurrent midodrine. Patients were excluded if they received study medication before admission, had clinical deterioration after study medication initiation requiring additional vasoactives/escalation of IV vasoactive dosage for at least 12 hours, had a diagnosis of hepatorenal syndrome, were prisoners, or were pregnant. INTERVENTIONS/METHODS:Droxidopa, atomoxetine, or both. MEASUREMENTS AND MAIN RESULTS/RESULTS:The primary endpoint was time to discontinuation of IV vasoactive agents after initiation of study medication, analyzed using a Kaplan-Meier estimate with the Wilcoxon method, censoring death within 24 hours of the last dose of study medication. No adjustment for repetitive analyses was made, as the analysis was hypothesis-generating. Of the 72 charts reviewed, 45 patients met inclusion criteria (18 atomoxetine, 17 droxidopa, and 10 both). There were no differences in median time to discontinuation of IV vasoactive agents (21.9 days v 8.0 days v 13.9 days, respectively; p = 0.259) or ICU or hospital length of stay between groups. A higher percentage of patients who survived to hospital discharge received both study medications or droxidopa alone (90% v 76.5%) than atomoxetine alone (44.4%, p = 0.028). CONCLUSIONS:Droxidopa and atomoxetine are oral vasoactive agents with potential mechanisms to facilitate IV vasopressor weaning for patients in the ICU with hypotension refractory to midodrine, but further prospective research is needed.
PMID: 37838507
ISSN: 1532-8422
CID: 5788372

Design and Execution of Clinical Trials in the Cardiac Intensive Care Unit

Pierce, Jacob B; Applefeld, Willard N; Senman, Balimkiz; Loriaux, Daniel B; Lawler, Patrick R; Katz, Jason N
Clinical practice in the contemporary cardiac intensive care unit (CICU) has evolved significantly over the last several decades. With more frequent multisystem organ failure, increasing use of advanced respiratory support, and the advent of new mechanical circulatory support platforms, clinicians in the CICU are increasingly managing patients with complex comorbid disease in addition to their high-acuity cardiovascular illnesses. Here, the authors discuss challenges associated with traditional trial design in the CICU setting and review novel clinical trial designs that may facilitate better evidence generation in the CICU.
PMID: 37973354
ISSN: 1557-8232
CID: 5788392

Shared Decision-making in Palliative and End-of-life Care in the Cardiac Intensive Care Unit

Godfrey, Sarah; Barnes, Alexis; Gao, Jing; Sulistio, Melanie S; Katz, Jason N; Chuzi, Sarah
Patients and clinicians in the cardiac intensive care unit (CICU) are often tasked with making high-stakes decisions about aggressive or life- sustaining therapies. Shared decision-making (SDM), a collaborative process where patients and clinicians work together to make medical decisions that are aligned with a patient's goals and values, is therefore highly relevant in the CICU, especially in the context of palliative or end-of-life decisions. Despite its importance, there are barriers to optimal integration and implementation of SDM. This review describes the fundamentals and models of SDM, the role of SDM in the CICU, and evidence-based strategies to promote SDM in the CICU.
PMCID:11526488
PMID: 39494405
ISSN: 1758-390x
CID: 5788502

Role of Advanced Practice Providers in the Cardiac Intensive Care Unit Team

Tennyson, Carolina D; Bowers, Margaret T; Dimsdale, Allison W; Dickinson, Sharon M; Sanford, R Monica; McKenzie-Solis, Jordan D; Schimmer, Hannah D; Alviar, Carlos L; Sinha, Shashank S; Katz, Jason N
PMID: 38057076
ISSN: 1558-3597
CID: 5589702