Faculty Bibliography

IMPORTANCE/UNASSIGNED:The Aspirin and Hemocompatibility Events With a Left Ventricular Assist Device in Advanced Heart Failure (ARIES-HM3) study demonstrated that aspirin may be safely eliminated from the antithrombotic regimen after HeartMate 3 (HM3 [Abbott Cardiovascular]) left ventricular assist device (LVAD) implantation. This prespecified analysis explored whether conditions requiring aspirin (prior percutaneous coronary intervention [PCI], coronary artery bypass grafting [CABG], stroke, or peripheral vascular disease [PVD]) would influence outcomes differentially with aspirin avoidance. OBJECTIVE/UNASSIGNED:To analyze aspirin avoidance on hemocompatibility-related adverse events (HRAEs) at 1 year after implant in patients with a history of CABG, PCI, stroke, or PVD. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This was an international, multicenter, prospective, double-blind, placebo-controlled, randomized clinical trial including patients implanted with a de novo HM3 LVAD across 51 centers. Data analysis was conducted from April to July 2024. INTERVENTIONS/UNASSIGNED:Patients were randomized in a 1:1 ratio to receive aspirin (100 mg per day) or placebo, in addition to a vitamin K antagonist (VKA) targeted to an international normalized ratio of 2 to 3 in both groups. MAIN OUTCOMES AND MEASURES/UNASSIGNED:Primary end point (assessed for noninferiority) was a composite of survival free of any nonsurgical (>14 days after implant) HRAEs including stroke, pump thrombosis, bleeding, and arterial peripheral thromboembolism at 12 months. Secondary end points included nonsurgical bleeding, stroke, and pump thrombosis events. RESULTS/UNASSIGNED:Among 589 of 628 patients (mean [SD] age, 57.1 [13.7] years; 456 male [77.4%]) who contributed to the primary end point analysis, a history of PCI, CABG, stroke, or PVD was present in 41% (240 of 589 patients). There was no interaction between the presence of an atherosclerotic vascular condition and effect of aspirin compared with placebo (P for interaction= .23). The preset 10% noninferiority margin was not crossed for the studied subgroup of patients. Thrombotic events were rare, with no differences between aspirin and placebo in patients with and without vascular disease (P for interaction = .77). Aspirin treatment was associated with a higher rate of nonsurgical major bleeding events in the group with prior vascular condition history compared with those without aspirin (rate ratio for placebo compared with aspirin, 0.52; 95% CI, 0.35-0.79). CONCLUSIONS AND RELEVANCE/UNASSIGNED:Results of this prespecified analysis of the ARIES-HM3 randomized clinical trial demonstrate that in patients with advanced heart failure who have classical indications for antiplatelet therapy use at the time of LVAD implantation, aspirin avoidance was safe and not associated with increased thrombosis risk. Importantly, elimination of aspirin was associated with no increased thrombosis but a reduction in nonsurgical bleeding events in patients with a history of PCI, CABG, stroke, or PVD. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04069156.

BACKGROUND:Cardiogenic shock (CS) can be complicated by severe valvular heart disease (VHD). We analyzed cardiac intensive care unit (CICU) admissions according to VHD status. METHODS AND RESULTS/RESULTS:The Critical Care Cardiology Trials Network is a multicenter network of tertiary CICUs. Centers contributed data from consecutive admissions during 2-month annual snapshots from 2017-2023. CS admissions were classified as having CS attributed to VHD, CS with noncausative VHD or CS without severe VHD. Demographics and therapies were compared. Unadjusted and adjusted odds ratios for in-hospital mortality were calculated. We analyzed 5242 admissions with CS (4.1% attributed to VHD, 18.8% with noncausative VHD, 77.1% without severe VHD). Mitral regurgitation (32.1%) and aortic stenosis (27.9%) were the most common pathologies in CS attributed to VHD. Admissions with CS attributed to VHD more commonly had LVEF ≥ 40% on admission (present in 62.8%, 22.6% and 15.1%, respectively; P < 0.001). Valve intervention was performed in 32.1% of those with CS attributed to VHD. Unadjusted in-hospital mortality in admissions with CS attributed to VHD was 40.0%, compared to 33.4% and 30.3% in the other groups. CONCLUSIONS:VHD is the underlying cause of CS in a minority of CICU admissions but is associated with high in-hospital mortality rates.

IMPORTANCE/UNASSIGNED:Few person-centered, scalable models of collaborative intensive care unit (ICU) clinician-palliative care specialist care exist. OBJECTIVE/UNASSIGNED:To evaluate the effect of a collaborative palliative care intervention compared to usual care among family members of patients in the ICU. DESIGN, SETTING, AND PARTICIPANTS/UNASSIGNED:This parallel-group randomized clinical trial with patient-level randomization was conducted between April 2021 and September 2023. The study was set at 6 medical and surgical ICUs in 1 academic hospital and 1 community hospital. The study participants included critically ill older adult patients with 1 of 11 poor outcome phenotypes, their family members with elevated palliative care needs, and their attending ICU physicians. INTERVENTION/UNASSIGNED:An automated electronic health record-integrated, mobile application-based communication platform that displayed family-reported needs over 7 days, coached ICU attending physicians on addressing needs, and prompted palliative care consultation if needs were not reduced within 3 study days. MAIN OUTCOMES AND MEASURES/UNASSIGNED:The primary outcome was change in the family-reported Needs at the End-of-Life Screening Tool (NEST) score between study days 1 and 3. The 13-item NEST score is a number between 0 and 130, with higher scores indicating a greater need. Secondary outcomes included quality of communication and goal of care concordance, as well as 3-month psychological distress. RESULTS/UNASSIGNED:Of 151 family members, the mean (SD) age was 57.4 (12.9) years, and 110 (72.9%) were female. Of 151 patients, the mean (SD) age was 69.8 (9.7) years, and 86 (57.0%) were male. Thirty-five ICU physicians were male (68.6%). Seventy-six patients were randomized to the intervention group and 75 to the control group. Treatment group differences in estimated mean NEST scores were similar at 3 days between the intervention and control groups (-3.1 vs -2.0, respectively; estimated mean difference in differences, -1.3 points [95% CI, -6.0 to 3.5]) and 7 days (-2.3 vs -2.2, respectively; estimated mean difference in differences, 0 points [95% CI, -6.2 to 6.2]). Median (IQR) need scores were lower among individuals who remained in the ICU at day 3 for intervention participants vs controls (24.5 [16.5-34.5] vs 27.5 [13.0-40.0], respectively); median (IQR) need scores were also lower among those who remained in the ICU at day 7 for intervention vs controls (22.0 [11.0-35.0] vs 28.0 [14.0-35.0], respectively). Goal concordance, quality of communication, and psychological distress symptoms did not differ. Twenty-nine intervention participants (38.2%) had palliative care consultations, compared to only 3 (4.0%) among controls, (P < .001); 66 intervention participants (87.0%) had a family meeting, compared to 48 (64.0%) among controls (P = .001). CONCLUSIONS AND RELEVANCE/UNASSIGNED:In this randomized clinical trial, a collaborative, person-centered, ICU-based palliative care intervention had no effect on palliative care needs or psychological distress compared to usual care despite a higher frequency of palliative care consultations and family meetings among intervention participants. TRIAL REGISTRATION/UNASSIGNED:ClinicalTrials.gov Identifier: NCT04414787.

BACKGROUND:Implantable cardioverter-defibrillator (ICD) shocks are a common complication after left ventricular assist device (LVAD) implantation; however, data on their frequency and causes are limited. OBJECTIVE:The purpose of this study was to define the incidence, programming, patient characteristics, and factors associated with appropriate and inappropriate ICD shocks in persons with LVADs. METHODS:We performed a retrospective review at Duke University Hospital of all LVAD recipients implanted between January 1, 2013, to June 30, 2019, with a preexisting ICD. ICD shocks were adjudicated by the treating physician and a second reviewer for the purpose of this study. RESULTS:Among 421 patients with an ICD in situ undergoing LVAD implant, 147 (33.9%) had at least 1 shock after LVAD implantation. Among 134 patients with complete device history, a total of 330 shock episodes occurred: 255 (77.3%) appropriate and 75 (22.7%) inappropriate. Etiologies for inappropriate shocks included supraventricular tachycardia (n = 66 [20.0%]), physiological oversensing (n = 1 [0.3%]), and nonphysiological oversensing (n = 8 [2.4%]) including LVAD electromagnetic interference (n = 1 [0.3%]). ICD programming with shorter detection delay (P <.001) and absence of antitachycardia pacing programming (P = .001) in high-rate zones was seen more commonly in inappropriate shock than appropriate shock. CONCLUSIONS:The rate of inappropriate shocks in LVAD recipients is very high and most often is due to supraventricular arrhythmias. LVAD electromagnetic interference is a rare cause of ICD shock. Implementation of current consensus American Heart Association recommendations for LVAD programming with long detection delays and high rate cutoffs may help prevent inappropriate ICD shocks.

Cardiogenic shock (CS) is a complex, multisystem disorder precipitated by hypoperfusion from cardiac dysfunction. Our current approach to defining and treating CS encompasses all patients under 1 umbrella regardless of phenotype. This has created challenges for clinical trials and patient care owing to the heterogeneity of the patient population with CS. The Society of Coronary Angiography and Interventions shock classification has created a universal language for CS that has been rapidly adopted by researchers and clinicians. Its latest iteration established the 3-axis model incorporating shock severity, risk modifiers, and phenotypes. Phenotypes of CS have unique hemodynamic profiles that require nuanced adjustment approaches. In this study, we discuss representative cases including acute myocardial infarction, acute-on-chronic heart failure, fulminant myocarditis, and right ventricular failure. For each phenotype, specific hemodynamic parameters may help confirm appropriate diagnosis and direct to therapeutic targets signaling stability and recovery. The underlying pathophysiology of each phenotype can also help predict the extent of stabilization with pharmacologic interventions or the need to escalate to mechanical circulatory support. In conclusion, this tailored approach to CS, rather than a 1-size-fits-all approach, could help improve outcomes.

BACKGROUND/UNASSIGNED:Liver synthetic dysfunction predicts outcomes in cardiac intensive care unit (CICU) patients. OBJECTIVES/UNASSIGNED:The purpose of this study was to evaluate the associations between the severity and extent of admission liver function test (LFT) abnormalities and mortality in a mixed CICU population. METHODS/UNASSIGNED:This historical cohort study included unique CICU patients from 2007 to 2018 with available data for admission LFT values. We categorized each LFT from grade 0 to grade 4 based on multiples of the upper limit of normal. We evaluated in-hospital mortality using logistic regression and 1-year mortality using Cox proportional hazards regression. RESULTS/UNASSIGNED: < 0.001) and increased incrementally as a function of the severity and extent of LFT abnormality. CONCLUSIONS/UNASSIGNED:The severity and extent of LFT abnormalities are positively associated with in-hospital and 1-year mortality in CICU patients. Cardiohepatic syndrome is an important predictor of prognosis in CICU patients, and inclusion of LFTs in future risk-prediction tools could enhance prognostication.

BACKGROUND/UNASSIGNED:With an increasing demand for critical care expertise and limitations in intensivist availability, innovative staffing models, such as the utilization of advanced practice providers (APPs), have emerged. OBJECTIVES/UNASSIGNED:The purpose of the study was to compare patient outcomes between APP and housestaff teams in the cardiac intensive care unit (CICU). METHODS/UNASSIGNED:This retrospective study, spanning March 2022 to July 2023, compares patient characteristics and outcomes between two CICU teams embedded in the same CICU at a large urban academic hospital: one staffed by housestaff and the other by APPs (80% physician assistants, 20% nurse practitioners) who each had approximately 1 to 2 years of experience in the CICU. The primary outcome was CICU mortality. Multivariable Cox regression analyses and Kaplan-Meier curves were used to assess the primary outcome. RESULTS/UNASSIGNED: < 0.0001). CONCLUSIONS/UNASSIGNED:Our moderately sized study demonstrated no difference in CICU or in-hospital mortality between patients managed by a housestaff team versus those managed by an APP team.