Faculty Bibliography

BACKGROUND:ARIES-HM3 (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump) demonstrated that aspirin avoidance with a fully magnetically levitated HeartMate 3 (HM3) left ventricular assist device (LVAD) reduces bleeding complications and does not increase thromboembolism. Whether a concomitant surgical procedure modifies the observed safety and benefits remains uncertain. OBJECTIVES/OBJECTIVE:This prespecified analysis of ARIES-HM3 studied clinical outcomes when concomitant surgical procedures are performed during LVAD implantation with excluding aspirin but maintaining a vitamin K antagonist. METHODS:Among 628 patients randomized to receive either placebo or aspirin with a vitamin K antagonist, 589 (296 placebo and 293 aspirin) contributed to the primary endpoint analysis. Sub-categorization with receiving a concomitant surgical procedure (valvular procedure/coronary artery bypass grafting or nonvalvular procedure) was done and the composite primary endpoint of survival free from major nonsurgical (>14 days postimplant) hemocompatibility-related adverse events at 12 months was assessed. RESULTS: = 0.231, 0.298, and 0.735 for any procedure, valvular/coronary artery bypass grafting, and nonvalvular procedures, respectively). There was a similar reduction in nonsurgical major hemorrhagic events with placebo compared with aspirin, observed in patients with or without any concomitant procedure: 0.64 (95% CI: 0.44-0.94) and 0.66 (95% CI: 0.46-0.93). CONCLUSIONS:Our findings support the safety and efficacy of aspirin avoidance from the antithrombotic regimen in HM3 LVAD patients undergoing concomitant surgical procedures. (Antiplatelet Removal and Hemocompatibility Events With the HeartMate 3 Pump [ARIES-HM3]; NCT04069156).

Critical care cardiology refers to the practice focus of and subspecialty training for the comprehensive management of life-threatening cardiovascular diseases and comorbid conditions that require advanced critical care in an intensive care unit. The development of coronary care units is often credited for a dramatic decline in mortality rates after acute myocardial infarction throughout the 1960s. As the underlying patient population became progressively sicker, changes in organizational structure, staffing, care delivery, and training paradigms lagged. The coronary care unit gradually evolved from a focus on rapid resuscitation from ventricular arrhythmias in acute myocardial infarction into a comprehensive cardiac intensive care unit designed to care for the sickest patients with cardiovascular disease. Over the past decade, the cardiac intensive care unit has continued to transform with an aging population, increased clinical acuity, burgeoning cardiac and noncardiac comorbidities, technologic advances in cardiovascular interventions, and increased use of temporary mechanical circulatory support devices. Herein, we provide an update and contemporary expert perspective on the organizational structure, staffing, and care delivery in the cardiac intensive care unit; examine the challenges and opportunities present in the education and training of the next generation of physicians for critical care cardiology; and explore quality improvement initiatives and scientific investigation, including multicenter registry initiatives and randomized clinical trials, that may change clinical practice, care delivery, and the research landscape in this rapidly evolving discipline.

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:Heart failure-related cardiogenic shock (HF-CS) accounts for a growing proportion of cardiogenic shock (CS) related admissions to contemporary cardiac intensive care units. Limited data exists comparing non-ischemic (NICM) and ischemic cardiomyopathies (ICM) in this setting. METHODS AND RESULTS/RESULTS:We sought to examine the differences in patient characteristics, in-hospital treatments, and outcomes among individuals admitted with ICM and NICM HF-CS. The study population included CS admissions within the Critical Care Cardiology Trials Network registry from 2017 to 2022. CS due to acute myocardial infarction or secondary causes was excluded. Admission characteristics, in-hospital treatments, and outcomes were captured. The primary outcome of all-cause in-hospital mortality for ICM versus NICM was compared using multivariable logistic regression. 2,463 hospital admissions for HF-CS including 902 (36.6%) admissions with ICM and 1561 (63.4%) admissions with NICM were included. Patients with ICM more frequently had pre-existing comorbidities, pre-admission cardiac arrest, and higher Sequential Organ Failure Assessment scores. Use of inotropes and temporary mechanical circulatory support were similar; however, the rates of mechanical ventilation and renal replacement therapies were higher for ICM. Patients with ICM were less likely to undergo cardiac transplantation, but had similar rates of durable left ventricular assist device implantation. After multivariable adjustment, patients with ICM were significantly more likely to die during the index hospitalization (OR 1.56, 95% CI 1.26-1.93; p <0.001). CONCLUSIONS:Among patients admitted to CICUs with HF-CS, patients with ICM were sicker, less likely to undergo cardiac transplantation, and more likely to die when compared with patients with NICM.

BACKGROUND:Acute decompensated heart failure (HF) can progress to cardiogenic shock, and patients with cancer are at an increased risk of HF compared to patients without cancer. However, limited data exist on outcomes of patients admitted for HF-related cardiogenic shock (HF-CS) with cancer versus without cancer. METHODS:Adult patients admitted for HF-CS between 2014-2020 were identified using the National Readmission Database. Propensity score matching (PSM) was used to match 1 patient with cancer to 10 patients without cancer. Primary outcomes were in-hospital death, major bleeding, and thrombotic complications. Exploratory outcomes were 90-day readmission rates among patients who survived initial hospitalization. Temporal trends were also explored. RESULTS:Of 137,316 admissions for HF-CS, 7,306 (5.3%) had active cancer. After PSM, patients with cancer had increased odds of in-hospital death (OR 1.12, 95% CI 1.06 - 1.18), thrombotic complications (OR 1.12, 95% CI 1.03 - 1.21), and major bleeding (OR 1.23, 95% CI 1.17 - 1.31) compared to patients without cancer, with risks differing by cancer type. In exploratory analyses, rates of readmission were similar for patients with and without cancer. From 2014-2020, patients with cancer had no significant change in in-hospital mortality (ptrend = 0.43), while patients without cancer had decreased mortality over time (ptrend < 0.001). CONCLUSIONS:Among patients admitted for HF-CS, patients with cancer are at increased risk of in-hospital death, thrombotic complications, and major bleeding compared to patients without cancer. Future studies are needed to guide nuanced evaluation and management of this population to improve outcomes.

BACKGROUND AND AIMS/OBJECTIVE:Patients with acute myocardial infarction (AMI) who require invasive mechanical ventilation (IMV) represent a critically ill population with limited data on optimal sedative and analgesic use. Clinical trials assessing dexmedetomidine use exclude or poorly represent patients with AMI. This study aimed to compare the use of early sedation with dexmedetomidine to usual-care sedation in patients with AMI requiring IMV. METHODS:We utilized the Vizient® Clinical Data Base to identify patients aged ≥18 years admitted between 2015 and 2019 with a primary diagnosis of AMI who required IMV. Patients receiving dexmedetomidine on the first day of IMV were included in the early dexmedetomidine group while the remaining patients were assigned to the usual care group. Inverse probability of treatment weighting (IPTW) was used to estimate adjusted risk differences between groups. RESULTS:We identified 15,928 patients, of which 1,620 (10.2%) received early dexmedetomidine. Patients who received early dexmedetomidine were more likely to present with cardiogenic shock (52.0% vs. 47.7%, P=0.001). In unadjusted analyses, patients receiving early dexmedetomidine had lower in-hospital mortality (33.0% vs 42.1%) and more ventilator-free days (13.6 vs 12.1) compared to usual care (both, P<0.05). After IPTW, patients receiving early dexmedetomidine had a 11.0% (95% confidence interval [CI]: 8.6% to 13.5%) lower mortality and more ventilator-free days (mean difference: +2.2 days, 95% CI: 1.6-2.8 days). CONCLUSION/CONCLUSIONS:Early sedation with dexmedetomidine was associated with lower mortality compared to usual care in patients with AMI requiring IMV. A randomized controlled trial of sedative agents in this population is warranted.

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.