Factors associated with Acute Limb Ischemia in Cardiogenic Shock and downstream Clinical Outcomes: Insights from the Cardiogenic Shock Working Group.

BACKGROUND: There are limited data depicting the prevalence and ramifications of acute limb ischemia (ALI) among cardiogenic shock (CS) patients. METHODS: We employed data from the Cardiogenic Shock Working Group (CSWG), a consortium including 33 sites. We constructed a multi-variable logistic regression to examine the association between clinical factors and ALI, we generated another logistic regression model to ascertain the association of ALI with mortality. RESULTS: There were 7,070 patients with CS and 399 (5.6%) developed ALI. Patients with ALI were more likely to be female (40.4% versus 29.4%) and have peripheral arterial disease (13.8% versus 8.3%). Stratified by maximum SCAI shock stage, the rates of ALI were stage B 0.0%, stage C 1.8%, stage D 4.1%, and stage E 10.3%. Factors associated with higher risk for ALI included: peripheral vascular disease OR 2.24 (95% CI: 1.53 - 3.23; p < 0.01) and ≥ 2 mechanical circulatory support (MCS) devices OR 1.66 (95% CI: 1.24 - 2.21, p < 0.01). ALI was highest for VA-ECMO patients (11.6%) or VA-ECMO + IABP/Impella CP (16.6%) yet use of distal perfusion catheters was less than 50%. Mortality was 38.0% for CS patients without ALI but 57.4% for CS patients with ALI. ALI was significantly associated with mortality, adjusted OR 1.40 (95% CI 1.01 - 1.95, p < 0.01). CONCLUSIONS: The rate of ALI was 6% among CS patients. Factors most associated with ALI include peripheral vascular disease and multiple MCS devices. The downstream ramifications of ALI were dire with a considerably higher risk of mortality.

Association of cardiovascular diseases with cognitive performance in older adults.

BACKGROUND: Cognitive function and cardiovascular disease (CVD) have a bidirectional relationship, but studies on the impact of CVD subtypes and aging spectrum have been scarce. METHODS: We assessed older adults aged ≥60 years from the 2011 to 2012 and 2013 to 2014 cycles of the National Health and Nutrition Examination Survey who had coronary heart disease, angina, prior myocardial infarction, congestive heart failure, or prior stroke. We compared CERAD-IR, CERAD-DR, Animal Fluency test, and DSST scores to assess cognitive performance in older adults with and without CVD. RESULTS: We included 3,131 older adults, representing 55,479,673 older adults at the national level. Older adults with CVD had lower CERAD-IR (mean difference 1.8, 95% CI 1.4-2.1, P < .001), CERAD-DR (mean difference 0.8, 95% CI 0.6-1.0, P < .001), Animal Fluency test (mean difference 2.1, 95% CI 1.6-2.6, P < .001), and DSST (mean difference 9.5, 95% CI 8.0-10.9, P < .001) scores compared with those without CVD. After adjustment, no difference in CERAD-IR, CERAD-DR, and Animal Fluency test scores was observed, but DSST scores were lower in older adults with CVD (adjusted mean difference 2.9, 95% CI 1.1-4.7, P = .001). Across CVD subtypes, individuals with congestive heart failure had lower performance on the DSST score. The oldest-old cohort of patients ≥80 years old with CVD had lower performance than those without CVD on both the DSST and Animal Fluency test. CONCLUSION: Older adults with CVD had lower cognitive performance as measured than those free of CVD, driven by pronounced differences among those with CHF and those ≥80 years old with CVD.

Chronological vs Biological Age in Interventional Cardiology: A Comprehensive Approach to Care for Older Adults: JACC Family Series.

Aging is the gradual decline in physical and physiological functioning leading to increased susceptibility to stressors and chronic illnesses, including cardiovascular disease. With an aging global population, in which 1 in 6 individuals will be older than 60 years by 2030, interventional cardiologists are increasingly involved in providing complex care for older individuals. Although procedural aspects remain their main clinical focus, interventionalists frequently encounter age-associated risks that influence eligibility for invasive care, decision making during the intervention, procedural adverse events, and long-term management decisions. The unprecedented growth in transcatheter interventions, especially for structural heart diseases at extremes of age, have pushed age-related risks and implications for cardiovascular care to the forefront. In this JACC state-of-the-art review, the authors provide a comprehensive overview of the aging process as it relates to cardiovascular interventions, with special emphasis on the difference between chronological and biological aging. The authors also address key considerations to improve health outcomes for older patients during and after their invasive cardiovascular care. The role of "gerotherapeutics" in interventional cardiology, technological innovation in measuring biological aging, and the integration of patient-centered outcomes in the older adult population are also discussed.

Frailty in the cardiac intensive care unit: assessment and impact.

Frailty, a clinical syndrome of increased vulnerability, due to diminished cognitive, physical, and physiological reserves is a growing concern in the cardiac intensive care unit (CICU). It contributes to morbidity, mortality, and complications and often exerts a bidirectional association with cardiovascular disease. Although it predominately affects older adults, frailty can also be observed in younger patients <65 years of age, with approximately 30% of those admitted in CICU are frail. Acute cardiovascular illness can also impair physical and cognitive functioning among survivors and these survivors often suffer from frailty and functional declines post-CICU discharge. Patients with frailty in the CICU often have higher comorbidity burden, and they are less likely to receive optimal therapy for their acute cardiovascular conditions. Given the significance of this geriatric syndrome, this review will focus on assessment, clinical outcomes, and interventions, in an attempt to establish appropriate assessment, management, and resource utilization in frail patients during and after CICU admission.

Propofol vs etomidate for induction prior to invasive mechanical ventilation in patients with acute myocardial infarction.

BACKGROUND: Patients with acute myocardial infarction (AMI) requiring invasive mechanical ventilation (IMV) have a high mortality. However, little is known regarding the impact of induction agents, used prior to IMV, on clinical outcomes in this population. We assessed for the association between induction agent and mortality in patients with AMI requiring IMV. METHODS: We compared clinical outcomes between those receiving propofol compared to etomidate for induction among adults with AMI between October 2015 and December 2019 using the Vizient® Clinical Data Base, a multicenter, US national database. We used inverse probability treatment weighting (IPTW) to assess for the association between induction agent and in-hospital mortality. RESULTS: We identified 5,147 patients, 1,386 (26.9%) of received propofol and 3,761 (73.1%) received etomidate for IMV induction. The mean (SD) age was 66.1 (12.4) years, 33.0% were women, and 51.6% and 39.8% presented with STEMI and cardiogenic shock, respectively. Patients in the propofol group were more likely to require preintubation vasoactive medication and mechanical circulatory support (both, P < .05). Utilization of propofol was associated with lower mortality compared to etomidate (32.3% vs 36.1%, P = .01). After propensity weighting, propofol use remained associated with lower mortality (weighted mean difference -4.7%; 95% confidence interval: -7.6% to -1.8%, P = .002). Total cost, ventilator days, and length of stay were higher in the propofol group (all, P < .001). CONCLUSIONS: Induction with propofol, compared with etomidate, was associated with lower mortality for patients with AMI requiring IMV. Randomized trials are needed to determine the optimal induction agent for this critically ill patient population.

Shorter Dual Antiplatelet Therapy for Older Adults After Percutaneous Coronary Intervention: A Systematic Review and Network Meta-Analysis.

Importance: The optimal duration of dual antiplatelet therapy (DAPT) for older adults after percutaneous coronary intervention (PCI) is uncertain because they are simultaneously at higher risk for both ischemic and bleeding events. Objective: To investigate the association of abbreviated DAPT with adverse clinical events among older adults after PCI. Data Sources: The Cochrane Library, Google Scholar, Embase, MEDLINE, PubMed, Scopus, and Web of Science were searched from inception to August 9, 2023. Study Selection: Randomized clinical trials comparing any 2 of 1, 3, 6, and 12 months of DAPT were included if they reported results for adults aged 65 years or older or 75 years or older. Data Extraction and Synthesis: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline was used to abstract data and assess data quality. Risk ratios for each duration of DAPT were calculated with alternation of the reference group. Main Outcomes and Measures: The primary outcome of interest was net adverse clinical events (NACE). Secondary outcomes were major adverse cardiovascular events (MACE) and bleeding. Results: In 14 randomized clinical trials comprising 19 102 older adults, no differences were observed in the risks of NACE or MACE for 1, 3, 6, and 12 months of DAPT. However, 3 months of DAPT was associated with a lower risk of bleeding compared with 6 months of DAPT (relative risk [RR], 0.50 [95% CI, 0.29-0.84]) and 12 months of DAPT (RR, 0.57 [95% CI, 0.45-0.71]) among older adults. One month of DAPT was also associated with a lower risk of bleeding compared with 6 months of DAPT (RR, 0.68 [95% CI, 0.54-0.86]). Conclusions and Relevance: In this systematic review and meta-analysis of different durations of DAPT for older adults after PCI, an abbreviated DAPT duration was associated with a lower risk of bleeding without any concomitant increase in the risk of MACE or NACE despite the concern for higher-risk coronary anatomy and comorbidities among older adults. This study, which represents the first network meta-analysis of this shortened treatment for older adults, suggests that clinicians may consider abbreviating DAPT for older adults.

Age and Aspirin Dosing in Secondary Prevention of Atherosclerotic Cardiovascular Disease.

BACKGROUND: In patients with atherosclerotic cardiovascular disease, increasing age is concurrently associated with higher risks of ischemic and bleeding events. The objectives are to determine the impact of aspirin dose on clinical outcomes according to age in atherosclerotic cardiovascular disease. METHODS AND RESULTS: In the ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness) trial, patients with atherosclerotic cardiovascular disease were randomized to daily aspirin doses of 81 mg or 325 mg. The primary effectiveness end point was death from any cause, hospitalization for myocardial infarction, or hospitalization for stroke. The primary safety end point was hospitalization for bleeding requiring transfusion. A total of 15 076 participants were randomized to aspirin 81 mg (n=7540) or 325 mg (n=7536) daily (median follow-up: 26.2 months; interquartile range: 19.0-34.9 months). Median age was 67.6 years (interquartile range: 60.7-73.6 years). Among participants aged <65 years (n=5841 [38.7%]), a primary end point occurred in 226 (7.54%) in the 81 mg group, and in 191 (6.80%) in the 325 mg group (adjusted hazard ratio [HR], 1.23 [95% CI, 1.01-1.49]). Among participants aged ≥65 years (n=9235 [61.3%]), a primary end point occurred in 364 (7.12%) in the 81 mg group, and in 378 (7.96%) in the 325 mg group (adjusted HR, 0.95 [95% CI, 0.82-1.10]). The age-dose interaction was not significant (P=0.559). There was no significant interaction between age and the randomized aspirin dose for the secondary effectiveness and the primary safety bleeding end points (P>0.05 for all). CONCLUSIONS: Age does not modify the impact of aspirin dosing (81 mg or 325 mg daily) on clinical end points in secondary prevention of atherosclerotic cardiovascular disease.

Stress Testing the Cardiac Catheterization Laboratory: A Novel Use of In Situ Simulation to Identify and Mitigate Latent Safety Threats During Acute Airway Management.

INTRODUCTION: Although uncommon, cardiac arrests in the cardiac catheterization laboratory (CCL) are often catastrophic and likely to increase with rising case complexity. In situ simulation (ISS) has been used to identify latent safety threats (LSTs) in inpatient units but has not yet been studied in the CCL. METHODS: Three Plan-Do-Study-Act (PDSA) cycles leveraging ISS were conducted focused on acute airway management. Data collected through debriefs focused on (1) airway management, (2) equipment availability, and (3) interdepartmental communication. The LSTs were subcategorized and plotted on the Survey Analysis for Evaluating Risk (SAFER)-Matrix. A SAFER score was calculated based on quantifying the likelihood of harm, scope, and the number of times a threat was identified during simulation. Time to definitive airway was collected as a secondary measure. Interventions were developed using cause and effect and driver diagrams between PDSA cycles. RESULTS: Eleven total simulations through 3 PDSA cycles were conducted between January and December 2021 (5 in PDSA 1, 4 in PDSA 2, and 2 in PDSA 3). One hundred one LSTs were identified with 14 total subcategories. The mean SAFER score decreased from 5.37 in PDSA 1, to 2.96 in PDSA 2, and to 1.00 in PDSA 3. Bivariate regression analysis showed a decrease in SAFER score of 2.19 for every PDSA cycle ( P = 0.011). Ordinary least squares regression had a decrease of 1.65 in airway-related threats every PDSA cycle ( P < 0.01) as well as an increase in intubation time of 35.0 seconds for every 1-unit increase in communication threat identified ( P = 0.037). CONCLUSIONS: This study successfully leveraged ISS and existing quality improvement initiatives in the CCL, resulting in a decrease in airway-related threats as measured through simulation.

Delaying reperfusion plus left ventricular unloading reduces infarct size: Sub-analysis of DTU-STEMI pilot study.

INTRODUCTION: The STEMI-DTU pilot study tested the early safety and practical feasibility of left ventricular (LV) unloading with a trans-valvular pump before reperfusion. In the intent-to-treat cohort, no difference was observed for microvascular obstruction (MVO) or infarct size (IS) normalized to either the area at risk (AAR) at 3-5 days or total LV mass (TLVM) at 3-5 days We now report a per protocol analysis of the STEMI-DTU pilot study. METHODS: In STEMI-DTU STUDY 50 adult patients (25 in each arm) with anterior STEMI [sum of precordial ST-segment elevation (ΣSTE) ≥4 mm] requiring primary percutaneous coronary intervention (PCI) were enrolled. Only patients who met all inclusion and exclusion criteria were included in this analysis. Cardiac magnetic resonance (CMR) imaging 3-5 days after PCI quantified IS/AAR and IS/TLVM and MVO. Group differences were assessed using Student's t-tests and linear regression (SAS Version-9.4). RESULTS: Of the 50 patients enrolled, 2 died before CMR imaging. Of the remaining 48 patients those without CMR at 3-5 days (n = 8), without PCI of a culprit left anterior descending artery lesion (n = 2), with OHCA (n = 1) and with ΣSTE < 4 mm (n = 5) were removed from this analysis leaving 32/50 (64 %) patients meeting all inclusion and exclusion criteria (U-IR, n = 15; U-DR, n = 17) as per protocol. Despite longer symptom-to-balloon times in the U-DR arm (228 ± 80 vs 174 ± 59 min, p < 0.01), IS/AAR was significantly lower with 30 min of delay to reperfusion in the presence of active LV unloading (47 ± 16 % vs 60 ± 15 %, p = 0.02) and remained lower irrespective of the magnitude of precordial ΣSTE. MVO was not significantly different between groups (1.5 ± 2.8 % vs 3.5 ± 4.8 %, p = 0.15). Among patients who received LV unloading within 180 min of symptom onset, IS/AAR was significantly lower in the U-DR group. CONCLUSION: In this per-protocol analysis of the STEMI-DTU pilot study we observed that LV unloading for 30 min before reperfusion significantly reduced IS/AAR compared to LV unloading and immediate reperfusion, whereas in the ITT cohort no difference was observed between groups. This observation supports the design of the STEMI-DTU pivotal trial and suggests that strict adherence to the study protocol can significantly influence the outcome.

Complex Percutaneous Coronary Intervention Outcomes in Older Adults.

Background Complex percutaneous coronary intervention (PCI) is increasingly performed in older adults (age ≥75 years) with stable ischemic heart disease. However, little is known about clinical outcomes. Methods and Results We derived a cohort of older adults undergoing elective PCI for stable ischemic heart disease across a large health system. We compared 12-month event-free survival (freedom from all-cause death, nonfatal myocardial infarction, stroke, and major bleeding), all-cause death, target lesion revascularization, and bleeding events for patients receiving complex versus noncomplex PCI and derived risk estimates with Cox regression models. We included 513 patients (mean age, 81±5 years). Patients receiving complex PCI versus noncomplex PCI did not significantly differ across a host of clinical characteristics including cardiovascular disease features, noncardiac comorbidities, guideline-directed medical therapy use, and frailty. Patients receiving complex PCI versus noncomplex PCI experienced worse event-free survival (80.4% versus 86.8%), which was not significant in adjusted analyses (hazard ratio [HR], 1.38 [95% CI, 0.88-2.16]). All-cause death at 1 year for patients undergoing complex PCI was nearly double that seen for patients receiving noncomplex PCI (10.2% versus 5.9%), and the risk was significant in models adjusted for clinical characteristics (HR, 1.97 [95% CI, 1.02-3.79]). Target lesion revascularization risk was lower for patients receiving complex PCI (2.2% versus 3.5%, adjusted HR), but bleeding events were not statistically different between groups (25.3% versus 20.5%; P=0.19). Conclusions Complex PCI in older adults with stable ischemic heart disease was associated with lower risk of target lesion revascularization but higher all-cause death compared with noncomplex PCI.

Comparative Outcomes of Catheter-Directed Thrombolysis Plus Systemic Anticoagulation Versus Systemic Anticoagulation Alone in the Management of Intermediate-Risk Pulmonary Embolism in a Systematic Review and Meta-Analysis.

There are limited and conflicting data on the initial management of intermediate-risk (or submassive) pulmonary embolism (PE). This study sought to compare the outcomes of catheter-directed thrombolysis (CDT) in combination with systemic anticoagulation (SA) to SA alone. A systematic search was conducted in MEDLINE, EMBASE, PubMed, and the Cochrane databases from inception to March 1, 2023 for studies comparing the outcomes of CDT + SA versus SA alone in intermediate-risk PE. The outcomes were in-hospital, 30-day, 90-day, and 1-year mortality; bleeding; blood transfusion; right ventricular recovery; and length of stay. Random-effects models was used to calculate the pooled incidence and risk ratios (RRs) with 95% confidence intervals (CIs). A total of 15 (2 randomized and 13 observational) studies with 10,549 (2,310 CDT + SA and 8,239 SA alone) patients were included. Compared with SA, CDT + SA was associated with significantly lower in-hospital mortality (RR 0.41, 95% CI 0.30 to 0.56, p <0.001), 30-day mortality (RR 0.34, 95% CI 0.18 to 0.67, p = 0.002), 90-day mortality (RR 0.34, 95% CI 0.17 to 0.67, p = 0.002), and 1-year mortality (RR 0.58, 95% CI 0.34 to 0.97, p = 0.04). There were no significant differences between the 2 cohorts in the rates of major bleeding (RR 1.39, 95% CI 0.72 to 2.68, p = 0.56), minor bleeding (RR 1.83, 95% CI 0.97 to 3.46, p = 0.06), and blood transfusion (RR 0.34, 95% CI 0.10 to 1.15, p = 0.08). In conclusion, CDT + SA is associated with significantly lower short-term and long-term all-cause mortality, without any differences in major/minor bleeding, in patients with intermediate-risk PE.

Prognostic significance of haemodynamic parameters in patients with cardiogenic shock.

AIMS: Invasive haemodynamic assessment with a pulmonary artery catheter is often used to guide the management of patients with cardiogenic shock (CS) and may provide important prognostic information. We aimed to assess prognostic associations and relationships to end-organ dysfunction of presenting haemodynamic parameters in CS. METHODS AND RESULTS: The Critical Care Cardiology Trials Network is an investigator-initiated multicenter registry of cardiac intensive care units (CICUs) in North America coordinated by the TIMI Study Group. Patients with CS (2018-2022) who underwent invasive haemodynamic assessment within 24 h of CICU admission were included. Associations of haemodynamic parameters with in-hospital mortality were assessed using logistic regression, and associations with presenting serum lactate were assessed using least squares means regression. Sensitivity analyses were performed excluding patients on temporary mechanical circulatory support and adjusted for vasoactive-inotropic score. Among the 3603 admissions with CS, 1473 had haemodynamic data collected within 24 h of CICU admission. The median cardiac index was 1.9 (25th-75th percentile, 1.6-2.4) L/min/m2 and mean arterial pressure (MAP) was 74 (66-86) mmHg. Parameters associated with mortality included low MAP, low systolic blood pressure, low systemic vascular resistance, elevated right atrial pressure (RAP), elevated RAP/pulmonary capillary wedge pressure ratio, and low pulmonary artery pulsatility index. These associations were generally consistent when controlling for the intensity of background pharmacologic and mechanical haemodynamic support. These parameters were also associated with higher presenting serum lactate. CONCLUSION: In a contemporary CS population, presenting haemodynamic parameters reflecting decreased systemic arterial tone and right ventricular dysfunction are associated with adverse outcomes and systemic hypoperfusion.

Hierarchical Development of Physical Frailty and Cognitive Impairment and Their Association With Incident Cardiovascular Disease.

BACKGROUND: Frailty and cognitive impairment (CI) are geriatric conditions that lead to poor health outcomes among older adults with cardiovascular disease. The association between their temporal patterns of development and cardiovascular risk is unknown. OBJECTIVES: This study aims to examine the 5-year cardiovascular outcomes by the pattern of development of frailty and CI in older adults without a history of coronary artery disease. METHODS: We used the National Health and Aging Trends Study, linked to Medicare data. Frailty was measured using the physical frailty phenotype. CI was measured using the AD8 Dementia Screening Interview, measured cognitive performance, or self-report by patient or caregiver for a diagnosis given by a physician. The primary outcome was incident major adverse cardiovascular event at 5 years. RESULTS: Of a total 2,189 study participants aged 65 and older, 38.5% were male. In this study population, 154 (7%) participants developed frailty first, 829 (38%) developed CI first, and 195 (9%) participants developed both simultaneously (frail-CI group). Those who developed frailty and CI simultaneously were older, more likely to be female, and had multiple chronic conditions. The frail-CI group had the highest risk of major adverse cardiovascular event (hazard ratio [HR]: 1.81; 95% CI: 1.47-2.23) followed by frail first (HR: 1.46; 95% CI: 1.17-1.81) and CI first (HR: 1.31; 95% CI: 1.15-1.50). Frailty first was associated with the greater risk of stroke (HR: 1.49; 95% CI: 1.06-2.09) compared to the intact group. CONCLUSIONS: The simultaneous development of frailty and CI is associated with an increased risk of adverse cardiovascular outcomes including death compared with the development of each syndrome alone. Diagnostics to detect frailty and CI are critical in assessment of cardiovascular risk in the older population.

Assessment and Management of Older Adults Undergoing PCI, Part 1: A JACC: Advances Expert Panel.

As the population ages, older adults represent an increasing proportion of patients referred to the cardiac catheterization laboratory. Older adults are the highest-risk group for morbidity and mortality, particularly after complex, high-risk percutaneous coronary interventions. Structured risk assessment plays a key role in differentiating patients who are likely to derive net benefit vs those who have disproportionate risks for harm. Conventional risk assessment tools from national cardiovascular societies typically rely on 3 pillars: 1) cardiovascular risk; 2) physiologic and hemodynamic risk; and 3) anatomic and procedural risks. We propose adding a fourth pillar: geriatric syndromes, as geriatric domains can supersede all other aspects of risk.

A Geriatric Approach to Percutaneous Coronary Interventions in Older Adults, Part II: A JACC: Advances Expert Panel.

We review a comprehensive risk assessment approach for percutaneous coronary interventions in older adults and highlight the relevance of geriatric syndromes within that broader perspective to optimize patient-centered outcomes in interventional cardiology practice. Reflecting the influence of geriatric principles in older adults undergoing percutaneous coronary interventions, we propose a "geriatric" heart team to incorporate the expertise of geriatric specialists in addition to the traditional heart team members, facilitate uptake of the geriatric risk assessment into the preprocedural risk assessment, and address ways to mitigate these geriatric risks. We also address goals of care in older adults, highlighting common priorities that can impact shared decision making among older patients, as well as frequently encountered pharmacotherapeutic considerations in the older adult population. Finally, we clarify gaps in current knowledge and describe crucial areas for future investigation.

Outcomes and Institutional Variation in Arterial Access Among Patients With AMI and Cardiogenic Shock Undergoing PCI.

BACKGROUND: Contemporary data comparing the outcomes of transradial access (TRA) vs transfemoral access (TFA) among patients presenting with acute myocardial infarction and cardiogenic shock (AMI-CS) undergoing percutaneous coronary intervention (PCI) are limited. OBJECTIVES: This study examines in-hospital outcomes and institutional variation among patients with AMI-CS undergoing TRA-PCI vs TFA-PCI. METHODS: Patients admitted with AMI-CS from the NCDR CathPCI registry between April 2018 and June 2021 were included. Multivariable logistic regression and inverse probability weighting models were used to assess the association between access site and in-hospital outcomes. A falsification analysis using non-access site-related bleeding was performed. RESULTS: Among 35,944 patients with AMI-CS undergoing PCI, 25.6% were performed with TRA. The proportion of TRA-PCI increased over the study period (22.0% in the second quarter of 2018 vs 29.1% in the second quarter of 2021; P-trend <0.001). Significant institutional-level variability in the use of TRA-PCI was also observed: 20.9% of all sites using TRA in <2% of PCIs (low utilization) vs 1.9% of all sites using TRA in >80% of PCIs (high utilization). Patients undergoing TRA-PCI had a significantly lower adjusted incidence of major bleeding (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.67-0.76), mortality (OR: 0.73; 95% CI: 0.69-0.78), vascular complications (OR: 0.67; 95% CI: 0.54-0.84), and new dialysis (OR: 0.86; 95% CI: 0.77-0.97). There was no difference in non-access site related bleeding (OR: 0.93; 95% CI: 0.84-1.03). Sensitivity analyses revealed similar benefit with TRA-PCI among patients without arterial cross-over. There were no significant interactions observed between TRA-PCI with mechanical circulatory support and in-hospital outcomes. CONCLUSIONS: In this large nationwide contemporary analysis of patients with AMI-CS, about quarter of PCIs were performed via TRA with wide variability across US institutions. TRA-PCI was associated with significantly lower incidence of in-hospital major bleeding, mortality, vascular complications, and new dialysis. This benefit was observed irrespective of mechanical circulatory support use.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock.

Importance: Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). Objective: To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. Design, Setting, and Participants: This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Interventions: Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Main Outcomes and Measures: Thirty-day all-cause mortality and readmissions. Results: Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. Conclusions: In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

Preoperative frailty and adverse outcomes following coronary artery bypass grafting surgery in US veterans.

BACKGROUND: Contemporary guidelines emphasize the value of incorporating frailty into clinical decision-making regarding revascularization strategies for coronary artery disease. Yet, there are limited data describing the association between frailty and longer-term mortality among coronary artery bypass grafting (CABG) patients. METHODS: We conducted a retrospective cohort study (2016-2020, 40 VA medical centers) of US veterans nationwide that underwent coronary artery bypass grafting (CABG). Frailty was quantified by the Veterans Administration Frailty Index (VA-FI), which applies the cumulative deficit method to render a proportion of 30 pertinent diagnosis codes. Patients were classified as non-frail (VA-FI ≤ 0.1), pre-frail (0.1 < VA-FI ≤ 0.2), or frail (VA-FI > 0.2). We used Cox proportional hazards models to ascertain the association of frailty with all-cause mortality. Our primary study outcome was 5-year all-cause mortality; the co-primary outcome was days alive and out of the hospital within the first postoperative year. RESULTS: There were 13,554 CABG patients (median 69 years, 79% White, 1.5% women). The mean pre-operative VA-FI was 0.21 (SD: 0.11); 31% were pre-frail (VA-FI: 0.17) and 47% were frail (VA-FI: 0.31). Frail patients were older and had higher co-morbidity burdens than pre-frail and non-frail patients. Compared with non-frail patients (13.0% [11.4, 14.7]), there was a significant association between frail and pre-frail patients and increased cumulative 5-year all-cause mortality (frail: 24.8% [23.3, 26.1]; HR: 1.75 [95% CI 1.54, 2.00]; pre-frail 16.8% [95% CI 15.3, 18.4]; HR 1.2 [1.08,1.34]). Compared with non-frail patients (mean 362[SD 12]), pre-frail (mean 361 [SD 14]; p < 0.01) and frail patients (mean 358[SD 18]; p < 0.01) spent fewer days alive and out of the hospital in the first postoperative year. CONCLUSIONS: Pre-frailty and frailty were prevalent among US veterans undergoing CABG and associated with worse mid-term outcomes. Given the high prevalence of frailty with attendant adverse outcomes, there may be an opportunity to improve outcomes by identifying and mitigating frailty before surgery.