Faculty Bibliography

BACKGROUND/UNASSIGNED:In ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), an invasive strategy demonstrated better health status outcomes than a conservative strategy in patients with chronic coronary disease (CCD). Some previous studies have shown greater health status benefits with coronary artery bypass grafting (CABG) than percutaneous coronary intervention (PCI). Whether the health status benefits of invasive management in ISCHEMIA were driven primarily by participants treated with CABG is unknown. METHODS/UNASSIGNED:The aim of this analysis was to describe the health status outcomes of participants treated with a conservative strategy (n=2232) compared with invasively managed participants treated with PCI (n=1198) or CABG (n=340) in ISCHEMIA. The Seattle Angina Questionnaire-7 summary score (SAQ-SS) and angina frequency score (SAQ-AF) were the primary outcomes, with higher scores indicating better health status. Proportional odds models comparing 1- and 3-year outcomes were fit, adjusting for demographic, clinical, and angiographic characteristics. RESULTS/UNASSIGNED:SAQ-SS in the conservative, PCI, and CABG groups increased by 9.9±18.1, 15.7±19.3, and 16.1±19.1 points at 1 year and 11.5±20.2, 16.5±21.8, and 15.0±19.4 points at 3 years, respectively. Freedom from angina in the conservative, PCI, and CABG groups was noted in 61.4%, 73.3%, and 82.4% at 1 year and 70.4%, 76.1%, 81.4% at 3 years, respectively. In risk-adjusted analyses, PCI and CABG were each associated with a higher SAQ-SS and SAQ-AF at 1 and 3 years compared with conservative management. SAQ-AF was higher with CABG than PCI at 1 year (odds ratio, 1.54 [95% CI, 1.03, 2.31]), but no differences between CABG and PCI were observed in SAQ-SS (odds ratio, 1.11 [95% CI, 0.78, 1.57]) or SAQ-AF (odds ratio, 0.94 [95% CI, 0.58, 1.54]) at 3 years. CONCLUSIONS/UNASSIGNED:In ISCHEMIA, both PCI and CABG were associated with better 3-year health status than conservative management. Better angina relief with CABG than PCI was seen at 1, but not 3, years. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

BACKGROUND/UNASSIGNED:Mechanical thrombectomy offers a promising alternative to thrombolytic-based approaches for reducing thrombus burden and right heart strain in acute pulmonary embolism. This pivotal Food and Drug Administration-approval trial evaluated the safety and efficacy of the Symphony Thrombectomy System (Imperative Care, Inc, Campbell, CA) in acute intermediate-risk pulmonary embolism. METHODS/UNASSIGNED:Patients with intermediate-risk pulmonary embolism (systolic blood pressure ≥90 mm Hg; right ventricle-to-left ventricle ratio >0.9) were enrolled without roll-ins. The primary safety end point was the rate of major adverse events within 48 hours, defined as a composite of all-cause major bleeding, device-related mortality, and serious device-related events, adjudicated by an academic independent safety board. The primary efficacy end point was the core laboratory-assessed mean change in right ventricle-to-left ventricle ratio from baseline to 48 hours. Prespecified performance goals were set for both. Exploratory end points included immediate postprocedure change in mean pulmonary artery pressure and change in modified Miller index at 48 hours. Safety was assessed in the intention-to-treat cohort and efficacy in the modified intention-to-treat cohort, excluding patients receiving nonstudy device treatments. RESULTS/UNASSIGNED:<0.001. CONCLUSIONS/UNASSIGNED:These data support the safety and effectiveness of the Symphony Thrombectomy System in patients with acute intermediate-risk pulmonary embolism. REGISTRATION/UNASSIGNED:URL: https://www.clinicaltrials.gov; Unique identifier: NCT06062329.

Ischemic heart disease is the leading cause of heart failure with reduced ejection fraction in the developed world. An evolution of background medical therapy over the past decade has spurred improvement in symptoms and a reduction in morbidity and mortality with ischemic cardiomyopathy. However, there is still ongoing debate about the role and impact of revascularization. Much of the societal guidance regarding revascularization with coronary artery bypass grafting in ischemic cardiomyopathy comes from the STICH trial (Surgical Treatment for Ischemic Heart Failure) which predates improvements in medical therapy. More recently, the REVIVED-BCIS2 trial (Revascularization for Ischemic Ventricular Dysfunction-British Cardiovascular Intervention Society) failed to show a benefit of percutaneous coronary intervention on heart failure hospitalization and mortality in ischemic cardiomyopathy over contemporary medical therapy alone. Yet, there are outstanding questions regarding the role and modality of revascularization required to improve outcomes. We review current data and future directions in the management of ischemic cardiomyopathy and the potential role of revascularization.

PURPOSE/OBJECTIVE:We aimed to compare the visit-to-visit variability in low-density lipoprotein cholesterol (LDL-C) according to different lipid-lowering strategies and evaluate its prognostic implications using data from previous trials. MATERIALS AND METHODS/METHODS:We analyzed two randomized clinical trials: the RACING trial and the LODESTAR trial. LDL-C variability was evaluated using standard deviation (SD), coefficient of variation, and variation independent of mean. The primary endpoint was a composite of death, myocardial infarction, stroke, or coronary revascularization. RESULTS:<0.001). Every 1-SD increase in LDL-C variability (SD) was also independently associated with higher risk of myocardial infarction by 2.1%, stroke by 3.5%, and coronary revascularization by 2.7%. CONCLUSION/CONCLUSIONS:Compared to high-intensity statin therapy, LDL-C variability was not increased with the moderate-intensity statin plus ezetimibe combination therapy; however, it was increased in the treat-to-target strategy. Even among those treated with moderate- or high-intensity statins or statins with a target LDL-C levels of 50-70 mg/dL, increased LDL-C variability was associated with higher risk of adverse cardiovascular outcomes.

Pulmonary embolism response teams (PERTs) are being increasingly used for the management of patients admitted with acute pulmonary embolism (PE) and are endorsed by societal guidelines. Whether PERT improves outcomes remains unknown. The objective of this meta-analysis was to compare the outcomes of patients with acute PE treated by a PERT versus no PERT.A systematic review and study level meta-analysis was conducted by searching PubMed and EMBASE databases from inception until November 10, 2024 and included studies evaluating efficacy of PERT vs no PERT in patients admitted for acute PE. Outcomes included all-cause mortality (in-hospital and 30-day mortality), major and clinically relevant bleeding, advanced therapies utilization, length of stay (LOS), and 30-day readmission. Twenty-four retrospective observational studies met the inclusion criteria, comprising 15,809 patients (mean age 61.6 years with 49% male) with acute PE of which 6228 were treated with a PERT and 9,581 without a PERT. Lower all-cause mortality (in-hospital or 30-day mortality) [odds ratio (OR)= 0.72; 95% CI: 0.56 to 0.93; 24 studies], major or clinically relevant bleeding (OR= 0.60; 95% CI: 0.42 to 0.86; 15 studies), higher utilization of advanced therapies (OR= 3.16; 95% CI: 1.81 to 5.49; 19 studies), and lower hospital LOS (MD= -1.49; 95% CI: -2.59 to -0.39; 14 studies) were seen in the patients treated by a PERT compared to those not treated by a PERT. In this large meta-analysis of observational studies comparing outcomes in patients treated by PERT versus not treated by PERT, there were significantly lower short-term mortality, lower major or clinically relevant bleeding, higher utilization of advanced therapies and lower hospital length of stay with the existence of PERT. PERT should be the standard of care for the management of patients with acute PE.

BACKGROUND:Catheter-based percutaneous mechanical aspiration (PMA) is an emerging acute intervention for debulking infective vegetations in right-sided infective endocarditis (RSIE); however, its outcomes and safety remain undefined. OBJECTIVES/OBJECTIVE:The authors sought to assess early clinical outcomes and safety of PMA in patients with RSIE. METHODS:The CLEAR-IE (Cardiac Lesion Extraction and Aspiration Registry for Infective Endocarditis) is a large multicenter retrospective registry of consecutive patients with RSIE who have undergone PMA. Procedural success was defined as a ≥70% reduction in site-reported vegetation size or a residual size ≤1 cm on intraprocedural echocardiography, which included transesophageal echocardiography (TEE), intracardiac echocardiography (ICE), and transthoracic echocardiography (TTE), selected at the operator's discretion to guide the intervention. The primary endpoint was a composite of in-hospital mortality, new pulmonary embolism (PE), or emergency surgery. Secondary endpoints included each component of the primary endpoint and in-hospital worsening tricuspid regurgitation (TR). RESULTS:Between January 2014 and January 2024, 256 patients from 19 institutions were included. Median age was 43 years; 43% were women, and 51% had history of injection drug use. Acute PE (50.8%) and shock (27%) were frequent at presentation. Tricuspid valve involvement was present in 70%, with a median site-reported vegetation size of 2.4 cm (Q1-Q3: 0.6-9 cm). Severe TR was noted in 31.3% at baseline. Staphylococcus aureus was the predominant pathogen (73.8%). Procedural success was achieved in 89.4%, with a median residual vegetation size of 0.7 cm (Q1-Q3: 0.2-1.1 cm). Overall, 86.9% completed the procedure free from procedure-related complications. The primary endpoint occurred in 18% (mortality: 9.8%; new PE: 8.3%; emergency surgery: 3.1%). Among those without baseline severe TR, worsening TR occurred in 16.9%. On univariate analysis, shock (OR: 2.27; 95% CI: 1.15-4.43; P = 0.03) and hypoxia (OR: 3.62; 95% CI: 1.83-7.17; P < 0.001) were significantly associated with the primary endpoint, whereas worsening TR was not. On multivariate analysis, hypoxia (OR: 2.76; 95% CI: 1.34-5.73; P = 0.006) remained significantly associated with the primary outcome. CONCLUSIONS:PMA of RSIE is feasible with high procedural success. Adverse events were acceptable and largely driven by underlying RSIE. Randomized trials are warranted to confirm the clinical impact and safety of PMA in RSIE.

BACKGROUND:In patients with intermediate-risk pulmonary embolism (PE), guidelines recommend further risk stratification (Class 1 indication). However, head-to-head comparison of different risk stratification tools are lacking. Our objective was to compare the performance of 4 scores in predicting adverse clinical events in intermediate-risk PE. METHODS:This was a retrospective study of 192 intermediate-risk PE patients spanning October 2016 to July 2019. Receiver operator characteristic curves were used to compare the predictive performance of the composite PE shock (CPES) score, Bova, simplified PE shock index (sPESI), National Early Warning Score (NEWS) and ESC intermediate-risk subcategory types for the primary outcome, which was a composite of PE-related in-hospital mortality, resuscitated cardiac arrest, or hemodynamic decompensation and its individual components. RESULTS:A total of 28 patients (14.6%) experienced the primary composite outcome. CPES demonstrated the highest discriminatory power for predicting the primary composite outcome (AUC: 0.74; 95% CI: 0.66-0.83) as well as its individual components compared to the other risk scores (p = 0.008). The AUCs for the other scores were as follows: Bova, 0.66 (95% CI: 0.56-0.76); sPESI, 0.67 (95% CI: 0.57-0.77); NEWS, 0.71 (95% CI: 0.63-0.82) and ESC intermediate-risk subcategory, AUC of 0.59 (95% CI: 0.51-0.68). The ESC intermediate-risk subcategory exhibited the lowest performance for the primary composite outcome and across all individual components. CONCLUSION/CONCLUSIONS:CPES score outperformed other commonly used risk stratification tools for PE-related morbidity and mortality in intermediate-risk PE patients. The findings support the integration of CPES into clinical practice to enhance patient selection for escalated care and timely interventions.

BACKGROUND:Pulmonary embolism (PE) is can present with cardiac arrest. Catheter-based therapies (CBT) provide rapid reperfusion for patients with PE, though their effect on outcomes of patients with PE and cardiac arrest are not well known. AIMS/OBJECTIVE:To evaluate the effect of CBT on outcomes among patients with PE and cardiac arrest. METHODS:This was a retrospective cohort study of patients with PE and cardiac arrest from 2017 to 2020, using the National Readmission Database (NRD). We compared patients who underwent CBT versus no CBT and patients managed with CBT alone versus systemic thrombolysis alone. The primary endpoint was in-hospital death; exploratory outcomes were 90-day death and readmissions. Multivariable logistic and Cox proportional hazards modeling were used. RESULTS:Nine hundred and seventy-three patients were included (111 with CBT). CBT was associated with a lower risk of in-hospital death (36.9% vs. 49.3%, p = 0.015; aOR 0.44, 95% CI 0.23-0.85) with no difference in 90-day readmission (11.3% vs. 18.7%, p = 0.19; aHR 0.63, 95% CI 0.27-1.47). Among the 390 patients with either CBT or systemic thrombolysis alone in-hospital death (34.4% vs. 48.5%, p = 0.023; aOR 0.51, 95% CI 0.21-1.25) and 90-day readmissions (13.3% vs. 11.8%, p = 0.79; aHR 1.04, 95% CI 0.39-2.76) were similar. Ninety-day survival was higher with CBT when compared with no CBT or systemic thrombolytic alone (log-rank p = 0.050 and 0.020, respectively). CONCLUSIONS:Among patients with PE and cardiac arrest, CBT was associated with decreased risk of in-hospital death and 90-day survival compared with no CBT. Further prospective study on utility of CBT in PE and cardiac arrest is needed.

The Predicting Risk of Cardiovascular EVENTS (PREVENT) equations, created and endorsed by the American Heart Association, provide cardiovascular risk estimates for the general population, but have not yet been tested in multiethnic populations. In the present study, in a large nationwide multiethnic sample of US veterans, the utility of PREVENT to predict the risk of total cardiovascular disease (CVD: fatal and nonfatal myocardial infarction, stroke or heart failure; PREVENT-CVD), atherosclerotic cardiovascular disease (ASCVD: fatal and nonfatal myocardial infarction or stroke; PREVENT ASCVD) and heart failure was evaluated. We assessed the discrimination and calibration performance of ASCVD prediction with PREVENT ASCVD compared with a previous risk-prediction score, pooled cohort equations (PCEs). Among 2,500,291 veterans aged 30-79 years (93.9% men and 6.1% women), 407,342 total CVD events occurred over a median (interquartile range (IQR)) follow-up of 5.8 (IQR = 3.1-8.3) years. The Concordance index (C-index) (95% confidence interval (CI)) for PREVENT-CVD was 0.65 (95% CI = 0.65-0.65) in the overall sample and was similar across different race and ethnic groups (Asian, Native Hawaiian or Pacific Islander, 0.70 (95% CI = 0.69-0.71); Hispanic, 0.70 (95% CI = 0.69-0.70); non-Hispanic Black. 0.68 (95% CI = 0.68-0.69) and non-Hispanic White, 0.65 (95% CI = 0.64-0.65)). C-indices were similar between PREVENT ASCVD and PCEs and ranged from 0.61 to 0.63. Calibration slopes for PREVENT-CVD and -ASCVD in the overall sample were 1.09 (s.e. = 0.04) and 1.15 (s.e. = 0.04), respectively. In contrast, PCEs demonstrated overprediction for ASCVD with a calibration slope of 0.51 (s.e. = 0.06). Calibration slopes for PREVENT and PCEs were similar across race and ethnic groups. Among US veterans, the PREVENT equations accurately estimated CVD and ASCVD risk with some variability across race and ethnicity groups and outperformed PCEs for ASCVD risk prediction.