Contemporary Revascularization Strategies and Outcomes Among Patients With Diabetes With Critical Limb Ischemia: Insights From the National Inpatient Sample

ObjectivesThe purpose of this study was to evaluate temporal trends in the frequency of revascularization and associated outcomes in patients with diabetes mellitus and critical limb ischemia (CLI).BackgroundLittle is known about outcomes following revascularization for CLI in patients with diabetes mellitus.MethodsTemporal trends in hospitalization for CLI among patients with diabetes were determined using the 2002–2015 National Inpatient Sample database. Propensity score matching was used to compare patients who underwent revascularization with those who did not and, separately, to compare those who underwent endovascular versus surgical revascularization. The main study outcome was in-hospital mortality.ResultsThe analysis included 1,222,324 hospitalizations. The number of hospitalizations for CLI among patients with diabetes increased over time (p_trend < 0.001). There was an increase in the use of lower extremity revascularization, paralleled by a decline in in-hospital mortality during the study period. In the matched cohort, patients who were revascularized had lower in-hospital mortality (odds ratio [OR]: 0.68; 95% confidence interval [CI]: 0.63 to 0.72) and major amputation (OR: 0.25; 95% CI: 0.24 to 0.27) compared with those who were treated medically. Compared with endovascular revascularization, those who underwent surgical revascularization had higher rates of in-hospital mortality (OR: 1.18; 95% CI: 1.04 to 1.35) but lower rates of major amputation (OR: 0.75; 95% CI: 0.70 to 0.81). Major bleeding, blood transfusion, post-operative infection, respiratory complications, discharges to nursing facility, and longer length of hospital stay were also more common among those who underwent surgery.ConclusionsIn this national analysis of patients with DM and CLI, we demonstrated an increase in hospitalization for CLI among patients with diabetes in the United States. Although in-hospital mortality decreased over time regardless of the treatment strategy used, this outcome occurred less frequently among those who underwent revascularization than not. Compared with surgical revascularization, endovascular revascularization was associated with lower in-hospital mortality but higher rates of major amputation.     

Operator Volumes and In-Hospital Outcomes: An Analysis of 7,740 Rotational Atherectomy Procedures From the BCIS National Database

ObjectivesThe aims of this study were to use a national percutaneous coronary intervention (PCI) registry to study temporal changes in procedure volumes of PCI using rotational atherectomy (ROTA-PCI), the patient and procedural factors associated with differing quartiles of operator ROTA-PCI volume, and the relationship between operator ROTA-PCI volumes and in-hospital patient outcomes.BackgroundWhether higher operator volume is associated with improved outcomes after ROTA-PCI is poorly defined.MethodsData from the British Cardiovascular Intervention Society national PCI database were analyzed for all ROTA-PCI procedures performed in the United Kingdom between 2013 and 2016. Individual logistic regressions were performed to quantify the independent association between annual operator ROTA-PCI volume and in-hospital outcomes.ResultsIn total, 7,740 ROTA-PCI procedures were performed, with a negatively skewed distribution and an annualized operator volume median of 2.5 procedures/year (range 0.25 to 55.25). Higher volume operators undertook more complex procedures in patients with greater comorbid burdens than lower volume operators. A significant inverse association was observed between operator ROTA-PCI volume and in-hospital mortality (odds ratio [OR]: 0.986/case; 95% confidence interval [CI]: 0.975 to 0.996; p = 0.007) and major adverse cardiac and cerebral events (OR: 0.983/case; 95% CI: 0.975 to 0.993; p < 0.001). Additionally, lower rates of emergency cardiac surgery (OR: 0.964/case; 95% CI: 0.939 to 0.991; p = 0.008), arterial complications (OR: 0.975/case; 95% CI: 0.975 to 0.982; p < 0.001) and in-hospital major bleeding (OR: 0.985/case; 95% CI: 0.977 to 0.993; p < 0.001) were associated with higher ROTA-PCI operator volume. Sensitivity analyses in several subgroups demonstrated a consistency of improved outcomes as annual ROTA-PCI volume increased. An annual volume of <4 ROTA-PCI procedures/year was observed to be associated with increased major adverse cardiac and cerebral events, with 239 of 432 operators (55%) not exceeding this threshold.ConclusionsIn-hospital adverse outcomes occurred less frequently as ROTA-PCI operator volume increased. These data suggest that operator volume is an important factor determining outcome after ROTA-PCI.     

Implementation of High-Sensitivity Cardiac Troponin Assays in the United States

BackgroundFew data exist regarding the implementation of high-sensitivity cardiac troponin (hs-cTn) assays in the United States since their approval.ObjectivesThis study sought to explore trends in hs-cTn assay implementation over time and assess the association of their use with in-hospital cardiac testing and outcomes.MethodsThe study examined trends in implementation of hs-cTn assays among participating hospitals in the National Cardiovascular Data Registry Chest Pain-MI [Myocardial Infarction] Registry from January 1, 2019 through September 30, 2021. Associations among hs-cTn use, use of in-hospital diagnostic imaging, and patient outcomes were assessed using generalized estimating equation models with logistic or gamma distributions.ResultsAmong 550 participating hospitals (N = 251,000), implementation of hs-cTn assays increased from 3.3% in the first quarter of 2019 to 32.6% in the third quarter of 2021 (P_trend < 0.001). Use of hs-cTn was associated with more echocardiography among persons with non–ST-segment elevation acute coronary syndrome (NSTE-ACS; 82.4% vs 75.0%; adjusted odds ratio: 1.43; 95% CI: 1.19-1.73) but not among low-risk chest pain individuals. Use of hs-cTn was associated with less invasive coronary angiography among low-risk patients (3.7% vs 4.5%; adjusted odds ratio: 0.73; 95% CI: 0.58-0.92) but similar use for patients with NSTE-ACS. There was no association between hs-cTn use and noninvasive stress testing or coronary computed tomography angiography testing. Among individuals with NSTE-ACS, hs-cTn use was not associated with revascularization or in-hospital mortality. Use of hs-cTn was associated with a shorter length of stay (median 47.6 hours vs 48.0 hours; ratio: 0.94; 95% CI: 0.90-0.98).ConclusionsImplementation of hs-cTn among U.S. hospitals is increasing, but most U.S. hospitals continue to use less sensitive assays. The use of hs-cTn was associated with modestly shorter length of stay, greater use of echocardiography for NSTE-ACS, and less use of invasive angiography among low-risk patients.     

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease

BackgroundNo adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease.ObjectivesThis study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx.MethodsPrincipal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days.ResultsA total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001).ConclusionsThese findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.     

Sex Differences in Management and Outcomes of Acute Myocardial Infarction Patients Presenting With Cardiogenic Shock

ObjectivesThe aim of this study was to examine the sex differences in the risk profile, management, and outcomes among patients presenting with acute myocardial infarction cardiogenic shock (AMI-CS).BackgroundContemporary clinical data regarding sex differences in the management and outcomes of AMI patients presenting with CS are scarce.MethodsPatients admitted with AMI-CS from the National Cardiovascular Data Registry Chest Pain-MI registry between October 2008 to December 2017 were included. Sex differences in baseline characteristics, in-hospital management, and outcomes were compared. Patients ≥65 years of age with available linkage data to Medicare claims were included in the analysis of 1-year outcomes. Multivariable logistic regression and Cox proportional hazards models adjusting for patient and hospital-related covariates were used to estimate sex-specific differences in in-hospital and 1-year outcomes, respectively.ResultsAmong 17,195 patients presenting with AMI-CS, 37.3% were women. Women were older, had a higher prevalence of comorbidities, and had worse renal function at presentation. Women were less likely to receive guideline-directed medical therapies within 24 hours and at discharge, undergo diagnostic angiography (85.0% vs 91.1%), or receive mechanical circulatory support (25.4% vs 33.8%). Women had higher risks of in-hospital mortality (adjusted OR: 1.10; 95% CI: 1.02-1.19) and major bleeding (adjusted OR: 1.23; 95% CI: 1.12-1.34). For patients ≥65 years of age, women did not have a higher risk of all-cause mortality (adjusted HR: 0.98; 95% CI: 0.88-1.09) and mortality or heart failure hospitalization (adjusted HR: 1.01; 95% CI: 0.91-1.12) at 1 year compared with men.ConclusionsIn this large nationwide analysis of patients with AMI-CS, women were less likely to receive guideline recommended care, including revascularization, and had worse in-hospital outcomes than men. At 1 year, there were no sex differences in the risk of mortality. Efforts are needed to address sex disparities in the initial care of AMI-CS patients.     

Association Between Number of Volunteer Responders and Interventions Before Ambulance Arrival for Cardiac Arrest

BackgroundVolunteer responder (VR) programs for activation of laypersons in out-of-hospital cardiac arrest (OHCA) have been deployed worldwide, but the optimal number of VRs to dispatch is unknown.ObjectivesThe purpose of this study was to investigate the association between the number of VRs arriving before Emergency Medical Services (EMS) and the proportion of bystander cardiopulmonary resuscitation (CPR) and defibrillation.MethodsWe included OHCAs not witnessed by EMS with VR activation from the Capital Region (September 2, 2017, to May 14, 2019) and the Central Region of Denmark (November 5, 2018, to December 31, 2019). We created 4 groups according to the number of VRs arriving before EMS: 0, 1, 2, and 3 or more. Using a logistic regression model adjusted for EMS response time, we examined associations between the number of VRs arriving before EMS and bystander CPR and defibrillation.ResultsWe included 906 OHCAs. The adjusted ORs for bystander CPR were 2.40 (95% CI: 1.42-4.05), 3.18 (95% CI: 1.39-7.26), and 2.70 (95% CI: 1.32-5.52) when 1, 2, or 3 or more VRs arrived before EMS (reference), respectively. The adjusted OR for bystander defibrillation increased when 1 (1.97 [95% CI: 1.12-3.52]), 2 (2.88 [95% CI: 1.48-5.58]), or 3 or more (3.85 [95% CI: 2.11-7.01]) VRs arrived before EMS (reference). The adjusted OR of bystander defibrillation increased to 1.95 (95% CI: 1.18-3.22) when ≥3 VRs arrived first compared with 1 VR arriving first (reference).ConclusionsWe found an association of increased bystander CPR and defibrillation when 1 or more VRs arrived before the EMS with a trend toward increased bystander defibrillation with increasing number of VRs arriving first.     

Intravascular Imaging and 12-Month Mortality After Unprotected Left Main Stem PCI: An Analysis From the British Cardiovascular Intervention Society Database

ObjectivesThe authors used the British Cardiovascular Intervention Society (BCIS) national percutaneous coronary intervention (PCI) database to explore temporal changes in the use of intravascular imaging for unprotected left main stem PCI (uLMS PCI), defined the associates of imaging use, and correlate clinical outcomes including survival with imaging use.BackgroundLimited registry data support the use of intravascular imaging during uLMS PCI to improve outcomes.MethodsData were analyzed from 11,264 uLMS PCI procedures performed in England and Wales between 2007 and 2014. Multivariate logistic regression was used to identify associates of imaging use. Propensity matching created 5,056 pairs of subjects with and without imaging and logistic regression was performed to quantify the association between imaging and outcomes. Multivariate logistic regression to identify the independent predictors of 12-month mortality was performed.ResultsImaging use increased from 30.2% in 2007 to 50.2% in 2014 (p for trend < 0.001). The factors associated with imaging use included stable angina presentation (odds ratio [OR]: 1.200; 95% confidence interval [CI]: 1.147 to 1.246; p < 0.001), bifurcation LMS disease (OR: 1.220; 95% CI: 1.140 to 1.300; p < 0.001), previous PCI (OR: 1.320; 95% CI: 1.200 to 1.440; p < 0.001), and radial access (OR: 1.266; 95% CI: 1.217 to 1.317; p < 0.001). A lower rate of coronary complications, lower in-hospital major adverse cardiac events (OR: 0.470; 95% CI: 0.37 to 0.590; p < 0.001), and improved 30-day (OR: 0.540; 95% CI: 0.430 to 0.680; p < 0.001) and 12-month (OR: 0.660; 95% CI: 0.570 to 0.770; p < 0.001) mortality were observed with imaging use compared with no imaging use. Greater mortality reductions were observed with higher operator LMS PCI volume. In logistic regression modeling, imaging use was associated with improved 12-month survival.ConclusionsThe observed lower mortality with use of intravascular imaging to guide uLMS PCI justifies the undertaking of a large-scale randomized trial.     

Impact of Subintimal Plaque Modification on Reattempted Chronic Total Occlusions Percutaneous Coronary Intervention

BackgroundPredictors of success in reattempted chronic total occlusion (CTO) percutaneous coronary intervention (PCI) procedures remain obscure, mainly owing to the lack of consecutive angiograms and procedural records of initial attempts in the same cohort.ObjectivesThis study sought to investigate the factors predicting the success of reattempted CTO PCI procedures.MethodsA total of 208 consecutive patients who underwent a failed CTO PCI attempt and received reattempted procedure at the same cardiac center were retrospectively analyzed. Predictors of the success of reattempted procedures were evaluated.ResultsThe overall technical success rate of reattempted CTO PCI procedures was 71.2%. Subintimal plaque modification (SPM) was implemented in 35 (16.8%) procedures in initial attempts. The reattempted technical success rate was 93.3% in cases in which SPM with guidewire (GW) crossing was achieved in the initial attempt; however, the success rate was 55.0% for procedures involving SPM without GW crossing. SPM with GW crossing (OR: 11.21; 95% CI: 1.31-96.16; P = 0.028), referral to high-volume operators (OR: 2.38; 95% CI: 1.14-4.98; P = 0.021), and a bidirectional approach (OR: 2.31; 95% CI: 1.12-4.79; P = 0.024) were positive independent predictors of technical success in the subsequent reattempt. The time interval for reattempt (per 90-day increment) was negatively correlated with the technical success of the reattempted procedures (OR: 0.85; 95% CI: 0.73-0.98; P = 0.030).ConclusionsThis study identified independent predictors of success in reattempted CTO PCI procedures. SPM with GW crossing achieved in the initial attempt is associated with a higher success rate in the subsequent reattempt.     

Deep-Learning for Epicardial Adipose Tissue Assessment With Computed Tomography: Implications for Cardiovascular Risk Prediction

BackgroundEpicardial adipose tissue (EAT) volume is a marker of visceral obesity that can be measured in coronary computed tomography angiograms (CCTA). The clinical value of integrating this measurement in routine CCTA interpretation has not been documented.ObjectivesThis study sought to develop a deep-learning network for automated quantification of EAT volume from CCTA, test it in patients who are technically challenging, and validate its prognostic value in routine clinical care.MethodsThe deep-learning network was trained and validated to autosegment EAT volume in 3,720 CCTA scans from the ORFAN (Oxford Risk Factors and Noninvasive Imaging Study) cohort. The model was tested in patients with challenging anatomy and scan artifacts and applied to a longitudinal cohort of 253 patients post-cardiac surgery and 1,558 patients from the SCOT-HEART (Scottish Computed Tomography of the Heart) Trial, to investigate its prognostic value.ResultsExternal validation of the deep-learning network yielded a concordance correlation coefficient of 0.970 for machine vs human. EAT volume was associated with coronary artery disease (odds ratio [OR] per SD increase in EAT volume: 1.13 [95% CI: 1.04-1.30]; P = 0.01), and atrial fibrillation (OR: 1.25 [95% CI: 1.08-1.40]; P = 0.03), after correction for risk factors (including body mass index). EAT volume predicted all-cause mortality (HR per SD: 1.28 [95% CI: 1.10-1.37]; P = 0.02), myocardial infarction (HR: 1.26 [95% CI:1.09-1.38]; P = 0.001), and stroke (HR: 1.20 [95% CI: 1.09-1.38]; P = 0.02) independently of risk factors in SCOT-HEART (5-year follow-up). It also predicted in-hospital (HR: 2.67 [95% CI: 1.26-3.73]; P ≤ 0.01) and long-term post–cardiac surgery atrial fibrillation (7-year follow-up; HR: 2.14 [95% CI: 1.19-2.97]; P ≤ 0.01).ConclusionsAutomated assessment of EAT volume is possible in CCTA, including in patients who are technically challenging; it forms a powerful marker of metabolically unhealthy visceral obesity, which could be used for cardiovascular risk stratification.     

Multivessel Versus Culprit-Vessel Percutaneous Coronary Intervention in Patients With Non–ST-Segment Elevation Myocardial Infarction and Cardiogenic Shock

ObjectivesThe aim of this study was to compare in-hospital outcomes and long-term mortality of multivessel versus culprit vessel–only percutaneous coronary intervention (PCI) in patients with non–ST-segment elevation myocardial infarction (NSTEMI), multivessel disease (MVD) and cardiogenic shock.BackgroundThe clinical benefits of complete revascularization in patients with NSTEMI, MVD, and cardiogenic shock remain uncertain.MethodsAmong 25,324 patients included in the National Cardiovascular Data Registry CathPCI Registry from July 2009 to March 2018, the rates of in-hospital procedural outcomes were compared between those undergoing multivessel PCI and those undergoing culprit vessel–only PCI after 1:1 propensity score matching. Among patients aged ≥65 years matched to the Centers for Medicare and Medicaid Services database, long-term mortality was compared using proportional hazards analysis.ResultsMultivessel PCI was performed in 9,791 patients (38.7%), which increased from 32.2% in 2010 to 44.2% in 2017 (p for trend <0.001). After 1:1 propensity matching (n = 7,864 in each group), those undergoing multivessel PCI had a 3.5% (95% confidence interval [CI]: 2.0% to 5.0%) lower absolute rate of in-hospital mortality (30.9% vs. 34.4%; p < 0.001; odds ratio [OR]: 0.85; 95% CI: 0.80 to 0.91), but a higher risk for bleeding (13.2% vs. 10.8%; p < 0.001; OR: 1.26; 95% CI: 1.15 to 1.40) and new requirement for dialysis (5.7% vs. 4.6%; p = 0.001; OR: 1.26; 95% CI: 1.10 to 1.46). Among those surviving to discharge, all-cause mortality was similar through 7 years (conditional hazard ratio: 0.95; 95% CI: 0.87 to 1.03; p = 0.20).ConclusionsNearly 40% of patients with NSTEMI with MVD and cardiogenic shock underwent multivessel PCI, which was associated with lower in-hospital mortality but greater peri-procedural complications. Among those surviving to discharge, multivessel PCI did not confer additional long-term mortality benefit.     

Genetic Risk Score for Coronary Disease Identifies Predispositions to Cardiovascular and Noncardiovascular Diseases

BackgroundThe taxonomy of cardiovascular (CV) diseases is divided into a broad spectrum of clinical entities. Many such diseases coincide in specific patient groups and suggest shared predisposition.ObjectivesThis study focused on coronary artery disease (CAD) and investigated the genetic relationship to CV and non-CV diseases with reported CAD comorbidity.MethodsThis study examined 425,196 UK Biobank participants to determine a genetic risk score (GRS) based on 300 CAD associated variants (CAD-GRS). This score was associated with 22 traits, including risk factors, diseases secondary to CAD, as well as comorbid and non-CV conditions. Sensitivity analyses were performed in individuals free from CAD or stable angina diagnosis.ResultsHypercholesterolemia (odds ratio [OR]: 1.27; 95% CI: 1.26 to 1.29) and hypertension (OR: 1.11; 95% CI: 1.10 to 1.12) were strongly associated with the CAD-GRS, which indicated that the score contained variants predisposing to these conditions. However, the CAD-GRS was also significant in patients with CAD who were free of CAD risk factors (OR: 1.37; 95% CI: 1.30 to 1.44). The study observed significant associations between the CAD-GRS and peripheral arterial disease (OR: 1.28; 95% CI: 1.23 to 1.32), abdominal aortic aneurysms (OR: 1.28; 95% CI: 1.20 to 1.37), and stroke (OR: 1.08; 95% CI: 1.05 to 1.10), which remained significant in sensitivity analyses that suggested shared genetic predisposition. The score was also associated with heart failure (OR: 1.25; 95% CI: 1.22 to 1.29), atrial fibrillation (OR: 1.08; 95% CI: 1.05 to 1.10), and premature death (OR: 1.04; 95% CI: 1.02 to 1.06). These associations were abolished in sensitivity analyses that indicated that they were secondary to prevalent CAD. Finally, an inverse association was observed between the score and migraine headaches (OR: 0.94; 95% CI: 0.93 to 0.96).ConclusionsA wide spectrum of CV conditions, including premature death, might develop consecutively or in parallel with CAD for the same genetic roots. In conditions like heart failure, the study found evidence that the CAD-GRS could be used to stratify patients with no or limited genetic overlap with CAD risk. Increased genetic predisposition to CAD was inversely associated with migraine headaches.     

Myocardial Injury on CMR in Patients With COVID-19 and Suspected Cardiac Involvement

BackgroundMyocardial injury in patients with COVID-19 and suspected cardiac involvement is not well understood.ObjectivesThe purpose of this study was to characterize myocardial injury in a multicenter cohort of patients with COVID-19 and suspected cardiac involvement referred for cardiac magnetic resonance (CMR).MethodsThis retrospective study consisted of 1,047 patients from 18 international sites with polymerase chain reaction–confirmed COVID-19 infection who underwent CMR. Myocardial injury was characterized as acute myocarditis, nonacute/nonischemic, acute ischemic, and nonacute/ischemic patterns on CMR.ResultsIn this cohort, 20.9% of patients had nonischemic injury patterns (acute myocarditis: 7.9%; nonacute/nonischemic: 13.0%), and 6.7% of patients had ischemic injury patterns (acute ischemic: 1.9%; nonacute/ischemic: 4.8%). In a univariate analysis, variables associated with acute myocarditis patterns included chest discomfort (OR: 2.00; 95% CI: 1.17-3.40, P = 0.01), abnormal electrocardiogram (ECG) (OR: 1.90; 95% CI: 1.12-3.23; P = 0.02), natriuretic peptide elevation (OR: 2.99; 95% CI: 1.60-5.58; P = 0.0006), and troponin elevation (OR: 4.21; 95% CI: 2.41-7.36; P < 0.0001). Variables associated with acute ischemic patterns included chest discomfort (OR: 3.14; 95% CI: 1.04-9.49; P = 0.04), abnormal ECG (OR: 4.06; 95% CI: 1.10-14.92; P = 0.04), known coronary disease (OR: 33.30; 95% CI: 4.04-274.53; P = 0.001), hospitalization (OR: 4.98; 95% CI: 1.55-16.05; P = 0.007), natriuretic peptide elevation (OR: 4.19; 95% CI: 1.30-13.51; P = 0.02), and troponin elevation (OR: 25.27; 95% CI: 5.55-115.03; P < 0.0001). In a multivariate analysis, troponin elevation was strongly associated with acute myocarditis patterns (OR: 4.98; 95% CI: 1.76-14.05; P = 0.003).ConclusionsIn this multicenter study of patients with COVID-19 with clinical suspicion for cardiac involvement referred for CMR, nonischemic and ischemic patterns were frequent when cardiac symptoms, ECG abnormalities, and cardiac biomarker elevations were present.     

Clinical and Coronary Plaque Predictors of Atherosclerotic Nonresponse to Statin Therapy

BackgroundStatins reduce the incidence of major cardiovascular events, but residual risk remains. The study examined the determinants of atherosclerotic statin nonresponse.ObjectivesThis study aimed to investigate factors associated with statin nonresponse-defined atherosclerosis progression in patients treated with statins.MethodsThe multicenter PARADIGM (Progression of AtheRosclerotic PlAque DetermIned by Computed TomoGraphic Angiography Imaging) registry included patients who underwent serial coronary computed tomography angiography ≥2 years apart, with whole-heart coronary tree quantification of vessel, lumen, and plaque, and matching of baseline and follow-up coronary segments and lesions. Patients with statin use at baseline and follow-up coronary computed tomography angiography were included. Atherosclerotic statin nonresponse was defined as an absolute increase in percent atheroma volume (PAV) of 1.0% or more per year. Furthermore, a secondary endpoint was defined by the additional requirement of progression of low-attenuation plaque or fibro-fatty plaque.ResultsThe authors included 649 patients (age 62.0 ± 9.0 years, 63.5% male) on statin therapy and 205 (31.5%) experienced atherosclerotic statin nonresponse. Age, diabetes, hypertension, and all atherosclerotic plaque features measured at baseline scan (high-risk plaque [HRP] features, calcified and noncalcified PAV, and lumen volume) were significantly different between patients with and without atherosclerotic statin nonresponse, whereas only diabetes, number of HRP features, and noncalcified and calcified PAV were independently associated with atherosclerotic statin nonresponse (odds ratio [OR]: 1.41 [95% CI: 0.95-2.11], OR: 1.15 [95% CI: 1.09-1.21], OR: 1.06 [95% CI: 1.02-1.10], OR: 1.07 [95% CI: 1.03-1.12], respectively). For the secondary endpoint (N = 125, 19.2%), only noncalcified PAV and number of HRP features were the independent determinants (OR: 1.08 [95% CI: 1.03-1.13] and OR: 1.21 [95% CI: 1.06-1.21], respectively).ConclusionsIn patients treated with statins, baseline plaque characterization by plaque burden and HRP is associated with atherosclerotic statin nonresponse. Patients with the highest plaque burden including HRP were at highest risk for plaque progression, despite statin therapy. These patients may need additional therapies for further risk reduction.     

Retrograde Chronic Total Occlusion Percutaneous Coronary Interventions: Predictors of Procedural Success From the ERCTO Registry

ObjectivesThe aim of this study was to identify independent predictors of procedural success after retrograde chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundRetrograde CTO PCI is an established technique, but predictors of success remain poorly understood.MethodsA multivariable logistic regression model was used to analyze potentially important demographic, clinical, anatomical, and technical aspects of retrograde CTO PCI cases uploaded to the multicenter European CTO (ERCTO) Club Registry.ResultsIn calendar years 2018 and 2019, 2,364 retrograde CTO PCI cases constituted the primary analysis cohort. A primary retrograde strategy was used in 1,953 cases (82.6%), and an initial antegrade approach was converted to retrograde in 411 cases (17.4%). Procedural success was achieved in 1,820 cases (77.0%) and was more likely to occur after a primary retrograde attempt versus conversion from an initial antegrade approach (80.9% vs 58.4%; P < 0.0001). After multivariable analysis, an absence of lesion calcification (OR: 1.86; 95% CI: 1.37-2.51; P < 0.0001), a higher degree of distal vessel opacification (OR: 2.47; 95% CI: 1.72-3.55; P < 0.0001), little or no proximal target vessel tortuosity (OR: 1.84; 95% CI: 1.28-2.64; P = 0.001), Werner collateral connection CC1 (OR: 4.87; 95% CI: 2.90-8.19; P < 0.0001) or CC2 (OR: 5.33; 95% CI: 3.02-9.42; P < 0.0001), and the top tertile of operator volume (>120 cases over 2 years) (OR: 1.88; 95% CI: 1.26-2.79; P = 0.002) were associated with the greatest chance of achieving angiographic success.ConclusionsLess calcification with good distal vessel opacification, little or absent proximal vessel tortuosity, and visible collateral connections, along with high-volume operator status, were all independently predictive of angiographically successful retrograde CTO PCI.     

Impact of Echocardiographic Guidance on Safety and Efficacy of Left Atrial Appendage Closure: An Observational Study

ObjectivesThe aim of this study was to evaluate the impact of echocardiographic guidance on the safety and efficacy of left atrial appendage closure (LAAC).BackgroundExpert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography or intracardiac echocardiography to guide LAAC. However, no evidence exists that intraprocedural echocardiographic guidance in addition to fluoroscopy improves the safety and efficacy of LAAC.MethodsConsecutive LAAC procedures performed at a high-volume center between January 2009 and October 2020 were stratified on the basis of intraprocedural imaging modalities, including fluoroscopic guidance (FG) only or intraprocedural echocardiographic guidance (EG) in addition to fluoroscopy. The primary safety endpoint was the composite of procedure-related complications occurring within 7 days after the procedure. Technical success at 7 days and at follow-up were secondary endpoints.ResultsAmong 811 LAAC procedures, 549 (67.7%) and 262 (32.3%) were assigned to the FG and EG groups, respectively. After adjusting for confounders, EG remained associated with a lower rate of the primary safety endpoint (3.4% vs 9.1%; P = 0.004; adjusted odds ratio [OR]: 0.31; 95% CI: 0.11-0.90; P = 0.030). Technical success trended higher at 7 days (92.1% vs 87.2%; P = 0.065; adjusted OR: 1.68; 95% CI: 0.95-3.01; P = 0.079) and was significantly improved with EG compared with FG (87.6% vs 79.9%; P = 0.018; OR: 4.06; 95% CI: 1.60-10.27; P = 0.003) after a median follow-up period of 4.9 months (interquartile range: 3.4 months-6.2 months).ConclusionsIn a large cohort of consecutive LAACs, the use of intraprocedural echocardiography to guide intervention in addition to standard fluoroscopy was associated with lower risks for procedural complications and higher mid-term technical success rates.     

Association of Hospital Procedural Volume With Outcomes of Percutaneous Left Atrial Appendage Occlusion

ObjectivesThe aim of this study was to examine the association between percutaneous left atrial appendage occlusion (LAAO) procedural volume and in-hospital outcomes.BackgroundSeveral studies have demonstrated an inverse volume-outcome relationship for patients undergoing invasive cardiac procedures. Whether a similar association exists for percutaneous LAAO remains unknown.MethodsPatients undergoing LAAO in 2017 were identified in the Nationwide Readmissions Database. Hospitals were categorized into 3 groups on the basis of tertiles of annual procedural volume: low (5 to 15 cases/year), medium (17 to 31 cases/year), and high (32 to 211 cases/year). Multivariate hierarchical logistic regression and restricted cubic spline analyses were performed to examine the association of hospital LAAO volume and outcomes. The primary outcome was in-hospital major adverse events (MAE), defined as a composite of mortality, stroke or transient ischemic attack, bleeding or transfusion, vascular complications, myocardial infarction, systemic embolization, and pericardial effusion or tamponade requiring pericardiocentesis or surgery.ResultsThis study included 5,949 LAAO procedures performed across 196 hospitals with a median annual procedural volume of 41 (interquartile range: 25 to 67). Low-volume hospitals had higher rates of in-hospital MAE (9.5% vs. 5.6%; p < 0.001), stroke or transient ischemic attack (2.1% vs. 1.3%; p = 0.049), and bleeding or transfusion (6.1% vs. 3.5%; p = 0.002) compared with high-volume hospitals. No differences were noted for other components of MAE and index length of stay. On multivariate analysis, higher procedural volume was associated with lower rates of in-hospital MAE, with an adjusted odds ratio for medium versus low volume of 0.69 (95% confidence interval: 0.46 to 1.04; p = 0.08) and for high versus low volume of 0.55 (95% confidence interval: 0.37 to 0.82; p = 0.003).ConclusionsHigher hospital procedural volume is associated with better outcomes for LAAO procedures. Further studies are needed to determine if this relationship persists for long-term outcomes.     

Racial,Ethnic, and Sex Disparities in Patients With STEMI and Cardiogenic Shock

ObjectivesThe aim of this study was to evaluate the combined impact of race, ethnicity, and sex on in-hospital outcomes using data from the National Inpatient Sample.BackgroundCardiogenic shock (CS) is a major cause of mortality following ST-segment elevation myocardial infarction (STEMI). Early revascularization reduces mortality in such patients. Mechanical circulatory support (MCS) devices are increasingly used to hemodynamically support patients during revascularization. Little is known about racial, ethnic, and sex disparities in patients with STEMI and CS.MethodsThe National Inpatient Sample was queried from January 2006 to September 2015 for hospitalizations with STEMI and CS. The associations between sex, race, ethnicity, and outcomes were examined using complex-samples multivariate logistic or generalized linear model regressions.ResultsOf 159,339 patients with STEMI and CS, 57,839 (36.3%) were women. In-hospital mortality was higher for all women (range 40% to 45.4%) compared with men (range 30.4% to 34.7%). Women (adjusted odds ratio [aOR]: 1.11; 95% confidence interval [CI]: 1.06 to 1.16; p < 0.001) as well as Black (aOR: 1.18; 95% CI: 1.04 to 1.34; p = 0.011) and Hispanic (aOR: 1.19; 95% CI: 1.06 to 1.33; p = 0.003) men had higher odds of in-hospital mortality compared with White men, with Hispanic women having the highest odds of in-hospital mortality (aOR: 1.46; 95% CI: 1.26 to 1.70; p < 0.001). Women were older (age: 69.8 years vs. 63.2 years), had more comorbidities, and underwent fewer invasive cardiac procedures, including revascularization, right heart catheterization, and MCS.ConclusionsThere are significant racial, ethnic, and sex differences in procedural utilization and clinical outcomes in patients with STEMI and CS. Women are less likely to undergo invasive cardiac procedures, including revascularization and MCS. Women as well as Black and Hispanic patients have a higher likelihood of death compared with White men.     

Prognostic Value of RCA Pericoronary Adipose Tissue CT-Attenuation Beyond High-Risk Plaques,Plaque Volume,and Ischemia

ObjectivesThis study was designed to assess the prognostic value of pericoronary adipose tissue computed tomography attenuation (PCATa) beyond quantitative coronary computed tomography angiography (CCTA)–derived plaque volume and positron emission tomography (PET) determined ischemia.BackgroundInflammation plays a crucial role in atherosclerosis. PCATa has been shown to assess coronary-specific inflammation and is of prognostic value in patients with suspected coronary artery disease (CAD).MethodsA total of 539 patients who underwent CCTA and [¹⁵O]H₂O PET perfusion imaging because of suspected CAD were included. Imaging assessment included coronary artery calcium score (CACS), presence of obstructive CAD (≥50% stenosis) and high-risk plaques (HRPs), total plaque volume (TPV), calcified/noncalcified plaque volume (CPV/NCPV), PCATa, and myocardial ischemia. The endpoint was a composite of death and nonfatal myocardial infarction. Prognostic thresholds were determined for quantitative CCTA variables.ResultsDuring a median follow-up of 5.0 (interquartile range: 4.7 to 5.0) years, 33 events occurred. CACS >59 Agatston units, obstructive CAD, HRPs, TPV >220 mm³, CPV >110 mm³, NCPV >85 mm³, and myocardial ischemia were associated with shorter time to the endpoint with unadjusted hazard ratios (HRs) of 4.17 (95% confidence interval [CI]: 1.80 to 9.64), 4.88 (95% CI: 1.88 to 12.65), 3.41 (95% CI: 1.72 to 6.75), 7.91 (95% CI: 3.05 to 20.49), 5.82 (95% CI: 2.40 to 14.10), 8.07 (95% CI: 3.33 to 19.55), and 4.25 (95% CI: 1.84 to 9.78), respectively (p < 0.05 for all). Right coronary artery (RCA) PCATa above scanner specific thresholds was associated with worse prognosis (unadjusted HR: 2.84; 95% CI: 1.44 to 5.63; p = 0.003), whereas left anterior descending artery and circumflex artery PCATa were not related to outcome. RCA PCATa above scanner specific thresholds retained is prognostic value adjusted for imaging variables and clinical characteristics associated with the endpoint (adjusted HR: 2.45; 95% CI: 1.23 to 4.93; p = 0.011).ConclusionsParameters associated with atherosclerotic burden and ischemia were more strongly associated with outcome than RCA PCATa. Nonetheless, RCA PCATa was of prognostic value beyond clinical characteristics, CACS, obstructive CAD, HRPs, TPV, CPV, NCPV, and ischemia.     

Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices

BackgroundProcedural complications limit the clinical benefit of transcatheter left atrial appendage occlusion (LAAO). Next-generation devices incorporate design modifications intended to improve procedural safety, but their clinical impact has not been described.ObjectivesThe aim of this study was to compare in-hospital outcomes for the Watchman FLX with the predicate Watchman 2.5 device.MethodsThe National Cardiovascular Data Registry LAAO Registry was used to identify patients who received the Watchman FLX and an identical number of patients receiving the Watchman 2.5 at the same sites directly preceding the first Watchman FLX case at each site. The primary endpoint was in-hospital major adverse events (MAE), defined as a composite of death, cardiac arrest, stroke, transient ischemic attack, intracranial hemorrhage, systemic arterial embolism, major bleeding, major vascular complication, myocardial infarction, pericardial effusion requiring intervention (percutaneous or surgical), and device embolization. A secondary analysis was performed using 2:1 propensity score matching of patients receiving the Watchman 2.5 or Watchman FLX.ResultsThe study cohort consisted of 27,013 patients receiving each device. The rate of in-hospital MAE was significantly lower for the Watchman FLX compared with the Watchman 2.5 (1.35% vs 2.40%; adjusted OR: 0.57; 95% CI: 0.50-0.65; P < 0.0001), driven largely by fewer pericardial effusions requiring intervention (0.42% vs 1.23%; adjusted OR: 0.34; 95% CI: 0.28-0.42; P < 0.0001). The Watchman FLX was also associated with significant lower rates of the individual endpoints of in-hospital mortality (0.12% vs 0.24%; P < 0.0001), major bleeding (1.08% vs 2.05%; P < 0.0001), cardiac arrest (0.13% vs 0.24%; P = 0.006), and device embolization (0.02% vs 0.06%; P = 0.028), while myocardial infarction, stroke, and major vascular complications did not differ between groups. Propensity score matching analysis demonstrated similar results, with lower rates of MAE with the Watchman FLX (1.34% vs 2.58%; OR: 0.51; 95% CI: 0.46-0.58; P < 0.0001).ConclusionsTranscatheter LAAO with the Watchman FLX was associated with lower rates of in-hospital MAE compared with the predicate Watchman device, including mortality, pericardial effusion, major bleeding, cardiac arrest, and device embolization. This may favorably influence the balance of risks and benefits of transcatheter LAAO for stroke prevention in patients with atrial fibrillation.     

Feasibility and Safety of Same-Day Discharge Following Transfemoral Transcatheter Aortic Valve Replacement

ObjectivesThis study evaluated the feasibility and safety of same-day discharge (SDD) following transfemoral transcatheter aortic valve replacement (TF-TAVR) compared with next-day discharge (NDD).BackgroundReducing hospital length of stay is an important goal for patients and hospitals. Cleveland Clinic implemented a post-TAVR SDD pathway beginning in March 2020.MethodsThe study retrospectively analyzed patients who underwent “minimalist” outpatient TF-TAVR in 2019 to 2020. SDD was applied to patients who met the predefined criteria. Outcomes included in-hospital and 30-day events and were compared between SDD and NDD (during and prior to availability of the SDD pathway).ResultsIn 2020, SDD and NDD accounted for 22.1% (n = 114 of 516) and 63.8% (n = 329 of 516) of outpatient TF-TAVR, respectively. SDD patients in 2020, compared with NDD patients in 2019 (n = 481), were younger, were more often male, and had a lower surgical risk. There were no significant differences in in-hospital events and 30-day readmissions (cardiovascular readmission: 3.5% vs 6.2%; P = 0.37; noncardiovascular readmission: 2.6% vs 4.0%; P = 0.78), and there were no deaths after SDD. These outcomes remained consistent after propensity score matching. Only 1 (0.9%) patient required pacemaker implantation after SDD (post-TAVR day 25). As expected based on SDD criteria, multivariable logistic regression analysis identified procedure end-time as the strongest predictor of SDD (adjusted OR: 7.74; 95% CI: 4.39-13.63), while male sex and baseline hemoglobin level were also associated with SDD.ConclusionsSDD after TF-TAVR was feasible in this early experience without impairing post-discharge safety. Our SDD pathway may serve as a useful strategy to improve bed utilization and reduce hospital stay for TAVR recipients.