Impact of Hospital Procedural Volume on Outcomes After Endovascular Revascularization for Critical Limb Ischemia

ObjectivesThe aim of this study was to evaluate the interaction between hospital endovascular lower extremity revascularization (eLER) volume and outcomes after eLER for critical limb ischemia (CLI).BackgroundThere is a paucity of data on the relationship between hospital procedural volume and outcomes of eLER for CLI.MethodsThe authors queried the Nationwide Readmission Database (2013-2015) for hospitalized patients who underwent eLER for CLI. Hospitals were divided into tertiles according to annual eLER volume: low volume (<100 eLER procedures), moderate volume (100-550 eLER procedures), and high volume (>550 eLER procedures). Stepwise multivariable regression models were used. The main outcomes were in-hospital mortality and 30-day readmission with major adverse limb events, defined as the composite of amputation, acute limb ischemia, or repeat revascularization.ResultsAmong 145,785 hospitalizations for eLER for CLI, 5,199 (3.6%) were at low-volume eLER hospitals, 27,857 (19.1%) at moderate-volume eLER hospitals, and 112,728 (77.3%) at high-volume eLER hospitals. On multivariable analysis, there was no difference with regard to in-hospital mortality among moderate-volume hospitals (adjusted odds ratio [OR]: 0.78; 95% CI: 0.60-1.01) and high-volume hospitals (adjusted OR: 0.84; 95% CI: 0.64-1.05) compared with low-volume hospitals. There was lower risk of in-hospital major amputation (adjusted OR: 0.82; 95% CI: 0.70-0.96) and minor amputation at high- versus low-volume hospitals. The length of hospital stay was shorter and discharges to nursing facilities were fewer among moderate- and high-volume hospitals compared with low-volume hospitals. Compared with low-volume hospitals, eLER for CLI at high-volume hospitals had a lower risk for 30-day readmission with major adverse limb events (adjusted OR: 0.83; 95% CI: 0.70-0.99), while there was no difference among moderate-volume hospitals (adjusted OR: 0.92; 95% CI: 0.77-1.10).ConclusionsThis nationwide observational analysis suggests that annual eLER volume does not influence in-hospital mortality after eLER for CLI. However, high eLER volume (>550 eLER procedures) was associated with better rates of limb preservation after eLER for CLI.     

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.     

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.     

FFR- Versus Angiography-Guided Revascularization for Nonculprit Stenosis in STEMI and Multivessel Disease: A Network Meta-Analysis

ObjectivesThe aim of this study was to examine the efficacy and safety of fractional flow reserve (FFR)–guided versus angiography-guided approaches for nonculprit stenosis among patients with acute ST-segment elevation myocardial infarction (STEMI) and multivessel disease.BackgroundThe optimal strategy to guide revascularization of nonculprit stenosis among patients with STEMI and multivessel disease remains uncertain.MethodsElectronic databases were searched for randomized trials evaluating the outcomes of culprit-only revascularization, angiography-guided complete revascularization (CR), or FFR-guided CR. A pairwise meta-analysis comparing CR versus culprit-only revascularization and a network meta-analysis comparing the different revascularization techniques were conducted. The primary outcome was major adverse cardiac events (MACE).ResultsThe analysis included 11 trials with 8,195 patients. CR (ie, angiography-guided or FFR-guided CR) was associated with a lower incidence of MACE (odds ratio [OR]: 0.46; 95% CI: 0.35 to 0.59), cardiovascular mortality (OR: 0.63; 95% CI: 0.41 to 0.98), recurrent myocardial infarction (OR: 0.67; 95% CI: 0.48 to 0.95), and repeat ischemia-driven revascularization (OR: 0.26; 95% CI: 0.19 to 0.35). Network meta-analysis demonstrated that the incidence of MACE was lower with both angiography-guided CR (OR: 0.43; 95% CI: 0.31 to 0.58) and FFR-guided CR (OR: 0.52; 95% CI: 0.35 to 0.78) compared with a culprit-only approach, while there was no difference in risk for MACE between angiography-guided and FFR-guided CR (OR: 0.81; 95% CI: 0.51 to 1.29).ConclusionsAmong patients with STEMI and multivessel disease, CR, with angiographic or FFR guidance for nonculprit stenosis, was associated with lower incidence of adverse events compared with culprit-only revascularization. FFR-guided CR was not superior to angiography-guided CR in reducing the incidence of adverse events. Future studies investigating other tools to risk-stratify nonculprit stenoses are encouraged.     

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 Radiotracer-Based Perfusion Imaging in Critical Limb Ischemia Patients Undergoing Lower Extremity Revascularization

ObjectivesThe purpose of this study was to evaluate the prognostic value of single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging of angiosome foot perfusion for predicting amputation outcomes in patients with critical limb ischemia (CLI) and diabetes mellitus (DM).BackgroundRadiotracer imaging can assess microvascular foot perfusion and identify regional perfusion abnormalities in patients with critical limb ischemia CLI and DM, but the relationship between perfusion response to revascularization and subsequent clinical outcomes has not been evaluated.MethodsPatients with CLI, DM, and nonhealing foot ulcers (n = 25) were prospectively enrolled for SPECT/CT perfusion imaging of the feet before and after revascularization. CT images were used to segment angiosomes (i.e., 3-dimensional vascular territories) of the foot. Relative changes in radiotracer uptake after revascularization were evaluated within the ulcerated angiosome. Incidence of amputation was assessed at 3 and 12 months after revascularization.ResultsSPECT/CT detected a significantly lower microvascular perfusion response for patients who underwent amputation compared with those who remained amputation free at 3 (p = 0.01) and 12 (p = 0.01) months after revascularization. The cutoff percent change in perfusion for predicting amputation at 3 months was 7.55%, and 11.56% at 12 months. The area under the curve based on the amputation outcome was 0.799 at 3 months and 0.833 at 12 months. The probability of amputation-free survival was significantly higher at 3 (p = 0.002) and 12 months (p = 0.03) for high-perfusion responders than low-perfusion responders to revascularization.ConclusionsSPECT/CT imaging detects regional perfusion responses to lower extremity revascularization and provides prognostic value in patients with CLI (Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease; NCT03622359)     

Long-Term Outcomes of Complete Revascularization With Percutaneous Coronary Intervention in Acute Coronary Syndromes

ObjectivesThe aim of this study was to evaluate the long-term outcomes of patients with acute coronary syndromes (ACS) with multivessel disease undergoing percutaneous coronary intervention (PCI).BackgroundControversy exists regarding the benefit of multivessel PCI across the spectrum of ACS.MethodsA total of 9,094 patients with ACS and multivessel disease (≥70% stenosis in 2 or more major epicardial vessels) undergoing PCI from the Alberta COAPT (Contemporary Acute Coronary Syndrome Patients Invasive Treatment Strategies) registry (April 1, 2007, to March 31, 2013) were reviewed. Comparisons were made between patients who underwent complete revascularization and those with incomplete revascularization. Complete revascularization was defined as multivessel PCI with a residual angiographic jeopardy score ≤10%. Associations between revascularization status and all-cause death or new myocardial infarction (primary composite endpoint) and all-cause death, new myocardial infarction, or repeat revascularization (secondary composite endpoint) were evaluated.ResultsOf the study cohort, 66.0% underwent complete revascularization. Compared with incomplete revascularization, the primary composite endpoint occurred less frequently with complete revascularization (event rate within 5 years 15.4% vs. 22.2%; inverse probability-weighted hazard ratio [IPW-HR]: 0.78; 95% confidence interval [CI]: 0.73 to 0.84; p < 0.0001). The secondary composite endpoint was less likely to occur with complete revascularization (event rate within 5 years 23.3% vs. 37.5%; IPW-HR: 0.61; 95% CI: 0.58 to 0.65; p < 0.0001). Complete revascularization was associated with a reduction in all-cause death (IPW-HR: 0.79; 95% CI: 0.73 to 0.86; p = 0.0004), new myocardial infarction (IPW-HR: 0.76; 95% CI: 0.69 to 0.84; p < 0.0001), and repeat revascularization (IPW-HR: 0.53; 95% CI: 0.49 to 0.57; p < 0.0001).ConclusionsResults from this large contemporary registry of patients with ACS and PCI for multivessel disease suggest that complete revascularization occurs commonly and is associated with improved clinical outcomes (including survival) within 5 years.     

Balloon Aortic Valvuloplasty as a Bridge to Aortic Valve Replacement: A Contemporary Nationwide Perspective

ObjectivesThis study sought to use a national representative database to assess the incidence, predictors, and outcomes of balloon aortic valvuloplasty (BAV) as a bridge to transcatheter aortic valve replacement (TAVR) in contemporary practice.BackgroundNationwide data on the use and outcomes of BAV as a bridge to TAVR are limited.MethodsPatients who underwent BAV between January and June in 2015 and 2016 were identified in the National Readmission Database. We assessed rate of subsequent TAVR following BAV, and predictors and timing of subsequent TAVR. We then identified a group of patients who had direct TAVR (without prior BAV) in the original 2015 to 2016 National Readmission Database dataset. We compared in-hospital outcomes following TAVR between patients with prior bridging BAV and those undergoing direct TAVR.ResultsAmong the 3,691 included patients 1,426 (38.6%) had subsequent TAVR. Timing of TAVR was pre-discharge in 7.4%, within 30 days in 35%, between 31 and 90 days in 47%, between 91 and 180 days in 14%, and >180 days in 4%. Negative predictors of subsequent TAVR included prior defibrillator (odds ratio [OR]: 0.56; 95% confidence interval [CI]: 0.36 to 0.85), dementia (OR: 0.60; 95% CI: 0.46 to 0.79), malnutrition (OR: 0.64; 95% CI: 0.45 to 0.90), and malignancy (OR: 0.62; 95% CI: 0.47 to 0.82). In propensity-score matched cohorts of patients who underwent direct TAVR versus those with prior BAV, in-hospital mortality during TAVR admission was similar (3.7% vs. 3.5%; p = 0.91). Major complications, length of stay, and discharge disposition were also comparable. However, cost of the hospitalization was higher in the direct TAVR group.ConclusionsAbout 40% of BAV patients undergo subsequent TAVR mostly within 90 days. In-hospital outcomes of TAVR in these patients were comparable with propensity-score matched patients who underwent TAVR without prior BAV. Further investigations are needed to define the role of BAV in contemporary practice.     

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.     

Real-World Experience With a Paclitaxel-Coated Balloon in Critical Limb Ischemia: 24-Month Subgroup Outcomes of BIOLUX P-III

ObjectivesThe aim of the BIOLUX P-III (A Prospective, International, Multi-Centre, Post-Market All-Comers Registry to Assess the Clinical Performance of the Passeo-18 Lux Paclitaxel Releasing Balloon Catheter in Infrainguinal Arteries – III) registry was to collect real-world data on the Passeo-18 Lux paclitaxel-coated balloon.BackgroundCritical limb ischemia (CLI) is a severe condition associated with high morbidity and mortality. Prospective data are needed to provide further insights on drug-eluting devices.MethodsBIOLUX P-III is a prospective, post-market, all-comers registry assessing the safety and performance of the Passeo-18 Lux. Clinical information was collected at 6, 12, and 24 months. The authors report 24-month outcomes of the CLI subgroup with patients in Rutherford classes 4 to 6.ResultsThe CLI subgroup included 328 patients with 422 lesions. Patients were 71.1 ± 10.5 years of age, and 61.0% had diabetes. Femoropopliteal lesions were present in 53.8% (n = 227), below-the-knee lesions were present in 27.0% (n = 114), and lesions were moderate or heavily calcified in 45.0% (n = 190). Major adverse events, defined as 30-day device- or procedure-related mortality, major target limb amputation, and clinically driven target lesion revascularization, occurred in 9.8% of patients through 6 months, in 14.9% through 12 months, and in 19.4% through 24 months. Clinically driven target lesion revascularization occurred in 4.4%, 8.5%, and 12.1%, major amputation in 4.9%, 5.2%, and 6.1%, and mortality in 8.1%, 11.1%, and 20.1%, respectively. Predictors of mortality were age ≥75 years and higher Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease class, and higher Rutherford class was associated with increased mortality and amputation rates.ConclusionsIn a large, multimorbid patient population with complex lesions and CLI, the safety and performance of the Passeo-18 Lux paclitaxel-coated balloon has been confirmed, with low rates of major amputation and target lesion revascularization.     

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.     

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.     

Long-Term Outcomes of Coronary Stenting With and Without Use of Intravascular Ultrasound

ObjectivesThis study sought to explore if intravascular ultrasound (IVUS) use in real-world patients is associated with improved long-term outcomes of percutaneous coronary intervention (PCI).BackgroundThe benefit of IVUS use with PCI in real world is uncertain.MethodsWe identified Medicare patients who underwent PCI from 2009 to 2017 and evaluated the association of IVUS use with long-term risk of mortality, myocardial infarction (MI), and repeat revascularization. We used propensity score matching and inverse probability weighting to adjust for baseline characteristics. To account for hospital effects, patients undergoing IVUS-guided PCI were matched to non-IVUS patients in the same hospital and year. Sensitivity analyses comparing outcomes with and without IVUS in stable coronary artery disease and acute coronary syndrome, PCI with bare-metal stents and drug-eluting stents, complex and noncomplex PCI, and facilities with 1% to 5%, 5% to 10%, and >10% IVUS use were performed.ResultsOverall, IVUS was used in 5.6% of all PCI patients (105,787 out of 1,877,177 patients). Patients with IVUS-guided PCI had a higher prevalence of most comorbidities. In the propensity matched analysis, IVUS-guided PCI was associated with lower 1-year mortality (11.5% vs. 12.3%), MI (4.9% vs. 5.2%), and repeat revascularization (6.1% vs. 6.7%) (p < 0.001 for all). In inverse probability weighting analysis with a median follow-up of 3.7 years (interquartile range: 1.7 to 6.4 years), IVUS-guided PCI was associated with a lower risk of mortality (adjusted hazard ratio [aHR]: 0.903; 95% confidence interval [CI]: 0.885 to 0.922), MI (aHR: 0.899; 95% CI: 0.893 to 0.904), and repeat revascularization (aHR: 0.893; 95% CI: 0.887 to 0.898) (p < 0.001 for all). These findings were consistent in all subgroups in sensitivity analyses.ConclusionsIn this contemporary U.S. Medicare cohort, the use of IVUS guidance in PCI remains low. Use of IVUS is associated with lower long-term mortality, MI, and repeat revascularization.     

Long-Term Prognostic Impact of Restenosis of the Unprotected Left Main Coronary Artery Requiring Repeat Revascularization

ObjectivesThe aim of this study was to evaluate the prognostic impact of target lesion revascularization (TLR) of the unprotected left main coronary artery (ULMCA) after stent failure.BackgroundAlthough drug-eluting stents are safe and effective for treatment of the ULMCA, increased rates of repeat revascularization have been observed.MethodsThis is a patient-level pooled analysis of the randomized ISAR-LEFT-MAIN (Drug-Eluting-Stents for Unprotected Left Main Stem Disease) and ISAR-LEFT-MAIN-2 (Drug-Eluting Stents to Treat Unprotected Coronary Left Main Disease) trials, in which patients underwent stenting of the ULMCA. The present analysis includes patients who underwent angiography during follow-up. Patients with TLR were compared with those without. Additional long-term clinical follow-up after TLR was conducted, and its influence on mortality was evaluated. Mortality was calculated using the Kaplan-Meier method. Predictors of mortality were assessed in a multivariate analysis.ResultsA total of 1,001 patients were eligible, of whom 166 experienced TLR. The 5-year mortality rate was 30.2% in patients with TLR compared with 17.3% in those without TLR (p < 0.001). In the multivariate analysis, glomerular filtration rate (−30 ml/min; hazard ratio [HR]: 2.25; 95% confidence interval [CI]: 1.54 to 3.27; p < 0.001), chronic obstructive pulmonary disease (HR: 4.95; 95% CI: 1.33 to 18.42; p = 0.02), and body mass index (+5 kg/m²; HR: 1.61; 95% CI: 1.12 to 2.32; p = 0.01) were independent predictors of mortality after TLR due to left main stent failure. The type of repeat revascularization and the underlying stent did not influence the mortality after TLR of the ULMCA.ConclusionsMortality after TLR for left main stent failure is high. Patient-related factors seem to have a greater impact on mortality after TLR than other variables.     

Clinical Outcomes in Patients With ST-Segment Elevation MI and No Standard Modifiable Cardiovascular Risk Factors

BackgroundThe author recently reported ～50% excess early mortality in patients with first-presentation ST-segment elevation myocardial infarction (STEMI) without standard modifiable cardiovascular risk factors (SMuRFs); the cause of this is not clear.ObjectivesThe aim of this study was to examine differences in infarct characteristics and clinical outcomes in patients with versus without SMuRFs (dyslipidemia, hypertension, diabetes mellitus, and smoking).MethodsIndividual-level data were pooled from 10 randomized percutaneous intervention (PCI) trials in which infarct size was measured within 1 month by either cardiac magnetic resonance or technetium-99m sestamibi single-photon emission computed tomography imaging. First-presentation STEMI was classified into 2 groups according to the presence or absence of at least 1 SMuRF.ResultsAmong 2,862 patients, 524 (18.3%) were SMuRF-less. After adjusting for study effect, SMuRF-less patients had more frequent poor pre-PCI flow Thrombolysis In Myocardial Infarction 0/1 compared with patients with at least 1 SMuRF (72.0% vs 64.1%; OR: 1.35; 95% CI: 1.08-1.70). There were no independent associations between the presence or absence of SMuRFs at baseline and infarct size (estimate = ?0.35; 95% CI: ?1.93 to 1.23), left ventricular ejection fraction (estimate = ?0.06; 95% CI: ?1.33 to 1.20), or mortality at 30 days (HR: 0.46; 95% CI: 0.19-1.07) and 1 year (HR: 0.74; 95% CI: 0.43-1.29).ConclusionsFirst-presentation STEMI patients with no identifiable baseline SMuRFs had a higher risk of Thrombolysis In Myocardial Infarction flow grade 0/1 pre-PCI. However, after adjustment, there were no significant associations between SMuRF-less status and infarct size, left ventricle ejection fraction, or mortality.     

Effect of Evolocumab on Complex Coronary Disease Requiring Revascularization

ObjectivesThis study sought to evaluate the ability of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab to reduce the risk of complex coronary atherosclerosis requiring revascularization.BackgroundPCSK9 inhibitors induce plaque regression and reduce the risk of coronary revascularization overall.MethodsFOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) was a randomized trial of the PCSK9 inhibitor evolocumab versus placebo in 27,564 patients with stable atherosclerotic cardiovascular disease on statin therapy followed for a median of 2.2 years. Clinical documentation of revascularization events was blindly reviewed to assess coronary anatomy and procedural characteristics. Complex revascularization was the composite of complex percutaneous coronary intervention (PCI) (as per previous analyses, ≥1 of: multivessel PCI, ≥3 stents, ≥3 lesions treated, bifurcation PCI, or total stent length >60 mm) or coronary artery bypass grafting surgery (CABG).ResultsIn this study, 1,724 patients underwent coronary revascularization, including 1,482 who underwent PCI, 296 who underwent CABG, and 54 who underwent both. Complex revascularization was performed in 632 (37%) patients. Evolocumab reduced the risk of any coronary revascularization by 22% (hazard ratio [HR]: 0.78; 95% CI: 0.71 to 0.86; p < 0.001), simple PCI by 22% (HR: 0.78; 95% CI: 0.70 to 0.88; p < 0.001), complex PCI by 33% (HR: 0.67; 95% CI: 0.54 to 0.84; p < 0.001), CABG by 24% (HR: 0.76; 95% CI: 0.60 to 0.96; p = 0.019), and complex revascularization by 29% (HR: 0.71; 95% CI: 0.61 to 0.84; p < 0.001). The magnitude of the risk reduction with evolocumab in complex revascularization tended to increase over time (20%, 36%, and 41% risk reductions in the first, second, and beyond second years).ConclusionsAdding evolocumab to statin therapy significantly reduced the risk of developing complex coronary disease requiring revascularization, including complex PCI and CABG individually. (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER); NCT01764633.)     

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.     

Thrombotic Risk and Cardiovascular Events in Patients With Revascularization Deferral After Fractional Flow Reserve Assessment

ObjectivesThe aim of this study was to evaluate the impact of thrombotic risk on the occurrence of cardiovascular events in patients with coronary artery disease with deferred revascularization after fractional flow reserve (FFR) measurements.BackgroundDeferral of revascularization on the basis of FFR is generally considered to be safe, but after deferral, some patients have cardiovascular events over time.MethodsFrom J-CONFIRM registry (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry), 1,263 patients with deferral of revascularization on the basis of FFR were evaluated. The association between thrombotic risk as assessed by CREDO-Kyoto (Coronary Revascularization Demonstrating Outcome Study in Kyoto) thrombotic score and 5-year target vessel failure (TVF) and major adverse cardiac and cerebrovascular events (MACCE) was investigated.ResultsFFR and high thrombotic risk (HTR) were associated with increased risk for 5-year TVF (FFR per 0.01-unit decrease: HR: 1.08; 95% CI: 1.05-1.11; P < 0.001; HTR: HR: 2.16; 95% CI: 1.37-3.39; P < 0.001) and MACCE (FFR per 0.01-unit decrease: HR: 1.05; 95% CI: 1.02-1.06; P < 0.001; HTR: HR: 2.11; 95% CI: 1.56-2.84; P = 0.001). Patients with HTR had higher risk for 5-year TVF (HR: 2.30; 95% CI: 1.45-3.66; P < 0.001) and MACCE (HR: 2.34; 95% CI: 1.75-3.13; P < 0.001) than those without HTR, even when they had negative FFR.ConclusionsAssessment of thrombotic risk provides additional prognostic value to FFR in predicting 5-year TVF and MACCE in patients with deferral of revascularization after FFR measurements. (Long-Term Outcomes of Japanese Patients With Deferral of Coronary Intervention Based on Fractional Flow Reserve in Multicenter Registry; UMIN000014473)     

Aortic Valve Replacement in Low-Risk Patients With Severe Aortic Stenosis Outside Randomized Trials

BackgroundRecent randomized trials including low-risk patients showed positive results for transcatheter aortic valve replacement (TAVR) compared to surgical aortic valve replacement (SAVR), but patients with non-tricuspid aortic valve (NTAV), severe coronary artery disease (SevCAD), and those requiring concomitant mitral/tricuspid valve (CMTV) or concomitant ascending aorta replacement (CAAR) interventions were excluded.ObjectivesThis study sought to evaluate the presence and impact of the main clinical variables not evaluated in TAVR versus SAVR trials (NTAV, SevCAD, and CMTV or CAAR intervention) in a large series of consecutive low-risk patients with severe aortic stenosis (SAS) undergoing SAVR.MethodsSingle-center study including consecutive patients with SAS and low surgical risk (Society of Thoracic Surgeons score of <4%) undergoing SAVR. Baseline, procedural characteristics, and 30-day outcomes were prospectively collected.ResultsOf 6,772 patients with SAS who underwent SAVR between 2000 and 2019, 5,310 (78.4%) exhibited a low surgical risk (mean Society of Thoracic Surgeons score: 1.94 ± 0.87%). Of these, 2,165 patients (40.8%) had at least 1 of the following: NTAV (n = 1,468, 27.6%), SevCAD (n = 307, 5.8%), CMTV (n = 306, 5.8%), and CAAR (n = 560, 10.5%). The 30-day mortality and stroke rates for the overall low-risk SAS cohort were 1.9% and 2.4%, respectively. The mortality rate was similar in the SevCAD (2.6%) and CAAR (2.1%) groups versus the rest of the cohort (odds ratio [OR]: 1.79; 95% confidence interval [CI]: 0.85 to 3.75, and OR: 1.64; 95% CI: 0.88 to 3.05, respectively), lower in the NTAV group (0.9%; OR: 0.42; 95% CI: 0.22 to 0.81), and higher in the CMTV group (5.9%; OR: 2.61; 95% CI: 1.51 to 4.5).ConclusionsIn a real-world setting, close to one-half of the low-risk patients with SAS undergoing SAVR exhibited at least 1 major criterion not evaluated in TAVR versus SAVR randomized trials. Clinical outcomes were better than or similar to those predicted by surgical scores in all groups but those patients requiring CMTV intervention. These results may help determine the impact of implementing the results of TAVR-SAVR trials in real practice and may inform future trials in specific groups.     

Mortality 10 Years After Percutaneous or Surgical Revascularization in Patients With Total Coronary Artery Occlusions

BackgroundThe long-term clinical benefit after percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) in patients with total occlusions (TOs) and complex coronary artery disease has not yet been clarified.ObjectivesThe objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG.MethodsThis is a subanalysis of patients with at least 1 TO in the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which investigated 10-year all-cause mortality in the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial, beyond its original 5-year follow-up. Patients with TOs were further stratified according to the status of TO recanalization or revascularization.ResultsOf 1,800 randomized patients to the PCI or CABG arm, 460 patients had at least 1 lesion of TO. In patients with TOs, the status of TO recanalization or revascularization was not associated with 10-year all-cause mortality, irrespective of the assigned treatment (PCI arm: 29.9% vs. 29.4%; adjusted hazard ratio [HR]: 0.992; 95% confidence interval [CI]: 0.474 to 2.075; p = 0.982; and CABG arm: 28.0% vs. 21.4%; adjusted HR: 0.656; 95% CI: 0.281 to 1.533; p = 0.330). When TOs existed in left main and/or left anterior descending artery, the status of TO recanalization or revascularization did not have an impact on the mortality (34.5% vs. 26.9%; adjusted HR: 0.896; 95% CI: 0.314 to 2.555; p = 0.837).ConclusionsAt 10-year follow-up, the status of TO recanalization or revascularization did not affect mortality, irrespective of the assigned treatment and location of TOs. The present study might support contemporary practice among high-volume chronic TO-PCI centers where recanalization is primarily offered to patients for the management of angina refractory to medical therapy when myocardial viability is confirmed. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972)