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OBJECTIVES This study sought to evaluate the long-term differences in survival between multiple arterial grafts (MAG) and single arterial grafts (SAG) in patients who underwent coronary artery bypass grafting (CABG) in the SYNTAX study. METHODS The present analysis included the randomized and registry-treated CABG patients (n = 1509) from the SYNTAX Extended Survival study (SYNTAXES). Patients with only venous (n = 42) or synthetic grafts (n = 1) were excluded. The primary end point was all-cause death at the longest follow-up. Multivariable Cox regression was used to adjust for differences in baseline characteristics. Sensitivity analysis using propensity matching with inverse probability for treatment weights was performed. RESULTS Of the 1466 included patients, 465 (31.7%) received MAG and 1001 (68.3%) SAG. Patients receiving MAG were younger and at lower risk. At the longest follow-up of 12.6 years, all-cause death occurred in 23.6% of MAG and 40.0% of SAG patients [adjusted hazard ratio (HR) 0.74, 95% confidence interval (CI) (0.55–0.98); P = 0.038], which was confirmed by sensitivity analysis. MAG in patients with the three-vessel disease was associated with significant lower unadjusted and adjusted all-cause death at 12.6 years [adjusted HR 0.65, 95% CI (0.44–0.97); P = 0.033]. In contrast, no significance was observed after risk adjustment in patients with the left main disease, with and without diabetes, or among SYNTAX score tertiles. CONCLUSIONS In the present post hoc analysis of all-comers patients from the SYNTAX trial, MAG resulted in markedly lower all-cause death at 12.6-year follow-up compared to a SAG strategy. Hence, this striking long-term survival benefit of MAG over SAG encourages more extensive use of multiple arterial grafting in selected patients with reasonable life expectancy. Trial registration SYNTAXES ClinicalTrials.gov reference: NCT03417050; SYNTAX ClinicalTrials.gov reference: NCT00114972.

Background Creatinine clearance (CrCl) is an independent determinant of mortality in predictive models of revascularisation outcomes for complex coronary artery disease. Aims This study aimed to investigate the impact of preprocedural biological markers on 10-year mortality following coronary revascularisation. Methods The SYNTAX Extended Survival (SYNTAXES) study evaluated the 10-year vital status follow-up of 1,800 patients with de novo three-vessel (3VD) and/or left main coronary artery disease (LMCAD) randomised to include percutaneous or surgical coronary revascularisation. The associations between mortality and preprocedural C-reactive protein (CRP), haemoglobin, HbA1c, CrCl, fasting triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol were analysed. Results Out of 1,800 patients, 460 patients died before the 10-year follow-up. CRP, HbA1c and CrCl with threshold values of ≥2 mg/L, ≥6% (42 mmol/mol) and l60 ml/min, respectively, were associated with 10-year all-cause death (adjusted hazard ratio [95% confidence interval]: 1.35 [1.01-1.82], 1.51 [1.16-1.95], and 1.46 [1.07-2.00], respectively). There was no significant interaction between the biological markers on all-cause mortality and the type of revascularisation. Preprocedural lipid markers were not significantly associated with 10-year all-cause death, but the non-use of statins was a determinant factor of worse prognosis (adjusted confidence interval [95% confidence interval]: 1.68 [1.26-2.25]). Conclusions Preprocedural biomarkers, such as CRP and HbA1c, are associated with long-term mortality post revascularisation, regardless of the revascularisation technique. Conventional lipidic biomarkers associated with high-risk of cardiovascular events seem to be effectively mitigated by the long-term use of statins, whereas the non-use of statins was a factor of a worse prognosis, emphasising the importance of pharmacological treatment. Trial registration SYNTAXES ClinicalTrials.gov reference: NCT03417050. SYNTAX ClinicalTrials.gov reference: NCT00114972.

OBJECTIVE To evaluate the epidemiology and outcomes of non-ST-segment-elevation myocardial infarction-cardiogenic shock (NSTEMI-CS) in the United States. METHODS Adult (>18 years) NSTEMI-CS admissions were identified using the National Inpatient Sample (2000-2017) and classified by tertiles of admission year (2000-2005, 2006-2011 and 2012-2017). Outcomes of interest included temporal trends of prevalence and in-hospital mortality, use of cardiac procedures, in-hospital mortality, hospitalization costs, and length of stay. RESULTS In over 7.3 million NSTEMI admissions, CS was noted in 189,155 (2.6%). NSTEMI-CS increased from 1.5% in 2000 to 3.6% in 2017 (adjusted odds ratio [aOR] 2.03 [95% confidence interval {CI} 1.97-2.09]; p

Aim The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG). Methods and results The current study is a post hoc analysis of the SYNTAX Extended Survival Study, which compared PCI with CABG in patients with three-vessel (3VD) and/or left main coronary artery disease (LMCAD) and evaluated survival with ≥10 years of follow-up. The primary endpoint was all-cause mortality at maximum follow-up (median 11.9 years) assessed in the as-treated population. Of the 1743 patients, 901 (51.7%) underwent PCI, 532 (30.5%) received SAG, and 310 (17.8%) had MAG. At maximum follow-up, all-cause death occurred in 305 (33.9%), 175 (32.9%), and 70 (22.6%) patients in the PCI, SAG, and MAG groups, respectively (P Conclusion Our findings suggest that MAG might be the more desirable configuration for CABG to achieve lower long-term all-cause mortality than PCI in patients with 3VD and/or LMCAD. Trial registration Registered on clinicaltrial.gov. SYNTAXES: NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050); SYNTAX: NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

Purpose: To develop a standardized method for tibial tunnel volumetric bone mineral density (BMD) analysis with quantitative computed tomography (qCT) using cadaveric specimens to provide validation of this technique on a healthy control population and to determine whether osteopenia occurs following an anterior cruciate ligament (ACL) injury.Methods: qCT was used to develop a volumetric BMD (mg/cm3) measurement technique throughout the region of a standard tibial tunnel. This method was applied to 90 lower extremities, including 10 matched cadaveric knees, 10 matched healthy knees, 25 ACL-injured knees, and 25 contralateral ACL-uninjured knees. The mean total and segmental (proximal, middle, and distal) tibial tunnel BMD were analyzed. Results: The mean entire tibial tunnel BMD measured 165.8 ± 30.5 mg/cm3 (cadaver), 255.9 ± 28.2 mg/cm3 (healthy control), 290.3 ± 36.4 mg/cm3 (ACL-injured), and 300.1 ± 35.1 (ACL-uninjured). Segmental tibial tunnel BMD demonstrated distal one-third segments as the greatest areas of BMD, followed by proximal one-third, and middle one-third for all cohorts with all pairwise comparisons (P < .001). The mean BMD was significantly greater in the uninjured extremity compared with the injured extremity in the entire tunnel (290.3 vs 300.1; P < .001), proximal (271.2 vs 279.1; P = .002), middle (167.6 vs 179.6; P < .001), and distal segments (432.7 vs 441.7; P = .004) at an average of 8 weeks following ACL injury. Conclusions: A standardized method to quantitatively measure the volumetric BMD within the region of a standard tibial tunnel for ACL reconstruction was successfully developed and validated. Significant osteopenia of the injured knee occurs following ACL injury when compared with the contralateral uninjured knee. This observation has potential clinical implications for ACL graft tibial fixation and healing. Level of Evidence: Descriptive diagnostic study, Level III.

Background: The significant interaction between major infection and 5-year mortality after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) for complex coronary artery disease (CAD) was observed previously. However, the very long-term outcomes beyond 5 years remains unclear. Methods and results: This is a subgroup analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the randomized SYNTAX trial comparing PCI versus CABG in patients with three-vessel disease (3VD) or left-main CAD (LMCAD). Out of 1517 patients enrolled in the SYNTAX trial with available survival status from 5 to 10 years, 140 patients had experienced major infections and survived at 5 years (major infection group). From 5 to 10 years, the mortality of major infection group was 19.8% whereas the mortality of no major infection group was 15.1% (p = 0.157). After the adjustment of other clinical factors, the risk of mortality from 5 to 10 years did not significantly differ between major infection and no major infection groups (HR: 1.10; 95% CI: 0.62–1.96; p = 0.740). When stratified by the presence or absence of periprocedural major infections, defined as a major infection within 60 days after index procedure, there was also no significant difference in 10-year mortality between two groups (30.8% vs. 24.5%; p = 0.057). Conclusions: Despite the initial association between major infections and 5 years mortality, postprocedural major infection was not evident in the 10 years follow-up, suggesting that the impact of major infection on mortality subsided over time beyond 5 years. Trial registration: SYNTAXES ClinicalTrials.gov reference: NCT03417050 SYNTAX ClinicalTrials.gov reference: NCT00114972

Background: Medical and/or economic reasons sometimes necessitate the staging of percutaneous coronary intervention (SPCI) procedures in patients with complex coronary artery disease; however, the impact of this on very long-term outcomes is unknown. The aim of the present study is to assess 10-year all-cause mortality in patients with the three-vessel disease (3VD) and/or left main disease (LM) undergoing SPCI. Methods: This is a sub-analysis of patients undergoing SPCI in the SYNTAXES study, which investigated 10-year all-cause mortality in patients with 3VD and/or LM in the randomized SYNTAX trial, beyond its original 5-year follow-up. An SPCI was allowed within 72 h or, if renal insufficiency or contrast-induced nephropathy occurred, within 14 days of the index procedure. Mortality was compared between patients having SPCI versus those not having SPCI or undergoing CABG. PCI patients were further stratified according to 3VD or LM. Results: In the SYNTAX PCI population (overall: n = 903, 3VD: n = 546, LM: n = 357), 125 (13.8%) patients underwent SPCI. Patients with SPCI had a higher 10-year mortality compared to those who didn't (40.0% vs 26.6%; hazard ratio [HR] 1.69; 95% confidence interval [CI] 1.23–2.32; p < 0.01) and those having CABG(40.0% vs 24.5%; HR 1.85; 95%CI 1.35–2.53; p < 0.01). Patients having SPCI with 3VD (n = 103) or LM (n = 22) had higher mortality than respective patients not having SPCI (3VD: 37.4% vs 27.1%; HR 1.52; 95%CI 1.05–2.21; p = 0.03 and LM: 51.8% vs 25.9%; HR 2.39; 95%CI 1.27–4.47; p = 0.01). Conclusions: At 10-year follow-up, SPCI was associated with higher mortality than single-session PCI, so that CABG may be preferable if a staged procedure is anticipated.

Aims The aim of this article was to compare rates of all-cause death at 10 years following coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in patients with or without diabetes. Methods and results The SYNTAXES study evaluated up to 10-year survival of 1800 patients with three-vessel disease (3VD) and/or left main coronary artery disease (LMCAD) randomized to receive either PCI or CABG in the SYNTAX trial. Ten-year all-cause death according to diabetic status and revascularization strategy was examined. In diabetics (n = 452), the risk of mortality was numerically higher with PCI compared with CABG at 5 years [19.6% vs. 13.3%, hazard ratio (HR): 1.53, 95% confidence interval (CI): 0.96, 2.43, P = 0.075], with the opposite seen between 5 and 10 years (PCI vs. CABG: 20.8% vs. 24.4%, HR: 0.82, 95% CI: 0.52, 1.27, P = 0.366). Irrespective of diabetic status, there was no significant difference in all-cause death at 10 years between patients receiving PCI or CABG, the absolute treatment difference was 1.9% in diabetics (PCI vs. CABG: 36.4% vs. 34.5%, difference: 1.9%, 95% CI: −7.6%, 11.1%, P = 0.551). Among insulin-treated patients (n = 182), all-cause death at 10 years was numerically higher with PCI (47.9% vs. 39.6%, difference: 8.2%, 95% CI: −6.5%, 22.5%, P = 0.227). Conclusions The treatment effects of PCI vs. CABG on all-cause death at 10 years in patients with 3VD and/or LMCAD were similar irrespective of the presence of diabetes. There may, however, be a survival benefit with CABG in patients with insulin-treated diabetes. The association between revascularization strategy and very long-term ischaemic and safety outcomes for patients with diabetes needs further investigation in dedicated trials. Trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972 and SYNTAX Extended Survival: ClinicalTrials.gov reference: NCT03417050., Graphical Abstract The treatment effects of PCI versus CABG on all-cause death at 10 years in 3VD/LMCAD patients with pharmacologically treated diabetes and insulin-treated diabetes.

Numerous studies have demonstrated a paradoxical association between higher baseline body mass index (BMI) and lower long-term mortality risk after coronary revascularization, known as the “obesity paradox”, possibly relying on the single use of BMI. The current study is a post-hoc analysis of the SYNTAX Extended Survival (SYNTAXES) trial, which is the extended follow-up of the SYNTAX trial comparing percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) in patients with left-main coronary artery disease (LMCAD) or three-vessel disease (3VD). Patients were stratified according to baseline BMI and/or waist circumference (WC). Out of 1,800 patients, 1,799 (99.9%) and 1,587 (88.2%) had available baseline BMI and WC data, respectively. Of those, 1,327 (73.8%) patients had High BMI (≥25 kg/m2), whereas 705 (44.4%) patients had High WC (>102 cm for men or >88 cm for women). When stratified by both BMI and WC, 10-year mortality risk was significantly higher in patients with Low BMI/Low WC (adjusted hazard ratio [HR]: 1.65; 95% confidence interval [CI]: 1.09 to 2.51), Low BMI/ High WC (adjusted HR: 2.74; 95% CI: 1.12 to 6.69), or High BMI/High WC (adjusted HR: 1.59; 95% CI: 1.11 to 2.27) compared to those with High BMI/Low WC. In conclusion, the “obesity paradox” following coronary revascularization would be driven by low long-term mortality risk of the High BMI/Low WC group. Body composition should be assessed by the combination of BMI and WC in the appropriate evaluation of the long-term risk of obesity in patients with LMCAD or 3VD.

Background: The benefit of optimal medical therapy (OMT) on 5-year outcomes in patients with 3-vessel disease and/or left main disease after percutaneous coronary intervention or coronary artery bypass grafting (CABG) was demonstrated in the randomized SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) trial. Objectives: The objective of this analysis is to assess the impact of the status of OMT at 5 years on 10-year mortality after percutaneous coronary intervention or CABG. Methods: This is a subanalysis of the SYNTAXES (Synergy Between PCI With Taxus and Cardiac Surgery Extended Survival) study, which evaluated for up to 10 years the vital status of patients who were originally enrolled in the SYNTAX trial. OMT was defined as the combination of 4 types of medications: at least 1 antiplatelet drug, statin, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, and beta-blocker. After stratifying participants by the number of individual OMT agents at 5 years and randomized treatment, a landmark analysis was conducted to assess the association between treatment response and 10-year mortality. Results: In 1,472 patients, patients on OMT at 5 years had a significantly lower mortality at 10 years compared with those on ≤2 types of medications (13.1% vs 19.9%; adjusted HR: 0.470; 95% CI: 0.292-0.757; P = 0.002) but had a mortality similar to those on 3 types of medications. Furthermore, patients undergoing CABG with the individual OMT agents, antiplatelet drug and statin, at 5 years had lower 10-year mortality than those without. Conclusions: In patients with 3-vessel and/or left main disease undergoing percutaneous coronary intervention or CABG, medication status at 5 years had a significant impact on 10-year mortality. Patients on OMT with guideline-recommended pharmacologic therapy at 5 years had a survival benefit. (Synergy Between PCI With Taxus and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES]; NCT03417050; Taxus Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX]; NCT00114972)

Coronary artery fistulas (CAFs) are rare coronary anomalies that are usually diagnosed incidentally with cardiac imaging. Small CAFs are generally asymptomatic and can close over time, while some untreated medium or large CAFs can enlarge, leading to clinical sequelae such as cardiac chamber enlargement or myocardial ischemia. With the advancement of transcatheter equipment and techniques, CAFs have been increasingly closed using a percutaneous approach. However, the procedure is not free of limitations given the risk for myocardial infarction, device embolization, and fistula recanalization. In this review, the authors illustrate the contemporary procedural considerations, techniques, and outcomes of transcatheter CAF closure.

Over the last 4 decades, percutaneous coronary intervention has evolved dramatically and is now an acceptable treatment option for patients with advanced coronary artery disease. However, trialists have struggled to establish the respective roles for percutaneous coronary intervention and coronary artery bypass graft surgery, especially in patients with multivessel disease and unprotected left-main stem coronary artery disease. Several pivotal trials and meta-analyses comparing these 2 revascularization strategies have enabled the relative merits of each technique to be established with regard to the type of ischemic syndrome, the coronary anatomy, and the patient's overall comorbidity. Precision medicine with individualized prognosis is emerging as an important method of selecting treatment. However, the never-ending advancement of technology, in conjunction with the emergence of novel pharmacological agents, will in the future continue to force us to reconsider the evolving question: "Which treatment strategy is better and for which patient?"

Background: The optimal revascularization strategy for the elderly with complex coronary artery disease remains unclear. Objectives: The goal of this study was to investigate 10-year all-cause mortality, life expectancy, 5-year major adverse cardiac or cerebrovascular events (MACCE), and 5-year quality of life (QOL) after percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in elderly individuals (>70 years old) with 3-vessel disease (3VD) and/or left main disease (LMD). Methods: In the present pre-specified analysis on age of the SYNTAX Extended Survival study, 10-year all-cause death and 5-year MACCE were compared with Kaplan-Meier estimates and Cox proportional hazards models among elderly or nonelderly patients. Life expectancy was estimated by restricted mean survival time within 10 years, and QOL status according to the Seattle Angina Questionnaire up to 5 years was assessed by linear mixed-effects models. Results: Among 1,800 randomized patients, 575 patients (31.9%) were elderly. Ten-year mortality did not differ significantly between PCI and CABG in elderly (44.1% vs. 41.1%; hazard ratio [HR]: 1.08; 95% confidence interval [CI]: 0.84 to 1.40) and nonelderly patients (21.1% vs. 16.6%; HR: 1.30; 95% CI: 1.00 to 1.69; pinteraction = 0.332). Among elderly patients, 5-year MACCE was comparable between PCI and CABG (39.4% vs. 35.1%; HR: 1.18; 95% CI: 0.90 to 1.56), whereas it was significantly higher in PCI over CABG among nonelderly patients (36.3% vs. 23.0%; HR: 1.69; 95% CI: 1.36 to 2.10; pinteraction = 0.043). There were no significant difference in life expectancy (mean difference: 0.2 years in favor of CABG; 95% CI: −0.4 to 0.7) and 5-year QOL status between PCI and CABG among elderly patients. Conclusions: Elderly patients with 3VD and/or LMD had comparable 10-year all-cause death, life expectancy, 5-year MACCE, and 5-year QOL status irrespective of revascularization mode. (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)

The Watchman device (WD) is a commonly used alternative strategy to oral anticoagulation for stroke risk reduction in patients with atrial fibrillation who have an increased bleeding risk. There are rare case reports of WD-related infection. Currently, there is no formal study that has systematically evaluated the incidence and outcomes WD-related infections. The objective of this study was to evaluate the incidence, risk factors, and outcomes for WD-associated infections in a single-center cohort over a 14-year period. All patients who underwent WD implantation over a 14-year study period (July 2004 through December 2018) comprised our cohort. Baseline characteristics, procedural data, and postimplantation events were identified through a retrospective chart review. Primary study outcomes included WD-related infection, other cardiovascular device-related infection, bacteremia, and mortality. A total of 181 patients (119 males; 65.7%) with a mean age of 75 years at implantation were included in the analysis. A total of 534.7 patient years of follow-up was accrued, with an average of 2.9 years per patient. The most common indications for implantation included gastrointestinal bleeding (56 patients; 30.9%) and intracerebral bleeding (51 patients; 28.2%). During the follow-up period, 37 (20.4%) patients died. Six developed evidence of bacteremia. Only 1 developed an implantable cardioverter defibrillator infection that required a complete system extraction. None of the cohort developed a WD-related device infection during the study period. We concluded that there is a low risk of WD-related infection even in the setting of a blood stream infection.

Background Although direct oral anticoagulants (DOACs) have been shown to be effective at reducing the risk of stroke in patients with atrial fibrillation/flutter (AF), they are sometimes underdosed off-label to mitigate their associated higher bleeding risk. We sought to evaluate frequency and clinical outcomes of inappropriate underdosing of DOACS in patients with AF. Methods We conducted a study of subjects with AF who had a clinical indication for stroke prophylaxis (with a congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 47 years, sex category [CHA2DS2-VASc] of 2 or greater) and were prescribed 1 of the 4 clinically approved DOACs (apixaban, rivaroxaban, dabigatran, or edoxaban). We compared all-cause mortality, composite of stroke and systemic embolism, composite of myocardial infarction (MI), acute coronary syndromes (ACS), and coronary revascularization, and major bleeding between patients appropriately dosed and inappropriately underdosed. Results A total of 8125 patients met inclusion criteria, with a mean follow up of 2.2 ± 2 years. Of those, 1724 patients (21.2%) were inappropriately dosed. After adjusting for baseline variables, there was no difference in all-cause mortality, risk of stroke or systemic embolism, International Society on Thrombosis and Haemostasis (ISTH) major bleeding, or composite of myocardial infarction, acute coronary syndromes, or coronary revascularization between patients appropriately dosed and inappropriately underdosed. In subgroup analysis, only apixaban demonstrated an increased incidence all-cause mortality (hazard ratio [HR] 1.24, 95% confidence interval [CI] 1.03-1.49) with inappropriate underdosing. There was no difference in the remaining clinical outcomes noted on subgroup analysis. Conclusion Underdosing of DOACs did not minimize risk of bleeding, systemic embolization or all-cause mortality in patients with AF. Inappropriate underdosing with apixaban in particular was associated with increased all-cause mortality.

Objectives: We investigated the impact of total stent length (TSL) and average nominal stent diameter (ASD) on 10-year mortality after percutaneous coronary intervention (PCI) in the SYNTAXES trial. Background: TSL and ASD in patients treated with PCI are associated with major adverse cardiovascular events. However, the treatment effect of PCI with extensive and/or small stenting as compared with coronary artery bypass grafting (CABG) for complex coronary artery disease has not been fully evaluated. Methods: Impacts on mortality of extensive stenting defined as TSL >100 mm and small stenting as ASD

Background: Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative. Methods: This was a prospective, nonrandomized, multicenter US Food and Drug Administration study. The primary safety end point was the occurrence of one of the following events within 7 days after the procedure or by hospital discharge, whichever was later: death, ischemic stroke, systemic embolism, or device- or procedure-related events requiring cardiac surgery. The primary effectiveness end point was the incidence of effective LAA closure (peri-device flow ≤5 mm), as assessed by the echocardiography core laboratory at 12-month follow-up. Results: A total of 400 patients were enrolled. The mean age was 73.8±8.6 years and the mean CHA 2 DS 2 -VASc score was 4.2±1.5. The incidence of the primary safety end point was 0.5% with a 1-sided 95% upper CI of 1.6%, meeting the performance goal of 4.2% ( P P Conclusions: LAA closure with this next-generation LAA closure device was associated with a low incidence of adverse events and a high incidence of anatomic closure. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02702271.

Aims There are limited contemporary data on the use of initial fibrinolysis in ST‐segment elevation myocardial infarction cardiogenic shock (STEMI‐CS). This study sought to compare the outcomes of STEMI‐CS receiving initial fibrinolysis vs. primary percutaneous coronary intervention (PPCI). Methods Using the National (Nationwide) Inpatient Sample from 2009 to 2017, a comparative effectiveness study of adult (>18 years) STEMI‐CS admissions receiving pre‐hospital/in‐hospital fibrinolysis were compared with those receiving PPCI. Admissions with alternate indications for fibrinolysis and STEMI‐CS managed medically or with surgical revascularization (without fibrinolysis) were excluded. Outcomes of interest included in‐hospital mortality, development of non‐cardiac organ failure, complications, hospital length of stay, hospitalization costs, use of palliative care, and do‐not‐resuscitate status. Results During 2009–2017, 5297 and 110 452 admissions received initial fibrinolysis and PPCI, respectively. Compared with those receiving PPCI, the fibrinolysis group was more often non‐White, with lower co‐morbidity, and admitted on weekends and to small rural hospitals (all P

Background/purpose Machine learning has been used to predict procedural risk in patients undergoing various medical interventions and procedures. One-year mortality in patients after Transcatheter Aortic Valve Replacement (TAVR) has a wide range (from 8.5 to 24% in various studies). We sought to apply machine learning to determine predictors of one year mortality in patients undergoing TAVR. Methods/materials A retrospective study of 1055 patients who underwent TAVR (Jan 2014–June 2017) with one-year follow up was completed. Baseline demographics, clinical, electrocardiography (ECG), Computed Tomography (CT) and echocardiography data were abstracted. Variables with near zero variance or ≥50% missing data were excluded. The Gradient Boosting Machine learning (GBM) prediction model included 163 variables and was optimized using 5-fold cross-validation repeated 10-times. The receiver operator characteristic (ROC) for the GBM model was calculated to predict one-year mortality post TAVR, and then compared to the TAVI2-SCORE and CoreValve score. Results Among 1055 TAVR patients (mean age 80.9 ± 7.9 years, 42% female), 14.02% died at one year. 78% had balloon expandable valves placed. Based on GBM, the ten most predictive variables for one-year survival were cardiac power index, hemoglobin, systolic blood pressure, INR, diastolic blood pressure, body mass index, valve calcium score, serum creatinine, aortic annulus area, and albumin. The area under ROC to predict survival for the GBM model vs TAVI2-SCORE and CoreValve Score was 0.72 (95% CI 0.68–0.78) vs 0.56 (95%CI 0.51–0.62) and 0.53 (95% CI 0.47–0.59) respectively with p Conclusion The GBM model outperforms TAVI2-SCORE and CoreValve Score in predicting mortality one-year post TAVR.

Heart Teams have come to occupy a prominent place in modern cardiovascular disease. While the concept is intuitively obvious - bringing together specialties of diverse backgrounds to focus on care ...

Background: The 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. Objectives: The objective of this analysis was to assess 10-year all-cause mortality in patients with TOs undergoing PCI or CABG. Methods: This 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. Results: Of 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). Conclusions: At 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)

A growing number of patients undergoing percutaneous coronary intervention (PCI) with stent implantation also have atrial fibrillation. This poses challenges for their optimal antithrombotic management because patients with atrial fibrillation undergoing PCI require oral anticoagulation for the prevention of cardiac thromboembolism and dual antiplatelet therapy for the prevention of coronary thrombotic complications. The combination of oral anticoagulation and dual antiplatelet therapy substantially increases the risk of bleeding. Over the last decade, a series of North American Consensus Statements on the Management of Antithrombotic Therapy in Patients with Atrial Fibrillation Undergoing Percutaneous Coronary Intervention have been reported. Since the last update in 2018, several pivotal clinical trials in the field have been published. This document provides a focused updated of the 2018 recommendations. The group recommends that in patients with atrial fibrillation undergoing PCI, a non–vitamin K antagonist oral anticoagulant is the oral anticoagulation of choice. Dual antiplatelet therapy with aspirin and a P2Y12inhibitor should be given to all patients during the peri-PCI period (during inpatient stay, until time of discharge, up to 1 week after PCI, at the discretion of the treating physician), after which the default strategy is to stop aspirin and continue treatment with a P2Y12inhibitor, preferably clopidogrel, in combination with a non–vitamin K antagonist oral anticoagulant (ie, double therapy). In patients at increased thrombotic risk who have an acceptable risk of bleeding, it is reasonable to continue aspirin (ie, triple therapy) for up to 1 month. Double therapy should be given for 6 to 12 months with the actual duration depending on the ischemic and bleeding risk profile of the patient, after which patients should discontinue antiplatelet therapy and receive oral anticoagulation alone.

AIMS There are limited data on the trends and outcomes of mechanical circulatory support (MCS)-assisted early percutaneous coronary intervention (PCI) in acute myocardial infarction with cardiogenic shock (AMI-CS). In this study, we sought to assess the use, temporal trends, and outcomes of percutaneous MCS-assisted early PCI in AMI-CS. METHODS AND RESULTS Using the National Inpatient Sample database from 2005-2014, a retrospective cohort of AMI-CS admissions receiving early PCI (hospital day zero) was identified. MCS use was defined as intra-aortic balloon pump (IABP), percutaneous left ventricular assist device (pLVAD) and extracorporeal membrane oxygenation (ECMO) support. Outcomes of interest included in-hospital mortality, resource utilisation, trends and predictors of MCS-assisted PCI. Of the 110,452 admissions, MCS assistance was used in 55%. IABP, pLVAD and ECMO were used in 94.8%, 4.2% and 1%, respectively. During 2009-2014, there was a decrease in MCS-assisted PCI due to a decrease in IABP, despite an increase in pLVAD and ECMO. Younger age, male sex, lower comorbidity, and cardiac arrest independently predicted MCS use. MCS-assisted PCI was predictive of higher in-hospital mortality (31% vs 26%, adjusted odds ratio 1.23 [1.19-1.27]; p

This study sought to define the 2-dimensional and Doppler echocardiographic hemodynamics associated with each Society for Cardiovascular Angiography and Interventions (SCAI) stage, and to determine their association with mortality.The SCAI shock stages classification stratifies mortality risk in cardiac intensive care unit (CICU) patients, but the echocardiographic and hemodynamic parameters that define these SCAI shock stages are unknown.Unique CICU patients admitted from 2007 to 2015 who had a transthoracic echocardiogram within 1 day of CICU admission were included. Echocardiographic variables were evaluated as a function of SCAI shock stage. Multivariable logistic regression determined the association between echocardiographic parameters with adjusted hospital mortality.We included 5,453 patients with a median age of 69.3 years (interquartile range: 58.2 to 79.0 years) (37% women), and a median left ventricular ejection fraction (LVEF) of 50% (interquartile range: 35% to 61%). Higher SCAI shock stages were associated with lower LVEF and worse systemic hemodynamics. Hospital mortality was higher in patients with LVEF 40%, cardiac index 1.8 l/min/mNoninvasive 2-dimensional and Doppler echocardiographic parameters correlate with the SCAI shock stages and improve risk stratification for hospital mortality in CICU patients. Low stroke volume index and high E/e' ratio demonstrated the strongest association with hospital mortality.

A 63-year-old man presented with hemoptysis and progressive dyspnea. His echocardiogram was concerning for pulmonary hypertension (PH) and CT chest showed fibrosing mediastinitis with possible cardiac involvement. Right heart catheterization revealed PH at rest and worsened with exercise. CT findings and simultaneous measurement of pulmonary capillary wedge pressure (PCWP), left atrial pressure, and left ventricular pressure helped diagnose pulmonary vein (PV) stenosis as the etiology of his PH. Both upper pulmonary veins were stented, and repeat exercise hemodynamic study revealed a substantial reduction in pulmonary arterial pressure with improvement in subjective dyspnea, cardiac output reserve, mechanical efficiency, and ventilatory efficiency. Repeat right upper PCWP normalized, consistent with resolution of the PV stenosis.

Item does not contain fulltext BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], pinteraction=0.019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0.66) and no linear trend across SYNTAX score tertiles (ptrend=0.30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

Background This study sought to assess the contemporary outcomes of patients transferred after receiving fibrinolytic therapy (‘drip-and-ship’) for ST-segment elevation myocardial infarction (STEMI) in the United States. Methods During 2009–2016, adults (>18 years) with STEMI (>18 years) without cardiac arrest and cardiogenic shock that received fibrinolytic therapy and were subsequently transferred were identified using the National Inpatient Sample (NIS). These admissions were divided into those undergoing fibrinolysis alone, subsequent coronary angiography (CA) without revascularization and subsequent CA with revascularization. Outcomes of interest included in-hospital mortality, resource utilization, and discharge disposition. Results A total of 27,454 STEMI admissions receiving a ‘drip-and-ship strategy’, 96.3% and 85.8% received subsequent coronary angiography and revascularization Admissions receiving CA and revascularization were younger, male, and with lower comorbidity. The fibrinolysis alone cohort had higher rates of organ failure, hemorrhagic sequelae, and intracranial hemorrhage. Compared to the fibrinolysis cohort, CA with revascularization (adjusted odds ratio [aOR] 0.17 [95% confidence interval {CI} 0.11–0.27]; p Conclusion Fibrinolysis with subsequent revascularization is associated with excellent outcomes in STEMI. Admissions receiving fibrinolysis alone were systematically different, sicker and had poorer outcomes.

The development of technology to treat unmet clinical patient needs in the United States has been an important focus for the U.S. Food and Drug Administration and the 2016 Congressional 21st Century Cures Act. In response, a program of early feasibility studies (EFS) has been developed. One of the important issues has been the outmigration of the development and testing of medical devices from the United States. The EFS committee has developed and implemented processes to address issues to develop strategies for early treatment of these patient groups. Initial implementation of the U.S. Food and Drug Administration EFS program has been successful, but residual significant problems have hindered the opportunity to take full advantage of the program. These include delays in gaining Institutional Review Board approval, timeliness of budget and contractual negotiations, and lack of access to and enrollment of study subjects. This paper reviews improvements that have been made to the U.S. EFS ecosystem and outlines potential approaches to address remaining impediments to program success.

BACKGROUND: There is a wide variation in radiation dose levels that can be used with chest CT in order to detect indeterminate pulmonary nodules. PURPOSE: To compare the performance of lower-radiation-dose chest CT with that of routine dose in the detection of indeterminate pulmonary nodules 5 mm or greater. MATERIALS AND METHODS: In this retrospective study, CT projection data from 83 routine-dose chest CT examinations performed in 83 patients (120 kV, 70 quality reference mAs [QRM]) were collected between November 2013 and April 2014. Reference indeterminate pulmonary nodules were identified by two nonreader thoracic radiologists. By using validated noise insertion, five lower-dose data sets were reconstructed with filtered back projection (FBP) or iterative reconstruction (IR; 30 QRM with FBP, 10 QRM with IR, 5 QRM with FBP, 5 QRM with IR, and 2.5 QRM with IR). Three thoracic radiologists circled pulmonary nodules, rating confidence that the nodule was a 5-mm-or-greater indeterminate pulmonary nodule, and graded image quality. Analysis was performed on a per-nodule basis by using jackknife alternative free-response receiver operating characteristic figure of merit (FOM) and noninferiority limit of −0.10. RESULTS: There were 66 indeterminate pulmonary nodules (mean size, 8.6 mm ± 3.4 [standard deviation]; 21 part-solid nodules) in 42 patients (mean age, 51 years ± 17; 21 men and 21 women). Compared with the FOM for routine-dose CT (size-specific dose estimate, 6.5 mGy ± 1.8; FOM, 0.86 [95% confidence interval: 0.80, 0.91]), FOM was noninferior for all lower-dose configurations except for 2.5 QRM with IR. The sensitivity for subsolid nodules at 70 QRM was 60% (range, 48%–72%) and was significantly worse at a dose of 5 QRM and lower, whether or not IR was used (P < .05). Diagnostic image quality decreased with decreasing dose (P < .001) and was better with IR at 5 QRM (P < .05). CONCLUSION: CT images reconstructed at dose levels down to 10 quality reference mAs (size-specific dose estimate, 0.9 mGy) had noninferior performance compared with routine dose in depicting pulmonary nodules. Iterative reconstruction improved subjective image quality but not performance at low dose levels.

Aims To evaluate the impact of various smoking status on 10-year all-cause mortality and to examine a relative treatment benefit of coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI) according to smoking habits. Methods and results The SYNTAX Extended Survival study evaluated vital status up to 10 years in 1800 patients with de novo three-vessel disease and/or left main coronary artery disease randomized to CABG or PCI in the SYNTAX trial. In the present analysis, patients were divided into three groups (current, former, or never smokers), and the primary endpoint of 10-year all-cause mortality was assessed according to smoking status. Smoking status was available in 1793 (99.6%) patients at the time of randomization, of whom 363 were current smokers, 798 were former smokers, and 632 were never smokers. The crude rates of 10-year all-cause mortality were 29.7% in current smokers, 25.3% in former smokers, and 25.9% in never smokers (Log-rank P = 0.343). After adjustment for imbalances in baseline characteristics, current smokers had a significantly higher risk of 10-year all-cause mortality than never smokers [adjusted hazard ratio (aHR): 2.29; 95% confidence interval (CI): 1.60–3.27; P Conclusion Current smokers had a higher adjusted risk of 10-year all-cause mortality, whereas former smokers did not. The treatment effect of CABG vs. PCI did not differ significantly according to smoking status. Clinical trial registration SYNTAX: ClinicalTrials.gov reference: NCT00114972; SYNTAX Extended Survival. ClinicalTrials.gov reference: NCT03417050.

Fibrosing mediastinitis is a rare disease characterized by fibrosis of mediastinal structures with subsequent constriction of the bronchi and pulmonary vessels leading to potential respiratory compromise and death. Presently, there is no effective curative treatment with available treatments focused on reducing symptomology, including placement of pulmonary artery stents. Limited studies examine the use of stents in fibrosing mediastinitis. Given this knowledge gap, we assessed stent patency, hemodynamics, complications, and secondary outcomes of clinical improvement of pulmonary artery stenting for fibrosing mediastinitis. Nine patients with fibrosing mediastinitis and pulmonary artery stents were retrospectively identified for inclusion (six females, three males; mean age 44.17 years, range 13–68; total 13 primary stents) from 2005 to 2018. Eight patients had history of PH. All patients had dyspnea on presentation. Seven patients had ventilation/perfusion studies demonstrating impairment. Results from computed tomography and echocardiography studies were collected to assess patency and physiologic response. All patients received initial angioplasty and stenting of the right pulmonary artery (10 stents). Two patients underwent additional left-sided intervention (3 stents). Stenting significantly increased lesion luminal patency (54–79%; P

INTRODUCTION: Exposure to low oxygen environments (hypoxia) can impair cognitive function; however, the time-course of the transient changes in cognitive function is unknown. In this study, we assessed cognitive function with a cognitive test before, during, and after exposure to hypoxia.METHODS: Nine participants (28 4 yr, 7 women) completed Conners Continuous Performance Test (CCPT-II) during three sequential conditions: 1) baseline breathing room air (fraction of inspired oxygen, FIo2 0.21); 2) acute hypoxia (FIo2 0.118); and 3) recovery after exposure to hypoxia. End-tidal gas concentrations (waveform capnography), heart rate (electrocardiography), frontal lobe tissue oxygenation (near infrared spectroscopy), and mean arterial pressure (finger photoplethysmography) were continuously assessed.RESULTS: Relative to baseline, during the hypoxia trial end-tidal (-30%) and cerebral (-9%) oxygen saturations were reduced. Additionally, the number of commission errors during the CCPT-II was greater during hypoxia trials than baseline trials (2.6 0.4 vs. 1.9 0.4 errors per block of CCPT-II). However, the reaction time and omission errors did not differ during the hypoxia CCPT-II trials compared to baseline CCPT-II trials. During the recovery CCPT-II trials, physiological indices of tissue hypoxia all returned to baseline values and number of commission errors during the recovery CCPT-II trials was not different from baseline CCPT-II trials.DISCUSSION: Oxygen concentrations were reduced (systemically and within the frontal lobe) and commission errors were increased during hypoxia compared to baseline. These data suggest that frontal lobe hypoxia may contribute to transient impairments in cognitive function during short exposures to hypoxia.Uchida K, Baker SE, Wiggins CC, Senefeld JW, Shepherd JRA, Trenerry MR, Buchholtz ZA, Clifton HR, Holmes DR, Joyner MJ, Curry TB. A novel method to measure transient impairments in cognitive function during acute bouts of hypoxia. Aerosp Med Hum Perform. 2020; 91(11):839844.

Background: There are limited sex-specific data on patients receiving temporary mechanical circulatory support (MCS) for acute myocardial infarction-cardiogenic shock (AMI-CS). Methods: All admissions with AMI-CS with MCS use were identified using the National Inpatient Sample from 2005 to 2016. Outcomes of interest included in-hospital mortality, discharge disposition, use of palliative care and do-not-resuscitate (DNR) status, and receipt of durable left ventricular assist device (LVAD) and cardiac transplantation. Results: In AMI-CS admissions during this 12-year period, MCS was used more frequently in men—50.4% vs 39.5%; P < 0.001. Of the 173,473 who received MCS (32% women), intra-aortic balloon pumps, percutaneous LVAD, extracorporeal membrane oxygenation, and ≥ 2 MCS devices were used in 92%, 4%, 1%, and 3%, respectively. Women were on average older (69 ± 12 vs 64 ± 13 years), of black race (10% vs 6%), and had more comorbidity (mean Charlson comorbidity index 5.0 ± 2.0 vs 4.5 ± 2.1). Women had higher in-hospital mortality than men (34% vs 29%, adjusted odds ratio [OR]: 1.19, 95% confidence interval [CI]: 1.16-1.23; P < 0.001) overall, in intra-aortic balloon pumps users (OR: 1.20 [95% CI: 1.16-1.23]; P < 0.001), and percutaneous LVAD users (OR: 1.75 [95% CI: 1.49-2.06]; P < 0.001), but not in extracorporeal membrane oxygenation or ≥ 2 MCS device users (P > 0.05). Women had higher use of palliative care, DNR status, and discharges to skilled nursing facilities. Conclusions: There are persistent sex disparities in the outcomes of AMI-CS admissions receiving MCS support. Women have higher in-hospital mortality, palliative care consultation, and use of DNR status. Résumé: Contexte: On dispose de peu de données quant à l’influence du sexe sur les résultats pour les patients qui reçoivent une assistance circulatoire mécanique (ACM) temporaire à la suite d’un infarctus aigu du myocarde accompagné d’un choc cardiogénique (IAM-CC). Méthodologie: Nous avons recensé dans l’échantillon national des patients hospitalisés (NIS, National Inpatient Sample) tous les patients admis à l’hôpital pour un IAM-CC qui ont reçu une ACM de 2005 à 2016. Les résultats d’intérêt comprenaient la mortalité hospitalière, l’état à la sortie, le recours aux soins palliatifs et à une ordonnance de non-réanimation (ONR), l’implantation d’un dispositif d’assistance ventriculaire gauche (DAVG) permanent et la transplantation cardiaque. Résultats: Chez les patients admis à l’hôpital pour un IAM-CC durant la période de 12 ans étudiée, l’ACM a été utilisée plus fréquemment chez les hommes que chez les femmes (50,4 % vs 39,5 %; p < 0,001). Sur les 173 473 patients qui ont reçu une ACM (dont 32 % étaient des femmes), les méthodes employées se répartissaient comme suit : ballon de contre-pulsion intra-aortique, 92 %; assistance ventriculaire gauche percutanée, 4 %; oxygénation extracorporelle par membrane, 1 %; et au moins 2 types d’ACM, 3 %. Les femmes étaient plus âgées en moyenne (69 ± 12 ans vs 64 ± 13 ans), étaient plus souvent de race noire (10 % vs 6 %) et présentaient un plus grand nombre d’affections concomitantes (indice de comorbidité de Charlson moyen de 5,0 ± 2,0 vs 4,5 ± 2,1). Le taux de mortalité hospitalière était plus élevé chez les femmes que chez les hommes (34 % vs 29 %, risque relatif approché [RRA] corrigé : 1,19; intervalle de confiance [IC] à 95 % : de 1,16 à 1,23; p < 0,001) dans l’ensemble, ainsi que chez les utilisateurs d’un ballon de contre-pulsion intra-aortique (RRA : 1,20 [IC à 95 % : de 1,16 à 1,23]; p < 0,001), et chez les utilisateurs d’un DAVG percutané (RRA : 1,75 [IC à 95 % : 1,49 à 2,06]; p < 0,001), mais pas chez les utilisateurs de l’oxygénation extracorporelle par membrane ni chez les utilisateurs d’au moins 2 types d’ACM (p > 0,05). Le recours aux soins palliatifs, l’établissement d’une ordonnance de non-réanimation et l’orientation vers un établissement de soins infirmiers spécialisés à la sortie de l’hôpital étaient plus fréquents chez les femmes. Conclusions: Il existe toujours des disparités entre les sexes à l’égard des résultats pour les patients admis à l’hôpital pour IAM-CC recevant une ACM. Le taux de mortalité hospitalière était plus élevé chez les femmes, et celles-ci avaient plus souvent recours à une consultation en soins palliatifs et à une ONR.

Objective: Nowadays, methods for ECG quality assessment are mostly designed to binary distinguish between good/bad quality of the whole signal. Such classification is not suitable to long-term data collected by wearable devices. In this paper, a novel approach to estimate long-term ECG signal quality is proposed. Methods: The real-time quality estimation is performed in a local time window by calculation of continuous signal-to-noise ratio (SNR) curve. The layout of the data quality segments is determined by analysis of SNR waveform. It is distinguished between three levels of ECG signal quality: signal suitable for full wave ECG analysis, signal suitable only for QRS detection, and signal unsuitable for further processing. Results: The SNR limits for reliable QRS detection and full ECG waveform analysis are 5 and 18 dB respectively. The method was developed and tested using synthetic data and validated on real data from wearable device. Conclusion: The proposed solution is a robust, accurate and computationally efficient algorithm for annotation of ECG signal quality that will facilitate the subsequent tailored analysis of ECG signals recorded in free-living conditions. Significance: The field of long-term ECG signals self-monitoring by wearable devices is swiftly developing. The analysis of massive amount of collected data is time consuming. It is advantageous to characterize data quality in advance and thereby limit consequent analysis to useable signals.

Left atrial appendage closure has emerged as a feasible stroke prevention strategy in selected patients with nonvalvular atrial fibrillation. Since its commercial approval in the United States in 2015, the use of percutaneous left atrial appendage closure has witnessed a substantial growth. However, certain issues remain unresolved with the technology. Knowledge of these issues, their significance, and the current and future efforts to resolve them is key for proper informed decision making by physicians and patients.

Aims Age is an important risk factor for mortality among patients with cardiogenic shock and heart failure (HF). We sought to assess the extent to which age modified the performance of the Society for Cardiovascular Angiography and Interventions (SCAI) shock stage for in‐hospital and 1 year mortality in cardiac intensive care unit (CICU) patients with and without HF. Methods and results We retrospectively reviewed unique admissions to the Mayo Clinic CICU during 2007–2015 and stratified patients by age and SCAI shock stage. The association between age and in‐hospital mortality was analysed using multivariable logistic regression, and 1 year mortality was analysed using Cox proportional hazards analysis, both in the entire cohort and among patients with an admission diagnosis of HF or acute coronary syndrome (ACS). The final study population included 10 004 unique patients with a mean age of 67 ± 15 years, including 46.1% with HF and 43.1% with ACS. Older patients more frequently had HF and had more extensive co‐morbidities, higher illness severity, more organ failure, and differential use of critical care therapies. The percentage of patients with SCAI shock stages A, B, C, D, and E were 46%, 30%, 16%, 7%, and 1%, respectively. Patients with HF were older, had greater severity of illness and higher SCAI shock stage, and had higher rates of death at all time points. In‐hospital mortality occurred in 908 (9%) patients, including 549 (12%) patients with HF (61% of all hospital deaths). Age was independently associated with hospital mortality (adjusted odds ratio per 10 years 1.3, 95% confidence interval 1.2–1.4, P

Although aortic valve replacement with implantation of a bioprosthesis has been widely performed for more than 50 years, appreciation of the development of bioprosthetic leaflet thrombosis has incr...

OBJECTIVE: To evaluate outcomes by sex in older adults with cardiogenic shock complicating acute myocardial infarction (AMI-CS). MATERIALS AND METHODS: A retrospective cohort of older (≥75 years) AMI-CS admissions during January 1, 2000, to December 31, 2014, was identified using the National Inpatient Sample. Interhospital transfers were excluded. Use of angiography, percutaneous coronary intervention (PCI), mechanical circulatory support (MCS), and noncardiac interventions was identified. The primary outcome was in-hospital mortality stratified by sex, and secondary outcomes included temporal trends of prevalence, in-hospital mortality, use of cardiac and noncardiac interventions, hospitalization costs, and length of stay. RESULTS: In this 15-year period, there were 134,501 AMI-CS admissions 75 years or older, of whom 51.5% (n=69,220) were women. Women were on average older, were more often Hispanic or nonwhite race, and had lower comorbidity, acute organ failure, and concomitant cardiac arrest. Compared with older men (n=65,281), older women (n=69,220) had lower use of coronary angiography (55.4% [n=35,905] vs 49.2% [n=33,918]), PCI (36.3% [n=23,501] vs 34.4% [n=23,535]), MCS (34.3% [n=22,391] vs 27.2% [n=18,689]), mechanical ventilation, and hemodialysis (all P

Background: The poorer prognosis of coronary artery disease in females compared with males is related mainly to differences in baseline characteristics. In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, the effect of treatment with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting surgery (CABG) on mortality at 5 years differed significantly between females and males; however, the optimal revascularization beyond 5 years according to sex has not been evaluated. Objectives: The aim of this study was to investigate the impact of sex on mortality and sex-treatment interaction at 10 years. Methods: The SYNTAXES (SYNTAX Extended Survival) study evaluated vital status up to 10 years in 1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial. All-cause death at 10 years was separately evaluated in female and male patients with complex coronary artery disease. Results: Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males. Females had a higher 10-year mortality rate compared with males (32.8% vs. 24.7%; log-rank p = 0.002), but female sex was not an independent predictor of mortality (adjusted hazard ratio: 1.02; 95% confidence interval: 0.76 to 1.36). Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76 [95% confidence interval: 0.56 to 1.02]; p for interaction = 0.952). Conclusions: Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease. The interaction between sex and treatment with PCI or CABG that was observed at 5 years was no longer present at 10 years. (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)

Objective: To assess the effects of weekend admission vs weekday admission on the management and outcomes of acute myocardial infarction (AMI). Methods: Adult ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) hospital admissions were identified using the National (Nationwide) Inpatient Sample (2000-2016). Interhospital transfers were excluded. Timing of coronary angiography (CA) and percutaneous coronary intervention (PCI) relative to the day of admission was identified. Outcomes of interest included in-hospital mortality, receipt of early CA, timing of CA and PCI, resource utilization, and discharge disposition for weekend vs weekday admissions. Results: Of the 9,041,819 AMI admissions, 2,406,876 (26.6%) occurred on weekends. Compared with 2000, in 2016 there was an increase in weekend STEMI (adjusted odds ratio [aOR], 1.12; 95% CI, 1.08-1.16; P

Background There are limited data on the seasonal variation in acute myocardial infarction (AMI) in the contemporary literature. Hypothesis There would be decrease in the seasonal variation in the management and outcomes of AMI. Methods Adult (>18 years) AMI admissions were identified using the National Inpatient Sample (2000‐2017). Seasons were classified as spring, summer, fall, and winter. Outcomes of interest included prevalence, in‐hospital mortality, use of coronary angiography, and percutaneous coronary intervention (PCI). Subgroup analyses for type of AMI and patient characteristics were performed. Results Of the 10 880 856 AMI admissions, 24.3%, 22.9%, 22.2%, and 24.2% were admitted in spring, summer, fall, and winter, respectively. The four cohorts had comparable age, sex, race, and comorbidities distribution. Rates of coronary angiography and PCI were slightly but significantly lower in winter (62.6% and 40.7%) in comparison to the other seasons (64‐65% and 42‐43%, respectively) (P

Objectives This study sought to report the largest series of patients receiving a surgical reoperation after transcatheter aortic valve replacement (TAVR) using the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database. Background TAVR has become an effective means of treating aortic stenosis. As TAVR is used in progressively lower-risk cohorts, management of device failure will become increasingly important. Methods The STS Adult Cardiac Surgery Database was queried for patients with a history of prior TAVR undergoing surgical aortic valve replacement from 2011 to 2015. Observed-to-expected (O/E) mortality ratios were determined to facilitate comparison across reoperative indications and timing from index TAVR procedure. Results A total of 123 patients met inclusion criteria (median age 77 years) with an STS Predicted Risk of Mortality of 4%, 4% to 8%, and >8% in 17%, 24%, and 59%, respectively. Median time to reoperation was 2.5 (interquartile range: 0.7 to 13.0) months, and the operative mortality rate was 17.1%. Common indications for reoperation included early TAVR device failures such as paravalvular leak (15%), structural prosthetic deterioration (11%), failed repair (11%), sizing or position issues (11%), and prosthetic valve endocarditis (10%). All pre-operative risk categories were associated with an increased O/E mortality ratio (Predicted Risk of Mortality 8%: O/E 1.2). Conclusions SAVR following early failure of TAVR, while rare, is associated with worse-than-expected outcomes as compared with similar patients initially undergoing SAVR. Continued experience with this developing technology is needed to reduce the incidence of early TAVR failure and further define optimal treatment of failed TAVR prostheses.

Data on the efficacy of left atrial appendage occlusion (LAAO) in clinical practice are limited. We performed a systematic review and meta-analysis of observational studies that reported observed versus expected rates of ischemic strokes and/or major bleeding following LAAO. Our primary end points were the pooled relative risk reduction (RRR) in ischemic stroke and major bleeding with corresponding 95% confidence intervals compared with what was expected by the CHA2DS2-VASc and HASBLED scores, respectively. Twenty-nine studies including 11,071 patients (age 74.0 ± 8.7 years, 60% males) met the inclusion criteria. The mean CHA2DS2-VASc score was 4.22 ± 1.48, and the mean HASBLED score was 3.04 ± 1.16. During 19,567 patient-year follow-up, 290 of 11,071 patients (2.62%) suffered an acute ischemic stroke. This represented a 73.6% (95% confidence interval 68.9-78.2%) RRR in ischemic strokes compared with what was expected based on the CHA2DS2-VASc score. A total of 26 studies reported observed versus expected major bleeding (10,056 patients; age 74.0 ± 8.7, 60% males). During 16,967 patient-year follow-up, 404 of 10,056 patients (4.0%) suffered a major bleeding event. This represented a 55% (95% confidence interval 44.2% to -65.9%) RRR in major bleeding compared with what was expected based on the HASBLED score. These estimates were consistent across subgroups stratified according to age, CHADS2VASc, HASBLED scores and type of LAAO device used. In conclusion, LAAO is associated with a favorable observed/expected ratio with regards to ischemic stroke and major bleeding in clinical practice. Future clinical trials remain essential to further assess the efficacy of LAAO via a direct comparison with oral anticoagulation.

Objectives The aim of this study was to compare bleeding, thromboembolic, device-related thrombus (DRT), and all-cause mortality events between patients treated with short-term oral anticoagulation (OAC) and those treated with short-term antiplatelet therapy (APT) following left atrial appendage occlusion (LAAO). Background Short-term OAC is recommended for patients following LAAO. However, in practice many patients receive APT rather than OAC because of excessive bleeding risk. However, the safety and efficacy of APT compared with OAC have been debated. Methods A search was conducted of databases for studies comparing OAC with APT following LAAO. The outcomes of interest were all-cause stroke, major bleeding, DRT, and all-cause mortality. Noncomparative studies were pooled into a single study to generate comparisons of the studies’ outcomes. Effects measure were pooled using the random-effect model. Results A total of 83 studies with 12,326 patients (APT, n = 7,900; OAC, n = 4,151) were included. Mean CHA2DS2-VASc and HAS-BLED scores were 4.1 ± 1.6 and 3.0 ± 1.3, respectively. There were no significance differences between the APT and OAC groups with regard to stroke (risk ratio [RR]: 1.04; 95% confidence interval [CI]: 0.54 to 1.98; p = 0.91; I2 = 31%), major bleeding (RR: 1.12; 95% CI: 0.68 to 1.84; p = 0.65; I2 = 53%), DRT (RR: 1.33; 95% CI: 0.74 to 2.39; p = 0.33; I2 = 36%), and all-cause mortality (RR: 1.29; 95% CI: 0.40 to 4.09; p = 0.18; I2 = 36%). These findings persisted in multiple secondary analyses: 1) excluding studies that reported no events; 2) including comparative studies only; 3) excluding patients who were treated with single APT; and 4) removing one study at a time to assess the effect of each study on the overall effect size. There was also no difference in the studies’ endpoints among patients who received different LAAO devices. Conclusions In a meta-analysis of observational data, there were no differences in the occurrence of stroke, major bleeding DRT, and all-cause mortality in patients treated with short-term OAC or APT following LAAO.

There are contrasting data on concomitant Impella device in cardiogenic shock patients treated with venoarterial extracorporeal membrane oxygenation (VA ECMO) (ECPELLA). This study sought to compare early mortality in patients with cardiogenic shock treated with ECPELLA in comparison to VA ECMO alone. We reviewed the published literature from 2000 to 2018 for randomized, cohort, case-control, and case series studies evaluating adult patients requiring VA ECMO for cardiogenic shock. Five retrospective observational studies, representing 425 patients, were included. Venoarterial extracorporeal membrane oxygenation with concomitant Impella strategy was used in 27% of the patients. Median age across studies varied between 51 and 63 years with 59-88% patients being male. Use of ECPELLA was associated with higher weaning from VA ECMO and bridging to permanent ventricular assist device or cardiac transplant in three and four studies, respectively. The studies showed moderate heterogeneity with possible publication bias. The two studies that accounted for differences in baseline characteristics between treatment groups reported lower 30 day mortality with ECPELLA versus VA ECMO. The remaining three studies did not adjust for potential confounding and were at high risk for selection bias. In conclusion, ECPELLA is being increasingly used as a strategy in patients with cardiogenic shock. Additional large, high-quality studies are needed to evaluate clinical outcomes with ECPELLA.

Aims The aim of this study is to evaluate the contemporary use of a pulmonary artery catheter (PAC) in acute myocardial infarction‐cardiogenic shock (AMI‐CS). Methods and results A retrospective cohort of AMI‐CS admissions using the National Inpatient Sample (2000–2014) was identified. Admissions with concomitant cardiac surgery or non‐AMI aetiology for cardiogenic shock were excluded. The outcomes of interest were in‐hospital mortality, resource utilization, and temporal trends in cohorts with and without PAC use. In the non‐PAC cohort, the use and outcomes of right heart catheterization was evaluated. Multivariable regression and propensity matching was used to adjust for confounding. During 2000–2014, 364 001 admissions with AMI‐CS were included. PAC was used in 8.1% with a 75% decrease during over the study period (13.9% to 5.4%). Greater proportion of admissions to urban teaching hospitals received PACs (9.5%) compared with urban non‐teaching (7.1%) and rural hospitals (5.4%); P < 0.001. Younger age, male sex, white race, higher comorbidity, noncardiac organ failure, use of mechanical circulatory support, and noncardiac support were independent predictors of PAC use. The PAC cohort had higher in‐hospital mortality (adjusted odds ratio 1.07 [95% confidence interval 1.04–1.10]), longer length of stay (10.9 ± 10.9 vs. 8.2 ± 9.3 days), higher hospitalization costs ($128 247 ± 138 181 vs. $96 509 ± 116 060), and lesser discharges to home (36.3% vs. 46.4%) (all P < 0.001). In 6200 propensity‐matched pairs, in‐hospital mortality was comparable between the two cohorts (odds ratio 1.01 [95% confidence interval 0.94–1.08]). Right heart catheterization was used in 12.5% of non‐PAC admissions and was a marker of greater severity but did not indicate worse outcomes. Conclusions In AMI‐CS, there was a 75% decrease in PAC use between 2000 and 2014. Admissions receiving a PAC were a higher risk cohort with worse clinical outcomes.

Background There are limited data on the timing and outcomes of in-hospital cardiac arrest (IHCA) in patients with ST-elevation myocardial infarction (STEMI) receiving primary percutaneous coronary intervention (pPCI). This study sought to examine the in-hospital mortality, temporal trends and resource utilization in early vs. delayed IHCA in STEMI. Methods Retrospective cohort study from the National Inpatient Sample of all STEMI admissions during 2000–2014 receiving pPCI on hospital day zero. Admissions transferred from other hospitals, with do-not-resuscitate status, without information on IHCA timing, and receiving surgical revascularization were excluded. IHCA was classified as early (hospital day zero) and delayed (on/after hospital day 1). The primary outcome was in-hospital mortality and secondary outcomes included prevalence, temporal trends, and resource utilization. Results During this 15-year period, 19,185 admissions met the inclusion criteria, with 15,404 (80%) experiencing an early IHCA. The cohort with delayed IHCA was on average older, female, with higher comorbidity, and greater prevalence of non-shockable rhythms and acute organ failure. There was a temporal increase in early IHCA (adjusted odds ratio [aOR] 1.67 [95% confidence interval {CI} 1.35–2.08]) and a decrease in delayed IHCA (aOR 0.60 [95% CI 0.48-0.74]) in 2014 compared to 2000. Compared to the early IHCA cohort, the delayed IHCA cohort had higher in-hospital mortality (aOR 5.35 [95% CI 4.83–5.94]), higher hospitalization costs ($115,165 ± 109,848 vs. 139,038 ± 142,745) and less frequent discharges to home (74% vs. 52%). Conclusions Delayed IHCA (on or after hospital day 1) was associated with higher in-hospital mortality and resource utilization compared to early IHCA.

Aims Left ventricular (LV) remodelling after ST-segment elevation myocardial infarction (STEMI) worsens outcome. The effect of sex on LV post-infarct remodelling is unknown. We therefore investigated the sex distribution and long-term prognosis of LV post-infarct remodelling after STEMI in the contemporary era of primary percutaneous coronary intervention (PCI) and optimal pharmacotherapy.Methods and results Data were obtained from an ongoing primary PCI STEMI registry. LV remodelling was defined as >= 20% increase in LV end-diastolic volume at either 3, 6, or 12 months post-infarct, and LV remodelling impact on outcome was evaluated with a log-rank test. A total population of 1995 STEMI patients were analysed (mean age 60 +/- 12 years): 1527 (77%) men and 468 (23%) women. The mean age of male patients was 60 +/- 11 versus 63 +/- 13 years for women (P < 0.001). A total of 953 (48%) patients experienced LV remodelling in the first 12 months of follow-up, and it was equally frequent amongst men (n = 729, 48%) and women (n = 224, 48%). After a median follow-up of 94 (interquartile range 69-119) months, 225 patients died: 171 (11%) men and 54 (12%) women. No survival difference was seen between remodellers and non-remodellers in the male (P = 0.113) and female (P = 0.920) groups.Conclusion LV post-infarct remodelling incidence, as well as long-term survival of LV remodellers and non-remodellers, was similar in men and women who were treated with primary PCI and optimal pharmacotherapy post-STEMI.