The Role of Hemodynamic Support in High-risk Percutaneous Coronary Intervention

Patients with advanced age, complex coronary anatomy, and multiple comorbidities are often unsuitable for surgical revascularization. In this setting, hemodynamic support devices are used as an adjunct to percutaneous coronary intervention to maintain hemodynamic stability and enable optimal revascularization. This article provides an overview of percutaneous hemodynamic support devices currently used in clinical practice for high-risk percutaneous coronary intervention. These include the intra-aortic balloon pump, centrifugal pumps (TandemHeart, venous arterial extracorporeal membrane oxygenation), and micro-axial Impella pump. The hemodynamic effects, clinical evidence supporting improved outcomes and recovery of heart function, and associated complications with these devices are highlighted, with a special focus on Impella pumps

Randomized Comparison of Everolimus- and Paclitaxel-Eluting Stents 2-Year Follow-Up From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV Trial

ObjectivesWe sought to determine whether the differences in outcomes present between everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial at 1 year were sustained with longer-term follow-up.BackgroundIn the SPIRIT IV trial, patients undergoing percutaneous coronary intervention who were randomized to EES compared with PES experienced lower 1-year rates of target lesion failure (cardiac death, target vessel myocardial infarction [MI], or ischemia-driven target lesion revascularization [TLR]), with significant reductions in the individual rates of MI, TLR, and stent thrombosis.MethodsWe prospectively randomized 3,687 patients with up to 3 noncomplex previously untreated native coronary artery lesions to EES versus PES at 66 U.S. sites. Follow-up through 2 years is complete in 3,578 patents (97.0%).ResultsTreatment with EES compared with PES reduced the 2-year rates of TLF (6.9% vs. 9.9%, p = 0.003), all MI (2.5% vs. 3.9%, p = 0.02), Q-wave MI (0.1% vs. 0.8%, p = 0.002), stent thrombosis (0.4% vs. 1.2%, p = 0.008), and ischemia-driven TLR (4.5% vs. 6.9%, p = 0.004), with nonsignificantly different rates of all-cause and cardiac mortality. Between 1 year and 2 years, there were no significant differences in adverse event rates between the 2 stent types.ConclusionsIn the large-scale, prospective, multicenter, randomized SPIRIT IV trial, the benefits of EES compared with those of PES present at 1 year were sustained at 2 years. (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System; NCT01016041

Outcomes and Complications With Off-Label Use of Drug-Eluting Stents Results From the STENT (Strategic Transcatheter Evaluation of New Therapies) Group

ObjectivesThis study evaluates outcomes and complications in patients treated with drug-eluting stents (DES) for “off-label” indications.BackgroundDrug-eluting stents have been effective in randomized trials, but their safety and efficacy for off-label indications has not been well studied.MethodsThe STENT (Strategic Transcatheter Evaluation of New Therapies) Registry is the largest multicenter U.S. registry evaluating outcomes of DES. Off-label indications included ostial, left main, long, bifurcation, and in-stent restenotic lesions, saphenous vein grafts, chronic total occlusions, small or large vessels, multilesion or multivessel percutaneous coronary interventions, and ST-segment elevation myocardial infarction. Outcomes were adjusted using Cox proportional hazards regression and propensity analyses.ResultsDrug-eluting stents were used in an off-label manner in 59% of patients. The patients who received off-label treatment were more often male, had a higher incidence of prior infarction and bypass surgery, and lower ejection fractions. Off-label versus “on-label” use of DES was associated with higher rates of death, myocardial infarction, target vessel revascularization, major adverse cardiac events, and stent thrombosis at 9 months and 2 years. Off-label use of DES compared with off-label use of bare-metal stents (BMS) had lower rates of death, myocardial infarction, target vessel revascularization, and major adverse cardiac events at 9 months and 2 years and lower rates of stent thrombosis at 9 months.ConclusionsOff-label use of DES is associated with higher event rates compared with on-label use of DES, which is consistent with a higher risk clinical and lesion profile. However, event rates with off-label use of DES are lower compared with off-label use of BMS. Pending results from randomized trials, our data support the use of DES for off-label indications in selected patients

Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease

Background Patients with obstructive left main coronary artery disease are usually treated with coronary-artery bypass grafting (CABG). Randomized trials have suggested that drug-eluting stents may be an acceptable alternative to CABG in selected patients with left main coronary disease. Methods We randomly assigned 1905 eligible patients with left main coronary artery disease of low or intermediate anatomical complexity to undergo either percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). Anatomic complexity was assessed at the sites and defined by a Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score of 32 or lower (the SYNTAX score reflects a comprehensive angiographic assessment of the coronary vasculature, with 0 as the lowest score and higher scores [no upper limit] indicating more complex coronary anatomy). The primary end point was the rate of a composite of death from any cause, stroke, or myocardial infarction at 3 years, and the trial was powered for noninferiority testing of the primary end point (noninferiority margin, 4.2 percentage points). Major secondary end points included the rate of a composite of death from any cause, stroke, or myocardial infarction at 30 days and the rate of a composite of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years. Event rates were based on Kaplan-Meier estimates in time-to-first-event analyses. Results At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval, 0.79 to 1.26; P=0.98 for superiority). The secondary end-point event of death, stroke, or myocardial infarction at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (P<0.001 for noninferiority, P=0.008 for superiority). The secondary end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (P=0.01 for noninferiority, P=0.10 for superiority). Conclusions In patients with left main coronary artery disease and low or intermediate SYNTAX scores by site assessment, PCI with everolimus-eluting stents was noninferior to CABG with respect to the rate of the composite end point of death, stroke, or myocardial infarction at 3 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776 .)

Randomized Comparison Between Everolimus-Eluting Bioresorbable Scaffold and Metallic Stent: Multimodality Imaging Through 3 Years

Objectives: The aim of this study was to investigate the vascular responses and fates of the scaffold after bioresorbable vascular scaffold (BVS) implantation using multimodality imaging. Background: Serial comprehen

The Art of Research: A Divergent/Convergent Framework and Opportunities for Science-Based Approaches

Applying science to the current art of producing engineering and research knowledge has proven difficult, in large part because of its seeming complexity. We posit that the microscopic processes underlying research are not so complex, but instead are iterative and interacting cycles of divergent (generation of ideas) and convergent (testing and selecting of ideas) thinking processes. This reductionist framework coherently organizes a wide range of previously disparate microscopic mechanisms which inhibit these processes. We give examples of such inhibitory mechanisms and discuss how deeper scientific understanding of these mechanisms might lead to dis-inhibitory interventions for individuals, networks and institutional levels

Keeping work and private life apart:Age‐related differences in managing the work–nonwork interface

Initial evidence suggests that older workers enjoy higher work–life balance than young workers. Yet little is known about the mechanisms of this effect or the robustness of age differences when accounting for differences in life context. We introduce and test the boundary management account of aging and work–life balance, which suggests that older workers maintain stronger work–nonwork boundaries as a pathway toward work–life balance. Both in Study 1 (cross‐sectional; N = 298 bank employees) and in Study 2 (aggregated diary entries; N = 608 workers), older workers reported better work–life balance and stronger boundaries at work than young workers; and stronger boundaries at home (Study 1). In both studies, stronger boundaries were related to better work–life balance, and boundary strength mediated the relationship between age and work–life balance. Study 2 additionally suggests that the use of boundary management strategies is responsible for stronger boundaries at higher age. Analyses accounted for differences in family and work context characteristics (both studies) and boundary preferences (Study 1). The findings corroborate evidence of older workers' enhanced work–life balance and suggest that it results from more successful boundary management with age rather than merely from changes in contextual factors or boundary preferences. (PsycINFO Database Record (c) 2018 APA, all rights reserved

Selection Mechanisms Underlying High Impact Biomedical Research - A Qualitative Analysis and Causal Model

BACKGROUND: Although scientific innovation has been a long-standing topic of interest for historians, philosophers and cognitive scientists, few studies in biomedical research have examined from researchers' perspectives how high impact publications are developed and why they are consistently produced by a small group of researchers. Our objective was therefore to interview a group of researchers with a track record of high impact publications to explore what mechanism they believe contribute to the generation of high impact publications. METHODOLOGY/PRINCIPAL FINDINGS: Researchers were located in universities all over the globe and interviews were conducted by phone. All interviews were transcribed using standard qualitative methods. A Grounded Theory approach was used to code each transcript, later aggregating concept and categories into overarching explanation model. The model was then translated into a System Dynamics mathematical model to represent its structure and behavior. Five emerging themes were found in our study. First, researchers used heuristics or rules of thumb that came naturally to them. Second, these heuristics were reinforced by positive feedback from their peers and mentors. Third, good communication skills allowed researchers to provide feedback to their peers, thus closing a positive feedback loop. Fourth, researchers exhibited a number of psychological attributes such as curiosity or open-mindedness that constantly motivated them, even when faced with discouraging situations. Fifth, the system is dominated by randomness and serendipity and is far from a linear and predictable environment. Some researchers, however, took advantage of this randomness by incorporating mechanisms that would allow them to benefit from random findings. The aggregation of these themes into a policy model represented the overall expected behavior of publications and their impact achieved by high impact researchers. CONCLUSIONS: The proposed selection mechanism provides insights that can be translated into research coaching programs as well as research policy models to optimize the introduction of high impact research at a broad scale among institutional and governmental agencies

Five-Year Outcomes after PCI or CABG for Left Main Coronary Disease.

BACKGROUND: Long-term outcomes after percutaneous coronary intervention (PCI) with contemporary drug-eluting stents, as compared with coronary-artery bypass grafting (CABG), in patients with left main coronary artery disease are not clearly established. METHODS: We randomly assigned 1905 patients with left main coronary artery disease of low or intermediate anatomical complexity (according to assessment at the participating centers) to undergo either PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents (PCI group, 948 patients) or CABG (CABG group, 957 patients). The primary outcome was a composite of death, stroke, or myocardial infarction. RESULTS: At 5 years, a primary outcome event had occurred in 22.0% of the patients in the PCI group and in 19.2% of the patients in the CABG group (difference, 2.8 percentage points; 95% confidence interval [CI], -0.9 to 6.5; P = 0.13). Death from any cause occurred more frequently in the PCI group than in the CABG group (in 13.0% vs. 9.9%; difference, 3.1 percentage points; 95% CI, 0.2 to 6.1). In the PCI and CABG groups, the incidences of definite cardiovascular death (5.0% and 4.5%, respectively; difference, 0.5 percentage points; 95% CI, -1.4 to 2.5) and myocardial infarction (10.6% and 9.1%; difference, 1.4 percentage points; 95% CI, -1.3 to 4.2) were not significantly different. All cerebrovascular events were less frequent after PCI than after CABG (3.3% vs. 5.2%; difference, -1.9 percentage points; 95% CI, -3.8 to 0), although the incidence of stroke was not significantly different between the two groups (2.9% and 3.7%; difference, -0.8 percentage points; 95% CI, -2.4 to 0.9). Ischemia-driven revascularization was more frequent after PCI than after CABG (16.9% vs. 10.0%; difference, 6.9 percentage points; 95% CI, 3.7 to 10.0). CONCLUSIONS: In patients with left main coronary artery disease of low or intermediate anatomical complexity, there was no significant difference between PCI and CABG with respect to the rate of the composite outcome of death, stroke, or myocardial infarction at 5 years. (Funded by Abbott Vascular; EXCEL ClinicalTrials.gov number, NCT01205776.)