ACC/AHA Task Force Members Jeffrey L. Anderson, MD, FACC, FAHA, Chair, Jonathan L. Halperin, MD, FACC, FAHA, Chair-Elect, Nancy M. Albert, PhD, CCNS, CCRN, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, ...Ralph G. Brindis, MD, MPH, MACC, Mark A. Creager, MD, FACC, FAHA§§Task Force member during the writing effort., Lesley H. Curtis, PhD, FAHA, David DeMets, PhD, Robert A. Guyton, MD, FACC§§, Judith S. Hochman, MD, FACC, FAHA, Richard J. Kovacs, MD, FACC, FAHA, E. Magnus Ohman, MD, FACC, Susan J. Pressler, PhD, RN, FAHA, Frank W. Sellke, MD, FACC, FAHA, Win-Kuang Shen, MD, FACC, FAHA, William G. Stevenson, MD, FACC, FAHA§§, Clyde W. Yancy, MD, FACC, FAHA§§ Table of Contents Preamble... An organized and directed approach to a thorough review of evidence has resulted in the production of clinical practice guidelines that assist clinicians in selecting the best management strategy for an individual patient. ...clinical practice guidelines can provide a foundation for other applications, such as performance measures, appropriate use criteria, and both quality improvement and clinical decision support tools. ...in view of the increasing number of comparative effectiveness studies, comparator verbs and suggested phrases for writing recommendations for the comparative effectiveness of one treatment or strategy versus another are included for COR I and IIa, LOE A or B only.\n Charney Division of Cardiology; Associate Director, Health Care Center None None None None None None Craig R. Smith Content Reviewer Columbia University College of Physicians and Surgeons--Professor of Surgery; Chair, Department of Surgery; New York-Presbyterian Hospital/Columbia University Medical Center--Surgeon-in-Chief None None None Edwards Lifesciences--PI None None Ruth H. Strasser Content Reviewer--AIG Heart Centre,University Hospital, University of Technology, Dresden--Professor, Director, and Chair, Internal Medicine and Cardiology Clinic; Medical Director, Heart Centre None None None None Abbottdagger AstraZenecadagger Bayerdagger Biosensorsdagger Pfizerdagger None Rakesh Suri Content Reviewer Mayo Clinic--Associate Professor of Surgery None None None None Edwards Lifesciencesdagger Sorindagger St. Jude Medicaldagger None Vinod Thourani Content Reviewer--Surgeon Council Emory University Edward Lifesciences Sorin St. Jude Medical None Apica Cardiovasculardagger Maquet None None Alec Vahanian Content Reviewer Hospital Bichat--Department de Cardiologie Abbott Vascular Edwards Lifesciences Medtronic St. Jude Medical Valtech None None None None None Andrew Wang Content Reviewer Duke University Medical Center--Professor of Medicine None None None Abbott Vascularlow * Edwards Lifescienceslow * None Defendant, Sudden death, 2012 * This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. Names are listed in alphabetical order within each category of review.According to the ACC/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; AHA, American Heart Association; AIG, Association of International Governors; ASE, American Society of Echocardiography; DSMB, Data and Safety Monitoring Board; MRI, magnetic resonance imaging; NIH, National Institutes of Health; NYU, New York University; PARTNERS, Placement Of Aortic Transcatheter Valves; PI, Principal Investigator; SCA, Society of Cardiovascular Anesthesiologists; SCAI, Society for Cardiovascular Angiography and Interventions; STS, Society of Thoracic Surgeons; and VA, Veterans Affairs.
A recent review by the International Agency for Research on Cancer (IARC) updated the assessments of the > 100 agents classified as Group 1, carcinogenic to humans (IARC Monographs Volume 100, parts ...A-F). This exercise was complicated by the absence of a broadly accepted, systematic method for evaluating mechanistic data to support conclusions regarding human hazard from exposure to carcinogens.
IARC therefore convened two workshops in which an international Working Group of experts identified 10 key characteristics, one or more of which are commonly exhibited by established human carcinogens.
These characteristics provide the basis for an objective approach to identifying and organizing results from pertinent mechanistic studies. The 10 characteristics are the abilities of an agent to 1) act as an electrophile either directly or after metabolic activation; 2) be genotoxic; 3) alter DNA repair or cause genomic instability; 4) induce epigenetic alterations; 5) induce oxidative stress; 6) induce chronic inflammation; 7) be immunosuppressive; 8) modulate receptor-mediated effects; 9) cause immortalization; and 10) alter cell proliferation, cell death, or nutrient supply.
We describe the use of the 10 key characteristics to conduct a systematic literature search focused on relevant end points and construct a graphical representation of the identified mechanistic information. Next, we use benzene and polychlorinated biphenyls as examples to illustrate how this approach may work in practice. The approach described is similar in many respects to those currently being implemented by the U.S. EPA's Integrated Risk Information System Program and the U.S. National Toxicology Program.
Smith MT, Guyton KZ, Gibbons CF, Fritz JM, Portier CJ, Rusyn I, DeMarini DM, Caldwell JC, Kavlock RJ, Lambert P, Hecht SS, Bucher JR, Stewart BW, Baan R, Cogliano VJ, Straif K. 2016. Key characteristics of carcinogens as a basis for organizing data on mechanisms of carcinogenesis. Environ Health Perspect 124:713-721; http://dx.doi.org/10.1289/ehp.1509912.
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CEKLJ, DOBA, IZUM, KILJ, NUK, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
Background The introduction of transcatheter aortic valve replacement mandates attention to outcomes after surgical aortic valve replacement (SAVR) in low-risk, intermediate-risk, and very high-risk ...patients. Methods The study population included 141,905 patients who underwent isolated primary SAVR from 2002 to 2010. Patients were risk-stratified by Society of Thoracic Surgeons (STS) predicted risk of mortality (PROM) <4% (group 1, n = 113,377), 4% to 8% (group 2, n = 19,769), and >8% (group 3, n = 8,759). The majority of patients were considered at low risk (80%), and only 6.2% were categorized as being at high risk. Outcomes were analyzed based on two time periods: 2002 to 2006 (n = 63,754) and 2007 to 2010 (n = 78,151). Results The mean age was 65 years in group 1, 77 in group 2, and 77 in group 3 ( p < 0.0001). The median STS PROM for the entire population was 1.84: 1.46% in group 1, 5.24% in group 2, and 11.2% in group 3 ( p < 0.0001). Compared with PROM, in-hospital mean mortality was lower than expected in all patients (2.5% vs 2.95%) and when analyzed within risk groups was as follows: group 1 (1.4% vs 1.7%), group 2 (5.1% vs 5.5%), and group 3 (11.8% vs 13.7%) ( p < 0.0001). In the most recent surgical era, operative mortality was significantly reduced in group 2 (5.4% vs 6.4%, p = 0.002) and group 3 (11.9% vs 14.4%, p = 0.0004) but not in group 1. Conclusions Nearly 80% of patients undergoing SAVR have outcomes that are superior to those by the predicted risk models. In the most recent era, early results have further improved in medium-risk and high-risk patients. This large real-world assessment serves as a benchmark for patients with aortic valve stenosis as therapeutic options are further evaluated.
Background The role of robotic instruments in mitral valve (MV) surgery continues to evolve. The purpose of this study was to assess the safety, efficacy, and scope of MV surgery using a lateral ...endoscopic approach with robotics (LEAR) technique. Methods From 2006 to 2013, a dedicated LEAR team performed 1,257 consecutive isolated MV procedures with or without tricuspid valve repair or atrial ablation. The procedures were performed robotically through five right-side chest ports with femoral artery or ascending aortic perfusion and balloon occlusion. Operative videos and data were recorded on all procedures and reviewed retrospectively. Results The mean age of all patients was 59.3 ± 20.5 years, and 8.4% (n = 105) had previous cardiac surgery. The MV repair was performed in 1,167 patients (93%). The MV replacement was performed in 88 patients (7%), and paravalvular leak repair in 2 patients. Concomitant atrial ablation was performed in 226 patients (18%), and tricuspid valve repair in 138 patients (11%). Operative mortality occurred in 11 patients (0.9%) and stroke in 9 patients (0.7%). Predischarge echocardiograms demonstrated mild or less mitral regurgitation in 98.3% of MV repair patients. At mean follow-up of 50 ± 26 months, 44 patients (3.8%) required MV reoperation. Application of the LEAR technique to all institutional isolated MV procedures increased from 46% in the first year to more than 90% in the last 3 years. Conclusions Mitral valve repair or replacement, including concomitant procedures, can be performed safely and effectively using the LEAR technique. With a dedicated robotic team, the vast majority of patients with MV disorders, either isolated or with concomitant problems, can be treated using the LEAR technique.
The optimal level of glycemic control needed to improve outcomes in cardiac surgery patients remains controversial.
We randomized patients with diabetes (n = 152) and without diabetes (n = 150) with ...hyperglycemia to an intensive glucose target of 100-140 mg/dL (n = 151) or to a conservative target of 141-180 mg/dL (n = 151) after coronary artery bypass surgery (CABG) surgery. After the intensive care unit (ICU), patients received a single treatment regimen in the hospital and 90 days postdischarge. Primary outcome was differences in a composite of complications, including mortality, wound infection, pneumonia, bacteremia, respiratory failure, acute kidney injury, and major cardiovascular events.
Mean glucose in the ICU was 132 ± 14 mg/dL (interquartile range IQR 124-139) in the intensive and 154 ± 17 mg/dL (IQR 142-164) in the conservative group (P < 0.001). There were no significant differences in the composite of complications between intensive and conservative groups (42 vs. 52%, P = 0.08). We observed heterogeneity in treatment effect according to diabetes status, with no differences in complications among patients with diabetes treated with intensive or conservative regimens (49 vs. 48%, P = 0.87), but a significant lower rate of complications in patients without diabetes treated with intensive compared with conservative treatment regimen (34 vs. 55%, P = 0.008).
Intensive insulin therapy to target glucose of 100 and 140 mg/dL in the ICU did not significantly reduce perioperative complications compared with target glucose of 141 and 180 mg/dL after CABG surgery. Subgroup analysis showed a lower number of complications in patients without diabetes, but not in patients with diabetes treated with the intensive regimen. Large prospective randomized studies are needed to confirm these findings.
Objectives We sought to investigate the association between new-onset atrial fibrillation after coronary artery bypass graft (CABG) (post-operative atrial fibrillation POAF) and long-term mortality ...in patients with no history of atrial fibrillation. Background POAF predicts longer hospital stay and greater post-operative mortality. Methods A total of 16,169 consecutive patients with no history of AF who underwent isolated CABG at our institution between January 1, 1996, and December 31, 2007, were included in the study. All-cause mortality data were obtained from Social Security Administration death records. A multivariable Cox proportional hazards regression model was constructed to determine the independent impact of new-onset POAF on long-term survival after adjusting for several covariates. The covariates included age, sex, race, pre-operative risk factors (ejection fraction, New York Heart Association functional class, history of myocardial infarction, index myocardial infarction, stroke, chronic obstructive pulmonary disease, peripheral arterial disease, smoking, diabetes, renal failure, hypertension, dyslipidemia, creatinine level, dialysis, redo surgery, elective versus emergent CABG, any valvular disorder) and post-operative adverse events (stroke, myocardial infarction, acute respiratory distress syndrome, and renal failure), and discharge cardiac medications known to affect survival in patients with coronary disease. Results New-onset AF occurred in 2,985 (18.5%) patients undergoing CABG. POAF independently predicted long-term mortality (hazard ratio: 1.21; 95% confidence interval: 1.12 to 1.32) during a mean follow-up of 6 years (range 0 to 12.5 years). This association remained true after excluding from the analysis those patients who died in-hospital after surgery (hazard ratio: 1.21; 95% confidence interval: 1.11 to 1.32). Patients with POAF discharged on warfarin experienced reduced mortality during follow-up. Conclusions In this large cohort of patients, POAF predicted long-term mortality. Warfarin anticoagulation may improve survival in POAF.
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