New in Clinical Documents Updated AUC Provides Guidance on Coronary Revascularization in ACS Patients The ACC, along with several partnering organizations, has released updated appropriate use criteria (AUC) for performing coronary revascularization in patients with acute coronary syndromes (ACS). The new criteria, published in the Journal of the American College of Cardiology, include clinical scenarios developed to mimic patient presentations that may be encountered in everyday practice and information on symptom status, presence of clinical instability or ongoing ischemic symptoms, prior reperfusion therapy, risk level as assessed by noninvasive testing, fractional flow reserve testing, and coronary anatomy. The clinical scenarios are scored to indicate whether revascularization is appropriate, may be appropriate or is rarely appropriate for the clinical scenario presented. The new AUC encourages clinicians to consider surgical revascularization as an option for patients with ACS, but less acute presentation, especially in those with complex multivessel coronary artery disease. They rate revascularization as “appropriate care” for patients presenting within 12 hours of the onset of STEMI, or up to 24 hours if there is clinical instability. For STEMI patients presenting more than 12 and up to 24 hours from symptom onset, but with no signs of clinical instability, revascularization was rated as “may be appropriate.” Nonculprit artery revascularization at the time of primary PCI was rated as “may be appropriate,” but AUC authors stress the use of clinical judgment by the operator, given the relative newness of the concept and the limited number and size of studies. For STEMI patients initially treated with fibrinolysis, revascularization was rated as “appropriate therapy” in the setting of suspected failed fibrinolytic therapy or in stable and asymptomatic patients from three to 24 hours after fibrinolysis. The only “rarely appropriate” rating occurred for asymptomatic patients with intermediate-severity nonculprit artery stenoses in the absence of any additional testing to demonstrate the functional significance of the stenosis. For patients with NSTEMI/unstable angina, and consistent with existing guidelines and the available evidence, revascularization was rated as “appropriate care” in the setting of cardiogenic shock or in a patient with intermediate- or high-risk features. For stable NSTE-ACS patients with low-risk features, revascularization was rated as “may be appropriate.” “The AUC for ACS are consistent with the large body of evidence and guideline recommendations that support invasive strategies to define anatomy and revascularize patients with ST-segment elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) ACS,” writes Debabrata Mukherjee, MD, FACC, in an ACC.org overview of the new criteria. “Although these AUC ratings do not compare the merits of PCI vs. CABG for revascularization in ACS, in clinical practice, patients presenting with STEMI typically are treated by PCI of the culprit stenosis.” “This update provides a reassessment of clinical scenarios that the writing group felt to be affected by significant changes in the medical literature or gaps from prior criteria,” said Manesh R. Patel, MD, FACC, chair of the writing committee. “The primary objective of the AUC is to provide a framework for the assessment of practice patterns that will hopefully improve physician decision making and ultimately lead to better patient outcomes.” Other partnering organizations on the AUC, include the American Association for Thoracic Surgery, the American Heart Association, American Society of Echocardiography, the American Society of Nuclear Cardiology, the Society for Cardiovascular Angiography and Interventions, the Society of Cardiovascular Computed Tomography and the Society of Thoracic Surgeons. The document is part one of a two-part revision for coronary revascularization. The updated AUC for coronary revascularization in patients with stable ischemic heart disease will be released next year. Decision Pathway Targeted at Periprocedural Anticoagulation The ACC has released a new decision pathway designed to assist clinicians with quickly and effectively making decisions regarding periprocedural management of anticoagulation for patients with nonvalvular atrial fibrillation (AFib) who are treated with chronic oral anticoagulants. The pathway, published in the Journal of the American College of Cardiology, provides guidance to physicians on: • The overall decision to keep a patient chronically on an anticoagulant by examining whether anticoagulation is warranted based on overall thrombotic risk • The decision to take the patient off an anticoagulant temporarily • How to temporarily stop the use of vitamin K antagonists and direct-acting oral anticoagulants • Deciding if “bridging” a patient before, during and after surgery is the best choice • Deciding how to bridge before, during and after surgery • Deciding how and when to restart the patient’s regular anticoagulant after a surgery The authors explain that managing patients during this time period is often challenging and varies among hospitals, practitioners and specialties. Typically, no matter where a patient is being treated, many specialists contribute to the decision-making process. “All these specialists possess valuable knowledge; however, they have differing perspectives, which can make the decision-making process complex,” said John U. Doherty, MD, FACC, chair of the writing committee. “With this new decision pathway, physicians will be able to make better-informed decisions, and this will contribute to improved patient outcomes. In North America alone, more than 250,000 nonvalvular Afib patients undergo surgery annually, so this document will impact many people.” New Performance Measures Focus on Preventing SCD A new report released by the ACC and the American Heart Association defines 10 quality and performance measures that are intended to help health systems, legislative bodies, and nongovernmental organizations, as well as health care practitioners, patients, families and communities, assess the quality of care for the prevention of sudden cardiac death (SCD). The measures, published Dec. 19 in the Journal of the American College of Cardiology and Circulation: Cardiovascular Quality and Outcomes, include the following recommendations: • Smoking cessation intervention in patients who suffered sudden cardiac arrest, have a life-threatening ventricular arrhythmia, or are at risk for SCD • Screening for family history of SCD • Screening for asymptomatic left ventricular dysfunction among individuals who have a strong family history of cardiomyopathy and SCD • Referring for CPR and AED education those family members of patients who are hospitalized with known heart conditions that increase the risk of sudden cardiac arrest • Use of implantable cardioverter defibrillators (ICDs) for prevention of SCD in patients with heart failure and reduced ejection fraction who have an anticipated survival of more than one year • Use of guideline-directed medical therapy for prevention of SCD in patients with heart failure and reduced ejection fraction • Use of guideline-directed medical therapy for prevention of SCD in patients with heart attack and reduced ejection fraction • Documenting the absence of reversible causes of ventricular tachycardia/ventricular fibrillation cardiac arrest and/or sustained ventricular tachycardia before a secondaryprevention ICD is placed • Counseling eligible patients about an ICD • Counseling first-degree relatives of survivors of sudden cardiac arrest associated with an inheritable condition about the need for screening for the inheritable condition “This is the first comprehensive measure set in the area of SCD prevention,” said Sana Al-Khatib, MD, FACC, co-chair of the writing committee. “Our vision is that these measures will be developed, tested, and implemented in clinical practice and that implementation will improve patient care and outcomes.” New Document Addresses Assessment of Patient Eligibility for TAVR Assisting clinicians and hospitals in assessing patients’ eligibility for transcatheter aortic valve replacement (TAVR), successfully performing the procedure and providing appropriate follow-up is the focus of a new ACC expert consensus decision pathway. In order to develop practice tools that could readily help centers improve their TAVR processes, patient safety and outcomes, the writing committee, chaired by Catherine M. Otto, MD, FACC, developed checklists that serve as a starting point for managing patients who are being considered for TAVR. The document also takes clinicians through the steps needed to successfully perform the procedure, including what imaging tests are needed and how to ensure continuity of care when patients transition back to their treating physicians. The document provides a framework with four key sets of considerations: (1) pre-procedure considerations; (2) which imaging tests and measurements are needed and when; (3) key issues and considerations in performing the TAVR procedure itself and managing complications; and (4) managing patients immediately after the procedure and for longer follow-up to ensure continuity of care. The new checklists help clinicians apply best practices, including determining if TAVR is appropriate in the context of individual patient considerations. The guidance also reinforces the central role of the heart valve team and the need for close collaboration with other clinicians, who should ideally have easy access to care plans, including what imaging tests are needed. The writing committee hopes hospitals and valve centers will expand upon these resources to create their own internal checklists to use in patient care and update them over time to reflect the most recent clinical recommendations. “TAVR is one of the most rapidly expanding technologies in medical care today, and as our population ages, we will see increasing numbers of people with severe aortic valve stenosis, so it is important to provide guidance on optimal use of this treatment,” Otto said. “There is also a great deal of interest among patients who usually prefer TAVR over open heart valve surgery, if this option is appropriate for their medical condition.” The 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement in the Management of Adults with Aortic Stenosis builds on recommendations set forth in the 2014 AHA/ACC Guidelines for Management of Patients with Valvular Heart Disease and was published Jan. 4 in the Journal of the American College of Cardiology. Peripheral Matters Endovascular Therapy vs. Bypass Surgery as First-Line Treatment Strategies for CLI When physicians are free to individualize therapy for patients with critical limb ischemia (CLI) , the “endovascular-first approach” achieved a noninferior amputation-free survival (AFS) rate compared with bypass surgery, according to an interim analysis of the CRITISCH Registry published in JACC: Cardiovascular Interventions. The study of 1,200 CLI patients from 27 vascular centers between January 2013 and September 2014 left first-line treatment selection up to the discretion of the responsible physician. Overall, endovascular therapy was applied to 642 patients (54 percent) and bypass surgery to 284 patients (24 percent). Median follow-up time was one year in both groups. The primary composite endpoint was AFS and/or death from any cause. Time-to-event analyses of major amputation, death, and the composite endpoint of reintervention and/or above-ankle amputation were also conducted. Results found one-year AFS was 75 percent in the endovascular group and 72 percent in the bypass surgery group. Researchers noted that the patients receiving endovascular treatment were older and frailer, had greater frequency of chronic kidney disease and usually presented with ischemic lesions of the digits. Bypass surgery was applied more commonly in patients having already had one or more previous vascular interventions. Nonetheless, the noninferiority of endovascular therapy versus bypass surgery for AFS was confirmed, while any impact of the treatment strategy on time until death, major amputation and reintervention and/or above-ankle amputation was not observed. “This study highlights that when physicians are free to individualize therapy for their CLI patients, they achieved encouraging outcomes with both therapies,” the authors say. “Despite the fact that sicker and higher risk patients were included in the endovascular group, a low early mortality rate as well as a statistically noticeable shorter in-hospital stay compared with bypass surgery were observed.” Moving forward, the authors suggest further investigation into the most effective treatment for patients with chronic kidney disease – the “most striking risk factor” for both amputation and death, according to the study.
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