VA/DoD Clinical Practice Guidelines THE MANAGEMENT OF DYSLIPIDEMIA FOR CARDIOVASCULAR RISK REDUCTION Provider Summary VA/DoD CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF DYSLIPIDEMIA FOR CARDIOVASCULAR RISK REDUCTION Department of Veterans Affairs Department of Defense Provider Summary QUALIFYING STATEMENTS The Department of Veterans Affairs and the Department of Defense guidelines are based upon the best information available at the time of publication. They are designed to provide information and assist decision making. They are not intended to define a standard of care and should not be construed as one. Neither should they be interpreted as prescribing an exclusive course of management. This Clinical Practice Guideline is based on a systematic review of both clinical trial and epidemiological evidence. Developed by a panel of multidisciplinary experts, it provides a clear explanation of the logical relationships between various care options and health outcomes while rating both the quality of the evidence and the strength of the recommendation. Variations in practice will inevitably and appropriately occur when clinicians take into account the needs of individual patients, available resources, and limitations unique to an institution or type of practice. Every healthcare professional making use of these guidelines is responsible for evaluating the appropriateness of applying them in the setting of any particular clinical situation. These guidelines are not intended to represent Department of Veterans Affairs nor TRICARE policy. Further, inclusion of recommendations for specific testing and/or therapeutic interventions within these guidelines does not guarantee coverage. Additional information on current TRICARE benefits may be found at www.tricare.mil or by contacting your regional TRICARE Managed Care Support Contractor. VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Table of Contents Scope of the CPG 1 A. Populations Included in this Guideline 1 B.


VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Table of Contents Scope of the CPG 1 A. Populations Included in this Guideline 1 B. Populations Excluded from this Guideline 1 Algorithm: Management of Dyslipidemia for Cardiovascular Risk Reduction 6 Statin and Non-statin Pharmacologic Agents 8 Guideline Work Group 9 Patient-centered Care 10 Shared Decision Making 11 References 11 VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Introduction The Department of Veterans Affairs (VA) and Department of Defense (DoD) Evidence-Based Practice Work Group (EBPWG) was established and first chartered in 2004, with a mission to advise the Health Executive Committee (HEC) on the use of clinical and epidemiological evidence to improve the health of the population across the Veterans Health Administration (VHA) and Military Health System (MHS), by facilitating the development of clinical practice guidelines (CPGs) for the VA and DoD populations.[1] This CPG is intended to provide healthcare providers with a framework by which to evaluate, treat, and manage the individual needs and preferences of patients with dyslipidemia, thereby leading to improved clinical outcomes. In 2014, the VA and DoD published a CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction (2014 VA/DoD Dyslipidemia CPG), which was based on evidence reviewed from January 2010 through February 2014. Since then, a growing body of research has expanded the general knowledge and understanding of dyslipidemia and cardiovascular (CV) risk. A recommendation to update the 2014 VA/DoD Dyslipidemia CPG was initiated in 2019. The system-wide goal of evidence-based guidelines is to improve the patient s health and well-being. To that end, this CPG is intended to guide providers who care for patients with dyslipidemia along management pathways supported by evidence.


To that end, this CPG is intended to guide providers who care for patients with dyslipidemia along management pathways supported by evidence. The expected outcomes of successful implementation of this guideline include: Emphasizing the use of patient-centered care using risk factors and event history Minimizing preventable complications and morbidity Optimizing each individual s health outcomes and improving quality of life Assessing the patient s condition and collaborating with the patient, family, and caregivers to determine the optimal treatment Scope of the CPG This CPG is designed primarily to assist primary care providers (or other providers as applicable) in managing patients with dyslipidemia for the purpose of cardiovascular disease (CVD) risk reduction. This guideline seeks to inform providers with practical evidence-based recommendations for the most common scenarios involving patients at risk for CVD. A. Populations Included in this Guideline The patient population of interest for this CPG is patients >40 years old and eligible for care in the VA and/or DoD healthcare systems. B. Populations Excluded from this Guideline Patients with heart failure with reduced ejection fraction (EF) 35%, a limited life expectancy (<5 years), or end-stage renal disease (ESRD) were excluded from most clinical outcome trials. Although some controlled trial data exists exclusively in patients with ESRD and chronic systolic heart failure, the available evidence is comparatively sparse. Additionally, the data that is available show an absence of CV benefit in these populations. A more nuanced review of this evidence can be found in the 2014 iteration of the VA/DoD VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Clinical Practice Guideline for the Management of Dyslipidemia for Cardiovascular Risk Reduction under section Populations Excluded from this Guideline. [3] Our updated systematic review found no new evidence that would alter this position. Genetic dyslipidemia conditions (e.g.


[3] Our updated systematic review found no new evidence that would alter this position. Genetic dyslipidemia conditions (e.g., homozygous familial hypercholesterolemia [HoFH], heterozygous familial hypercholesterolemia [HeFH], TGs >500 mg/dL, etc.) were also excluded from the guideline given their uncommon occurrence and sparse clinical trial data. Although younger patients (i.e., <40 years old) are more common in the DoD, this cohort comprises a low short-term risk population that has been excluded from dyslipidemia intervention trials. Thus, the Work Group was unable to provide evidence-based recommendations for these populations and suggests that providers consider basing treatment decisions for these cohorts on comorbidity, quality of life, and patient s values and preferences. Such shared and informed decision-making should clearly lay out the uncertainty of benefit and known risks associated with pharmacologic treatment. Recommendations The following recommendations were made using a systematic approach considering four domains as per the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach as detailed in the section on Methods and Appendix A in the full text Dyslipidemia CPG. These domains include: confidence in the quality of the evidence, balance of desirable and undesirable outcomes (i.e., benefits and harms), patient or provider values and preferences, and other implications, as appropriate (e.g., resource use, equity, acceptability). Topic Sub- topic # Recommendation Strengtha Primary Prevention: Screening and Assessment of Cardiovascular Risk 1. For primary prevention in patients over age 40 and not on statin therapy who have not developed new cardiovascular risk factors (e.g., diabetes, hypertension, tobacco use), we suggest against offering a cardiovascular disease risk assessment more frequently than every five years. Weak against 2. For primary prevention in patients not on statin therapy, we suggest against routinely ordering a lipid panel more frequently than every 10 years. Weak against 3.


For primary prevention in patients not on statin therapy, we suggest against routinely ordering a lipid panel more frequently than every 10 years. Weak against 3. For cardiovascular risk assessment in primary prevention, we suggest using a 10- year risk calculator. Weak for 4. We suggest against the routine use of coronary artery calcium testing. Weak against 5. We suggest against the routine use of additional risk markers (e.g., high- sensitivity C-reactive protein, ankle-brachial index, coronary artery calcium) when assessing cardiovascular risk. Weak against VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Topic Sub- topic # Recommendation Strengtha Pharmacotherapy, Supplements, and Nutraceuticals a. Primary Prevention 6. For primary prevention, we recommend offering a moderate-dose statin in patients with a >12% 10-year cardiovascular risk or low-density lipoprotein cholesterol >190 mg/dL or diabetes. Strong for 7. For primary prevention, we suggest offering a moderate-dose statin for patients with a 10-year cardiovascular risk between 6% and 12% following a discussion of risks, limited benefit, and an exploration of the patient s values and preferences. Weak for 8. For primary prevention in patients on moderate-dose statins, we suggest against maximizing the statin dose due to the lack of evidence proving added cardiovascular benefits and the risks of higher dose statins. Weak against 9. For primary prevention, there is insufficient evidence to recommend for or against using ezetimibe with or without statins. Neither for nor against 10. For primary prevention, we recommend against offering PCSK9 inhibitors due to unknown long-term safety, inconclusive evidence for benefit, and high cost. Strong against b. Secondary Prevention 11. For secondary prevention, we recommend using at least a moderate-dose statin.* Strong for 12.


For secondary prevention, we recommend using at least a moderate-dose statin.* Strong for 12. For secondary prevention in higher risk patients** who are willing to intensify treatment, we suggest offering high-dose statins for reducing non-fatal cardiovascular events after discussion of the risk of high-dose statins and an exploration of the patient s values and preferences. Weak for 13. For secondary prevention in higher risk patients** who are willing to intensify treatment, we suggest adding ezetimibe to either moderate- or high-dose statins for reducing non-fatal cardiovascular events following a discussion of the risks, additional benefits, and an exploration of the patient s values and preferences. Weak for 14. For secondary prevention in higher risk patients** who are willing to intensify treatment, we suggest offering a PCSK9 inhibitor in addition to a maximally tolerated statin dose with ezetimibe for reducing non-fatal cardiovascular events following a discussion of their uncertain long-term safety, additional benefits, and an exploration of the patient s values and preferences. Weak for c. Other Medications, Supplements, and Nutraceuticals 15. For primary or secondary prevention, we recommend against using niacin (i.e., supplements or prescriptions). Strong against 16. For primary or secondary prevention, we suggest against adding fibrates to statins. Weak against 17. There is insufficient evidence to recommend for or against using bempedoic acid with or without statins for either primary or secondary prevention. Neither for nor against VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Topic Sub- topic # Recommendation Strengtha Pharmacotherapy, Supplements, and Nutraceuticals (cont.) c. Other Medications, Supplements, and Nutraceuticals (cont.) 18. For primary prevention, there is insufficient evidence to recommend for or against icosapent ethyl in patients on statin therapy with persistently elevated fasting triglycerides. Neither for nor against 19.


For primary prevention, there is insufficient evidence to recommend for or against icosapent ethyl in patients on statin therapy with persistently elevated fasting triglycerides. Neither for nor against 19. For secondary prevention, we suggest offering icosapent ethyl in patients on statin therapy with persistently elevated fasting triglycerides >150 mg/dL to reduce cardiovascular morbidity and mortality. Weak for 20. For primary or secondary prevention, we suggest against the use of omega-3 fatty acids as a dietary supplement to reduce cardiovascular disease risk. Weak against 21. There is insufficient evidence to recommend for or against the use of fiber, garlic, ginger, green tea, and red yeast rice supplements to reduce cardiovascular risks. Neither for nor against d. Monitoring and Adherence 22. We suggest against the routine monitoring of lipid levels in patients taking statins. Weak against 23. For patients who cannot tolerate a statin, we suggest a washout period followed by a re-challenge with the same or a different statin or lower dose, and if that fails, a trial of intermittent (nondaily) dosing. Weak for 24. We suggest offering intensified patient care (e.g., phone calls, emails, patient education, drug regimen simplification) to improve adherence to lipid-lowering medications. Weak for Lifestyle Interventions 25. For primary and secondary prevention of cardiovascular disease, we suggest a dietitian-led Mediterranean diet. Weak for 26. For primary and secondary prevention of cardiovascular disease, we suggest regular aerobic physical activity of any intensity and duration. Weak for 27. We recommend a structured, exercise-based cardiac rehabilitation program for patients with recent occurrence of coronary heart disease (i.e., myocardial infarction, diagnosis of coronary artery disease, coronary artery bypass grafting, or percutaneous coronary intervention) to reduce cardiovascular morbidity and mortality.


, myocardial infarction, diagnosis of coronary artery disease, coronary artery bypass grafting, or percutaneous coronary intervention) to reduce cardiovascular morbidity and mortality. Strong for a For additional information, please refer to the section on Grading Recommendations in the full text Dyslipidemia CPG * Statin doses listed as moderate are equivalent to moderate intensity; statin doses listed as high are equivalent to high intensity **Higher risk patients include those with (1) MI or ACS in past 12 months; (2) recurrent ACS, MI, or CVA; or (3) established CVD and with additional risk factors (e.g., currently smoking, DM, PAD, or CABG/PCI) VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Algorithm This CPG s algorithm is designed to facilitate understanding of the clinical pathway and decision-making process used in identifying patients at risk for CVD who are then eligible for management of their dyslipidemia. This algorithm format represents a simplified flow of the management of patients with dyslipidemia and helps foster efficient decision making by providers. It includes: An ordered sequence of steps of care Recommended decision criteria Decisions to be considered Actions to be taken The algorithm is a step-by-step decision tree. Standardized symbols are used to display each step, and arrows connect the numbered boxes indicating the order in which the steps should be followed.[2] Sidebars provide more detailed information to assist in defining and interpreting elements in the boxes.


[2] Sidebars provide more detailed information to assist in defining and interpreting elements in the boxes. Shape Description Rounded rectangles represent a clinical state or condition Hexagons represent a decision point in the guideline, formulated as a question that can be answered Yes or No Rectangles represent an action in the process of care Ovals represent a link to another section within the guideline VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Algorithm: Management of Dyslipidemia for Cardiovascular Risk Reduction * There are no evidence-based recommendations for patients under age 40 because there is no evidence for the benefit of lipid screening and treatment within this age group. In patients younger than 40 years old interested in pursuing lipid testing and management, shared decision making is recommended to discuss the risks and unknown benefit of pharmacotherapy, with therapeutic lifestyle changes being the primary focus of CVD primary prevention. Suggest regular aerobic activity of any intensity or duration. Although incremental benefit is associated with increased doses of physical activity, lower doses including leisure time activity (i.e., walking, landscaping, washing dishes) are associated with benefit when compared to mostly sedentary behavior. A provider s considerations when recommending physical activity might include a patient s motivation, functional capacity, and physical activity preferences. Abbreviations: ACS: acute coronary syndrome; CABG: coronary artery bypass grafting; CVD: cardiovascular disease; DM: diabetes mellitus; EF: ejection fraction; ESRD: end-stage renal disease; HF: heart failure; LDL: low-density lipoprotein cholesterol; mg/dL: milligrams per deciliter; MI: myocardial infarction; PCI: percutaneous coronary intervention VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Sidebar 1: CVD and Equivalents MI or ACS CABG/PCI Stable CAD (angina or equivalent) Atherosclerotic CVA/TIA PAD (claudication or AAA) Does not include asymptomatic incidental finding of potential atherosclerosis (e.g.


Abbreviations: ACS: acute coronary syndrome; CABG: coronary artery bypass grafting; CVD: cardiovascular disease; DM: diabetes mellitus; EF: ejection fraction; ESRD: end-stage renal disease; HF: heart failure; LDL: low-density lipoprotein cholesterol; mg/dL: milligrams per deciliter; MI: myocardial infarction; PCI: percutaneous coronary intervention VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Sidebar 1: CVD and Equivalents MI or ACS CABG/PCI Stable CAD (angina or equivalent) Atherosclerotic CVA/TIA PAD (claudication or AAA) Does not include asymptomatic incidental finding of potential atherosclerosis (e.g., CAC) Abbreviations: AAA: abdominal aortic aneurysm; ACS: acute coronary syndrome; CABG: coronary artery bypass grafting; CAC: coronary artery calcium; CAD: coronary artery disease; CVA: cerebrovascular accident; CVD: cardiovascular disease; MI: myocardial infarction; PAD: peripheral arterial disease; PCI: percutaneous coronary intervention; TIA: transient ischemic attack Abbreviations: ACS: acute coronary syndrome; CABG: coronary artery bypass grafting; CVA: cerebrovascular accident; CVD: cardiovascular disease; DM: diabetes mellitus; MI: myocardial infarction; PAD: peripheral arterial disease; PCI: percutaneous coronary intervention Sidebar 3: Drug Doses Generic name Moderate-dose High-dose Simvastatin 20 40 mg N/A Pravastatin 40 80 mg N/A Lovastatin 40 80 mg N/A Fluvastatin 80 mg (XL) or 40 mg BID N/A Pitavastatin 1 4 mg N/A In patients who are intolerant of statins: after washout (e.g., 1 month), re-challenge with same or a different statin or lower dose, and if that fails, a trial of intermittent (nondaily) dosing Intensified patient care (e.g.


, 1 month), re-challenge with same or a different statin or lower dose, and if that fails, a trial of intermittent (nondaily) dosing Intensified patient care (e.g., phone calls, emails, patient education, drug regimen simplification) may improve adherence to lipid-lowering medications Statin doses listed as moderate are equivalent to moderate intensity; statin doses listed as high are equivalent to high intensity Abbreviations: BID: twice per day; mg: milligrams; XL: sustained release Sidebar 2: Higher Risk CVD Patients MI or ACS in past 12 months; or Recurrent ACS, MI, or CVA; or Known CVD (see Sidebar 1) and any of the following: currently smoking, DM, PAD, or CABG/PCI VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Statin and Non-statin Pharmacologic Agents Table 1. Summary of Statin and Non-statin Pharmacologic Agents* Drug Category Dose Major Drug Interactions Adverse Drug Reactions Notes Statins Atorvastatin once daily Since statins vary in their metabolic pathway, refer to product labeling for drug-drug interactions and statin dose limits Risk for myalgia, myopathy and, very rarely, rhabdomyolysis. Other risks include diabetes, LFT elevations, and asymptomatic CK elevations. First line therapy for primary or secondary prevention of CVD Rosuvastatin 5 40 mg once daily Simvastatin 5 40 mg once daily Lovastatin once daily Pravastatin once daily Fluvastatin 20 80 mg per day Pitavastatin 1 4 mg once daily Cholesterol absorption inhibitors Ezetimibe 10 mg once daily Increased incidence of transaminase elevation >3x ULN when combined with statins versus statins respectively) Generally well tolerated Benefit for reducing non- fatal CV events in secondary prevention patients in addition to statin inhibitors Alirocumab 75 mg once every 2 weeks OR 300 mg once every 4 weeks Max: 150 mg every 2 weeks No known significant interactions Injection site reactions (3 7%).


First line therapy for primary or secondary prevention of CVD Rosuvastatin 5 40 mg once daily Simvastatin 5 40 mg once daily Lovastatin once daily Pravastatin once daily Fluvastatin 20 80 mg per day Pitavastatin 1 4 mg once daily Cholesterol absorption inhibitors Ezetimibe 10 mg once daily Increased incidence of transaminase elevation >3x ULN when combined with statins versus statins respectively) Generally well tolerated Benefit for reducing non- fatal CV events in secondary prevention patients in addition to statin inhibitors Alirocumab 75 mg once every 2 weeks OR 300 mg once every 4 weeks Max: 150 mg every 2 weeks No known significant interactions Injection site reactions (3 7%). Adverse reactions inhibitors reported in RCTs appear to be similar to placebo. Alirocumab had higher incidence of influenza, bronchitis, myalgia, muscle spasm, sinusitis, cough, and musculoskeletal pain compared to placebo Evolocumab had a higher incidence of cough, arthralgia, and fatigue Benefit for reducing non-fatal CV events in secondary prevention in addition to maximally tolerated statin +/- ezetimibe It is recommended that patients receive maximally tolerated statins plus ezetimibe prior to adding alirocumab or evolocumab Limited data on long- term safety Evolocumab 140 mg once every 2 weeks OR 420 mg once monthly VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Drug Category Dose Major Drug Interactions Adverse Drug Reactions Notes fatty acids Icosapent ethyl 2 gm twice daily with meals May enhance antiplatelet and anticoagulation effects. Caution with concomitant agents that increase risk of bleeding. oropharyngeal pain, peripheral edema, constipation, gout, and atrial fibrillation. Potential for allergic reactions in patients with fish allergy.


oropharyngeal pain, peripheral edema, constipation, gout, and atrial fibrillation. Potential for allergic reactions in patients with fish allergy. Benefit for reduction of CV mortality and morbidity in patients treated for secondary prevention on statins with persistently elevated TG (>150 mg/dL); evidence is limited to one RCT Hospitalization for atrial fibrillation or flutter was statistically higher with icosapent and a non-significant trend towards a higher incidence of hospitalization for serious bleeding events was also observed * Refer to product prescribing insert for more information regarding use restrictions, dose modification, dosing in special populations (e.g., renal or liver impairment, advanced age, pregnancy, etc.)


Benefit for reduction of CV mortality and morbidity in patients treated for secondary prevention on statins with persistently elevated TG (>150 mg/dL); evidence is limited to one RCT Hospitalization for atrial fibrillation or flutter was statistically higher with icosapent and a non-significant trend towards a higher incidence of hospitalization for serious bleeding events was also observed * Refer to product prescribing insert for more information regarding use restrictions, dose modification, dosing in special populations (e.g., renal or liver impairment, advanced age, pregnancy, etc.), drug-drug interactions, and adverse events Abbreviations: CK: creatine kinase; CV: cardiovascular; CVD: cardiovascular disease; dL: deciliter; gm: grams; LFT: liver function test; mg: milligrams; PCSK9: proprotein convertase subtilisin/kexin type 9; RCT: randomized controlled trial; TG: triglyceride; ULN: upper limit of the normal range Guideline Work Group Organization Name* Department of Veterans Affairs John R. Rick Downs, MD, FACP (Champion) Jennifer Ballard-Hernandez, DNP, FNP-BC Andrew Buelt, DO Mark Donahue, MD Cathy Kelley, PharmD Amanda Logan, MPS, RDN, LD Sundar Natarajan, MD, MSc Lance Spacek, MD Department of Defense Lt Col Brian Neubauer, MD, MHPE, FACP (Champion) COL Patrick G. O Malley, MD, MPH, FACP (Champion) CDR Michael J. Arnold, MD Karen Grace, PharmD Joan Ritter, MD, FACP LTC Nikki Smith, DNP, FNP-BC Lauren Thomas, MS, RD, LD Elena Vagichev, PharmD, BCPS, BCACP VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Organization Name* Office of Quality and Patient Safety Veterans Health Administration M. Eric Rodgers, PhD, FNP-BC James Sall, PhD, FNP-BC Rene Sutton, BS, HCA Office of Evidence Based Practice U.S. Army Medical Command Corinne K. B. Devlin, MSN, RN, FNP-BC Lisa Jones, BSN, RN, MHA, CPHQ The Lewin Group Clifford Goodman, PhD Christine Jones, MS, MPH, PMP Erika Beam, MS Ben Agatston, JD, MPH Nicolas Stettler-Davis, MD, MSCE Ruben Ganesh, BS ECRI James Reston, PhD, MPH Jeff Oristaglio, PhD Joann Fontanarosa, PhD Kristy McShea, MSLIS Benjamin Rouse, MHS Nancy Sullivan, BA Anjali Jain Research & Consulting Anjali Jain, MD Sigma Health Consulting Frances Murphy, MD, MPH Duty First Consulting Rachel Piccolino, BA Megan McGovern, BA MK Curley, BA *Additional contributor contact information is available in Appendix H in the full Dyslipidemia CPG.


, drug-drug interactions, and adverse events Abbreviations: CK: creatine kinase; CV: cardiovascular; CVD: cardiovascular disease; dL: deciliter; gm: grams; LFT: liver function test; mg: milligrams; PCSK9: proprotein convertase subtilisin/kexin type 9; RCT: randomized controlled trial; TG: triglyceride; ULN: upper limit of the normal range Guideline Work Group Organization Name* Department of Veterans Affairs John R. Rick Downs, MD, FACP (Champion) Jennifer Ballard-Hernandez, DNP, FNP-BC Andrew Buelt, DO Mark Donahue, MD Cathy Kelley, PharmD Amanda Logan, MPS, RDN, LD Sundar Natarajan, MD, MSc Lance Spacek, MD Department of Defense Lt Col Brian Neubauer, MD, MHPE, FACP (Champion) COL Patrick G. O Malley, MD, MPH, FACP (Champion) CDR Michael J. Arnold, MD Karen Grace, PharmD Joan Ritter, MD, FACP LTC Nikki Smith, DNP, FNP-BC Lauren Thomas, MS, RD, LD Elena Vagichev, PharmD, BCPS, BCACP VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Organization Name* Office of Quality and Patient Safety Veterans Health Administration M. Eric Rodgers, PhD, FNP-BC James Sall, PhD, FNP-BC Rene Sutton, BS, HCA Office of Evidence Based Practice U.S. Army Medical Command Corinne K. B. Devlin, MSN, RN, FNP-BC Lisa Jones, BSN, RN, MHA, CPHQ The Lewin Group Clifford Goodman, PhD Christine Jones, MS, MPH, PMP Erika Beam, MS Ben Agatston, JD, MPH Nicolas Stettler-Davis, MD, MSCE Ruben Ganesh, BS ECRI James Reston, PhD, MPH Jeff Oristaglio, PhD Joann Fontanarosa, PhD Kristy McShea, MSLIS Benjamin Rouse, MHS Nancy Sullivan, BA Anjali Jain Research & Consulting Anjali Jain, MD Sigma Health Consulting Frances Murphy, MD, MPH Duty First Consulting Rachel Piccolino, BA Megan McGovern, BA MK Curley, BA *Additional contributor contact information is available in Appendix H in the full Dyslipidemia CPG. Methods The 2020 Dyslipidemia CPG is an update to the 2014 VA/DoD Dyslipidemia CPG.


Methods The 2020 Dyslipidemia CPG is an update to the 2014 VA/DoD Dyslipidemia CPG. The methodology used in developing the 2020 CPG follows the Guideline for Guidelines, a VA and DoD EBPWG document that was updated in January 2019.[4] The Guideline for Guidelines can be downloaded from http://www.healthquality.va.gov/policy/index.asp and a full description of this guideline s methodology is available at https://www.healthquality.va.gov/guidelines/cd/lipids/. Patient-centered Care VA/DoD CPGs encourage a patient-centered care approach (i.e., individualized treatment based on patient needs, characteristics, and preferences) that is culturally appropriate and available to people with limited literacy skills, and physical, sensory, or learning disabilities. Regardless of the setting, all patients should be able to access evidence-based care that is appropriate to them. Patient-centered care may decrease patient anxiety, increase trust in providers, and improve treatment adherence.[8-10] Good communication is essential and should be supported by evidence-based information tailored to the patient s needs. An empathetic and non-judgmental approach facilitates discussions sensitive to gender, culture, ethnicity, and other differences. The focus is using an individual s risk factors and event history to guide the various treatment and management strategies among patients at risk for CVD morbidity and mortality. VA/DoD CPG for the Management of Dyslipidemia for Cardiovascular Risk Reduction Provider Summary Shared Decision Making The authors of this CPG encourage providers to practice shared decision making. Shared decision making was emphasized in Crossing the Quality Chasm, an Institute of Medicine (IOM) (now the NAM) report, in 2001.[11] Providers must be adept at presenting information to their patients regarding individual treatments, expected risks, expected outcomes, and levels and/or locations of care, especially as differences between risks and benefits become less clear. Shared decision making strategies should be used to individualize treatment goals and plans based on patient capabilities, needs, and preferences. References 1.


Shared decision making strategies should be used to individualize treatment goals and plans based on patient capabilities, needs, and preferences. References 1. U.S. Department of Veterans Affairs/Department of Defense Health Executive Committee (HEC). Evidence based practice work group charter. January 9, 2017. 2. Society for Medical Decision Making Committee on Standardization of Clinical Algorithms. Proposal for clinical algorithm standards. Med Decis Making. Apr-Jun 1992;12(2):149-154. PMID: 1573982. 3. U.S. Department of Veterans Affairs and Department of Defense. Va/dod clinical practice guideline for the management of dyslipidemia for cardiovascular risk reduction. 2014; https://www.healthquality.va.gov/guidelines/CD/lipids/VADoDDyslipidemiaCPG2014.pdf. 4. U.S. Department of Veteran Affairs, Department of Defense. Guideline for guidelines. Veterans Health Administration, Office of Quality & Performance, Evidence Review Subgroup; Revised January 29, 2019. 5. Andrews J, Guyatt G, Oxman AD, et al. GRADE guidelines: 14. Going from evidence to recommendations: The significance and presentation of recommendations. J Clin Epidemiol. Jul 2013;66(7):719-725. PMID: 23312392. 6. National Institute for Health and Care Excellence. The guidelines manual. 2012; September 16, 2019. 7. Martinez Garcia L, McFarlane E, Barnes S, Sanabria AJ, Alonso-Coello P, Alderson P. Updated recommendations: An assessment of NICE clinical guidelines. Implement Sci. 2014;9:72. PMID: 24919856. 8. Robinson JH, Callister LC, Berry JA, Dearing KA. Patient-centered care and adherence: definitions and applications to improve outcomes. J Am Acad Nurse Pract. Dec 2008;20(12):600-607. PMID: 19120591. 9. Stewart M, Brown JB, Donner A, et al. The impact of patient-centered care on outcomes. J Fam Pract. Sep 2000;49(9):796-804. PMID: 11032203. 10. Fiscella K, Meldrum S, Franks P, et al. Patient trust: Is it related to patient-centered behavior of primary care physicians? Med Care. Nov 2004;42(11):1049-1055. PMID: 15586831. 11. Institute of Medicine. Crossing the quality chasm: A new health system for the 21st century. Washington DC: National Academies Press; 2001.


Crossing the quality chasm: A new health system for the 21st century. Washington DC: National Academies Press; 2001. Access to the full guideline and additional resources are available at the following link: https://www.healthquality.va.gov/guidelines/CD/lipids


Atrial fibrillation: diagnosis and management NICE guideline NICE 2022. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Last updated 30 June 2021 Your responsibility The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian. All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme. Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Contents Overview 5 Who is it for?


Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Contents Overview 5 Who is it for? 5 1.1 Detection and diagnosis 6 1.2 Assessment of stroke and bleeding risks 7 1.3 Assessment of cardiac function 9 1.4 Personalised package of care and information 10 1.5 Referral for specialised management 11 1.6 Stroke prevention 11 1.7 Rate and rhythm control 15 1.8 Management for people presenting acutely with atrial fibrillation 20 1.9 Initial management of stroke and atrial fibrillation 22 1.10 Preventing and managing postoperative atrial fibrillation 23 Terms used in this guideline 25 Recommendations for research 27 Key recommendations for research 27 Rationale and impact 30 Detection and diagnosis 30 Stroke risk 31 Bleeding risk 32 Stroke prevention 34 Rate control 35 Left atrial ablation 37 Preventing recurrence after ablation 38 Rate and rhythm control for people presenting acutely 40 Preventing postoperative atrial fibrillation 40 Managing atrial fibrillation after cardiothoracic surgery 41 Stopping anticoagulation 42 Finding more information and committee details 45 Update information 46 This guideline replaces CG180. This guideline is the basis of QS93. Overview This guideline covers diagnosing and managing atrial fibrillation in adults. It includes guidance on providing the best care and treatment for people with atrial fibrillation, including assessing and managing risks of stroke and bleeding. The recommendations in this guideline were developed before the COVID-19 pandemic. See the MHRA advice on warfarin and other anticoagulants monitoring of patients during the COVID-19 pandemic, which includes reports of supratherapeutic anticoagulation with warfarin. Who is it for?


See the MHRA advice on warfarin and other anticoagulants monitoring of patients during the COVID-19 pandemic, which includes reports of supratherapeutic anticoagulation with warfarin. Who is it for? Healthcare professionals Commissioners and providers People with atrial fibrillation, their families and carers Recommendations People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about your care. Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding. 1.1 Detection and diagnosis 1.1.1 Perform manual pulse palpation to assess for the presence of an irregular pulse if there is a suspicion of atrial fibrillation. This includes people presenting with any of the following: breathlessness palpitations syncope or dizziness chest discomfort stroke or transient ischaemic attack. [2006] 1.1.2 Perform a 12-lead electrocardiogram (ECG) to make a diagnosis of atrial fibrillation if an irregular pulse is detected in people with suspected atrial fibrillation with or without symptoms. [2021] 1.1.3 In people with suspected paroxysmal atrial fibrillation undetected by 12-lead ECG recording: use a 24-hour ambulatory ECG monitor if asymptomatic episodes are suspected or symptomatic episodes are less than 24 hours apart use an ambulatory ECG monitor, event recorder or other ECG technology for a period appropriate to detect atrial fibrillation if symptomatic episodes are more than 24 hours apart. [2021] For a short explanation of why the committee made the 2021 recommendations and how they might affect practice, see the rationale and impact section on detection and diagnosis.


[2021] For a short explanation of why the committee made the 2021 recommendations and how they might affect practice, see the rationale and impact section on detection and diagnosis. Full details of the evidence and the committee's discussion are in evidence review A: effectiveness of tests for detection and evidence review B: accuracy of tests for detection. 1.2 Assessment of stroke and bleeding risks Stroke risk 1.2.1 Use the CHA2DS2-VASc stroke risk score to assess stroke risk in people with any of the following: symptomatic or asymptomatic paroxysmal, persistent or permanent atrial fibrillation atrial flutter a continuing risk of arrhythmia recurrence after cardioversion back to sinus rhythm or catheter ablation. [2021] See the section on review of people with atrial fibrillation for advice on reassessment of stroke risk. For a short explanation of why the committee made this recommendation and how it might affect practice, see the rationale and impact section on stroke risk. Full details of the evidence and the committee's discussion are in evidence review C and D: tools to predict stroke in people with atrial fibrillation. Bleeding risk 1.2.2 Assess the risk of bleeding when: considering starting anticoagulation in people with atrial fibrillation and reviewing people already taking anticoagulation. Use the ORBIT bleeding risk score because evidence shows that it has a higher accuracy in predicting absolute bleeding risk than other bleeding risk tools. Accurate knowledge of bleeding risk supports shared decision making and has practical benefits, for example, increasing patient confidence and willingness to accept treatment when risk is low and prompting discussion of risk reduction when risk is high. Although ORBIT is the best tool for this purpose, other bleeding risk tools may need to be used until it is embedded in clinical pathways and electronic systems.


Although ORBIT is the best tool for this purpose, other bleeding risk tools may need to be used until it is embedded in clinical pathways and electronic systems. [2021] 1.2.3 Offer monitoring and support to modify risk factors for bleeding, including: uncontrolled hypertension (see NICE's guideline on hypertension in adults) poor control of international normalised ratio (INR) in patients on vitamin K antagonists concurrent medication, including antiplatelets, selective serotonin reuptake inhibitors (SSRIs) and non-steroidal anti-inflammatory drugs (NSAIDs) harmful alcohol consumption (see NICE's guideline on alcohol-use disorders: diagnosis, assessment and management of harmful drinking and alcohol dependence) reversible causes of anaemia. [2021] Discussing the results of the risk assessment 1.2.4 Discuss the results of the assessments of stroke and bleeding risk with the person taking into account their specific characteristics, for example comorbidities, and their individual preferences. For further guidance, see the section on enabling patients to actively participate in their care in NICE's guideline on patient experience in adult NHS services. [2021] For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on bleeding risk. Full details of the evidence and the committee's discussion are in evidence review E and F: risk stratification tools for predicting bleeding in people with atrial fibrillation.


Full details of the evidence and the committee's discussion are in evidence review E and F: risk stratification tools for predicting bleeding in people with atrial fibrillation. 1.3 Assessment of cardiac function 1.3.1 Perform transthoracic echocardiography (TTE) in people with atrial fibrillation: for whom a baseline echocardiogram is important for long-term management for whom a rhythm-control strategy that includes cardioversion (electrical or pharmacological) is being considered in whom there is a high risk or a suspicion of underlying structural or functional heart disease (such as heart failure or heart murmur) that influences their subsequent management (for example, choice of antiarrhythmic drug) in whom refinement of clinical risk stratification for antithrombotic therapy is needed (see section 1.2 on assessment of stroke and bleeding risks and section 1.6 on stroke prevention). [2006, amended 2014] 1.3.2 Do not routinely perform TTE solely for the purpose of further stroke risk stratification in people with atrial fibrillation for whom the need to start anticoagulation therapy has already been agreed on appropriate clinical criteria (see section 1.2 on assessment of stroke and bleeding risks and section 1.6 on stroke prevention). [2006, amended 2014] 1.3.3 Perform transoesophageal echocardiography (TOE) in people with atrial fibrillation: when TTE demonstrates an abnormality (such as valvular heart disease) that warrants further specific assessment in whom TTE is technically difficult and/or of questionable quality and when there is a need to exclude cardiac abnormalities for whom TOE-guided cardioversion is being considered. [2006] 1.4 Personalised package of care and information 1.4.1 Offer people with atrial fibrillation a personalised package of care.


[2006] 1.4 Personalised package of care and information 1.4.1 Offer people with atrial fibrillation a personalised package of care. Ensure that the package of care is documented and delivered, and that it covers: stroke awareness and measures to prevent stroke rate control assessment of symptoms for rhythm control who to contact for advice if needed psychological support if needed up-to-date and comprehensive education and information on: cause, effects and possible complications of atrial fibrillation management of rate and rhythm control anticoagulation practical advice on anticoagulation in line with the recommendations on information and support for people having anticoagulation treatment in NICE's guideline on venous thromboembolic diseases support networks (for example, cardiovascular charities). [2014] 1.4.2 Follow the recommendations in NICE's guideline on shared decision Medicines adherences and optimisation 1.4.3 To support adherence and ensure safe and effective medicines use in people with atrial fibrillation, follow the recommendations in NICE's guidelines on medicines adherence and medicines optimisation. [2021] 1.5 Referral for specialised management 1.5.1 Refer people promptly at any stage if treatment fails to control the symptoms of atrial fibrillation and more specialised management is needed. This should be within 4 weeks after the failed treatment or after recurrence of atrial fibrillation after cardioversion. [2014] 1.6 Stroke prevention Anticoagulation 1.6.1 When discussing the benefits and risks of anticoagulation use clinical risk profiles and personal preferences to guide treatment choices. Discuss with the person that: for most people the benefit of anticoagulation outweighs the bleeding risk for people with an increased risk of bleeding, the benefit of anticoagulation may not always outweigh the bleeding risk, and careful monitoring of bleeding risk is important.


Discuss with the person that: for most people the benefit of anticoagulation outweighs the bleeding risk for people with an increased risk of bleeding, the benefit of anticoagulation may not always outweigh the bleeding risk, and careful monitoring of bleeding risk is important. [2021] 1.6.2 When deciding between anticoagulation treatment options: Discuss the risks and benefits of different drugs with the person and follow the Follow the recommendations on patient involvement in decisions about medicines in NICE's guideline on medicines adherence and patient decision aids in NICE's guideline on medicines optimisation. Take into account any contraindications for each drug and follow the guidance in the British National Formulary and the MHRA advice on direct-acting oral anticoagulants, in particular for advice on dosages in people with renal impairment, reversal agents and monitoring. [2021] 1.6.3 Offer anticoagulation with a direct-acting oral anticoagulant to people with atrial fibrillation and a CHA2DS2-VASc score of 2 or above, taking into account the risk of bleeding. Apixaban, dabigatran, edoxaban and rivaroxaban are all recommended as options, when used in line with the criteria specified in the relevant NICE technology appraisal guidance (see the NICE technology appraisal guidance on our topic page on embolism and thrombosis). [2021] 1.6.4 Consider anticoagulation with a direct-acting oral anticoagulant for men with atrial fibrillation and a CHA2DS2-VASc score of 1, taking into account the risk of bleeding. Apixaban, dabigatran, edoxaban and rivaroxaban are all recommended as options, when used in line with the criteria specified in the relevant NICE technology appraisal guidance (see the NICE technology appraisal guidance on our topic page on embolism and 1.6.5 If direct-acting oral anticoagulants are contraindicated, not tolerated or not suitable in people with atrial fibrillation, offer a vitamin K antagonist. See the section on self-monitoring and self-management of vitamin K antagonists. [2021].


See the section on self-monitoring and self-management of vitamin K antagonists. [2021]. 1.6.6 For adults with atrial fibrillation who are already taking a vitamin K antagonist and are stable, continue with their current medication and discuss the option of switching treatment at their next routine appointment, taking into account the person's time in therapeutic range. 1.6.7 Do not offer stroke prevention therapy with anticoagulation to people aged under 65 years with atrial fibrillation and no risk factors other than their sex (that is, very low risk of stroke equating to a CHA2DS2-VASc score of 0 for men or 1 for women). [2021] 1.6.8 Do not withhold anticoagulation solely because of a person's age or their risk of falls. [2021] For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on stroke prevention. Full details of the evidence and the committee's discussion are in evidence review G1: anticoagulant therapy for stroke prevention in people with atrial fibrillation and evidence review G2: anticoagulant therapy health economics analysis. Assessing anticoagulation control with vitamin K antagonists 1.6.9 Calculate the person's time in therapeutic range (TTR) at each visit. When calculating TTR: use a validated method of measurement such as the Rosendaal method for computer-assisted dosing or proportion of tests in range for manual dosing exclude measurements taken during the first 6 weeks of treatment calculate TTR over a maintenance period of at least 6 months. [2014] 1.6.10 Reassess anticoagulation for a person whose anticoagulation is poorly controlled shown by any of the following: 2 INR values higher than 5 or 1 INR value higher than 8 within the past 2 INR values less than 1.5 within the past 6 months TTR less than 65%.


[2014] 1.6.10 Reassess anticoagulation for a person whose anticoagulation is poorly controlled shown by any of the following: 2 INR values higher than 5 or 1 INR value higher than 8 within the past 2 INR values less than 1.5 within the past 6 months TTR less than 65%. [2014] 1.6.11 When reassessing anticoagulation, take into account and if possible address the following factors that may contribute to poor anticoagulation control: cognitive function adherence to prescribed therapy illness interacting drug therapy lifestyle factors including diet and alcohol consumption. [2014] 1.6.12 If poor anticoagulation control cannot be improved, evaluate the risks and benefits of alternative stroke prevention strategies and discuss these with the person. [2014] Self-monitoring and self-management of vitamin K antagonists NICE has developed diagnostics guidance on atrial fibrillation and heart valve disease: self-monitoring coagulation status using point-of-care coagulometers (the CoaguChek XS system). Antiplatelets For guidance on antiplatelet therapy for people who have had a myocardial infarction and are having anticoagulation, see antiplatelet therapy for people with an ongoing separate indication for anticoagulation in NICE's guideline on acute coronary syndromes. 1.6.13 Do not offer aspirin monotherapy solely for stroke prevention to people with atrial fibrillation. [2014] Review of people with atrial fibrillation 1.6.14 For people who are not taking an anticoagulant, review stroke risk when they reach age 65 or if they develop any of the following at any age: diabetes heart failure peripheral arterial disease coronary heart disease stroke, transient ischaemic attack or systemic thromboembolism. [2014] 1.6.15 For people who are not taking an anticoagulant because of bleeding risk or other factors, review stroke and bleeding risks annually, and ensure that all reviews and decisions are documented.


[2014] 1.6.15 For people who are not taking an anticoagulant because of bleeding risk or other factors, review stroke and bleeding risks annually, and ensure that all reviews and decisions are documented. [2014] 1.6.16 For people who are taking an anticoagulant, review the need for anticoagulation and the quality of anticoagulation (taking into account MHRA advice on direct-acting oral anticoagulants about bleeding risk and the need to monitor renal function in patients with renal impairment) at least annually, or more frequently if clinically relevant events occur affecting anticoagulation or bleeding risk. [2014] Left atrial appendage occlusion 1.6.17 Consider left atrial appendage occlusion (LAAO) if anticoagulation is contraindicated or not tolerated and discuss the benefits and risks of LAAO with the person. For more information see NICE's interventional procedure guidance on percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation for the prevention of 1.6.18 Do not offer LAAO as an alternative to anticoagulation unless anticoagulation is contraindicated or not tolerated. [2014] 1.7 Rate and rhythm control This section covers rate and rhythm control in non-acute settings. See section 1.8 for rate and rhythm control for people presenting acutely (either new onset or destabilisation of existing atrial fibrillation).


See section 1.8 for rate and rhythm control for people presenting acutely (either new onset or destabilisation of existing atrial fibrillation). Rate control 1.7.1 Offer rate control as the first-line treatment strategy for atrial fibrillation except in people: whose atrial fibrillation has a reversible cause who have heart failure thought to be primarily caused by atrial fibrillation with new-onset atrial fibrillation with atrial flutter whose condition is considered suitable for an ablation strategy to restore sinus rhythm for whom a rhythm-control strategy would be more suitable based on clinical 1.7.2 Offer either a standard beta-blocker (that is, a beta-blocker other than sotalol) or a rate-limiting calcium-channel blocker (diltiazem or verapamil) as initial rate-control monotherapy to people with atrial fibrillation unless the person has the features described in recommendation 1.7.4. Base the choice of drug on the person's symptoms, heart rate, comorbidities and preferences. [2021] In April 2021, this was an off-label use of diltiazem. See NICE's information on prescribing medicines. 1.7.3 For people with atrial fibrillation and concomitant heart failure, follow the recommendations on the use of beta-blockers and avoiding calcium- channel blockers in NICE's guideline on chronic heart failure. [2021] 1.7.4 Consider digoxin monotherapy for initial rate control for people with non-paroxysmal atrial fibrillation if: the person does no or very little physical exercise or other rate-limiting drug options are ruled out because of comorbidities or the person's preferences. [2021] 1.7.5 If monotherapy does not control the person's symptoms, and if continuing symptoms are thought to be caused by poor ventricular rate control, consider combination therapy with any 2 of the following: a beta-blocker diltiazem digoxin. [2021] In April 2021, this was an off-label use of diltiazem. See NICE's information on prescribing medicines. 1.7.6 Do not offer amiodarone for long-term rate control.


See NICE's information on prescribing medicines. 1.7.6 Do not offer amiodarone for long-term rate control. [2021] For a short explanation of why the committee made the 2021 recommendations and how they might affect practice, see the rationale and impact section on rate control. Full details of the evidence and the committee's discussion are in evidence review I: non-ablative rate control therapies. Rhythm control 1.7.7 Consider pharmacological and/or electrical rhythm control for people with atrial fibrillation whose symptoms continue after heart rate has been controlled or for whom a rate-control strategy has not been successful. Antiarrhythmic drug therapy 1.7.8 Assess the need for drug treatment for long-term rhythm control, taking into account the person's preferences, associated comorbidities, risks of treatment and likelihood of recurrence of atrial fibrillation. [2014] 1.7.9 Do not offer class 1c antiarrhythmic drugs such as flecainide or propafenone to people with known ischaemic or structural heart disease. 1.7.10 If drug treatment for long-term rhythm control is needed, consider a standard beta-blocker (that is, a beta-blocker other than sotalol) as first-line treatment unless there are contraindications. [2014] 1.7.11 If beta-blockers are contraindicated or unsuccessful, assess the suitability of alternative drugs for rhythm control, taking comorbidities into account. [2014] 1.7.12 Follow the advice on dronedarone as a second-line treatment option for long-term rhythm control after successful cardioversion in NICE's technology appraisal guidance on dronedarone for the treatment of non- permanent atrial fibrillation. [2014] 1.7.13 Consider amiodarone for people with left ventricular impairment or heart 1.7.14 In people with infrequent paroxysms and few symptoms, or if symptoms are induced by known precipitants (such as alcohol, caffeine), a 'no drug treatment' strategy or a 'pill-in-the-pocket' strategy (in which antiarrhythmic drugs are taken only when an episode starts) should be considered and discussed with the person.


[2014] 1.7.13 Consider amiodarone for people with left ventricular impairment or heart 1.7.14 In people with infrequent paroxysms and few symptoms, or if symptoms are induced by known precipitants (such as alcohol, caffeine), a 'no drug treatment' strategy or a 'pill-in-the-pocket' strategy (in which antiarrhythmic drugs are taken only when an episode starts) should be considered and discussed with the person. [2006] 1.7.15 In people with paroxysmal atrial fibrillation, a 'pill-in-the-pocket' strategy should be considered for those who: have no history of left ventricular dysfunction, or valvular or ischaemic heart disease and have a history of infrequent symptomatic episodes of paroxysmal atrial fibrillation and have a systolic blood pressure greater than 100 mmHg and a resting heart rate above 70 bpm and are able to understand how to, and when to, take the medication. [2006] Cardioversion 1.7.16 For people having cardioversion for atrial fibrillation that has persisted for longer than 48 hours, offer electrical (rather than pharmacological) 1.7.17 Consider amiodarone therapy starting 4 weeks before and continuing for up to 12 months after electrical cardioversion to maintain sinus rhythm, and discuss the benefits and risks of amiodarone with the person. [2014] 1.7.18 For people with atrial fibrillation of greater than 48 hours' duration, in whom elective cardioversion is indicated: both transoesophageal echocardiography (TOE)-guided cardioversion and conventional cardioversion should be considered equally effective a TOE-guided cardioversion strategy should be considered: if experienced staff and appropriate facilities are available and if a minimal period of precardioversion anticoagulation is indicated due to the person's choice or bleeding risks. [2006] Left atrial ablation 1.7.19 If drug treatment is unsuccessful, unsuitable or not tolerated in people with symptomatic paroxysmal or persistent atrial fibrillation: consider radiofrequency point-by-point ablation or if radiofrequency point-by-point ablation is assessed as being unsuitable, consider cryoballoon ablation or laser balloon ablation.


[2006] Left atrial ablation 1.7.19 If drug treatment is unsuccessful, unsuitable or not tolerated in people with symptomatic paroxysmal or persistent atrial fibrillation: consider radiofrequency point-by-point ablation or if radiofrequency point-by-point ablation is assessed as being unsuitable, consider cryoballoon ablation or laser balloon ablation. [2021] 1.7.20 When considering left atrial ablation, discuss the risks and benefits and take into account the person's preferences. In particular, explain that the procedure is not always effective and that the resolution of symptoms may not be long-lasting. [2021] 1.7.21 Consider left atrial surgical ablation at the same time as other cardiothoracic surgery for people with symptomatic atrial fibrillation. For NICE interventional procedures guidance on left atrial ablation for atrial fibrillation, see the NICE interventional procedures guidance on our topic page on heart rhythm conditions. For a short explanation of why the committee made the 2021 recommendations and how they might affect practice, see the rationale and impact section on left atrial ablation. Full details of the evidence and the committee's discussion are in evidence review J1: ablation, evidence review J2: ablation network meta-analysis and evidence review J3: ablation cost-effectiveness analysis. Preventing recurrence after ablation 1.7.22 Consider antiarrhythmic drug treatment for 3 months after left atrial ablation to prevent recurrence of atrial fibrillation, taking into account the person's preferences, and the risks and potential benefits. [2021] 1.7.23 Reassess the need for antiarrhythmic drug treatment at 3 months after left atrial ablation. [2021] For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on preventing recurrence after ablation. Full details of the evidence and the committee's discussion are in evidence review K: antiarrhythmic drugs after ablation.


Full details of the evidence and the committee's discussion are in evidence review K: antiarrhythmic drugs after ablation. Pace and ablate strategy 1.7.24 Consider pacing and atrioventricular node ablation for people with permanent atrial fibrillation with symptoms or left ventricular dysfunction thought to be caused by high ventricular rates. [2014] 1.7.25 When considering pacing and atrioventricular node ablation, reassess symptoms and the consequent need for ablation after pacing has been carried out and drug treatment further optimised. [2014] 1.7.26 Consider left atrial catheter ablation before pacing and atrioventricular node ablation for people with paroxysmal atrial fibrillation or heart failure caused by non-permanent (paroxysmal or persistent) atrial fibrillation. 1.8 Management for people presenting acutely with atrial fibrillation Rate and rhythm control for people presenting acutely 1.8.1 Carry out emergency electrical cardioversion, without delaying to achieve anticoagulation, in people with life-threatening haemodynamic instability caused by new-onset atrial fibrillation. [2014] 1.8.2 In people with atrial fibrillation presenting acutely without life-threatening haemodynamic instability: offer either rate or rhythm control if the onset of the arrhythmia is less than offer rate control if onset is more than 48 hours or is uncertain. [2014] 1.8.3 In people with atrial fibrillation presenting acutely with suspected concomitant acute decompensated heart failure, seek senior specialist input on the use of beta-blockers and do not use calcium-channel 1.8.4 Consider either pharmacological or electrical cardioversion depending on clinical circumstances and resources in people with new-onset atrial fibrillation who will be treated with a rhythm-control strategy. [2014] 1.8.5 If pharmacological cardioversion has been agreed on clinical and resource grounds for new-onset atrial fibrillation, offer: a choice of flecainide or amiodarone to people with no evidence of structural or ischaemic heart disease or amiodarone to people with evidence of structural heart disease.


[2014] 1.8.5 If pharmacological cardioversion has been agreed on clinical and resource grounds for new-onset atrial fibrillation, offer: a choice of flecainide or amiodarone to people with no evidence of structural or ischaemic heart disease or amiodarone to people with evidence of structural heart disease. [2014] 1.8.6 In people with atrial fibrillation in whom the duration of the arrhythmia is greater than 48 hours or uncertain and considered for long-term rhythm control, delay cardioversion until they have been maintained on therapeutic anticoagulation for a minimum of 3 weeks. During this period offer rate control as appropriate. [2006, amended 2014] 1.8.7 Do not offer magnesium or a calcium-channel blocker for pharmacological cardioversion. [2014] For a short explanation of why the committee made the 2021 recommendation and how it might affect practice, see the rationale and impact section on rate and rhythm control for people presenting acutely. Full details of the evidence and the committee's discussion are in evidence review I: non-ablative rate control therapies. Anticoagulation for people presenting acutely with atrial fibrillation 1.8.8 In people with new-onset atrial fibrillation who are receiving no, or subtherapeutic, anticoagulation therapy: in the absence of contraindications, offer heparin at initial presentation continue heparin until a full assessment has been made and appropriate antithrombotic therapy has been started, based on risk stratification (see section 1.2 on assessment of stroke and bleeding risks and section 1.6 on stroke prevention).


Anticoagulation for people presenting acutely with atrial fibrillation 1.8.8 In people with new-onset atrial fibrillation who are receiving no, or subtherapeutic, anticoagulation therapy: in the absence of contraindications, offer heparin at initial presentation continue heparin until a full assessment has been made and appropriate antithrombotic therapy has been started, based on risk stratification (see section 1.2 on assessment of stroke and bleeding risks and section 1.6 on stroke prevention). [2006, amended 2014] 1.8.9 In people with a confirmed diagnosis of atrial fibrillation of recent onset (less than 48 hours since onset), offer oral anticoagulation if: stable sinus rhythm is not successfully restored within the same 48-hour period after onset of atrial fibrillation or there are factors indicating a high risk of atrial fibrillation recurrence, including history of failed cardioversion, structural heart disease, prolonged atrial fibrillation (more than 12 months), or previous recurrences or it is recommended in section 1.2 on assessment of stroke and bleeding risks and section 1.6 on stroke prevention. [2006, amended 2014] 1.8.10 In people with new-onset atrial fibrillation, if there is uncertainty over the precise time since onset, offer oral anticoagulation as for persistent atrial fibrillation (see section 1.2 on assessment of stroke and bleeding risks and section 1.6 stroke prevention). [2006, amended 2014] 1.9 Initial management of stroke and atrial fibrillation 1.9.1 For guidance on the initial management of stroke and atrial fibrillation see recommendation 1.4.17 in NICE's guideline on stroke and transient ischaemic attack in over 16s. [2014] 1.10 Preventing and managing postoperative atrial fibrillation Preventing postoperative atrial fibrillation 1.10.1 In people having cardiothoracic surgery: reduce the risk of postoperative atrial fibrillation by offering 1 of the following: amiodarone a standard beta-blocker (that is, a beta-blocker other than sotalol) a rate-limiting calcium-channel blocker (diltiazem or verapamil) do not offer digoxin.


[2014] 1.10 Preventing and managing postoperative atrial fibrillation Preventing postoperative atrial fibrillation 1.10.1 In people having cardiothoracic surgery: reduce the risk of postoperative atrial fibrillation by offering 1 of the following: amiodarone a standard beta-blocker (that is, a beta-blocker other than sotalol) a rate-limiting calcium-channel blocker (diltiazem or verapamil) do not offer digoxin. [2006, amended 2014] In April 2021, this was an off-label use of diltiazem. See NICE's information on prescribing medicines. 1.10.2 In people having cardiothoracic surgery who are already on beta-blocker therapy, continue this treatment unless contraindications develop (such as postoperative bradycardia or hypotension). [2006, amended 2014] 1.10.3 Do not start statins in people having cardiothoracic surgery solely to prevent postoperative atrial fibrillation. [2021] 1.10.4 In people having cardiothoracic surgery who are already on statins, continue this treatment. For further advice on statins for the prevention of cardiovascular disease, see NICE's guideline on cardiovascular disease: risk assessment and reduction. [2021] For a short explanation of why the committee made the 2021 recommendations and how they might affect practice, see the rationale and impact section on preventing postoperative atrial fibrillation. Full details of the evidence and the committee's discussion are in evidence review M: statins for preventing atrial fibrillation after cardiothoracic surgery. Managing postoperative atrial fibrillation Atrial fibrillation after cardiothoracic surgery 1.10.5 Consider either a rhythm-control or rate-control strategy for the initial treatment of new-onset postoperative atrial fibrillation after cardiothoracic surgery. [2021] 1.10.6 If a rhythm-control strategy is chosen, reassess the need for antiarrhythmic drug treatment at a suitable time point (usually at around Atrial fibrillation after non-cardiothoracic surgery 1.10.7 Manage postoperative atrial fibrillation after non-cardiothoracic surgery in the same way as for new-onset atrial fibrillation with any other cause.


[2021] 1.10.6 If a rhythm-control strategy is chosen, reassess the need for antiarrhythmic drug treatment at a suitable time point (usually at around Atrial fibrillation after non-cardiothoracic surgery 1.10.7 Manage postoperative atrial fibrillation after non-cardiothoracic surgery in the same way as for new-onset atrial fibrillation with any other cause. Antithrombotic therapy for postoperative atrial fibrillation 1.10.8 In the prophylaxis and management of postoperative atrial fibrillation, use appropriate antithrombotic therapy and correct identifiable causes (such as electrolyte imbalance or hypoxia). [2006, amended 2014] For a short explanation of why the committee made the 2021 recommendations and how they might affect practice, see the rationale and impact section on managing atrial fibrillation after cardiothoracic surgery. Full details of the evidence and the committee's discussion are in evidence review L: treatment strategies for atrial fibrillation after cardiothoracic surgery. 1.11 Stopping anticoagulation 1.11.1 In people with a diagnosis of atrial fibrillation, do not stop anticoagulation solely because atrial fibrillation is no longer detectable. [2021] 1.11.2 Base decisions to stop anticoagulation on a reassessment of stroke and bleeding risk using CHA2DS2-VASc and ORBIT and a discussion of the person's preferences. [2021] For a short explanation of why the committee made these recommendations and how they might affect practice, see the rationale and impact section on stopping anticoagulation. Full details of the evidence and the committee's discussion are in evidence review H: discontinuing anticoagulation in people whose atrial fibrillation has resolved. Terms used in this guideline This section defines terms that have been used in a particular way for this guideline. People with atrial fibrillation presenting acutely People presenting with atrial fibrillation of definite recent onset or with destabilisation of existing atrial fibrillation. This does not include people with atrial fibrillation that has been discovered incidentally, for example through pulse palpitation before routine blood pressure measurement.


This does not include people with atrial fibrillation that has been discovered incidentally, for example through pulse palpitation before routine blood pressure measurement. Pill-in-the-pocket strategy The person self-manages paroxysmal atrial fibrillation by taking antiarrhythmic drugs only when an episode of atrial fibrillation starts. Paroxysmal atrial fibrillation Episodes of atrial fibrillation that stop within 7 days, usually within 48 hours, without any treatment. Recommendations for research As part of the 2021 update, the guideline committee made 4 new research recommendations (marked [2021]). Research recommendations retained from the 2014 guideline are labelled [2014]. Key recommendations for research 1 Tests to diagnose persistent atrial fibrillation What is the diagnostic accuracy of key index tests (such as the KardiaMobile heart monitor (AliveCor), MyDiagnostik, Microlife BP monitors, iPhone plethysmography and pulse palpation) compared with the gold standard of 12-lead ECG in people with risk factors for or symptoms of atrial fibrillation? [2021] For a short explanation of why the committee made the recommendation for research, see the rationale on detection and diagnosis. Full details of the evidence and the committee's discussion are in evidence review B: accuracy of tests for detection. 2 Tests to diagnose paroxysmal atrial fibrillation What is the diagnostic accuracy of key index tests compared with the gold standard of prolonged ambulatory monitoring in people suspected of having paroxysmal atrial For a short explanation of why the committee made the recommendation for research, see the rationale on detection and diagnosis. Full details of the evidence and the committee's discussion are in evidence review B: accuracy of tests for detection. 3 Stopping anticoagulation after ablation What is the clinical and cost effectiveness of stopping anticoagulation in people whose atrial fibrillation has resolved after ablation?


3 Stopping anticoagulation after ablation What is the clinical and cost effectiveness of stopping anticoagulation in people whose atrial fibrillation has resolved after ablation? [2021] For a short explanation of why the committee made the recommendation for research, see the rationale on stopping anticoagulation. Full details of the evidence and the committee's discussion are in evidence review H: discontinuing anticoagulation in people whose atrial fibrillation has resolved. 4 Stopping anticoagulation after resolution of postoperative atrial fibrillation What is the clinical and cost effectiveness of stopping anticoagulation in people whose postoperative atrial fibrillation after cardiac surgery has resolved? [2021] For a short explanation of why the committee made the recommendation for research, see the rationale on stopping anticoagulation. Full details of the evidence and the committee's discussion are in evidence review H: discontinuing anticoagulation in people whose atrial fibrillation has resolved. 5 Cognitive behavioural therapy for people with atrial fibrillation What is the clinical and cost effectiveness of cognitive behavioural therapy compared with usual care for people with newly diagnosed atrial fibrillation? [2014] 6 Rate-control drug treatment for people aged 75 and over with atrial fibrillation What is the comparative effectiveness of the 3 main drug classes used for rate control (beta-blockers, calcium-channel blockers and digoxin) in people aged 75 and over with atrial fibrillation in controlling symptoms, improving quality of life and reducing morbidity and mortality? [2014] 7 Stroke risk assessment Can routine data from UK primary care databases clarify stroke risk in people with atrial fibrillation according to baseline risk factors and treatment? [2014] Rationale and impact These sections briefly explain why the committee made the recommendations and how they might affect practice.


[2014] Rationale and impact These sections briefly explain why the committee made the recommendations and how they might affect practice. Detection and diagnosis Why the committee made the recommendations The evidence did not support changing the recommended diagnostic tests to either replace 12-lead ECG as the test to confirm persistent atrial fibrillation or replace pulse palpation as the initial step for persistent atrial fibrillation in a 2-step strategy. The committee clarified that 12-lead ECG should be used as the test to confirm atrial fibrillation, to prevent the use of less accurate ECG devices, such as mobile and lead-I ECG devices. The committee agreed that, although the evidence showed that accuracy varied, there was some evidence that new devices were accurate and showed promise. It was noted that NICE has produced diagnostics guidance on lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care. The committee made a research recommendation on tests to diagnose persistent atrial fibrillation to encourage further high-quality research in this area to guide future practice. The committee agreed that the evidence on tests to detect paroxysmal atrial fibrillation was not clear enough to warrant a change in practice from the 2014 recommendation. However, the evidence did show that longer durations of detection increased accuracy. The committee made a research recommendation on tests to diagnose paroxysmal atrial fibrillation. How the recommendations might affect practice The recommendations reflect current good practice and are unlikely to have an impact on practice. Return to recommendations Stroke risk Why the committee made the recommendations The committee decided to prioritise identifying people above or below a certain risk threshold (discrimination) in its interpretation of the evidence rather than estimating a person's risk of stroke in absolute terms.


Return to recommendations Stroke risk Why the committee made the recommendations The committee decided to prioritise identifying people above or below a certain risk threshold (discrimination) in its interpretation of the evidence rather than estimating a person's risk of stroke in absolute terms. The evidence suggested that a score of 2 or more is the ideal threshold for the CHA2DS2-VASC in terms of indicating the need for anticoagulation. (Men with a CHA2DS2-VASc score of 1 were regarded as being at intermediate risk, and a group in whom anticoagulation should also be considered.) The evidence showed that this threshold of 2 or more offered a good combination of high sensitivity (0.92) and adequate specificity (0.23). The high sensitivity means that the tool would correctly identify almost everyone who would later have a stroke if they did not receive anticoagulants. Importantly, this will allow them to be prescribed anticoagulants to reduce their risk of stroke. The adequate specificity means that 23% of the people who would not later have a stroke (even when not taking anticoagulants) would be correctly identified as not needing anticoagulation. This would prevent these people from having adverse events from anticoagulants. It also means that 77% of people who would not later have a stroke (without anticoagulation) would be wrongly identified as needing anticoagulation. However, this was thought to be acceptable given the perceived lesser harms from unnecessarily giving anticoagulants compared with not giving anticoagulants to people who need them, together with the inevitable trade-off between sensitivity and specificity. The ATRIA stroke risk score was shown to have better overall accuracy, but although it had better specificity than CHA2DS2-VASc (fewer false-positive results) it had lower sensitivity, meaning that more people at risk would be missed (more false-negative results) compared with the CHA2DS2-VASc score.


The ATRIA stroke risk score was shown to have better overall accuracy, but although it had better specificity than CHA2DS2-VASc (fewer false-positive results) it had lower sensitivity, meaning that more people at risk would be missed (more false-negative results) compared with the CHA2DS2-VASc score. As already suggested, sensitivity was agreed by the committee to be more important than specificity because the risks of unnecessary anticoagulation are outweighed by the risks of not treating people who need anticoagulation. In addition, the ATRIA risk score may result in a time delay in calculating the results. The committee also discussed that the evidence for the QStroke risk calculator suggested that it might be a useful tool. However, the evidence was limited, and they agreed that further research was needed. How the recommendation might affect practice The recommendation does not constitute a change in practice, and so there would not be a resource impact on the NHS. Return to recommendations Bleeding risk Why the committee made the recommendations The committee agreed that anticoagulation should usually be considered in people at risk of stroke even if bleeding risk is high, and so a bleeding risk tool should not be used to provide a cut off for determining who should have anticoagulation. Instead, the tool should be used to provide accurate knowledge of absolute bleeding risk, which can support discussions between the person and their healthcare professional about bleeding risk modification and appropriate levels of vigilance. They therefore agreed that accurately estimating absolute risk (calibration) is more important than identifying a risk threshold for anticoagulation (discrimination) when choosing between different bleeding risk tools. The committee focused on calibration data for the tools with the most evidence: ORBIT, HAS-BLED and ATRIA.


The committee focused on calibration data for the tools with the most evidence: ORBIT, HAS-BLED and ATRIA. The calibration evidence clearly suggested that ORBIT was more accurate than HAS-BLED and ATRIA at predicting absolute risk of major bleeding, both for people using vitamin K antagonists and those using direct-acting oral anticoagulants. Importantly, ORBIT was better calibrated at all levels of major bleeding risk, including higher levels. ORBIT was also better at predicting absolute risk of intracranial haemorrhage. The discrimination data showed little difference between tools in predicting major bleeding, with some outcome measures showing no difference and others showing a slight benefit for either ORBIT or HAS-BLED. Evidence showed that ORBIT had a significantly higher specificity and a slighter lower sensitivity than the other tools, but the committee agreed that the lower sensitivity would not be a drawback when used to inform discussions of risk. The committee agreed that the evidence overall, and particularly the calibration data demonstrating higher accuracy of absolute risk, strongly supported ORBIT as the tool of choice. The committee agreed that NICE's previous advice on monitoring and addressing modifiable risk factors was still relevant and added reversible causes of anaemia because it is a component of the ORBIT tool. How the recommendations might affect practice Use of the ORBIT score is a change in practice, which will take time to implement. The committee considered that the more accurate prediction of the absolute risk of bleeding is a real advantage in supporting patients and clinicians in shared decision making, which should lead to better clinical outcomes. The committee considered carefully a number of practical issues set out in this section. Overall, the committee concluded that this change is one that is worth making.


Overall, the committee concluded that this change is one that is worth making. One potential concern discussed by the committee is that ORBIT does not include all of the modifiable risk factors included in HAS-BLED so does not serve as a reminder of these to clinicians. However, the committee considered that fully investigating modifiable risk factors is established clinical practice, regardless of the tool used. Another potential challenge is that ORBIT is not the recommended bleeding risk tool for other conditions (such as venous thromboembolism). Therefore, an initial transition period may be needed for training and education in both primary and secondary care while healthcare professionals become familiar with the tool. This will have a resource impact, although it will be time limited. The committee also noted that use of the ORBIT tool, and access to online versions, is straightforward. Finally, the committee also discussed that, unlike HAS-BLED, ORBIT is not embedded in GP systems, which may cause some initial practical difficulties. However, because this will involve changes to centralised software, it is thought that it will be straightforward to implement and ORBIT will quickly be included in GP systems. Neither tool is included in hospital systems although both are widely available on smartphone apps. Return to recommendations Stroke prevention Why the committee made the recommendations Evidence from an analysis of several studies showed that direct-acting oral anticoagulants are more effective than warfarin for a number of outcomes. An economic model also showed that they offered a better balance of benefits to costs than warfarin. There were no studies directly comparing the direct-acting anticoagulants head-to-head but indirect comparisons based on the clinical evidence showed that the different direct-acting oral anticoagulants offered different benefits depending on the outcome considered.


There were no studies directly comparing the direct-acting anticoagulants head-to-head but indirect comparisons based on the clinical evidence showed that the different direct-acting oral anticoagulants offered different benefits depending on the outcome considered. When all these outcomes were combined in the cost-effectiveness analysis, apixaban was the most clinically effective and cost-effective anticoagulant based on UK drug tariff prices at the time. However, the committee had concerns over the lack of head-to-head comparisons, differences in the study populations and uncertainties in the economic model. Based on the evidence and their experience, the committee decided not to recommend one direct-acting oral anticoagulant over the others, but instead to emphasise that treatment should be tailored to the person's clinical needs and preferences. Each anticoagulant has different risks and benefits that should be considered and fully discussed with the person as part of informed shared decision making. The committee highlighted that the choice might be affected by factors such as renal impairment and swallowing difficulties, and that healthcare professionals should refer to the BNF for advice on contraindications and cautions. They also stressed the importance of adherence and factors that might affect this, such as dosing frequency, when making the decision. If direct-acting oral anticoagulants are not suitable, for example in people with antiphospholipid syndrome, the committee agreed that a vitamin K antagonist should be offered. For people already established and stable on a vitamin K antagonist, the committee agreed that the benefits of changing to a direct-acting anticoagulant need to be discussed. Therefore, the risks and benefits of changing medication, the person's time in therapeutic range and the person's preferences should be explored at their next routine appointment. The committee agreed that the existing thresholds for the CHA2DS2-VASc score threshold for anticoagulation are in line with current practice.


The committee agreed that the existing thresholds for the CHA2DS2-VASc score threshold for anticoagulation are in line with current practice. Although bleeding risk scores may occasionally be used as a reason not to offer anticoagulation, the committee agreed that they should typically be used as a prompt to identify and manage modifiable risk factors for bleeding rather than as a reason for not offering anticoagulation in people at increased risk. The committee discussed that when anticoagulation is not given because of bleeding risk, people should have regular review and reconsideration for treatment. The committee were concerned that anticoagulation is sometimes not recommended for people at risk of falls and for older people, even though age is factored into the bleeding risk score and falls are rarely a cause of major haemorrhage. Age was therefore added to the previous recommendation on people at risk of falls to ensure that anticoagulation is offered in this population when needed. The benefits and harms should be discussed with the person. How the recommendations might affect practice The recommendations are likely to lead to a change in current practice, with a reduction in warfarin use. The committee noted that this has been a prescribing trend over recent years and it may lead to a contraction in warfarin clinic services. The unit cost of direct-acting anticoagulants is greater than that for warfarin, so there is likely to be a resource impact from increased use of direct-acting anticoagulants. Return to recommendations Rate control Why the committee made the recommendations The committee made some updates to the 2014 recommendations, based on their experience and knowledge. The use of beta-blockers or rate-limiting calcium-channel blockers for initial rate-control treatment was retained by the committee because this is current practice and there was insufficient evidence to suggest an alternative option.


The use of beta-blockers or rate-limiting calcium-channel blockers for initial rate-control treatment was retained by the committee because this is current practice and there was insufficient evidence to suggest an alternative option. The committee agreed that the choice of treatment should still be made based on the symptoms, heart rate, comorbidities and preferences of those being treated. The committee agreed that the recommendations should refer to NICE's guideline on chronic heart failure for advice on using beta-blockers and avoiding rate-limiting calcium-channel blockers such as diltiazem and verapamil in people who have atrial fibrillation with heart failure. The committee agreed that digoxin monotherapy for non-paroxysmal atrial fibrillation should continue to be considered for people who are sedentary. Based on their experience, the committee agreed that it may also be considered as a treatment option when other rate-limiting drugs are not suitable, so they expanded the recommendation in the previous guideline to also cover these circumstances. The committee were aware that some clinicians feel that digoxin monotherapy is often better than alternatives for improving symptoms; however, the lack of evidence currently available meant that the recommendation for digoxin was not expanded to cover further groups of people. In the absence of new evidence, the committee also agreed with the existing recommendation for combination therapy options if initial monotherapy fails, which is consistent with the committee's experience and current practice. There was a lack of evidence on long-term rate control, and the committee were aware of numerous serious side effects associated with the long-term use of amiodarone (including thyroid, lung and nerve damage), many of which are irreversible. The committee noted that although the most common side effects were less severe, the occurrence of severe side effects was unpredictable and long-term rate control with amiodarone should be avoided.


The committee noted that although the most common side effects were less severe, the occurrence of severe side effects was unpredictable and long-term rate control with amiodarone should be avoided. Amiodarone should only be used as an interim therapy, for example while waiting for cardioversion, and would not usually be taken for longer than 12 months. How the recommendations might affect practice The recommendations reflect current practice. Digoxin monotherapy may now be an option in non-paroxysmal atrial fibrillation if comorbidities or patient preferences limit other rate-control drug choices. However, the committee agreed that this already happens in practice. Return to recommendations Left atrial ablation Why the committee made the recommendations Ablation may be a treatment option if antiarrhythmic drug treatment has not been successful or is not tolerated. The committee reviewed new clinical and health economic evidence for the different types of ablation for people with paroxysmal atrial fibrillation and agreed that the catheter ablation techniques were the most clinically effective ablation options. Thoracoscopy and the hybrid techniques led to lower recurrence, but they also led to more serious adverse effects. There were no clear differences in efficacy between the 4 catheter ablation techniques: radiofrequency point-by-point, radiofrequency multi-electrode, laser and cryoballoon ablation. A new economic model was developed for the guideline using the clinical evidence from people with paroxysmal atrial fibrillation. It showed that radiofrequency point-by-point ablation was more cost effective over a lifetime than antiarrhythmic drug treatment and other ablation strategies in people for whom 1 or more antiarrhythmic drug has failed. Cryoballoon, radiofrequency multi-electrode and laser ablation were the second, third and fourth most cost-effective options respectively. The committee acknowledged that the NHS reference cost used for the catheter ablation procedures may not fully capture differences in resource use between the different techniques.


The committee acknowledged that the NHS reference cost used for the catheter ablation procedures may not fully capture differences in resource use between the different techniques. However, despite further analysis to adjust costs and account for this, radiofrequency point-by-point ablation remained the most cost-effective option, and other catheter ablation techniques are therefore unlikely to provide a cost-effective use of NHS resources. Based on the economic model results the committee agreed that radiofrequency point-by-point ablation should be considered in people with symptomatic paroxysmal atrial fibrillation if drug treatment is unsuccessful, unsuitable or not tolerated. The committee noted that cryoballoon and laser ablation may be more suitable for some patients because they can sometimes be carried out without general anaesthesia, and cryoballoon ablation may be quicker to perform, with same-day discharge more likely. There is also an increased risk of fluid overload from saline irrigated radiofrequency ablation. They decided that either cryoballoon or laser ablation could be considered if radiofrequency point-by-point ablation is not suitable; for example, if a short procedure time is a priority or for people with a recent history of decompensated heart failure who are at increased risk of fluid overload. Radiofrequency multi-electrode was not included as an alternative due to its lower efficacy relative to cryoballoon and laser ablation and concerns about a higher risk of stroke. There was limited evidence for ablation in people with persistent atrial fibrillation. Despite this, the committee decided that the evidence, combined with their experience and knowledge (also noting the Packer et al. CABANA randomized clinical trial, 2019, which contained a mixed population of people with persistent and paroxysmal atrial fibrillation) was sufficient to support ablation as an option to be considered for those with persistent symptoms that are not alleviated by, or who cannot have, antiarrhythmic drugs.


CABANA randomized clinical trial, 2019, which contained a mixed population of people with persistent and paroxysmal atrial fibrillation) was sufficient to support ablation as an option to be considered for those with persistent symptoms that are not alleviated by, or who cannot have, antiarrhythmic drugs. The committee agreed that ablation can be effective in people with persistent atrial fibrillation, and that this population might have as much to gain from ablation as people with paroxysmal symptoms. The committee agreed that the cost-effectiveness analyses of different types of ablation in paroxysmal atrial fibrillation could also be applied to this population. The committee emphasised the importance of discussing the risks and benefits of catheter ablation with the person, in particular the risk of adverse events. The discussion should also include that, in the experience of the committee, the effects of ablation may not be long term. How the recommendations might affect practice The committee noted that the recommendations are likely to reinforce current practice. Ablation is carried out in a relatively restricted population (approximately 1% to 2% of all people with atrial fibrillation currently have ablation) and is usually reserved for people in whom antiarrhythmic drugs have failed. The recommendation is likely to lead to a change in the types of ablation offered, with more people receiving radiofrequency point-by-point ablation and fewer having other catheter ablation techniques. Return to recommendations Preventing recurrence after ablation Why the committee made the recommendations Most of the evidence on preventing recurrence after ablation was for amiodarone. The evidence suggested that amiodarone may reduce recurrence of atrial fibrillation after ablation. However, there was evidence of an increased risk of hospitalisation and the committee noted the known side effects of amiodarone, which, although rare, can be severe and life-threatening.


However, there was evidence of an increased risk of hospitalisation and the committee noted the known side effects of amiodarone, which, although rare, can be severe and life-threatening. There was a lack of evidence for other antiarrhythmic drugs and there were no comparisons between different antiarrhythmic drugs. Therefore, the committee agreed that there was too much uncertainty to recommend one specific antiarrhythmic drug over others. In addition, the studies often made no distinction between people who had been on antiarrhythmic drugs up to ablation and those who had not. There is variation in current practice on whether people who were not previously taking antiarrhythmic drugs should start them after ablation to reduce recurrence. However, the evidence did not support making separate recommendations to clarify this. The committee decided that antiarrhythmic drug treatment should be considered after ablation, but only after discussion with the person, taking into account their preferences for treatment and the potential individual risks and benefits. In particular, the committee noted that people should fully understand the potential adverse events associated with these drugs. While there is some variation, the committee agreed that good current practice is for patients taking antiarrhythmic drugs up to ablation to continue them for 3 months after ablation and reassess the need for drug treatment after this time. How the recommendations might affect practice There is some variation in current practice. Practice is likely to change in some centres both in prescribing and in the need for a more formal reassessment of treatment at 3 months. The impact on use of antiarrhythmic drugs is difficult to predict, but there may be an increase from current levels. Increased resources may be needed for reassessment, but it is anticipated that this could be performed at routine follow-up appointments with a cardiologist.