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- Article
- Table of Contents
- Preamble
- Methodology and Modernization
- 1. Introduction
- 2. General Principles
- 3. Aortic Stenosis
- 7. Mitral Regurgitation
- 11. Prosthetic Valves
- 12. Infective Endocarditis
- ACC/AHA Task Force Members
- Presidents and Staff
- Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (January 2016)
- Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive)—2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (September 2016)
- Appendix 3. Abbreviations
- Footnotes
- References
- Figures & Tables
- Supplemental Materials
- Info & Metrics
- eLetters
- AHA Scientific Statements
- anticoagulation therapy
- aortic stenosis
- cardiac surgery
- heart valves
- mitral regurgitation
- prosthetic valves
- transcatheter aortic valve replacement
- tricuspid stenosis
- valvular heart disease
Table of Contents
Preamblee 1160
1. Introduction e1161
1.1. Methodology and Evidence Review e1162
1.2. Organization of the Writing Group e1162
1.3. Document Review and Approval e1163
2. General Principles e1163
2.4. Basic Principles of Medical Therapy e1163
2.4.2. Infective Endocarditis Prophylaxis: Recommendation e1163
2.4.3. Anticoagulation for Atrial Fibrillation in Patients With VHD: Recommendations (New Section) e1164
3. Aortic Stenosis e1164
3.2. Aortic Stenosis e1164
3.2.4. Choice of Intervention: Recommendations e1164
7. Mitral Regurgitation e1167
7.2. Stages of Chronic MR e1167
7.3. Chronic Primary MR e1168
7.3.3. Intervention: Recommendations e1168
7.4. Chronic Secondary MR e1170
7.4.3. Intervention: Recommendations e1170
11. Prosthetic Valves e1171
11.1. Evaluation and Selection of Prosthetic Valves e1171
11.1.2. Intervention: Recommendations e1171
11.2. Antithrombotic Therapy for Prosthetic Valves e1172
11.2.1. Diagnosis and Follow-Up e1172
11.2.2. Medical Therapy: Recommendations e1173
11.3. Bridging Therapy for Prosthetic Valves e1174
11.3.1. Diagnosis and Follow-Up e1174
11.3.2. Medical Therapy: Recommendations e1174
11.6. Acute Mechanical Prosthetic Valve Thrombosis e1175
11.6.1. Diagnosis and Follow-Up: Recommendation e1175
11.6.3. Intervention: Recommendation e1176
11.7. Prosthetic Valve Stenosis e1176
11.7.3. Intervention: Recommendation e1177
11.8. Prosthetic Valve Regurgitation e1178
11.8.3. Intervention: Recommendations e1178
12. Infective Endocarditis e1179
12.2. Infective Endocarditis e1179
12.2.3. Intervention: Recommendations e1179
Referencese 1181
Appendix 1. Author Relationships With Industry and Other Entities (Relevant) e1189
Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive) e1191
Appendix 3. Abbreviations e1195
Preamble
Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines (guidelines) with recommendations to improve cardiovascular health. These guidelines, which are based on systematic methods to evaluate and classify evidence, provide a cornerstone for quality cardiovascular care. The ACC and AHA sponsor the development and publication of guidelines without commercial support, and members of each organization volunteer their time to the writing and review efforts. Guidelines are official policy of the ACC and AHA.
Intended Use
Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a global impact. Although guidelines may be used to inform regulatory or payer decisions, their intent is to improve patients’ quality of care and align with patients’ interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances and should not replace clinical judgment.
Clinical Implementation
Guideline recommended management is effective only when followed by healthcare providers and patients. Adherence to recommendations can be enhanced by shared decision making between healthcare providers and patients, with patient engagement in selecting interventions based on individual values, preferences, and associated conditions and comorbidities.
Methodology and Modernization
The ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) continuously reviews, updates, and modifies guideline methodology on the basis of published standards from organizations including the Institute of Medicine1,2 and on the basis of internal reevaluation. Similarly, the presentation and delivery of guidelines are reevaluated and modified on the basis of evolving technologies and other factors to facilitate optimal dissemination of information at the point of care to healthcare professionals. Given time constraints of busy healthcare providers and the need to limit text, the current guideline format delineates that each recommendation be supported by limited text (ideally, <250 words) and hyperlinks to supportive evidence summary tables. Ongoing efforts to further limit text are underway. Recognizing the importance of cost–value considerations in certain guidelines, when appropriate and feasible, an analysis of the value of a drug, device, or intervention may be performed in accordance with the ACC/AHA methodology.3
To ensure that guideline recommendations remain current, new data are reviewed on an ongoing basis, with full guideline revisions commissioned in approximately 6-year cycles. Publication of new, potentially practice-changing study results that are relevant to an existing or new drug, device, or management strategy will prompt evaluation by the Task Force, in consultation with the relevant guideline writing committee, to determine whether a focused update should be commissioned. For additional information and policies regarding guideline development, we encourage readers to consult the ACC/AHA guideline methodology manual4 and other methodology articles.5–8
Selection of Writing Committee Members
The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds. Writing committee members represent different geographic regions, sexes, ethnicities, races, intellectual perspectives/biases, and scopes of clinical practice. The Task Force may also invite organizations and professional societies with related interests and expertise to participate as partners, collaborators, or endorsers.
Relationships With Industry and Other Entities
The ACC and AHA have rigorous policies and methods to ensure that guidelines are developed without bias or improper influence. The complete relationships with industry and other entities (RWI) policy can be found online. Appendix 1 of the current document lists writing committee members’ relevant RWI. For the purposes of full transparency, writing committee members’ comprehensive disclosure information is available online, as is comprehensive disclosure information for the Task Force.
Evidence Review and Evidence Review Committees
When developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data.4–7 Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only key references are cited.
An independent evidence review committee (ERC) is commissioned when there are 1 or more questions deemed of utmost clinical importance that merit formal systematic review. This systematic review will strive to determine which patients are most likely to benefit from a drug, device, or treatment strategy and to what degree. Criteria for commissioning an ERC and formal systematic review include: a) the absence of a current authoritative systematic review, b) the feasibility of defining the benefit and risk in a time frame consistent with the writing of a guideline, c) the relevance to a substantial number of patients, and d) the likelihood that the findings can be translated into actionable recommendations. ERC members may include methodologists, epidemiologists, healthcare providers, and biostatisticians. When a formal systematic review has been commissioned, the recommendations developed by the writing committee on the basis of the systematic review are marked with “sr”.
Guideline-Directed Management and Therapy
The term guideline-directed management and therapy (GDMT) encompasses clinical evaluation, diagnostic testing, and pharmacological and procedural treatments. For these and all recommended drug treatment regimens, the reader should confirm the dosage by reviewing product insert material and evaluate the treatment regimen for contraindications and interactions. The recommendations are limited to drugs, devices, and treatments approved for clinical use in the United States.
Class of Recommendation and Level of Evidence
The Class of Recommendation (COR) indicates the strength of the recommendation, encompassing the estimated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates the quality of scientific evidence that supports the intervention on the basis of the type, quantity, and consistency of data from clinical trials and other sources (Table 1).4–6
ACC/AHA Recommendation System: Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care* (Updated August 2015)
Glenn N. Levine, MD, FACC, FAHA
Chair, ACC/AHA Task Force on Clinical Practice Guidelines
1. Introduction
The focus of the “2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease”9,10 (2014 VHD guideline) was the diagnosis and management of adult patients with valvular heart disease (VHD). The field of VHD is rapidly progressing, with new knowledge of the natural history of patients with valve disease, advances in diagnostic imaging, and improvements in catheter-based and surgical interventions. Several randomized controlled trials (RCTs) have been published since the 2014 VHD guideline, particularly with regard to the outcomes of interventions. Major areas of change include indications for transcatheter aortic valve replacement (TAVR), surgical management of the patient with primary and secondary mitral regurgitation (MR), and management of patients with valve prostheses.
All recommendations (new, modified, and unchanged) for each clinical section are included to provide a comprehensive assessment. The text explains new and modified recommendations, whereas recommendations from the previous guideline that have been deleted or superseded no longer appear. Please consult the full-text version of the 2014 VHD guideline10 for text and evidence tables supporting the unchanged recommendations and for clinical areas not addressed in this focused update. Individual recommendations in this focused update will be incorporated into the full-text guideline in the future. Recommendations from the prior guideline that remain current have been included for completeness but the LOE reflects the COR/LOE system used when initially developed. New and modified recommendations in this focused update reflect the latest COR/LOE system, in which LOE B and C are subcategorized for greater specificity.4–7 The section numbers correspond to the full-text guideline sections.
1.1. Methodology and Evidence Review
To identify key data that might influence guideline recommendations, the Task Force and members of the 2014 VHD guideline writing committee reviewed clinical trials that were presented at the annual scientific meetings of the ACC, AHA, European Society of Cardiology, and other groups and that were published in peer-reviewed format from October 2013 through November 2016. The evidence is summarized in tables in the Online Data Supplement.
1.2. Organization of the Writing Group
For this focused update, representative members of the 2014 VHD writing committee were invited to participate, and they were joined by additional invited members to form a new writing group, referred to as the 2017 focused update writing group. Members were required to disclose all RWI relevant to the data under consideration. The group was composed of experts representing cardiovascular medicine, cardiovascular imaging, interventional cardiology, electrophysiology, cardiac surgery, and cardiac anesthesiology. The writing group included representatives from the ACC, AHA, American Association for Thoracic Surgery (AATS), American Society of Echocardiography (ASE), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Cardiovascular Anesthesiologists (SCA), and Society of Thoracic Surgeons (STS).
1.3. Document Review and Approval
The focused update was reviewed by 2 official reviewers each nominated by the ACC and AHA; 1 reviewer each from the AATS, ASE, SCAI, SCA, and STS; and 40 content reviewers. Reviewers’ RWI information is published in this document (Appendix 2).
This document was approved for publication by the governing bodies of the ACC and the AHA and was endorsed by the AATS, ASE, SCAI, SCA, and STS.
2. General Principles
2.4. Basic Principles of Medical Therapy
2.4.2. Infective Endocarditis Prophylaxis: Recommendation
With the absence of RCTs that demonstrated the efficacy of antibiotic prophylaxis to prevent infective endocarditis (IE), the practice of antibiotic prophylaxis has been questioned by national and international medical societies.11–14 Moreover, there is not universal agreement on which patient populations are at higher risk of developing IE than the general population. Protection from endocarditis in patients undergoing high-risk procedures is not guaranteed. A prospective study demonstrated that prophylaxis given to patients for what is typically considered a high-risk dental procedure reduced but did not eliminate the incidence of bacteremia.15 A 2013 Cochrane Database systematic review of antibiotic prophylaxis of IE in dentistry concluded that there is no evidence to determine whether antibiotic prophylaxis is effective or ineffective, highlighting the need for further study of this longstanding clinical dilemma.13 Epidemiological data conflict with regard to incidence of IE after adoption of more limited prophylaxis, as recommended by the AHA and European Society of Cardiology,16–20 and no prophylaxis, as recommended by the U.K. NICE (National Institute for Health and Clinical Excellence) guidelines.21 Some studies indicate no increase in incidence of endocarditis with limited or no prophylaxis, whereas others suggest that IE cases have increased with adoption of the new guidelines.16–22 The consensus of the writing group is that antibiotic prophylaxis is reasonable for the subset of patients at increased risk of developing IE and at high risk of experiencing adverse outcomes from IE. There is no evidence for IE prophylaxis in gastrointestinal procedures or genitourinary procedures, absent known active infection.
Recommendation for IE Prophylaxis
2.4.3. Anticoagulation for Atrial Fibrillation in Patients With VHD: Recommendations (New Section)
Recommendations for Anticoagulation for Atrial Fibrillation (AF) in Patients With VHD
3. Aortic Stenosis
3.2. Aortic Stenosis
3.2.4. Choice of Intervention: Recommendations
The recommendations for choice of intervention for AS apply to both surgical AVR and TAVR; indications for AVR are discussed in Section 3.2.3 in the 2014 VHD guideline. The integrative approach to assessing risk of surgical AVR or TAVR is discussed in Section 2.5 in the 2014 VHD guideline. The choice of proceeding with surgical AVR versus TAVR is based on multiple factors, including the surgical risk, patient frailty, comorbid conditions, and patient preferences and values.41 Concomitant severe coronary artery disease may also affect the optimal intervention because severe multivessel coronary disease may best be served by surgical AVR and coronary artery bypass graft surgery (CABG). See Figure 1 for an algorithm on choice of TAVR versus surgical AVR.
Choice of TAVR Versus Surgical AVR in the Patient With Severe Symptomatic AS.
AS indicates aortic stenosis; AVR, aortic valve replacement; and TAVR, transcatheter aortic valve replacement.
Recommendations for Choice of Intervention
7. Mitral Regurgitation
7.2. Stages of Chronic MR
In chronic secondary MR, the mitral valve leaflets and chords usually are normal (Table 2 in this focused update; Table 16 from the 2014 VHD guideline). Instead, MR is associated with severe LV dysfunction due to coronary artery disease (ischemic chronic secondary MR) or idiopathic myocardial disease (nonischemic chronic secondary MR). The abnormal and dilated left ventricle causes papillary muscle displacement, which in turn results in leaflet tethering with associated annular dilation that prevents adequate leaflet coaptation. There are instances in which both primary and secondary MR are present. The best therapy for chronic secondary MR is not clear because MR is only 1 component of the disease, with clinical outcomes also related to severe LV systolic dysfunction, coronary disease, idiopathic myocardial disease, or other diseases affecting the heart muscle. Thus, restoration of mitral valve competence is not curative. The optimal criteria for defining severe secondary MR have been controversial. In patients with secondary MR, some data suggest that, compared with primary MR, adverse outcomes are associated with a smaller calculated effective regurgitant orifice, possibly because of the fact that a smaller regurgitant volume may still represent a large regurgitant fraction in the presence of compromised LV systolic function (and low total stroke volume) added to the effects of elevated filling pressures. In addition, severity of secondary MR may increase over time because of the associated progressive LV systolic dysfunction and dysfunction due to adverse remodeling of the left ventricle. Finally, Doppler methods for calculations of effective regurgitant orifice area by the flow convergence method may underestimate severity because of the crescentic shape of the regurgitant orifice, and multiple parameters must be used to determine the severity of MR.67,68 Even so, on the basis of the criteria used for determination of “severe” MR in RCTs of surgical intervention for secondary MR,69–72 the recommended definition of severe secondary MR is now the same as for primary MR (effective regurgitant orifice ≥0.4 cm2 and regurgitant volume ≥60 mL), with the understanding that effective regurgitant orifice cutoff of >0.2 cm2 is more sensitive and >0.4 cm2 is more specific for severe MR. However, it is important to integrate the clinical and echocardiographic findings together to prevent unnecessary operation when the MR may not be as severe as documented on noninvasive studies.
Stages of Secondary MR (Table 16 in the 2014 VHD Guideline)
7.3. Chronic Primary MR
7.3.3. Intervention: Recommendations
Recommendations for Chronic Primary MR Intervention
7.4. Chronic Secondary MR
7.4.3. Intervention: Recommendations
Chronic severe secondary MR adds volume overload to a decompensated LV and worsens prognosis. However, there are only sparse data to indicate that correcting MR prolongs life or even improves symptoms over an extended time. Percutaneous mitral valve repair provides a less invasive alternative to surgery but is not approved for clinical use for this indication in the United States.70,72,125–127 The results of RCTs examining the efficacy of percutaneous mitral valve repair in patients with secondary MR are needed to provide information on this patient group.128,129
Indications for Surgery for MR (Updated Figure 4 From the 2014 VHD guideline).
*MV repair is preferred over MV replacement when possible.
AF indicates atrial fibrillation; CAD, coronary artery disease; CRT, cardiac resynchronization therapy; EF, ejection fraction; ERO, effective regurgitant orifice; HF, heart failure; LV, left ventricular; LVEF, left ventricular ejection fraction; LVESD, left ventricular end-systolic diameter; MR, mitral regurgitation; MV, mitral valve; NYHA, New York Heart Association; PASP, pulmonary artery systolic pressure; RF, regurgitant fraction; RVol, regurgitant volume; and Rx, therapy.
Recommendations for Secondary MR Intervention
11. Prosthetic Valves
11.1. Evaluation and Selection of Prosthetic Valves
11.1.2. Intervention: Recommendations
Recommendations for Intervention of Prosthetic Valves
11.2. Antithrombotic Therapy for Prosthetic Valves
11.2.1. Diagnosis and Follow-Up
Effective oral antithrombotic therapy in patients with mechanical heart valves requires continuous VKA anticoagulation with an INR in the target range. It is preferable to specify a single INR target for each patient and to recognize that the acceptable range includes 0.5 INR units on each side of this target. A specific target is preferable because it reduces the likelihood of patients having INR values consistently near the upper or lower boundary of the range. In addition, fluctuations in INR are associated with an increased incidence of complications in patients with prosthetic heart valves, so patients and caregivers should strive to attain the specific INR value.170,171 The effects of VKA anticoagulation vary with the specific drug, absorption, various foods, alcohol, other medications, and changes in liver function. Most of the published studies of VKA therapy used warfarin, although other coumarin agents are used on a worldwide basis. In clinical practice, a program of patient education and close surveillance by an experienced healthcare professional, with periodic INR determinations, is necessary. Patient monitoring through dedicated anticoagulation clinics results in lower complication rates than those seen with standard care and is cost effective because of lower rates of bleeding and hemorrhagic complications.172,173 Periodic direct patient contact and telephone encounters174 with the anticoagulation clinic pharmacists175,176 or nurses are equally effective in reducing complication rates.177 Self-monitoring with home INR measurement devices is another option for educated and motivated patients.
Factors Used for Shared Decision Making About Type of Valve Prosthesis
11.2.2. Medical Therapy: Recommendations
Recommendations for Antithrombotic Therapy for Patients with Prosthetic Heart Valves
11.3. Bridging Therapy for Prosthetic Valves
11.3.1. Diagnosis and Follow-Up
The management of patients with mechanical heart valves for whom interruption of anticoagulation therapy is needed for diagnostic or surgical procedures should take into account the type of procedure; bleeding risk; patient risk factors; and type, location, and number of heart valve prostheses.
11.3.2. Medical Therapy: Recommendations
Recommendations for Bridging Therapy for Prosthetic Valves
11.6. Acute Mechanical Prosthetic Valve Thrombosis
11.6.1. Diagnosis and Follow-Up: Recommendation
Recommendation for Mechanical Prosthetic Valve Thrombosis Diagnosis and Follow-Up
11.6.3. Intervention: Recommendation
Recommendation for Mechanical Prosthetic Valve Thrombosis Intervention
11.7. Prosthetic Valve Stenosis
Surgical reoperation to replace the stenotic prosthetic heart valve has been the mainstay treatment modality. Although it is associated with acceptable mortality and morbidity in the current era, it remains a serious clinical event and carries a higher risk than the initial surgery. Reoperation is usually required for moderate-to-severe prosthetic dysfunction (structural and nonstructural), dehiscence, and prosthetic valve endocarditis. Reoperation may also be needed for recurrent thromboembolism, severe intravascular hemolysis, severe recurrent bleeding from anticoagulant therapy, and thrombosed prosthetic valves. In 2015, catheter-based therapy with transcatheter valve-in-valve emerged as an acceptable alternative to treat high- and extreme-risk patients with bioprosthetic aortic valve stenosis (stenosis, insufficiency, or combined) in the absence of active IE.154
Symptomatic prosthetic valve stenosis secondary to thrombosis is observed predominantly with mechanical valves. Mechanical prosthetic valve thrombosis and its treatment are discussed in Section 11.6. Bioprosthetic valve thrombosis can result in thromboembolic events or obstruction. In a pooled analysis from 3 studies including 187 patients who underwent either TAVR or bioprosthetic surgical AVR, reduced leaflet motion was noted on 4-dimensional volume-rendered CT imaging in 21% of patients.203 In this small cohort, therapeutic anticoagulation with warfarin was associated with lower incidence of reduced leaflet motion than that associated with dual antiplatelet therapy, as well as more restoration of leaflet motion on follow-up CT imaging. Subclinical leaflet thrombosis was identified as the likely cause on the basis of advanced and characteristic imaging findings.203 As outlined by the US Food and Drug Administration, most cases of reduced leaflet motion (which occurs in 10% to 40% of TAVR patients and 8% to 12% of surgical AVR patients) were discovered by advanced imaging studies in asymptomatic patients.236 The diagnosis of bioprosthetic valve thrombosis remains difficult, with most suspected bioprosthetic valve thrombosis based on increased transvalvular gradients.
Fibrinolysis Versus Surgery for ProstheticValve Thrombosis
In some patients, the size of the prosthetic valve that can be implanted results in inadequate blood flow to meet the metabolic demands of the patient, even when the prosthetic valve itself is functioning normally. This situation, called patient–prosthesis mismatch (defined as an indexed effective orifice area ≤0.85 cm2/m2 for aortic valve prostheses), is a predictor of a high transvalvular gradient, persistent LV hypertrophy, and an increased rate of cardiac events after AVR.237,238 The impact of a relatively small valve area is most noticeable with severe patient– prosthesis mismatch, defined as an indexed orifice area <0.65 cm2/m2. Patient–prosthesis mismatch is especially detrimental in patients with reduced LVEF and may decrease the likelihood of resolution of symptoms and improvement in LVEF. Patient–prosthesis mismatch can be avoided or reduced by choice of a valve prosthesis that will have an adequate indexed orifice area, determined by the patient’s body size and annular dimension. In some cases, annular enlargement or other approaches may be needed to allow implantation of an appropriately sized valve or avoidance of a prosthetic valve. With bileaflet mechanical valves, patterns of blood flow are complex, and significant pressure recovery may be present; this may result in a high velocity across the prosthesis that should not be mistaken for prosthetic valve stenosis or patient–prosthesis mismatch, particularly in those with small aortic diameters.
11.7.3. Intervention: Recommendation
Recommendations for Prosthetic Valve Stenosis
11.8. Prosthetic Valve Regurgitation
11.8.3. Intervention: Recommendations
Recommendations for Prosthetic Valve Regurgitation
12. Infective Endocarditis
12.2. Infective Endocarditis
12.2.3. Intervention: Recommendations
Recommendations for IE Intervention
ACC/AHA Task Force Members
Glenn N. Levine, MD, FACC, FAHA, Chair; Patrick T. O’Gara, MD, MACC, FAHA, Chair-Elect; Jonathan L. Halperin, MD, FACC, FAHA, Immediate Past Chair*; Sana M. Al-Khatib, MD, MHS, FACC, FAHA; Kim K. Birtcher, MS, PharmD, AACC; Biykem Bozkurt, MD, PhD, FACC, FAHA; Ralph G. Brindis, MD, MPH, MACC*; Joaquin E. Cigarroa, MD, FACC; Lesley H. Curtis, PhD, FAHA; Lee A. Fleisher, MD, FACC, FAHA; Federico Gentile, MD, FACC; Samuel Gidding, MD, FAHA; Mark A. Hlatky, MD, FACC; John Ikonomidis, MD, PhD, FAHA; José Joglar, MD, FACC, FAHA; Susan J. Pressler, PhD, RN, FAHA; Duminda N. Wijeysundera, MD, PhD
Presidents and Staff
American College of Cardiology
Richard A. Chazal, MD, FACC, President
Shalom Jacobovitz, Chief Executive Officer
William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publishing
Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing
American College of Cardiology/American Heart Association
Katherine Sheehan, PhD, Director, Guideline Strategy and Operations
Lisa Bradfield, CAE, Director, Guideline Methodology and Policy
Abdul R. Abdullah, MD, Science and Medicine Advisor
Clara Fitzgerald, Project Manager, Clinical Practice Guidelines
American Heart Association
Steven R. Houser, PhD, FAHA, President
Nancy Brown, Chief Executive Officer
Rose Marie Robertson, MD, FAHA, Chief Science and Medicine Officer
Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations
Jody Hundley, Production Manager, Scientific Publications, Office of Science Operations
Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (January 2016)
| Committee Member | Employment | Consultant | Speakers Bureau | Ownership/Partnership/Principal | Personal Research | Institutional, Organizational, or Other Financial Benefit | Expert Witness | Voting Recusals by Section* |
|---|---|---|---|---|---|---|---|---|
| Rick A. Nishimura, Co-Chair | Mayo Clinic, Division of Cardiovascular Disease—Judd and Mary Morris Leighton Professor of Medicine | None | None | None | None | None | None | None |
| Catherine M. Otto, Co-Chair | University of Washington Division of Cardiology—Professor of Medicine | None | None | None | None | None | None | None |
| Robert O. Bonow | Northwestern University Feinberg School of Medicine—Goldberg Distinguished Professor of Cardiology | None | None | None | None | None | None | None |
| Blase A. Carabello | East Carolina University, Brody School of Medicine, East Carolina Heart Institute—Chief Cardiology Director | None | None | None | • Edwards Lifesciences (DSMB)† | • Medtronic† | 3.2.4, 7.3.3, 7.4.3, and 11.1. | |
| John P. Erwin III | Texas A&M College of Medicine, Baylor Scott and White Health—Senior Staff Cardiologist, Clinical Professor and Chair of Internal Medicine | None | None | None | None | None | None | None |
| Lee A. Fleisher | University of Pennsylvania, Department of Anesthesiology—Professor of Anesthesiology | None | None | None | None | None | None | None |
| Hani Jneid | Baylor College of Medicine—Associate Professor of Medicine, Director of Interventional Cardiology Research; The Michael E. DeBakey VA Medical Center—Director of Interventional Cardiology | None | None | None | None | None | None | None |
| Michael J. Mack | The Heart Hospital Baylor Plano—Director | None | None | None | None | • Abbott Vascular • Edwards Lifesciences | None | 3.2.4, 7.3.3, 7.4.3, and 11.1 |
| Christopher J. McLeod | Mayo Clinic, Division of Cardiovascular Disease—Assistant Professor of Medicine | None | None | None | None | None | None | None |
| Patrick T. O’Gara | Brigham and Women’s Hospital—Professor of Medicine; Harvard Medical School—Director of Clinical Cardiology | None | None | None | None | None | None | |
| Vera H. Rigolin | Northwestern University Feinberg School of Medicine—Professor of Medicine; Northwestern Memorial Hospital—Medical Director, Echocardiography Laboratory | None | None | None | • Pfizer | None | None | None |
| Thoralf M. Sundt III | Massachusetts General Hospital—Chief, Division of Cardiac Surgery, Harvard Medical School—Professor of Surgery | None | None | None | • Edwards LifeScience—Partner trial (PI) • Medtronic—Perigon trial (PI) | • Thrasos (Steering Committee)‡ | None | 3.2.4, 7.3.3, 7.4.3, and 11.1. |
| Annemarie Thompson | Duke University Medical Center—Department of Anesthesiology, Professor of Anesthesiology; Residency Program Director | None | None | None | None | None | None | None |
This table represents relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that existwith no financial benefit are also included for the purpose of transparency. Relationships in this table aremodest unless otherwise noted. According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whomthe relationship exists)makes a drug, drug class, or device addressed in the document ormakes a competing drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document.
↵* Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply. Section numbers pertain to those in the full-text guideline.
↵† No financial benefit.
↵‡ Significant relationship.
ACC indicates American College of Cardiology; AHA, American Heart Association; Partner, Placement of Aortic Transcatheter Valve; Perigon, Pericardial Surgical Aortic Valve Replacement; and VA, Veterans Affairs.
Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive)—2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (September 2016)
| Reviewer | Representation | Employment | Consultant | Speakers Bureau | Ownership/Partnership/Principal | Personal Research | Institutional, Organizational, or Other Financial Benefit | Expert Witness |
|---|---|---|---|---|---|---|---|---|
| Salvatore P. Costa | Official Reviewer—AHA | Dartmouth-Hitchcock Medical Center; Section of Cardiology | None | None | None | None | None | None |
| Federico Gentile | Official Reviewer—ACC/AHA Task Force on Clinical Practice Guidelines Lead Reviewer | Centro Medico Diagnostico—Director, Cardiovascular Disease | None | None | None | None | None | None |
| Lawrence G. Rudski | Official Reviewer—ACC Board of Governors | Jewish General Hospital, McGill University—Professor of Medicine; Integrated Cardiovascular Sciences Program—Director | None | None | • Medtronic* | • Sanofi/Genzyme* | • GE Healthcare* • CSE† | None |
| John J. Ryan | Official Reviewer—AHA | University of Utah Health Sciences Center—Division of Cardiovascular Medicine | None | None | None | None | • Novartis | None |
| David Adams | Organizational Reviewer—AATS | Mount Sinai Medical Center; Department of Cardiovascular Surgery—Professor and System Chair | None | None | None | • Medtronic • NeoChord | • Edwards Lifesciences* • Medtronic* | None |
| Joseph E. Bavaria | Organizational Reviewer—STS | Hospital of the University of Pennsylvania; Division of Cardiovascular Surgery—Vice Chief; Thoracic Aortic Surgery Program—Director; Transcatheter Valve Program—Co-Director | None | None | None | • CyotoSorbents • Edwards Lifesciences • Medtronic • St. Jude Medical • Vascutek • W.L. Gore | • Edwards Lifesciences • Medtronic | None |
| Wael A. Jaber | Organizational Reviewer—ASE | Cleveland Clinic Foundation, Cardiovascular Medicine, Cardiovascular Imaging Core Laboratory—Director | None | None | None | • Edwards Lifesciences | None | None |
| Stanton Shernan | Organizational Reviewer—SCA | Brigham and Women’s Hospital, Cardiac Anesthesia Division—Director; Harvard Medical School—Professor | None | None | None | None | • Philips Healthcare • National Board of Echocardiography† | None |
| Molly Szerlip | Organizational Reviewer—SCAI | The Heart Group—Interventional Cardiologist; The Heart Hospital Baylor Plano—Medical Director, Inpatient and Outpatient Valve Program | • Edwards Lifesciences • Medtronic | • Abiomed† • Edwards Lifesciences† | None | None | • Edwards Lifesciences • Medtronic | None |
| Kim K. Birtcher | Content Reviewer—ACC/AHA Task Force on Clinical Practice Guidelines | University of Houston College of Pharmacy—Clinical Professor | • Jones & Bartlett • Learning | None | None | None | None | None |
| Vera Bittner | Content Reviewer—ACC Prevention of Cardiovascular Disease Section Leadership Council | University of Alabama at Birmingham—Professor of Medicine; Section Head, General Cardiology, Prevention and Imaging | • Eli Lilly • ABIM* • Alabama ACC • Alabama ACP | None | None | • Amgen • AstraZeneca* • Bayer Healthcare* • DalCor* • Pfizer • Sanofi-aventis* | • National Lipid Association | None |
| Emmanouil Brilakis | Content Reviewer | Laboratory, VA North Texas Healthcare System—Director Cardiac Catheterization | • Abbott Vascular* • Asahi • Cardinal Health • Elsevier • GE Healthcare • St. Jude Medical | None | None | • Boston Scientific* • InfraRedx* | • Abbott Vascular† • AstraZeneca† • Cerenis Therapeutics* • Cordis* • Daiichi Sankyo* • Guerbet* • InfraRedx* • SCAI | None |
| James Fang | Content Reviewer | University of Utah School of Medicine—Chief of Cardiovascular Medicine; University of Utah Health Care—Director, Cardiovascular Service Line | • Accordia | None | None | • Actelion (DSMB) • Cardiocell (DSMB) • NIH (DSMB | • CardioKinetix • NIH • Novartis | None |
| Michael S. Firstenberg | Content Reviewer—ACC Surgeons’ Council | The Summa Health System—Thoracic and Cardiac Surgery | • Allmed* • Johnson & Johnson • Maquet Cardiovascular* | None | None | None | • Grisfols | None |
| Annetine Gelijns | Content Reviewer | Mount Sinai Medical Center, Population Health Science and Policy—Professor and System Chair | None | None | None | None | • Icahn School of Medicine at Mount Sinai* • NIH | None |
| Samuel Gidding | Content Reviewer—ACC/AHA Task Force on Clinical Practice Guidelines | Nemours/Alfred I. duPont Hospital for Children—Chief, Division of Pediatric Cardiology | • FH Foundation† • International FH Foundation† | None | None | • FH Foundation† • NIH* | None | None |
| Paul A. Grayburn | Content Reviewer | Baylor Heart and Vascular Institute—Director of Cardiology Research | • Abbott Vascular* • Tendyne | None | None | • Abbott Vascular† • Boston Scientific† • Medtronic† • Tendyne† • Valtech Cardio† | • American Journal of Cardiology • NeoChord† | None |
| Richard Grimm | Content Reviewer—ACC Heart Failure and Transplant Section Leadership Council | Cleveland Clinic Foundation, Department of Cardiovascular Medicine—Medical Director of Echo Lab | • Abbott Laboratories | None | None | None | None | None |
| Jonathan L. Halperin | Content Reviewer—ACC/AHA Task Force on Clinical Practice Guidelines | Mount Sinai Medical Center—Professor of Medicine | • AstraZeneca • Bayer • Boston Scientific | None | None | None | None | None |
| Alex Iribarne | Content Reviewer—ACC Surgeons’ Council | Dartmouth Hitchcock Medical Center—Attending Cardiac Surgeon; Cardiac Surgical Research—Director; The Dartmouth Institute—Assistant Professor of Surgery | None | None | None | None | None | None |
| Craig January | Content Reviewer | University of Wisconsin-Madison—Professor of Medicine, Cardiovascular Medicine Division | None | None | None | None | None | None |
| José Joglar | Content Reviewer—ACC/AHA Task Force on Clinical Practice Guidelines | UT Southwestern Medical Center—Associate Professor of Internal Medicine | None | None | None | None | • Medtronic* • St. Jude Medical* | None |
| Kyle W. Klarich | Content Reviewer | Mayo Clinic—Professor of Medicine | None | None | None | None | None | None |
| Gautam Kumar | Content Reviewer—ACC Interventional Section Leadership Council | Emory University, Division of Cardiology—Assistant Professor of Medicine | • Abiomed • CSI Medical • T3 Labs • Trireme Medical | None | None | None | • Orbus-Neich Medical • Osprey Medical • Stentys | None |
| Richard Lange | Content Reviewer | Content Reviewer Texas Tech University Health Sciences Center at El Paso—President | None | None | None | None | None | None |
| Susan T. Laing | Content Reviewer—ACC Heart Failure and Transplant Section Leadership Council | UT Health Science Center at Houston (UT Health)—Professor of Medicine, Division of Cardiology, Associate Chief; Director of Echocardiography | None | None | None | None | None | None |
| Glenn Levine | Content Reviewer—ACC/AHA Task Force on Clinical Practice Guidelines | Baylor College of Medicine—Professor of Medicine; Director, Cardiac Care Unit | None | None | None | None | None | • Defendant, Hospital Death, 2016 • Defendant, Catheterization Laboratory Procedure, 2016 |
| Brian Lindman | Content Reviewer | Washington University School of Medicine in St. Louis, Cardiovascular Division—Associate Professor of Medicine | • Roche Diagnostics | None | None | • AHA Clinical Research Grant* • Barnes-Jewish Hospital Foundation* • Doris Duke Charitable Foundation* • Edwards Lifesciences* • NIH • Roche • Diagnostics* | • NIH* | None |
| D. Craig Miller | Content Reviewer | Stanford University Medical Center—Cardiothoracic Surgeon | • Medtronic • NHLBI | None | None | • Abbott Laboratories • Edwards Lifesciences • Medtronic | None | None |
| Stefano Nistri | Content Reviewer | CMSR Veneto Medica—Chief, Cardiology Service | None | None | None | None | None | None |
| Philippe Pibarot | Content Reviewer | Université Laval—Professor of Medicine; Canada Research in Valvular Heart Diseases | None | None | None | • Cardiac Phoenix* • Edwards Lifesciences* • Medtronic* • V-Wave* • Canadian Institute of Health | None | None |
| Hartzell V. Schaff | Content Reviewer | Mayo Clinic—Professor of Surgery | None | None | None | None | None | None |
| Allan Schwartz | Content Reviewer | Columbia University Medical Center—Chief, Division of Cardiology, Vice Chair of Department of Medicine | None | None | None | None | None | None |
| Karen Stout | Content Reviewer | University of Washington—Director, Adult Congenital Heart Disease Program, Professor, Internal Medicine and Pediatrics | None | None | None | None | None | None |
| Rakesh Suri | Content Reviewer | Cleveland Clinic Foundation—Professor of Surgery, Department of Thoracic and Cardiovascular Surgery | • Sorin† Abbott | None | None | • St. Jude Medical | • St. Jude Medical | None |
| Vinod Thourani | Content Reviewer | Emory University School of Medicine, Division of Cardiothoracic Surgery— Professor of Surgery; Structural Heart and Valve Center of the Emory Heart and Vascular Center—Co-Director; Emory University Hospital Midtown—Chief of Cardiothoracic Surgery | • Edwards Lifesciences • St. Jude Medical | None | None | • Abbott Medical • Boston Scientific† • Edwards Lifesciences† • Medtronic† | None | None |
| E. Murat Tuzcu | Content Reviewer | Cleveland Clinic Abu Dhabi—Cardiovascular Medicine | None | None | None | None | • Boston Scientific • Direct Flow Medical • St. Jude Medical • Tendyne | None |
| Andrew Wang | Content Reviewer | Duke University Medical Center—Professor of Medicine; Cardiovascular Disease Fellowship Program—Director | • Heart Metabolics* • ACP* | None | None | None | • Abbott Vascular* • Gilead Sciences* • Maokardia* • Edwards Lifesciences • Medtronic | None |
| L. Samuel Wann | Content Reviewer | Columbia St. Mary’s Cardiovascular Physicians—Clinical Cardiologist | • United Healthcare | None | None | None | None | None |
| Frederick Welt | Content Reviewer—ACC Interventional Section Leadership Council | University of Utah Health Sciences Center, Division of Cardiology—Director, Interventional Cardiology | • Medtronic | None | None | None | • Athersys • Capricor • CardioKinetix • Medtronic • Renova Therapeutics • Siemens • Teva Pharmaceuticals • Washington University | None |
This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review, including those not deemed to be relevant to this document, at the time this document was under review. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Please refer to http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees.
↵* Significant relationship.
↵† No financial benefit.
AAFP indicates American Academy of Family Physicians; AATS, American Association for Thoracic Surgery; ABIM, American Board of Internal Medicine; ACC, American College of Cardiology; ACP, American College of Physicians; AHA, American Heart Association; ASE, American Society of Echocardiography; CSE, Canadian Society of Echocardiography; DSMB, data safety monitoring board; FH, familial hyperlipidemia; NHLBI, National Heart, Lung, and Blood Institute; NIH, National Institutes of Health; SCAI, Society for Cardiovascular Angiography and Interventions; SCA, Society of Cardiovascular Anesthesiologists; STS, Society of Thoracic Surgeons; UT, University of Texas; and WVU, West Virginia University.
Appendix 3. Abbreviations
| AF = atrial fibrillation |
| AS = aortic stenosis |
| AVR = aortic valve replacement |
| CABG = coronary artery bypass graft surgery |
| CI = confidence interval |
| CT = computed tomography |
| DOACs = direct oral anticoagulants |
| EF = ejection fraction |
| GDMT = guideline-directed management and therapy |
| HF = heart failure |
| HR= hazard ratio |
| IE = infective endocarditis |
| INR = International Normalized Ratio |
| LV = left ventricular |
| LVEF = left ventricular ejection fraction |
| LVESD = left ventricular end-systolic diameter |
| MR = mitral regurgitation |
| MS = mitral stenosis |
| MVR = mitral valve replacement |
| NYHA = New York Heart Association |
| RCT = randomized controlled trial |
| TAVR = transcatheter aortic valve replacement |
| VHD = valvular heart disease |
| VKA = vitamin K antagonist |
Footnotes
The American Heart Association requests that this document be cited as follows: Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O’Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC focused update of the 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e1159–e1195. DOI: 10.1161/CIR.0000000000000503.
This document was approved by the American College of Cardiology Clinical Policy Approval Committee on behalf of the Board of Trustees, the American Heart Association Science Advisory and Coordinating Committee in January 2017, and the American Heart Association Executive Committee in February 2017.
The online Comprehensive RWI Data Supplement table is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000503/-/DC1.
The online Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000503/-/DC2.
This article has been copublished in the Journal of the American College of Cardiology.
Copies: This document is available on the World Wide Web sites of the American Heart Association (professional.heart.org) and the American College of Cardiology (www.acc.org). A copy of the document is available at http://professional.heart.org/statements by using either “Search for Guidelines & Statements” or the “Browse by Topic” area. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com.
Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements. Select the “Guidelines & Statements” drop-down menu, then click “Publication Development.”
Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright-Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page.
Circulation is available at http://circ.ahajournals.org.
↵* Former Task Force member; current member during the writing effort.
- © 2017 by the American Heart Association, Inc., and the American College of Cardiology Foundation.
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This Issue
Jump to
- Article
- Table of Contents
- Preamble
- Methodology and Modernization
- 1. Introduction
- 2. General Principles
- 3. Aortic Stenosis
- 7. Mitral Regurgitation
- 11. Prosthetic Valves
- 12. Infective Endocarditis
- ACC/AHA Task Force Members
- Presidents and Staff
- Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (January 2016)
- Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive)—2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease (September 2016)
- Appendix 3. Abbreviations
- Footnotes
- References
- Figures & Tables
- Supplemental Materials
- Info & Metrics
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