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Surgery for aortic dilatation in patients with bicuspid aortic valves

A statement of clarification from the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines
Open AccessPublished:December 09, 2015DOI:https://doi.org/10.1016/j.jtcvs.2015.12.001

      Abstract

      Two guidelines from the American College of Cardiology (ACC), the American Heart Association (AHA), and collaborating societies address the risk of aortic dissection in patients with bicuspid aortic valves and severe aortic enlargement: The “2010 ACCF/AHA/AATS/ACR/ASA/SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease” (J Am Coll Cardiol. 2010;55:e27-130) and the “2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease” (J Am Coll Cardiol. 2014;63:e57-185). However, the 2 guidelines differ with regard to the recommended threshold of aortic root or ascending aortic dilatation that would justify surgical intervention in patients with bicuspid aortic valves. The ACC and AHA therefore convened a subcommittee representing members of the 2 guideline writing committees to review the evidence, reach consensus, and draft a statement of clarification for both guidelines. This statement of clarification uses the ACC/AHA revised structure for delineating the Class of Recommendation and Level of Evidence to provide recommendations that replace those contained in Section 9.2.2.1 of the thoracic aortic disease guideline and Section 5.1.3 of the valvular heart disease guideline.

      Key Words

      See Editorial Commentary page 967.

      ACC/AHA Task Force Members:

      Jonathan L. Halperin, MD, FACC, FAHA, Chair, Glenn N. Levine, MD, FACC, FAHA, Chair-Elect, Jeffrey L. Anderson, MD, FACC, FAHA, Immediate Past Chair,‡ Nancy M. Albert, PhD, RN, FAHA,‡ Mark A. Hlatky, MD, FACC, Sana M. Al-Khatib, MD, MHS, FACC, FAHA, John Ikonomidis, MD, PhD, FAHA, Kim K. Birtcher, PharmD, AACC, Jos_e Joglar, MD, FACC, FAHA, Biykem Bozkurt, MD, PhD, FACC, FAHA, Richard J. Kovacs, MD, FACC, FAHA,‡ Ralph G. Brindis, MD, MPH, MACC, E. Magnus Ohman, MD, FACC,‡ Joaquin E. Cigarroa, MD, FACC, Susan J. Pressler, PhD, RN, FAHA, Lesley H. Curtis, PhD, FAHA, Frank W. Sellke, MD, FACC, FAHA,‡ Lee A. Fleisher, MD, FACC, FAHA, Win-Kuang Shen, MD, FACC, FAHA,‡ Federico Gentile, MD, FACC, Duminda N. Wijeysundera, MD, PhD, and Samuel Gidding, MD, FAHA
      Table 1Applying class of recommendation and level of evidence to clinical strategies, interventions, treatments, or diagnostic testing in patient care∗ (updated August 2015)
      Table 2Risk assessment combining STS risk estimate, frailty, major organ system dysfunction, and procedure-specific impediments
      Low risk (must meet ALL criteria in this column)Intermediate risk (any 1 criterion in this column)High risk (any 1 criterion in this column)Prohibitive risk (any 1 criterion in this column)
      STS PROM
      Use of the STS PROM to predict risk in a given institution with reasonable reliability is appropriate only if institutional outcomes are within 1 standard deviation of STS average observed/expected ratio for the procedure in question.
      <4%

      AND
      4%-8%

      OR
      >8%

      OR
      Frailty
      Seven frailty indices: Katz Activities of Daily Living (independence in feeding, bathing, dressing, transferring, toileting, and urinary continence) and independence in ambulation (no walking aid or assist required or 5-m walk in <6 s). Other scoring systems can be applied to calculate no, mild, or moderate-to-severe frailty.
      None

      AND
      1 Index (mild)

      OR
      ≥2 Indices (moderate to severe)

      OR
      Predicted risk with surgery of death or major morbidity (all-cause) >50% at 1 y

      OR
      Major organ system compromise not to be improved postoperatively
      Examples of major organ system compromise: Cardiac—severe LV systolic or diastolic dysfunction or RV dysfunction, fixed pulmonary hypertension; CKD stage 3 or worse; pulmonary dysfunction with FEV1 <50% or DL co2 <50% of predicted; CNS dysfunction (dementia, Alzheimer’s disease, Parkinson’s disease, CVA with persistent physical limitation); GI dysfunction—Crohn’s disease, ulcerative colitis, nutritional impairment, or serum albumin <3.0; cancer—active malignancy; and liver—any history of cirrhosis, variceal bleeding, or elevated INR in the absence of VKA therapy.
      None

      AND
      1 Organ system

      OR
      No more than 2 organ systems

      OR
      ≥3 Organ systems

      OR
      Procedure-specific impediment
      Examples: tracheostomy present, heavily calcified ascending aorta, chest malformation, arterial coronary graft adherent to posterior chest wall, or radiation damage. Reproduced from Nishimura et al.2.
      NonePossible procedure-specific impedimentPossible procedure-specific impedimentSevere procedure-specific impediment
      CKD, Chronic kidney disease; CNS, central nervous system; CVA, cerebrovascular accident (stroke); DL co2, diffusion capacity for carbon dioxide; FEV1, forced expiratory volume in 1 s; GI, gastrointestinal; INR, international normalized ratio; LV, left ventricular; PROM, predicted risk of mortality; RV, right ventricular; STS, Society of Thoracic Surgeons; and VKA, vitamin K antagonist.
      Use of the STS PROM to predict risk in a given institution with reasonable reliability is appropriate only if institutional outcomes are within 1 standard deviation of STS average observed/expected ratio for the procedure in question.
      Seven frailty indices: Katz Activities of Daily Living (independence in feeding, bathing, dressing, transferring, toileting, and urinary continence) and independence in ambulation (no walking aid or assist required or 5-m walk in <6 s). Other scoring systems can be applied to calculate no, mild, or moderate-to-severe frailty.
      Examples of major organ system compromise: Cardiac—severe LV systolic or diastolic dysfunction or RV dysfunction, fixed pulmonary hypertension; CKD stage 3 or worse; pulmonary dysfunction with FEV1 <50% or DL co2 <50% of predicted; CNS dysfunction (dementia, Alzheimer’s disease, Parkinson’s disease, CVA with persistent physical limitation); GI dysfunction—Crohn’s disease, ulcerative colitis, nutritional impairment, or serum albumin <3.0; cancer—active malignancy; and liver—any history of cirrhosis, variceal bleeding, or elevated INR in the absence of VKA therapy.
      § Examples: tracheostomy present, heavily calcified ascending aorta, chest malformation, arterial coronary graft adherent to posterior chest wall, or radiation damage. Reproduced from Nishimura et al.
      • Nishimura R.A.
      • Otto C.M.
      • Bonow R.O.
      • et al.
      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 Practice Guidelines [published correction appears in J Am Coll Cardiol. 2014;63:2489].
      .

      Appendix.

      Appendix 1Author relationships with industry and other entities (relevant)—surgery for aortic dilatation in patients with bicuspid aortic valves: A statement of clarification from the ACC/AHA Task Force on Clinical Practice Guidelines (December 2014)
      Committee memberEmploymentConsultantSpeakers bureauOwnership/partnership/principalPersonal ResearchInstitutional, organizational, or other financial benefitExpert witnessVoting recusals
      Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply.
      Loren F. Hiratzka, TAD, ChairTriHealth Heart Institute—Medical Director, Cardiac SurgeryNoneNoneNoneNoneNoneNoneNone
      Rick A. Nishimura, VHD, ChairMayo Clinic, Division of Cardiovascular Disease—Judd and Mary Morris Leighton Professor of MedicineNoneNoneNoneNoneNoneNoneNone
      Mark A. Creager, TAD LiaisonDartmouth-Hitchcock Medical Center—Director, Heart and Vascular Center and Geisel School of Medicine at Dartmouth—Professor of MedicineNoneNoneNoneNoneNoneNoneNone
      Robert A. Guyton, VHD LiaisonEmory Healthcare—Professor and Chief, Division of Cardiothoracic Surgery
      • Medtronic
        Significant relationship.
      NoneNoneNoneNoneNoneRecused
      Eric M. Isselbacher, TADMassachusetts General Hospital—Co-Director Thoracic Aortic Center; Harvard Medical School—Associate Professor of MedicineNoneNoneNoneNoneNoneNoneNone
      Lars G. Svensson, TADCleveland Clinic, Heart and Vascular Institute—Chairman; Cleveland Clinic Lerner College of Medicine of Case Western Reserve University—Professor of SurgeryNoneNoneNoneNone
      • Posthorax
      NoneRecused
      Robert O. Bonow, VHDNorthwestern University Feinberg School of Medicine—Goldberg Distinguished Professor of CardiologyNoneNoneNoneNoneNoneNoneNone
      Thoralf M. Sundt III, VHDMassachusetts General Hospital—Chief, Division of Cardiac Surgery; Harvard Medical School—Professor of SurgeryNoneNoneNone
      • Edwards LifeScience—Partner trial (PI)
      • Medtronic—Perigon trial (PI)
      NoneNoneRecused
      This table represents the 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 exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest 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 whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document. ACC, American College of Cardiology; AHA, American Heart Association; PI, principal investigator; TAD, thoracic aortic disease; VHD, valvular heart disease.
      Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply.
      Significant relationship.
      Appendix 2Reviewer relationships with industry and other entities (relevant)—surgery for aortic dilatation in patients with bicuspid aortic valves: A statement of clarification from the ACC/AHA Task Force on Clinical Practice Guidelines (June 2015)
      ReviewerRepresentationEmploymentConsultantSpeakers bureauOwnership/partnership/principalPersonal researchInstitutional, organizational, or other financial benefitExpert witness
      David H. AdamsOfficial reviewer—AATSThe Mount Sinai Medical Center—Marie-Josee and Henry R. Kravis Professor; Chairman, Department of Cardiothoracic Surgery
      • Edward Lifesciences
        Significant relationship.
      • Medtronic
        Significant relationship.
      NoneNoneNoneNoneNone
      Albert T. CheungOfficial reviewer—SCAStanford University School of Medicine—Professor, Department of Anesthesiology; Division Chief, Cardiothoracic Anesthesiology; Program Director, Adult Cardiothoracic Anesthesiology
      • Covidien
      NoneNoneNoneNoneNone
      Michael D. DakeOfficial reviewer—SIRStanford University School of Medicine, Cardiothoracic Surgery—Chief, Interventional Radiology
      • Abbott Vascular
      • CR Bard
      • Cook Medical
        Significant relationship.
      • Gore
        Significant relationship.
      • Medtronic
      NoneNoneNoneNoneNone
      Mario J. GarciaOfficial reviewer—AHAMontefiore Medical Center-Albert Einstein College of Medicine—Chief, Division of CardiologyNoneNoneNone
      • Medtronic
        No financial benefit.
      NoneNone
      Steven A. GoldsteinOfficial reviewer—ASEWashington Hospital Center—Director, Noninvasive Cardiology LaboratoryNoneNoneNoneNoneNoneNone
      Antionette S. GomesOfficial reviewer—AHAUCLA School of Medicine—Professor, Radiology and MedicineNoneNoneNoneNoneNoneNone
      Anuj GuptaOfficial reviewer—ACC Board of GovernorsUniversity of Maryland School of Medicine—Assistant Professor of Medicine and Director, Cardiac Catheterization LaboratoryNoneNoneNone
      • Direct Flow Medical (Co–PI)
        No financial benefit.
      • Edwards (Co–PI)
        No financial benefit.
      • Medtronic (Co–PI)
        No financial benefit.
      NoneNone
      Jonathan L. HalperinOfficial reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesMt. Sinai Medical Center—Professor of Medicine
      • Medtronic
      NoneNoneNoneNoneNone
      Clifford J. KavinskyOfficial reviewer—SCAIRush-Presbyterian-St. Luke’s Medical Center—Training DirectorNoneNoneNoneNoneNoneNone
      Scott KinlayOfficial reviewer—SVMVA Boston Healthcare System—Director, Cardiac Catheterization LabNoneNoneNone
      • Medtronic
        Significant relationship.
      NoneNone
      Michael J. MackOfficial reviewer—ACC Board of TrusteesThe Heart Hospital Baylor Plano—DirectorNoneNoneNone
      • Abbott Vascular
        No financial benefit.
      • Edwards
        No financial benefit.
      NoneNone
      Steven R. MesséOfficial reviewer—ASAUniversity of Pennsylvania—Department of NeurologyNoneNoneNoneNoneNoneNone
      Eric RoselliOfficial reviewer—STSCleveland Clinic—Director of the Aortic Center, Heart and Vascular Institute
      • Edwards
        Significant relationship.
      • Medtronic
        Significant relationship.
      • Sorin
        Significant relationship.
      NoneNoneNoneNoneNone
      Frank J. RybickiOfficial reviewer—ACRThe Ottawa Hospital—Chief of Medical Imaging and Professor and Chair of RadiologyNoneNoneNone
      • Toshiba
      NoneNone
      Richard D. WhiteOfficial reviewer—AHAThe Ohio State University Medical Center—Professor and Chairman, CardiologyNoneNoneNoneNoneNoneNone
      This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant to this document. It 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. A relationship is considered to be modest if it is less than significant under the preceding definition. 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. According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person’s household has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document. AATS, The American Association for Thoracic Surgery; ACC, American College of Cardiology; ACR, American College of Radiology; AHA, American Heart Association; ASE, American Society of Echocardiography; ASA, American Stroke Association; PI, principal investigator; SCA, Society of Cardiovascular Anesthesiologists; SCAI, Society for Cardiovascular Angiography and Interventions; SIR, Society of Interventional Radiology; STS, Society of Thoracic Surgeons; SVM, Society of Vascular Medicine.
      Significant relationship.
      No financial benefit.