Special report from the Society of Thoracic Surgeons
2012 ACCF/AATS/SCAI/STS Expert Consensus Document on Transcatheter Aortic Valve Replacement: Developed in collaboration with the American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Mended Hearts, Society of Cardiovascular Anesthesiologists, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance

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Preamble

This document has been developed as an Expert Consensus Document (ECD) by the American College of Cardiology Foundation (ACCF), American Association for Thoracic Surgery (AATS), Society for Cardiovascular Angiography and Interventions, and The Society of Thoracic Surgeons (STS) in collaboration with the American Heart Association (AHA), American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Failure Society of America, Society of Cardiovascular Computed

Background and Historical Aspects

The most common cause of valvular aortic stenosis (AS) in adults is calcification of a normal trileaflet or congenital bicuspid valve [2, 3, 4]. Calcific AS is characterized by lipid accumulation, inflammation, fibrosis, and calcification [5, 6] and is common in the United States. It typically presents in older individuals (i.e., >75 years) in contrast to bicuspid AS, which presents a decade or more earlier. Rheumatic AS, uncommon in the Western world, occurs due to fusion of the commissures

Surgical AVR

AVR is the only effective treatment considered a Class I recommendation by ACCF/AHA and ESC guidelines in adults with severe symptomatic AS [28, 29]. Not only does it offer symptomatic relief, the operation improves long-term survival. Since 1960, when AVR was first introduced, advancement in prosthetic technology including improved hemodynamics, durability and thromboresistance, and techniques in cardiac surgery such as cardioplegia, management of the small aortic root, resection of associated

Background and History

Given the increased mortality and morbidity of AVR surgery for high-risk patients and the poor long-term results of balloon aortic valvuloplasty, there has been interest in the development of a percutaneously delivered aortic heart valve [91]. As early as 1992, investigators evaluated stent-based porcine bioprostheses delivered to various aortic sites in animal models [92]. This early work culminated in 2000 with implantation of a percutaneous heart valve in a 12-year-old patient with a failing

Multidisciplinary Team

The creation of a multidisciplinary team that includes the patient in the decision process in choosing the most appropriate form of treatment for AS including AVR (i.e., surgical or percutaneous) is essential. It is similar in concept to the “heart team” approach for CAD [142]. Factors such as sex, race, availability, experience, and institutional commitment to managing very high-risk patients, technical skills, local results, referral patterns, and patient preference all may have an impact on

Technology Evolution

Next-generation devices promise the potential for improvements, offering expanded clinical utility with advances that include: lower profile delivery catheters, more accurate positioning, reduced paravalvular leak, and ability to either reposition or even retrieve (Table 14) [246]. Many of the new device technologies utilize a self-expandable, high radial strength repositionable prosthesis consisting of pericardial tissue on a nitinol frame. Two additional valves have recently received approval

Applications in New Patient Populations and New Study Designs

As experience is gained and technology evolves, the patient population best served with TAVR is likely to change, and 3 areas that merit specific consideration are the “valve-in valve” technique for patients with dysfunctional aortic bioprostheses, the use of TAVR in patients with stenotic bicuspid aortic valves, and application to lower-risk surgical patients. Other patient populations, such as those with chronic or end-stage renal disease, may also be candidates for this technology and will

U.S. Perspective

The U.S. perspective reflects the fact that TAVR approval required a randomized controlled trial, the full extent of which has just now been published [124]. This contrasts with Europe where 5 new valves or iterations of current valves are already in relatively widespread clinical use. Accordingly, from the U.S. perspective, the rollout of this technology is a key issue. This rollout is influenced by the societal beliefs in a free market; convenient and timely access to medical care; patient

Role of Registries

Post-marketing data collection for medical device evaluation is an essential component in the assessment of device performance and its benefit/risk balance throughout the product life cycle. In addition to confirmation of data observed in pre-approval studies, post-marketing studies provide information regarding ‘real world’ use in patient subsets not fully tested in pre-market clinical trials. Registries offer an important platform for post-marketing device evaluation. For example, the STS

Summary and Recommendations

There are a number of potential treatment recommendations for patients with AS (Table 15). Consideration of the risk/benefit of each option needs to be carefully evaluated and discussed with the patient and family. The involvement of the heart team in decision making is also essential.

The approval of TAVR represents a fundamental change in the management of aortic valvular heart disease by offering an alternative to traditional surgical aortic valve replacement in carefully selected patients.

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  • Cited by (0)

    Author Recusals: Writing committee members are required to recuse themselves from voting on sections to which their specific relationship with industry and other entities may apply; see Appendix 1 for recusal information.

    This document was approved by the American College of Cardiology Foundation (ACCF) Board of Trustees, American Association for Thoracic Surgery (AATS) Council, Society for Cardiovascular Angiography and Interventions (SCAI) Board of Directors, Society of Thoracic Surgeons (STS) Board of Directors in January 2012 and endorsed by the governing bodies of the American Heart Association (AHA) Science Advisory and Coordinating Committee, American Society of Echocardiography (ASE), European Association for Cardio-Thoracic Surgery (EACTS), Heart Failure Society of America (HFSA), Mended Hearts, Society of Cardiovascular Anesthesiologists (SCA), Society of Cardiac Computed Tomography (SCCT), and the Society for Cardiovascular Magnetic Resonance (SCMR) in January 2012. For the purpose of complete transparency, disclosure information for the ACCF Board of Trustees, the board of the convening organization of this document, is available at: http://www.cardiosource.org/ACC/About-ACC/Leadership/Officers-and-Trustees.aspx. ACCF board members with relevant relationships with industry to the document may review and comment on the document but may not vote on approval.

    The Society of Thoracic Surgeons requests that this document be cited as follows: Holmes DR Jr., Mack MJ, Kaul S, Agnihotri A, Alexander KP, Bailey SR, Calhoon JH, Carabello BA, Desai MY, Edwards FH, Francis GS, Gardner TJ, Kappetein AP, Linderbaum JA, Mukherjee C, Mukherjee D, Otto CM, Ruiz CE, Sacco RL, Smith D, Thomas JD. 2012 ACCF/AATS/SCAI/STS expert consensus document on transcatheter aortic valve replacement. Ann Thorac Surg 2012;93:1340–95.

    This article has been copublished in Anesthesia and Analgesia, The Annals of Thoracic Surgery, Catheterization and Cardiovascular Interventions, Journal of the American College of Cardiology, and the Journal of Thoracic and Cardiovascular Surgery.

    Copies: This document is available on the World Wide Web sites of the American College of Cardiology (http://www.cardiosource.org), the American Association for Thoracic Surgery (http://www.aats.org), the Society for Cardiovascular Angiography and Interventions (http://www.scai.org), The Society of Thoracic Surgeons (http://sts.org), the American Society of Echocardiography (http://www.asecho.org), the Heart Failure Society of America (http://www.hfsa.org), and Mended Hearts (http://mendedhearts.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax 212-633-3820, e-mail [email protected].

    Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of The Society of Thoracic Surgeons. Please contact Elsevier's permission department at [email protected].

    ACCF Task Force Members: Robert A. Harrington, MD, Chair; Deepak L. Bhatt, MD, MPH, Vice Chair; Victor A. Ferrari, MD; John D. Fisher, MD; Mario J. Garcia, MD; Timothy J. Gardner, MD; Federico Gentile, MD; Michael F. Gilson, MD; Adrian F. Hernandez, MD; Alice K. Jacobs, MD; Sanjay Kaul, MBBS; Jane A. Linderbaum, MS, CNP; David J. Moliterno, MD; Howard H. Weitz, MD

    *

    American College of Cardiology Foundation Representative;

    Society of Thoracic Surgeons Representative;

    American Association for Thoracic Surgery Representative;

    §

    The Society for Cardiovascular Angiography and Interventions Representative;

    Society of Cardiovascular Computed Tomography Representative;

    Society for Cardiovascular Magnetic Resonance Representative;

    #

    Heart Failure Society of America Representative;

    **

    European Association for Cardio-Thoracic Surgery Representative;

    ††

    Society of Cardiovascular Anesthesiologists Representative;

    ‡‡

    American Heart Association Representative;

    §§

    Mended Hearts Consumer Advocate, Patient Representative;

    ∥∥

    American Society of Echocardiography Representative.

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