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Editorial Implementing Shared Decision Making in the Rapidly Evolving Field of Valvular Heart Disease Karen R. Sepucha, PhD; Jason H. Wasfy, MD, MPhil

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n shared decision making (SDM), healthcare providers engage patients in selecting the best treatment for their clinical and personal circumstances. SDM is an interactive process that combines the latest evidence with clinicians’ and patients’ relevant expertise (eg, how the disease is impacting their life, their goals, and preferences).1,2 Patient decision aids (PtDAs) are evidence-based tools designed to support SDM. More than 100 randomized controlled trials of PtDAs have demonstrated their efficacy in increasing patients’ knowledge, confidence in decision-making, and clarifying goals of treatment.3

health preoperatively compared with the control group. The study provides the first efficacy data for a decision aid for valvular disease, and it also highlights 2 potential challenges for SDM and PtDA developers more broadly. First, ≈20% of patients in the decision aid group, who were expecting to be involved in selecting a prosthetic valve, were told that the heart team had already selected the type of valve. This finding highlights a problem with the common assumption that providing patients a PtDA is enough to ensure SDM; a decision aid is irrelevant if the clinical team has already taken the decision out of the hands of the patient. Second, the widening indications for transcatheter approaches are changing the balance of potential benefits and harms of mechanical versus bioprosthetic valves. The PtDA in the trial did not seem to include this option, and to be accepted in routine care, PtDAs need to keep up with changes in evidence and practice. Because guidelines and payers increase emphasis on SDM, researchers, clinicians, and decision aid developers will need to address these challenges to implement SDM. SDM and PtDAs have a rich history in cardiology. SDM is emphasized as an approach to guide selection of treatment in a range of American College of Cardiology/American Heart Association clinical guidelines such as percutaneous coronary intervention,7 lipid management,8 and most recently for transcatheter aortic valve replacement.9 The rationale for SDM is that evidence-based guidelines alone are not sufficient to make a recommendation or decision; rather, the evidence has to be considered from the viewpoint of what matters to individual patients.8 PtDAs can help facilitate SDM, and randomized controlled trials of decision aids have demonstrated benefit for many decisions within cardiology, including lipid management,10 treatment of stable coronary disease,11 and the evaluation of chest pain in the emergency department.12 The Korteland et al4 study in this issue adds evidence of the efficacy of decision aids for valvular heart disease to the existing literature. Clinical guidelines for valvular heart disease emphasize SDM, both for the choice of intervention (repair or replacement) and the type of prosthetic valve.13 Clinicians who are interested in using PtDAs with their patients with aortic valve disease, however, have limited options. The decision aid developed by Korteland et al4 is available in Dutch, contains individual risk estimates of bleeding and reoperation based on age and sex, and has demonstrated modest efficacy in a rigorous multicenter trial. There is one other existing decision aid available online and in English, for patients deciding among aortic valve prostheses (titled Heart Valve Problems: Should I Choose a Mechanical or Tissue Valve to Replace My Heart Valve?). This online PtDA provides general information about the benefits and harms of the options, but there are no published data on its efficacy.14 The American College of

See Article by Korteland et al The study by Korteland et al4 in this issue of Circulation: Cardiovascular Quality and Outcomes is the first published randomized controlled trial of a PtDA for valvular heart disease. The PtDA addresses the choice of prosthetic valve (mechanical versus bioprosthetic) for patients who have decided to have elective surgical aortic or mitral valve replacement. The major benefit of mechanical prosthetic valves is increased durability and reduced need for reoperation, whereas the major benefit of bioprosthetic valves is the avoidance of the need for permanent anticoagulation. Earlier work by this group had uncovered gaps in patients’ understanding of these issues and evidence that patients were not involved in decision-making as much as they would like to be.5 Korteland et al6 also found that Dutch cardiothoracic surgeons were more willing to involve patients in selection of valve type compared with Dutch cardiologists. Further, Dutch surgeons tended to prefer bioprosthetic valves, whereas cardiologists preferred mechanical.6 In short, patients may not be well informed or engaged in decisions about the selection of the type of valve, and PtDAs may be needed to help clinicians involve patients in an unbiased manner. Although Korteland’s multicenter randomized controlled trial did not find any difference between groups in the primary outcome (decisional conflict), it did find that the decision aid group had higher knowledge, less anxiety, and better mental The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. From the Health Decision Sciences Center, Division of General Internal Medicine (K.R.S.) and Cardiology Division, Department of Medicine (J.H.W.), Massachusetts General Hospital, Harvard Medical School, Boston. Correspondence to Karen R. Sepucha, PhD, Health Decision Sciences Center, MGH, 50 Staniford St, Suite 802, Boston, MA 02114. E-mail [email protected] (Circ Cardiovasc Qual Outcomes. 2017;10:e003549. DOI: 10.1161/CIRCOUTCOMES.117.003549.) © 2017 American Heart Association, Inc. Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org DOI: 10.1161/CIRCOUTCOMES.117.003549

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Cardiology has recently developed a decision aid for patients deciding between transcatheter aortic valve replacement and management of symptoms without procedural intervention, and it is currently under evaluation.15 The limited availability of high-quality tools will make it difficult for clinicians interested in engaging patients in SDM. Even if we had readily available, effective PtDAs, it is a challenge to integrate these tools into routine care. At our hospital, clinicians have access to a set of 40 decision aids that include 4 heart topics: treatment choices for stable chest discomfort, heart tests, congestive heart failure, and secondary prevention of heart disease. Despite interest on the part of the cardiology clinicians, use of these PtDAs is rare—of the nearly 10 000 PtDAs distributed to our patients in 2016, only 24 were for these 4 heart topics.16 In their article, Korteland et al acknowledge that their decision aid was not well integrated into routine care and that some of the cardiologists and surgeons may not have recognized or supported its use. It seems that ≈20% of patients in the study did not feel that they were given a choice.4 To ensure that SDM occurs, more attention is needed to incorporate PtDAs into the routine workflow and to engage clinicians more directly in the process. Another challenge for PtDAs highlighted by this study is the need for these tools to stay relevant and up to date with clinical practice. With the increased focus on the decision between transcatheter aortic valve replacement and surgical aortic valve replacement, the context of clinical practice in this area is changing quickly. Historically, the clinical trade-off in this decision has been between the need for anticoagulation with a mechanical valve and the need for reoperation in the future with a bioprosthesis. Newer techniques have allowed the percutaneous insertion of transcatheter valves into degenerated aortic bioprostheses.17 With these advances, predicting treatment options that will be available for patients who might need a reoperation after having a bioprosthetic valve in the upcoming 10 to 15 years is nearly impossible. Clinicians, however, must provide guidance to current patients in the face of this future uncertainty. Decision aids, if done well, are designed to help communicate uncertainty and to help patients evaluate options—even when there is incomplete or limited information about the potential outcomes. International guidelines for decision aid development recommend developers establish an update policy to incorporate new evidence and new options, but it is not consistently done. Given the rapid changes in this space, further evolution of valvular decision aids is likely needed before widespread adoption. The importance of this issue is not merely academic. In fact, policymakers are already implementing programs that encourage, or even mandate, the adoption of decision aids in cardiology and other conditions. For example, the Centers for Medicare and Medicaid Services is funding the ACC Foundation SmartCare project, to integrate SDM, PtDAs, and clinical decision support for patients with stable ischemic heart disease.18 In atrial fibrillation, Centers for Medicare and Medicaid Services has required SDM to justify reimbursement for percutaneous closure of the left atrium for the prevention of cardioembolic stroke.19 Further, Centers for Medicare and Medicaid Services recently announced another demonstration

project that would reimburse participating Accountable Care Organizations for providing decision aids and conducting SDM conversations in 6 preference-sensitive conditions, including stable coronary artery disease.20 These demonstration projects will hopefully provide practical models for implementing SDM into the complex, multidisciplinary pathways of care in cardiology and, if successful, will also provide adequate incentives and reimbursement for those efforts. There are both opportunities and huge challenges implementing SDM and PtDAs in cardiology. In principle, a treatment decision that involves a choice between known, current challenge (eg, anticoagulation after a mechanical valve) and a future, uncertain risk (eg, subsequent surgery or procedures many years after a prosthetic valve) is exactly the sort of treatment decision amenable to decision support. But that uncertainty—driven by rapid innovation in percutaneous techniques—is also what will make durable, useful decision support tools in this space difficult to develop. The agenda needed going forward is clear, but these tasks will be challenging.

Disclosures Dr Sepucha receives salary support as a medical editor from the Informed Medical Decisions Foundation, which is now a part of Healthwise, a not-for-profit foundation that develops and distributes patient education and decision support materials. Dr Wasfy reports no conflicts.

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Implementing Shared Decision Making in the Rapidly Evolving Field of Valvular Heart Disease Karen R. Sepucha and Jason H. Wasfy Downloaded from http://circoutcomes.ahajournals.org/ by guest on April 29, 2018

Circ Cardiovasc Qual Outcomes. 2017;10: doi: 10.1161/CIRCOUTCOMES.117.003549 Circulation: Cardiovascular Quality and Outcomes is published by the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231 Copyright © 2017 American Heart Association, Inc. All rights reserved. Print ISSN: 1941-7705. Online ISSN: 1941-7713

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