Shared Decision-Making for Patients at Risk for Poor Outcomes With TAVR
An 85-year-old woman presents with increasing dyspnea on exertion. She has a history of emphysema, osteoarthritis, and atrial fibrillation. An echocardiogram reveals an ejection fraction of 35%, aortic valve area of 0.5, and mean gradient of 43 mmHg. The patient is diagnosed with severe aortic stenosis (AS) and deemed high risk for surgical aortic valve replacement. The heart team recommends undergoing transcatheter aortic valve replacement (TAVR). The patient defers decision-making to her physicians.
Severe AS is the most common valvular heart disease, occurring in 3% of the elderly population.1 Over 100,000 people in the United States suffer from severe, symptomatic AS, with mortality among untreated patients at prohibitive risk for surgery reaching 50% at 1 year.2 TAVR is now an option for intermediate, high-risk, and inoperable patients, including the very elderly, and is shown to have an outcome that is superior to surgery in high-risk patients.3 However, even after undergoing TAVR, 1 in 4 patients deemed high risk for surgery die within 1 year.4
Thus, physicians are challenged when providing guidance to individuals like the high-risk patient described above. A shared decision-making approach is recommended by professional guidelines for patients with AS who are considering TAVR.5 Shared decision-making is a communication strategy by which clinicians and patients make treatment decisions together using the best clinical evidence and guided by patient preferences.6 Vulnerable patients, including the elderly, benefit from the use of tools designed to increase patient knowledge and engagement in shared decision-making known as "decision aids."7 Decision aids consistently demonstrate improvement in patient satisfaction and reduction in decisional conflict (a measure of how well the decision matches the patient's values and preferences).8 However, research shows inconsistent use of decisions aids in routine care by clinicians.
It is clear that effective decision aidsand implementation strategies to get them into routine clinical practiceare needed to improve patient selection and integrate patient preferences into decisions about treatment choices for AS. Decision tools often incorporate patient-specific estimates of benefits and risks of the treatment options that are deemed appropriate by the patient's clinical team. Recent work by Suzanne Arnold and colleagues uniquely focuses on identifying those high-risk patients who have less of a chance of benefitting from TAVR through the development and testing of the TAVR Poor Outcome Risk model.9 This predictive model incorporated patient-reported quality-of-life outcomes in addition to mortality. The models are shown to have modest predictive power with regard to the probability of a poor outcome.4 Recognizing limitations of predictive models, prior literature supports that it may be useful for clinicians to consider weighing the quality of evidence in partnership with patients.10 The shared decision-making process strives to recognize and embrace uncertainty in current evidence through careful and transparent evaluation of that evidence.11 Shared decision-making is one of the most effective methods to ethically and appropriately communicate with patients where complexity and uncertainty is high.12,13
Decision aids for TAVR are currently undergoing investigation. Aortic Stenosis Choice is a paper-based decision aid designed for use during clinic visits for patients choosing between TAVR and medical management (Figure 1). This decision aid was designed in conjunction with the American College of Cardiology's initiative Championing Care for the Patient with Aortic Stenosis. The mission of this initiative was to empower members of the heart valve team to appropriately assess, refer, and provide timely patient-centered interventions for older patients with severe, symptomatic AS. Aortic Stenosis Choice models general trends for patients at high risk for surgery in quality of life, survival, and stroke displayed as pictographs, along with other potential complications for TAVR and medical therapy. The tool is designed as a conversation aid for physicians and their patients to encourage a shared decision-making approach. Some decision aids require data input to generate patient-specific risk calculations. However, this may be a barrier to implementation of decision aid use because it requires time, and often additional staffing, to complete. The Aortic Stenosis Choice decision aid was tested using both general statistics and patient-specific data points, with the general model proving to be more acceptable by end users in the clinical setting.
Although the benefits of shared decision-making are well-documented, data suggest that elicitation of patient preferences by clinicians is missing. When given the chance, patients are willing and able to share their personal goals.14 Research demonstrates that it is rare for physicians to consistently elicit patient preferences, and that physicians may take over decision-making when patients like the one above say early in the visit, "Doctor, what would you do?"15 This response may be due to a perception from patients that they are not invited to participate in decision-making.16 Among the elderly, most patient-centered goals are based on the ability to perform a specific activity as opposed to improved symptomology or increased lifespan.3,14 These preferences may not be expressed without direct prompting by the physician.
Given the documented benefits of shared decision-making and its limited implementation in clinical practice, there is a need to both train and motivate physicians to elicit patient preferences and values during clinical visits. In the future, physicians may be mandated to utilize this approach for TAVR patients. Currently, Medicare requires performance and documentation of shared decision-making utilizing evidence-based decision aids to obtain reimbursement for left atrial appendage closure devices such as the WATCHMAN (Boston Scientific Corporation; Marlborough, MA).17 Research is ongoing to discover whether this type of mandate may lead to improved physician implementation of shared decision-making.
Use of shared decision-making combined with new predictive modeling may aid in the selection of the most appropriate patients with AS who are considering TAVR. This strategy may improve outcomes and lead to decision-making that truly aligns with patient preferences. In addition to providing benefits for patients at prohibitive risk for surgery, shared decision-making may be used to aid low- to intermediate-risk patients considering TAVR versus surgical aortic valve replacement. Future research is needed to identify the best ways to improve physician facilitation of shared decision-making and elicitation of patient preferences and to determine whether implementation of shared decision-making leads to enhanced patient satisfaction with the decisions made during clinical visits.
Following a successful TAVR procedure, the patient received a permanent pacemaker and had a prolonged inpatient stay. The patient had subtle improvement in her volume management but continued to report poor quality of life. She died 6 months later.
- Osnabrugge RL, Mylotte D, Head SJ, et al. Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modeling study. J Am Coll Cardiol 2013;62:1002-12.
- Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010;363:1597-607.
- Basra SS, Holper EM. Transcatheter Aortic Valve Replacement in Nonagenerians. http://www.acc.org. Feb. 23, 2016. Accessed Nov. 15, 2016. https://www.acc.org/latest-in-cardiology/articles/2016/02/22/14/52/transcatheter-aortic-valve-replacement-in-nonagenarians.
- Arnold SV, Afilalo J, Spertus JA, et al. Prediction of Poor Outcome After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol 2016;68:1868-77.
- Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014;63:2438-88.
- Alston C, Berger ZD, Brownlee S, et al. Shared Decision-Making Strategies for Best Care: Patient Decision Aids (National Academy of Sciences website). 2014. Available at: https://nam.edu/wp-content/uploads/2015/06/SDMforBestCare2.pdf. Accessed Nov. 15, 2016.
- Coylewright M, Branda M, Inselman JW, et al. Impact of sociodemographic patient characteristics on the efficacy of decision AIDS: a patient-level meta-analysis of 7 randomized trials. Circ Cardiovasc Qual Outcomes 2014;7:360-7.
- Stacey D, Légaré F, Col NF, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014;1:CD001431.
- Arnold SV, Reynolds MR, Lei Y, et al. Predictors of poor outcomes after transcatheter aortic valve replacement: results from the PARTNER (Placement of Aortic Transcatheter Valve) trial. Circulation 2014;129:2682-90.
- Saba GW, Wong ST, Schillinger D, et al. Shared decision making and the experience of partnership in primary care. Ann Fam Med 2006;4:54-62.
- Epstein RM, Gramling RE. What is shared in shared decision making? Complex decisions when the evidence is unclear. Med Care Res Rev 2013;70(1 Suppl):94S-112S.
- Légaré F, Thompson-Leduc P. Twelve myths about shared decision making. Patient Educ Couns 2014;96:281-6.
- Elwyn G, Tilburt J, Montori V. The ethical imperative for shared decision-making. Eur J Pers Cent Healthc 2013;1:129-31.
- Coylewright M, Palmer R, O'Neill ES, Robb JF, Fried TR. Patient‐defined goals for the treatment of severe aortic stenosis: a qualitative analysis. Health Expect 2016;19:1036-43.
- Tucker Edmonds B, McKenzie F, Panoch JE, Wocial LD, Barnato AE, Frankel RM. "Doctor, what would you do?": physicians' responses to patient inquiries about periviable delivery. Patient Educ Couns 2015;98:49-54.
- Joseph-Williams N, Elwyn G, Edwards A. Knowledge is not power for patients: a systematic review and thematic synthesis of patient-reported barriers and facilitators to shared decision making. Patient Educ Couns 2014;94:291-309.
- Jensen TS, Chin J, Ashby L, Long K, Schafer J, Hakim R. Decision Memo for Percutaneous Left Atrial Appendage (LAA) Closure Therapy (CAG-00445N) (Centers for Medicare & Medicaid Services website). 2016. Available at: https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=281. Accessed Nov. 15, 2016.
Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Interventions and Structural Heart Disease
Keywords: Aortic Valve, Aortic Valve Stenosis, Atrial Appendage, Atrial Fibrillation, Decision Support Techniques, Decision Making, Dyspnea, Emphysema, Heart Valve Diseases, Osteoarthritis, Physical Exertion, Risk Assessment, Stroke, Transcatheter Aortic Valve Replacement
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