Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

How do we determine the comparative safety and effectiveness of transcatheter aortic valve replacement in patients with heart failure and within specific high-risk subgroups of interest?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

Transcatheter aortic valve replacement versus aortic valve surgery versus medical therapy

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Patients with severe aortic stenosis

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

High-risk patients who are not candidates for surgical replacement, women vs men, elderly patients

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

All patient-related benefits, including but not limited to: reduction in mortality and strokes/transient ischemic events, symptomatic improvement

Describe any health-related risks, side effects, or harms that you are concerned about.

All patient-related harms, including but not limited to: mortality and strokes/transient ischemic events

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cardiovascular disease, including stroke and hypertension

AHRQ Priority Populations

• Minority groups
• Women
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

• Medicaid
• Medicare

Importance

Describe why this topic is important.

While conventional surgical placement of the aortic valve has been the mainstay for severe aortic stenosis, transcatheter aortic valve replacement (TAVR) has emerged as a disruptive technology whose efficacy has been demonstrated in randomized clinical trials. As a result, there may be a rapid uptake of TAVR in patients with aortic stenosis with extrapolation to subgroups not completely represented by clinical trial populations. Patients with heart failure with reduced ejection fraction represent one such subgroup. Given that the mean left ventricular ejection fraction in PARTNER was above 50% in the intervention and control groups of both cohorts A and B, the benefit of TAVR in patients with moderate to severe left ventricular systolic dysfunction is unknown.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

This topic was ranked as a priority by a panel of stakeholders convened through the Duke EPC’s Cardiovascular Topic Identification project to recommend a research agenda for future systematic reviews within the EHC cardiovascular domain.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

Stakeholders considered uncertainty for clinicians and/or policy-makers as part of the ranking process, and with that criterion considered, this topic received a priority designation.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

This topic was identified by a group of stakeholders in cardiovascular disease as an area in which significant morbidity, mortality, and/or variation in resource utilization persists, and future systematic review development should be prioritized. Answers to this question are expected to inform practice and guideline development, and ultimately improve the quality of care by reducing morbidity, mortality, and costs.

Describe the timeframe in which an answer to your question is needed.

Though no specific timeframe is applicable, this topic was identified by the stakeholder group as immediately relevant.

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Stakeholders considered variation in clinical practice and inequities in care as part of the ranking process, and with that criterion considered, this topic received a priority designation.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

This topic was identified by a group of stakeholders in cardiovascular disease as an area in which significant morbidity, mortality, and/or variation in resource utilization persists, and future systematic review development should be prioritized. Answers to this question are expected to inform practice and guideline development, and ultimately improve the quality of care by reducing morbidity, mortality, and costs.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program

Involvement in the Evidence-based Practice Center Program