Peripheral artery disease (PAD) affects up to 12 million Americans and accounts for a significant burden of health care expenditures in the United States.1,2 The most common symptom of PAD is claudication, which is pain upon exertion that is relieved with rest. The presence of PAD portends a poor prognosis, as patients with PAD have substantially higher rates of myocardial infarction, stroke, and cardiovascular death.3 Despite this increase in overall mortality, only a minority of patients with symptomatic PAD progress to critical limb ischemia (CLI) and require amputation.

Although the risk of limb loss is low, claudication has a major impact on a patient’s quality of life (QOL) and well-being.4,5 Patients with claudication rate their physical functioning significantly lower than patients with congestive heart failure.5 More than 2 million individuals with claudication have a reduced QOL.6 Patients with claudication often avoid walking, which may exacerbate the decline in physical function and further impair their ability to perform activities of daily living. Moreover, depressive symptoms are present in a substantial proportion of patients with PAD and are associated with reduced functional capacity.7

Early revascularization of symptomatic PAD has not been shown to prevent progression to CLI; thus, the primary reason to recommend an intervention for patients with claudication is to improve QOL.3 However, the ability to identify patients most likely to benefit from an intervention and monitor their response to the intervention is dependent on a physician’s ability to accurately assess a patient’s preferences, QOL, risk tolerance, and subjective sense of physical limitations.

NHLBI GRANT OVERVIEW: INCORPORATING SHARED DECISION-MAKING INTO PAD CARE

When evaluating a patient with PAD, clinical indices such as the ankle-brachial index (ABI) and the Rutherford score are commonly used metrics for assessing severity of disease and clinical decision-making. The ABI correlates well with a patient’s risk of cardiovascular events but not with the patient’s self-reported assessment of QOL.8 This is similar for the Rutherford score.9 Validated tools for assessing health-related QOL are not commonly used in clinical settings. In one study, surgeons asked patients a median of five questions prior to recommending a treatment strategy, and only 9% of questions elicited patient preferences.10 Another study found that surgeons are only moderately good at evaluating patients’ QOL.11 The result is that recommendations for treatments for PAD are heterogeneous among physicians and are based on clinical scoring systems and hemodynamic parameters that are poor proxies for the outcomes that matter most to patients.

The author (ES), with support from the Smith Center for Cardiovascular Outcomes Research in Cardiology (Beth Israel Deaconess Medical Center, Boston, Massachusetts), was awarded a 5-year career mentored award from the National Heart, Lung, and Blood Institute (NHLBI) (K23HL150290) to investigate how to incorporate shared decision-making into routine PAD care. This grant involves three specific aims, with the overarching goal of facilitating better assessments of patients’ QOL and integrating patient perspectives, as defined by patient-reported outcome measures (PROMs), into clinical decision-making for the treatment of claudication.

Aim 1: Develop and Validate Prediction Tools

To counsel patients in an individualized way, prediction tools will be developed to model changes in PROMs using existing data from the large PORTRAIT study.12 PORTRAIT is a prospective, multicenter, international study that enrolled > 1,000 patients with PAD prior to receiving PAD therapies. The study collected information about patients’ QOL before and after they received optimal medical therapy, supervised exercise therapy, or peripheral vascular intervention. QOL and health status were measured using a disease-specific evaluation, the Peripheral Artery Questionnaire (PAQ), which assesses the following domains of patient function: physical function, symptom stability, social limitation, treatment satisfaction, and QOL.

The prediction tools will be able to project patients’ changes in health status (ie, symptomatic, functional, and QOL benefits) after starting a comprehensive PAD treatment program and will help better understand who may have the greatest improvement in PAQ score with an invasive strategy compared with an initial conservative therapy (medical and/or supervised exercise). Once these prediction models have been developed, they will be validated using additional clinical trial data to ensure generalizability. After validation, these prediction models will be incorporated into an established PAD decision aid, SHOW ME PAD,13 to provide both qualitative and quantitative counseling material for patients seeking management of their claudication.

Aim 2: Improve Shared Decision-Making in Routine Care

Critically, despite substantial work in the field of decision sciences in PAD, there has been poor uptake of shared decision-making into clinical practice. The second aim of the grant will focus on improving the implementation of shared decision-making into routine vascular care. As part of this aim, a mixed-methods approach will be employed to assess beliefs, goals, and concerns regarding use of decision aids and shared decision-making among a diverse population of vascular nurses, office managers, physicians, and patients from clinics throughout Massachusetts. The information gathered will be used to propose strategies to facilitate implementation of shared decision-making and create a resource for external vascular clinics interested in implementing shared decision-making.

Aim 3: Assess the Impact of SHOW ME PAD on Treatment Decision Quality

Finally, a prospective pilot study will be conducted using the SHOW ME PAD decision aid to assess its impact on treatment decision quality. Fifty patients referred for the management of new claudication will be enrolled. Baseline PAQ measures will be collected, as well as baseline decision quality and knowledge assessments. Half of the patients will then undergo usual care and counseling, while the other half will be presented with the decision aid prior to their physician visit. After the visit, patients will undergo a decision quality and knowledge assessment, which will evaluate how much knowledge patients have about PAD and their sense of preparedness to make treatment decisions regarding their PAD.

SUMMARY

The primary goal of the treatment for claudication is to improve QOL. Therefore, validated methods for assessing QOL and understanding how to incorporate patient preferences into routine clinical care is essential for improving outcomes. Through this work and other ongoing studies, the ultimate goal is to restructure PAD care so that it aligns treatment with the goals of each individual patient.

1. Virani SS, Alonso A, Benjamin EJ, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141:e139-e596. doi: 10.1161/CIR.0000000000000757

2. Song P, Rudan D, Zhu Y, et al. Global, regional, and national prevalence and risk factors for peripheral artery disease in 2015: an updated systematic review and analysis. Lancet Glob Health. 2019;7:e1020-e1030. doi: 10.1016/S2214-109X(19)30255-4

3. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e686-e725. doi: 10.1161/CIR.0000000000000470

4. Dumville JC, Lee AJ, Smith FB, Fowkes FGR. The health-related quality of life of people with peripheral arterial disease in the community: the Edinburgh Artery Study. Br J Gen Pract. 2004;54:826-831.

5. Smolderen KG, Pelle AJ, Kupper N, et al. Impact of peripheral arterial disease on health status: a comparison with chronic heart failure. J Vasc Surg. 2009;50:1391-1398. doi: 10.1016/j.jvs.2009.07.109

6. Mays RJ, Casserly IP, Kohrt WM, et al. Assessment of functional status and quality of life in claudication. J Vasc Surg. 2011;53:1410-1421. doi: 10.1016/j.jvs.2010.11.092

7. Smolderen KGE, Aquarius AE, de Vries J, et al. Depressive symptoms in peripheral arterial disease: a follow-up study on prevalence, stability, and risk factors. J Affect Disord. 2008;110:27-35. doi: 10.1016/j.jad.2007.12.238

8. Wu A, Coresh J, Selvin E, et al. Lower extremity peripheral artery disease and quality of life among older individuals in the community. J Am Heart Assoc. 2017;6:e004519. doi: 10.1161/JAHA.116.004519

9. Johnston AL, Vemulapalli S, Gosch KL, et al. Ankle-brachial index in patients with intermittent claudication is a poor indicator of patient-centered and clinician-based evaluations of functional status. J Vasc Surg. 2019;69:906-912. doi: 10.1016/j.jvs.2018.07.039

10. Troëng T, Weibull H, Lyttkens CH, et al. Decisions about treatment of aortoiliac claudication: the current practice among Swedish vascular surgeons. Eur J Surg Acta Chir. 1997;163:643-650.

11. Pell JP. Impact of intermittent claudication on quality of life. The Scottish Vascular Audit Group. Eur J Vasc Endovasc Surg. 1995;9:469-472. doi: 10.1016/s1078-5884(05)80018-8

12. Smolderen KG, Gosch K, Patel M, et al. PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): overview of design and rationale of an international prospective peripheral arterial disease study. Circ Cardiovasc Qual Outcomes. 2018;11:e003860. doi: 10.1161/circoutcomes.117.003860

13. Show Me PAD. Accessed September 3, 2020. https://showme-pad.org/.

Anna Krawisz, MD
Vascular Medicine Fellow
Beth Israel Deaconess Medical Center
Research Fellow
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology
Boston, Massachusetts
akrawisz@bidmc.harvard.edu
Disclosures: None.

Eric A. Secemsky, MD, MSc, RPVI, FACC, FSCAI, FSVM
Director, Vascular Intervention
Director, Vascular Research
Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology
Beth Israel Deaconess Medical Center
Assistant Professor of Medicine
Harvard Medical School
Boston, Massachusetts
esecemsk@bidmc.harvard.edu
Disclosures: Research grants to BIDMC from AstraZeneca, BD, Boston Scientific, Cook, CSI, Medtronic, NHLBI (K23HL150290), Philips, and UCSF; consulting/speaking, Abbott, Bayer, BD, Boston Scientific, Cook, CSI, Janssen, Medtronic, and Philips.