Value-Based Interventions for Lower Extremity Peripheral Vascular Interventions

Each year at the Society for Cardiovascular Angiography & Interventions (SCAI) Annual Scientific Sessions meeting, collaborative Think Tanks involving interventional cardiologists, administrative partners, and members of industry are convened for each SCAI clinical practice area to discuss topics of particular interest to the group. This document presents the proceeding of the 2022 peripheral session, which focused on value-based peripheral vascular interventions (PVI). The primary clinical role of PVI is to improve quality of life (QOL) for patients with claudication and limb preservation for those with chronic limb-threatening ischemia; however, PVI trials have historically focused on short-term procedure-related outcomes, resulting in few rigorous high-quality data on QOL or economic outcomes. The metrics of limb preservation are often reported, but typically without cost data, resulting in a lack of consensus on accepted measures of value in PVI. In this session, the group explored how to transition from a focus on episodic care of peripheral artery disease (PAD) to a more holistic strategy including QOL benefits, long-term health care economics, as well as patient- and society-centered value metrics. This effort should prioritize value for a diverse set of stakeholders, including patients, physicians, insurers and/or payers, hospital systems and/or outpatient-based laboratories, and industry (Figure 1). Think Tank members identified several critical themes for moving toward a value-based strategy. First, value and effectiveness are poorly defined by different stakeholders who measure costs and benefits along varied time scales and are driven by unique incentives; however, there is the potential for advancing quality PAD care when individual and collective goals are balanced in the long-term interests of the patients (Figure 2). It has been noted that defining value is dependent on perspective. The consensus opinion was that patient's perspective should be prioritized, with sustained QOL improvement and limb salvage as the predominant goal. A challenge facing the field is how to best define quality measures that accurately reflect these outcomes. Once defined, outcomes should be aligned with physician interests. In the current system, short-term outcomes may be prioritized over long-term value. With the alignment of incentives for all stakeholders in patient care (physicians, hospitals, payers or insurers, government, industry, etc) toward a well-defined value-based intervention, the currently diverse set of goals can be aligned to maximize impact for patients. Payers represent important stakeholders whose goals include lowering cost per PVI and/or hospitalization. However, payers should also prioritize patient-focused outcomes. By rewarding value-based care, payers should not penalize more expensive therapies that demonstrate improved longer-term outcomes with regard to QOL and limb salvage, which is especially relevant in therapies for PAD. For all sites of service, including hospitals, outpatient-based laboratories, and ambulatory surgical centers, the current goal is often cost containment per service, which favors short-term procedural safety and success over longer-term patient outcomes. These goals can conflict with patients' interests. If payers shift reimbursement to reward performance based on patient-centered value-based metrics, system goals would come into alignment with those of patients and physicians. From the perspective of industry, there is benefit in aligning the goals of payers, sites of service, physicians, and patients to help narrow market needs and drive innovation of high-quality devices that meet those shared goals. Clarifying the heterogeneous perspectives on value-based health care provides industry with motivation to improve quality and effectiveness, and this ultimately promotes devices with demonstrated durability and longevity in PAD treatment. Unifying the needs of stakeholders—patients, physicians, payers, and hospitals—also affords industry the possibility to better refine their approach to clinical studies and informs the selection of clinically-meaningful end points in future studies. Ultimately, this may position industry as a better partner to physicians in helping to define a PAD treatment algorithm focused on value, longevity, and QOL for patients. Finally, patients, who are at the center of this model, should remain engaged in their treatment and accountable regarding known risk factor modifications, including smoking cessation, participation in supervised exercise therapy, and adherence to evidence-based medical therapies, so that invasive therapies are applied in the context of best medical care. Taken together, the overlap between all these stakeholders occurs in therapies and devices that are most cost effective for the longest term, based on well-defined patient-centered measures of value. This allows each stakeholder to identify individual strategies that also contribute to the collective goal of high-value patient-centric care. As the first step, long-term patient-centered measures of value must be clearly defined and widely adopted. Once defined, incentives for all stakeholders can be targeted to promote these outcomes. Patients should be encouraged to take health ownership of risk factor modification prior to PVI, as this will benefit their goals of sustained QOL and limb outcomes from PVI. If interventions are needed beyond this, patients should be engaged as partners in discussions about long-term goals of interventions and the potential risks and benefits of various treatment modalities available to them. Physicians must, therefore, consistently engage with patients as partners in risk factor modification and decision making around PVI. This physician-patient relationship centered on long-term patient outcomes is far more likely to be adopted if payers structure reimbursement to reward patient outcomes relative to the established definitions of value and shared metrics for success of PAD therapy. This should include reimbursement for preventive programs, including application of noninvasive therapies (eg, smoking cessation, supervised exercise therapy, application of medical therapies, including anticoagulant therapy) as well as high-quality invasive therapies and devices. Conversely, payers may consider financial disincentives to PVIs for patients who are not medically optimized and readmission penalties for PVI if the best therapies (medical and invasive) are not applied. In conjunction, the sites of service must similarly select and promote technologies and devices with demonstrated durable benefits to the health and QOL of patients. This means that hospital systems, outpatient-based laboratories, and ambulatory surgical centers should identify metrics of longer-term cost effectiveness so that the potentially high costs of durable index revascularization do not prevent the implementation of more effective therapies. This can be accomplished by tracking PVI readmissions and reinterventions associated with current therapies. Additionally, industry should closely engage with patients and physicians around important questions relevant to defining procedural and long-term success in PVI, with a focus on durable, value-driven patient-related outcomes and limb salvage. Additionally, a collaborative trial design featuring cardiovascular risk factor modification can move toward mortality improvement in this high-risk patient population. Importantly, moving forward, studies should ensure adequacy of racial, ethnic, sex, and geographic diversity to understand the differential impacts of deprivation on treatment strategies in order to improve care overall. Principal investigators should be actively engaged, along with community partners, to address gaps in noninvasive and invasive care of PAD. Ultimately, the members agreed on several important concepts. The first is the need to address and define value, balancing the perspectives and needs of key stakeholders while prioritizing patients. Second, the members identified that assignation of value had an important time-based component given the chronic disease course of PAD. Ultimately, all agreed that there needs to be alignment of incentives toward value-based rather than fee-for-service–based care in the treatment of chronic PAD. Given his role as Associate Editor, Sahil A. Parikh had no involvement in the peer review of this article and has no access to information regarding its peer review. Full responsibility for the editorial process for this article was delegated to Alexandra J. Lansky. S. Elissa Altin, Lyndon C. Box, Tony Das, Dmitriy N. Feldman, Sasanka Jayasuriya, Andrew J. Klein, Faisal Latif, Jun Li, Sahil A. Parikh, Eric A. Secemsky, and Rajesh V. Swaminathan reported no financial interests. Ellie Boutin is an employee at Terumo. Fely Canorea-Vega and James Hasegawa are employees at Abbott. Anjan K. Chakrabarti is an employee at Inari Medica. Nicole Howie is an employee at Medtronic. Toni Kohler and Holly M. Lauridsen are employees at WL Gore & Associates. Oscar Perez and Novena Rangwala are employees at GE Healthcare. Michele Schicchi and Laurie Zinn are employees at Cordis. Margaret Taber is an employee at Boston Scientific. John Venditto is an employee at AstraZeneca Pharmaceuticals. Jude Wimberger is an employee at Philips Healthcare. This manuscript did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.