Is target lesion revascularisation (TLR) a meaningful clinical endpoint for research or should it be “tossed as a legitimate endpoint for peripheral vascular disease treatment success in US FDA [Food and Drug Administration] approval trials?” Recent keynote presentations and conference debate on appropriate care for peripheral vascular disease leave overuse of interventional therapy, particularly for claudication, staring down the end of a barrel. They also trigger a conversation around TLR becoming a target in and of itself.
Kim Hodgson, the 2019–2020 Society for Vascular Surgery (SVS) president, delivered a “delayed-due-to-COVID-19” presidential address at the 2021 Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online) laying out a path to champion appropriateness in vascular care. He wasted little time in conveying the message he has long sought to convey to SVS members: that the threat posed to vascular surgery by a small number of “bad actors” carrying out inappropriate procedures is real—and that it is long past time to address the issue.
The day after Hodgson introduced the concept during the Crawford Issues Forum, data were presented by Caitlin W Hicks, associate professor of Surgery at Johns Hopkins Medicine in Baltimore, USA, and colleagues at VAM on the overuse of early peripheral vascular interventions for claudication. Since then, further research has built upon the charge that outliers are performing inordinate levels of certain procedures, including atherectomy carried out in the office-based lab (OBL) setting.
The impact of the explosive growth of atherectomy on patients and healthcare finances is problematic and growing exponentially, Hodgson lamented. He turned to further findings from Hicks showing that of the roughly US$267 million reimbursed by Medicare for first-time femoropopliteal peripheral vascular interventions in 2019, 90% was for atherectomy, “leaving only US$26 million to pay for all of the other therapies that actually have evidence showing that they work.”
Hodgson called out what he called “the enablers” of this type of practice—“people or constructs that encourage or enable negative behaviour in others.” The Centers for Medicare & Medicaid Services (CMS) was one, with “distorted reimbursement incentives” contributing to the problem, he argued.
Another enabler is the FDA, Hodgson said, calling for TLR to be “tossed as a legitimate endpoint for peripheral vascular disease treatment success in FDA approval trials.” Hodgson also called out vascular surgery’s industry partners. He said they should be “the canary in the coalmine for inappropriateness. You are uniquely positioned to spot abuse early—before patients are harmed. You know every one of the outliers in vascular care.”
Jim A Reekers, professor emeritus of Radiology at Amsterdam University, Amsterdam, The Netherlands, is currently the editor-in-chief of CVIR Endovascular and has served as president of several national and international organisations, such as the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) and the interventional radiology division of the European Union of Medical Specialists (UEMS). He tells Interventional News: “I read with great interest the address of Dr Hodgson during the 2021 iteration of VAM about inappropriateness in care. I fully agree with the content, and I am happy with this initiative for change. I truly hope that his address will mark the start of a new era where the patient will be again the focus of our work and not only the patient’s lesion. As mentioned by Dr Hodgson, there has never been any scientific evidence for atherectomy while there is overwhelming high[1]quality evidence for SET [supervised exercise therapy], and there has been for a long time. Dr Hodgson also touched on the holy grail of TLR, which is instrumental to what he says about inappropriateness in care. TLR is a flawed and constructed pseudo endpoint for peripheral vascular disease treatment success, without any relation to real clinical patient outcome, benefitting only commercial trials (as published by Reekers in The Lancet in 2019). His idea that industry partners are uniquely positioned to spot abuse is true and needs no further discussion.”
Speaking at a separate VAM sponsored session on paclitaxel safety, which drew a mix of sceptical and cautious responses to the latest meta-analysis from interventional radiologist Konstantinos Katsanos and colleagues (Patras University Hospital, Patras, Greece), that reported a heightened risk of major amputation after use of paclitaxel-coated balloons (PCBs) in femoropopliteal and infrapopliteal arteries, Joseph Mills, professor and chief, Division of Vascular Surgery and Endovascular Therapy, Baylor College of Medicine, Houston, USA, and SVS vice president, made the point that there was a real need for studies that are redesigned to look at […] clinically significant endpoints for patients.”
As specialists interested in patency, Mills continued, vascular providers tend to think that if a treated lesion stays patent for a bit longer, then the treatment “has got to be better for the patient. But the actual endpoint for a claudicant would be how far they can walk, what their quality of life is; and, for a chronic limb-threatening ischaemia (CLTI) patient, it is going to be: do they heal? do they have recurrent wounds? Those questions are a little bit different than the actual lesion-specific focus. I think if we can do anything from this, it would be to get industry to start looking at different endpoints.”
