In the USA, atherectomy use in peripheral vascular interventions (PVIs) “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of this increase. This is according to published US data from the Vascular Quality Initiative (VQI), which also revealed wide regional variability in the use of atherectomy.
According to authors Tonga Nfor (Aurora St Luke’s Medical Center, Milwaukee, USA) and colleagues, small, older studies have indicated that the use of atherectomy devices has become common in PVIs despite what they describe as the “paucity of strong clinical guidelines”.
The study, published in the Journal of Vascular Surgery (JVS), was a retrospective analysis of prospectively collected data from the VQI registry, which the investigators say provides a “unique opportunity” to fill knowledge gaps in this field of research using “real-world” data originating from across the USA. The team identified all patients who had undergone endovascular PVIs for occlusive lower-extremity arterial disease from 2010 to 2019. Procedures in which an atherectomy device had been used as the primary or secondary device were classified as the atherectomy group, Nfor et al write.
In the study period, the authors note that 205,377 PVIs were performed for 152,693 unique patients. They report in JVS is that, during the 10-year study period, 16.6% of the PVIs had used atherectomy, with the data showing that use “significantly increased” from 8.5% in 2010 to 19.7% in 2019.
Geographic variation was evident in the study results, with Nfor and colleagues stating that they found a significant difference in the prevalence of atherectomy use across 17 geographic regions, ranging from 8.2% to 29%. These regions were further split into North, East, South, and West, the authors write, revealing that the observed frequency of atherectomy use in PVIs during the 10-year period was highest in the South at 22.5%, followed by the West (19.9%), North (17.3%), and East (12.6%; p<0.0001).
The 10-year VQI data also clarified predictors of atherectomy use. According to the study authors, the strongest predictor of use was performance of PVI in an office setting (odds ratio [OR], 10.08; 95% confidence interval [CI], 9.17–11.09) or ambulatory centre (OR, 4; 95% CI, 3.65–4.39) versus a hospital setting. Furthermore, the geographic trend in atherectomy use followed the distribution of the proportion of office-based PVI procedures—South (6.1%), followed by the West (4%), North (3.9%), and East (0.5%).
They note that the presence of severe (OR, 2.6; 95% CI, 2.4–2.85) or moderate (OR, 1.5; 95% CI, 1.4–1.69) lesion calcification was also predictive of atherectomy use, as well as some other factors including elective status, insurance provider, lesion length, prior PVI, claudication symptoms, and diabetes mellitus.
The researchers also examined the reimbursement aspect of the atherectomy discussion, highlighting differences in compensation levels for hospital-based versus office-based procedures, and for angioplasty versus angioplasty with atherectomy. For angioplasty performed in a hospital, the physician total relative value units (RVU) was 12.94, averaging about US$466, they report. For the same procedure performed in an office-based laboratory [OBL], the total RVU was 100.68 (procedure total), translating to US$3,628. Nfor et al further reveal that, when angioplasty was performed with atherectomy in a hospital, the physician RVU was 17.61, averaging US$635. However, when atherectomy with angioplasty was performed in an OBL, the reimbursement increased to 345 RVU— approximately US$12,444. The authors, however, point out that these total RVU reimbursement figures for office and ambulatory centre procedures includes the technical and facility fees.
“To provide patients with the highest quality of care, physicians must allow their decision-making to be guided only by the clinical factors and the best interest of the patient, and should be mindful of any biases that might influence their practice, including the reimbursement structure and financial incentives,” the researchers stress.
Despite the financial incentives that exist, the authors acknowledge that clinical considerations “play an important role in interventional decisions that guide patient care”. For example, they note that patients in the hospital setting will tend to have more acute disease with greater urgency and a greater risk of complications. “It follows naturally that operators might want to avoid long, complicated procedures that will subject patients to more risk, which might partly explain the lower use of atherectomy,” the investigators remark.
There are a number of limitations to the present study which the authors address in their discussion. For example, while the VQI database offers researchers a “large sample of patients from multiple regions,” they acknowledge that a selection bias could still occur because the nature of the database is “dynamic” and different centres were added cumulatively over time.
Despite this and other drawbacks, Nfor and colleagues claim that, to the best of their knowledge, the present study was “the largest to investigate specific clinical and non-clinical predictors of atherectomy use and also to examine the trend and geographic distribution”.
Routine use of atherectomy for infrainguinal PVI called into question
In a commentary on Nfor and colleagues’ report, Caitlin Hicks (Johns Hopkins University School of Medicine, Baltimore, USA) underscores the “overwhelming message” of the analysis: that atherectomy is being overused in the USA.
“This is not an attack on physicians who work in OBLs,” Hicks stresses at the outset of her commentary—titled ‘Atherectomy overuse is a real problem’—but rather a “statement of the facts,” of which she assembles four from this latest addition to the available research:
- Atherectomy use for infrainguinal PVI has been “increasing rapidly” in the USA
- No high-quality evidence that atherectomy improves outcomes compared with alternative endovascular therapies is available
- Atherectomy is much more frequently used in OBL settings than in hospital-based settings
- Reimbursement for atherectomy procedures is substantially higher than that for stenting and balloon angioplasty in the outpatient setting
“Based on these facts, the routine use of atherectomy for infrainguinal PVI is suspicious at best,” Hicks remarks. She acknowledges that cases exist for which atherectomy has proven beneficial—calcific disease, popliteal lesions that cannot or should not be stented, and recalcitrant lesions, for example. However, Hicks also notes that the data have shown the use of atherectomy in up to 100% of cases by some physicians—a fact that is “not right” in her view.
Hicks concludes: “As a field, vascular surgeons need to come together and unite on this issue. If we do not police ourselves regarding the appropriate use of high-cost technologies, the Centers for Medicare and Medicaid will most certainly do it for us.”