Elective PVI Linked to Higher Amputation Risk: Ken Cohen, MD, FACP

A new retrospective observational study led by Ken Cohen, MD, FACP, chief medical officer for Optum Health and chief scientific officer for the Healthcare Transformation Hub, raises serious concerns about the safety and appropriateness of elective peripheral vascular interventions (PVI) for stable peripheral arterial disease (PAD).

The analysis found a 4-fold increase in major amputations among patients undergoing elective PVI compared with similarly matched patients managed without intervention. Cohen attributes this alarming signal to a combination of overestimating procedure benefits, underestimating harms, and a resulting “treatment trap.”

Once patients enter the interventional pathway, they face a substantial risk of repeat procedures: about 26% of those who undergo PVI return to the vascular lab within a year. Cohen explained that the interventions themselves can damage blood vessels and force operators to move “downstream” into smaller arteries, especially below the knee, where outcomes are known to worsen. Each additional intervention incrementally raises the risk of complications, including limb loss.

To distinguish a procedure-driven treatment trap from simply more severe underlying disease, the research team used rigorous matching methods. They assembled 2 cohorts of roughly 13,000 patients each—1 treated with PVI and 1 managed without intervention—and carefully controlled for comorbidities using Elixhauser measures, smoking status, PAD-related medications (eg, statins, antihypertensives, and antiplatelets), and patterns of PAD-related office visits. Although Cohen acknowledges that no observational study can fully eliminate confounding, he emphasizes that these “digital twin” cohorts were very closely matched, supporting the conclusion that the excess amputations and repeat procedures are directionally attributable to the intervention strategy rather than baseline disease severity alone.

Collectively, the findings suggest that many stable patients with PAD who undergo elective PVI might have been better served with conservative management and that clinicians should exercise greater caution before initiating an invasive trajectory that can be difficult, and dangerous, to reverse.