Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) speaks to Vascular News at this year’s VEITHsymposium (14–18 November, New York, USA) on deep vein arterialisation [DVA] with the LimFlow system (LimFlow). The technology aims to fill a treatment gap for ‘no-option’ chronic limb-threatening ischaemia (CLTI) patients.
New data from PROMISE II show durable outcomes for the LimFlow device—recently approved for use by the US Food and Drug Administration (FDA)—at 12 months. These results build on the six-month data presented last year and recently published in the New England Journal of Medicine.
In this interview, Clair analyses the data further. He considers some key differences between PROMISE I and II, noting the inclusion of patients with end-stage renal disease in the latter, for example. Despite this and other variances, Clair points out, outcomes proved similar across the two trials.
Clair also considers how the PROMISE trials compare to data from Europe. A presentation on data from the ALPS registry featured at VEITHsymposium 2023, in which Clair notes limb salvage rates were “very similar” to those in PROMISE I and PROMISE II, as was amputation-free survival.
In light of these most recent data, Clair outlines what is next for deep vein arterialisation, pointing towards the recently initiated PROMISE III trial.
While these are early days for the technology, Clair is optimistic about the future. “We are doing very well when we compare [DVA with LimFlow] to historical controls,” he remarks, adding that the technology represents “a real advance” for patients with complex CLTI disease.
