Tissue removal by ultrasound evaluation (the TRUE study): the Jetstream G2 system post-market peripheral vascular IVUS study.

Background: Balloon angioplasty and stenting of infra-inguinal lesions is limited by poor long-term patency rates. Atherectomy decreases plaque burden and provides an alternative means of revascularizing patients with peripheral arterial disease. The Jetstream G2™ (Pathway Medical Technologies, Inc., Kirkland, Washington) is a newer rotational aspiration atherectomy device, uniquely combining rotablation with aspiration capability. We evaluated the debulking properties of this device by analyzing changes in the plaque volume and composition and vessel size using intravascular ultrasound (IVUS) and virtual histology (VH). Freedom from target lesion revascularization (TLR) at 6 and 12 months was also evaluated.

Methods And Results: Eighteen patients with peripheral arterial disease requiring intervention (severe claudication despite optimal medical treatment or critical limb ischemia) were treated with rotational atherectomy. The mean age was 69.6 ± 11 years, 66.7% were male, and 44.4% had diabetes. The mean total plaque volume decreased by 56.6 mm³ (479.8 ± 172.5 mm³ to 423.2 ± 156.6 mm³; p < 0.0001), which resulted in a mean luminal volume increase of 64.3 mm³ (148.4 ± 84.1 mm³ to 212.7 ± 72.1 mm³; p < 0.0001). This was achieved without significant Dotter effect with either technique, as evidenced by the virtually unchanged vessel volume before and after treatment (628.3 ± 158.5 mm³ and 635.9 ± 169.0 mm³, respectively; p = 0.22). There was a significant reduction in fibrotic and fibro-fatty plaque volume, with no appreciable effect on necrotic core and dense calcium. There were no reported procedure-related complications and the 6- and 12-month TLR rate was 11% (2/18).

Conclusion: Atherectomy with the Jetstream G2 system results in substantial plaque volume reduction by removing fibrotic and fibro-fatty plaque. This resulted in substantial luminal volume expansion without concomitant vessel expansion. There were no major procedure-related complications, along with a relatively low 6- and 12-month rate of TLR. Future studies involving a larger number of patients are warranted to examine the potential clinical benefits of this promising technology.