title: Tissue removal by ultrasound evaluation (the TRUE study): the Jetstream G2 system post-market peripheral vascular IVUS study.
abstract: 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.
  
  
  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).
  
  
  CONCLUSIONS
  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.
authors: Department of Cardiology at St. John Hospital and Medical Center, Detroit, MI 48236, USA.
authors: Tejwant
authors: T
authors: Singh
authors: Deepak
authors: D
authors: Koul
authors: Susanna
authors: S
authors: Szpunar
authors: James
authors: J
authors: Torey
authors: Jigishu
authors: J
authors: Dhabuwala
authors: Lisa
authors: L
authors: Saigh
authors: Luis A
authors: LA
authors: Pires
authors: Thomas
authors: T
authors: Davis
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017225:Atherectomy, Coronary / Q000009:adverse effects / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging* / Q000473:pathology; D005355:Fibrosis; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009336:Necrosis; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging* / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging* / Q000473:pathology; D015203:Reproducibility of Results; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*