title: Two Blades-Up Runs Using the JetStream Navitus Atherectomy Device Achieve Optimal Tissue Debulking of Nonocclusive In-Stent Restenosis: Observations From a Porcine Stent/Balloon Injury Model.
abstract: OBJECTIVE
  To determine the number of runs with blades up (BU) using the JetStream Navitus to achieving optimal debulking in a porcine model of femoropopliteal artery in-stent restenosis (ISR).
  
  
  METHODS
  In this porcine model, 8 limbs were implanted with overlapping nitinol self-expanding stents. ISR was treated initially with 2 blades-down (BD) runs followed by 4 BU runs (BU1 to BU4). Quantitative vascular angiography (QVA) was performed at baseline, after 2 BD runs, and after each BU run. Plaque surface area and percent stenosis within the treated stented segment were measured. Intravascular ultrasound (IVUS) was used to measure minimum lumen area (MLA) and determine IVUS-derived plaque surface area.
  
  
  RESULTS
  QVA showed that plaque surface area was significantly reduced between baseline (83.9%±14.8%) and 2 BD (67.7%±17.0%, p=0.005) and BU1 (55.4%±9.0%, p=0.005) runs, and between BU1 and BU2 runs (50.7%±9.7%, p<0.05). Percent stenosis behaved similarly with no further reduction after BU2. There were no further reductions in plaque surface area or percent stenosis with BU 3 and 4 runs (p=0.10). Similarly, IVUS (24 lesions) confirmed optimal results with BU2 runs and no additional gain in MLA or reduction in plaque surface area with BU3 and 4. IVUS confirmed no orbital cutting with JetStream Navitus. There were no stent strut discontinuities on high-resolution radiographs following atherectomy.
  
  
  CONCLUSIONS
  JetStream Navitus achieved optimal tissue debulking after 2 BD and 2 BU runs with no further statistical gain in debulking after the BU2 run. Operators treating ISR with JetStream Navitus may be advised to limit their debulking to 2 BD and 2 BU runs to achieve optimal debulking.
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA shammas@mchsi.com.
authors.forename: Nicolas W
authors.initials: NW
authors.lastname: Shammas
authors.affiliation: Boston Scientific, Maple Grove, MN, USA.
authors.forename: Nicole
authors.initials: N
authors.lastname: Aasen
authors.affiliation: CBSET Inc, Lexington, MA, USA.
authors.forename: Lynn
authors.initials: L
authors.lastname: Bailey
authors.affiliation: CBSET Inc, Lexington, MA, USA.
authors.forename: Jay
authors.initials: J
authors.lastname: Budrewicz
authors.affiliation: Boston Scientific, Maple Grove, MN, USA.
authors.forename: Trent
authors.initials: T
authors.lastname: Farago
authors.affiliation: Boston Scientific, Maple Grove, MN, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Jarvis
mesh_terms: D000792:Angiography; D000800:Angioplasty, Balloon; D000818:Animals; D017073:Atherectomy / Q000295:instrumentation*; D065426:Cytoreduction Surgical Procedures / Q000295:instrumentation; D004195:Disease Models, Animal; D005263:Femoral Artery / Q000601:surgery*; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000601:surgery*; D011150:Popliteal Artery / Q000601:surgery*; D015607:Stents; D013552:Swine
keywords: atherectomy; in-stent restenosis; intravascular ultrasound; minimum lumen diameter; optimal debulking; percent stenosis; plaque surface area; porcine model; quantitative angiography