title: JetStream Rotational and Aspiration Atherectomy in Treating In-Stent Restenosis of the Femoropopliteal Arteries: Results of the JETSTREAM-ISR Feasibility Study.
abstract: OBJECTIVE
  To evaluate the outcomes and stent-device interaction of the JetStream atherectomy device in the treatment of in-stent restenosis (ISR) of the femoropopliteal segment.
  
  
  METHODS
  The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective cohort of 29 patients (mean age 69.9 ± 11.7 years; 11 men) with femoropopliteal ISR in 32 limbs (ClinicalTrials.gov identifier NCT01722877). Lesion length was 17.4 ± 13.1 cm. The primary effectiveness outcome was acute success (≤ 30% residual narrowing with no serious adverse events). The primary safety endpoint was major adverse events. Secondary endpoints included clinically driven target lesion revascularization (TLR) at 6 months and 1 year and loss of stent integrity as assessed by an angiographic core laboratory.
  
  
  RESULTS
  Treated length was 19.5 ± 12.9 cm. Acute success was obtained in 29/32 (91%) limbs. Acute device success (<50% residual narrowing after atherectomy alone) was 76% (22/29). Adjunctive balloon angioplasty was performed in all cases at a mean pressure of 11.6 ± 3.3 atm. Embolic filter protection was used in 16 (50%) of 32 limbs. Macrodebris was noted in 2 (12%) of 16 filters. Distal embolization requiring treatment occurred in 3/32 (9.4%) limbs (2 with no filter). Other non-procedure-related adverse events were 1 (3%) death (nonvascular) and 1 (3%) case of major bleeding. There were no new stent fractures or deformities (n=24) postatherectomy. Follow-up was completed on 27 patients (29 limbs) at 6 and 12 months. TLR at these time points occurred in 4/29 (14%) and 12/29 (41%) patients. Patency (duplex-derived peak systolic velocity ratio <2.4) was 72% at 6 months.
  
  
  CONCLUSIONS
  JetStream atherectomy using the XC device has favorable acute results in treating femoropopliteal ISR with high procedure success, no device-stent interaction, and favorably low TLR rates. A multicenter trial is needed to confirm these results.
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA shammas@mchsi.com.
authors.forename: Nicolas W
authors.initials: NW
authors.lastname: Shammas
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA, USA.
authors.forename: Gail A
authors.initials: GA
authors.lastname: Shammas
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Subhash
authors.initials: S
authors.lastname: Banerjee
authors.affiliation: VA Medical Center, Dallas, TX, USA.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA, USA.
authors.forename: Atif
authors.initials: A
authors.lastname: Mohammad
authors.affiliation: St Ambrose University, Davenport, IA, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Jerin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods*; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D012008:Recurrence; D015607:Stents; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States; D014654:Vascular Patency
keywords: embolization; femoropopliteal segment; in-stent restenosis; popliteal artery; protection filter; rotational atherectomy; stent; superficial femoral artery; target lesion revascularization