title: Safety and Effectiveness of the Nav-6 Filter in Preventing Distal Embolization During Jetstream Atherectomy of Infrainguinal Peripheral Artery Lesions.
abstract: BACKGROUND
  The risk of distal embolization (DE) during infrainguinal peripheral artery interventions (PAI) is often mitigated by the use of embolic protection devices. There are limited data on the use of filters with the Jetstream (JS) atherectomy device, a rotational cutter with aspiration capacity. The Nav-6 filter is uniquely suited for use with the JS due to its wire compatibility and detachment from the filter; however, data on the off-label use of this combination have not been reported.
  
  
  METHODS
  Consecutive patients between October 2008 and April 2015 undergoing endovascular infrainguinal PAI with JS were analyzed as part of the Excellence in Peripheral Artery Disease (XL-PAD) registry (NCT01904851). Patients were divided into two subgroups with Nav-6 filter use vs no filter use. Descriptive and univariate analyses were performed.
  
  
  RESULTS
  Among 141 patients (mean age, 67.8 ± 10.8 years; 169 lesions) included in this study, the Nav-6 filter was used in 82 (59%). Use of a filter was more frequent in longer lesions (146 ± 106 mm vs 91 ± 72 mm; P=.01), in more severe stenoses (95% vs 87%; P=.04), and in chronic total occlusions (33% vs 8.3%; P=.01). Patients receiving filters had longer procedure duration (102 ± 51 min vs 66 ± 41 min; P=.01) and longer fluoroscopy times (31 ± 16 min vs 21 ± 10 min; P<.001). Use of the Nav-6 filter with the JS during PAI was associated with numerically lower rates of DE (1.8% vs 8%; P=.10) and similar rates of death and amputation. At 12 months, the target-lesion revascularization rate was higher in the filter group (22% vs 2.7%; P=.02), likely secondary to use of the filter in more complex lesions.
  
  
  CONCLUSIONS
  Nav-6 filter during JS atherectomy was predominantly used during complex infrainguinal PAI and was associated with less occurrence of DE.
authors.forename: Avantika
authors.initials: A
authors.lastname: Banerjee
authors.forename: Karan
authors.initials: K
authors.lastname: Sarode
authors.forename: Atif
authors.initials: A
authors.lastname: Mohammad
authors.forename: Emmanouil S
authors.initials: ES
authors.lastname: Brilakis
authors.forename: Subhash
authors.initials: S
authors.lastname: Banerjee
authors.forename: Gail A
authors.initials: GA
authors.lastname: Shammas
authors.affiliation: Midwest Cardiovascular Research Foundation, 1622 E. Lombard Street, Davenport, IA 52803 USA. shammas@mchsi.com.
authors.forename: Nicolas W
authors.initials: NW
authors.lastname: Shammas
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D057505:Embolic Protection Devices / Q000009:adverse effects / Q000706:statistics & numerical data; D004617:Embolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000601:surgery; D012042:Registries; D014481:United States / Q000453:epidemiology; D014654:Vascular Patency