title: Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.
abstract: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease.
  
  
  
  The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance.
  
  
  
  The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy.
  
  
  
  OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.
authors.affiliation: 1 Department of Vascular Surgery, St Franziskus-Hospital Münster, Germany.
authors.forename: Arne G
authors.initials: AG
authors.lastname: Schwindt
authors.affiliation: 2 St Dominic-Jackson Memorial Hospital, Jackson, MI, USA.
authors.forename: J Gray
authors.initials: JG
authors.lastname: Bennett
authors.affiliation: 2 St Dominic-Jackson Memorial Hospital, Jackson, MI, USA.
authors.forename: William H
authors.initials: WH
authors.lastname: Crowder
authors.affiliation: 3 Cedars Sinai Medical Center, West Hollywood, CA, USA.
authors.forename: Suhail
authors.initials: S
authors.lastname: Dohad
authors.affiliation: 4 Einstein Medical Center, Philadelphia, PA, USA.
authors.forename: Sean F
authors.initials: SF
authors.lastname: Janzer
authors.affiliation: 5 Deborah Heart and Lung Center, Brown Mills, NJ, USA.
authors.forename: Jon C
authors.initials: JC
authors.lastname: George
authors.affiliation: 6 St Bernards Medical Center, Jonesboro, AR, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Tedder
authors.affiliation: 7 St John Hospital and Medical Center, Detroit, MI, USA.
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Davis
authors.affiliation: 8 Arkansas Heart Hospital, Little Rock, AR, USA.
authors.forename: Ian M
authors.initials: IM
authors.lastname: Cawich
authors.affiliation: 9 Heart Hospital of Austin, TX, USA.
authors.forename: Roger S
authors.initials: RS
authors.lastname: Gammon
authors.affiliation: 10 Good Samaritan Hospital, Cincinnati, OH, USA.
authors.forename: Patrick E
authors.initials: PE
authors.lastname: Muck
authors.affiliation: 11 Jobst Vascular Institute Promedica Toledo Hospital, Toledo, OH, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: Pigott
authors.affiliation: 12 Methodist South Hospital, Memphis, TN, USA.
authors.forename: Dwight A
authors.initials: DA
authors.lastname: Dishmon
authors.affiliation: 13 St Joseph's Hospital, Fort Wayne, IN, USA.
authors.forename: Lou A
authors.initials: LA
authors.lastname: Lopez
authors.affiliation: 14 Advocate Christ Hospital and Medical Center, Oak Lawn, IL, USA.
authors.forename: Jaafer A
authors.initials: JA
authors.lastname: Golzar
authors.affiliation: 15 Alexian Brothers Medical Center, Elk Grove Village, IL, USA.
authors.forename: Jack R
authors.initials: JR
authors.lastname: Chamberlin
authors.affiliation: 16 University of Nebraska Medical Center, Omaha, NE, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Moulton
authors.affiliation: 17 St Peters University Hospital, New Brunswick, NJ, USA.
authors.forename: Ramzan M
authors.initials: RM
authors.lastname: Zakir
authors.affiliation: 18 DMC Cardiovascular Institute Harper-Hutzel Hospital, Detroit, MI, USA.
authors.forename: Amir K
authors.initials: AK
authors.lastname: Kaki
authors.affiliation: 19 Good Samaritan Hospital, Dayton, OH, USA.
authors.forename: Gary J
authors.initials: GJ
authors.lastname: Fishbein
authors.affiliation: 20 Coastal Vascular and Interventional, Pensacola, FL, USA.
authors.forename: Huey B
authors.initials: HB
authors.lastname: McDaniel
authors.affiliation: 21 Avinger Inc, Redwood City, CA, USA.
authors.forename: Ayala
authors.initials: A
authors.lastname: Hezi-Yamit
authors.affiliation: 21 Avinger Inc, Redwood City, CA, USA.|22 Sequoia Hospital, Redwood City, CA, USA.
authors.forename: John B
authors.initials: JB
authors.lastname: Simpson
authors.affiliation: 21 Avinger Inc, Redwood City, CA, USA.|23 Stanford University Medical Center, Stanford, CA, USA.
authors.forename: Arjun
authors.initials: A
authors.lastname: Desai
mesh_terms: D000368:Aged; D017130:Angioplasty / Q000295:instrumentation; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D002983:Clinical Competence; D003251:Constriction, Pathologic; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging* / Q000503:physiopathology; D005858:Germany; D006801:Humans; D059032:Learning Curve; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging* / Q000503:physiopathology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014481:United States; D062666:Vascular Access Devices
keywords: adventitia; angioplasty; atherectomy; femoropopliteal segment; guidance; histology; occlusion; optical coherence tomography; peripheral vascular disease; plaque; stenosis; stent; target lesion revascularization