title: Orbital atherectomy for symptomatic lower extremity disease.
abstract: BACKGROUND
  Plaque-debulking technologies have been proposed as alternative treatment options for peripheral arterial disease. Orbital atherectomy (OA), using the DiamondBack360 device, has emerged as one promising modality.
  
  
  METHODS
  We evaluated the safety and efficacy of OA in the first 200 lesions treated at our institution. Patient demographics, clinical characteristics, and lesion and procedural variables were collected and analyzed. The primary safety endpoint was the 30-day major adverse events (MAE), including death, myocardial infarction, stroke, unplanned amputation, or target lesion revascularization. Other safety endpoints included access-site complications, occurrence of dissections, perforations, distal embolization, spasm, and hemolysis. The efficacy endpoints were procedural success, need for adjunctive therapy, and improvement in ankle-brachial index. Multivariate analysis was performed to find independent predictors of the safety endpoints.
  
  
  RESULTS
  One hundred seventeen (58.5%) lesions were femoral, 31 (15.5%) were popliteal, and 52 (26.0%) were tibial. The procedural success (residual stenosis ≤30%) was comparable between the femoral and tibial lesions (86.3% vs. 92.5%, P = 0.18), but significantly lower for the popliteal lesions when compared with femoral and tibial (64.7% vs. 86.3%, P = 0.058, and 64.7% vs. 92.5%, P = 0.007 respectively). MAE at 30-days occurred in 3 (2.2%) procedures, and major access-site complications also occurred in 3 (2.2%). There were 31 (15.5%) dissections; independent predictors were diabetes mellitus (OR: 7.3, P = 0.008), crown-to-RVD ratio <0.6 (OR: 11.6, P = 0.005), and atherectomy time >360 sec (OR: 11.8, P = 0.001). There were 2 (1.0%) distal embolizations, 6 (3.0%) arterial spasms, and no perforations. Laboratory evidence of hemolysis was noted in 33.8% of cases.
  
  
  CONCLUSIONS
  Orbital atherectomy allows for a significant procedural success, limited need for stenting, and favorable safety profile.
authors.affiliation: Saint Vincent's Hospital Manhattan, New York Medical College, New York, NY, USA.
authors.forename: Ravikiran
authors.initials: R
authors.lastname: Korabathina
authors.forename: Kanika P
authors.initials: KP
authors.lastname: Mody
authors.forename: Jennie
authors.initials: J
authors.lastname: Yu
authors.forename: Seol Young
authors.initials: SY
authors.lastname: Han
authors.forename: Ruchika
authors.initials: R
authors.lastname: Patel
authors.forename: Cezar S
authors.initials: CS
authors.lastname: Staniloae
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D055109:Ankle Brachial Index; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods* / Q000401:mortality; D016009:Chi-Square Distribution; D004617:Embolism / Q000209:etiology; D005260:Female; D006461:Hemolysis; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009519:New York City; D016017:Odds Ratio; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D013035:Spasm / Q000209:etiology; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome