title: Study to determine the clinical significance of HEmolysis During Orbital AtheRectomy (CLEAR study).
abstract: OBJECTIVE
  To evaluate the incidence of clinically evident hemolysis associated with orbital atherectomy used to treat severe peripheral artery disease.
  
  
  METHODS
  The observational CLEAR study enrolled 31 subjects (16 men; mean age 71 ± 10 years, range 44-92) with claudication (58.1%) or critical limb ischemia (38.7%) who underwent orbital atherectomy with the Diamondback 360 system at 4 US centers. The 42 lesions in 31 limbs were located in the superficial femoral (n = 19, 45.2%), popliteal (n = 8, 19.0%), and tibial arteries (n = 15, 35.8%). The majority of lesions (34, 81.0%) were de novo; moderate or severe calcification was identified in 90.5% of cases. Lesion and procedural parameters were analyzed at a core laboratory. Blood samples were collected during and post procedure and analyzed for markers of hemolysis. The primary endpoint was the occurrence of clinically significant hemolysis. The secondary endpoints included the occurrence of any clinical symptoms/signs potentially related to hemolysis. Statistical analysis was performed to identify predictors for hemolysis.
  
  
  RESULTS
  Laboratory evidence of hemolysis was seen in 11 (35.5%) subjects. No one met the clinical event criteria, and so the primary endpoint of the study was not reached. The secondary endpoints were hypertensive crisis (1, 3.2%) and transient hemoglobinuria (3, 9.7%). Lower glomerular filtration rates, calcified plaque, long atherectomy runs, and solid crown selection were independent predictors of hemolysis.
  
  
  CONCLUSIONS
  There was no clinically significant hemolysis after orbital atherectomy. The results of this study will enable users to predict conditions that predispose to high levels of red cell hemolysis following orbital atherectomy and to take appropriate measures to limit its occurrence.
authors.affiliation: Cardiac and Vascular Institute, New York University Medical Center, New York, New York 10016, USA. cezar.staniloae@nyumc.org
authors.forename: Cezar S
authors.initials: CS
authors.lastname: Staniloae
authors.forename: Ravikiran
authors.initials: R
authors.lastname: Korabathina
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Lane
authors.forename: Raymond
authors.initials: R
authors.lastname: Dattilo
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Church
authors.forename: Kanika P
authors.initials: KP
authors.lastname: Mody
authors.forename: Guy S
authors.initials: GS
authors.lastname: Mayeda
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017073:Atherectomy / Q000009:adverse effects* / Q000295:instrumentation; D016638:Critical Illness; D004867:Equipment Design; D005260:Female; D006461:Hemolysis; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000628:therapy*; D007511:Ischemia / Q000209:etiology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000150:complications / Q000628:therapy*; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States