title: Acute oxygenation changes on ischemic foot of a novel intermittent pneumatic compression device and of an existing sequential device in severe peripheral arterial disease.
abstract: BACKGROUND
  Intermittent pneumatic compression (IPC) improves haemodynamics in peripheral arterial disease (PAD), but its effects on foot perfusion were scarcely studied. In severe PAD patients we measured the foot oxygenation changes evoked by a novel intermittent IPC device (GP), haemodynamics and compliance to the treatment. Reference values were obtained by a sequential foot-calf device (SFC).
  
  
  METHODS
  Twenty ischemic limbs (Ankle-Brachial Index = 0.5 ± 0.2) of 12 PAD patients (7 male, age: 74.5 ± 10.8 y) with an interval of 48 ± 2 hours received a 35 minute treatment in supine position with two IPC devices: i) a Gradient Pump (GP), which slowly inflates a single thigh special sleeve and ii) an SFC (ArtAssist®, ACI Medical, San Marcos, CA, USA), which rapidly inflates two foot-calf sleeves.
  
  
  METHODS
  changes of oxygenated haemoglobin at foot (HbO2foot) by continuous near-infrared spectroscopy recording and quantified as area-under-curve (AUC) for periods of 5 minutes. Other measures: haemodynamics by echo-colour Doppler (time average velocity (TAV) and blood flow (BF) in the popliteal artery and in the femoral vein), patient compliance by a properly developed form.
  
  
  RESULTS
  All patients completed the treatment with GP, 9 with SFC. HbO2foot during the working phase, considered as average value of the 5 minutes periods, increased with GP (AUC 458 ± 600 to 1216 ± 280) and decreased with SFC (AUC 231 ± 946 to -1088 ± 346), significantly for most periods (P < 0.05). The GP treatment was associated to significant haemodynamic changes from baseline to end of the treatment (TAV = 10.2 ± 3.3 to 13.5 ± 5.5 cm/sec, P = 0.004; BF = 452.0 ± 187.2 to 607.9 ± 237.8 ml/sec, P = 0.0001), not observed with SFC (TAV = 11.2 ± 3.4 to 11.8 ± 4.3 cm/sec; BF  = 513.8 ± 203.7 to 505.9 ± 166.5 ml/min, P = n.s.). GP obtained a higher score of patient compliance (P < 0.0001).
  
  
  CONCLUSIONS
  A novel IPC thigh device, unlike a traditional SFC device, increased foot oxygenation in severe PAD, together with favourable haemodynamic response and high compliance to the treatment under the present experimental conditions.
authors.forename: Fabio
authors.initials: F
authors.lastname: Manfredini
authors.affiliation: Vascular Diseases Center, University of Ferrara, Ferrara, Italy. mlgnmr@unife.it.
authors.forename: Anna Maria
authors.initials: AM
authors.lastname: Malagoni
authors.forename: Michele
authors.initials: M
authors.lastname: Felisatti
authors.forename: Simona
authors.initials: S
authors.lastname: Mandini
authors.forename: Nicola
authors.initials: N
authors.lastname: Lamberti
authors.forename: Roberto
authors.initials: R
authors.lastname: Manfredini
authors.forename: Francesco
authors.initials: F
authors.lastname: Mascoli
authors.forename: Nino
authors.initials: N
authors.lastname: Basaglia
authors.forename: Paolo
authors.initials: P
authors.lastname: Zamboni
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D055109:Ankle Brachial Index; D019540:Area Under Curve; D015415:Biomarkers / Q000097:blood; D001783:Blood Flow Velocity; D004867:Equipment Design; D005260:Female; D005528:Foot / Q000098:blood supply*; D006801:Humans; D048228:Intermittent Pneumatic Compression Devices; D007511:Ischemia / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010100:Oxygen / Q000097:blood; D010108:Oxyhemoglobins / Q000378:metabolism; D010349:Patient Compliance; D056888:Patient Positioning; D058729:Peripheral Arterial Disease / Q000097:blood / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011237:Predictive Value of Tests; D012372:ROC Curve; D012039:Regional Blood Flow; D012720:Severity of Illness Index; D019265:Spectroscopy, Near-Infrared; D016683:Supine Position; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color
chemical_list: D015415:Biomarkers; D010108:Oxyhemoglobins; D010100:Oxygen