title: Critical limb ischemia: a global epidemic.A critical analysis of current treatment unmasks the clinical and economic costs of CLI.
abstract: BACKGROUND
  Multiple reports document the higher costs of primary amputation (PA) compared to infrainguinal bypass surgery (IBS). Recent reports document 40-50% cost-effectiveness for percutaneous transluminal angioplasty (PTA) compared to IBS. The literature suggests appropriate initial treatment for critical limb ischemia (CLI) to be IBS = 38%, PTA = 28%, and PA = 16%. The encouraging 6-month Laser Angioplasty for Critical Limb Ischemia (LACI) 93% limb salvage rate prompted an independent CLI and LACI clinical and economic analysis.
  
  
  METHODS
  Between 1999-2001 a reference amputation population (RAP) of 417 patients with at least one infrainguinal amputation were identified from a 2.5 million patients Medicare/insurance dataset. Clinical data and all medical cost claims for 18 continuous months, 12-month prior and 6-month post-amputation, were analyzed for PTA, IBS, and PA treatment pathways. Based on multiple assumptions and the LACI phase II results, economic outcomes were used for a LACI pathway analysis compared to PTA, IBS and PA pathways by substituting the LACI trial pathway as the initial treatment in lieu of the RAP actual treatment.
  
  
  RESULTS
  Initial treatments for CLI RAP were PA = 67%, IBS = 23%, PTA = 10%; A majority of wound complications (80%) and myocardial infarction 7/9 (77.7%), stroke 13/16 (81.2%), and death 2/2 (100%) occurred in the PA RAP. Only 35% of the RAP had an ankle brachial index (ABI) and only 16% angiography before PA. 227/417 (56%) of the RAP had multiple procedures. Average total costs / patient = $31,638 without LACI and $25,373 with LACI. Average savings/patient with LACI = $6,265.
  
  
  CONCLUSIONS
  The most common current treatments in the US for CLI are still characterized by high rates of primary amputations, multiple procedures, and high rates of procedure-related complications. Despite the limitations and assumptions of this analysis, the utilization of a LACI pathway first revascularization treatment strategy may provide clinical and economic cost savings in treating patients with CLI.
authors.affiliation: Chief of Cardiothoracic & Endovascular Surgery - Cardiovascular Institute of the South/Lafayette2730 Ambassador Caffery Parkway - Lafayette, LA 70506 - USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Allie
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Hebert
authors.forename: Mitchell D
authors.initials: MD
authors.lastname: Lirtzman
authors.forename: Charles H
authors.initials: CH
authors.lastname: Wyatt
authors.forename: V Antoine
authors.initials: VA
authors.lastname: Keller
authors.forename: Mohamed H
authors.initials: MH
authors.lastname: Khan
authors.forename: Muhammad A
authors.initials: MA
authors.lastname: Khan
authors.forename: Peter S
authors.initials: PS
authors.lastname: Fail
authors.forename: Krishnamoorthy
authors.initials: K
authors.lastname: Vivekananthan
authors.forename: Elena V
authors.initials: EV
authors.lastname: Mitran
authors.forename: Sonja E
authors.initials: SE
authors.lastname: Allie
authors.forename: Gary
authors.initials: G
authors.lastname: Chaisson
authors.forename: Samuel J
authors.initials: SJ
authors.lastname: Stagg
authors.forename: Adam A
authors.initials: AA
authors.lastname: Allie
authors.forename: Michael W
authors.initials: MW
authors.lastname: McElderry
authors.forename: Craig M
authors.initials: CM
authors.lastname: Walker