title: Bailout revascularization of chronic femoral artery occlusions with the new outback catheter following failed conventional endovascular intervention.
abstract: OBJECTIVE
  To report the application of a true lumen re-entry device in the bailout treatment of chronic total occlusions (CTO) of the superficial femoral artery (SFA) after failed angioplasty.
  
  
  METHODS
  Nineteen patients (12 men; mean age 81 years, range 61-97) with 20 SFA CTOs and Rutherford category 2 to 5 ischemia were prospectively evaluated. All CTOs had unsuccessful recanalization using conventional techniques and were subsequently treated with the Outback LTD catheter. Follow-up at 3, 6, and 12 months included ankle/toe pressure measurement and pulse volume recordings. Endpoints were revascularization rate, target lesion revascularization, and limb salvage.
  
  
  RESULTS
  Revascularization was achieved in 95% of the cases. There were 2 (10%) periprocedural complications unrelated to the re-entry device, which were resolved by endovascular or surgical treatment. The target lesion revascularization rate was 10%, with the 2 events occurring at 3 and 6 months, respectively, in patients with Rutherford category 4-5 ischemia. There was one below-the-knee amputation in the patient with failed revascularization.
  
  
  CONCLUSIONS
  The acute failure of endovascular treatment of SFA CTOs is most often due to an inability to re-enter the true lumen after the occlusion is crossed in a subintimal plane. Bailout revascularization with the Outback LTD catheter is highly successful and shows a low device-related complication rate. This needle- and fluoroscopic-based re-entry device increases the endovascular success rate and is therefore expanding the minimally invasive treatment options for surgically unfit patients.
authors.affiliation: Cardiovascular Department, Clinical and Interventional Angiology, University Hospital Berne and University of Berne, Switzerland.
authors.forename: Marc
authors.initials: M
authors.lastname: Husmann
authors.forename: Jonas
authors.initials: J
authors.lastname: Federer
authors.forename: Hak Hong
authors.initials: HH
authors.lastname: Keo
authors.forename: Jürg
authors.initials: J
authors.lastname: Schmidli
authors.forename: Ralph
authors.initials: R
authors.lastname: Kickuth
authors.forename: Iris
authors.initials: I
authors.lastname: Baumgartner
authors.forename: Dai-Do
authors.initials: DD
authors.lastname: Do
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000671:Amputation, Surgical; D017130:Angioplasty; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery / Q000628:therapy*; D002406:Catheterization, Peripheral / Q000009:adverse effects / Q000295:instrumentation*; D002908:Chronic Disease; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology / Q000601:surgery / Q000628:therapy*; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015641:Radiography, Interventional; D012008:Recurrence; D013997:Time Factors; D017211:Treatment Failure