title: Rotational and aspiration atherectomy for infrainguinal in-stent restenosis.
abstract: BACKGROUND
  To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis.
  
  
  METHODS
  33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex.
  
  
  RESULTS
  Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months.
  
  
  CONCLUSIONS
  The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.
authors.affiliation: Herzzentrum Bad Krozingen, Bad Krozingen, Germany. ulrich.beschorner@herzzentrum.de
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Roland
authors.initials: R
authors.lastname: Macharzina
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D055109:Ankle Brachial Index; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012008:Recurrence; D015607:Stents; D013396:Suction; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D062666:Vascular Access Devices; D014654:Vascular Patency