title: Percutaneous rotational and aspiration atherectomy in infrainguinal peripheral arterial occlusive disease: a multicenter pilot study.
abstract: OBJECTIVE
  To report a safety and efficacy study of the first rotational aspiration atherectomy system (Pathway PV) for the treatment of arterial lesions below the femoral bifurcation.
  
  
  METHODS
  From December 2005 to February 2006, 15 patients (9 men; mean age 71+/-9 years) with Rutherford stage 2 to 5 lower limb ischemia were enrolled at 3 study sites. Target lesions were in the superficial femoral (n = 7, 47%), popliteal (n = 7, 47%), and posterior tibial (n = 1, 6%) arteries. Mean diameter stenosis was 97%+/-10%; mean lesion length was 61+/-62 mm (range 5-250). The primary study endpoint was the 30-day serious adverse event (SAE) rate.
  
  
  RESULTS
  Interventional success (residual stenosis <30%) was achieved in all lesions (100%). Stand alone atherectomy was performed in 6 (40%) patients, adjunctive balloon angioplasty in 7 (47%), and stenting/endografting in 2 (13%). The SAE rate at 30 days was 20% (3/15), including 1 perforation due to an unrecognized displacement of the guidewire (sealed with an endograft), 1 false aneurysm at the puncture site (successful duplex-guided compression therapy), and 1 dissection in conjunction with a distal embolism (stent implantation and aspiration thrombectomy). Primary patency rates measured by duplex ultrasound at 1 and 6 months were 100% and 73%, respectively; the TLR rate was 0% after 6 months. The ankle-brachial index increased significantly from 0.54+/-0.3 at baseline to 0.89+/-0.16, 0.88+/-0.19, and 0.81+/-0.20 (p<0.05) at discharge, 1 month, and 6 months, respectively. Mean Rutherford categories were 2.92+/-1.19 (range 1-5), 0.64+/-1.12 (range 0-1), and 0.83+/-1.33 (range 0-3) at the same time points (p<0.05).
  
  
  CONCLUSIONS
  The application of this new atherectomy device was feasible in all cases. The serious adverse event rate was moderate; however, all events were solved during the index procedure. The 0% 6-month TLR rate is promising.
authors.affiliation: Department of Angiology, Heart-Centre Bad Krozingen, Germany. thomas.zeller@herzzentrum.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Thomas
authors.initials: T
authors.lastname: Schwarz
authors.forename: Ulrich
authors.initials: U
authors.lastname: Frank
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Bürgelin
authors.forename: Uwe
authors.initials: U
authors.lastname: Schwarzwälder
authors.forename: Kirsten
authors.initials: K
authors.lastname: Hauswald
authors.forename: Martin
authors.initials: M
authors.lastname: Kliem
authors.forename: Volker
authors.initials: V
authors.lastname: Pochert
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation; D003251:Constriction, Pathologic / Q000601:surgery; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D005858:Germany; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology* / Q000503:physiopathology / Q000601:surgery; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D010865:Pilot Projects; D011150:Popliteal Artery / Q000601:surgery; D011446:Prospective Studies; D011859:Radiography; D012399:Rotation; D012720:Severity of Illness Index; D015607:Stents; D013396:Suction / Q000295:instrumentation; D016909:Tibial Arteries / Q000601:surgery; D016896:Treatment Outcome; D014654:Vascular Patency