title: Two-year results after directional atherectomy of infrapopliteal arteries with the SilverHawk device.
abstract: OBJECTIVE
  To report the 12- and 24-month results after directional atherectomy (DA) of below-the-knee (BTK) arterial lesions with the SilverHawk device.
  
  
  METHODS
  Forty-nine BTK lesions in 36 patients (58% men; mean age 70+/-11 years) with peripheral occlusive disease of the lower limbs were treated with DA; 19 (53%) of the limbs were classified with Rutherford-Becker 4 or 5 ischemia. Target lesions were in the popliteal artery (n = 6, 12%), tibioperoneal trunk (n = 25, 51%), peroneal artery (n = 10, 20%), anterior tibial artery (n = 5, 10%), and posterior tibial artery (n = 3, 6%). Nine (18%) lesions were located in a stent. Twelve lesions extended to 2 artery segments. The average degree of diameter stenosis was 89%+/-10% (range 70%-100%); there were 11 (22%) occlusions. The mean lesion length was 48+/-28 mm.
  
  
  RESULTS
  Sixteen (33%) lesions were treated after predilation; 33 (67%) lesions were treated with primary DA. All but 1 (2%) lesion could be treated with DA. In 19 (39%) lesions, additional balloon angioplasty was performed, and 2 (4%) lesions required stent implantation as a result of dissection. The mean stenosis diameter after DA was 12%+/-18% (range 0%-100%). After additional therapy, the mean stenosis diameter was 8%+/-9% (range 0%-100%). A residual stenosis </ or 30% was achieved in 48 (98%) lesions. The mean ankle-brachial index significantly increased from 0.48+/-0.26 to 0.81+/-0.32 (p<0.05) before discharge and remained improved during follow-up. Primary and secondary patency rates were 67% and 91% after 1 year and 60% and 80% after 24 months. The 12- and 24-month cumulative event-free survival rates (primary patency) by Kaplan-Meier analysis were 58%+/-8% and 46%+/-9%; at the same time intervals, the cumulative survival rates (secondary patency) were 88%+/-6% and 73%+/-9%, respectively.
authors.affiliation: Department of Angiology, Heart Center Bad Krozingen, Germany. thomas.zeller@herzzentrum.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sixt
authors.forename: Uwe
authors.initials: U
authors.lastname: Schwarzwälder
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: Volker
authors.initials: V
authors.lastname: Pochert
authors.forename: Christian
authors.initials: C
authors.lastname: Müller
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Kirsten
authors.initials: K
authors.lastname: Hauswald
authors.forename: Franz-Josef
authors.initials: FJ
authors.lastname: Neumann
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000401:mortality / Q000473:pathology / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation*; D003251:Constriction, Pathologic / Q000601:surgery; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D007866:Leg / Q000098:blood supply*; D008297:Male; D016491:Peripheral Vascular Diseases / Q000401:mortality / Q000473:pathology / Q000503:physiopathology / Q000601:surgery / Q000628:therapy*; D011150:Popliteal Artery / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D012107:Research Design; D012720:Severity of Illness Index; D015607:Stents; D016909:Tibial Arteries / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency