title: Safety and 1-year revascularization outcome of SilverHawk atherectomy in treating in-stent restenosis of femoropopliteal arteries: a retrospective review from a single center.
abstract: BACKGROUND
  Treatment of in-stent restenosis of the femoropopliteal arteries with balloon angioplasty carries a high rate of recurrence and requires frequent repeat stenting. In the "Instructions for Use," SilverHawk atherectomy (SA) is contraindicated for in-stent restenosis at a peripheral site. SA, however, has a theoretical advantage of reducing the volume of restenotic tissue and potentially delaying the need for frequent repeat revascularization and additional stenting. We present a retrospective analysis from our center on the safety and outcomes of SA in the treatment of in-stent restenosis of the femoropopliteal arteries.
  
  
  METHODS
  Demographic, clinical, angiographic, and procedural data were collected on all patients who underwent SA for in-stent restenosis from February 2005 to April 2010 at a single medical center. Major adverse events and 1-year target lesion revascularization (TLR) and target vessel revascularization (TVR) were obtained by review of medical records and phone calls. Descriptive analysis was performed on all variables. Kaplan-Meier survival curves for TVR were plotted.
  
  
  RESULTS
  A total of 41 consecutive patients (mean age 70.9±9.2 years, 56% males) were included and followed for a mean of 331.63 days. The following variables were noted: mean ankle brachial index (ABI) of treated leg 0.66±0.2; chronic renal failure (creatinine >2.0 at baseline) 14.6%; diabetes 61%; history of smoking 85.4%; number of vessel runoffs of treated limb 1.9±0.9; hypertension 90.2%; lesion length 126.2±79.3mm; lesion severity 90.7±8.2%; vessel diameter 5.8±0.7 mm. All patients received bivalirudin during the procedure and were on aspirin. Ninety-five percent of patients were placed on clopidogrel. Adjunctive balloon angioplasty was performed in 97.6% at a mean pressure of 11.9±3.3atm. Embolic filter protection (EFP) was used in 56.1% of patients. Bailout stenting was 24.4%. Acute procedural success (<30% angiographic residual narrowing) occurred in 100% of patients. Compared to baseline, ABI at 1 month significantly improved to 0.91±0.19 (P<0.05) but was not statistically different at 1 year (0.61±0.28). Debris was noted in 81.9% of filters used; 36.4% were macrodebris. The following adverse events were reported: distal embolization (DE) requiring treatment 7.3%; stent thrombosis 4.9%; planned minor amputation in the nonindex limb 2.4%. No device-related complications occurred. There was no death or amputation. TLR and TVR occurred in 31.7% and 34.1%, respectively.
  
  
  CONCLUSIONS
  SA has favorable acute results in treating in-stent restenosis of the femoropopliteal arteries. At 1 year, TLR and TVR remain high but compare favorably to published data. DE also occurs significantly with SA and EFP appears to be effective in capturing the debris.
authors.affiliation: Midwest Cardiovascular Research Foundation, Davenport, IA 52722, USA. shammas@mchsi.com
authors.forename: Nicolas W
authors.initials: NW
authors.lastname: Shammas
authors.forename: Gail A
authors.initials: GA
authors.lastname: Shammas
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Helou
authors.forename: Cara M
authors.initials: CM
authors.lastname: Voelliger
authors.forename: Luay
authors.initials: L
authors.lastname: Mrad
authors.forename: Michael
authors.initials: M
authors.lastname: Jerin
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000295:instrumentation; D000925:Anticoagulants / Q000627:therapeutic use; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation*; D003131:Combined Modality Therapy; D003251:Constriction, Pathologic; D057505:Embolic Protection Devices; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D006801:Humans; D007484:Iowa; D053208:Kaplan-Meier Estimate; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011859:Radiography; D012008:Recurrence; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors