Topic: F. Clinical Cardiothoracic/Vascular
Novel Treatment of Patients with Lower Extremity Ischemia: Use of Percutaneous Atherectomy in 559 Lesions
James F McKinsey, Lee Goldstein, Habib U Kahn, Ashley Graham, Combiz Rezayat, Nicholas Morrissey, Elliot B Sambol, Kenneth Craig Kent
New York Presbyterian Hospital Columbia/Cornell Universities, New York, NY
OBJECTIVE(S): Endovascular options for treatment of lower extremity peripheral arterial disease are typified with diminished patency. A novel alternative to standard endovascular therapy is excision of obstructing arterial plaque using a minimally invasive technique, the Silverhawk Atherectomy device.
METHODS: A prospective database was maintained of SilverHawk procedures from 2004-2007. 559 lesions were treated in 255 patients(claudication 230 lesions; critical limb ischemia(CLI) 329 lesions). Noninvasive laboratory evaluation was performed at 1,3,6 months and yearly. Stand alone atherectomy was attempted and adjunct therapy was used for residual stenosis.
RESULTS: Mean age was 70.4(61% male, 39.6% smokers, 55.3% DM). Lesion characteristics were 228 SFA(avg. length 9.4cm, 106 occlusions), 176 popliteal(avg. length 5.0cm, 84 occlusions) and 229 tibials (avg. length 4.1cm, 130 occlusions). 30 Day perioperative mortality was 0.4%. Mean follow up was 8.8 months(range 0-36 months). 18 month primary and secondary patency for all lesions was 45.9%±3.4 and 80.3%±2.5(p<.0001). 18 month primary and secondary patency for claudicants was 59.2% ± 4.9 and 88.1% ± 3.3(p<.0001) and for CLI 34.3%± 4.5 and 73.6%± 3.6(p<.0001). Reintervention rates for claudicants and CLI were 23.0% and 30.8%, respectively. Overall limb salvage was 93.1% and only 6.1% required bypass.
CONCLUSIONS: This is the largest series with the longest follow up showing the SilverHawk device as an effective endovascular
therapy for claudication and CLI with low mortality, amputation rate and rare conversion to bypass. 