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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Long-Term Results After Directional Atherectomy of Femoro-Popliteal Lesions

Thomas Zeller, MD^_*,_*, Aljoscha Rastan, MD^_*, Sebastian Sixt, MD^_*, Uwe Schwarzwälder, MD^_*, Thomas Schwarz, MD^_*, Ulrich Frank, MD^_*, Karlheinz Bürgelin, MD^_*, Christian Müller, MD, Uwe Rothenpieler, MD^_*, Peter-Christian Flügel, MD^_*, Gunnar Tepe, MD and Franz-Josef Neumann, MD, FACC^_*

^_* Department of Angiology, Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany
Department of Internal Medicine, University Hospital Basel, Basel, Switzerland
Department of Diagnostic and Interventional Radiology, University Hospital Tübingen, Tübingen, Germany

Manuscript received February 8, 2006; revised manuscript received June 28, 2006, accepted July 3, 2006.

^_* Reprint requests and correspondence: Dr. Thomas Zeller, Department of Angiology, Herz-Zentrum Bad Krozingen, Südring 15, D-79189 Bad Krozingen, Germany (Email: thomas.zeller{at}herzzentrum.de).

OBJECTIVES: Our objective in this research was the evaluation of the long-term results after directional atherectomy using the Silverhawk device (FoxHollow Technologies, Redwood City, California) of femoro-popliteal lesions.

BACKGROUND: Considering reports on stent fractures in femoro-popliteal arteries, atherectomy may be a valuable alternative to stenting.

METHODS: Eighty-four patients with 100 legs and 131 lesions with peripheral occlusive disease Rutherford categories 2 to 5 were included in a prospective registry. Forty-five lesions were de novo lesions (group 1; 34%), 43 lesions native vessel restenoses (group 2; 33%), and 43 lesions in-stent restenoses (group 3; 33%). Additional low pressure balloon angioplasty was used in 78 of 131 lesions (59%) and stenting in 8 lesions (6%).

RESULTS: Technical success rate was 86% for atherectomy only and 100% after additional therapy. Mean lesion length was 43 ± 54 mm, 105 ± 122 mm, and 131 ± 111 mm for group 1, group 2, and group 3, respectively (p < 0.001). Primary patency, defined as freedom of a >50% restenosis detected by duplex, was 84%, 54%, and 54% at 12 months (p = 0.002) and 73%, 42%, and 49%, at 18 months (p = 0.008); secondary patency rates were 100%, 93%, and 91% at 12 months (p = NS) and 89%, 67%, and 79% at 18 months (p = 0.001), respectively; and target lesion revascularization rate was 16%, 44%, and 47% at 12 months and 22%, 56%, and 49% at 18 months (p = 0.003 each) for group 1, group 2, and group 3, respectively. The only independent predictor for restenosis was treatment of restenotic lesions. Ankle-brachial index was significantly improved after 12 months and 18 months in all groups.

CONCLUSIONS: Long-term technical and clinical results after directional atherectomy of femoro-popliteal lesions are in favor of de novo lesions compared with restenotic lesions.

Abbreviations and Acronyms   ASA = acetylsalicylic acid   MLD = minimal lumen diameter   POD = peripheral occlusive disease   SFA = superficial femoral artery   TALON = Treating peripherALs with silverhawk: Outcomes collectioN registry

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