OBJECTIVE: The purpose of this study was to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease. BACKGROUND: Infrapopliteal occlusive disease is a common cause of critical limb ischemia and claudication. There are no American College of Cardiology/American Heart Association guidelines for infrapopliteal revascularization for chronic limb ischemia. METHODS: One hundred twenty four patients (201 stenoses) were enrolled in a prospective non-randomized multicenter registry of orbital atherectomy for severe infrapopliteal disease. Data were collected as part of an investigational device exemption from the Food and Drug Administration. RESULTS: The primary safety endpoint of major adverse events (MAE) at 30-days (death, myocardial infarction, amputation, or repeat revascularization) was observed in four patients (3.2%). The primary efficacy endpoint (final diameter stenosis) was 17.8 +/- 13.5%. The secondary endpoints of procedural success (final diameter stenosis < or =30%) and 6 month MAE (death, amputation, or target vessel revascularization) were observed in 90.1 and 10.4% of patients, respectively. Stand-alone atherectomy was performed in 116 lesions (57.4%). At 6-months, no patients required surgical bypass or unplanned amputation, and improvement in Rutherford ordinal scale was observed in 78.2% of patients. CONCLUSIONS: Orbital atherectomy is a unique approach to infrapopliteal disease, and provides predictable and safe lumen enlargement. Short-term data demonstrate substantial symptomatic improvement and infrequent need for further revascularization or amputation. Copyright 2009 Wiley-Liss, Inc.
OBJECTIVE: The purpose of this study was to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease. BACKGROUND:Infrapopliteal occlusive disease is a common cause of critical limb ischemia and claudication. There are no American College of Cardiology/American Heart Association guidelines for infrapopliteal revascularization for chronic limb ischemia. METHODS: One hundred twenty four patients (201 stenoses) were enrolled in a prospective non-randomized multicenter registry of orbital atherectomy for severe infrapopliteal disease. Data were collected as part of an investigational device exemption from the Food and Drug Administration. RESULTS: The primary safety endpoint of major adverse events (MAE) at 30-days (death, myocardial infarction, amputation, or repeat revascularization) was observed in four patients (3.2%). The primary efficacy endpoint (final diameter stenosis) was 17.8 +/- 13.5%. The secondary endpoints of procedural success (final diameter stenosis < or =30%) and 6 month MAE (death, amputation, or target vessel revascularization) were observed in 90.1 and 10.4% of patients, respectively. Stand-alone atherectomy was performed in 116 lesions (57.4%). At 6-months, no patients required surgical bypass or unplanned amputation, and improvement in Rutherford ordinal scale was observed in 78.2% of patients. CONCLUSIONS: Orbital atherectomy is a unique approach to infrapopliteal disease, and provides predictable and safe lumen enlargement. Short-term data demonstrate substantial symptomatic improvement and infrequent need for further revascularization or amputation. Copyright 2009 Wiley-Liss, Inc.
Authors: George L Adams; Puneet K Khanna; Cezar S Staniloae; John P Abraham; Ephraim M Sparrow Journal: J Cardiovasc Transl Res Date: 2011-02-11 Impact factor: 4.132
Authors: Giovanni Di Minno; Gaia Spadarella; Giovanni Cafaro; Maurizio Petitto; Roberta Lupoli; Alessandro Di Minno; Giovanni de Gaetano; Elena Tremoli Journal: Ann Med Date: 2014-07-21 Impact factor: 4.709
Authors: Anna Franzone; Marco Ferrone; Giuseppe Carotenuto; Andreina Carbone; Laura Scudiero; Federica Serino; Fernando Scudiero; Raffaele Izzo; Raffaele Piccolo; Savio Saviano; Bruno Amato; Cinzia Perrino; Bruno Trimarco; Giovanni Esposito Journal: BMC Surg Date: 2012-11-15 Impact factor: 2.102