Orbital atherectomy for infrapopliteal disease: Device concept and outcome data for the OASIS trial Export

@article{citeulike:4119789, abstract = {The purpose of this study was to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease.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.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.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 le30\%) 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.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.}, address = {William Beaumont Hospital, Royal Oak, Michigan; Emory University, Atlanta, Georgia; Christ Hospital, Cincinnati, Ohio; Mercy Medical Center, Minneapolis, Minnesota; Florida Hospital, Orlando, Florida; Arizona Heart Institute, Phoenix, Arizona; St Luke's Hospital, Phoenix, Arizona}, author = {Safian, Robert D. and Niazi, Khusrow and Runyon, John P. and Dulas, Dan and Weinstock, Barry and Ramaiah, Venkatesh and Heuser, Richard and For}, citeulike-article-id = {4119789}, citeulike-linkout-0 = {http://dx.doi.org/10.1002/ccd.21898}, citeulike-linkout-1 = {http://www3.interscience.wiley.com/cgi-bin/abstract/121506050/ABSTRACT}, doi = {10.1002/ccd.21898}, journal = {Catheterization and Cardiovascular Interventions}, keywords = {atherectomy, pad}, number = {3}, pages = {406--412}, posted-at = {2009-03-02 16:24:38}, priority = {3}, title = {Orbital atherectomy for infrapopliteal disease: Device concept and outcome data for the OASIS trial}, url = {http://dx.doi.org/10.1002/ccd.21898}, volume = {73}, year = {2009} }

TY - JOUR ID - citeulike:4119789 L3 - citeulike-article-id:4119789 N2 - The purpose of this study was to assess the safety and short-term efficacy of orbital atherectomy for chronic infrapopliteal arterial occlusive disease.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.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.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 le30%) 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.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. © 2009 Wiley-Liss, Inc. IS - 3 JF - Catheterization and Cardiovascular Interventions AD - William Beaumont Hospital, Royal Oak, Michigan; Emory University, Atlanta, Georgia; Christ Hospital, Cincinnati, Ohio; Mercy Medical Center, Minneapolis, Minnesota; Florida Hospital, Orlando, Florida; Arizona Heart Institute, Phoenix, Arizona; St Luke's Hospital, Phoenix, Arizona EP - 412 TI - Orbital atherectomy for infrapopliteal disease: Device concept and outcome data for the OASIS trial VL - 73 SP - 406 KW - atherectomy KW - pad AU - Safian, Robert AU - Niazi, Khusrow AU - Runyon, John AU - Dulas, Dan AU - Weinstock, Barry AU - Ramaiah, Venkatesh AU - Heuser, Richard AU - For PY - 2009/// UR - http://dx.doi.org/10.1002/ccd.21898 ER -