| Percutaneous rotational and aspiration atherectomy in infrainguinal peripheral arterial occlusive disease: a multicenter pilot study. | |
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MedLine Citation:
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PMID: 17723023 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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PURPOSE: To report a safety and efficacy study of the first rotational aspiration atherectomy system (Pathway PV) for the treatment of arterial lesions below the femoral bifurcation. METHODS: From December 2005 to February 2006, 15 patients (9 men; mean age 71+/-9 years) with Rutherford stage 2 to 5 lower limb ischemia were enrolled at 3 study sites. Target lesions were in the superficial femoral (n = 7, 47%), popliteal (n = 7, 47%), and posterior tibial (n = 1, 6%) arteries. Mean diameter stenosis was 97%+/-10%; mean lesion length was 61+/-62 mm (range 5-250). The primary study endpoint was the 30-day serious adverse event (SAE) rate. RESULTS: Interventional success (residual stenosis <30%) was achieved in all lesions (100%). Stand alone atherectomy was performed in 6 (40%) patients, adjunctive balloon angioplasty in 7 (47%), and stenting/endografting in 2 (13%). The SAE rate at 30 days was 20% (3/15), including 1 perforation due to an unrecognized displacement of the guidewire (sealed with an endograft), 1 false aneurysm at the puncture site (successful duplex-guided compression therapy), and 1 dissection in conjunction with a distal embolism (stent implantation and aspiration thrombectomy). Primary patency rates measured by duplex ultrasound at 1 and 6 months were 100% and 73%, respectively; the TLR rate was 0% after 6 months. The ankle-brachial index increased significantly from 0.54+/-0.3 at baseline to 0.89+/-0.16, 0.88+/-0.19, and 0.81+/-0.20 (p<0.05) at discharge, 1 month, and 6 months, respectively. Mean Rutherford categories were 2.92+/-1.19 (range 1-5), 0.64+/-1.12 (range 0-1), and 0.83+/-1.33 (range 0-3) at the same time points (p<0.05). CONCLUSION: The application of this new atherectomy device was feasible in all cases. The serious adverse event rate was moderate; however, all events were solved during the index procedure. The 0% 6-month TLR rate is promising. |
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Authors:
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Thomas Zeller; Hans Krankenberg; Aljoscha Rastan; Sebastian Sixt; Andrej Schmidt; Thilo Tübler; Thomas Schwarz; Ulrich Frank; Karlheinz Bürgelin; Uwe Schwarzwälder; Kirsten Hauswald; Martin Kliem; Volker Pochert; Franz-Josef Neumann; Dierk Scheinert |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study |
Journal Detail:
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Title: Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists Volume: 14 ISSN: 1526-6028 ISO Abbreviation: J. Endovasc. Ther. Publication Date: 2007 Jun |
Date Detail:
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Created Date: 2007-08-28 Completed Date: 2007-09-21 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 100896915 Medline TA: J Endovasc Ther Country: United States |
Other Details:
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Languages: eng Pagination: 357-64 Citation Subset: IM |
Affiliation:
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Department of Angiology, Heart-Centre Bad Krozingen, Germany. thomas.zeller@herzzentrum.de |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Angioplasty, Balloon Arterial Occlusive Diseases / complications, physiopathology, radiography, surgery* Atherectomy / adverse effects, instrumentation*, methods Blood Vessel Prosthesis Implantation Constriction, Pathologic / surgery Equipment Design Feasibility Studies Female Femoral Artery / surgery Germany Humans Ischemia / etiology*, physiopathology, radiography, surgery Lower Extremity / blood supply* Male Middle Aged Peripheral Vascular Diseases / complications, physiopathology, radiography, surgery* Pilot Projects Popliteal Artery / surgery Prospective Studies Rotation Severity of Illness Index Stents Suction / instrumentation Tibial Arteries / surgery Treatment Outcome Vascular Patency |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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