Document Detail

Percutaneous rotational and aspiration atherectomy in infrainguinal peripheral arterial occlusive disease: a multicenter pilot study.
MedLine Citation:
PMID:  17723023     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
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:
Created Date:  2007-08-28     Completed Date:  2007-09-21     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  357-64     Citation Subset:  IM    
Department of Angiology, Heart-Centre Bad Krozingen, Germany.
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MeSH Terms
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
Femoral Artery / surgery
Ischemia / etiology*,  physiopathology,  radiography,  surgery
Lower Extremity / blood supply*
Middle Aged
Peripheral Vascular Diseases / complications,  physiopathology,  radiography,  surgery*
Pilot Projects
Popliteal Artery / surgery
Prospective Studies
Severity of Illness Index
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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