Percutaneous rotational and aspiration atherectomy in infrainguinal peripheral arterial occlusive disease: a multicenter pilot study.
OBJECTIVE
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).


CONCLUSIONS
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.
Zeller
Thomas
T
Department of Angiology, Heart-Centre Bad Krozingen, Germany. thomas.zeller@herzzentrum.de
Krankenberg
Hans
H
Rastan
Aljoscha
A
Sixt
Sebastian
S
Schmidt
Andrej
A
Tübler
Thilo
T
Schwarz
Thomas
T
Frank
Ulrich
U
Bürgelin
Karlheinz
K
Schwarzwälder
Uwe
U
Hauswald
Kirsten
K
Kliem
Martin
M
Pochert
Volker
V
Neumann
Franz-Josef
FJ
Scheinert
Dierk
D
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D017073:Atherectomy / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation; D003251:Constriction, Pathologic / Q000601:surgery; D004867:Equipment Design; D005240:Feasibility Studies; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D005858:Germany; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000209:etiology* / Q000503:physiopathology / Q000601:surgery; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000150:complications / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D010865:Pilot Projects; D011150:Popliteal Artery / Q000601:surgery; D011446:Prospective Studies; D011859:Radiography; D012399:Rotation; D012720:Severity of Illness Index; D015607:Stents; D013396:Suction / Q000295:instrumentation; D016909:Tibial Arteries / Q000601:surgery; D016896:Treatment Outcome; D014654:Vascular Patency