Abstract
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.
Keywords
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