Femoropopliteal total occlusion therapy advances
MedWire News: Researchers report that a novel balloon catheter system, the ENABLER-P, may provide an effective method of recanalizing chronic total occlusions (CTOs) of the superficial femoral artery (SFA) and popliteal arteries.
CTO, defined as an arterial occlusion lasting more than 30 days, is a common occurrence in individuals with peripheral artery disease (PAD), explain the investigators.
They highlight that current recanalization strategies can be time consuming, involve the use of "a high contrast load, and are often associated with increased radiation exposure when compared to other (non-CTO) endovascular procedures."
Quicker, radiation-free procedures are therefore required, they surmise.
The ENABLER-P system was designed to facilitate movement of the guidewire used during revascularization. It adopts a balloon-anchoring technique and relies on automatic balloon inflation to ensure that a guidewire can be carefully advanced during recanalization.
Thomas Zeller (Herz-Zentrum, Bad Krozingen, Germany) and co-investigators tested the efficacy and safety of the ENABLER-P system in 37 patients with a mean age of 67 years, a history of PAD, and an untreated femoropopliteal occlusion.
Guidewire recanalization with the ENABLER-P system was followed by balloon angioplasty, atherectomy, and/or stent insertion in all patients.
As reported in the Journal of Endovascular Therapy, successful crossing of the occlusion occurred in 86% of the patients, with a mean crossing time of 5.3 minutes. Recanalization was successful in 97% of these patients.
Only one complication (an arterial perforation) was observed in association with use of the ENABLER-P system.
In a related editorial, Carlo Setacci (University of Siena, Italy) and co-authors highlight that subintimal angioplasty, the gold standard for recanalizing femoropopliteal occlusions, carries a risk for accidental dissection plane creation. If such an event occurs, further surgical revascularization may not be possible at a later date.
Setacci et al add that use of the ENABLER-P system does not create a dissection plane and therefore avoids this complication.
Zeller and colleagues note that the current study is limited by its small size and the absence of a control group.
Nonetheless, they conclude: "The ENABLER-P Balloon Catheter System appears to be safe and effective for the recanalization of femoropopliteal occlusions."
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By Lauretta Ihonor