In a small cohort, Thomas Zeller, Universitäts-Herzzentrum, Bad Krozingen, Germany, and colleagues, investigated the use of the Proteus embolic capture angioplasty balloon for peripheral vascular disease. They reported on their initial experience using the angioplasty balloon in a study published in the Journal of Endovascular Therapy.
“To date, no dedicated embolic protection device has been designed for use during lower limbs intervention. The filters currently approved for embolic capture in the carotid arteries are considered expensive, difficult to handle, and time consuming in the lower limb vessels, so they are almost solely used in conjunction with atherectomy procedures,” said Zeller et al.
However, Zeller and colleagues said that, recently, a novel peripheral angioplasty balloon with embolic capability has been introduced—the Proteus embolic capture angioplasty balloon (Angioslide) which is FDA approved and CE marked for use in the lower extremity. Therefore, the authors aimed to asses the safety and the performance of the angiography balloon in the treatment of peripheral vascular disease.
The study was a non-randomised single-arm study which enrolled 15 patients. The 5x300mm Proteus balloon catheter was implemented as first-line treatment strategy (including as provisional stenting after insufficient balloon dilation) and as secondary treatment it was used as adjunctive therapy to post-dilate nitinol stents following direct implantation or following rational thrombectomy. The primary endpoint of the study was the rate of clinically significant vessel dissections and device-related distal embolisations. Secondary endpoints included: rate of acute serious adverse events; rate of adverse events related to device malfunction, and; procedure success rate.
There were 20 TASC II C (n=4) and D (n=16) lesions, according to Zeller and colleagues, of which 15 were in the superficial femoral, five in the popliteal and superficial femoral arteries. Five of the lesions de novo, five were restenoses, and five were in-stent restenoses. The average lesion length was 211±78mm per lesion.
According to the authors the procedure was performed using a 7F sheath over a 0.035-inch guidewire for all cases.
Zeller et al reported that procedure and device success were 100% and there were no device malfunctions, vessel dissections, or distal embolisations. In the cohort, according to the study results, the embolic capture angioplasty balloon was used for predilation in 11 lesions and for postdilation in nine. Four lesions required the use of the angioplasty balloon after rational thrombectomy and 18 target lesions had self-expanding stents applied.
According to the results, there were three non-device related complications: pseudoaneurysm, myocardial infarction, and acute renal failure which were resolved without any sequelae at 30 days.
In five cases the captured embolic material was transferred from the balloon at a filter and stained with violet Davidson tissue marking dye (Bradley Products), which were analysed to determine the overall count and major axial dimension of each particle. The analysis of the particles (although no histopathology was no conducted) suggested chronic thrombus and neointima.
“We believe that the Proteus embolic capture angioplasty balloon should be applied especially in cases where the potential risk of distal embolism is high and the need to minimise complications is prominent,” said Zeller et al. “Such cases include lower extremity chronic arterial occlusions, critical limb ischaemia, long and/or thrombotic lesions, stenting, after artherectomy, and/or patients with poor distal runoff.”
“It is, however, important to add that the rationale for using embolic capture angioplasty with the Proteus device needs to be further investigated by large-scale clinical trials,” they concluded.