Purpose: To report a single-center experience with the Proteus embolic capture angioplasty balloon catheter for the treatment of symptomatic lower extremity peripheral artery disease.
Methods: Between June 2010 and January 2012, 36 lower extremity lesions were treated in 30 patients (29 men; mean age 65±9 years) with symptomatic peripheral artery disease. Nearly half of the patients had diabetes mellitus. The mean lesion length was 140 mm, and three quarters of the lesions were considered complex owing to severe calcification, chronic total occlusion (≥3 months), in-stent stenosis, and/or length >150 mm. The volume of debris retrieved in the balloon was estimated from the number and size of particles, and a debris score was assigned and classified as low (≤2), moderate (2-4), or high (>4).
Results: Immediate procedural success was 86%, and no in-hospital serious adverse events (e.g., death, amputation, or surgical intervention) were reported. Embolic debris was captured in 32 (89%) of 36 cases. Debris scores for totally occluded, long, and in-stent stenotic lesions were 4.8±3.3, 4.6±3.0, and 3.8±2.5, respectively. Angiographic distal embolizations were reported in 2 (5.5%) procedures.
Conclusion: Embolic capture angioplasty with the Proteus angioplasty balloon catheter during peripheral artery interventions is technically feasible and captures debris in a large proportion of the cases.