Elizabeth M Sharis1, Nicolas W Shammas2, Gail A Shammas1, Susan Jones-Miller1. 1. Midwest Cardiovascular Research Foundation, Davenport, IA, United States of America. 2. Midwest Cardiovascular Research Foundation, Davenport, IA, United States of America. Electronic address: shammas@mchsi.com.
Abstract
BACKGROUND: The WIRION EPS filter was recently approved by the Food and Drug Administration (FDA) to be used in conjunction with all atherectomy devices when treating infrainguinal peripheral arterial disease. The safety of this filter with Jetstream atherectomy (JA) in a real world setting remains unclear. METHODS: Consecutive patients from the practice of one operator who underwent JA under WIRION EPS when treating femoropopliteal arteries were enrolled in this retrospective analysis. The primary safety endpoint was the ability of the filter to capture macrodebris with no dissection or thrombosis at the filter site and no filter-related major adverse events. Descriptive analysis on demographics, clinical, procedural and angiographic variables was done using mean ± SD for continuous variables and percentages for categorical variables. RESULTS: 37 patients were enrolled in this study between June 2016 and September of 2018 (64.9% males, age 68.7 ± 9.0, BMI 27.7 ± 5.4). TASC II classification of the treated lesions were 51.4% B, 24.3% A, 21.6% C, and 2.7% D. At the filter site, spasm occurred in 1/37 (2.7%), while dissection did not occur (0%). Embolization within the filter was found in 51.4% of patients: 14/37 (37.8%) macro debris and 5/35 (13.5%) micro debris. Clinically significant embolization distal to the filter that required treatment with more than a simple aspiration was 1/37 (2.7%). CONCLUSION: WIRION EPS filter use with Jetstream atherectomy was safe and was associated with a low rate of significant distal embolization that required more than a simple aspiration to treat.
BACKGROUND: The WIRION EPS filter was recently approved by the Food and Drug Administration (FDA) to be used in conjunction with all atherectomy devices when treating infrainguinal peripheral arterial disease. The safety of this filter with Jetstream atherectomy (JA) in a real world setting remains unclear. METHODS: Consecutive patients from the practice of one operator who underwent JA under WIRION EPS when treating femoropopliteal arteries were enrolled in this retrospective analysis. The primary safety endpoint was the ability of the filter to capture macrodebris with no dissection or thrombosis at the filter site and no filter-related major adverse events. Descriptive analysis on demographics, clinical, procedural and angiographic variables was done using mean ± SD for continuous variables and percentages for categorical variables. RESULTS: 37 patients were enrolled in this study between June 2016 and September of 2018 (64.9% males, age 68.7 ± 9.0, BMI 27.7 ± 5.4). TASC II classification of the treated lesions were 51.4% B, 24.3% A, 21.6% C, and 2.7% D. At the filter site, spasm occurred in 1/37 (2.7%), while dissection did not occur (0%). Embolization within the filter was found in 51.4% of patients: 14/37 (37.8%) macro debris and 5/35 (13.5%) micro debris. Clinically significant embolization distal to the filter that required treatment with more than a simple aspiration was 1/37 (2.7%). CONCLUSION: WIRION EPS filter use with Jetstream atherectomy was safe and was associated with a low rate of significant distal embolization that required more than a simple aspiration to treat.
Authors: Nicolas W Shammas; Bhaskar Purushottam; W John Shammas; Lori Christensen; Gail Shammas; Desyree Weakley; Sue Jones-Miller Journal: Vasc Health Risk Manag Date: 2022-08-02