Highly‐calcific carotid lesions endovascular management in symptomatic and increased‐stroke‐risk asymptomatic patients using the CGuard™ dual‐layer carotid stent system: Analysis from the PARADIGM study. Issue 1 (3rd April 2019)

• Record Type: Journal Article
• Authors: Mazurek, Adam; Partyka, Lukasz; Trystula, Mariusz; Jakala, Jacek; Proniewska, Klaudia; Borratynska, Anna; Tomaszewski, Tomasz; Slezak, Magdalena; Malinowski, Krzysztof P.; Drazkiewicz, Tomasz; Podolec, Piotr; Rosenfiled, Kenneth; Musialek, Piotr
• Is Part Of: Catheterization and cardiovascular interventions. Volume 94:Issue 1(2019)
• Page Start: 149
• Page End: 156
• Publication Date: 2019-04-03
• Subjects: angiographic grading algorithm -- calcific lesion -- calcification -- calcification evaluation -- carotid artery stenting -- carotid stenosis -- CGuard™ dual‐layer stent system -- complications -- endovascular management -- revascularization; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.28219
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract: Objectives: To assess feasibility, safety, angiographic, and clinical outcome of highly‐calcific carotid stenosis (HCCS) endovascular management using CGuard™ dual‐layer carotid stents. Background: HCCS has been a challenge to carotid artery stenting (CAS) using conventional stents. CGuard combines a high‐radial‐force open‐cell frame conformability with MicroNet sealing properties. Methods: The PARADIGM study is prospectively assessing routine CGuard use in all‐comer carotid revascularization patients; the focus of the present analysis is HCCS versus non‐HCCS lesions. Angiographic HCCS (core laboratory evaluation) required calcific segment length to lesion length ≥2/3, minimal calcification thickness ≥3 mm, circularity (≥3 quadrants), and calcification severity grade ≥3 (carotid calcification severity scoring system [CCSS]; G0‐G4). Results: One hundred and one consecutive patients (51–86 years, 54.4% symptomatic; 106 lesions) received CAS (16 HCCS and 90 non‐HCCS); eight others (two HCCS) were treated surgically. CCSS evaluation was reproducible, with weighted kappa (95% CI) of 0.73 (0.58–0.88) and 0.83 (0.71–0.94) for inter‐ and intra‐observer reproducibility respectively. HCCS postdilatation pressures were higher than those in non‐HCCS; 22 (20–24) versus 20 (18–24) atm, p = .028; median (Q1–Q3). Angiography‐optimized HCCS‐CAS was feasible and free of contrast extravasation or clinical complications. Overall residual diameter stenosis was single‐digit but it was higher in HCCS; 9 (4–17) versus 3 (1–7) %, p = .002. At 30 days and 12 months HCCS in‐stent velocities were normal and there were no adverse clinical events. Conclusion: CGuard HCCS endovascular management was feasible and safe. A novel algorithm to grade carotid artery calcification severity was reproducible and applicable in clinical study setting. Larger HCCS series and longer‐term follow‐up are warranted.