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

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.

Circumferential degree of carotid calcification is associated with new ischemic brain lesions after carotid artery stenting

“…As the hard calcified plaques are more rigid against deformation, vessel segments with soft plaques on the same circumference have to compensate by overstretching in order to achieve sufficient stent expansion (18). Therefore, when the carotid vessel wall contains considerable circumferential calcification but little soft component, the inserted stent is opened inadequately due to excessive resistance from the rigid vessel wall, with possible consequences being stent recoil and restenosis, which eventually leads to cerebral ischemia (19). Achieving adequate stent expansion requires a significantly greater force, which increases the risk of excessive stretching of the vessel wall.…”

Commentary: Double-Layer Carotid Stents: From the Clinical Need, through a Stent-in-Stent Strategy, to Effective Plaque Isolation… the Journey Toward Safe Carotid Revascularization Using the Endovascular Route

“…59 It is important to note that the outcome difference between the conventional-stent CAS vs CEA and between the conventional-stent CAS vs a dual-layer stent CAS likewise is driven by high-risk patients and plaques. 16,[33][34][35][36][37] Therefore, to provide clinically-relevant answers, carotid revascularization studies should strive to include highrisk 58,59 rather than low-risk 60 patients. As evidenced in cardiovascular studies in other areas, inclusion of low(er)-risk patients and low(er)-risk lesions (while assigning their high(er)-risk counterparts to intervention outside the study) leads to generating "answers" that are not relevant to clinical practice involving significant proportions of high-risk patients.…”

“…In contrast, the primary interest of the physician and his/her patient is to define the right treatment method for the particular patient. Therefore, externally monitored all-comer registries 58,59 and multicenter individual patient–level data analyses 22,66 are fundamental. Moreover, clinical guidelines and likewise everyday clinical decision-making should also consider the underutilized but not trivial endpoint of patient-perceived quality of life.…”

“…15,30,68,69 Accumulating evidence suggests that routine prevention of plaque prolapse by means of a dedicated dual-layer stent may work far better than reacting to plaque prolapse with another stent that might or might not trap enough embolizing plaque. 27,29 The wait-for-stroke strategy (ie, revascularize only once the patient becomes symptomatic) becomes hardly acceptable when the risk of percutaneous intervention is down to the level of ~1% 22,40,58,59 compared with the annual stroke risk of up to 2.5% to 2.9% in patients on optimized pharmacotherapy. 4-6 This critical question is being addressed in the CREST-2 study.…”

Transient flow reversal combined with sustained embolic prevention in transcervical revascularization of symptomatic and highly-emboligenic carotid stenosis for optimized endovascular lumen reconstruction and improved peri- and post-procedural outcomes

“…Our experience, over the years, involved a high-proportion proximal cerebral protection use [6,[13][14][15] and it also involved our introduction [16] and every-day clinical practice all-comer patient-and-lesion evaluation [15][16][17] of the MicroNET-covered embolic prevention stent. As an International 'TCAR Center of Excellence' (2018) we systematically paired the TCAR system (EnRoute, Silk Road) with our routine use of the CGuard embolic prevention stent system (InspireMD) to minimize not only intra-procedural but also post-procedural cerebral embolism in relation to the index carotid lesion [8,12].…”