Background Diffusion-weighted magnetic resonance imaging indicates that micronet-covered embolic prevention stent system effectively minimizes peri-procedural and prevents lesion-related post-procedural cerebral embolism in carotid artery stenting but long-term clinical evidence is missing. Purpose To provide long-term clinical and duplex ultrasound evaluation of safety and efficacy of the system use in consecutive carotid revascularization patients. Methods PARADIGM-EXTEND is in all-comer, all-referrals-tracked study with no exclusion criteria other than lack of NeuroVascular Team-determined indication. Clinically asymptomatic patients receive revascularization only in case of increased-stroke-risk characteristics. Adverse events are independently adjudicated. Results Currently 451 patients (48–87 years, 59% symptomatic, 127 women) with 490 arteries crossed the first follow-up window of 30 days. There has been 100% micronet-covered embolic prevention stent system use (ie, no other stent type/s used throughout study). Proximal/distal intra-procedural neuroprotection use was 38.3%/61.7%. Large balloon/high-pressure stent optimization was routine, leading to a single-digit (mean 6.9%) residual diameter stenosis. Independent neurologist and duplex evaluation are before and after revascularization (48h and 30 days, then yearly). Peri-procedural death or major ischemic stroke rate was 0%. One event (prior infarct scar asymptomatic extension in prolonged hypotension course) was adjudicated as minor stroke (0.22%), and there was 1 periprocedural MI (type 2, in 2-vessel non-revascularizable CTO; 0.22%). By 30 days there were no further ischaemic strokes (0%) but there was 1 haemorrhagic transformation that led to death (0.22%) and 1 bleeding-related death (0.22%). Thus total 30-day death/stroke was 0.66%, and total death/stroke/MI was 0.88%. By 60 months there were 3 contralateral, 1 ipsilateral (device-unrelated), and 2 posterior circulation strokes. Baseline internal carotid artery velocities were 3.72±1.25 and 0.63±0.69 m/s (peak-systolic and end-diastolic). Post-procedural in-stent velocities were normal and remained normal throughout the 60-month follow-up period: 0.78±040 and 0.21±0.10 (1y); 0.75±0.36 0.19±0.09 (2y); 0.75±0,35 and 0.21±0.09 (3y); 0.72±0.27 and 0.20±0.07 (4y); 0.79±0.58 and 0.21±0.11m/s (5y). There were 2 in-stent restenoses by 1y (including 1 that occurred with de novo neck radiotherapy) and 1 other by 2y (total 2y in-stent restenosis of 1.1%) but no further ones (0% in-stent restenosis at 2–5y). Conclusions PARADIGM-Extend long-term clinical and duplex ultrasound evidence is consistent with normal healing and sustained safety and stroke prevention efficacy of the micronet-covered embolic prevention stent system used routinely, on top of optimized medical therapy, for stroke prevention in symptomatic and increased-stroke-risk asymptomatic subjects with carotid stenosis recommended for revasularization by the NeuroVascular Team. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Jagiellonian University Medical College
Background Shortage of endovascular operators able to deliver manual thrombectomy in acute ischemic stroke (AIS) on a 24/7/365 basis is a main challenge in many health care settings around the world. Another fundamental barrier is getting multispecialy teams to work collaboratively with each other in AIS as is already done (albeit on an elective rather than acute basis and in absence of “territorial” issues) in managing stroke mechanistic pathologies such as atrial fibrillation (pharmacology/ablation) or PFO (diagnosis/closure). Purpose To establish a practical path towards a clinically and orranizationally effective cardiology cathlab-based acute ischaemic stroke service, including intracranial manual thrombectomy, in a large multi-specialty hospital with a high-volume stroke unit but absence of neuroradiology service. Methods Withn a symptomatic and increased-stroke-risk asymptomatic carotid stenosis all-comer endovascular revascularization study (NeuroVascular Team decision-making) we have treated, on an emergent basis, 17 patients (13 men, age 58–75 years, median 67 years) with AIS caused by severe thrombotic carotid artery stenoses. All cases were performed as part of our pathway towards a full 24/7 thrombectomy stroke service. Results All lesions (100%) were thrombotic (mobile thrombus - 29%). Proximal neuroprotection (flow reversal using a common carotid artery±external carotid artery occlusive balloon/s) was used in 15/17 patients (88%). In 2 patients (12%) filter protection was applied as proximal system use was unfeasible for anatomic or clinical reasons. All cases were done under activated clotting time control and using a micronet-covered embolic prevention stent system that was routinely optimized -under an effective neuroprotection- with large balloons/high pressures. There were no procedure- or device-related complications. TIMI/TICI-3 was achieved in all cases. Vascular access closure device use was 76%. A 30-day good clinical outcome (mRS of 0–2) rate was 94%. One patient had a haemorrhagic stroke transformation that finally led to death. By 30 days no new stroke, stent thrombosis, myocardial infarction or other SAE occurred Conclusions Cardiologists skilled in carotid interventions are naturally positioned to deliver AIS treatment. 24/7 interventional services and networks for acute myocardial infarction have long been established and, as demonstrated in our centre, the services and skills can be translated -in collaboration with a local stroke unit/neurology- to AIS. Breaking away from traditionally-perceived “territories” towards working as a multispecialy AIS team is a logical concept that provides an effective healthcare solution for large numbers of stroke patients currently needing -and not receving- thrombectomy. Working hand in hand with neurology and radiology in managing acute carotid syndromes is thus part of a natural evolution towards full interventional stroke services including thrombectomy. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Jagiellonian University Medical College
Aims To provide long-term clinical (incl neurologic) and duplex ultrasound (DUS) evaluation of the CGuard MicroNet-covered embolic prevention stent system (EPS) routine use to perform CAS in all-comer (no exclusion criteria) patients with symptomatic or increased-stroke-risk asymptomatic carotid stenosis recommended for revascularization by the NeuroVascular Team. Methods and results PARADIGM-Extend is a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic carotid stenosis. In asymptomatic lesions, intervention is mandated only in case of increased-stroke-risk features. There is first-line consideration to use the study device, with EPD choice according to tailored-CAS algorithm. Independent neurologist evaluation and DUS are performed before CAS, at 48h, 30 days, and then every 12 months. There is external source data verification, external angiographic corelab, and external statistical analysis. Currently 325 patients (48–87 years, 54.2% symptomatic) crossed the 1st follow-up window. There has been 100% CGuardEPS use. Angiographic DS was reduced from 84±8% to only 6.9±5% (p<0.001, “CEA-like” effect of CAS). Peri-procedural death or major stroke rate was 0%. One event was CEC-adjudicated as minor stroke (0.3%), and there was one (type2) MI (0.3%). By 30 days there was one haemorrhagic transformation leading to death (0.3%) and one bleeding-related death (0.3%). Thus total death/major stroke/minor stroke rate at 30 days was 0.9%, and total death/major stroke/minor stroke/MI rate at 30 days was 1.2%. At 1- 12 months were no strokes or stroke-related deaths (0%). At 12–24 months there was one cerebellar stroke in an AFib patient that was confirmed on MRI imaging but no carotid-territory stroke or stroke deaths (0%). By 24 and 36 months there was one posterior circulation (cerebellal) infarct but no cerebral infarctions. Post-procedural in-stent velocities were normal and remained normal throughout the 36-month follow-up period (peak-systolic/end-diastolic velocity 0.69±0.29/0.18±0.09 m/s at 30 days, 0.82±0.47/0.22±0.13m/s at 12 months, 0.73±0.31/0.19±0.09m/s at 24months and 0.80±0.31/0.21±0.11 at 24months), indicating normal device healing. Conclusions PARADIGM-Extend accumulating 36-month clinical and DUS evidence is consistent with unprecedented, sustained safety and cerebral embolism prevention efficacy of the CGuard™ MicroNET-covered embolic prevention stent system used routinely for stroke prevention in symptomatic and increased-stroke-risk asymptomatic subjects with carotid stenosis. Acknowledgement/Funding K/ZDS/007819 Jagiellonian University Medical College
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