Abstract 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

Abstract 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

1342 and OR: 2.22, respectively) and those without antithrombotic therapy (OR: 2.79, 95% CI: 1.53-5.57;and OR: 2.45, 95% CI: 1.30-4.91,respectively) (Figure).Conclusion: Elevated DD level on admission was a significant determinant of ischemic stroke shortly after admission for AHF, suggesting a predictive role of DD level for short-term ischemic stroke in AHF patients.

Closure of the atrial septal defect in the elderly patients is controversial. The aim of the study was to evaluate the outcomes of transcatheter closure of secundum atrial septal defect (ASD) in elderly patients. From a total of 650 pts with ASD who underwent transcatheter closure 120 pts over 60 years (70 F, 50 M) with a mean age of 66.7±18.1 (60–78) were analyzed. All patients had an isolated secundum ASD with a mean Qp:Qs: 2.79±1.8 (1.5–3.9). A symptom-limited treadmill exercise tests with respiratory gas exchange analysis and transthoracic color Doppler echocardiographic study as well as Quality of life (QoL) measured using the SF36 questionnaire (SF36q) were repeated in all pts before procedure and after 12 months of follow-up. The device was successfully implanted in all pts (procedure time 30.1±9.9 (10–59) minutes, fluoroscopy time 10.1±7.2 (6–40) minutes). There were no major complications. The defect echo diameter was 19.5±15.4 (12 - 34) mm. The mean balloon stretched diameter of ASD was 22.0±7.8 (14 - 36) mm. The diameter of the implanted devices ranged 16 - 38 mm. After 12 months of ASD closure, all the pts showed a significant improvement of exercise capacity parameters. Seven QoL parameters (except mental health) improved at 12 months follow up compared to their baseline data. The mean SF36q scale increased significantly in 96 (80.2%) pts of mean 41.6±26.1 (4–71). The right ventricular dimension decreased in 101 pts (84.2%) (Table 1). Closure of ASD in elderly patients caused a significant clinical and hemodynamic improvement after percutaneous treatment, which is maintained to long-term follow-up what justified this procedure in old age. Type of funding source: None