Clinical impact of Sim & Size® simulation software in the treatment of patients with cerebral aneurysms with flow-diverter Pipeline stents

Objectives This study evaluated the clinical impact of the Sim&Size® simulation software on the endovascular treatment with flow-diverter stents of patients with unruptured saccular intracranial aneurysms. Methods This monocentric retrospective study evaluated a cohort of patients treated with flow-divert stents between June 1, 2014, and December 31, 2019, for cerebral aneurysms. Patients belonged to two groups, patients treated with and without the Sim&Size® simulation software. Univariate, bivariate, and multivariate analyses were used to evaluate the clinical impact of simulation software. Results Out of the 73 interventions involving 68 patients analyzed by the study, 76.7% were simulated using the Sim&Size® simulation software, and 23.3% were not. Patients treated with the simulation software had shorter stent lengths (16.00 mm vs. 20.00 mm p-value = 0.001) and surgical time (100.00 min vs. 118.00 min p-value = 0.496). Also, fewer of them required more than one stent (3.6% vs. 17.6% p-value = 0.079). Three patients belonging to the non-stimulated group presented hemorrhagic complications. Conclusions Using the Sim&Size® simulation software for the endovascular treatment of intracranial aneurysms with pipeline flow-diverter stents reduces the stent length.

Patient exposure dose in interventional cardiology per clinical and technical complexity levels. Part 1: results of the VERIDIC project

Background Patients can be exposed to high skin doses during complex interventional cardiology (IC) procedures. Purpose To identify which clinical and technical parameters affect patient exposure and peak skin dose (PSD) and to establish dose reference levels (DRL) per clinical complexity level in IC procedures. Material and Methods Validation and Estimation of Radiation skin Dose in Interventional Cardiology (VERIDIC) project analyzed prospectively collected patient data from eight European countries and 12 hospitals where percutaneous coronary intervention (PCI), chronic total occlusion PCI (CTO), and transcatheter aortic valve implantation (TAVI) procedures were performed. A total of 62 clinical complexity parameters and 31 technical parameters were collected, univariate regressions were performed to identify those parameters affecting patient exposure and define DRL accordingly. Results Patient exposure as well as clinical and technical parameters were collected for a total of 534 PCI, 219 CTO, and 209 TAVI. For PCI procedures, body mass index (BMI), number of stents ≥2, and total stent length >28 mm were the most prominent clinical parameters, which increased the PSD value. For CTO, these were total stent length >57 mm, BMI, and previous anterograde or retrograde technique that failed in the same session. For TAVI, these were male sex, BMI, and number of diseased vessels. DRL values for Kerma-area product ( PKA), air kerma at patient entrance reference point ( Ka,r), fluoroscopy time (FT), and PSD were stratified, respectively, for 14 clinical parameters in PCI, 10 in CTO, and four in TAVI. Conclusion Prior knowledge of the key factors influencing the PSD will help optimize patient radiation protection in IC.

Symptomatic atherosclerotic plaque progression in a first-generation carotid stent—case report: Management and 5-year clinical and imaging outcome

Background Restenosis in first-generation (single-layer, nitinol) carotid stents (FGS) is believed to represent an exaggerated healing response of (neo)intimal hyperplasia (NIH) formation. Rather than NIH, we describe symptomatic in-FGS unstable plaque (neo)atherosclerosis mandating re-revascularization. To halt continued plaque evolution, we propose a novel treatment strategy involving a micronet-covered stent to sequestrate the plaque from the vessel lumen. A durable long-term result is documented using multi-modal imaging. Case summary With a seemingly optimal result of FGS (Precise) symptomatic carotid lesion revascularization followed by optimal medical therapy, a late (≥3 years) progressive ISR arose. At year 11, crescendo ipsilateral transient ischaemic attacks occurred. Angiography showed an ulcerated tight lesion throughout stent length. Intravascular ultrasound (IVUS) revealed thin-cap fibroatheroma. Re-intervention was performed under distal protection. Undersized balloon predilatation caused symptomatic no-flow, and aspiration catheter was used to reduce the filter load. A micronet-covered stent (CGuard) was implanted and post-dilated to ensure full lumen gain; IVUS confirmed complete plaque sequestration. The optimal anatomic result remained unchanged throughout 5 years (ultrasound and computed tomography verification); this was accompanied by clinical cure. Discussion This is the first demonstration of in-FGS (neo)atherosclerosis resolution using a micronet-covered stent to sequestrate and insulate the atherosclerotic plaque. We show that ISR may be underlined by late atherosclerotic plaque progression via the FGS single-layer stent struts that may show vulnerable plaque phenotype and may be associated with cerebral ischaemia. The anatomically and clinically effective exclusion of the atherosclerotic plaque by a micronet-covered stent enabled lasting, optimal endovascular reconstruction and clinical cure.

Hemodynamic Impact of Stenting on Carotid Bifurcation: A Potential Role of the Stented Segment and External Carotid Artery

Carotid stenting near the bifurcation carina is associated with adverse events, especially in-stent restenosis, thrombosis, and side branch occlusion in clinical data. This study is aimed at determining the potential biomechanical mechanisms for these adverse events after carotid stenting. The patient-specific carotid models were constructed with different stenting scenarios to study the flow distribution and hemodynamic parameters, such as wall shear stress (WSS), flow velocity, relative residence time (RRT), and oscillating shear index (OSI) in the carotid bifurcation. The results suggested that the existing stents surely reduced blood flow to the external carotid artery (ECA) but enhanced local flow disturbance both in ECA and stented internal carotid artery (ICA), and the inner posterior wall of the stented ICA and the outer posterior wall of ECA might endure a relatively low level of WSS and remarkably elevated OSI and RRT. In addition, the implanted stent leads to more ECA adverse flow than ICA after stenting. While disturbed flow near the strut increased as stent length increased, blood flow and areas of local flow disturbance in ECA slightly decreased as stent length increased. In conclusion, the results revealed that ECA might be in relatively high levels of abnormal local hemodynamics after stenting, followed by stented ICA, leading to potential adverse events after intervention.

Arterial Preparation by Longitudinal Micro-Incisions Before Balloon Angioplasty of the Superficial Femoral and Popliteal Artery: Acute and 12-Month Results

Purpose: Percutaneous transluminal angioplasty (PTA) with conventional plain old balloon (POBA) and/or drug-coated balloon (DCB) is the primary intervention to treat peripheral artery stenoses. However, acute dissections during the procedure and potential for future target lesion revascularization remain procedural complications. The purpose of this study was to assess the acute and 12-month outcomes in patients who underwent novel vessel preparation with longitudinal, controlled-depth micro-incisions prior to PTA. Materials and Methods: Patients with symptomatic lower extremity peripheral arterial disease with a Rutherford class of 2 to 6 and >70% de novo stenosis of the superficial femoral or popliteal arteries were included in this retrospective study. Patients with thrombotic or embolic lesions, restenosis, or in-stent restenosis were excluded. The FLEX Vessel Prep System (FLEX VP) was used to prepare the vessel prior to PTA by creating micro-incisions at the target lesion. The FLEX VP was followed by POBA or paclitaxel DCB. Results: The study included 65 patients. Lesion characteristics were 90% median stenosis (range = 70%–100%), 75.4% mild-to-severe calcifications, and 33.8% occlusion rate, and median lesion length was 196 (range = 10–480) mm. Following vessel preparation, 82.1% of the patients had low severity dissection or no flow-limiting dissection. The provisional stent rate postprocedure was 16.9%, with a median stent length of 60 mm. The freedom from target lesion revascularization (FFTLR) in 63 evaluable patients at 6 and 12 months was 98.4% and 93.7%, respectively. Freedom from amputation was 100%. Conclusion: In this real-world/all-comers patient population with long, stenotic lesions across the calcification spectrum, vessel preparation with longitudinal micro-incisions prior to PTA was associated with low dissection rate, low dissection severity, low stent implantation, and high FFTLR with the absence of amputation at 12 months relative to published reports in long-lesion cohorts. These results support vessel preparation via micro-incisions.

Abstract 1122‐000136: Stent Length is Associated with Restenosis of the Vertebral Artery Ostium

Introduction : Background: Stenosis of the vertebral artery ostium (VAOS), while under‐diagnosed, is common and may cause 25% of posterior circulation infarctions. Stenting is widely employed as a secondary prevention strategy, but is associated with high rates of restenosis. Objective: To identify factors associated with higher risk of VAOS recurrence after stenting. Methods : A combined retrospective cohort of subjects who underwent vertebral ostial stenting at two academic hospitals: SSM Health Saint Louis University Hospital and the University of Iowa, was analyzed. The demographic profile of the subjects, medical comorbidities, periprocedural complications, 30 day complications, and change in Modified Rankin score, and radiographic follow up were analyzed using IBM SPSS Statistics version 26. Results : There were 80 patients who underwent vertebral artery stenting in this cohort. 72.5% (n = 58) were male, 70% (n = 56) were Caucasian. Hypertension (67.5%, n = 54) and hyperlipidemia (65%, n = 52) were the most prevalent vascular risk factors. Of these subjects, 31 underwent radiographic follow up with catheter angiography. The mean interval at which the last angiogram was performed was, 9.3 months (+/‐ 4.3). Independent samples t‐tests and univariate linear regression models revealed that four factors were identified as most associated with in‐stent restenosis: hypertension, diabetes mellitus, stent length, and post‐stent residual stenosis. When analyzed as a backwards stepwise multivariate model, stent length was the only variable that trended towards significance (t = 1.74, p = 0.09). Additionally, only 4 of the 31 patients did not have HTN and none of them had a recurrence of stenosis post‐procedure. Conclusions : Stent length may be associated with risk of recurrent stenosis after vertebral ostial stenting. This along with risk factors such as hypertension should be studied in future prospective studies as possible predictors of in‐stent restenosis.

Effect of risk enhancers versus technical aspects of high thrombotic risk criteria on adverse clinical events after PCI: insights from 2020 ESC NSTE-ACS Guidelines

Background The long-term clinical outcome after PCI is affected by various clinical and angiographic risk features. The present study was designed to investigate the long-term prognostic impact of risk enhancers and technical aspects as defined by 2020 ESC NSTE-ACS Guidelines for high thrombotic risk (HTR) criteria on the risk of adverse events after PCI. Methods A total of 10,167 patients were enrolled from the Fuwai PCI registry. Risk enhancers and technical aspects were retrospectively assessed according to 2020 ESC NSTE-ACS Guidelines. Risk enhancers were defined as having at least one of the following characteristics: diabetes mellitus requiring medication, history of recurrent MI, any multivessel CAD, peripheral artery disease, premature (<45 years) CAD, and chronic kidney disease. Technical aspects were defined as having at least one of the following characteristics: ≥3 stents implanted, ≥3 lesions treated, total stent length >60 mm, left main PCI, bifurcation stenting with ≥2 stents implanted, and chronic total occlusion. The primary endpoint was 30-month major adverse cardiac and cerebrovascular events (MACCE, a composite of cardiac death, myocardial infarction [MI], stent thrombosis, any revascularization, and ischemic stroke). Results MACCE occurred in 1188 (11.7%) patients during the follow-up period (median duration: 881 days). Risk enhancers were present in 8,437 patients (83.0%) and was associated with increased 30-month risk for the MACCE (adjusted hazard ratio [adjHR]: 2.11; 95% CI: 1.72–2.60). Technical aspects were present in 3,335 patients (32.8%) and was an independent predictor of MACCE at 30 months (adjHR: 1.32; 95% CI: 1.17–1.49). The risk of MACCE associated with risk enhancers was significantly higher than for technical aspects (2.11 vs. 1.32; relative risk [RR]: 1.60; 95% CI: 1.47–1.75). Results were consistent when risk enhancers and technical aspects were modeled as a continuous variable. Adjusted HRs of MACCE within the 12 months for patients with risk enhancers and technical aspects were 2.35 (95% CI: 1.80–3.07) and 1.50 (95% CI: 1.30–1.73), respectively. Risk enhancers significantly influenced MACCE beyond 12 months (adjHR: 1.78; 95% CI: 1.29–2.46), whereas technical aspects were not associated with very late (12-month to 30-month) MACCE (adjHR: 1.01; 95% CI: 0.82–1.25). Both risk enhancers and technical aspects were not significantly associated with BARC type 2, 3, or 5 bleeding within 12 months and between 12 and 30 months. Conclusions Both risk enhancers and technical aspects of HTR criteria significantly affected long-term ischemic clinical events but not major bleeding in patients undergoing PCI. Risk enhancers appeared to have a greater and more prolonged effect on poor prognosis than technical aspects, suggesting the importance of compliance with guideline-directed medical therapy. Funding Acknowledgement Type of funding sources: Foundation. Main funding source(s): Beijing Municipal Health Commission (Grant No. 2020-1-4032)Chinese College of Cardiovascular Physicians, CS Optimizing Antithrombotic Research Fund (Grant number: BJUHFCSOARF201801-01)

Risk factors of in-stent restenosis among coronary artery disease patients with syphilis undergoing percutaneous coronary intervention: a retrospective study

Background The risk factors of in-stent restenosis (ISR) among coronary artery disease (CAD) patients with syphilis after percutaneous coronary intervention (PCI) are not fully understood. Therefore, this study aimed to elucidate not only the risk factors of ISR among CAD patients with syphilis after performing PCI, but also the population attributable risk percentage (PAR%), which is used to quantify the proportion of ISR that could be eliminated if particular risk factors are not present. Methods Evaluation of the prevalence, risk factors, and their PAR% for ISR among CAD patients with syphilis undergoing PCI was conducted retrospectively at Beijing Ditan Hospital. CAD patients with syphilis underwent PCI from August 2010 to August 2019 and received a diagnosis, coronary angiography, PCI, and periodical follow-up. The clinical, laboratory, and imaging data were reviewed and summarised anonymously from electronic medical records. The chi-square or Fisher exact test was used in data analysis. Results Among 114 CAD patients with syphilis undergoing PCI, ISR occurred in 18 patients (15.78%). The multivariate Cox regression model indicated that average stent length ≥ 35 mm (adjusted hazard ratio [HR] = 4.47, 95% confidence interval [CI] = 1.30–15.44, p = 0.018) and titres of the toluidine red unheated serum test (TRUST) > 1:16 (adjusted HR = 3.72, 95% CI = 1.22–11.36, p = 0.021) were associated with an increased risk of ISR, while successful antisyphilitic treatment (adjusted HR = 0.12, 95% CI = 0.02–0.95, p = 0.045) was protective predictor of ISR among these patients. The PAR% values of particular risk factors associated with ISR including average stent length ≥ 35 mm, titres of TRUST > 1:16, and successful antisyphilitic treatment were 12.2%, 24.0%, and -39.6%, respectively, among these patients. Conclusions Preventing the occurrence of ISR among CAD patients with syphilis undergoing PCI requires clinical intervention. Our results indicated that carefully evaluating the length of the vessel lesion to determine whether the stent length is < 35 mm, prioritising the clinical intervention for titres of TRUST > 1:16, and providing successful antisyphilitic treatment could reduce the risk of ISR occurrence.

Safety and Feasibility of Intravascular Ultrasound-Guided Robotic

PurposePrevious studies have demonstrated the benefit of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) for preventing longitudinal geographic miss (LGM). However, it is yet unclear whether IVUS guidance is useful for robotic PCI (R-PCI). This retrospective observational study sought to compare expected stent landing positions between IVUS and angiography.MethodsA total of 58 consecutive patients with stable angina who underwent IVUS-guided R-PCI was enrolled. The stent landing position was angiographically marked using a balloon marker before stenting followed by measurements of the expected stent length using balloon pullback. Subsequently, pre-stenting IVUS was performed to determine stent landing. All pre-PCI IVUS images were assessed for lesion length and percent plaque volume (%PV) using both IVUS and angiographic marking. LGM was defined as a residual %PV > 50% at either the distal or proximal stent edge, any stent edge dissection, and/or additional stent deployment immediately after stenting. Major adverse cardiac events were assessed at the 6-month follow-up.ResultsThe included patients, 41 of whom were male, had an average age of 67.1 ± 10.1 years. IVUS guidance had significantly longer lesion lengths compared to angiographic marking. Based on IVUS-guided stent deployment, 9 cases exhibited LGM immediately after stenting. IVUS-marked landing points had a significantly smaller %PV and significantly larger LA compared to those for angiography. No adverse cardiac events were noted during the 6-month follow-up.ConclusionIVUS-guided R-PCI was safe and may be better at preventing LGM compared to angiography-guided R-PCI.