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We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease.Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients.The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient.Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up.

Background: In some randomized clinical trials, transradial access (TRA) compared with transfemoral access (TFA) was associated with lower mortality in patients with coronary artery disease undergoing invasive management. We analyzed the effects of TRA versus TFA across multicenter randomized clinical trials and whether these associations are modified by patient or procedural characteristics. Methods: We performed an individual patient data meta-analysis of multicenter randomized clinical trials comparing TRA with TFA among patients undergoing coronary angiography with or without percutaneous coronary intervention. The primary outcome was all-cause mortality and the co–primary outcome was major bleeding at 30 days. The primary analysis was conducted by 1-stage mixed-effects models on the basis of the intention-to-treat cohort. The effect of access site on mortality and major bleeding was assessed further by multivariable analysis. The relationship among access site, bleeding, and mortality was investigated by natural effect model mediation analysis with multivariable adjustment. Results: A total of 21 600 patients (10 775 TRA, 10 825 TFA) from 7 randomized clinical trials were included. The median age was 63.9 years, 31.9% were women, 95% presented with acute coronary syndrome, and 75.2% underwent percutaneous coronary intervention. All-cause mortality (1.6% versus 2.1%; hazard ratio, 0.77 [95% CI, 0.63–0.95]; P =0.012) and major bleeding (1.5% versus 2.7%; odds ratio, 0.55 [95% CI, 0.45–0.67]; P P interaction =0.003), indicating that the benefit of TRA was substantial in patients with moderate or severe anemia, whereas it was not significant in patients with milder or no baseline anemia. After adjustment, TRA remained associated with 24% and 51% relative risk reduction of all-cause mortality and major bleeding, respectively. A mediation analysis showed that the benefit of TRA on mortality was only partially driven by major bleeding prevention and ancillary mechanisms are required to fully explain the causal association. Conclusions: TRA is associated with lower all-cause mortality and major bleeding at 30 days compared with TFA. The effect on mortality was driven by patients with anemia. The reduction in major bleeding only partially explains the mortality benefit. Registration: URL: https://www.crd.york.ac.uk/prospero ; Unique identifier: CRD42018109664.

Objective The multicenter proximal upper limb artery (PULA) Registry was created to study the optimal puncture sites for the interventions involving the subclavian, axillary, and innominate arteries. Background Little is known about the optimal vascular access for PULA interventions, despite the well-known technical complexity of these procedures. Methods We performed the retrospective analysis of consecutive patients treated for symptomatic steno-occlusive disease of the proximal upper limb arteries between January 2015 and December 2019 in three high-volume centers. Acute thrombotic occlusions were excluded from the study. Results Two hundred and seventy-two patients were treated for significant stenosis and 108 for total occlusion. The baseline patient's characteristics were similar, except for the higher median age of the stenotic patients: 68.5 years (31.1; 90.0) versus 64 years (38.0; 86.0) p = 0.0015. Successful revascularization rate was higher in the stenotic group 93.75% (255/272) versus 86.11% (93/108) p = 0.0230, while the procedure length 27 min (8; 133) versus 46 min (7; 140) p = 0.0001 and fluoroscopy times 439 s (92; 2993) versus 864 s (86; 4176) p = 0.0001 were higher in the occlusion group. The main adverse event rate was similarly low. Dual access was used more often to treat occlusions (60.19% (65/108) vs. 11.40% (31/272) p = 0.0001) without significantly increasing the complication rate. The safest access was ultrasound-guided distal radial artery puncture, significantly better than conventional radial access with 0% (0/31) versus 13.6% (18/131) p = 0.0253 complication. Conclusions The percutaneous revascularization of proximal upper limb arteries is a safe and effective. Dual access can be applied to increase treatment efficacy, without significantly compromising safety.

Objectives To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) O2 pilot study results. Background Despite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire. Methods and results The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man O2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases assessed successively with OptoWire™ and Aegis™ (Abbott Vascular, USA) bland-Altman analysis showed a mean difference of 0.002 ± 0.052 mmHg (p = .91) for Pd/Pa and 0.01 ± 0.06 for FFR calculation (p = .45). There was no device-related complication. Upon these initial results, several design changes aimed to improve overall performance including torquability, stiffness, resistance to kink and pressure drift were completed. Conclusion The novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment.

Purpose: To compare the acute success and complication rates of distal radial (DR) vs proximal radial (PR) artery access for superficial femoral artery (SFA) interventions. Materials and Methods: Between 2016 and 2019, 195 consecutive patients with symptomatic SFA stenosis were treated via DR (n=38) or PR (n=157) access using a sheathless guide. Secondary access was achieved through the pedal artery when necessary. The main outcomes were technical success, major adverse events (MAEs), and access site complications. Secondary outcomes were treatment success, fluoroscopy time, radiation dose, procedure time, and crossover rate to another puncture site. Results: Overall technical success was achieved in 188 patients (96.4%): 37 of 38 patients (97.3%) in the DR group and 151 of 157 patients (96.2%) in the PR group (p=0.9). Dual (transradial and transpedal) access was used in 14 patients (36.8%) in the DR group and 28 patients (18.9%) in the PR group (pConclusion: SFA interventions can be safely and effectively performed using PR or DR access with acceptable morbidity and a high technical success rate. DR access is associated with few access site complications.

© The Author(s) 2020. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com, Aims: The COLchicine Cardiovascular Outcomes Trial (COLCOT) demonstrated the benefits of targeting inflammation after myocardial infarction (MI). We aimed to determine whether time-to-treatment initiation (TTI) influences the beneficial impact of colchicine. Methods and results: In COLCOT, patients were randomly assigned to receive colchicine or placebo within 30 days post-MI. Time-to-treatment initiation was defined as the length of time between the index MI and the initiation of study medication. The primary efficacy endpoint was a composite of cardiovascular death, resuscitated cardiac arrest, MI, stroke, or urgent hospitalization for angina requiring coronary revascularization. The relationship between endpoints and various TTI (8 days) was examined using multivariable Cox regression models. Amongst the 4661 patients included in this analysis, there were 1193, 720, and 2748 patients, respectively, in the three TTI strata. After a median follow-up of 22.7 months, there was a significant reduction in the incidence of the primary endpoint for patients in whom colchicine was initiated < Day 3 compared with placebo [hazard ratios (HR) = 0.52, 95% confidence intervals (CI) 0.32–0.84], in contrast to patients in whom colchicine was initiated between Days 4 and 7 (HR = 0.96, 95% CI 0.53–1.75) or > Day 8 (HR = 0.82, 95% CI 0.61–1.11). The beneficial effects of early initiation of colchicine were also demonstrated for urgent hospitalization for angina requiring revascularization (HR = 0.35), all coronary revascularization (HR = 0.63), and the composite of cardiovascular death, resuscitated cardiac arrest, MI, or stroke (HR = 0.55, all P, The COLCOT trial was supported by the Government of Quebec, the Canadian Institutes of Health Research, the Montreal Heart Institute Foundation and other philanthropic foundations. The funding sources had no role in study design, conduct, or analyses.

Obesity is associated with the development and progression of multiple cardiovascular risk factors, such as hypertension, dyslipidemia, and type 2 diabetes mellitus, and is an important contributor to the global burden of atherosclerotic cardiovascular disease (CVD). Guidelines suggest that clinicians provide lifestyle counseling and promote lifestyle modifications before considering weight-loss surgery. However, despite lifestyle modifications and increased physical activity, most patients with obesity will not lose significant weight or will experience weight regain. Weight-loss pharmacotherapy added to lifestyle modification has long been perceived as a bridge between lifestyle modifications alone and weight-loss surgery. However, since its inception, weight-loss pharmacotherapy has been plagued by variable efficacy and concern about cardiovascular safety. Following requirements from regulatory authorities, efficacy and cardiovascular safety trials have been conducted for the currently available weight-loss pharmacotherapeutic agents. Overall, these trials have shown that weight-loss pharmacotherapy is only modestly efficient for the inducement of weight loss. Recent trials have also demonstrated the cardiovascular safety of some of these agents. We review these trials with a focus on the clinical impact of these weight-loss pharmacotherapeutic agents in patients with atherosclerotic CVD.

Although the superiority of manual compression of the radial, mainly due to its selectivity and progressive grading, had been hypothesized from the early days of the transradial use, data on efficacy and safety of this method are only scarce. This review tries to delineate the aspects of manual hemostasis in transradial catheterization. Current data demonstrate that manual compression of the radial artery is a possible (second line) hemostatic option in transradial catheterization with main advantage the shorter hemostasis duration, and major disadvantage the need for larger involvement of post-procedural care team in hemostasis. Manual compression of the radial artery is a possible (second line) hemostatic option with main advantage the shorter hemostasis duration, and major disadvantages the need for larger involvement of post-procedural care team in hemostasis.

An 80-year-old man followed for aortic stenosis was found to have an intracardiac mass. Multiple imaging modalities were inconclusive in characterizing the mass but raised concerns about the potential malignancy of the mass. Fear of operating on an elderly patient with a potential for cardiac neoplasia led to a percutaneous transseptal biopsy that failed to provide a clear diagnosis. Cardiac valvular surgery was performed in addition to excisional biopsy of the mass that turned out to be caseous necrosis of mitral annular calcifications.

Predictive coding accounts of brain functions profoundly influence current approaches to perceptual synthesis. However, a fundamental paradox has emerged, that may be very relevant for understanding hallucinations, psychosis, or cognitive inflexibility: in some situations, surprise or prediction error-related responses can decrease when predicted, and yet, they can increase when we know they are predictable. This paradox is resolved by recognizing that brain responses reflect precision-weighted prediction error. This presses us to disambiguate the contributions of precision and prediction error in electrophysiology. To meet this challenge for the first time, we appeal to a methodology that couples an original experimental paradigm with fine dynamic modeling. We examined brain responses in healthy human participants (N= 20; 10 female) to unexpected and expected surprising sounds, assuming that the latter yield a smaller prediction error but much more amplified by a larger precision weight. Importantly, addressing this modulation requires the modeling of trial-by-trial variations of brain responses, that we reconstructed within a fronto-temporal network by combining EEG and MEG. Our results reveal an adaptive learning of surprise with larger integration of past (relevant) information in the context of expected surprises. Within the auditory hierarchy, this adaptation was found tied down to specific connections and reveals in particular precision encoding through neuronal excitability. Strikingly, these fine processes are automated as sound sequences were unattended. These findings directly speak to applications in psychiatry, where specifically impaired precision weighting has been suggested to be at the heart of several conditions such as schizophrenia and autism.SIGNIFICANCE STATEMENTIn perception as Bayesian inference and learning, context sensitivity expresses as the precision weighting of prediction errors. A subtle mechanism that is thought to lie at the heart of several psychiatric conditions. It is thus critical to identify its neurophysiological and computational underpinnings. We revisit the passive auditory oddball paradigm by manipulating sound predictability and use a twofold modeling approach to simultaneous EEG-MEG recordings: (1) trial-by-trial modeling of cortical responses reveals a context-sensitive perceptual learning process; (2) the dynamic causal modeling (DCM) of evoked responses uncovers the associated changes in synaptic efficacy. Predictability discloses a link between precision weighting and self-inhibition of superficial pyramidal (SP) cells, a result that paves the way to a fine description of healthy and pathologic perception.

Background: Once occluded, the radial artery becomes unsuitable for repeat interventions and obligates the need for alternative vascular access, such as the femoral approach, which is not encouraged by current guidelines. With the dissemination of distal radial access (DRA), which allows the cannulation of the artery in its distal segment and which remains patent even in the case of radial artery occlusion (RAO), the option to perform angioplasty at this level becomes feasible. Methods: Thirty patients with RAO were enrolled in this pilot study. Recanalization was performed through DRA using hydrophilic guidewires. The feasibility endpoint was procedural success, namely the successful RAO recanalization, the efficacy endpoint was patency of the artery at 30 days, and the safety endpoint was the absence of periprocedural vascular major complications or major adverse cardiac and cerebrovascular events. Results: The mean age of the patients was 63 ± 11 years, and 15 patients (50%) were men. Most patients had asymptomatic RAO (n = 28, 93.3%), and only two (6.6%) reported numbness in their hands. The most common indication for the procedure was PCI (19, 63.2%). Total procedural time was 41 ± 22 min, while the amount of contrast used was 140 ± 28 mL. Procedural success was 100% (n = 30). Moreover, there were no major vascular complications (0%); only two small hematomas were described (10%) and one had an angiographically visible perforation (3%). One case of periprocedural stroke was reported (3%), with onset immediately after the procedure and recovering 24 h later. Twenty-seven radial arteries (90%) remained patent at the one-month follow-up. Conclusions: RAO recanalization is feasible and safe, and by using dedicated hydrophilic guidewires, the success rate is high without significantly increasing procedural time or the amount of used contrast.

Introduction: Distal radial access (dRA) has recently gained global popularity as an alternative access route for vascular procedures. Among the benefits of dRA are the low risk of entry site bleeding complications, the low rate of radial artery occlusion, and improved patient and operator comfort. The aim of this large multicenter registry was to demonstrate the feasibility and safety of dRA in a wide variety of routine procedures in the catheterization laboratory, ranging from coronary angiography and percutaneous coronary intervention to peripheral procedures. Methods: The study comprised 1240 patients who underwent coronary angiography, PCI or noncoronary procedures through dRA in two Hungarian centers from January 2019 to April 2021. Baseline patient characteristics, number and duration of arterial punctures, procedural success rate, crossover rate, postoperative compression time, complications, hospitalization duration, and different learning curves were analyzed. Results: The average patient age was 66.4 years, with 66.8% of patients being male. The majority of patients (74.04%) underwent a coronary procedure, whereas 25.96% were involved in noncoronary interventions. dRA was successfully punctured in 97% of all patients, in all cases with ultrasound guidance. Access site crossover was performed in 2.58% of the patients, mainly via the contralateral dRA. After experiencing 150 cases, the dRA success rate plateaued at >96%. Our dedicated dRA step-by step protocol resulted in high open radial artery (RA) rates: distal and proximal RA pulses were palpable in 99.68% of all patients at hospital discharge. The rate of minor vascular complications was low (1.5%). A threshold of 50 cases was sufficient for already skilled radial operators to establish a reliable procedural method of dRA access. Conclusion: The implementation of distal radial artery access in the everyday routine of a catheterization laboratory for coronary and noncoronary interventions is feasible and safe with an acceptable learning curve.

Background Although not yet recommended by the guidelines, distal radial access, a new site for cardiovascular interventions, has been rapidly acknowledged and adopted by many centers due to its high rate of success, safety and fewer complications. We present our experience using secondary distal radial access during transcatheter aortic valve implantation (TAVI), proposing a new, even more minimal approach. Methods As of November 2020, a systematic distal radial approach as secondary access site for TAVI was adopted in our center. Primary endpoints were technical success and major adverse events (MAEs). Secondary endpoints: the access site complication rate, hemodynamic and clinical results of the intervention, procedural related factors, crossover rate to the femoral access site, and hospitalization duration (in days). Results From November 2020, 41 patients underwent TAVI using this strategy. Patients had a mean age of 76 ± 11.2 years, 41% were male. Six (14.63%) patients received a balloon-expandable valve and 35 (85.37%) received a self-expandable valve. TAVI was successful in all cases. No complications occurred due to transradial access. Puncture success, defined as completed sheath placement was maximum (N = 41/41,100%) and emergent transfemoral secondary access was not required in any case. Primary transfemoral vascular access site complications occurred in 7 cases (17%) of which 4 (13.63%) were resolved through distal radial access: one occlusion, two flow-limiting stenoses and four perforations of the common femoral artery. There were no additional major vascular complications at 30 days. Overall MACE rate was 2.4%. Conclusion The use of the distal radial approach for secondary access in TAVI is safe, feasible and has several advantages over old access sites.

The clinical benefit of bariatric surgery in patients with severe obesity and established coronary artery disease (CAD) is unclear. We aimed to compare the cardiovascular outcomes of severely obese CAD patients with and without bariatric surgery. Patients with a history of myocardial revascularization documented prior to bariatric surgery were identified from a dedicated database with prospectively collected outcomes. These patients were matched 1 to 1 with CAD patients who had prior revascularization but who did not undergo bariatric surgery. The primary outcomes were death (cardiac and non-cardiac) and major adverse cardio-cerebral events (MACCE), including death, myocardial infarction (MI), stroke, and repeat myocardial revascularization throughout follow-up. After propensity score matching, 116 bariatric patients were matched with 116 control patients. Ninety-eight had a history of coronary artery bypass surgery and 134 had a previous percutaneous coronary intervention. After a median follow-up of 8.9 (6.3–14.2) years, MACCE was significantly lower in the bariatric group (HR 0.65; 95% CI 0.42–1.00; P = 0.049) driven by a significant reduction in non-cardiac mortality (HR 0.49; 95% CI 0.23–1.00; P = 0.049). There was no significant difference in the rates of all-cause death (HR 0.58; 95% CI 0.33–1.01; P = 0.056), cardiovascular death (HR 0.77; 95% CI 0.31–1.85; P = 0.55), MI (HR 1.09; 95% CI 0.47–2.58; P = 0.85), stroke (HR 1.47; 95% CI 0.24–11.2; P = 0.67), and repeat myocardial revascularization (HR 0.56; 95% CI 0.27–1.13; P = 0.11). Although bariatric surgery in obese CAD patients may reduce the composite MACCE endpoint during long-term follow-up, this effect seems unrelated to cardiovascular outcomes.

Background/purpose Bariatric embolization of the left gastric artery (LGA) is being investigated as a technique to induce substantial weight loss in obese patients. Radial access is associated with less vascular complications than femoral access, especially in patients with severe obesity . We sought to assess the feasibility, safety and technical challenges of LGA angiography through radial access. Methods/materials Patients with suspected coronary artery disease (CAD) and obesity (BMI > 30 kg/m 2 ) referred for diagnostic catheterization and/or percutaneous coronary intervention (PCI) were eligible. After completion of diagnostic and/or PCI, selective cannulation of celiac artery was performed and images of the LGA were taken from multiple views. Detailed procedural parameters such as procedure time, contrast volume and radiation data as well as anatomical variations were assessed. Results Between February and December 2018, we successfully achieved 50 selective angiographies of celiac artery from 54 enrolled patients (92.6%) and LGA was optimally visualized in 47/50 (97%) of cases. Right radial access was used in 50 cases. Mean age was 63.9 ± 8.0 years and 74% were men. Median BMI was 34.4 kg/m2 [32.2–39.4]. The median procedural time was 7 [5–10] minutes, contrast volume was 41 ml [33–63], fluoroscopy time was 160 [103–248] seconds and radiation exposure was 3125 [1906–4735] Gy.cm 2 . No complications were noted. The mean difficulty of the procedure on a visual analogue scale was 4/10. Conclusions LGA angiography via transradial approach was feasible in the large majority of CAD patients with obesity . No safety issues were encountered.

There is little data regarding the risks and benefits of bariatric surgery in patients with coronary artery disease (CAD). We aimed to assess the short- and long-term cardiovascular outcomes of patients with CAD undergoing bariatric surgery. Patients with a history of CAD were identified from a dedicated database with prospectively collected outcomes, comprising all 6795 patients who underwent bariatric surgery between January 1992 and October 2017. Patients were matched with patients who did not have CAD before the bariatric surgery procedure. The primary endpoints were mortality (cardiac and noncardiac) and major adverse cardiocerebral events (MACCE), including all-cause death, myocardial infarction, stroke, and myocardial revascularization at 30 days after bariatric surgery and throughout follow-up. After propensity score matching, 249 patients with chronic CAD were matched with 249 patients without CAD. Throughout follow-up (7.4 years; interquartile range 4.1 to 11.5, maximum 22 years), mortality (mainly cardiac mortality) remained significantly higher in the CAD compared with the non-CAD group (18% vs 10%, hazard ratio [HR] 1.70, 95% confidence interval [CI]: 1.03 to 2.79, p = 0.037). At 30 days, MACCE rate was significantly higher in the CAD compared with the non-CAD group (3.6% vs 0.4%, p = 0.011), essentially driven by non-ST elevation myocardial infarctions. After 30 days, MACCE rates remained significantly higher in the CAD group (30% vs 14%, HR 2.18, 95% CI: 1.45-3.28, p = 0.0002). In conclusion, patients with severe obesity and CAD referred to bariatric surgery were at a higher risk of early and late MACCE compared with non-CAD severely obese patients. Further study is required to define how this cardiovascular risk compares with nonoperated patients.

Biodegradable stents show promise to revolutionize coronary artery disease treatment. Its successful implementation in the global market remains limited due to the constraints of current generation biodegradable materials. Cold gas dynamic spraying (CGDS) has been proposed as a manufacturing approach to fabricate a metallic biodegradable amalgamate for stent application. Iron and 316L stainless steel powders are combined in a 4:1 ratio to create a novel biomaterial through cold spray. Cold spray processing however, produces a coating in a work hardened state, with limited ductility, which is a critical mechanical property in stent design. To this end, the influence of annealing temperature on the mechanical and corrosion performances of the proposed Fe-316L amalgamate is investigated. It was found that annealing at 1300 °C yielded a complex material microstructure, with an ultimate tensile strength of approximately 280 MPa and ductility of 23%. The static corrosion rate determined at this annealing temperature was equal to 0.22 mg cm−2 day−1, with multiple corrosion species identified within the degradation layers. Precipitates were observed throughout the microstructure, which appeared to accelerate the overall corrosion behaviour. It was shown that cold-sprayed Fe-316L has significant potential to be implemented in a clinical setting. Statement of Significance Biodegradable stents have potential to significantly improve treatment of coronary artery disease by decreasing or potentially eliminating late-term complications, including stent fracture and in-stent restenosis. Current generation polymer biodegradable stents have led to poorer patient outcomes in comparison to drug-eluting stents, however, and it is evident that metallic biomaterials are required, which have increased strength. To this end, a novel iron and stainless steel 316L biomaterial is proposed, fabricated through cold-gas dynamic spraying. This study analyses the effect of annealing on the Fe-316L biomaterial through corrosion, mechanical, and microstructural investigations. The quantitative data presented in this work suggests that Fe-316L, in its annealed condition, has the mechanical and corrosion properties necessary for biodegradable stent application.

Highlights •RAO remains the most frequent post-procedural complication of transradial access, restricting the use of the same radial artery for future procedures, as a conduit for coronary artery bypass grafting or for arteriovenous fistula creation in patients requiring hemodialysis. •The real-world reported incidence of RAO remains high, with wide variability in the uptake of RAO prevention strategies. •The paper reviews the main recent advances in the field of RAO prevention and provides a series of expert recommendations to prevent RAO. •This consensus document is meant to provide guidance to increase the adoption of simple and effective methods to achieve an institutional rate of RAO

Background The aim of this randomized study was to compare the success and complication rates of different access sites for the treatment of superficial artery stenosis. Methods and Results A total of 180 consecutive patients were randomized in a prospective study to treat symptomatic superficial femoral artery stenosis via radial (RA), femoral (FA), or pedal artery (PA) access. Technical success was achieved in 96.7%, 100%, and 100% of the patients in the RA, FA, and PA groups, respectively (p=0.33). Secondary access sites were used in 30%, 3.3%, and 30% of the patients in the RA, FA, and PA access groups, respectively (p=0.0002). Recanalization for chronic total occlusion was performed in 34/36 (94.4%), 30/30 (100%), and 46/46 (100%) patients in the RA, FA, and PA groups, respectively (p=0.17). The X-ray dose was significantly lower in the PA group than that in the RA and FA access groups (63.1 vs 162 vs 153 Dyn, p=0.0004). The cumulative rates of access site complications in the RA, FA, and PA groups were 3.3% (0% major and 3.3% minor), 16.7% (3.3% major and 13.3% minor), and 3.3% (3.3% major and 0% minor) (p=0.0085), respectively. The cumulative incidence of MACEs at 6 months in the RA, FA, and PA groups was 5%, 6.7%, and 1.7%, respectively. The cumulative incidence of MALEs at 6 months in the RA, FA, and PA groups was 20%, 16.7%, and 9.2%, respectively (p=0.54). Conclusion Femoral artery intervention can be safely and effectively performed using radial, femoral, and pedal access, but radial and pedal access is associated with a lower access site complication rate and hospitalization. Pedal access is associated with a lower X-ray dose than that with radial and femoral access.

Dual-tasking is extremely prominent nowadays, despite ample evidence that it comes with a performance cost: the Dual-Task (DT) cost. Neuroimaging studies have established that tasks are more likely to interfere if they rely on common brain regions, but the precise neural origin of the DT cost has proven elusive so far, mostly because fMRI does not record neural activity directly and cannot reveal the key effect of timing, and how the spatio-temporal neural dynamics of the tasks coincide.Recently, DT electrophysiological studies in monkeys have recorded neural populations shared by the two tasks with millisecond precision to provide a much finer understanding of the origin of the DT cost. We used a similar approach in humans, with intracranial EEG, to assess the neural origin of the DT cost in a particularly challenging naturalistic paradigm which required accurate motor responses to frequent visual stimuli (task T1) and the retrieval of information from long-term memory (task T2), as when answering passengers’ questions while driving.We found that T2 elicited neuroelectric interferences in the gamma-band (>40 Hz), in key regions of the T1 network including the Multiple Demand Network. They reproduced the effect of disruptive electrocortical stimulations to create a situation of dynamical incompatibility, which might explain the DT cost. Yet, participants were able to flexibly adapt their strategy to minimize interference, and most surprisingly, reduce the reliance of T1 on key regions of the executive control network – the anterior insula and the dorsal anterior cingulate cortex – with no performance decrement.HIGHLIGHTS- First direct evidence in humans of neural interferences between two tasks.- First explanation of the Dual-Task cost at the neural level in humans.- First Dual-Tasking study with intracranial EEG in naturalistic conditions.

Background The COVID-19 pandemic creates new challenges for healthcare, including invasive cardiology. Case summary We discuss the case of a 65-year-old man who presented with non-ST segment elevation myocardial infarction combined with bilateral pneumonia. The patient had known severe iliac artery lesions with prior interventions and bilateral subclavian artery occlusions. After unsuccessful femoral artery access, the diagnostic angiography and the right coronary artery percutaneous coronary intervention were successfully performed from ultrasound-guided lower superficial temporal artery access. Discussion We showed that superficial temporal access can be used as an alternate access site for diagnostic coronary angiography and intervention when standard wrist and femoral access sites are not readily accessible.

Introduction The primary purpose of this multicenter prospective register was to evaluate the success and complication rate of different access sites for subclavian artery intervention. Secondary purpose was to investigate the safety of the distal radial artery access for subclavian artery intervention. Methods The clinical and angiographic data of 223 consecutive patients with symptomatic subclavian and anonym artery stenosis treated via transradial (TR), transbrachial (TB) and transfemoral (TF) access between 2015 and 2019 were evaluated in a multicenter registry. The exclusion criteria of the intervention was the acute proximal subclavian artery thrombosis. Primary endpoint: angiographic outcome of the subclavian and anonym artery intervention, rate of major and minor access site complications. Secondary endpoints: procedural complications, consumption of the angioplasty equipment, cross over rate to another puncture site and hospitalization in days. Results The procedure was successful in 182/184 in TR, in 5/5 in TB and in 32/32 patients in TF group. The cross over rate in the TR, TB and TF group was 0%. Chronic total occlusion recanalization was successful in 75/77 cases in TR, and 15/15 cases in the TF group. Contrast consumption was 152±106 ml in TR, 99±22.5 ml in TB and 152±95 in TF group, respectively (p=ns). Cummulativ dose was 602±1205 mGray in RA, 455±210 mGray in BA and 1089±1674 mGray in FA group (p Conclusions Subclavian artery intervention can be safely and effectively performed using radial access with acceptable morbidity and high technical success. Femoral and brachial access is associated with more access site complications than radial artery access. Distal radial access is associated with less radial artery occlusion than proximal radial artery access. Funding Acknowledgement Type of funding source: None

Bariatric embolization of the left gastric artery is a promising technique to induce weight loss in obese patients. We aimed to assess long-term effects.Patients with severe obesity were recruited to undergo left gastric artery embolization via transradial access. We report clinical outcomes and weight loss up to 2 years.We completed 7 procedures successfully in 7 men with severe obesity after diagnostic coronary angiography. Median weight was 160 kg (interquartile range, 140.0-180.0 kg) and body mass index was 49.4 kg/m² (interquartile range, 43.2-61.7 kg/m²). Acutely, no adverse events were reported other than mild epigastric pain, which subsided within 24 hours with proton pump inhibitors. No delayed gastrointestinal complications were reported up to 2 years after index procedure. One patient died of pulmonary embolism 18 months after the procedure. One patient underwent a second embolization procedure after it was shown that the left gastric artery was patent 18 months after the initial procedure. Compared with baseline in the 6 surviving patients, overall weight loss was 7.7% (range, 3.2%-14.1%).Bariatric embolization of the left gastric artery may induce weight loss, which appears sustained up to 2 years. Spontaneous recanalization of the left gastric artery may pave the way for repeat procedures and other interventions. Further research is necessary to define the benefits, safety, and indications for this technique.

To review the technical limitations of available pressure-wires, present the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man (FIM) ODespite increasing use of physiology assessment of coronary lesions, several technical limitations persist. We present technical details, design evolution and early clinical results with a novel 0.014" nitinol fiber-optic based pressure-wire.The 0.014' OptoWire™ (Opsens Medical, Quebec, Canada) was designed to combine improved handling properties compared to standard pressure-wires and to offer extremely reliable pressure recording and transmission due to fiber-optic properties compared to piezo-electric sensors and electrical wires. In vitro assessment showed that OptoWire™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First-in-Man OThe novel 0.014" fiber-optic OptoWire™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology assessment.

BACKGROUND: Inflammation is causally related to atherothrombosis. Treatment with canakinumab, a monoclonal antibody that inhibits inflammation by neutralizing interleukin-1β, resulted in a lower rate of cardiovascular events than placebo in a previous randomized trial. We sought to determine whether an alternative approach to inflammation inhibition with low-dose methotrexate might provide similar benefit. METHODS: We conducted a randomized, double-blind trial of low-dose methotrexate (at a target dose of 15 to 20 mg weekly) or matching placebo in 4786 patients with previous myocardial infarction or multivessel coronary disease who additionally had either type 2 diabetes or the metabolic syndrome. All participants received 1 mg of folate daily. The primary end point at the onset of the trial was a composite of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Near the conclusion of the trial, but before unblinding, hospitalization for unstable angina that led to urgent revascularization was added to the primary end point. RESULTS: The trial was stopped after a median follow-up of 2.3 years. Methotrexate did not result in lower interleukin-1β, interleukin-6, or C-reactive protein levels than placebo. The final primary end point occurred in 201 patients in the methotrexate group and in 207 in the placebo group (incidence rate, 4.13 vs. 4.31 per 100 person-years; hazard ratio, 0.96; 95% confidence interval [CI], 0.79 to 1.16). The original primary end point occurred in 170 patients in the methotrexate group and in 167 in the placebo group (incidence rate, 3.46 vs. 3.43 per 100 person-years; hazard ratio, 1.01; 95% CI, 0.82 to 1.25). Methotrexate was associated with elevations in liver-enzyme levels, reductions in leukocyte counts and hematocrit levels, and a higher incidence of non–basal-cell skin cancers than placebo. CONCLUSIONS: Among patients with stable atherosclerosis, low-dose methotrexate did not reduce levels of interleukin-1β, interleukin-6, or C-reactive protein and did not result in fewer cardiovascular events than placebo. (Funded by the National Heart, Lung, and Blood Institute; CIRT ClinicalTrials.gov number, NCT01594333.)

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial. info:eu-repo/semantics/publishedVersion

Objectives To gain insight into current practice of transradial angiography and intervention in the United States and around the world. Background Transradial access (TRA) has grown worldwide. In a prior survey, there was significant practice variation and there was minimal US participation which limited the generalizability to US operators. Methods We used an internet-based survey software program to solicit input from practicing interventional cardiologists from the United States and around the world. US operators were compared with outside the United States (OUS) operators and respondent-level comparisons were made with the prior survey to assess for temporal changes in practice. Results Between August 2016 and January 1, 2017, 125 interventional cardiologists completed the survey representing 91 countries with the United States having 449 (39.9%) respondents. Preprocedure, noninvasive testing for collateral circulation is used more commonly in the United States (54.1%) than around the world (26.6%) but its use has decreased since 2010. In the US, 48.8% of operators never use ultrasound and 92.6% of OUS operators never use it; only 4.4% overall use ultrasound in >50% of cases. Use of bivalirudin has decreased in the US and OUS. Nearly, 30% of operators do not assess for radial artery patency following hemostasis. US respondents used TRA less commonly for primary PCI for STEMI than their global counterparts. Conclusions There is wide variation in how TRA procedures are performed including relatively low rates of adherence to practices that are known to improve outcomes. Further education aimed at increasing use of best practices will impact patient outcomes.

Background\ud \ud We sought to systematically review the available literature on limb dysfunction after transradial or transfemoral cardiac catheterization.\ud \ud Methods & Results\ud MEDLINE and EMBASE were searched for studies evaluating any transradial or transfemoral procedures and limb function outcomes. Data was extracted, results were narratively synthesized with similar treatment arms. 15 studies with 3616 participants were included in transradial access (TRA) group. 3 studies reported nerve damage with a combined incidence of 0.16%, 4 studies reported sensory loss, tingling and numbness with a pooled incidence of 1.61%. Pain after TRA was the most common form of limb dysfunction (7.77%) reported in 3 studies. The incidence of hand dysfunction defined as disability, grip strength change, power loss or neuropathy was low at 0.49%. Although RAO was not a primary end point for this review, it was observed in 3.57% of the participants in a total of 8 studies included.4 studies with 15,903,894 participants were included in the transfemoral access (TFA) group. Rate of peripheral neuropathy was observed at 0.004%, sensory neuropathy due to local groin injury and retroperitoneal haematomas was 0.04% and 0.17% respectively, whereas motor deficit due to femoral and obturator nerve damage was 0.13%.\ud \ud Conclusions\ud Limb dysfunction post cardiac catheterization is rare, patients may have nonspecific sensory and motor complaints that resolve over a period of time.

BACKGROUND Whether polymeric bioresorbable vascular scaffolds (BVS) implantation with transradial approach is feasible and safe is unknown. We compared the feasibility and safety of the transradial approach for BVS delivery with metallic drug-eluting stents (DES). METHODS We identified 118 consecutive patients who underwent BVS implantation and we compared 30-days and 1-year results with 118 matched patients with DES. Patients were matched for age, sex, risk factors and clinical indication. RESULTS Rates of transradial approach were 98% in the BVS group vs 95% in the DES group (P = 0.16) with 5Fr used in 38% and 32% (P = 0.34), respectively. The number of stents was similar in both groups, 2.6 ± 1.5 vs 2.4 ± 1.3 (P = 0.23). Although maximal pressure for stent deployment was identical in both groups (16 ± 3 atm), more lesions were pre-dilated (83% vs 52%, P

AIMS To assess the benefit of routine preprocedural radial artery (RA) angiography in patients with ST segment elevation myocardial infarction (STEMI). METHODS AND RESULTS All consecutive STEMI patients, in the period from January 2010 until December 2016 were included in the study. Preprocedural radial artery angiography was performed in all patients since March 2011. We compared clinical and procedure characteristics, access site bleeding complications and failure of primary chosen TRA between two groups of STEMI patients before and after we started performing routine RA angiography. We compared 762 STEMI patients from 2010 until March 2011 and 4306 STEMI patients after March 2011 until December 2016. Mean age of patients was 60 ± 11 years with 73% males. The latter group had more elderly and obese patients (P

Objectives The aim of this study was to compare manual versus mechanical compression of the radial artery after coronary angiography via transradial access regarding radial artery occlusion (RAO), access-site bleeding complications, and duration of hemostasis. Background Hemostasis of the radial artery after sheath removal can be achieved either by manual compression at the puncture site or by using a mechanical hemostasis device. Because mechanical compression exerts a more stable, continuous pressure on the artery, it could be hypothesized that it is more effective compared with manual compression regarding hemostasis time, bleeding, and RAO risks. Methods A total of 589 patients undergoing diagnostic coronary angiography by transradial access with a 5-F sheath were randomized in a 1:1 ratio to receive either manual or mechanical patent hemostasis of the radial artery. Radial artery patency was evaluated by color duplex ultrasonography 24 h after the procedure. The primary endpoint was early RAO at 24 h. Secondary endpoints included access-site bleeding complications and duration of hemostasis. Results Thirty-six (12%) early RAOs occurred in the manual group, and 24 (8%) occurred in the mechanical group (p = 0.176). There were no significant differences between the 2 groups regarding access-site bleeding complications (hematoma, 52 [17%] vs. 50 [18%]; p = 0.749; bleedings, 8 [3%] vs. 9 [3%]; p = 1.000). Duration of hemostasis was significantly shorter in the manual group (22 ± 34 min vs. 119 ± 72 min with mechanical compression; p Conclusions Manual and mechanical compression resulted in similar rates of early RAO, although the total duration of hemostasis was significantly shorter in the manual group.

Objectives The authors sought to determine the relationships between left radial access (LRA) or right radial access (RRA) and clinical outcomes using the British Cardiovascular Intervention Society (BCIS) database. Background LRA has been shown to offer procedural advantages over RRA in percutaneous coronary intervention (PCI) although few data exist from a national perspective around its use and association with clinical outcomes. Methods The authors investigated the relationship between use of LRA or RRA and clinical outcomes of in-hospital or 30-day mortality, major adverse cardiovascular events (MACE), in-hospital stroke, and major bleeding complications in patients undergoing PCI between 2007 and 2014. Results Of 342,806 cases identified, 328,495 (96%) were RRA and 14,311 (4%) were LRA. Use of LRA increased from 3.2% to 4.6% from 2007 to 2014. In patients undergoing a repeat PCI procedure, the use of RRA dropped to 72% at the second procedure and was even lower in females (65%) and patients >75 years of age (70%). Use of LRA (compared with RRA) was not associated with significant differences in in-hospital mortality (odds ratio [OR]: 1.19, 95% confidence interval [CI]: 0.90 to 1.57; p = 0.20), 30-day mortality (OR: 1.17, 95% CI: 0.93 to 1.74; p = 0.16), MACE (OR: 1.06, 95% CI: 0.86 to 1.32; p = 0.56), or major bleeding (OR: 1.22, 95% CI: 0.87 to 1.77; p = 0.24). In propensity match analysis, LRA was associated with a significant decrease in in-hospital stroke (OR: 0.52, 95% CI: 0.37 to 0.82; p = 0.005). Conclusions In this large PCI database, use of LRA is limited compared with RRA but conveys no increased risk of adverse outcomes, but may be associated with a reduction in PCI-related stroke complications.

The aim of this study was to assess the applicability of fractional flow reserve measurement (FFR) in below-the-knee (BTK) arteries and to evaluate its correlation with non-invasive functional parameters before and after angioplasty.We enrolled 39 patients with severe BTK arterial lesions. Inclusion criteria were critical limb ischemia (Rutherford 4-6) and angiographically proven arterial stenosis of the distal lower limb (percent diameter stenosis ≥70%). Exclusion criteria were chronic total occlusion, diabetic foot syndrome and non-viable distal lower limb. The transstenotic distal/proximal pressure ratio was measured under resting (Pd/Pa) and hyperemic (FFR) conditions induced by 40mg intra-arterial Papaverin and was compared with quantitative angiography-, laser Doppler- and duplex ultrasound-derived measurements before and after percutaneous angioplasty (PTA).Comparing measurements before and after PTA, we found significant improvements in the resting Pd/Pa values (0.79 [0.67-0.90] vs 0.90 [0.85-0.97]; p0.001) and FFR values (0.60±0.19 vs 0.76±0.15; p0.001), respectively. At baseline, Pd/Pa ratio and FFR were significantly albeit weakly correlated with % area stenosis (r:-0.31, p=0.05 and r:-0.31, p=0.05, respectively). After PTA, neither Pd/Pa nor FFR remained correlated with % area stenosis. Similarly, prior PTA, Pd/Pa ratio and FFR were significantly correlated with TcO2% and perfusion unit change (r:0.48, p0.01 and r:0.34, p0.05, respectively), but after intervention, these significant correlations vanished. Pd/Pa and FFR values did not show correlation with duplex ultrasound-derived measurements. At 1year, major adverse events (MAEs) and major adverse cardiovascular and cerebrovascular (MACCEs) were observed in 7 (17.9%) and in 9 (23.1%) patients, respectively.CLI due to severe BTK arterial disease was associated with several impediments of baseline pressure measurements which were significantly improved after successful PTA and stenting. Significant relationships between pressure data and functional and imaging parameters existed prior intervention but vanished after. Further studies are required to determine the clinical value of pre- and post-PTA pressure measurements in BTK arterial disease.

Objectives To determine the role of warfarin (WF) prophylaxis in the prevention of left ventricular thrombus (LVT) formation and subsequent embolic complications following an anterior ST elevation myocardial infarction (STEMI) complicated by reduced left ventricular ejection fraction (LVEF) and wall motion abnormalities. Background The role of oral anticoagulation prophylaxis, in addition to dual antiplatelet therapy (DAPT), in the current era of percutaneous coronary intervention has not been well studied, despite being a class IIb recommendation in the AHA/ACC STEMI guidelines. Methods The Cochrane search strategy was used to search PubMed, Embase and the Cochrane library for relevant results. Four studies, two retrospective, one prospective registry, and a randomized feasibility control trial met criteria for inclusion. Data was pooled using a random effects model and reported as odds ratios (OR) with their 95% confidence intervals (CI). Primary outcomes of interest were rate of stroke, major bleeding and mortality. Results Pooled analysis included 526 patients in the No WF group and 347 patients in the WF group. No statistical difference in rate of stroke (OR: 2.72 [95% CI: 0.47–15.88; p =0.21]) or mortality (OR: 1.50 [95% CI 0.29–7.71; p =0.63]) was observed. Major bleeding was significantly higher in the WF group (OR: 2.56 [95% CI: 1.34–4.89; p =0.004]). Conclusions The routine use of DAPT and WF for prophylaxis against LVT formation following an anterior STEMI with associated decrease in LVEF and wall motion abnormalities, appears to result in no mortality benefit or reduction in stroke rates, but may increase the frequency of major bleeding.

Prediction of coronary events remains elusive. Carotid atherosclerosis may be a surrogate for coronary risk, as carotid and coronary diseases occur simultaneously — albeit at times with a weak association — depending on clinical presentation. We investigated carotid and coronary atherosclerosis in men with new-onset unstable coronary artery disease (CAD) presenting with acute ST-segment elevation myocardial infarction (STEMI) vs. long-standing severe chronic stable angina (CSA). Bilateral carotid artery and 3-vessel coronary artery atherosclerosis burdens were measured within 1 month, respectively, by 3D-volumetric carotid magnetic resonance imaging and coronary angiography-derived modified CASS-50 score. Men with STEMI (n = 50) and long-standing CSA (n = 50), matched for age, were enrolled (58.6 ± 8.8 years). All of them had carotid atherosclerosis. Atherosclerosis burden was greater in the carotid arteries of STEMI vs. CSA (wall volume: 196.2 ± 44.4 vs. 169.2 ± 38.0 mm3/4 mm, p = 0.002), but greater in the coronary arteries of CSA vs. STEMI (modified CASS-50 score: 3 vs. 1, p < 0.0001). Normalized wall index (NWI) of internal carotid was associated with modified CASS-50 score in STEMI (ρ = 0.40, p = 0.022) and in CSA (ρ = −0.39, p = 0.031). Carotid atherosclerosis was observed in all CAD patients, and atherosclerosis burden in carotid and in coronary arteries varied according to clinical presentation.

Background There has been an increasing use of transpedal arterial access (TPA) for evaluation and treatment of peripheral arterial disease (PAD) over a transfemoral approach (TFA). TPA, it is expected to be associated with better patient comfort, less recovery time and possibly less access site complications compared to standard TFA. Access site complications and pseudoaneurysm (PSA) associated with the TPA have not been previously reported. Objective Here we report a series of pedal artery PSA related to access site complicating TPA catheterization. Methods We studied 1460 patients with symptomatic PAD who underwent 2236 peripheral diagnostic and/or interventional procedures between 06/2014 and 01/2016 via TPA. Hemostasis was achieved using patent hemostasis technique by a radial artery compression device for 2 h. PSA related to the access site were suspected clinically and confirmed with arterial duplex ultrasound. Results The incidence of PSA related to any access site was 0.002%. In this series all PSA occurred only in the posterior tibial artery, after an interventional procedure. All patients were treated successfully with thrombin injection with no residual complications. Conclusions PSA associated with TPA is extremely rare and seems to occur exclusively after posterior tibial artery access. It is easily treatable by thrombin injection.