Outcomes and Comparative Analysis of the Initial Results of Standard Balloon Angioplasty Versus Drug-Coated Balloons Alone Versus in Association With Laser-Excimer Atherectomy in the Treatment of Femoropopliteal Artery In-Stent Restenosis (INTACT).

BACKGROUND: Despite improved patency with newer-generation nitinol stents, one-half of patients will require secondary interventions for in-stent restenosis (ISR). The best treatment strategy remains unclear. This study aimed to compare drug-coated balloons (DCBs) used alone or in association with excimer laser atherectomy (ELA) to simple percutaneous transluminal angioplasty (PTA) in the treatment of femoropopliteal-ISR. METHODS: The INTACT trial is a multicenter, prospective, triple-arm randomized trial conducted across 14 centers from December 2015 to November 2019. Patients Rutherford Class 2-5 with ISR≥70% were followed-up for 18 months. The primary efficacy endpoint was recurrent ISR>70% by duplex ultrasound analysis. The primary safety endpoint was major adverse events (MAEs) defined as death, major amputation, or target lesion revascularization (TLR). RESULTS: Around 134 subjects were randomized to PTA alone (n=41), PTA+DCB (n=43) or PTA+ELA+DCB (n=50). Procedural success was similar (p=.74), as was clinical success (p=.17). The number of recurrent ISR>70% decreased after PTA+ELA+DCB (30.0%; p=.04) and PTA+DCB (30.2%; p=.05) compared to PTA alone (51.2%). Primary patency was higher after PTA+ELA+DCB (log-rank p=.04) and PTA+DCB (log-rank p=.02) compared to PTA alone at 12 months (78.7% and 70.4% vs 61.5%) and 18 months (61.6% and 67.7% vs 37.3%). Freedom from MAEs was lower after PTA+DCB (27.9%) compared to PTA alone (53.7%; p=.02) but did not differ with PTA+ELA+DCB (40.0%). It was primarily driven by TLR; 2 major amputations occurred after PTA+ELA+DCB (4.0%; p=.18). CONCLUSION: This independent study demonstrated a decrease in recurrent ISR>70% and increase in primary patency up to 18 months after PTA+ELA+DCB and PTA+DCB compared to PTA alone in the treatment of FP-ISR. It did not show an increase in MAEs but could have lacked power. CLINICAL IMPACT: This multicenter, prospective, triple-arm randomized, controlled trial focuses on the results of adjunctive therapies, such as excimer laser atherectomy (ELA) and/or drug-coated balloons (DCBs) in the treatment of in-stent restenosis (ISR) in femoropopliteal lesions in 134 patients. It has the originality of being an independent study funded by a grant from the French Ministry of Health. This study confirms a significant decrease in recurrent ISR >70% and increase in primary patency up to 18 months after the use of ELA+DCB and DCBs compared to simple percutaneous transluminal angioplasty in the treatment of femoropopliteal ISR without an increase in major adverse events.

Eco-friendly hospital architecture.

Following a reminder on the quantities of carbon emitted in the healthcare sector, and casting a spotlight on those directly related to architecture, the authors of this article will develop three large-scale themes, the objective being to render hospital construction sustainable. 1. Energy consumption and how to reduce it. 2. "Low-carbon" construction and how building designers can limit emissions by the choice of construction materials. 3. The "resilience" of some constructions, their capacity to stave off obsolescence. As a conclusion, the authors present one of the most recent projects of the Brunet Saunier & Associates architecture agency: the Saint-Ouen university hospital, Grand Paris Nord. This project is illustrative of these preoccupations and demonstrates the possibility of meeting the challenges of sustainable development by means of simple and durable architecture.

Head-to-Head Comparison of 2 Paclitaxel-Coated Balloons for Femoropopliteal Lesions.

BACKGROUND: There is a scarcity of published head-to-head comparisons between different paclitaxel-coated angioplasty balloons. More prospective safety data to support the health care economic reimbursement processes are needed. OBJECTIVES: The aim of this study was to report the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) (Biotronik AG) for the treatment of symptomatic peripheral artery disease caused by stenosis, restenosis, or occlusion of the femoral and/or popliteal arteries. METHODS: A total of 302 patients were randomized 1:1 and assigned to the Passeo-18 Lux DCB (study device) group or the IN.PACT Admiral DCB (control device, Medtronic Vascular) group for testing of noninferiority. The primary efficacy endpoint was freedom from clinically driven target lesion revascularization at 12 months. The primary safety endpoint was a composite of freedom from device-/procedure-related death through 30 days postindex procedure, major target limb amputation, and clinically driven target vessel revascularization at 12 months. RESULTS: At 12 months, 130 of 134 patients in the IN.PACT Admiral group had freedom from clinically driven target lesion revascularization (97.0%) compared with 137 of 141 patients in the Passeo-18 Lux group (97.2%). The primary safety endpoint showed 96.3% in the control group vs 95.7% in the study device group. The null hypothesis of inferiority on both efficacy and safety was rejected. The Kaplan-Meier estimate of primary patency at 1 year was 88.7% in the control arm vs 91.5% in the study device arm. CONCLUSIONS: The Passeo-18 Lux and the IN.PACT Admiral DCBs demonstrate comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions.

Prevalence of transthyretin amyloidosis in patients undergoing carpal tunnel surgery: a prospective cohort study and risk factor analysis.

Transthyretin amyloidosis is a frequent cause of heart failure, resulting from an accumulation of abnormal proteins in the myocardium. Recent research has highlighted the importance of early diagnosis to enhance the effectiveness of specific treatments. Extra-cardiac symptoms may precede several years before cardiac complications, with carpal tunnel syndrome often considered a red flag. The aim of this prospective, observational cohort study was to determine the incidence rate of positive synovial biopsies for transthyretin amyloidosis in patients aged 60-80 years undergoing carpal tunnel decompression, and to identify risk factors. The diagnosis of transthyretin amyloidosis was confirmed through the analysis of synovial tissue biopsies using Congo Red and immunohistochemical staining. The study included 254 patients, with an 18.5% prevalence of transthyretin amyloidosis. Risk factors for positive test results were identified as male sex, trigger finger, hearing disorders and valve disease. A predictive analysis using logistic regression yielded a probability model for individuals belonging to the positive group.Level of evidence III.

Comparison of results of arthroscopic arthrolysis between traumatic and degenerative elbow stiffness.

INTRODUCTION: Elbow stiffness significantly affects the patient's quality of life. This joint must have at least 30°/130° extension/flexion and 50°/50° pronation/supination to function normally according to Morrey. HYPOTHESIS: The objective of this study was to evaluate functional outcome of arthroscopic arthrolysis by comparing stiffness of post-traumatic and degenerative origin. The hypothesis was that this surgical technique allows functional improvement in any indication but with a faster result in degenerative pathology. MATERIAL AND METHODS: This was a retrospective study including all patients who underwent elbow arthrolysis under arthroscopy, operated on by a single operator, between 2013 and 2020. Thirty-four patients were included, with a mean age of 45years (range, 18-78years). Patients were divided into two groups according to etiology. Group A (post-traumatic) consisted of 18 patients with a mean age of 33years (range, 18-64years) and group B (degenerative) of 16 patients with a mean age of 59years (range, 42-78years). All patients were clinically assessed at a mean 27months. Range of motion, level of satisfaction and Mayo Elbow Performance Score (MEPS) were collected. RESULTS: In the overall series, preoperative range of motion was 81° and significantly improved postoperatively to 122° (p<0.001). The preoperative data of the 2 groups were comparable except for age (p<0.001) and MEPS (p=0.044). Postoperatively, range of motion improved significantly in both groups but with greater gain in group A (p=0.003). MEPS improved significantly in both groups, but the postoperative score was poorer in group B (p=0.001). Recovery of range of motion was faster in group B (2.4months) than in group A (3.7months) (p=0.021). There were 5 complications: 4 secondary decompensations of ulnar tunnel syndrome, and 1 postoperative radial nerve paresis. 94% of patients were satisfied or very satisfied with the result of surgery. CONCLUSION: Arthroscopic arthrolysis is an effective option for post-traumatic and non-traumatic elbow stiffness. Improvement was significant in terms of both function and range of motion, with, however, better results in the post-traumatic group but results achieved more rapidly in the degenerative pathology group. LEVEL OF EVIDENCE: IV, retrospective study.

Acute pain after digital crushing and nicotine intoxication. Cigarettes are always a false friend. A prospective study.

BACKGROUND: Nicotine addiction is a public health problem. Our hypothesis was that the degree of nicotine dependence is positively correlated with the perceived intensity of acute pain. MATERIALS AND METHODS: A single-center prospective comparative observational study was conducted from 2019 to 2021. Patients included presented distal phalanx extra-articular trauma of less than 24hours' progression. We compared a group of smokers with a group of non-smokers. A Digital Pain Scale (DPS) was assessed at time of trauma, at first consultation, and once a day until the fifth day post-trauma. A Fagerström test was performed. The primary endpoints were the correlation between dependence and DPS and the correlation between the amount of tobacco consumed and DPS. The secondary endpoints were analgesic consumption according to Fagerström, DPS and tobacco consumption. RESULTS: Sixty-seven patients were included: 26 smokers, 41 non-smokers. No significant correlation was found between dependence level or amount of tobacco used and DPS. Consumption of level II analgesics was significantly 2-fold higher in the smoking group on the second, third and fifth day: respectively, 2.15 tablets versus 1.22 (p=0.02), 1.27 versus 0.49 (p=0.01), and 0.69 versus 0.20 (p=0.04). CONCLUSION: Patients who smoke are exposed to more frequent and more intense pain and consume more palliative painkillers. LEVEL OF EVIDENCE: IIB; exposed vs. non-exposed cohort.

[Contribution of intracoronary imaging in CTO PCI]. / Apport de l'imagerie endocoronaire dans l'angioplastie des occlusions chroniques.

The interest in revascularization of chronic total occlusions (CTO) of the coronary arteries during the last decade has not waned. It is one of the latest challenges for percutaneous coronary interventions (PCI), requiring a specific organization of the patient pathway, dedicated equipment, and targeted medical expertise, now establishing CTO as a new discipline in interventional cardiology. Despite technical progress, the success rate of CTO-PCI is still lower than that of non-CTO-PCI, mainly due to guidewire failure. What can be the place of IVUS in CTO recanalization? IVUS offers a real-time cross-sectional image of the lumen and the vessel wall and meets all the criteria for assisting guidewire crossing. In addition, and as in any angioplasty of long and calcified complex lesions, IVUS participates in an optimal sizing of the stent and ensures its proper expansion. Optical coherence tomography (OCT) has no place, for multiple reasons, in the management of a CTO procedure but can help on remote control to ensure an optimal result, to validate the interest of a technique. Endocoronary imaging in CTO as in other complex situations is likely to optimize procedural results, to validate strategic options with the ultimate goal of improving clinical results.

Methodology of the BIOPACT RCT, a Multi-center, Randomized, Non-inferiority Trial Evaluating Safety and Efficacy of Passeo-18 Lux Drug-Coated Balloon (DCB) of Biotronik Compared to the Medtronic IN.PACT Admiral DCB in the Treatment of Subjects with Lesions of the Femoropopliteal Artery.

PURPOSE: Although effectiveness and safety of many different paclitaxel coated balloons in the treatment of peripheral arterial disease (PAD) are extensively studied, there is a lack of direct head-to-head comparison studies. To meet this need and to avoid potential "class-effects", the BIOPACT was set up. The purpose is to demonstrate the safety and efficacy of the Passeo-18 Lux DCB (Biotronik) for treatment of patients with symptomatic PAD due to femoropopliteal lesions. METHODS: 302 patients are randomized in a 1:1 manner to treatment with either the Passeo-18 Lux DCB or the IN.PACT Admiral DCB (Medtronic) for testing of a formal non-inferiority hypothesis. The participants will be followed for 5 years. The primary efficacy endpoint is freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months, defined as any re-intervention at the target lesion due to symptoms, drop of ankle brachial index (ABI) > 20% or > 0.15 compared to post-procedural ABI. Primary safety endpoint is a composite of freedom from device/procedure-related death through 30 days post-index procedure, freedom from major target limb amputation and clinically-driven target vessel revascularization (CD-TVR) through 12 months post-index procedure. Secondary endpoints can be found at clinicaltrials.gov, ID NCT03884257. DISCUSSION: As full enrolment was reached by the beginning of September, the investigators expect complete analysis of the primary endpoints by the end of 2022; Meanwhile preliminary results will be disclosed during 2022. As in terms of randomized head-to-head efficacy and safety analysis, this study on paclitaxel coated balloons may provide additional information to clinicians and healthcare providers. Trial registration ClinicalTrials.gov ID: NCT03884257 LEVEL OF EVIDENCE: Level 2, Randomized trial.

Phthalocyanines and Porphyrins/Polyaniline Composites (PANI/CuPctBu and PANI/TPPH2) as Sensing Materials for Ammonia Detection.

We combined a conducting polymer, polyaniline (PANI), with an organic semiconducting macrocyclic (MCs) material. The macrocycles are the phthalocyanines and porphyrins used to tune the electrical properties of the PANI, which benefits from their ability to enhance sensor response. For this, we proceeded by a simple ultrasonically assisted reaction involving the two components, i.e., the PANI matrix and the MCs, to achieve the synthesis of the composite nanostructure PANI/MCs. The composite nanostructure has been characterized and deposited on interdigitated electrodes (IDEs) to construct resistive sensor devices. The isolated nanostructured composites present good electrical properties dominated by PANI electronic conductivity, and the characterization reveals that both components are present in the nanostructure. The experimental results obtained under gas exposures show that the composite nanostructures can be used as a sensing material with enhanced sensing properties. The sensing performance under different conditions, such as ambient humidity, and the sensor's operating temperature are also investigated. Sensing behavior in deficient humidity levels and their response at different temperatures revealed unusual behaviors that help to understand the sensing mechanism. Gas sensors based on PANI/MCs demonstrate significant stability over time, but this stability is highly reduced after experiments in lower humidity conditions and at high temperatures.

Effect of roughness on surface plasmons propagation along deep and shallow metallic diffraction gratings.

The roughness of shallow or deep metallic diffraction gratings modifies the propagation of surface plasmon mode along the metallic-air interface. The scattering losses lead to a spectral or angular broadening of the surface plasmon resonance (SPR) and to a shift of the resonance wavelength and coupling angle. This mechanism is deeply analyzed both experimentally and theoretically to overcome these effects when such structures, in particular deep ones, are used as SPR-based sensors.

Nanomaterials for the Selective Detection of Hydrogen Sulfide in Air.

This paper presents a focused review on the nanomaterials and associated transduction schemes that have been developed for the selective detection of hydrogen sulfide. It presents a quite comprehensive overview of the latest developments, briefly discusses the hydrogen sulfide detection mechanisms, identifying the reasons for the selectivity (or lack of) observed experimentally. It critically reviews performance, shortcomings, and identifies missing or overlooked important aspects. It identifies the most mature/promising materials and approaches for achieving inexpensive hydrogen sulfide sensors that could be employed in widespread, miniaturized, and inexpensive detectors and, suggests what research should be undertaken for ensuring that requirements are met.

Electrochemical Sensors Based on Screen-Printed Electrodes: The Use of Phthalocyanine Derivatives for Application in VFA Detection.

Here, we report on the use of electrochemical methods for the detection of volatiles fatty acids (VFAs), namely acetic acid. We used tetra-tert-butyl phthalocyanine (PcH2-tBu) as the sensing material and investigated its electroanalytical properties by means of cyclic voltammetry (CV) and square wave voltammetry (SWV). To realize the electrochemical sensing system, the PcH2-tBu has been dropcast-deposited on carbon (C) orgold (Au)screen-printed electrodes (SPEs) and characterized by cyclic voltammetry and scanning electron microscopy (SEM). The SEM analysis reveals that the PcH2-tBu forms mainly aggregates on the SPEs. The modified electrodes are used for the detection of acetic acid and present a linear current increase when the acetic acid concentration increases. The Cmodified electrode presents a limit of detection (LOD) of 25.77 mM in the range of 100 mM-400 mM, while the Aumodified electrode presents an LOD averaging 40.89 mM in the range of 50 mM-300 mM. When the experiment is realized in a buffered condition, theCmodified electrode presents a lower LOD, which averagesthe 7.76 mM. A pronounced signal decay attributed to an electrode alteration is observed in the case of the gold electrode. This electrode alteration severely affects the coating stability. This alteration is less perceptible in the case of the carbon electrode.

Percutaneous management of lower limb ischemia after the use of vascular closure devices.

BACKGROUND: Lower extremity ischemia after the use of vascular closure devices (VCDs) after transfemoral percutaneous coronary and peripheral interventions is an infrequent though relevant clinical entity. We aimed to assess immediate and midterm outcomes of a systematic endovascular approach for the treatment of VCD-related lower limb ischemia. METHODS: Between 2006 and 2008, all the patients who developed lower limb ischemia after the use of a VCD in a high volume French institution were systematically managed percutaneously and constituted the study population. Clinical characteristics, immediate, and midterm outcomes are reported. RESULTS: Of 2944 consecutive patients undergoing VCD placement after femoral access, 18 (3 men and 15 women) had VCD-related lower limb ischemia and were all managed percutaneously. Median age was 66.5 years. Devices were Angio-Seal (St Jude Medical) in 12 cases, StarClose (Abbott Vascular Devices) in 3 cases, and Perclose (Abbott Vascular Devices) in 3 cases. Limb ischemia occurred with a median delay of 2 days after device placement. Index procedures were coronary interventions in 14 cases and peripheral in 4 cases. The occlusion site was successfully crossed in all cases. Twelve patients were treated with balloon angioplasty and 6 with stent implantation. Angiographic success was obtained in all cases. After a median 32-month follow-up, only 2 patients initially treated using percutaneous transluminal angioplasty needed reintervention consisting of a balloon angioplasty in 1 case and stent implantation in the second case. At final follow-up, all the patients were asymptomatic. CONCLUSIONS: Endovascular treatment for VCD-related limb ischemia is a feasible and effective approach resulting in excellent immediate and midterm outcomes.

Indigo molecules adsorbed on carbonaceous nanomaterials as chemical filter for the selective detection of NO2 in the environment.

In order to enhance the durability of chemical filters for ozone molecules, devoted to microsystem for the selective detection of NO2 in the environment, the adsorption of indigo molecules onto the surface of carbonaceous nanomaterials (multi-walled carbon nanotubes, a mixture of nanodisks/nanocones, nanofibres) was investigated. The surface of the multi-walled carbon nanotubes was coated by π-stacking with adsorbed indigo molecules. An excess of indigo has resulted in a biphasic sample where nanotubes covered with indigo coexist with free indigo particles. Although similar filtering yields toward O3 (close to 100%) and NO2 (around 0%) were obtained as compared to individual materials, the indigo/MWCNTs samples exhibit enhanced durability as chemical filter at high ozone concentration (1 ppm).

EuroSCORE is a good global predictor of long-term outcomes in high-risk but not in low-risk patients after unprotected left main angioplasty.

BACKGROUND: Percutaneous coronary intervention is increasingly emerging as a valuable alternative to surgery for the treatment of patients with unprotected left main coronary artery (ULMCA) disease. In this study, we aimed to assess the ability of the EuroSCORE risk stratification model to predict long-term major adverse cardiac events after unprotected left main angioplasty according to the individual level of risk. METHODS: Two hundred forty-six consecutive patients who underwent ULMCA in a single high volume center over a 5-year period were included. Major adverse cardiac events were defined as a combined end point of cardiac death, nonfatal myocardial infarction, or target lesion revascularization. RESULTS: Areas under the receiver-operating characteristic curve of EuroSCORE in the entire cohort were 0.687 (P = 0.005; 95% CI: 0.575-0.846) and 0.589 (P = 0.038; 95% CI: 0.511-0.673) respectively for cardiac death and major adverse cardiac events (MACE). One hundred twenty-four patients had a EuroSCORE value > 6 and constituted the high surgical risk (HSR) group. Actuarial 4-year survivals free from cardiac death and free from MACE were significantly lower in this group respectively at 84% versus 93% (log rank P = 0.02) and 50% versus 74% (log rank P = 0.004). EuroSCORE was the only independent predictor of long-term cardiac mortality by the Cox analysis (HR = 3.95, P = 0.027, 95% CI: 1.16-13.39). It had a good discriminatory power for predicting both cardiac death and MACE with AUC respectively at was 0.705 (P = 0.01, 95% CI: 0.55-0.86) and 0.65 (P = 0.013, 95% CI: 0.54-0.78) in the HSR cohort but not in the lower risk (EuroSCORE ≤ 6) cohort. CONCLUSION: EuroSCORE is a good predictor not only of cardiac death but also of MACE after ULMCA angioplasty; however, the discriminatory ability of EuroSCORE appears to be limited to patients with high surgical risk as defined by EuroSCORE values > 6.

The use of nanocarbons as chemical filters for the selective detection of nitrogen dioxide and ozone.

The gas filtering abilities of different nanocarbon materials such as nanocones/nanodiscs, and nanofibres, either as-prepared or modified by physical (annealing, grinding) or chemical (fluorination) treatment are reported. The aptitude to filter nitrogen dioxide and ozone, two of the most significant gaseous pollutants of the atmosphere, have been correlated to both the BET specific surface area studied by N2 adsorption at 77 K, and the presence of chemical functional groups at the surface. Valuable information regarding the mechanisms of gas-nanocarbon interaction has been obtained, in terms of chemisorption and physisorption. A prototype microsystem is proposed for the selective measurement of nitrogen dioxide and ozone concentration by means of organic semiconductor gas sensors.

Unprotected left main angioplasty in nonagenarians: clinical characteristics, procedural features and outcome: a case series study.

UNLABELLED: Limited information is available on clinical characteristics and outcomes in very old patients with unprotected left main coronary artery disease (ULMCA) undergoing percutaneous coronary intervention (PCI). METHODS: From January 2004 and December 2008, 248 patients with ULMCA stenosis underwent coronary revascularization with stent implantation. Among those, 6 were older than 90 years at the time of the procedure and were included in this study. RESULTS: There were 5 males and 1 female; mean age was 91.5 years (range 91-93). All the patients presented with acute coronary syndromes. All of them had multivessel disease with a distal left main stenosis in 4 patients. All were deemed inoperable, with a mean EuroSCORE of 12.66 (range 10-20) and a predicted mortality at 34% (range15.8-86.6%). 5 patients received bare-metal stents and 1 patient a paclitaxel-eluting stent. Rotational atherectomy was required in 2 patients. Provisional side branch T-stenting with final kissing balloons was the technique used in all bifurcation lesions. Angiographic success was obtained in all patients. There were no in-hospital deaths or complications. After a 29.8-month (range 8-59) mean follow up period, a myocardial infarction caused by late stent thrombosis occurred in 1 patient and ischemia-driven target vessel revisualization was required in another; however, all patients were alive. CONCLUSION: In the very elderly patients at excessively high risk for surgery, PCI for ULMCA disease is a suitable alternative with excellent short-term results and acceptable long-term outcomes.

Molecular semiconductor-doped insulator (MSDI) heterojunctions: an alternative transducer for gas chemosensing.

New organic devices including a heterojunction between a semiconducting molecular material (MS)--lutetium bisphthalocyanine (LuPc2)--and a doped insulator (DI)--copper phthalocyanine (Cu(F(n)Pc), where n = 0, 8, 16)--are designed and studied as transducers for redox-active species sensing.