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To review the presentation and long-term oncologic outcomes of patients with regressed ("burnt out") primary testicular germ cell tumors (GCT). Certain testicular GCT can present with complete regression of the primary tumor. It is not well established if this is associated with more aggressive disease or worse oncologic outcomes. We queried our prospectively maintained testicular cancer clinical database at a tertiary cancer center and identified patients without prior chemotherapy who had regressed primary GCT at radical orchiectomy from 1990 to 2023. All specimens were reviewed by a genitourinary pathologist at diagnosis. Long-term clinical outcomes were reported by Kaplan-Meier method. Fifty-six patients met inclusion criteria; at diagnosis, 17 had no evidence of extra-testicular disease and 39 had advanced (clinical stage [CS] II+) GCT. All CSx (no viable disease or germ cell neoplasia in situ at orchiectomy, and no evidence of advanced disease) and CS0 patients were managed with surveillance and had 5-year recurrence-free survival (RFS) of 88% (95% CI: 39%, 98%). All patients with CS II+ disease underwent primary treatment with surgery (n = 5) or first-line chemotherapy (n = 34). Two- and 5-year RFS for patients with CSII+ disease was 94% (95% CI: 78%, 98%) and 90% (95% CI: 72%, 97%), respectively. Patients with regressed primary testicular GCT often present with advanced disease, possibly due to lack of early clinical signs from the primary tumor. Our analysis shows excellent long-term oncologic outcomes similar to those reported in the literature for patients with viable primary testicular GCT. [ABSTRACT FROM AUTHOR]

In this paper, design strategies for improving electrical efficiency, thermal design and fuel utilization of an ammonia-fed SOFC are investigated. Three strategies are presented to improve system performances: (i) the introduction of an additional stack to distribute the power i.e. power rating, (ii) the evaluation of the anode off gasses recirculation and (iii) the use of the off gasses to operate a cascade stack (re-powering), where the anode flue gas is recuperated. A system design that integrates these new features is modelled with zero-dimension thermodynamic equations. The three strategies were evaluated for net system efficiency and the heat exchanger area as main design parameters. The power rating allows to reduce the heat exchanger surface while the recirculation and repowering are suitable to increase system efficiency. With an integration of the three solutions, it is possible to achieve an increase in net efficiency from 52.1% to 66% and a reduction in heat exchanger surface area of 67% compared to the reference design that does not consider any of the proposed design strategies. • Efficiency can be improved using multiple stacks and by recycling the anode gases. • Heat exchanger area can be reduced by introducing additional stacks to the system. • Afterburner can be avoided by optimizing the air flow management. [ABSTRACT FROM AUTHOR]

• Patients without retroperitoneal disease at pRPLND have excellent long-term outcomes. • Recurrences occur early in the lungs, likely due to pre-existing distant disease. • Reduced surveillance is possible for patients without disease at pRPLND. • More sensitive diagnostics are needed to reduce rates of negative pRPLND. Patients who undergo primary retroperitoneal lymph node dissection (pRPLND) for early-stage testicular cancer and have no cancer (pN0) found in the retroperitoneum are believed to have an excellent prognosis. However, some experience relapse, potentially due to limitations of current staging methods. We aim to describe long-term outcomes and relapse patterns among a contemporary cohort of patients found to be pN0 at pRPLND to identify opportunities for improved diagnostic approaches and optimal patient selection. We reviewed our prospectively maintained database for patients who underwent pRPLND for nonseminomatous germ cell tumors at our tertiary cancer center during the period from January 1, 2000, through September 30, 2023 (n = 628). We excluded 282 patients with node-positive pathology for a final analytic cohort of 346 patients. Our primary outcome was recurrence-free survival (RFS). Secondary outcomes included timing and location of recurrence. Of 346 included patients with pN0 pathology, 23 experienced relapse with a 2-year RFS rate of 93% (95% confidence interval: 90, 96). Most recurrences (70%) occurred in the lungs and within 6 months of pRPLND. Serum tumor markers were positive in 43% of patients at the time of relapse. All patients who relapsed were treated with salvage chemotherapy; 6 patients required additional surgical procedures. There was no testis cancer–related deaths. Two-year RFS for patients with pN0 pRPLND pathology is excellent. All recurrences were outside of the retroperitoneum, suggesting subclinical distant metastases at time of surgery and the benefits of a bilateral template dissection. Improved diagnostics may help better identify patients with disease within or outside of the retroperitoneum prior to pRPLND, helping guide treatment decisions. We describe the incidence and patterns of relapse for men with pN0 primary RPLND pathology treated for testicular germ cell tumor. 2-year RFS was 7%. Most recurrences occured in the lungs and within 6 months of pRPLND [ABSTRACT FROM AUTHOR]

• The impacts of CO 2 capture methods on Denmark's future energy sector have been assessed. • The capacity of RES must be increased to meet the demands of CO 2 capture processes. • Choosing cryogenic method results in a 45% reduction in annual investment costs. • Using cryogenic method with energy storage cuts variable costs in energy sector by 2.5%. Utilizing CO 2 capture technologies is an essential part of achieving a future carbon-neutral Society. So far, amine-based technologies, which are the most mature post-combustion CO 2 capture technologies, have been predominantly applied in large-scale CO 2 capture applications. However, the cryogenic process has also been proven to be a potential CO 2 capture technology suitable for large-scale applications. Cryogenic carbon capture offers two potential advantages over amine-based technology. First, the efficiency is higher and thus the energy penalty is lower. Next, the flexibility of system integration is also higher, and thus the technology carries the potential of better balancing variable renewable electricity productions. By using the software tool EnergyPLAN and dedicated scenarios of achieving a carbon-neutral Denmark, this paper quantitatively estimates these benefits. It is observed that, from a system perspective, utilizing cryogenic technologies to capture 90 % of CO 2 emissions in 2045 can reduce the demand for wind power by approximately 47 %, leading to a decrease in annual system costs by nearly 45 %. [ABSTRACT FROM AUTHOR]

Purpose: Epilepsy is a main manifestation in the autosomal dominant mental retardation syndrome caused by heterozygous variants in MEF2C. We aimed to delineate the electro-clinical features and refine the genotype-phenotype correlations in patients with MEF2C haploinsufficiency.Methods: We thoroughly investigated 25 patients with genetically confirmed MEF2C-syndrome across 12 different European Genetics and Epilepsy Centers, focusing on the epileptic phenotype. Clinical features (seizure types, onset, evolution, and response to therapy), EEG recordings during waking/sleep, and neuroimaging findings were analyzed. We also performed a detailed literature review using the terms "MEF2C", "seizures", and "epilepsy".Results: Epilepsy was diagnosed in 19 out of 25 (~80%) subjects, with age at onset <30 months. Ten individuals (40%) presented with febrile seizures and myoclonic seizures occurred in ~50% of patients. Epileptiform abnormalities were observed in 20/25 patients (80%) and hypoplasia/partial agenesis of the corpus callosum was detected in 12/25 patients (~50%). Nine patients harbored a 5q14.3 deletion encompassing MEF2C and at least one other gene. In 7 out of 10 patients with myoclonic seizures, MIR9-2 and LINC00461 were also deleted, whereas ADGRV1 was involved in 3/4 patients with spasms.Conclusion: The epileptic phenotype of MEF2C-syndrome is variable. Febrile and myoclonic seizures are the most frequent, usually associated with a slowing of the background activity and irregular diffuse discharges of frontally dominant, symmetric or asymmetric, slow theta waves with interposed spike-and-waves complexes. The haploinsufficiency of ADGRV1, MIR9-2, and LINC00461 likely contributes to myoclonic seizures and spasms in patients with MEF2C syndrome. [ABSTRACT FROM AUTHOR]

Partial breast irradiation for the treatment of early-stage breast cancer patients can be performed by means of Intra Operative electron Radiation Therapy (IOeRT). One of the main limitations of this technique is the absence of a treatment planning system (TPS) that could greatly help in ensuring a proper coverage of the target volume during irradiation. An IOeRT TPS has been developed using a fast Monte Carlo (MC) and an ultrasound imaging system to provide the best irradiation strategy (electron beam energy, applicator position and bevel angle) and to facilitate the optimisation of dose prescription and delivery to the target volume while maximising the organs at risk sparing. The study has been performed in silico, exploiting MC simulations of a breast cancer treatment. Ultrasound-based input has been used to compute the absorbed dose maps in different irradiation strategies and a quantitative comparison between the different options was carried out using Dose Volume Histograms. The system was capable of exploring different beam energies and applicator positions in few minutes, identifying the best strategy with an overall computation time that was found to be completely compatible with clinical implementation. The systematic uncertainty related to tissue deformation during treatment delivery with respect to imaging acquisition was taken into account. The potential and feasibility of a GPU based full MC TPS implementation of IOeRT breast cancer treatments has been demonstrated in-silico. This long awaited tool will greatly improve the treatment safety and efficacy, overcoming the limits identified within the clinical trials carried out so far. • A fast GPU based MC has been developed for IOeRT breast treatment planning. • The input is an ultrasound image with defined PTV and OARs. • Different applicator positions, dimensions and angles and beam energies are tested. • Plan is optimised using absorbed dose maps and related DVHs. • Results in the context of conventional and FLASH irradiations are discussed. [ABSTRACT FROM AUTHOR]

• Identification of apparent kinetics for industrial processes. • Application of innovative procedures for safety evaluations for chemical reactors. • Integration of techno-economic aspects with safety and environmental factors. • Comparison of possible configurations for a scale-up of chemical processes. The design of chemical reactors has been largely considered primarily related to techno-economic evaluations. However, the recent need for sustainable solutions and processes has promoted the inclusion of environmental and safety parameters to identify the most suitable solution. In this sense, an innovative procedure has been developed in this work to identify and design a reactive section in chemical processes. To this aim, different key performance indicators have been defined and quantified for each domain considered within the analysis, namely technological, economic, environmental, and safety domains. In addition, the safety aspects have been quantified by integrating Semenov's theory and Varma, Morbidelli and Wu's theory. The validity and potentiality of the proposed procedure have been tested and shown by applying it to a case study representative for the scale-up of pharmaceutical processes: the industrial synthesis of a Vitamin A intermediate. A preliminary design has been performed for different configurations based on apparent kinetics determined from experimental data and ab initio coefficients available in the current literature. Among the analysed solutions, a single reactor with a volume of 15.90 m3 has been indicated as the most suitable for the process requirements regarding overall sustainability. Hence, the developed procedure can be intended as a powerful tool for screening among available configurations, enabling a more informed decision by simplifying and optimising the scale-up and the detailed design. [ABSTRACT FROM AUTHOR]

• BMI negatively affects breast cancer survival. • Higher BMI is associated with older age, post-menopausal status and advanced stages. • Obese patients experience a poorer iDFS and OS at 15 years. • Obesity is an independent prognostic factor for late outcome. • The distribution of late events varies significantly according to BMI class. [ABSTRACT FROM AUTHOR]

A targeted treatment approach is increasingly promoted in epilepsy management. To investigate if etiology (both established or initially presumed) influences antiepileptic drug choice of experts in neonatal seizures. An invitation to participate to a web-based questionnaire was sent to Italian pediatric neurologists affiliated to the Italian Society of Pediatric Neurology (SINP). 19 pediatric neurologists from different centers, all consultants of third level Neonatal Intensive Care Units (NICUs) answered. As first-line drug phenobarbital was the most common choice, it was used in 79% of cases of acute symptomatic seizures, in 63% of structural epilepsy, in 42% of genetic epilepsies. As second-line drug phenytoin was used by 58% in acute symptomatic seizures, 37% in structural epilepsy, 5% in genetic epilepsy. Pyridoxine/pyridoxalphosphate was much more used in genetic epilepsy (as first-line in 26%, as second-line in 37%) than in the other two conditions. Long-term conventional EEG monitoring was suggested as important to verify efficacy of drugs in controlling seizures by 84% of interviewed neurologists, but EEG was available around the clock in only 53% of their centers. 1 to 3-channel aEEG/EEG (commonly named CFM) was often used instead of conventional EEG monitoring. This is the first survey looking at a targeted approach in treatment of neonatal seizures by pediatric neurologists consulted by NICUs. The treatment approach is similar to previous surveys in case of acute symptomatic seizures, but in case of other etiologies the choices are different, especially for the second-line option. Larger studies should address this topic. [ABSTRACT FROM AUTHOR]

Lennox-Gastaut syndrome (LGS) is a severe epileptic encephalopathy with a prevalence of 1-2% of all patients with epilepsy. It is characterized by multiple pharmaco-resistant seizure types, including tonic, atypical absences and tonic or atonic drop attacks, and the presence of electroencephalographic abnormalities, such as slow-spike waves and paroxysmal fast rhythms. Intellectual disability, behavioural and psychiatric disorders are common comorbidities; these disturbances have a multi-factorial pathogenesis. The selection of the most appropriate drug must be tailored to each patient and guided by the prevalent seizure type. In this paper available pharmacological options are discussed and for each pharmacological agent, current evidence of efficacy and tolerability is provided. Valproic acid represents one of the first-line options in the treatment of LGS. Anyway, other antiepileptic drugs (AEDs) may be considered and added: lamotrigine, rufinamide, topiramate, clobazam can be efficacious. The use of felbamate must be carefully evaluated because of its adverse events. Perampanel, zonisamide, levetiracetam and fenfluramine have shown to be useful in the treatment of selected patients; nevertheless, the lack of RCTs does not allow to recommend their use in a systematic way. Recently, cannabidiol has provided high evidence of efficacy against LGS seizures; however, these data must be confirmed by long-term extensive studies and by trials comparing different AEDs, one to each other. [ABSTRACT FROM AUTHOR]

We present an atypical association of SCN2A epileptic encephalopathy with severe cortical dysplasia. SCN2A mutations are associated with epileptic syndromes from benign to extremely severe in absence of such macroscopic brain findings. Prenatal MRI (Magnetic Resonance Imaging) in a 32 weeks fetus, with US (Ultrasonography) diagnosis of isolated ventriculomegaly showed CNS (Central Nervous System) dysplasia characterized by lack of differentiation between cortical and subcortical layers, pachygyria and corpus callosum dysgenesis. Postnatal MRI confirmed the prenatal findings. On day 6 the baby presented a focal status epilepticus, partially controlled by phenobarbital, phenytoin, and levetiracetam. After three weeks a moderate improvement in seizure control has been achieved with carbamazepine. Exome sequencing detected a de novo heterozygous mutation in the SCN2A gene, encoding the α II -subunit of a sodium channel. The patient findings expand the phenotype spectrum of SCN2A mutations to epileptic encephalopathies with macroscopic brain developmental features. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to appraise 2-year outcomes after percutaneous transluminal angioplasty of long femoropopliteal artery disease using paclitaxel-coated balloons (PCBs). Background Percutaneous transluminal angioplasty with PCBs for TransAtlantic Inter-Society Consensus types C and D femoropopliteal artery disease has provided favorable results ≤12 months but no prospective studies performed longer term follow-up assessment. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency (i.e., freedom from the combined endpoint of clinically driven target lesion revascularization and >50% restenosis in the treated lesion as appraised by a duplex ultrasound peak systolic velocity ratio of >2.4) at 24 months. Secondary endpoints included major adverse events (the composite of death, target limb amputation, thrombosis at the target lesion, or clinically driven nontarget lesion revascularization), changes in Rutherford class, and quality of life ≤24 months post-procedure. Results A total of 105 patients (age 68 ± 9 years; 81.9% men) successfully treated with PCBs were included (treated lesion length was 251 ± 71 mm; 49.5% total occlusions). The 24-month follow-up data were available in 98 patients; they showed a primary patency rate of 70.4%, with major adverse events occurred in 10 patients (10.2%, 5 non–procedure-related deaths) and persistently significant clinical benefits in Rutherford class (51% of asymptomatic patients at 24 months). Conclusions PCBs benefits on primary patency and target vessel revascularization satisfactorily extend over 24 months in patients undergoing percutaneous transluminal angioplasty for symptomatic femoropopliteal disease. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons. Background Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non–target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure. Results A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class. Conclusions Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540 ) [ABSTRACT FROM AUTHOR]

A single-channel proton exchange membrane fuel cell model (anode side) based on computational fluid dynamics is used to investigate the possibility of operating a fuel cell at low stoichiometric flow ratios using completely dry inlet hydrogen. A case study of three different stoichiometric flow ratios (ξ = 1.01, ξ = 1.03, ξ = 1.05), three different operating temperatures (343.15 K, 347.15 K, 353.15 K), and three different operating pressures (1 atm, 1.2 atm and 1.5 atm) are presented. It is found that the predicted hydrogen concentration and relative humidity (RH) in the catalyst layer (CL) have opposite trends: the RH in CL decreases with increasing stoichiometric flow ratios, but it reaches 100% at the outlet. While hydrogen concentration in CL increases with increasing stoichiometric flow ratios and the largest difference is at the inlet, with a maximum of 3.6%. The results also suggest that PEM fuel cells may be operated in a stoichiometric flow ratio as low as ξ = 1.01 at the anode side. This cell operation would allow open-ended anode operation without a recirculation system, thus significantly reducing system complexity and cost. The CFD code is disclosed to provide a starting point for more complex model development. • An anode fuel cell CFD model includes the bipolar plate, channel, gas diffusion layer, microporous layer and catalyst layer. • Demonstration that the anode side can be operated at a very low stoichiometry of 1.01. • Demonstration that fuel cell anode can operate on completely dry inlet gases employing the water uptake layer. [ABSTRACT FROM AUTHOR]

Aim The number of examined lymph nodes (NLN) was associated with survival of stages II and III colorectal cancer (CRC) patients. Guidelines recommend examining at least 12 lymph nodes. This study investigated the influence of surgical specimen length on lymph node harvest and compliance with international guidelines. Materials and methods This population-based study included 4,724 cases of surgically treated CRC that were diagnosed from 2002 to 2008. Multivariate analyses were performed for the main study variables (age, gender, diagnosis at screening or in symptomatic patients, cancer site, staging, grading, number of positive nodes, neo-adjuvant treatment for rectal cancer, hospital were surgery was performed). Fractional polynomial models investigated the relationship between continuous variables and outcomes. Results The NLN increased over time reaching ≥12 NLN in 64% of cases at the end of the study period. More NLN were associated with young age, right colon cancer, pT3–T4 disease, stages II and III and high grade. Fewer NLN were associated with short surgical specimen length and neo-adjuvant treatment in rectal cancer patients. Use of laparoscopy increased sharply over time. Conclusions NLN increased over time in accordance with international guidelines. Surgical specimen length correlated with NLN which may determine therapeutic choices, particularly in stage II colon cancer. When harvested lymph nodes are under 10 in number and all are negative, chemotherapy is always recommended. As specimen lengths <20 cm were associated with a high risk of inadequate NLN counts, patients are at risk of over-treatment. [ABSTRACT FROM AUTHOR]

Polymer electrolyte membrane (PEM) fuel cells require good hydration in order to deliver high performance and ensure long life operation. Water is essential for proton conductivity in the membrane which increases by nearly six orders of magnitude from dry to fully hydrated. Adequate water management in PEM fuel cell is crucial in order to avoid an imbalance between water production and water removal from the fuel cell. In the present study, a novel mathematical zero-dimensional model has been formulated for the water mass balance and hydration of a polymer electrolyte membrane. This model incorporates all the essential fundamental physical and electrochemical processes occurring in the membrane electrolyte and considers the water adsorption/desorption phenomena in the membrane. The effect of diffusivity model, surface roughness and water content driving force is considered. The model is validated against experimental data. In the results it is shown that the fuel cell water balance calculated by this model shows better fit with experimental data-points compared with model where only steady state operation were considered. We conclude that this discrepancy is due a different rate of water transport when membrane absorption/desorption is considered in the model. The model becomes useful in system modeling when studying fuel cells in dynamic conditions. [ABSTRACT FROM AUTHOR]

Anaplastic thyroid cancer (ATC) is an unusual tumor with the worst prognosis among thyroid malignancies. Treatment of the patients diagnosed with ATC is not standardized and the feasible options include surgery, radiotherapy and chemotherapy. ATC cannot be regarded as a very chemo-sensitive tumor. Herein, we reported a case of a 91-year-old woman with complete response after induction chemotherapy (weekly carboplatin and docetaxel) that underwent subsequent radiotherapy. [ABSTRACT FROM AUTHOR]

Abstract: Temperature changes in PEM fuel cell stacks are considerably higher during load variations and have a negative impact as they generate thermal stresses and stack degradation. Cell hydration is also of vital importance in fuel cells and it is strongly dependent on operating temperature. A combination of high temperature and reduced humidity increases the degradation rate. Stack thermal management and control are, thus, crucial issues in PEM fuel cell systems especially in automotive applications such as forklifts. In this paper we present a control-oriented dynamic model of a liquid-cooled PEM fuel cell system for studying temperature variations over fast load changes. A temperature dependent cell polarization and hydration model integrated with the compressor, humidifier and cooling system are simulated in dynamic condition. A feedback PID control was implemented for stack cooling. The stack energy balance was reduced to a first order differential equation using a lumped approach. The first-order Linear Time-Invariant system was used to obtain the transfer function which was determined based on experimental data at different stack loads. The developed model approach can assist designers in choosing the required coolant mass flow rate and radiator size to minimize the stack temperature gradients. [Copyright &y& Elsevier]

Abstract: Objective: Placenta-specific1 (PLAC1) is a trophoblast-specific gene encoding for a protein that is highly expressed in human placenta, on the surface of the syncytiotrophoblast. PLAC1 was found to elicit spontaneous antibody responses in cancer patients. We aimed to determine the levels of anti-PLAC1 antibodies in infertile women with a history of unexplained repeated implantation failure after IVF cycles as compared to fertile women. Study design: An observational case–control clinical study. Main outcome measure(s): Two groups of patients were analysed in two different experimental settings: 21 infertile women and 81 control patients were enrolled in the first group, 16 infertile women and 67 fertile controls in the second group. Anti-PLAC1 antibody levels and ranking were analysed by ELISA test. Results: In both groups of infertile patients enrolled, optical densities (OD) from ELISA test ranked significantly higher than those of controls (0.27 ± 0.2 vs. 0.13 ± 0.1 respectively; p = 0.0009 in the first group), (0.62 ± 0.38 vs. 0.39 ± 0.35 respectively; p = 0.0044 in the second experiment). In the first group about one case in four (29%) had OD levels above the 95thpercentile (0.337) for healthy controls (p = 0.005). In the second experiment 4 out of 16 cases (25%) had OD levels above the 95th percentile (0.878) for healthy controls (p = 0.023). Conclusions: Anti-PLAC1 antibodies could represent a biomarker associated with infertility and with high probability of repeated implantation failure after ovarian stimulation and IVF-ET, greatly improving the diagnostic work up of infertile couples. [Copyright &y& Elsevier]

Objectives This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons. Background Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results. Methods Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months. Results A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%). Conclusions PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization. [ABSTRACT FROM AUTHOR]

Objectives: This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease. Background: Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described. Methods: This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed. Results: The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up. Conclusions: PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization. [ABSTRACT FROM AUTHOR]