BACKGROUND: Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR.
METHODS: Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis.
RESULTS: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups.
CONCLUSIONS: This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318).
METHOD: A set of three psychophysics conditions of hearing (critical band spectral estimation, equal loudness hearing curve, and the intensity loudness power law of hearing) is used to estimate the auditory spectrum. The auditory spectrum and all-pole models of the auditory spectrums are computed and analyzed and used in a Gaussian mixture model for an automatic decision.
RESULTS: In the experiments using the Massachusetts Eye & Ear Infirmary database, an ACC of 99.56% is obtained for pathology detection, and an ACC of 93.33% is obtained for the pathology classification system. The results of the proposed systems outperform the existing running-speech-based systems.
DISCUSSION: The developed system can effectively be used in voice pathology detection and classification systems, and the proposed features can visually differentiate between normal and pathological samples.
METHODS: Sixteen New Zealand white rabbits, 20 to 24 weeks old, were randomly divided into 4 experimental groups. Modified hyrax expanders were placed across their interfrontal sutures and secured with miniscrew implants located bilaterally in the frontal bone. The hyrax appliances were activated as follows: group 1 (control), 0.5-mm per day expansion for 12 days; group 2, 1-mm instant expansion followed by 0.5 mm per day for 10 days; group 3, 2.5-mm instant expansion followed by 0.5 mm per day for 7 days, and group 4, 4-mm instant expansion followed by 0.5 mm per day for 4 days. After 6 weeks of retention, sutural separation and sutural bone modeling were assessed by microcomputed tomography and quantified. Statistical analysis was performed using Kruskal Wallis and Mann-Whitney U tests and the Spearman rho correlation (P <0.05).
RESULTS: Median amounts of sutural separation ranged from 2.84 to 4.41 mm for groups 1 and 4, respectively. Median bone volume fraction ranged from 59.96% to 69.15% for groups 4 and 3, respectively. A significant correlation (r = 0.970; P <0.01) was observed between the amounts of instant expansion and sutural separation.
CONCLUSIONS: Pending histologic verifications, our findings suggest that the protocol involving 2.5 mm of instant expansion followed by 0.5 mm per day for 7 days is optimal for accelerated sutural expansion. When 4 mm of instant expansion was used, the sutural bone volume fraction was decreased.