The evolution of percutaneous coronary intervention (PCI) has led to significant advances in drug-coated balloon (DCB) technology, offering a stent-free alternative for treating coronary artery disease. While paclitaxel-coated balloons (PCBs) have been the standard, sirolimus-coated balloons (SCBs) are emerging as a viable alternative with distinct pharmacokinetic and clinical benefits. This review explores the mechanisms of action of paclitaxel and sirolimus, their impact on different plaque morphologies, and the clinical implications of DCB selection. Paclitaxel facilitates positive vascular remodeling and is particularly effective in fibrotic and lipid-rich plaques, but its poor penetration in calcified lesions remains a limitation. Sirolimus, with its homogeneous tissue distribution and anti-inflammatory properties, is better suited for unstable, lipid-rich, and inflammatory plaques, where it promotes plaque stabilization. Recent randomized trials and meta-analyses have compared SCBs vs. PCBs in both de novo lesions and in-stent restenosis, showing non-inferior outcomes. Additionally, DCBs demonstrate comparable efficacy to DES in small vessel disease, reducing the need for permanent metallic scaffolds. This review summarizes the current evidence on DCB selection based on plaque characteristics and highlights areas for further investigation in personalized PCI strategies. Given the narrative review design, the authors conducted a comprehensive literature search using databases such as PubMed and MEDLINE. Keywords included “drug-coated balloon”, “paclitaxel-coated balloon”, “sirolimus-coated balloon”, “in-stent restenosis”, and “plaque morphology”. Studies were selected based on relevance, including randomized controlled trials, registries, and meta-analyses. No formal inclusion/exclusion criteria or systematic screening were applied due to the nature of narrative synthesis.

Background: Stapes prostheses represent one of the earliest and most widely applied “biomedical actuators” designed to restore hearing in patients with otosclerosis. Unlike conventional actuators, which convert energy into motion, stapes prostheses function as passive or smart micro-actuators, transmitting and modulating acoustic energy through the ossicular chain. Objective: This paper provides a comprehensive analysis of stapes prostheses from an engineering and biomedical perspective, emphasizing design principles, materials science, and recent innovations in smart actuators based on shape-memory alloys combined with surgical applicability. Methods: A narrative review of the evolution of stapes prostheses was consolidated by institutional surgical experience. Comparative evaluation focused on materials (Teflon, Fluoroplastic, Titanium, Nitinol) and design solutions (manual crimping, clip-on, heat-activated prostheses). Special attention was given to endoscopic stapes surgery, which highlights the ergonomic and functional requirements of new device designs. Results: Traditional fluoroplastic and titanium pistons provide reliable sound conduction but require manual crimping, with a higher risk of incus necrosis and displacement. Innovative prostheses, particularly those manufactured from nitinol, act as self-crimping actuators activated by heat, improving coupling precision and reducing surgical trauma. Emerging designs, including bucket-handle and malleus pistons, expand applicability to complex or revision cases. Advances in additive manufacturing and middle ear cement fixation offer opportunities for customized, patient-specific actuators. Conclusions: Stapes prostheses have evolved from simple passive pistons to innovative biomedical actuators exploiting shape-memory and biocompatible materials. Future developments in stapes prosthesis design are closely linked to 3D printing technologies. These developments have the potential to enhance acoustic performance, durability, and patient outcomes, thereby bridging the gap between otologic surgery and biomedical engineering.

Objectives: This scoping review aimed to map European and Romanian pharmaceutical legislation and policy-related evidence and to examine how legislative harmonization translates into access outcomes in Romania. Eligibility criteria: Legislative documents, institutional reports, market analyses, and peer-reviewed studies addressing pharmaceutical regulation, pricing, reimbursement, and access to medicines (2000–2024). Sources of evidence: EUR-Lex, the Romanian Legislative Portal, PubMed, Scopus, Google Scholar, and institutional sources (European Commission, OECD, WHO, EFPIA, NAMMDR, CNAS). Charting methods: Data were extracted using a standardized charting form and synthesized narratively across thematic domains (regulatory harmonization, pricing and reimbursement, medicine shortages, comparative EU indicators, and health system implications). Results: Fifty sources were included. The mapped evidence consistently identified three dominant patterns: (1) prolonged time-to-availability for centrally authorized medicines, with mean delays exceeding 800 days in Romania compared with approximately 578 days at EU level; (2) limited availability of innovative therapies, particularly in oncology (approximately 20% availability in Romania versus around 50% EU average); and (3) recurrent medicine shortages associated with low-price regulation and parallel export dynamics. Evidence gaps include limited Romania-specific empirical evaluation of the causal effects of individual policy levers (e.g., external reference pricing, reimbursement timelines, clawback mechanisms). Conclusions: Legislative harmonization alone has not ensured equitable or timely access to medicines in Romania. The evidence suggests that national pricing, reimbursement, and supply governance mechanisms mediate the relationship between EU regulation and real-world patient access, highlighting the need for targeted policy reforms and further empirical investigation.

Stapes surgery is the gold standard for managing otosclerosis. It has become increasingly appreciated to perform endoscopic ear surgery worldwide as the field of endoscopy expands. In basic terms, a stapes surgery intends to restore ossicular mobility and therefore improve sound energy transduction into the inner ear, thereby improving communication and sound amplification and bringing hearing levels back to acceptable levels. The aim of the study is to analyze surgical techniques comparing microscopic and endoscopic approaches for stapes surgery. The perspectives of Surgical Pioneers in Early Stapes Surgery and the contemporary development of surgical technology will be explored as well. Specifically, this study compiles well-documented, reliable information concerning the surgical outcomes for the endoscopic approach to stapes surgery and the results of recent studies.

Background/Objectives: Drug-induced sleep endoscopy (DISE) is used in obstructive sleep apnea (OSA) to visualize dynamic upper airway collapse, but sedation protocols vary widely with no consensus on the optimal agent or technique. This narrative review aims to clarify current sedation strategies for DISE in OSA and their clinical implications. Methods: We systematically searched PubMed, Scopus, Web of Science, and Cochrane Library for English-language publications on DISE sedation (2000–2025). Relevant clinical studies, guidelines, and reviews were included. Data were qualitatively synthesized due to heterogeneity among studies. Results: Sedation approaches in DISE varied considerably. Propofol, dexmedetomidine, and midazolam were the primary agents identified. Propofol provided rapid, titratable sedation but increased airway collapsibility at higher doses; dexmedetomidine produced a more natural sleep-like state with minimal respiratory depression; midazolam was less favored due to prolonged effects. Use of target-controlled infusion (TCI) and pharmacokinetic–pharmacodynamic (PK–PD) models improved control of propofol sedation. Co-sedative adjuncts (e.g., opioids) reduced the required sedative dose but added risk of respiratory depression. Careful titration to the lowest effective dose-often guided by bispectral index (BIS) monitoring—was emphasized to achieve adequate sedation without artifactual airway collapse. No universal DISE sedation protocol was identified. Conclusions: Optimal DISE sedation balances adequate depth with patient safety to ensure reliable findings. Using the minimum effective dose, guided by objective monitoring (e.g., BIS), is recommended. There is a need for standardized sedation protocols and further research (e.g., in obese patients) to resolve current controversies and improve DISE’s utility in OSA management.

Background and Objectives: To evaluate the surgical management and outcomes of lateral semicircular canal fistulas (LSCFs) in patients with middle ear cholesteatoma, focusing on hearing preservation and vestibular function. Materials and Methods: A retrospective study was conducted on nine adult patients diagnosed with LSCFs secondary to cholesteatoma who underwent surgery at a tertiary referral center between 2018 and 2024. The preoperative evaluation included otoscopy, audiometry, vestibular testing (HINTS), and high-resolution CT (HRCT) of the temporal bone. Surgical techniques included canal wall up (CWU) or canal wall down (CWD) mastoidectomy, depending on the disease extent. Cholesteatoma matrix removal from the fistula was performed carefully. Fistula closure involved layered grafts of temporalis fascia, temporalis muscle, and/or gelfoam. The postoperative follow-up included audiometry and vestibular assessments. Results: Nine patients with LSCFs were identified (one Type III, three Type IIb, and four Type I/IIa). Five patients were found to have additional disease complications intraoperatively, including facial nerve involvement and middle fossa dehiscence. Postoperatively, hearing outcomes varied, with some patients experiencing improvement, others demonstrating stable hearing, and some exhibiting further decline, particularly in cases with extensive disease. Vestibular symptoms, including vertigo, generally resolved postoperatively, although some patients required prolonged vestibular rehabilitation. Conclusions: LSCF management in cholesteatoma surgery requires a careful preoperative assessment, meticulous surgical technique, and individualized fistula closure based on the size and type. While hearing preservation remains a challenge, particularly in extensive cases, the “underwater technique” and layered grafting may contribute to minimizing further damage and promoting fistula closure. Vestibular rehabilitation plays a crucial role in managing postoperative balance issues. A long-term follow-up is essential to monitor for recurrence and assess both auditory and vestibular function.