Expert Review of Medical Devices最新文献

Background: The prognosis for heart failure (HF) patients remains poor, with a high mortality rate, and a marked reduction in quality of life (QOL) and functional status. This study aims to explore the ongoing needs of HF management and the epidemiology of patients followed by Italian HF clinics, with a specific focus on cardiac contractility modulation (CCM).

Research design and methods: Data from patients admitted to 14 HF outpatients clinics over 4 weeks were collected and compared to the results of a survey open to physicians involved in HF management operating in Italian centers.

Results: One hundred and five physicians took part in the survey. Despite 94% of patients receive a regular follow-up every 3-6 months, available therapies are considered insufficient in 30% of cases. Physicians reported a lack of treatment options for 23% of symptomatic patients with reduced ejection fraction (EF) and for 66% of those without reduced EF. Approximately 3% of HF population (two patients per month per HF clinic) meets the criteria for immediate CCM treatment, which is considered a useful option by 15% of survey respondents.

Conclusions: Despite this relatively small percentage, considering total HF population, CCM could potentially benefit numerous HF patients, particularly the elderly, by reducing hospitalizations, improving functional capacity and QOL.

Introduction: At present, the double balloon represented by the COOK Cervix Ripening Balloon and the single balloon represented by the Foley catheter are the commonly used intrauterine balloons. The application of intrauterine balloons in cervical ripening has evolved over 100 years. Although intrauterine balloons have been widely used in cervical ripening, the effect of labor induction in clinical practice does not satisfy all clinicians, especially patients with poor cervical maturity.

Areas covered: The research in this review is about intrauterine balloons and cervical ripening.

Expert opinion: This article reviews the historical evolution and different application methods of intrauterine balloons in cervical ripening, such as application range, placement method and placement duration of intrauterine balloons, volume and temperature of the solution fillings, and whether to apply traction to the catheter. We aim to better understand the principle of intrauterine balloons in cervical ripening and make this method more effective.

Introduction: One-way endobronchial valve treatment improves lung function, exercise capacity, and quality of live in patients with severe emphysema and hyperinflation. Other areas of therapeutic application include treatment of persistent air leak (PAL), giant emphysematous bullae, native lung hyperinflation, hemoptysis, and tuberculosis.

Areas covered: In this review, we will assess the clinical evidence and safety of the different applications of one-way endobronchial valves (EBV).

Expert opinion: There is solid clinical evidence for the use of one-way EBV for lung volume reduction in emphysema. Treatment with one-way EBV can be considered for the treatment of PAL. The application of one-way EBV for giant bullae, post lung transplant native lung hyperinflation, hemoptysis, and tuberculosis is under investigation and more research is required to investigate the efficacy and safety of these applications.

Introduction: Although there has been extensive research on mechanical ventilation for acute respiratory distress syndrome (ARDS), treatment remains mainly supportive. Recent studies and new ventilatory modes have been proposed to manage patients with ARDS; however, the clinical impact of these strategies remains uncertain and not clearly supported by guidelines. The aim of this narrative review is to provide an overview and update on ventilatory management for patients with ARDS.

Areas covered: This article reviews the literature regarding mechanical ventilation in ARDS. A comprehensive overview of the principal settings for the ventilator parameters involved is provided as well as a report on the differences between controlled and assisted ventilation. Additionally, new modes of assisted ventilation are presented and discussed. The evidence concerning rescue strategies, including recruitment maneuvers and extracorporeal membrane oxygenation support, is analyzed. PubMed, EBSCO, and the Cochrane Library were searched up until June 2023, for relevant literature.

Expert opinion: Available evidence for mechanical ventilation in cases of ARDS suggests the use of a personalized mechanical ventilation strategy. Although promising, new modes of assisted mechanical ventilation are still under investigation and guidelines do not recommend rescue strategies as the standard of care. Further research on this topic is required.

Objective: To assess the pediatric anterior segment characteristics in ocular pathology using spectral domain optical coherence tomography (SD-OCT).

Methods: This case series follows 115 eyes of 78 children (2-17 years) with anterior segment pathology in an academic facility. The anterior segment OCT (AS-OCT) analysis was done using the Optopol Revo 80 high-resolution SD-OCT using an imaging adapter. All pathological features visible on imaging were observed, studied, tabulated, and analyzed.

Results: The average age was 11.84 years, with 44 males and 34 females. The primary clinical diagnosis was cataract in 40 (34.8%) eyes, followed by corneal disease in 28 (24.3%) eyes, glaucoma in 18 (15.7%) eyes, and trauma in 15 (13%) eyes. Systemic diseases were associated with 20.9% of the cases. The most common imaging pathology observed was lens opacification in 43 (37.4%), increased reflectivity of the cornea in 31 (28.2%), corneal stromal thinning in 34 (29.6%), increased corneal thickness in 28 (24.3%), a shallow anterior chamber in 17 (14.8%), and cells in the anterior chamber in 18 (15.7%) eyes, along with a multitude of other findings.

Conclusion: This study demonstrates that anterior segment OCT is a useful non-contact technique for the detailed anatomic and pathologic assessment of pediatric ocular diseases.

Introduction: Bone biopsies have great value for the diagnosis of, amongst others, hematologic diseases. Although the bone biopsy procedure is mostly performed minimally invasive with the use of a slender cannula, the patient may still experience discomfort, especially when the procedure has to be repeated due to an unsuccessful biopsy.

Areas covered: This review presents a comprehensive overview of bone biopsy devices presented in the patent literature. The patents were obtained using a classification search combined with keywords in the Espacenet patent database and were subsequently verified using pre-set eligibility criteria. This resulted in 62 unique patents included in this review.

Expert opinion: The included patents were categorized based on the used strategies for the three steps that can be identified during a bone biopsy (1) biopsy sampling, (2) biopsy severing and (3) biopsy harvesting. Most patents described strategies for multiple steps. Insight into the used strategies and the comprehensive overview may serve as a source of inspiration for the design of novel bone biopsy devices.

Background: Proper maintenance of electro-medical devices is crucial for the quality of care to patients and the economic performance of healthcare organizations. This research aims to identify the interaction between Ultrasound scanners (US) maintenance variables as a function of maintenance indicators: US in service or decommissioned, excessive number of failures, and failure rate. Knowing those interactions, specific maintenance measures will be developed to improve the reliability of the US.

Research design and methods: Multifactor Dimensionality Reduction (MDR) method was eployed to analyze data from 222 US and their four-year maintenance history. Models were developed based on the variables with the greatest influence on maintenance indicators, where US were classified according to the associated risk.

Results: US with more than one major failure or at least one major component replacement had up to 496.4% more failures than the average. Failure rate increased by up to 188.7% over the average for those US with more than three moderate failures, three replacements, or both.

Conclusions: This study identifies and quantifies the causes of risk to establish a specific maintenance plan for US. It helps to better understand the degradation of US to optimize their operation and maintenance.