Expert review of medical devices最新文献

Introduction: Mammography has been a cornerstone of breast cancer screening for decades, demonstrating population-level reductions in breast cancer mortality. Limitations of mammography include reduced sensitivity in dense breast tissue, false-positive recalls and biopsies, and possible overdiagnosis. Emerging mammography technologies, including digital breast tomosynthesis (DBT), contrast-enhanced mammography (CEM), and artificial intelligence (AI) applications, seek to address these limitations and improve screening outcomes.

Areas covered: In this review, we discuss endpoints for the assessment of emerging mammography technologies, including cancer detection, interval cancer, and advanced cancer rates. We review clinical trial data for DBT, highlighting studies reporting interval and advanced cancer rates, and contrast performance in average-risk and high-risk populations. We review CEM as a new modality for supplemental screening in women with dense breasts. Lastly, we cover the rapidly expanding space of AI-supported mammography tools, including those for lesion detection, exam triage, breast density assessment, and risk prediction.

Expert opinion: Emerging technologies in digital screening mammography have demonstrated improvements in surrogate endpoints like cancer detection, however, their effect on clinically meaningful outcomes such as interval cancer and advanced cancer reduction remains unproven. To ensure that innovations translate into tangible patient benefit, future research should prioritize clinically relevant endpoints and real-world evaluation.

Introduction: Pediatric patients with high-degree or complete atrioventricular block require permanent pacing. Pacing in this population is challenging due to changes in age, body and heart size, vascular anatomy, associated congenital abnormalities, physical activity, and expected long-term pacing needs.

Areas covered: This review evaluates recommendations, strategies, limitations, and complications of pediatric pacing, based on a comprehensive literature search (PubMed, using keywords as cardiac pacing, children, pacing complications, etc.). Currently, no pacing devices or leads are specifically designed for children; adult systems are adapted for pediatric use. Recommendations and strategies vary according to age, size, and associated congenital heart defects. Guidelines published between 2021 and 2023 provide updated recommendations. Advances in tools and techniques have improved management of pediatric bradyarrhythmias. Both transvenous and epicardial pacing systems can be implanted, with generally good outcomes, although complications remain relatively frequent.

Expert opinion: Cardiac pacing in children is effective and safe, but no single approach fits all patients. Implantation strategies, device selection, and techniques should be individualized based on patient characteristics, anatomy, and long-term needs. Future improvements in device design, lead technology, and procedural approaches will further optimize outcomes and reduce complications in this population.

Introduction: Obstructive sleep apnea (OSA) is a treatable risk factor for hypertension. Continuous Positive Airway Pressure (CPAP) and mandibular advancement devices (MAD) are effective treatments for OSA and have been shown to improve blood pressure in OSA.

Areas covered: This review explores the role of CPAP and MAD in the treatment of OSA for blood pressure control. Important clinical phenotypes associated with improved blood pressure in OSA are explored. A PubMed search of relevant articles within the past 10-years was performed.

Expert opinion: OSA therapy is shifting from a one-size-fits-all toward a precision medicine approach. Both CPAP and MAD have been demonstrated to reduce blood pressure in selected OSA patients. Neutral randomized controlled trials add to the uncertainty of treating OSA for the reduction of cardiovascular risk. Further work is needed to identify individual patients who are likely to gain a cardiovascular benefit from OSA treatment, including a reduction in blood pressure. Recent advances in wearable devices and sensor technologies present exciting opportunities for improving patient compliance with OSA therapy, monitoring long-term outcomes, and informing precision medicine approaches in clinical practice to improve blood pressure management in OSA.

Introduction: The transfusion of blood and blood components is essential for the resuscitation of patients with critical bleeding. These fragile biological therapeutics demand specialized devices for procurement, processing, transport, storage, and transfusion.

Areas covered: We discuss some of the challenges and solutions to the often-overlooked phases of transport and storage of blood and blood components.

Expert opinion: Strict maintenance of temperatures is required to ensure the efficacy and safety of blood components. This can be achieved using active or passive transport systems, known as shippers. Additional storage and transportation considerations include pre-conditioning of cold or frozen bricks, packing construct of protective insulating material, location of blood components in shipper, and labeling of blood transport shippers. Blood components are usually collected and stored in polyvinyl chloride bags. Historically, plasticizers such as di-(2-ethylhexyl) phthalate (DEHP) were added to preserve the quality of the product, but regulatory bans have led blood services to explore alternative plasticizers. Newer, dried blood components require innovative storage solutions currently ranging from glass containers to plastic bags that are modified to minimize degradation from light and moisture. Innovation in blood components demands innovation in devices for collection and storage, with oversight by accredited bodies for quality assurance.

Introduction: Sacroiliac joint (SIJ) dysfunction accounts for up to 30% of axial low back pain and is increasingly managed surgically after failure of conservative care. While traditional open SIJ fusion carried significant morbidity, minimally invasive (MIS) approaches have transformed outcomes. More recently, stereotactic navigation and robotic assistance have emerged to enhance implant placement accuracy and reduce radiation exposure.

Areas covered: We conducted a narrative review of the literature (PubMed, EMBASE, Cochrane Reviews, inception) on SIJ fusion techniques, implant accuracy, complications, fusion rates, and patient-reported outcomes. MIS SIJ fusion now predominates over open approaches, with lateral and posterior techniques both achieving >90% fusion at 12-18 months. Navigation and robotic systems achieve 92-98% implant accuracy (vs. 76-87% with fluoroscopy) and reduce intraoperative radiation exposure by up to 85%, especially in anatomically complex or revision cases.

Expert opinion: Navigated and robotic-assisted SIJ fusion represents significant technical progress. While short-term clinical outcomes remain comparable to fluoroscopic MIS fusion, navigation, and robotics improve safety, reproducibility, and radiation safety. Future multicenter trials should assess long-term outcomes, cost-effectiveness, and integration of augmented reality, AI, and novel implants to define their optimal role in sacroiliac joint surgery.

Introduction: Endoscopic ultrasound (EUS) has emerged as a cornerstone in gastrointestinal diagnostics and therapeutics worldwide. In Saudi Arabia, however, its development has not yet been comprehensively reviewed in the context of evolving clinical practice and training needs.

Areas covered: This narrative review synthesises published literature between 2000 and April 2025 to map the progression of EUS practice in Saudi Arabia. A systematic search of PubMed, Scopus, Google Scholar, and regional academic repositories was performed. Inclusion criteria targeted studies reporting on diagnostic or therapeutic EUS performed in Saudi healthcare institutions. Nine relevant publications were identified, including original research, case series, and survey-based data. Early studies highlighted EUS's role in diagnosing pancreatic lesions, choledocholithiasis, and subepithelial tumors. More recent reports demonstrated therapeutic advances such as biliary drainage, liver abscess management, and EUS-guided liver biopsy. One multinational survey provided insight into local training infrastructure gaps and simulator access.

Expert opinion: EUS in Saudi Arabia is transitioning from a specialized diagnostic modality to a broader interventional platform. To fully realize its potential, coordinated efforts in workforce training, national procedural registries, and multicentre collaboration will be essential to standardize access and quality across the Kingdom.

Introduction: Transcatheter aortic valve replacement (TAVR) has transformed treatment of severe aortic stenosis, offering a less invasive alternative to surgery. Despite advances, stroke remains a serious complication, impacting morbidity, mortality, and long-term cognitive function, thus the need for effective prevention strategies.

Areas covered: Based on a targeted review of the PubMed literature, this review addresses mechanisms and risk factors for stroke after TAVR and evaluates current preventive approaches. Cerebral embolic protection devices (CEPDs), particularly the Sentinel system, are discussed alongside other devices. Antithrombotic strategies before, during, and after TAVR are also reviewed, emphasizing the balance between thromboembolic protection and bleeding risk in an elderly population.

Expert opinion: While some studies suggest CEPDs may reduce stroke, randomized trials have not confirmed broad and robust benefit, and high cost limits routine adoption. Future work should focus on high-risk subgroups, device refinement, and large-scale trials. For now, individualized antithrombotic therapy and selective CEPD use remain central to stroke prevention in TAVR.

Introduction: Temporary mechanical circulatory support (tMCS) has become essential in managing severe cardiac dysfunction, particularly refractory cardiogenic shock (CS). Despite widespread adoption, the optimal use of tMCS is often guided by institutional experience rather than robust evidence, leaving questions about device selection and patient outcomes.

Areas covered: We conducted a structured literature review of studies published in major databases (PubMed), using keywords such as intra-aortic balloon pump, veno-arterial extracorporeal membrane oxygenation, percutaneous ventricular assist devices, cardiogenic shock, and related terms. Key clinical scenarios reviewed include acute myocardial infarction-related CS, post-cardiotomy shock, and support for high-risk percutaneous coronary interventions. We critically examine randomized controlled trials, extensive observational studies, and consensus statements published in the last five years.

Expert opinion: While tMCS has revolutionized the management of CS, its optimal use is still limited by a lack of high-quality evidence, ongoing device-related complications, and economic challenges. Future advancements in device technology, patient stratification, and standardized protocols, alongside continued research and innovation, are essential to improve outcomes and broaden the accessibility.