Expert review of medical devices最新文献_第6页

Pulsed field ablation for atrial fibrillation. 脉冲场消融治疗心房颤动。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI: 10.1080/17434440.2025.2475239

Vedran Pašara, Tommaso Sattin, Carlo De Asmundis, Gian-Battista Chierchia, Gezim Bala

{"title":"Pulsed field ablation for atrial fibrillation.","authors":"Vedran Pašara, Tommaso Sattin, Carlo De Asmundis, Gian-Battista Chierchia, Gezim Bala","doi":"10.1080/17434440.2025.2475239","DOIUrl":"10.1080/17434440.2025.2475239","url":null,"abstract":"Introduction: Atrial fibrillation is the most common sustained arrhythmia, associated with substantial morbidity and a reduced quality of life. The current standard of care, transcatheter pulmonary vein isolation using thermal ablation techniques, provides symptom relief but carries a risk of collateral tissue damage. In recent years, pulsed field ablation, a nonthermal technique based on irreversible electroporation, has emerged as a promising alternative to conventional thermal ablation methods.Areas covered: This review provides an overview of pulsed field ablation, a novel nonthermal ablation technique. We briefly explain its biophysical principles and general technical aspects, describe currently available technologies, and summarize findings from clinical studies. Additionally, we discuss its safety profile, unresolved issues, and limitations, while also exploring future perspectives.Expert opinion: Pulsed field ablation offers distinct advantages over traditional thermal ablation methods, such as shorter procedure times and a favorable safety profile due to precise tissue targeting. Future improvements in ablation device design, energy delivery settings, integration with mapping systems, workflow efficiency, ablation protocols, and patient selection criteria are expected to further enhance clinical outcomes.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"311-320"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560389","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

New insights of the adaptation of flow diverters to the local geometry of vessel in the treatment of intracranial aneurysms. 血流分流器在颅内动脉瘤治疗中适应局部血管几何的新见解。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-20 DOI: 10.1080/17434440.2025.2478247

Arià Jaimejuan, Santiago Estevez-Areco, Laura Obradó, Hector Fernandez, Jordi Blasco, Luis San Román, Juan M Macho, Demetrius Lopes, Carlos Castaño, Sebastian Remollo, Ignacio Larrabide

{"title":"New insights of the adaptation of flow diverters to the local geometry of vessel in the treatment of intracranial aneurysms.","authors":"Arià Jaimejuan, Santiago Estevez-Areco, Laura Obradó, Hector Fernandez, Jordi Blasco, Luis San Román, Juan M Macho, Demetrius Lopes, Carlos Castaño, Sebastian Remollo, Ignacio Larrabide","doi":"10.1080/17434440.2025.2478247","DOIUrl":"10.1080/17434440.2025.2478247","url":null,"abstract":"Purpose: It is unclear how flow diverters (FDs) and vessels interact in the treatment of intracranial aneurysms. In this study, we examine the local changes in artery and device morphology caused by their mutual interaction.Methods: Pre-treatment 3DRA and post-treatment XperCT or DynaCT images were collected retrospectively from 25 patients. Vessel anatomies and FD models were obtained by segmenting the corresponding images. Perpendicular cross-sections of vessels and FDs were extracted and described in terms of area, perimeter, and circularity. The geometrical parameters from each vessel were paired point-by-point with those from FDs.Results: FD cross-sections are typically circular, regardless of the vessel's morphology. The area and perimeter of FD cross-sections were smaller than those of the vessel in 66.8% of the data; however, they were larger in 30.1%, suggesting that the vessel is radially stretching to accommodate the FD expansion. In 3.1% of the slices, the FD area was larger than the vessel, but its perimeter was smaller, indicating a change in the shape of the artery.Conclusions: Expansion of FD is generally restricted by the morphology of the vessel, but the vessel is also able to adapt to the device by changing its shape or stretching.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"379-386"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143582420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Quantifying insertional effects in deep brain stimulation: clinical outcomes and neurophysiological mechanisms. 量化脑深部刺激的插入效应：临床结果和神经生理机制。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-17 DOI: 10.1080/17434440.2025.2480660

Aaron Lawson McLean, Jakob Nemir

{"title":"Quantifying insertional effects in deep brain stimulation: clinical outcomes and neurophysiological mechanisms.","authors":"Aaron Lawson McLean, Jakob Nemir","doi":"10.1080/17434440.2025.2480660","DOIUrl":"10.1080/17434440.2025.2480660","url":null,"abstract":"Introduction: Deep brain stimulation (DBS) has revolutionized the treatment of various neurological and psychiatric disorders. However, recent findings highlight the significant clinical and molecular responses elicited by the mere insertion of DBS electrodes, termed 'insertional effects.' This review explores the clinical manifestations and underlying mechanisms of these effects, emphasizing their implications for neuromodulation therapies.Areas covered: A comprehensive literature search was conducted, examining studies that document the clinical benefits observed immediately following DBS electrode implantation in conditions such as Parkinson's disease, epilepsy, chronic pain, and psychiatric disorders. The review delves into the molecular and cellular mechanisms, including neuroinflammatory responses and ion channel dynamics, that contribute to these insertional effects. Additionally, the potential for these effects to predict DBS efficacy and inform the development of closed-loop DBS systems is discussed.Expert opinion: The insertional effects of DBS represent a crucial yet underappreciated phenomenon with significant implications for optimizing therapeutic protocols and enhancing patient outcomes. Recognizing and harnessing these effects could lead to more personalized and effective neuromodulation strategies, advancing the field of DBS and improving treatment for a range of neurological and psychiatric disorders.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"285-291"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143652813","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Percutaneous auricular neuromodulation for postoperative analgesia. 经皮耳神经调节术在术后镇痛中的应用。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-05 DOI: 10.1080/17434440.2025.2474731

John J Finneran Iv, Brian M Ilfeld

{"title":"Percutaneous auricular neuromodulation for postoperative analgesia.","authors":"John J Finneran Iv, Brian M Ilfeld","doi":"10.1080/17434440.2025.2474731","DOIUrl":"10.1080/17434440.2025.2474731","url":null,"abstract":"Introduction: Postoperative pain is often severe, with many patients still experiencing significant pain upon discharge. While opioids are effective for pain relief, they have numerous side effects and carry a high risk for misuse and dependence. Auricular electric stimulation, a form of neuromodulation, offers a promising alternative by electrically stimulating nerves of the auricle to modulate central pain pathways, potentially reducing postoperative pain and opioid requirements.Areas covered: This review, based on a search of the MEDLINE/PubMed, Scopus, and Cochrane review online sources from 1980 to 2024, discusses the use of auricular electric stimulation as a form of neuromodulation for management of postoperative pain focusing on the available evidence and future avenues for research.Expert opinion: Percutaneous auricular nerve stimulation offers a promising neuromodulation technique for managing postoperative pain. By modulating central pain processing through peripheral stimulation, this approach may reduce pain during recovery. Small pilot studies have suggested that auricular stimulation may lower pain intensity and reduce opioid consumption after surgery; however, further research is needed regarding both potential benefits and risks. As a minimally invasive technique, percutaneous auricular stimulation may provide a valuable adjunct to multimodal analgesia, especially in patients at risk of opioid-related complications.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"339-348"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Comments on: 'Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States'. 评论："使用速效亚感知疗法进行脊髓刺激的两年结果：美国真实世界多中心研究的结果"。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-19 DOI: 10.1080/17434440.2025.2479808

Triwiyanto T, I Putu Alit Pawana, Sari Luthfiyah

引用次数: 0

Printing hearts: three-dimensional printing as a transformative technology in transcatheter mitral valve interventions. 打印心脏：三维打印作为经导管二尖瓣介入的变革性技术。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-13 DOI: 10.1080/17434440.2025.2477608

Apurva H Bharucha, Mehdi Eskandari

引用次数: 0

Response to letter to the editor: "Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States". 给编辑的信的回复：“使用速效亚知觉疗法治疗脊髓刺激的两年结果：美国一项真实世界多中心研究的结果”。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-04-02 DOI: 10.1080/17434440.2025.2479820

Clark Metzger

引用次数: 0

Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach. 发展三维经直肠前列腺多参数超声训练：人因工程方法。

Expert review of medical devices Pub Date : 2025-04-01 Epub Date: 2025-03-06 DOI: 10.1080/17434440.2025.2473632

Daniel L van den Kroonenberg, Jurre Went, Auke Jager, Anna Garrido-Utrilla, Jaap C A Trappenburg, Arnoud W Postema, Harrie P Beerlage, Jorg R Oddens

{"title":"Developing a training for 3D transrectal multiparametric ultrasound of the prostate: a human factors engineering approach.","authors":"Daniel L van den Kroonenberg, Jurre Went, Auke Jager, Anna Garrido-Utrilla, Jaap C A Trappenburg, Arnoud W Postema, Harrie P Beerlage, Jorg R Oddens","doi":"10.1080/17434440.2025.2473632","DOIUrl":"10.1080/17434440.2025.2473632","url":null,"abstract":"Objective: Three-dimensional multiparametric ultrasound (3D mpUS) shows promise for accurately diagnosing prostate cancer. However, its technical complexity presents usability challenges. Human Factor Engineering (HFE) studies the interaction between devices and users, by reducing human error, increasing productivity, and enhancing safety. The objective is to develop a training program for 3D mpUS using HFE (NCT04605276).Methods: This study employs a human-centered design approach, a principle of HFE, with a formative and summative phase. In the formative phase, six trainees underwent 3D mpUS training and iteratively provided feedback. The summative phase included 15 trainees who completed the finalized training, probe and ultrasound machine handling, contrast agent (CA) preparation, and conducting 3D mpUS. Performance was evaluated through observing 23 tasks.Results: Feedback from the formative phase led to several improvements. In the summative phase, all pass criteria were met, most errors were related to CA administration or inadequate acquisition termination. Trainee confidence in independently performing 3D mpUS was high, with 93% of scans meeting quality standards.Conclusion: HFE proved effective in generating feedback to improve the training program for 3D mpUS acquisition. The training ensured that users were well prepared to perform the 3D mpUS procedure with minimal errors and a short learning curve.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"361-367"},"PeriodicalIF":0.0,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143560379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Advancing flow diverter porosity assessment: what can it tell us about occlusion rates? 先进的分流剂孔隙度评估：它能告诉我们关于封堵率的什么信息？

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-10 DOI: 10.1080/17434440.2025.2464177

Santiago Estevez-Areco, Laura Obradó, Romina Muñoz, Ignacio Larrabide

引用次数: 0

Current status and prospects of robot-assisted spine surgery. 机器人辅助脊柱手术的现状与展望。

Expert review of medical devices Pub Date : 2025-03-01 Epub Date: 2025-02-17 DOI: 10.1080/17434440.2025.2467779

Zhang Qi, He Da, Fang Yanming, Fan Mingxing

{"title":"Current status and prospects of robot-assisted spine surgery.","authors":"Zhang Qi, He Da, Fang Yanming, Fan Mingxing","doi":"10.1080/17434440.2025.2467779","DOIUrl":"10.1080/17434440.2025.2467779","url":null,"abstract":"Introduction: Traditional spine surgery is frequently impeded by a number of challenges, including the complexity of the underlying anatomy, the depth of the surgical locations, and the limited visibility. These factors can collectively result in prolonged operation times and a reduction in the precision. The advent of robot-assisted spine surgery has brought about a transformative solution, particularly in the context of screw placement. Robot-assisted spine surgery has the potential to enhance accuracy and safety while minimizing soft tissue damage.Areas covered: This article presents a review of the current state of robot systems in spine surgery. The principal advantages of robot-assisted technology include high precision in screw placement, robust imaging capabilities, reduced surgeon fatigue, and the potential for remote operation, thereby addressing disparities in healthcare access. Clinical studies indicate that robot-assisted techniques significantly improve the accuracy of screw placement and may reduce the incidence of postoperative complications. Challenges such as cost, technology limitations, and the need for comprehensive clinical guidelines persist.Expert opinion: It is anticipated that future advancements in surgical navigation, artificial intelligence integration and the expansion of robot functions will further enhance the efficacy of robot-assisted spine surgery, with the potential to improve patient outcomes and facilitate broader adoption in clinical practice.","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":" ","pages":"187-192"},"PeriodicalIF":0.0,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143426840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0