Pub Date : 2024-08-19DOI: 10.1080/17434440.2024.2393773
Denise Battaglini, Sergio Lassola, Marcus J Schultz, Patricia Rm Rocco
{"title":"Innovations in protective mechanical ventilation for acute respiratory distress syndrome management.","authors":"Denise Battaglini, Sergio Lassola, Marcus J Schultz, Patricia Rm Rocco","doi":"10.1080/17434440.2024.2393773","DOIUrl":"https://doi.org/10.1080/17434440.2024.2393773","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142006151","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}
Pub Date : 2024-08-11DOI: 10.1080/17434440.2024.2390581
Ann Merin Pinheiro, Bijaya Chettri, Anjali Mehra, Isha Deepti, Ramya Ravi
Introduction: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety.
Areas covered: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks.
Expert opinion: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.
{"title":"Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana.","authors":"Ann Merin Pinheiro, Bijaya Chettri, Anjali Mehra, Isha Deepti, Ramya Ravi","doi":"10.1080/17434440.2024.2390581","DOIUrl":"10.1080/17434440.2024.2390581","url":null,"abstract":"<p><strong>Introduction: </strong>Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety.</p><p><strong>Areas covered: </strong>This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks.</p><p><strong>Expert opinion: </strong>The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141908627","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}
Pub Date : 2024-08-06DOI: 10.1080/17434440.2024.2389235
Guanghong Zhou, Yan Yang, Yi Liao, Lijuan Chen, Yang Yang, Jun Zou
Background: The diagnosis of peripheral pulmonary lesions (PPLs) remains challenging. Despite advancements in guided transbronchial biopsy (TBB) techniques, diagnostic yields haven't reached ideal levels. Optical coherence tomography (OCT) has been developed for application in pulmonary diseases, yet no data existed evaluating effectiveness in diagnosing PPLs.
Research design and methods: This study included patients who underwent OCT and radial endobronchial ultrasound (R-EBUS)-guided TBB. OCT and R-EBUS imaging features were analyzed to differentiate between benign and malignant PPLs and subtypes of lung cancer.
Results: A total of 89 patients were included in this study. The diagnostic yield of OCT-guided TBB stood at 56.18%, R-EBUS-guided TBB was 83.15% (P<0.01). The accuracy of OCT to judge the nature of lesions was 92.59%, while R-EBUS was 77.92%. The accuracy of OCT in predicting squamous carcinoma (SCC) and adenocarcinoma were both 91.30%.
Conclusions: Although the diagnostic yield of OCT-guided TBB fell short of that achieved by R-EBUS, OCT possessed the capability to judge the nature of lesions and guide the pathological classification of malignant lesions. Further extensive prospective studies are necessary to thoroughly assess the characteristics of this procedure.
Clinical trial registration: https://register.clinicaltrials.gov/ identifier is NCT06419114.
背景:肺外周病变(PPL)的诊断仍然具有挑战性。尽管经支气管活检(TBB)技术不断进步,但诊断率仍未达到理想水平。光学相干断层扫描(OCT)已被开发应用于肺部疾病,但尚无数据评估其在诊断PPLs方面的有效性:本研究纳入了接受 OCT 和径向支气管内超声(R-EBUS)引导的 TBB 的患者。对 OCT 和 R-EBUS 的成像特征进行分析,以区分良性和恶性 PPLs 以及肺癌的亚型:本研究共纳入 89 例患者。OCT引导下的TBB诊断率为56.18%,R-EBUS引导下的TBB诊断率为83.15%:虽然OCT引导下的TBB诊断率低于R-EBUS,但OCT具有判断病变性质和指导恶性病变病理分类的能力。有必要进一步开展广泛的前瞻性研究,以全面评估该手术的特点。临床试验注册:https://register.clinicaltrials.gov/ 识别码为 NCT06419114。
{"title":"A pilot study of optical coherence tomography-guided transbronchial biopsy in peripheral pulmonary lesions.","authors":"Guanghong Zhou, Yan Yang, Yi Liao, Lijuan Chen, Yang Yang, Jun Zou","doi":"10.1080/17434440.2024.2389235","DOIUrl":"https://doi.org/10.1080/17434440.2024.2389235","url":null,"abstract":"<p><strong>Background: </strong>The diagnosis of peripheral pulmonary lesions (PPLs) remains challenging. Despite advancements in guided transbronchial biopsy (TBB) techniques, diagnostic yields haven't reached ideal levels. Optical coherence tomography (OCT) has been developed for application in pulmonary diseases, yet no data existed evaluating effectiveness in diagnosing PPLs.</p><p><strong>Research design and methods: </strong>This study included patients who underwent OCT and radial endobronchial ultrasound (R-EBUS)-guided TBB. OCT and R-EBUS imaging features were analyzed to differentiate between benign and malignant PPLs and subtypes of lung cancer.</p><p><strong>Results: </strong>A total of 89 patients were included in this study. The diagnostic yield of OCT-guided TBB stood at 56.18%, R-EBUS-guided TBB was 83.15% (P<0.01). The accuracy of OCT to judge the nature of lesions was 92.59%, while R-EBUS was 77.92%. The accuracy of OCT in predicting squamous carcinoma (SCC) and adenocarcinoma were both 91.30%.</p><p><strong>Conclusions: </strong>Although the diagnostic yield of OCT-guided TBB fell short of that achieved by R-EBUS, OCT possessed the capability to judge the nature of lesions and guide the pathological classification of malignant lesions. Further extensive prospective studies are necessary to thoroughly assess the characteristics of this procedure.</p><p><strong>Clinical trial registration: </strong>https://register.clinicaltrials.gov/ identifier is NCT06419114.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141899229","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}
Pub Date : 2024-08-05DOI: 10.1080/17434440.2024.2388135
Ana Carolina Pinheiro Campos, Clement Hamani
{"title":"Insertional effect following deep brain stimulation electrode implants.","authors":"Ana Carolina Pinheiro Campos, Clement Hamani","doi":"10.1080/17434440.2024.2388135","DOIUrl":"https://doi.org/10.1080/17434440.2024.2388135","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141891358","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}
Pub Date : 2024-08-01Epub Date: 2024-07-23DOI: 10.1080/17434440.2024.2382234
Mark N Malinowski, Brandon E Gish, Alexandra M Moreira, Marcin Karcz, Lucas A Bracero, Timothy R Deer
Introduction: For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society.
Areas covered: We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data.
Expert opinion: Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.
{"title":"Electrical neuromodulation for the treatment of chronic pain: derivation of the intrinsic barriers, outcomes and considerations of the sustainability of implantable spinal cord stimulation therapies.","authors":"Mark N Malinowski, Brandon E Gish, Alexandra M Moreira, Marcin Karcz, Lucas A Bracero, Timothy R Deer","doi":"10.1080/17434440.2024.2382234","DOIUrl":"10.1080/17434440.2024.2382234","url":null,"abstract":"<p><strong>Introduction: </strong>For over 60 years, spinal cord stimulation has endured as a therapy through innovation and novel developments. Current practice of neuromodulation requires proper patient selection, risk mitigation and use of innovation. However, there are tangible and intangible challenges in physiology, clinical science and within society.</p><p><strong>Areas covered: </strong>We provide a narrative discussion regarding novel topics in the field especially over the last decade. We highlight the challenges in the patient care setting including selection, as well as economic and socioeconomic challenges. Physician training challenges in neuromodulation is explored as well as other factors related to the use of neuromodulation such as novel indications and economics. We also discuss the concepts of technology and healthcare data.</p><p><strong>Expert opinion: </strong>Patient safety and durable outcomes are the mainstay goal for neuromodulation. Substantial work is needed to assimilate data for larger and more relevant studies reflecting a population. Big data and global interconnectivity efforts provide substantial opportunity to reinvent our scientific approach, data analysis and its management to maximize outcomes and minimize risk. As improvements in data analysis become the standard of innovation and physician training meets demand, we expect to see an expansion of novel indications and its use in broader cohorts.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753567","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}
Pub Date : 2024-08-01DOI: 10.1080/17434440.2024.2380330
Fatima Kayali, Tiffany Agbobu, Thurkga Moothathamby, Yousif F Jubouri, Matti Jubouri, Amr Abdelhaliem, Samuel N S Ghattas, Samuel S S Rezk, Damian M Bailey, Ian M Williams, Wael I Awad, Mohamad Bashir
Introduction: Cardiogenic shock (CS) is a complex life-threatening condition that results from primary cardiac dysfunction, leading to persistent hypotension and systemic hypoperfusion. Among the therapeutic options for CS are various percutaneous mechanical circulatory support (MCS) devices that have emerged as an increasingly effective hemodynamic support option. Percutaneous therapies can act as short-term mechanical circulatory assistance and can be split into intra-aortic balloon pump (IABP) and non-IABP percutaneous mechanical devices.
Areas covered: This review will evaluate the MCS value while considering the mortality rate improvements. We also aim to outline the function of pharmacotherapies and percutaneous hemodynamic MCS devices in managing CS patients to avoid the onset of end-organ dysfunction and improve both early and late outcomes.
Expert opinion: Given the complexity, acuity and high mortality associated with CS, and despite the availability and efficacy of pharmacological management, MCS is required to achieve hemodynamic stability and improve survival. Various percutaneous MCS devices are available with varying indications and clinical outcomes. The rates of early mortality and complications were found to be comparable between the four devices, yet, IABP seemed to show the most optimal clinical profile whilst ECMO demonstrated its more long-term efficacy.
{"title":"Haemodynamic support with percutaneous devices in patients with cardiogenic shock: the current evidence of mechanical circulatory support.","authors":"Fatima Kayali, Tiffany Agbobu, Thurkga Moothathamby, Yousif F Jubouri, Matti Jubouri, Amr Abdelhaliem, Samuel N S Ghattas, Samuel S S Rezk, Damian M Bailey, Ian M Williams, Wael I Awad, Mohamad Bashir","doi":"10.1080/17434440.2024.2380330","DOIUrl":"10.1080/17434440.2024.2380330","url":null,"abstract":"<p><strong>Introduction: </strong>Cardiogenic shock (CS) is a complex life-threatening condition that results from primary cardiac dysfunction, leading to persistent hypotension and systemic hypoperfusion. Among the therapeutic options for CS are various percutaneous mechanical circulatory support (MCS) devices that have emerged as an increasingly effective hemodynamic support option. Percutaneous therapies can act as short-term mechanical circulatory assistance and can be split into intra-aortic balloon pump (IABP) and non-IABP percutaneous mechanical devices.</p><p><strong>Areas covered: </strong>This review will evaluate the MCS value while considering the mortality rate improvements. We also aim to outline the function of pharmacotherapies and percutaneous hemodynamic MCS devices in managing CS patients to avoid the onset of end-organ dysfunction and improve both early and late outcomes.</p><p><strong>Expert opinion: </strong>Given the complexity, acuity and high mortality associated with CS, and despite the availability and efficacy of pharmacological management, MCS is required to achieve hemodynamic stability and improve survival. Various percutaneous MCS devices are available with varying indications and clinical outcomes. The rates of early mortality and complications were found to be comparable between the four devices, yet, IABP seemed to show the most optimal clinical profile whilst ECMO demonstrated its more long-term efficacy.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141861922","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}
Pub Date : 2024-08-01Epub Date: 2024-07-24DOI: 10.1080/17434440.2024.2383376
Manuel Ángel Gómez-Ríos, Teresa López, Alfredo Abad-Gurumeta, José A Sastre
{"title":"Promoting the widespread adoption of videolaryngoscopy: addressing resistance to change.","authors":"Manuel Ángel Gómez-Ríos, Teresa López, Alfredo Abad-Gurumeta, José A Sastre","doi":"10.1080/17434440.2024.2383376","DOIUrl":"10.1080/17434440.2024.2383376","url":null,"abstract":"","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753568","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}
Pub Date : 2024-08-01Epub Date: 2024-07-25DOI: 10.1080/17434440.2024.2379925
Kyle Finos, Sanjit Datta, Art Sedrakyan, Jeffrey W Milsom, Bradley B Pua
Introduction: Augmented reality (AR) and virtual reality (VR) are emerging tools in interventional radiology (IR), enhancing IR education, preprocedural planning, and intraprocedural guidance.
Areas covered: This review identifies current applications of AR/VR in IR, with a focus on studies that assess the clinical impact of AR/VR. We outline the relevant technology and assess current limitations and future directions in this space. We found that the use of AR in IR lags other surgical fields, and the majority of the data exists in case series or small-scale studies. Educational use of AR/VR improves learning anatomy, procedure steps, and procedural learning curves. Preprocedural use of AR/VR decreases procedure times, especially in complex procedures. Intraprocedural AR for live tracking is accurate within 5 mm live patients and has up to 0.75 mm in phantoms, offering decreased procedure time and radiation exposure. Challenges include cost, ergonomics, rapid segmentation, and organ motion.
Expert opinion: The use of AR/VR in interventional radiology may lead to safer and more efficient procedures. However, more data from larger studies is needed to better understand where AR/VR is confers the most benefit in interventional radiology clinical practice.
{"title":"Mixed reality in interventional radiology: a focus on first clinical use of XR90 augmented reality-based visualization and navigation platform.","authors":"Kyle Finos, Sanjit Datta, Art Sedrakyan, Jeffrey W Milsom, Bradley B Pua","doi":"10.1080/17434440.2024.2379925","DOIUrl":"10.1080/17434440.2024.2379925","url":null,"abstract":"<p><strong>Introduction: </strong>Augmented reality (AR) and virtual reality (VR) are emerging tools in interventional radiology (IR), enhancing IR education, preprocedural planning, and intraprocedural guidance.</p><p><strong>Areas covered: </strong>This review identifies current applications of AR/VR in IR, with a focus on studies that assess the clinical impact of AR/VR. We outline the relevant technology and assess current limitations and future directions in this space. We found that the use of AR in IR lags other surgical fields, and the majority of the data exists in case series or small-scale studies. Educational use of AR/VR improves learning anatomy, procedure steps, and procedural learning curves. Preprocedural use of AR/VR decreases procedure times, especially in complex procedures. Intraprocedural AR for live tracking is accurate within 5 mm live patients and has up to 0.75 mm in phantoms, offering decreased procedure time and radiation exposure. Challenges include cost, ergonomics, rapid segmentation, and organ motion.</p><p><strong>Expert opinion: </strong>The use of AR/VR in interventional radiology may lead to safer and more efficient procedures. However, more data from larger studies is needed to better understand where AR/VR is confers the most benefit in interventional radiology clinical practice.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141763486","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}
Pub Date : 2024-08-01Epub Date: 2024-07-09DOI: 10.1080/17434440.2024.2378093
Laura Douze, Jessica Schiro, Louise Heyndels, Lionel Pazart, Sylvia Pelayo
Objective: Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice?
Methods: We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them.
Results: 77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients.
Conclusion: Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).
{"title":"Evaluations of medical device usability during clinical investigations: a scoping review of clinical study protocols.","authors":"Laura Douze, Jessica Schiro, Louise Heyndels, Lionel Pazart, Sylvia Pelayo","doi":"10.1080/17434440.2024.2378093","DOIUrl":"10.1080/17434440.2024.2378093","url":null,"abstract":"<p><strong>Objective: </strong>Combining clinical investigations with usability studies provides valuable information for medical devices evaluation. But both types of study are very different in terms of objectives and methodologies. How are usability studies integrated into clinical investigations in practice?</p><p><strong>Methods: </strong>We searched the ClinicalTrials.gov database for clinical investigation protocols that included usability outcome(s) and analyzed them.</p><p><strong>Results: </strong>77 study protocols were identified for the analysis, including 102 outcomes related to usability in total. The most frequently assessed outcomes were satisfaction (53/102) and ease of use (33/102). The questionnaire was the most frequently planned technique (85/102) followed by interviews (24/102). Other methods were used, such as observation (9/102), mostly when the end users was a healthcare professional, and diary (6/102), mostly with patients.</p><p><strong>Conclusion: </strong>Our study results showed that the collection of usability data can be included in a clinical investigation, with various levels of investment. Resource-light, rapid integration via a questionnaire will enable the collection of subjective data on the users' perceptions. When more resources are available, observation in accessible environments can be set up (especially during use by healthcare professionals in hospital) or interviews and/or diaries for home-based environments (especially by patients).</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141565409","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}
Pub Date : 2024-08-01Epub Date: 2024-07-31DOI: 10.1080/17434440.2024.2380801
André N Capitain, Bartosz Rylski, Tim Berger, Stoyan Kondov, Philipp Discher, Tim Walter, Nikola Batinkov, Magdalena Bork, Matthias D'Inka, Martin Czerny, Maximilian Kreibich
Introduction: Since its introduction in the mid-1990s the frozen elephant trunk (FET) technique has quickly evolved into an effective hybrid treatment option for patients with various thoracic aortic pathologies, acute and chronic. However, a notable incidence of and risk for distal aortic reinterventions persists after the implementation of the FET device. In this review, the authors analyze the indications and outcomes of thoracic endovascular aortic repair completion following FET.
Areas covered: For this review, we looked not only at our own data but also searched PubMed for relevant studies, comments, and current recommendations of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Additionally, we outline our approach in this 2-stage-treatment plan.
Expert opinion: The treatment of acute or chronic aortic pathologies involving the aortic arch frequently requires a 2-stage treatment approach. Sometimes, a tertiary procedure is needed to fix the entire aortic pathology. Thoracic endovascular aortic repair completion following FET requires careful planning to achieve the excellent clinical outcomes that we and numerous other aortic centers have shown. Only a dedicated aortic clinic provides the long-term continuous follow-up required to identify the few patients in need of a tertiary procedure.
简介:冷冻大象躯干(FET)技术自 20 世纪 90 年代中期问世以来,已迅速发展成为治疗各种胸主动脉病变(急性和慢性)患者的有效混合治疗方案。然而,在使用 FET 装置后,远端主动脉再介入的发生率和风险仍然显著存在。在这篇综述中,作者分析了 FET 后完成胸主动脉血管内修复的适应症和结果:为了撰写这篇综述,我们不仅查阅了自己的数据,还在 PubMed 上搜索了相关研究、评论以及欧洲心胸外科学会 (EACTS) 和欧洲血管外科学会 (ESVS) 目前的建议。此外,我们还概述了我们的两阶段治疗方案:专家意见:治疗涉及主动脉弓的急性或慢性主动脉病变通常需要采用两阶段治疗方法。专家观点:治疗涉及主动脉弓的急性或慢性主动脉病变通常需要两阶段治疗方法,有时需要三级手术来修复整个主动脉病变。在 FET 之后完成胸腔内主动脉血管修补术需要精心策划,以实现我们和其他许多主动脉中心所展示的卓越临床效果。只有专门的主动脉诊所才能提供所需的长期持续随访,以确定少数需要进行三级手术的患者。
{"title":"Thoracic endovascular aortic repair completion following frozen elephant trunk: how it's done and device selection.","authors":"André N Capitain, Bartosz Rylski, Tim Berger, Stoyan Kondov, Philipp Discher, Tim Walter, Nikola Batinkov, Magdalena Bork, Matthias D'Inka, Martin Czerny, Maximilian Kreibich","doi":"10.1080/17434440.2024.2380801","DOIUrl":"10.1080/17434440.2024.2380801","url":null,"abstract":"<p><strong>Introduction: </strong>Since its introduction in the mid-1990s the frozen elephant trunk (FET) technique has quickly evolved into an effective hybrid treatment option for patients with various thoracic aortic pathologies, acute and chronic. However, a notable incidence of and risk for distal aortic reinterventions persists after the implementation of the FET device. In this review, the authors analyze the indications and outcomes of thoracic endovascular aortic repair completion following FET.</p><p><strong>Areas covered: </strong>For this review, we looked not only at our own data but also searched PubMed for relevant studies, comments, and current recommendations of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society for Vascular Surgery (ESVS). Additionally, we outline our approach in this 2-stage-treatment plan.</p><p><strong>Expert opinion: </strong>The treatment of acute or chronic aortic pathologies involving the aortic arch frequently requires a 2-stage treatment approach. Sometimes, a tertiary procedure is needed to fix the entire aortic pathology. Thoracic endovascular aortic repair completion following FET requires careful planning to achieve the excellent clinical outcomes that we and numerous other aortic centers have shown. Only a dedicated aortic clinic provides the long-term continuous follow-up required to identify the few patients in need of a tertiary procedure.</p>","PeriodicalId":94006,"journal":{"name":"Expert review of medical devices","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141794288","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}