Expert Review of Medical Devices最新文献

{"title":"Single-lead VDD pacing: a literature review on short-term and long-term performance.","authors":"Davide Antonio Mei,&nbsp;Jacopo Francesco Imberti,&nbsp;Marco Vitolo,&nbsp;Niccolò Bonini,&nbsp;Luigi Gerra,&nbsp;Giulio Francesco Romiti,&nbsp;Marco Proietti,&nbsp;Gregory Y H Lip,&nbsp;Giuseppe Boriani","doi":"10.1080/17434440.2023.2178901","DOIUrl":"https://doi.org/10.1080/17434440.2023.2178901","url":null,"abstract":"<p><strong>Introduction: </strong>VDD pacing system was introduced more than 30 years ago. Its use is considered by the 2021 European Society of Cardiology guidelines on cardiac pacing as a potential alternative to dual chambers system for patients with atrioventricular block and normal sinus node function.</p><p><strong>Areas covered: </strong>In this article, we performed a narrative review of current literature in order to identify the strengths and weaknesses of this pacing system. VDD system allows the maintenance of AV synchronous pacing and its hemodynamic advantages. Some disadvantages may be related to the non-negligible incidence of atrial undersensing and the possible subsequent need for upgrade to DDD system. On the other hand, shorter implantation time and lower complications rate may be advantages.</p><p><strong>Expert opinion: </strong>In the modern pacing era, VDD pacing system struggles to find its own space. However, it may still be considered as a valuable alternative to a dual-chamber pacemaker for selected patients, in specific clinical scenarios.</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 3","pages":"187-197"},"PeriodicalIF":3.1,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9488937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development of theranostic wound dressings: harnessing the knowledge of biospecific interactions at the biomaterial interface to promote healing and identify biomarkers.","authors":"Shirin Saberianpour,&nbsp;Gianluca Melotto,&nbsp;Rachel Forss,&nbsp;Lucy Redhead,&nbsp;Jacqueline Elsom,&nbsp;Nadia Terrazini,&nbsp;Susan Sandeman,&nbsp;Dipak Sarker,&nbsp;Giselda Bucca,&nbsp;Andrew Hesketh,&nbsp;Cyril Crua,&nbsp;Matteo Santin","doi":"10.1080/17434440.2023.2181694","DOIUrl":"https://doi.org/10.1080/17434440.2023.2181694","url":null,"abstract":"Chronic wounds are widely recognized as a global health challenge, but both our understanding of wound biology and the implementation of technological innovations for their treatment have made only limited progress in the last few decades [1]. Currently, the clinical assessment of the wound is based on the experience of the clinicians who follow recommendations taken from a range of available guidelines and choose commercially available wound dressings on the basis of their suitability to the wound conditions [2]. For example, the Wounds UK’s best practice statement on the management of chronic wounds recommends several criteria for the assessment of lesions that are mainly based on a subjective clinical inspection of the overall wound bed and peri-wound area status (e.g. inflammation), the exudate volume and viscosity, pain, and infectiongenerated malodor. Methods of wound size measurement provide quantitative data, but they suffer from limited intra-rater reliability. Likewise, the choice of the most suitable wound dressing is made with the aim of providing biological conditions favorable to healing. Despite the wide range available, wound dressings are all designed with two main characteristics: (i) an absorbent layer made of a polymeric porous hydrogel capable of absorbing excess exudate while keeping the wound moist and (ii) a film (e.g. silicon) protecting the wound from external contaminants and bacteria [3]. More advanced wound dressings include anti-microbial agents (e.g. silver nanoparticles) or growth factors known to promote healing [3]. The use of the latter is limited by their costs, need for refrigerated storage conditions, and debated healing properties. In this context, up to 42% of wounds do not heal within 6 months from the first presentation, often leading to severe complications [4]. Based on these premises, the quest for both healing-promoting wound dressings and objective parameters of wound evaluation is legitimately advocated. 2. Theranostic wound dressings","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 3","pages":"163-165"},"PeriodicalIF":3.1,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9495563","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peregrine system infusion catheter for neurolytic renal denervation in hypertension: an overview of its safety and efficacy.","authors":"Adam Janas,&nbsp;Wojciech Wojakowski","doi":"10.1080/17434440.2023.2183838","DOIUrl":"https://doi.org/10.1080/17434440.2023.2183838","url":null,"abstract":"<p><strong>Introduction: </strong>Resistant hypertension (HTN), despite the tremendous advances in pharmacotherapy, is a major global problem. Transcatheter renal denervation (RDN) could be a pertinent strategy for resistant HTN and patients with poor pharmacotherapy adherence. Nonetheless, the adoption of energy-based RDN in clinical practice is slow and alternative approaches are needed.</p><p><strong>Areas covered: </strong>The review focuses on the assessment of the Peregrine System Infusion Catheters. The system is designed for chemically mediated transcatheter RDN by the infusion publications on the Peregrine system. The theoretical assumptions for chemically mediated RDN, design of the system, data from preclinical and clinical studies, and further perspectives are discussed.</p><p><strong>Expert opinion: </strong>Peregrine System Infusion Catheters are the only catheter on the market designed for chemically mediated RDN by the infusion of the neurolytic agent. Chemical neurolysis more efficiently destroys nerves around the renal artery in comparison to energy-based catheters, due to deeper tissue penetration and circumferential distribution resulting in a wider range of effective nerve injury. Chemically mediated RDN by the infusion of the neurolytic agent (alcohol) has an excellent safety profile as confirmed in initial clinical trials which also suggested high efficacy. Currently, there is an ongoing phase III sham-control study. Other possible applications of this technology include clinical settings like heart failure or atrial fibrillation.</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 3","pages":"179-186"},"PeriodicalIF":3.1,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9119971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of patients with bicuspid and tricuspid aortic valve in transcatheter aortic valve implantation.","authors":"Zhongkai Zhu,&nbsp;Tianyuan Xiong,&nbsp;Mao Chen","doi":"10.1080/17434440.2023.2184686","DOIUrl":"https://doi.org/10.1080/17434440.2023.2184686","url":null,"abstract":"<p><strong>Background: </strong>Transcatheter aortic valve implantation (TAVI) has emerged as a safe and effective alternative to surgery for aortic stenosis (AS). However, there are still differences in the procedural process and outcome of bicuspid aortic valve (BAV) treated with TAVI compared with tricuspid aortic valve.</p><p><strong>Areas covered: </strong>This review paper aims to summarize the main characteristics and clinical evidence of TAVI in patients with bicuspid and tricuspid aortic valves and compare the outcomes of TAVI procedure.</p><p><strong>Expert opinion: </strong>The use of TAVI in patients with BAV has shown similar clinical outcomes compared with tricuspid aortic valve. The efficacy of TAVI for challenging BAV anatomies remains a concern due to the lack of randomized trials. Detailed preprocedural planning is of great importance in low-surgical-risk BAV patients. A better understanding of which subtypes of BAV anatomy are at greater risk for adverse outcomes can potentially benefit the selection of TAVI or open-heart surgery in low surgical risk AS patients.</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 3","pages":"209-220"},"PeriodicalIF":3.1,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9119477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tests for the identification of reflex syncope mechanism.","authors":"Michele Brignole,&nbsp;Giulia Rivasi,&nbsp;Artur Fedorowski,&nbsp;Marcus Ståhlberg,&nbsp;Antonella Groppelli,&nbsp;Andrea Ungar","doi":"10.1080/17434440.2023.2174428","DOIUrl":"https://doi.org/10.1080/17434440.2023.2174428","url":null,"abstract":"<p><strong>Introduction: </strong>Treatment efficacy of reflex syncope is mainly related to the mechanism underlying syncope rather than its etiology or clinical presentation. The predominant mechanism underlying reflex syncope can be assigned to hypotensive or to bradycardic phenotypes.</p><p><strong>Areas covered: </strong>Methodology and diagnostic criteria of the most useful tests for the identification of hypotensive and bradycardic phenotypes are discussed. Diagnostic tests for the hypotensive phenotype include office blood pressure measurement with active standing test, home, and wearable blood pressure monitoring, 24-h ambulatory blood pressure monitoring and tilt table test. Diagnostic tests for the bradycardic phenotype include carotid sinus massage, tilt table test and prolonged ECG monitoring.</p><p><strong>Expert opinion: </strong>In reflex syncope, the documentation of bradycardia/asystole during a syncopal episode does not rule out the possibility that a preceding or parallel hypotensive reflex plays an important role. Similarly, even when a hypotensive mechanism is established, the possibility of an associated cardioinhibitory reflex should be investigated. Investigating the mechanism of reflex syncope is mandatory in patients with severe recurrent episodes, with the final aim to develop a personalized treatment strategy. Recent trials have demonstrated the benefits of personalized mechanism-based therapy, thus highlighting the importance of a comprehensive assessment of the mechanisms underlying syncope.</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 2","pages":"109-119"},"PeriodicalIF":3.1,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9072634","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Partial vs full glottic view with CMAC^TM D blade intubation of airway with simulated cervical spine injury: a randomized controlled trial.","authors":"Chao Chia Cheong,&nbsp;Soon Yiu Ong,&nbsp;Siu Min Lim,&nbsp;Wan Zakaria Wan A,&nbsp;Marzida Mansor,&nbsp;Sook Hui Chaw","doi":"10.1080/17434440.2023.2174850","DOIUrl":"https://doi.org/10.1080/17434440.2023.2174850","url":null,"abstract":"<p><strong>Purpose: </strong>A previous study reported a shorter time to tracheal intubation by reducing percentage of glottic opening (POGO) view to <50% when intubating a normal adult airway using the Glidescope^TM blade. We evaluate the efficacy of reducing POGO to <50% when intubating patients with rigid cervical immobilization using CMAC^TM D blade.</p><p><strong>Methods: </strong>One hundred and four adult patients were randomized to group POGO 100% or POGO <50% . Laryngoscopy was performed by advancing tip of the D blade at vallecula. POGO 100% was achieved by exerting upward force to displace epiglottis until glottic opening from the anterior commissure to inter arytenoid notch. POGO < 50% was acquired by withdrawing the D blade tip dorsally from vallecula. The primary outcome was time to intubation.</p><p><strong>Results: </strong>The median time (IQR) to successful intubation was 29 (25-35) seconds for group POGO < 50% and 34 (28-40) seconds for group with POGO 100% (difference in medians, 5 seconds; 95% confidence interval, 2 to 8, p = 0.003). Complications were minor.</p><p><strong>Conclusion: </strong>Using the CMAC^TM D blade with a reduced POGO in patients with cervical spine immobilization resulted in faster tracheal intubation.</p><p><strong>Trial registration: </strong>The trial is registered at ClinicalTrial.gov (CT.gov identifier: NCT04833166).</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 2","pages":"151-160"},"PeriodicalIF":3.1,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9383243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Addendum.","authors":"Jack Kingdon,&nbsp;Adam Gwozdz,&nbsp;Rachael Morris,&nbsp;Stephen Black,&nbsp;Alberto Smith,&nbsp;Prakash Saha","doi":"10.1080/17434440.2022.2152229","DOIUrl":"https://doi.org/10.1080/17434440.2022.2152229","url":null,"abstract":"","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 2","pages":"161"},"PeriodicalIF":3.1,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9495034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"EVO/EVO+ Visian Implantable Collamer Lenses for the correction of myopia and myopia with astigmatism.","authors":"Elena Martínez-Plaza,&nbsp;Alberto López-de la Rosa,&nbsp;Alberto López-Miguel,&nbsp;Alfredo Holgueras,&nbsp;Miguel J Maldonado","doi":"10.1080/17434440.2023.2174429","DOIUrl":"https://doi.org/10.1080/17434440.2023.2174429","url":null,"abstract":"<p><strong>Introduction: </strong>Intraocular lens implantation in phakic eyes for the correction of refractive error is currently a widespread procedure. The EVO and EVO+ Visian Implantable Collamer Lenses (ICL) are two of the most prevalent lenses implanted. They incorporate a central orifice to avoid the need for iridotomy. The main difference between both ICL is the higher optical diameter zone provided by the EVO+, allowing a better quality of vision at night. This review aims to provide an overview of the current ICL models available for correcting myopia and myopic astigmatism.</p><p><strong>Areas covered: </strong>During the last decade, more than 100 scientific papers analyzing the performance of EVO and EVO+ lenses have been published. This review describes the objective visual performance achieved with the implantation of central hole ICL lenses and the subjective perception of the patients implanted with these lenses. In addition, the safety and the potential complications associated with undergoing an EVO and EVO+ ICL implantation have been addressed.</p><p><strong>Expert opinion: </strong>Refractive surgeons and candidates to undergo ICL implantation should be aware of the excellent safety and visual outcomes provided by the implantation of central hole ICL lenses. However, future research could address minor issues currently not resolved.</p>","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 2","pages":"75-83"},"PeriodicalIF":3.1,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10827622","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transcatheter edge-to-edge mitral valve repair in mitral regurgitation: current status and future prospects.","authors":"Lukas Stolz,&nbsp;Daniel Braun,&nbsp;Satoshi Higuchi,&nbsp;Martin Orban,&nbsp;Philipp M Doldi,&nbsp;Thomas J Stocker,&nbsp;Ludwig T Weckbach,&nbsp;Mirjam G Wild,&nbsp;Christian Hagl,&nbsp;Steffen Massberg,&nbsp;Michael Näbauer,&nbsp;Jörg Hausleiter,&nbsp;Mathias Orban","doi":"10.1080/17434440.2022.2098013","DOIUrl":"https://doi.org/10.1080/17434440.2022.2098013","url":null,"abstract":"ABSTRACT Introduction Mitral regurgitation (MR) is associated with substantial morbidity and mortality. Within the past 15 years, mitral valve edge-to-edge repair (M-TEER) has developed from an experimental approach to a guideline-recommended, safe, and effective treatment option for patients with severe primary or secondary mitral regurgitation. Areas covered This review covered relevant publications of M-TEER and summarizes the development of M-TEER devices within the last 15 years. It outlines anatomical challenges which drove the evolution of M-TEER devices, provides an overview about the current state of clinical application and research, and offers an outlook into the future of transcatheter mitral valve treatment. Expert opinion The development and refinement of new M-TEER device generations offer the possibility to treat a wide range of mitral valve anatomies. Choosing the best device for the individual anatomic properties of the patients and considering comorbidities is the key to maximized MR reduction, minimalized complication rates, and thus optimized postinterventional prognosis. Independent from prognostic implications, quality of life has become an important patient-centered outcome that can be improved by M-TEER in virtually all patients treated.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 2","pages":"99-108"},"PeriodicalIF":3.1,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10825587","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prevention of prosthetic joint infection/surgical site infection: what did the International Consensus Meeting decide?","authors":"Farideh Najafi,&nbsp;Neusha Hollingsworth,&nbsp;Nicholas V Peterson,&nbsp;Javad Parvizi","doi":"10.1080/17434440.2023.2174849","DOIUrl":"https://doi.org/10.1080/17434440.2023.2174849","url":null,"abstract":"Surgical site infection (SSI) and periprosthetic joint infection (PJI) are devastating complications following orthopedic surgery [1]. Hence, the prevention of these infections is of paramount importance. During the 2018 International Consensus Meeting (ICM), numerous proposals regarding the prevention of SSI/PJI were discussed. A large contingent comprising 869 delegates from 68 countries and different subspecialties (hip and knee, foot and ankle, oncology, pediatrics, shoulder and elbow, spine, sports, and trauma) worked to develop consensus on the most effective methods of prevention of SSI/PJI. The conclusions and recommendations of ICM 2018 will be discussed in this article.","PeriodicalId":12330,"journal":{"name":"Expert Review of Medical Devices","volume":"20 2","pages":"71-74"},"PeriodicalIF":3.1,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9495078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}