Device-based Technologies Research Articles

Innovations in intestinal organoid technology featuring an open apical surface.

Since the development of the three-dimensional (3D) "mini-gut" culture system, adult stem cell-derived organoid technology has rapidly advanced, providing in vitro models that replicate key cellular, molecular, and physiological properties of multiple organs. The 3D intestinal organoid system has resolved many long-standing challenges associated with immortalized or cancer cell cultures, offering unparalleled capabilities for modeling gastrointestinal development and diseases. However, significant limitations remain, including restricted accessibility to the epithelial apical surface for studying host-microbe interactions, interruptions in modeling chronic gastrointestinal diseases due to frequent passaging and dissociation, and the absence of mechanical cues such as peristalsis and luminal flow, which are critical for organ development and function. To address these challenges, recent advancements have introduced Transwell-based monolayer cultures and microfluidic device-based technologies including "organ-on-a-chip" and scaffold-guided 'mini-gut' system. This review highlights these innovations, with a focus on adult stem cell-derived intestinal organoid models that feature an open apical surface and discusses their prospects and challenges for advancing basic research and clinical applications.

PP40 Structuring Unstructured Medical Device Reimbursement In India

IntroductionAs India makes rapid strides towards universal health coverage, focusing on medical device reimbursement is key to ensuring patient access to device-based technologies. The nascent medical device reimbursement process offers a promising opportunity for interventions driven by a diverse group of stakeholders. We conducted policy research to capture these diverse perspectives and highlight key elements to develop a structured framework for reimbursement.MethodsThis research was a two-part process, including secondary research with expert interviews followed by policy research using focus group discussions (FGDs) through an online workshop with key stakeholders. We developed a white paper proposing changes to the reimbursement pathway, based on a benchmarking study of global markets and interviews with experts in the field. As a next step, key changes proposed in the white paper were deliberated upon by three focus groups (six to eight participants). Group participants were selected by quota sampling and represented key stakeholders in the reimbursement process. A discussion guide was used to capture participants’ opinions and an addendum to the white paper was released highlighting small, actionable, and impactful changes to the reimbursement process.ResultsFGDs with key stakeholders highlighted the need to establish a more structured, inclusive, and transparent process. Accordingly, we proposed key recommendations to the medical device reimbursement process in India. A first change is the creation of an online submission portal allowing different healthcare stakeholders to submit new technologies for consideration through a streamlined pathway. Secondly, we proposed enhancing evaluation transparency by improving availability of publicly shared information on the evaluation process, metrics, and assessment timelines. We also suggested adoption of adaptive health technology assessments to leverage existing evidence for faster, efficient decision-making.ConclusionsThrough this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care for poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd (now Abbott).

Heart Failure in Complex Congenital Heart Disease of the Adult.

Adult congenital heart disease (ACHD) patients have demonstrated improved survival, especially those with severely complex disease, mainly single-ventricle/Fontan physiology and those with a systemic right ventricle. We describe the heart failure phenotypes of complex CHD, reversible causes for heart failure, and considerations for advanced therapy. While initially marketed for application to patients with acquired causes for heart failure, newer devices and technologies have started to be used in the ACHD population. After reversible causes for heart failure in CHD are addressed, it is reasonable to consider use of new device-based technologies and orthotopic heart transplant (OHT) for end-stage disease. New heart failure technology and organ transplant should carefully be considered and applied in complex ACHD, where there may be significant improvement in morbidity and mortality.

New Strategies to Prevent Rehospitalizations for Heart Failure.

Purpose of reviewHeart failure (HF) hospitalizations are common, costly, associated with poor outcomes and potentially avoidable. Reducing HF hospitalizations is therefore a major objective of US healthcare. This review aims to outline causes for HF hospitalizations and provides actionable strategies for HF hospitalization prevention.Recent findingsHeart failure hospitalizations often have multifactorial and diverse etiologies associated with medical and social patient factors leading to increased congestion. The most recently updated American Heart Association/American College of Cardiology/Heart Failure Society of America Guidelines for the Management of HF were published in 2022 and utilize high-quality evidence to offer a framework for analyzing and preventing HF hospitalizations.SummaryPrevention of hospitalizations can be achieved by optimizing guideline-directed medical therapies, incorporating appropriate device-based technologies, and utilizing systems-based practices. By identifying treatment gaps and opportunities for improved HF care, this review comprehensively defines the challenges associated with HF rehospitalizations as well as potential solutions.

A comprehensive analysis of the 21st century's research trends in English Mobile Learning: a bibliographic review of the literature

PurposeThis study examines the importance of English Mobile Learning research as a foundation for lifelong and sustainable education from different points of view, including those of technology innovation experts, psychologists and educators. It aims to explore the current status and relevant research trends through the application of bibliometric mapping and bibliometric analysis.Design/methodology/approachFor this study, all Web of Science records (in total 5,343) from 2000 to 2020 in the field of English Mobile Learning were analyzed using the VOSviewer and CiteSpace software tools. The WoS built-in functions, including “Refine” and “Analyze,” were employed to perform the bibliometric analysis. The study further analyzed a sample of the five most-cited articles to identify the previous studies with the highest quality or impact.FindingsThe results showed that research in English Mobile Learning is growing quickly and steadily with a noticeable emphasis on various device-based technologies and applications. The study also discusses the key implications for research institutions, education policymakers and academicians, and identifies the most prominent avenues for future research on English Mobile Learning. Moreover, the results shared in this review highlight the most important and emerging areas of research in the field.Originality/valueThis article is the most recent bibliographic review of literature that particularly addresses the English Mobile Learning research during the past two decades.

A Compendium on Hypertension: New Advances and Future Impact.

A Compendium on Hypertension: New Advances and Future Impact.

PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

Cardiac resynchronization therapy: state of the art 2013

Cardiac resynchronization therapy (CRT) is currently an established device therapy for heart failure (HF) patients. Cumulated knowledge on the pathophysiological mechanisms, implantation techniques, advancement of device-based technologies, and clinical trial experience has impacted on this evolving therapy significantly in the last few years. This article will address the updated CRT guideline and potentially new indications of CRT such as patients with New York Heart Association Class I, normal QRS duration, and non-HF patients with pacing indications. Furthermore, important but unresolved issues will also be discussed which include the impact of QRS morphology and QRS duration on CRT response, new approaches for placement of left ventricular (LV) lead, multisite LV pacing, and the role of HF disease monitoring program.

Highlights in clinical autonomic neurosciences: Device-based therapy for resistant hypertension

Hypertension is one of the most significant medical problems affecting society today. There is a significant burden of both morbidity and mortality resulting directly from uncontrolled hypertension, and this adds greatly to healthcare costs. This burden is not restricted to North America and Europe, but has a worldwide impact. The challenges to treating hypertension are numerous. Importantly, the problem is often multifactorial. Contributions to hypertension in any one individual can result from perturbations in the renin–angiotensin–aldosterone system, problems with endothelial function involving the nitric oxide or endothelin systems, as well as problems involving the autonomic nervous system and, in particular, the sympathetic nervous system. There are many pharmaceutical agents available to treat hypertension that target different points in these multiple pathways. Despite these multiple therapeutic options, sometimes multiple drugs are not enough. Resistant hypertension is defined as elevated blood pressure despite at least 3 antihypertensive medications from different drug classes. There are two recent devicebased technologies that are being developed to help treat resistant hypertension. The first involves a radiofrequency ablation of renal sympathetic nerves. The second involves chronic stimulation of the carotid baroreceptors. Studies have recently been published during the development of these two different technologies.

Review: The New Concept of ‘‘Interventional Heart Failure Therapy’’: Part 2—Inotropes, Valvular Disease, Pumps, and Transplantation

Recent advances in heart failure therapy include a variety of mechanical and device-based technologies that target structural aspects of heart failure that cannot be treated with drug therapy alone; these newer therapies can collectively be described as interventional heart failure therapy. This article is the second in a 2-part series reviewing interventional heart failure therapy. Interventions included in this discussion include those indicated for the treatment of end-stage refractory heart failure, including interventional medical therapy, interventional treatment of valvular disease, mechanical assist devices, and heart transplantation. Also included is a review of the currently available catheter-based pumps, which are intended to provide temporary support in patients with acute hemodynamic compromise. The use of cellular or stem cell therapy for the treatment of heart failure is an emerging interventional therapy and data supporting its use for the treatment heart failure will also be presented, as will a discussion of the role of palliative care and self-care in heart failure therapy.

Ventilator-associated pneumonia: current status and future recommendations

Ventilator-associated pneumonia (VAP) is a common hazardous complication in ICU patients. The aim of the current review is to give an update on the current status and future recommendations for VAP prevention. This article gives an updated review of the current literature on VAP. The first part briefly reviews pathogenesis and epidemiology while the second includes an in-depth review of evidence-based practice guidelines (EBPG) and new technologies developed for prevention of VAP. VAP remains a frequent and costly complication of critical illness with a pooled relative risk of 9-27% and mortality of 25-50%. Strikingly, VAP adds an estimated cost of more than $40,000 to a typical hospital admission. An important aetiological mechanism of VAP is gross or micro-aspiration of oropharyngeal organisms around the cuff of the endotracheal tube (ETT) into the distal bronchi. Prevention of VAP is preferable. Preventative measures can be divided into two main groups: the implemen- tation of EBPGs and use of device-based technologies. EBPGs have been authored jointly by the American Thoracic Society and the Infectious Diseases Society of America. The Canadian Critical Care Trials group also published VAP Guidelines in 2008. Their recommendations are detailed in this review. The current device-based technologies include drainage of subglottic secretions, silver coated ETTs aiming to influence the internal bio-layer of the ETT, better sealing of the lower airways with ultrathin cuffs and loops for optimal cuff pressure control. EBPG consensus includes: elevation of the head of the bed, use of daily "sedation vacations" and decontamination of the oropharynx. Technological solutions should aim to use the most comprehensive combination of subglottic suction of secretions, optimization of ETT cuff pressure and ultrathin cuffs. VAP is a type of hospital-acquired pneumonia that develops more than 48 h after endotracheal intubation. Its incidence is estimated to be 9-27%, with a mortality of 25-50% [Am J Respir Crit Care Med 171:388-416 (2005), Am J Med 85:499-506 (1988), Chest 122:2115-2121 (2002), Intensive Care Med 35:9-29 (2009)]. The most important target in VAP handling is its prevention. The aim of this article is to review the pathogenesis, epidemiology and the different strategies/technologies for prevention of VAP.

Advances in Imaging Technology and the Growth of Vascular and Interventional Radiology: A Brief History

THE development of vascular and interventional radiology (IR) as a discipline or a set of patient-care techniques can be described from many viewpoints. One could study its pioneering and innovative physicians or assess how advances in catheters and other device-based technologies have influenced the course of vascular and IR. This article will focus on how imaging technology has shaped the discipline. The advent and subsequent evolution of the modern fluoroscopically based angiographic interventional suite enabled the development of early diagnostic angiography and subsequent interventions. Cross-sectional imaging techniques such as computerized axial tomography and real-time ultrasound (US) also enabled the development of specific interventions. These modalities have also had a profound influence on case selection and case mix and have helped catalyze the evolution of vascular and IR into an interventional specialty. The first iodine-based contrast arteriogram in a patient was reported in 1929 by Dos Santos (1), approximately 34 years after the discovery of the x ray (2) and almost simultaneously with the description of the first iodinated contrast medium (3). Without the benefit of fluoroscopy, a nonselective aortogram could be obtained only by a blind translumbar puncture advancing a stiff metallic cannula with use of surface anatomic landmarks. Filming consisted of a timed single radiographic exposure. Evolution of the translumbar technique was relatively glacial for three decades, probably for two reasons. First, there was no real push to develop it because there were few operative techniques for atherosclerotic occlusive disease or aneurysmal disease, and therefore there were few real indications for the procedure. Second, there was no practical imaging technique that allowed easy and effective visualization of catheter manipulation in real time.