Expert review of medical devices最新文献

Introduction: The direct anterior approach (DAA) has its origins in the first and oldest approach for hip replacement in the literature, but at the same time it would not be fanciful to suggest its increasing popularity as the latest approach for hip replacement procedures, especially among younger surgeons. However, in a geographical context, the DAA is not considered the major approach in most countries. Moreover, the term DAA encompasses numerous variations in terms of technique.

Areas covered: In this narrative review, we describe our recent experience of advances in the DAA in terms of improved techniques and devices, along with some of its disadvantages. Also, we express our perspective on its future application.

Expert opinions: The DAA is established as one of exemplary approaches to THA. The use of fluoroscopy, the traction table, and appropriate soft tissue management has become essential in the DAA for a safe and trouble-free procedure with adequate patient comfort. With the combination of recent technologies such as robotics, three-dimensional preoperative planning, and artificial intelligence (AI)-based surgeon assist systems, we can look forward to the DAA being performed more efficiently in the future.

Introduction: A clear consensus exists on the role of IUS for the assessment and monitoring of Crohn's disease (CD) in the 'treat-to-target' strategy.

Areas covered: IUS is an accurate tool for the management of CD. It is noninvasive and well tolerated. IUS has good-to-optimal inter-operator reliability either for assessing disease activity or for evaluating treatment response, especially combining Bowel Wall Thickness (BWT) and Color Doppler Signals (CDS). IUS is able to evaluate transmural remission (TR), the ultimate goal of the 'treat-to-target' strategy. Several studies confirmed its accuracy in the assessment of the post-operative recurrence (POR). Thanks to recent advances in trans-perineal ultrasound technique (TPUS), it allows to characterize peri-anal disease and its complications. Small intestine contrast ultrasound (SICUS) and contrast-enhancement ultrasound (CEUS) may improve IUS performance, particularly in stricturing or penetrating CD. Ultrasound elastography (USE) is raising interest for its accuracy in differentiating CD phenotypes (fibrotic versus inflamed).

Expert opinion: IUS is a pivotal step in the management of CD, in early assessment as in therapeutic monitoring, with advantages of evaluating transmural response. Development and validation of novel ultrasound biomarkers of activity and fibrosis, especially those linked to advanced ultrasound techniques, are expected in the coming years.

Introduction: The Valsalva maneuver and its modifications have been utilized across several conditions in medicine; however, there have been difficulties in its application. Thus, at the University of Texas Health Science Center in San Antonio, we designed and patented an affordable and accessible device that mimics Valsalva called "Forced Inspiratory Suction and Swallow Tool (FISST).

Areas covered: In this review, we discuss the premise for the design of FISST, based on applications of the law of conservation energy, the continuity equation, and Bernoulli's principle. We then detail the mechanism by which FISST stimulates hiccup cessation by increasing negative inspiratory pressure when drinking through the apparatus, causing diaphragmatic contraction and disruption of the hiccup reflex. We then detail the efficacy and future applications of FISST in addressing other pathologies.

Expert opinion: FISST has been used to address hiccups by utilizing its reverse-Valsalva effect to increase parasympathetic stimulation by increasing vagal tone. In a prospective study that we conducted on a cohort of 249 hiccup subjects worldwide, this tool achieved 92% effectiveness. Additionally, several cases, including a published case report, have found FISST successful in terminating supraventricular tachycardias (SVT). FISST may be further utilized in diagnosing or addressing various upper airway pathologies and should be explored further.

Introduction: With the increasing demand for total knee arthroplasty (TKA) and the burden of revision TKA on the healthcare system, as well as the quality of life implications for patients, it is extremely important for surgeons to be able to anticipate and prevent TKA mechanical complications. Surgeons must be familiar with the different causes and mechanisms of TKA complications so that they can properly treat patients with failed TKAs and better avoid these complications.

Areas covered: This review addresses TKA mechanical complications and provides context for the topic. A detailed review of surgical factors, implant factors, and patient factors that contribute to mechanical complications after TKA is provided. All of the literature cited in this review was gathered from the PubMed online database using different keywords based on the section of the manuscript.

Expert opinion: As surgeons and engineers solve certain issues in TKA, new challenges will inevitably arise. We must continue to push forward and innovate from both a surgical technique and implant design perspective.

Introduction: Postpartum depression (PPD) is common, persistent, and stigmatized. There are insufficient trained professionals to deliver appropriate screening, diagnosis, and treatment.

Areas covered: WB001 is a Software as a Medical Device (SaMD) based Agent-Guided Cognitive-Behavioral Therapy (AGCBT) program for the treatment of PPD, for which Breakthrough Device Designation was recently granted by the US Food and Drug Administration. WB001 combines therapeutic alliance, human-centered design, machine learning techniques, and established principles from CBT and interpersonal therapy (IPT). We introduce AGCBT as a new model of service delivery, whilst describing Woebot, the agent technology that enables guidance through the replication of some elements of human relationships. The profile describes the device's design principles, enabling technology, risk handling, and efficacy data in PPD.

Expert opinion: WB001 is a dynamic and personalized tool with which patients may establish a therapeutic bond. Woebot is designed to augment (rather than replace) human healthcare providers, unlocking the therapeutic potency associated with guidance, whilst retaining the scalability and agency that characterizes self-help approaches. WB001 has the potential to improve both the quality and the scalability of care through providing support to patients on waiting lists, in between clinical encounters, and enabling automation of measurement-based-care.

Introduction: Transcatheter aortic valve implantation (TAVI) is the standard of care for selected patients with severe aortic stenosis, irrespective of the surgical risk. Over the last two decades of TAVI practice, multiple limitations were identified. In addition, the extension of TAVI into a wider patient spectrum created new challenges.

Areas covered: This review provides an overview of emerging transcatheter heart valves (THVs) beyond the approved contemporary THVs for the treatment of aortic stenosis.

Expert opinion: The incidence of degenerative aortic stenosis is expected to increase with more aging of the population. Therefore, TAVI needs to meet this increase in the number of patients indicated for aortic valve replacement alongside a wide and complex anatomical variability. An increasing number of Aortic THVs are available in the market. This includes upgraded iterations of contemporary devices and innovative devices developed by emerging manufacturers. The new devices aim for the reduction or elimination of undesirable outcomes like paravalvular leakage and conduction disturbances requiring permanent pacemaker implantation. Alternatively, emerging THVs should provide feasibility regarding yet unproven TAVI indications like Bicuspid aortic valve, aortic regurgitation, or very large anatomy. Furthermore, some of the emerging THVs are designed to tackle the long-term durability issue of biological valves.

Background: More than 20 years have passed since the first company introduced drug-eluting stent (DES) in 2002, but competing companies still have improved their DESs under regulatory approval. This study aimed to investigate the criteria for interventional cardiologists performing percutaneous coronary intervention (PCI) in selecting a DES.

Research design and methods: From 10 April 2023, to 30 April 2023, 3,422 cardiologists were requested to complete a questionnaire, of whom 126 responded to the survey.

Results: Overall, 86.5% of the respondents used Xience cobalt-chromium everolimus-eluting stent (Xience) in > 10% of PCI procedures. For Xience, brand loyalty and calcified lesions were important independent variables for the DES selection criteria. Ultimaster sirolimus-eluting stent (Ultimaster) was not affected by the clinical data delivered by the company, whereas the respondents were shown to seek support for their activities from the Ultimaster supplier. The relationship with the company and/or sales representative and the planned surgical procedure affected the use of Coroflex ISAR NEO sirolimus-eluting polymer-free stent.

Conclusions: Patient background and lesion characteristics had little impact on the DES selection criteria, suggesting that DES performance has already reached its physical limitations to the extent that respondents may not value further improvements in performance or characteristics of DES.

Background: The telemedicine/telehealth is well established and rapidly evolving innovation in modern practice of medicine. It is used in nearly every aspect of obstetrics and gynecology. Telehealth intervention may reduce the need for in-person visits amongst high-risk obstetric patients. It is an effective innovation for chronic gynecological conditions.

Research design and methods: This was a prospective, observational study where the online platform 'e-Sanjeevani' was used. It was a health care worker to doctor (specialist) consultation regarding the patient. After an interaction, provisional diagnosis and management plan was made, and an electronic prescription for the same was generated and printed at the patient's end.

Results: A total of 3219 patients were attended in 10 months. The majority of the cases had a gynecological problem (71.5%), with menstrual irregularity being the commonest. Among pregnant patients, consultations for early pregnancy complications were made in 29% of the cases. 5.8% were referred because of some surgical intervention.

Conclusion: Non-emergency patients who can be managed medically can be prevented from unnecessary visits to the hospital and managed through teleconsultation, which decreases the burden of patient load at the tertiary center.