Expert Review of Medical Devices

INTRODUCTION: Right heart failure (RHF) is a well-known complication after left ventricular assist device (LVAD) implantation and portends increased morbidity and mortality. Understanding the mechanisms and predictors of RHF in this clinical setting may offer ideas for early identification and aggressive management to minimize poor outcomes. A variety of medical therapies and mechanical circulatory support options are currently available for the management of post-LVAD RHF. AREAS COVERED: We reviewed the existing definitions of RHF including its potential mechanisms in the context of durable LVAD implantation and currently available medical and device therapies...

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INTRODUCTION: Osteoarthritis is a musculoskeletal disease that can lead to the loss and inability of those affected to perform normal daily functions, which leads to a decrease in quality of life. The main symptoms of osteoarthritis are tenderness, joint pain, stiffness, crepitus, limited movement, and local inflammation. AREAS COVERED: The selected patents were deposited from 2010 to April 2022 involving 57 documents that were in line with the study objective in the final selection...

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is becoming the standard of care for severe symptomatic aortic stenosis (AS). Yet, some patients with AS are not indicated/eligible for TAVI. Several noninvasive, catheter-based or surgical alternatives exist, and other therapeutic options are emerging. AREAS COVERED: This review provides an overview of non-TAVI options for severe AS. Non-invasive, transcatheter, and alternative surgical strategies are discussed, emphasizing their backgrounds, techniques, and outcomes...

INTRODUCTION: Single-pulse transcranial magnetic stimulation (TMS) has many applications for pediatric clinical populations, including infants with perinatal brain injury. As a noninvasive neuromodulation tool, single-pulse TMS has been used safely in infants and children to assess corticospinal integrity and circuitry patterns. TMS may have important applications in early detection of atypical motor development or cerebral palsy. AREAS COVERED: The authors identified and summarized relevant studies incorporating TMS in infants, including findings related to corticospinal development and circuitry, motor cortex localization and mapping, and safety...

INTRODUCTION: The advancement of hybrid PET/CT or PET/MRI imaging for non-prostate genitourinary cancers has not experienced the rapid progress of prostate cancer. Nevertheless, these neoplasms are aggressive and reliable imaging plays a pivotal role in enhancing patients' quality of life and prognosis. AREAS COVERED: the main evidence regarding [18 F]FDG and non-[18 F]FDG PET/CT or PET/MRI in non-prostate uro-oncological malignancies are summarized and discussed...

INTRODUCTION: Over the last two decades, mitral transcatheter edge-to-edge repair (M-TEER) has become a safe and effective therapy for severe mitral regurgitation in patients deemed at high surgical risk. AREAS COVERED: This review aims to encompass the most relevant and updated evidence in the field of M-TEER from its inception, focusing on clinical and anatomical features for proper patient and device selection. EXPERT OPINION: Growing operator experience and device iterations have resulted in improved clinical outcomes and an expansion of the therapy to patients with complex anatomies and clinical scenarios...

OBJECTIVES: The purpose of this study was to investigate the efficacy of noninvasive auricular vagus nerve stimulation (AVNS) on sports performance. METHODS: The intervention group ( n  = 30) received a single session of AVNS, while the control group ( n  = 30) received a single session of sham AVNS. Pre- and post-treatment isometric quadriceps muscle strength, heart rate, lower extremity balance, and grip strength were measured. RESULTS: It was ascertained that the differences in heart rate (-0...

OBJECTIVES: To investigate the clinical value of rigid bronchoscopy combined with fiberoptic bronchoscopy in patients with early bronchogenic lung cancer who underwent sleeve lobectomy. METHODS: A retrospective study was performed on 76 patients with early bronchogenic lung cancer admitted to our center from March 2016 to March 2017. Patients in the control group received conventional sleeve lobectomy ( n  = 38), while patients in the observation group underwent sleeve lobectomy by using rigid bronchoscopy combining fiberoptic bronchoscopy ( n  = 38)...

INTRODUCTION: Wearable devices and telemedicine are increasingly used to track health-related parameters across patient populations. Since gait and postural control deficits contribute to mobility deficits in persons with movement disorders and multiple sclerosis, we thought it interesting to evaluate devices in telemedicine for gait and posture monitoring in such patients. METHODS: For this systematic review, we searched the electronic databases MEDLINE (PubMed), SCOPUS, Cochrane Library, and SPORTDiscus...

INTRODUCTION: The steadily growing and aging world population, in conjunction with continuously increasing prevalences of vision-threatening retinal diseases, is placing an increasing burden on the global healthcare system. The main challenges within retinology involve identifying the comparatively few patients requiring therapy within the large mass, the assurance of comprehensive screening for retinal disease and individualized therapy planning. In order to sustain high-quality ophthalmic care in the future, the incorporation of artificial intelligence (AI) technologies into our clinical practice represents a potential solution...

OBJECTIVES: This study investigates the benefits, limitations and awareness of using Real World Evidence and Real World Data for post-market clinical follow-up studies and clinical evaluation reports in the European Medical Device Regulations. METHODOLOGY: A mixed methods study was utilized with qualitative interviews and a quantitative survey. RESULTS: The findings from the study demonstrate that in the case of the Medical Device Regulations, opportunities exist for manufacturers of legacy devices to conduct Real World Evidence studies to bridge gaps in clinical evidence...

INTRODUCTION: The use of tissue expanders (TE) in post-mastectomy breast reconstruction is a widely accepted practice, especially in patients desiring implant-based breast reconstruction. It has become the standard of care to perform a two-staged breast reconstruction using tissue expanders for the past 50 years due to its reliability, safety, cost-effectiveness, and versatility. Due to its popularity, there are numerous types and features of breast tissue expanders and various surgical approaches available for plastic surgeons...

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) is one of the most significant inventions in cardiology, as it provides a viable minimally invasive treatment option for patients with aortic stenosis, the most common valvular disease in the developed world and one with a poor prognosis when left untreated. Using data available to date, this review aims to discuss and identify possible predictors of TAVI valve durability - an essential requirement for the device's wide-spread use, especially in younger patients...

INTRODUCTION: Sustaining a healthy weight is a great challenge and obesity has become a pandemic with associated risk of co-morbidities, hence a major concern for public health bodies worldwide. Surgical interventions, such as bariatric surgery, have shown a great promise for many where pharmacological and lifestyle interventions failed to work. However, challenges and limitations associated with bariatric surgery has pushed the demand for less invasive, reversible (anatomically) interventions, such as intragastric balloons (IGBs)...

INTRODUCTION: Total knee replacement (TKR) reduces pain, it increases quality of life and it generally lasts a long time with revision rates of less than 5% at 10 years. Some authors have suggested that outcomes may be further improved by technology assistance. AREAS COVERED: Technology assistance in primary TKR includes technologies such as navigated TKR, patient specific instrumentation TKR and robotic TKR. EXPERT OPINION: In general technology assistance results in higher accuracy of component positioning and alignment, but this is likely not clinically relevant as no clinically important difference in clinical outcomes, quality of life and complications such as revisions has been demonstrated in meta-analyses of randomized controlled trials...

INTRODUCTION: Sentinel lymph node biopsy for breast cancer is a method to localize and excise the first draining lymph node from an invasive cancer of the breast. The histopathologic evaluation of the sentinel lymph node is used for predicting recurrence and survival and thus, guiding oncologists for treatment-decision making to administer adjuvant therapies. The ability to identify the sentinel node depends on methods to map lymphatic drainage from the breast to the sentinel node and accurately discriminate that node from other non-sentinel lymph nodes of the axilla...

INTRODUCTION: Superb microvascular imaging (SMI) is an advanced ultrasound technique that portrays microcirculation. Its clinical applications have been studied in various diseases, including carpal tunnel syndrome (CTS) i.e. the most common entrapment neuropathy. This scoping review explores the role of SMI in diagnosing CTS or the assessment of relevant neural structures. METHODS: We conducted a comprehensive search of electronic databases (PubMed, Embase and Web of Science) up to 26 September 2023...

INTRODUCTION: Cochlear implants (CIs) provide access to sound for children and adults who do not receive adequate benefit from hearing aids. Age at implantation is known to affect outcomes across the lifespan. AREAS COVERED: The effects of age on CI outcomes are examined for infants, children, adolescents, and older adults. A variety of outcome measures are considered, including speech perception, language, cognition, and quality of life measures. EXPERT OPINION/COMMENTARY: For those meeting candidacy criteria, CIs are beneficial at any age...

INTRODUCTION: This review provides an update of 18 F-fluorodeoxyglucose ([18 F] FDG) for Brown adipose tissue (BAT) activity quantification, whose role is not completely understood. AREAS COVERED: We conducted an unstructured search of the literature for any studies employing the [18 F] FDG PET in BAT assessment. We explored BAT quantification both in healthy individuals and in different pathologies, after cold exposure and as a metabolic biomarker. The assessment of possible BAT modulators by using [18 F] FDG PET is shown...