Device Therapy Research Articles

Examining Long-Term Influences of Frailty on Outcomes for Adults Undergoing Left Ventricular Assist Device Therapy.

Frailty is common in adults with end-stage heart failure receiving a left ventricular assist device (LVAD). Short-term studies show frailty reversal post-LVAD. Little is known about long-term frailty and how frailty relates to key LVAD outcomes, including depression, quality of life (QoL), and cognition beyond 6 months. The purpose of this study was to examine physical frailty, depression, QoL, and cognition from pre-LVAD implantation to 3, 6, and 12 months post-LVAD implantation. Clinical data and measures of physical frailty, depression, QoL, and cognition pre- and post-LVAD were extracted from an existing institutional database. Descriptive statistics and tests for statistical significance were used to describe and compare changes over time. Frailty trajectories were identified to describe physical frailty from pre-LVAD to 12 months post-LVAD. The sample (n = 46) was predominantly male (76%), with a mean age of 64.7 ± 11 years, and over half (n = 25) were physically frail. Physical frailty was reduced by nearly half at 12 months. Frailty, depression, and QoL significantly improved at all time points (P < .001). Improvements in cognition did not reach statistical significance. Recipients of LVAD without improvement in frailty exhibited worse depression, QoL, and cognition scores at 12 months compared with those not frail pre-LVAD or no longer frail post-LVAD implantation. Some recipients of LVADs experienced physical frailty reversal with benefits sustained long-term. Those without improvement recorded worse long-term patient-reported outcomes. Identifying factors that predict physical frailty response to LVAD implantation is a key area of future research.

Real-World Safety of Prostate Cancer Focal Therapy: MAUDE Database Analysis.

Objective: The aim of this study was to assess the real-world safety profile of medical devices used in focal prostate cancer treatment utilizing the Manufacturer and User Facility Device Experience (MAUDE) database. Methods: The MAUDE database was searched for reports on high-intensity focused ultrasound (HIFU), cryoablation, laser ablation, and irreversible electroporation (IRE) devices used in prostate cancer treatment from 1993 to 2023. Adverse events were identified and categorized. Results: We identified 175 reports for HIFU, 1362 for cryoablation, 615 for laser ablation, and 135 for IRE devices, with 28, 284, 126, and 2 respective reports, directly related to prostate cancer treatment. The aggregated data revealed the majority of complications were minor, with 82.5% (n = 363 out of 440 total complications) classified as Clavien-Dindo grade 1 or 2. Common minor complications included erectile dysfunction and urinary retention. Severe complications such as rectal fistulas were noted in HIFU and IRE treatments, along with singular mortality due to pulmonary embolism in cryoablation. Conclusions: Our analyses from MAUDE reveal that devices used in focal therapy for prostate cancer are predominantly associated with minor complications, underscoring their overall real-world safety profile. However, the occurrence of severe adverse events emphasizes the critical importance of rigorous patient selection and meticulous procedural planning. These findings provide valuable insights into the safety profile of focal therapy devices and contribute to the growing body of evidence on their use in prostate cancer treatment.

Drug induced sleep endoscopy and simultaneous polysomnography to predict the effectiveness of mandibular advancement device in obstructive sleep apnea treatment.

To evaluate whether mandibular advancement device therapy is recommended in patients affected by obstructive sleep apnea. In order to predict oral appliances therapy response, drug induced sleep endoscopy with cardio-respiratory polygraphy and mandibular advancement device simulator was carried out. Patients in which upper airway obstruction was resolved on all levels and AHI was normalized (< 5/h), were referred for oral appliance therapy. At 5 months follow up, a cardio-respiratory polygraphy with MAD was performed. 36 patients who have evidence of resolution of UA collapse and AHI below 5 events per hour, were referred for MAD therapy. At follow up, the mean AHI decreased from 29.1 ± 13.1 to 3.3/h ± 1.9 (p < 0.001). All the patients were responders. Combining the evaluation of drug induced sleep endoscopy and cardio-respiratory polygraphy data simultaneously during mandibular protrusion, has the potential to be a useful tool for prediction of MAD therapy response.

Comparing Google Trends Public Interest in Microcurrent Therapy Devices With Scientific Evidence for Microcurrents for Antiaging.

Comparing Google Trends Public Interest in Microcurrent Therapy Devices With Scientific Evidence for Microcurrents for Antiaging.

Factors Associated with Patient Activation in People with Heart Failure based on the Individual and Family Self-Management Theory: A Cross-sectional Study.

Patient activation (PA) is crucial for effective self-management of people with heart failure (HF). Clarifying factors associated with PA might be important to develop interventions to promote PA. This study aimed to explore Context factors associated with PA in people with HF. 268 patients were enrolled in a cross-sectional study (Median age=65 years). We surveyed variables based on Context factors of the Individual and Family Self-Management Theory (IFSMT), including demographic and disease factors, quality of chronic care, family function, and depression. Correlation analysis was conducted for data analysis, and path analysis was used to verify our hypothesis model about Context factors and PA. The median PA score was 51.10. Path analysis showed that age, educational level, living arrangement, device therapy, quality of chronic care, family function, and depression were directly or indirectly related to PA. The quality of chronic care mediated the associations between device therapy and educational level and PA. Age, educational level, living arrangement, and quality of chronic care affected family function and then affected activation. Depression mediated the relationships between the quality of chronic care, educational level, family function, and PA. This study increased the understanding of factors associated with PA in the HF population. When assessing PA in people with HF, those who are older, have a low educational level, living alone need more attention from healthcare professionals. Interventions focusing on improving the quality of chronic care, family function, and depression might help activate people to practice self-management.

Adaptive Movement Analysis And Enhanced Self-Monitoring Hypercube For Parkinson’s Disease

Parkinson’s Disease (PD) is a chronic neurodegenerative disorder characterized by motor impairments, including tremors, rigidity, bradykinesia, and postural instability, which progressively diminish patients’ ability to perform daily activities independently. Current rehabilitation practices, primarily focused on physical therapy, medication, and traditional support devices, provide essential symptom management but often lack customization to individual patient needs, leading to inconsistent adherence and limited long-term benefits. This paper introduces the Adaptive Movement Analysis and Enhanced Self-Monitoring Hypercube, a novel rehabilitation framework aimed at improving PD management through a comprehensive, adaptive approach.The system leverages cutting-edge sensors, including the MPU6050 Inertial Measurement Unit (IMU) and infrared proximity sensors, integrated with a Teensy microcontroller to deliver real-time movement analysis and tailored exercise feedback. Through Bluetooth-enabled connectivity, patient data is transmitted to a digital platform where it can be analyzed and adjusted based on performance metrics. Additionally, gamification techniques, task-specific training modules, and customizable feedback mechanisms are embedded to increase patient engagement and adherence to exercise routines. This adaptive solution provides a structured, motivating environment that addresses the fluctuating capabilities of PD patients, promoting functional recovery and enhanced self-monitoring.

Device therapies for heart failure with reduced ejection fraction: a new era.

Even with significant advancements in the treatment modalities for patients with heart failure (HF), the rates of morbidity and mortality associated with HF are still high. Various therapeutic interventions, including cardiac resynchronization therapy, Implantable Cardiovascular-Defibrillators, and left ventricular assist devices, are used for HF management. Currently, more research and developments are required to identify different treatment modalities to reduce hospitalization rates and improve the quality of life of patients with HF. In relation to this, various non-valvular catheter-based therapies have been recently developed for managing chronic HF. These devices target the pathophysiological processes involved in HF development including neurohumoral activation, congestion, and left ventricular remodeling. The present review article aimed to discuss the major transcatheter devices used in managing chronic HF. The rationale and current clinical developmental stages of these interventions will also be addressed in this review.

Electroosmotic peristaltic transport of magnetohydrodynamic Casson nanofluid in a non-uniform wavy porous asymmetric micro-channel

Magnetohydrodynamics (MHD) have numerous engineering and biomedical applications such as sensors, MHD pumps, magnetic medications, MRI, cancer therapy, astronomy, cosmology, earthquakes, and cardiovascular devices. In view of these applications and current developments, we investigate the magnetohydrodynamic MHD electro-osmotic flow of Casson nanofluid during peristaltic movement in a non-uniform porous asymmetric channel. The effect of thermal radiation, heat source, and Hall current on the Casson fluid peristaltic pumping in a porous medium is taken into consideration. The effect of chemical reactions is also considered. The mass, momentum, energy, and concentration equations were constructed using the proper transformations and dimensionless variables to make them easier for non-Newtonian fluids. A lubricating strategy is used to make the system less complicated. The Boltzmann distribution of electric potential over an electric double layer is studied using the Debye–Huckel approximation. The temperature and concentration equations are addressed using the homotopy perturbation method (HPM), while the exact solution is determined for the velocity field. The study examines the performance of velocity, pressure rise, temperature, concentration, streamlines, Nusselt, and Sherwood numbers for the involved parameters using graphical illustrations and tables. Asymmetric channels exhibit varying behavior, with velocity declining near the left wall and accelerating towards the right wall while enhancing the Casson fluid parameter. The pumping rate boosts in the retrograde region due to the evolution of the permeability parameter value, while it declines in the augment region. The temperature profile optimizes as the value of the heat source parameter gets higher. The concentration profile significantly falls as the chemical reaction parameter rises. The size of the trapped bolus strengthens with a spike in the parameter for the Casson fluid.

Microinstability of Major Joints in Movement Disorders: The Hidden Challenge.

Microinstability, characterized by subtle and often painful disturbances in joint stability, significantly impacts individuals engaged in activities requiring extensive ranges of motion, such as dancing or gymnastics, and is particularly prevalent in young female athletes. This condition, resulting from progressive microtrauma, architectural and functional abnormalities, or iatrogenic factors, is challenging to diagnose and often underreported. Understanding the biomechanical nuances of microinstability is essential for accurate diagnosis and effective management. Upper limb joints, including the shoulder, elbow, wrist, and hand, each exhibit unique anatomical and functional characteristics that contribute to their susceptibility to microinstability. Movement disorders, such as Parkinson's disease, essential tremor, dystonia, and cerebral palsy, exacerbate joint instability due to impaired proprioception, altered muscle tone, and uncoordinated muscle contractions. Effective diagnosis involves physical examination techniques and advanced imaging modalities. Therapeutic interventions encompass physical therapy, pharmacological treatments, surgical procedures, and assistive devices, tailored to enhance joint stability and improve the quality of life for affected individuals.

Taurolidine-containing solution for reducing cardiac implantable electronic device infection-early report from the European TauroPace™ registry.

Infection is a significant complication of cardiac implantable electronic device (CIED) therapy. The European TauroPace™ Registry investigates the safety and efficacy of TauroPace™ (TP), an antimicrobial solution containing taurolidine, designed to prevent CIED infections. This multicenter study included patients undergoing CIED procedures at participating centers where TP was used as a disinfectant for external hardware surfaces and an antiseptic for irrigating surgical sites. All patients eligible for CIED placement with adjunctive TP as the standard of care were included. Other aspects of CIED procedures adhered to current guidelines. Data on CIED-related infective endocarditis, CIED pocket infection, device and procedure-related complications, adverse events, and all-cause mortality were prospectively collected for 12 months. In cases of revision, the previous procedure was censored, and a new procedure was created. Binomial and Kaplan-Meier statistics were employed to analyze event rates. From January 2020 to November 2022, TP was used in 822 out of 1170 CIED procedures. Among patients who completed the 3-month follow-up, no CIED pocket infections were observed, and one case of CIED-related infective endocarditis was reported. In the 12-month follow-up cohort, two additional local pocket CIED infections were observed, resulting in a total of three major CIED infections within 1 year after the CIED placement procedure. The 3-month and 12-month major CIED infection rates were 0.125% and 0.51%, respectively. During the observation a complication rate of 4.4% was reported. No adverse events related to TP were observed. TP appears to be effective and safe in preventing CIED infections. gov Identifier: NCT04735666.

Comprehensive vs. standard remote monitoring of cardiac resynchronization devices in heart failure patients: results of the ECOST-CRT study.

Integrating remote monitoring (RM) into existing healthcare practice for heart failure (HF) patients to improve clinical outcome remains challenging. The ECOST-CRT study compared the clinical outcome of a comprehensive RM scheme including a patient questionnaire capturing signs and symptoms of HF and notifications for HF specific parameters to traditional RM in patients with cardiac resynchronization therapy (CRT) devices. Patients were randomized 1:1 to standard daily RM (notification for technical parameters and ventricular arrhythmias; control group) or comprehensive RM (adding a monthly symptom questionnaire and notifications for biventricular pacing, premature ventricular contraction, atrial arrhythmias; active group). The primary endpoint was all-cause mortality or hospitalization for worsening HF (WHF). Six hundred fifty-two patients (70.4 ± 10.3 years, 73% men, left ventricular ejection fraction 29.1 ± 7.6%, 68% CRT-Defibrillators, 32% CRT-Pacemakers) were enrolled. The COVID-19 pandemic caused an early termination of the study, so the mean follow-up duration was 18 ± 8 months. No statistically significant difference in the primary endpoint was found between the groups [59 (18.3%) control vs. 77 (23.3%) active group; log-rank test P = 0.13]. Among the secondary endpoints, the MLHF questionnaire showed a larger share of patients with improvement of quality of life compared to baseline in the active group (78%) vs. control (61%; P = 0.03). The study does not support the notion that comprehensive RM, when compared to standard RM, in HF patients with CRT improves the clinical outcome of all-cause mortality or WHF hospitalizations. However, this study was underpowered due to an early termination and further trials are required. Clinical Trials.gov Identifier: NCT03012490.

Frequency of and outcomes associated with nonadherence to guideline-based recommendations for an implantable cardioverter-defibrillator in patients with congenital long QT syndrome

BackgroundGuideline-directed device therapy for long QT syndrome (LQTS) has evolved during the years, and indications for an implantable cardioverter-defibrillator (ICD) vary between professional cardiac societies. ObjectiveWe aimed to identify the subset of patients with LQTS who satisfied a class I or class II 2022 European Society of Cardiology guideline-based recommendation for an ICD and to determine the outcomes of those patients who received an ICD compared with those treated without an ICD. MethodsRetrospective analysis was conducted of 2861 patients with LQT1, LQT2, or LQT3 to identify patients meeting contemporary recommendations for guideline-directed device therapy. Basic demographics, clinical characteristics, and frequency/type of breakthrough cardiac events (BCEs) were extracted, and outcomes/complications were compared between patients treated with an ICD and those treated without one. ResultsOf the 290 patients (approximately 10%) who met a guideline-based recommendation, 53 (18%) satisfied a class I/level B indication for an ICD; 56 (19%), a class I/level C indication; 19 (7%), a class IIa/level C indication; and 162 (56%), a class IIb/level B indication. However, most patients (156/290 [54%]) did not receive an ICD. Of those who received an ICD, 55 of 134 (41%) experienced ≥1 appropriate ventricular fibrillation–terminating ICD therapy, whereas ICD-related complications occurred in 13 patients (10%). Of those who were treated without an ICD, only 6 of 154 patients (4%) had nonlethal BCEs, which was significantly lower compared with the ICD group (P < .001). ConclusionWith >1200 years of combined follow-up, the experience and evidence from our 2 LQTS specialty centers suggest that many patients who satisfy a recommendation for an ICD based on the latest 2022 European Society of Cardiology guidelines may not need one. This is particularly true when the indication stemmed from a BCE while receiving beta blocker therapy or in asymptomatic patients with an increased 1-2-3-LQTS-Risk score.

Early stroke following durable left ventricular assist device (LVAD) implantation: An analysis of the Society of Thoracic Surgeons Intermacs National Database

BackgroundStroke remains a devastating complication of durable left ventricular assist device (LVAD) therapy. This study evaluated the incidence and risk factors for early stroke within 7 days following LVAD implantation investigating both traditional pre-implant and new intraoperative variables collected by The Society of Thoracic Surgeons (STS) Intermacs National Database. MethodsSTS Intermacs was queried for patients undergoing implantation of a fully magnetically levitated centrifugal LVAD between 11/25/2020 and 6/30/2023. STS Intermacs stroke definitions were used to identify patients who suffered a stroke within the first 7 postoperative days (POD). A multivariable logistic regression model was created to generate adjusted odd ratios (OR) for variables associated with early stroke. ResultsAmong 6950 patients in the study cohort, 5.9% (413/6950) developed a stroke after a median follow-up of 11 months, with 50% (205/413) of strokes occurring within 7 days after LVAD implantation. Of the strokes occurring during POD 0-7, 70% (144/205) occurred on POD 0-2. By multivariable analysis, the following factors were associated with early stroke: older age (70 vs. 50; OR 1.4, P=0.0129), white race (OR 1.5, P=0.0078), pre-implant temporary MCS bridge (temporary LVAD only: OR 1.6, ECMO only: OR 1.7, combination of both devices: OR 3.3; P=0.0001) and presence of an unremoved left atrial clot (OR 8.0, P<0.0001). ConclusionA significant proportion of strokes occur within the first 7 days following LVAD implantation, particularly within the first 2 days. In addition to pre-implant variables, we identified modifiable intraoperative factors associated with stroke that provide an opportunity for further risk mitigation and improvement in quality of care.

Medium to long-term ventricular assist device support in adults with congenital heart disease

Heart failure is the leading cause of morbidity and mortality in adults with congenital heart disease. Though for many in this population, heart transplantation is not possible or requires longer wait times necessitating prolonged circulatory support. Medium to long-term durable ventricular assist device therapy provides a possible solution. We analyzed outcomes of nine patients with congenital heart disease and at least 3 years of durable mechanical support, all age 18 or older at time of ventricular assist device implantation at our affiliated pediatric and adult hospitals. Palliated congenital anatomies varied and included biventricular physiologies as well as single ventricle with Fontan circulation. Median duration of support was 4.2 years including three patients successfully bridged to transplant averaging 2.1 years on the waitlist. Device-related complications were infrequent with HeartMate 3, a feasible and sustainable option for either bridge to transplant or destination strategies in adults with congenital heart disease.

Predictors of death without prior appropriate therapy in ICD recipients: the comorbidities, frailty and functional status (COMFFORT study)

ObjectiveMost patients who have an implantable cardioverter-defibrillator (ICD) implant do not receive life-prolonging therapy from it. Little research has been undertaken to determine which patients benefit the least from ICD...

Body-worn and self-powered flexible optoelectronic device for metronomic photodynamic therapy

Photodynamic therapy (PDT) as a clinical method relies on appropriate light delivery to activate photosensitizers, usually necessitates the utilization of cumbersome surgical instruments and high irradiation intensity, along with the requirement for hospitalization. To extend the applicability of PDT beyond hospital for better patient mobility, we design a wearable and self-powered metronomic PDT (mPDT) system for chronic wound infection treatment. A flexible alternative current electroluminescent (ACEL) device is constructed through sandwiching an emissive layer between conductive hydrogel electrodes. This ACEL device works as a therapeutic patch by loading photosensitizer (PS) in its bottom hydrogel electrode, thus aviods the intravenous administration to patients. Under the triboelectric nanogenerator generated AC pulse, the electroluminescence produced from emissive layer can be absorbed by the PS-loaded electrode to generate reactive oxygen species for mPDT. Benefited from its arbitrary tailorability, this device can be customized into on-demand shapes and sizes. Using diabetic infected wound as a model condition, this ACEL mPDT device effectively eliminates drug-resistant bacteria and accelerates wound healing. Thus, the body-worn optoelectronic device successfully avoids the utilization of extracorporeal physical light and power sources, providing a promising strategy for convenient, user-friendly, and prolonged treatment of superficial diseases.

Socio-economic inequalities and heart failure morbidity and mortality: A systematic review and data synthesis.

Socio-economic status (SES) has been associated with incident and prevalent heart failure (HF), as well as its morbidity and mortality. However, the precise nature of the relationship between SES and HF remains unclear due to inconsistent data. This study aims to provide a comprehensive assessment and data synthesis of the relationship between SES and HF morbidity and mortality. We performed a systematic search and data synthesis using six databases following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Guidelines. The included studies comprised observational studies that reported on HF incidence and prevalence, HF hospitalizations, worsening HF (WHF) and all-cause mortality, as well as treatment options (medical, device and advanced HF therapies). SES was measured on both individual and area levels, encompassing single (e.g., income, education, employment, social risk score, living conditions and housing characteristics) and composite indicators. Among the 4124 studies screened, 79 were included, with an additional 5 identified through cross-referencing. In the majority of studies, a low SES was associated with an increased HF incidence (72%) and prevalence (75%). For mortality, we demonstrated that low SES was associated with increased mortality in 45% of the studies, with 18% of the studies showing mixed results (depending on the indicator, gender or follow-up) and 38% showing non-significant results. Similar patterns were observed for the association between SES, WHF, medical therapy prescriptions and the utilization of devices and advanced HF therapies. There was no clear pattern in the used SES indicators and HF outcomes. This systematic review, using contemporary data, shows that while socio-economic disparity may influence HF incidence, management and subsequent adverse events, these associations are not uniformly predictive. Our review highlights that the impact of SES varies depending on the specific indicators used, reflecting the complexity of its influence on health disparities. Assessment and recognition of SES as an important risk factor can assist clinicians in early detection and customizing HF treatment, while also aiding policymakers in optimizing resource allocation.

Relationship between sun exposure and seasonal affective disorder symptoms in rural older people with different personalities: a cross-sectional study

ObjectivesEvidence suggests that environmental support, personality traits, and psychological factors can influence seasonal changes in human mood and behavior, particularly in rural middle-aged women and older people. This study aimed to quantify the associations between personality traits, seasonal affective disorder symptoms, and sun exposure in rural older people.MethodsThis study is a cross-sectional analytical study, the participants were 300 rural older persons from 12 natural villages and 5 geriatric service centers in 4 different cities in Jiangxi Province, China. The Eysenck Personality Questionnaire (EPQ), the Personal Inventory of Depression and Seasonal Affective Disorder (PIDS-SA-SimpChi), and the Sunlight Exposure Scale were used to conduct follow-up interviews throughout the year. Spatial analysis was performed using ArcGIS and Geodetic Probes. The data were analyzed using SPSS 21 and Amos 23.0 mediated models.ResultsRural older people with low sun exposure exhibited higher personality trait scores (p < 0.001). Personality traits were directly associated with seasonal affective disorder symptoms(p < 0.01); Sun exposure mediated this effect in rural older people (p < 0.05).ConclusionHigh-scoring personalities are more typical of rural older people with low sun exposure, and there is a greater risk of emotional and behavioral instability. Latitudinal differences are not a determinant of SAD. Increased sun exposure is associated with symptom relief. The promotion of light therapy devices in rural areas with low sunlight is warranted.

Design and Application of the New Multi-functional Moxibustion Box

Our team is dedicated to exploring new models for the treatment of spleen and stomach diseases using external therapy techniques of Traditional Chinese Medicine (TCM). We have developed a new multi-functional external therapy device for TCM that innovatively combines the concept of combined therapy with moxibustion. Additionally, through the application of artificial intelligence and new cross-industry intelligent manufacturing technologies, we have creatively incorporated an intelligent anti-burning system, enhancing the automation and informatization level of the product. We have implemented the concept of digitalization from the design stage, thus truly realizing an in-depth exploration of moxibustion, a method of external therapy in TCM. This chapter will summarize the design and application of a new multi-functional moxibustion box, aiming to provide a comprehensive reference for improving the symptoms of spleen and stomach diseases through moxibustion therapy.

2024 updated European Heart Rhythm Association core curriculum for physicians and allied professionals: a statement of the European Heart Rhythm Association of the European Society of Cardiology.

Heart rhythm management is a continuously evolving sub-speciality of cardiology. Every year, many physicians and allied professionals (APs) start and complete their training in cardiac implantable electronic devices (CIEDs) or electrophysiology (EP) across the European Heart Rhythm Association (EHRA) member countries. While this training ideally ends with an EHRA certification, the description of the learning pathway (what, how, when, and where) through an EHRA core curriculum is also a prerequisite for a successful training. The first EHRA core curriculum for physicians was published in 2009. Due to the huge developments in the field of EP and device therapy, this document needed updating. In addition, a certification process for APs has been introduced, as well as a recertification process and accreditation of EHRA recognized training centres. Learning pathways are more individualized now, with Objective Structured Assessment of Technical Skills (OSATS) to monitor learning progression of trainees. The 2024 updated EHRA core curriculum for physicians and APs describes, for both CIED and EP, the syllabus, OSATS, training programme and certification, and recertification for physicians and APs and stresses the importance of continued medical education after certification. In addition, requirements for accreditation of training centres and trainers are given. Finally, suggested reading lists for CIED and EP are attached as online supplements.