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1.
Orthop J Sports Med ; 12(8): 23259671241263593, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39143984

RESUMEN

Background: Previous research in sport populations has demonstrated that abnormal magnetic resonance imaging (MRI) findings may be present in individuals without symptoms or known pathology. Extending this understanding to ballet, particularly in relation to the foot and ankle, is important to guide medical advice given to dancers. Purpose: To assess foot and ankle MRI scans in asymptomatic ballet dancers focusing on bone marrow edema and the posterior ankle and to investigate whether these MRI findings would become symptomatic within 1 year. Study Design: Case series; Level of evidence, 4. Methods: In total, 31 healthy dancers (62 feet/ankles; 15 male and 16 female; age, 26.5 ± 4.3 years) who were dancing in full capacity were recruited from an elite professional ballet company. Orthogonal 3-plane short tau inversion recovery imaging of both feet and ankles was obtained using 3T MRI and the images were reviewed using a standardized evaluation form by 2 musculoskeletal radiologists. Injuries in the company were recorded and positive MRI findings were assessed for correlation with any injuries requiring medical attention during the subsequent 12 months. Results: A total of 51 (82%) of the 62 feet and ankles had ≥1 area of bone marrow edema. The most common locations of bone marrow edema were the talus (n = 41; 66%), followed by first metatarsal (n = 14; 23%). Os trigonum and Stieda process were seen in 5 (8%) and 8 (13%) ankles, respectively. Among them, 2 os trigona showed bone marrow edema. Fluid in the anterior and posterior talocrural joints and the subtalar joint was observed in 48%, 63%, and 63% of these joints, respectively. Fluid around foot and ankle tendons was observed, with the most prevalent being the flexor hallucis longus tendon (n = 13; 21%). Two dancers who had positive findings on their MRI subsequently developed symptoms during the next 12 months. Conclusion: Positive MRI findings are commonplace in the foot and ankle of asymptomatic professional ballet dancers. The majority do not result in the development of symptoms requiring medical attention within 12 months. Careful interpretation of MRI findings with the dancer's clinical picture is required before recommending activity modification or further intervention.

3.
Open Forum Infect Dis ; 11(8): ofae395, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39113826

RESUMEN

During routine clinical practice, infectious disease physicians encounter patients with difficult-to-diagnose clinical syndromes and may order advanced molecular testing to detect pathogens. These tests may identify potential infectious causes for illness and allow clinicians to adapt treatments or stop unnecessary antimicrobials. Cases of pathogen-agnostic disease testing also provide an important window into known, emerging, and reemerging pathogens and may be leveraged as part of national sentinel surveillance. A survey of Emerging Infections Network members, a group of infectious disease providers in North America, was conducted in May 2023. The objective of the survey was to gain insight into how and when infectious disease physicians use advanced molecular testing for patients with difficult-to-diagnose infectious diseases, as well as to explore the usefulness of advanced molecular testing and barriers to use. Overall, 643 providers answered at least some of the survey questions; 478 (74%) of those who completed the survey had ordered advanced molecular testing in the last two years, and formed the basis for this study. Respondents indicated that they most often ordered broad-range 16S rRNA gene sequencing, followed by metagenomic next-generation sequencing and whole genome sequencing; and commented that in clinical practice, some, but not all tests were useful. Many physicians also noted several barriers to use, including a lack of national guidelines and cost, while others commented that whole genome sequencing had potential for use in outbreak surveillance. Improving frontline physician access, availability, affordability, and developing clear national guidelines for interpretation and use of advanced molecular testing could potentially support clinical practice and public health surveillance.

4.
J Soc Cardiovasc Angiogr Interv ; 3(3Part A): 101231, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-39131780

RESUMEN

Background: While patients with spontaneous coronary artery dissection (SCAD) occasionally present with concurrent ventricular arrhythmias (VA), the impact of VA on in-hospital outcomes in the United States (US) is not well-established. This study aims to analyze in-hospital outcomes of patients with SCAD and concurrent VA and to determine the factors associated with VA occurrence in this high-risk population in the US. Methods: Using the Nationwide Readmissions Database, our study included patients age 18 years or older who had SCAD between 2017 and 2020. We categorized the cohort into 2 groups depending on the presence of VA during hospitalization. In-hospital outcomes were assessed between SCAD patients with VA and those without. Weighted analysis was performed. We analyzed the independent factors associated with VA occurring among SCAD patients through univariable and multivariable analyses. Results: Eight hundred seventy-seven SCAD patients were included in the study: 118 (13.5%) with VA and 759 (86.6%) without. SCAD patients with concurrent VA were associated with higher rates of early mortality (10.2% vs 2.0%; P < .01), prolonged index hospital stay (≥7 days) (33.1% vs 11.7%; P < .01), and non-home discharge (21.2% vs 5.9%; P < .01). The length of hospital stay was longer in the SCAD with concurrent VA group (7.39 days vs 3.58 days; P < .01), and the median cumulative cost of hospitalization was also higher in this group ($31,451 vs $13,802; P < .01). SCAD patients with concurrent VA had increased in-hospital adverse events: acute heart failure, cardiac arrest, cardiogenic shock, cerebral infarction, pulmonary edema, and acute kidney injury. In multivariable analysis, the independent factors associated with VA occurrence among SCAD patients were chronic liver disease (aOR, 3.42; 95% CI, 1.43-8.20; P < .01) and heart failure (aOR, 5.63; 95% CI, 3.36-9.42; P < .01). Conclusions: Concurrence of VA among SCAD patients was associated with poorer in-hospital outcomes. Heart failure and chronic liver disease were the independent factors associated with VA occurrence in SCAD patients.

5.
Curr Rev Musculoskelet Med ; 17(9): 386-392, 2024 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-39090374

RESUMEN

PURPOSE OF REVIEW: Spinal fusion, vital for treating various spinal disorders, has evolved since the introduction of the minimally invasive Lateral Lumbar Interbody Fusion (LLIF) by Pimenta in 2001. Traditionally performed in the lateral decubitus position, LLIF faces challenges such as intraoperative repositioning, neurological complications, and lack of access to lower lumbar levels. These challenges lead to long surgery times, increased rates of perioperative complications, and increased costs. The more recently popularized prone lateral approach mitigates these issues primarily by eliminating patient repositioning, thereby enhancing surgical efficiency, and reducing operative times. This review examines the progression of spinal fusion techniques, focusing on the advantages and recent findings of the prone lateral approach compared to the traditional LLIF. RECENT FINDINGS: The prone lateral approach has shown improved patient outcomes, including lower blood loss and shorter hospital stays, and has been validated by multiple studies for its safety and efficacy compared to the LLIF approach. Significant enhancements in postoperative metrics, such as the Oswestry Disability Index, Visual Analog Scale, and radiological improvements have been noted. Comparatively, the prone lateral approach offers superior segmental lordosis correction and potentially better subjective outcomes than the lateral decubitus position. Despite these advances, both techniques present similar risks of neurological complications. Overall, the prone lateral approach has emerged as a promising alternative in lumbar interbody fusion, combining efficiency, safety, and improved clinical outcomes.

6.
Artículo en Inglés | MEDLINE | ID: mdl-39003679

RESUMEN

PURPOSE OF REVIEW: To summarize the history of titanium implants in spine fusion surgery and its evolution over time. RECENT FINDINGS: Titanium interbody cages used in spine fusion surgery have evolved from solid metal blocks to porous structures with varying shapes and sizes in order to provide stability while minimizing adverse side effects. Advancements in technology, especially 3D printing, have allowed for the creation of highly customizable spinal implants to fit patient specific needs. Recent evidence suggests that customizing shape and density of the implants may improve patient outcomes compared to current industry standards. Future work is warranted to determine the practical feasibility and long-term clinical outcomes of patients using 3D printed spine fusion implants. Outcomes in spine fusion surgery have improved greatly due to technological advancements. 3D printed spinal implants, in particular, may improve outcomes in patients undergoing spine fusion surgery when compared to current industry standards. Long term follow up and direct comparison between implant characteristics is required for the adoption of 3D printed implants as the standard of care.

7.
Europace ; 26(7)2024 Jul 02.
Artículo en Inglés | MEDLINE | ID: mdl-39031021

RESUMEN

AIMS: Ventricular tachycardia (VT) non-inducibility in response to programmed ventricular stimulation (PVS) is a widely used procedural endpoint for VT ablation despite inconclusive evidence with respect to clinical outcomes in high-risk patients. The aim is to determine the utility of acute post-ablation VT inducibility as a predictor of VT recurrence, mortality, or mortality equivalent in high-risk patients. METHODS AND RESULTS: We conducted a retrospective analysis of high-risk patients (defined as PAINESD > 17) who underwent scar-related VT ablation at our institution between July 2010 and July 2022. Patients' response to PVS (post-procedure) was categorized into three groups: Group A, no clinical VT or VT with cycle length > 240 ms inducible; Group B, only non-clinical VT with cycle length > 240 ms induced; and Group C, all other outcomes (including cases where no PVS was performed). The combined primary endpoint included death, durable left ventricular assist device placement, and cardiac transplant (Cox analysis). Ventricular tachycardia recurrence was considered a secondary endpoint (competing risk analysis). Of the 1677 VT ablation cases, 123 cases met the inclusion criteria for analysis. During a 19-month median follow-up time (interquartile range 4-43 months), 82 (66.7%) patients experienced the composite primary endpoint. There was no difference between Groups A and C with respect to the primary [hazard ratio (HR) = 1.21 (0.94-1.57), P = 0.145] or secondary [HR = 1.18 (0.91-1.54), P = 0.210] outcomes. These findings persisted after multivariate adjustments. The size of Group B (n = 13) did not permit meaningful statistical analysis. CONCLUSION: The results of post-ablation PVS do not significantly correlate with long-term outcomes in high-risk (PAINESD > 17) VT ablation patients.


Asunto(s)
Ablación por Catéter , Cicatriz , Recurrencia , Taquicardia Ventricular , Humanos , Taquicardia Ventricular/fisiopatología , Taquicardia Ventricular/cirugía , Taquicardia Ventricular/etiología , Taquicardia Ventricular/diagnóstico , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Cicatriz/fisiopatología , Cicatriz/etiología , Anciano , Medición de Riesgo , Resultado del Tratamiento , Factores de Riesgo
8.
J Virol ; 98(8): e0071124, 2024 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-39082839

RESUMEN

Cytotoxic T lymphocytes (CTLs) mediate host defense against viral and intracellular bacterial infections and tumors. However, the magnitude of CTL response and their function needed to confer heterosubtypic immunity against influenza virus infection are unknown. We addressed the role of CD8+ T cells in the absence of any cross-reactive antibody responses to influenza viral proteins using an adenoviral vector expressing a 9mer amino acid sequence recognized by CD8+ T cells. Our results indicate that both CD8+ T cell frequency and function are crucial for heterosubtypic immunity. Low morbidity, lower viral lung titers, low to minimal lung pathology, and better survival upon heterosubtypic virus challenge correlated with the increased frequency of NP-specific CTLs. NP-CD8+ T cells induced by differential infection doses displayed distinct RNA transcriptome profiles and functional properties. CD8+ T cells induced by a high dose of influenza virus secreted significantly higher levels of IFN-γ and exhibited higher levels of cytotoxic function. The mice that received NP-CD8+ T cells from the high-dose virus recipients through adoptive transfer had lower viral titers following viral challenge than those induced by the low dose of virus, suggesting differential cellular programming by antigen dose. Enhanced NP-CD8+ T-cell functions induced by a higher dose of influenza virus strongly correlated with the increased expression of cellular and metabolic genes, indicating a shift to a more glycolytic metabolic phenotype. These findings have implications for developing effective T cell vaccines against infectious diseases and cancer. IMPORTANCE: Cytotoxic T lymphocytes (CTLs) are an important component of the adaptive immune system that clears virus-infected cells or tumor cells. Hence, developing next-generation vaccines that induce or recall CTL responses against cancer and infectious diseases is crucial. However, it is not clear if the frequency, function, or both are essential in conferring protection, as in the case of influenza. In this study, we demonstrate that both CTL frequency and function are crucial for providing heterosubtypic immunity to influenza by utilizing an Ad-viral vector expressing a CD8 epitope only to rule out the role of antibodies, single-cell RNA-seq analysis, as well as adoptive transfer experiments. Our findings have implications for developing T cell vaccines against infectious diseases and cancer.


Asunto(s)
Linfocitos T CD8-positivos , Infecciones por Orthomyxoviridae , Linfocitos T Citotóxicos , Animales , Infecciones por Orthomyxoviridae/inmunología , Infecciones por Orthomyxoviridae/virología , Ratones , Linfocitos T CD8-positivos/inmunología , Linfocitos T Citotóxicos/inmunología , Ratones Endogámicos C57BL , Femenino , Traslado Adoptivo , Interferón gamma/inmunología , Interferón gamma/metabolismo , Proteínas de la Nucleocápside/inmunología , Pulmón/inmunología , Pulmón/virología , Proteínas de Unión al ARN/inmunología , Proteínas de Unión al ARN/genética , Nucleoproteínas/inmunología , Nucleoproteínas/genética , Proteínas del Núcleo Viral/inmunología , Proteínas del Núcleo Viral/genética
9.
Artículo en Inglés | MEDLINE | ID: mdl-38961792

RESUMEN

PURPOSE: The anatomy of the deltoid ligament is complex. There is agreement on the presence of superficial and deep layers but the number and frequency of fascicles remains controversial. Identifying injuries to specific components of the deltoid ligament may inform decision-making on their management. The anatomy was reviewed to establish the number and dimension of fascicles visible with three-dimensional (3D) volumetric magnetic resonance images (MRI). METHODS: Twenty ankles from asymptomatic healthy volunteers were imaged with 3D volumetric MRI. The presence of individual fascicles was recorded and measured in 3D. RESULTS: The median age of participants was 26 years (range: 20-37) of which 13 (65%) were female. All 20 ankles had a deltoid ligament formed of four fascicles in two layers: three fascicles in the superficial layer; tibionavicular (mean dimensions 22.5 × 10.0 × 2.4 mm), tibiospring (16.6 × 6.7 × 1.9 mm) and tibiocalcaneal (23.8 × 4.6 × 1.8 mm) and a deep layer consisting of the tibiotalar fascicle, which could be divided into two parts: anterior tibiotalar (mean dimensions 10 × 5.6 × 4.1 mm) and the significantly larger posterior tibiotalar (14.2 × 13.8 × 17.5 mm, p < 0.01). There were no additional fascicles observed. CONCLUSIONS: The deltoid ligament complex was consistently visualised as four fascicles (tibionavicular, tibiospring, tibiocalcaneal, tibiotalar) in two layers (superficial and deep) in all 20 ankles. The posterior part of the tibiotalar fascicle was the thickest of all the fascicles in the deltoid ligament. It is, therefore, possible to accurately identify the components of the deltoid ligament, and 3T MRI can be used to assess fascicle-specific injury, which will guide treatment and rehabilitation. LEVEL OF EVIDENCE: Level III.

10.
Mol Ther ; 2024 Jun 22.
Artículo en Inglés | MEDLINE | ID: mdl-38910325

RESUMEN

Extracellular vesicles (EVs) are considered a vital component of cell-to-cell communication and represent a new frontier in diagnostics and a means to identify pathways for therapeutic intervention. Recently, studies have revealed the importance of tissue-derived EVs (Ti-EVs), which are EVs present in the interstitial spaces between cells, as they better represent the underlying physiology of complex, multicellular tissue microenvironments in biology and disease. EVs are native, lipid bilayer membraned nano-sized particles produced by all cells that are packaged with varied functional biomolecules including proteins, lipids, and nucleic acids. They are implicated in short- and long-range cellular communication and may elicit functional responses in recipient cells. To date, studies have often utilized cultured cells or biological fluids as a source for EVs that do not capture local molecular signatures of the tissue microenvironment. Recent work utilizing Ti-EVs has elucidated novel biomarkers for disease and provided insights into disease mechanisms that may lead to the development of novel therapeutic agents. Still, there are considerable challenges facing current studies. This review explores the vast potential and unique challenges for Ti-EV research and provides considerations for future studies that seek to advance this exciting field.

14.
Urol Pract ; 11(4): 761-768, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38899654

RESUMEN

INTRODUCTION: Since the integration of the intern year into urology residencies, programs are mandated to introduce fundamental skills to junior residents. Our goal was to assess the impact of one such program: the 2023 New York Section of the AUA (NYS-AUA) EMPIRE (Educational Multi-institutional Program for Instructing REsidents) Boot Camp. METHODS: Junior urology residents from all 10 NYS-AUA institutions attended a free EMPIRE Boot Camp on June 9, 2023. The seminar covered procedural skills including urethral catheterization, cystoscopy, renal and bladder ultrasound, transrectal prostate ultrasound with biopsy, and an introduction to robotics/laparoscopy. Sessions focused on urologic emergencies and postoperative scenarios. Participants completed questionnaires before, immediately after, and 6 months post course, assessing comfort with procedures and overall program quality using a 5-point Likert scale and free text responses. t Tests compared pre and immediate/6-month post scores. RESULTS: Forty junior residents, along with faculty and resident instructors from all 10 NYS-AUA programs, participated. Of the 40 trainees, 35 (87.5%) completed pre- and immediate post-boot camp surveys, while 23 (57.5%) responded to the 6-month follow-up survey. Ratings showed significant improvement in comfort with basic urologic technical skills for 13 out of 14 domains (93%) immediately after the course and at the 6-month mark. Attendees reported notably higher comfort levels in managing obstructive pyelonephritis (P = .003) and postoperative complications (P = .001) following didactic sessions. CONCLUSIONS: A skills-based, free collaborative urology boot camp for junior residents is feasible and can be effective. Trainees reported improved comfort performing certain technical skills and managing urologic emergencies both immediately after the course and at 6 months of follow-up.


Asunto(s)
Competencia Clínica , Internado y Residencia , Entrenamiento Simulado , Urología , Humanos , Urología/educación , Entrenamiento Simulado/métodos , Proyectos Piloto , Procedimientos Quirúrgicos Urológicos/educación , New York , Masculino
15.
J Burn Care Res ; 2024 Jun 26.
Artículo en Inglés | MEDLINE | ID: mdl-38918900

RESUMEN

Appropriate identification of burn depth and size is paramount. Despite the development of burn depth assessment aids [e.g., laser doppler imaging (LDI)], clinical assessment, which assesses partial thickness burn depth with 67% accuracy, currently remains the most consistent standard of practice. We sought to develop an image-based artificial intelligence system that predicts burn severity and wound margins for use as a triaging tool in thermal injury management. Modified EfficientNet architecture trained by 1684 mobile-device-captured images of different burn depths were previously utilized to create a convoluted neural network (CNN). The CNN was modified to a novel Boundary-Attention Mapping (BAM) algorithm using elements of saliency mapping, which was utilized to recognize the boundaries of burns. For validation, 144 patient charts that included clinical assessment, burn location, total body surface area, and LDI assessment were retrieved for a retrospective study. The clinical images underwent CNN-BAM assessment and were directly compared with the LDI assessment. CNN using a four-level burn severity classification achieved an accuracy of 85% (micro/macro-averaged ROC scores). The CNN-BAM system can successfully highlight burns from surrounding tissue with high confidence. CNN-BAM burn area segmentations attained a 91.6% accuracy, 78.2% sensitivity, and 93.4% specificity, when compared to LDI methodology. Results comparing the CNN-BAM outputs to clinical and LDI assessments have shown a high degree of correlation between the CNN-BAM burn severity predictions to those extrapolated from LDI healing potential (66% agreement). CNN-BAM algorithm gives equivalent burn-depth detection accuracy as LDI with a more economical and accessible application when embedded in a mobile device.

16.
Pract Radiat Oncol ; 14(4): 358-359, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38942573
17.
J Stroke Cerebrovasc Dis ; 33(8): 107762, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38723924

RESUMEN

INTRODUCTION: Disparities in stroke outcomes, influenced by the use of systemic thrombolysis, endovascular therapies, and rehabilitation services, have been identified. Our study assesses these disparities in mortality after stroke between rural and urban areas across the United States (US). METHODS: We analyzed the CDC data on deaths attributed to cerebrovascular disease from 1999 to 2020. Data was categorized into rural and urban regions for comparative purposes. Age-adjusted mortality rates (AAMR) were computed using the direct method, allowing us to examine the ratios of rural to urban deaths for the cumulative population and among demographic subpopulations. Linear regression models were used to assess temporal changes in mortality ratios over the study period, yielding beta-coefficients (ß). RESULTS: There was a total of 628,309 stroke deaths in rural regions and 2,556,293 stroke deaths within urban regions. There were 1.13 rural deaths for each one urban death per 100,000 population in 1999 and 1.07 in 2020 (ß = -0.001, ptrend = 0.41). The rural-urban mortality ratio in Hispanic populations decreased from 1.32 rural deaths for each urban death per 100,000 population in 1999 to 0.85 in 2020 (ß = -0.011, ptrend < 0.001). For non-Hispanic populations, mortality remained stagnant with 1.12 rural deaths for each urban death per 100,000 population in 1999 and 1.07 in 2020 (ß = -0.001, ptrend = 0.543). Regionally, the Southern US exhibited the highest disparity with a urban-rural mortality ratio of 1.19, followed by the Northeast (1.13), Midwest (1.04), and West (1.01). CONCLUSIONS: Our findings depict marked disparities in stroke mortality between rural and urban regions, emphasizing the importance of targeted interventions to mitigate stroke-related disparities.


Asunto(s)
Disparidades en el Estado de Salud , Salud Rural , Accidente Cerebrovascular , Salud Urbana , Humanos , Estados Unidos/epidemiología , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/terapia , Accidente Cerebrovascular/diagnóstico , Femenino , Masculino , Anciano , Persona de Mediana Edad , Factores de Riesgo , Factores de Tiempo , Disparidades en Atención de Salud , Anciano de 80 o más Años , Hispánicos o Latinos , Adulto , Bases de Datos Factuales , Factores Raciales , Causas de Muerte
18.
Vaccines (Basel) ; 12(5)2024 May 07.
Artículo en Inglés | MEDLINE | ID: mdl-38793756

RESUMEN

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has evolved into numerous lineages with unique spike mutations and caused multiple epidemics domestically and globally. Although COVID-19 vaccines are available, new variants with the capacity for immune evasion continue to emerge. To understand and characterize the evolution of circulating SARS-CoV-2 variants in the U.S., the Centers for Disease Control and Prevention (CDC) initiated the National SARS-CoV-2 Strain Surveillance (NS3) program and has received thousands of SARS-CoV-2 clinical specimens from across the nation as part of a genotype to phenotype characterization process. Focus reduction neutralization with various antisera was used to antigenically characterize 143 SARS-CoV-2 Delta, Mu and Omicron subvariants from selected clinical specimens received between May 2021 and February 2023, representing a total of 59 unique spike protein sequences. BA.4/5 subvariants BU.1, BQ.1.1, CR.1.1, CQ.2 and BA.4/5 + D420N + K444T; BA.2.75 subvariants BM.4.1.1, BA.2.75.2, CV.1; and recombinant Omicron variants XBF, XBB.1, XBB.1.5 showed the greatest escape from neutralizing antibodies when analyzed against post third-dose original monovalent vaccinee sera. Post fourth-dose bivalent vaccinee sera provided better protection against those subvariants, but substantial reductions in neutralization titers were still observed, especially among BA.4/5 subvariants with both an N-terminal domain (NTD) deletion and receptor binding domain (RBD) substitutions K444M + N460K and recombinant Omicron variants. This analysis demonstrated a framework for long-term systematic genotype to antigenic characterization of circulating and emerging SARS-CoV-2 variants in the U.S., which is critical to assessing their potential impact on the effectiveness of current vaccines and antigen recommendations for future updates.

19.
Int J Heart Fail ; 6(2): 76-81, 2024 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-38694934

RESUMEN

Background and Objectives: Real-world clinical data, outside of clinical trials and expert centers, on adverse events related to the use of SyncCardia total artificial heart (TAH) remain limited. We aim to analyze adverse events related to the use of SynCardia TAH reported to the Food and Drug Administration (FDA)'s Manufacturers and User Defined Experience (MAUDE) database. Methods: We reviewed the FDA's MAUDE database for any adverse events involving the use of SynCardia TAH from 1/01/2012 to 9/30/2020. All the events were independently reviewed by three physicians. Results: A total of 1,512 adverse events were identified in 453 "injury and death" reports in the MAUDE database. The most common adverse events reported were infection (20.2%) and device malfunction (20.1%). These were followed by bleeding events (16.5%), respiratory failure (10.1%), cerebrovascular accident (CVA)/other neurological dysfunction (8.7%), renal dysfunction (7.5%), hepatic dysfunction (2.2%), thromboembolic events (1.8%), pericardial effusion (1.8%), and hemolysis (1%). Death was reported in 49.4% of all the reported cases (n=224/453). The most common cause of death was multiorgan failure (n=73, 32.6%), followed by CVA/other non-specific neurological dysfunction (n=44, 19.7%), sepsis (n=24, 10.7%), withdrawal of support (n=20, 8.9%), device malfunction (n=11, 4.9%), bleeding (n=7, 3.1%), respiratory failure (n=7, 3.1%), gastrointestinal disorder (n=6, 2.7%), and cardiomyopathy (n=3, 1.3%). Conclusions: Infection was the most common adverse event following the implantation of TAH. Most of the deaths reported were due to multiorgan failure. Early recognition and management of any possible adverse events after the TAH implantation are essential to improve the procedural outcome and patient survival.

20.
Res Sq ; 2024 Apr 17.
Artículo en Inglés | MEDLINE | ID: mdl-38699332

RESUMEN

H2O2 is a key oxidant in mammalian biology and a pleiotropic signaling molecule at the physiological level, and its excessive accumulation in conjunction with decreased cellular reduction capacity is often found to be a common pathological marker. Here, we present a red fluorescent Genetically Encoded H2O2 Indicator (GEHI) allowing versatile optogenetic dissection of redox biology. Our new GEHI, oROS-HT, is a chemigenetic sensor utilizing a HaloTag and Janelia Fluor (JF) rhodamine dye as fluorescent reporters. We developed oROS-HT through a structure-guided approach aided by classic protein structures and recent protein structure prediction tools. Optimized with JF635, oROS-HT is a sensor with 635 nm excitation and 650 nm emission peaks, allowing it to retain its brightness while monitoring intracellular H2O2 dynamics. Furthermore, it enables multi-color imaging in combination with blue-green fluorescent sensors for orthogonal analytes and low auto-fluorescence interference in biological tissues. Other advantages of oROS-HT over alternative GEHIs are its fast kinetics, oxygen-independent maturation, low pH sensitivity, lack of photo-artifact, and lack of intracellular aggregation. Here, we demonstrated efficient subcellular targeting and how oROS-HT can map inter and intracellular H2O2 diffusion at subcellular resolution. Lastly, we used oROS-HT with other green fluorescence reporters to investigate the transient effect of the anti-inflammatory agent auranofin on cellular redox physiology and calcium levels via multi-parametric, dual-color imaging.

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