The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments.

PURPOSE: The Functional Assessment of Cancer Therapy item (FACT-GP5) has the potential to provide an understanding of global treatment tolerability from the patient perspective. Longitudinal evaluations of the FACT-GP5 and challenges posed by data missing-not-at-random (MNAR) have not been explored. Robustness of the FACT-GP5 to missing data assumptions and the responsiveness of the FACT-GP5 to key side-effects are evaluated. METHODS: In a randomized, double-blind study (NCT00065325), postmenopausal women (n = 618) with hormone receptor-positive (HR+), advanced breast cancer received either fulvestrant or exemestane and completed FACT measures monthly for seven months. Cumulative link mixed models (CLMM) were fit to evaluate: (1) the trajectory of the FACT-GP5 and (2) the responsiveness of the FACT-GP5 to CTCAE grade, Eastern Cooperative Oncology Group (ECOG) Performance Status scale, and key side-effects from the FACT. Sensitivity analyses of the missing-at-random (MAR) assumption were conducted. RESULTS: Odds of reporting worse side-effect bother increased over time. There were positive within-person relationships between level of side-effect bother (FACT-GP5) and severity of other FACT items, as well as ECOG performance status and Common Terminology Criteria for Adverse Events (CTCAE) grade. The number of missing FACT-GP5 assessments impacted the trajectory of the FACT-GP5 but did not impact the relationships between the FACT-GP5 and other items (except for nausea [FACT-GP2]). CONCLUSIONS: Results support the responsiveness of the FACT-GP5. Generally speaking, the responsiveness of the FACT-GP5 is robust to missing assessments. Missingness should be considered, however, when evaluating change over time of the FACT-GP5. TRIAL REGISTRATION: NCT00065325. TRIAL REGISTRATION YEAR: 2003.

Researchers have been exploring the use of a single question, FACT-GP5 ("I am bothered by side effects of treatment"), as a quick way to learn about drug tolerability from the patients' perspective. This study explores if this single question can capture changes in tolerability during treatment, and if the assessment is missed by patients, whether that impacts the interpretation of tolerability. In our study, we found that the FACT-GP5 can be used to understand how tolerability changes during treatment. Missing assessments of the FACT-GP5 are important to account for when interpreting results. The FACT-GP5 may be a useful question for capturing the patient experience of drug tolerability.

Advanced Sensing System for Sleep Bruxism across Multiple Postures via EMG and Machine Learning.

Diagnosis of bruxism is challenging because not all contractions of the masticatory muscles can be classified as bruxism. Conventional methods for sleep bruxism detection vary in effectiveness. Some provide objective data through EMG, ECG, or EEG; others, such as dental implants, are less accessible for daily practice. These methods have targeted the masseter as the key muscle for bruxism detection. However, it is important to consider that the temporalis muscle is also active during bruxism among masticatory muscles. Moreover, studies have predominantly examined sleep bruxism in the supine position, but other anatomical positions are also associated with sleep. In this research, we have collected EMG data to detect the maximum voluntary contraction of the temporalis and masseter muscles in three primary anatomical positions associated with sleep, i.e., supine and left and right lateral recumbent positions. A total of 10 time domain features were extracted, and six machine learning classifiers were compared, with random forest outperforming others. The models achieved better accuracies in the detection of sleep bruxism with the temporalis muscle. An accuracy of 93.33% was specifically found for the left lateral recumbent position among the specified anatomical positions. These results indicate a promising direction of machine learning in clinical applications, facilitating enhanced diagnosis and management of sleep bruxism.

A Hybrid Approach for Energy Consumption and Improvement in Sensor Network Lifespan in Wireless Sensor Networks.

In this paper, we propose an improved clustering algorithm for wireless sensor networks (WSNs) that aims to increase network lifetime and efficiency. We introduce an enhanced fuzzy spider monkey optimization technique and a hidden Markov model-based clustering algorithm for selecting cluster heads. Our approach considers factors such as network cluster head energy, cluster head density, and cluster head position. We also enhance the energy-efficient routing strategy for connecting cluster heads to the base station. Additionally, we introduce a polling control method to improve network performance while maintaining energy efficiency during steady transmission periods. Simulation results demonstrate a 1.2% improvement in network performance using our proposed model.

Evaluating postoperative outcomes in patients with hostile neck anatomy undergoing transcarotid artery revascularization versus transfemoral carotid artery stenting.

BACKGROUND: Carotid endarterectomy is relatively contraindicated in patients with a hostile neck anatomy who were historically revascularized with transfemoral carotid artery stenting (TFCAS). As transcarotid artery revascularization (TCAR) has progressively replaced TFCAS, evidence pertaining to hostile neck anatomy and TCAR is necessary to establish its safety and feasibility in this subgroup of patients. Therefore, we analyzed the impact of a hostile neck anatomy on outcomes in patients undergoing TCAR and further compared them with those undergoing TFCAS to establish recommendations for standard of care. METHODS: All patients undergoing TCAR and TFCAS from November 2016 to June 2021 in the Vascular Quality Initiative database were included. Patients were characterized into two groups based on the neck anatomy. Hostile neck anatomy was defined as a history of neck radiation or prior neck surgery including prior carotid endarterectomy or radical neck dissection. Primary outcomes included technical failure, access site complications (hematoma, stenosis, infection, pseudoaneurysm and arteriovenous fistula), and stroke or death. Secondary outcomes included stroke, transient ischemic attack (TIA), myocardial infarction (MI), death, and a composite end point of stroke or TIA. Patients with nonatherosclerotic or multiple lesions were excluded from the analysis. Primary analysis was performed with all patients undergoing TCAR and outcomes between patients with hostile and nonhostile neck anatomy were compared. Further analysis included a comparison of patients with a hostile neck anatomy undergoing TCAR and TFCAS. Univariable and multivariable logistic regression was used to assess impact of hostile neck anatomy on postoperative outcomes. Results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, comorbidities, preoperative medications, anesthesia type, and protamine use. RESULTS: Among the 19,859 patients who underwent TCAR during the study period, 3636 (18.3%) had a hostile neck anatomy. On univariate analysis, both groups had comparable outcomes except for higher rates of stroke or death in patients with hostile neck anatomy. After adjusting for potential confounders, there were no differences in technical failure (adjusted odds ratio [aOR], 1.14; 95% confidence interval [CI], 0.59-2.21; P = .699), stroke (aOR, 0.86; 95% CI, 0.58-1.28; P = .464), death (aOR, 0.82; 95% CI, 0.39-1.71; P = .598), and MI (aOR, 1.18; 95% CI, 0.71-1.97; P = .518). However, patients with hostile neck were at a 30% increased risk of access site complications (aOR, 1.30; 95% CI, 1.0-1.6; P = .023). Further adjusted analysis comparing the outcomes in TFCAS and TCAR among patients with hostile neck anatomy showed an almost four-fold increase in risk of death (aOR, 3.77; 95% CI, 1.49-9.53; P = .005) and technical failure (aOR, 3.69; 95% CI, 1.82-7.47; P < .001) among patients undergoing treatment with TFCAS. CONCLUSIONS: Patients with a hostile neck anatomy undergoing TCAR experienced an increased risk of access site complications; however, the risk for technical failure and postoperative stroke/death, stroke, TIA, MI, or death was similar among both groups. TFCAS was associated with significant increase in the risk of death and technical failure compared with TCAR in this group of patients. These results confirm that TCAR should be the preferred minimally invasive revascularization procedure for patients with hostile neck anatomy.

Management of bone loss due to endocrine therapy during cancer treatment.

Bone modifying agents BMAs (oral and IV bisphosphonates, denosumab) are used to treat bone loss due to endocrine therapy in patients with hormone receptor positive (HR +) early breast cancer and non-metastatic prostate cancer (NMPC). Timely initiation of appropriate sequential therapy is imperative to reduce cancer treatment-induced bone loss (CTIBL). This narrative review summarizes current literature regarding management of CTIBL in HR + early breast cancer and NMPC patients. Risk factors for fragility fractures, screening strategies, optimal timing for the treatment, dosing/duration of therapy, and post treatment monitoring have not been clearly defined in HR + early breast and NMPC patients receiving endocrine therapy. This review aims to discuss the utility of fracture risk assessment (FRAX) tool for the prevention and management of CTIBL, osteoanabolic therapy for imminent fracture risk reduction, and sequential therapy options. Using predefined terms, PubMed, MEDLINE, and Google Scholar were searched for studies on CTIBL in HR + breast and NMPC patients. We included randomized clinical trials, meta-analysis, evidence-based reviews, observational studies, and clinical practice guidelines. Fracture risk assessment tools (FRAX) guide therapy for osteoporosis in patients with early HR + breast cancer and NMPC. BMAs to prevent bone loss should be initiated at higher T-score than recommended by FRAX in premenopausal HR + breast cancer patients with chemotherapy-induced ovarian failure, oophorectomy and gonadotropin releasing hormone (GnRH) therapy, post-menopausal women with HR + breast cancer receiving aromatase inhibitor therapy, and NMPC patients with androgen deprivation therapy. Sequential therapy with osteoanabolic agents as first line treatment offers a potential therapeutic strategy in patients with high imminent fracture risk. Due to limited data in cancer patients regarding management of osteoporosis, a dosing schedule similar to osteoporosis is considered appropriate. Risk stratification to identify vulnerable patient population, choosing the appropriate sequential therapy, and close monitoring of patients at the risk of bone loss can potentially reduce the mortality, morbidity, and health care cost related to CTIBL.

The Impact of Endovascular Repair of Abdominal Aortic Aneurysms on Vascular Surgery Training in Open Aneurysm Repair.

BACKGROUND: Since the introduction of endovascular aneurysm repair (EVAR) in 1992, the number of open AAA repair (OAR) cases continue to decline. The consequence of reduced OAR cases raises valid concerns related to patient safety and the future training of vascular surgeons that need to be appropriately addressed. Our objective is to analyze trends in OAR and EVAR cases and to assess their implications on the quality of vascular surgery training. METHODS: We analyzed the Accreditation Council for Graduate Medical Education (ACGME) case log database for total clinical experience in OAR and EVAR for graduating vascular surgery fellows (VSFs) finishing 5 + 2 programs between 2002 and 2019 and vascular surgery integrated residents (VSRs) between 2013 and 2019. VSF case totals were calculated by combining average total cases of open and endovascular supra- and infrarenal AAA repair during fellowship years combined with total cases performed during their general surgery residency. VSR case totals included only the cases performed during the 5-year residency period. Isolated Iliac and thoracic aortic aneurysms were excluded from our analysis. RESULTS: The average number of OAR cases per trainee has decreased by 60% (from 36.9 to 14.7) with a rate of 1.4 cases per year (P < 0.001) for VSF. Meanwhile, EVAR average cases have increased by 102% (from 22 to 44.4). However, there were 2 different trends exhibited with EVAR over the study period. Between 2002 and 2007, EVAR cases tended to increase by 5.9 cases per year (P < 0.001). Whereas, between 2007 and 2019, there was a slightly decreased trend in EVAR cases by 0.3 cases per year (P = 0.01). For VSR, while no significant trend was observed in the mean number of OAR cases (Coef. -0.3, P = 0.2) due to the limited time frame, the proportion of open cases was significantly lower compared to endovascular cases. Additionally, there were 2 different trends exhibited with EVAR over the study period. Between 2013 and 2015, EVAR cases tended to increase by 1.7 cases per year (P = 0.1). Whereas, between 2015 and 2019, there was a slightly decreased trend in EVAR cases by 0.2 cases per year (P = 0.007). CONCLUSIONS: A significant reduction in average OAR cases and an increase in EVAR cases were observed over the study period. Vascular surgery training programs may need to introduce further training programs in open surgical repair to ensure vascular surgery trainees have the required technical skills and expertize to perform such a high-risk procedure safely and independently.

Cost-Effectiveness Analysis of Open Versus Endovascular Revascularization for Chronic Mesenteric Ischemia.

BACKGROUND: Recent studies have shown a trend supporting endovascular revascularization (ER) in the treatment of chronic mesenteric ischemia (CMI). However, few studies have compared the cost effectiveness of ER and open revascularization (OR) for this indication. The purpose of this study is to conduct a cost-effectiveness analysis comparing open versus ER for CMI. METHODS: We built a Markov model with Monte Carlo microsimulation using transition probabilities and utilities from existing literature for CMI patients undergoing OR versus ER. Costs were derived from the hospital perspective using the 2020 Medicare Physician Fee Schedule. The model randomized 20,000 patients to either OR or ER and allowed for 1 subsequent reintervention with 3 other intervening health states: alive, alive with complications, and dead. Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratio (ICER) were analyzed over a 5-year period. One-way sensitivity and probabilistic sensitivity analyses were conducted to study the impact of parameter variability on cost effectiveness. RESULTS: OR cost $4,532 for 1.03 QALYs while ER cost $5,092 for 1.21 QALYs, leading to an ICER of $3,037 per QALY gained in the ER arm. This ICER was less than our willingness to pay threshold of $100,000. Sensitivity analysis demonstrated that our model was most sensitive to costs, mortality, and patency rates after OR and ER. Probabilistic sensitivity analysis demonstrated ER would be considered cost effective 99% of iterations. CONCLUSIONS: This study found that while 5-year costs for ER were greater than OR, ER afforded greater QALYs than OR. Although ER is associated with lower long-term patency and higher rates of reintervention, it appears to be more cost effective than OR for the treatment of CMI.

Comparing Outcomes of Transfemoral Versus Transbrachial or Transradial Approach in Carotid Artery Stenting (CAS).

BACKGROUND: While Transfemoral Carotid Artery Stenting (TFCAS) is a valid minimally invasive option for patients who also might be suitable for carotid endarterectomy (CEA) or transcarotid artery revascularization (TCAR), alternative access sites such as transbrachial (TB) or transradial (TR) are only utilized when anatomic factors preclude direct carotid or transfemoral access. In this study, we aimed to evaluate the outcomes of TR/TB access in comparison to TF for percutaneous carotid artery revascularization. METHODS: All patients undergoing non-TCAR carotid artery stenting (CAS) from January 2012 to June 2021 in the Vascular Quality Initiative (VQI) Database were included. Patients were divided into 2 groups based on the access site for CAS: TF or TR/TB. Primary outcomes included stroke/death, technical failure and access site complications (hematoma, stenosis, infection, pseudoaneurysm and AV fistula). Secondary outcomes included stroke, TIA, MI, death, non-home discharge, extended length of postoperative stay (LOS) (>1 day), and composite endpoints of stroke/MI and stroke/death/MI. Univariable and multivariable logistic regression models were used to assess postoperative outcomes, and results were adjusted for relevant potential confounders including age, gender, race, degree of stenosis, symptomatic status, anesthesia, comorbidities, and preoperative medications. RESULTS: Out of the 23,965 patients, TR/TB approach was employed in 819 (3.4%) while TF was used in 23,146 (96.6%). Baseline characteristics found men were more likely to undergo revascularization using TR/TB approach (69.4% vs. 64.9%, P = 0.009). Patients undergoing TR/TB approach were also more likely to be symptomatic (49.9% vs. 28.6%, P < 0.001). Guideline directed medications were more frequently used with TR/TB including P2Y12 inhibitor (80.3% vs. 74.7%, P < 0.01), statin (83.8% vs. 80.6%), and aspirin (88.3% vs. 84.5%, P = 0.003) preoperatively. On univariate analysis, patients with TB/TR approach experienced higher rates of adverse outcomes. After adjusting for potential confounders, TR/TB patients had no significant increase in the risk of stroke/death [aOR 1.10 (0.69-1.76), P = 0.675]; however, the use of TR/TB access was associated with a more than 2-fold increase in risk for in-hospital MI [aOR 2.39 (1.32-4.30), P = 0.004] and 2-fold increase in risk of technical failure [aOR 2.21 (1.31-3.73) P = 0.003]. The use of TR/TB access was also associated with a 50% reduction in the risk of access site complications [aOR 0.53 (0.32-0.85), P = 0.009]. CONCLUSIONS: This study confirms that although technically more challenging, TR or TB approach serves as a reasonable alternative with lower access site complications for CAS particularly in patients where anatomic factors preclude revascularization by TFCAS or TCAR. However, TR/TB is associated with an increased risk of technical failure and myocardial infarction, which requires further study.

Global liver transplantation: emerging trends and ethical challenges.

PURPOSE: Liver transplant (LT) is the only definitive treatment for end-stage liver disease (ESLD). This review aims to explore current global LT practices, with an emphasis on challenges and disparities that limit access to LT in different regions of the world. METHODS: A detailed analysis was performed of present-day liver transplant practices throughout the world, including the etiology of liver disease, patient access to transplantation, surgical costs, and ongoing ethical concerns. RESULTS: Annually, only 10% of the patients needing a liver transplant receive an organ. Currently, the USA performs the highest volume of liver transplants worldwide, followed by China and Brazil. In both North America and Europe, nonalcoholic fatty liver disease is becoming the most common indication for LT, compared to hepatitis B and C in most Asian, South American, and African countries. While deceased donor liver transplant remains the most performed type of LT, living donor liver transplant is becoming increasingly popular in some parts of the world where it is often the only option due to a lack of well-developed infrastructure for deceased organ donation. Ethical concerns in liver transplantation fundamentally revolve around the definition of a deceased donor and the exploitation of living donor liver donation systems. CONCLUSION: Globally, liver transplant practices and outcomes are varied, with differences driven by healthcare policies, inequities in healthcare access, and ethical concerns.

Hybridizing video-based learning with simulation for flipping the clinical skills learning at a university hospital in Pakistan.

BACKGROUND: While learning and practicing on actual patients is a major mode of teaching clinical skills, concerns about patient safety, unavailability, and lack of standardization have led to the development of simulation for medical education. Simulation-based teaching is affected by challenges such as lack of protected time for faculty, inexperienced learners, and the number of students per group. These have led to the integration of various eLearning formats in the curriculum. The hybridized format changes the traditional clinical skills teaching into the flipped classroom. This study aims to measure the effectiveness of hybridizing video-based learning with simulation for flipping the clinical skills teaching of fourth-year medical students at the Department of Paediatrics and Child Health at Aga Khan University, Pakistan. METHODS: The study employed a mixed-methods design. Fourth-year medical students of the batch 2020-21 (n = 100) consented to participate in the study. The quantitative component focuses on identifying the effect of the intervention on the perceived self-efficacy of medical students (batch 2020-21) relevant to the clinical skill. Along with this, the performance of the intervention batch of 2020-21 on the end of clerkship objective structured clinical exam (OSCE) was compared with the previous batch of 2019-20, taught using simulation alone. Focused group discussions (FGDs) were used to explore the experiences of medical students (batch 2020-21) about the intervention. Quantitative data underwent descriptive and inferential analysis using Stata v16 while qualitative data underwent content analysis using NVivo software. RESULTS: Hybridization of video-based learning with simulation significantly improved self-efficacy scores for all examinations (cardiovascular, respiratory, neurological, and abdomen) with p-value < 0.05. OSCE scores of the intervention group were significantly higher on the neurological and abdominal stations as compared to the previous batch (p-value < 0.05). In addition, the overall structure of the intervention was appreciated by all the students, who stated it allowed reinforcement of basic concepts, retention, and further insight into clinical applications. CONCLUSION: The hybridization of video-based learning with simulation facilitated in creation of better opportunities for medical students to revive their prior knowledge, apply core concepts for the problem and engage in clinical reasoning.

Preparation and Performance Analysis of 3D Thermoformed Fluidic Polymer Temperature Sensors for Aquatic and Terrestrial Applications.

Employing a combination of Polyethylene terephthalate (PET) thermoforming and 3D-printed cylindrical patterns, we carefully engineer a linear resistive temperature sensor. This intricate process involves initial PET thermoforming, yielding a hollow cylindrical chamber. This chamber is then precisely infused with a composite fluid of graphite and water glue. Ensuring electrical connectivity, both ends are affixed with metal wires and securely sealed using a hot gun. This cost-effective, versatile sensor adeptly gauges temperature shifts by assessing composite fluid resistance alterations. Its PET outer surface grants immunity to water and solubility concerns, enabling application in aquatic and aerial settings without extra encapsulation. Rigorous testing reveals the sensor's linearity and stability within a 10 °C to 60 °C range, whether submerged or airborne. Beyond 65 °C, plastic deformation arises. To mitigate hysteresis, a 58 °C operational limit is recommended. Examining fluidic composite width and length effects, we ascertain a 12 Ω/°C sensitivity for these linear sensors, a hallmark of their precision. Impressive response and recovery times of 4 and 8 s, respectively, highlight their efficiency. These findings endorse thermoforming's potential for fabricating advanced temperature sensors. This cost-effective approach's adaptability underscores its viability for diverse applications.

Probing Antibacterial and Anticancer Potential of Selenicereus undatus, Pistacia vera L. and Olea europaea L. against Uropathogens, MCF-7 and A2780 Cancer Cells.

Urinary tract infection is an infectious disease that requires immediate treatment. It can occur in any age group and involves both genders equally. The present study was to check the resistance of some antibiotics and to assess the antibacterial potential of three extracts of three plants against notorious bacteria involved in urinary tract infections. Along with assessing the antibacterial activity of plant extracts, we checked for the anticancer potential of these extracts against the cancer cell lines MCF-7 and A2780. Cancer is the leading cause of mortality in developed countries. Determinations of total flavonoid content, total phenolic content, total alkaloid content, total tannin content, total carotenoid content, and total steroid content were performed. The disk diffusion method was used to analyze the antibacterial activity of plant extracts. Ethanolic extract of Selenicereus undatus showed sensitivity (25-28 mm) against bacteria, whereas chloroform and hexane extracts showed resistance against all bacteria except Staphylococcus (25 mm). Ethanolic extract of Pistacia vera L. showed sensitivity (22-25 mm) against bacteria, whereas chloroform and hexane extracts showed resistance. Ethanolic extract of Olea europaea L. showed sensitivity (8-16 mm) against all bacteria except Staphylococcus, whereas chloroform and hexane extracts showed resistance. Positive controls showed variable zones of inhibition (2-60 mm), and negative control showed 0-1 mm. The antibiotic resistance was much more prominent in the case of hexane and chloroform extracts of all plants, whereas ethanolic extract showed a sensitivity of bacteria against extracts. Both cell lines, MCF-7 and A2780, displayed decreased live cells when treated with plant extracts.

Contemporary outcomes of limb-salvage procedures using Vascular Quality Initiative-Medicare-linked data: Racial and ethnic disparities persist.

BACKGROUND: Several reports have shown that ethnic and racial minority patients with chronic limb-threatening ischemia (CLTI) are more likely to undergo major amputation. Whether this disparity is driven by limited access to care, statistical discrimination, or biologic factors has remained a matter of debate. We studied the effects of race and ethnicity on the short- and long-term outcomes of limb-salvage procedures among patients with new-onset CLTI. METHODS: We identified all patients who had undergone first time (open or endovascular) revascularization for CLTI between January 2010 and December 2016 in the Vascular Quality Initiative-Medicare-linked database. These patients were divided into two groups: non-Hispanic White (NHW) and racial and ethnic minority (REM). The early end points included length of stay and operative mortality. The 2-year outcomes included major amputation, freedom from subsequent revascularization, number of limb salvage reinterventions, and all-cause mortality. Subanalyses comparing NHW and Hispanic patients and NHW and Black patients were also performed. RESULTS: Of 16,249 patients presenting with CLTI, 73.9% were NHW. The REM patients were younger (mean age, 69.9 ± 11.3 years vs 74.2 ± 10.5 years; P < .001) and more likely to be women (45.9% vs 37.7%; P < .001). Other baseline differences included a higher rate of smoking history, coronary artery disease, chronic obstructive pulmonary disease, and chronic kidney disease for the NHW group. In contrast, the REM patients were more likely to have diabetes and hypertension and were more likely to present with tissue loss (78% vs 76.6%; P = .04). The preoperative ankle brachial index and procedure type (endovascular vs open) were similar between the two groups. On multivariable analysis, the NHW group had had a 13% increase in the length of stay and a 25% decrease in operative mortality. Of the 2-year outcomes, the limb salvage estimate was 86% for the NHW group and 77.1% for the REM group (P < .001). A comparison between the two groups showed similar rates of freedom from subsequent revascularization (67.9% vs 67.1%; P =.2). The REM patients had had higher rates of overall survival (70.3% vs 68.4%; P = .01) compared with their NHW counterparts. The patients in the REM group were also more likely to have undergone more than two limb salvage reinterventions during follow-up (14.2% vs 8.6%; P < .001). After adjusting for potential confounders, the REM patients had significantly greater odds of major amputation at 2 years (adjusted hazard ratio, 1.49; 95% confidence interval, 1.36-1.63; P < .001). CONCLUSIONS: The results from the present Vascular Quality Initiative-Medicare-matched study have shown that REM patients continue to face a higher major amputation risk despite equivalent attempts at limb salvage. Further studies to identify the risk factors and evaluate intervention strategies that might be more effective in preventing amputation in this particular population are warranted.

The correlation of aortic neck length to late outcomes following EVAR with the Ovation stent graft.

OBJECTIVE: Endovascular aneurysm repair (EVAR) performed outside manufacturers' instructions for use due to short aortic neck for the treatment of abdominal aortic aneurysm (AAA) is associated with unfavorable outcomes. Newer endografts now have an indication for shorter neck aneurysms that previous endografts do not, but this cohort has yet to be evaluated individually. The aim of this study is to evaluate 5-year outcomes after EVAR in patients with short aortic necks (<10 mm) using the Ovation stent graft. METHODS: The study comprised 238 patients who underwent EVAR as part of the prospective international multicenter Ovation stent graft trials. The main inclusion criteria were AAA diameter ≥ 5 cm, proximal parallel neck length ≥7 mm, neck angulation ≤60°, and bilateral iliac fixation length ≥10 mm. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Patients were divided into short neck (<10 mm) and standard neck (≥10 mm) groups. End points included long-term survival, freedom from aneurysm-related mortality (ARM), freedom from type Ia endoleak, and freedom from reintervention. RESULTS: Patients were predominantly male (81%) with a mean age of 73 ± 8 years. Median follow-up time was 58 months (interquartile range, 36-60 months). Of 238 patients, 41 (17.2%) had a proximal neck length <10 mm and would be considered outside the instructions for use with other stent grafts. Baseline characteristics were relatively similar between the two groups. The 5-year overall survival estimates were 77.8% for the standard neck group compared with 59.5% for the short neck group (P = .03). There were no differences in the 5-year freedom from ARM (99.2% vs 100%; P = .7), freedom from type Ia endoleak (96.3% vs 96.3%; P = .8), and freedom from reintervention (77.9% vs 79.7%; P = .7) between the standard and short neck groups, respectively. After adjusting for age and other potential confounders, short proximal neck was associated with a two-fold increase in 5-year all-cause mortality (adjusted hazard ratio, 2; 95% confidence interval, 1.02-3.8; P = .04]. CONCLUSIONS: The Ovation endograft performed well in short AAA neck with no difference in 5-year type Ia endoleak, reintervention, and ARM rates. However, short proximal neck was independently associated with a two-fold increase in the risk of all-cause mortality at 5 years. These findings confirm the prior literature on the association of hostile neck anatomy with late mortality following EVAR.

Carotid lesion length independently predicts stroke and death after transcarotid artery revascularization and transfemoral carotid artery stenting.

OBJECTIVES: Prior data from the Carotid Revascularization Endarterectomy vs Stenting Trial suggested that the higher perioperative stroke or death event rate among patients treated with transfemoral carotid artery stenting (TFCAS) appears to be strongly related to the lesion length. Nonetheless, data regarding the impact of lesion length on outcomes of transcarotid artery revascularization (TCAR) with flow reversal are lacking. Herein, we aimed to compare the outcomes of TCAR vs TFCAS stratified by the length of the carotid lesion. METHODS: Our cohort was derived from the Vascular Quality Initiative database for carotid artery stenting between 2016 and 2021. Restricted cubic spline analysis was used to describe the relationship between the primary outcome (in-hospital stroke/death) and the exposure variable (lesion length) in the overall cohort. This relationship was not linear, and knots were identified where significant changes in the slope of the curve occurred. We therefore divided patients based on knot with the most significant inflection into two groups: lesion length <25 mm (short) and lesion length ≥25 mm. Clinically relevant and statistically significant variables on univariable analysis were added to the final logistic regression model clustered by center identifier to study the association between lesion length and in-hospital outcomes stratified by the stent approach. RESULTS: The study cohort included 17,931 TCAR (52.6% with long lesions) and 12,036 TFCAS (53.2% with long lesions) patients. Patients with long lesions had higher rates of being symptomatic among both TCAR (27.2% vs 24.3%, P < .001) and TFCAS (43.5% vs 38.5%, P < .001) and were more likely to undergo general anesthesia in TCAR (84.7% vs 81.9%, P < .001) and TFCAS (21.6% vs 15.8%, P < .001). After adjusting for potential confounders, long carotid lesions were associated with higher odds of stroke, stroke/transient ischemic attack (TIA), and stroke/death compared with short lesions among patients who underwent TCAR or TFCAS. However, when comparing TCAR vs TFCAS outcomes in patients with long lesions, TCAR was found to be associated with a 30% reduction in stroke/TIA (adjusted odds ratio [aOR]: 0.7, 95% confidence interval [CI]: 0.6-0.9, P = .015), stroke (aOR: 0.7, 95% CI: 0.5-0.9, P = .009), and extended length of stay (ELOS) (aOR: 0.7, 95% CI: 0.6-0.8, P < .001). There was also a 40% reduction in the odds of in-hospital stroke/death (aOR: 0.6, 95% CI: 0.5-0.8, P < .001) and a 70% reduction in mortality (aOR: 0.3, 95% CI: 0.2-0.4, P < .001) in TCAR compared with TFCAS. CONCLUSIONS: In this large contemporary retrospective national study, carotid lesion length appears to negatively impact in-hospital outcomes for TCAR and TFCAS. In the presence of lesions longer than 25 mm, TCAR appears to be safer than TFCAS with regard to the risk of in-hospital stroke, stroke/TIA, death, stroke/death, and ELOS. These favorable outcomes seem to confirm the relative advantage of flow reversal compared with distal embolic protection devices in terms of neuroprotection.

Association of abdominal aortic aneurysm diameter indexed to patient height with symptomatic presentation and mortality.

BACKGROUND: The current guidelines have recommended repair of abdominal aortic aneurysms (AAAs) according to the maximal AAA diameter and/or its growth rate. However, many studies have suggested that the AAA diameter alone is not sufficient to predict the risk of rupture or symptomatic presentation. Several investigators have attempted to relate the AAA diameter to the body surface area in predicting for rupture. However, these calculations have not resulted in conclusive evidence. We sought in the present analysis to introduce a novel diameter-to-height index (DHI) and test its utility in predicting for symptomatic presentations, including rupture and 30-day and 5-year mortality. METHODS: The Vascular Quality Initiative database (2003-2020) was used to identify patients who had undergone open or endovascular AAA repair. The DHI was defined as the AAA diameter in centimeters divided by the height in centimeters, yielding a score of 1 to 10. Multivariable logistic regression analysis was performed to assess the risk of symptomatic presentation, including rupture and 30-day mortality. Receiver operating characteristic curves were plotted, and survival analysis techniques were used to determine the hazard of 5-year mortality. RESULTS: A total of 64,595 patients were identified, of whom, 16.3% had presented with symptomatic AAAs, including rupture. Endovascular AAA repair was performed for 69.8% of the symptomatic AAAs and 84.3% of asymptomatic AAAs (P < .001). The symptomatic group were more likely to be women (24.6% vs 19.8%; P < .001) and Black (7.81% vs 4.44%; P < .001). The mean DHI was higher in the symptomatic group than in the asymptomatic group (mean DHI, 3.92 ± 1.1 vs 3.24 ± 0.7; P < .001). The adjusted odds of a symptomatic presentation increased with an increasing DHI (adjusted odds ratio [aOR], 1.70; 95% confidence interval [CI], 1.59-1.83; P < .001). Active smoking increased the risk of a symptomatic presentation (aOR, 1.38; 95% CI, 1.28-1.51; P < .001). However, the use of preoperative statins and beta-blockers significantly reduced the odds of a symptomatic presentation (aOR, 0.58; 95% CI, 0.53-0.64; P < .001; and aOR, 0.76; 95% CI, 0.69-0.84; P < .001), respectively. Compared with the AAA diameter, the receiver operating characteristic curve for the DHI to predict for symptomatic status was slightly, but significantly, higher (aOR, 0.702; 95% CI, 0.695-0.708; vs aOR, 0.695; 95% CI, 0.688-0.701; P < .001). The DHI increment was associated with a 1.08 greater odds of 30-day mortality (aOR, 1.08; 95% CI, 1.01-1.15; P < .001) for those with symptomatic AAAs. Similarly, the hazard of 5-year mortality was increased with an increasing DHI (adjusted hazard ratio, 1.20; 95% CI, 1.13-1.29; P < .001) only for those with asymptomatic AAAs. CONCLUSIONS: The DHI is a simple tool that could be more effective than the AAA diameter in predicting for symptomatic presentations. The DHI varied by sex and race, which could collectively help to provide an individualized prognosis. The DHI can additionally predict the 5-year mortality after AAA repair for those with asymptomatic AAAs only. However, the odds of 30-day mortality remained similar in both groups.

Contemporary Outcomes of Open Femoropopliteal Bypass by Autogenous Vein Graft in Infra-inguinal Arterial Occlusive Disease.

BACKGROUND: Although the majority of patients presenting with symptomatic peripheral arterial disease (PAD) are treated with the endovascular first approach, a significant number of these patients still require open bypass because of the extent of atherosclerotic burden or failure of the endovascular therapy. However, data available on the outcomes of femoropoliteal bypass in the contemporary era of PAD management is scarce. In this study, we evaluate realworld mid-term outcomes of femoropopliteal bypass for PAD. METHODS: We identified all patients who underwent open femoropopliteal revascularization with autogenous vein conduits for PAD at one institution between January 2012 and December 2017. Main endpoints included primary patency, amputation-free survival, overall survival, and limb salvage at 2 years. Outcomes were defined as per the Society for Vascular Surgery standards. Descriptive statistics were performed using univariable analyses including the mean and standard deviation for continuous variables and frequency and percentage for categorical variables. Event-free survival rates were estimated using Kaplan-Meier methods. RESULTS: There were 129 patients who received autogenous vein grafts. Median follow-up was 19 months (interquartile rangeIQR 11-26). Patients were predominantly male (59.7%), white (72.9%) with a mean age of 65 ± 11 years. The indications for surgery were disabling claudication in 36.4% of patients (n = 47) and chronic limb threatening ischemia (CLTI) in 63.6% (n = 82). Most patients had Trans-Atlantic Inter-Society Consensus C or D lesions (n = 81, 62.8%). Seventeen cases (16.3%) were redoing bypasses. Arm veins and spliced vein conduits were used in 12% and 7%, respectively. In 66% of procedures, the distal anastomosis was below the knee. Primary patency estimates at 6 months, 1 year and 2 years were 81.3%, 68.6% and 59.2%, respectively. Amputation-free survival rates were 93.4%, 88% and 82.1% at 6 months, 1 year and 2 years, respectively. Limb salvage rates among patients with CLTI were 93.4%, 90.4% and 87.2% at 6 months, 1 year and 2 years, respectively. Overall survival was 97.5%, 92.1% and 87.8% at 6 months, 1 year and 2 years, respectively. CONCLUSIONS: In this contemporary cohort of patients, femoropopliteal bypass showed lower patency than previously described. The fact that bypass surgery is performed on sicker patients with more extensive disease in the endovascular era might explain this discrepancy. However, our results demonstrated satisfactory patency and limb salvage rates and suggest that vein should always be used if available.

Open Repair Versus Endovascular Repair in the Treatment of Symptomatic Popliteal Artery Aneurysms.

BACKGROUND: Endovascular and open surgical modalities are currently used to treat popliteal artery aneurysms (PAA). However, there is limited data on the comparative durability of both repairs to guide physicians especially in the treatment of patients presenting symptomatic. We aimed to study the comparative effectiveness of endovascular PAA repair (EPAR) versus open PAA repair (OPAR). METHODS: The vascular quality initiative (VQI)-Medicare linked database was queried for patients with symptomatic PAA who underwent OPAR or EPAR from January 2010 to December 2018. Kaplan-Meier estimates, log-rank tests and multivariable Cox proportional hazard regression were employed to study the outcomes of amputation free survival (AFS), freedom from first reintervention, freedom from major amputation, and overall survival in 2 years following the index procedure. RESULTS: A total of 1,375 patients were studied, of which 23.7% (n = 326) were treated with EPAR. Patients treated with OPAR were younger, less likely to have coronary artery disease (CAD) and chronic kidney disease (CKD), but more likely to be smokers and to present with acute lower extremity ischemia. OPAR treated patients had better 2-year AFS (84.5% vs. 72.5%, P < 0.001) and overall survival (86.2% vs. 74.7%, P < 0.001). Freedom from major amputation at 2 years were comparable between EPAR and OPAR (95.5% vs. 97.7%, P = 0.164) in the overall cohort. Within the sub cohort of patients with acute limb ischemia, freedom from major amputation was significantly higher for OPAR compared to EPAR (97.4% vs. 90.6%, P = 0.021). After adjustment for confounders, OPAR was associated with decreased risk of amputation or death (aHR, 0.62; 95% CI, 0.48-0.80; P < 0.001) and mortality (aHR, 0.63; 95% CI, 0.48-0.81; P < 0.001) at 2 years. OPAR and EPAR had comparable adjusted risk of 2-year major amputation in the overall cohort. However, for patients presenting with acute limb ischemia OPAR was associated with 72% lower risk of 2-year major amputation compared to EPAR (aHR, 0.28; 95% CI, 0.10-0.83; P = 0.021). CONCLUSIONS: In this multi-institutional observational study of symptomatic popliteal aneurysms, OPAR was associated with significantly better amputation free and overall survival compared to EPAR. For patients with acute limb ischemia, OPAR was associated with reduced risk of amputation. These findings suggest that OPAR may be superior to EPAR in the treatment of symptomatic PAA. A consideration of OPAR as first line definitive treatment for symptomatic PAA patients who are good surgical candidates is suggested.

Impact of Frailty on Postoperative Outcomes in Patients Undergoing TransCarotid Artery Revascularization (TCAR).

BACKGROUND: Frailty is a clinical syndrome characterized by a reduction in metabolic reserves leading to increased susceptibility to adverse outcomes following invasive surgical interventions. The 5-item modified frailty index (mFI-5) validated in prior studies has shown high predictive accuracy for all surgical specialties, including vascular procedures. In this study, we aim to utilize the mFI-5 to predict outcomes in Transcarotid Revascularization (TCAR). METHODS: All patients who underwent TCAR from November 2016 to April 2021 in the Vascular Quality Initiative (VQI) Database were included. The mFI-5 was calculated as a cumulative score divided by 5 with 1 point each for poor functional status, presence of diabetes, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and hypertension. Patients were stratified into two groups based on prior studies: low mFI-5 (0.6) and high (≥0.6). Primary outcomes included in-hospital death, extended length of postoperative stay (>1 day), and nonhome discharge. Secondary outcomes included in-hospital stroke, transient ischemic attack (TIA), myocardial infarction (MI), a composite endpoint of stroke/death, stroke/TIA, and stroke/death/MI. Univariate and multivariable logistic regression were used to assess the association between mFI-5 and postoperative outcomes. Secondary analysis stratified by symptomatic status was performed. RESULTS: Out of the 17,983 patients who underwent TCAR, 4526(25.2%) had mFI-5 score of ≥0.6 and considered clinically frail. Compared to the nonfrail group, frail patients were more likely to be female (38.7% vs. 35.6%, P < 0.001), have poor functional status (43.6 vs. 8.3%, P < 0.001), and present with significant comorbidities, including diabetes (75.3% vs. 26.1%, P < 0.001), hypertension (98.9% vs. 88.5%, P < 0.001), CHF (52.2% vs. 5.6, P < 0.001), and COPD (60.3% vs. 14.2%, P < 0.001). They were also more likely to be active smokers (25.4% vs. 20.4%, P < 0.001) and symptomatic prior to intervention (28.7% vs. 25.3%, P < 0.001). On univariate analysis, frail patients were at significantly higher risk to experience adverse outcomes, including in-hospital mortality, TIA, MI, stroke/death, stroke/TIA, stroke/death/MI, discharge to nonhome facility, and extended LOS. After adjusting for potential confounders, frail patients remained at significantly higher risk of in-hospital mortality [aOR 2.26(1.41,3.61), P = 0.001], TIA [aOR 1.65(1.08, 2.54), P = 0.040], nonhome discharge [aOR 1.99(1.71,2.32) P < 0.001], and extended LOS [aOR 1.41(1.27, 1.55) P < 0.001]. On further stratified analysis based on symptomatic status, the increased risk of stroke/death, TIA, and death was observed only in symptomatic patients. CONCLUSIONS: Modified Frailty Index is a reliable tool that can be used to identify high-risk patients for TCAR prior to intervention. This could help vascular surgeons, patients, and families in informed decision making to further optimize perioperative care and medical management in frail patients.

Eating habits are associated with subjective sleep quality outcomes among university students: findings of a cross-sectional study.

PURPOSE: This study investigated the relationships between eating habits and sleep quality among university students. METHODS: In a cross-sectional study, university students completed a self-report questionnaire to assess eating habits and meal timing. We assessed subjective sleep quality using the Pittsburgh Sleep Quality Index (PSQI) questionnaire and examined the associations between eating habits and overall sleep quality and its components. RESULTS: Four hundred ninety-eight students participated in the study. Students who used to skip breakfast, ate late-night snacks, and replaced meals with snacks were at 1.20 times, 1.24 times, and 1.25 times higher likelihood of having poor overall sleep quality, respectively. Multiple logistic regression analysis showed that skipping breakfast (r = - 0.111, P = 0.007), late-night snacks (r = - 0.109, P = 0.007), replacing meals with snacks (r = - 0.126, P = 0.002), and irregular mealtimes (r = - 0.094, P = 0.018) were the best correlates with poor sleep quality. After adjustment to demographic variables, replacing meals with snacks followed by skipping breakfast were the best independent associations with poor sleep quality by the PSQI. CONCLUSIONS: Eating habits and meal timing were significantly associated with sleep quality. We speculate that healthy eating habits may lead to improved sleep quality and sleep components among university students.