Dawn-to-dusk dry fasting decreases circulating inflammatory cytokines in subjects with increased body mass index.

Background: The circadian rhythm involves numerous metabolic processes, including sleep/awakening, body temperature regulation, hormone secretion, hepatic function, cellular plasticity, and cytokine release (inflammation), that appear to have a dynamic relationship with all the processes above. Studies have linked various cytokines to the chronic state of low-grade inflammation and oxidative stress in obesity. Dawn-to-dusk dry fasting (DDDF) could alleviate the adverse effects of obesity by decreasing inflammation. This study examined the effects of DDDF on circulating inflammatory cytokines in subjects with increased body mass index (BMI). Methods: The current observational prospective study included adult subjects with a BMI equal to or greater than 25 kg/m2 who practiced the annual religious 30-day DDDF. Individuals with significant underlying medical conditions were excluded to limit confounding factors. All subjects were evaluated within two weeks before 30-day DDDF, within the fourth week of 30-day DDDF, and within two weeks after 30-day DDDF. Multiple cytokines and clinical health indicators were measured at each evaluation. Results: Thirteen subjects (10 men and three women) with a mean age of 32.9 years (SD = 9.7 years) and a mean BMI of 32 kg/m2 (SD = 4.6 kg/m2) were included. An overall associated decrease in the levels of multiple cytokines with DDDF was observed. A significant decrease in the mean interleukin 1 beta level was observed within the fourth week of 30-day DDDF (P = 0.045), which persisted even after the fasting period (P = 0.024). There was also a significant decrease in the mean levels of interleukin 15 (IL-15) (P = 0.014), interleukin 1 receptor antagonist (P = 0.041), macrophage-derived chemokine (MDC) (P = 0.013), and monokine induced by interferon gamma/chemokine (C-X-C motif) ligand 9 (P = 0.027) within the fourth week of 30-day DDDF and in the mean levels of fibroblast growth factor 2 (P = 0.010), interleukin 12 p40 subunit (P = 0.038), interleukin 22 (P = 0.025) and tumor necrosis factor alpha (P = 0.046) within two weeks after 30-DDDF. In terms of anthropometric parameters, there was a decrease in mean body weight (P = 0.032), BMI (P = 0.028), and hip circumference (P = 0.007) within the fourth week of 30-day DDDF and a decrease in mean weight (P = 0.026), BMI (P = 0.033) and hip circumference (P = 0.016) within two weeks after 30-day DDDF compared with the levels measured within two weeks before 30-day DDDF. Although there was no significant correlation between changes in weight and changes in circulating inflammatory cytokines, there was a significant positive correlation between changes in waist circumference and changes in specific inflammatory cytokines (e.g., IL-15, MDC, platelet-derived growth factor, soluble CD40L, vascular endothelial growth factor A) within the fourth week of 30-day DDDF and/or two weeks after 30-day DDDF. A significant decrease in mean average resting heart rate within the fourth week of 30-day DDDF was also observed (P = 0.023), and changes between average resting heart rate and changes in interleukin-8 levels within the fourth week of 30-day DDDF compared with baseline levels were positively correlated (r = 0.57, P = 0.042). Conclusion: DDDF appears to be a unique and potent treatment to reduce low-grade chronic inflammation caused by obesity and visceral adiposity. Further studies with more extended follow-up periods are warranted to investigate the long-term anti-inflammatory benefits of DDDF in individuals with increased BMI.

Harnessing physical activity monitoring and digital biomarkers of frailty from pendant based wearables to predict chemotherapy resilience in veterans with cancer.

This study evaluated the use of pendant-based wearables for monitoring digital biomarkers of frailty in predicting chemotherapy resilience among 27 veteran cancer patients (average age: 64.6 ± 13.4 years), undergoing bi-weekly chemotherapy. Immediately following their first day of chemotherapy cycle, participants wore a water-resistant pendant sensor for 14 days. This device tracked frailty markers like cadence (slowness), daily steps (inactivity), postural transitions (weakness), and metrics such as longest walk duration and energy expenditure (exhaustion). Participants were divided into resilient and non-resilient groups based on adverse events within 6 months post-chemotherapy, including dose reduction, treatment discontinuation, unplanned hospitalization, or death. A Chemotherapy-Resilience-Index (CRI) ranging from 0 to 1, where higher values indicate poorer resilience, was developed using regression analysis. It combined physical activity data with baseline Eastern Cooperative Oncology Group (ECOG) assessments. The protocol showed a 97% feasibility rate, with sensor metrics effectively differentiating between groups as early as day 6 post-therapy. The CRI, calculated using data up to day 6 and baseline ECOG, significantly distinguished resilient (CRI = 0.2 ± 0.27) from non-resilient (CRI = 0.7 ± 0.26) groups (p < 0.001, Cohen's d = 1.67). This confirms the potential of remote monitoring systems in tracking post-chemotherapy functional capacity changes and aiding early non-resilience detection, subject to validation in larger studies.

Development of a Sensor Technology to Objectively Measure Dexterity for Cardiac Surgical Proficiency.

BACKGROUND: Technical skill is essential for good outcomes in cardiac surgery. However, no objective methods exist to measure dexterity while performing surgery. The purpose of this study was to validate sensor-based hand motion analysis (HMA) of technical dexterity while performing a graft anastomosis within a validated simulator. METHODS: Surgeons at various training levels performed an anastomosis while wearing flexible sensors (BioStamp nPoint, MC10 Inc) with integrated accelerometers and gyroscopes on each hand to quantify HMA kinematics. Groups were stratified as experts (n = 8) or novices (n = 18). The quality of the completed anastomosis was scored using the 10 Point Microsurgical Anastomosis Rating Scale (MARS10). HMA parameters were compared between groups and correlated with quality. Logistic regression was used to develop a predictive model from HMA parameters to distinguish experts from novices. RESULTS: Experts were faster (11 ± 6 minutes vs 21 ± 9 minutes; P = .012) and used fewer movements in both dominant (340 ± 166 moves vs 699 ± 284 moves; P = .003) and nondominant (359 ± 188 moves vs 567 ± 201 moves; P = .02) hands compared with novices. Experts' anastomoses were of higher quality compared with novices (9.0 ± 1.2 MARS10 vs 4.9 ± 3.2 MARS10; P = .002). Higher anastomosis quality correlated with 9 of 10 HMA parameters, including fewer and shorter movements of both hands (dominant, r = -0.65, r = -0.46; nondominant, r = -0.58, r = -0.39, respectively). CONCLUSIONS: Sensor-based HMA can distinguish technical dexterity differences between experts and novices, and correlates with quality. Objective quantification of hand dexterity may be a valuable adjunct to training and education in cardiac surgery training programs.

Potential applications of artificial intelligence and machine learning on diagnosis, treatment, and outcome prediction to address health care disparities of chronic limb-threatening ischemia.

Chronic limb-threatening ischemia (CLTI) is the most advanced form of peripheral artery disease. CLTI has an extremely poor prognosis and is associated with considerable risk of major amputation, cardiac morbidity, mortality, and poor quality of life. Early diagnosis and targeted treatment of CLTI is critical for improving patient's prognosis. However, this objective has proven elusive, time-consuming, and challenging due to existing health care disparities among patients. In this article, we reviewed how artificial intelligence (AI) and machine learning (ML) can be helpful to accurately diagnose, improve outcome prediction, and identify disparities in the treatment of CLTI. We demonstrate the importance of AI/ML approaches for management of these patients and how available data could be used for computer-guided interventions. Although AI/ML applications to mitigate health care disparities in CLTI are in their infancy, we also highlighted specific AI/ML methods that show potential for addressing health care disparities in CLTI.

Frailty in People with Chronic Limb Threatening Ischemia and Diabetes-Related Foot Ulcers: A Systematic Review.

BACKGROUND: Frailty represents a state of multisystem impairment that may adversely impact people presenting with chronic limb-threatening ischemia (CLTI) and diabetes-related foot ulcers (DFUs). The aim of this systematic review was to explore the association between frailty and outcomes from CLTI and DFUs. METHODS: We performed a systematic literature search of electronic databases to find studies using a validated measure of frailty in individuals with CLTI and/or DFUs. The primary outcomes were the impact of frailty on the severity of initial clinical presentation and unfavorable follow-up outcomes including readmissions, major limb amputation, cardiovascular events, revascularization, and wound healing. RESULTS: Ten cohort studies were included. Two studies had a low risk of bias, 1 was unable to be assessed, 5 had moderate risk of bias, and 2 high risk of bias. The prevalence of frailty in people presenting with CLTI ranged from 27% to 88% and was 71% in people with DFUs. The presence of frailty in both people with CLTI and DFUs was associated with substantially increased severity at presentation (severity of ischemia and tissue loss) and poorer outcomes at follow-up (risk of readmission, limb amputation, and all-cause mortality). CONCLUSIONS: The presence of frailty in both people with CLTI and DFUs is likely associated with substantially higher complexity at presentation followed by a greater risk for readmission, amputation, and death during follow-up. Heterogeneity in the tools used to screen for frailty, poor definition of frailty, and unclear evaluation of exposure and outcomes limit further interpretation of findings.

Pilot Study for Correlation of Heart Rate Variability and Dopamine Transporter Brain Imaging in Patients with Parkinsonian Syndrome.

BACKGROUND: Parkinsonian syndrome (PS) is a broad category of neurodegenerative movement disorders that includes Parkinson disease, multiple system atrophy (MSA), progressive supranuclear palsy, and corticobasal degeneration. Parkinson disease (PD) is the second most common neurodegenerative disorder with loss of dopaminergic neurons of the substantia nigra and, thus, dysfunction of the nigrostriatal pathway. In addition to the motor symptoms of bradykinesia, rigidity, tremors, and postural instability, nonmotor symptoms such as autonomic dysregulation (AutD) can also occur. Heart rate variability (HRV) has been used as a measure of AutD and has shown to be prognostic in diseases such as diabetes mellitus and cirrhosis, as well as PD. I-123 ioflupane, a gamma ray-emitting radiopharmaceutical used in single-photon emission computed tomography (SPECT), is used to measure the loss of dopaminergic neurons in PD. Through the combination of SPECT and HRV, we tested the hypothesis that asymmetrically worse left-sided neuronal loss would cause greater AutD. METHODS: 51 patients were enrolled on the day of their standard of care I-123 ioflupane scan for the work-up of possible Parkinsonian syndrome. Demographic information, medical and medication history, and ECG data were collected. HRV metrics were extracted from the ECG data. I-123 ioflupane scans were interpreted by a board-certified nuclear radiologist and quantified by automated software to generate striatal binding ratios (SBRs). Statistical analyses were performed to find correlations between the HRV and SPECT parameters. RESULTS: 32 patients were excluded from the final analysis because of normal scans, prior strokes, cardiac disorders and procedures, or cancer. Abnormal I-123 ioflupane scans were clustered using T-SNE, and one-way ANOVA was performed to compare HRV and SBR parameters. The analysis was repeated after the exclusion of patients taking angiotensin-converting enzyme inhibitors, given the known mechanism on autonomic function. Subsequent analysis showed a significant difference between the high-frequency domains of heart rate variability, asymmetry of the caudate SBR, and putamen-to-caudate SBR. CONCLUSION: Our results support the hypothesis that more imbalanced (specifically worse left-sided) neuronal loss results in greater AutD.

The Application of Digital Frailty Screening to Triage Nonhealing and Complex Wounds.

OBJECTIVE: We investigated the association between the complexity of diabetic foot ulcers (DFUs) and frailty. RESEARCH DESIGN AND METHODS: Individuals (n = 38) with Grade 2 Wagner DFU were classified into 3 groups based on the Society for Vascular Surgery risk-stratification for major limb amputation as Stage 1 at very low risk (n = 19), Stage 2 at low risk (n = 9), and Stage 3 to 4 at moderate-to-high risk (n = 10) of major limb amputation. Frailty status was objectively assessed using a validated digital frailty meter (FM). The FM works by quantifying weakness, slowness, rigidity, and exhaustion over a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of frailty. Skin perfusion pressure (SPP), albumin, and tissue oxygenation level (SatO2) were also measured. One-way analysis of variance (ANOVA) was used to identify group effect for wound complexity. Pearson's correlation coefficient was used to assess the associations with frailty and clinical endpoints. RESULTS: Frailty index was higher in Stage 3 and 4 as compared to Stage 1 (d = 1.4, P < .01) and Stage 2 (d = 1.2, P < .01). Among assessed frailty phenotypes, exhaustion was correlated with SPP (r = -0.63, P < .01) and albumin (r = -0.5, P < .01). CONCLUSION: Digital biomarkers of frailty may predict complexity of DFU and thus triage individuals who can be treated more simply in their primary clinic versus higher risk patients who require prompt referral to multidisciplinary, more complex care.

Improvement of Disability in Neurogenic Thoracic Outlet Syndrome by Robotic First Rib Resection.

BACKGROUND: Robotic transthoracic first rib resection (R-FRR) has advantages over traditional approaches; however, its impact on postoperative neurogenic thoracic outlet syndrome (nTOS) outcomes is unknown. Our primary objective was to determine improvement of patient-reported outcome measures (PROMs) of pain and disability after R-FRR in nTOS. Our secondary objective was to compare improvement of patient-reported pain between R-FRR and supraclavicular FRR (SC-FRR) in nTOS. METHODS: We queried a prospectively maintained, single-surgeon, single-institution database for patients with nTOS undergoing R-FRR or SC-FRR with available preoperative and postoperative PROMs. PROMs included the Disability of the Arm, Hand, and Shoulder (DASH) questionnaire and visual analog scale (VAS) for pain. RESULTS: Cohort 1 included 37 patients (32 women) undergoing 40 R-FRRs, with an average age of 36 years. Preoperative VAS and DASH (6.0 and 64.2, respectively) improved significantly at the first (2.8 and 35.0; P < .001 for both) and second postoperative visits (1.4 and 30.2; P < .01 for both) which occurred at 2.6 and 15.3 weeks, respectively. Cohort 2 included 57 R-FRRs performed in 53 patients and 35 SC-FRRs performed in 34 patients. The R-FRR and SC-FRR groups did not significantly differ in sex, age, hand dominance, TOS laterality, or preoperative VAS. At the first postoperative visit (2.4 weeks), R-FRR was associated with lower VAS scores (P = .023) and greater VAS improvement than SC-FRR (53% and 27% decrease, respectively; P = .008). CONCLUSIONS: R-FRR results in significant improvement in disability and pain in nTOS and may have a greater impact on patient-reported pain than SC-FRR in the early postoperative period.

Digital Biomarkers for the Objective Assessment of Disability in Neurogenic Thoracic Outlet Syndrome.

Neurogenic thoracic outlet syndrome (nTOS) is a musculoskeletal disorder in which compression of the brachial plexus between the scalene muscles of the neck and the first rib results in disabling upper extremity pain and paresthesia. Currently there are no objective metrics for assessing the disability of nTOS or for monitoring response to its therapy. We aimed to develop digital biomarkers of upper extremity motor capacity that could objectively measure the disability of nTOS using an upper arm inertial sensor and a 20-s upper extremity task that provokes nTOS symptoms. We found that digital biomarkers of slowness, power, and rigidity statistically differentiated the affected extremities of patients with nTOS from their contralateral extremities (n = 16) and from the extremities of healthy controls (n = 13); speed and power had the highest effect sizes. Digital biomarkers representing slowness, power, and rigidity correlated with patient-reported outcomes collected with the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and the visual analog scale of pain (VAS); speed had the highest correlation. Digital biomarkers of exhaustion correlated with failure of physical therapy in treating nTOS; and digital biomarkers of slowness, power, and exhaustion correlated with favorable response to nTOS surgery. In conclusion, sensor-derived digital biomarkers can objectively assess the impairment of motor capacity resultant from nTOS, and correlate with patient-reported symptoms and response to therapy.

The detrimental association between fear of falling and motor performance in older cancer patients with chemotherapy-induced peripheral neuropathy.

BACKGROUND: Cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) are at increased risk of falls and developing fear of falling (FoF). Although FoF may continue to impair motor performance and increase the risk of falling even further, this association remains unexplored in CIPN. RESEARCH QUESTION: Does high FoF in patients with CIPN further deteriorate motor performance beyond the impairment from CIPN-related sensory deficits? METHODS: In this secondary analysis of data collected from two clinical trials, gait parameters during habitual walking condition and postural sway parameters during 30-second quiet standing (eye-open and eyes-closed) were compared among older participants (≥ 65 years) with CIPN and high FoF (CIPN FoF+; n=16), older participants with CIPN and low FoF (CIPN FoF-; n=19) and normal older controls (i.e., non-cancer, non-diabetic, non-neurologic, and non-orthopedic; n=16). We measured gait and postural sway parameters using wearable sensors (BioSensics, Newton, MA, USA), and FoF severity using the Falls Efficacy Scale-International. RESULTS: The largest between-group differences were found in gait speed. The CIPN FoF + group had significantly slower gait speed (0.78 ± 0.21 m/s) than the CIPN FoF- (0.93 ± 0.17 m/s) and normal control groups (1.17 ± 0.13 m/s) (all p < .05; effect sizes = 0.79 and 2.23, respectively). We found a significant association between gait speed and FoF severity (R2 = 0.356; p < .001) across all participants with CIPN. Among participants with CIPN, no significant differences in postural sway parameters were found between the CIPN FoF+and CIPN FoF- groups. SIGNIFICANCE: Our results suggest that gait performance further deteriorates in patients with CIPN and high FoF beyond the impairment from CIPN-related sensory deficits. Our results also suggest further research is needed regarding FoF, and fall risk, as FoF is a simple tool that healthcare providers can use in clinical practice.

Dosing Activity and Return to Preulcer Function in Diabetes-Related Foot Ulcer Remission.

Diabetes-related foot ulcers are a leading cause of global morbidity, mortality, and health-care costs. People with a history of foot ulcers have a diminished quality of life attributed to limited walking and mobility. One of the largest concerns is ulceration recurrence. Approximately 40% of patients with ulcerations will have a recurrent ulcer in the year after healing, and most occur in the first 3 months after wound healing. Hence, this period after ulceration is called "remission" due to this risk of reulceration. Promoting and fostering mobility is an integral part of everyday life and is important for maintaining good physical health and health-related quality of life for all people living with diabetes. In this short perspective, we provide recommendations on how to safely increase walking activity and facilitate appropriate off-loading and monitoring in people with a recently healed foot ulcer, foot reconstruction, or partial foot amputation. Interventions include monitored activity training, dosed out in steadily increasing increments and coupled with daily skin temperature monitoring, which can identify dangerous "hotspots" prone to recurrence. By understanding areas at risk, patients are empowered to maximize ulcer-free days and to enable an improved quality of life. This perspective outlines a unified strategy to treat patients in the remission period after ulceration and aims to provide clinicians with appropriate patient recommendations based on best available evidence and expert opinion to educate their patients to ensure a safe transition to footwear and return to activity.

Harnessing digital health to objectively assess cancer-related fatigue: The impact of fatigue on mobility performance.

OBJECTIVE: Cancer-related fatigue (CRF) is highly prevalent among cancer survivors, which may have long-term effects on physical activity and quality of life. CRF is assessed by self-report or clinical observation, which may limit timely diagnosis and management. In this study, we examined the effect of CRF on mobility performance measured by a wearable pendant sensor. METHODS: This is a secondary analysis of a clinical trial evaluating the benefit of exercise in cancer survivors with chemotherapy-induced peripheral neuropathy (CIPN). CRF status was classified based on a Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) score ≤ 33. Among 28 patients (age = 65.7±9.8 years old, BMI = 26.9±4.1kg/m2, sex = 32.9%female) with database variables of interest, twenty-one subjects (75.9%) were classified as non-CRF. Mobility performance, including behavior (sedentary, light, and moderate to vigorous activity (MtV)), postures (sitting, standing, lying, and walking), and locomotion (e.g., steps, postural transitions) were measured using a validated pendant-sensor over 24-hours. Baseline psychosocial, Functional Assessment of Cancer Therapy-General (FACT-G), Falls Efficacy Scale-International (FES-I), and motor-capacity assessments including gait (habitual speed, fast speed, and dual-task speed) and static balance were also performed. RESULTS: Both groups had similar baseline clinical and psychosocial characteristics, except for body-mass index (BMI), FACT-G, FACIT-F, and FES-I (p<0.050). The groups did not differ on motor-capacity. However, the majority of mobility performance parameters were different between groups with large to very large effect size, Cohen's d ranging from 0.91 to 1.59. Among assessed mobility performance, the largest effect sizes were observed for sedentary-behavior (d = 1.59, p = 0.006), light-activity (d = 1.48, p = 0.009), and duration of sitting+lying (d = 1.46, p = 0.016). The largest correlations between mobility performance and FACIT-F were observed for sitting+lying (rho = -0.67, p<0.001) and the number of steps per day (rho = 0.60, p = 0.001). CONCLUSION: The results of this study suggest that sensor-based mobility performance monitoring could be considered as a potential digital biomarker for CRF assessment. Future studies warrant evaluating utilization of mobility performance to track changes in CRF over time, response to CRF-related interventions, and earlier detection of CRF.

Utilization of Flexible-Wearable Sensors to Describe the Kinematics of Surgical Proficiency.

BACKGROUND: Traditional assessment (e.g., checklists, videotaping) for surgical proficiency may lead to subjectivity and does not predict performance in the clinical setting. Hand motion analysis is evolving as an objective tool for grading technical dexterity; however, most devices accompany with technical limitations or discomfort. We purpose the use of flexible wearable sensors to evaluate the kinematics of surgical proficiency. METHODS: Surgeons were recruited and performed a vascular anastomosis task in a single institution. A modified objective structured assessment of technical skills (mOSATS) was used for technical qualification. Flexible wearable sensors (BioStamp RCTM, mc10 Inc., Lexington, MA) were placed on the dorsum of the dominant hand (DH) and nondominant hand (nDH) to measure kinematic parameters: path length (Tpath), mean (Vmean) and peak (Vpeak) velocity, number of hand movements (Nmove), ratio of DH to nDH movements (rMov), and time of task (tTask) and further compared with the mOSATS score. RESULTS: Participants were categorized as experts (n = 12) and novices (n = 8) based on a cutoff mean mOSATS score. Significant differences for tTask (P = 0.02), rMov (P = 0.07), DH Tpath (P = 0.04), Vmean (P = 0.07), Vpeak (P = 0.04), and nDH Nmove (P = 0.02) were in favor of the experts. Overall, mOSATS had significant correlation with tTask (r = -0.69, P = 0.001), Nmove of DH (r = -0.44, P = 0.047) and nDH (r = -0.66, P = 0.001), and rMov (r = 0.52, P = 0.017). CONCLUSIONS: Hand motion analysis evaluated by flexible wearable sensors is feasible and informative. Experts utilize coordinated two-handed motion, whereas novices perform one-handed tasks in a hastily jerky manner. These tendencies create opportunity for improvement in surgical proficiency among trainees.

Safety of robotic first rib resection for thoracic outlet syndrome.

OBJECTIVES: Robotic first rib resection (R-FRR) is an emerging approach in the field of thoracic outlet syndrome (TOS) that has technical advantages over traditional open approaches, including superior exposure of the first rib and freedom from retracting neurovascular structures. We set out to define the safety of R-FRR and compare it with that of the conventional supraclavicular approach (SC-FRR). METHODS: We queried a prospectively maintained, single-surgeon, single-institution database for all FRR operations performed for neurogenic TOS and venous TOS. Preoperative, intraoperative, and complications were compared between approaches. RESULTS: Seventy-two R-FRRs and 51 SC-FRRs were performed in 66 and 50 patients, respectively. These groups were not significantly different in age, body mass index, sex, type of TOS, or preoperative use of opioids. Length of procedure and hospital stay were not different between groups. Postoperative inpatient self-reported pain (visual analog scale score 4.7 vs 5.2; P = .049) and administered morphine milligram equivalents (37.5 vs 81.1 MME, P < .001) were significantly lower in R-FRR than SC-FRR. Brachial plexus palsy was less frequent after R-FRR than SC-FRR (1% vs 18%, P = .002) and resolved by 4 months in call cases. All cases were sensory palsies with the exception of 2 motor palsies, which were both in the SC-FRR group. In multivariable analyses, R-FRR was independently associated with less frequent total complications than SC-FRR (P = .002; odds ratio, 0.08; 95% confidence interval, 0.02-0.39). CONCLUSIONS: R-FRR provides outstanding exposure of the first rib and eliminates retraction of the brachial plexus and its consequences.

Association Between Wearable Device-Based Measures of Physical Frailty and Major Adverse Events Following Lower Extremity Revascularization.

Importance: Physical frailty is a key risk factor associated with higher rates of major adverse events (MAEs) after surgery. Assessing physical frailty is often challenging among patients with chronic limb-threatening ischemia (CLTI) who are often unable to perform gait-based assessments because of the presence of plantar wounds. Objective: To test a frailty meter (FM) that does not rely on gait to determine the risk of occurrence of MAEs after revascularization for patients with CLTI. Design, Setting, and Participants: This cohort study included 184 consecutively recruited patients with CLTI at 2 tertiary care centers. After 32 individuals were excluded, 152 participants were included in the study. Data collection was conducted between May 2018 and June 2019. Exposures: Physical frailty measurement within 1 week before limb revascularization and incidence of MAEs for as long as 1 month after surgery. Main Outcomes and Measures: The FM works by quantifying weakness, slowness, rigidity, and exhaustion during a 20-second repetitive elbow flexion-extension exercise using a wrist-worn sensor. The FM generates a frailty index (FI) ranging from 0 to 1; higher values indicate progressively greater severity of physical frailty. Results: Of 152 eligible participants (mean [SD] age, 67.0 [11.8] years; 59 [38.8%] women), 119 (78.2%) were unable to perform the gait test, while all could perform the FM test. Overall, 53 (34.9%), 58 (38.1%), and 41 (27.0%) were classified as robust (FI <0.20), prefrail (FI ≥0.20 to <0.35), or frail (FI ≥0.35), respectively. Within 30 days after surgery, 24 (15.7%) developed MAEs, either major adverse cardiovascular events (MACE; 8 [5.2%]) or major adverse limb events (MALE; 16 [10.5%]). Baseline demographic characteristics were not significantly different between frailty groups. In contrast, the FI was approximately 30% higher in the group that developed MAEs (mean [SD] score, 0.36 [0.14]) than those who were MAE free (mean [SD] score, 0.26 [0.13]; P = .001), with observed MAE rates of 4 patients (7.5%), 7 patients (12.1%), and 13 patients (31.7%) in the robust, prefrail and frail groups, respectively (P = .004). The FI distinguished individuals who developed MACE and MALE from those who were MAE free (MACE: mean [SD] FI score, 0.38 [0.16]; P = .03; MALE: mean [SD] FI score, 0.35 [0.13]; P = .004) after adjusting by body mass index. Conclusions and Relevance: In this cohort study, measuring physical frailty using a wrist-worn sensor during a short upper extremity test was a practical method for stratifying the risk of MAEs following revascularization for CLTI when the administration of gait-based tests is often challenging.

Endovascular Therapy in an "All-Comers" Risk Group for Chronic Limb-Threatening Ischemia Demonstrates Safety and Efficacy When Compared with the Established Performance Criteria Proposed by the Society for Vascular Surgery.

BACKGROUND: The aim of this study was to describe the applicability of the Society for Vascular Surgery (SVS) objective performance goals (OPGs) as a tool to evaluate results in the context of endovascular management of noncomplex and complex patients (i.e., end stage renal disease/history of prosthetic conduit) with chronic limb-threatening ischemia (CLTI). METHODS: Patients diagnosed with CLTI undergoing endovascular procedures from March 2016 to April 2017 were included, and medical records were examined. Patients were categorized as OPG risk (OPGR) and non-OPG risk (nOPGR) groups in accordance with the SVS performance criteria. We compared clinical events between the two groups and then further to the SVS OPGs. Thirty-day outcomes (safety) were major amputation (AMP), major adverse limb events (MALEs), and major adverse cardiovascular events (MACEs), and 1-year outcomes (efficacy) were limb salvage, MALE + 30-day perioperative death (MALE + POD), and survival. Mortality was demonstrated using Kaplan-Meier analysis. RESULTS: A total of 72 patients were included (OPGR = 58.3% vs. nOPGR = 41.7%). Mean follow-up was 20 months (range, 1-40 months). Retrograde pedal access was used in 65.2% of patients. The overall AMP rate was 2.7% (OPGR = 4.7%, nOPGR = 0%, P = 0.225, vs. SVS OPG<3%), MALE was 4.1% (OPGR = 7.1%, nOPGR = 0%, P = 0.135, vs. SVS OPG<8%), and MACE was 6.9% (OPGR = 2.3%, nOPGR = 13.3%, P = 0.071, vs. SVS OPG<8%). The limb salvage was 90.3% (OPGR = 88%, nOPGR = 93.3%, P = 0.46, vs. SVS OPG>84%), MALE + POD was 76.4% (OPGR = 78.6%, nOPGR = 73.4%, P = 0.606, vs. SVS OPG>71%), and survival was 77.7% (OPGR = 83.3%, nOPGR = 70%, P = 0.18, vs. SVS OPG>80%). CONCLUSIONS: The SVS OPGs set appropriate safety and efficacy standards as a bar for new technologies. In this series, endovascular therapy in all-comers exceeded the safety and efficacy endpoints proposed by the limited risk OPG panel.

Using wearables to screen motor performance deterioration because of cancer and chemotherapy-induced peripheral neuropathy (CIPN) in adults - Toward an early diagnosis of CIPN.

OBJECTIVE: An essential component for optimizing quality of life in adults with cancer is determining the degree to which therapy may negatively impact motor-performance, so that patients can maintain their quality of life and independence. This study examined whether instrumented gait and balance could determine the magnitude of deterioration in motor-performance from chemotherapy-induced peripheral neuropathy (CIPN). METHODS: We recruited 84 adults with cancer (age = 71.1 ±â€¯9.7 years old, BMI = 26.8 ±â€¯6.2 kg/m2, gender = 56%female) and 57 age-matched non-cancer patients (age = 69.5 ±â€¯9.8 years old, BMI = 27.1 ±â€¯6.0 kg/m2, gender = 79%female). Based on clinical screening, the group with cancer was classified into two groups: participants with CIPN (CIPN+) and without CIPN (CIPN-). Gait and balance were quantified using validated wearables. The Vibration Perception Threshold (VPT) test was used to stratify the CIPN+ group into mild (Mild-CIPN) and severe (Severe-CIPN) subgroups. RESULTS: All gait and balance parameters were deteriorated in the group with cancer compared to non-cancer group with the largest effects observed for stride-time (11%, Cohen's effect size d = 1.00, p < 0.001) and eyes-closed ankle sway (94%, d = 0.49, p = 0.001). The same trend was observed when the Severe-CIPN subgroup was compared to the Mild-CIPN. VPT correlates significantly with motor deterioration, with the largest correlation found in stride-time (Rho = 0.37, p = 0.007). Severe-CIPN subjects were significantly older and overall had more deterioration in the majority of motor-performance parameters after adjusting for age (p < 0.050). CONCLUSION: These results confirmed the negative impact of CIPN on motor-performance with the largest effects on ankle stability and stride-time. VPT is a predictor of motor deterioration and may be used to determine the severity of CIPN symptom.

Diffusion Tensor Imaging of the Ankle as a Possible Predictor of Chemotherapy Induced Peripheral Neuropathy: Pilot Study.

PURPOSE: Chemotherapy induced peripheral neuropathy (CIPN) is seen in up to 75% of treated cancer patients and can drastically limit their medical management and affect quality of life. Clinical and electrodiagnostic testing for CIPN have many pitfalls. Magnetic resonance neurography (MRN) is being increasingly used in the evaluation of peripheral nerves. Diffusion tensor imaging (DTI) shows promise in the workup of peripheral nerves. In this prospective pilot study, we investigated a possible relationship between DTI and peripheral neuropathy of the ankle and foot in cancer patients treated with chemotherapy. METHODS: Nine cancer patients with and without CIPN were clinically evaluated using vibratory perception threshold (VPT) testing. VPT score of >25Volts defined presence of CIPN. The posterior tibial nerve and branches in both feet were imaged using MRN and DTI. Fractional anisotropy (FA) and apparent diffusion coefficient (ADC) values were measured at the posterior tibial, medial plantar, and lateral plantar nerves. Measurements for the CIPN group were compared to without CIPN by VPT cutoff. Correlations and possible relationships between DTI parameters and CIPN were analyzed. RESULTS: A total of 16feet of 9 enrolled patients were imaged (9feet with CIPN and 7feet without CIPN). Average age was 60.6 ± 13.4 years (range: 33-74). Posterior tibial nerve ADC values were significantly lower than the medial plantar nerve ADC values in all feet (F = 3.50, P = 0.04). We found a correlation with FA and ADC values at specific nerve locations with CIPN, with the left medial plantar nerve FA value and left lateral plantar nerve ADC value demonstrating the strongest positive correlations (0.73 and 0.62, respectively). CONCLUSIONS: The use of DTI for assessing CIPN is challenging but promising. This pilot study provides preliminary data showing correlations between FA and ADC measurements with CIPN and potential utility of DTI as a predictive marker of onset and severity of CIPN in the ankle and foot, which could aid in preventive strategies. Larger, prospective DTI studies are needed to draw definitive conclusions. CLINICAL RELEVANCE: MRN with DTI shows promising results as a potential predictive marker of CIPN in the ankle and foot.

Pilot study evaluating the efficacy of exergaming for the prevention of deep venous thrombosis.

OBJECTIVE: Current prophylactic protocols fail to prevent deep venous thrombosis (DVT) in a significant minority of patients, and it remains one of the leading causes of preventable death. We therefore quantified the efficacy of novel game-based exercises (exergaming) to augment femoral venous parameters relative to ankle movement and muscle flexion. METHODS: Healthy volunteers were recruited to perform a series of ankle and foot exercises using a wireless foot sensor (LEGSys; BioSensics LLC, Watertown, Mass) to navigate a computer cursor sequentially on a screen to the center of 200 circular targets. A single ultrasound technician (W.A.M.) measured each patient's mean flow volume, peak flow velocity, mean flow velocity, and cross-sectional area of the right femoral vein at baseline and obtained immediate postexercise (PEX), 5-minute PEX, and 15-minute PEX measurements. Electromyography (EMG) was performed at baseline and during the exercise. Baseline demographics and medical and surgical comorbidities were also recorded. The primary end point was the difference between baseline and immediate PEX mean flow volume estimates. We secondarily explored the association of baseline characteristics and EMG measurements with femoral vein parameters. RESULTS: Fifteen healthy subjects (53% male; 28.1 ± 4.6 years) completed the exergaming task within a mean of 4 minutes, 2 ± 21 seconds. Immediately after exercise, the femoral vein mean flow volume, mean velocity, and peak systolic velocity increased by 49%, 53%, and 48%, respectively (P < .02 for each). Mean flow volume and velocity remained significantly elevated 5 minutes after exercise (P < .04 for each). Plantar flexion and dorsiflexion velocities and EMG frequency and intensity were not significantly correlated with PEX mean flow volume estimates (P > .05). Subgroup analysis revealed that women (P < .01) and Hispanics (P < .01) exhibited significantly slower PEX responses. Subjects with the largest improvements in mean flow volume had lower peak plantar flexion velocities (P < .01). CONCLUSIONS: Exergaming increases mean flow volume, mean flow velocity, and peak systolic velocity within the femoral vein by approximately 50% above baseline. Exergaming represents a novel and potentially attractive method of DVT prevention by augmenting femoral vein mean volume flow and capitalizing on biofeedback. Less forceful but more uniform contractions were found to be most effective at augmenting venous blood flow. Exergaming will require further validation in larger study bases, among patients at higher risk of DVT.